On August 29, 2024, a statement released by a Virginia Senator urged congress to be ready to take action in response to a recent report indicating that the DEA is contemplating a proposed rule that would significantly impact patients’ ability to access certain controlled substances through telehealth.
The DEA’s reported proposed rule is said to provide an “even worse solution” than the first proposed rule published in February 2023. Following the issuance of the first proposed rule, which limited the prescribing of controlled substances via telemedicine to one 30-day supply of a controlled medication without an in-person evaluation, the DEA and HHS received an outpouring of approximately 38,000 public comments. The response resulted in the DEA and HHS issuing an initial extension of the current COVID-era flexibilities that permit the prescribing of controlled substances via telehealth, hosting of a public listening session, and subsequently confirming a second extension of the COVID flexibilities through the end of 2024.
The DEA has not yet published its new proposed rule or directly provided details to the public. However, reports have mentioned that the rule will incorporate new restrictions that allow no more than half of a provider’s prescriptions to be ordered virtually. Additionally, preliminary reports indicate that to prevent diversion, the new rule may require multi-state prescription drug monitoring program (PDMP) review before virtually prescribing to patients. If accurate and enacted, the additional review standard would elevate a provider’s responsibility from checking the applicable state PDMP to checking all PDMPs before ordering, creating a burdensome task in the absence of centralized searching. Providers who utilize telehealth to prescribe controlled substances should be prepared for the new rule to create new prescribing limitations, potentially different and potentially more restrictive, than the previously proposed rule.
Telehealth providers and administrators, especially those who have built or are participating in models incorporating the prescribing of controlled substances, must remain cognizant of the status of this rule and how it may impact their practices. Stakeholders should also take this time to explore contingency plans that may alter their standard workflow but preserve the viability of their models.
How Frier Levitt Can Help
Frier Levitt continues to monitor new and proposed telehealth legislation affecting providers. Frier Levitt attorneys regularly advise providers, digital health and management companies, and marketers on developing and restructuring telehealth business models to comply with applicable law while considering obstacles related to prescribing, licensing, and insurance reimbursement concerns that are unique to each arrangement. If you are seeking to Launch a Telemedicine Practice or Telehealth Startup or want to ensure your compliance in an existing model, contact us to speak to an experienced telehealth attorney who can comprehensively evaluate and recommend a compliant, sustainable model.
