Opinion ID: 1653213
Heading Depth: 1
Heading Rank: 4

Heading: applicable requirements and criteria for issuance of a certificate of need

Text: The requirements and criteria concerning Manor Care's application are found in 182 Neb.Admin. Code, ch. 2, § 005 (1983): 005 REVIEW CRITERIA. The applicant bears the burden of demonstrating in its application that the proposal satisfies all of the review criteria in this section which are appropriate and significant to the proposal in order to be granted a certificate of need. 005.01 The Need for Services. 005.01A. The applicant must establish that there is an unmet need for health care services for a specific population. 005.01A1 A need exists when additional services for health care are essential to make high-quality health care available and accessible to all citizens of the state. 005.01A2 Under this part 005.01A, the population in need and the health care services which are needed must be identified, and the need of that population for the identified services must be established. The need which must be established under this part 005.01A is the need for diagnostic, treatment, rehabilitation, or maintenance services, not facilities or equipment. Facilities or equipment for providing the needed services must be identified under subsection 005.02 below. The population in need of services must be identified by the applicant both numerically and geographically in terms of Nebraska counties and the metropolitan areas, but applicant's service area will be determined with emphasis on referral patterns and travel time and without strict observance of geographical or political boundaries. For applicants which establish that they provide a substantial portion of their services or resources to individuals who reside outside the immediate or adjacent health service areas (which entities may include medical and other health professions schools, multidisciplinary clinics and specialty centers), the population in need of services shall include the proportion of individuals in special patient groups and out-of-area population groups to whom the applicant provides services. .... 005.01B The need established under part 005.01A above must be consistent with the need projections in section 006 of these regulations (182 NAC 2), and with those in the state health plan most recently adopted under section 1524(c)(2)(A) of P.L. 93-641, 42 U.S.C. 300m-3(c)[2](A), and on file with the Secretary of State, each of which is hereinafter referred to as a document. Projections in section 006 of these regulations shall take priority over those in the state health plan in the case of conflicts between those documents. Exceptions to the requirement of consistency with the projections in the document having priority shall be made when justification is shown by a preponderance of the evidence. 005.02 The Project Proposed for Meeting the Need. 005.02A Alternatives. 005.02A1 The applicant must identify all the alternatives which could satisfy the need established under part 005.01A above, and describe their relative merits. The proposed project must be discussed along with the other alternatives, and sharing among facilities must be considered as a possible alternative. 005.02A2 The applicant must demonstrate that the proposed project is the least costly of the alternatives for meeting the need established under part 005.01A above, or if it is not the least costly, that it is the most effective alternative for meeting such need. In determining which alternative is the least costly, consideration shall include (but without limitation to) the following: the total cost of the project; charges to all consumers and payers, including government reimbursement programs; the effect of the proposed means of financing on consumers and payers considered as a whole; and, in the case of construction projects (including remodeling), the design, methods, and materials of construction and the long-term energy costs for the project. The most effective alternative is the alternative which makes high-quality health care available and accessible to the greatest number of people in need of the services established as needed under part 005.01A above, maximizes the effectiveness of expenditures made for health care, minimizes unnecessary duplication of facilities and services, encourages development of appropriate alternative methods of delivering health care, and promotes wherever appropriate a more competitive health care delivery system. 005.02B Cost. 005.02B1 Any increase in costs or charges (to any class of payers or to all payers) resulting from the proposed project must be justified by the needs of the population established under part 005.01A above which will be met by the project. In estimating increases in costs or charges which will result from the proposed project, capital costs, operating costs, projected utilization of the proposed services, and any other factors bearing on future costs or charges shall be considered. 005.02B2 Increases in costs may be justified in part where improvements or innovations in the financing and delivery of health services will foster competition and promote quality assurance and cost effectiveness for consumers and payers. 005.02C Financial Feasibility. 005.02C1 The resources and proposed means of financing the proposed project must in fact be available. 005.02C2 It must be reasonably certain that the proposed project will be financially feasible for the period of life of the assets. 005.02D Continuity and Quality. 005.02D1 The proposed project must be coordinated with the existing health care system in a manner that assures continuity of care including a succession of levels of service. 005.02D2 Ancillary or support services necessary to operate and maintain the proposed services under high standards of quality must be available or arranged. 005.02D3 It must be reasonably certain that the proposed services will be provided to the population in need on a continuous basis for the period of life of the assets. 005.02D4 The proposed project must be designed to provide or support high quality care. The quality of care provided by the applicant in the past may be considered in determining whether high quality care will be provided by the proposed project. 005.02E Impact on the Health Care Delivery System. 005.02E1 The proposed project must be consistent with the utilization requirements and the projections of need for the specific services proposed, which are contained in section 006 of these regulations and in the state health plan most recently adopted under section 1524(c)(2)(A) of P.L. 93-641, 42 U.S.C. 300m-3(c)[2](A), and on file with the Secretary of State. Requirements or projections in section 006 of these regulations shall take priority over those in the state health plan in the case of conflicts between those documents. Exceptions to the requirements or projections in the document having priority shall be made when justification is shown by a preponderance of the evidence. 005.02E2 If the applicant has a long-range development plan, the applicant must demonstrate that the proposed project is part of that plan and is consistent with other parts of that plan. 005.02E3 The proposed project must provide access for and contribute to meeting the health-related needs of medically underserved groups in its service area, particularly low-income persons, racial and ethnic minorities, women, handicapped persons, and the elderly. 005.02E4 In the case of a reduction or elimination of a service, including the relocation of a facility or service, the needs of the population presently served must be adequately met by another facility or service, or by other arrangements. 005.02E5 If the proposed services are to be available in a limited number of facilities, health professional training programs in the area must have access to the services if necessary for training purposes. 005.02F Competition/Sharing. 005.02F1 Except as provided in subparts 005.02F2 and 005.02F3 below, the proposed project must increase the range of choices available to consumers and third-party payers with respect to the price and use of services, and must have the effect of fostering price competition among providers of health services. 005.02F2 In the case of leases or acquisitions of existing health care facilities, except as provided in subpart 005.02F3 below, the proposed lease or acquisition must not have the effect of reducing price competition among providers. 005.02F3 Where it is demonstrated that competition would not serve to promote quality assurance and cost effectiveness, the proposed project must optimize sharing and minimize unnecessary duplication in the health care delivery system.