Attached (pdf), please find a Notice of Adoption published in the State Register by the State Department of Health on May 21st related to In-Person Medical Evaluation Requirements and Exceptions for Controlled Substance Prescribing. This rule clarifies existing language with regard to the requirement for a practitioner to conduct an in-person medical evaluation prior to the issuance of a prescription for a controlled substance medication. Further, the rule aligns allowances for the prescribing of controlled substance medications by telemedicine or telehealth in New York State with federal law and regulation and aligns New York State with changes made to 21 USC § 823, and reduce stigma associated with substance use disorders.
Key Provisions:
In clarifying the in-person patient evaluation requirements the rule states the following with exceptions (see bolded): (d) No controlled substance shall be prescribed prior to an in-person medical evaluation of the patient by the prescribing practitioner for the medical condition for which the controlled substance is being considered. The practitioner shall determine the parameters for the medical evaluation, and frequency of future medical evaluations as part of the patient’s continuing treatment, utilizing generally accepted medical standards and taking into account the drug to be prescribed and the patient’s medical condition, history and disposition toward the use of controlled substances.
(e) Notwithstanding subdivision (d) of this section, a controlled substance may be prescribed by a practitioner, in the absence of the practitioner performing an in-person medical evaluation, in the following circumstances:
(1) when utilizing a consulting or referring practitioner – for their patient after review of the patient’s record if the record contains the result of an in-person medical evaluation performed by a consulting or referring practitioner within the previous 12 months specific to the medical condition for which the prescription is being considered.
(2) for a covering practitioner – in the temporary absence of the initial prescriber for a patient as part of a continuing therapy, provided the prescribing practitioner either:
(i) is part of the same practice as the initial prescriber and has direct access to the patient’s medical records, and such records warrant continued controlled substance prescribing, or
(ii) has direct and adequate consultation with the initial prescriber, who assures the necessity of continued controlled substance prescribing and with which the practitioner concurs. If the patient record is not available, the practitioner shall document the activity for their own record and shall transmit to the initial prescriber the prescription information within 72 hours. The initial prescriber shall include the prescription information in the patient’s record.
(3) for a new condition in an emergency situation – if a patient develops a new medical condition that would warrant the issuance of a prescription for a controlled substance, provided that:
(i) the prescribing practitioner has a previously established practitioner/patient relationship with the patient;
(ii) an emergency exists such that the immediate administration of the drug is necessary for the proper treatment of the patient and no alternative treatment is available; and
(iii) the prescription does not exceed a 5-day supply as determined by the directions for use. If the practitioner prescribes such substance orally, the practitioner must comply with the requirements of section 80.68 and section 80.70 of this Part.
(4) through telemedicine or telehealth – as such terms are defined by article 29-G of the Public Health Law, consistent with all applicable state laws and regulations and the laws, rules and regulations of the Drug Enforcement Administration, United States Department of Justice, or any successor agency. This is inclusive of any controlled substance as approved by the Food and Drug Administration (FDA), or its successor agency, and the New York State Department of Health for the treatment of opioid use disorder as listed in section 80.84 of this Part (embedded below).
Section 80.84 is amended to read as follows:
80.84 Practitioners and pharmacies; prescribing, administering and dispensing for the treatment of opioid use disorder [narcotic addiction]. [Pursuant to the provisions of the federal Drug Addiction Treatment Act of 2000 (DATA 2000) (106 P.L. 310, Div. B, Title XXXV, Section 3502(a)), an authorized] A practitioner may prescribe, administer or dispense an approved controlled substance, and a licensed registered pharmacist may dispense an approved controlled substance, to a patient, pursuant to a prescription, for the treatment of opioid use disorder. [participating in an authorized controlled substance maintenance program approved pursuant to Article 32 of the Mental Hygiene Law for the treatment of narcotic addiction.] if a practitioner is prescribing, administering, or dispensing for the treatment of opioid use disorder as more than a minor part of their practice, the practitioner shall also comply with article 32 of the Mental Hygiene Law.