Wisconsin Legislature: DHS 75.59(14)(a)1.

b. For patient time in treatment starting day 61 through day 90, the patient shall be allowed no more than 2 take-home doses of medication per week.

c. For patient time in treatment starting day 91 through day 120, the patient shall be allowed no more than 3 take-home doses of medication per week.

d. For patient time in treatment starting day 121 through day 240, the patient shall be allowed no more than 4 take-home doses of medication per week.

e. For patient time in treatment starting day 241 through day 365, the patient shall be allowed no more than 6 take-home doses of medication per week.

f. For patient time in treatment starting day 366 through completion of treatment, the patient shall be allowed no more than 13 take-home doses every 2 weeks.

(i) Denial or rescinding of approval. A service shall deny or rescind approval for take-home privileges for any of the following reasons:

1. Signs or symptoms of withdrawal.

2. Continued illicit substance use.

3. The absence of laboratory evidence of FDA-approved narcotic treatment in test samples, including serum levels.

4. Potential complications from concurrent disorders.

5. Ongoing or renewed criminal behavior.

6. An unstable home environment.

(j) Review.

1. The service physician shall review the status of every patient provided with take-home medication at least every 90 days and more frequently if clinically indicated.

2. The service treatment team shall review the merits and detriments of continuing a patient’s take-home privilege and shall make appropriate recommendations to the service physician as part of the service physician’s 90-day review.

3. Service staff shall use biochemical monitoring to ensure that a patient with take-home privileges is not using illicit substances and is consuming the FDA-approved narcotic provided.

4. Service staff may not recommend denial or rescinding of a patient’s take-home privilege to punish the patient for an action not related to meeting requirements for take-home privileges.

(k) Reduction of take-home privileges or requirement of more frequent visits to the service.

1. A service may reduce a patient’s take-home privileges or may require more frequent visits to the service if the patient inexcusably misses a scheduled appointment with the service, including an appointment for dosing, counseling, a medical review or a psychosocial review or for an annual physical or an evaluation.

2. A service shall reduce a patient’s take-home privileges or may require more frequent visits to the service if the patient shows positive results in drug test analysis for morphine-like substances or substances of abuse or if the patient tests negative for the narcotic drug administered or dispensed by the service.

(L) Reinstatement. A service shall not reinstate take-home privileges that have been revoked until:

1. The patient has had at least 3 consecutive tests or analyses that are neither positive for morphine-like substances or substances of abuse, or negative for the narcotic drug administered or dispensed by the service. The tests must be at least one week apart.

2. The service physician determines that the patient can responsibly handle narcotic drugs.

(m) Clinical probation.

1. A patient receiving a 6-day supply of take-home medication or more who has a test or analysis that is confirmed to be positive for a substance of abuse or negative for the narcotic drug dispensed by the service shall be placed on clinical probation for 3 months.

2. A patient on 3-month clinical probation who has a test or analysis that is confirmed to be positive for a substance of abuse or negative for the narcotic drug administered or dispensed by the service shall be required to attend the service at least twice weekly for observation of the ingestion of medication, and may receive no more than a 3-day take-home supply of medication.

(n) Employment-related exception to 6-day supply. A patient who is employed and working on Saturdays may apply for an exception to the dosing requirements if dosing schedules of the service conflict with working hours of the patient. A service may give the patient an additional take-home dose after verification of work hours through pay slips or other reliable means, and following approval for the exception from the SOTA and the designated federal agency.

(14) Exceptions to take-home requirements.

(a) Exception requests. A service may submit a request to the designated federal authority and the SOTA for an exception to certain take-home requirements for a particular patient if, in the reasonable clinical judgment of the service physician, any of the following conditions is met:

1. The patient has a physical disability that interferes with his or her ability to conform to the applicable mandatory schedule. The patient may be permitted a temporarily or permanently reduced schedule provided that she or he is found under par. (c) to be responsible in handling narcotic drugs.

2. The patient, because of an exceptional circumstance such as illness, personal or family crisis, travel or other hardship, is unable to conform to the applicable mandatory schedule. The patient may be permitted a temporarily reduced schedule, provided that she or he is found under par. (c) to be responsible in handling narcotic drugs.

(b) Rationale for exception. The program physician or program personnel supervised by the program physician shall record the rationale for an exception to an applicable mandatory schedule in the patient’s case record. A patient may not be given more than a 14-day supply of narcotic drugs at one time.

(c) Exception criteria. The service physician’s judgment that a patient is responsible in handling narcotic drugs shall be supported by information in the patient’s case file that the patient meets all of the following criteria:

1. Absence of recent abuse of narcotic or non-narcotic drugs including alcohol.

2. Regularity of service attendance.

3. Absence of serious behavior problems in the service.

4. Absence of known recent criminal activity such as drug dealing.

5. Stability of the patient’s home environment and social relationships.

6. Length of time in maintenance treatment.

7. Assurance that take-home medication can be safely stored within the patient’s home.

8. The rehabilitative benefit to the patient derived from decreasing the frequency attendance outweighs the potential risks of diversion.

(d) Exception outcome.

1. Any exception to the take-home requirements is subject to approval of the designated federal agency and the SOTA. Both the designated federal agency and the SOTA must approve the exception. If one does not approve then the exception is considered denied.

2. Service staff on receipt of notices of approval or denial of a request for an exception from the SOTA and the designated federal agency shall place the notices in the patient’s case record.

(e) Exception review. Service staff shall review an exception when the conditions of the request change or at the time of review of the treatment plan, whichever occurs first.

(f) Exception duration. An exception shall remain in effect only as long as the conditions establishing the exception remain in effect.

(15) Testing and analysis for drugs.

(a) Use.

1. A service shall use drug tests and analyses to determine the presence of opiates, methadone, fentanyl, buprenorphine, amphetamines, benzodiazepines, methamphetamine, cocaine, and THC. Alcohol testing will occur for individuals with a history of alcohol use disorders and when concerns exist. Alcohol testing may occur via breathalyzer, urinalysis or blood testing. If any other drug has been determined by a service or the SOTA to be abused in that service’s locality, a specimen shall also be analyzed for that drug. A service shall receive a 30-day notice and opportunity to provide input before it must begin analyzing for any additional substances other than those listed above. Any laboratory that performs the testing shall comply with 42 CFR part 493. A patient’s specimen shall be tested for the medication they are receiving for their opioid use disorder as well as the appropriate metabolite for that medication.

2. A service shall use the results of a drug test or analysis on a patient as a guide to review and modify treatment approaches and not as the sole criterion to discharge the patient from treatment. If a patient tests positive for any illicit substance or alcohol, that substance must be specifically addressed in the patient’s treatment plan.

3. A service’s policies and procedures shall integrate testing and analysis into treatment planning and clinical practice.

(b) Drawing blood for testing. A service shall determine a patient’s methadone levels in plasma or serum via a peak and trough when medically indicated but no less frequently than annually for patients who receive methadone or whenever split dosing is requested. The trough blood level should be drawn immediately prior to that day’s dose and the peak blood level should be drawn 3-4 hours after the dose is administered.

(c) Obtaining urine specimens. A service shall obtain urine specimens for testing from a patient, unless a patient is medically unable to provide a urine specimen, in which case an exception to use another testing device may be requested from the Division of Quality Assurance and the SOTA. Specimens shall be collected in a clinical atmosphere that respects the patient’s confidentiality, as follows:

1. A urine specimen shall be collected on a random basis. During the first 90 days of treatment urine drug screens shall occur weekly. After that time period, urine drug screens shall occur at least once a month.

2. The patient shall be informed about how test specimens are collected and the responsibility of the patient to provide a specimen when asked.

3. The bathroom used for collection shall be clean and always supplied with soap, paper towels, and toilet articles.

4. Specimens shall be collected in a manner that minimizes the possibility of falsification.

5. When service staff must directly observe the collection of a urine sample, this task shall be done with respect for patient privacy.

(d) Response to positive test results.

1. Service staff shall discuss positive test results with the patient within one week of the sample being taken by the service and shall document them in the patient’s case record with the patient’s response noted.

2. The service shall provide counseling, casework, medical review and other interventions when continued use of substances is identified.

3. When there is a positive test result, service staff shall allow sufficient time before re-testing to prevent a second positive test result from the same substance use.

4. Service staff confronted with a patient’s denial of substance use shall consider the possibility of a false positive test. Patients shall be given the opportunity to challenge a test result by having the sample given retested.

5. Service staff shall review a patient’s dosage and shall counsel the patient regarding their use when test reports are positive for morphine-like substances and negative for the FDA-approved treatment.

(e) Frequency of drug screens.

1. The frequency that a service shall require drug screening shall be clinically appropriate for each patient, allow for a rapid response to the possibility of relapse, and occur at least on a monthly basis.

2. A service shall arrange for drug screens with sufficient frequency so that they can be used to assist in making informed decisions about take-home privileges.

(16) Treatment duration and retention.

(a) Patient retention. Patient retention shall be a major objective of treatment. The service shall do all of the following to retain patients for the planned course of treatment:

1. Render treatment in a way that is least disruptive to the patient’s travel, work, educational activities, ability to use supportive services, and family life.

2. Determine hours based on patient needs.

3. Ensure that a patient has ready access to clinical staff, particularly to the patient’s primary counselor.

4. Ensure that clinical staff are adequately trained and are sensitive to gender- and culture-specific issues.

5. Provide services that incorporate evidence based practice standards for substance use treatment.

6. Ensure that patients receive adequate doses of medication based on their individual needs.

7. Ensure that all clinical staff are accepting of medication-assisted treatment.

8. Ensure that patients understand that they are responsible for complying with all aspects of their treatment, including participating in counseling sessions.

(b) Effort to retain patients. Since treatment duration and retention are directly correlated to rehabilitation success, a service shall make a concerted effort to retain patients within the first year following admission. Evidence of this concerted effort shall include written documentation of all of the following:

1. Whether the patient continues to benefit from the treatment.

2. Whether the risk of relapse is discontinued.

3. Whether the patient exhibits no side effects from the treatment.

4. Whether continued treatment is medically necessary in the professional judgement of the service physician.

(c) Referral for further treatment. A service shall refer a patient discharged from the service to a more suitable treatment modality when further treatment is required or is requested by the patient and cannot be provided by the service.

(17) Multiple substance use and co-occurring treatment.

(a) Assessment. A service shall assess a prospective patient for admission during the admission process to distinguish substance use, abuse and dependence, and determine patterns of other substance use and self-reported etiologies, including non-prescription, non-therapeutic and prescribed therapeutic use and mental health problems.

(b) Multiple substance use patients.

1. A service shall provide a variety of services that support cessation by a patient of alcohol and prescription and non-prescription substance use as the desired goal.

2. Service objectives shall indicate that abstinence by a patient from alcohol and prescription and non-prescription substance use should extend for increasing periods, progress toward long-term abstinence and be associated with improved life functioning and well-being.

3. Service staff shall instruct multiple substance use patients about their vulnerabilities to cross-tolerance, drug-to-drug interaction and potentiation and the risk of dependency substitution associated with self-medication.