‘This Is a Life and Death Matter’: DEA Faces Tsunami of Criticism on Proposed Telehealth-Controlled Substances Rules

The two proposed rules from the Drug Enforcement Administration (DEA) that effectively undue controlled substances prescribing via telehealth have received over 21,000 submissions so far during its public comment period.

And the overwhelming majority of those comments oppose the proposed rules as presented.

The DEA released the proposed rules on Feb. 24. The proposed rules largely eliminate telehealth-only prescribing for Schedule III to V narcotic and Schedule II non-narcotic controlled substances without a prior in-person examination. There are narrow exceptions for time-limited supplies of non-narcotic drugs and buprenorphine, a popular drug used to treat opioid-use disorder (OUD) before an in-person exam is administered.

The public comment period ends March 31. The proposed rules would become effective at the end of the coronavirus public health emergency on May 11.

Industry reactions to the rules have been swift and negative.

“The rule does not determine who receives care and who does not based on medical necessity — instead, it determines who receives care based on the luck of geography, mobility and wealth,” Mindbloom Medical Director Dr. Leonardo Vando wrote in a comment. 

Mindbloom provides in-home ketamine therapy services.

What few comments there are in support of the proposed rules highlight a lack of oversight in the current telehealth environment when it comes to controlled substances.

Still, some behavioral health insiders see the rule proposed by the DEA as some form of progress toward clarifying how telehealth and controlled substance prescribing may fit together, something the agency has opted not to do for years.

“While I certainly don’t think that what’s on the table right now is perfect or complete, I think it’s progress,” Geoffrey Boyce, CEO of telepsychiatry provider Array Behavioral Care, told Behavioral Health Business. “I’m frankly excited that we’ve got something specific on the table to react to.”

Boyce noted that Array Behavioral Care, which was founded in 1999, has engaged with regulators like the DEA for over 10 years, trying to establish clarity in the gray areas that the Ryan Haight Act and DEA’s approach to it created around telehealth and prescribing controlled substances.

The rule does not determine who receives care and who does not based on medical necessity—instead, it determines who receives care based on the lack of geography, mobility, and wealth.

Dr. Leonardo Vando, medical director of Mindbloom

The Ryan Haight Act, passed in 2008, required the DEA to create a special registration process for telehealth prescribing of controlled substances without an initial in-person visit. The SUPPORT for Patients and Communities Act of 2018 reaffirmed DEA’s obligation by law to do so.

The DEA says its new proposed rules satisfy its obligations under both acts.

Several commenters disagree.

“The proposed rule is definitively and categorically not the same as the special registration rule,” Dr. David Kan, chief medical officer of Walnut Creek, California-based Bright Heart Health, wrote in a comment.

During the most acute onset of the coronavirus pandemic, the Trump administration issued a PHE declaration. Among many things, it allowed much greater flexibility for telehealth to be used in place of in-person care as states rolled out mitigation measures.

Since then, the behavioral health industry has experienced a gold rush of telehealth-focused startups as well as a genuine and widely observed explosion in the use of telehealth by patients. Even today, the most commonly billed telehealth reimbursement codes are for behavioral health-related services, according to data maintained by the nonprofit data clearinghouse Fair Health.

Support for the DEA’s proposed rules

Several organizations and individuals do support the proposed rules, arguing that DEA’s plan ensures that controlled substances and chemicals at risk for abuse or harm are appropriately regulated. Several cite the opioid crisis, which they say spiraled out of an era of lax oversight and prescribing abuse of opioid prescription.

Others simply dismiss the worries about the time restriction of the proposed DEA rules. In part, providers will have 180 days for existing patients and 30 days for new patients to be seen in person after the end of the PHE.

The proposed rules are “consistent with effective controls against diversion and otherwise consistent with public health and safety,” the Idaho Association of Addiction Professionals wrote in support of the rule in its comment.

The comment noted it’s critical that “those individuals in the preparation and action stages of change will receive the medicine they need at a critical moment in their recovery and won’t have to be seen in person for up to 30 days.”

“This proposed amendment also increases access to care for those without transportation in their area, providing them with extra time to coordinate transit, an important consideration for those living in rural America,” it continued.

Others maintain that previous deregulation efforts around buprenorphine prescribing better enable access to care and that telehealth should be considered an adjunct, not a replacement, for locally based care.

“In-person examination allows for a more robust assessment of adherence, risk stratification and compliance with a treatment plan,” Dr. Nasser Khan, operations group president of comprehensive treatment centers for Acadia Healthcare Co. Inc. (Nasdaq: ACHC), wrote. Khan told BHB he was commenting in his personal capacity, not as a representative of the company.

He also wrote in his comment his concern that any number of the telehealth-only, venture capital-backed behavioral health startups that popped up during the PHE may cease to exist following a downturn in capital markets, potentially leaving patients without care.

“We have seen this, for example, in the autism industry,” Khan wrote. “The advantage of forcing some degree of a local provider relationship is that if a digital-only model were to fail, there is a redundancy in place to ensure care continuity.

“For patients with addiction, this is a life and death matter,” he explained.

A middle ground

However, comments like Khan’s and the Idaho Association of Addiction Professionals were few and far between. Nearly all other comments offer varying levels of opposition, critique or compromise with the DEA’s austere approach to telehealth.

Several comments center around how the proposed rules limit access to care. A plethora of comments expresses concern for rural communities and other economically disadvantaged areas that don’t have access to behavioral health-specific prescribers. Meanwhile, others point to increasing struggles in accessing medication from supply chain issues or pharmacies discriminating against people with prescriptions from telehealth providers.

Many fear that the proposed rules, requiring prescriptions written via telehealth consult before an in-person exam to have a label identifying itself as such, could lead to even worse discrimination by pharmacies.

“Pharmacies and pharmacists do not want to repeat the mistakes of the past, and have thus erred on the side of restricting access rather than risk over-dispensing,” Kyle Zebley, executive director ATA Action and senior vice president of public policy for American Telemedicine Association, wrote. “Inconsistent guidance and enforcement by the DEA has fueled this fire.

“Unfortunately, telehealth often falls into the category of perceived potential risk, and thus we see blanket denials of legitimate prescriptions,” he continued. “This has a true impact on patients who are unable to access necessary medications.”

A number of comments focused on specific treatments, especially stimulants to treat ADHD, buprenorphine to treat OUD and hormone therapy.

Many point to the impact of the proposed rules falling hard on child psychiatry, an especially limited medical specialty. Others fear that telehealth limitations could lead people to the black market as well as other health risks from ending treatment.

“If the goal of the DEA is to increase overdoses and drive patients to seek illicit substances in rural communities, this is a great way to do so,” Clatsop Behavioral Healthcare, a clinic based in Clatsop County, Oregon, wrote. “Clatsop Behavioral Healthcare has relied solely on telehealth psychiatry for the past four years. Please do not make our challenges worse and potentially catastrophic by disallowing effective services.”

Some commenters called on the DEA to finally develop a special registration process for telehealth-only prescribers. The agency has failed to do so since 2008. The special registration would address many of the problems the DEA’s proposed rule seeks to address, commenters said.

“In light of the ongoing medication shortages and the increasing demand for remote healthcare services, the implementation of a national telehealth prescribing program for controlled substances is not only necessary, but also timely,” Dr. Owen Muir, founder of Fermata Health, wrote. “This program would enable health care providers like myself to more efficiently manage our patients’ medications, ensuring that they receive the care they need without undue delays or complications.”

Boyce said he is more hesitant about the development of a special registration process for telehealth prescribers. This would be yet another layer of administrative and regulatory burden on the industry.

And given the DEA’s uneven application of other registrations and outmoded approaches to records and data, Boyce worries the special registration would create new headaches for providers.

Still, DEA could come to the end of the comment period and present final rules that largely represent the proposals, Boyce said, citing “precedent from some bad actors in the recent past combined with the opioid epidemic” as motivators for a conservative approach by the DEA.