New Jersey Administrative Code
Title 8 - HEALTH
Chapter 33E - CERTIFICATE OF NEED: CARDIAC DIAGNOSTIC FACILITIES AND CARDIAC SURGERY CENTERS
Subchapter 1 - CARDIAC DIAGNOSTIC FACILITIES
Section 8:33E-1.2 - Definitions
For the purposes of this subchapter, the following definitions shall apply:
"Cardiac catheterization" means the insertion of a thin, flexible tube (catheter) into a vein or artery and guiding it into the heart for purposes of determining cardiac anatomy and function.
"Cardiac surgery center" refers to a facility capable of providing invasive diagnostic catheterization, and all treatment modalities including open and closed heart surgical procedures. This includes: coronary artery bypass graft (CABG) surgery, PCI, and complex EPS studies.
"Complex Electrophysiology Study" (EPS): Refers to the more complex variety of electrophysiology study and includes:
Procedures which intend to induce ventricular or supraventricular tachycardia;
Activation sequence mapping of cardiac tachyarrhythmias;
Electrode catheter ablative procedures;
Implantation of anti-tachyarrhythmia devices and implantable cardioverter defibrillators.
These complex procedures are in contrast to non-complex electrophysiologic procedures, which primarily involve His-Purkinje conduction evaluation without arrhythmia induction.
"Coronary artery bypass graft" surgery (CABG) means a surgical procedure to treat narrowing or stenosis of the coronary arteries. The procedure is performed by a cardiothoracic surgeon who creates bypasses around the obstructions in the coronary arteries with arteries or veins from elsewhere in the body to improve blood flow to the heart (that is, revascularization of the myocardium).
"Full service adult diagnostic cardiac catheterization facility" means an acute care general hospital providing invasive cardiac diagnostic (cardiac catheterization) services to adult patients without cardiac surgery backup. These facilities have laboratories which must meet the requirement of procedures performed on at least 400 patients annually.
"Hospital-based" means the provision of a health care service that is physically located on the campus of, and is a permanent structure within, a licensed acute care hospital offering inpatient support services.
"Left-heart catheterization" refers to the measurement of left heart hemodynamics and definition of the left heart anatomy/function by catheter-delivered radiopaque contrast media.
"Low risk cardiac catheterization facility" means an acute care general hospital providing invasive cardiac diagnostic (cardiac catheterization) services within its permanent structure as defined in "hospital-based" above that is limited in the provision of its service to low risk adult patients. Patients with the following conditions listed below are to be considered high-risk and shall be excluded from catheterization at pilot facilities and transferred in accordance with 8:33E-1.8:
1. Left main coronary syndrome;
2. Unstable myocardial infarction;
3. Acute myocardial infarction within three days;
4. Unstable angina with persistent angina;
5. Congestive heart failure, defined as NYHA Class III or IV;
6. Cardiogenic shock or severe hemodynamic instability;
7. Aortic stenosis, as measured by Doppler mean gradient over 40 mm of HG;
8. Ejection fraction below 30 percent; or
9. Concomitant severe medical or vascular problems.
"Low-risk patients" shall be defined by the November 1, 1994 participation guidelines of the American College of Cardiology's Database Committee and "low-risk patients" are those patients excluded from the definition of "high-risk" who are able to be managed by the low risk facilities for diagnostic cardiac catheterization.
"Medically underserved" means segments of the population whose utilization of health care services is less than those numbers approximately proportionate to their presence in the population as adjusted to account for their need for such services. Medically underserved includes, but is not limited to, racial and ethnic minority populations, migrant workers, the handicapped, Medicaid recipients, and the medically indigent, defined as those individuals lacking third party insurance coverage whose income is less than or equal to 200 percent of the United States Department of Health and Human Services Income Poverty Guidelines, 42 U.S.C. § 9902(2).
"Normal coronary study" means a clinical finding subsequent to the performance of a cardiac catheterization procedure indicating less than 50 percent stenosis in all of the following arteries: left main, proximal left anterior descending (LAD), right coronary artery (RCA) or left circumflex (LCX). A finding of any stenosis of greater than or equal to 50 percent is considered an abnormal cardiac catheterization study. A finding of valvular disease is to be considered as an abnormal finding in a study. A case in which there is a finding of cardiomyopathy or congenital cardiac disorder shall be excluded from the normal coronary study calculation.
"Open heart surgery" refers to a therapeutic operative procedure performed on the heart and/or its coronary arteries in order to correct anomalous conditions (for example, coronary artery bypass surgery, heart valve replacement), often using a heart-lung by-pass machine to perform the functions of circulation during surgery.
"Pediatric cardiac surgery centers" are those cardiac surgery centers specifically designated to provide the full range of invasive cardiac diagnostic, therapeutic and surgical services to patients less than 16 years of age.
"Percutaneous coronary intervention (PCI)" means the passage of a balloon-tipped catheter (thin tube) to the site of narrowing in an artery and the inflation of the balloon to reduce the obstruction. For purposes of these rules, PCI also includes other invasive procedures to dilate coronary obstruction such as atherectomy of various kinds (for example, excisional, laser) and arterial stenting procedures.
"Primary angioplasty" means the mechanical reopening of an occluded vessel using a balloon-tipped catheter in patients with acute myocardial infarction (AMI) who have not received antecedent thrombolytic therapy.
"Stent procedure" means the use of a wire mesh tube (a stent) to prop open an artery that has recently been cleared using coronary angioplasty. The stent is collapsed to a small diameter, placed over an angioplasty balloon catheter and moved into the area of the blockage. Once the balloon is inflated, the stent expands, locks in place and forms a permanent scaffold to hold the artery open. Stents may be used as an alternative to--or in combination with--angioplasty.
