CHAPTER 16B. INSPECTOR GENERAL.

ARTICLE 13. MEDICATION-ASSISTED TREATMENT PROGRAM LICENSING ACT.

§16B-13-2. Definitions.

"Addiction" means a primary, chronic disease of brain reward, motivation, memory, and related circuitry. Dysfunction in these circuits leads to characteristic biological, psychological, social, and spiritual manifestations which is reflected in an individual pathologically pursuing reward or relief by substance use, or both, and other behaviors. Addiction is characterized by inability to consistently abstain; impairment in behavioral control; craving; diminished recognition of significant problems with one’s behaviors; interpersonal problems with one’s behaviors and interpersonal relationships; a dysfunctional emotional response; and as addiction is currently defined by the American Society of Addiction Medicine.

"Administrator" means an individual designated by the governing body to be responsible for the day-to-day operation of the opioid treatment programs.

"Advanced alcohol and drug abuse counselor" means an alcohol and drug abuse counselor who is certified by the West Virginia Certification Board for Addiction and Prevention Professionals who demonstrates a high degree of competence in the addiction counseling field.

"Alcohol and drug abuse counselor" means a counselor certified by the West Virginia Certification Board for Addiction and Prevention Professionals for specialized work with patients who have substance use problems.

"Biopsychosocial" means relating to, or concerned with, biological, psychological, and social aspects in contrast to the strictly biomedical aspects of disease.

"Center for Substance Abuse Treatment" means the center under the Substance Abuse and Mental Health Services Administration that promotes community-based substance abuse treatment and recovery services for individuals and families in the community and provides national leadership to improve access, reduce barriers, and promote high quality, effective treatment and recovery services.

"Controlled Substances Monitoring Program Database" means the database maintained by the West Virginia Board of Pharmacy pursuant to §60A-9-3 of this code that monitors and tracks certain prescriptions written or dispensed by dispensers and prescribers in West Virginia.

"Director" means the Director of the Office of Health Facility Licensure and Certification, or his or her designee.

"Dispense" means the preparation and delivery of a medication-assisted treatment medication in an appropriately labeled and suitable container to a patient by a medication-assisted treatment program or pharmacist.

"Governing body" means 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. The governing body must comply with the requirements prescribed in rules promulgated pursuant to this article.

"Inspector General" means the Inspector General of the Office of Inspector General as described in §16B-2-1 of this code, or his or her designee.

"Medical director" means a physician licensed within the State of West Virginia who assumes responsibility for administering all medical services performed by the medication-assisted 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 and functioning within their scope of practice.

"Medication-assisted treatment" means the use of medications and drug screens, in combination with counseling and behavioral therapies, to provide a holistic approach to the treatment of substance use disorders.

"Medication-assisted treatment program" means all publicly and privately owned opioid treatment programs and office-based, medication-assisted treatment programs, which prescribe medication-assisted treatment medications and treat substance use disorders, as those terms are defined in this article.

"Medication-assisted treatment medication" means 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 U. S. C. § 355, for use in the treatment of substance use disorders that is an opioid agonist or partial opioid agonist and is listed on the Schedule of Controlled Substances in §60A-2-2201 et seq. of this code.

"Office-based, medication-assisted treatment" means all publicly or privately owned clinics, facilities, offices, or programs that provide medication-assisted treatment to individuals with substance use disorders through the prescription, administration, or dispensing of a medication-assisted treatment medication in the form of a partial opioid agonist.

"Office of Health Facility Licensure and Certification" means the West Virginia Office of Health Facility Licensure and Certification within the Office of Inspector General.

"Opioid agonist" means 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 article, the term "opioid agonist" does not include partial agonist medications used as an alternative to opioid agonists in the treatment of opioid addiction.

"Opioid treatment program" means all publicly- or privately-owned medication-assisted treatment programs in clinics, facilities, offices, or programs that provide medication-assisted treatment to individuals with substance use disorders through on-site administration or dispensing of a medication-assisted treatment medication in the form of an opioid agonist or partial opioid agonist.

"Owner" means any person, partnership, association, or corporation listed as the owner of a medication-assisted treatment program on the licensing or registration forms required by this article.

"Partial opioid agonist" means a Federal Drug Administration approved medication that is used as an alternative to opioid agonists for the treatment of substance use disorders and that binds to and activates opiate receptors, but not to the same degree as full agonists.

"Physician" means an individual licensed in this state to practice allopathic medicine or surgery by the West Virginia Board of Medicine or osteopathic medicine or surgery by the West Virginia Board of Osteopathic Medicine and that meets the requirements of this article.

"Prescriber" means a person authorized in this state, working within their scope of practice, to give direction, either orally or in writing, for the preparation and administration of a remedy to be used in the treatment of substance use disorders.

"Program sponsor" means the person named in the application for the certification and licensure of an opioid treatment program who is responsible for the administrative 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.

"State opioid treatment authority" means the agency or individual designated by the Governor to exercise the responsibility and authority of the state for governing the treatment of substance use disorders, including, but not limited to, the treatment of opiate addiction with opioid drugs.

"State oversight agency" means the agency or office of state government identified by the Inspector General to provide regulatory oversight of medication-assisted treatment programs on behalf of the State of West Virginia.

"Substance" means the following:

(1) Alcohol;

(2) Controlled substances defined by §60A-2-204, §60A-2-206, §60A-2-208, and §60A-2-210 of this code; or

(3) Any chemical, gas, drug, or medication consumed which causes clinically and functionally significant impairment, such as health problems, disability, and failure to meet major responsibilities at work, school, or home.

"Substance Abuse and Mental Health Services Administration" means the agency under the United States Department of Health and Human Services responsible for the accreditation and certification of medication-assisted 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.

"Substance use disorder" means patterns of symptoms resulting from use of a substance that the individual continues to take, despite experiencing problems as a result; or as defined in the most recent edition of the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders.

"Telehealth" means the mode of delivering health care services and public health via information and communication technologies to facilitate the diagnosis, consultation, treatment education, care management, and self-management of a patient’s health care while the patient is at the originating site and the health care provider is at a distant site.

"Variance" means written permission granted by the Inspector General, or designee, to a medication-assisted treatment program that a requirement of this article or rules promulgated pursuant to this article may be accomplished in a manner different from the manner set forth in this article or associated rules.

"Waiver" means a formal, time-limited agreement between the designated oversight agency and the medication-assisted treatment program that suspends a rule, policy, or standard for a specific situation so long as the health and safety of patients is better served in the situation by suspension of the rule, policy, or standard than by enforcement.

Bill History For §16B-13-2