Section DHS 75.59 - Opioid treatment program(1)SERVICE DESCRIPTION. In this section, oopioid treatment program, or "OTP", means a service that provides for the management and rehabilitation of persons with an opioid use disorder through the use of methadone and other FDA-approved medications for the treatment of persons with an opioid use disorder, and also provides a broad range of medical and psychological services, substance use counseling and social services. OTPs shall provide adequate medical, counseling, vocational, educational, and other assessment and treatment services. These services must be available at the primary facility, except where the program sponsor has entered into a formal, documented agreement with a private or public agency, organization, practitioner, or institution to provide these services to patients enrolled in the OTP. The program sponsor, in any event, must be able to document that these services are fully and reasonably available to patients. An OTP is subject to the oversight of the SOTA.(2)REQUIREMENTS. To receive certification from the department under this chapter, an OTP shall comply with all requirements included in subch. IV, as applicable, be certified under and follow all requirements included in s. DHS 75.50, and the requirements of this section. If a requirement in this section conflicts with an applicable requirement in subch. IV or s. DHS 75.50, 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 patient identifying information from 2 or more OTPs 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 due to rule violations.(d) "Guest dose means administration of a medication used for the treatment of opioid addiction to a person who is not a client of the program that is administering or dispensing the medication.(e) "Initial dosing means the first administration of methadone or other FDA-approved medication for the treatment of opioid use disorder to relieve a degree of withdrawal and drug craving of the patient.(f) "Maintenance treatment means the dispensing of a narcotic drug in the treatment of an individual for opioid dependence.(g) "Mandatory schedule means the required dosing schedule for a patient and the established frequency that the patient must attend the service.(h) "Medically-supervised withdrawal means dispensing, administering, or prescribing of an FDA-approved medication for the treatment of opioid use disorder in gradually decreasing doses to alleviate adverse physical or psychological effects incident to withdrawal from the continuous or sustained use of opioid drugs. The purpose of medically supervised withdrawal is to bring a patient maintained on maintenance medication to a medication-free state within a target period.(i) "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.(j) "Objectively intoxicated person means a person who is determined through a breathalyzer test to be under the influence of alcohol.(k) "Opioid addiction means psychological and physiological dependence on an opiate substance, either natural or synthetic, that is beyond voluntary control. (l) "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.(m) "Phase means a patient's level of dosing frequency.(n) "Potentiation means the increasing of potency and, in particular, the synergistic action of two or more drugs which produces an effect that is greater than the effect of each drug used alone.(o) "SAMHSA means the Substance Abuse and Mental Health Services Administration.(p) "Service physician means a physician licensed to practice medicine in the jurisdiction in which the service is located, and knowledgeable in addiction treatment, who assumes responsibility for the administration of all medical services performed by the OTP including ensuring that the service is in compliance with all federal, state and local laws relating to medical treatment of an opioid use disorder with an FDA approved medication for the treatment of an opioid use disorder.(q) "Program sponsor means the person named in the application for certification described in 42 CFR 8.11(b) who is responsible for the operation of the OTP and who assumes responsibility for all its employees, including any practitioners, agents, or other persons providing medical, rehabilitative, or counseling services at the program or any of its medication units. The program sponsor need not be a licensed physician but shall employ a licensed physician for the position of medical director. The program sponsor is responsible for ensuring the service is in continuous compliance with all federal, state, and local laws and regulations. (r) "State opioid treatment authority (SOTA) means the subunit of the department designated by the governor to exercise the responsibility and authority in this state for governing the treatment of a narcotic addiction with a narcotic drug.(s) "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 at a minimum 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.(t) "Treatment contracting means an agreement developed between the primary counselor or the clinic director and the patient in an effort to allow the patient to remain in treatment on condition that the patient adheres to service rules.(u) "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 clinic director.(4)STATE OPIOID TREATMENT AUTHORITY. The powers and duties of the SOTA include: (a) Facilitating the development and implementation of rules, regulations, standards, and evidence-based practices, emerging best practices, or promising practices, to ensure the quality of services delivered by OTPs.(b) Monitoring and evaluation of program outcomes for service recipients and the community. The SOTA may establish or follow already established performance indicators by accrediting bodies or SAMHSA including improvement in medical condition, recidivism rates, and such other measures as appropriate.(c) Acting as a liaison between relevant state and federal agencies.(d) Reviewing opioid treatment guidelines and regulations developed by the federal government.(e) Delivering technical assistance and informational materials to OTPs as needed.(f) Performing both scheduled and unscheduled site visits to OTPs in cooperation with department certification office or other oversight agencies, or as designated by the SOTA, when necessary and appropriate, and preparing reports as appropriate to assist the department's certification office or to meet the requirements set forth in s. 51.4223, Stats.(g) Consulting with the federal government regarding approval or disapproval of requests for exceptions to federal regulations, where appropriate.(h) Reviewing and approving exceptions to federal and state dosage and take home policies and procedures.(i) Receiving and addressing service recipient appeals and grievances in partnership with the department's client rights office.(j) Working cooperatively with other relevant state and local agencies to determine the service need in the location of a proposed program by reviewing data to include overdose deaths, ambulance runs, hospitalizations, etc.(k) Issuing a list of required evidence-based practices, emerging best practices, and promising practices to be delivered by OTPs, so long as the required practices are recognized by SAMHSA, Centers for Disease Control, or National Institute of Health. The SOTA may also provide a list of recommended evidence-based practices, emerging best practices, and promising practices. The SOTA may update the required practices list and the recommended practices list as needed to reflect advances in outcomes research and medical services for persons living with opioid use disorders. The SOTA shall take into consideration the adequacy of evidence to support the efficacy of the practice, the quality of workforce available, and the current availability of the practice in the state when updating the lists. At least 120 days before issuing the initial required practices list and any revisions to the required practices list, the SOTA shall provide stakeholders with an opportunity to comment and shall take those comments into consideration when updating the required practices list. (l) Monitoring the central registry to prevent dual enrollments in OTP's and ensure that all required information is entered.(5)REQUIRED PERSONNEL.(a)Clinic director. The service shall designate in writing a clinic director who is responsible for the day to day operation of the service and overall compliance with federal, state and local laws and regulations regarding the operation of OTPs, and for all employees including practitioners, agents, or other persons providing services at the facility. The service shall notify the SOTA in writing within 5 calendar days whenever there is a change in clinic director. If the clinic director is also licensed to provide counseling services they shall carry a caseload of patients that is reasonable to ensure prompt and adequate access to care of those patients while balancing their other business responsibilities to the clinic.(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.(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.(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.(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.(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.(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).(6) ADMISSION. (a)Admission criteria. For admission to the service, a person shall meet all of the following criteria as determined by the service physician: 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.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.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: a. A patient released from penal institutions within 6 months of release.b. A pregnant patient certified as pregnant by a service physician.c. A previously treated patient who was discharged from the service less than 2 years prior.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.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.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.(b)Voluntary treatment. Participation in an OTP shall be voluntary.(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.(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.(e)Examination.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.2. The service shall complete a psychosocial assessment and initial treatment plan within 3 days of admission.(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. (g)Central registry. All facilities shall participate in the department's central registry, subject to all of the following requirements: 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.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.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.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.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.6. A patient shall not be dosed prior to a central registry check being conducted.7. Documentation of the central registry check shall be kept in the patient's file.(h)Information provided at admission. A patient admitted to the OTP shall receive written copies of the following information at the time of admission: 1. The mission and goals of the OTP.2. The hours during which services are provided.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.5. Patient rights and responsibilities.6. Federal confidentiality requirements.(i)Admissions protocol. The service shall have a written admissions protocol that accomplishes all of the following: 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.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.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. 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.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.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.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.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.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.10. Obtains the patient's written consent for the service to secure records from other agencies that may assist the service with treatment planning.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.(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: 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.2. Pregnant women who are drug or alcohol dependent and need treatment.3. Other individuals who inject drugs.4. Others individuals who are drug or alcohol dependent and need treatment.(k)Capacity management and wait list.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. 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. (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.(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.(7)ORIENTATION OF NEW PATIENTS.(a)Orientation information. Within 3 days of admission, a patient shall receive an orientation to OTP services providing information on the following: 1. The mission and goals of the OTP.2. The hours during which services are provided.4. Patient rights and responsibilities.6. Federal confidentiality requirements.7. Attendance expectations.8. The OTP's treatment philosophy and service structure.9. How to attain self-administered dose privileges and requirements to maintain those privileges.10. Referral to services not provided by the OTP.11. Rules governing patient conduct and infractions that can lead to disciplinary action or discharge from the OTP.12. Information about initiating a discontinuation of medication.(b)Written materials. Information provided in the orientation shall be accompanied by the provision of written materials on all covered topics.(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.(d)Additional orientation requirements for pregnant patients. For pregnant patients, the OTP shall explain the following: 1. The risks and benefits of opioid treatment medication during pregnancy.2. The program requirement for prenatal medical care.(e)Documentation. Documentation of the provision of the above information shall be included in the patient's record.(8)HOURS OF OPERATION.(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.(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.(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.(d)Training day. Any service may also be closed for one mandatory training day, if required by the SOTA.(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.(9)RESEARCH.(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.(b)Proposed research. All proposed research involving patients shall meet the requirements of s. 51.61(1) (j), Stats., 45 CFR part 46 and this subsection.(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: 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.(10)MEDICAL SERVICES.(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.(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.(c)Medical director responsibilities. The medical director of a service is responsible for all of the following: 1. Overseeing 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 an opioid use disorder.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.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. 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 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.b. The patient 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 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 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.6. Ensuring that appropriate laboratory studies have been performed and reviewed.7. 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. Orders for additional take-home medication for an emergency situation.8. Reviewing and countersigning each treatment plan 4 times annually.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.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.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.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.(d)Service physician responsibilities. A service physician is responsible for all of the following: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.2. Approving, by signature and date, any request for an exception to the requirements under sub. (13) relating to take-home medications.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.4. A history and physical examination of the patient determining that the patient is a suitable candidate for admission to an OTP.(11)DOSAGE.(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.(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.(c)Patient sanctioning. Any dose adjustment to sanction the patient, to reinforce the patient's behavior, or for purposes of treatment contracting, is prohibited.(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.(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.(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.(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.(12)INVOLUNTARY TERMINATION FROM AN OTP.(a)Emergency termination. 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: 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.b. The program's medical director reasonably determines that continued treatment of a client presents a serious documented medical risk. 2. Upon termination under this paragraph, the service shall:a. Immediately notify the patient of the decision and the reasons for the decision.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.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.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.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.(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: 1. Prior to initiating medically supervised withdrawal, the service shall provide the client with prompt written notice which shall contain: 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.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.c. A copy of the service's hearing procedures.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.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.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.(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.(d)Hearing procedures. The service shall ensure that hearings are conducted in accordance with the following procedures: 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.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.3. At a hearing, the service bears the burden of proving, by a preponderance of the evidence, that the alleged violation occurred.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.5. The patient shall be entitled to call his or her own witnesses and to question any adverse witnesses.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.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.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.(e)Department review of program decisions to terminate.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: 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.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. 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.(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.(13)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 and State requirements that shall be adhered to by the SOTA and the service are as follows: 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.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.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. 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.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. 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.(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: 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 applicable criteria for length of time in treatment provided in pars. (e) and (h).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 and exceptions. The time in treatment criteria under par. (h) 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 designated federal agency and the SOTA for a particular patient.(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-home privilege. 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)Phases.1. Methadone shall be provided on a take-home basis as follows: a. For patient time in treatment starting day 31 through day 90, the patient shall be allowed no more than one take-home dose of medication per week.b. For patient time in treatment starting day 91 through 180, the patient shall be allowed no more than 2 take-home doses of medication per week.c. For patient time in treatment starting day 181 through day 270, the patient shall be allowed no more than 3 take-home doses of medication per week.d. For patient time in treatment starting day 271 through day 365, the patient shall be allowed no more than 4 take-home doses of medication per week.e. For patient time in treatment starting day 366 through day 730, the patient shall be allowed no more than 6 take-home doses of medication per week.f. For patient time in treatment starting day 731 through completion of treatment, the patient shall be allowed no more than 13 take-home doses every 2 weeks. 2. Buprenorphine Oral Products shall be provided on a take-home basis as follows: a. For patient time in treatment starting day 31 through day 60, the patient shall be allowed no more than 1 take-home dose of medication per week.b. For patient time in treatment starting day 61 through day 90, the patient shall be allowed no more than 2 take-home doses of medication per week.c. For patient time in treatment starting day 91 through day 120, the patient shall be allowed no more than 3 take-home doses of medication per week.d. For patient time in treatment starting day 121 through day 240, the patient shall be allowed no more than 4 take-home doses of medication per week.e. For patient time in treatment starting day 241 through day 365, the patient shall be allowed no more than 6 take-home doses of medication per week.f. For patient time in treatment starting day 366 through completion of treatment, the patient shall be allowed no more than 13 take-home doses every 2 weeks.(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 takehome 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 shall 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: 1. The patient has had at least 3 consecutive 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. The tests must be at least one week apart.2. The service physician determines that the patient can responsibly handle narcotic drugs.(m)Clinical probation.1. A patient receiving a 6-day supply of take-home medication or more who has a test or analysis that is confirmed to be positive for a substance of abuse or negative for the narcotic drug dispensed by the service shall be placed on clinical probation for 3 months. 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 SOTA and the designated federal agency.(14)EXCEPTIONS TO TAKE-HOME REQUIREMENTS.(a)Exception requests. A service may submit a request to the designated federal authority and the SOTA for an exception to certain take-home requirements for a particular patient if, in the reasonable clinical judgment of the service physician, any of the following conditions is met: 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)Rationale for exception. The program physician or program personnel supervised by the program physician shall record the rationale for an exception to an applicable mandatory schedule in the patient's case record. A patient may not be given more than a 14-day supply of narcotic drugs at one time.(c)Exception criteria. The service physician's judgment that a patient is responsible in handling narcotic drugs shall be supported by information in the patient's case file that the patient meets all of the following criteria: 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 attendance outweighs the potential risks of diversion.(d)Exception outcome.1. Any exception to the take-home requirements is subject to approval of the designated federal agency and the SOTA. Both the designated federal agency and the SOTA must approve the exception. If one does not approve then the exception is considered denied. 2. Service staff on receipt of notices of approval or denial of a request for an exception from the SOTA and the designated federal agency shall place the notices in the patient's case record.(e)Exception review. Service staff shall review an exception when the conditions of the request change or at the time of review of the treatment plan, whichever occurs first.(f)Exception duration. An exception shall remain in effect only as long as the conditions establishing the exception remain in effect.(15)TESTING AND ANALYSIS FOR DRUGS.(a)Use.1. A service shall use drug tests and analyses to determine the presence of opiates, methadone, fentanyl, buprenorphine, amphetamines, benzodiazepines, methamphetamine, cocaine, and THC. Alcohol testing will occur for individuals with a history of alcohol use disorders and when concerns exist. Alcohol testing may occur via breathalyzer, urinalysis or blood testing. If any other drug has been determined by a service or the SOTA to be abused in that service's locality, a specimen shall also be analyzed for that drug. A service shall receive a 30-day notice and opportunity to provide input before it must begin analyzing for any additional substances other than those listed above. Any laboratory that performs the testing shall comply with 42 CFR part 493 . A patient's specimen shall be tested for the medication they are receiving for their opioid use disorder as well as the appropriate metabolite for that medication.2. A service shall use the results of a drug test or analysis on a patient as a guide to review and modify treatment approaches and not as the sole criterion to discharge the patient from treatment. If a patient tests positive for any illicit substance or alcohol, that substance must be specifically addressed in the patient's treatment plan.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 methadone levels in plasma or serum via a peak and trough when medically indicated but no less frequently than annually for patients who receive methadone or whenever split dosing is requested. The trough blood level should be drawn immediately prior to that day's dose and the peak blood level should be drawn 3-4 hours after the dose is administered.(c)Obtaining urine specimens. A service shall obtain urine specimens for testing from a patient, unless a patient is medically unable to provide a urine specimen, in which case an exception to use another testing device may be requested from the Division of Quality Assurance and the SOTA. Specimens shall be collected in a clinical atmosphere that respects the patient's confidentiality, as follows:1. A urine specimen shall be collected on a random basis. During the first 90 days of treatment urine drug screens shall occur weekly. After that time period, urine drug screens shall occur at least once a month.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, paper towels, 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 of the sample being taken by the service 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.3. When there is a positive test result, service staff shall allow sufficient time before re-testing to prevent a second positive test result from the same substance use.4. Service staff confronted with a patient's denial of substance use shall consider the possibility of a false positive test. Patients shall be given the opportunity to challenge a test result by having the sample given retested.5. Service staff shall review a patient's dosage and shall counsel the patient regarding their use when test reports are positive for morphine-like substances and negative for the FDA-approved treatment.(e)Frequency of drug screens.1. The frequency that a service shall require drug screening shall be clinically appropriate for each patient, allow for a rapid response to the possibility of relapse, and occur at least on a monthly basis.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.(16)TREATMENT DURATION AND RETENTION.(a)Patient retention. Patient retention shall be a major objective of treatment. The service shall do all of the following to retain patients for the planned course of treatment:1. Render treatment in a way that is least disruptive to the patient's travel, work, educational activities, ability to use supportive services, and family life.2. Determine hours based on patient needs.3. Ensure that a patient has ready access to clinical staff, particularly to the patient's primary counselor.4. Ensure that clinical staff are adequately trained and are sensitive to gender- and culture-specific issues.5. Provide services that incorporate evidence based practice standards for substance use treatment.6. Ensure that patients receive adequate doses of medication based on their individual needs.7. Ensure that all clinical staff are accepting of medication-assisted treatment.8. Ensure that patients understand that they are responsible for complying with all aspects of their treatment, including participating in counseling sessions.(b)Effort to retain patients. Since treatment duration and retention are directly correlated to rehabilitation success, a service shall make a concerted effort to retain patients within the first year following admission. Evidence of this concerted effort shall include written documentation of all of the following: 1. Whether the patient continues to benefit from the treatment.2. Whether the risk of relapse is discontinued.3. Whether the patient exhibits no side effects from the treatment.4. Whether continued treatment is medically necessary in the professional judgement of the service physician.(c)Referral for further treatment. A service shall refer a patient discharged from the service to a more suitable treatment modality when further treatment is required or is requested by the patient and cannot be provided by the service.(17)MULTIPLE SUBSTANCE USE AND CO-OCCURRING TREATMENT.(a)Assessment. A service shall assess a prospective patient for admission during the admission process to distinguish substance use, abuse and dependence, and determine patterns of other substance use and self-reported etiologies, including non-prescription, non-therapeutic and prescribed therapeutic use and mental health problems.(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 nonprescription substance use as the desired goal.2. Service objectives shall indicate that abstinence by a patient from alcohol and prescription and non-prescription substance use should extend for increasing periods, progress toward long-term abstinence and be associated with improved life functioning and well-being.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)Patients with co-occurring disorders.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 co-occurring disorder exists, a service shall develop with the patient a treatment plan that integrates measures for treating all alcohol, drug and mental health problems. For the treatment of a patient with co-occurring disorders, the service shall arrange for a mental health professional to help develop the treatment plan and provide ongoing treatment services. The mental health professional shall be available either as an employee of the service or through a written agreement. The mental health professional shall complete a mental health assessment within 3 business days of admission.(18)PREGNANCY. Each OTP shall have written procedures for pregnant patients including the following minimum standards: (a)Risks. A requirement that each patient admitted to the OTP be informed of the possible risks to herself or to her unborn child from the use of medication-assisted treatment, and be informed that abrupt withdrawal from these medications may adversely affect the unborn child.(b)Medication-assisted treatment. A requirement that a pregnant patient who has a documented past opioid dependency and who may be in direct jeopardy of returning to opioid dependency with all of its attendant dangers during pregnancy, be informed that they may be placed on a medication-assisted treatment regimen. The service shall also provide a statement that for such pregnant women, evidence of current physiological dependence on opioid drugs is not needed if the medical director or other authorized program physician certifies the pregnancy, determines and documents that the woman may resort to the use of opioid drugs, and determines that medication-assisted treatment is justified in their clinical opinion.(c)Approval of admission. A requirement that the admission of each pregnant patient to an OTP be approved by the medical director or other authorized program physician prior to admitting the patient to the program.(d)Coordination of care. A requirement that OTPs develop a form for release of information between themselves and the healthcare provider in care of obstetrical care. This voluntary form should be offered to all pregnant patients for coordination of medical care.(e)Education. A requirement that each pregnant patient be given education on recognizing the symptoms of neonatal abstinence syndrome near the time of delivery.(f)Prenatal care. Procedures for prenatal care that include: 1. Providing prenatal care by the service or by referral to an appropriate health care provider. If appropriate prenatal care is neither available on-site or by referral, or if the pregnant patient cannot afford care or refuses prenatal care services on-site or by referral, an OTP, at a minimum, should offer basic prenatal instruction on maternal, physical, and dietary care as part of its counseling services. If a pregnant patient refuses the offered on-site or referred prenatal services, the medical director or treating physician must use informed consent procedures to have the patient formally acknowledge, in writing, refusal of these services.2. A requirement that if a patient is referred to prenatal care outside the agency, the name, address and telephone number of the health care provider shall be recorded in the patient's clinical record.3. A requirement that if prenatal care is provided by the OTP, the clinical record shall include documentation to reflect services provided.4. A requirement that if a patient is referred outside of the agency for prenatal services, the provider to whom she has been referred shall be notified that she is on medication-assisted treatment; however, such notice shall only be given after the patient has signed a release of information.5. A requirement that any changes in medication-assisted treatment be communicated to the appropriate healthcare provider if the woman has prenatal care outside the agency if the patient allows communication among providers.6. A requirement that the service monitor the medication dose carefully throughout the pregnancy, moving rapidly to supply increased or split dose if it becomes necessary.7. A recommendation that blood serum levels for methadone agonist be monitored once a trimester, and every three days for two weeks after delivery to ensure appropriate level of medication before and after delivery by the appropriate healthcare professional. The medical director shall request and review serum levels to determine whether any changes to treatment need to be made.8. A requirement that the service shall offer on-site parenting education and training to all patients who are parents or shall refer interested patients to appropriate alternative services for the training; and,(g)Pregnant patients that refuse prenatal services. Procedures for a patient who refuses prenatal service by the OTP or an outside provider, including that 1. The medical director or other authorized program physician shall note this in the clinical record.2. Requiring that the patient be asked to sign a statement that says oI have been offered the opportunity for prenatal care by the opioid treatment program or by a referral to a prenatal clinic or by a referral to the physician of my choice. I refuse prenatal counseling by the opioid treatment program. I refuse to permit the opioid treatment program to refer me to a physician or prenatal clinic for prenatal services. If the patient refuses to sign the statement, the medical director or other authorized program physician shall indicate in the signature block that opatient refused to sign and affix their signature and the date on the statement.(19)COMMUNICABLE DISEASE.(a)Tuberculosis - patients. An OTP shall screen patients for tuberculosis in a manner and frequency consistent with current CDC standard of practice. Tuberculosis treatment may be provided by referral to an appropriate public health agency or community medical service.(b)Tuberculosis - staff. A service shall screen prospective new staff and ongoing staff for tuberculosis in a manner and frequency consistent with current CDC standard of practice.(c)Screening. A service shall screen all patients via a risk factor assessment at admission and annually thereafter for viral hepatitis and sexually transmitted diseases and shall ensure that any necessary medical follow-up occurs, either on site or through referral to community medical services. Positive screening results or disease risks must have a management plan that is seen through to completion regardless of whether this is accomplished via services provided directly on-site or by referral and care coordination.(d)Hepatitis B. A service shall ensure that all clinical staff have been immunized against hepatitis B. Documentation of refusal to be immunized shall be entered in the staff member's personnel record.(20)FACILITY. A service shall provide a setting that is conducive to rehabilitation of the patients and that meets all of the following requirements:(a)Cleanliness. The waiting area, restrooms, dosing areas, and counseling offices shall be clean.(b)Ventilation and lighting. Waiting areas, dosing stations and all other areas for patients shall be provided with adequate ventilation and lighting.(c)Confidentiality. Dosing stations and adjacent areas shall be kept sanitary and ensure privacy and confidentiality.(d)Sound proofing. 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)Security. Adequate security shall be provided inside and outside the facility for the safety of the patients and to prevent loitering and illegal activities.(f)Restrooms. Separate toilet facilities shall be provided for patient and staff use.(g)Accessibility. The facility and areas within the facility shall be accessible to persons with physical disabilities.(h)Physical environment. The physical environment within the facility shall be conducive to promoting improved functioning and a drug-free lifestyle.(i)Facility regulations. Meet all local, state, and federal requirements.(j)Annual inspection. Post an annual inspection report from appropriate officials.(k)First aid kit. The facility shall maintain stocked first aid kits for emergency use including naloxone. (l)Disaster plan. Have a disaster plan and facility evacuation plan that is updated annually and posted in an area accessible to staff and patients.(m)Accreditation body. The facility shall meet physical facility standards established by the services accreditation body.(21)DIVERSION CONTROL.(a)Staff member responsibility. Each staff member of the OTP is responsible for being alert to potential diversion of medication by patients and staff.(b)Minimize diversion. Service staff shall take all of the following measures to minimize diversion: 1. Require that doses of Methadone shall be dispensed only in liquid form. Other FDA approved medications are allowable in their FDA-approved formats as determined by the medical staff.2. Require that each take-home bottle or other form of medication packaging used for medication-assisted treatment dispensed have a label that contains the following information: a. The OTPs name, address and telephone number.b. The name of the patient.c. The name of service physician prescribing the medication.d. The name of the medication.e. The dosing instructions and schedule.f. The date that the take-home dose was prepared.g. A warning that reads "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.h. Any other requirements pursuant to rules adopted by the department.3. Require a patient to return all empty take-home bottles on the patient's next day of service attendance following take-home dosing. Clinical staff shall examine the bottles to ensure that the bottles are received from the appropriate patient and in an intact state.4. The service may discontinue take-home medications for patients who fail to return empty take-home bottles in the prescribed manner. If upon review of take home medication it is determined that medication is missing and cannot reasonably be accounted for the service shall discontinue take home medication.(c)Counselor responsibility. If a service receives reliable information that a patient is diverting medication, the patient's primary counselor shall immediately discuss the problem with the patient.(d)Revocation of take homes. Based on information provided by the patient or continuing reports of diversion, a service may revoke take-home privileges of the patient.(e)State revocation of take-homes. The SOTA may, based on reports of diversion, revoke take-home privileges, exceptions or exemptions granted to or by the service for all patients. If a service agency disagrees with the SOTA's decision, it may provide additional relevant information to the SOTA, request that SOTA review the revocation decision, or file a request for review and reconsideration of the revocation decision with the Department's Division of Care and Treatment Services.(f)State revocation of a services ability to grant take-homes. The SOTA may revoke the authority of an OTP to grant take-home privileges when the service cannot demonstrate that all requirements have been met in granting take-home privileges to patients. If a service agency disagrees with the SOTA's decision, it may provide additional relevant information to the SOTA, request that SOTA review the revocation decision, or file a request for review and reconsideration of the revocation decision with the Department's Division of Care and Treatment Services.(g)Loitering. An OTP 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.(h)Callbacks. The diversion control plan shall contain, at a minimum, a random call-back program with mandatory compliance that includes: 1. Call-backs shall be in addition to the regular schedule of clinic visits.2. Each patient receiving two or more take-home medications shall be called back randomly but no less frequently than on a quarterly basis.3. Upon call back a service recipient shall report to the clinic the next day within dosing hours, with all take-home medications. The quantity and integrity of packaging shall be verified for all doses. If a take-home dose shows evidence of tampering, the clinic shall impose uniform sanctions for violating take-home policies, including sanctions for a patient's tampering with a takehome dose.4. Patients shall be informed of consequences for violating the take-home policy.5. The service shall maintain individual call-back results in the patient record.(22)SERVICE APPROVAL.(a)Approval of primary service. An applicant for approval to operate an OTP in Wisconsin with the intent of administering or dispensing medication for the treatment of an opioid use disorder shall submit all of the following to the SOTA: 1. Copies of all completed designated federal agency applications.2. A copy of the request for registration with the DEA 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 medication.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. A description 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. Documentation that the service will have ready access to a comprehensive range of medical and rehabilitative services that will be available if needed, including 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 SAMHSA, the DEA and the SOTA may be used for treating persons with an opioid use disorder 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.(23)ASSENT TO REGULATION.(a)Service sponsor. A person who sponsors an OTP 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)Responsibilities. 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)Written agreement. 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)Replacement. The service shall notify the designated federal agency and SOTA within 5 business days after replacement of the service sponsor or medical director.(e)Required services. OTPs shall provide adequate medical, counseling, vocational, educational, and other assessment and treatment services. These services must be available at the primary facility, except where the program sponsor has entered into a formal, documented agreement with a private or public agency, organization, practitioner, or institution to provide these services to patients enrolled in the OTP. The program sponsor, in any event, must be able to document that these services are fully and reasonably available to patients. This documentation must be provided to the department upon request.(24)DEATH REPORTING. An OTP shall report the death of a patient and deaths related to a patient's medication to the SOTA within 5 business days after learning of the death.(25) Prescription drug monitoring program. (a)Policy and procedure. The service must develop and maintain a policy and procedure that requires the ongoing monitoring of the data from the prescription drug monitoring program (PDMP) for each patient. The policy and procedure must include how the service meets the requirements in par. (b).(b)Requirements. If a medication used for the treatment of substance use disorder is administered or dispensed to a patient, the OTP shall be subject to the following requirements: 1. Upon admission a patient must be notified in writing that the medical director must monitor the PDMP to review the prescribed controlled drugs a client received.2. The medical director or the medical director's delegate must review the data from the PDMP before the patient is ordered any controlled substance including medications for maintenance therapy, and subsequent reviews of the PDMP data must occur at least every 90 days.3. A copy of the PDMP data reviewed must be maintained in the client's file.4. When the PDMP data contains a recent history of multiple prescribers or multiple prescriptions for controlled substances, the physician's review of the data and subsequent actions must be documented in the patient's file within 72 hours and must contain the medical director's determination of whether the prescriptions place the patient at risk of harm and the actions to be taken in response to the PDMP findings. The provider must conduct subsequent reviews of the PDMP in these circumstances on a monthly basis.5. If at any time the medical director believes the use of the controlled substances places the patient at risk of harm, the service must seek the patient's consent to discuss the patient's opioid treatment with other prescribers and for other prescribers to disclose to the OTP's medical director of the client's condition that formed the basis of the other prescriptions. If the information is not obtained within 7 days, the medical director must document whether or not changes to the client's medication dose or number of unsupervised use doses are necessary until the information is obtained.(25m)GUEST DOSING.(a)Approval. To receive a guest dose, the patient must be enrolled in an OTP elsewhere in the state or country and be receiving the medication on a temporary basis because the client is not able to receive the medication at the program in which the client is enrolled. A patient may guest dose at a different OTP if prior approval is obtained from the patient's medical director or program physician to receive services on a temporary basis from another OTP certified under this rule or by SAMHSA. The approval shall be noted in the patient's record and shall include the following documentation: 1. The patient's signed and dated consent for disclosing identifying information to the program which will provide services on a temporary basis.2. A medication change order by the referring medical director or program physician permitting the patient to receive services on a temporary basis from the other program for a length of time not to exceed 30 days.3. Evidence that the medical director or program physician for the program contacted to provide services on a temporary basis has accepted responsibility to treat the visiting patient, concurs with his or her dosage schedule, and supervises the administration of the medication.(b)Maximum number of days. Guest dosing shall be provided for a maximum of 30 days.(c)Patient requirement. Patients receiving guest dosing shall have been enrolled at the home clinic for a minimum of 30 days before being eligible for a guest dose. Patients enrolled less than 30 days at the home clinic shall be eligible for guest dosing only if approved by the SOTA.(d)Drug screen requirement. Patients shall have two consecutive urine drug screens free of illicit substances or substances of abuse before being eligible for a guest dose, unless the medical director determines that the benefits of guest dosing outweigh the risks and documents the justification for granting guest dosing privileges in the patient's record.(26)OVERDOSE PREVENTION.(a)Naloxone. An OTP shall provide a patient with a naloxone kit or a prescription for naloxone at admission. The OTP shall provide instruction on the kits use including recognizing the signs and symptoms of overdose and calling 911 in overdose situations.(b)Use or expiration of Naloxone. The OTP shall provide a new naloxone kit or prescription upon expiration or use of the old kit.(c)Exemption. The OTP shall be exempt from this requirement for one year if the client refuses the naloxone kit or already has a naloxone kit.(d)Orientation training. Documentation that the patient has completed the orientation training on recognizing an overdose and how to use naloxone and received written information shall be completed and signed by service staff and the patient and maintained in the patient's record.(27)INTERIM MAINTENANCE TREATMENT.(a) The provision of interim maintenance with medication assisted treatment is prohibited under this rule unless the opioid treatment program has a waiver from the department in addition to authorization from SAMHSA in accordance with 42 CFR 8.11(g).(b) All of the requirements for comprehensive maintenance treatment apply to interim maintenance treatment with the following exceptions for patients receiving methadone: no take-home doses are permitted except on federal holidays if the program is closed on those days; an initial and periodic treatment plan are not required; a primary counselor is not required; and the rehabilitative and other services described in 42 CFR. 8.12 (f) (4), (f) (5) (i), and (f) (5) (iii) are not required.(c) Interim maintenance cannot be provided to an individual for more than 120 days in any 12-month period.(d) To receive interim maintenance, a patient must be fully eligible for admission to comprehensive maintenance.(e) Interim maintenance treatment is for those patients who cannot be enrolled in comprehensive maintenance treatment in a reasonable geographic area within fourteen days of application for admission.(f) During interim maintenance, the initial toxicology and at least two additional toxicology screening tests should be obtained.(g) Programs offering interim maintenance must develop clear policies and procedures governing the admission to interim maintenance and transfer of patients to comprehensive maintenance.(28)DISASTER PLANNING.(a)Emergency situations. Each OTP shall maintain an up-to-date disaster plan that addresses emergency situations including fire emergencies, tornadoes, earth quakes, flooding, winter storms, pandemics, and involuntary temporary or permanent facility closure.(b)Committee. OTPs shall establish a health and safety committee that initiates planning actions for disaster scenarios. This committee shall: 1. Identify internal resources and areas of need that shall include, at minimum, considerations of: d. Backup systems for payroll, billing records, and patient records.e. Communications with staff, patients and local, state, and federal partners.2. Identify external resources and areas of need that shall include, at minimum: a. Suppliers of medication used for treatment of substance use disorder.c. Alternative dosing locations.3. Develop a communication plan for the disaster scenario to inform patients, the SOTA, SAMHSA, the DEA, and any other parties deemed necessary.4. Develop disaster documentation procedures for guest patients that shall include at minimum: a. A temporary chart and client identification number.b. Identity verification.c. Medication verification. (c)Emergency contact. Each OTP shall provide the SOTA with the emergency contact information for at least one member of the service.(d)Medication supply. Each OTP shall keep at least a 10-day supply based on average caseload of methadone and buprenorphine products on site to prepare to receive clients from other facilities in disaster scenarios.Wis. Admin. Code Department of Health Services DHS 75.59
Adopted by, CR 20-047: cr. Register October 2021 No. 790, eff. 10-1-22; correction in (5) (b), (g), (6) (a) 3. a., 4., (h), (k) 2., (7) (a) (intro.), (9) (a), (10) (c) 12., (12) (b) 2., (d) 2., 7., (h) 1. d. to f., 2. a. to e., (15) (a) 1., (21) (e), (f), (23) (a) made under s. 35.17, Stats., correction in numbering in (25m) made under s. 13.92(4) (b) 1, Stats., correction in (6) (i) 3. made under s. 13.92(4) (b) 4, Stats., and (10) (b) (title) created under s. 13.92(4) (b) 2, Stats., Register October 2021 No. 790, eff. 10/1/2022This section is created eff. 10-1-22 by CR 20-047.