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. DHS 75.59(12)(d)4.4. The patient shall be entitled, upon request, to examine any documentary evidence in the possession of the service that pertains to the subject matter of the hearing. DHS 75.59(12)(d)5.5. The patient shall be entitled to call his or her own witnesses and to question any adverse witnesses. DHS 75.59(12)(d)6.6. The service shall make an audio recording of the hearing. The patient may also make an audio recording of the hearing at the patient’s expense. DHS 75.59(12)(d)7.7. The hearing officer shall make a decision within 7 business days after the hearing and will base the decision solely upon the information presented at the hearing. The decision shall be based upon the services policy and procedures in effect and posted at the time of the violation. DHS 75.59(12)(d)8.8. The hearing officer shall issue the decision in writing, and shall provide the patient or and patient’s representative, or both, with a copy of the decision. The decision shall include an explanation of the reasons for the decision, and instructions explaining how to file an appeal of an adverse decision to the department. The instructions shall inform the client that the client’s written request for an appeal constitutes the client’s consent to release information to the department. DHS 75.59(12)(e)1.1. A patient has the right to appeal an adverse decision of a hearing officer to the department’s client rights office. The patient must request this appeal in writing to the department within 3 business days following the receipt of the adverse decision. This request must be postmarked within the 3 business day time frame. The patient’s written appeal shall contain the patient’s argument in support of the appeal. The department will either affirm or reverse the hearing officer’s decision, or remand the decision to a new hearing officer for a new hearing. The decision of the department shall be made as follows in writing: DHS 75.59(12)(e)1.a.a. In the case of an emergency termination, the department shall decide within one business day of receipt of the complete hearing record and written materials submitted by both parties. DHS 75.59(12)(e)1.b.b. In the case of a non-emergency termination, the department shall decide within 10 business days of the department’s receipt of the complete hearing record and written materials submitted by both parties. A service’s failure to submit the complete hearing record will result in a finding for the patient. The department shall deliver a written decision, outlining the reason(s) for the decision, to the patient, the patient’s advocate, and the service. The decision of the department is final. DHS 75.59(12)(e)2.2. In the case of a non-emergency termination, if the patient timely appeals the hearing decision, the service may not terminate the client or begin medically supervised withdrawal without first receiving, and ensuring that the client also receives, the department’s decision on appeal. DHS 75.59(12)(f)(f) Humane taper. 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. DHS 75.59(13)(a)(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 and State requirements that shall be adhered to by the SOTA and the service are as follows: DHS 75.59(13)(a)1.1. Take-home doses are not allowed during the first 30 days of treatment. Patients are expected to attend the service daily. Exception requests may be submitted for review when extenuating circumstances (i.e. pandemic) arise and will be reviewed and a determination made by the SOTA. DHS 75.59(13)(a)2.2. Take-home doses shall 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. DHS 75.59(13)(a)3.3. 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. DHS 75.59(13)(a)4.4. Service staff shall go over the requirements for take-home privileges with a patient before the take-home practice for self-dosing is implemented. Clinical 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. DHS 75.59(13)(a)5.5. Service staff may not use the level of the daily dose to determine whether a patient receives take-home medication. DHS 75.59(13)(b)(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. DHS 75.59(13)(c)(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. Physician orders for take-home medication for substance use disorders shall expire every 90 days. The physician shall document how a patient meets all criteria in par. (d) 1. to 8. within the order for take-home medication and what phase level the patient is at for which medication. DHS 75.59(13)(d)(d) Service physician determination. The service physician shall determine whether, in the service physician’s reasonable clinical judgment, the patient has made substantial progress in rehabilitation and can responsibly handle narcotic drugs. In order to make this determination in the affirmative and grant take home privileges, the service physician must consider and attest to all of the following:
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