West Virginia Code of State Rules
Agency 69 - Health And Human Resources
Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES
Series 69-11 - Medication-Assisted Treatment - Opioid Treatment Programs
Section 69-11-2 - Definitions

2.1. Definitions incorporated by reference. -- Those terms defined in W. Va. Code §§ 16-5Y-1, et seq. are incorporated herein by reference.

2.2. Accreditation Body -- A body approved by the Substance Abuse and Mental Health Services Administration (SAMHSA) under 42 C.F.R. § 8.3 to accredit opioid treatment programs that use medication-assisted treatment medications.

2.3. Administrative Detoxification or Administrative Withdrawal -- The detoxification from the approved medication-assisted treatment medication for the safety and well-being of the patient, other patients, and staff of the MAT program.

2.4. 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, who is responsible for developing, implementing, 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.

2.5. Advanced Practice Registered Nurse -- A registered nurse who has acquired advanced clinical knowledge and skills preparing him or her to provide direct and indirect care to patients, completed a board-approved graduate-level education program, passed a board-approved national certification examination, and has met all the requirements set forth by the West Virginia Board of Examiners for Professional Registered Nurses.

2.6. Adverse Event or Incident -- An event involving an immediate threat to the care or safety of an individual, either staff, patient, or visitor; the possibility of serious operational or personnel problems within the MAT program facility; or the potential to undermine public confidence in the MAT program.

2.7. 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.

2.8. Approved Authorities -- Programs or authorities that publish practice or treatment guidelines, standards, or protocols that the Secretary has approved for use by MAT programs. Approved authorities include, but are not limited to, 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); the Federation of State Medical Boards (FSMB); and any other program or authority approved by the Secretary.

2.9. Case Management -- The process of coordinating and monitoring the services provided to a patient both within the program and in conjunction with other providers.

2.10. Certification -- The process by which SAMHSA determines that an opioid treatment program is qualified to provide medication-assisted treatment under federal opioid treatment standards.

2.11. Clinical Staff -- The individuals employed by or associated with a MAT program who provide treatment, care, or rehabilitation to program patients or patients' families.

2.12. Co-Occurring Disorders -- The combination of current or former substance use disorders and any other mental disorders recognized in the current edition of the Diagnostic and Statistical Manual of Mental Disorders published by the American Psychiatric Association.

2.13. Counseling Session -- A face-to-face interaction, which could include telehealth, in a private location between a patient and a primary counselor for a period of no less than 30 continuous minutes designated to address patient substance use disorder issues or coping strategies and individualized treatment plan of care.

2.14. Counselor -- A person who, by education, training, and experience, is qualified to provide psychosocial education, treatment and guidance to patients enrolled with a MAT program and, if desired, to the families of such patients, in order to accomplish behavioral health wellness, education, and other life goals.

2.15. Crisis -- A deteriorating or unstable situation often developing suddenly or rapidly that produces acute, heightened, emotional, mental, physical, medical, or behavioral distress; or any situation or circumstances in which the individual perceives or experiences a sudden loss of his ability to use effective problem-solving and coping skills.

2.16. Critical Incident -- A life, safety, or health threat involving the staff or patients participating in a program, including, but not limited to, death or physical or sexual assault.

2.17. Detoxification or Medically Supervised Withdrawal Treatment -- The dispensing of a medication-assisted treatment medication to a patient in decreasing doses over time, under the supervision of a program physician, to alleviate adverse physical or psychosocial effects incident to withdrawal from the continuous or substantial use of an opioid drug.

2.18. Discharge Plan -- The written plan that establishes the criteria for a patient's discharge from a service and identifies and coordinates delivery of any services needed after discharge.

2.19. Dispense -- The preparation and delivery of a medication-assisted treatment medication in an appropriately labeled and suitable container to a patient by a MAT program, but 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.

2.20. Diversion -- An activity involving the legitimate acquisition of pharmaceutical agents illegally diverted to entities not intended as the recipients by the initial supplier.

2.21. Diversion Control Plan -- A required plan developed and implemented by the MAT program, which may include, but is not limited to, the assigning of responsibilities to medical and administrative staff and other specific measures to reduce the possibility of diversion of controlled substances from legitimate treatment to illicit use.

2.22. Federal Opioid Treatment Standards -- The standards established by the United States Department of Health and Human Services, 42 C.F.R. § 8.12, that are used to determine whether an opioid treatment program is qualified to engage in medication-assisted treatment and to determine the quantities of medication-assisted treatment medications which may be provided for unsupervised use.

2.23. For-Cause Inspection -- An inspection by any federal or state agency or accreditation body of a MAT program that may be operating in violation of 42 C.F.R. § 8 or state medication-assisted treatment rules, may be providing substandard treatment, or may be serving as a possible source of diverted medications.

2.24. Grievance -- A written or oral complaint filed by a patient with a program administrator, medical director, or state agency alleging inadequate treatment by the MAT program.

2.25. Individualized Treatment Plan of Care or Treatment Plan -- A plan or strategy of treatment and care developed by the patient's physician, counselors,, and other health care professionals in conjunction with the patient that outlines attainable short-term treatment goals that are mutually acceptable to the patient and the MAT program and which specifies the services to be provided and the frequency and schedule for their provision.

2.26. Induction -- Initial treatment of a patient with medication-assisted treatment medication in order to suppress signs or symptoms of withdrawal or substance cravings; and generally includes a gradual increase in medication-assisted treatment medication therapy until the symptoms are regularly and reliably suppressed or controlled.

2.27. Initial Assessment -- An assessment conducted prior to or at admission and initial screening of a proposed patient that focuses on the individual's eligibility or need for admission and treatment; and provides indicators for initial dosage level and forms the basis for the individualized treatment plan of care.

2.28. Inspection or Survey -- Any examination by the Secretary or his or her designee of a MAT program including, but not limited to, the premises, staff, patients, and documents pertinent to initial and continued licensing, so that the Secretary or his or her designee may determine whether a program is operating in compliance with licensing requirements or has violated any licensing requirements. This includes any survey, monitoring visit, complaint investigation or other inquiry conducted for the purposes of making a compliance determination with respect to licensing requirements.

2.29. Interdisciplinary Team -- A representative of the clinical staff of the opioid treatment program, and the patient's primary substance abuse counselor, 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.

2.30. Long-Term Detoxification Treatment -- Detoxification or medically supervised withdrawal treatment for a period of more than 30 days.

2.31. Maintenance Dose -- The level of medication-assisted treatment medication considered medically necessary to consistently suppress signs or symptoms of substance use disorders and substance cravings for individuals with a substance use disorder; and is generally administered at the end of the induction period and is individualized for each patient and may gradually change over time.

2.32. Medical and Rehabilitative Services -- Treatment and recovery services such as medical assessments and evaluations, counseling and rehabilitative and other special programs intended to help patients in MAT programs become and remain productive members of society.

2.33. Medical or Patient Record -- Medical histories, records, reports, summaries, diagnoses, prognoses, records of treatment, and medication ordered and given, entries, x-rays, radiology interpretations, and other written electronic, or graphic data prepared, kept, made, or maintained in a facility that pertains to services rendered to patients.

2.34. Medical Withdrawal -- The medically managed, gradual, voluntary, and therapeutic withdrawal of a patient from medication-assisted treatment, agreed upon by the patient and appropriate staff.

2.35. Medication Administration -- The direct application of medications by injection, inhalation, ingestion, or any other means to a patient receiving services by persons legally permitted to administer medication-assisted treatment medications or the individual at the direction and in the presence of persons legally permitted to administer medication-assisted treatment medications.

2.36. Medication Error -- An error in administering a medication to an individual and includes when any of the following occur: the wrong medication is given to an individual; the wrong individual is given the medication; the wrong dosage is given to an individual; medication is given to an individual at the wrong time or not at all; or the wrong method is used to administer the medication.

2.37. Mental Health Professional -- A person licensed under Chapter 30 of the West Virginia Code as a social worker, psychologist, or professional counselor.

2.38. Misuse or Non-Medical Use -- All uses of a prescription medication or substance other than those that are directed by a physician and used by an intended patient within the law and the requirements of good medical practice.

2.39. Opioid Antagonist -- A drug that blocks opioids by attaching to the opioid receptors without activating them thereby causing no opioid effect and blocking full agonist opioids.

2.40. Opioid Drug -- Any substance or drug having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug or substance having such addiction-forming or addiction-sustaining liability including, but not limited to, heroin, morphine, codeine, oxycodone, hydrocodone, fentanyl, oxymorphone, hydromorphone, methadone, buprenorphine, and any natural, semi-synthetic, or synthetic drug that acts primarily through the opioid receptor in the brain.

2.41. Opioid Treatment Services -- Treatment and services provided by a MAT program that uses medication-assisted treatment medications as a part of its treatment modality. Opioid treatment services may be provided through outpatient, residential, or hospital settings and may include medical maintenance, medically supervised withdrawal and detoxification, various levels of medical, psychosocial, and other types of care, detoxification treatment, and maintenance treatment.

2.42. Peer Recovery Support Services -- Non-clinical recovery support services which are recipient directed and delivered by peers who have life experience with recovery.

2.43. 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, and shall include at least one physician licensed in the state of West Virginia.

2.44. Pharmacotherapy -- The treatment of disease or medical condition through the administration of drugs.

2.45. Physical Dependence -- A state of biologic adaption that is evidenced by a class-specific withdrawal syndrome when the substance is abruptly discontinued or the dose rapidly reduced, or by the administration of an antagonist.

2.46. Physician Assistant -- A person who meets the qualifications set forth in W. Va. Code §§ 30-3E-1, et seq. and is licensed pursuant to that article to practice medicine under the supervision of a physician or podiatrist licensed under the West Virginia Board of Medicine or the West Virginia Board of Osteopathic Medicine.

2.47. Physician Extender -- A medical staff person other than a program physician, functioning within his or her scope of practice to provide medical services to patients admitted to MAT programs. Physician extenders approved for employment at a MAT program include advanced practice registered nurses and physician assistants. Registered nurses and licensed practical nurses are not authorized to act as physician extenders in a MAT program, although they may work within the program in other capacities.

2.48. Plan of Correction -- A written description of the actions the MAT program intends to take to correct and prevent the reoccurrence of violations of a statute, rule, regulation or policy identified by the designated state oversight agency during an investigation or survey.

2.49. Plan of Education -- An approved continuing education plan that results in a physician, counselor or physician extender attaining professional competence in the field of substance use disorder treatment.

2.50. Positive Drug Screen -- A test that results in the presence of any drug or substance listed in subdivision 34.2.e. of this rule or any other drug or substance prohibited by the MAT 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.

2.51. Primary Counselor -- The individual designated by the MAT 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 for opioid treatment programs.

2.52. Program Physician -- Any physician licensed in this state pursuant to Chapter 30 of the West Virginia Code, designated and approved by the medical director to prescribe and monitor medication-assisted treatment for patients admitted to a MAT program. The medical director may serve as a program physician.

2.53. Random Drug Testing -- Approved medical screening and testing of patients for drugs, alcohol or other substances that shall be conducted so each patient of a MAT program has a statistically equal chance of being selected for testing at random, unscheduled times.

2.54. 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.

2.55. Relapse Prevention Plan -- A plan of action developed by a patient and his or her primary 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.

2.56. 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.

2.57. Titration -- The gradual increasing or decreasing of doses of a medication-assisted treatment medication to the minimal level clinically required for maintenance.