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Telehealth Update: DEA Issues Long-Awaited Proposed Rule on Prescribing Controlled Substances via Telehealth

With just over two months before the COVID-19 Public Health Emergency (PHE) expected expiration on May 11, 2023, the Drug Enforcement Agency (DEA) has finally announced its proposed rule on prescribing controlled substances via telehealth. As previously covered, the waivers allowing providers to prescribe controlled substances without a prior in-person examination were set to expire upon the end of the PHE without further action from the DEA. The long-awaited rule has finally arrived, but many in the industry are concerned that it is overly restrictive and poses an unnecessary barrier to care. The comment period for the proposed rule is open until March 31, 2023, after which time the final rule will be published.

Under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, providers may not prescribe controlled substances without an in-person visit, unless an exception applies. One exception allowed providers to establish a patient relationship and prescribe controlled substances via synchronous, audio-visual interaction during the PHE. This exception allowed patients to continue accessing necessary care during the height of the COVID-19 pandemic, and opened up new opportunities for providers to deliver care. Providers and others in the telehealth industry have been anxiously awaiting the proposed rule, which they hoped would help avoid a “telehealth cliff” at the end of the PHE.

The proposed rule, while allowing for some flexibility, provides for a much more restrictive framework than the one with which providers and patients have become accustomed over the past 3 years. Once the rule goes into effect, providers may prescribe a 30-day supply of Schedule III-V non-narcotic controlled substances to new patients based on a synchronous, audio-visual interaction without conducting an in-person examination. The controlled-substances prescriptions may not be renewed beyond 30 days without an in-person examination, conducted either by the prescribing provider or by another DEA-registered practitioner, who then refers the patient to the telehealth provider for treatment. Telehealth providers who have established a provider-patient relationship via telehealth during the PHE may continue prescribing controlled substances to those existing patients for 180 days after the effective date or after the PHE expiration date, whichever is later. Following the 180 days, the patient must have an in-person examination that meets the requirements described above. All other federal and state requirements must also be met. Similar requirements apply to the prescribing of buprenorphine for the treatment of opioid use disorder.

In its announcement of the proposed rule, the DEA emphasized that the rule does not affect telehealth services that do not involve controlled substance prescriptions and telehealth consultations with a provider who has previously conducted an in-person medical examination of the patient. The proposed rule also does not create the long-expected special telemedicine DEA registration; however, the proposed rule does suggest that telehealth providers who otherwise meet the requirements of the rule need only hold a DEA registration in the state where the provider is located.

If the DEA promulgates the final rule as is, telehealth-only providers will be placed at a severe disadvantage and patients who have been relying on telehealth for things like mental health treatment and gender-affirming care will lose access to these important health care services. We will continue to track the status of the proposed rule throughout and following the comment period and will provide additional updates on this important issue.

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Ellen provides strategic advice to health care providers, investors, and start-ups on telehealth initiatives as well as the traditional practice of medicine across multiple states.
Cassandra L. Paolillo is Of Counsel at Mintz whose practice involves advising health care clients on transactional and regulatory matters, including mergers and acquisitions, regulatory compliance, and general contracting. Cassie primarily works with providers and payors.