Telehealth companies, legal experts and behavioral health advocates are criticizing a proposed rule the Drug Enforcement Administration released on remote prescribing of controlled substances.
The DEA rule, released late Friday, would end most of the pandemic-era flexibilities that temporarily halted the 2008 Ryan Haight Act and allowed providers to prescribe controlled substances virtually without an in-person appointment. The flexibilities were scheduled to end at the expiration of the public health emergency, slated for May 11.
If the rule is finalized, Schedule II substances like Vicodin, OxyContin, Adderall and Ritalin will go back to fully requiring an in-person visit before getting prescribed virtually. Schedule III-V substances like codeine, Xanax and Ambien as well as buprenorphine, a narcotic used to treat opioid addiction, will only be prescribed over telehealth for an initial 30-day dose. After the 30 days, patients would need to see a doctor once to get a refill.
Critics say the DEA’s proposal is too limiting. Libby Baney, a partner in health IT law at Faegre Drinker Biddle & Reath, said by restricting usage of a provider’s ability to prescribe controlled substances remotely, the agency is inviting people to acquire the drugs through their own methods.
“I am predicting that Americans will go to the open, wild internet to [find] illegal drug sources for Adderall,” Baney said.
Patients will still be able to obtain common prescriptions like antibiotics, skin creams, birth control and insulin prescribed through telehealth visits.
The rule is scheduled to be published Wednesday in the federal register and will be followed by a 30-day comment period. There is a six-month grace period from when the final rule would take effect for the Schedule II-V drugs.
Industry groups such as the Alliance for Connected Care said the rule will reduce access to behavioral health in areas lacking in-person services.
“I think it’s going to be extremely problematic for companies offering services primarily virtually or outside of the immediate geographic footprint of their facility,” said Chris Adamec, the alliance's vice president. “Many of the patients who are receiving these services will be cut off from access.”
Nathaniel Lacktman, chair of the telemedicine and digital health industry team at the Foley & Lardner law firm, said the proposed rule creates complex requirements and administrative burdens on prescribers and pharmacies filling the orders. He predicted many pharmacies will start denying all orders from telemedicine prescribers to avoid the problem.
Not everyone agrees with that assessment. Dr. Joel Young, medical director of the Rochester Center for Behavioral Medicine in Rochester, Michigan, said the proposal was reasonable and will allow mental telehealth visits to continue at his practice.
“My preoccupation was making sure that we maintain virtual access to our patients, and I think with some modifications, we can do that,” Young said.
Baney said she was surprised by the rule concerning buprenorphine and the requirement that those prescribed it need to see a provider in person after 30 days. She cited a study published by the Centers for Disease Control and Prevention and other federal agencies that found expanding access to the opioid use treatment disorder drug via telehealth did not result in more overdoses. The evidence backs the drug’s effectiveness in reducing opioid use, she said.
“That part of the rule will put lives at risk, if not result in unnecessary deaths of patients who cannot see a treatment provider for that form of care in that limited period of time before they continue their substance use disorder treatment,” Baney said. “I suspect members of Congress and advocates, including practitioners [who engage in] substance use disorder treatment, will raise holy heck about that concern.”
Jeremy Sherer, digital health co-chair at law firm Hooper, Lundy & Bookman, who represents providers and telehealth companies, said he expects the industry to push back against that part of the proposal.
The agency did not include an outline of how prescribers can register to waive the in-person requirement. The registration process is required as part of the Ryan Haight Act and reinforced in the SUPPORT Act of 2018. Congress could intervene with those two factors in mind, Sherer said.
Ankit Gupta, founder and CEO at Bicycle Health, a virtual care startup providing opioid use disorder treatments, also criticized the buprenorphine rule. “This rulemaking unnecessarily limits access at a time when it’s needed the most and puts thousands of lives at risk,” Gupta said in a statement. “We plan to work with the DEA during the public comment period toward common sense revisions.”
Last year, Bicycle Health sent providers to self-created pop-up clinics to satisfy in-person visit requirements in Alabama, but Gupta said it is not a sustainable solution. While the company has access to some in-person clinic locations in each of the states it operates, Gupta said sticking with the rule could have consequences.
“This DEA rule is overly restrictive and is going to throttle access to buprenorphine, instead of increasing access to effective treatment. If this rule were to become final, we will see a sharp increase in overdose deaths,” Gupta said.
The Associated Press contributed.
This story first appeared in Digital Health Business & Technology.