ARTICLE
15 December 2022

American Hospital Association Urges DEA To Issue Special Registration For Telemedicine Controlled Substances

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Foley & Lardner
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Foley & Lardner LLP looks beyond the law to focus on the constantly evolving demands facing our clients and their industries. With over 1,100 lawyers in 24 offices across the United States, Mexico, Europe and Asia, Foley approaches client service by first understanding our clients’ priorities, objectives and challenges. We work hard to understand our clients’ issues and forge long-term relationships with them to help achieve successful outcomes and solve their legal issues through practical business advice and cutting-edge legal insight. Our clients view us as trusted business advisors because we understand that great legal service is only valuable if it is relevant, practical and beneficial to their businesses.
The American Hospital Association (AHA), on behalf of its nearly 5,000 member hospitals and health systems, sent a letter urging the Drug Enforcement Agency (DEA) to take immediate action to allow telemedicine prescribing of controlled substances before the Public Health Emergency waivers expire.
United States Food, Drugs, Healthcare, Life Sciences
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The American Hospital Association (AHA), on behalf of its nearly 5,000 member hospitals and health systems, sent a letter urging the Drug Enforcement Agency (DEA) to take immediate action to allow telemedicine prescribing of controlled substances before the Public Health Emergency (PHE) waivers expire. The letter exhorts the DEA to publish the proposed rule for a special telemedicine registration, something the DEA has said it would do since 2009 (yes, 13 years ago; not a typo).

The letter also asks the DEA to publish an interim plan to support continuity of care for the period between the expiration of the COVID-19 PHE waivers and the implementation of the special registration. Such action is essential to ensure patients can confidently continue receiving necessary treatment where and when they need it, while simultaneously creating a bridge to avoid the Telehealth Gap. "There is growing concern" the AHA wrote, "that the pending expiration of the COVID-19 PHE and its associated waivers, combined with the lack of a special registration regulation, will leave providers in a position where they will need to cut services and leave patients without access to necessary treatment." The AHA letter is availablehere.

Before the PHE occurred, thePresident signed a lawinstructing the DEA to issue regulations for a Special Telemedicine Registration under the Ryan Haight Act. The regulations would offer an exception to the Ryan Haight Act's in-person exam requirement, allowing clinicians who received the special registration to prescribe controlled substances via telemedicine without conducting an initial in-person exam. The law mandated DEA to promulgate the regulations before a deadline of October 25, 2019. Regrettably, that date came and went. More than three years after the deadline imposed by federal law, DEA has not published the regulation.

"While waiving the in-person requirement has supported continuity of care in the interim, providers, hospitals and health systems need clarity on the permanent, post-pandemic process for virtual prescribing." - Stacey Hughes, EVP Government Relations and Public Policy, American Hospital Association

A few months after the 2019 deadline, the COVID-19 pandemic arose and, along with it, the official declaration of a PHE and associated rule waivers. During the PHE, the DEA acted swiftly to waive the Ryan Haight Act's in-person exam requirement for the prescription of controlled substances, thereby ensuring millions of both established and new patients were able to receive medically necessary prescriptions via telemedicine. But once the PHE waivers expire, the in-person requirement is set to revert into place, without any special registration rule or other process established to ensure continuity of care.

With access to care already limited, and nationwide drug shortages making certain medications scarce, many patients may be left with nowhere to turn and could end up with delayed care, no care, or even worse negative outcomes.

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ARTICLE
15 December 2022

American Hospital Association Urges DEA To Issue Special Registration For Telemedicine Controlled Substances

United States Food, Drugs, Healthcare, Life Sciences
Contributor
Foley & Lardner LLP looks beyond the law to focus on the constantly evolving demands facing our clients and their industries. With over 1,100 lawyers in 24 offices across the United States, Mexico, Europe and Asia, Foley approaches client service by first understanding our clients’ priorities, objectives and challenges. We work hard to understand our clients’ issues and forge long-term relationships with them to help achieve successful outcomes and solve their legal issues through practical business advice and cutting-edge legal insight. Our clients view us as trusted business advisors because we understand that great legal service is only valuable if it is relevant, practical and beneficial to their businesses.
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