One of the nation’s most potent addiction treatment advocacy groups rebuked calls for a special registration process.
The special registration process would allow telehealth providers to prescribe controlled substances via telehealth without a prior in-person exam. Regulatory flexibilities during the pandemic opened a new lane of business for behavioral health providers, especially addiction treatment providers.
Even though the special registration process has long been prescribed by federal law, the president of the American Society of Addiction Medicine (ASAM), Brian Hurley, came out in opposition to establishing a special registration process for telehealth controlled substance prescribing.
He called this approach a “misguided” venture in an article published in Health Affairs. While arguing for continued flexibility for telehealth prescribing, he called for regulators to take another approach to regulation that is spelled out in the Ryan Haight Act.
The Ryan Haight Act governs telehealth and controlled substances. It includes two provisions that would allow the federal government to establish new regulations to allow telehealth prescribing without a prior in-person exam. One is the special registration process, detailed in 21 U.S.C. Sect. 802(54)(E). This requires the Drug Enforcement Administration (DEA) to develop and implement the process. Hurley calls for another section of the Ryan Haight Act to be considered:, 21 U.S.C. Sect. 802(54)(G).
In this section, the U.S. Department of Health and Human Services (HHS) and the DEA would come to consensus on new regulations outside of a special registration process where the DEA would have exclusive authority.
Through this process, HHS and DEA could theoretically develop regulations that are “consistent with effective controls against diversion and otherwise consistent with the public health and safety.”
At its core, questions about telehealth controlled substance prescribing center on the historic requirement that a patient first be seen in person before receiving medication, in addition to other bureaucratic requirements. The DEA has put off making a final rule on the topic until late in 2024 after originally reinstituting the in-person exam in its original proposed rules released in March.
The special registration provision would not include HHS and includes the requirement that providers demonstrate a “legitimate need” to establish a special registration.
Hurley says a special registration would lead to a greater entanglement of law enforcement in treatment and limit access to care. Further, the special registration could lead to higher regulatory burdens and dissuade the use of telehealth in treating addiction with controlled substances.
While the DEA-HHS consensus approach is more free-wheeling, it allows more room for regulations that balance industry and patient needs for flexibility while ensuring the DEA’s patient protection goals are implemented.
“In short, the DEA and HHS got it partly right the first time,” Hurley said. “A special registration process should not be the next step for telemedicine prescribing of buprenorphine.”
The special registration process, in Hurley’s view, would establish an additional regulatory process akin to the now-defunct X waiver. Congress eliminated the X waiver in the last omnibus funding bill.
“Even so, it didn’t seem to work very well, as instances of criminal buprenorphine prescribing involved clinicians with an X-waiver conducting cursory, in-person exams, nevertheless,” Hurley said. “Thus, history informs us that a telehealth-focused special registration process would not likely deter clinicians who knowingly or intentionally wish to prescribe buprenorphine in an unauthorized manner without also reducing access to legitimate medical care.”
Concerns about diversion are also misplaced, Hurley said, pointing to research from the federal government that finds increased access to buprenorphine during the pandemic-era regulatory flexibilities did not translate to more overdose deaths.
He also points to research that shows telehealth isn’t as risky as it seems.
“Historically, the DEA has seen a lack of an in-person medical evaluation as an indication of likely diversion,” Hurley said. “But, after three years of successful virtual practice, it should no longer be considered a red flag.”
Going for the HHS-DEA consensus approach would allow the federal government to create a “bona fide exam requirement.” This type of exam, which could be conducted virtually, would allow for case-by-case determinations by clinicians as to whether or not the patient would succeed or be at risk in telehealth treatment.
“Indeed, a final rule can include a bona fide exam requirement and commonsense guardrails, such as prescription drug monitoring checks and required electronic prescribing, without needlessly conditioning telemedicine access to a lifesaving medication on the implementation of a special registration process for which there is no reasonably defined or accepted approach,” Hurley said.