DHS 75.59(3)(a)
(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.
DHS 75.59(3)(b)
(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.
DHS 75.59(3)(c)
(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.
DHS 75.59(3)(d)
(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.
DHS 75.59(3)(e)
(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.
DHS 75.59(3)(f)
(f) “Maintenance treatment” means the dispensing of a narcotic drug in the treatment of an individual for opioid dependence.
DHS 75.59(3)(g)
(g) “Mandatory schedule” means the required dosing schedule for a patient and the established frequency that the patient must attend the service.
DHS 75.59(3)(h)
(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.
DHS 75.59(3)(i)
(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:
DHS 75.59(3)(i)2.
2. Authorized to conduct biochemical monitoring for narcotic drugs.
DHS 75.59(3)(j)
(j) “Objectively intoxicated person” means a person who is determined through a breathalyzer test to be under the influence of alcohol.
DHS 75.59(3)(k)
(k) “Opioid addiction” means psychological and physiological dependence on an opiate substance, either natural or synthetic, that is beyond voluntary control.
DHS 75.59(3)(L)
(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.
DHS 75.59(3)(n)
(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.
DHS 75.59(3)(o)
(o) “SAMHSA” means the Substance Abuse and Mental Health Services Administration.
DHS 75.59(3)(p)
(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.
DHS 75.59(3)(q)
(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.
DHS 75.59(3)(r)
(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.
DHS 75.59(3)(s)
(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.
DHS 75.59(3)(t)
(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.
DHS 75.59(3)(u)
(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.
DHS 75.59(4)
(4)
State Opioid Treatment Authority. The powers and duties of the SOTA include:
DHS 75.59(4)(a)
(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.
DHS 75.59(4)(b)
(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.
DHS 75.59(4)(c)
(c) Acting as a liaison between relevant state and federal agencies.
DHS 75.59(4)(d)
(d) Reviewing opioid treatment guidelines and regulations developed by the federal government.
DHS 75.59(4)(e)
(e) Delivering technical assistance and informational materials to OTPs as needed.
DHS 75.59(4)(f)
(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.
DHS 75.59(4)(g)
(g) Consulting with the federal government regarding approval or disapproval of requests for exceptions to federal regulations, where appropriate.
DHS 75.59(4)(h)
(h) Reviewing and approving exceptions to federal and state dosage and take home policies and procedures.
DHS 75.59(4)(i)
(i) Receiving and addressing service recipient appeals and grievances in partnership with the department's client rights office.
DHS 75.59(4)(j)
(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.
DHS 75.59(4)(k)
(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.
DHS 75.59(4)(L)
(L) Monitoring the central registry to prevent dual enrollments in OTP's and ensure that all required information is entered.
DHS 75.59(5)(a)(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.
DHS 75.59(5)(b)
(b)
Medical director. The service shall designate a physician licensed under ch.
448, Stats., as its medical director.
The medical director shall have at least one year of experience in addiction medicine or addiction psychiatry, be licensed to practice medicine or osteopathy, and meet all other requirements listed in s.
DHS 75.03 (52). If a service is not able to secure a medical director who meets the one year of experience requirement, as documented through recruitment efforts, there shall be a specific plan for the person to acquire equivalent training and skills within 4 months after beginning employment. The medical director, service physician, or mid-level practitioner that has a federal exception approved by SAMHSA and the SOTA to
42 CFR 8.12 (b), (e), (h), and (i) shall be physically present at the OTP at least 40 percent of the time that the program administers or dispenses medication in order to comply with s.
DHS 94.08, assure regulatory compliance, and carry out duties specifically assigned by regulation as required by SAMHSA under
42 CFR 8.12. OTPs in the first 60 days of operation may reduce the time requirement medical directors must be present on site to at least 20 percent of the time that the program administers or dispenses medication. On the 61st day of operation the service shall be subject to the requirements of this rule.
DHS 75.59(5)(c)
(c)
Nurses. The service shall have a registered nurse on staff to supervise the dosing process and perform other functions delegated by the physician. A registered nurse shall be physically on the premises any time dosing is occurring.
DHS 75.59(5)(d)
(d)
Nursing assistants. The service may employ nursing assistants and related medical ancillary personnel to perform functions permitted under state medical and nursing practice statutes and administrative rules.
DHS 75.59(5)(e)
(e)
Licensed counselors. The service shall employ at least one of the following: substance abuse counselors, substance abuse counselors-in training, licensed marriage and family therapists, licensed professional counselors, licensed clinical social workers or clinical substance abuse counselors who are under the supervision of a clinical supervisor. An OTP shall employ one of these identified clinicians for a minimum of one full-time equivalent of 40 hours per week for every 55 enrolled patients in the service. All counselors rostered to the service are subject to this ratio.
DHS 75.59(5)(f)
(f)
Supervision of counseling staff. The service shall provide for ongoing clinical supervision of the counseling staff in accordance with s.
SPS 162.01. The service shall employ one full-time clinical supervisor at an equivalent of 40 hours per week for every 10 counselors employed. The clinical supervisor shall not carry a caseload greater than 30 patients to ensure access to prompt and adequate care of those patients while balancing their clinical supervision responsibilities.
DHS 75.59(5)(g)
(g)
Physician assistants. The service may employ physician assistants to practice in accordance with ch.
Med 8 and carry out duties specifically allowed by regulation as required by SAMHSA under
42 CFR 8.11 (h).
DHS 75.59(6)(a)(a)
Admission criteria. For admission to the service, a person shall meet all of the following criteria as determined by the service physician:
DHS 75.59(6)(a)1.
1. `Maintenance treatment for an adult.' The service shall maintain current procedures determined by the service physician to ensure that patients are admitted to maintenance treatment by qualified personnel who have determined, using accepted medical criteria, such as those listed in the DSM, that the person is currently addicted to an opioid drug, and that the person became addicted at least one year before admission for treatment. In addition, a service physician shall ensure that each patient voluntarily chooses maintenance treatment and that all relevant facts concerning the use of the opioid drug are clearly and adequately explained to the patient, and that each patient provides informed written consent to treatment.
DHS 75.59(6)(a)2.
2. `Maintenance treatment for a minor.' A minor shall be eligible for maintenance treatment only if the minor has had at least 2 documented unsuccessful attempts at short-term detoxification or drug-free treatment within a 12-month period. No minor may be admitted to maintenance treatment unless a parent, legal guardian, or responsible adult designated by the relevant state authority consents in writing to such treatment.
DHS 75.59(6)(a)3.
3. `Maintenance treatment admission exceptions.' If clinically appropriate, the program physician may waive the requirement of a one-year history of addiction of subd.
1. for any of the following:
DHS 75.59(6)(a)3.c.
c. A previously treated patient who was discharged from the service less than 2 years prior.
DHS 75.59(6)(a)4.
4. `Detoxification treatment.' An OTP shall maintain current procedures that are designed to ensure that patients are admitted to short- or long-term detoxification treatment by qualified personnel, such as a service physician, who determines that such treatment is appropriate for the specific patient by applying established diagnostic criteria. Patients with two or more unsuccessful detoxification episodes within a 12-month period must be assessed by the service physician for other forms of treatment. A service shall not admit a patient for more than 2 detoxification treatment episodes in one year.
DHS 75.59(6)(a)5.
5. `Health care release of information.' When the patient receives health care services from outside the service, the patient shall provide names, addresses and written consents for release of information from each health care provider to allow the service to contact the providers, and shall update releases if changes occur.
DHS 75.59(6)(a)6.
6. `Prohibition on reward for referral.' No service shall provide a bounty, free services, medication or other reward for referral of potential service recipients to the clinic.
DHS 75.59(6)(b)
(b)
Voluntary treatment. Participation in an OTP shall be voluntary.
DHS 75.59(6)(c)
(c)
Explanation. Clinical staff shall clearly and adequately explain to the patient being admitted all relevant facts concerning the use of medications used by the service, service rules, and expectations.
DHS 75.59(6)(d)
(d)
Consent. The service shall require a patient to complete an informed medication consent form which clearly indicates which FDA-approved medication for opioid use disorder they will be receiving, the reason for the use of the medication, the expected benefits of the use of the medication, and the potential side effects of the medication.
DHS 75.59(6)(e)1.1. For each patient eligible for admission, the service shall arrange for a comprehensive physical examination and clinically indicated laboratory work-up. The comprehensive physical examination shall be ordered by the service physician on the day of admission and shall include a complete blood count and liver function testing. The service shall test for Hepatitis A, B, C and HIV if the patient gives informed consent in writing. If the patient declines permission to test shall be documented in the patient's record. An updated comprehensive physical examination including lab work shall be completed annually.
DHS 75.59(6)(e)2.
2. The service shall complete a psychosocial assessment and initial treatment plan within 3 days of admission.
DHS 75.59(6)(f)
(f)
Initial dose. If a person meets the admission criteria under par.
(a), an initial dose of an FDA-approved medication may be administered to the patient on the day of admission. For each new patient enrolled in a service, the initial dose of methadone shall not exceed 30 milligrams and the total dose for the first day shall not exceed 40 milligrams, unless the service physician documents in the patient's record that 40 milligrams did not suppress opioid abstinence symptoms.
DHS 75.59(6)(g)
(g)
Central registry. All facilities shall participate in the department's central registry, subject to all of the following requirements:
DHS 75.59(6)(g)1.
1. A patient shall be informed of the service's participation in the central registry, and prior to initiating a central registry inquiry the service shall obtain the patient's written consent.
DHS 75.59(6)(g)2.
2. To prevent simultaneous enrollment of a patient in more than one OTP, at the time of admission and prior to the dosing of a patient, the service shall initiate a clearance inquiry by submitting to the approved central registry the patient's name, date of birth, and relevant information as required for the clearance procedure. No patient who is reported by the central registry to be participating in another such service shall be admitted to an OTP. When a dual enrollment is found, the patient shall be discharged from one OTP in order to continue enrollment at another OTP. The SOTA shall be notified within 24 hours of any dual enrollment discovered.
DHS 75.59(6)(g)3.
3. A disclosure shall be made with the patient's written consent that meets the requirements of
42 CFR part 2, relating to alcohol and drug abuse patient records, except that the consent shall list the name and address of each central registry or acceptable alternative and each known OTP to which a disclosure will be made.
DHS 75.59(6)(g)4.
4. Reports received by the central registry shall be treated as confidential and shall not be released except to a licensed service or its designated legal representative, as required by law or as part of continuity of operations in the case of an emergency. Information made available by the central registry shall also be treated as confidential.
DHS 75.59(6)(g)5.
5. If a service operates not more than 200 miles away from an OTP in an adjoining state, the SOTA may direct the service to share service recipient information with the OTP in the other state to prevent simultaneous enrollment of persons in more than one OTP service.
DHS 75.59(6)(g)6.
6. A patient shall not be dosed prior to a central registry check being conducted.
DHS 75.59(6)(g)7.
7. Documentation of the central registry check shall be kept in the patient's file.
DHS 75.59(6)(h)
(h)
Information provided at admission. A patient admitted to the OTP shall receive written copies of the following information at the time of admission:
DHS 75.59(6)(h)3.
3. The service must provide access to staff support 24 hours a day 7 days a week to ensure that the service provides a mechanism to address patient emergencies (which includes medication verification by any other OTP, Emergency Department, correctional institution, or jail) by establishing an emergency contact system. The purpose of the contact system is to obtain dosage levels and other pertinent patient information on a 24 hour, 7-day-a-week-basis, as appropriate under confidentiality regulations. This subdivision does not require staff to be on site at all times, but at least one designated staff member is available “on call” as the emergency contact.
DHS 75.59(6)(i)
(i)
Admissions protocol. The service shall have a written admissions protocol that accomplishes all of the following:
DHS 75.59(6)(i)1.
1. Identifies the patient on the basis of appropriate substantiated documents that contain the patient's name and address, date of birth, sex and race or ethnic origin as evidenced by a valid driver's license or other suitable documentation such as a passport.
DHS 75.59(6)(i)2.
2. Determines the patient's current addiction, to the extent possible, the current degree of dependence on narcotics or opiates, or both, including route of administration, length of time of the patient's dependence, old and new needle marks, past treatment history and arrest record.
DHS 75.59(6)(i)3.
3. Determines and verifies the patient's age. If the patient is a minor, the policy shall require documentation as provided in par.
(a) 2. DHS 75.59(6)(i)4.
4. Identifies all substances being used. To the extent possible, service staff shall obtain information on all substances used, route of administration, length of time used and amount and frequency of use.
DHS 75.59(6)(i)5.
5. Obtains information about past treatment. To the extent possible, service staff shall obtain information on a patient's treatment history, use of secondary substances while in the treatment, dates and length of time in treatment and reasons for discharge.
DHS 75.59(6)(i)6.
6. Obtains personal information about the patient. Personal information includes history and current status regarding employment, education, legal status (including arrests and conviction history), military service, family and psychiatric and medical information.
DHS 75.59(6)(i)7.
7. Identifies the patient's reasons for seeking treatment. Reasons shall include why the patient chose the service and whether they fully understand the treatment options and the nature and requirements of medication assisted treatment are fully understood.
DHS 75.59(6)(i)8.
8. Completes an initial drug screening or analysis to detect the use of opiates, methadone, buprenorphine, synthetic opioids, amphetamines, methamphetamine, benzodiazepines, cocaine, alcohol, and THC. The analysis shall show positive for narcotics, or an adequate explanation for negative results shall be provided and noted in the prospective patient's record.
DHS 75.59(6)(i)9.
9. Refers a patient who also has a physical health problem that cannot be treated within the service to an appropriate agency for appropriate treatment.
DHS 75.59(6)(i)10.
10. Obtains the patient's written consent for the service to secure records from other agencies that may assist the service with treatment planning.
DHS 75.59(6)(i)11.
11. Refers prospective patients who are physiologically dependent on alcohol, sedatives, or to anxiolytics to hospital detoxification before initiating treatment. If prospective patient refuses hospital detoxification, the medical director shall determine if the risk of treating a patient with a history of use of alcohol, sedatives, or anxiolytics outweighs the risk of non-admission to the service.
