N.J. Admin. Code § 8:33E-2.15

Current through Register Vol. 56, No. 11, June 3, 2024

Section 8:33E-2.15 - Competitive review criteria

(a) The Department's goal in considering applications for additional cardiac surgery programs is to improve access to all cardiac services, especially for medically underserved and minority populations, while at the same time ensuring the quality of services at cardiac surgery centers. The Department also seeks to foster collaboration among existing healthcare providers offering preventive, primary, diagnostic and therapeutic cardiac services when considering applications for additional invasive therapeutic cardiac services programs.

(b) During certificate of need review, consideration for approval shall be limited to the applicant(s) that meets the following requirements and does so to a greater extent than the competing applicants, has documented compliance with the following competitive review criteria and has documented compliance with all other applicable criteria in this subchapter and 26:2H-8. Unless otherwise specified in the certificate of need call issued by the Commissioner, a maximum of one new cardiac surgery program shall be considered for approval in any certificate of need call under these competitive review criteria.

1. The applicant is able to provide quantifiable documentation of its historic commitment to access to cardiac services, including preventive and primary cardiac services as well as invasive cardiac diagnostic services, for minority and medically underserved populations;

i. The applicant shall provide documentation, which shows the proportion of minority and medically underserved residents residing in the proposed service area, which shall be no larger than the county in which the applicant is located as well as contiguous counties;

ii. The applicant is able to provide a plan that is designed to ensure that appropriate access to the preventive, primary, diagnostic, and therapeutic cardiac interventions by minority and medically underserved populations, and other population groups that have historically been underrepresented in the provision of cardiac surgical services (for example, Medicaid recipients, indigent/self-pay patients), shall be achieved. The plan is subject to review and approval by the Department. The Department's approval shall be based on the hospital's demonstration that, to the maximum extent possible, it will provide cardiac therapeutic interventions to minority and medically underserved populations in comparable proportion to the general population in the hospital's proposed service area. This plan may serve as a basis for conditions placed on certificate of need approval;

2. The applicant is able to document that it has collaborated over at least the previous two years with either existing in-State cardiac surgery centers located within the applicant's county, unless the applicant demonstrates compelling reasons consistent with good patient care to be collaborating with a cardiac surgery center(s) in a contiguous county, or where there is no existing cardiac surgery center located within the county, then with one of the two closest cardiac surgery centers. Except in cases where the applicant can demonstrate that the closest in-State cardiac surgery center is geographically remote from applicant and would present an access problem for patients, such collaboration shall minimally include documentation that the applicant's transfer agreements with existing in-State cardiac surgery centers are in use. Applicants able to document participation in a comprehensive system of collaboration with an existing in-State cardiac surgery center, including such elements as joint credentialing of physicians, planning, training, transportation arrangements, development of care paths, and case review, technological linkages, etc., resulting in an integrated continuum of cardiac care for patients, are preferred;

3. The applicant is able to provide quantifiable documentation that, despite its collaborative efforts, there exist geographic access problems for invasive therapeutic cardiac services that include, but are not limited to, factors such as distance, in terms of mileage or average travel time, to alternate cardiac surgery centers within its county or contiguous counties. Documentation of minority and/or elderly residents in the applicant's proposed service area shall be considered in evaluating the applicant's documentation of geographic access problems;

4. The applicant is able to provide the Department with independently audited data on major complication rates, including mortality, myocardial infarctions, sustained ventricular arrhythmia, neurological complications and major vascular complications, which together comprise no more than two percent of all diagnostic cardiac catheterizations performed in the applicant's facility during the most recent three years;

5. The applicant is able to provide quantifiable documentation that the initiation of its new service shall not have an adverse impact on the quality of care or the efficient delivery of health care services in the region or Statewide in accordance with 26:2H-8;

6. The applicant is able to provide quantifiable documentation of its ability to capture cases that are currently being performed at out-of-State cardiac surgery centers;

7. The applicant can demonstrate that there is availability of sufficient manpower in the several professional disciplines (for example, physicians, nurses, physician assistants, and perfusion therapists) that will be used to staff the new or additional cardiac surgical services; and

8. The applicant may document the impact of technological and/or medical advances on the future need for cardiac surgery services in the applicant's county and contiguous counties.

N.J. Admin. Code § 8:33E-2.15

New Rule, R.1998 d.280, effective 6/1/1998.
See: 30 N.J.R. 1008(a), 30 N.J.R. 1996(a).
Recodified from N.J.A.C. 8:33E-2.16 and amended by R.2001 d.210, effective 6/18/2001.
See: 33 N.J.R. 616(b), 33 N.J.R. 2105(a).
Former N.J.A.C. 8:33E-2.15, Submission of Certificate of Need applications, recodified to N.J.A.C. 8:33E-2.14.
Repeal and new rule, R.2001 d.482, effective 12/17/2001.
See: 33 N.J.R. 3256(a), 33 N.J.R. 4342(a).
Section was "Competitive review criteria".
Amended by R.2004 d.37, effective 1/20/2004.
See: 35 N.J.R. 3773(a), 36 N.J.R. 416(a).