NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION
Argued June 3, 2013
On appeal from the Division of Medical Assistance and Health Services, Department of Human Services.
David E. Dopf argued the cause for appellant (Reed Smith LLP, attorneys; Murray J. Klein and Mr. Dopf, of counsel and on the brief).
Michael J. Kennedy, Deputy Attorney General, argued the cause for respondent (Jeffrey S. Chiesa, Attorney General, attorney; Melissa Raksa, Assistant Attorney General, of counsel; Mr. Kennedy, on the brief).
Before Judges Sabatino, Fasciale and Maven.
Warren Hospital ("Warren") appeals a June 30, 2011 final agency decision of the New Jersey Department of Health and Senior Services ("the Department") imposing sanctions against the hospital under N.J.A.C. 8:43G-2.4(c) for conducting emergency primary angioplasty services on two patients respectively in 2006 and 2007 without having a license to perform those procedures. Warren contends that the sanctions are preempted by a federal statute, 42 U.S.C.A. § 1395dd. Warren construes the federal statute to authorize the emergency procedures, despite state-imposed restrictions, in a situation where a patient faces imminent death, the hospital cannot stabilize the patient, and the medical risks of attempting to transfer the patient to a qualified facility outweigh the potential benefits. Warren also contends that the Department's action conflicts with the professional duties of its staff physicians in their practice of medicine, who saved the lives of the two patients in question.
For the reasons that follow, we remand this matter to the Department to develop the factual record more extensively. Based upon that amplified record, the Department should reevaluate whether the transfer risks involved here were substantially self-created by the hospital's own action and inactions and, if so, whether such self-created risks negate Warren's asserted justifications for performing the angioplasties. Regardless of the outcome of the remand, we also make clear that the Department is not foreclosed from filing a new administrative action seeking prospective measures against Warren for lacking sufficient patient transfer capability, in violation of N.J.A.C. 8:33E-1.8(a), a separate regulation that was not charged in this case.
Warren is a 129-bed acute-care hospital located in Phillipsburg. Among other things, the hospital is licensed to perform low-risk cardiac catheterization, a procedure used to diagnose heart conditions. Patients at Warren who require cardiac surgery and primary angioplasty are usually transferred to Easton Hospital in Pennsylvania, which is a five-mile drive from Warren. Easton is licensed and equipped for such procedures. Although the record is not entirely clear, it appears that no New Jersey hospital in Warren County or other in-state hospital near Warren is licensed to perform primary angioplasties.
On January 19, 2006, Patient A was brought to Warren's emergency room by a friend. He was complaining of chest pain and shortness of breath. Patient A's condition rapidly deteriorated, and his blood pressure fell to 50 systolic. Emergency doses of medications to increase Patient A's blood pressure were not effective. A cardiac monitor revealed an uncontrolled atrial fibrillation of 128 beats per minute, and Patient A was also experiencing acute myocardial infarction ("AMI") and "extraordinarily low" blood pressure. Dr. Amin, who is a cardiologist at Warren and the Director of its catheterization laboratory, was contacted, and he examined Patient A.
Dr. Amin initially perceived that insertion of an intra-aortic balloon pump to augment the pumping power of Patient A's heart could stabilize Patient A enough to allow for emergency transportation to Easton. Dr. Amin consequently took Patient A to Warren's catheterization laboratory and inserted the pump. Unfortunately Patient A's systolic blood pressure remained in the 50-60 range, meaning to Dr. Amin that Patient A had not been stabilized and was too unstable for transportation. Dr. Amin consulted with other doctors in Warren's emergency room, including the Director of Warren's Emergency Department, Dr. Daria Starosta. The doctors concluded that if transportation of Patient A were attempted, Patient A "would almost certainly die en route to that facility."
Dr. Amin then undertook further investigation of Patient A's condition by inserting a diagnostic pulmonary catheter through Patient A's femoral artery. This procedure revealed a high degree of hardening of the patient's major arteries, a lesion indicating a plaque rupture, one major clot completely blocking an artery and several branches simultaneously, and an elevated pressure indicative of congestive heart failure.
Faced with these circumstances, Dr. Amin decided to proceed with primary angioplasty in light of Patient A's serious condition. Dr. Amin concluded, "in [his] best medical judgment and to a reasonable degree of medical certainty, that the benefit of administering angioplasty" at Warren "outweighed the risks associated with transporting [Patient A] to Easton Hospital, because the trip to Easton Hospital would likely kill him." In fact, Dr. Amin asserted at a subsequent hearing that the risk of transporting Patient A was "outrageous" and that there would be "no benefit" to it. He further said that he could not have ethically signed a certification to allow transfer of Patient A to Easton.
It is undisputed that Warren did not possess the necessary equipment to perform primary angioplasty on Patient A. Dr. Amin, who also happened to be a member of Easton's staff and who "regularly" performed angioplasty there, notified Easton of the situation and arranged for the emergency transportation of the necessary equipment from Easton to Warren. Dr. Starosta then travelled to Easton to retrieve the equipment, "which she did on an extremely expedited basis."
Dr. Amin performed the emergency angioplasty on Patient A without incident. The procedure was "highly successful, " resulting in an immediate restoration of flow to Patient A's heart. Patient A made "essentially a 100% recovery." The Department does not dispute this favorable outcome. Warren thereafter sent a letter to the Department disclosing that an emergency angioplasty had been performed there on Patient A.
The circumstances involving Patient B were substantially similar, although not identical. On April 27, 2007, Patient B was brought to Warren at 8:15 a.m. while complaining of chest pain. Patient B was already a patient of Dr. Amin, had a history of coronary artery disease, and had already had a stent in place in his heart. Without consulting Dr. Amin, Patient B had discontinued his anti-platelet therapy intended to prevent blood clots from forming since he had experienced a gastrointestinal bleed in October 2006.
Soon after Patient B arrived at Warren, emergency room physicians determined that he was suffering from AMI and that he was unstable. His blood pressure was 63/48, and resuscitative efforts increased it to only 70-75 systolic. Dr. Amin was contacted when the emergency room physicians could not stabilize Patient B.
Dr. Amin inserted an intra-aortic balloon pump into Patient B to augment his heart's pumping power and potentially stabilize him for transfer. Patient B nevertheless remained "extremely unstable."
According to Dr. Amin, he and the emergency room officials "believed, in [their] best medical judgment, and to a reasonable degree of professional certainty, that [Patient B] was too unstable to transport to Easton Hospital, and that undertaking emergency transport would likely kill him." Patient B went into ventricular fibrillation, which, according to Dr. Amin, is a "dangerous" condition in which the heart muscle ...