Health Tech

200 Stakeholders Push DEA for Updated Proposed Rule on Virtual Prescribing of Controlled Substances

In a letter, several stakeholders urged the Drug Enforcement Administration to release a revised proposed rule on the virtual prescribing of controlled substances. This comes as Covid-19 flexibilities that allow controlled substances to be prescribed via telehealth without an in-person exam are set to expire at the end of the year.

In an April 2 letter, a group of over 200 stakeholders urged the Drug Enforcement Administration (DEA) to release a revised proposed rule that would “permit and regulate the prescribing of controlled substances through telehealth.” The stakeholders include the Alliance for Connected Care, the American Telemedicine Association, ATA Action, the Consumer Technology Association, the Healthcare Information and Management Systems Society and the Partnership to Advance Virtual Care.

The DEA released a proposed rule last year that would remove some of the Covid-19 telehealth flexibilities for the prescribing of controlled substances. These flexibilities allowed physicians to virtually prescribe controlled substances without an in-person visit. But the proposed rule would require an in-person exam before prescribing drugs like narcotics and stimulants. For less addictive psychiatric medications and drugs that treat substance use disorder, patients would be able to get an initial 30-day supply virtually but would require an in-person visit afterward.

This led to an outroar from telehealth advocates and companies, and the DEA received more than 38,000 public comments on the proposed rule. Since then, the agency has extended the flexibilities through December of this year.

A revised rule is “crucial for access to mental health, substance use disorder, and other telehealth care,” the letter stated. The stakeholders urged the DEA to update the proposed rule “immediately” for several reasons. For example, due to the “complexity of these issues and the significant stakeholder interest,” the DEA needs to give stakeholders enough time to provide feedback on the proposed rule.

In addition, the DEA has proposed creating a special registration process that would allow medical professionals to register with the agency to virtually prescribe controlled substances. If the DEA were to do this, then “significant operational lead time would be needed for DEA, practitioners, pharmacies, and other related service providers to implement the new special registration process and comply with other potential operational requirements and guardrails.”

The stakeholders added that there would need to be staff training for pharmacies and others in the healthcare delivery system. Policy changes could also greatly impact patients’ access to care.

“Given widespread provider shortages, particularly in the mental health and substance use disorder treatment spaces, a rulemaking late in the year that makes significant policy changes would affect the ability of patients and clinicians to make appointments and ensure consistent access to care,” they said. “While we hope the final rulemaking preserves patient access, any policy change that requires patients to seek in-person care would be extremely disruptive due to long scheduling lead times and in-office wait times.”

In addition, the country needs the DEA’s leadership in order to “encourage more consistent definitions and aligned requirements from state regulatory bodies,” the stakeholders said.

“Alignment of requirements is needed to simplify compliance for healthcare providers and encourage telehealth providers to offer care in our nation’s most underserved areas – without geographic barriers such as state lines limiting access to care,” they stated.

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