DHS 75.59(13)(d)7.
7. The patient provides assurance that take-home medication will be safely stored in a locked metal box within the home.
DHS 75.59(13)(d)8.
8. The rehabilitative benefit to the patient in decreasing the frequency of service attendance outweighs the potential risks of diversion.
DHS 75.59(13)(e)
(e)
Time in treatment criteria and exceptions. The time in treatment criteria under par.
(h) shall be the minimum time before take-home medications will be considered unless there are exceptional circumstances and the service applies for and receives approval from the designated federal agency and the SOTA for a particular patient.
DHS 75.59(13)(f)
(f)
Individual consideration of request. A request for take-home privileges shall be considered on an individual basis. No request for take-home privileges may be granted automatically to any patient.
DHS 75.59(13)(g)
(g)
Additional criteria for 6-day take-home privilege. When a patient is considered for 6-day take-homes, the patient shall meet the following additional criteria:
DHS 75.59(13)(g)1.
1. The patient is employed, attends school, is a homemaker, or is disabled.
DHS 75.59(13)(g)2.
2. The patient is not known to have used or abused substances, including alcohol, in the previous year.
DHS 75.59(13)(g)3.
3. The patient is not known to have engaged in criminal activity in the previous year.
DHS 75.59(13)(h)1.a.
a. For patient time in treatment starting day 31 through day 90, the patient shall be allowed no more than one take-home dose of medication per week.
DHS 75.59(13)(h)1.b.
b. For patient time in treatment starting day 91 through 180, the patient shall be allowed no more than 2 take-home doses of medication per week.
DHS 75.59(13)(h)1.c.
c. For patient time in treatment starting day 181 through day 270, the patient shall be allowed no more than 3 take-home doses of medication per week.
DHS 75.59(13)(h)1.d.
d. For patient time in treatment starting day 271 through day 365, the patient shall be allowed no more than 4 take-home doses of medication per week.
DHS 75.59(13)(h)1.e.
e. For patient time in treatment starting day 366 through day 730, the patient shall be allowed no more than 6 take-home doses of medication per week.
DHS 75.59(13)(h)1.f.
f. For patient time in treatment starting day 731 through completion of treatment, the patient shall be allowed no more than 13 take-home doses every 2 weeks.
DHS 75.59(13)(h)2.
2. Buprenorphine Oral Products shall be provided on a take-home basis as follows:
DHS 75.59(13)(h)2.a.
a. For patient time in treatment starting day 31 through day 60, the patient shall be allowed no more than 1 take-home dose of medication per week.
DHS 75.59(13)(h)2.b.
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.
DHS 75.59(13)(h)2.c.
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.
DHS 75.59(13)(h)2.d.
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.
DHS 75.59(13)(h)2.e.
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.
DHS 75.59(13)(h)2.f.
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.
DHS 75.59(13)(i)
(i)
Denial or rescinding of approval. A service shall deny or rescind approval for take-home privileges for any of the following reasons:
DHS 75.59(13)(i)3.
3. The absence of laboratory evidence of FDA-approved narcotic treatment in test samples, including serum levels.
DHS 75.59(13)(j)1.1. 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.
DHS 75.59(13)(j)2.
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.
DHS 75.59(13)(j)3.
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.
DHS 75.59(13)(j)4.
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.
DHS 75.59(13)(k)
(k)
Reduction of take-home privileges or requirement of more frequent visits to the service. DHS 75.59(13)(k)1.
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.
DHS 75.59(13)(k)2.
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.
DHS 75.59(13)(L)
(L)
Reinstatement. A service shall not reinstate take-home privileges that have been revoked until:
DHS 75.59(13)(L)1.
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.
DHS 75.59(13)(L)2.
2. The service physician determines that the patient can responsibly handle narcotic drugs.
DHS 75.59(13)(m)1.1. 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.
DHS 75.59(13)(m)2.
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.
DHS 75.59(13)(n)
(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.
DHS 75.59(14)(a)
(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:
DHS 75.59(14)(a)1.
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.
DHS 75.59(14)(a)2.
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.
DHS 75.59(14)(b)
(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.
DHS 75.59(14)(c)
(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:
DHS 75.59(14)(c)1.
1. Absence of recent abuse of narcotic or non-narcotic drugs including alcohol.
DHS 75.59(14)(c)5.
5. Stability of the patient's home environment and social relationships.
DHS 75.59(14)(c)7.
7. Assurance that take-home medication can be safely stored within the patient's home.
DHS 75.59(14)(c)8.
8. The rehabilitative benefit to the patient derived from decreasing the frequency attendance outweighs the potential risks of diversion.
DHS 75.59(14)(d)1.1. 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.
DHS 75.59(14)(d)2.
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.
DHS 75.59(14)(e)
(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.
DHS 75.59(14)(f)
(f)
Exception duration. An exception shall remain in effect only as long as the conditions establishing the exception remain in effect.
DHS 75.59(15)(a)1.1. 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.
DHS 75.59(15)(a)2.
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.
DHS 75.59(15)(a)3.
3. A service's policies and procedures shall integrate testing and analysis into treatment planning and clinical practice.
DHS 75.59(15)(b)
(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.
DHS 75.59(15)(c)
(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:
DHS 75.59(15)(c)1.
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.
DHS 75.59(15)(c)2.
2. The patient shall be informed about how test specimens are collected and the responsibility of the patient to provide a specimen when asked.
DHS 75.59(15)(c)3.
3. The bathroom used for collection shall be clean and always supplied with soap, paper towels, and toilet articles.
DHS 75.59(15)(c)4.
4. Specimens shall be collected in a manner that minimizes the possibility of falsification.
DHS 75.59(15)(c)5.
5. When service staff must directly observe the collection of a urine sample, this task shall be done with respect for patient privacy.
DHS 75.59(15)(d)1.1. 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.
DHS 75.59(15)(d)2.
2. The service shall provide counseling, casework, medical review and other interventions when continued use of substances is identified.
DHS 75.59(15)(d)3.
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.
DHS 75.59(15)(d)4.
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.
DHS 75.59(15)(d)5.
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.
DHS 75.59(15)(e)1.1. 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.
DHS 75.59(15)(e)2.
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.
DHS 75.59(16)(a)
(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:
DHS 75.59(16)(a)1.
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.
