The Drug Enforcement Administration and the HHS are extending flexibilities for providers prescribing controlled substances via telehealth for another year. The temporary extension marks the third time regulators have prolonged the pandemic-era flexibilities, which allow providers to prescribe some controlled medications, like Adderall for ADHD or drugs to treat opioid use disorder, without first conducting an in-person evaluation. Telehealth groups applauded the temporary rule. Advocates had been concerned regulators might miss a year-end deadline to extend the flexibilities again or propose more stringent prescribing rules.
More on Rule
With the issuance of the Third Temporary Rule, the DEA and HHS implicitly acknowledge that the final set of telemedicine regulations will not be issued this fall as previously anticipated. Instead, the Third Temporary Rule appears to be a stop-gap measure to ensure continued access to controlled substances by patients and practitioners relying on telemedicine while the DEA and HHS promulgate proposed and final telemedicine regulations. According to the DEA and HHS, the Third Temporary Rule will allow adequate time for practitioners to comply with any new standards or safeguards eventually adopted in a final set of regulations.
Further, the DEA and HHS reiterate that the purpose of the Third Temporary Rule, as well as the previous Temporary Rules, is to extend, for a limited period of time, the telemedicine flexibilities that existed during the PHE, to, among other things, prevent a reduction in access to care for patients without an existing telemedicine relationship, prevent backlogs for in-person medical evaluations, ensure the availability of telemedicine for practitioners and patients, address the urgent public health need for continued access to buprenorphine as a treatment for opioid use disorder, and avoid incentivizing or enabling problematic prescribing practices.
The Third Temporary Rule does not create or remove any regulatory requirements to 21 C.F.R. § 1307.41 or 42 C.F.R. § 12.1, which address temporary extensions of certain COVID-19 telemedicine flexibilities for prescription of controlled medications.
Looking Ahead
The pandemic-era flexibilities were implemented to ensure continued access to necessary medications during COVID-19, allowing providers to prescribe controlled substances without an initial in-person visit. This was crucial in maintaining patient care and managing public health concerns, including the opioid crisis.
Despite the one-year extension, the DEA and HHS have yet to reach a consensus on the long-term future of telehealth prescribing for controlled substances. The ongoing debate centers around ensuring access to treatment while preventing misuse and ensuring patient safety, particularly when the patient and provider have not had an in-person consultation.
The incoming Trump administration, particularly with President-elect Donald Trump’s pick for HHS Secretary, Robert F. Kennedy Jr., will play a pivotal role in shaping the future of these regulations. As a known skeptic of the pharmaceutical industry, Kennedy’s influence could lead to stricter guidelines or new approaches to telehealth prescribing practices.
The DEA must still contend with the issues recently issued controlled substance prescribing when the patient and provider do not know each other and have not had an in-person visit. The DEA has tried to solve the issue twice in two separate proposed rules. Both the DEA and the HHS will have new faces, and it remains to be seen how the two agencies will work together to solve the issue. The DEA has struggled with the question of whether to allow Schedule 2 substances like Adderall and oxycodone to continue to be prescribed via telehealth with no in-person guardrails.
While the DEA has provided a temporary solution, it is anticipated that Congress will consider additional healthcare packages to extend telehealth visit capabilities under Medicare for another two years before the end of this Congress. This legislative action would further solidify the role of telehealth in the healthcare system. The DEA’s extension of telehealth prescribing flexibilities marks an important step in maintaining access to controlled substances via telemedicine. However, the future remains uncertain as new leadership in both the DEA and HHS will need to navigate the complex landscape of telehealth regulations.