Title: Section 670.6 - End stage renal dialysis service

670.6 End stage renal dialysis service. (a) This methodology will be utilized in the evaluation of certificate of need applications involving the construction or establishment of new or replacement dialysis stations used in the treatment of End Stage Renal Disease. It is the intent of the Public Health Council that this methodology, when used in conjunction with the planning standards and criteria set forth in section 670.1 of this Part, become a statement of basic principles and planning/decision making tools for guiding and directing the development of dialysis stations for End Stage Renal Disease services throughout the state. Additionally, it is intended that the methodology will provide the health systems agencies and potential applicants with sufficient flexibility to consider the unique characteristics of their respective areas in determining need. The goals and objectives of the methodology expressed herein are expected to ensure that an adequate supply of dialysis stations are available to provide access to care to all those in need of in-facility dialysis.

(b) The factors to be considered in determining the public need for dialysis stations shall include, but not be limited to, the following:

(1) evidence that the proposed dialysis services capacity proposed will be utilized sufficiently to be financially feasible as demonstrated by a five year analysis of projected costs and revenues associated with the program;

(2) evidence that the proposed service or additional capacity will enhance access to services by patients including members of medically underserved groups which have traditionally experienced difficulties in obtaining equal access to health services (for example, low-income persons, racial and ethnic minorities, women and handicapped persons), and/or appropriate rural populations;

(3) evidence that the facilities hours of operation and admission policies will promote the availability of services which are acceptable to those in need of such services, in particular, operational hours that permit individuals in dialysis to continue employment;

(4) the facility's willingness and ability safely to serve dialysis patients; and

(5) evidence, derived from analysis of factors including, but not necessarily limited to, patient referral and use patterns of existing dialysis facilities and services and projected referral and use patterns of both the proposed facility, and of existing facilities or services within the applicant's planning area which would result from approval of the proposed facility, indicating that approval of the proposed facility will not jeopardize the quality of services provided at or the financial viability of such existing facilities or services. However, a finding that the proposed facility will jeopardize the financial viability of one or more existing facilities will not of itself require a recommendation of disapproval of the proposed application.

(c) Public need for a proposed facility or station shall be deemed to exist when review and consideration of evidence concerning each of the five factors set forth in subdivision (b) of this section results in an affirmative finding.