West Virginia Code 16-5Y-3 – Opioid treatment programs to obtain license; application; fees and inspections
(b) Any person, partnership, association or corporation desiring a license to operate an opioid treatment program in this state shall file with the Office of Health Facility Licensure and Certification an application in such form and with such information as the secretary shall prescribe and furnish accompanied by an application fee.
Terms Used In West Virginia Code 16-5Y-3
- Addiction: means a primary, chronic disease of brain reward, motivation, memory, and related circuitry. See West Virginia Code 16-5Y-2
- board: means a board of health serving one or more counties or one or more municipalities or a combination thereof. See West Virginia Code 16-1-2
- Corporation: A legal entity owned by the holders of shares of stock that have been issued, and that can own, receive, and transfer property, and carry on business in its own name.
- Department: means the West Virginia Department of Health and Human Resources: Provided, That beginning January 1, 2024, as used in this chapter, "department" and "Department of Health and Human Resources" means the Department of Health. See West Virginia Code 16-1-2
- Director: means the Director of the Office of Health Facility Licensure and Certification. See West Virginia Code 16-5Y-2
- 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. See West Virginia Code 16-5Y-2
- 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. See West Virginia Code 16-5Y-2
- 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. See West Virginia Code 16-5Y-2
- 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 . See West Virginia Code 16-5Y-2
- 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. See West Virginia Code 16-5Y-2
- Partnership: A voluntary contract between two or more persons to pool some or all of their assets into a business, with the agreement that there will be a proportional sharing of profits and losses.
- 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. See West Virginia Code 16-5Y-2
- Secretary: means the Secretary of the West Virginia Department of Health and Human Resources or his or her designee. See West Virginia Code 16-5Y-2
- State: when applied to a part of the United States and not restricted by the context, includes the District of Columbia and the several territories, and the words "United States" also include the said district and territories. See West Virginia Code 2-2-10
- Substance: means the following:
(1) Alcohol. See West Virginia Code 16-5Y-2
(c) The Director of the Office of Health Facility Licensure and Certification or his or her designee shall inspect each facility and review all documentation submitted with the application. The director shall then provide a recommendation to the secretary whether to approve or deny the application for a license. The secretary shall issue a license if the facility is in compliance with the provisions of this article and with the rules lawfully promulgated pursuant to this article.
(d) A license shall be issued in one of three categories:
(1) An initial twelve month license shall be issued to an opioid treatment program establishing a new program or service for which there is insufficient consumer participation to demonstrate substantial compliance with this article and with all rules promulgated pursuant to this article;
(2) A provisional license shall be issued when an opioid treatment program seeks a renewal license, or is an existing program as of the effective date of this article and is seeking an initial license, and the opioid treatment program is not in substantial compliance with this article and with all rules promulgated pursuant to this article, but does not pose a significant risk to the rights, health and safety of a consumer. It shall expire not more than six months from the date of issuance, and may not be consecutively reissued; or
(3) A renewal license shall be issued when an opioid treatment program is in substantial compliance with this article and with all rules promulgated pursuant to this article. A renewal license shall expire not more than one year from the date of issuance.
(e) At least sixty days prior to the license expiration date, an application for renewal shall be submitted by the opioid treatment program to the secretary on forms furnished by the secretary. A license shall be renewed if the secretary determines that the applicant is in compliance with this article and with all rules promulgated pursuant to this article. A license issued to one program location pursuant to this article is not transferrable or assignable. Any change of ownership of a licensed medication-assisted treatment program requires submission of a new application. The medication-assisted treatment program shall notify the secretary of any change in ownership within ten days of the change and must submit a new application within the time frame prescribed by the secretary.
(f) Any person, partnership, association or corporation that seeks to obtain or renew a license for an opioid treatment program in this state must submit to the secretary the following documentation:
(1) Full operating name of the program as advertised;
(2) Legal name of the program as registered with the West Virginia Secretary of State;
(3) Physical address of the program;
(4) Preferred mailing address for the program;
(5) Email address to be used as the primary contact for the program;
(6) Federal Employer Identification Number assigned to the program;
(7) All business licenses issued to the program by this state, the state Tax Department, the Secretary of State and all other applicable business entities;
(8) Brief description of all services provided by the program;
(9) Hours of operation;
(10) Legal Registered Owner Name – name of the person registered as the legal owner of the program. If more than one legal owner (i.e., partnership, corporation, etc.) list each legal owner separately, indicating the percentage of ownership;
(11) Medical director’s full name, medical license number, Drug Enforcement Administration registration number, and a list of all current certifications;
(12) For each employee of the program, provide the following:
(A) Employee’s role and occupation within the program;
(B) Full legal name;
(C) Medical license, if applicable;
(D) Drug Enforcement Administration registration number, if applicable;
(E) Drug Enforcement Administration identification number to prescribe buprenorphine for addiction, if applicable; and
(F) Number of hours per week worked at program;
(13) Name and location address of all programs owned or operated by the applicant;
(14) Notarized signature of applicant;
(15) Check or money order for licensing fee and inspection fee;
(16) Verification of education and training for all physicians, counselors and social workers practicing at or used by referral by the program such as fellowships, additional education, accreditations, board certifications and other certifications;
(17) Board of Pharmacy Controlled Substance Prescriber Report for each prescriber practicing at the program for the three months preceding the date of application; and
(18) If applicable, a copy of a valid Certificate of Need or a letter of exemption from the West Virginia Health Care Authority.
(g) Upon satisfaction that an applicant has met all of the requirements of this article, the secretary shall issue a license to operate an opioid treatment program. An entity that obtains this license may possess, have custody or control of, and dispense drugs indicated and approved by the United States Food and Drug Administration for the treatment of substance use disorders.
(h) The opioid treatment program shall display the current license in a prominent location where services are provided and in clear view of all patients.
(i) The secretary or his or her designee shall inspect on a periodic basis all opioid treatment programs that are subject to this article and all rules adopted pursuant to this article to ensure continued compliance.
(j) Any license in effect at the time of the passage of this section in the 2016 regular session of the Legislature shall remain in effect until such time as new legislative rules promulgated pursuant to this article become effective. Upon the effective date of the new rules any licensee shall file for a new license within six months pursuant to the licensing procedures and requirements of this section and the new rules promulgated hereunder. The existing license shall remain effective until receipt of the new license.