DHS 75.60(2)(2)Service description. In this section, “office-based opioid treatment,” or “OBOT” service means pharmacotherapy for opioid use disorder, delivered in a stand-alone office-based opioid treatment clinic, a private office, or public sector clinic setting, excluding certified settings exempted in s. DHS 75.60 (1) or otherwise certified under this chapter, by practitioners authorized to prescribe outpatient supplies of medications approved by the FDA for the treatment of opioid addiction or dependence, prevention of relapse of opioid addiction or dependence, or both. An OBOT is subject to the oversight of the state opioid treatment authority. OBOT includes treatment with all medications approved by the FDA for such treatment.
DHS 75.60(3)(3)Relationship to treatment service general requirements. A service that provides OBOT under this section shall be exempt from the treatment service general requirements in subchapter IV, unless otherwise indicated in this section.
DHS 75.60(4)(4)Definitions. In this section:
DHS 75.60(4)(a)(a) “Drug Addiction Treatment Act of 2000” (DATA 2000) means Title XXXV, Section 3502 of the Children’s Health Act, permits physicians who meet certain qualifications to treat opioid addiction with Schedule III, IV, and V narcotic medications that have been specifically approved by the FDA for that indication.
DHS 75.60(4)(b)(b) “DATA 2000 waiver” means an authorization conveyed by SAMHSA and the DEA to a practitioner that permits them to prescribe or administer buprenorphine products to an individual with an opioid use disorder.
DHS 75.60(4)(c)(c) “Primary care service” means outpatient general health care services provided by a clinic for regular health care services, preventive care, or for a specific health concern, and includes all of the following:
DHS 75.60(4)(c)1.1. Care that promotes and maintains mental and physical health and wellness.
DHS 75.60(4)(c)2.2. Care that prevents disease.
DHS 75.60(4)(c)3.3. Screening, diagnosing, and treating acute or chronic conditions caused by disease, injury, or illness.
DHS 75.60(4)(c)4.4. Patient counseling and education.
DHS 75.60(4)(c)5.5. Provision of a broad spectrum of preventive and curative health care over a period of time.
DHS 75.60(4)(c)6.6. Coordination of care.
DHS 75.60(5)(5)State opioid treatment authority. The powers and duties of the SOTA include:
DHS 75.60(5)(a)(a) Facilitating the development and implementation of rules, regulations, standards, and evidence-based practices, emerging best practices, or promising practices, to ensure the quality of services delivered by OBOT services.
DHS 75.60(5)(b)(b) Acting as a liaison between relevant state and federal agencies.
DHS 75.60(5)(c)(c) Reviewing opioid treatment guidelines and regulations developed by the federal government.
DHS 75.60(5)(d)(d) Delivering technical assistance and informational materials to OBOT services as needed.
DHS 75.60(5)(e)(e) Performing both scheduled and unscheduled site visits OBOTs in cooperation with department certification office or other oversight agencies, or as designated by the SOTA, when necessary and appropriate, and preparing reports as appropriate.
DHS 75.60(5)(f)(f) Consulting with the federal government regarding approval or disapproval of requests for exceptions to federal regulations, where appropriate.
DHS 75.60(5)(g)(g) Receiving and addressing service recipient appeals and grievances in partnership with the department’s client rights office.
DHS 75.60(5)(h)(h) Issuing a list of required evidence-based practices, emerging best practices, and promising practices to be delivered by OBOT services, so long as the required practices are recognized by SAMHSA, Centers for Disease Control, or National Institute of Health. The SOTA may also provide a list of recommended evidence-based practices, emerging best practices, and promising practices. The SOTA may update the required practices list and the recommended practices list as needed to reflect advances in outcomes research and medical services for persons living with opioid use disorders. The SOTA shall take into consideration the adequacy of evidence to support the efficacy of the practice, the quality of workforce available, and the current availability of the practice in the state when updating the lists. At least 120 days before issuing the initial required practices list and any revisions to the required practices list, the SOTA shall provide stakeholders with an opportunity to comment and shall take those comments into consideration when updating the required practices list.
DHS 75.60(6)(6)General requirements.
DHS 75.60(6)(a)(a) Governing authority or entity owner. The governing authority or entity owner of an OBOT service shall do all of the following:
DHS 75.60(6)(a)1.1. Designate a member or representative of the governing body that is legally responsible for the operation of a service that has the authority to conduct the policy, actions, and affairs of the service, to complete the entity owner background check and to be the entity owner responsible for a service.
DHS 75.60(6)(a)2.2. Appoint a service director whose qualifications, authority, and duties are defined in writing.
DHS 75.60(6)(a)3.3. Establish written policies and procedures for the operation of the service and exercise general direction over the service, to ensure the following:
DHS 75.60(6)(a)3.a.a. Compliance with local, state and federal laws.
DHS 75.60(6)(a)3.b.b. That no person will be denied service or discriminated against on the basis of sex, race, color, creed, sexual orientation, disability, or age, in accordance with 45 CFR part 92 and Title VI of the Civil Rights Act of 1964, as amended, 42 USC. 2000d, Title XI of the Education Amendments of 1972, 20 USC 1681-1686 and s. 504 of the Rehabilitation Act of 1973, as amended, 29 USC 794, and the Americans with Disabilities Act of 1990, as amended, 42 USC 12101-12213.
DHS 75.60(6)(b)(b) Caregiver background check. At the time of hire, employment, or contract, and every 4 years after, the service shall conduct and document a caregiver background check following the procedures in s. 50.065, Stats., and ch. DHS 12. A service shall not employ or contract with a person who has been convicted of a crime or offense, or has a governmental finding of misconduct, found in s. 50.065, Stats., and ch. DHS 12, Appendix A, unless the person has been approved under the department’s rehabilitation process as defined in ch. DHS 12.