New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33E - CERTIFICATE OF NEED: CARDIAC DIAGNOSTIC FACILITIES AND CARDIAC SURGERY CENTERS › Subchapter 2 - REGIONAL CARDIAC SURGERY CENTERS › Section 8:33E-2.14 - Petition for and submission of certificate of need applications

Current through Register Vol. 56, No. 14, July 15, 2024
(a) All certificate of
				need applicants seeking to initiate cardiac surgical services shall be subject to
				the requirements of this subchapter, as applicable, and the following:
1. The Department shall only process certificate
				of need applications for the initiation of cardiac surgical services in accordance
				with procedures set forth below and in N.J.A.C. 8:33. Certificate of need
				applications shall only be accepted for processing from general hospitals after a
				hospital has petitioned the Department and established the potential need for new
				cardiac surgery services by demonstrating that it meets the following minimum
				standards, which indicate a potential unmet need and that the petitioner is
				qualified to meet the unmet need:
i. The petitioner
				is an existing provider of full service invasive cardiac diagnostic services that
				has complied with all applicable requirements at N.J.A.C. 8:43G-7 and this chapter
				and has for the previous three years had at least 500 adult cardiac catheterization
				cases per year, as demonstrated by the most current data maintained by the
				Department;
ii. The petitioner is not
				located in the same county as a facility which, in the previous 12 months,
				successfully petitioned the Department for a call;
iii. The petitioner can demonstrate a potential
				volume of at least 350 cardiac surgery cases per year, based on one or more of the
				following. In demonstrating this potential volume, petitioners must provide a
				detailed explanation of the methodology used to identify potential cases based on
				minority, medically underserved and/or out-of-State residents and the Department
				shall indicate whether it accepts the number of cases identified through this
				methodology. The Department shall, on an annual basis, indicate what proportion of
				the 350 cases shall be derived from each of the specific criteria listed below:
(1) Patients receiving diagnostic cardiac
				catheterizations at the petitioner's facility who had cardiac surgery within the
				following 90 days;
(2) People residing
				in the county where the petitioner is located who had cardiac surgery in the
				previous year at a facility outside the petitioner's service area, which shall
				include the petitioner's county and contiguous counties, including at out-of-State
				facilities;
(3) Potential cases from
				minority and/or medically underserved patients in the petitioner's county or in a
				contiguous county; and/or
(4) Potential
				cases from out-of-State residents;
iv. The petitioner can demonstrate that retaining
				cardiac surgery cases that currently are referred to an existing New Jersey cardiac
				surgery center(s) is not likely to cause cardiac surgery volume at that
				facility(ies) to fall below the minimum annual volume required for maintenance of
				quality and is consistent with the findings of the Legislature as set forth at
				26:2H-6.1(h);
				and
v. The petitioner can demonstrate
				the current availability, and quantify the utilization of, its cardiology and/or
				cardiovascular disease community prevention services and clinics for all
				populations, specifically targeting minority and medically underserved population
				groups. Examples of community prevention programs are those primary and secondary
				prevention initiatives which include:
(1) Diet and
				drug therapy for hypercholesterolemia in patients at high risk or with established
				coronary artery disease;
(2) Smoking
				cessation programs with objective outcome measures;
(3) Exercise rehabilitation programs for patients
				with established coronary artery disease; and
(4) Public education programs.