Telehealth providers and advocates are balking at proposed telemedicine rules released by the Drug Enforcement Administration (DEA) late Friday. If made permanent, the rules would be a marked change from the suspension of the Ryan Haight Online Pharmacy Consumer Protection Act, which propelled a telepsychiatry boom during the COVID-19 pandemic.
Under the proposed rule released by the DEA, developed in concert with the U.S. Department of Health and Human Services (HHS) and in coordination with the U.S. Department of Veterans Affairs, some medications would require an in-person doctor’s visit. Controlled substances (PDF) including stimulants like Adderall and opioids such as oxycodone and buprenorphine used to treat opioid use disorder (OUD) would require at least one in-person visit.
The American Telemedicine Association (ATA) is one of many groups calling the new rule more restrictive than warranted.
“Our concern lies with the potential public health crisis this could cause for individuals needing access to clinically appropriate prescriptions of controlled substances for a wide variety of medical circumstances, including for mental health and substance use disorders,” Kyle Zebley, the ATA’s senior vice president of public policy, said in a press release. “The continuity of care for countless Americans will be severed, potentially leaving these patients to fall through the cracks of our healthcare system without access to needed medications.”
Under the proposed rule, Schedule II medications or narcotics would require (PDF) an in-person prescription. Schedule III or higher medications, including buprenorphine, can be prescribed for 30 days via telehealth but would require an in-person visit before a refill. Non-narcotic drugs like Ambien, Valium, Xanax and ketamine also fall into this category. If a patient is referred to a provider, an in-person appointment is not required as long as one took place with the referring physician.
If a telemedicine relationship was established during the COVID-19 public health emergency, the DEA will extend the in-person exam waiver an additional 180 days.
According to the administration, the new rule seeks to provide safeguards to prevent online over-prescribing of controlled medications. Teleprescribing has been touted as a robust tool for bringing medications for opioid use disorder (MOUDs) to rural areas in the ongoing treatment of the opioid epidemic.
HHS Secretary Xavier Becerra backed the ruling by emphasizing its leniency compared to pre-pandemic regulations.
“Improved access to mental health and substance use disorder services through expanded telemedicine flexibilities will save lives,” Becerra said in a press release. “We still have millions of Americans, particularly those living in rural communities, who face difficulties accessing a doctor or health care provider in-person. At HHS, we are committed to working with our federal partners and stakeholders to advance proven technologies and lifesaving care for the benefit of all Americans.”
Some have argued that without in-person requirements, companies facilitating the prescribing of Adderall or ketamine have not conducted adequate screenings or follow-up appointments.
In the text (PDF) of the proposed ruling, the DEA emphasized the initial impetus for the Ryan Haight Act, referencing the internet “pill mills” of the early 2000s that led to the death of a California high school student. The text seemed to imply that the “ease of access to the Internet, combined with the lack of medical supervision” could lead to future tragedies if not carefully corralled.
Nathaniel Lacktman, partner at law firm Foley and Lardner LLP, said the proposed rules were both “complex and more restrictive” than regulations for remote prescribing over the last three years.
“For the last year, there have been repeated assurances by HHS, DEA, SAMHSA, ONDCP and the White House that these buprenorphine patients will not fall off the telehealth cliff,” Lacktman wrote in the firm’s blog. “Unless the proposed rule is changed, stakeholders are left to ask: Will DEA’s decision to end telemedicine-only buprenorphine help, or will it harm patients struggling with opioid use disorder and trigger more overdoses and diversion?”
Advocates for remote prescribing have urged the DEA to create a special registration process to avoid a potential disruption in medication. Congress mandated the DEA to craft the process after the passing of the Ryan Haight Act in 2008, but the administration has yet to do so.
“The DEA’s proposed rules are not the special registration process that Congress mandated and could gravely disrupt millions of patients’ treatments and care regimens,” Talkiatry co-founder and CEO Robert Krayn said in a press release. “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. There is nothing novel about sending vulnerable patients back into the dark ages of care delivery.”
Talkiatry is one of many companies with a business model that relies on remote prescribing. The telepsychiatry company released a report in January stating that 14,700 of its patients would lose access to their treatment if COVID-era exemptions were to end.
The expanded use of telehealth services during the pandemic was shown to reduce the risk of opioid overdoses, according to a 2022 study published in JAMA Psychiatry. The study, conducted by the National Institute on Drug Abuse, followed 175,000 Medicaid beneficiaries and found that telehealth services led to an increase in OUD treatment access and adherence.
Bicycle Health is a MOUD telepsychiatry company. The company flew psychiatrists to Alabama in July 2022 when the state passed a bill requiring providers to perform one annual in-person visit. Bicycle Health's CEO and founder Ankit Gupta told Fierce Healthcare earlier this month that the company is prepared to take drastic efforts again if necessary.
“Every piece of research we’ve seen shows that teleOUD leads to increased access to lifesaving medications and decreases overdoses—with no evidence of an increase in drug diversion,” Gupta said in a press release. “This rulemaking unnecessarily limits access at a time when it’s needed the most and puts thousands of lives at risk. We plan to work with the DEA during the public comment period toward common sense revisions.”
The proposed changes will now enter a 30-day public comment period.
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