The U.S. Drug Enforcement Agency has released its notice of proposed rulemaking for a framework to permit medically necessary controlled substances without an in-person visit without violating the Ryan Haight Online Pharmacy Consumer Protection Act.
WHY IT MATTERS
The NPRM comes two months after the DEA and U.S. Health and Human Services announced they extended the pandemic-era virtual prescribing of controlled substances a third time. The most recent extension of COVID-19 flexibilities for prescribing runs through 2025.
“DEA has determined that the best course of action to ensure patient access to care, while maintaining sufficient safeguards to prevent and detect diversion of controlled substances, is to establish and maintain a regulatory scheme,” the agency said in the notice published Wednesday.
To prevent patients from losing access to their telehealth-prescribed medications, the DEA is offering three types of special registration:
- Telemedicine Prescribing Registration – authorizes qualified clinician practitioners to prescribe Schedule III-V controlled substances.
- Advanced Telemedicine Prescribing Registration – authorizes qualified specialized clinician practitioners to prescribe Schedule II-V controlled substances.
- Telemedicine Platform Registration – authorizes qualified covered online telemedicine platforms – in their capacity as platform practitioners – to dispense Schedule II-V controlled substances.
“Once properly registered under the Special Registration framework, clinician practitioners would be considered clinician special registrants and covered online telemedicine platforms, in their capacity as platform practitioners, would be considered platform special registrants,” DEA explained.
While DEA has been “diligent” in its efforts, getting the framework “right for the millions of patients impacted by these actions,” is critical, said Kyle Zebley, senior vice president of public policy for the American Telemedicine Association and executive director of ATA Action said in a letter Tuesday.
The letter, to DEA Administrator Anne Milgram and Tom Prevoznik, assistant administrator for diversion control, calls on the agency to establish a workgroup to create the framework.
“While we are still digesting the DEA’s Special Registration framework, and will have a comprehensive analysis shortly, it is clear that these updates carry significant implications for the telehealth community,” Zebley said in a written reaction to the NPRM Wednesday.
“Early indications suggest the proposed rule includes elements that represent significant operational challenges,” he noted.
DEA said in the notice that registering covered online telemedicine platforms under the third special registration “is necessary given the pivotal role they sometimes play in the delivery of healthcare through telemedicine.”
The agency, concerned about ‘doctor shopping,’ said that “the lack of proper oversight and verification of clinician practitioners’ credentials” can open a door “bad actors” could take advantage of.
“While these covered online telemedicine platforms may improve healthcare accessibility by connecting patients with clinician practitioners, their emergence also brings more, and sometimes easier, avenues to divert or abuse controlled substances, particularly when such entities have financial incentives tied to prescriptions and/or do not adequately screen the clinician practitioners utilizing their system or platform.”
The Alliance for Connected Care said in a statement that it is “very concerned to see language in the proposed rulemaking mandating what portion of patient care can be offered through telemedicine” and deemed it an inappropriate guardrail.
“Limiting the proportion of Schedule II prescriptions issued through telemedicine would help to manage the risks associated with the prescribing of Schedule II controlled substances by ensuring that a significant portion of these prescriptions are issued following in-person medical evaluations, which can provide a more comprehensive assessment of the patient’s medical history and condition than can be done remotely,” DEA said in the NPRM.
“Restricting the geography in which telemedicine can be offered undermines the value of creating virtual access for those patients who need it most,” the alliance said.
DEA is accepting comments on the proposed telehealth prescribing registry framework through March 15.
THE LARGER TREND
Without a third extension before the end of 2024, the expiration of telehealth prescribing flexibilities would have required patients to have an in-person visit with a provider within 30 days or lose access to medications.
Lawmakers urged the agency to act in an October letter addressed to Anne Milgram, the DEA’s administrator. Along with numerous industry groups, lawmakers have also been concerned that restrictions would result in a return to access barriers many patients experienced before the pandemic.
DEA’s initial 2023 draft rule to make some telehealth prescribing flexibilities permanent would have required affected patients to have in-person exams, but a litany of healthcare industry groups and observers argued a return to pre-pandemic prescribing rules would risk patient harm.
Industry groups and lawmakers have also long questioned why a registry for telemedicine providers similar to the existing prescribing of controlled substances system had not already been created. They have said that the agency has a responsibility to create one under the 2018 Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act or SUPPORT Act.
In 2023, the agency held Telemedicine Listening Sessions to facilitate stakeholder engagement centered on what would be needed to create a special registration for telehealth prescribers and held a second comment period on its draft rule.
According to DEA’s docket, Telemedicine Prescribing of Controlled Substances has received 35,470 comments.
On Friday, DEA said it will also publish a rulemaking on Expansion of Buprenorphine Treatment via Telemedicine Encounter. According to the American Hospital Association, the final rule will allow providers to prescribe a six-month initial supply to treat opioid use disorder via audio-only telemedicine interaction without a prior in-person evaluation. “Requirements for the special registration proposed rule would not apply to clinicians prescribing buprenorphine for OUD,” AHA said in a statement.
ON THE RECORD
“DEA’s goal is to provide telehealth access for needed medications while ensuring patient safety and preventing the diversion of medications into the illicit drug market,” said Milgram Thursday in a statement. “We understand the difficulties some patients have accessing medical providers in-person, and we want to ease this burden while also providing safeguards to keep patients safe.
“These rules also mark a significant step forward for patient safety by requiring online telemedicine platforms to register with DEA and taking steps to establish a nationwide Prescription Drug Monitoring Program,” she added.
Andrea Fox is senior editor of Healthcare IT News.
Email: afox@himss.org
Healthcare IT News is a HIMSS Media publication.