W. Va. Code R. § 69-11-6

Current through Register Vol. XLI, No. 50, December 13, 2024

Section 69-11-6 - Licensure; Fees and Costs

6.1. General Licensure Provisions.

6.1.a. No person, partnership, association or corporation may operate an opioid treatment program in the State of West Virginia without first obtaining a license pursuant to W. Va. Code § 16-5Y-3 and this rule.

6.1.b. A license is valid only for the location and persons named and described in the application.

6.1.c. Each opioid treatment program location shall be licensed separately, regardless of whether the program is operated under the same business name or management as another program.

6.1.d. Before establishing, operating, maintaining or advertising an opioid treatment program within the State of West Virginia, a program shall:

6.1.d.1. Hold current, valid certification from the SAMHSA;

6.1.d.2. Be registered and qualified by the United States Department of Health and Human Services under the Controlled Substances Act, 21 U.S.C. §§ 801, et seq. (1970), as amended, to dispense medication-assisted treatment medications in the treatment of substance use disorder;

6.1.d.3. Be approved by the state opioid treatment authority for operation of an opioid treatment program in this state;

6.1.d.4. Have been approved for a certificate of need pursuant to W. Va. Code § 16-5Y-12 and §§ 16-2D-1, et seq.; and

6.1.d.5. Obtain from the Secretary a license authorizing the operation of the opioid treatment program and facility.

6.1.e. Each licensed opioid treatment program shall designate a medical director. The medical director shall practice at the program and be responsible for the operation of the program in accordance with the requirements of this rule. An opioid treatment program may have two co-medical directors.

6.1.f. A license is not transferable or assignable.

6.1.g. If the ownership of an opioid treatment program changes, the new owner shall notify the Secretary within 10 days of the change in ownership and immediately apply for a new license. The new owner's application for a license is valid for three months from the date the application is received by the director.

6.1.h. The opioid treatment program shall notify the Secretary in writing 30 days prior to a change in name or location of the program and request an application form for a license amendment.

6.1.i. If there is a change in the medical director, the opioid treatment program must comply with the provisions of subdivisions 6.1.e. and 8.4.f. of this rule.

6.1.j. If the opioid treatment program is not in substantial compliance with this rule, but does not pose a significant risk to the health, safety or rights of the patients, a license expiring in less than one year may be issued.

6.1.k. A licensure survey may be conducted periodically during the course of the annual licensing term.

6.1.l. The Secretary or his or her designee may enter the premises of any practice, office or facility if the Secretary has reasonable belief that it is being operated or maintained as an opioid treatment program without a license.

6.1.m. If the owner, medical director or other person in charge of a licensed opioid treatment program or of any other unlicensed practice, office or facility which the Secretary has reasonable belief is being operated as an opioid treatment program refuses entry pursuant to this rule, the Secretary shall petition the Circuit Court of Kanawha County or the county in which the program is located for an inspection warrant.

6.1.n. If the Secretary finds on the basis of an inspection that any person, partnership, association or corporation is operating as an opioid treatment program without a license, the opioid treatment program shall apply for a license within 10 days of receipt of notification by the Secretary.

6.1.o. An opioid treatment program that fails to apply for a license is subject to the penalties established by section 38 of this rule.

6.1.p. An opioid treatment program shall surrender an expired, revoked or otherwise invalid license to the Secretary upon written demand.

6.2. Licensure Application.

6.2.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 30 days and not more than 60 days prior to the anticipated initiation of services.

6.2.b. All applications for an initial, provisional or renewed license shall include and provide the documentation specified in W. Va. Code § 16-5Y-3 in addition to the following:

6.2.b.1. Documentation of all current federal accreditations, certifications and authorizations; and

6.2.b.2. A description of the organizational structure of the opioid treatment program, including identification of the governing body, advisory council and peer review committee.

6.3. License Fees and Inspection Costs.

6.3.a. All applicants for an initial, provisional or renewed license shall be accompanied by a non-refundable 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 amounts for initial, provisional and renewal feeds are as follows:

6.3.a.1. Initial license fee - $250;

6.3.a.2. Provisional license fee - only for existing programs as of the effective date of this rule seeking an initial license - $250;

6.3.a.3. Renewal license fee - fewer than 500 patients - $521.12;

6.3.a.4. Renewal license fee - 500 to 1,000 patients - $1,042.24; and

6.3.a.5. Renewal license fee - more than 1,000 patients - $1,563.36.

6.3.b. An opioid treatment program shall pay for the cost of the initial inspection made by the Secretary prior to issuance of a license. The cost of the initial inspection of an opioid treatment program is $400, plus the actual costs of the initial inspections and shall be billed by the Secretary.

6.4. Initial Inspection and Issuance of License.

6.4.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 program and facility in order to determine whether the program has satisfied all of the federal and state requirements for licensure.

6.4.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 of the deficiencies. The program may submit one or more written plans of correction demonstrating compliance with the corrections required. The Secretary may conduct follow-up inspections if required.

6.4.c. Following an application review, onsite inspection or inspections and approval of subsequent plans of correction by the Department of Health and Human Resources 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 subdivision 6.3.b., the Secretary will issue a license in one of three categories:

6.4.c.1. An initial license, valid for 12 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;

6.4.c.2. A provisional license shall be issued when an opioid treatment program seeks a renewal, or is an existing program as of the effective date of this rule and is seeking an initial license, and the opioid treatment program is not in substantial compliance with this rule, 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

6.4.c.3. A renewal license shall be issued when an opioid treatment program is in substantial compliance with this rule. A renewal license shall expire not more than 12 months from the date of issuance.

6.4.d. A license is valid for the opioid treatment program named in the application and is not transferable or assignable.

6.5. Denial of License.

6.5.a. The Secretary may deny an application for an initial, provisional or renewal license if:

6.5.a.1. The Secretary determines that the application is deficient in any respect;

6.5.a.2. The opioid treatment program will not be or is not being operated in accordance with federal or state standards, or federal or state standards, laws and rules;

6.5.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 records or information deemed relevant by the Secretary;

6.5.a.4. The opioid treatment program has made misrepresentations in obtaining accreditation, certification or licensure;

6.5.a.5. The opioid treatment program has an owner, employee or associate who has received an ineligible employment fitness determination from the West Virginia Clearance for Access: Registry and Employment Screening unit of the West Virginia Department of Health and Human Resources and has not received a variance;

6.5.a.6. The opioid treatment program fails to have a medical director practicing at the program location; or

6.5.a.7. The opioid treatment programs fails to have an established process for maintaining current, accessible patient records from admission through discharge.

6.5.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. Following the denial, the program must follow closure procedures in subdivision 37.2.c. of this rule, including notification to existing patients.

6.5.c. An opioid treatment program shall surrender an expired, revoked or otherwise invalid license to the Secretary upon written demand.

6.5.d. An opioid treatment program may protest the denial of an initial, provisional or renewal license pursuant to the administrative procedures in section 39 of this rule.

6.6. Renewed or Amended Licenses.

6.6.a. The opioid treatment program shall submit an application for a license to the Secretary not less than 60 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.

6.6.b. The program shall notify the Secretary 30 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.

W. Va. Code R. § 69-11-6