(a) No person, partnership, association, or corporation may operate an office-based, medication-assisted treatment program without first obtaining a registration from the director in accordance with the provisions of this article and the rules lawfully promulgated pursuant to this article.
(b) Any person, partnership, association, or corporation desiring a registration to operate an office-based, medication-assisted 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 director shall prescribe and furnish accompanied by an application fee.
(c) The Director of the Office of Health Facility Licensure and Certification or his or her designee shall inspect and review all documentation submitted with the application. The director shall approve or deny the application for registration. The director shall issue a registration if the facility is in compliance with the provisions of this article and with the rules lawfully promulgated pursuant to this article.
(d) A registration shall be issued in one of three categories:
(1) An initial 12-month registration shall be issued to an office-based, medication-assisted 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 registration shall be issued when an office-based, medication-assisted treatment program seeks a renewal registration, or is an existing program as of the effective date of this article and is seeking an initial registration, and the office-based, medication-assisted 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 registration shall be issued when an office-based, medication-assisted treatment program is in substantial compliance with this article and with all rules promulgated pursuant to this article. A renewal registration shall expire not more than one year from the date of issuance.
(e) At least 60 days prior to the registration expiration date, an application for renewal shall be submitted by the office-based, medication-assisted treatment program to the director on forms furnished by the director. A registration shall be renewed if the director determines that the applicant is in compliance with this article and with all rules promulgated pursuant to this article. A registration issued to one program location pursuant to this article is not transferrable or assignable. Any change of ownership of a registered office-based, medication-assisted treatment program requires submission of a new application. The office-based, medication-assisted treatment program shall notify the director of any change in ownership within 10 days of the change and must submit a new application within the time frame prescribed by the director.
(f) Any person, partnership, association, or corporation seeking to obtain or renew a registration for an office-based, medication-assisted treatment program in this state must submit to the director 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 listing of all current certifications;
(12) For each physician, counselor, or social worker 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 worked at program per week;
(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 registration 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; and
(17) Board of Pharmacy Controlled Substance Prescriber Report for each prescriber practicing at the program for the three months preceding the date of application.
(g) Upon satisfaction that an applicant has met all of the requirements of this article, the director shall issue a registration to operate an office-based, medication-assisted treatment program. An entity that obtains this registration 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 office-based, medication-assisted treatment program shall display the current registration in a prominent location where services are provided and in clear view of all patients.
(i) The director or his or her designee shall perform complaint and verification inspections on all office-based, medication-assisted treatment programs that are subject to this article and all rules adopted pursuant to this article to ensure continued compliance.
(j) Any person, partnership, association, or corporation operating an office-based, medication-assisted treatment program shall be permitted to continue operation until the effective date of the new rules promulgated pursuant to this article. At that time a person, partnership, association, or corporation shall file for registration within six months pursuant to the licensing procedures and requirements of this section and the new rules promulgated hereunder. The existing procedures of the person, partnership, association, or corporation shall remain effective until receipt of the registration.
(k) A person, partnership, association, or corporation providing office-based, medication-assisted treatment to no more than 30 patients of their practice or program is exempt from the registration requirement contained in §16-5Y-4(a) of this code:Provided, That it:
(1) Attests to the Office of Health Facility Licensure and Certification on a form prescribed by the director that the person, partnership, association, or corporation requires counselling and drug screens, has implemented diversion control measures, has completed medical education training on addiction treatment encompassing all forms of medication-assisted treatment, will provide patient numbers upon request, and will provide any other information required by the director related to patient health and safety; and
(2) Is prohibited from establishing an office-based, medication-assisted treatment at any other location or facility after the submission of an attestation submitted pursuant to §16-5Y-4(k)(2) of this code. This subdivision includes any person, partnership, association, or corporation that has an ownership interest in a partnership, association, or corporation or other corporate entity providing office-based, medication-assisted treatment.
(l) A licensed behavioral health center, pursuant to Behavioral Health Center Licensure, 64 CSR 11, providing office-based medication-assisted treatment is exempt from the registration requirement contained in §16-5Y-4(a) of this code:Provided, That it:
(1) Attests to the Office of Health Facility Licensure and Certification on a form prescribed by the director that the person, partnership, association, or corporation requires counseling and drugs screens, has implemented diversion control measures, will provide patient numbers upon request, and will provide any other information required by the director related to patient health and safety; and
(2) Must notify the Office of Health Facility Licensure and Certification prior to establishing or terminating an office-based medication-assisted treatment program at any other licensed behavioral health center location after the submission of an attestation submitted pursuant to §16-5Y-4(l)(1) of this code.