A special registration process could strike the right balance between increasing access to the drug used to treat opioid use disorder while limiting diversion and possible misuse, say an MHE editorial advisory board member and two co-authors.
A special registration process for telehealth prescribers of buprenorphine, the drug used to treat opioid use disorder, would strike the right balance between increasing access to the drug and concerns telehealth prescriptions would lead to misuse of the drug, three researchers argue in Health Affairs Forefront blog post today.
One of the authors of the post, Ateev Mehrotra, M.D., M.P.H., a Harvard Medical School professor, is a member of the Managed Healthcare Executive editorial advisory board.
Congress, clinicians and policy makers have been pushing for special registration that would allow for prescriptions without an in-person visit for a decade, write Mehrotra and his co-authors.
“It’s clear to us that the time to implement the pathway is now,” they say in the blog post.
They list nine limitations, or “guardrails,” to reduce diversion of buprenorphine that they say would be less likely to curtail access to the treatment drug than others limitations. Electronic prescribing, a requirement that clinicians accept insurance (to exclude cash-only pill mills), and patient identity verification (two-factor authentication) are among their suggestions.
Before the COVID-19 pandemic, an in-person visit was required before controlled substances, such as buprenorphine was prescribed via telehealth. Like many telehealth rules, that requirement was waived during pandemic public health emergency. But now that the public emergency is over, the Drug Enforcement Agency (DEA), which has regulatory powers over controlled substances, needs to come up with permanent policies,
As Mehrotra and his co-authors, Lori Uscher-Pines, a Rand senior policy researcher, and Haiden A. Huskamp, a Harvard Medical School professor like Mehrotra, explain, the DEA issued regulations in March 2023 that seemed to aim for middle ground. The proposed rule would have allowed the initial prescription to be written after a telehealth visit but would have required an in-person visit within 30 days to get a refill. The DEA was flooded with negative comments and so extended the pandemic flexibilities through November 2023 while it weighed another version of permanent rules.
Mehrotra, Uscher-Pines and Huskamp say it is important to acknowledge that buprenorphine involves some risk both for patients for whom it is prescribed and those who may take it after it has been prescribed. Buprenorphine is an opioid partial agonist. According to the federal Substance Abuse and Mental Health Services Administration website, it produces effects such as euphoria or respiratory depression at low to moderate doses, but the effects are weaker than full opioid agonists, such as methadone and heroin.
Creating a special registration process was mentioned in the 2008 Ryan Haight Act and in the 2018 SUPPORT Act, but the DEA has balked at setting up special registration. Mehrotra and his colleagues call the agency’s arguments for not setting up registration — that it would be burdensome for telehealth providers and patients — are “weak.” They say the agency may be reluctant for several reasons, including worries that they lack the resources to administer and monitor the program and “limited consensus” on the standards that would be placed on registrants.
Mehrotra, Uscher-Pines and Huskamp said the DEA should consider a registration program that would require only high-volume prescribers. “This would limit administrative cost and focus the policy on clinicians in a position to have the greatest public health impact,” they said in the blog post.
The DEA is a law enforcement agency focused on inappropriate prescribing and diversion, while clinicians and public health officials who deal with the opioid overuse disorder are more concerned about access, the trio noted. “They (clinicians and public health officials) may not even interpret diversion as something that needs to be prevented given that the diversion that does occur has primarily been for the purpose for which it was intended — helping people with opioid use disorder to reduce use of other opioids and to treat the symptoms of withdrawal.”