Telehealth companies and other industry stakeholders have had a watchful eye towards the end of 2024 and the impending “telehealth cliff” as COVID-era Drug Enforcement Agency (DEA) flexibilities and Medicare expanded telehealth coverage are set to expire. Although a recent temporary joint rule from the DEA and the Department of Health and Human Services (HHS) along with the 2025 Medicare Physician Fee Schedule final rule has provided some hope, questions regarding telehealth access in 2025 and under a new Administration remain unclear. Further, calls continue for increased oversight of telehealth services. Below, we breakdown recent updates for the telehealth industry.

DEA Telehealth Flexibilities

Providing some good news, late last month the DEA and HHS jointly issued a temporary rule (the Temporary Rule) extending the COVID-era flexibilities for prescribing controlled substances via telehealth through the end of 2025. The flexibilities, which previously were twice extended and set to expire December 31, 2024, temporarily waive the in-person requirements for prescribing under the Controlled Substances Act.

The DEA and HHS issued the Temporary Rule to ensure that providers and patients who have come to rely on telehealth services are able to smoothly transition to the new requirements, which as previously covered, are likely to significantly limit providers’ ability to prescribe controlled substances without an in-person interaction. The Temporary Rule also acknowledges that the DEA and HHS continue to work with relevant stakeholders and will use the additional time to promulgate proposed and final regulations that “effectively expand access to telemedicine” in a manner that is consistent with public health and safety, while mitigating the risk of diversion. The agencies also note that the limited time period of the extension is aimed at avoiding investment in new telemedicine companies that may encourage or enable problematic prescribing practices.

The Temporary Rule effectively allows all DEA-registered providers to prescribe Schedule II-V controlled substances via telehealth through the end of 2025, regardless of when the provider-patient relationship was formed. Consistent with the prior temporary rules, the following requirements continue to apply:

• The prescription must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.
• The prescription must be issued pursuant to a telehealth interaction using two-way, real-time audio-visual technology, or for prescriptions to treat a mental health disorder, a two-way, real-time audio-only communication if the patient is not capable of, or does not consent to, the use of video technology.
• The practitioner must be authorized under their DEA registration to prescribe the basic class of controlled medication specified on the prescription or be exempt from obtaining a registration to dispense controlled substances.
• The prescription must meet all other requirements of the DEA regulations.

Providers should also be cognizant of applicable state laws that may place additional restrictions on the ability to prescribe certain medications or otherwise provide treatment via telehealth.

Medicare Coverage of Telehealth Services 

Unlike the DEA flexibilities, many of the COVID-era flexibilities for traditional Medicare coverage of telehealth services will end on December 31, 2024. Despite bipartisan support, congressional action is required to extend broad coverage for certain telehealth services existing since March 2020. Most notably, unless Congress acts, beginning January 1, 2025 expiring flexibilities include waiving the originating site requirements to allow beneficiaries to receive services in their homes and expanding the list of Medicare-enrolled providers who can furnish telehealth services.

Further, beginning January 1, 2025, Medicare coverage of telehealth services for beneficiaries outside of rural health care settings will be limited to:

• Monthly End-Stage Renal Disease visits for home dialysis;
• Services for diagnosis, evaluation, or treatment of symptoms of an acute stroke;
• Treatment of substance use disorder or a co-occurring mental health disorder, or for the diagnosis, evaluation or treatment of a mental health disorder;
• Behavioral health services;
• Diabetes self-management training; and
• Nutrition therapy.

For its part, the Centers for Medicare & Medicaid Services (CMS) recently issued its 2025 Medicare Physician Fee Schedule Final Rule (the MPFS Final Rule) extending and making permanent certain telehealth flexibilities within its authority. In particular, through December 31, 2025, practitioners may continue to utilize live video to meet certain Medicare direct supervision requirements and reference their currently enrolled practice when providing telehealth services from their home. The MPFS Final Rule continues to remove frequency limitations for certain hospital inpatient/observation care, skilled nursing facility visits, and critical care consultation services furnished via telehealth. Additionally, the MPFS Final Rule makes permanent the utilization of audio-only telehealth for any Medicare-covered telehealth service.

Increased Telehealth Oversight 

Recent months also have seen renewed calls for increased oversight of telehealth services. In September, the HHS Office for Inspector General (OIG) issued a report (the OIG Report) recommending increased oversight of Medicare coverage of remote patient monitoring. As a basis for its findings, the OIG Report cites the dramatic increased utilization of and payments for remote patient monitoring from 2019 to 2022, the fact that over 40% of Medicare beneficiaries receiving remote patient monitoring did not receive all three components of the service (i.e., education and setup, device supply, and treatment management), and the observation that Medicare lacks key information regarding the data being collected and the types of monitoring devices utilized. Notably, OIG conducted its review in part because of the potential for significant expansion of remote patient monitoring in the Medicare population.

Given these factors, the OIG Report recommends that CMS:

1. Implement additional safeguards to ensure that remote patient monitoring is used and billed appropriately in Medicare.
2. Require that remote patient monitoring be ordered and that information about the ordering provider be included on claims and encounter data for remote patient monitoring.
3. Develop methods to identify what health data are being monitored.
4. Conduct provider education about billing of remote patient monitoring.
5. Identify and monitor companies that bill for remote patient monitoring.

Separately, concerns also have been raised regarding the recent emergence of direct-to-consumer telehealth platforms sponsored by pharmaceutical companies. In this model, patients seeking specific medications are linked to a health care provider who can virtually prescribe the requested medication. In October, U.S. Senate Majority Whip Dick Durbin (D-IL), joined by Senators Bernie Sanders (I-VT), Peter Welch (D-VT), and Elizabeth Warren (D-MA) sent letters to several pharmaceutical companies requesting written response to questions regarding these platforms including the cost of direct-to-consumer advertising, the arrangements between the telehealth providers and the pharmaceutical companies, and whether the virtual consultation comply with the standard of care.

Conclusion

Despite attempts to preserve and expand telehealth access and affordability, effective January 1, 2025, many Medicare beneficiaries will be cut off from certain telehealth services unless one of the bills currently pending in Congress is passed. Crucially, bipartisan support for increased access to telehealth services is likely to continue in both chambers of Congress. Although the incoming Administration has not detailed its plans regarding telehealth access on a permanent, or even temporary basis, telehealth will continue to play an important role in the United States health care system through 2025 and beyond. As telehealth continues to play an important role in increasing access to care, increased oversight and enforcement is almost certain, even if future oversight priorities are unclear. As always, we will continue to monitor and report on important telehealth developments.

©1994-2024 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved. by: Daniel A. Cody, Cassandra L. Paolillo of Mintz For more on Telehealth, visit the NLR Health Law Managed Care section