New DEA Rule Expected to Extend Controlled Substance Telemedicine Prescribing Flexibilities Through 2025

After appreciable strain from each Congress and the White House, the Drug Enforcement Administration (DEA) submitted a proposed rule relating to flexibilities on telemedicine prescribing of managed substances on October 11, 2024. Specifics of the proposed rule are usually not but obtainable, however we anticipate the rule will prolong the present DEA telemedicine prescribing flexibilities for at the very least yet another 12 months, presumably two. The proposed rule is predicted to be launched and obtainable for public overview earlier than the top of the 12 months and will prolong each the in-person examination waiver and the state-by-state DEA registration waiver. 

In late August 2024, POLITICO broke information on the DEA’s inside plans to launch an unworkable regulation that may render telemedicine prescribing of managed substances functionally impractical. Although the draft rule was not publicly launched, reporters uncovered how the U.S. Department of Health and Human Services strongly opposed the DEA’s draft, having formally objected to its launch at the very least 3 times and lodging roughly 400 line-item issues relating to it. After the information broke, stakeholders had been shocked and disenchanted. Soon after, sufferers, clinicians, and main advocacy associations such because the American Telemedicine Association, ATA Action, and the Alliance for Connected Care, took motion by means of on-line petitions, and a sequence of scathing letters from Senators and different members of Congress urged the DEA to honor its prior guarantees to problem a set of telemedicine laws earlier than the top of 2024.

Now, with inadequate time earlier than the top of the 12 months to enact a particular registration rule, the one path ahead to keep away from the Telehealth Cliff is to prolong the flexibilities additional. This will permit time for the DEA to draft a brand new proposed rule (ideally doing so in collaboration with a taskforce comprised of training clinicians and trade stakeholders). Without an extension, the flexibilities which have elevated entry to well being care for people in rural and underserved communities over the previous 4 years will disappear after December 31, 2024, leading to hundreds of sufferers going through the Telehealth Cliff and shedding entry to essential drugs.

A Brief History

The guidelines stem from the Ryan Haight Act, which amended the Controlled Substances Act to prohibit clinicians from prescribing managed substances except the clinician conducts an in-person examination of the affected person. The Controlled Substances Act additionally requires clinicians get hold of a separate DEA registration in every state the place their sufferers are positioned. Congress anticipated the DEA to problem the particular registration rule shortly after the Ryan Haight Act was signed into legislation in 2008. After years of DEA failing to accomplish that, Congress and the White House signed the SUPPORT Act of 2018, a federal legislation that mandated DEA promulgate the particular registration rule by October 2019. Five years later, DEA has but to launch the rule.

During the COVID-19 Public Health Emergency (PHE), the DEA enacted sure flexibilities permitting clinicians to prescribe managed substances with out an in-person examination and with a DEA registration in only one state. In February 2023, two months earlier than the top of the PHE, the DEA proposed a rule on telemedicine prescribing of managed substances, however the rule was not favorably-viewed. The DEA obtained large criticism from personal trade and public officers with the proposed rule netting a record-breaking 38,000 public feedback, practically all of which had been scathingly essential of the rule and the way it failed to acknowledge how medical providers are literally delivered by clinicians and pharmacies. Following the general public backlash, the DEA shortly rescinded the proposed rule and prolonged the COVID-era flexibilities (as soon as in May 2023 and once more in October 2023). The two extensions had been meant to present further time for the DEA to draft a workable rule on a particular registration for telemedicine prescribing of managed substances. (For extra particulars, see our earlier discussions on the DEA’s proposed guidelines for telemedicine prescribing of managed substances and first and second short-term guidelines extending COVID-era flexibilities.)

What Happens if the Flexibilities Expire?

If the flexibilities expire, clinicians planning to prescribe managed substances by way of telemedicine should:

• Meet one of many seven (slim) exceptions below the Ryan Haight Act or conduct an in-person examination of the affected person; and
• Obtain a separate DEA registration in each state through which their sufferers are positioned.

These necessities should be met even when the clinician has been treating the affected person since 2020 below the COVID-era flexibilities as a result of DEA has said there isn’t any “grandfathering” provision below the legislation that may permit clinicians to proceed to prescribe for these sufferers after the flexibilities expire. The stakes are excessive for clinicians, as failure to adjust to these necessities constitutes a per se violation of the Controlled Substances Act and will lead to prison or civil penalties and revocation or suspension of the clinician’s DEA registration. Any hostile motion taken towards the clinician’s DEA registration would set off disclosures to state skilled licensing boards, Medicare, Medicaid, and sure the clinician’s employer.

Make Your Voice Heard

Although there isn’t any revealed rule to touch upon but, so as to keep sufferers’ ongoing entry to managed drugs, stakeholders ought to proceed to make their voice heard so the DEA will:

• Extend the telemedicine prescribing flexibilities for 2 extra years.
• Create a private-public taskforce composed of stakeholders and training clinicians who prescribe by way of telemedicine to present important suggestions to the DEA so it’s higher outfitted to draft a brand new proposed rule establishing the particular registration course of.
• Publish the brand new proposed particular registration rule early in 2024 so the rule has enough time to undergo the executive rulemaking course of earlier than the expiration of the flexibilities.

People who care about this problem can share their issues by way of the next channels:

• Email the DEA
• Send a letter or electronic mail to:
  • Senator Mark Warner‘s workplace
  • US Representative Buddy Carter’s workplace
  • Senator Doris Matsui‘s workplace
  • Your native Congressperson
• Send a letter or electronic mail to the White House
• Sign the net petition for Women’s Health entry urging the DEA to prolong the telemedicine prescribing flexibilities
• Sign the ATA Action on-line petition calling on Congress and the Biden Administration to help extending the telemedicine prescribing flexibilities

Conclusion

We will proceed to monitor the rule improvement and supply updates. 

For extra info on telemedicine, telehealth, digital care, distant affected person monitoring, digital well being, and different well being improvements, together with the crew, publications, and consultant expertise, go to Foley’s Telemedicine & Digital Health Industry Team.