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					                              State of New Jersey
                            OFFICE OF ADMINISTRATIVE LAW


                                                                  INITIAL DECISION
                                                                  OAL DKT. NO. HLT 13991-08
                                                                  AGENCY DKT. NO. AX08036


WARREN HOSPITAL,
      Petitioner,
      v.
DEPARTMENT OF HEALTH AND
SENIOR SERVICES,
      Respondent.
__________________________


      Steven B. Roosa, Esq., for petitioner (Reed, Smith, attorneys)


      Rachana R. Munshi, Deputy Attorney General, for respondent (Paula T. Dow,
             Attorney General of New Jersey)


Record Closed: February 15, 2011                                           Decided: April 1, 2011


BEFORE JOANN LASALA CANDIDO, ALJ:


            STATEMENT OF THE CASE AND PROCEDURAL HISTORY

      This matter involves the appeal of petitioner, Warren Hospital (Warren) of the
determination made by respondent, the New Jersey Department of Health and Senior
Services (DHSS), alleging that Warren, a small (129 bed) acute-care hospital located in
Phillipsburg, New Jersey, violated a licensure requirement of N.J.A.C. 8:43G-2.4(c) that



                             New Jersey is an Equal Opportunity Employer
OAL DKT. NO. HLT 13991-08


does not permit a hospital facility to accept patients in any new service, unit, or facility
until the hospital has a written approval and/or license by the Certificate of Need and
Acute Care Licensure Program of the Department, when it performed angioplasty
procedures on January 16, 2006, and April 27, 2007, without having the appropriate
license. The hospital was only permitted to perform low-risk-catheterization services.
Warren received a Notice of Assessment of Penalties and Directed Plan of Correction
on October 6, 2008. This notice required a full-time overseer to be hired, altered the
licensure status to “conditional” and assessed monetary penalties. The basis of the
notice was the alleged violations of the Certificate of Need rules, specifically that
provision which requires that no hospital accept patients in any new service, unit, or
facility until the hospital has a written approval and/or license issued by the Acute Care
Licensure Program of the Department.             N.J.A.C. 8:43G-2.4(c).    Warren denies
implementing a new service and claims the procedures were performed under emergent
circumstances.


       On November 5, 2008, the DHSS received Warren’s request for a hearing. The
matter was transmitted to the Office of Administrative Law on December 8, 2008, as a
contested case. The hearing was initially scheduled for July 13, 2009, but adjourned at
the request of both parties. It was then rescheduled for October 20, 2009, but again
adjourned at the request of both parties. The matter was scheduled for hearing on
February 8, 2010, but was adjourned after DHSS filed a Motion for Summary Decision
on January 28, 2010. Opposition was filed on March 12, 2010. The last reply brief was
received on April 20, 2010. The motion was ultimately denied and hearings were held
on May 27, 2010, and September 13, 2010. Telephone status conferences were held
on October 21, 2010 and December 1, 2010. Briefs were received on February 15,
2011, on which date the record closed.


                                       TESTIMONY

       The following is intended to summarize the testimony of the witnesses relevant to
the issues in this matter:




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OAL DKT. NO. HLT 13991-08


       Daria Starosta, D.O., the chairperson of the Emergency Department at Warren
testified on its behalf. She is board certified in emergency services and licensed in New
Jersey and Pennsylvania. Starosta is responsible for care provided to the patients at
Warren and its emergency room services.          She stated that Warren’s goal in the
emergency room is to immediately catheterize a heart patient, which is performed in the
CATH laboratory for purposes of stabilization. Thereafter, the patient is transported to
nearby Easton Hospital which provides full cardiac care.


       She recounted the circumstances of January 16, 2006, when patient “A,” a
seventy-nine-year-old male, came to the emergency room via private car complaining of
shortness of breath and chest pain over the past three days.              After an initial
examination, including an EKG, patient A was diagnosed with having an emergency
medical condition, and was treated for angina and myocardial ischemia. The patient
received an electrocardiogram and was given aspirin in a low dose, nitroglycerin, and IV
fluids. When the patient’s pain did not subside, another nitroglycerin dose was given,
but his blood pressure suddenly dropped. Morphine was then administered but his
blood pressure continued to drop. Dopamine was then administered, but the patient’s
blood pressure remained dangerously low. After Levafed was given, his blood pressure
began to rise. However, his blood pressure did not stabilize, which prevented him from
being transported.   Patient A was suffering from coronary ischemia which Starosta
described as not having enough oxygen going to the heart, causing an unstable
condition.


       She stated that Dr. Devendra Amin, a cardiologist on staff at Warren, was able to
stabilize the patient by inserting an intra-aortic balloon pump, which stabilized the
patient’s heart. Prior to this procedure, Starostra went to Easton Hospital to obtain the
equipment needed by Amin.


       Starostra was of the opinion that, within a medical degree of certainty, the patient
would have died had Amin not performed the procedure.


       Then Starostra testified about patient “B” who arrived at Warren via ambulance at
8:15 a.m. on April 27, 2007. She described this patient as “three-quarters dead” on his

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OAL DKT. NO. HLT 13991-08


arrival with a blood pressure reading of 60/40. This patient was suffering from an acute
myocardial infarction and immediately underwent an electrocardiogram, was given fluids
and medication, but his blood pressure, nevertheless, remained seriously low. Amin
was summoned who inserted a tre-ortic [sic] balloon pump to elevate the patient’s blood
pressure.


       In support of Warren’s actions, Starostra referred to the Emergency Medical
Treatment and Active Labor Act (EMTALA) (42 U.S.C.S. § 13955dd and adopted in
N.J.A.C. 8:43G-12.7), which requires a hospital to save a patient’s life.


       Dr. Amin, M.D. also testified on behalf of Warren. He was aware that Warren
was only licensed to perform low-risk catheterizations and that it was not licensed for
interventional procedures, such as putting in place pacemakers, defibrillators and
balloon pumps, which he does at Easton Hospital.            He emphasized that it was
necessary to have a patient stabilized before being transported to Easton Hospital for
coronary care.


       During his testimony, Amin referred to his certification dated March 10, 2010,
where he outlined the events which led up to his involvement with patient “A.” Patient
“A” came to Warren on January 19, 2006, extremely unstable. He received a call from
the emergency room to assist in stabilizing the patient’s blood pressure. The patient
was in shock and had poor heart function. Amin asked to have the patient brought to
the catheterization laboratory at 11:59 a.m. There he inserted an intra-aortic balloon
pump to enable the heart to pump blood to the organs. Amin, through an angiogram,
found a blockage in one of the patient’s main arteries which was affecting three arteries
at the same time. He was not able to stabilize the patient whose blood pressure at the
time was 81/55.


       He then requested that certain equipment be brought from Easton Hospital in
order to perform an angioplasty.      The patient’s blood pressure at the start of the
procedure was 115/80. Thirty minutes prior to this reading, patient A’s systolic pressure
was in the 70s or 80s, which, according to Amin, needed to be at least 90 in order to
have him transported. He performed an emergency angioplasty.

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OAL DKT. NO. HLT 13991-08



       Amin opined that patient A would have died had he been transported to Easton
Hospital prior to the agioplasty because he was in a “continuous state of cardiogenic
shock.” Amin refused to sign a certification allowing patient A to be transported to
another facility. He was eventually able to stabilize the patient making it unnecessary to
transport him to Easton.


       Regarding patient B, Amin stated that he was familiar with this patient since he
was a patient of his. Upon his arrival at Warren on April 27, 2007, Amin found that
patient B had low blood pressure, chest pain and a blockage in a critical artery. The
patient was brought to the catherization laboratory at 9:54 a.m. with blood pressure of
81/47. Amin placed an intra-aortic balloon pump into the patient’s heart. However, this
procedure was ineffective in stabilizing the patient.           Amin then performed a
catheterization angiogram and found the artery to be 100% blocked, which was the
cause of the instability.   He stated that the patient developed arrhythmia including
ventricular fibrillation, which he described as the heart stopping to function because the
bottom ventricle is fibrillating and the patient goes into cardiac arrest. With the use of a
guide wire, Amin traversed the blockage and opened the vessel enough to regain blood
flow. Amin then performed an emergency angioplasty between 10:08 and 10:14 a.m.,
which stabilized the patient enough to be transported to Easton Hospital around 11:42
a.m.


       He opined that this patient would have died had the patient been transported to
Easton Hospital without performing the procedures he did.


       Amin stated that a peripheral angioplasty is permitted at Warren which he
described as an intervention performed on the arteries of the leg by inserting a balloon
in an artery. He further stated that the techniques and equipment used are often the
same as primary angioplasty, a procedure that is not permitted at Warren.

       No other witnesses testified on behalf of petitioner.




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OAL DKT. NO. HLT 13991-08


      Dr. Charles Dennis, board certified in internal medicine and cardiovascular
disease, testified on behalf of respondent. The majority of his work involves diagnostic
procedures which he performs at the Virtua Memorial Hospital in its catheterization
laboratory. Dennis serves as chairperson of the Cardiovascular Health Advisory Panel
(CHAP). CHAP reviewed the cases of patients A and B and determined that patient A
did not require the cardio-catheterization laboratory, was misdiagnosed, and could have
been transferred to a cardiac surgery center. He opined that there was no evidence of
an Acute Myocardial Infarction (AMI) and that patient A was only suffering from atrial
fibrillation which needed to be cardioverted and nothing further.         The procedure
administered to patient A was a dangerous one requiring special equipment which
Warren did not possess since it was a low-risk hospital.       Dennis opined that once
patient A became stabilized in the cardio-catheterization laboratory after the
cardioconversion was performed Warren should not have performed an emergency
angioplasty, a procedure for which it was not licensed nor properly equipped.


      Dennis further testified that patient B came to the emergency room awake, alert,
oriented, and was not in distress. His vital signs were normal except for his blood
pressure. Patient B’s complaint was chest pains with no signs of a heart attack. Dennis
opined that this patient should have been immediately transported to another facility
after he arrived at Warren for an angioplasty because he was stable enough. He further
found that patient B should have been provided with more fluids and the only
abnormality with this patient was low blood pressure.        On June 18, 2008, CHAP
determined that patient B should have been transported to Easton Hospital, which was
only three miles away, and that Warren provided a service for which it was not licensed.


      John Gontarski, an employee of respondent, also testified on its behalf.         He
reviews Certificates of Need and handles license issues. He stated that a low-risk-
catheterization laboratory, such as Warren, was required to have a transfer agreement
with an appropriate facility so that it could stabilize patients and then transfer them to
that facility in compliance with the Certificate of Need.    Warren did not have such
agreement.




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OAL DKT. NO. HLT 13991-08


        Deborah Gottlieb, who is employed by respondent as its director of program
compliance and healthcare financing, testified on its behalf. Gottlieb oversees federal
enforcement violations of state-licensor regulations in facilities, such as Warren. She
also manages the informal dispute-resolution program.        Gottlieb stated that staff at
Warren came to her for dispute resolution regarding the events of patients A and B, but
because she was not a physician, she referred the matter to CHAP. She then relied
upon CHAP’s recommendation to impose a penalty because it determined that the
patients A and B were able to be transported to a cardiac surgery facility.


        The testimony provided by Amin was both compelling and straightforward. He
was able to personally assess the medical conditions of both patients A and B upon
their respective arrivals at Warren. In his professional opinion, both patients would
likely have succumbed had they been transported in their then existing conditions.


                                STATEMENT OF FACTS


        Based upon a consideration of the testimonial and documentary evidence
presented at the hearing, and having had the opportunity to observe the demeanor of
the witnesses and assess their credibility, I find the following: FACTS:


        Warren, located in Phillipsburg, New Jersey, is a small (129 bed) acute-care
hospital which provides community services, including emergency services and cardiac
care.    It is licensed by respondent to perform low-risk cardiac catheterization, a
procedure involving the insertion of a catheter into a vein or artery to diagnose the
condition of the heart.


        Patients who require cardiac surgery and primary angioplasty are usually
transferred to Easton Hospital in Pennsylvania, a few miles from Warren. At the time
involving patients A and B, there was no emergency transport service in place.


        Patient A, a seventy-nine-year-old male, came to the emergency room at Warren
on January 16, 2006, complaining of shortness of breath and chest pain. Amin placed
an intra-aortic balloon pump into the patient’s heart. An angioplasty was performed.

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OAL DKT. NO. HLT 13991-08


Patient A was diagnosed with having an emergency medical condition, suffering from
coronary ischemia.


       Patient B came to Warren via ambulance at 8:15 a.m. on April 27, 2007
complaining of chest pain. He was suffering from an acute myocardial infarction, and
was given fluids and medication, but his blood pressure remained seriously low. Amin
then placed an intra-aortic balloon pump into the patient’s heart, which did not stabilize
the patient. Amin then performed a catheterization angiogram and found the artery to
be totally blocked. He then performed an emergency angioplasty, stabilizing patient B
for transport to Easton Hospital.


       According to the terms of its licensure requirements, as an acute-care facility,
Warren did not possess a Certificate of Need to perform cardiac surgery or primary
angioplasty.


       Warren performed two primary angioplasties one on January 19, 2006 and the
other on April 27, 2007, without the required Certificate of Need.


                                    LEGAL DISCUSSION


       In 1971, the Legislature enacted the Health Care Facilities Planning Act (HCFPA)
to decrease the cost of hospital care in New Jersey. Saint Peter’s Univ. Hosp. v. Lacy,
185 N.J. 1, 5 (2005). To achieve its cost-containment ends, the HCFPA provides that
“[n]o health care facility shall be constructed or expanded, and no new health care
service shall be instituted . . . except upon application for and receipt of a certificate of
need[.]” N.J.S.A. 26:2H-7. Thus, the Certificate of Need requirement was promulgated
primarily as a cost-saving measure. Cooper Univ. Hosp. v. Jacobs, 191 N.J. 125, 136-
37 (2007); Saint Peter’s, supra, 185 N.J. at 5.          As part of the mechanisms for
implementing the HCFPA, the Legislature mandated that the Commissioner, with the
approval of the Board, adopt and amend rules and regulations in accordance with the
Administrative Procedure Act to effectuate the provisions of the HCFPA Saint Peter’s,
supra, 185 N.J. at 6. Accordingly, N.J.A.C. 8:43G-2.4(c) reads that “[n]o hospital shall
accept patients in any new service, unit, or facility until the hospital has written approval

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OAL DKT. NO. HLT 13991-08


and/or license issued by the Certificate of Need and Acute Care Licensure Program of
the Department.” N.J.A.C. 8:43G-2.4(c).


       In stark contrast to the cost-saving goals of the HCFPA, the Emergency Medical
Treatment and Active Labor Act (EMTALA)—which is found in 42 U.S.C.S. § 13955dd
and adopted in N.J.A.C. 8:43G-12.7—was enacted with “life-saving” in mind. Congress
enacted EMTALA in response to a growing problem known as patient dumping, wherein
hospitals turned away or transferred indigent patients before their emergency conditions
were stabilized solely based on their inability to pay healthcare costs. In re Baby “K”, 16
F.3d 590, 593 (4th Cir. 1994). In response to this growing concern, Congress’s solution
was to guarantee all individuals access to an emergency department’s examination and
treatment procedures. Harry v. Marchant, 291 F.3d 767, 773 (11th Cir. 2002). In fact,
there is nothing in the statute that requires proof of indigence, inability to pay, or any
other improper motive on the part of the hospital as a prerequisite to recovery. Power v.
Arlington Hosp. Ass’n, 42 F.3d 851, 858 (4th Cir. 1994); Baby “K”, supra, 16 F.3d at 593
(Congress sought to provide an adequate first response to a medical crisis for all
patients.); Brooker v. Desert Hosp. Corp., 947 F.2d 412, 415 (9th Cir. 1991) (holding
that EMTALA applies to all patients); 42 U.S.C.S. § 13955(b) (“If any individual (whether
or not eligible for benefits under this title) comes to a hospital . . . ”). Therefore, the
protections of EMTALA are triggered when any individual comes to the emergency
department and requests treatment. Torretti v. Main Line Hosps., 580 F.3d 168, 175
(3rd Cir. 2009).


       EMTALA imposes two distinct duties on hospitals that have entered into
Medicare provider agreements.       First and foremost, a hospital with an emergency
medical department must provide an appropriate medical-screening examination to
determine whether an emergency medical condition exists. 42 U.S.C.S. § 13955dd(a);
N.J.A.C. 8:43G-12.7(c); Baby “K”, supra, 16 F.3d at 593. A hospital fulfills this duty if it
utilizes identical screening procedures for all patients complaining of the same condition
or exhibiting the same symptoms. Ibid. (citation omitted).


       Second, an additional duty arises if an emergency medical condition is
discovered during the screening process. Id. at 593; see 42 U.S.C.S. § 13955dd(b);

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OAL DKT. NO. HLT 13991-08


N.J.A.C. 8:43G-12.7(d). In particular, when an individual is diagnosed as presenting
with an emergency medical condition, the hospital is required to stabilize the condition
before transferring or discharging the patient.           42 U.S.C.S. § 13955dd(b)(1)(A).
Restated, the hospital is “generally” proscribed from transferring or discharging unstable
patients. Torretti, supra, 580 F.3d at 178 (to succeed under a failure-to-stabilize theory,
the plaintiff must demonstrate that he/she: (1) had an emergency medical condition; (2)
the hospital actually knew of that condition; and (3) the patient was not stabilized before
being transferred).

                “Generally” proscribed because EMTALA enumerates two
                exceptions to this otherwise clear cut rule against
                transferring unstable patients; either [t]he patient (or a legally
                responsible person acting on the patient’s behalf), after
                being informed of the hospital’s obligations under this
                section and of the risk of transfer, in writing requests transfer
                to a medical facility; or [a] physician has signed a
                certification that, based upon the information available at the
                time of the transfer, the medical benefits reasonably
                expected from the provision of appropriate medical treatment
                at another medical facility outweigh the increased risks to the
                patient . . . from effecting the transfer.

                [N.J.A.C. 8:43G-12.7(e)(1) and (2) (emphasis added); see
                42 U.S.C.S. § 13955dd(c)(1)(A).]

       The term “to stabilize” means “to provide such medical treatment of the condition
as may be necessary to assure, within reasonable medical probability, that no material
deterioration of the condition is likely to result from or occur during the transfer of the
individual from a facility[.]”    42 U.S.C.S. § 13955dd(e)(3)(A) (emphasis added); 42
C.F.R. § 489.24(a)(ii); N.J.A.C. 8:43G-12.7(d) (“If it is determined that an emergency
medical condition exists, the patient must be evaluated by a physician and provided with
such medical treatment as is necessary to assure that the condition has been stabilized
. . .”) (emphasis added); see also Baby “K”, supra, 16 F.3d at 598 (“Congress rejected a
case-by-case approach to determining what emergency medical treatment hospitals
must provide and to whom they must provide it; instead it required hospitals and
physicians to provide stabilizing care to any individual presenting an emergency medical
condition.”).



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OAL DKT. NO. HLT 13991-08


       Therefore, once an individual has been diagnosed with an emergency medical
condition, the hospital may provide any treatment as may be necessary to prevent the
material deterioration of the individual’s condition and is proscribed from transferring an
unstable patient without written request of the patient or certification of the physician.
Failure to abide by these requirements will subject the hospital to civil monetary
penalties in amounts of up to $50,000 for each violation. U.S.C.S. § 13955dd(d). To
ensure compliance with its regulations, EMTALA likewise requires receiving hospitals to
report any time it has reason to believe it may have received an individual who has
been transferred in an unstable medical condition from another hospital in violation of
the applicable statutes and regulations. 42 C.F.R. § 489.20.


       Of critical importance, EMTALA specifically provides for preemption of certain
state and local laws. In particular, EMTALA sets forth that “provisions of this section do
not preempt any state or local law requirement, except to the extent that the
requirement directly conflicts with a requirement of this section.”        42 U.S.C.S. §
13955dd(f). A state statute directly conflicts with federal law when compliance with both
federal and state regulations is physically impossible or the state law stands as an
obstacle to the execution of the full purposes and objectives of Congress. Hardy, supra,
164 F.3d at 794-95 (citations omitted).


       In Baby “K”, a hospital filed a declaratory judgment action, seeking to resolve the
issue of whether it was obligated under EMTALA to provide emergency health services
in the form of respiratory assistance to stabilize an anencephalic infant’s emergency
medical condition. Baby “K”, supra, 16 F.3d at 593. The hospital’s position was that it
was not. First, the hospital argued that Congress did not intend to require physicians to
provide medical treatment above the prevailing standard of medical care. To that end,
the hospital contended that because of the infant’s extremely limited life expectancy and
because any treatment of the condition would be futile, the prevailing standard of
medical care is simply the provision of warmth, nutrition, and hydration.            Thus,
according to the hospital, the provision of respiratory assistance was excessive and not
appropriate even in a medical emergency. Id. at 596. The court, however, found the
hospital’s arguments unpersuasive, stating that the “the plain language of EMTALA
requires stabilizing treatment for any individual who comes to a participating hospital, is

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OAL DKT. NO. HLT 13991-08


diagnosed as having an emergency medical condition, and cannot be transferred.” Ibid.
(emphasis added). The court went on to state: “nor has our research revealed any
statutory language or legislative history evincing a Congressional intent to create an
exception to the duty to provide stabilizing treatment when the required treatment would
exceed the prevailing standard of medical care.” Ibid. Accordingly, the court concluded
that the hospital was required to provide respiratory support; the stabilizing treatment
necessary to prevent the material deterioration of the infant’s emergency medical
condition.


       Second, the hospital argued that state law exempted its physicians from
providing care which they deemed to be ethically or medically inappropriate. Id. at 597.
The hospital contended, therefore, that EMTALA cannot be construed to require a
physician to provide stabilizing treatment if, as was the case here, such treatment is
deemed ethically or medically inappropriate by the attending doctors.          The court,
however, found this argument likewise unpersuasive.         Relying again on legislative
history as well as the plain language of the statute, the court maintained that EMTALA
does not provide an exception for stabilizing treatment which physicians deem medically
or ethically inappropriate.   “Consequently, to the extent [the state law] exempts
physicians from providing care they consider medically or ethically inappropriate, it
directly conflicts with the provisions of EMTALA that require stabilizing treatment to be
provided.” Ibid. Therefore, the state law is preempted by EMTALA.


       Here, Warren was charged with two violations of N.J.A.C. 8:43G-2.4(c) for
performing two emergency angioplasties, one on January 19, 2006, and the other on
April 27, 2007. N.J.A.C. 8:43G-2.4(c) sets forth that, “[n]o hospital facility shall accept
patients in any new service, unit, or facility until the hospital has a written approval
and/or license by the Certificate of Need and Acute Care Licensure Program of the
Department.” According to respondent, because Warren is conditionally licensed to
perform low-risk-catheterization services, angioplasty procedures exceeded the scope
of that license and therefore, the angioplasty procedures performed were licensure
deficiencies.   It is undisputed that petitioner performed two emergency angioplasty
procedures without a Certificate of Need; making the issue, therefore, whether
respondent’s enforcement of N.J.A.C. 8:43G-2.4(c) is preempted by EMTALA.

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OAL DKT. NO. HLT 13991-08



       A state statute directly conflicts with federal law when compliance with both
federal and state regulations is physically impossible or the state law stands as an
obstacle to the execution of the full purposes and objectives of Congress. Hardy, supra,
164 F.3d at 794-95 (citations omitted).


       Congress’s objective in enacting EMTALA was to guarantee all patients entry
into the medical system via mandatory appropriate medical screenings and stabilization
prior to transfer.


       There appears to be an absence of statutory language or legislative history
evincing a Congressional intent to create an exception to the duty to provide stabilizing
treatment if a hospital does not have a Certificate of Need. To the contrary, EMTALA
requires stabilizing treatment for any individual who comes to a participating hospital
with a diagnosis of an emergency medical condition, and cannot be transferred. Baby
“K”, supra, 16 F.3d at 596. Indeed, it must not be overlooked that the HCFPA was
adopted and the Certificate of Need requirement was implemented in response to “a
growing concern over the rising cost of hospital care and, consequently, hospitalization
insurance, in this state.”   St.Peter’s, supra, 185 N.J. at 6.    It is essentially cost-
containment legislation. By enforcing a cost-savings regulation, without considering the
wellbeing of the patient, respondent has misplaced its emphasis. That could not have
been the intention of the Legislature in enacting the HCFPA. Accordingly, respondent’s
enforcement of N.J.A.C. 8:43G-2.4(c) is in direct conflict with the provisions of EMTALA
in that it proscribes, on its face, the provision of treatment necessary to stabilize an
emergency medical condition or to save an individual’s life.     As an obstacle to the
execution of the full purposes and objectives of Congress in the enactment of EMTALA,
respondent’s enforcement of N.J.A.C. 8:43G-2.4(c) was preempted. See Hardy, supra,
164 F.3d at 794-95.


       Finally, it was physically impossible for petitioner to simultaneously comply with
the requirements of N.J.A.C. 8:43G-2.4(c) and EMTALA. In the case at hand, patient A
arrived at petitioner’s emergency room around 10:13 a.m. on January 19, 2006,
experiencing chest pain and shortness of breath. Patient A was diagnosed with having

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OAL DKT. NO. HLT 13991-08


an emergency medical condition and was treated for coronary ischemia. According to
Dr. Starosta, the patient was unstable upon arrival. Patient A failed to respond to initial
treatment, and his signs rapidly deteriorated as his pressure fell.       More aggressive
pressure-raising medication was administered in an effort to stabilize patient A, but to
no avail. Furthermore, patient A’s blood pressure remained dangerously low despite all
attempts to raise it.     According to the testimony of Starosta, patient A was also
experiencing coronary ischemia.


       As a result of patient A’s failure to respond to stabilizing medications and
procedures, it was determined that Amin’s expertise and assistance was needed to
stabilize the patient for transport. After examining the patient, Amin felt that it might be
possible to stabilize the patient by inserting an intra-aortic balloon pump to assist the
heart in pumping blood.        Thereafter, patient A was immediately taken to the
catheterization lab where a pump was inserted, but the patient’s blood pressure
remained dangerously low. It was at this point that Amin concluded that patient A was
too unstable for transport and any attempt to do so would have likely resulted in his
death. In other words, Amin concluded that the risks of transport outweighed the risks
of stabilizing the patient.


       It was at this point that Amin determined that emergency angioplasty needed to
be done to save the patient’s life.      Amin likewise concluded that the benefits of
performing the procedure on-site outweighed the risks of transporting the patient in his
unstable condition, likely resulting in the patient’s demise. Thereafter, the procedure
was performed and patient A’s life was saved.


       The doctors at Warren initially diagnosed patient A with an emergency medical
condition of angina and myocardial ischemia and subsequently with acute myocardial
infarction. Accordingly, the hospital had a legal duty to stabilize his condition before
releasing or transferring the patient.           After less-invasive procedures proved
unsuccessful in stabilizing the patient, Amin determined that emergency angioplasty
was needed to be performed to treat the total blockage and, in the process, save the
patient’s life. According to EMTALA, petitioner was proscribed from transferring the
patient in his unstable state, unless the hospital obtained a written request from the

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OAL DKT. NO. HLT 13991-08


patient’s family or pursuant to a certification from Amin or another qualified physician.
Amin concluded that the risks of transportation outweighed the risks of on-site
angioplasty. Amin confirmed that he did not and would not have signed a certification to
transport patient A to another facility in light of his condition. Therefore, Warren was
proscribed from transferring the patient. An emergency angioplasty was the final and
only available remedy to stabilize the patient on-site. Therefore, Warren could have
avoided sanctions for performing the angioplasty if it transferred patient A to another
hospital while in his precarious condition.


       Clearly it would have been physically impossible for Warren to comply with
N.J.A.C. 8:43G-2.4(c) by transferring patient A and at the same time, complying with
EMTALA.     See Torretti, supra, 580 F.3d at 178 (EMTALA proscribes inappropriate
transfers, i.e., transfers of an unstable patient). Accordingly, respondent’s enforcement
of N.J.A.C. 8:43G-2.4(c) was directly in conflict with EMTALA.


       Next for consideration are the circumstances surrounding patient B, who was
brought to the emergency room by a family member. Patient B, a patient of Amin, had a
history of coronary artery disease, and who complained of chest pain upon arrival.
Almost immediately after patient B presented to the emergency room, an initial
examination was conducted and the physicians determined that he was unstable,
suffering from an AMI, and close to death.


       Unable to stabilize patient B’s condition by way of medication and other
resuscitative methods, Amin determined that the insertion of an intra-aortic balloon
pump could stabilize patient B so that he could be transported to Easton Hospital. After
the pump was inserted, the patient remained highly unstable. Amin added that during
this time, patient B went into ventricular fibrillation. Patient B could not be stabilized
with medication and other resuscitative efforts and Amin determined that an emergency
angioplasty needed to be performed to stabilize the patient. Amin likewise felt that the
risk of performing the procedure on-site was greatly outweighed by the risk of
transporting the patient to Easton Hospital. He thereupon commenced the procedure
and immediately noticed that the right coronary artery was totally blocked. With the use
of a guide wire, Amin was able to open the vessel enough to regain blood flow.

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OAL DKT. NO. HLT 13991-08


Following the reopening of his right coronary artery, the patient began to stabilize and
was subsequently transported to Easton Hospital.


      The facts pertaining to both patients A and B were similar. Both failed to respond
to typical stabilizing treatments for AMI patients. Accordingly, the hospital had a legal
duty to stabilize before releasing or transporting. According to EMTALA, petitioner was
proscribed from transferring patient B in his unstable state unless the hospital obtained
a written request from the patient’s or pursuant to a certification from Amin or another
qualified physician. Amin concluded that the risks of transportation outweighed the risks
of on-site angioplasty. Therefore, an emergency angioplasty was the only available
remedy, under the circumstances that then existed, to stabilize the patient on-site and to
save his life. Accordingly, it would have been impossible for petitioner to comply with
both N.J.A.C. 8:43G-2.4(c) and EMTALA.          See Torretti, supra, 580 F.3d at 178.
Accordingly, I CONCLUDE that respondent’s enforcement of N.J.A.C. 8:43G-2.4(c) for
both patients A and B was directly in conflict with EMTALA.


      I further CONCLUDE that the Certificate of Need requirement was not intended
to supersede a physician’s medical judgment in stabilizing a patient to save life. In such
a scenario, the applicable requirements are enumerated in EMTALA and adopted by
N.J.A.C. 8:43G-12.7.


      Dennis opined that the patient could have been transferred to another facility
because he felt that there was no objective evidence of an acute myocardial infarction,
only an atrial fibrillation which needed to be cardioverted. He further opined that it was
improper for Amin to perform the emergency procedure when the angioplasty supplies
where not readily available on-site, but had to be retrieved from Easton Hospital.


      He also felt that patient B was stable enough to be transferred to another facility
and should have been provided with more fluids. The only abnormality he noted was
the patient’s low blood pressure.


      Dennis did not note whether Warren complied with its duties under EMTALA,
namely, to (a) provide a medical screening examination and (b) provide stabilizing

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OAL DKT. NO. HLT 13991-08


treatment prior to transfer or discharge.           As previously stated, the protections of
EMTALA are not intended to guarantee proper diagnosis or to provide a federal remedy
for misdiagnosis or medical negligence. Rather, EMTALA was enacted to fill a void in
traditional state tort law by imposing on hospitals a legal duty to provide emergency
care to all. That is precisely what transpired regarding both patients.


       Respondent contends that petitioner failed to develop and maintain written
agreements with cardiac surgery centers as is required in the above regulation.
Specifically, respondent asserts that the hospital’s failure to maintain emergency
transportation agreements or instruct its staff on proper transport procedures put the
physicians in a difficult position and the patients at risk.

       N.J.A.C. 8:33E-1.8(a) sets forth that:

              [e]very facility applying to provide or providing invasive
              cardiac diagnostic services pursuant to this subchapter
              which is not also licensed to provide cardiac surgery
              services on site shall develop and maintain written
              agreements with cardiac surgery centers which shall include,
              but not necessarily be limited to: provisions for insuring
              quality control, rapid referral for surgery, emergency backup
              and transport procedures, and regular communication
              between the cardiologist performing catheterizations and the
              surgeons to whom patients are referred. In addition, one of
              the referral agreements must be within one hour travel time
              from the diagnostic facility and at least one of the referral
              agreements shall be written with a New Jersey cardiac
              center.

              [Emphasis added.]

       The question of whether Warren developed and maintained written agreements
with cardiac surgery centers remained unanswered.              Respondent neither charged
petitioner with this violation nor amended its pleadings to encompass it. The failure to
develop proper transfer protocols is separate and apart from a Certificate of Need
violation.




                                               17
OAL DKT. NO. HLT 13991-08


                                   CONCLUSION


      Based upon the facts adduced and the legal principles cited above, I
CONCLUDE that Warren, under the compelling provisions and intent of EMTALA (42
U.S.C.S. § 13955dd), acted appropriately.


                                       ORDER


      Based upon the foregoing, it is hereby ORDERED that the respondent’s Notice of
Assessment and Penalties be and is hereby DISMISSED.


      I hereby FILE my initial decision with the COMMISSIONER OF THE
DEPARTMENT OF HEALTH AND SENIOR SERVICES for consideration.




                                            18
OAL DKT. NO. HLT 13991-08



       This recommended decision may be adopted, modified or rejected by the
COMMISSIONER OF THE DEPARTMENT OF HEALTH AND SENIOR SERVICES,
who by law is authorized to make a final decision in this matter. If the Commissioner of
the Department of Health and Senior Services does not adopt, modify or reject this
decision within forty-five days and unless such time limit is otherwise extended, this
recommended decision shall become a final decision in accordance with N.J.S.A.
52:14B-10.


       Within thirteen days from the date on which this recommended decision was
mailed to the parties, any party may file written exceptions with the COMMISSIONER
OF THE DEPARTMENT OF HEALTH AND SENIOR SERVICES, John Fitch Plaza,
P.O. Box 360, Room 805, Trenton, New Jersey 08625-0360, marked “Attention:
Exceptions.” A copy of any exceptions must be sent to the judge and to the other
parties.




April 1, 2011


DATE                                            JOANN LASALA CANDIDO, ALJ


Date Received at Agency:                        April 1, 2011


Date Mailed to Parties:
ljb




                                           19
OAL DKT. NO. HLT 13991-08



                                        APPENDIX


                                       WITNESSES


For Petitioner:
         Daria Starosta, D.O.
         Devendra Amin, M.D.


For Respondent:
         Charles Dennis, M.D.
         John Gontarski
         Deborah Gottlieb


                                         EXHIBITS


Joint:
J-A            DHSS’s February 2, 2007 letter to Warren
J-B            Warren’s March 15, 2005, [sic] letter to DHSS
J-C            Warren’s May 11, 2007, letter
J-D            DHSS’s letter dated August 24, 2007
J-E            Not admitted
J-F            CHAP meeting minutes of June 18, 2008
J-G            DHSS’s Notice of Assessment of Penalties and Directed Plan of Action
               dated September 24, 2008
J-H            Warren’s request for hearing dated November 4, 2008
J-I            Curriculum Vitae of Charles Dennis, M.D.


For Petitioner:
WH-1           Order Denying Summary Decision
WH-2           Letter Brief dated April 15, 2010
WH-3           Answers to Interrogatories dated January 22, 2010
WH-4           Curriculum Vitae of Devendra K. Amin, M.D.

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OAL DKT. NO. HLT 13991-08


WH-5       Curriculum Vitae of Daria M. Starosta, D.O.
WH-6       Response to request for admissions
WH-7       Certification of Dr. Devandra Amin
WH-8       Certification of Dr. Daria Starosta
WH-9       Letter from DHSS dated August 24, 2007
WH-10      Notice of Assessment




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