DHS 75.60(1)(e)
(e) A service providing medication for addiction to less than 30 patients.
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)(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)3.
3. Screening, diagnosing, and treating acute or chronic conditions caused by disease, injury, or illness.
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(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)(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.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.
DHS 75.60(6)(c)
(c)
Personnel records. Employee records shall be available upon request at the service for review by the department. A separate record for each employee shall be maintained, kept current, and at a minimum, include:
DHS 75.60(6)(c)1.
1. A written job description including duties, responsibilities and qualifications required for the employee.
DHS 75.60(6)(c)5.
5. A copy of a signed statement regarding confidentiality of client information.
DHS 75.60(6)(d)
(d)
Confidentiality. A service shall have written policies, procedures, and staff training to ensure compliance with confidentiality provisions of
42 CFR part 2,
45 CFR parts 164 and
170, s.
51.30, Stats., and ch.
DHS 92. Each staff member shall sign a statement acknowledging responsibility to maintain confidentiality of personal information about persons served.
DHS 75.60(7)(a)(a) An OBOT service shall perform and document an assessment of each patient. The assessment shall include all of the following:
DHS 75.60(7)(a)5.
5. Clinically appropriate physical examination at the time of admission and annually thereafter.
DHS 75.60(7)(a)12.
12. Consideration of screening for tuberculosis and sexually transmitted diseases in patients with known risk factors.
DHS 75.60(7)(b)
(b) A prescriber may satisfy the assessment requirements, other than toxicology testing, by reviewing records from a physical examination and laboratory testing of the patient that was conducted within a reasonable period of time prior to the visit.
DHS 75.60(7)(c)
(c) If any part of the assessment cannot be completed prior to the initiation of medication for opioid use disorder, the prescriber shall document the reasons in the patient's record.
DHS 75.60(7)(d)
(d) For medical needs of a patient that exceed the scope of the service under this chapter, the service shall coordinate with appropriate medical providers.
DHS 75.60(8)
(8)
Intake. An OBOT service shall comply with all of the following requirements:
DHS 75.60(8)(a)
(a) Before initiating a medication for opioid use disorder, an approved DATA 2000-waived prescriber shall give the patient or the patient's representative information about all drugs approved by the FDA for use in medication-assisted treatment. The information must be provided both orally and in writing. The prescriber or the prescriber's delegate shall note in the patient's medical record when this information was provided and make the record available to employees of the department upon request.
DHS 75.60(8)(b)
(b) Comply with all federal and state laws and regulations governing the prescribing of the medication.
DHS 75.60(9)(a)(a) An OBOT service shall establish and document a treatment plan that includes all of the following:
DHS 75.60(9)(a)1.
1. The prescriber's rationale for selection of the specific drug to be used in the medication-assisted treatment.
DHS 75.60(9)(a)2.
2. Patient education regarding the medication and the services to be provided.
DHS 75.60(9)(a)3.
3. The patient's written, informed consent to treatment and for the medication they will be receiving.
DHS 75.60(9)(a)5.
5. A signed treatment agreement that outlines the responsibilities of the patient and the prescriber.
DHS 75.60(9)(b)
(b) The prescriber shall only provide medication for opioid use disorder in accordance with an acceptable treatment protocol for assessment, induction, stabilization, maintenance, and tapering. Acceptable protocols include any of the following:
DHS 75.60(9)(b)1.
1. SAMHSA treatment improvement protocol publications for medication assisted treatment.
DHS 75.60(9)(b)2.
2. ASAM national practice guidelines for the use of medications in the treatment of addiction involving opioid use.
DHS 75.60(9)(c)
(c) Unless the prescriber providing OBOT services is a board-certified addictionologist, board certified addiction psychiatrist, or psychiatrist, the prescriber shall refer and work jointly with a qualified behavioral healthcare provider, community mental health services provider, or community addiction services provider, to determine the optimal type and intensity of psychosocial treatment for the patient and document the treatment plan in the patient record. The treatment provided shall, at minimum, include:
DHS 75.60(9)(c)1.
1. A psychosocial needs assessment, substance abuse counseling, links to existing family supports, and referral to community services.
DHS 75.60(9)(c)2.
2. Substance use treatment services addressing the patient's needs identified during the assessment.
DHS 75.60(9)(c)3.
3. Procedures for revising the treatment plan if the patient does not adhere to the original plan.
DHS 75.60(9)(c)4.
4. When clinically appropriate, and if the patient refuses treatment from a qualified behavioral healthcare provider, community mental health services provider, or community addiction services provider, the prescriber shall document the reason for the refusal in the patient's medical record.
DHS 75.60(9)(c)5.
5. Additional requirements related to the provision of behavioral health services, including:
DHS 75.60(9)(c)5.a.
a. If the prescriber who prescribes the medication for opioid use disorder is also a board-certified addictionologist, psychiatrist, or board certified psychiatrist, the prescriber may personally provide behavioral health services for addiction.
DHS 75.60(9)(c)5.b.
b. If the prescriber refers the patient to a qualified behavioral healthcare provider, community addiction services provider, or community mental health services provider, the prescriber shall document the referral and the maintenance of meaningful interactions with the provider in the patient record.
DHS 75.60(10)(a)(a) The OBOT service shall ensure that all of its patients receive the following:
DHS 75.60(10)(a)2.
2. Instructions for naloxone including recognizing the signs and symptoms of overdose and calling 911 in an overdose situation.
DHS 75.60(10)(a)3.
3. An offer for a new prescription for naloxone upon expiration or use of the old kit.
DHS 75.60(10)(a)4.
4. If the patient refuses the prescription for naloxone the prescriber shall provide the patient with information on where to obtain naloxone without a prescription.
DHS 75.60(10)(b)
(b) The OBOT service shall ensure that all prescriptions for buprenorphine products shall comply with all of the following requirements:
DHS 75.60(10)(b)1.
1. The provision shall be in compliance with the FDA-approved risk evaluation and mitigation strategy" for buprenorphine products.
