West Virginia Code of State Rules › Agency 69 - Health And Human Resources › Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 69-07 - Regulations of Opioid Treatment Programs › Section 69-7-3 - Definitions

Current through Register Vol. XLI, No. 28, July 12, 2024
3.1. 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 problems
3.13.
				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
§ 30-14-1
et
				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 Virginia
3.69.
				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.