With an ongoing shortage of mental health providers, particularly in rural areas, requiring patients to see doctors in-person to get prescriptions for controlled drugs severely restricts access to care and could increase patient harm, telehealth leaders and doctors told officials at the Drug Enforcement Administration (DEA) on Tuesday.
"Ultimately, if in-person requirements are mandated for controlled medications, particularly Schedule 2 medications, simply as a means of diversion control, which is an important effort, it will lead to unnecessary delays in care and the prolonging of significant human suffering for legitimate patients seeking legitimate treatment from legitimate DEA registered providers," said Thomas Milam, M.D., a psychiatrist and chief medical officer at Iris Telehealth.
At the same time, requiring an arbitrary, one-time, in-person evaluation will not effectively prevent abuse or limit drug diversion nor when prescribed drugs are obtained or used illegally, Kyle Zebley, senior vice president, public policy at the American Telemedicine Association (ATA) and executive director of ATA Action, said during a DEA listening session Tuesday.
"We believe that a requirement that a patient see a clinician in person is not an effective control against diversion and instead simply limits access to legitimate healthcare," he told DEA officials. "During the COVID-19 public health emergency, DEA has used its emergency authority to waive the prior in-person requirements. This has enabled providers to safely prescribe controlled substances remotely using telemedicine, increasing access to clinically appropriate medications."
A recent Doximity survey of 1,200 physicians found that nearly 88% of doctors believe telemedicine increased patient access to healthcare, particularly among populations that may have faced barriers to care previously.
The DEA held a two-day listening session to inform the agency's regulations on prescribing controlled substances, such as Adderall or buprenorphine used to treat opioid use disorder, via telemedicine.
During the COVID-19 pandemic public health emergency, the DEA granted flexibilities for prescribing controlled substances remotely and waived a requirement, as mandated by the 2008 Ryan Haight Act, that an in-person visit occur prior to prescribing controlled drugs via telehealth.
In February, the DEA issued proposed rules that pulled back some of those flexibilities and reinstated strict limitations on the virtual prescribing of controlled substances. Under the proposed rule, Schedule 2 medications or narcotics would require (PDF) an in-person prescription. Schedule 3 or higher medications, including buprenorphine, can be prescribed for 30 days via telehealth but would require an in-person visit before a refill.
The Biden administration said at the time that the new rule seeks to provide safeguards to prevent online over-prescribing of controlled medications.
The DEA faced immediate and major backlash from doctors and telehealth groups. Many providers voiced concerns about patients' ability to obtain in-person appointments within 30 days.
In May, the agency said it would extend telehealth flexibilities that enabled clinicians to virtually prescribe controlled medications to their patients for another six months as it ironed out a more permanent policy.
The agency received a record 38,000 comments on its proposed telemedicine rules, according to DEA Administrator Anne Milgram. "We believe that it is among the highest number of comments we have gotten in the DEA's history. And we read every single one," she said at the start of the listening session on Tuesday.
"The DEA has been and remains committed to expanding access to telemedicine in a way that puts patients and their safety first," Milgram said. "That means a final set of rules that is simple to understand and apply, that reflects technological advancements and that is consistent with the lessons that we have all learned during the COVID public health emergency. And that also recognizes and understands the ongoing opioid epidemic."
She added, "As I say all the time here, eventually, we are all patients. And so this matters very much and doing this well matters very much to all of us at DEA."
Under the proposed rules, many Americans who rely on telemedicine services will lose access to mental health, substance use disorder treatment and other healthcare services, providers argued.
The current proposed requirements will be operationally and technically burdensome to implement especially for complex health systems, Helen Hughes, M.D., medical director of the Office of Telemedicine at Johns Hopkins Medicine in Baltimore, told DEA officials Tuesday.
The pandemic spurred a digital evolution, she said, and, since March 2020, Johns Hopkins Medicine providers have completed more than 1.8 million telehealth visits to over 470,000 unique patients. "This care represents over half of our outpatient care during the early months of the pandemic and 13% of outpatient care over the last 12 months at our institution. This rate has been steady over the past one and a half years with about 30,000 visits per month. We consider this to be our new normal. Although we've seen telemedicine use across all specialties, we found it particularly impactful to increase access to mental healthcare."
Sixty-five percent of outpatient psychiatry visits were conducted via telemedicine in 2022, she noted.
"We feel strongly that the DEA should not interfere with reasonable clinical decision-making," Hughes said. "The ability for these providers to prescribe controlled substances and use their medical judgment for telemedicine without a prior in-person visit allows patients to receive clinically appropriate, essential care via a convenient and patient-centered modality, and we strongly believe the in-person medical requirement should be removed in its entirety."
The DEA's proposed rules do nothing to "prevent a provider who saw a patient one time in person—even 10 years ago—from recklessly prescribing controlled substances via either telemedicine or in-person care," she added.
Dan Reck, CEO of MATClinics, an opioid use disorder treatment provider based in Maryland, had a conflicting view and argued that a virtual-only approach to prescribing controlled substances posed a substantial risk for diversion and misuse of buprenorphine.
"Without proper oversight of patients prescribed controlled substances, including regular in-person visits combined with definitive toxicology testing, there is no reason to believe that some telemedicine-only providers won't become buprenorphine mills, just as painkiller mills once flourished," he said. "We are concerned that the consequences of unregulated buprenorphine will contribute further to the already deadly opioid epidemic."
To address concerns about the safe prescribing of controlled drugs via telehealth, the ATA, doctors and telepsychiatry groups urged the DEA to create a "special registration" pathway to enable practitioners to prescribe controlled substances via telemedicine without a prior, in-person medical evaluation.
Several lawmakers, including Sens. Mark Warner, John Thune, Catherine Cortez Masto and Shelley Moore Capito, also wrote to the DEA calling for an extension of pandemic telehealth rules and urged the agency to establish a special registration pathway.
Robert Ben Mitchell, D.O., a Florida licensed osteopathic physician who treats opioid addiction, said mandatory in-person evaluation is a barrier to addiction treatment for low-income and no-income individuals, people who are uninsured or under-insured and those living in medically underserved areas. In comments to Fierce Healthcare, Mitchell said he supports the creation of a special registration process to enable telehealth prescribing of buprenorphine.
History of DEA's 'special registration' pathway
Fifteen years ago, the DEA was mandated, within the Ryan Haight Act, to create a special registration process for remote prescribing, but it failed to do so. Congress again required the DEA to establish such a pathway in the 2018 SUPPORT Act. The DEA still did not act.
The recent SUPPORT for Patients and Communities Reauthorization Act of 2023 also directs the DEA to issue a special registration process.
In the 2023 proposed rules, the DEA briefly discussed why they rejected the special registration idea. They argued that the process would be too “burdensome for both prospective telemedicine providers and patients.”
The American Hospital Association recently called out this behavior in an open letter to lawmakers, noting that the DEA has continued to "ignore congressional intent on this process," and the agency's recently proposed rules impose "burdensome restrictions and additional administrative requirements on providers and patients."
In a meeting notice (PDF) issued in August, DEA said it is "open to considering—for some controlled substances—implementation of a separate Special Registration for telemedicine prescribing for patients without requiring the patient to ever have had an in-person medical evaluation at all."
But the agency also stated that it believes a new era of telehealth-supported healthcare requires additional compliance mandates on providers, particularly "increased data collection and visibility into prescription practices in order to ensure patient safety and prevent diversion in near-real-time," according to the meeting notice.
In its comment letter, the ATA outlined several recommendations for setting up a special registration pathway for clinicians that works in conjunction with the existing registration process. The organization recommended that telemedicine providers should not be required to maintain local addresses in every state where they practice and the special registration should include the elements DEA needs to monitor for illegitimate practitioners and illegal prescribing practices.
The process also should enable dispensers, such as pharmacies and pharmacists, to able to identify legitimate prescribers who have a current special registration. And, the process should not place any arbitrary limits on a clinician’s ability to practice within the scope of their authority, the ATA said in its comment letter.
"Our recommendations seek to strike the balance between ensuring legitimate prescribers may practice—thereby expanding access to needed healthcare services using the telehealth modality—with preventing diversion," Zebley wrote. "Our recommendations are also designed to fit into DEA’s current infrastructure without creating undue burdens for providers and urge DEA to consider realistic timelines when implementing these new processes."
In comments to the DEA, telepsychiatry groups Talkiatry, Quartet Health/innovaTel Telepsychiatry, Array Behavioral Care and Iris Telehealth proposed that the DEA set up two registration licenses: the commonly known DEA Registration and a new special registration.
The special registration license would allow qualified providers to prescribe Schedule 2N non-narcotic, 3, 4 and 5 medications via telemedicine without an in-person visit or referral, the groups recommended. That registration would primarily impact large provider groups that see patients predominantly or exclusively via telemedicine without an in-person evaluation, the groups said.
The groups also recommend exemptions from certain requirements for providers at not-for-profit organizations or hospitals and buprenorphine prescriptions.
The DEA has not yet signaled whether it intends to create a special registration process, but momentum is clearly building and lawmakers are putting pressure on the agency to "fulfill its statutory requirements."