Wisconsin Legislature: DHS 75.60(1)(b)

(d) To receive interim maintenance, a patient must be fully eligible for admission to comprehensive maintenance.

(e) Interim maintenance treatment is for those patients who cannot be enrolled in comprehensive maintenance treatment in a reasonable geographic area within fourteen days of application for admission.

(f) During interim maintenance, the initial toxicology and at least two additional toxicology screening tests should be obtained.

(g) Programs offering interim maintenance must develop clear policies and procedures governing the admission to interim maintenance and transfer of patients to comprehensive maintenance.

(28) Disaster planning.

(a) Emergency situations. Each OTP shall maintain an up-to-date disaster plan that addresses emergency situations including fire emergencies, tornadoes, earth quakes, flooding, winter storms, pandemics, and involuntary temporary or permanent facility closure.

(b) Committee. OTPs shall establish a health and safety committee that initiates planning actions for disaster scenarios. This committee shall:

1. Identify internal resources and areas of need that shall include, at minimum, considerations of:

a. Personnel training.

b. Equipment needs.

c. Evacuation plans.

d. Backup systems for payroll, billing records, and patient records.

e. Communications with staff, patients and local, state, and federal partners.

2. Identify external resources and areas of need that shall include, at minimum:

a. Suppliers of medication used for treatment of substance use disorder.

b. Other OTPs; and

c. Alternative dosing locations.

3. Develop a communication plan for the disaster scenario to inform patients, the SOTA, SAMHSA, the DEA, and any other parties deemed necessary.

4. Develop disaster documentation procedures for guest patients that shall include at minimum:

a. A temporary chart and client identification number.

b. Identity verification.

c. Medication verification.

(c) Emergency contact. Each OTP shall provide the SOTA with the emergency contact information for at least one member of the service.

(d) Medication supply. Each OTP shall keep at least a 10-day supply based on average caseload of methadone and buprenorphine products on site to prepare to receive clients from other facilities in disaster scenarios.

History: CR 20-047: cr. Register October 2021 No. 790, eff. 10-1-22; correction in (5) (b), (g) , (6) (a) 3. a., 4., (h), (k) 2., (7) (a) (intro.), (9) (a), (10) (c) 12., (12) (b) 2., (d) 2., 7., (h) 1. d. to f., 2. a. to e., (15) (a) 1., (21) (e), (f), (23) (a) made under s. 35.17, Stats., correction in numbering in (25m) made under s. 13.92 (4) (b) 1., Stats., correction in (6) (i) 3. made under s. 13.92 (4) (b) 4., Stats., and (10) (b) (title) created under s. 13.92 (4) (b) 2., Stats., Register October 2021 No. 790.

DHS 75.60 Office-based opioid treatment.

(1) Applicability. This section shall not apply to office-based opioid treatment occurring in any of the following settings:

(a) A treatment service in which all patients receiving medication for addiction are enrolled in a service otherwise certified under this chapter.

(b) A state or local correctional facility.

(d) A primary care service.

(e) A service providing medication for addiction to less than 30 patients.

(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.

(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.

(4) Definitions. In this section:

(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.

(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.

(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:

1. Care that promotes and maintains mental and physical health and wellness.

2. Care that prevents disease.

3. Screening, diagnosing, and treating acute or chronic conditions caused by disease, injury, or illness.

4. Patient counseling and education.

5. Provision of a broad spectrum of preventive and curative health care over a period of time.

6. Coordination of care.

(5) State opioid treatment authority. The powers and duties of the SOTA include:

(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.

(b) Acting as a liaison between relevant state and federal agencies.

(d) Delivering technical assistance and informational materials to OBOT services as needed.

(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.

(f) Consulting with the federal government regarding approval or disapproval of requests for exceptions to federal regulations, where appropriate.

(g) Receiving and addressing service recipient appeals and grievances in partnership with the department’s client rights office.

(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.

(6) General requirements.

(a) Governing authority or entity owner. The governing authority or entity owner of an OBOT service shall do all of the following:

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.

2. Appoint a service director whose qualifications, authority, and duties are defined in writing.

3. Establish written policies and procedures for the operation of the service and exercise general direction over the service, to ensure the following:

a. Compliance with local, state and federal laws.

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.

(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.

(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:

1. A written job description including duties, responsibilities and qualifications required for the employee.

2. Beginning date of employment.

3. Qualifications based on education or experience.

4. A completed caregiver background check following procedures under s. 50.065, Stats., and ch. DHS 12.

5. A copy of a signed statement regarding confidentiality of client information.

6. Documentation of any required training.

7. A copy of any required licenses or certifications.

(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.

(7) Assessment.

(a) An OBOT service shall perform and document an assessment of each patient. The assessment shall include all of the following:

1. A comprehensive medical and psychiatric history.

2. A brief mental status exam.

3. Substance abuse history.

4. Family history and psychosocial supports.

5. Clinically appropriate physical examination at the time of admission and annually thereafter.

6. Urine drug screen or oral fluid drug testing.

7. Pregnancy test for patients of childbearing age and ability.

8. Review of the patient’s prescription information in the PDMP.

9. Testing for human immunodeficiency virus.

10. Testing for hepatitis B.

11. Testing for hepatitis C.

12. Consideration of screening for tuberculosis and sexually transmitted diseases in patients with known risk factors.

(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.

(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.

(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.

(8) Intake. An OBOT service shall comply with all of the following requirements: