Current through Register Vol. XLI, No. 50, December 13, 2024
Section 69-7-3 - Definitions3.1. Accreditation- The process of review and acceptance of an opioid treatment program by an accreditation body.3.2. Accreditation Body - A body approved by SAMHSA under 42 CFR §8.3 to accredit opioid treatment programs that use opioid treatment medications.3.3. Accreditation Elements - The elements or standards that are developed and adopted by an accreditation body and approved by SAMHSA.3.4. Accreditation Survey - An onsite review and evaluation of an opioid treatment program by an accreditation body for the purpose of determining compliance with the federal opioid treatment standards.3.5. Addiction- A disease characterized by the individual's pursuing reward and/or relief by substance use and/or other behaviors. Addiction is characterized by impairment in behavioral control, craving, inability to consistently abstain, and diminished recognition of significant problems with one's behaviors and interpersonal relationships; likely to involve cycles of relapse and remission.3.6. Administrative Withdrawal - A brief, involuntary withdrawal or administrative discharge from pharmacotherapy.3.7. Administrator- An individual designated by the governing body to be responsible for the day-to-day operation of the opioid treatment program.3.8. Admissions Committee - A designated group of individuals within the opioid treatment program consisting of the program administrator, or his or her designee, the medical director, or his or her designee, and a senior counselor, which is responsible for developing, administering and reviewing program admissions policies and procedures, granting any exceptions to program admissions policies and procedures, and tracking the outcomes of patient admissions and exceptions.3.9. Advanced Alcohol and Drug Abuse Counselor (AADC) - An alcohol and drug abuse counselor that is certified by the West Virginia Certification Board for Addiction & Prevention Professionals as demonstrating a high degree of competence in the addiction counseling field.3.10. Adverse Event or Incident - An event involving an immediate threat to the care or safety of an individual, either staff or patient; the possibility of serious operational or personnel problems within the opioid treatment program facility; or the potential to undermine public confidence in the opioid treatment program. 3.11. Advisory Council - A designated group of individuals representing staff, patients and the community who are appointed to serve in a non-managerial advisory capacity to the governing body of an opioid treatment program.3.12. Alcohol and Drug Abuse Counselor (ADC) - A counselor certified by the West Virginia Certification Board for Addiction & Prevention Professionals for specialized work with patients who have substance abuse problems3.13. Approved Authorities - Programs or authorities that publish practice or treatment guidelines, standards or protocols that the secretary has approved for use by opioid treatment programs. Approved authorities include the American Society of Addiction Medicine (ASAM); the Center for Substance Abuse Treatment (CSAT); the National Institute on Drug Abuse (NIDA); the American Association for the Treatment of Opioid Dependence (AATOD); and any other program or authority approved by the secretary.3.14. Certification- The process by which SAMHSA determines that an opioid treatment program is qualified to provide opioid treatment under federal opioid treatment standards.3.15. Complaint- A verbal or written statement made by a patient, family member or community member and filed with the program administrator or a state agency alleging inadequate or inappropriate service on the part of an opioid treatment program.3.16. Comprehensive Bio-Psychosocial Assessment - A medical and bio-psychosocial evaluation of a patient completed within thirty days of admission that evaluates all aspects of the individual's physical, psychological and adaptive functioning.3.17. Controlled Substances Monitoring Program Database - The database maintained by the West Virginia Board of Pharmacy pursuant to W.Va. Code § 60A-9-3 that monitors and tracks certain prescriptions written or dispensed by physicians or pharmacies in West Virginia.3.18. Co-Occurring Disorders - The combination of current or former substance use disorders and any other Axis I or Axis II mental disorders recognized by the Diagnostic and Statistical Manual of Mental Disorders published by the American Psychiatric Association.3.19. Counseling Session - A face-to-face interaction in a private location between a patient and a primary counselor. Counseling sessions may be private, individual sessions, with only the patient and a counselor, or group sessions, in which the counselor works with one or more patients on similar issues.3.20. Counselor - A person who, by education, training and experience, is qualified to provide psycho-social education, treatment and guidance to patients enrolled with an opioid treatment program and, if desired, to the families of such patients, in order to accomplish behavioral health, wellness, education and other life goals.3.21. Detoxification Treatment - The dispensing of an opioid treatment medication to a patient in decreasing doses to alleviate adverse physical or psychological effects incident to withdrawal from the continuous or substantial use of an opioid drug. Detoxification utilizes the process of dose tapering from maintenance medication as a method of bringing the individual to a drug-free state within a desired period of time.3.22. Dispense- The preparation and delivery of an opioid treatment medication in an appropriately labeled and suitable container to a patient by an opioid treatment program. For purposes of this rule, the term does not include the preparation and delivery of medications by a pharmacy licensed pursuant to the provisions of W.Va. Code § 30-5-1, et seq.3.23. Diversion Control Plan - A required plan developed by the opioid treatment program to minimize the diversion of methadone or other medications to illicit use.3.24. Facility - The physical building in which an opioid treatment program is provided.3.25. Federal Opioid Treatment Standards - The standards established by the United States Department of Health and Human Services, 42 CFR, section 8.12, that are used to determine whether an opioid treatment program is qualified to engage in opioid treatment and to determine the quantities of opioid drugs which may be provided for unsupervised use.3.26. For-Cause Inspection - An inspection by any federal or state agency or accreditation body of an opioid treatment program that may be operating in violation of federal or state opioid treatment standards, may be providing substandard treatment or may be serving as a possible source of diverted medications.3.27. Governing Body - The person or persons identified as being legally responsible for the operation of the opioid treatment program. A governing body may be a board, a single entity or owner or a partnership.3.28. Grievance- A written or oral complaint filed by a patient with the program administrator or the state agency alleging inadequate or inappropriate treatment by the opioid treatment program.3.29. Individualized Treatment Plan of Care - A plan of treatment and care developed by the patient's physician, counselors and other health care professionals in conjunction with the patient that outlines for the patient attainable short-term treatment goals that are mutually acceptable to the patient and the opioid treatment program and which specifies the services to be provided and the frequency and schedule for their provision.3.30. Induction- Initial treatment of an opioid addicted patient with opioid treatment medication in order to suppress signs or symptoms of withdrawal and drug cravings. Induction usually includes a gradual increase in opioid treatment medication therapy until the symptoms are regularly and reliably suppressed or controlled.3.31. Induction Period - The period of time during which a patient receives an induction of opioid treatment medication.3.32. Informed Consent to Treatment - Written acknowledgement and verification by a patient stating that the patient has been informed of the advantages and disadvantages of all aspects of the treatment provided to the patient and that the patient agrees to the treatment.3.33. Initial Assessment - The first medical interview and initial screening of a patient that focus on the individual's eligibility or need for admission and treatment. The initial assessment provides indicators for initial dosage level should admission be determined appropriate, and forms the basis for the individualized treatment plan of care.3.34. Interdisciplinary Team - A representative of the medical staff of the opioid treatment program, and the patient's primary counselor, all working in conjunction with the patient and family members, if desired by the patient, to develop, approve and coordinate the individualized treatment plan of care for the patient.3.35. Long-Term Detoxification Treatment - Detoxification treatment for a period more than 30 days but not in excess of 180 days.3.36. Maintenance Dose - The level of opioid treatment medication considered medically necessary to consistently suppress signs or symptoms of opioid withdrawal and drug cravings for individuals with opioid addiction. A maintenance dose is generally administered at the end of the induction period. The dose is individualized for each patient and may gradually change over time.3.37. Medical Director - The physician licensed within the state of West Virginia who assumes responsibility for administering all medical services performed by the opioid treatment program, either by performing them directly or by delegating specific responsibility to authorized program physicians and health care professionals functioning under the medical director's direct supervision.3.38. Medical and Rehabilitative Services - Treatment and recovery services such as medical evaluations, counseling and rehabilitative and other social programs intended to help patients in opioid treatment programs become and/or remain productive members of society.3.39. Medical Withdrawal - The gradual voluntary and therapeutic withdrawal of a patient from opioid replacement therapy, agreed upon by the patient and staff. Medical withdrawal may occur against medical advice.3.40. Mental Health Professional - A person licensed under Chapter 30 of the West Virginia Code as a social worker, psychologist or licensed professional counselor.3.41. Methadone- A medication of the opioid agonist type, which can be used as replacement therapy for opioids for an addicted patient.3.42. Opiate Addiction - A cluster of cognitive, behavioral and physiological symptoms in which the individual continues use of opiates despite significant opiate-induced problems. Opiate dependence is characterized by repeated self-administration that usually results in opiate tolerance, withdrawal symptoms and compulsive drug-taking. Dependence may occur with or without the physiological symptoms of tolerance and withdrawal.3.43. Opioid Treatment Medication - Any medication that is approved by the United States Food and Drug Administration under section 505 of the Federal Food, Drug and Cosmetic Act, 21 USC 355, for use in the treatment of opiate addiction.3.44. Opioid Agonists - Substances that bind to and activate the opiate receptors resulting in analgesia and pain regulation, respiratory depression and a wide variety of behavioral changes. As used in this rule, the term "opioid agonist" does not include partial agonist medications used as an alternative to opioid agonists in the treatment of opioid addiction.3.45. Opioid Drug - Any drug having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addiction-sustaining liability. Opioids include heroin, morphine, codeine, Oxycontin, oxycodone and other medications that block the transmission of pain messages to the brain.3.46. Opioid Treatment Program ("program") - A program or practitioner engaged in the treatment of individuals with opioid dependence through on-site administration or dispensing of an opioid treatment medication in the form of an opioid agonist or partial opioid agonist . As used in this rule, the term "opioid treatment program" does not include programs or practitioners that issue prescriptions for partial opioid agonist medications.3.47. Opioid Treatment Services - Treatment and services provided by an opioid treatment program that uses opioid treatment medications as a part of its treatment modality. Opioid treatment services may be provided through intensive outpatient, residential or hospital settings. Treatment may include medical maintenance, medically supervised withdrawal and detoxification, various levels of medical, psychosocial and other types of care, detoxification treatment, short-term detoxification treatment, long-term detoxification treatment and maintenance treatment.3.48. Orientation- The introduction of a patient to the policies and procedures of the opioid treatment program and to the theory and process of recovery-based, medication-assisted therapy.3.49. Partial Opioid Agonist - A medication that is used as an alternative to opioid agonists in the treatment of opioid addiction. At certain dosages, a partial agonist can both activate and block the effects of opioid medications or receptors, thereby assisting in control of opioid addiction. Partial agonists bind to the receptors and activate them, but not to the same degree as full agonists. Buprenorphine is an example of a partial opioid agonist.3.50. Patient- An individual consumer who undergoes treatment in an opioid treatment program.3.51. Peer Review Committee - A group of individuals designated by each opioid treatment program that is responsible for ensuring that the program follow approved national guidelines for opioid treatment facilities and programs. The peer review committee shall include at least one physician licensed in the state of West Virginia.3.52. Pharmacotherapy - The treatment of a disease or medical condition through the administration of drugs.3.53. Physician - An individual licensed to practice medicine by the West Virginia Board of Medicine pursuant to W.Va. Code § 30-3-1, et seq., or osteopathic medicine by the West Virginia Board of Osteopathy pursuant to W.Va. Code § 30-14-1et seq.3.54. Physician Extender - A medical staff person other than a physician, functioning within his or her scope of practice to provide medical services to patients admitted to opioid treatment programs. An approved physician extender must meet the requirements for his or her scope of practice and complete the certification or training programs recommended and approved by the medical director of the opioid treatment program. Physician extenders approved for employment at an opioid treatment program include advanced practice registered nurses or physician assistants. Registered nurses and licensed practical nurses are not authorized to act as physician extenders in an opioid treatment program, although they may work within the program in other capacities.3.55. Plan of Correction - A written description of the actions the opioid treatment program intends to take to correct and prevent the reoccurrence of violations of a rule or policy identified by the designated state oversight agency during an investigation or survey.3.56. Plan of Education - An approved continuing education plan that results in a physician, counselor or physician extender attaining professional competence in the field of opioid treatment.3.57. Positive Drug Test - A test that results in the presence of any drug or substance listed in §41.2.e of this rule or any other drug or substance prohibited by the opioid treatment program. The presence of medication which is part of the patient's individualized treatment plan of care shall not be considered a positive test. Any refusal to participate in a random drug test shall be considered a positive drug test.3.58. Primary Counselor - The individual designated by the opioid treatment program to serve as a consultant and advisor to a patient on a regular basis. The primary counselor may be an addiction counselor and shall be included as a member of the patient's interdisciplinary team.3.59. Program Physician - One or more physicians designated and approved by the medical director to prescribe and monitor medication-assisted treatment for patients admitted to an opioid treatment program. At least one program physician must be present or on call during all hours of operation. The medical director may serve as the program physician.3.60. Program Sponsor - The person named in the application for certification and licensure of an opioid treatment program who is responsible for the operation of the opioid treatment program, and who assumes responsibility for all of its employees, including any practitioners, agents or other persons providing medical, rehabilitative or counseling services at the program. The program sponsor need not be a licensed physician, but shall employ a licensed physician for the position of medical director.3.61. Random Drug Testing - Approved medical screening or testing of patients for drugs, alcohol or other substances. Random drug testing shall be conducted so that each patient of an opioid treatment facility has a statistically equal chance of being selected for testing at random and at unscheduled times.3.62. Recovery- A process of change through which an individual improves his or her health and wellness, lives a self-directed life and strives to achieve his or her full potential.3.63. Recovery Model - A recovery initiative that focuses on various dimensions that support recovery from opioid addiction, including health, home, individual purpose and community relationships and services.3.64. Relapse Prevention Plan - A plan of action developed by a patient and his or her counselor to help the patient anticipate and prepare for situations or environmental stimuli that were previously associated with substance abuse or addiction in order to avoid a return to use of opioids or other inappropriate or addictive substances.3.65. Secretary- The Secretary of the West Virginia Department of Health and Human Resources or his or her designee.3.66. Short-Term Detoxification Treatment - Detoxification treatment for a period not in excess of 30 days.3.67. State Authority or State Methadone Authority - The agency or individual designated by the Governor to exercise the responsibility and authority of the state for governing the treatment of opiate addiction with an opioid drug. The state authority shall act as the state's coordinator for the development and monitoring of narcotic treatment programs and shall serve as a liaison with the appropriate federal agencies. The Bureau for Behavioral Health and Health Facilities has been designated by the Governor as the state methadone authority for the state of West Virginia.3.68. State Oversight Agency - The agency or office of state government identified by the secretary to provide regulatory oversight of opioid treatment programs on behalf of the state of West Virginia. The designated state oversight agency is responsible for licensing, monitoring and investigating complaints or grievances regarding opioid treatment programs. The Office of Health Facility Licensure and Certification is the agency designated by the Secretary to provide regulatory oversight on behalf of the state of West Virginia3.69. Substance- Alcohol, controlled substances as by W.Va. Code § 60A-2-208 or § 60A-2-210, or anything consumed for its psychoactive effect, whether or not designed for human consumption.3.70. Substance Abuse - The inappropriate use of any medication, alcohol or other substance that results in or contributes to the person becoming addicted to the substance contrary to accepted medical or social standards. 3.71. Substance Abuse and Mental Health Services Administration (SAMHSA) - The agency under the United States Department of Health and Human Services responsible for the accreditation and certification of opioid treatment programs and that provides leadership, resources, programs, policies, information, data, contracts and grants for the purpose of reducing the impact of substance abuse and mental or behavioral illness.3.72. Take-Home Medication - Any medication that is approved under federal standards to be dispensed to a patient for unsupervised use based upon the patient's demonstrated compliance with the individualized treatment plan of care. Each dose of take-home medication must be recommended by the primary counselor and be approved by the medical director or program physician. Take-home medication may not exceed the dosages permitted under federal law or recommended by approved national guidelines.3.73. Titration - The gradual decreasing of doses of an opioid treatment medication to the point of elimination of the use of the medication in the withdrawal process.3.74. Toxicology Screen - Urine drug screens or other approved medical screening processes designed to monitor and evaluate the patient's initial need for treatment and subsequent progress in treatment.3.75. Variance - A formal agreement between the state authority or designated oversight agency and the program that allows the program to comply with the intent of a regulatory rule, policy or standard in a manner not otherwise permitted by the rule, policy or standard. A variance may not be obtained based solely on the inability to achieve compliance.3.76. Waiver- A formal, time-limited agreement between the designated oversight agency and the opioid treatment program that suspends a rule, policy or standard for a specific situation so long as the health and safety of patients are better served in the situation by suspension of the rule, policy or standard than by enforcement.