Current through Register Vol. XLI, No. 45, November 8, 2024
Section 65-11-6 - New Services6.1. Any legal entity which is otherwise subject to the certificate of need program which wishes to offer one or more of the health services set forth in subsection 6.3 and which health service was not or services were not offered on a regular basis by or on behalf of such legal entity within the twelve-month period prior to the time such service or services would now be offered shall follow either the procedures set forth here or those described in the legislative rule "Certificate of Need," § 65 CSR 7 (1983). It is expressly provided that subsection 4.3 of the legislative rule "Certificate of Need," § 65 CSR 7 (1983), is hereby repealed and no longer in effect from the date of the final promulgation of this legislative rule. 6.2. If a health service is one of the health services set forth in subsection 6.3, the proposed initial offering of that service by an established legal entity is subject to review. If the legal entity is established and if it proposes to add a health service not on the following list, then such addition is not reviewable under the Act unless It is associated with a capital expenditure in excess of the expenditure minimum. In this latter event, the proposed expenditure will be subject to review as provided for by the legislative rule "Certificate of Need," § 65 CSR 7 (1933). 6.3. The list of health services subject to review pursuant to section 3(e) of the Act is as follows. This list is all inclusive and may not be added to except by formal amendment to this legislative rule. A health service on the list shall hereafter be referred to as a "listed health service." 6.3.1. Alcohol and other drug treatment and rehabilitation if offered in a discrete unit. 6.3.2. Ambulatory surgical facilities or ambulatory surgical centers. 6.3.3. Cardiac catheterization. 6.3.4. Comprehensive medical rehabilitation on an inpatient basis. 6.3.5. End-stage renal dialysis stations and home training, 6.3.6. Hyperbaric oxygen therapy. 6.3.7. Intermediate care for the mentally retarded.6.3.8. Discrete units for intermediate or skilled nursing care. 6.3.10. Magnetic resonance imaging, 6.3.11. Medical or surgical beds.6.3.12. Discrete obstetrical units. 6.3.13. Organ transplants such as heart, lungs, kidney, liver, and other organs. 6.3.14. Open heart surgery. 6.3.15. Discrete pediatric units. 6.3.16. Discrete inpatient psychiatric units. 6.3.17. Special care units for burns, intensive care, cardiac care, neonatal intensive care, neonatal intermediate care, and pediatric intensive care. 6.3.18. Surgical services.6.3.19. Radiation therapy. 6.4. If a listed health service is proposed to be added and if the proposed capital expenditure associated with that addition is either zero or less than the expenditure minimum and if the annual operating costs for each of the first three (3) twelve-month periods following the initiation of the offering of the listed health service are projected to be less than the expenditure minimum for annual operating costs, then the proposed addition is eligible for the review procedures set forth below. If either the capital expenditure exceeds the expenditure minimum or if the annual operating costs are projected to exceed the expenditure minimum for annual operating costs for any of the first three (3) twelve-month periods following the initiation of the offering of the listed health service, then the legal entity shall be subject to review under the expedited review provisions of the legislative rule "Certificate of Need," § 65 CSR 7 (1983).6.5. An eligible listed health service as provided by subsection 6.4 of this legislative rule shall be reviewed as follows. 6.5.1. The legal entity shall file an expedited exempt application with the state agency. Upon receipt of the application, the state agency shall publish a notice of the filing in the Saturday Charleston newspaper, the State Register, and the state agency's newsletter. The notice shall identify the legal entity, shall describe the proposal, and shall state the rights of affected parties to a hearing. 6.5.2. Upon the receipt of the application, the state agency shall have fifteen (15) days in which to determine whether or not the application is complete. If the application is not complete, then the state agency may request additional information. Upon receipt of that additional information, the state agency shall have fifteen (15) days within which to determine if the application is complete. 6.5.3. Upon determining that the application is complete, the state agency shall publish a notice in the Saturday Charleston newspapers, the State Register, and the state agency's newsletter. The notice shall identify the legal entity, shall describe the proposal, and, if a hearing has been requested, shall state the time, date, and place of the hearing. 6.5.4. If a hearing has been requested by an affected party, the state agency shall follow the provisions of subsections 7.1 and 7.2 of this legislative rule. At the conclusion of the hearing, the parties may submit proposed findings of fact, conclusions of law, and legal briefs within five (5) days of the close of the hearing. This period may be extended only with the consent of the applicant. The state agency shall then have ten (10) days from the receipt of those items or the closure of the record if those items are not tendered to make its determination in writing. 6.5.5. If a hearing has not been requested, then the state agency shall make a written decision within ten (10) days of the determination of completeness. 6.5.6. In order to be effective, the request for a hearing must be from an affected party and must be filed in writing with the state agency within fifteen (15) days of the publication of the notice in the Saturday Charleston newspapers as required by subsection 6.5.1. 6.5.7. A written decision made pursuant to subsections 6.5.4 or 6.5.5 shall be a final decision for purposes of West Virginia Code, § 16-2D-7(r) and § 16-2D-10. Notice of such decision shall be made by publication in the Saturday Charleston Newspapers, the State Register, and the state agency's newsletter.6.5.8. The only criteria for review that shall be applicable to the review of a listed health service under this section shall be that the proposal has no obvious inconsistency with the state health plan and that the proposal is financially feasible. Findings that the proposal is not obviously inconsistent with the state health plan and that the proposal is financially feasible shall satisfy the requirements of West Virginia Code, § 16-2D-6(e) and -9(b). No other conclusions shall be required for approval of the proposal.