NYSDOH Proposed Regulations on In-Person Medical Evaluation Requirements and Exceptions for Controlled Substance Prescribing
In response to the COVID-19 public health emergency (PHE), the U.S. Department of Health and Human Services (DOH) waived the Ryan Haight Act’s requirement that at least one in-person medical evaluation take place prior to issuance of a prescription for controlled substances via telehealth. The flexibility granted by DOH allowed telemedicine to be used in place of the in-person evaluation for the prescription of schedule II-V controlled substances. Since the conclusion of the federally declared PHE, the Drug Enforcement Administration (DEA) issued two temporary rules, the last of which extended the rules through December 31, 2024 to permit the prescription of controlled medications through telemedicine.
In light of this impending expiration, on May 15, 2024, the New York State Department of Health (NYSDOH) proposed amendments to Sections 80.62, 80.63, and 80.84 of Title 10 of the Official Compilation of Codes, Rules, and Regulations to align with the DEA’s policy permitting the prescription of controlled substance medications via telemedicine. For example, the proposed regulations adopt the federal regulatory term “in-person medical evaluation” in lieu of the current NY regulatory phrase “physical examination”.
If adopted, these proposed regulations will limit the circumstances in which a controlled substance can be prescribed in the absence of an in-person medical evaluation of the patient by the prescribing practitioner. If the regulations go into effect as proposed, a controlled substance may be prescribed without an in-person medical evaluation, only under the following circumstances:
- When utilizing a consulting and referring practitioner for their patient if the patient’s medical record includes an in-person medical evaluation for the specific medical condition within 12 months performed by the practitioner who referred the patient.
- For a covering practitioner in the temporary absence of the initial prescriber as part of continuing therapy for the patient if the covering practitioner is a part of the same practice or has direct consultation with the initial prescriber confirming the necessity of the prescription.
- For a new condition in an emergency, provided that there is a pre-existing practitioner-patient relationship, the immediate administration of the drug is necessary, no alternative treatment is possible, and the prescription does not exceed a five-day supply.
- Through telemedicine – as such term is defined by article 29-G of the Public Health Law.
The new NYSDOH regulations align with the DEA requirement that prescribers of controlled substances using telehealth must use audio-visual, real-time two-way interaction and write the prescriptions only for legitimate medical purposes. The proposed regulations also seek to align with federal law by removing outdated references to a DEA requirement for prescribing buprenorphine and a patient number limitation which are no longer in effect. Further, the outdated phrase “narcotic addiction” is now replaced with the term “opioid use disorder”.
As the DEA considers permanent changes to federal rules governing the prescription of controlled substances, given NYDOH’s additional intent to align NYS regulations with the federal rules, it is likely that NYDOH will propose revisions to its proposed regulations.
We will continue to monitor all developments. Contact Robert Braumuller at (914) 287- 6185 or rbraumuller@bpslaw.com for additional information.