Telehealth Companies Face Existential Crisis as DEA Seeks to Pull Plug on Virtual Controlled Substance Prescribing

After years of waiting, the Drug Enforcement Administration (DEA) on Friday rolled out a new proposal to better formalize controlled substance prescriptions via telehealth.

However, the proposal is not the long-awaited registration process Congress mandated for addiction treatment. If finalized, DEA’s proposed plan also moves some aspects of telehealth prescribing back to a pre-public health emergency (PHE) state of regulation.

“Instead of taking inspiration from more modern state-level prescribing policy already introduced in Connecticut and Florida, the rules reinstate obsolete and counterproductive in-person requirements under the guise of novelty,” Robert Krayn, co-founder and CEO at Talkiatry, a telepsychiatry company, said in a statement. “There is nothing novel about sending vulnerable patients back into the dark ages of care delivery.”

What’s more, the proposed rule could disrupt the care regimens of millions of patients, Krayn added.

Instead, the newly proposed rule appears to be a bridge between the relative freedom of the loosened regulatory environment that the federal PHE provided to something that resembles the pre-COVID status quo. 

Several companies have built their businesses around virtual prescribing over the past few years. DEA’s proposal could pose a major challenge to their operational viability moving forward.

“DEA is committed to the expansion of telemedicine with guardrails that prevent the online overprescribing of controlled medications that can cause harm,” DEA Administrator Anne Milgram said in a statement.

The proposed regulations would allow for prescribing of 30-day supplies of “Schedule III-V non-narcotic controlled medications” and “buprenorphine for the treatment of opioid use disorder” via telehealth with no prior in-person exam, according to a news release from the DEA. If finalized, the proposal would halt controlled substance prescribing without an in-person exam.

The proposed rule would not impact telehealth visits unrelated to controlled medications, at least in instances where there has been a previous in-person examination. Leeway would also be given to telehealth visits following a referral to another provider where the previous provider conducted an in-person examination. 

Friday’s proposed rule would require that providers note that the prescription comes from a telehealth visit. It would also require providers to track their telehealth prescriptions. 

Before the pandemic, the federal government limited prescribing controlled substances via telehealth visits through the Ryan Haight Act, a 2008 amendment to the 1970 Controlled Substances Act. It, among other things, required in-person exams before prescribing via telehealth.

During the COVID-19 pandemic, the federal government temporarily lifted the Ryan Haight Act’s mandate that providers facilitate an in-person assessment before prescribing controlled substances as part of the PHE.

Many controlled substances are critical for treating behavioral health conditions. The DEA’s list of controlled substances includes buprenorphine, a vital treatment for opioid use disorder (OUD); the brand-named ADHD drug Adderall, mixed amphetamine salts and a potent stimulant; and alprazolam, better known as Xanax.

The Ryan Haight Act proposed rule appears to delineate itself from other another rule the federal government is working on related to telehealth and prescribing buprenorphine, a drug that’s part of medication-assisted treatment (MAT) for OUD. However, the newly proposed rule altering the Ryan Haight Act would require patients receiving buprenorphine to follow the same in-person examination requirements. 

“Unquestionably, the DEA’s proposal is not what most industry stakeholders were anticipating,” Nathaniel Lacktman, partner of the law firm Foley & Lardner, wrote in a blog post. “The initial reaction is the rules are more restrictive than necessary and impose concerning limitations and burdens on clinicians and the patients they treat.”

Lacktman is chair of the firm’s national telemedicine and digital health industry team, and a member of the Board of Directors of the American Telemedicine Association (ATA), which also criticized the newly proposed rule.

“The continuity of care for countless Americans will be severed, potentially leaving these patients to fall through the cracks of our health care system without access to needed medications,” Kyle Zebley, ATA’s senior vice president of public policy and executive director ATA Action, said in a statement. “Our hope is that the DEA works with us to avoid unnecessary and inappropriate restrictions on the prescription of essential medications for these vulnerable and underserved populations.”

The text of the proposed rule gives further insights into the thinking behind the DEA’s decision.

In sum, the rule seeks to keep the mission of the Ryan Haight Act — to protect the public from “rouge websites.” It also equates in-person exams before prescribing a controlled substance as fundamental to “a valid doctor-patient relationship.”

The law is named after a California teen of the same name who died of an overdose of a medication received from “a rogue online pharmacy.”

“In Ryan’s case, and in many others, the ‘[e]ase of access to the Internet, combined with lack of medical supervision, … led to tragic consequences in the online purchase of prescriptions for controlled substances,'” the proposed rule states. 

In 2018, then-President Donald Trump signed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act. It mandated that the DEA create a special process for addiction treatment via telehealth by October 2019.

It has so far not done so, leading to a number of real-world consequences, such as complicating the entry and growth of new MAT-focused, tech-enabled addiction treatment providers.

During the PHE, the relaxed regulations introduced new digital behavioral health providers that prescribed controlled substances over telemedicine. Several of these, including Cerebral and Done, later faced public scrutiny and investigations by federal prosecutors. 

Cerebral has already begun shifting its business away from some of these flexibilities, a company spokesperson told Behavioral Health Business.

“Cerebral stopped accepting new patients for OUD treatment in December 2022,” the spokesperson said. “There are currently less than 20 clients under care for OUD, all of which will be safely transitioned to alternative care by mid-March 2023.”