DEA plans to create a dedicated telehealth registry for prescribers

The U.S. Drug Enforcement Agency has published a notice of proposed rulemaking for a framework to authorize medically necessary controlled substances without an in-person visit, without violating the Ryan Haight Online Pharmacy Consumer Protection Act.

WHY IT’S IMPORTANT

The NPRM comes two months after the DEA and U.S. Health and Human Services announced they have extended pandemic-era virtual prescribing of controlled substances for a third time. The latest extension of COVID-19 prescribing flexibility extends until 2025.

“DEA has determined that the best course of action to ensure patient access to care, while maintaining adequate safeguards to prevent and detect misuse of controlled substances, is to establish and maintain a regulatory regime,” the agency said in the report. notification Published Wednesday.

To prevent patients from losing access to their telehealth prescribed medications, the DEA offers three types of special registrations:

  1. Telemedicine Prescribing Registration – Authorizes qualified physicians to prescribe Schedule III-V controlled substances.
  2. Advanced Telemedicine Prescribing Registry – Authorizes qualified specialty physicians to prescribe Schedule II-V controlled substances.
  3. Telemedicine Platform Registration – Authorizes qualified covered online telemedicine platforms – in their capacities as platform practitioners – to dispense Schedule II-V controlled substances.

“Once properly registered under the special registration framework, physicians would be considered special registrants and covered online telemedicine platforms, in their capacity as platform practitioners, would be considered special platform registrants,” DEA explains.

While the DEA has been “diligent” in its efforts, it is critical to get the framework “right for the millions of patients affected by these actions,” said Kyle Zebley, American’s senior vice president of public policy Telemedicine Association and Executive Director of ATA. Action wrote this in a letter on Tuesday.

The letter, to DEA Administrator Anne Milgram and Tom Prevoznik, Assistant Administrator for Diversion Control, calls on the agency to set up a working group to create the framework.

“While we are still processing the DEA’s Special Registration Framework and will have a comprehensive analysis soon, it is clear that these updates have significant impacts on the telehealth community,” Zebley said in a statement written response to the NPRM Wednesday.

“Early indications suggest that the proposed rule contains 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 critical role they sometimes play in delivering health care via telemedicine.”

Concerned about doctor shopping, the agency said “the lack of proper oversight and verification of doctors’ credentials” could open a door for “bad actors” to exploit.

“While these covered online telemedicine platforms can improve healthcare accessibility by connecting patients with physicians, their emergence also provides greater and sometimes easier opportunities to divert or misuse controlled substances, especially when such entities have financial incentives linked to prescriptions and/or do not adequately screen the physicians who use their system or platform.”

The Alliance for Connected Care said in a statement that it is “very concerned to see language in the proposed regulations prescribing what portion of patient care can be provided via telemedicine” and considers it an inappropriate guardrail.

“Limiting the share of Schedule II prescriptions dispensed via telemedicine would help manage the risks associated with prescribing Schedule II controlled substances by ensuring that a significant portion of these prescriptions are dispensed after in-person medical evaluations, which can provide a more comprehensive picture. assessment of the patient’s medical history and condition than can be done remotely,” DEA said in the NPRM.

“Limiting the geography in which telemedicine can be offered undermines the value of creating virtual access for patients who need it most,” the alliance said.

DEA is accepting comments on the proposed telehealth prescribing framework through March 15.

THE BIG TREND

Without a third extension before the end of 2024, the expiration of telehealth prescribing flexibility would have required patients to make an in-person visit to a healthcare provider within 30 days or lose access to medications.

Lawmakers urged the agency to take action in October letter addressed to Anne Milgram, the administrator of the DEA. Along with many industry groups, lawmakers are also concerned that restrictions would result in a return to access barriers that many patients experienced before the pandemic.

The DEA’s original 2023 draft rule to make some telehealth prescribing flexibilities permanent would have required affected patients to undergo in-person exams, but a litany of health care groups and observers argued that a returning to pre-pandemic prescribing rules would pose a risk to the patient.

Industry groups and lawmakers have also long wondered why a registry for telemedicine providers, similar to the existing system for prescribing controlled substances, had not already been established. They have said the agency has a responsibility to create one under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patient and Communities Act, or SUPPORT Act, of 2018.

In 2023, the agency held telemedicine listening sessions to facilitate stakeholder engagement, focused on what it would take to create a dedicated registry for telehealth prescribers, and held a second comment period on its draft rule.

According to the role of DEA, Telemedicine Prescribing of controlled substances has received 35,470 responses.

On Friday, DEA said it will also publish regulations on the matter Expansion of treatment with buprenorphine via Telemedicine Encounter. According to the American Hospital Association, the final rule will allow providers to prescribe an initial six-month supply for the treatment of opioid use disorder via audio-only telemedicine interaction, without a prior in-person evaluation. “Requirements for the proposed special registration rule would not apply to physicians prescribing buprenorphine for OUD,” AHA said in a statement.

ON THE RECORD

“DEA’s goal is to provide telehealth access to needed medications while ensuring patient safety and preventing diversion of medications into the illicit drug market,” Milgram said in a statement Thursday. “We understand the difficulties some patients have accessing medical providers in person, and we want to ease this burden while providing safeguards to keep patients safe.

“These rules also mark an important step forward for patient safety by requiring online telemedicine platforms to register with the DEA and take steps to establish a nationwide prescription drug monitoring program,” she added.

Andrea Fox is editor-in-chief of Healthcare IT News.
Email: afox@himss.org

Healthcare IT News is a HIMSS Media publication.