Prior to the Comprehensive Addiction and Recovery Act of 2016 (CARA) only “physicians” could dispense and prescribe narcotic drugs for maintenance and detoxification treatment. CARA expanded who may prescribe for maintenance and detoxification treatment to “qualifying practitioners” (temporarily through October 1, 2021), a broader term than “physicians” that allows for a wider array of practitioners to prescribe. This change opened the door for advanced registered nurse practitioners (ARNPs) and physician assistants (PAs) to provide these needed services to patients battling opioid addiction, once they obtain a Drug Enforcement Administration (DEA) mid-level practitioner registration and meet the CARA requirements below.

The DEA adopted its Final Rule, effective January 22, 2018, that recognizes ARNPs and PAs to be “other qualifying practitioners” if they meet the CARA criteria which generally provides:

(I) The ARNP or PA is licensed under State law to prescribe schedule III, IV, or V medications for the treatment of pain;

(II) The ARNP or PA has completed at least 24 hours of initial training addressing: opioid maintenance and detoxification; appropriate clinical use of all drugs approved by the Food and Drug Administration for the treatment of opioid use disorder; initial and periodic patient assessments (including substance use monitoring); individualized treatment planning, overdose reversal, and relapse prevention; counseling and recovery support services; staffing roles and considerations; diversion control; and other best practices, as identified by the Secretary; or

Has such other training or experience as the Secretary determines will demonstrate the ability of the ARNP or PA to treat and manage opiate-dependent patients.

(III) The ARNP or PA is supervised by, or works in collaboration with, a qualifying physician, if the ARNP or PA is required by State law to prescribe medications for the treatment of opioid use disorder in collaboration with or under the supervision of a physician.

The DEA requires an additional DEA registration for practitioners and qualified practitioners who provide maintenance and detoxification treatment for drug addiction. However, there is a waiver process through the Substance Abuse and Mental Health Services Administration (“SAMHSA”). SAMHSA had previously set the maximum number of patients for which a practitioner could receive a waiver at 100. In 2016, SAMHSA raised the maximum number from 100 patients to 275 patients. SAMHSA’s rulemaking preceded the enactment of CARA, so it only addresses practitioner (physicians) and does not directly address the “qualified practitioners.” The DEA’s recent rule amendment likewise increased the number of patients a practitioner or qualified practitioner treats to 275 patients without the need for an additional DEA registration to dispense maintenance and detoxification treatment controlled substances.

Key Takeaways:

Florida ARNPs and PAs wishing to prescribe and dispense these drugs should:

  1. Check that they qualify under CARA and state law;
  2. Complete the required course outlined above and submit certificates to SAMHSA;
  3. Register as mid-level practitioners with DEA;
  4. Comply with the required SAMHSA waiver process as to the number of patients being treated in order to avoid separate DEA registration for opioid treatment and maintenance; and
  5. Register as dispensing practitioners if they wish to dispense, but recognize the restrictions on dispensing Schedule II and III drugs.