Section 75.15. Narcotic treatment service for opiate addiction.

 

(1)   Service description. A narcotic treatment service for opiate addiction provides for the management and rehabilitation of selected narcotic addicts through the use of methadone or other FDA-approved narcotics and a broad range of medical and psychological services, substance abuse counseling and social services. Methadone and other FDA-approved narcotics are used to prevent the onset of withdrawal symptoms for 24 hours or more, reduce or eliminate drug hunger or craving and block the euphoric effects of any illicitly self-administered narcotics while the patient is undergoing rehabilitation.

(2)   Requirements. To receive certification from the department under this chapter, a narcotic treatment service for opiate addiction shall comply with all requirements included in s. DHS 75.03 and all requirements included in s. DHS 75.13 that apply to a narcotic treatment service for opiate addiction, as shown in Table 75.03, and, in addition, a narcotic treatment service for opiate addiction shall comply with the requirements of this section. If a requirement in this section conflicts with an applicable requirement in s. DHS 75.03 , the requirement in this section shall be followed.

(3)   Definitions. In this section:

(a) "Biochemical monitoring" means the collection and analysis of specimens of body fluids, such as blood or urine, to determine use of licit or illicit drugs.

(b) "Central registry" means an organization that obtains from 2 or more methadone programs patient identifying information about individuals applying for maintenance treatment or detoxification treatment for the purpose of preventing an individual's concurrent enrollment in more than one program.

(c) "Clinical probation" means the period of time determined by the treatment team that a patient is required to increase frequency of service attendance.

(d) "Initial dosing" means the first administration of methadone or other FDA-approved narcotic to relieve a degree of withdrawal and drug craving of the patient.

(e) "Mandatory schedule" means the required dosing schedule for a patient and the established frequency that the patient must attend the service.

(f) "Medication unit" means a facility established as part of a service but geographically separate from the service, from which licensed private practitioners and community pharmacists are:

1. Permitted to administer and dispense a narcotic drug.

2. Authorized to conduct biochemical monitoring for narcotic drugs.

(g) "Objectively intoxicated person" means a person who is determined through a breathalyzer test to be under the influence of alcohol.

(h) "Opioid addiction" means psychological and physiological dependence on an opiate substance, either natural or synthetic, that is beyond voluntary control.

(i) "Patient identifying information" means the name, address, social security number, photograph or similar information by which the identity of a patient can be determined with reasonable accuracy and speed, either directly or by reference to other publicly available information.

(j) "Phase" means a patient's level of dosing frequency.

(k) "Service physician" means a physician licensed to practice medicine in the jurisdiction in which the program is located, who assumes responsibility for the administration of all medical services performed by the narcotic treatment service including ensuring that the service is in compliance with all federal, state and local laws relating to medical treatment of narcotic addiction with a narcotic drug.

(L) "Service sponsor" means a person or a representative of an organization who is responsible for the operation of a narcotic treatment service and for all service employees including any practitioners, agents or other persons providing services at the service or at a medication unit.

(m) "Take-homes" means medications such as methadone that reduce the frequency of a patient's service visits and with the approval of the service physician, are dispensed in an oral form and are in a container that discloses the treatment service name, address and telephone number and the patient's name, the dosage amount and the date on which the medication is to be ingested.

(n) "Treatment contracting" means an agreement developed between the primary counselor or the program director and the patient in an effort to allow the patient to remain in treatment on condition that the patient adheres to service rules.

(o) "Treatment team" means a team established to evaluate the progress of a patient and consisting of at least the primary counselor, the service staff nurse who administers doses and the program director.

(4)   Required personnel.

(a) A narcotic treatment service for opiate addiction shall designate a physician licensed under ch. 448 , Stats. , as its medical director. The physician shall be readily accessible and able to respond in person in a reasonable period of time, not to exceed 45 minutes.

(b) The service shall have a registered nurse on staff to supervise the dosing process and perform other functions delegated by the physician.

(c) The service may employ nursing assistants and related medical ancillary personnel to perform functions permitted under state medical and nursing practice statutes and administrative rules.

(d) The service shall employ substance abuse counselors, substance abuse counselors-in training, or clinical substance abuse counselors who are under the supervision of a clinical supervisor on a ratio of at least one to 50 patients in the service or fraction thereof.

(dm) A narcotic treatment services for opiate addiction shall provide for ongoing clinical supervision of the counseling staff. Ongoing clinical supervision shall be provided as required as required in s. SPS 162.01 .

(e) The clinical supervisor shall provide supervision and performance evaluation of substance abuse counselors in the areas identified in s. SPS 162.01 (5) .

(5)   Admission.

(a) Admission criteria. For admission to a narcotic addiction treatment service for opiate addiction, a person shall meet all of the following criteria as determined by the service physician:

1. The person is physiologically and psychologically dependent upon a narcotic drug that may be a synthetic narcotic.

2. The person has been physiologically and psychologically dependent upon the narcotic drug not less than one year before admission.

3. In instances where the presenting drug history is inadequate to substantiate such a diagnosis, the material submitted by other health care professionals indicates a high degree of probability of such a diagnosis, based on further evaluation.

4. When the person receives health care services from outside the service, the person has provided names, addresses and written consents for release of information from each health care provider to allow the service to contact the providers, and agrees to update releases if changes occur.

(b) Voluntary treatment. Participation in narcotic addiction treatment shall be voluntary.

(c) Explanation. Service staff shall clearly and adequately explain to the person being admitted all relevant facts concerning the use of the narcotic drug used by the service.

(d) Consent. The service shall require a person being admitted to complete the most current version of FDA form 2635, "Consent to Narcotic Addiction Treatment."

(e) Examination. For each applicant eligible for narcotic addiction treatment, the service shall arrange for completion of a comprehensive physical examination, clinically indicated laboratory work-up prescribed by the physician, psycho-social assessment, initial treatment plan and patient orientation during the admission process.

(f) Initial dose. If a person meets the admission criteria under par. (a) , an initial dose of narcotic medication may be administered to the patient on the day of application.

(g) Distance of service from residence. A person shall receive treatment at a service located in the same county or at the nearest location to the person's residence, except that if a service is unavailable within a radius of 50 miles from the patient's residence, the patient may, in writing, request the state methadone authority to approve an exception. In no case may a patient be allowed to attend a service at a greater distance to obtain take-home doses.

(h) Non-residents. A self-pay person who is not a resident of Wisconsin may be accepted for treatment only after written notification to the Wisconsin state methadone authority. Permission shall be obtained before initial dosing.

(i) Central registry.

1. The service shall participate in a central registry, or an alternative acceptable to the state methadone authority, in order to prevent multiple enrollments in detoxification and narcotic addiction treatment services for opiate addiction. The central registry may include services and programs in bordering states.

2. The service shall make a disclosure to the central registry whenever any of the following occurs:

a. A person is accepted for treatment.

b. The person is disenrolled in the service.

3. The disclosure shall be limited to:

a. Patient-identifying information.

b. Dates of admission, transfer or discharge from treatment.

4. A disclosure shall be made with the patient's written consent that meets the requirements of 42 CFR Part 2 , relating to alcohol and drug abuse patient records, except that the consent shall list the name and address of each central registry or acceptable alternative and each known detoxification or narcotic treatment service for opiate addiction to which a disclosure will be made.

(j) Admissions protocol. The service shall have a written admissions protocol that accomplishes all of the following:

1. Identifies the person on the basis of appropriate substantiated documents that contain the individual's name and address, date of birth, sex and race or ethnic origin as evidenced by a valid driver's license or other suitable documentation such as a passport.

2. Determines the person's current addiction, to the extent possible, the current degree of dependence on narcotics or opiates, or both, including route of administration, length of time of the patient's dependence, old and new needle marks, past treatment history and arrest record.

3. Determines the person's age. The patient shall verify that he or she is 18 years or older.

4. Identifies the substances being used. To the extent possible, service staff shall obtain information on all substances used, route of administration, length of time used and amount and frequency of use.

5. Obtains information about past treatment. To the extent possible, service staff shall obtain information on a person's treatment history, use of secondary substances while in the treatment, dates and length of time in treatment and reasons for discharge.

6. Obtains personal information about the person. Personal information includes history and current status regarding employment, education, legal status, military service, family and psychiatric and medical information.

7. Identifies the person's reasons for seeking treatment. Reasons shall include why the person chose the service and whether the person fully understands the treatment options and the nature and requirements of narcotic addiction treatment are fully understood.

8. Completes an initial drug screening or analysis of the person's urine to detect use of opiates, methadone, amphetamines, benzodiazepines, cocaine or barbiturates. The analysis shall show positive for narcotics, or an adequate explanation for negative results shall be provided and noted in the applicant's record. The primary counselor shall enter into the patient's case record the counselor's name, the content of a patient's initial assessment and the initial treatment plan. The primary counselor shall make these entries immediately after the patient is stabilized on a dose or within 4 weeks of admission, whichever is sooner.

9. If the service is at capacity, immediately advises the applicant of the existence of a waiting list and providing that person with a referral to another treatment service that can serve the person's treatment needs.

10. Refers a person who also has a physical health or mental health problem that cannot be treated within the service to an appropriate agency for appropriate treatment.

11. Obtains the person's written consent for the service to secure records from other agencies that may assist the service with treatment planning.

12. Arranges for hospital detoxification for patients seriously addicted to alcohol or sedatives or to anxiolytics before initiating outpatient treatment.

(k) Priority admissions. A service shall offer priority admission either through immediate admission or priority placement on a waiting list in the following order:

1. Pregnant women.

2. Persons with serious medical or psychiatric problems.

3. Persons identified by the service through screening as having an infectious or communicable disease, including screening for risk behaviors related to human immunodeficiency virus infection, sexually transmitted diseases and tuberculosis.

(L) Appropriate and uncoerced treatment. Service staff shall determine through a screening process that narcotic addiction treatment is the most appropriate treatment modality for the applicant and that treatment is not coerced.

(m) Correctional supervision notification. A service shall require a person who is under correctional supervision to provide written information releases that are necessary for the service to notify and communicate with the patient's probation and parole officer and any other correctional authority regarding the patient's participation in the service.

(6)   Orientation of new patients. A service shall provide new patients with an orientation to the service that includes all of the following:

(a) A description of treatment policies and procedures.

(b) A description of patient rights and responsibilities.

(c) Provision of a copy of a patient handbook that covers treatment policies and procedures, and patient rights and responsibilities. The service shall require a new patient to acknowledge, in writing, receipt of the handbook.

(7)   Research and human rights committee. A narcotic treatment service conducting or permitting research involving human subjects shall establish a research and human rights committee in accordance with s. 51.61 (4) , Stats., and 45 CFR Part 46 .

(8)   Research.

(a) All proposed research involving patients shall meet the requirements of s. 51.61 (1) (j) , Stats., 45 CFR Part 46 and this subsection.

(b) No patient may be subjected to any experimental diagnostic or treatment technique or to any other experimental intervention unless the patient gives written informed consent and the research and human rights committee established under s. 51.61 (4) , Stats., has determined that adequate provisions are made to do all of the following:

1. Protect the privacy of the patient.

2. Protect the confidentiality of treatment records in accordance with s. 51.30 , Stats., and ch. DHS 92 .

3. Ensure that no patient may be approached to participate in the research unless the patient's participation is approved by the person responsible for the patient's treatment plan.

(9)   Medical services.

(a) A service may not provide any medical services not directly related to narcotic treatment. If a patient has medical service needs that are not directly related to narcotic treatment, the service shall refer the patient for appropriate health care.

(b) The medical director of a service is responsible for all of the following:

1. Administering all medical services provided by the service.

2. Ensuring that the service complies with all federal, state, and local statutes, ordinances and regulations regarding medical treatment of narcotic addiction.

3. Ensuring that evidence of current physiological or psychological dependence, length of history of addiction and exceptions as granted by the state methadone authority to criteria for admission are documented in the patient's case record before the initial dose is administered.

4. Ensuring that a medical evaluation including a medical history and a physical examination have been completed for a patient before the initial dose is administered.

5. Ensuring that appropriate laboratory studies have been performed and reviewed.

6. Signing or countersigning all medical orders as required by federal or state law, including all of the following:

a. Initial medical orders and all subsequent medical order changes.

b. Approval of all take-home medications.

c. Approval of all changes in frequency of take-home medication.

d. Prescriptions for additional take-home medication for an emergency situation.

7. Reviewing and countersigning each treatment plan 4 times annually.

8. Ensuring that justification is recorded in the patient's case record for reducing the frequency of service visits for observed drug ingesting and providing additional take-home medication under exceptional circumstances or when there is physical disability, as well as when any medication is prescribed for physical health or psychiatric problems.

9. The amount of narcotic drug administered or dispensed, and for recording, signing and dating each change in the dosage schedule in a patient's case record.

(c) A service physician is responsible for all of the following:

1. Determining the amount of the narcotic drug to be administered or dispensed and recording, signing and dating each change in a patient's dosage schedule in the patient's case record.

2. Ensuring that written justification is included in a patient's case record for a daily dose greater than 100 milligrams.

3. Approving, by signature and date, any request for an exception to the requirements under sub. (11) relating to take-home medications.

4. Detoxification of a patient from narcotic drugs and administering the narcotic drug or authorizing an agent to administer it under physician supervision and physician orders in a manner that prevents the onset of withdrawal symptoms.

5. Making a clinical judgment that treatment is medically justified for a person who has resided in a penal or chronic care institution for one month or longer, under the following conditions:

a. The person is admitted to treatment within 14 days before release or discharge or within 6 months after release without documented evidence to support findings of physiological dependence.

b. The person would be eligible for admission if he or she were not incarcerated or institutionalized before eligibility was established.

c. The admitting service physician or service personnel supervised by the service physician records in the new patient's case record evidence of the person's prior residence in a penal or chronic care institution and evidence of all other findings of addiction.

d. The service physician signs and dates the recordings under subd. 5. c. before the initial dose is administered to the patient or within 48 hours after administration of the initial dose to the patient.

(d) A patient's history and physical examination shall support a judgment on the part of the service physician that the patient is a suitable candidate for narcotic addiction treatment.

(e) A service shall provide narcotic addiction treatment to a patient for a maximum of 2 years from the date of the person's admission to the service, unless clear justification for longer service provision is documented in the treatment plan and progress notes. Clear justification for longer service shall include documentation of all of the following:

1. The patient continues to benefit from the treatment.

2. The risk of relapse is no longer present.

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

4. Continued treatment is medically necessary in the professional judgment of the service physician.

(10)   Dosage.

(a) Because methadone and other FDA-approved narcotics are medications, the dose determination for a patient is a matter of clinical judgment by a physician in consultation with the patient and appropriate staff of the service.

(b) The service physician who has examined a patient shall determine, on the basis of clinical judgment, the appropriate narcotic dose for the patient.

(c) Any dose adjustment, either up or down, to sanction the patient, to reinforce the patient's behavior or for purposes of treatment contracting, is prohibited, except as provided in par. (h) .

(d) The service shall delay administration of methadone to an objectively intoxicated patient until diminution of intoxication symptoms can be documented, or the patient shall be readmitted for observation for withdrawal symptoms while augmenting the patient's daily dose in a controlled, observable fashion.

(e) The narcotic dose that a service provides to a patient shall be sufficient to produce the desired response in the patient for the desired duration of time.

(f) A patient's initial dose shall be based on the service physician's evaluation of the history and present condition of the patient. The evaluation shall include knowledge of local conditions, such as the relative purity of available street drugs. The initial dose may not exceed 30 milligrams except that the total dose for the first day may not exceed 40 milligrams.

(g) A service shall incorporate withdrawal planning as a goal in a patient's treatment plan, and shall begin to address it once the patient is stabilized. A service physician shall determine the rate of withdrawal to prevent relapse or withdrawal symptoms.

(h)

1. A service physician may order the withdrawal of a patient from medication for administrative reasons, such as extreme antisocial behavior or noncompliance with minimal service standards.

2. The process of withdrawal from medication for administrative reasons shall be conducted in a humane manner as determined by the service physician, and referral shall be made to other treatment services.

(11)   Take-home medication practices.

(a) Granting take-home privileges. During treatment, a patient may benefit from less frequent required visits for dosing. This shall be based on an assessment by the treatment staff. Time in treatment is not the sole consideration for granting take-home privileges. After consideration of treatment progress, the service physician shall determine if take-home doses are appropriate or if approval to take home doses should be rescinded. Federal requirements that shall be adhered to by the state methadone authority and the service are as follows:

1. Take-home doses are not allowed during the first 90 days of treatment. Patients shall be expected to attend the service daily, except Sundays, during the initial 90-day period with no exceptions granted.

2. Take-home doses may not be granted if the patient continues to use illicit drugs and if the primary counselor and the treatment team determine that the patient is not making progress in treatment and has continued drug use or legal problems.

3. Take-home doses shall only be provided when the patient is clearly adhering to the requirements of the service. The patient shall be expected to show responsibility for security and handling of take-home doses.

4. Service staff shall go over the requirements for take-home privileges with a patient before the take-home practice for self-dosing is implemented. The service staff shall require the patient to provide written acknowledgment that all the rules for self-dosing have been provided and understood at the time the review occurs.

5. Service staff may not use the level of the daily dose to determine whether a patient receives take-home medication.

(b) Treatment team recommendation. A treatment team of appropriate staff in consultation with a patient shall collect and evaluate the necessary information regarding a decision about take-home medication for the patient and make the recommendation to grant take-home privileges to the service physician.

(c) Service physician review. The rationale for approving, denying or rescinding take-home privileges shall be recorded in the patient's case record and the documentation shall be reviewed, signed and dated by the service physician.

(d) Service physician determination. The service physician shall consider and attest to all of the following in determining whether, in the service physician's reasonable clinical judgment, a patient is responsible in handling narcotic drugs and has made substantial progress in rehabilitation:

1. The patient is not abusing substances, including alcohol.

2. The patient keeps scheduled service appointments.

3. The patient exhibits no serious behavioral problems at the service.

4. The patient is not involved in criminal activity, such as drug dealing and selling take-home doses.

5. The patient has a stable home environment and social relationships.

6. The patient has met the following criteria for length of time in treatment starting from the date of admission:

a. Three months in treatment before being allowed to take home doses for 2 days.

b. Two years in treatment before being allowed to take home doses for 3 days.

c. Three years in treatment before being allowed to take home doses for 6 days.

7. The patient provides assurance that take-home medication will be safely stored in a locked metal box within the home.

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

(e) Time in treatment criteria. The time in treatment criteria under par. (d) 6. 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 FDA and the state methadone authority for a particular patient for a longer period of time.

(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.

(g) Additional criteria for 6-day take-homes. When a patient is considered for 6-day take-homes, the patient shall meet the following additional criteria:

1. The patient is employed, attends school, is a homemaker or is disabled.

2. The patient is not known to have used or abused substances, including alcohol, in the previous year.

3. The patient is not known to have engaged in criminal activity in the previous year.

(h) Observation requirement. A patient receiving a daily dose of a narcotic medication above 100 milligrams is required to be under observation while ingesting the drug at least 6 days per week, irrespective of the length of time in treatment, unless the service has received prior approval from the designated federal agency, with concurrence by the state methadone authority, to waive this requirement.

(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 may 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 the patient has had at least 3 consecutive months of 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, and the service physician determines that the patient is responsible in handling narcotic drugs.

(m) Clinical probation.

1. A patient receiving a 6-day supply of take-home medication 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 state methadone authority.

(12)   Exceptions to take-home requirements.

(a) A service may grant an exception to certain take-home requirements for a particular patient if, in the reasonable clinical judgment of the program 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) 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. If program personnel record the rationale, the physician shall review, countersign and date the rationale in the patient's record. A patient may not be given more than a 14-day supply of narcotic drugs at one time.

(c) 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 of attendance outweighs the potential risks of diversion.

(d)

1. Any exception to the take-home requirements exceeding 2 times the amount in that phase is subject to approval of the designated federal agency and the state methadone authority. The following is the amount of additional take-home doses needing approval: Phase 1 = 2 additional (excluding Sunday); phase 2 = 4 additional; phase 3 = 6 additional; phase 4 = 12 take-home doses required for approval.

2. Service staff on receipt of notices of approval or denial of a request for an extension from the state methadone authority and the designated federal agency shall place the notices in the patient's case record.

(e) 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) An exception shall remain in effect only as long as the conditions establishing the exception remain in effect.

(13)   Testing and analysis for drugs.

(a) Use.

1. A service shall use drug tests and analyses to determine the presence in a patient of opiates, methadone, amphetamines, cocaine or barbiturates. If any other drug has been determined by a service or the state methadone authority to be abused in that service's locality, a specimen shall also be analyzed for that drug. Any laboratory that performs the testing shall comply with 42 CFR Part 493 .

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.

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 drug levels in plasma or serum at the time the person is admitted to the service to determine a baseline. The determinations shall also be made at 3 months, 6 months and annually subsequently. If a patient requests and receives doses above 100 milligrams, serum levels shall be drawn to evaluate peak and trough determinations after the patient's dose is stabilized.

(c) Obtaining urine specimens. A service shall obtain urine specimens for testing from a patient in a clinical atmosphere that respects the patient's confidentiality, as follows:

1. A urine specimen shall be collected upon each patient's service visit and specimens shall be tested on a random basis.

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 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 after receipt of results 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. Punishment is not appropriate.

3. When there is a positive test result, service staff shall allow sufficient time before retesting 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.

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

(e) Monitoring of test reports. A service shall monitor test reports to do all of the following:

1. Ensure compliance with this section and with federal regulations.

2. Discover trends in substance use that may require a redirection of clinical resources.

3. Ensure that staff appropriately address with the patient a positive test report within one week after the report is received and that the report and the patient's response is documented in the patient's case record.

(f) Frequency of drug screens.

1. The frequency that a service shall require drug screening shall be clinically appropriate for each patient and allow for a rapid response to the possibility of relapse.

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.

(14)   Treatment duration and retention.

(a) 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. Make the service physically accessible.

2. 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.

3. Determine hours based on patient needs.

4. Provide affordable treatment to all needing it.

5. Ensure that a patient has ready access to staff, particularly to the patient's primary counselor.

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

7. Provide services that incorporate good practice standards for substance abuse treatment.

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

9. Ensure that the attitude of staff is accepting of narcotic addiction treatment.

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

(b) 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. The patient continues to benefit from the treatment.

2. The risk of relapse is discontinued.

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

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

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

(d) For services needed by a patient but not provided by the service, the service shall refer the individual to an appropriate service provider.

(15)   Multiple substance use and dual diagnosis treatment.

(a) Assessment. A service shall assess an applicant for admission during the admission process and a patient, as appropriate, 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 abuse as the desired goal.

2. Service objectives shall indicate that abstinence by a patient from alcohol and prescription and non-prescription substance abuse 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.

(c) Dually-diagnosed patients.

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.

2. When a dual diagnosis 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 dually-diagnosed patient, 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.

(16)   Pregnancy.

(a) A service that provides narcotic addiction treatment to pregnant women shall provide that treatment within a comprehensive treatment service that addresses medical, prenatal, obstetrical, psychosocial and addiction issues.

(b) A diagnosis of opioid addiction and need of the patient to avoid use of narcotic antagonists shall be based on the same factors, such as medical and substance abuse history, psychosocial history, physical examination, test toxicology and signs and symptoms of withdrawal, that are used in diagnosing opiate addiction in non-pregnant opioid-dependent women. In this paragraph, "narcotic antagonist" means a drug primarily used to counter narcotic-induced respiratory depression.

(c) A pregnant woman seeking narcotic addiction treatment shall be referred to a perinatal specialist or obstetrician as soon as possible after initiating narcotic addiction treatment with follow up contact, to coordinate care of the woman's prenatal health status, evaluate fetal growth and document physiologic dependence.

(d)

1. When withdrawal from narcotic medication is the selected treatment option, withdrawal shall be conducted under the supervision of a service physician experienced in perinatal addiction, ideally in a perinatal unit equipped with fetal monitoring equipment.

2. Withdrawal shall not be initiated before the 14th week of pregnancy or after the 32nd week of pregnancy.

(e) Pregnant women shall be monitored and their dosages individualized, as needed.

(f) A service shall not change the methadone dose that a pregnant woman was receiving before her pregnancy unless necessary to avoid withdrawal.

(g) A service shall increase the methadone dose for a patient, if needed, during the later stages of the patient's pregnancy to maintain the same plasma level and avoid withdrawal.

(h) A service shall arrange for appropriate assistance for pregnant patients, including education and parent support groups, to improve mother-infant interaction after birth and to lessen the behavioral consequences of poor mother-infant bonding.

(17)   Communicable disease.

(a) A narcotic treatment service for opiate addiction shall screen patients immediately following admission and annually thereafter for tuberculosis (TB). Tuberculosis treatment may be provided by referral to an appropriate public health agency or community medical service.

(b) A service shall screen prospective new staff for TB, and shall annually test all service staff for TB.

(c) A service shall screen all patients at admission and annually thereafter for viral hepatitis and sexually transmitted diseases (STDs) and shall ensure that any necessary medical follow-up occurs, either on-site or through referral to community medical services.

(d) A service shall ensure that all service staff have been immunized against hepatitis B. Documentation of refusal to be immunized shall be entered in the staff member's case record.

(18)   Facility. A service shall provide a setting that is conducive to rehabilitation of the patients and that meets all of the following requirements:

(a) The waiting area for dosing shall be clean.

(b) Waiting areas, dosing stations and all other areas for patients shall be provided with adequate ventilation and lighting.

(c) Dosing stations and adjacent areas shall be kept sanitary and ensure privacy and confidentiality.

(d) Patient counseling rooms, physical examination rooms and other rooms or areas in the facility that are used to meet with patients shall have adequate sound proofing so that normal conversations will be confidential.

(e) Adequate security shall be provided inside and outside the facility for the safety of the patients and to prevent loitering and illegal activities.

(f) Separate toilet facilities shall be provided for patient and staff use.

(g) The facility and areas within the facility shall be accessible to persons with physical disabilities.

(h) The physical environment within the facility shall be conducive to promoting improved functioning and a drug free lifestyle.

(19)   Diversion control.

(a) Each staff member of the narcotic treatment service for opiate addiction is responsible for being alert to potential diversion of narcotic medication by patients and staff.

(b) Service staff shall take all of the following measures to minimize diversion:

1. Doses of narcotic medication shall be dispensed only in liquid form.

2. Bottles of narcotic medication shall be labeled with the patient's name, the dose, the source service, the prescribing physician and the date by which the dose is to be consumed.

3. The service shall require a patient to return all empty take-home bottles on the patient's next day of service attendance following take-home dosing. Service staff shall examine the bottles to ensure that the bottles are received from the appropriate patient and in an intact state.

4. The service shall discontinue take-home medications for patients who fail to return empty take-home bottles in the prescribed manner.

(c) If a service receives reliable information that a patient is diverting narcotic medication, the patient's primary counselor shall immediately discuss the problem with the patient.

(d) Based on information provided by the patient or continuing reports of diversion, a service may revoke take-home privileges of the patient.

(e) The state methadone authority may, based on reports of diversion, revoke take-home privileges, exceptions or exemptions granted to or by the service for all patients.

(f) The state methadone authority may revoke the authority of a narcotic treatment service for opiate addiction to grant take-home privileges when the service cannot demonstrate that all requirements have been met in granting take-home privileges.

(g) A narcotic treatment service for opiate addiction shall have a written policy to discourage the congregation of patients at a location inside or outside the service facility for non-programmatic reasons, and shall post that policy in the facility.

(20)   Service approval.

(a) Approval of primary service. An applicant for approval to operate a narcotic treatment service for opiate addiction in Wisconsin with the intent of administering or dispensing a narcotic drug to narcotic addicts for maintenance or detoxification treatment shall submit all of the following to the state methadone authority:

1. Copies of all completed designated federal agency applications.

2. A copy of the request for registration with the U.S. drug enforcement administration for the use of narcotic medications in the treatment of opiate addiction.

3. A narrative description of the treatment services that will be provided in addition to chemotherapy.

4. Documentation of the need for the service.

5. Criteria for admitting a patient.

6. A copy of the policy and procedures manual for the service, detailing the operation of the service as follows:

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. Descriptions 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.

a. Documentation that the service will have ready access to a comprehensive range of medical and rehabilitative services that will be available if needed.

b. 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 the FDA, the U.S. drug enforcement administration and the state methadone authority may be used for treating narcotic addicts with a narcotic drug.

(c) Approval of medication units.

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.

(21)   Assent to regulation.

(a) A person who sponsors a narcotic treatment service for opiate addiction 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) 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) 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) The service shall notify the designated federal agency and state methadone authority within 3 weeks after replacement of the service sponsor or medical director.

(22)   Death reporting. A narcotic treatment service for opiate addiction shall report the death of any of its patients to the state methadone authority within one week after learning of the patient's death.

History: Cr. Register, July, 2000, No. 535 , eff. 8-1-00; correction in (8) (b) 2. made under s. 13.92 (4) (b) 7. , Stats., Register November 2008 No. 635 ; CR 09-109 : am. (4) (d) and (e), cr. (4) (dm) Register May 2010 No. 653 , eff. 6-1-10; correction in (4) (dm), (e) made under s. 13.92 (4) (b) 7. , Stats. Register November 2011 No. 671 .

Note

Section SPS 162.01 (1) states that a clinical supervisor shall provide a minimum of: Microsoft Windows NT 6.1.7601 Service Pack 1 1. Two hours of clinical supervision for every 40 hours of work performed by a substance abuse counselor-in-training. Microsoft Windows NT 6.1.7601 Service Pack 1 2. Two hours of clinical supervision for every 40 hours of counseling provided by a substance abuse counselor. Microsoft Windows NT 6.1.7601 Service Pack 1 3. One hour of clinical supervision for every 40 hours of counseling provided by a clinical substance abuse counselor. Microsoft Windows NT 6.1.7601 Service Pack 1 4. One in person meeting each calendar month with a substance abuse counselor-in-training, substance abuse counselor, or clinical substance abuse counselor. This meeting may fulfill a part of the requirements above. Microsoft Windows NT 6.1.7601 Service Pack 1 Section SPS 162.01 (5) states that the goals of clinical supervision are to provide the opportunity to develop competency in the transdisciplinary foundations, practice dimensions and care functions, provide a context for professional growth and development and ensure a continuance of quality patient care. Microsoft Windows NT 6.1.7601 Service Pack 1 For copies of FDA Form 2635, Consent to Narcotic Addiction Treatment, a service may write to Commissioner, Food and Drug Administration, Division of Scientific Investigations, 5600 Fishers Lane, Rockville, MD 20857. Microsoft Windows NT 6.1.7601 Service Pack 1 To apply for approval to operate a medication unit, contact the State Methadone Authority in the Bureau of Prevention, Treatment and Recovery at P.O. Box 7851, Madison, WI 53707-7851. Approvals of the Center for Substance Abuse Treatment and the U.S. Drug Enforcement Administration to operate a medication unit are also required. The State Methadone Authority will facilitate the application consideration by the Center for Substance Abuse Treatment and the U.S. Drug Enforcement Administration. Microsoft Windows NT 6.1.7601 Service Pack 1