The US Drug Enforcement Agency has proposed expanding the rules to allow providers to use telemedicine to prescribe controlled medications. Telehealth advocates say the new rules aren't that helpful.
Federal regulators are taking steps to expand the use of telemedicine in prescribing controlled substances, a key pandemic waiver that has helped behavioral health and substance abuse providers but which is scheduled to end soon.
The US Drug Enforcement Agency (DEA) unveiled proposed permanent rules on Friday, aiming to put them in place before the COVID-19 Public Health Emergency ends on May 11. They would allow providers to use telemedicine to prescribe 30-day supplies of Schedule III-V non-narcotic controlled medications and buprenorphine, the latter specifically for the treatment of opioid abuse disorder, for new patients and without the need for an in-person evaluation.
“DEA is committed to ensuring that all Americans can access needed medications,” DEA Administrator Anne Milgram said in a press release. “The permanent expansion of telemedicine flexibilities would continue greater access to care for patients across the country, while ensuring the safety of patients. DEA is committed to the expansion of telemedicine with guardrails that prevent the online overprescribing of controlled medications that can cause harm.”
“Medication for opioid use disorder helps those who are fighting to overcome substance use disorder by helping people achieve and sustain recovery, and also prevent drug poisonings,” Milgram added. “The telemedicine regulations would continue to expand access to buprenorphine for patients with opioid use disorder.”
While the proposed new rule would be an improvement for some providers, there are limitations. According to the DEA, the proposed rules do not affect telemedicine consults that don’t involve the prescribing of controlled substances or consults with established patients. They would also not affect consults by a care provider to whom a patient has been referred, as long as the referring provider has previously conducted an in-person exam with the patient.
Reaction to the new rules has been mixed. Nathanial Lacktman, a partner in the Foley & Lardner law firm and chair of the firm's national Telemedicine & Digital Health Industry Team, said they were "not what most industry stakeholders were anticipating" in a blog posted today.
"The proposed rules are intended to bridge between the DEA’s current PHE waivers and a post-PHE environment," he wrote. "In so doing, DEA proposed creating two new limited options for telemedicine prescribing of controlled substances without a prior in-person exam. The options [are] both complex and more restrictive than what has been allowed for the past three years under the PHE waivers. The DEA’s proposal will discontinue the ability for telemedicine prescribing of controlled substances where the patient never has any in-person exam (with the exception of an initial prescription period of no more than 30 days’ supply). Moreover, if the patient requires a Schedule II medication or a Schedule III-V narcotic medication (with the sole exception of buprenorphine for opioid use disorder (OUD) treatment), an initial in-person exam is required before any prescription can be issued."
The proposed rules, which now go through a 30-day public comment period, were drafted with the help of the Health and Human Services Department and US Department of Veterans Affairs.
“Improved access to mental health and substance use disorder services through expanded telemedicine flexibilities will save lives,” HHS Secretary Xavier Becerra said in the 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.”
When the PHE was enacted in January 2020 to help the nation deal with the growing pandemic, a number of waivers and exemptions were put in place by federal and state regulators to help healthcare organizations expand and be reimbursed for digital health and telehealth services. The idea behind this was to allow providers to use virtual and connected health tools and platforms to reduce the spread of the virus and make sure consumers were able to access needed healthcare services.
Many of those waivers were extended until the end of 2024 in the Consolidated Appropriations Act of 2023. But the waiver on the use of telemedicine to prescribe controlled substances wasn't included in that bill.
Passed into law in 2008, the Ryan Haight Online Pharmacy Consumer Protection Act severely restricts the prescription of controlled substances, and requires an in-person exam by a qualified provider before those drugs can be prescribed via telemedicine. Enforcement is handled by the DEA.
Writing in their Health Care Law Today blog earlier this year, Thomas Ferrante and Rachel Goodman, partners with the Foley & Lardner Law Firm and members of the firm's Telemedicine & Digital Health Industry Team, say the waiver of the in-person exam during the PHE ensured that "millions of both established and new patients were able to receive medically necessary prescriptions via telemedicine."
"There have been efforts to amend the Ryan Haight Act and encourage the DEA to activate the telemedicine special registration rule before the PHE expires, including pending federal legislation," they wrote. "However, to date, the Ryan Haight Act has not been changed and the DEA has not activated the telemedicine special registration rule."
Telehealth advocates say the new rules don't go far enough, and that the DEA still needs to set up a special registration process so that more providers can use telemedicine for behavioral health and substance abuse treatment.
"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," Robert Krayn, co-founder and CEO of telepsychiatry company Talkiatry, said in an e-mail to HealthLeaders. "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."
"Rather than restrict bad actors, this over-corrective proposal disadvantages and disproportionately affects mental health care, preventing responsible physicians and clinical leaders from expanding care access," he added. "The mental health care community must unite and fight for patient access to quality care, regardless of a patients’ location and socio-economic status or the societal stigma attached to their condition."
Eric Wicklund is the associate content manager and senior editor for Innovation, Technology, Telehealth, Supply Chain and Pharma for HealthLeaders.
The US Drug Enforcement Agency has proposed expanding the rules to allow healthcare providers to use telemedicine to prescribed controlled medications for new patients without first needing an in-person consult.
The new rules expand upon waivers enacted during the pandemic to expand telehealth access and address key flexibilities that behavioral health and substance abuse treatmment providers say are crucial.
Telehealth advocates say the proposed rule changes don't go far enough and could actually be more restrictive that what had been in place prior to the pandemic.