On appeal from the Final Decision of the Commissioner, New Jersey Department of Health and Senior Services.
The opinion of the court was delivered by: Parrillo, J.A.D.
NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION
Before Judges Parrillo, Lihotz and Messano.
At issue is a regulatory agency's classification of a certain medical procedure, transmyocardial revascularization (TMR), when performed by its licensees in conjunction with coronary artery bypass graft (CABG) surgery. On March 6, 2008, the Commissioner of the Department of Health and Senior Services (DHSS) announced a change in the manner of reporting to the public risk-adjusted mortality data on open heart surgery, having determined to treat cases involving CABG plus TMR as stand-alone or "Isolated CABG" in its cardiac report cards dating from 2005 forward. Maintaining that this inclusion would inflate its mortality statistics, Deborah Heart and Lung Center (Deborah), a licensed cardiac surgery center, challenges the unilateral agency decision, made without benefit of formal rulemaking, as violative of both the Health Care Facilities Planning Act (HCFPA), N.J.S.A. 26:2H-1 to -26, and the Administrative Procedure Act (APA), N.J.S.A. 52:14B-1 to -15, and consequently, of its right to administrative due process. For the following reasons, we disagree.
The essential facts are not in dispute. Deborah is a notfor-profit tertiary care hospital. Located in Browns Mills, Deborah serves a disproportionately high number of uninsured and charity care patients and, therefore, must rely on its volume of services and the revenues generated by them to carry out its charity. Deborah, one of eighteen licensed cardiac surgery centers in New Jersey, specializes in state-of-the-art cardiac services, including CABG surgeries, performed both as stand-alone procedures and in conjunction with other surgical interventions. The CABG surgical procedure treats narrowing or stenosis of the coronary arteries. A cardiothoracic surgeon performs the procedure by creating 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).
Depending on the patient's underlying condition, CABG surgery may be accompanied by any one or more of a number of other cardiac or non-cardiac procedures. Certain of these other procedures, when performed with a CABG surgery, may be associated with a significant risk to the patient, while others are considered low-risk. One such "other procedure" is TMR, which involves creation of multiple channels in the left ventricular myocardium with a laser fiber.
Since 1977, as part of its cardiac licensing regulations, N.J.A.C. 8:33E-2.10, the DHSS has published an annual report on CABG surgery at the State's eighteen cardiac surgery centers.*fn1
These publications, known as cardiac report cards, are intended to provide hospitals and surgeons with data in assessing the quality of cardiac procedures, and physicians and their patients with information in deciding where to have these procedures performed. The report cards, in turn, are based on statistical data on the results of CABG surgeries, which the cardiac surgery centers, by regulation, have been providing the DHSS since 1994. From the collected data, the DHSS forms a database used to calculate hospital, surgeon, and statewide Observed/Expected (O/E) mortality rates, which, in turn, form the basis for the published report cards.
To report this information, the facilities use open heart surgery data collection forms, which require disclosure of cardiac surgeries performed in conjunction with one or more other procedures. Cases in which the "other procedure," when performed with a CABG surgery, is associated with a significant risk to the patient, are excluded from the DHSS' report card's data analysis. Correspondingly, if the "other procedure" is determined to be low risk when performed with the CABG surgery, the patient is considered to have had CABG only, or "Isolated CABG" surgery, and therefore this data would be included in the agency's analysis. The forms have gone through several modifications over the years as a result of developments in technologies or best practices adopted by the Society of Thoracic Surgeons. The current version of the form is dated January 1, 2005.
To assist cardiac surgery centers in completing the data forms, the DHSS publishes an open heart surgery (OHS) data collection system instruction manual. The manual's instructions and data specifications are aligned with the guidelines of the Society of Thoracic Surgeons. The guidelines require cardiac surgery centers to provide complete data for each patient undergoing cardiac surgery. These facilities are also permitted to submit mortality cases to be considered for exclusion from data reporting where there are extenuating circumstances such as resuscitation of the patient en-route to the operation room; an angioplasty or cardiac catheterization crash; or a patient's refusal of blood products. Since its first publication in 1998, the instruction manual has been modified three times: on January 1, 2000, January 1, 2005, and January 1, 2007.
All three previously published manuals instructed that where a TMR procedure was performed during a CABG surgery, the cardiac surgery centers were to report the surgery as "CABG Other," and, therefore would not be included in the DHSS' data analysis. Despite these instructions, however, there has been an inconsistency over the years in the manner in which the cardiac surgery centers were reporting CABG surgery with TMR. Some were reporting CABG surgeries that included TMR as "CABG Other" surgeries, while others reported these surgeries simply as "Isolated CABG" surgeries.
DHSS staff first noticed the inconsistent reporting while preparing to issue its first cardiac report card following the 2005 revision of the data collection form. Because the inconsistency in reportage impacted the integrity of the its cardiac surgery mortality data, the DHSS consulted with its Clinical Review Panel,*fn2 who unanimously recommended that TMR be considered a "low risk" procedure and that CABG surgery plus low risk additional procedures be designated as "Isolated CABG" and be kept in the analysis, while CABG surgeries with high risk additional procedures be designated as "CABG Other," and be excluded from the analysis. The Panel ...