Wisconsin Legislature: DHS 75.59(25m)(a)

a. A description of the intake process.

b. A description of the treatment process.

c. A description of the expectations the service has for a patient.

d. A description of any service privileges or sanctions.

e. A description of the service’s use of testing or analysis to detect substances and the purposes for which the results of testing or analysis are used as well as the frequency of use.

7. Documentation that there are adequate physical facilities to provide all necessary services.

8. Documentation that the service will have ready access to a comprehensive range of medical and rehabilitative services that will be available if needed, including the name, address, and a description of each hospital, institution, clinical laboratory or other facility available to provide the necessary services.

9. A list of persons working in the service who are licensed to administer or dispense narcotic drugs even if they are not responsible for administering or dispensing narcotic drugs.

(b) Approval of service sites. Only service sites approved by SAMHSA, the DEA and the SOTA may be used for treating persons with an opioid use disorder with a narcotic drug.

1. To operate a medication unit, a service shall apply to the department for approval to operate the medication unit. A separate approval is required for each medication unit to be operated by the service. A medication unit is established to facilitate the needs of patients who are stabilized on an optimal dosage level. The department shall approve a medication unit before it may begin operation.

2. Approval of a medication unit shall take into consideration the distribution of patients and other medication units in a geographic area.

3. If a service has its approval revoked, the approval of each medication unit operated by the service is automatically revoked. Revocation of the approval of a medication unit does not automatically affect the approval of the primary service.

(23) Assent to regulation.

(a) Service sponsor. A person who sponsors an OTP and any personnel responsible for a particular service shall agree in writing to adhere to all applicable requirements of this chapter and 21 CFR part 291 and 42 CFR part 2.

(b) Responsibilities. The service sponsor is responsible for all service staff and for all other service providers who work in the service at the primary facility or at other facilities or medication units.

(c) Written agreement. The service sponsor shall agree in writing to inform all service staff and all contracted service providers of the provisions of all pertinent state rules and federal regulations and shall monitor their activities to ensure that they comply with those rules and regulations.

(d) Replacement. The service shall notify the designated federal agency and SOTA within 5 business days after replacement of the service sponsor or medical director.

(e) Required services. OTPs shall provide adequate medical, counseling, vocational, educational, and other assessment and treatment services. These services must be available at the primary facility, except where the program sponsor has entered into a formal, documented agreement with a private or public agency, organization, practitioner, or institution to provide these services to patients enrolled in the OTP. The program sponsor, in any event, must be able to document that these services are fully and reasonably available to patients. This documentation must be provided to the department upon request.

(24) Death reporting. An OTP shall report the death of a patient and deaths related to a patient’s medication to the SOTA within 5 business days after learning of the death.

(25) Prescription drug monitoring program.

(a) Policy and procedure. The service must develop and maintain a policy and procedure that requires the ongoing monitoring of the data from the prescription drug monitoring program (PDMP) for each patient. The policy and procedure must include how the service meets the requirements in par. (b).

(b) Requirements. If a medication used for the treatment of substance use disorder is administered or dispensed to a patient, the OTP shall be subject to the following requirements:

1. Upon admission a patient must be notified in writing that the medical director must monitor the PDMP to review the prescribed controlled drugs a client received.

2. The medical director or the medical director’s delegate must review the data from the PDMP before the patient is ordered any controlled substance including medications for maintenance therapy, and subsequent reviews of the PDMP data must occur at least every 90 days.

3. A copy of the PDMP data reviewed must be maintained in the client’s file.

4. When the PDMP data contains a recent history of multiple prescribers or multiple prescriptions for controlled substances, the physician’s review of the data and subsequent actions must be documented in the patient’s file within 72 hours and must contain the medical director’s determination of whether the prescriptions place the patient at risk of harm and the actions to be taken in response to the PDMP findings. The provider must conduct subsequent reviews of the PDMP in these circumstances on a monthly basis.

5. If at any time the medical director believes the use of the controlled substances places the patient at risk of harm, the service must seek the patient’s consent to discuss the patient’s opioid treatment with other prescribers and for other prescribers to disclose to the OTP’s medical director of the client’s condition that formed the basis of the other prescriptions. If the information is not obtained within 7 days, the medical director must document whether or not changes to the client’s medication dose or number of unsupervised use doses are necessary until the information is obtained.

(25m) Guest dosing.

(a) Approval. To receive a guest dose, the patient must be enrolled in an OTP elsewhere in the state or country and be receiving the medication on a temporary basis because the client is not able to receive the medication at the program in which the client is enrolled. A patient may guest dose at a different OTP if prior approval is obtained from the patient’s medical director or program physician to receive services on a temporary basis from another OTP certified under this rule or by SAMHSA. The approval shall be noted in the patient’s record and shall include the following documentation:

1. The patient’s signed and dated consent for disclosing identifying information to the program which will provide services on a temporary basis.

2. A medication change order by the referring medical director or program physician permitting the patient to receive services on a temporary basis from the other program for a length of time not to exceed 30 days.

3. Evidence that the medical director or program physician for the program contacted to provide services on a temporary basis has accepted responsibility to treat the visiting patient, concurs with his or her dosage schedule, and supervises the administration of the medication.

(b) Maximum number of days. Guest dosing shall be provided for a maximum of 30 days.

(c) Patient requirement. Patients receiving guest dosing shall have been enrolled at the home clinic for a minimum of 30 days before being eligible for a guest dose. Patients enrolled less than 30 days at the home clinic shall be eligible for guest dosing only if approved by the SOTA.

(d) Drug screen requirement. Patients shall have two consecutive urine drug screens free of illicit substances or substances of abuse before being eligible for a guest dose, unless the medical director determines that the benefits of guest dosing outweigh the risks and documents the justification for granting guest dosing privileges in the patient’s record.

(26) Overdose prevention.

(a) Naloxone. An OTP shall provide a patient with a naloxone kit or a prescription for naloxone at admission. The OTP shall provide instruction on the kits use including recognizing the signs and symptoms of overdose and calling 911 in overdose situations.

(b) Use or expiration of Naloxone. The OTP shall provide a new naloxone kit or prescription upon expiration or use of the old kit.

(c) Exemption. The OTP shall be exempt from this requirement for one year if the client refuses the naloxone kit or already has a naloxone kit.

(d) Orientation training. Documentation that the patient has completed the orientation training on recognizing an overdose and how to use naloxone and received written information shall be completed and signed by service staff and the patient and maintained in the patient’s record.

(27) Interim maintenance treatment.

(a) The provision of interim maintenance with medication assisted treatment is prohibited under this rule unless the opioid treatment program has a waiver from the department in addition to authorization from SAMHSA in accordance with 42 CFR 8.11 (g).

(b) All of the requirements for comprehensive maintenance treatment apply to interim maintenance treatment with the following exceptions for patients receiving methadone: no take-home doses are permitted except on federal holidays if the program is closed on those days; an initial and periodic treatment plan are not required; a primary counselor is not required; and the rehabilitative and other services described in 42 CFR. 8.12 (f) (4), (f) (5) (i), and (f) (5) (iii) are not required.

(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.