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.
DHS 75.59(9)(c)
(c)
Written consent. 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:
DHS 75.59(9)(c)3.
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.
DHS 75.59(10)(a)(a)
Primary medical services. An OTP may provide primary medical services for patients. The OTPs may use all FDA-approved medications and formulations for use in treating the patient with a substance use disorder.
DHS 75.59(10)(b)
(b)
Coordination with medical providers. For medical needs of a patient that exceed the scope of the service under this chapter, the service shall coordinate with appropriate medical providers.
DHS 75.59(10)(c)
(c)
Medical director responsibilities. The medical director of a service is responsible for all of the following:
DHS 75.59(10)(c)2.
2. Ensuring that the service complies with all federal, state, and local statutes, ordinances and regulations regarding medical treatment of an opioid use disorder.
DHS 75.59(10)(c)3.
3. Ensuring that evidence of current physiological or psychological dependence, length of history of addiction and exceptions as granted by the SOTA to criteria for admission are documented in the patient's case record before the initial dose is administered.
DHS 75.59(10)(c)4.
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.
DHS 75.59(10)(c)5.
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:
DHS 75.59(10)(c)5.a.
a. The patient 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.
DHS 75.59(10)(c)5.b.
b. The patient would be eligible for admission if he or she were not incarcerated or institutionalized before eligibility was established.
DHS 75.59(10)(c)5.c.
c. The admitting service physician or service personnel supervised by the service physician records in the 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.
DHS 75.59(10)(c)5.d.
d. The medical director 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.
DHS 75.59(10)(c)6.
6. Ensuring that appropriate laboratory studies have been performed and reviewed.
DHS 75.59(10)(c)7.
7. Signing or countersigning all medical orders as required by federal or state law, including all of the following:
DHS 75.59(10)(c)9.
9. 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.
DHS 75.59(10)(c)10.
10. Ensuring the correct amount of medication is administered or dispensed, and for recording, signing and dating each change in the dosage schedule in a patient's case record.
DHS 75.59(10)(c)11.
11. Ensuring that all physician orders are executed by the date given in the order or, if no date is specified, within 24 hours of the order being written.
DHS 75.59(10)(c)12.
12. Having a valid DEA registration for prescribing, administering, or dispensing controlled substances, and having a DEA waiver if they or any other healthcare professional they supervise prescribes, administers, or dispenses partial opioid agonists.
DHS 75.59(10)(d)
(d)
Service physician responsibilities. A service physician is responsible for all of the following:
DHS 75.59(10)(d)1.
1. Determining the amount of the medication to be administered or dispensed and recording, signing and dating each change in a patient's dosage schedule in the patient's case record.
DHS 75.59(10)(d)2.
2. Approving, by signature and date, any request for an exception to the requirements under sub.
(13) relating to take-home medications.
DHS 75.59(10)(d)3.
3. 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.
DHS 75.59(10)(d)4.
4. A history and physical examination of the patient determining that the patient is a suitable candidate for admission to an OTP.
DHS 75.59(11)(a)(a)
Dose determination. The dose determination for a patient is a matter of clinical judgment by a physician in consultation with the patient and appropriate clinical staff.
DHS 75.59(11)(b)
(b)
Verbal orders. The service physician shall determine, on the basis of clinical judgment, the appropriate medication dose for the patient and may also use verbal orders pursuant to state, accreditation, and federal rules. Upon receiving the service physician's order, the receiver shall record the order in the patient's record, and then shall read back the written order to the issuing professional to assure that the order is understood clearly. Orders made orally or telephonically must be documented as such and staff recording must sign their name and title. Oral or telephone orders must be countersigned by the service physician no later than 72 hours after being given.
DHS 75.59(11)(c)
(c)
Patient sanctioning. Any dose adjustment to sanction the patient, to reinforce the patient's behavior, or for purposes of treatment contracting, is prohibited.
DHS 75.59(11)(d)
(d)
Patients under the influence. The service shall delay administration of an FDA-approved medication for the treatment of an opioid use disorder to a patient under the influence of illicit drugs or alcohol until diminution of intoxication symptoms can be observed and documented, or the patient shall be readmitted for observation for withdrawal symptoms while augmenting the patient's daily dose in a controlled, observable fashion.
DHS 75.59(11)(e)
(e)
Sufficient dosing. The FDA-approved medication 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.
DHS 75.59(11)(f)
(f)
Initial methadone dose. A patient's initial dose shall be based on the service physician's evaluation of the history and present condition of the patient. The initial dose of methadone may not exceed 30 milligrams except that the total dose for the first day may not exceed 40 milligrams.
DHS 75.59(11)(g)
(g)
Withdrawal planning. A service shall incorporate withdrawal planning as a goal in a patient's initial treatment plan and all subsequent treatment plans. A service physician shall determine the rate of withdrawal to prevent relapse or withdrawal symptoms.
DHS 75.59(12)(a)1.
1. The service may terminate a patient immediately, prior to a fair hearing and without provision for medically supervised withdrawal, when either of the following occurs:
DHS 75.59(12)(a)1.a.
a. The clinic director reasonably determines and documents that the patient's continuance in the service presents an immediate and substantial threat of physical harm to other clients, service personnel or property.
DHS 75.59(12)(a)1.b.
b. The program's medical director reasonably determines that continued treatment of a client presents a serious documented medical risk.
DHS 75.59(12)(a)2.a.
a. Immediately notify the patient of the decision and the reasons for the decision.
DHS 75.59(12)(a)2.b.
b. Schedule a hearing, to be held on the next business day and in accordance with par.
(d), on the decision to terminate and provide notice of the hearing to the patient.
DHS 75.59(12)(a)2.c.
c. After a hearing is held in accordance with par.
(d), notify the patient of the hearing officer's decision within one business day of the hearing.
DHS 75.59(12)(a)2.d.
d. Provide referrals to ensure a continuum of care for the client, including continued counseling, medication, withdrawal management, and other services, including risk reduction and outreach.
DHS 75.59(12)(a)3.
3. Facilities that are in the process of termination are not required to provide medically supervised withdrawal services to clients who are discharged involuntarily on an emergency basis, but referrals for assistance elsewhere must be provided in such circumstances.
DHS 75.59(12)(b)
(b)
Non-emergency termination. In a non-emergency situation, the service must afford the client the following procedural rights in addition to the rights listed in s.
51.61, Stats., and ch.
DHS 94:
DHS 75.59(12)(b)1.
1. Prior to initiating medically supervised withdrawal, the service shall provide the client with prompt written notice which shall contain:
DHS 75.59(12)(b)1.a.
a. A statement of the reasons for the proposed termination, such as
violations of a specific rule or rules, non-compliance with treatment contract,
and the particulars of the infraction including the date, time, and place.
DHS 75.59(12)(b)1.b.
b. Notification that the client has the right, within 2 business days following receipt of written notice, to submit a written request for a fair hearing on the proposed termination; if a fair hearing is requested the medically supervised withdrawal is stopped until the hearing occurs and a decision is rendered.
DHS 75.59(12)(b)2.
2. If a timely request for a hearing is made, arrange with the patient or patient's advocate for a mutually convenient date and time for a hearing within 10 business days of receipt of the notice. Additional time to secure appropriate representation may be granted to the client under exceptional circumstances.
DHS 75.59(12)(b)3.
3. Afford the client the opportunity of medically supervised withdrawal. If the client chooses medically supervised withdrawal, the service shall provide medically supervised withdrawal, or make arrangements for appropriate medically supervised withdrawal in another OTP. The rate of dosage reduction shall be determined by the services medical director in accordance with the patient's medical condition and the dosage level at which the client was medicated before the decision was made to terminate or suspend. In determining an appropriate course of withdrawal, the medical director shall review the record, consider the patient's physical and mental health status, and, upon request of the client, may take into account the opinions of the patients other physicians and medical providers. If a hearing is requested by the patient, the medically supervised withdrawal shall cease until the hearing occurs and a decision is rendered.
DHS 75.59(12)(b)4.
4. If a patient is terminated for non-payment of fees, medically supervised withdrawal may begin immediately upon providing written notice of termination, and continue concurrent with client's appeal, if any.
DHS 75.59(12)(c)
(c)
Documentation of receipt of notice. The service shall document provision of notice to the patient by obtaining the signature of the staff person providing notice and by obtaining a signed, dated receipt from the patient. If the patient refuses to sign a receipt, the service shall document that refusal on its record of notice.
DHS 75.59(12)(d)
(d)
Hearing procedures. The service shall ensure that hearings are conducted in accordance with the following procedures:
DHS 75.59(12)(d)1.
1. An impartial hearing officer shall preside over the hearing. The hearing officer may be any staff or other person not directly involved in the facts of the incident giving rise to the disciplinary proceedings or in the decision to commence the proceedings, provided that the persons involved in either the facts of the incident or in the decision to commence the proceedings shall not have authority over the hearing officer.
DHS 75.59(12)(d)2.
2. The patient may be represented at the hearing by any responsible adult of the client's choosing. If the patient chooses to be represented by legal counsel, the patient must give the service at least 72 hours' notice in advance of the hearing, so that the service may consult its own legal counsel prior to the hearing.
DHS 75.59(12)(d)3.
3. At a hearing, the service bears the burden of proving, by a preponderance of the evidence, that the alleged violation occurred.
