Navigating Telemedicine Regulations: Updates in Healthcare Policy
PROPOSED RULEMAKING – OPEN COMMENT PERIODS
Currently, there are open comment periods for two Notices of Proposed Rulemaking (NPRM), one issued by the Drug Enforcement Administration (DEA) and the other by the US Department of Health and Human Services Office for Civil Rights (HHS OCR).
Open comment periods are a crucial part of the rulemaking process, allowing the public and key stakeholders, such as industry professionals, advocacy groups, and affected individuals, to provide feedback, raise concerns, and offer suggestions on proposed regulations before they are finalized. These comments help regulatory agencies better understand how the proposed rules may impact various groups, identify potential unintended consequences, and refine the regulations. By participating in the open comment process, individuals and organizations can contribute to shaping policies that directly affect the healthcare industry and its broader community. Your opinion really does count!
HHS OCR: HIPAA Security Rule NPRM
On December 27, 2024, HHS OCR announced a NPRM to amend the Health Insurance Portability and Accountability Act (HIPAA) of 1996 Security Rule. The proposed changes aim to strengthen cybersecurity protections for electronic protected health information in response to escalating cyber threats targeting the health care sector. The updated rule would enhance security standards for covered entities, including health plans, health care clearinghouses, most health care providers, and their business associates, collectively known as regulated entities. This proposal aligns with the HHS Healthcare and Public Health critical infrastructure sector Cybersecurity Performance Goals and reflects OCR's ongoing efforts to safeguard the U.S. health care system from increasing cyberattacks. The existing Security Rule continues to be in effect while HHS works on this rulemaking process.
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DEA: Special Registration for Telemedicine and Limited State Telemedicine Registrations NPRM
On January 17, 2025, the DEA released a NPRM detailing plans to establish a Special Registration framework for telemedicine. This framework would enable certain DEA-registered practitioners to deliver telemedicine services in compliance with the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Act”).
The proposal outlines three types of Special Registration:
- Telemedicine Prescribing Registration – Grants qualified clinicians the ability to prescribe Schedule III-V controlled substances.
- Advanced Telemedicine Prescribing Registration – Permits specialized clinicians to prescribe Schedule II-V controlled substances.
- Telemedicine Platform Registration – Authorizes eligible online telemedicine platforms, acting as platform practitioners, to dispense Schedule II-V controlled substances.
The Act requires an in-person medical evaluation before prescribing controlled substances. However, it includes an exception allowing practitioners to prescribe via telemedicine, provided the services meet the criteria outlined in the Act.
The DEA considers these changes essential to successfully broaden patient access to controlled substance medications through telemedicine while minimizing the potential risks of diversion associated with this expansion. The proposed framework includes enhanced requirements for prescription management, recordkeeping, and reporting to ensure greater accountability and security in the prescribing and dispensing of controlled substances via telemedicine.
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NOTICE OF FINAL RULES
HHS & DEA: Continuity of Care via Telemedicine for Veterans Affairs Patients Final Rule
On January 17, 2025, the DEA and HHS jointly issued a final rule expanding prescribing authority for Department of Veterans Affairs (VA) practitioners. The rule eliminates the need for Special Registration requirements for VA providers. Once a VA medical practitioner completes an in-person medical examination, the resulting provider-patient relationship is extended to include any VA practitioner offering care via telemedicine.
The rule is intended to enhance access to care for VA patients by reducing barriers to timely treatment, particularly for those who rely on telemedicine or face challenges in accessing in-person care.
The final rule will take effect on February 18, 2025, allowing VA facilities time to implement the necessary procedural adjustments to comply with the updated regulations.
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HHS & DEA: Expansion of Buprenorphine Treatment via Telemedicine Encounter Final Rule
On January 17, 2025, the DEA and HHS jointly issued a final rule expanding access to buprenorphine treatment for opioid use disorder (OUD) via telemedicine. This rule allows practitioners to prescribe a six-month initial supply of buprenorphine through audio-only telemedicine consultations, eliminating the need for an in-person evaluation prior to the first prescription. Subsequent prescriptions beyond the initial six-month supply will require either an in-person visit or a real-time, two-way audio-visual telemedicine encounter.
The final rule also makes permanent the telemedicine flexibilities that were previously extended through the end of 2025, ensuring continued access to buprenorphine treatment via telemedicine encounters. This regulatory change is expected to enhance access to buprenorphine treatment, particularly for individuals in rural or underserved areas, by leveraging telemedicine to overcome geographical and logistical barriers to care.
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CONCLUSION
The open comment period in notices of proposed rulemaking and final rules represent significant developments for telemedicine and healthcare access. From strengthening cybersecurity protection requirements under HIPAA to expanding prescribing authority and increasing access to treatments such as buprenorphine, these initiatives aim to address challenges and opportunities in the evolving healthcare industry.
Federal agencies, such as the DEA and HHS, rely on stakeholders in telemedicine to inform them via the open comment period on how these proposed regulations will impact their practices and patients. By staying informed and participating in these discussions, healthcare professionals and organizations can contribute to shaping policies that impact telemedicine as a tool for improving healthcare delivery and accessibility.
HHS invites feedback from all stakeholders to share their comments via regulations.gov. The public has 60 days from the NPRM's publication in the Federal Register to submit comments.
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