Loyola University Chicago School of Law, JD 2024
During the COVID-19 pandemic, the federal government and the Drug Enforcement Agency (DEA) temporarily lifted the Ryan Haight Act’s mandate that imposes federal prohibition on online prescribing of controlled substances. The DEA waived its in-person medical examination requirement and set forth different criteria for controlled substances. For as long as the duration of the public health emergency (which was extended through January of 2023 this month), a patient can receive a controlled substance prescription without an in-person examination if the communication was conducted in a two-way, audio-visual, and real-time interactive communication. Covid highlighted the increased use of telehealth and digital health platforms. However, as telehealth surged, public policy has failed to move at the same speed.
Telehealth companies under fire
The prescribing of controlled substances via telehealth companies has come under scrutiny for alleged deceptive practices. They have been cited for alleged improper prescribing of opioid and stimulant medication for patients purported to be suffering from a variety of conditions, but especially attention deficit-hyperactivity disorder (ADHD). Two mental health companies in particular – Cerebral and Done – have been singled out by the Department of Justice and are reported to be targets of investigations by the FTC and DEA.
The volume of prescriptions from these telehealth companies has become so large that major pharmacies – including Walmart, Walgreens, and CVS – stopped filling them because of concerns about shortages and improper practices. Aetna, Optum, and UnitedHealth Group already removed Cerebral as an in-network provider.
After the probe, Cerebral has stopped prescribing Adderall to new patients. In fact, Cerebral has just announced on October 24, that they would be cutting 20% of its current staff for operational efficiency as part of their transformation.
The next Opioid Crisis?
Some particularly concerned critics call the current surge in Adderall use the next opioid crisis. Others argue that just like the doctors who prescribed opioids were well-meaning, the doctors who prescribe ADHD drugs for adults are as well-meaning and trying to help patients improve focus and performance.
People who are concerned regarding the increase in Adderall prescriptions point out that there are alarming parallels with the beginning of the opioid crisis. In the 1990s and 2000s, healthcare providers started overprescribing opioid as painkillers. By 2010s, realizing its addictive nature, the industry reformulated opioid-heavy pills and changed its prescribing habits. However, patients had already become dependent and addicted to the drug. Not being able to lay hands on prescribed painkillers, patients turned to the black market for other illicit opiates. Overdoses and deaths naturally rose.
Similarly, the increased use and a nationwide shortage of Adderall has left patients who rely on the pills for attention-deficit/hyperactivity disorder scrambling to find alternative treatments. Uncertain whether they will be able to refill their medication, people are rationing pills, driving for hours, and begging their doctors for substitute medication.
Drug shortages are not uncommon; there are over 200 happening right now in the US alone. But this one requires special attention and particularly challenging for patients and providers because there is no readily available drug which serves as a substitute alternative. Without an ideal substitute, extended shortages may lead heavily dependent patients to stronger addictive drugs, quite possibly the ones available in the black market.
Conversely, there are voices that claim that the drug is not being overprescribed. Some argue that the new telehealth services have improved medical access for a new group of patients that previously did not have access due to lack of information and economic disparity. Cerebral has said their role has filled an important need for mental-health care services during a period demand outstrips supply. Many patients professed that the online health companies have helped them get needed mental-health treatment.
The Adderall demand and shortage
As a Schedule II controlled substance, Adderall is closely monitored by the DEA, which places strict caps on the number of pills produced by each company. A company simply cannot manufacture more to solve the backorders. Then there is demand that more than doubled between 2006 and 2016. Fueled by the pandemic, prescriptions increased 22 percent from 2019 to 2021 for patients between the ages of 22 and 44.
Four major Adderall producers (Epic Pharma, Rhodes, SpecGX and Teva) have amphetamine salts (Adderall) on backorder at a time of unprecedented demand for the ADHD drug. The FDA estimates the industry supply chain to normalize in March 2023.
On the other hand, the drug manufacturers don’t blame excess prescriptions for the short supply. According to Teva, US’s biggest producer of Adderall, the problem is due to labor shortages, which have caused delays in production and packaging. In part, the shortage is caused by the US government’s quota limit on the manufacturers, and the pharmaceutical firms advocate for a new limit increase.
Return to the original regulations under the Ryan Haight Act is unlikely
In March 2022, the American Psychiatric Association sent a letter to the DEA and HHS (Department of Health and Human Services) calling for the permanent removal of the in-person evaluation requirement for prescribing controlled substances via telemedicine. The White House first tried to make the DEA waiver permanent in June 2020 when they introduced the Telehealth Response for E-prescribing Addiction Therapy Services (TREATS) Act, which would give providers the ability to prescribe controlled substances without an in-person examination, thus making the DEA waiver permanent.
Alternatively, a new regulatory scheme for telehealth could be crafted. It could take a moderate approach, recognizing both the demonstrated need for providing telehealth and balancing it against the interest in protecting patients with safety protocols. For example, the DEA could create a registration process for telemedicine providers. This would enable the agency to implement oversight over the practitioners of telemedicine, rather than restricting the practice of telemedicine. In 2018, Congress directed the DEA to create this kind of program as part of the SUPPORT for Patients and Communities Act, but the program has yet to be established.
In the upcoming months, policymakers will determine the arc of telehealth’s growth trajectory in a broad sense as the country is slowly returning to normalcy.