Regulators recently extended certain temporary telemedicine waivers granted during the pandemic, with some flexibilities now sunsetting in 2025 rather than the end of this year.

The U.S. Drug Enforcement Administration (DEA) and the U.S. Department of Health and Human Services (HHS) have announced the extension of telemedicine flexibilities for the prescribing of controlled medications until Dec. 31, 2025. These waivers were initially set to expire on the same date in 2024.

The move was made in response to feedback the agencies received from more than 38,000 comments and two days of public listening sessions. The extension allows for more time to consider a “new path forward” for telemedicine, according to the DEA and HHS.

“We continue to carefully consider the input received and are working to promulgate a final set of telemedicine regulations,” the agencies stated in an announcement. “With the end of 2024 quickly approaching, DEA, jointly with HHS, has extended current telemedicine flexibilities through December 31, 2025.”

The temporary rule, entitled as the Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications, was recently submitted to the Federal Register and will become effective Jan. 1, 2025.

The flexibilities authorized a DEA-registered practitioner to prescribe schedule II–V controlled substances via telemedicine to a patient without having conducted an in-person medical evaluation if certain conditions are met. These conditions include prescriptions issued for a legitimate medical purpose by a practitioner acting in the usual course of their professional practice, as well as prescriptions provided following communications between a provider and patient via an interactive telecommunications system, among others.

The temporary telemedicine rules allowed hospices and other health care providers to prescribe controlled substances via telemedicine such as ketamine, cannabis, MDMA and psychedelics such as LSD and psilocybin, among other drugs. Research has shown that these substances can aid in treating pain, anxiety, depression, trauma, post-traumatic stress disorder (PTSD), grief and other medical conditions and existential crises.

The extension could result in cost-savings benefits to prescribers and patients, as well as reduced transfer payments to the federal government, the DEA and HHS indicated.

Telemedicine’s expanded impacts

Hospice providers face a host of legal and regulatory challenges when seeking to expand patients’ access to certain controlled substances. A good deal of legal, ethical and logistical work goes into whether these drugs can be used for medicinal and symptom relief purposes, including in-person versus virtual avenues of prescribing.

Among the myriad regulations is the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, which stipulates that a provider may prescribe controlled substances to a patient only after conducting an in-person evaluation. The temporary telemedicine regulations allowed for virtual exceptions to this in-person rule.

The waivers have allowed for reconciliation with the new normal of realities in health care delivery, according to Dr. Michael Fratkin, a California-based palliative care physician and board president of the Institute for Rural Psychedelic Care. Fratkin is also a palliative care specialist at Humboldt Center for New Growth.

Among the slew of considerations for policymakers is how to develop future regulations amid growing recognition of the positive impacts of telemedicine utilization when it comes to providing guided therapies that include controlled substances, Fratkin stated.

“Most professionals and interest groups have strongly advocated that we do not throw the proverbial baby out with the bathwater,” Fratkin told Hospice News. “It may be a necessity to require that we actually write new legislation to replace the Ryan Haight Act, or reconcile the historical obsolescence of it. But it’s more likely at this point that this will continue to get kicked down the road again at the end of 2025. There’s all kinds of implications and tons of anxieties for organizations and individuals who are risk-averse and know that current telemedicine rules are going to run out in 13 months.”

The temporary telemedicine waivers, along with other telehealth flexibilities, have been crucial in removing some of the most significant barriers to hospice care amid prolific workforce shortages that were exacerbated by the pandemic, according to Madison Summers, manager of public affairs at the National Alliance for Care at Home.

“By allowing practitioners to prescribe controlled substances without requiring in-person evaluations, it directly addresses workforce challenges and ensures patients receive essential medications without unnecessary delays,” Summers told Hospice News in an email. “Without DEA prescribing flexibilities, patients could face delays in receiving critical pain management medications, and providers would face increased logistical and staffing challenges.”

Telemedicine has also become an important part of addressing the complex needs of serious and terminally ill patients. The end of these flexibilities could impact patients and families, particularly those in rural areas or with limited mobility, poor health equity or social determinants of health needs, according to Katy Barnett, director of home care and hospice operations and policy at LeadingAge.

Homebound hospice patient populations faced tremendous risks of increased symptom burden and issues with timely access if the telemedicine flexibilities were to have expired as planned this year, Barnett stated. Granting an additional year of telemedicine flexibilities allows regulators to engage providers who rely on these waivers to reach patients in some of the most rural regions of the nation, Barnett added.

The third extension of the telemedicine flexibilities for controlled substance prescribing highlights how contentious this issue has become, she added.

“An extension … is certainly a good thing for hospice providers to have the flexibility to prescribe controlled substances like high-level pain medications and anxiety medications to patients in home hospice more quickly and without an in-person visit,” Barnett told Hospice News in an email. “If the flexibility were to end, it would have a detrimental impact on hospice’s ability to manage their staffing in the best way possible for patients and families.”

The end of the DEA extension could result in a heavier workload for prescribing staff, as they will need to visit hospice patients in person to establish a relationship before prescribing controlled substances, according to Barnett. While this was the standard practice prior to the pandemic, current labor pressures could lead to delays in providing pharmacological hospice and palliative care, she stated.

“Challenges in reaching a consensus on how to ensure access to necessary medications, while also preventing diversion, will remain,” Barnett said.

Without clarity on the future of telemedicine regulations, hospices and other health care providers have much to navigate when it comes to balancing clinical capacity, building operational efficiencies and shaping care delivery models, according to Fratkin.

Policymakers must consider the “wildly complex” details about telemedicine utilization regarding controlled substance prescribing such as what best practices look like as technology increasingly comes into the fold of health care delivery, he stated.

Program integrity concerns are also a large consideration in future telemedicine regulation. Legislators must find a way to safeguard against fraud, waste and abuse, as well as misuse of unsafe and unethical billing practices, Fratkin added.

“There has been tons of handwringing among providers in the last couple of months about these rules going away,” Fratkin said. “We have to change our policies, but there’s tension around defining what’s safe and what’s good clinical practice in a new landscape of health care programs. We’ve seen bad and irresponsible actors put profit in front of safety, but how much significance these small, but high-impact infractions have on policymakers can create biases around the use of telehealth technology. When done safely, it saves a lot of time and money.”