W. Va. Code R. § 69-12-6

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

Section 69-12-6 - Registration for OBMAT programs; Fees and Costs

6.1. General Registration Provisions.

6.1.1. No person, partnership, association, or corporation may operate an OBMAT program in the state of West Virginia without first obtaining a registration pursuant to W. Va. Code §16-5Y-4 and this rule.

6.1.2. A registration is valid only for the location and persons named and described in the application.

6.1.3. Each OBMAT program location shall be registered separately, regardless of whether the program is operated under the same business name or management as another program.

6.1.4. Before operating an OBMAT program within the state of West Virginia, a program shall:

6.1.4.a. 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, if the OBMAT program dispenses MAT medications; and

6.1.4.b. Obtain from the Secretary a registration authorizing the operation of the OBMAT program and facility.

6.1.5. Each registered OBMAT program shall designate a medical director. The medical director shall be responsible for the operation of the program in accordance with the requirements of this rule. Nothing within this rule prevents an OBMAT program from designating two co-medical directors.

6.1.6. If the ownership of an OBMAT program changes, the new owner shall notify the Secretary within 10 days and immediately apply for a new registration. The new owner's application for a registration is valid for three months from the date the application is received by the director.

6.1.7. The OBMAT program shall notify the Secretary within 30 days prior to a change in name or physical address of the program and request an application form for a registration amendment.

6.1.8. If there is a change in the medical director, the OBMAT program must comply with provisions 6.1.5. and 7.3.4. of this rule.

6.1.9. If the OBMAT 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 registration expiring in less than one year may be issued.

6.1.10. 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 OBMAT program without a registration.

6.1.11. If the owner, medical director, or other person in charge of a registered OBMAT program or of any other unregistered practice, office, or facility which the Secretary has reasonable belief is being operated as an OBMAT 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.

6.1.12. If the Secretary finds on the basis of an inspection that any person, partnership, association, or corporation is operating as an OBMAT program without a registration, the OBMAT program shall apply for a registration within 10 days.

6.1.13. An OBMAT program that fails to apply for a registration is subject to the penalties established in this rule.

6.1.14. An OBMAT program shall surrender an expired, revoked, or otherwise invalid registration to the Secretary upon written demand.

6.2. Registration Application.

6.2.1. An OBMAT program shall submit an application for registration to the Secretary not less than 30 days and not more than 60 days prior to the anticipated initiation of services.

6.2.2. All applications for an initial, provisional, or renewal registration shall include and provide the documentation specified in W. Va. Code §16-5Y-4 in addition to the following:

6.2.2.a. Documentation of all current federal accreditations, certifications and authorizations; and

6.2.2.b. A description of the organizational structure of the OBMAT program.

6.3. Registration Fees and Inspection Costs.

6.3.1. All applicants for an initial, provisional, or renewal registration shall be accompanied by a non-refundable fee in the amount required by this rule. 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 Office of Health Facility Licensure and Certification shall post the annual consumer price index increases on its website located at: http://ohflac.wvdhhr.org/. The base amounts for initial, provisional, and renewal fees are as follows:

6.3.1.a. Initial registration fee - $250;

6.3.1.b. Provisional registration fee - only for existing programs as of the effective date of this rule seeking an initial registration of $250; and

6.3.1.c. Renewal registration fee:

6.3.1.c.1. 1-50 patients - $250 plus adjustment;

6.3.1.c.2. 51-100 patients - $300 plus adjustment;

6.3.1.c.3. 101-200 patients - $400 plus adjustment; or

6.3.1.c.4. 201 or more patients - $500 plus adjustment.

6.3.2. An OBMAT program shall pay for the cost of the initial inspection prior to issuance of a registration. The fee for the initial inspection of an OBMAT program is $250 plus the actual cost of the inspection and shall be billed to the applicant.

6.4. Initial Inspection and Issuance of Registration.

6.4.1. Upon receipt of an application for an initial registration to operate as an OBMAT program, the Secretary 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 registration.

6.4.2. If the inspection reveals violations, deficiencies, or shortcomings on the part of the OBMAT program, 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.

6.4.3. 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 this rule, the Secretary shall issue a registration in one of three categories:

6.4.3.a. An initial registration, 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;

6.4.3.b. A provisional registration shall be issued when an OBMAT program seeks a renewal or is an existing program as of the effective date of this rule and is seeking an initial registration, and the OBMAT 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

6.4.3.c. A renewal registration shall be issued when an OBMAT program is in substantial compliance with this rule. A renewal registration shall expire not more than 12 months from the date of issuance.

6.4.4. A registration is valid for the OBMAT program named in the application and is not transferrable or assignable.

6.5. Denial of Registration.

6.5.1. The Secretary may deny an application for an initial, provisional, or renewal registration if:

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

6.5.1.b. The OBMAT program will not be or is not being operated in accordance with federal or state treatment standards, or federal or state standards, laws, and rules;

6.5.1.c. The OBMAT program will not permit an inspection or survey to proceed or will not permit timely access to records or information deemed relevant by the Secretary;

6.5.1.d. The OBMAT program has made misrepresentations in obtaining accreditation, certification, licensure, or registration;

6.5.1.e. The OBMAT program fails to designate a medical director at the program; or

6.5.1.f. The OBMAT program fails to have an established process for maintaining current, accessible patient records from admission through discharge.

6.5.2. If the Secretary determines not to issue a registration, 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 this rule, including notification to existing patients.

6.5.3. An OBMAT program shall surrender an expired, revoked, or otherwise invalid registration to the Secretary upon written demand.

6.5.4. An OBMAT program may protest the denial of an initial, provisional, or renewal registration pursuant to the administrative procedures in this rule.

6.6. Renewal or Amended Registrations.

6.6.1. The OBMAT program shall submit an application for a renewal registration to the Secretary not less than 60 days prior to the expiration of the current registration. After the Secretary receives a complete renewal application with the required fee, the existing registration shall not expire until the new registration has been issued or denied.

6.6.2. 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 OBMAT program and simultaneously shall apply for an amended registration.

W. Va. Code R. § 69-12-6