Current through Register Vol. XLI, No. 50, December 13, 2024
Section 69-7-7 - Licensure, Fees and Costs7.1. Before establishing, operating, maintaining or advertising a opioid treatment program within the state of West Virginia, an opioid treatment program shall: 7.1.a. Hold current, valid certification from the Substance Abuse and Mental Health Services Administration (SAMHSA);7.1.b. Be registered and qualified by the United States Department of Health and Human Services under the Controlled Substances Act to dispense opioid drugs in the treatment of opioid addiction; and7.1.c. Be approved by the state authority for operation of an opioid treatment program in this state; and7.1.d. Have been approved for a certificate of need pursuant to W.Va. Code § 16-2D-1, et seq.; and7.1.e.Obtain from the secretary a license authorizing the operation of the opioid treatment program and facility.7.2. License Application. 7.2.a. The program sponsor of an opioid treatment program shall submit an application for an opioid treatment program license to the secretary not less than thirty days and not more than sixty days prior to the anticipated initiation of services.7.2.b. All applications for an initial or renewed license shall include the following: 7.2.b.1. The name and address of the program sponsor;7.2.b.2. The name and address of the opioid treatment program;7.2.b.3. The service location and office or offices operated by the program;7.2.b.4. Documentation of all current federal accreditations, certifications and authorizations;7.2.b.5. A description of the organizational structure of the opioid treatment program, including identification of the governing body, the advisory council and peer review committee; and7.2.b.6. The applicable filing fee.7.3. License Fees and Inspection Costs.7.3.a. All applications for an initial or renewed license shall be accompanied by a non-refundable license fee in the amount required by this rule. The annual renewal fee is based upon the average daily total census of the program. In addition to the set fee, the annual renewal fee shall be adjusted on the first day of June of each year to correspond with increases in the consumer price index. The base amounts for initial and renewal fees are as follows: 7.3.a.1. Initial license fee - $250;7.3.a.2. Renewal fee - fewer than 500 patients - $500 plus adjustment;7.3.a.3. Renewal fee - 500 to 1,000 patients - $1,000 plus adjustment;7.3.a.4. Renewal fee - more than 1,000 patients - $1,500 plus adjustment.7.3.b. An opioid treatment program shall pay for the cost of the initial inspection made by the secretary prior to issuing a license. The cost of the initial inspection is $400, and shall be billed to the applicant by the secretary within five business days after the inspection. The cost of the initial inspection must be paid in full by the applicant before a license may be issued.7.3.c. The Office of Health Facility Licensure and Certification shall use the fee for increased oversight on opioid treatment programs.7.4. Initial Inspection and Issuance of License. 7.4.a. Upon receipt of an application for an initial license to operate as an opioid treatment program, the secretary or his or her designee shall make an inspection of the opioid treatment program and facility in order to determine whether the program has satisfied all of the federal and state requirements for licensure.7.4.b. If the inspection reveals violations, deficiencies or shortcomings on the part of the opioid treatment program or facility, the secretary shall advise the program sponsor of the deficiencies. The program sponsor may submit one or more written plans of correction demonstrating compliance with the corrections required. The secretary may conduct follow-up inspections if required.7.4.c. Following an application review, onsite inspection or inspections, and approval of subsequent plans of correction as may be needed, if there is substantial compliance with the requirements of this rule and the cost of the inspection has been paid as required by §7.3.b., the secretary shall issue a license in one of three categories: 7.4.c.1. An initial license, valid for six months from the date of issuance, shall be issued to programs establishing a new service found to be in substantial compliance on initial review with regard to policy, procedure, facility and recordkeeping regulations.7.4.c.2. A provisional license shall be issued when a program seeks a renewal license and is not in substantial compliance with this rule but does not pose a significant risk to the rights, health and safety of a patient. A provisional license expires not more than six months from date of issuance, and shall be consecutively reissued only upon action of the secretary, unless the provisional recommendation is that of the state fire marshal.7.4.d. A renewal license shall be issued when an opioid treatment program is in substantial compliance with this rule and expires not more than one year from date of issuance.7.4.e. A license is valid for the opioid treatment program named in the application and is not transferable.7.5. Denial of License. 7.5.a. The secretary may deny an application for an initial or renewed license if: 7.5.a.1. The secretary determines that the application is deficient in any respect;7.5.a.2. The opioid treatment program will not be or is not operated in accordance with federal or state opioid treatment standards;7.5.a.3. The opioid treatment program will not permit an inspection or survey to proceed or will not permit in a timely manner access to relevant records or information; or7.5.a.4. The opioid treatment program has made misrepresentations in obtaining accreditation, certification or licensure.7.5.b. If the secretary determines not to issue a license, the secretary shall notify the applicant in writing of the denial and the basis for the decision.7.5.c. An opioid treatment program shall surrender an expired, revoked or otherwise invalid license to the secretary upon written demand.7.5.d. An opioid treatment program may protest the denial of a new or renewed license pursuant to the administrative procedures included in this rule.7.6. Renewed or Amended Licenses. 7.6.a. The program manager of an opioid treatment program shall submit an application for a renewed license to the secretary not less than sixty days prior to the expiration of the current license. After the secretary receives a complete renewal application with the required fee, the existing license shall not expire until the new license has been issued or denied.7.6.b. The program sponsor shall notify the secretary thirty days prior to a change in the name, geographic location or services of a program or a change in the substantial nature of the opioid treatment program and simultaneously shall apply for a license amendment.7.7. Administrative Due Process. 7.7.a. Any person aggrieved by an order or other action by the secretary based on this rule may request in writing a hearing by the secretary.7.7.b. All hearings shall be conducted in accordance with the Department of Health and Human Resources rule, "Rules of Procedure for Contested Case Hearings and Declaratory Rulings," 64 CSR 1, a copy of which may be obtained from the Secretary of State.