Section 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.(c) A hospital as defined under s. 50.33(2), Stats., and their affiliates.(d) A primary care service.(e) A service providing medication for addiction to less than 30 patients.(2)SERVICE DESCRIPTION. In this section, ooffice-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.(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.(c) Reviewing opioid treatment guidelines and regulations developed by the federal government.(d) Delivering technical assistance and informational materials to OBOT services as needed.(e) Performing both scheduled and unscheduled site visits OBO's 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: (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.(b) Comply with all federal and state laws and regulations governing the prescribing of the medication.(9)TREATMENT PLAN.(a) An OBOT service shall establish and document a treatment plan that includes all of the following: 1. The prescriber's rationale for selection of the specific drug to be used in the medication-assisted treatment.2. Patient education regarding the medication and the services to be provided.3. The patient's written, informed consent to treatment and for the medication they will be receiving.4. Random urine-drug screens or oral swabs.5. A signed treatment agreement that outlines the responsibilities of the patient and the prescriber.6. A plan for psychosocial treatment, pursuant to par. (c).(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: 1. SAMHSA treatment improvement protocol publications for medication assisted treatment. Note: SAMSHA treatment improvement protocols are available at: https://store.samhsa.gov.
2. ASAM national practice guidelines for the use of medications in the treatment of addiction involving opioid use. Note: ASAM national practice guidelines are available at https://www.asam.org/.
(c) Unless the prescriber providing OBOT services is a board-certified addic-tionologist, 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: 1. A psychosocial needs assessment, substance abuse counseling, links to existing family supports, and referral to community services.2. Substance use treatment services addressing the patient's needs identified during the assessment.3. Procedures for revising the treatment plan if the patient does not adhere to the original plan.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.5. Additional requirements related to the provision of behavioral health services, including: 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.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.(10)PRESCRIBING REQUIREMENTS.(a) The OBOT service shall ensure that all of its patients receive the following: 1. A prescription for naloxone.2. Instructions for naloxone including recognizing the signs and symptoms of overdose and calling 911 in an overdose situation.3. An offer for a new prescription for naloxone upon expiration or use of the old kit.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.(b) The OBOT service shall ensure that all prescriptions for buprenorphine products shall comply with all of the following requirements: 1. The provision shall be in compliance with the FDA-approved risk evaluation and mitigation strategy for buprenorphine products. Note: The FDA-approved risk evaluation and mitigation strategy for buprenorphine products can be found at https://www.accessdata.fda.gov/scripts/cder/ rems/index.cfm.
2. With the exception of those conditions listed in subd. 3. a. to e., a prescriber who treats opioid use disorder with a buprenorphine product shall only prescribe buprenorphine and naloxone combination products for use in the OBOT service. 3. The prescriber shall prescribe buprenorphine without naloxone (buprenorphine mono-product) at the OBOT service only in the following situations, and shall fully document the evidence for the decision to use buprenorphine mono-product in the patient's record when any of the following apply: a. A patient is pregnant or breast-feeding.b. Converting a patient from buprenorphine mono-product to buprenorphine and naloxone combination product.c. Formulations other than tablet or film form approved by the FDA are administered.d. A buprenorphine and naloxone combination product is contraindicated for withdrawal management and the contraindication documented in the patient record.e. The patient, after an explanation by the service of the difference between an allergic reaction and symptoms of opioid withdrawal precipitated by buprenorphine or naloxone, has an allergy to or intolerance of a buprenorphine and naloxone combination product. This information shall be included in the patient's record.4. Due to a higher risk of fatal overdose when buprenorphine is prescribed with other opioids, benzodiazepines, sedative hypnotics, carisoprodol, or tramadol, the prescriber shall only co-prescribe these substances when it is medically necessary and the following requirements are met:a. The prescriber shall verify the diagnosis for which the patient is receiving the other drug and coordinate care with the prescriber for the other drug, including whether it is possible to taper the drug to discontinuation. If the prescriber prescribing buprenorphine is the prescriber of the other drug, the prescriber shall taper the other drug to discontinuation, if it is safe to do so. The prescriber shall educate the patient about the serious risks of the combined use.b. The prescriber shall document progress with achieving the tapering plan.5. During the induction phase the prescriber shall not prescribe a dosage that exceeds the recommendation in the United States FDA-approved labeling, except for medically indicated circumstances as documented in the patient record. The prescriber shall see the patient at least once per week during this phase.6. During the stabilization phase, when using any oral formulation of buprenorphine, the prescriber shall increase the daily dosage of buprenorphine in safe and effective increments to achieve the lowest dose that avoids intoxication, withdrawal, or significant drug craving.7. During the first 90 days of treatment, no more than a 2-week supply of the buprenorphine and naloxone combination product may be prescribed.8. Starting with the 91st day of treatment and until the completion of 12 months of treatment, no more than a 30-day supply of the buprenorphine and naloxone combination product may be prescribed.8m. The prescriber shall take steps to reduce the chances of buprenorphine diversion by using the lowest effective dose, appropriate frequency of office visits, pill or film counts, and checks of the PDMP. The prescriber shall require urine drug screens, serum medication levels, or oral fluid testing at least twice per quarter for the first year of treatment and at least once per quarter thereafter.9. When using any oral formulation of buprenorphine, the prescriber shall document in the medical record the rationale for prescribed doses exceeding 16 milligrams of buprenorphine per day.10. Relapse prevention strategies shall be incorporated into counseling or assure that they are addressed by a qualified behavioral healthcare provider who has the education and experience to provide substance abuse counseling.11. Extended-release, injectable, or implanted buprenorphine product may be used. In using these formulations, the prescriber shall:a. Strictly comply with any required risk evaluation and mitigation strategy program for the drug.b. Prescribe an extended-release buprenorphine product strictly in accordance with the FDA's approved labeling for the drug's use.c. Document in the patient record the rationale for the use of the extended-release buprenorphine product.d. Require the extended-release, injectable, or implanted buprenorphine product to be administered by a licensed health care professional acting in accordance with the scope of the professional license.(c) The OBOT service that utilizes naltrexone to treat opioid use disorder shall comply with all of the following requirements: 1. Prior to treating a patient with naltrexone, the patient shall be informed about the risk of opioid overdose if the patient ceases naltrexone and then uses opioids.2. The prescriber shall take measures to ensure that the patient is adequately detoxified from opioids prior to treatment with naltrexone.3. The prescriber shall use oral naltrexone only for treatment of patients who can be closely supervised and who are highly motivated and: a. The dosage regime shall strictly comply with FDA-approved labeling for naltrexone hydrochloride tablets.b. The patient shall be encouraged to have a support person administer and supervise the medication. Examples of a support person are a family member, close friend, or employer.c. The OBOT service shall require urine drug screens, serum medication levels, or oral fluid drug testing at least every 3 months for the first year of treatment and at least every 6 months thereafter.d. The OBOT service shall incorporate relapse prevention strategies into counseling or assure that they are addressed by a qualified behavioral healthcare provider who has the education and experience to provide substance abuse counseling.4. The OBOT service may treat a patient with extended-release naltrexone for opioid dependence or for co-occurring opioid and alcohol use disorders. a. Treatment with extended-release naltrexone for patients who have issues with treatment adherence should be considered.b. The injections dosage shall strictly comply with FDA-approved labeling for extended-release naltrexone.c. Relapse prevention strategies shall be incorporated into counseling or assure that they are addressed by a qualified behavioral healthcare provider who has the education and experience to provide substance abuse counseling.Wis. Admin. Code Department of Health Services DHS 75.60
Adopted by, CR 20-047: cr. Register October 2021 No. 790, eff. 10-1-22; correction in (1) (c), (2), (6) (a) 3. b., (d) made under s. 35.17, Stats., correction in numbering of (4) (c) 1. to 6., (10) (b) 8m. made under s. 13.92(4) (b) 1, Stats., and correction in (10) (b) 2. made under s. 13.92(4) (b) 7, Stats., Register October 2021 No. 790, eff. 10/1/2022This section is created eff. 10-1-22 by CR 20-047.