By Elena Eyber, J.D.
The DEA issued an interim final rule to revise its regulations to reflect the new provisions of the CSA amended by the SUPPORT Act.
The Drug Enforcement Administration (DEA) issued an interim final rule to update DEA regulations to reflect changes made to the Controlled Substances Act (CSA) by the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018 (SUPPORT Act). The following changes of the SUPPORT Act are being implemented into the DEA regulations: (1) revising the definition of a qualifying practitioner; (2) permanently allowing a nurse practitioner (NP) or physician assistant (PA) to be considered a qualifying other practitioner; (3) expanding the options available for a physician to be considered a qualifying physician; and (4) allowing a pharmacy to deliver prescribed controlled substances to a practitioner’s registered location for the purpose of maintenance or detoxification treatment. The DEA anticipates that this interim final rule will increase the number of treatment providers and the number of patients treated, resulting in a reduction in the economic burden of opioid abuse. This interim final rule became effective on October 30, 2020 (Interim final rule, 85 FR 69153, November 2, 2020).
Increase in patient limit. Section 3201(a) of the SUPPORT Act amended the CSA to provide flexibility to practitioners regarding the number of patients they may treat, without being separately registered as a narcotic treatment program, by adding more opportunities to increase the applicable number of patients that may be treated to 100. In general, the applicable number of patients that may be treated at one time is 30. A practitioner may treat up to 100 patients under two additional circumstances: (1) if the practitioner holds additional credentialing; or (2) if a practitioner provides medication-assisted treatment using covered medications in a qualified practice setting. Section 3201(a) also allows a practitioner to treat more patients, increasing the applicable number to 275 patients if a practitioner meets the requirements in 42 C.F.R. §8.610–8.655. The DEA is implementing these changes to the CSA by revising DEA regulations in 21 C.F.R. §1301.28(b)(1)(iii)(B)–(C).
Expansion of definition of ‘qualifying other practitioner.’ The CSA mandates that a practitioner who dispenses narcotic drugs for maintenance treatment or detoxification treatment must be a qualifying practitioner. Prior to the SUPPORT Act, the CSA defined a qualifying practitioner, under 21 U.S.C. §823(g)(2)(G)(iii), as a qualifying physician and also temporarily (until October 1, 2021) as a "qualifying other practitioner," which included a nurse practitioner or physician assistant who meets certain qualifications set forth in 21 U.S.C. §823(g)(2)(G)(iv). Sections 3201(b) through (d) of the SUPPORT Act updated the CSA by permanently allowing a nurse practitioner or a physician assistant to be considered a "qualifying other practitioner," and temporarily (until October 1, 2023) expanding the definition of a "qualifying practitioner" to also include a clinical nurse specialist, certified registered nurse anesthetist, or a certified nurse midwife who meets certain qualifications set forth in 21 U.S.C. §823(g)(2)(G)(iv), allowing more flexibility. The DEA is implementing these changes to the CSA by revising DEA regulations.
Option to allow a physician to become a qualifying physician. Section 3202(a) of the SUPPORT Act amended 21 U.S.C. §823(g)(2)(G)(ii) by adding a new option for a physician to be considered a "qualifying physician." Prior to the SUPPORT Act, a physician could become a qualifying physician through seven different options. The additional option allows a physician to be considered a qualifying physician if they graduated in good standing from an accredited school of allopathic medicine or osteopathic medicine in the United States within the five-year period immediately preceding the date that the physician submitted a written notification to the Secretary of HHS of their intent to dispense narcotic drugs for maintenance or detoxification treatment, and successfully completed a comprehensive allopathic or osteopathic medicine curriculum or accredited medical residency. This curriculum or residency must have included at least eight hours of training on treating and managing opioid-dependent patients, and, at a minimum, included training described in the regulations, and any other training the Secretary of HHS determines should be included in the curriculum. The SUPPORT Act added this training requirement to the CSA; however, there is no corresponding regulation in the Code of Federal Regulations that the DEA needs to revise and update because the definition of "qualifying physician" is only referred to in the regulations.
Delivery of controlled substance by pharmacy to practitioner. Section 3204(a) of the SUPPORT Act amended the CSA by adding language that sets forth the conditions in which a pharmacy may deliver a controlled substance to an administering practitioner. Specifically, a pharmacy is authorized to deliver a prescribed controlled substance to the practitioner’s registered location for the purpose of maintenance or detoxification treatment to be administered to a patient under specific conditions. Prior to this, pharmacies were only allowed to deliver controlled substances to the ultimate user or research subject. Under the new regulations, a pharmacy is allowed to dispense prescribed narcotic drugs in schedule III, IV, or V to a practitioner for the purpose of maintenance or detoxification treatment.
Specifically, the prescription must be issued by a qualifying practitioner and the prescription issued cannot be used to supply any practitioner with a stock of controlled substances for the purpose of general dispensing to patients. In addition, the practitioner must meet the following conditions: (1) the practitioner must administer the controlled substance to the patient named on the prescription by implantation or injection within 14 days after the date of receipt of the controlled substance by the practitioner; (2) the practitioner and pharmacy are authorized to conduct these activities in the State in which such activities take place; and (3) the prescribing practitioner and administering practitioner of the controlled substance must maintain complete and accurate records of all controlled substances delivered, received, administered, and disposed, including the persons to whom controlled substances were delivered.
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