Category: KB

US Senate News:

Source: United States Senator for Illinois Dick Durbin
10.22.24
In Letters to Pfizer and Eli Lilly, Durbin, Sanders, Welch, and Warren request details about whether the companies’ new advertising & telehealth schemes create conflicts of interest that steer patients toward particular medications
CHICAGO – U.S. Senate Majority Whip Dick Durbin (D-IL) sent a letter to the CEOs of Pfizer Inc. and Eli Lilly demanding answers about the pharmaceutical companies’ recent move to establish new direct-to-consumer (DTC) telehealth platforms.  These new arrangements steer patients toward particular medications and create the potential for inappropriate prescribing that can increase spending for federal health care programs. 
As Durbin notes in his letters, federal law, specifically the Anti-Kickback Statute, prohibits the willful payment of remuneration to induce patient referrals for Medicare or Medicaid-covered services or goods.  Durbin requested additional information about the nature of Pfizer and Eli Lilly’s contracts with their chosen telehealth platforms, including the characteristics of the medical evaluation and whether the telehealth providers are pressured to prescribe Pfizer or Eli Lilly medications.
Along with Durbin, the letters were also signed by U.S. Senators Bernie Sanders (I-VT), Peter Welch (D-VT), and Elizabeth Warren (D-MA) .
“Pfizer recently launched a new telehealth platform, PfizerForAll, that links patients interested in receiving specific medications with a health care provider who can virtually prescribe that medication…  We write to learn more about the financial relationship between Pfizer and its chosen telehealth prescribers, given the potential implications for the federal Anti-Kickback Statute (AKS),” the Senators began their letter to Pfizer.
The United States is one of only two countries in the world that permit DTC advertising of prescription drugs, in part because this practice has been shown to increase patient demand for advertised drugs and the likelihood of a patient receiving a prescription for that drug.  Pharmaceutical companies, including Pfizer, spend an estimated $6 billion annually on DTC advertising to boost patient demand for medications.  As a result, a small number of prescription drugs advertised on television accounted for 58 percent of Medicare’s overall spending on prescription drugs between 2016 and 2018. 
The Senators continued their letter, expressing his concern that Pfizer and Eli Lilly’s new telehealth platforms may be pressuring health care providers into prescribing their medications, which could violate federal law. 
“The launch of Pfizer’s new telehealth platform, similar to an existing platform for the virtual prescribing of Nurtec, raises questions about the nature of Pfizer’s relationship with its hired telehealth prescribers and the potential for inducement of prescriptions payable by federal health care programs,” the Senators wrote in their letter to Pfizer.
“After describing Pfizer’s medications and the benefit they can have for patients, Pfizer’s telehealth platform provides a link for patients to ‘talk to a doctor now’ and fill prescriptions via an online pharmacy.  This creates the impression that any patient interested in a particular medication can indeed receive it with just a few clicks, and the appearance of Pfizer’s approval that these chosen telehealth providers can ensure a patient receives the given medication,” the Senators wrote.
The U.S. Department of Health and Human Services’ Office of the Inspector General (HHS OIG) has been wary of telehealth platforms, issuing a Special Fraud Alert in 2022 to warn health care practitioners of specific risks of schemes involving telehealth platforms that “intentionally paid physicians … kickbacks to generate … prescriptions for medically unnecessary … medications, resulting in submission of fraudulent claims to Medicare [and] Medicaid.”  HHS OIG listed limited interaction with the purported patient, limited opportunity to review the patient’s medical records, and/or a directive to prescribe a preselected item, regardless of clinical appropriateness as potential fraudulent aspects of telehealth platforms’ arrangements with prescribers.
In their letter to Pfizer, the Senators points to a specific example of PfizerForAll engaging in behavior that HHS OIG warned 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 Senators wrote.
The Senators continued, “These concerns are underscored by statements by Pfizer’s chosen prescribing contractor—Populus—for its Nurtec migraine medication.  Populus’ co-founder claimed in reporting by STAT News that more than 90 percent of eligible patients receive a prescription for the brand of drug whose marketing they clicked on, further adding, ‘We’re driving prescriptions.’  Similarly, UpScriptHealth has advertised job openings to prescribers with the statement, ‘on average, providers can complete 6-10 visits an hour’ and by defining ‘a completed visit is either an approval or denial of prescription request,’ which raises concerns about the adequacy of the provider’s patient engagement, quality of medical review, and expected outcomes.”
The Senators concluded their letters to both Pfizer and Eli Lilly by requesting details about how the companies run their telehealth platforms and if patients are receiving adequate care rather than a hastily written prescription to a heavily-advertised medication produced by the pharmaceutical company.
Today’s letters are Durbin’s latest action in cracking down on excessive prescription drug advertising that can harm patients and increase prescription drug costs.  Last November, Durbin took to the Senate floor to request unanimous consent for his bipartisan Drug-price Transparency for Consumers (DTC) Act, a bill that would require price disclosures on advertisements for prescription drugs in order to empower patients and reduce excessive spending on medications.  Durbin also introduced the Protecting Patients from Deceptive Drug Ads Online Act, bipartisan legislation that would protect public health and close regulatory loopholes by having the Food and Drug Administration (FDA) address false and misleading prescription drug promotions by social media influencers and telehealth companies. 
In May, Durbin chaired a Senate Judiciary Committee hearing entitled “Ensuring Affordable & Accessible Medications: Examining Competition in the Prescription Drug Market.”  The hearing examined prescription drug prices, competition, and innovation, and how to ensure medications are accessible and affordable for American families.
In his role as Chair of the Judiciary Committee, Durbin also supported the advancement of a package of bills, which were reported unanimously out of Committee in February 2023, to lower prescription drug prices.  The package included Durbin’s Interagency Patent Coordination and Improvement Act, which establishes an interagency task force between the United States Patent and Trademark Office and FDA for purposes of sharing information and providing technical assistance with respect to patents.
A copy of the letter to Eli Lilly is available here.
A copy of the letter to Pfizer is available here and below:
October 21, 2024
Dear Mr. Bourla:
            Pfizer recently launched a new telehealth platform, PfizerForAll, that links patients interested in receiving specific medications with a health care provider who can virtually prescribe that medication.  This 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.  We write to learn more about the financial relationship between Pfizer and its chosen telehealth prescribers, given the potential implications for the federal Anti-Kickback Statute (AKS). 
            Direct-to-consumer (DTC) advertising of prescription drugs has been shown to increase both patient demand for specific medications and the likelihood of a patient receiving a prescription for that drug.  Pharmaceutical manufacturers like Pfizer spend an estimated $6 billion annually in DTC advertising to boost patient awareness and demand for advertised medications.  The U.S. is one of only two developed countries in the world that permits such health claims.  The American Medical Association has stated, “direct-to-consumer advertising inflates demand for new and expensive drugs, even when these drugs may not be appropriate.”
            A recent study found that more than two-thirds of drugs advertised on television were considered “low added value.”  This creates concern for taxpayers, as a review by the Government Accountability Office (GAO) found that the small number of prescription drugs advertised on television accounted for 58 percent of Medicare’s overall spending on prescription drugs between 2016-2018.  For example, these DTC advertisements helped to balloon Medicare spending on Pfizer’s Xeljanz to more than $886 million in 2022.
            Telehealth can help to address barriers to care, including by expanding access for patients facing transportation barriers, helping to overcome stigma, and identifying providers when there may be workforce shortages.  But those important aspects of care can be undermined without comprehensive services that ensure a thorough patient evaluation and follow-up, especially if there is any appearance of a conflict of interest for the treatment provider.
The launch of Pfizer’s telehealth platform, similar to an existing one for the virtual prescribing of Nurtec, raises questions about the nature of Pfizer’s relationship with its contracted telehealth prescribers and the potential for inducement of prescriptions payable by federal health programs.  The Department of Health and Human Services’ Office of the Inspector General (HHS OIG) warns, “as a physician, you are an attractive target for kickback schemes because you can be a source of referrals for … health care … suppliers.”  OIG adds, “many … companies want your patients’ business and would pay you to send that business their way.”
            After describing Pfizer’s medications and the benefit they can have for patients, Pfizer’s telehealth platform provides a link for patients to “talk to a doctor now” and fill prescriptions via an online pharmacy.  This creates the impression that any patient interested in a particular medication can indeed receive it with just a few clicks, and the appearance of Pfizer’s approval that these chosen telehealth providers can ensure a patient receives the given medication. 
In 2022, the HHS OIG issued a Special Fraud Alert to notify health care practitioners of the specific risks of schemes involving telehealth platforms that “intentionally paid physicians … kickbacks to generate … prescriptions for medically unnecessary … medications, resulting in submission of fraudulent claims to Medicare [and] Medicaid.”  According to the HHS OIG, fraudulent aspects of these arrangements for prescribers may include: limited interaction with the purported patient, limited opportunity to review the patient’s medical records, and/or a directive to prescribe a preselected item, regardless of clinical appropriateness.
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. 
These concerns are underscored by statements from Pfizer’s chosen prescribing contractor—Populus—for its Nurtec migraine medication.  Populus’ co-founder claimed in reporting by STAT News that more than 90 percent of eligible patients receive a prescription for the brand of drug whose marketing they clicked on, further adding, “We’re driving prescriptions.”  Similarly, UpScriptHealth has advertised job openings to prescribers with the statement, “on average, providers can complete 6-10 visits an hour” and by defining “a completed visit is either an approval or denial of prescription request,” which raises concerns about the adequacy of the provider’s patient engagement, quality of medical review, and expected outcomes.
To better understand the nature of Pfizer’s relationship with contracted telehealth prescribers, we request written responses to the following questions by November 25, 2024:
1.       Do Pfizer’s DTC advertisements for certain medications, including commercials on television or promotions on social media, direct consumers to PfizerForAll or the Nurtec/Populus page?
1.       How much has Pfizer spent on such advertisements in the most recent six-month period for which data is available?
2.       How much has Pfizer spent on disease awareness, continuing medical education activities, medical publications, patient advocacy/engagement, or other health promotion directed at prescribers or consumers for diseases related to medications listed on PfizerForAll or the Nurtec/Populus page in the most recent six-month period for which data is available?
2.       Are any forms of insurance excluded from eligibility or participation with PfizerForAll or the Nurtec/Populus page?  Please list which types of insurance are not eligible to participate.
3.       Does Pfizer direct, encourage, or educate UpScriptHealth- or Populus-affiliated health care providers to prescribe Pfizer’s medications?
4.       Did Pfizer share, consult, or communicate with UpScriptHealth or Populus in creating the “discussion guide” for patients to speak with their Pfizer-linked telehealth provider?
5.       What is the average duration of the virtual health care visit between an UpScriptHealth- or Populus-affiliated health care provider and a patient who is connected to them via Pfizer’s website? 
1.       After initially filling out information, are such visits always conducted via a video platform, or are there other options available?
6.       Do UpScriptHealth- or Populus-affiliated health care providers always review the medical history and records of a patient who is connected to them via Pfizer’s website?  If so, please describe in detail how those records are accessed.
7.       How does Pfizer set the compensation paid to its telehealth partners?  Please provide a copy of the terms of agreement between Pfizer and UpScriptHealth, and between Pfizer and Populus.
1.       Is Pfizer paying fair market value for the services of UpScriptHealth or Populus?
2.       Does Pfizer make a bonus payment to UpScriptHealth or Populus based on the number of prescriptions written, including refills?
3.       Does Pfizer contract with UpScriptHealth or Populus to furnish a certain number of prescriptions for certain medications?
4.       Would the UpScriptHealth- or Populus-affiliated health care provider have actual or constructive knowledge that a patient was referred to them via Pfizer’s telehealth platform?
5.       What metrics does Pfizer use to evaluate the performance of its contracts with UpScriptHealth and Populus and affiliated health care providers?
8.       What data is being provided by UpScriptHealth or Populus to Pfizer as part of these agreements?  Please list all fields or categories of data being provided to Pfizer, including patient information, consumer behavior information, and marketing outcomes information.
9.       What role, if any, does Pfizer play in collecting, defraying, or otherwise interacting with the co-pay that is associated with the provider consultation on Pfizer’s telehealth platforms?
10.   Based upon prescribing or claims data that Pfizer has access to, how many prescriptions for a Pfizer medication have UpScriptHealth- or Populus-affiliated health care providers written in the most recent 30-day period for which Pfizer has available information?
11.   What percentage of consumers who meet virtually with an UpScriptHealth- or Populus-affiliated health care provider receive a prescription for a Pfizer medication?
1.       What percentage of such consumers receive a prescription for a medication manufactured by another brand-name company?
2.       What percentage of such consumers receive a prescription for a generic medication?
3.       What percentage of such consumers receive no prescription?
12.   How much revenue has Pfizer generated from these telehealth platforms in the most recent 30-day period for which Pfizer has available information?
13.   Outside of the contract terms with UpScriptHealth or Populus, please provide a list of all payments by Pfizer to each health care provider that is linked to via PfizerForAll over the past 12-month period, including for “speaking,” “consulting,” or other goods, fees, or services.
Thank you for your attention to this matter.  We look forward to your response. 
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