Rule 24-2-53.4 - Opioid Treatment Program ServicesA. Medical Services must be provided and/or managed by the Medical Director of the program. The Medical Director must:1. Be a physician licensed under Mississippi law who has been designated to oversee all medical services of an agency provider and has been given the authority and responsibility for medical care delivered by an agency provider. This includes ensuring the program is in compliance with all federal, state, and local laws and regulations regarding the medical treatment of addiction to an opioid drug.2. Be American Society of Addiction Medicine or American Board of Addiction Medicine (ABAM) certified, or hold a comparable accreditation approved by DMH; (a) Hold a Drug Enforcement Administration license for prescribing opioid treatment medication; and(b) Have completed an employee training plan to include appropriate components as determined by DMH.3. Be available to the program on a continual basis, seven (7) days per week, 24 hours per day.4. Be present or ensure that qualified medical personnel are present in the program location for two (2) hours per week for each 50 people enrolled.5. Complete a full physical evaluation for each person annually to re-confirm the need for continued participation in the OTP.6. Ensure that a pharmacist licensed by the state of Mississippi is present and overseeing the dispensing of medication at each service location. Based on the Mississippi Board of Pharmacy rules and regulations, DMH defines "dispensing" as the interpretation of a valid prescription or order of a practitioner by a pharmacist and the subsequent preparation of the drug or device for administering to or use by a patient or other person entitled to receive the drug. The pharmacist is not required to be on-site at all times that medications are distributed in single doses (by a nurse at the dosing counter). However, the pharmacist is required to be present during the creation of take-home doses and at the time that people pick up their take-home doses. It should be outlined in the agency provider's policies and procedures the required duties of the pharmacist (such as verifying dosing parameters or completing necessary paperwork, etc.) and sufficient time in the service to complete these tasks should be allowed. B. Services must include, but are not limited to, the following: 1. Medical Services under the direction of the Medical Director will include an initial history and physical evaluation to determine diagnosis and if the person meets criteria for medication-assisted treatment, unless the person can provide documentation of a medical examination (including laboratory test results) that was conducted within 14 days prior to admission. The admission activities outlined in this requirement can be completed by a licensed medical professional, in accordance with their scope of practice, as per their licensure board. The physical evaluation will include but not be limited to the following: (a) A complete medical history;(b) Baseline toxicology report produced from a urine drug screen that includes at a minimum, testing for any drug known to be frequently used in the locality of the OTP, including cutoff concentrations;(c) A TB skin test or chest x-ray if the skin was ever previously positive;(e) Other laboratory tests as clinically indicated by the person's history and physical examination; and(f) A pregnancy test shall be completed, and the results documented, for each female of childbearing potential prior to the initiation of medication-assisted treatment, medically-assisted withdrawal, or detoxification procedures.2. Provide for the medical needs (annual physical exams, prescribing of medications, follow-up evaluations, ordering and review of lab work) of the people being served in accordance with current standards of medical practice;3. Ensure that the program is in compliance with local, state, and federal guidelines as each related to the medical treatment of opioid addiction;4. Determine the adequate treatment dose of medication to meet the needs of the person served;5. Provide for dosing and counseling services seven (7) days each week, including as needed by people, on days when the OTP is closed;6. Establish hours of operations for at least six (6) days each week (except on federal holidays), which are flexible to accommodate the majority of a person's school, work, and family responsibility schedules;7. Maintain physical plant that is adequate in size to accommodate the proposed number of people, required program activities, and provide a safe, therapeutic environment that supports enhancement of each person's well-being and affords protection of privacy and confidentiality;8. Reconcile administration and dispensing medication inventory;9. Approve all take-home medications; and10. Participate in treatment planning including approval and signing of all plans.C. Nursing Services provided must be in compliance with the applicable scope of practice and licensure board. These duties and responsibilities are in addition to requirements of the DMH Operational Standards and must include the following: 1. Administration of all medications as prescribed by the licensed Medical Director;2. Documentation of all medication administered and countersigning of all changes in dosage schedule;3. Provision of general nursing care in addition to substance use services when ordered by the program's licensed Medical Director;4. Supervision of functions that may be supplemented by an LPN; and5. Participation in treatment team meetings.D. Therapy and Recovery Support Services are a part of a holistic approach to treating a person with an opioid addiction. Therapy services must be provided by a licensed psychologist, licensed professional counselor, licensed certified social worker, or DMH-credentialed Addictions Therapist, and must be provided in accordance with the following requirements: 1. Written documentation must support decisions of the treatment team including indicators such as a positive drug screen, inappropriate behavior, criminal activity, and withdrawal management procedures.2. Therapy must be provided individually or in small groups of people (not to exceed 12 people) with similar treatment needs.3. Each person must be assigned to a primary therapist and the therapist must be familiar with all people on their caseload and document all contacts in the person's record.4. Specialized information and therapy approaches for people who have special problems, (e.g., terminal illness) must be provided and documented.5. Therapists must assess the psychological and sociological backgrounds of people, contribute to the treatment team, and monitor individual treatment programs.6. Therapist to person ratio cannot exceed 1:40 (one [1] therapist to every 40 people receiving services).E. Through the provision of Therapy Services, therapeutic interventions must be available as needed but at a minimum consist of the following:1. Evidence-based therapeutic services/practices, stress/anxiety management, and relapse prevention must be included as a schedule of therapeutic interventions.2. Individual, group, or family therapy sessions must be provided for one (1) hour per week for the first 90 days of treatment.3. Individual, group, or family therapy sessions must be provided for two (2) hours per month for days 91 through 180 of treatment.4. Individual, group, or family therapy sessions must be provided for one (1) hour per month for the remainder of treatment.5. Provide referrals for special needs.6. Provide focused counseling in cases of psychosocial stressors such as: (a) Abuse/neglect (known or suspected);(b) Marital (relationship);(e) Vocational/educational;(f) Infectious disease; and/or(g) Other services as ordered/indicated.F. Women's Services must be provided to ensure accessibility of services to pregnant women. The program must develop, implement, maintain, and document implementation of written policies and procedures to ensure the provision and accessibility of adequate services for women. The program must adhere to (and document wherever possible) the following:1. Give priority to pregnant women in its admission policy:(a) Cannot deny admission solely on the basis of the pregnancy; and(b) If a program is unable to provide services for a pregnant woman, the State Opioid Treatment Authority must be notified as to how the program will assist the pregnant woman in locating services.2. Arrange for and document medical care during pregnancy by appropriate referral and written and recorded verification that the woman receives prenatal care as planned.3. Implement informed consent procedures for women who refuse prenatal care to ensure the woman acknowledges in writing that she was offered prenatal treatment but refused.4. Ensure that the pregnant woman is fully informed of the possible risks to her unborn child from continued use of illicit drugs or from a narcotic drug administered during maintenance or withdrawal management treatment.5. Ensure that the pregnant woman is fully informed of the possible risks and benefits to her unborn child from participating in the OTP.6. Implement a process to provide pregnant women with access to or referral for prenatal care, pregnancy/parenting education, and postpartum follow-up.7. Obtain written consent to reciprocally share a woman's information with existing medical providers or future medical providers that have been or will be treating the pregnant woman.8. For pregnant women who refuse appropriate referral for prenatal services, the program shall: (a) Utilize informed consent procedures to have the woman formally acknowledge, in writing, that the OTP offered a referral to prenatal services that was refused by the woman; and(b) Provide the woman with the basic prenatal instruction on maternal, physical, and dietary care as part of the OTP therapy services and document service delivery in the woman's record.9. Implement the following procedures to care for pregnant women:(a) Women who become pregnant during treatment shall be maintained on the pre-pregnancy dosage, if effective, as determined by the Medical Director;(b) Dosing strategies will be consistent with those used for non-pregnant women if effective, as determined by the Medical Director; and(c) Methadone dosage shall be monitored more intensely during the third (3rd) trimester.10. The program shall describe in writing and document in the woman's record the decision by and process utilized if a pregnant woman elects to withdraw from methadone or buprenorphine which shall, at the minimum, include the following requirements: (a) The Medical Director shall supervise the withdrawal process.(b) Regular fetal assessments, as appropriate for gestational age, shall be part of the withdrawal process.(c) Education shall be provided on medically supervised withdrawal and the impact of medically supervised withdrawal services on the health and welfare of the unborn child.(d) Withdrawal procedures shall adhere to accepted medical standards regarding adequate dosing strategies.(e) When providing medically supervised withdrawal services to pregnant women whose withdrawal symptoms cannot be eliminated, referrals to inpatient medical programs shall be made.(f) The program shall describe in writing and document implementation of policies and procedures, including informed consent, to ensure appropriate post-pregnancy follow-up and primary care for the new mother and well-baby care for the infant.11. Maintain documentation of an annual review implemented by the Medical Director of the protocol for treating pregnant women.