06/25/2024
And this is why we have a stimulant shortage
On June 13th the U.S. Department of Justice (DOJ) announced a federal health care fraud indictment against the founder and CEO of Done Global Inc., as well as the company’s clinical president, alleging the individuals were conspiring to commit health care fraud, amongst other charges. The issue has put the currently waived in-person requirements related to controlled substance prescribing in the spotlight due to the fact that the company was focused around Adderall (which is a Schedule II controlled substance) and other stimulant prescribing via telehealth. As noted in the DOJ press release announcing the arrests, it is the Justice Department’s first criminal drug distribution prosecution related to a digital health company distributing controlled substances using telemedicine. Nevertheless, it is important that the telehealth component of the story not overshadow the fraud focus, since inappropriate prescribing can occur both in-person and via telehealth, as can inappropriate corporate profit-seeking. As Principal Deputy Assistant Attorney General Nicole M. Argentieri stated regarding the indictment, “As these charges make clear, corporate executives who put profit over the health and safety of patients – including by using technological innovation – will be held to account.”
The recent DOJ press release notes that the defendants are alleged to have “exploit[ed] telemedicine” and spent millions on deceptive social media advertising to provide “easy” access to Adderall and other stimulants – generating over $100 million in revenue and the prescribing of more than 40 million pills. The allegations are focused not on telehealth but rather on the use of an internet-based infrastructure to illegally distribute drug sales and conspiracy to distribute controlled substances. The company is also charged with conspiring to defraud insurers, including Medicare and Medicaid, and causing pharmacies to dispense potentially inappropriate medications to Done Global’s patients. Additionally, the defendants allegedly structured the Done platform to “push” addictive medications, such as by limiting information available to prescribers as well as limiting the amount of time designated for initial encounters. The platform also allegedly instructed providers to prescribe stimulants regardless of whether patients qualified for a prescription, included an auto-refill function to automatically request patient refills each month, and instituted a provider compensation structure that was based on volume while discouraging follow-up care.
Despite an understanding of the facts of the case, some concerned with “telehealth fraud” may conflate the company’s alleged actions with currently expanded telehealth policies to justify tightening telehealth access long-term. A recent Politico article (subscription required) on the case refers to the indictments as “major telehealth arrests”, noting they “come at a crucial time for industry” – and were in fact announced the same day that the DOJ’s Drug Enforcement Administration (DEA)’s proposed telemedicine prescribing rules reached the White House for review. When the DEA previously released their proposed long-term telemedicine prescribing policy, which maintained in-person prescribing requirements in most circumstances, they received nearly 40,000 comments with many advocates concerned that the policies could restrict the improved access afforded by telehealth and the relaxed temporary pandemic policies. In response, the DEA further extended pandemic policies, lifting restrictions on virtual prescribing and allowing prescriptions without an in-person visit through December 31, 2024 to allow more time to craft permanent policy. For more information, review CCHP’s Newsletter covering the DEA Telemedicine Extension (dated October 10, 2023). The permanent DEA rules are expected by this Fall, prior to the in-person requirement waiver expiring at the end of the year.
The DEA has also reportedly been investigating another direct-to-consumer (DTC) platform company, Cerebral, for questionable prescribing practices, and has previously raised concerns related to digital health companies potentially overprescribing. Consequently, these specific cases of DTC companies inappropriately prescribing may cause policymakers to seek a general return to in-person prescribing requirements for all individual providers. Even more concerning than the impact of these two cases on long-term telehealth prescribing policy, as well as highlighting the importance of access to care, is that those who were receiving such prescriptions through Done’s platform now potentially face losing care altogether. The same day the DOJ filed the recent indictment against Done’s executives, the Centers for Disease Control and Prevention issued a Health Alert Network (HAN) Health Advisory regarding the possible disruption of access to stimulant medications and increased risks for injury and overdose (as patients may feel forced to seek medications outside of the regulated health care system), potentially affecting as many as 50,000 Done patients. In addition, all this comes amidst a national drug shortage in prescription stimulants, including Adderall, which was announced by the Food and Drug Administration (FDA) in 2022. Done Global has posted a company statement on their website noting they disagree with the charges filed and will continue to operate to ensure stable care for their patients. A recent Centers for Medicare and Medicaid Services (CMS) newsletter highlights the Health Advisory disruption concerns as well as its recommendations to clinicians to assist patients that may have lost access.
While it may be easy to point blame toward relaxed telehealth prescribing regulations as the primary culprit behind the latest arrests, in reality there are multiple issues at play, and again, it warrants noting that fraud and inappropriate prescribing can occur via both in-person and telehealth visits. The burden of appropriate prescribing ultimately falls on the individual practitioner issuing the prescription, and their medical license will be on the line if they fail to adhere to the medical standard of care – which exists outside of the modality in which the care is provided. In addition, while states vary in their laws regarding the corporate practice of medicine, a company cannot dictate medical decisions that are in the purview of medical providers only. As can also be seen by the recent news around Amazon’s One Medical, patient safety concerns arise when individuals that are not medical providers or directly charged with a patient’s care get tasked with making medical determinations. In Amazon’s case, issues arose when call center contractors became responsible for triaging patient concerns and given their lack of medical training, were found to have not appropriately flagged caller concerns once the cases were reviewed by clinical providers. Whereas in the Done case, providers need to be aware of their own responsibilities to patient care and question company involvement in directing medical decision-making.
In 2022, the U.S. Department of Health and Human Services, Office of the Inspector General (OIG) released a fraud alert specific to questionable telemedicine company practices, including a number of suspect characteristics that could possibly indicate a heightened risk of fraud that providers should be aware of. OIG stated at the time that the fraud alert was not necessarily regarding telehealth itself, or providers utilizing telehealth, rather it was specific to potentially dubious arrangements with purported telemedicine companies (see the CCHP Newsletter on the OIG Fraud Alert (dated 7/26/22) for more information). As CCHP has covered in numerous newsletters, it is always important to clarify whether allegations of “telehealth fraud” are in fact “telefraud” (see CCHP Telefraud vs. Telehealth Newsletter (dated 10/5/21). In addition, it is important to note that there are differences between seeing your primary providers via telehealth versus accessing telehealth services via DTC platform companies (see CCHP’s Platform Therapy Newsletter (dated 6/4/24). These differences and details provide helpful context in understanding the specific circumstances applicable to the current case, showcasing that it is not necessarily representative of actual telehealth use as a whole – and should not necessarily be used to justify more general policy limitations across the entire telehealth landscape.
The foregoing serves as an important reminder that despite different policies, practice arrangements, and modalities in which care is provided, fraud is fraud, and providers still must be able to make decisions based on the appropriate standard of care for each individual patient regardless of potential cost and profit implications. Similarly, providers must make medical decisions regardless of what may be allowed under the law – meaning even if virtual prescribing is allowed, providers may determine an in-person visit is necessary in certain circumstances. For many patients, allowing medically necessary prescribing without an in-person visit may be appropriate and improve access to care. Therefore, the law should not arbitrarily prevent such determinations and access, instead it should allow medical providers that are typically in the best position to make those varying decisions to do so. Rather than legislate based on the actions of the few, policies should contemplate the full context of the circumstances and continue to focus on preserving access, trusting that the system in which providers operate remains capable of catching individuals potentially operating outside of the law.
For more information, please review the DOJ press release regarding the charges against Done Global’s executives.
