It’s an exciting time for telehealth companies and telehealth providers. On Tuesday, November 19, 2024, the Department of Health and Human Services (HHS) and the Drug Enforcement Administration (DEA) extended the telemedicine prescribing flexibilities for another year through December 31, 2025. Platforms and practitioners leveraging technology to reach patients via audio-video telemedicine encounters can continue providing increased access to care under this Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications (the “Third Extension”).
Through 2025, a DEA-registered practitioner is authorized to continue prescribing schedule II-V controlled substances via telemedicine to a patient even when the prescribing practitioner has not conducted an in-person medical evaluation. Historically, under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, an in-person evaluation of the patient was required until HHS and DEA, on January 31, 2020, granted temporary exceptions in response to the COVID-19 Public Health Emergency and nationwide shutdowns. This Third Extension allows practitioners to continue using telehealth platforms via audio-video telemedicine to prescribe for a legitimate medical purpose in the usual course of professional practice and in compliance with applicable Federal and State law and agency guidance. As described in the Third Extension, “DEA and HHS believe this extension creates a benefit in the form of cost savings to prescribers and patients” and will give lawmakers and the agencies additional time to develop a more permanent solution. Some additional reasons identified in the Third Extension include to:
- Prevent a reduction in access to care for patients who do not yet have an existing telemedicine relationship with their practitioners;
- Prevent backlogs with respect to in-person medical evaluations in the months shortly before and after the expiration of the telemedicine flexibilities and ensure the availability of telemedicine for practitioners and patients who have come to rely on it;
- Address the urgent public health need for continued access to buprenorphine as medication for opioid use disorder in the context of the continuing opioid public health crisis;
- Allow patients, practitioners, pharmacists, service providers, and other stakeholders sufficient time to prepare for the implementation of any future regulations that apply to prescribing of controlled medications via telemedicine; and
- Enable DEA and HHS to conduct a thorough evaluation of regulatory alternatives in order to promulgate regulations that most effectively expand access to telemedicine encounters in a manner that is consistent with the public health and safety, while also effectively mitigating against the risk of possible diversion.
Despite this positive development, more action is needed from Congress prior to the end of the year to extend some of the telehealth flexibilities that patients and providers currently rely on in accessing or delivering services. Currently, two overlapping bills in Congress would renew these flexibilities:
The Telehealth Modernization Act of 2024 (H.R. 7623) and the CONNECT for Health Act (H.R. 4189)
These overlapping bills aim to extend critical telehealth flexibilities under Medicare, which were introduced during the COVID-19 pandemic and are set to expire at the end of the year. These flexibilities have become essential in providing continued access to care for Medicare beneficiaries beyond the pandemic. Industry focus is currently on the Telehealth Modernization Act, which seeks to preserve the following key provisions:
- Waiver of Geographic and Originating Site Restrictions allowing Medicare beneficiaries to continue to access telehealth services from their home or other location, giving beneficiaries greater access and flexibility to receive care.
- Maintaining Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) ability to serve as distant sites for telehealth services, ensuring continued access for rural and underserved populations.
- Continuation of an Expanded List of Medicare providers eligible to deliver telehealth services, including professionals like physical therapists, to increase beneficiary access to a range of health services.
- Continued coverage for audio-only telehealth services.
Both bills aim to ensure telehealth remains a permanent, flexible, and accessible option for Medicare beneficiaries to address the evolving needs of today’s health care landscape, and the passage of either before the end of the year would help provide consistency and continuity in the current telehealth reimbursement landscape. Although both bills enjoy bipartisan support, it remains to be seen whether Congress will act to pass either bill before the end of the year. There is also the potential that these flexibilities could be incorporated, in whole or in part, to an end of the year omnibus measure, as they were in 2022, the last time these flexibilities were up for renewal.
As we look into the new year, several other proposed measures at the federal level, such as the Medicare Telehealth Privacy Act (H.R. 6364), which would help Medicare-enrolled providers to keep home addresses confidential, or the Teleheath Benefit Expansion for Workers Act (H.R. 824), which would make it easier for employers to add stand-alone telehealth benefits to their sponsored health plans, may merit attention if they are reintroduced in the 119th Congress. Additionally, there is always the possibility of continued legislative activity at the state level, following the passage and subsequent veto of AB 3129 in California which, among other changes, attempted regulated private equity and venture capital involvement in the relationships between medical practices and MSOs. As laws and regulations move towards a more permanent solution, telehealth platforms and practitioners continue to drive the healthcare industry forward by delivering affordable, accessible, and quality care.