W. Va. Code R. § 69-8-4

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

Section 69-8-4 - Licensure

4.1. General Licensure Provisions.

4.1.1. No person, partnership, association, or corporation may operate a pain management clinic in the state of West Virginia without first obtaining a license.

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

4.1.3. Each pain management clinic location shall be licensed separately, regardless of whether the clinic is operated under the same business name or management as another clinic.

4.1.4. Each licensed clinic location shall designate a physician owner unique to that clinic. The designated physician owner shall practice at the clinic and be responsible for the operation of the clinic in accordance with the requirements of this rule.

4.1.5. A license is not transferable or assignable.

4.1.6. If the ownership of a pain management clinic changes, the new owner shall notify the secretary within 10 days and immediately apply for a new license. The new owner's application for a license has the effect of a valid license for three months from the date the application is received by the director.

4.1.7. The pain management clinic shall notify the secretary in writing 30 days prior to a change in the name or location of the clinic and submit an application form for a license amendment.

4.1.8. If there is a change in the designated physician owner, the pain management clinic must comply with the provisions of subsection 6.4.3. of this rule.

4.1.9. Initial and renewal licenses shall expire one year from issuance.

4.1.10. If the pain management clinic 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.

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

4.1.12. 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 a pain management clinic without a license.

4.1.13. If the owner or person in charge of a licensed pain management clinic or of any other unlicensed practice, office, or facility which the secretary has reasonable belief that it is being operated as a pain management clinic refuses entry pursuant to this rule, the secretary shall petition the Circuit Court of Kanawha County for an inspection warrant.

4.1.14. If the secretary finds on the basis of an inspection that any person, partnership, association, or corporation is operating as a pain management clinic without a license, the pain management clinic shall apply for a license within 10 days.

4.1.15. A pain management clinic that fails to apply for a license is subject to the penalties established by sections 17 and 18 of this rule.

4.1.16. A pain management clinic shall surrender an expired, revoked, or otherwise invalid license to the secretary upon written demand.

4.2. Initial license.

4.2.1. An applicant shall submit a completed application to the secretary, on a form prescribed by the secretary. A non-refundable fee required by section 4 of this rule shall be submitted with the application. Any person, partnership, association, corporation, or facility that qualifies as a pain management clinic under this rule, shall apply for a pain management clinic license within 90 days of the effective date of this rule.

4.2.1.a. A new clinic shall apply for an initial license within the first 30 days of operation.

4.2.1.b. An existing practice shall apply for an initial license not less than 30 days and not more than 60 days once the pain management patient census is more than 50 percent, pursuant to the definition in this rule.

4.2.2. The application shall include:

4.2.2.a. The legal name, office location, mailing address, and telephone number of the pain management clinic;

4.2.2.b. The name, address, principal occupation, and official position for each owner. At least one owner shall be a physician with an active license in West Virginia;

4.2.2.c. The name and address of all other pain management clinics owned and operated by the applicant;

4.2.2.d. A description of the organizational structure of the pain management clinic, including the owners, designated physician owner, and administrator;

4.2.2.e. If applicable, a copy of a valid Certificate of Need or a letter of exemption from the West Virginia Health Care Authority;

4.2.2.f. A list of the owners' and physicians' names, medical licenses, drug enforcement agency numbers, and any pain management specialty certifications;

4.2.2.g. A list of all business licenses issued by this state, the secretary of state, the state tax department, and all other applicable business or license entities;

4.2.2.h. Days and times of operation;

4.2.2.i. A verified statement that no owner or operator applying for the license has been the owner or operator of a licensed pain management clinic that has had its license suspended or revoked in the five years preceding the date of application;

4.2.2.j. Evidence that each anticipated owner, physician, employee, volunteer, associate, or contracted agent has received an eligibility fitness determination or variance from the West Virginia Clearance for Access: Registry and Employment Screening unit of the Department of Health and Human Resources; and

4.2.2.k. A description of services provided.

4.2.3. The secretary shall issue an initial license only after an inspection is completed at the pain management clinic which finds the clinic complies with this rule and W. Va. Code §§16-5H-1, et seq.

4.2.4. If, at the initial licensing survey, a pain management clinic has more than five violations of any minimum requirements or if any cited violation is determined to be of such a serious nature that it may cause or have the potential to cause harm, the secretary shall deny licensing.

4.2.5. If an application for license is denied, the clinic, upon correction of all citations, may reapply for an initial license by submitting a new application together with the applicable fee.

4.3. Renewal license.

4.3.1. An applicant shall submit a completed application to the secretary, on a form prescribed by the secretary, 60 days prior to the expiration date of the current license. A non-refundable fee required by section 4 of this rule shall be submitted with the application.

4.3.2. The secretary shall issue a renewal license when it is found the pain management clinic is determined to be in compliance with this rule and W. Va. Code §§16-5H-1, et seq., and the licensee submits a completed application and the correct renewal fee.

4.4. License fees and Inspection costs.

4.4.1. All applications for an initial or renewal pain management clinic license shall be accompanied by a non-refundable license fee. The annual renewal fee is based upon the total census of the clinic. 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 and renewal fees are as follows:

4.4.1.a. Initial license fee - $250;

4.4.1.b. Renewal fee - fewer than 500 patients - $250 plus adjustment;

4.4.1.c. Renewal fee - 500 to 1,000 patients - $500 plus adjustment; and

4.4.1.d. Renewal fee - more than 1,000 patients - $750 plus adjustment.

4.4.2. A pain management clinic shall pay a $400 fee plus the actual costs of the initial inspections made by the secretary prior to issuing a license. The cost shall be billed to the pain management clinic or owner(s) by the secretary after the inspections and must be paid in full before a license is issued.

4.5. Denial of License.

4.5.1. The secretary may deny an application for an initial or renewal license if:

4.5.1.a. The secretary determines that the application is deficient in any respect;

4.5.1.b. The pain management clinic will not be or is not operated in accordance with applicable federal or state standards, laws, and rules;

4.5.1.c. The pain management clinic 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;

4.5.1.d. The pain management clinic has made misrepresentations in obtaining licensure;

4.5.1.e. The pain management clinic 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 Department of Health and Human Resources and has not received a variance.

4.5.1.f. The pain management clinic fails to have a designated physician owner practicing at the clinic location; or

4.5.1.g. The pain management clinic fails to have an established process for maintaining current, accessible patient records from admission through discharge.

4.5.2. 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 clinic must follow closure procedures in section 17 of this rule, including notification of existing patients.

W. Va. Code R. § 69-8-4