DHS 75.59(22)(a)(a) Approval of primary service. An applicant for approval to operate an OTP in Wisconsin with the intent of administering or dispensing medication for the treatment of an opioid use disorder shall submit all of the following to the SOTA:

DHS 75.59(22)(a)2.2. A copy of the request for registration with the DEA for the use of narcotic medications in the treatment of opiate addiction.

DHS 75.59(22)(a)6.6. A copy of the policy and procedures manual for the service, detailing the operation of the service as follows:

DHS 75.59(22)(a)6.e.e. A description of the service’s use of testing or analysis to detect substances and the purposes for which the results of testing or analysis are used as well as the frequency of use.

DHS 75.59(22)(a)8.8. Documentation that the service will have ready access to a comprehensive range of medical and rehabilitative services that will be available if needed, including the name, address, and a description of each hospital, institution, clinical laboratory or other facility available to provide the necessary services.

DHS 75.59(22)(a)9.9. A list of persons working in the service who are licensed to administer or dispense narcotic drugs even if they are not responsible for administering or dispensing narcotic drugs.

DHS 75.59(22)(b)(b) Approval of service sites. Only service sites approved by SAMHSA, the DEA and the SOTA may be used for treating persons with an opioid use disorder with a narcotic drug.

DHS 75.59(22)(c)(c) Approval of medication units.

DHS 75.59(22)(c)1.1. To operate a medication unit, a service shall apply to the department for approval to operate the medication unit. A separate approval is required for each medication unit to be operated by the service. A medication unit is established to facilitate the needs of patients who are stabilized on an optimal dosage level. The department shall approve a medication unit before it may begin operation.

DHS 75.59(22)(c)2.2. Approval of a medication unit shall take into consideration the distribution of patients and other medication units in a geographic area.

DHS 75.59(22)(c)3.3. If a service has its approval revoked, the approval of each medication unit operated by the service is automatically revoked. Revocation of the approval of a medication unit does not automatically affect the approval of the primary service.

DHS 75.59(23)(a)(a) Service sponsor. A person who sponsors an OTP and any personnel responsible for a particular service shall agree in writing to adhere to all applicable requirements of this chapter and 21 CFR part 291 and 42 CFR part 2.

DHS 75.59(23)(b)(b) Responsibilities. The service sponsor is responsible for all service staff and for all other service providers who work in the service at the primary facility or at other facilities or medication units.

DHS 75.59(23)(c)(c) Written agreement. The service sponsor shall agree in writing to inform all service staff and all contracted service providers of the provisions of all pertinent state rules and federal regulations and shall monitor their activities to ensure that they comply with those rules and regulations.

DHS 75.59(23)(d)(d) Replacement. The service shall notify the designated federal agency and SOTA within 5 business days after replacement of the service sponsor or medical director.

DHS 75.59(23)(e)(e) Required services. OTPs shall provide adequate medical, counseling, vocational, educational, and other assessment and treatment services. These services must be available at the primary facility, except where the program sponsor has entered into a formal, documented agreement with a private or public agency, organization, practitioner, or institution to provide these services to patients enrolled in the OTP. The program sponsor, in any event, must be able to document that these services are fully and reasonably available to patients. This documentation must be provided to the department upon request.