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.
DHS 75.60(10)(b)2.
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.
DHS 75.60(10)(b)3.
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:
DHS 75.60(10)(b)3.b.
b. Converting a patient from buprenorphine mono-product to buprenorphine and naloxone combination product.
DHS 75.60(10)(b)3.c.
c. Formulations other than tablet or film form approved by the FDA are administered.
DHS 75.60(10)(b)3.d.
d. A buprenorphine and naloxone combination product is contraindicated for withdrawal management and the contraindication documented in the patient record.
DHS 75.60(10)(b)3.e.
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.
DHS 75.60(10)(b)4.
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:
DHS 75.60(10)(b)4.a.
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.
DHS 75.60(10)(b)5.
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.
DHS 75.60(10)(b)6.
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.
DHS 75.60(10)(b)7.
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.
DHS 75.60(10)(b)8.
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.
DHS 75.60(10)(b)8m.
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.
DHS 75.60(10)(b)9.
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.
DHS 75.60(10)(b)10.
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.
DHS 75.60(10)(b)11.
11. Extended-release, injectable, or implanted buprenorphine product may be used. In using these formulations, the prescriber shall:
DHS 75.60(10)(b)11.a.
a. Strictly comply with any required risk evaluation and mitigation strategy program for the drug.
DHS 75.60(10)(b)11.b.
b. Prescribe an extended-release buprenorphine product strictly in accordance with the FDA's approved labeling for the drug's use.
DHS 75.60(10)(b)11.c.
c. Document in the patient record the rationale for the use of the extended-release buprenorphine product.
DHS 75.60(10)(b)11.d.
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.
DHS 75.60(10)(c)
(c) The OBOT service that utilizes naltrexone to treat opioid use disorder shall comply with all of the following requirements:
DHS 75.60(10)(c)1.
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.
