Ohio Laws

Requirements for Licensure and Operations of Medications for Opioid Use Disorder Treatment

Question:

Does the state regulate the licensure of opioid treatment programs (OTPs)?

Answer:
Yes
This answer is derived from 3 section of law
Citation:
  • citation 1: see full citation
    (A) (1) (a) Except as provided in division (A) (1)(b) of this section, no person or government entity shall operate an opioid treatment program requiring certification, as certification is defined in 42 C.F.R. 8.2, unless the person or government entity is a community addiction services provider and the program is licensed under this section. see full law
  • citation 2: see full citation
    (11) " Opioid treatment program" or "program" means a community addiction services provider that engages in supervised assessment and treatment, using any form of medication assisted treatment for individuals who have opioid use disorders. Services include medically supervised withdrawal and/or maintenance treatment, along with various levels of medical, psychiatric, psychosocial, and other types of supportive care. see full law
  • citation 3: see full citation
    (A) An alcohol and drug addiction program desiring to obtain an initial license or renew a license as an opioid treatment program shall:(1) Be certified as a provider pursuant to Chapter 5122-25 of the Administrative Code at a minimum for the following services:(a) General services in accordance with rule 5122-29-03 of the Administrative Code;(b) SUD case management services in accordance with rule 5122-29-13 of the Administrative Code; and,(c) Crisis intervention in accordance with rule 5122-29-10 of the Administrative Code.(2) Submit with the application for initial license or license renewal a licensure fee as set by paragraph (B)(2) of rule 5122-40-08 of the Administrative Code;(3) Submit a renewal application at least ninety days prior to the expiration of the current license.(4) When applying for renewal licensure, be accredited as an opioid treatment program by an accreditation body that has been approved by SAMHSA;(5) Be certified by SAMHSA pursuant to "certification of opioid treatment programs," 42 C.F.R. Part 8.11;(6) Have a category III terminal distributor of dangerous drugs license from the state board of pharmacy pursuant to Chapter 4729. of the Revised Code;(7) Have a security and alarm system that is approved by the United States drug enforcement administration;(8) Meet the security requirements for the distribution and storage of controlled substances as required by 21 C.F.R. 1301.72 to 21 C.F.R. 1301.76;(9) Operate the program in accordance with 21 C.F.R. 291.505, conditions for the use of narcotic drugs; appropriate methods of professional practice for medical treatment of the narcotic addiction of various classes of narcotic addicts under section 4 of the Comprehensive Drug Abuse Prevention and Control Act of 1970, Pub. L. No. 91-513, 84 Stat. 1236 (Oct. 27, 1970);(10) Have a program sponsor who has signed and submitted SAMHSA form SMA-162, application for certification to use opioid drugs in a treatment program under 42 CFR 8.11;(11) Be in good standing with the state board of pharmacy, centers for medicare and medicaid services, Ohio department of medicaid,, and the United States drug enforcement administration;(12) Be in good standing as defined by division (C)(1) of section 5119.391 of the Revised Code until June 29, 2019 and division (C)(1) of section 5119.37 of the Revised Code after June 29, 2019;(13) Demonstrate the ability to meet the standards of medical care for opioid treatment services established by the American society of addiction medicine (ASAM) criteria, third edition (2013), or other nationally recognized standards organization selected by the director; see full law