Telehealth Update: Telehealth Flexibilities, Convictions And Indictment, And 2026 Outlook

The end of 2025 saw several notable developments for the telehealth industry with early 2026 poised to potentially challenge the industry with the impending expiration of the short-term extension of the Medicare telehealth flexibilities. Below we highlight activity from late 2025 and provide an outlook for 2026.

DEA/HHS Controlled Substances Prescribing Telehealth Flexibilities

As December drew to a close, telehealth providers were anxiously awaiting news regarding the COVID-19 era flexibilities for prescribing controlled substances via telehealth. The flexibilities, which have been extended three times and were set to expire on December 31, 2025, temporarily waive the in-person requirements for prescribing under the Controlled Substances Act. On December 30, 2025, the Drug Enforcement Agency (DEA) and the Department of Health and Human Services (HHS) jointly issued a temporary rule (the Temporary Rule) extending the flexibilities for another year, through December 31, 2026.

The Temporary Rule effectively allows all DEA-registered providers to prescribe Schedule II-V controlled substances via telehealth through the end of 2026, regardless of when the provider-patient relationship was formed. Consistent with the prior temporary rules and applicable state laws that may place additional restrictions on the ability to prescribe certain medications via telehealth, 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.

The Temporary Rule states that the further extension is designed to prevent disruption of care and a backlog of patients requiring in-person appointments while the DEA/HHS finalizes proposed regulations to ensure safe access to controlled substances through telemedicine. Specifically, in January 2025, the DEA released a proposed rule providing a "special registration" process for controlled substance prescribing without an initial in-person visit. The DEA received over 6,000 public comments to the proposed rule many of which requested further clarity of the rule's provisions and minimizing operational and administrative burdens potentially impacting patient access.

Notably, the Temporary Rule also discusses the interaction between the rule and the two January 2025 final telehealth rules issued by the DEA regarding buprenorphine treatment and continuity of care for Veterans Affairs patients. While the two final rules are independent of the Temporary Rule and contain provisions more stringent than the Temporary Rule, the DEA expressly states that practitioners may follow the applicable final rule or the provisions of the less burdensome Temporary Rule.

Medicare Coverage of Telehealth Services and Acute Hospital Care at Home Program

As the telehealth industry will painfully recall, with the United States government shutdown on October 1, 2025, the abrupt cessation of Medicare's telehealth flexibilities and the Acute Hospital Care at Home Program led to dramatic adverse impacts to patients and the availability of clinical services. See our prior post here. With the over forty-day government shutdown, the COVID-19 era flexibilities ended reinstating the following, among others:

• Originating Site/Geographic Limitations. The vast majority of Medicare beneficiaries were only eligible to receive telehealth services from specific originating sites, such as a provider's office, a hospital, or skilled nursing facility, and only if they were located in a rural professional health shortage area.
• Eligible Practitioners. The list of practitioners eligible to provide virtual clinical services reverted to the limited list of physicians, physician assistants, advanced practice registered nurses, certain behavioral health providers, and registered dietitians or nutrition professionals and excluding therapists.
• Mental Health Services. With exceptions for existing patients, the diagnosis, evaluation, and treatment of a behavioral health disorder via telehealth were only Medicare-covered if there was an in-person visit within six months prior to the initial telehealth visit.
• Audio-Only Services. Audio-only services were only covered if the patient received services from home and the patient could not or would not utilize video.

On November 12, 2025, the government shutdown ended with the passage of a short-term continuing resolution funding most federal agencies and extending the Medicare flexibilities through January 30, 2026. On December 1, 2025, the House passed the "Hospital Inpatient Services Modernization Act," which would further extend the Hospital at Home waiver flexibilities through 2030, but the legislation has not yet passed the Senate.

While many providers made the difficult determination to still provide telehealth services during the shutdown consistent with the flexibilities and hold Medicare claims submission, others were unable to do so due to uncertainty, operational, and/or financial reasons. To their credit, HHS and the Centers for Medicare & Medicaid Services agreed to retroactively pay all outstanding Medicare claims for providers who continued to provide telehealth services pursuant to the flexibilities.

While there is bipartisan support in Congress and the administration supports further extension of the Medicare telehealth flexibilities, the industry is again faced with a telehealth cliff on January 30th. While the politics surrounding another government shutdown currently appear significantly less likely than last year, it remains unclear when and how long the Medicare telehealth flexibilities might be extended. Notwithstanding the fact that there are standalone bills pending in Congress (like the CONNECT for Health Act and the Telehealth Modernization Act) to make the flexibilities permanent, Congress has been unable to pass much legislation beyond continuing funding resolutions. As such, the industry awaits to see what happens over the next several weeks.

Done Global Verdict and Further Indictment

The criminal case against Done Global's (Done) Ruthia He (founder and CEO) and David Brody (clinical president and sole shareholder of Done Health, P.C.), resulted in a decisive jury verdict. See our prior blog posts here and here. The case proceeded before Senior U.S. District Judge for the Northern District of California Charles Breyer. In November 2025, following trial, a federal jury returned guilty verdicts (with sentencing forthcoming) against both He and Brody in connection with a telemedicine criminal scheme centered on the virtual prescribing of controlled stimulants for the treatment of attention-deficit/hyperactivity disorder. The case marks the Department of Justice's first criminal drug distribution prosecution arising out of telemedicine prescribing practices and underscores a broader evolution in enforcement from traditional fraud models to more complex, platform-driven conduct.

Prosecutors alleged that from approximately February 2020 through January 2023, Done-affiliated clinicians issued extraordinarily high volumes of prescriptions for Adderall and other controlled stimulants while operating under policies and practices that undermined independent clinical judgment. The government charged that Done, He, and Brody:

• Limited initial encounters to brief, non-comprehensive visits.
• Relied on limited intake processes with minimal audio/video engagement.
• Pressured prescribers to issue stimulant prescriptions even when not medically supported.
• Discouraged follow-up encounters and adopted "auto-refill" features.
• Tied compensation to prescription volumes rather than clinical time or follow-up care.
  

The indictment also alleged violations of state corporate practice of medicine prohibitions by blurring the line between management and clinical control, prescribing across state lines without proper licensure or supervision, and submitting claims based on misleading documentation. The government further charged obstruction-of-justice conduct, including document destruction and the use of encrypted or personal communications after receipt of a grand jury subpoena.

Moreover, on December 17, 2025, a federal grand jury returned an indictment charging Done and Mindful Mental Wellness, P.A. (MMW Florida) with substantively similar charges for the period through February 2025. In that indictment, prosecutors allege that a new professional corporation, MMW Florida, was created by Done and He after pharmacies ceased filing prescriptions issued by the former Brody-owned professional corporation. Through a new physician-owner of MMW Florida, the indictment alleges that Done sought to continue its criminal conspiracy until February 2025.

The verdict and subsequent indictment confirm that criminal exposure in telemedicine is not limited to traditional "telefraud" schemes featuring marketers and sham consults. Instead, prosecutors and investigators are pursuing complex arrangements where management practices, clinical protocols, platform design, and financial incentives collectively impact prescribing behavior. As such, compliance efforts should be tailored to acknowledge this evolving reality.

As federal agencies consider permanent rules for telemedicine prescribing of controlled substances, the He and Brody verdicts and further indictment likely will factor into regulatory decision-making. Policymakers must balance access to clinically appropriate virtual care with the imperative to deter controlled substances prescribing without legitimate medical purpose.

Take Aways

If history is any guide, 2026 will continue to be an impactful year for the telehealth industry. Beyond a potential telehealth special registration final rule and potential extension of the Medicare flexibilities, 2026 is likely to see further oversight and enforcement regarding telehealth services. We will continue to monitor and report on important telehealth developments as they evolve.

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