Key Update:
On May 15, 2024, the New York State Department of Health (DOH) announced a pivotal change in its regulations, as it intends to permit health care providers to use telemedicine to conduct patient evaluations before prescribing controlled substances. Prior to the COVID-19 pandemic, DOH required health care providers to perform an initial in-person physical evaluation of patients before prescribing controlled substances.
This significant regulatory shift aims to alleviate practitioner confusion between federal and state prescribing requirements, as well as enhance access to treatment for patients, particularly those who may have difficulty accessing in-person care, like individuals living in rural or underserved areas or those with mobility or transportation issues.
DOH will be accepting comments on the proposed regulatory changes for sixty (60) days or through July 14, 2024.
Federal Considerations:
It is important to note that this change at the state level is contingent upon the ongoing federal allowances under the Drug Enforcement Administration (DEA) regulations. During the COVID-19 public health emergency, the DEA waived its initial in-person medical evaluation requirements, permitting the prescription of Schedule II-V controlled substances via audio-video telemedicine encounters. However, this flexibility, in its current form, is set to expire on December 31, 2024.
The DEA has proposed regulations that would allow medical practitioners to prescribe a 30-day supply of Schedule III-V non-narcotic controlled substance medications or a 30-day supply of buprenorphine for the treatment of opioid use disorder without first having conducted an in-person evaluation or without a referral from a medical practitioner that has conducted such evaluation. In its commentary on the proposed regulations, the DEA has clearly signaled that it does not intend to permanently allow Schedule II controlled substances prescribing via telemedicine without an in-person medical evaluation, stating that allowing the practice to continue would be inconsistent with effective controls against diversion and would pose too great a risk to public health and safety. As of this Alert, the DEA is reportedly still working through the record-breaking 38,000 comments it received on its proposed telemedicine rules.
The continuation of this federal policy is crucial for New York’s new regulation to be effectively implemented.
We will continue to monitor DOH and the DEA’s regulatory activities and will provide updates as they become available.
Should you have any questions regarding these changes, please contact the authors, the Garfunkel Wild attorney with whom you regularly work, or email us at [email protected].