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

Current through Register Vol. 56, No. 14, July 15, 2024
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.