Bill Summary – FastDemocracy

WEST VIRGINIA LEGISLATURE
REGULAR SESSION
               Introduced Senate Bill 295
          By Senators Tarr and Stuart [Introduced January 11, 2024; referred to the Committee on the Health and Human Resources]
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  A BILL to amend and reenact §16-5Y-2, §16-5Y-3, §16-5Y-5, §16-5Y-6, §16-5Y-7, and §16-5Y-13
         of the Code of West Virginia, 1931, as amended; and to amend said code by adding
         thereto a new article, designated §16-5EE-1, §16-5EE-2, §16-5EE-3, and §16-5EE-4, all
         relating to opioid treatment programs; defining terms; making opioid treatment programs
         unlawful; allowing for an administrative time frame for referral; requiring the imposition of
         fees for noncompliance; and permitting injunctive relief.
     Be it enacted by the Legislature of West Virginia:
     ARTICLE 5Y. MEDICATION ASSISTED TREATMENT PROGRAM LICENSING ACT.
     §16-5Y-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 medication-assisted 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 of, relating to, or concerned with, biological, psychological, and
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 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.
           "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 medication-assisted 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.
           "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
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 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, excluding methadone,
 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.
            "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
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 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.
           "Secretary" means the Secretary of the West Virginia Department of Health and Human
 Resources or his or her designee.
           "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
 secretary 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
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  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 secretary 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.
      §16-5Y-3. Opioid treatment programs to obtain license; application; fees and inspections.
            [Repealed.]
      §16-5Y-5.                                 Operational requirements.
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            (a) The medication-assisted treatment program shall be licensed and registered in this
  state with the secretary, the Secretary of State, the State Tax Department, and all other applicable
  business or licensing entities.
            (b) The program sponsor need not be a licensed physician but shall employ a licensed
  physician for the position of medical director, when required by the rules promulgated pursuant to
  this article.
            (c) Each medication-assisted treatment program shall designate a medical director. If the
  medication-assisted treatment program is accredited by a Substance Abuse and Mental Health
  Services Administration approved accrediting body that meets nationally accepted standards for
 providing medication-assisted treatment, including the Commission on Accreditation of
 Rehabilitation Facilities or the Joint Commission on Accreditation of Healthcare Organizations,
 then the program may designate a medical director to oversee all facilities associated with the
 accredited medication-assisted treatment program. The medical director shall be responsible for
 the operation of the medication-assisted treatment program, as further specified in the rules
 promulgated pursuant to this article. He or she may delegate the day-to-day operation of a
 medication-assisted treatment program as provided in rules promulgated pursuant to this article.
 Within 10 days after termination of a medical director, the medication-assisted treatment program
 shall notify the director of the identity of another medical director for that program. Failure to have
 a medical director practicing at the program may be the basis for a suspension or revocation of the
 program license. The medical director shall:
           (1) Have a full, active, and unencumbered license to practice allopathic medicine or
 surgery from the West Virginia Board of Medicine or to practice osteopathic medicine or surgery
 from the West Virginia Board of Osteopathic Medicine in this state and be in good standing and not
 under any probationary restrictions;
           (2) Meet both of the following training requirements:
           (A) If the physician prescribes a partial opioid agonist, he or she shall complete the
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 requirements for the Drug Addiction Treatment Act of 2000; and
           (B) Complete other programs and continuing education requirements as further described
 in the rules promulgated pursuant to this article;
           (3) Practice at the licensed or registered medication-assisted treatment program a
 sufficient number of hours, based upon the type of medication-assisted treatment license or
 registration issued pursuant to this article, to ensure regulatory compliance, and carry out those
 duties specifically assigned to the medical director as further described in the rules promulgated
 pursuant to this article;
           (4) Be responsible for monitoring and ensuring compliance with all requirements related to
 the licensing and operation of the medication-assisted treatment program;
           (5) Supervise, control, and direct the activities of each individual working or operating at
 the medication-assisted treatment program, including any employee, volunteer, or individual
 under contract, who provides medication-assisted treatment at the program or is associated with
 the provision of that treatment. The supervision, control, and direction shall be provided in
 accordance with rules promulgated by the secretary; and
           (6) Complete other requirements prescribed by the secretary by rule.
           (d) Each medication-assisted treatment program shall designate counseling staff, either
 employees, or those used on a referral-basis by the program, which meet the requirements of this
 article and the rules promulgated pursuant to this article. The individual members of the
 counseling staff shall have one or more of the following qualifications:
           (1) Be a licensed psychiatrist;
           (2) Certification as an alcohol and drug counselor;
           (3) Certification as an advanced alcohol and drug counselor;
           (4) Be a counselor, psychologist, marriage and family therapist, or social worker with a
 master’s level education with a specialty or specific training in treatment for substance use
 disorders, as further described in the rules promulgated pursuant to this article;
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           (5) Under the direct supervision of an advanced alcohol and drug counselor, be a
 counselor with a bachelor’s degree in social work or another relevant human services field:
 Provided, That the individual practicing with a bachelor’s degree under supervision applies for
 certification as an alcohol and drug counselor within three years of the date of employment as a
 counselor;
           (6) Be a counselor with a graduate degree actively working toward licensure or certification
 in the individual’s chosen field under supervision of a licensed or certified professional in that field
 and/or advanced alcohol and drug counselor;
           (7) Be a psych-mental health nurse practitioner or a psych-mental health clinical nurse
 specialist; or
           (8) Be a psychiatry CAQ-certified physician assistant.
           (e) The medication-assisted treatment program shall be eligible for, and not prohibited
 from, enrollment with West Virginia Medicaid and other private insurance. Prior to directly billing a
 patient for any medication-assisted treatment, a medication-assisted treatment program must
 receive either a rejection of prior authorization, rejection of a submitted claim, or a written denial
 from a patient’s insurer or West Virginia Medicaid denying coverage for such treatment: Provided,
 That the secretary may grant a variance from this requirement pursuant to §15-5Y-6 of this code.
 The program shall also document whether a patient has no insurance. At the op