DHS 75.59(5)(b)
(b)
Medical director. The service shall designate a physician licensed under ch.
448, Stats., as its medical director.
The medical director shall have at least one year of experience in addiction medicine or addiction psychiatry, be licensed to practice medicine or osteopathy, and meet all other requirements listed in s.
DHS 75.03 (52). If a service is not able to secure a medical director who meets the one year of experience requirement, as documented through recruitment efforts, there shall be a specific plan for the person to acquire equivalent training and skills within 4 months after beginning employment. The medical director, service physician, or mid-level practitioner that has a federal exception approved by SAMHSA and the SOTA to
42 CFR 8.12 (b), (e), (h), and (i) shall be physically present at the OTP at least 40 percent of the time that the program administers or dispenses medication in order to comply with s.
DHS 94.08, assure regulatory compliance, and carry out duties specifically assigned by regulation as required by SAMHSA under
42 CFR 8.12. OTPs in the first 60 days of operation may reduce the time requirement medical directors must be present on site to at least 20 percent of the time that the program administers or dispenses medication. On the 61st day of operation the service shall be subject to the requirements of this rule.
DHS 75.59(5)(c)
(c)
Nurses. The service shall have a registered nurse on staff to supervise the dosing process and perform other functions delegated by the physician. A registered nurse shall be physically on the premises any time dosing is occurring.
DHS 75.59(5)(d)
(d)
Nursing assistants. 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.
DHS 75.59(5)(e)
(e)
Licensed counselors. The service shall employ at least one of the following: substance abuse counselors, substance abuse counselors-in training, licensed marriage and family therapists, licensed professional counselors, licensed clinical social workers or clinical substance abuse counselors who are under the supervision of a clinical supervisor. An OTP shall employ one of these identified clinicians for a minimum of one full-time equivalent of 40 hours per week for every 55 enrolled patients in the service. All counselors rostered to the service are subject to this ratio.
DHS 75.59(5)(f)
(f)
Supervision of counseling staff. The service shall provide for ongoing clinical supervision of the counseling staff in accordance with s.
SPS 162.01. The service shall employ one full-time clinical supervisor at an equivalent of 40 hours per week for every 10 counselors employed. The clinical supervisor shall not carry a caseload greater than 30 patients to ensure access to prompt and adequate care of those patients while balancing their clinical supervision responsibilities.
DHS 75.59(5)(g)
(g)
Physician assistants. The service may employ physician assistants to practice in accordance with ch.
Med 8 and carry out duties specifically allowed by regulation as required by SAMHSA under
42 CFR 8.11 (h).
DHS 75.59(6)(a)(a)
Admission criteria. For admission to the service, a person shall meet all of the following criteria as determined by the service physician:
DHS 75.59(6)(a)1.
1. `Maintenance treatment for an adult.' The service shall maintain current procedures determined by the service physician to ensure that patients are admitted to maintenance treatment by qualified personnel who have determined, using accepted medical criteria, such as those listed in the DSM, that the person is currently addicted to an opioid drug, and that the person became addicted at least one year before admission for treatment. In addition, a service physician shall ensure that each patient voluntarily chooses maintenance treatment and that all relevant facts concerning the use of the opioid drug are clearly and adequately explained to the patient, and that each patient provides informed written consent to treatment.
DHS 75.59(6)(a)2.
2. `Maintenance treatment for a minor.' A minor shall be eligible for maintenance treatment only if the minor has had at least 2 documented unsuccessful attempts at short-term detoxification or drug-free treatment within a 12-month period. No minor may be admitted to maintenance treatment unless a parent, legal guardian, or responsible adult designated by the relevant state authority consents in writing to such treatment.
DHS 75.59(6)(a)3.
3. `Maintenance treatment admission exceptions.' If clinically appropriate, the program physician may waive the requirement of a one-year history of addiction of subd.
1. for any of the following:
DHS 75.59(6)(a)3.c.
c. A previously treated patient who was discharged from the service less than 2 years prior.
DHS 75.59(6)(a)4.
4. `Detoxification treatment.' An OTP shall maintain current procedures that are designed to ensure that patients are admitted to short- or long-term detoxification treatment by qualified personnel, such as a service physician, who determines that such treatment is appropriate for the specific patient by applying established diagnostic criteria. Patients with two or more unsuccessful detoxification episodes within a 12-month period must be assessed by the service physician for other forms of treatment. A service shall not admit a patient for more than 2 detoxification treatment episodes in one year.
DHS 75.59(6)(a)5.
5. `Health care release of information.' When the patient receives health care services from outside the service, the patient shall provide names, addresses and written consents for release of information from each health care provider to allow the service to contact the providers, and shall update releases if changes occur.
DHS 75.59(6)(a)6.
6. `Prohibition on reward for referral.' No service shall provide a bounty, free services, medication or other reward for referral of potential service recipients to the clinic.
DHS 75.59(6)(b)
(b)
Voluntary treatment. Participation in an OTP shall be voluntary.
DHS 75.59(6)(c)
(c)
Explanation. Clinical staff shall clearly and adequately explain to the patient being admitted all relevant facts concerning the use of medications used by the service, service rules, and expectations.
DHS 75.59(6)(d)
(d)
Consent. The service shall require a patient to complete an informed medication consent form which clearly indicates which FDA-approved medication for opioid use disorder they will be receiving, the reason for the use of the medication, the expected benefits of the use of the medication, and the potential side effects of the medication.
DHS 75.59(6)(e)1.1. For each patient eligible for admission, the service shall arrange for a comprehensive physical examination and clinically indicated laboratory work-up. The comprehensive physical examination shall be ordered by the service physician on the day of admission and shall include a complete blood count and liver function testing. The service shall test for Hepatitis A, B, C and HIV if the patient gives informed consent in writing. If the patient declines permission to test shall be documented in the patient's record. An updated comprehensive physical examination including lab work shall be completed annually.
DHS 75.59(6)(e)2.
2. The service shall complete a psychosocial assessment and initial treatment plan within 3 days of admission.
DHS 75.59(6)(f)
(f)
Initial dose. If a person meets the admission criteria under par.
(a), an initial dose of an FDA-approved medication may be administered to the patient on the day of admission. For each new patient enrolled in a service, the initial dose of methadone shall not exceed 30 milligrams and the total dose for the first day shall not exceed 40 milligrams, unless the service physician documents in the patient's record that 40 milligrams did not suppress opioid abstinence symptoms.
DHS 75.59(6)(g)
(g)
Central registry. All facilities shall participate in the department's central registry, subject to all of the following requirements:
DHS 75.59(6)(g)1.
1. A patient shall be informed of the service's participation in the central registry, and prior to initiating a central registry inquiry the service shall obtain the patient's written consent.
DHS 75.59(6)(g)2.
2. To prevent simultaneous enrollment of a patient in more than one OTP, at the time of admission and prior to the dosing of a patient, the service shall initiate a clearance inquiry by submitting to the approved central registry the patient's name, date of birth, and relevant information as required for the clearance procedure. No patient who is reported by the central registry to be participating in another such service shall be admitted to an OTP. When a dual enrollment is found, the patient shall be discharged from one OTP in order to continue enrollment at another OTP. The SOTA shall be notified within 24 hours of any dual enrollment discovered.
DHS 75.59(6)(g)3.
3. 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 OTP to which a disclosure will be made.
DHS 75.59(6)(g)4.
4. Reports received by the central registry shall be treated as confidential and shall not be released except to a licensed service or its designated legal representative, as required by law or as part of continuity of operations in the case of an emergency. Information made available by the central registry shall also be treated as confidential.
DHS 75.59(6)(g)5.
5. If a service operates not more than 200 miles away from an OTP in an adjoining state, the SOTA may direct the service to share service recipient information with the OTP in the other state to prevent simultaneous enrollment of persons in more than one OTP service.
DHS 75.59(6)(g)6.
6. A patient shall not be dosed prior to a central registry check being conducted.
DHS 75.59(6)(g)7.
7. Documentation of the central registry check shall be kept in the patient's file.
DHS 75.59(6)(h)
(h)
Information provided at admission. A patient admitted to the OTP shall receive written copies of the following information at the time of admission:
DHS 75.59(6)(h)3.
3. The service must provide access to staff support 24 hours a day 7 days a week to ensure that the service provides a mechanism to address patient emergencies (which includes medication verification by any other OTP, Emergency Department, correctional institution, or jail) by establishing an emergency contact system. The purpose of the contact system is to obtain dosage levels and other pertinent patient information on a 24 hour, 7-day-a-week-basis, as appropriate under confidentiality regulations. This subdivision does not require staff to be on site at all times, but at least one designated staff member is available “on call” as the emergency contact.
DHS 75.59(6)(i)
(i)
Admissions protocol. The service shall have a written admissions protocol that accomplishes all of the following:
DHS 75.59(6)(i)1.
1. Identifies the patient on the basis of appropriate substantiated documents that contain the patient'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.
DHS 75.59(6)(i)2.
2. Determines the patient'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.
DHS 75.59(6)(i)3.
3. Determines and verifies the patient's age. If the patient is a minor, the policy shall require documentation as provided in par.
(a) 2. DHS 75.59(6)(i)4.
4. Identifies all 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.
DHS 75.59(6)(i)5.
5. Obtains information about past treatment. To the extent possible, service staff shall obtain information on a patient's treatment history, use of secondary substances while in the treatment, dates and length of time in treatment and reasons for discharge.
DHS 75.59(6)(i)6.
6. Obtains personal information about the patient. Personal information includes history and current status regarding employment, education, legal status (including arrests and conviction history), military service, family and psychiatric and medical information.
DHS 75.59(6)(i)7.
7. Identifies the patient's reasons for seeking treatment. Reasons shall include why the patient chose the service and whether they fully understand the treatment options and the nature and requirements of medication assisted treatment are fully understood.
DHS 75.59(6)(i)8.
8. Completes an initial drug screening or analysis to detect the use of opiates, methadone, buprenorphine, synthetic opioids, amphetamines, methamphetamine, benzodiazepines, cocaine, alcohol, and THC. The analysis shall show positive for narcotics, or an adequate explanation for negative results shall be provided and noted in the prospective patient's record.
DHS 75.59(6)(i)9.
9. Refers a patient who also has a physical health problem that cannot be treated within the service to an appropriate agency for appropriate treatment.
DHS 75.59(6)(i)10.
10. Obtains the patient's written consent for the service to secure records from other agencies that may assist the service with treatment planning.
DHS 75.59(6)(i)11.
11. Refers prospective patients who are physiologically dependent on alcohol, sedatives, or to anxiolytics to hospital detoxification before initiating treatment. If prospective patient refuses hospital detoxification, the medical director shall determine if the risk of treating a patient with a history of use of alcohol, sedatives, or anxiolytics outweighs the risk of non-admission to the service.
DHS 75.59(6)(j)
(j)
First priority for services. A service shall offer priority admission either through immediate admission or priority placement on a waiting list in the following order:
DHS 75.59(6)(j)1.
1. Pregnant women who inject drugs. Pregnant women are to be assessed for appropriateness for admission by a physician within 24 hours of contacting the service.
DHS 75.59(6)(j)2.
2. Pregnant women who are drug or alcohol dependent and need treatment.
DHS 75.59(6)(j)4.
4. Others individuals who are drug or alcohol dependent and need treatment.
DHS 75.59(6)(k)1.1. `Capacity management.' An OTP must notify the SOTA within seven days of the program reaching both 90 and 100 percent of the program's capacity to care for clients. Each week, the service must report its capacity, currently enrolled dosing clients, and any waiting list. A service reporting 90 percent of capacity must also notify the SOTA when the program's census increases or decreases from the 90 percent level.
DHS 75.59(6)(k)2.
2. `Waiting list.' If the service is at capacity, it shall immediately advise a prospective patient of the service's waiting list and provide that person with a referral to another treatment service that can serve the person's treatment needs. The OTP shall provide the SOTA documentation of any waiting list and where prospective patients were referred for treatment upon request. An OTP must have a waiting list system. If the prospective patient seeking admission cannot be admitted within 14 days of the date of application, each person seeking admission must be placed on the waiting list, unless the person seeking admission is assessed by the service and found ineligible for admission according to this chapter,
42 CFR parts 2 to
11, or
45 CFR parts 160 to
164. The waiting list must assign a unique client identifier for each person seeking treatment while awaiting admission.
DHS 75.59(6)(L)
(L)
Appropriate and un-coerced treatment. Service staff shall determine through a screening process that an OTP is the most appropriate treatment modality for the prospective patient and that treatment is not coerced.
DHS 75.59(6)(m)
(m)
Non-admissions. The service shall maintain written logs that identify persons who were considered for admission or initially screened for admission but were not admitted. Such logs shall identify the reasons why the person was not admitted and what referrals were made for them by the service. These logs will be provided to the department upon request.
DHS 75.59(7)(a)
(a)
Orientation information. Within 3 days of admission, a patient shall receive an orientation to OTP services providing information on the following:
DHS 75.59(7)(a)9.
9. How to attain self-administered dose privileges and requirements to maintain those privileges.
DHS 75.59(7)(a)11.
11. Rules governing patient conduct and infractions that can lead to disciplinary action or discharge from the OTP.
DHS 75.59(7)(b)
(b)
Written materials. Information provided in the orientation shall be accompanied by the provision of written materials on all covered topics.
DHS 75.59(7)(c)
(c)
Proof of orientation. The OTP shall require a new patient to acknowledge in writing that the patient has received a full orientation to all requirements and responsibilities associated with service enrollment.
DHS 75.59(7)(d)
(d)
Additional orientation requirements for pregnant patients. For pregnant patients, the OTP shall explain the following:
DHS 75.59(7)(d)1.
1. The risks and benefits of opioid treatment medication during pregnancy.
DHS 75.59(7)(e)
(e)
Documentation. Documentation of the provision of the above information shall be included in the patient's record.
DHS 75.59(8)(a)(a)
Accommodation of all patients. A service's hours of operation shall accommodate patients involved in activities such as school, homemaking, child care and employment.
DHS 75.59(8)(b)
(b)
Availability of dosing and counseling. Dosing and counseling shall be available at a medically appropriate level to meet patient needs and shall offer non-traditional hours of operation that meet the majority of patient's schedule needs.
DHS 75.59(8)(c)
(c)
Daily operations. All clinics must be open for dosing and counseling at least 6 days per week and shall be open 7 days a week if they have any patients that do not meet criteria for take home medication if those patients cannot be served via guest dosing at other nearby clinics. Facilities shall notify the SOTA and patients of the date of any holiday when the service will be closed at least 7 days in advance of the holiday. Clinics may only close for a holiday if all patients are eligible for take-home medication. In the event that all patients are not eligible for take-home medication, the service may request to offer modified hours for the holiday.
DHS 75.59(8)(d)
(d)
Training day. Any service may also be closed for one mandatory training day, if required by the SOTA.
DHS 75.59(8)(e)
(e)
Comprehensive services. Facilities shall offer comprehensive services, including individual and group counseling, and referral services, at least six days per week. Medical exams shall be provided on days when new admissions are scheduled and as needed for current patients.
DHS 75.59(9)(a)(a)
Human subjects. An OTP 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.
