Ohio Rev. Code Ann. § 5119.37 – Requirements to operate opioid addiction treatment programs

(A)
1. (1)
  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.
  2. (b) Division (A)(1)(a) of this section does not apply to a program operated by the United States department of veterans affairs.
2. (2) No community addiction services provider licensed under this section shall operate an opioid treatment program in a manner inconsistent with this section and the rules adopted under it.
(B) A community addiction services provider seeking a license to operate an opioid treatment program shall apply to the department of mental health and addiction services. The department shall review all applications received.
(C) The department may issue a license to operate an opioid treatment program to a community addiction services provider only if all of the following apply:
1. (1) During the three-year period immediately preceding the date of application, the provider or any owner, sponsor, medical director, administrator, or principal of the provider has been in good standing to operate an opioid treatment program in all other locations where the provider or such other person has been operating a similar program, as evidenced by both of the following:
  1. (a) Not having been denied a license, certificate, or similar approval to operate an opioid treatment program by this state or another jurisdiction;
  2. (b) Not having been the subject of any of the following in this state or another jurisdiction:
    1. (i) An action that resulted in the suspension or revocation of the license, certificate, or similar approval of the provider or other person;
    2. (ii) A voluntary relinquishment, withdrawal, or other action taken by the provider or other person to avoid suspension or revocation of the license, certificate, or similar approval;
    3. (iii) A disciplinary action that was based, in whole or in part, on the provider or other person engaging in the inappropriate prescribing, dispensing, administering, personally furnishing, diverting, storing, supplying, compounding, or selling of a controlled substance or other dangerous drug.
2. (2) It affirmatively appears to the department that the provider is adequately staffed and equipped to operate an opioid treatment program.
3. (3) It affirmatively appears to the department that the provider will operate an opioid treatment program in strict compliance with all laws relating to drug abuse and the rules adopted by the department.
4. (4) Except as provided in division (D) of this section and section 5119.371 of the Revised Code, if the provider is seeking an initial license for a particular location, the proposed opioid treatment program is not located on a parcel of real estate that is within a radius of five hundred linear feet of the boundaries of a parcel of real estate having situated on it a public or private school, child day-care center licensed under Chapter 5104. of the Revised Code, or child-serving agency regulated by the department under this chapter.
5. (5) The provider meets any additional requirements established by the department in rules adopted under division (F) of this section.
(D) The department may waive the requirement of division (C)(4) of this section if it receives, from each public or private school, child day-care center, or child-serving agency that is within the five hundred linear feet radius described in that division, a letter of support for the location. The department shall determine whether a letter of support is satisfactory for purposes of waiving the requirement.
(E) A license to operate an opioid treatment program shall expire one year from the date of issuance. Licenses may be renewed.
(F) The department shall establish procedures and adopt rules for licensing, inspection, and supervision of community addiction services providers that operate an opioid treatment program. The rules shall establish standards for the control, storage, furnishing, use, dispensing, and administering of medications used in medication-assisted treatment; prescribe minimum standards for the operation of the opioid treatment program component of the provider's operations; and comply with federal laws and regulations. All rules adopted under this division shall be adopted in accordance with Chapter 119. of the Revised Code. All actions taken by the department regarding the licensing of providers to operate opioid treatment programs shall be conducted in accordance with Chapter 119. of the Revised Code, except as provided in division (L) of this section.
(G)
1. (1) The department shall inspect all community addiction services providers licensed to operate an opioid treatment program. Inspections shall be conducted at least annually and may be conducted more frequently. In addition, the department may inspect any provider or other person that it reasonably believes to be operating an opioid treatment program without a license issued under this section.
2. (2) When conducting an inspection, the department may do both of the following:
  1. (a) Examine and copy all records, accounts, and other documents relating to the provider's or other person's operations, including records pertaining to patients or clients;
  2. (b) Conduct interviews with any individual employed by or contracted or otherwise associated with the provider or person, including an administrator, staff person, patient, or client.
3. (3) No person or government entity shall interfere with a state or local government official acting on behalf of the department while conducting an inspection.
(H) A community addiction services provider shall not administer or dispense methadone in a tablet, powder, or intravenous form. Methadone shall be administered or dispensed only in a liquid form intended for ingestion. A community addiction services provider shall not administer or dispense a medication used in medication-assisted treatment for pain or other medical reasons.
(I) As used in this division, "program sponsor" means a person who assumes responsibility for the operation and employees of the opioid treatment program component of a community addiction services provider's operations. A community addiction services provider shall not employ an individual who receives a medication used in medication-assisted treatment from that provider. A provider shall not permit an individual to act as a program sponsor, medical director, or director of the provider if the individual is receiving that medication from any community addiction services provider.
(J) The department may issue orders to ensure compliance with all laws relating to drug abuse and the rules adopted under this section. Subject to section 5119.27 of the Revised Code, the department may hold hearings, require the production of relevant matter, compel testimony, issue subpoenas, and make adjudications. Upon failure of a person without lawful excuse to obey a subpoena or to produce relevant matter, the department may apply to a court of common pleas for an order compelling compliance.
(K) The department may refuse to issue, or may withdraw or revoke, a license to operate an opioid treatment program. A license may be refused if a community addiction services provider does not meet the requirements of division (C) of this section. A license may be withdrawn at any time the department determines that the provider no longer meets the requirements for receiving the license. A license may be revoked in accordance with division (L) of this section. Once a license is issued under this section, the department shall not consider the requirement of division (C)(4) of this section in determining whether to renew, withdraw, or revoke the license or whether to reissue the license as a result of a change in ownership.
(L) If the department finds reasonable cause to believe that a community addiction services provider licensed under this section is in violation of any state or federal law or rule relating to drug abuse, the department may issue an order immediately revoking the license, subject to division (M) of this section. The department shall set a date not more than fifteen days later than the date of the order of revocation for a hearing on the continuation or cancellation of the revocation. For good cause, the department may continue the hearing on application of any interested party. In conducting hearings, the department has all the authority and power set forth in division (J) of this section. Following the hearing, the department shall either confirm or cancel the revocation. The hearing shall be conducted in accordance with Chapter 119. of the Revised Code, except that the provider shall not be permitted to operate an opioid treatment program pending the hearing or pending any appeal from an adjudication made as a result of the hearing. Notwithstanding any provision of Chapter 119. of the Revised Code to the contrary, a court shall not stay or suspend any order of revocation issued by the department under this division pending judicial appeal.
(M) The department shall not revoke a license to operate an opioid treatment program unless all clients receiving medication used in medication-assisted treatment from the community addiction services provider are provided adequate substitute medication or treatment. For purposes of this division, the department may transfer the clients to other providers licensed to operate opioid treatment programs or replace any or all of the administrators and staff of the provider with representatives of the department who shall continue on a provisional basis the opioid treatment component of the provider's operations.
(N) Each time the department receives an application from a community addiction services provider for a license to operate an opioid treatment program, issues or refuses to issue a license, or withdraws or revokes a license, the department shall notify the board of alcohol, drug addiction, and mental health services of each alcohol, drug addiction, and mental health service district in which the provider operates.
(O) Whenever it appears to the department from files, upon complaint, or otherwise, that a community addiction services provider has engaged in any practice declared to be illegal or prohibited by section 3719.61 of the Revised Code, or any other state or federal laws or regulations relating to drug abuse, or when the department believes it to be in the best interest of the public and necessary for the protection of the citizens of the state, the department may request criminal proceedings by laying before the prosecuting attorney of the proper county any evidence of criminality which may come to its knowledge.
(P) The department shall maintain a current list of community addiction services providers licensed by the department under this section and shall provide a copy of the current list to a judge of a court of common pleas who requests a copy for the use of the judge under division (H) of section 2925.03 of the Revised Code. The list of licensed community addiction services providers shall identify each licensed provider by its name, its address, and the county in which it is located.