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.
DHS 75.59(16)(a)3.
3. Ensure that a patient has ready access to clinical staff, particularly to the patient's primary counselor.
DHS 75.59(16)(a)4.
4. Ensure that clinical staff are adequately trained and are sensitive to gender- and culture-specific issues.
DHS 75.59(16)(a)5.
5. Provide services that incorporate evidence based practice standards for substance use treatment.
DHS 75.59(16)(a)6.
6. Ensure that patients receive adequate doses of medication based on their individual needs.
DHS 75.59(16)(a)7.
7. Ensure that all clinical staff are accepting of medication-assisted treatment.
DHS 75.59(16)(a)8.
8. Ensure that patients understand that they are responsible for complying with all aspects of their treatment, including participating in counseling sessions.
DHS 75.59(16)(b)
(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:
DHS 75.59(16)(b)4.
4. Whether continued treatment is medically necessary in the professional judgement of the service physician.
DHS 75.59(16)(c)
(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.
DHS 75.59(17)
(17)
Multiple substance use and co-occurring treatment. DHS 75.59(17)(a)(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.
DHS 75.59(17)(b)1.1. 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.
DHS 75.59(17)(b)2.
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.
DHS 75.59(17)(b)3.
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.
DHS 75.59(17)(c)1.1. A service shall have the ability to provide concurrent treatment for a patient diagnosed with both a mental health disorder and a substance use disorder. The service shall arrange for coordination of treatment options and for provision of a continuum of care across the boundaries of physical sites, services and outside treatment referral sources.
DHS 75.59(17)(c)2.
2. When a co-occurring disorder exists, a service shall develop with the patient a treatment plan that integrates measures for treating all alcohol, drug and mental health problems. For the treatment of a patient with co-occurring disorders, the service shall arrange for a mental health professional to help develop the treatment plan and provide ongoing treatment services. The mental health professional shall be available either as an employee of the service or through a written agreement. The mental health professional shall complete a mental health assessment within 3 business days of admission.
DHS 75.59(18)
(18)
Pregnancy. Each OTP shall have written procedures for pregnant patients including the following minimum standards:
DHS 75.59(18)(a)
(a)
Risks. A requirement that each patient admitted to the OTP be informed of the possible risks to herself or to her unborn child from the use of medication-assisted treatment, and be informed that abrupt withdrawal from these medications may adversely affect the unborn child.
DHS 75.59(18)(b)
(b)
Medication-assisted treatment. A requirement that a pregnant patient who has a documented past opioid dependency and who may be in direct jeopardy of returning to opioid dependency with all of its attendant dangers during pregnancy, be informed that they may be placed on a medication-assisted treatment regimen. The service shall also provide a statement that for such pregnant women, evidence of current physiological dependence on opioid drugs is not needed if the medical director or other authorized program physician certifies the pregnancy, determines and documents that the woman may resort to the use of opioid drugs, and determines that medication-assisted treatment is justified in their clinical opinion.
DHS 75.59(18)(c)
(c)
Approval of admission. A requirement that the admission of each pregnant patient to an OTP be approved by the medical director or other authorized program physician prior to admitting the patient to the program.
DHS 75.59(18)(d)
(d)
Coordination of care. A requirement that OTPs develop a form for release of information between themselves and the healthcare provider in care of obstetrical care. This voluntary form should be offered to all pregnant patients for coordination of medical care.
DHS 75.59(18)(e)
(e)
Education. A requirement that each pregnant patient be given education on recognizing the symptoms of neonatal abstinence syndrome near the time of delivery.
DHS 75.59(18)(f)1.
1. Providing prenatal care by the service or by referral to an appropriate health care provider. If appropriate prenatal care is neither available on-site or by referral, or if the pregnant patient cannot afford care or refuses prenatal care services on-site or by referral, an OTP, at a minimum, should offer basic prenatal instruction on maternal, physical, and dietary care as part of its counseling services. If a pregnant patient refuses the offered on-site or referred prenatal services, the medical director or treating physician must use informed consent procedures to have the patient formally acknowledge, in writing, refusal of these services.
DHS 75.59(18)(f)2.
2. A requirement that if a patient is referred to prenatal care outside the agency, the name, address and telephone number of the health care provider shall be recorded in the patient's clinical record.
DHS 75.59(18)(f)3.
3. A requirement that if prenatal care is provided by the OTP, the clinical record shall include documentation to reflect services provided.
DHS 75.59(18)(f)4.
4. A requirement that if a patient is referred outside of the agency for prenatal services, the provider to whom she has been referred shall be notified that she is on medication-assisted treatment; however, such notice shall only be given after the patient has signed a release of information.
DHS 75.59(18)(f)5.
5. A requirement that any changes in medication-assisted treatment be communicated to the appropriate healthcare provider if the woman has prenatal care outside the agency if the patient allows communication among providers.
DHS 75.59(18)(f)6.
6. A requirement that the service monitor the medication dose carefully throughout the pregnancy, moving rapidly to supply increased or split dose if it becomes necessary.
DHS 75.59(18)(f)7.
7. A recommendation that blood serum levels for methadone agonist be monitored once a trimester, and every three days for two weeks after delivery to ensure appropriate level of medication before and after delivery by the appropriate healthcare professional. The medical director shall request and review serum levels to determine whether any changes to treatment need to be made.
DHS 75.59(18)(f)8.
8. A requirement that the service shall offer on-site parenting education and training to all patients who are parents or shall refer interested patients to appropriate alternative services for the training; and,
DHS 75.59(18)(g)
(g)
Pregnant patients that refuse prenatal services. Procedures for a patient who refuses prenatal service by the OTP or an outside provider, including that
DHS 75.59(18)(g)1.
1. The medical director or other authorized program physician shall note this in the clinical record.
DHS 75.59(18)(g)2.
2. Requiring that the patient be asked to sign a statement that says “I have been offered the opportunity for prenatal care by the opioid treatment program or by a referral to a prenatal clinic or by a referral to the physician of my choice. I refuse prenatal counseling by the opioid treatment program. I refuse to permit the opioid treatment program to refer me to a physician or prenatal clinic for prenatal services." If the patient refuses to sign the statement, the medical director or other authorized program physician shall indicate in the signature block that “patient refused to sign" and affix their signature and the date on the statement.
DHS 75.59(19)(a)(a)
Tuberculosis - patients. An OTP shall screen patients for tuberculosis in a manner and frequency consistent with current CDC standard of practice. Tuberculosis treatment may be provided by referral to an appropriate public health agency or community medical service.
DHS 75.59(19)(b)
(b)
Tuberculosis - staff. A service shall screen prospective new staff and ongoing staff for tuberculosis in a manner and frequency consistent with current CDC standard of practice.
