Biden’s Proposal to Limit Online Prescribing Is a Raw Deal for the Most Vulnerable Patients
During the pandemic, it became possible for the first time for controlled substances such as buprenorphine, which is used to treat opiate addiction, and other controlled medications like Adderall and Xanax to be prescribed entirely via telemedicine. For millions of patients, this expansion was a boon that enabled them to receive much-needed treatment that would be otherwise inaccessible. Now, however, the Drug Enforcement Administration is proposing to change the rules to require prescribers to conduct an in-person medical evaluation in order to prescribe controlled medications beyond 30 days, as well as putting in place more stringent record-keeping requirements.
The DEA is framing the rule changes as a continuation of flexible care after the public health emergency ends, while simultaneously, in its telling, “providing effective controls against diversion.” In reality, these measures will interrupt the flexibility patients have come to enjoy by adding new hurdles and imposing new limits upon their ability to access these medications. In the context of the ongoing pandemic, in-person doctors’ visits remain dangerous for immunocompromised and disabled patients, as Covid-19 safety measures are dropped across the country. In a number of states, including New York—with California, Oregon, and Washington soon to follow—masks are no longer required even in health care settings, making in-person visits even riskier for these patients, for whom telemedicine opened doors to timely access to the pharmaceuticals they need to manage and maintain a continuity of care.
“Forcing people with disabilities who are immunocompromised or high-risk to choose between potential Covid exposure and forgoing vital medications is ableist and dangerous,” said Madeline T. Morcelle, a federal health policy attorney at the National Health Law Program.
The announcement raised alarm bells for many patients and mental health professionals. When Stephanie Cartwright-Karlsson—a licensed clinical social worker in Minnesota who has ADHD and is disabled—saw the news, she said, “My heart sank, and I had an immediate rush of anxiety and a sense of despair and hopelessness.”
“I immediately thought of my clients who have already been waiting months to see a psychiatrist for an ADHD medication consultation, many of whom are rural, disabled and/or immunocompromised,” she said, “The majority of these clients are scheduled for telehealth consults due to geographical location or concerns about in-person appointments being safe due to Covid.”
Cartwright-Karlsson herself has been using telehealth to access her ADHD medication during the pandemic. Getting to an in-person appointment would be onerous, requiring a three-hour round-trip journey by car, and she’s concerned about the safety risks. “While I have access to transportation and high-quality masks, not all of my clients are as fortunate,” she said. “I’m angry because as someone who has ADHD with physical health disabilities, under this proposal I would have to navigate additional barriers to secure medication that I need to function effectively and efficiently simply because my brain functions differently than others. It feels discriminatory and ableist.”
Rafael Boccamazzo, a clinical psychologist in the Seattle area who also has ADHD, also had trouble finding a prescriber for his condition. “I’m a psychologist with 15 years’ experience navigating the health system, who lives in a major metropolitan area, has reliable transportation, health insurance, and a flexible schedule at my job, but I couldn’t find an available, adult ADHD prescriber within 15 miles of me who took my insurance or who didn’t already have a six-month or longer wait list,” he said. “If I—with all of those advantages—couldn’t find a prescriber easily, how much worse is it going to be for others?”
But as Morcelle suggested, it could get much worse, as the DEA’s proposal would “deepen already unconscionable health inequities.” People who rely on these medications, who are often disabled or struggling with chronic illness, already face structural barriers to access care. “This is particularly true for Black, Indigenous, and other people of color, women, LGBTQI+ people, immigrants and their families, people in rural communities, and people with low incomes with these conditions.”
When it comes to medication-assisted treatment for opioid use disorder, a number of moves were made during the pandemic to make it more readily available to patients. In a much-needed and long overdue move, the DEA permitted buprenorphine to be prescribed via telemedicine for the first time during the pandemic—though the agency remains hamstrung by state and local regulations, which are often more stringent and biased against medication-assisted treatment, especially methadone. Biden’s omnibus bill, signed late last year, made huge strides in codifying access by nixing a requirement that prescribers have a special waiver to prescribe buprenorphine.
But the DEA proposal’s requirement for an in-person medical evaluation after 30 days will be “insurmountable” for many, as Morcelle put it. Many patients do not have access to a nearby provider, or have to wait longer than 30 days for an in-person appointment with a prescribing provider. This means that these patients face a potential interruption to their care, which could drive users into withdrawal amid a dangerous overdose crisis. People with opiate use disorder are more likely to be on Medicaid, further limiting their care options—not to mention the stigma they often face for their condition.
ADHD and other patients relying on controlled stimulant medications are already facing an extreme Adderall shortage, a huge barrier for seeking care. Many have found themselves spending hours calling pharmacies trying to procure their Adderall, sometimes just to get a couple of pills. Both Boccamazzo and Cartwright-Karlsson were able to switch to Vyvanse, another stimulant ADHD medication. It doesn’t work as well for Cartwright-Karlsson and is much more expensive if insurance decides not to cover it.
Other patients have also had to adjust, ration, and even skip doses—often managing their own dosage rather than doing so with guidance from a doctor, which carries significant risk. “Not being able to access their provider via telehealth could lead someone to make decisions about their mental health care without the input from their psychiatrist,” Cartwright-Karlsson warned. “I have had some clients stop or adjust their dosages of medications on their own when they haven’t been able to get an appointment with their psychiatrist, which can be dangerous for many individuals.”
Compounding that, there is a shortage of psychiatrists who treat ADHD in the first place, and many do not accept insurance due to low insurance reimbursement rates. This makes telehealth the only option for many patients, according to Jack Turban, a doctor and psychiatry professor at the University of California, San Francisco, who specializes in child and adolescent ADHD. Without insurance, a single visit to a child or adolescent psychiatrist costs hundreds of dollars. “While inappropriate prescribing of stimulants is a reasonable concern, this needs to be weighed against the fact that it’s extremely difficult for families to access mental health treatment for their children,” he said.
A spokesperson at the DEA declined to comment on the proposed rule changes, as they are not finalized and will undergo a public comment period through March 31. There has already been significant pushback to the proposal, including by the telehealth lobby. Morcelle added that “it is especially critical that the federal government hear from people with disabilities who will be affected,” before the proposal is finalized.
Rather than place more restrictions on increasingly desperate patients, exacerbating the issue at hand, the Food and Drug Administration could lift the artificial quotas it places on Adderall production and allow manufacturers to simply produce more of the drug. But it has already announced that production quotas for 2023 will not be increased, despite recent advocacy efforts by Virginia Congresswoman Abigail Spanberger. The DEA spokesperson suggested that manufacturing delays are holding up Adderall availability and that its production quotas are appropriate but can always be revisited throughout the year.
“The answer to a medication shortage that you helped to create is not to make access more difficult for people with disabilities,” said Morcelle.
Reluctance to increase quotas is undoubtedly in part due to fears around these drugs being prescribed inappropriately or in ways that facilitate abuse—the idea being that if prescriptions aren’t controlled, we could have another OxyContin situation. These concerns are real; in fact, two startups prescribing ADHD drugs and other controlled substances like Xanax, Done, and Cerebral are under investigation by the Justice Department. Cartwright-Karlsson agreed that these companies were not conducting a proper comprehensive ADHD evaluation for patients. “That is not a model I support, and I feel that it was dangerous and reckless,” she said.
But she believes that “the claim that people are being overprescribed ADHD medications misses the mark in significant ways.” She and other practitioners I spoke with believe that ADHD was, in fact, under- and misdiagnosed in the past, especially among adults and women. In addition, during the pandemic, more people sought out this type of care as they struggled with a lack of structure amid lockdown, she said.
“We need to worry about the young people who truly have ADHD and will go without treatment,” added Turban. “Untreated ADHD carries substantial risk, including the development of substance use disorders and falling behind academically, which can be extraordinarily difficult to overcome later.”
As more people are diagnosed with ADHD, it seems logical to increase the production of medications that treat the condition and speed up manufacturing. The Biden administration could work to improve the quality and flexibility of telehealth care, increase production of drugs in short supply, or advocate for more doctors, telehealth and in person, to prescribe buprenorphine.
As Boccamazzo suggested, “I would love to see the Biden administration expand access to ADHD training for licensed prescribers and diagnosticians. The more qualified practitioners we have locally to everyone, the better off we’ll all be, especially if those local practitioners also reliably accommodate the needs of immunocompromised and disabled patients.”
Especially in the context of our broken health care system, in which seeking care often feels like a battle royal between David and Goliath, in the form of insurance and pharmaceutical companies, limiting health care options in any way is the wrong approach.
“Improving quality of care is always a great goal,” said Boccamazzo. “But placing restrictions on avenues of care without expanding access to equal-quality care will ultimately hurt those who are already most vulnerable.”