US telehealth controlled substances prescribing waiver may expire at year’s end; DEA may further restrict

Current waivers end 31 December without DEA, Congressional action. The Drug Enforcement Administration (DEA) apparently through inaction, will allow the current virtual prescribing flexibilities impacting Schedule II and higher drugs to expire at the end of year. These waivers which removed the in-person examination requirement under the Ryan-Haight Act were instituted during the Covid pandemic and extended twice [TTA 11 Oct 23, 11 May 23] with a final expiration of 31 December 2024.

Reportedly, the DEA is not only wishing to reinstate the status quo ante, but also reportedly wants to institute additional restrictions. However, any draft rule that would reimpose or changes restrictions has not been put out for the public comment period, review, and final rule implementation which typically takes anywhere from 60 to 120 days, well past year’s end. Last year, when a draft rule was released for comment, nearly 40,000 comments were received.

At the time of the 2023 extension that kicked this particular can down the road into the end of a presidential election year, DEA had stated that they would use 2024 to finalize telemedicine prescribing rules, but no action has been taken. Since then, the Department of Justice has filed multiple charges of Medicare and Medicaid fraud and illegal distribution of controlled substances against seven Done Global employees [TTA 3 July and prior], with investigations pending on practices by provider Cerebral and pharmacy Truepill

Under the aegis of the American Telemedicine Association (ATA), a coalition of 330+ organizations have again written as of Tuesday 10 September to the current administration and both houses of Congress to 1) extend the waivers for two years, as part of the end of the Federal fiscal year (starting 1 Oct) package, and 2) use the time for DEA to “to fulfill its congressional mandate to establish a special registration pathway that balances access to medically necessary care with appropriate enforcement.” The rationale centers on the lack of time, but strongly around the availability of psychiatrists throughout most of the US–there are none in half of US counties especially in rural areas. (The average MD psychiatrist is well over 50, nearing retirement, and not well reimbursed for his or her time–which is why med school grads in heavy debt don’t gravitate to the specialty.) What is not stated is that many if not most telepsychiatry providers do not have models that will support in-person evaluations as required without waivers.

There are no public actions or responses either by Congress or by the DEA as of today (13 September).

ATA press release, Biden Administration letter, House letter, Senate Leadership letter, Healthcare Dive

ATA Action, ATA’s trade organization and advocacy arm, has also formed a political action committee (PAC), ATA Action PAC. Its stated purpose is to support incumbent Federal candidates including Congressmembers who support their goals in virtual care policy. Candidates on the Federal or state levels will not receive support.  Release

News from ATA 2023: debate over DEA in-person prescribing requirement, winners of Telehealth Innovators Challenge, 2024 board chair announced

The American Telemedicine Association’s annual conference, ATA2023, which wrapped two weekends ago, had some major debates, awards, and some board changes.

Special ‘listening’ session on DEA’s proposed changes on telemedicine prescribing of controlled substances. This would resume the in-person visit requirement for Schedule III-V non-narcotic controlled medications. A 30-day limit on a prescription would be permitted for a telehealth remote visit and prescription, but an in-person visit would be required during that period or thereafter before any renewal. The DEA proposed rule issued 24 February (draft here) includes allowing care to be delivered uninterrupted for 180 days after the end of the public health emergency (PHE) ending 11 May, but then requires an in-person physician visit. ATA opposes this new requirement for patients who were prescribed these medications solely during telehealth during the PHE (release 25 Feb). Public comment on the proposed rule is open for 30 days (27 March). A representative of the DEA was in the audience for the Monday 6 March discussion moderated by Kyle Zebley, ATA’s senior vice president of public policy. Other telehealth measures were extended for two years in last year’s passage of the 2023 Federal budget bill [TTA 4 Jan]. Healthcare Finance

Winners were announced for ATA’s Telehealth Innovators Challenge. The four categories and winners were:

Femtech and Women’s Health Winner: SimpliFed. SimpliFed is a virtual breastfeeding and baby feeding provider network that improves access to professional lactation support.

In-patient Care Solutions Winner: Great Speech. Great Speech provides speech therapy through a network of 200+ therapists and adds artificial intelligence (AI) technology and proprietary algorithms.

The Patient Experience: Clearstep Health. Clearstep guides healthcare consumers to the best next steps for care based on their symptoms, insurance, location and preferences via a virtual triage system set up for providers. 

Tools That Deliver Care: Strados Labs. The Strados Cardiopulmonary Platform, using the RESP Biosensor, captures wheezing, coughing, and other lung sounds plus respiratory dynamics, then to a clinician portal supported by machine learning algorithms.

SimpliFed also won the overall Judges’ Choice Award. Oshi Health, a virtual-first gastrointestinal care clinic integrating evidence-based medical care and behavioral health support into a convenient, high-touch, data-driven care model, received the overall People’s Choice Award. Release

Sree Chaguturu, MD, has been named Chair-elect of ATA’s Board of Directors for a two-year term starting May 2024. Dr. Chaguturu is executive vice president and chief medical officer, CVS Health. He has served on the ATA Board of Directors since December 2020. He will follow Kristi Henderson, DNP, CEO, MedExpress and senior vice president of the Center for Digital Health and Innovation for Optum Health, who is now Immediate Past Chair. Release