Court Opinion

ID: 4640127
Source: CourtListenerOpinion
Date Created: 2020-12-07 16:08:32.486543+00
Date Added: 2024-06-11T08:00:11.389725
License: Public Domain

NOT FOR PUBLICATION WITHOUT THE
                            APPROVAL OF THE APPELLATE DIVISION
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                                                     SUPERIOR COURT OF NEW JERSEY
                                                     APPELLATE DIVISION
                                                     DOCKET NOS. A-1605-18T3
                                                                  A-1606-18T3

IN THE MATTER OF THE
CERTIFICATE OF NEED
APPLICATION OF
CENTRASTATE MEDICAL
CENTER TO INITIATE FULL
SERVICE ADULT CARDIAC
CATHETERIZATIONS.
___________________________

IN THE MATTER OF THE
CERTIFICATE OF NEED
APPLICATION OF
CENTRASTATE MEDICAL
CENTER TO OFFER ON-SITE
PRIMARY PERCUTANEOUS
CORONARY INTERVENTION.
____________________________

                Argued October 15, 2020 – Decided December 7, 2020

                Before Judges Whipple, Rose and Firko.

                On appeal from the New Jersey Department of Health,
                CN Nos. ER 0801-13-01 and ER 0802-13-01.

                James A. Robertson argued the cause for appellant
                (Greenbaum Rowe Smith & Davis, LLP, attorneys;
            James A. Robertson, of counsel and on the briefs; John
            W. Kaveney and Parampreet Singh, on the briefs).

            Melissa H. Raksa, Assistant Attorney General, argued
            the cause for respondent (Gurbir S. Grewal, Attorney
            General, attorney; Melissa H. Raksa, of counsel; Mark
            D. McNally, Deputy Attorney General, on the briefs).

PER CURIAM

      In these two appeals we calendared back-to-back and have consolidated

for the purpose of writing one opinion, CentraState Medical Center appeals from

two final agency decisions issued by the Department of Health (DOH): (1)

denying its application for permission to expand its low-risk catheterization

laboratory (low-risk cath lab) to include high-risk cardiac diagnostic services

within a full-service adult diagnostic cardiac catheterization laboratory (full-

service cath lab); and (2) denying its application for permission to expand its

service line by offering on-site primary percutaneous coronary intervention

(PCI) services, as a complement to those already offered in its low-risk cath lab.

      The DOH refused to process CentraState's application in both matters

because the hospital failed to meet the threshold eligibility and application

review criteria set forth in the applicable regulations. CentraState appealed the

rejection of both applications, emphasizing that the hospital demonstrated a

special need to provide full-service cardiac care in the region due to its unique

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location, its service to a predominantly elderly population, and the growth of its

primary service area (PSA).      We reject these arguments and affirm both

decisions.

                                        I.

                                       A.

      The material facts of each claim are generally undisputed and are gleaned

from the record. In CentraState's matter filed under docket number A-1605-18,

the hospital sought to expand its cardiac program to include a full -service cath

lab. CentraState is a stand-alone community hospital located in Freehold and

primarily serves residents from Monmouth, Middlesex, Mercer, Ocean, and

Burlington Counties, the PSA.         According to CentraState's application

describing the PSA, the area recently underwent a transformation from farmland

to residential developments, increasing the area's population, tourism, and need

for modern conveniences.

      Currently, CentraState's cardiology services include a cardiac diagnostic

center, which performs electrocardiogram (EKG), echocardiogram, and stress

testing, the low-risk cath lab, cardiac rehabilitation,1 and a women's heart

1
  CentraState's cardiac rehabilitation program has been accredited by the
American Association of Cardiovascular and Pulmonary Rehabilitation.
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                                        3
program. CentraState has operated its low-risk cath lab since April 20, 2005.

In 2016, CentraState noted 692 patients who received or could have received

low-risk cardiac catheterization services at its facility. 2 CentraState also cites

487 additional patients from its service area who went to other hospitals for

these procedures, which it could have served if it had the proper facilities.

      CentraState contends it has an active, award-winning endovascular

program, which performed 4088 procedures at the time of its application. The

program allows CentraState physicians to perform stent procedures "on every

other area of the body except the heart," despite the general use of the same type

of wire and stents and oftentimes, the performance of higher-risk procedures.

Currently, the program has twenty-two physicians credentialed to perform low-

risk catheterizations in CentraState's low-risk cath lab, and a minimum of three

registered nurses or technologists available for each procedure.

      According to an Outpatient Press Ganey report, CentraState scored a

ninety-five percent patient satisfaction rating for the period commencing

February 1, 2017 through April 30, 2017. William H. Matthai, Jr., M.D., FACC,

2
    This number includes the 205 low-risk catheterizations performed at
CentraState, the 127 patients admitted for these procedures but transferred
elsewhere, and the 360 elective catheterizations that were scheduled by
cardiologists elsewhere due to unavailability of PCI at the hospital.
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FACP, FSCAI, conducted an external review of the low-risk cath lab specifically

and found it to be "outstanding" in accordance with DOH requirements. Dr.

Matthai was impressed that there had never been a procedure-related mortality

in the low-risk cath lab and emphasized its safety initiatives. He concluded that

the quality of care in CentraState's low-risk cath lab was "excellent and decision

making appropriate," with proper patient selection and care, and an experienced

physician and nursing staff.

      On August 1, 2017, CentraState submitted a certificate of need (CN)

application to the DOH seeking to expand its cardiac program to include a full-

service cath lab. CentraState sought to expand its low-risk catheterization

program to include invasive cardiac diagnostic services for adult patients within

a full-service facility at the hospital. Doing so would permit CentraState to treat

patients with conditions that are classified as high-risk.3 Because there is no

physical difference between a low-risk cath lab and a full-service cath lab,

CentraState contends the program expansion would not require any construction

3
   CentraState provided examples of high-risk conditions including: left main
coronary syndrome, unstable myocardial infarction, acute myocardial infarction
within three days, unstable angina with persistent angina, congestive heart
failure, cardiogenic shock or severe hemodynamic instability, aortic stenosis,
ejection fraction below thirty percent, or concomitant severe medical or vascular
problems.
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or renovation, or even the acquisition of additional equipment, other than minor

supplies.

      In making these applications, CentraState cited a special need for basic,

essential cardiac care among the disproportionately elderly populations living

within its PSA, specifically in Monroe and Jackson Townships. CentraState

emphasized that the hospital's patients are on average sixty-eight years old, and

Monmouth County, in particular, accounts for 7.3% more residents over the age

of sixty-five than the average for the entire State of New Jersey. Truven Health

Analytics projections indicate that the number of people aged sixty-five and

older living within CentraState's PSA would increase 16% by 2021. Further,

CentraState cited that the percentage of Monmouth County residents with some

form of cardiovascular disease was 9% higher than the national average and

were more likely than others in the nation to have at least one cardiovascular

risk factor, like high blood pressure, high cholesterol, or diabetes.

      Currently, residents living within CentraState's PSA must travel farther to

receive basic cardiac services than those living within close proximity to other

hospitals that offer those services. Freehold is located within a triangle of

highways, with no fluid access through the middle of Monmouth County. There

is no train service that runs from east to west in Monmouth County, leaving the

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heart of the county unserved by that form of public transportation , and it can

also take up to an hour-and-a-half for a patient to arrive by bus from certain

parts of CentraState's PSA.

      Therefore, if a patient who is admitted at CentraState must be transferred

to another hospital to receive services not offered at its hospital, the transfer

could involve up to four patient hand-offs,4 which is inconsistent with

coordinated patient care and patient risk. And, it adds at least an additional hour

of travel time to the small window patients have to receive life-saving cardiac

procedures, which is approximately ninety minutes.

      Based on this information, in its application, CentraState asserted a

substantial need for cardiac services in its PSA. While CentraState failed to

meet the DOH's 400-low-risk case volume requirement and precondition for a

full-service cath lab, it argued that the DOH was still required to address this

substantial need and to relax its regulatory requirements.

4
  A patient who first appears at CentraState's emergency room is first transferred
to the CentraState cardiac team. If the cardiac services cannot be provided at
CentraState, the patient must be transferred to emergency medical personnel for
transport in an ambulance to another hospital. The emergency transporters then
hand-off the patient to the other hospital's emergency personnel, and finally to
the receiving hospital's catheterization lab staff.
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      On November 2, 2018, the DOH Director, Certificate of Need and

Healthcare Facility Licensure Program, issued a written final decision. In his

decision, the Director refused to process CentraState's application to expand its

low-risk cath lab to include high-risk cardiac diagnostic services because it

"failed to document full unconditional compliance with the eligibility and

application review criteria set forth at N.J.S.A. 8:33E-1.3 [to] -1.10." For a low-

risk cath lab to apply for expansion, it must demonstrate compliance with a

minimum annual volume of 400 cases, which CentraState failed to do. Because

of CentraState's inability to meet that requirement for submission of its

application the DOH refused to review the substance of the request.

      On appeal, CentraState claims that because the DOH "flatly refused to

process" the application instead of addressing it on the merits, the DOH did not

learn of the special need for services presented by "the uniqueness of

CentraState's geographic location, the extensive population growth across

Monmouth and other surrounding counties, and in particular, the elderly

populations residing in Jackson and Monroe Townships . . . ." Instead of

analyzing the merits of the application, CentraState claims the DOH flatly

refused to process it, and did not properly consider the special needs it identified

in its rejection.

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                                         8
                                         B.

      Turning to CentraState's matter filed under docket number A-1606-18, the

hospital sought to expand its service line by offering on-site PCI services, as a

complement to those already offered in its low-risk cath lab. Primary PCI is a

non-surgical procedure which uses a catheter to place a stent into the heart for

the purpose of opening blood vessels that have been narrowed by plaque

buildup. CentraState intended these expansions to its low-risk catheterization

program to offer a broader range of life-saving cardiac services to adult patients

within a full-service facility at the hospital. Doing so would permit CentraState

to treat patients with conditions that are classified as high-risk.

      Because there is no physical difference between a low-risk cath lab and a

full-service cath lab, the program and service expansion would not require

physical construction or renovation, or even the acquisition of additional

equipment, other than minor supplies. Additionally, all of the physicians on

CentraState's medical staff who would be responsible for performing primary

PCI procedures are already qualified to do so, and perform them frequently at

other facilities. The cardiologists and nursing staff also regularly conduct stent

and balloon procedures on every other part of the body in CentraState's

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                                         9
Endovascular Division.     Given this information, CentraState claims to be

staffed, equipped, and prepared to offer primary PCI services.

      In making this application, CentraState made the same demographic and

statistical arguments as in the other matter under docket number A-1605-18.

The DOH refused to process CentraState's application for the provision of PCI

services because it must first operate as a full-service adult diagnostic cardiac

catheterization program for a period of six months. Because Centra -State was

not licensed to operate as a full-service cardiac facility at the time it submitted

its application, the DOH refused to consider it.

      In a November 2, 2018 letter, the Director denied processing CentraState's

CN application regarding PCI services because the hospital "failed to document

full unconditional compliance with the eligibility and application review criteria

set forth in [the administrative code]." Specifically, CentraState's:

            eligibility to initiate primary angioplasty (PCI) without
            on-site cardiac surgery backup is limited to any general
            hospital having a full[-]service adult diagnostic cardiac
            catheterization program that has been licensed for at
            least six months . . . prior to the application submission
            date and has documented, to the satisfaction of the
            [DOH], licensure and full compliance with all cardiac
            catherization program and facility utilization for the
            most recent four quarters.

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                                       10
       On appeal in this matter, CentraState argues: (1) the DOH's failure to

accept CentraState's CN application for processing and grant a CN to provide

primary PCI services violates our holding in Irvington General Hosp. v.

Department of Health;5 (2) the DOH's regulation imposing a requirement that

CentraState operate a full service diagnostic catheterization laboratory for six

months as a precondition to applying for a CN to offer primary PCI services is

arbitrary and inconsistent with the 400-case volume requirement regulation,

which is undermined by modern science; and (3) the DOH failed to make any

findings of fact or conclusions of law as to CentraState's contention that special

need for cardiac services exists among the over sixty-five populations in Monroe

and Jackson townships warranting a remand.

                                       II.

       Our review of an agency's decision is limited. In re Stallworth, 208 N.J.

182, 194 (2011) (citing Henry v. Rahway State Prison, 81 N.J. 571, 579 (1980)).

A reviewing court "should not disturb an administrative agency's determinations

or findings unless there is a clear showing that (1) the agency did not follow the

law; (2) the decision was arbitrary, capricious, or unreasonable; or (3) the

decision was not supported by substantial evidence." In re Virtua-West Jersey

5
    149 N.J. Super. 461 (App. Div. 1977).
                                                                          A-1605-18T3
                                       11
Hosp. Voorhees for a Certificate of Need, 194 N.J. 413, 422 (2008) (citing In re

Herrmann, 192 N.J. 19, 28 (2007)); see also Bergen Pines Cty. Hosp. v. N.J.

Dep't of Human Servs., 96 N.J. 456, 477 (1984).

      CentraState argues that the DOH improperly disqualified the hospital's

CN application for a full-service cath lab on the grounds that CentraState has

not demonstrated compliance with the minimum annual facility volume

requirement of 400 cases. CentraState contends the decision ignored the factors

enumerated in the CN statute, as well as the clear mandate of Irvington General,

149 N.J. Super. at 461.

      Establishment of health care facilities in New Jersey is governed by the

Health Care Facilities Planning Act (HCFPA), N.J.S.A. 26:2H-1 to -26, which

allows the State to supervise changes in the statewide delivery of health care.

In re Virtua-West, 194 N.J. at 416. The government oversight includes the

construction, expansion, modernization, and addition of health care facilities,

services, and plans. Desai v. St. Barnabas Med. Ctr., 103 N.J. 79, 88-89 (1986).

The legislative intent of the HCFPA is "to provide state residents with high

quality health care services at a contained cost." In re Virtua-West, 194 N.J. at

423 (citing N.J.S.A. 26:2H-1).

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                                      12
      In furtherance of that objective, the HCFPA implemented the CN process,

which requires health care providers to submit proposals to the DOH before any

new health care facility is constructed or expanded. N.J.S.A. 26:2H-7. The

HCFPA dictates that no CN shall be issued unless the action proposed in the

application is

            necessary to provide required health care in the area to
            be served, can be economically accomplished and
            maintained, will not have an adverse economic or
            financial impact on the delivery of health care services
            in the region or Statewide, and will contribute to the
            orderly development of adequate and effective health
            care services.

            [N.J.S.A. 26:2H-8.]

Specifically, in assessing a CN, the Commissioner of Health must consider:

            (a) the availability of facilities or services which may serve
            as alternatives or substitutes,

            (b) the need for special equipment and services in the area,

            (c) the possible economies and improvement in services to
            be anticipated from the operation of joint central services,

            (d) the adequacy of financial resources and sources of
            present and future revenues,

            (e) the availability of sufficient manpower in the several
            professional disciplines, and

            (f) such other factors as may be established by regulation.

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            The State Health Plan may also be considered in
            determining whether to approve a certificate of need
            application.

            [N.J.S.A. 26:2H-8.]

The DOH is required to consider this criterion in determining whether to grant a CN.

The process may be done on an "expedited" basis, which dispenses with the

otherwise necessary secondary review by the State Health Planning Board and

leaves it entirely in the hands of the DOH. N.J.A.C. 8:33-4.1(b).

      Regulations adopted under the HCFPA "establish standards and general

criteria for the planning of cardiac diagnostic facilities and for the preparation

of an application for a [CN] for such a facility." N.J.A.C. 8:33E-1.1(a). Invasive

cardiac diagnostic facilities must meet the minimum standards and criteria set

forth in N.J.A.C. 8:33E-1.1(d).         Because "[t]he American College of

Cardiology/American Heart Association Task Force supports the position that

the safety and efficacy of laboratory performance requires a caseload of

adequate size to maintain the skills and efficacy of the staff[,]" N.J.A.C. 8:33E -

1.1(c), "[u]tilization criteria for all invasive cardiac diagnostic facilities are

based on the number of patients upon whom invasive cardiac diagnostic

procedures . . . are performed." N.J.A.C. 8:33E-1.4(a).

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      Specifically, all facilities licensed to provide invasive cardiac diagnostic

services pursuant to low-risk catheterization facility standards must maintain a

minimum of 200 adult cardiac catheterization patients per year. N.J.A.C. 8:33E-

1.4(c)(1).   All facilities licensed to provide full-service invasive cardiac

diagnostic services must maintain a minimum of 400 adult cardiac

catheterization patients per year.      N.J.A.C. 8:33E-1.4(b)(1).      The volume

requirements are calculated based on the last four quarters of operation prior to

the facility's licensure anniversary date. N.J.A.C. 8:33E-1.4(b)(1). Applications

to provide new full-service invasive cardiac diagnostic services are limited to

             [l]icensed providers of low-risk cardiac catheterization
             services that have demonstrated full unconditional
             compliance with State licensure requirements that
             includes . . . compliance with the minimum annual
             facility volume requirement for full[-]service cardiac
             catheterization (that is, 400 cases) . . . throughout their
             . . . most recent four quarters of operation . . . .

             [N.J.A.C. 8:33E-1.15(a)(1).]

      "Pursuant to the Planning Act, and specifically N.J.S.A. 26:2H-7, no

health care facility, including a hospital, may construct new facilities, expand

existing ones, or initiate a new health care service, unless a CN has been applied

for by the facility and granted by the Commissioner." In re Certificate of Need

for the Mem. Hosp. of Salem Cnty., 464 N.J. Super. 236, 247 (App. Div. 2020).

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"The ultimate policy goals of the Planning act are to 'protect and promote the

health of the inhabitants of the State' and to 'guard against the closing of

important institutions and the transfer of services from facilities in a manner that

is harmful to the public interest.'" Id. at 247-48 (quoting N.J.A.C. 8:33-1.1(a)).

Further, the Planning Act states that the Commissioner shall not grant a CN

unless the proposal:

            is necessary to provide required health care in the area
            to be served, can be economically accomplished and
            maintained, will not have an adverse economic or
            financial impact on the delivery of health care services
            in the region or [s]tatewide, and will contribute to the
            orderly development of adequate and effective health
            care services.

            [N.J.S.A. 26:2H-8.]

      In determining whether to grant a CN, the Commissioner shall consider:

            (a) the availability of facilities or services which may
            serve as alternatives or substitutes, (b) the need for
            special equipment and services in the area; (c) the
            possible economies and improvement in services to be
            anticipated from the operation of joint central services,
            (d) the adequacy of financial resources and sources of
            present and future revenues (e) the availability of
            sufficient manpower in the several professional
            disciplines, and (f) such other factors as may be
            established by regulation.

            [Ibid.; see also N.J.A.C. 8:33-4.9(a)(1)-(5); N.J.A.C.
            8:33-4.10(b).]

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      The application and review process regarding CNs is further outlined in

N.J.A.C. 8:33-1.1 to -6.2. In this regard, the applicable regulations provide for

either a full or expedited review of a CN application. N.J.A.C. 8:33-4.1(a) to

(b). As defined by N.J.A.C. 8:33-1.3, a full review includes "the review of an

application by the . . . Planning Board, as well as the Department," while an

expedited review "means the review by the Department of a [CN] application

meeting certain specified criteria" without a Planning Board review.

      On November 2, 2018, the DOH refused to accept CentraState's CN

application for processing because the department found "the [a]pplicant failed

to document full unconditional compliance with the eligibility and appl ication

review criteria set forth in [the regulations]." Specifically, the DOH explained:

            In accordance with N.J.A.C. 8:33E1.15(a)[(1)]
            eligibility     to     initiate   full[-]service    cardiac
            catheterization services is limited to licensed providers
            of low[-]risk cardiac catherization services that have
            demonstrated full unconditional compliance with state
            licensure requirements that includes, but is not limited
            to, compliance with the minimum annual facility
            volume requirement for full[-]service cardiac
            catheterization of 400 cases with the most recent data
            available to the [DOH]. The [a]pplicant has not met the
            eligibility criteria in that the most recent licensure of its
            low[-]risk cardiac catheterization program is
            conditional (effective May 1, 2018) and the
            [a]pplicant's low[-]risk cardiac catheterization program
            performed only 154 adult diagnostic cardiac

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            catheterization cases for the four quarters ended March
            31, 2018.

The DOH refused to process the application because CentraState did not meet

the threshold eligibility criteria. CentraState's licensure of its low-risk cath lab

was conditional, effective May 1, 2018, and it performed only 154 adult

diagnostic cardiac catheterization cases for the four quarters ending March 31,

2018, making it ineligible to apply for a full-service cath lab. See N.J.A.C.

8:33E-1.15(a)(1) (limiting applications for new full-service cath labs to

"[l]icensed providers of low-risk cardiac catheterization services that have

demonstrated full unconditional compliance with State licensure requirements

[including], . . . compliance with the minimum annual facility volume

requirement" of 400 cases).

      CentraState does not contend that the DOH should have considered its

application because it met the regulatory requirements, but instead, that those

requirements should be disregarded. CentraState cites Irvington General for the

principle that the DOH erroneously relied on the case volume requirement in its

refusal to process the application and it should have instead relaxed its standards

in order to ensure the special need cited in its application was met.

      In Irvington General, the hospital submitted an application for a CN

seeking to construct an addition to its building and to add two surgical beds, six

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intensive care units, and seventeen intermediate care beds, which are essentially

the equivalent of surgical beds. 149 N.J. Super. at 464. While the application

was pending, the Health Care Administration Board reclassified 150 long-term

care beds at another hospital to surgical beds, thereby creating an excess of the

type in Essex County. Id. at 465. The hearing officer then recommended the

application be denied solely on that ground. Ibid.

      On appeal, we held that while the hearing officer "was permitted to

consider the latest statistics on bed need at the time of the remand hearing[,]" it

did not mean "those figures [could] be the sole determinative factor." Id. at 466.

We cited N.J.S.A. 26:2H-8, emphasizing that certificates are issued upon a

showing that the action "is necessary to provide required health care in the area

to be served, can be economically accomplished and maintained, and will

contribute to the orderly development of adequate and effective health care

services[,]" taking into account the several enumerated factors. Ibid.

      In that case, we concluded the hearing officer erroneously rejected the

application as not "necessary" to provide health care services to the area, only

citing "the availability of facilities or services which may serve as alternatives

or substitutes" as a factor in the decision, without reference to the others. Id. at

467 (citing N.J.S.A. 26:2H-8). We remanded for consideration of all the factors

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set out in N.J.S.A. 26:2H-8, specifically, "the need for special . . . services in

the area" for the Township of Irvington's large density of citizens over the age

of sixty-five. Id. at 467-68.

      CentraState argues the holding in Irvington General requires this court to

reverse the DOH decision in this case because the DOH wrongly relied

exclusively on the 400-case volume requirement to the exclusion of other CN

factors and because the DOH failed to recognize the special need for full

services among the residents aged sixty-five and older living within the

hospital's PSA.

      First, CentraState argues that the DOH's sole reliance on the 400-case

volume requirement is the equivalent of its erroneous reliance on bed statistics

in Irvington General because the decision similarly ignores the remaining CN

statutory factors. CentraState contends the DOH reached its decision by only

considering the sixth statutory factor, "such other factors as may be established

by regulation[,]" to the exclusion of the others, including "the need for special

equipment and services in the area" when it refused to process the application

citing N.J.A.C. 8:33E-1.15(a)(1). And, CentraState claims the DOH's neglect

of the remaining factors was at odds with the statute and the holding of Irvington

General, and therefore, constituted improper ultra vires action.

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      CentraState cites the 487 patients from its PSA who had to inconveniently

undergo low-risk cardiac catheterizations at other hospitals because of

CentraState's limited services, as well as the rapidly growing elderly population

in the area, as support for its argument that the CN is "necessary to provide

required health care in the area to be served." N.J.S.A. 26:2H-8. CentraState

also emphasizes that it requires no additional construction or improvement to its

facilities if the CN is granted, showing that the action can easily be

"economically accomplished and maintained." Ibid.

      CentraState additionally notes that there is no indication there will be "an

adverse economic or financial impact on the delivery of health care services in

the region or Statewide" if the CN is granted and argues that its history of highly-

rated service will translate to the "orderly development of adequate and effective

health care services" in the full-service cath lab. Ibid. CentraState maintains

that the DOH erroneously ignored its satisfaction of all of the elements of

N.J.S.A. 26:2H-8 and relied solely on the outdated case volume requirement to

deny its application.

      Whether CentraState made a showing under the statutory factors is

irrelevant and the holding of Irvington General is inapplicable here.

CentraState's argument focuses on N.J.S.A. 26:2H-8, and emphasizes that it has

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                                        21
met the requirements for a CN to be issued by the DOH. Even if that is true,

however, CentraState failed to meet N.J.A.C. 8:33E-1.15(a)(1), which outlines

the requirements to submit a CN application in the first place.

      The regulatory requirements were intended to "establish standards and

general criteria for the planning of cardiac diagnostic facilities and for the

preparation of an application for a [CN] for such a facility." N.J.A.C. 8:33E -

1.1(a). The requirement for submission of a CN application to provide full-

service invasive cardiac diagnostic services, relevant to the issue in this case,

includes the applicant be a "[l]icensed provider[] of low-risk cardiac

catheterization services" that has complied with the State's licensure

requirements, including "with the minimum annual facility volume requirement

for full[-]service cardiac catheterization (that is, 400 cases) as set forth at

N.J.A.C. 8:33E-1.4(b)(1) . . . ." N.J.A.C. 8:33E-1.15(a)(1). The reason this

requirement is important is because "the safety and efficacy of laboratory

performance requires a caseload of adequate size to maintain the skills and

efficiency of the staff." N.J.A.C. 8:33E-1.1(c).

      Here, the record is clear that CentraState's low-risk cardiac catheterization

program was conditional, effective May 1, 2018, and performed only 154 adult

diagnostic cardiac catheterization cases in the relevant period, plainly failing to

                                                                           A-1605-18T3
                                       22
satisfy the 400-case requirement.        Because CentraState did not meet the

"[e]ligibility for submission of [CN] applications[,]" the content of its

application was immaterial. The question of whether a CN should be granted

only arises when an application is properly submitted. See N.J.A.C. 8:33E-

1.15(a)(1). Therefore, whether CentraState met the statutory factors of N.J.S.A.

26:2H-8 is not germane to our analysis.

             In Irvington General, the hospital's application was submitted to the

DOH and accepted for consideration. See id. at 464-65. Upon evaluation of the

application, the hearing officer recommended the request be denied and the

Board agreed based on the bed statistics in the county. Id. at 465. We remanded

the matter because the DOH focused entirely on "the availability of facilities

. . . which . . . serve[d] as alternatives or substitutes" in the area, and ignored the

remaining factors of N.J.S.A. 26:2H-8, including "the need for special

equipment and services in the area." Id. at 468.

      The holding of Irvington General is inapplicable here because, in that

case, the application was properly before the DOH and the issue centered on

whether the DOH should have issued the CN, not on whether the application

should have been submitted at all. Because the application was accepted for

processing, it presumably met the threshold requirements that CentraState failed

                                                                               A-1605-18T3
                                         23
to overcome here, inviting argument on the N.J.S.A. 26:2H-8 factors. Therefore,

Irvington General simply does not and cannot stand for the principle that the

DOH has an obligation to address the statutory factors, including a special need

for services, when the applicant has not demonstrated a threshold eligibility to

apply.

      Because the volume requirement is not one of the factors the DOH must

consider when issuing a CN, but instead, a threshold consideration for

submission of the application, the DOH did not wrongly rely on it to the

exclusion of any N.J.S.A. 26:2H-8 factors. Instead, the DOH's refusal to process

CentraState's CN application was consistent with the regulatory requirements

adopted under the HCFPA and the principles articulated in Irvington General.

      CentraState also argues that, like in Irvington General, the DOH failed to

adequately consider the CN factors, including "the need for special . . . services

in the area." N.J.S.A. 26:2H-8(b). It argues that the DOH in this case similarly

ignored the large density of elderly citizens in the area and the lack of adequate

transportation to other hospitals in the county. Because the DOH failed to

account for the special unmet need for cardiac services in its PSA, CentraState

contends the DOH refusal of its application was in error.

                                                                          A-1605-18T3
                                       24
      While in the Irvington General matter we faulted the DOH for relying

solely on bed need statistics and not the special need articulated in the hospital 's

application when evaluating its expansion request, the DOH in the matter under

review was not required to consider the substance of the application because the

requirements for submitting the application were not met. While CentraState

argues the DOH overlooked its articulated "special need," which it identifies as

a large density of elderly persons within its PSA and lack of public

transportation to and from the area, the DOH had no obligation to consider that

factor or any other in its determination of whether CentraState could submit a

CN application at all.

      Moreover, the facility volume requirement for submission of a CN

application in N.J.A.C. 8:33E-1.15 is clearly a threshold issue in respect of the

DOH's consideration of whether to issue the requested relief in that application.

Accordingly, the DOH did not improperly ignore the special need asserted by

CentraState, but instead, properly refused to process its application for a

different reason entirely – that the hospital failed to maintain a caseload of

adequate size to demonstrate the skills and efficiency of its staff, necessary to

sustain a full-service cath lab. We conclude that the DOH complied with express

                                                                             A-1605-18T3
                                        25
legislative policies and did not act in an arbitrary, capricious, or unreasonable

manner. In re Herrmann, 192 N.J. 19, 27-28 (2007).

      CentraState next contends that the applicable DOH regulations impose

two different, incongruent volume requirements and are therefore, internally

inconsistent.   Further, CentraState claims that those same regulations are

contrary to law and modern science and should not be arbitrarily used to

summarily reject its application. Specifically, CentraState challenges the DOH's

interpretation of the regulation, calling it unreasonable and unsupported by the

record, because it: (1) creates volume prerequisites for CN applicants that

newly-licensed full-service cath labs do not need to demonstrate until their

second year of operations; (2) doubles the number of annual low-risk cases a

low-risk cath lab must perform; and (3) ignores modern science, including DOH

expert recommendations.

      CentraState identifies the interplay between N.J.A.C. 8:33E-1.15 and

N.J.A.C. 8:33E-1.4 as problematic. The former sets forth the prerequisites for

the DOH to consider a CN application by a low-risk cath lab seeking to operate

as a full-service cath lab.   The relevant language of N.J.A.C. 8:33E-1.15

includes:

            Eligibility for the submission of such applications will
            be limited to the following:

                                                                         A-1605-18T3
                                      26
           Licensed providers of low-risk cardiac catheterization
           services that have demonstrated full unconditional
           compliance with State licensure requirements that
           includes, but is not limited to, compliance with the
           minimum annual facility volume requirement for
           full[-]service cardiac catheterization (that is, 400 cases)
           as set forth at N.J.A.C. 8:33E-1.4(b)[(1)] throughout
           their second year of operation or their most recent four
           quarters of operation, whichever is later . . . .

The latter regulation, incorporated by N.J.A.C. 8:33E-1.15(a)(1), more

thoroughly outlines the existing volume requirement:

           [F]acilities licensed to provide full[-]service invasive
           cardiac diagnostic services shall, as a condition of
           continued licensure, be required to maintain the
           following basic utilization criteria:

           . . . The minimum acceptable number of adult cardiac
           catheterization patients per full[-]service cardiac
           laboratory is 400 per year. New full[-]service providers
           (those previously operating as low[-]risk cardiac
           catheterization        laboratories)    must     provide
           documentation of full compliance with the minimum
           utilization level during their second year of operation
           or their most recent four quarters of operation,
           whichever is later and fully documented by the
           Department using audited data. Existing full[-]service
           invasive cardiac diagnostic providers (with or without
           cardiac surgery on site) must achieve minimum
           utilization levels each year. Compliance with minimum
           annual facility volume requirements will be calculated
           on the basis of the last four quarters of operation prior
           to the facility's licensure anniversary date.

           [N.J.A.C. 8:33E-1.4(b)(1).]

                                                                         A-1605-18T3
                                      27
      CentraState contends that when both regulations are considered together,

they require only that CentraState demonstrate at the time it applies for a CN,

compliance with a 200-case volume and the ability to comply with a 400-case

volume by its second year of operation as a new full-service cath lab.

CentraState supports that position by arguing that a regulation requiring a new

facility to artificially meet the 400-case requirement of only low-risk

catheterizations is arbitrary and capricious, serving no logical objective.

Because CentraState identified over 400 patients it served or would have served

if it had the capacity of a full-service cath lab, CentraState claims to have met

the proper interpretation of the requirement.

      We interpret regulations de novo. US Bank, N.A. v. Hough, 210 N.J. 187,

198-99 (2012) (citing Bedford v. Riello, 195 N.J. 210, 221-22 (2008)). In doing

so, we review the intent of the drafter as the paramount goal, which is generally

"found in the actual language of the enactment." Id. at 199. It is not the court's

function to "rewrite a plainly-written enactment" or "presume that the drafter

intended a meaning other than the one 'expressed by way of the plain language.'"

Ibid. (quoting DiProspero v. Penn, 183 N.J. 477, 492 (2005)). We simply

construe the regulation as written. Ibid.

                                                                          A-1605-18T3
                                       28
      N.J.A.C. 8:33E-1.4(c)(1) is clear, and CentraState agrees, that all low-risk

catheterization facilities are required to meet the acceptable volume number of

200 cases per year.     CentraState also concedes that it is evident from the

regulation's language that a full-service cath lab is required to maintain a volume

of 400 cases per year under N.J.A.C. 8:33E-1.4(b)(1). However, CentraState

contends the error in the DOH interpretation was that new full-service providers

are not required to maintain a 400-case volume before applying for a CN like

already operating full-service cath labs, but must alternatively show a

compliance with the 200-case volume requirement and an ability to comply with

the 400-case volume requirement by the second year of operation. We disagree.

      N.J.A.C. 8:33E-1.15(a)(1) clearly requires that low-risk cath labs seeking

to submit a CN application to become full-service cath labs must demonstrate a

compliance with all State licensure requirements including "compliance with the

minimum annual facility volume requirement for full-service cardiac

catheterization (that is, 400 cases)" as set forth at N.J.A.C. 8:33E-1.4(b)(1). The

language clearly indicates that for a low-risk cath lab to become a full-service

cath lab, the low-risk cath lab must not simply show that it can comply with the

minimum annual facility volume requirement for a full-service cath lab, but

                                                                           A-1605-18T3
                                       29
actually comply with that requirement. To hold otherwise would ignore the

plain language of the regulation.

         Instead, when read in conjunction with other regulatory provisions, it is

apparent the regulation's intent was to impose a more stringent standard on low-

risk cath labs seeking to provide full cardiac catheterization services, as opposed

to low-risk cath labs simply seeking to comply with their current 200-case

minimum to maintain low-risk licensure. See N.J.A.C. 8:33E-1.1(c) ("[T]he

safety and efficacy of laboratory performance requires a caseload of adequate

size to maintain the skills and efficiency of the staff."); N.J.A.C. 8:33E-1.4(a)

("Utilization criteria for all invasive cardiac diagnostic facilities are based on

the number of patients upon whom invasive cardiac diagnostic procedures

(cardiac catheterization) are performed."). CentraState's proposed interpretation

of the regulation is inconsistent with the statute's clear language and common

sense.

         It is beyond cavil that a reading of the two regulatory requirements makes

clear CentraState had to maintain a 400-case volume throughout its second year

of operation or its most recent four quarters of operation, whichever was later,

in order to meet the requirements for submission of the CN application for a

full-service cath lab. The low-risk lab was required to demonstrate an ability of

                                                                           A-1605-18T3
                                         30
its staff and facilities to meet and maintain a 400-case volume, which would

become its new minimum if approved for full-service, before requesting that the

DOH consider making that number permanent.                  Therefore, we reject

CentraState's statutory argument to the contrary as it is unsupported by the

statute's language and clear intent to test the efficacy of the lab's performance

before considering its application for expansion.

      CentraState also challenges the notion that the 400-case volume

requirement serves as a necessary means of maintaining quality of full-service

cath labs, calling it contrary to undisputed scientific evidence. In support of this

argument, CentraState points to the Cardiovascular Health Advisory Panel

(CHAP), a group created by N.J.A.C. 8:33E-1.14 to provide the Commissioner

with expert clinical and technical advice related to cardiovascular health policy,

which opined against the volume requirement in favor of more relaxed standards

to increase cardiac care providers in 2011. Specifically, CentraState highlights

CHAP's recommendations to abandon low-risk cath lab designations altogether,

to require low-risk facilities transitioning to full-service cath labs to perform a

minimum of 250 cases in the second year after transition to the new level of

service, and to permit the Commissioner to waive annual volume requirements

under certain circumstances.

                                                                            A-1605-18T3
                                        31
      More recently, CentraState highlights the current legislative undertakings

to update the medical regulatory standards.       CentraState contends pending

legislation focuses on eliminating distinctions between low-risk and full-service

cath labs, reducing the 400-case volume requirement to 250 cases, providing a

two-year transition periods for new full-service cath labs to meet volume

requirements, and codifying the Commissioner's waiver authority.           See S.

2427/A. 3769 (2018). However, CentraState explains that, after a decade of

governmental inaction and the stall of the relevant bill before the July 2019

recess, it has no confidence a legislative solution is forthcoming and requests a

favorable decision by this court.       CentraState contends that the CHAP

recommendations and pending bill reflect the scientific advancements in

cardiovascular services, lessening the need for strict regulatory oversight.

      Saliently, CHAP's 2011 recommendations have not been implemented and

the pending legislation has not been signed into law. Therefore, the adopted

regulations remain unchanged and serve as the governing law in this case. See

Johnson v. Roselle EZ Quick LLC, 226 N.J. 370, 389 (2016) (alterations in

original) (quoting James v. N.J. Mfrs. Ins. Co, 216 N.J. 552, 573 (2014)) ("For

example, a party may not rely on pending legislation because '[t]he possibility

that a bill might become law is an expectation built on uncertainty until it

                                                                          A-1605-18T3
                                       32
happens.'"); Cty. of Hudson v. Dep't of Corr., 152 N.J. 60, 71 (1997)

("[A]lthough an administrative agency may change its regulations, so long as

they are in force the agency is bound by them."). Because the regulations are

clear and consistent, and it is not the court's function to "rewrite a plainly-written

enactment," Hough, 210 N.J. at 199, we see no basis to reverse the DOH denial

of CentraState's CN application.

      CentraState next argues that the DOH failed to properly assess and

acknowledge all the CN factors as required, and instead, mechanically applied

the regulatory standard. CentraState contends the DOH was responsible for

considering its "special need" argument on the merits, and since the DOH chose

to reject the application, it was responsible for providing a reasoned explanation

for why the DOH believed that need was not established. In the alternative to

granting a full-service cath lab, CentraState seeks to have the matter remanded

to the DOH with instructions that it: (1) accept the application for processing;

(2) review the evidence within the application regarding the articulated need;

(3) grant or deny the CN based on those facts; and (4) issue findings and

conclusions of law on the merits. CentraState further requests that the DOH

complete its review within thirty days of remand.          We reject CentraState's

arguments.

                                                                              A-1605-18T3
                                         33
      Here, the DOH was not obligated to address CentraState's "special need"

argument on the merits because the CN application was not accepted for

processing for failing to satisfy the eligibility and application review criteria of

the regulations. The application did not even make it to the point of the process

where the DOH was supposed to review its substance. Without that review,

there can be no findings.

      A CN application will only be accepted for review when a "[l]icensed

provider[] of low-risk cardiac catheterization services . . . ha[s] demonstrated

full unconditional compliance with State licensure requirements that includes

. . . compliance with the minimum annual facility volume requirement for

full[-]service cardiac catheterization (that is, 400 cases) . . . " at the designated

time. N.J.A.C. 8:33E-1.15(a)(1). Here, CentraState's most recent licensure was

conditional, effective May 1, 2018, and the low-risk cath lab only performed

154 adult diagnostic cardiac catheterizations for the most recent four quarters

ending March 31, 2018.

      We reiterate that CentraState failed to meet the eligibility criteria to even

apply for the full-service cath lab, which was the basis of the DOH's rejection.

The DOH explained in its rejection letter:

             Please be advised that the above-referenced [CN]
             application to initiate full[-]service adult cardiac

                                                                             A-1605-18T3
                                        34
            catheterization, submitted for consideration on August
            1, 2017, cannot be accepted for processing . . . . The
            [DOH] approved [CentraState's] requested six-month
            deferral of the above noted CN application . . . effective
            January 8, 2018 through July 8, 2018. Upon the
            [a]pplicant's decision to reactivate the CN application,
            the [DOH] finds the [a]pplicant has failed to document
            full unconditional compliance with the eligibility and
            application review criteria set forth at N.J.A.C. 8:33E-
            1.3 through 1.10.

            In accordance with N.J.A.C. 8:33E-1.15(a)[(1)]
            eligibility to initiate full[-]service cardiac catherization
            services is limited to licensed providers of low[-]risk
            cardiac catheterization services that have demonstrated
            full unconditional compliance with state licensure
            requirements that includes, but is not limited to,
            compliance with the minimum annual facility volume
            requirement for full[-]service cardiac catherization of
            400 cases with the most recent data available to the
            [DOH]. The [a]pplicant has not met the eligibility
            criteria in that the most recent licensure of its low[-]risk
            cardiac catheterization program is conditional
            (effective May 1, 2018) and the [a]pplicant's low[-]risk
            cardiac catheterization program performed only 154
            adult diagnostic cardiac catheterization cases for the
            four quarters ended March 31, 2018.

      We are satisfied the DOH provided a reasoned explanation for its rejection

of the application according to the regulatory guidelines and was not required to

address the substance of the application at that time. The findings of fact and

conclusions of law on the "special need" issue were irrelevant to the DOH's

                                                                           A-1605-18T3
                                       35
decision at this point, and not required in its initial rejection of the CN

application.

                                         III.

       Applying the same considerations to the matter under docket number A-

1606-18, we similarly reject CentraState's argument that the DOH improvidently

disqualified its application for primary PCI services summarily because the

hospital did not operate a full-service adult diagnostic cardiac cath lab for at

least six months. Again, we conclude that the DOH properly refused to process

CentraState's application because it did not meet the threshold eligibility

criteria.

       On November 2, 2018, the DOH refused to accept CentraState's CN

application for processing because the department found "the [a]pplicant failed

to document full unconditional compliance with the eligibility and application

review criteria set forth in N.J.A.C. 8:33E-2.16."          Specifically, the DOH

explained:

               In accordance with N.J.A.C. 8:33E-2.16(a)[(1)]
               eligibility to initiate primary angioplasty (PCI) without
               on-site cardiac surgery backup is limited to any general
               hospital having a full[-]service adult diagnostic cardiac
               catheterization program that has been licensed for at
               least six months as a full[-]service adult diagnostic
               cardiac catheterization program prior to the application
               submission date and has documented, to the satisfaction

                                                                           A-1605-18T3
                                         36
            of the [DOH], licensure and full compliance with all
            cardiac catheterization program and facility utilization
            for the more recent four quarters. The [a]pplicant has
            not met this eligibility criteria in that it is not currently
            licensed as a full[-]service adult diagnostic cardiac
            catheterization program.

      At the time of its application for primary PCI services, CentraState only

operated a low-risk cath lab, and therefore, could not have operated a full-

service cath lab for the requisite six-month period. We agree with the DOH that

CentraState's application was not subject to consideration on that ground. It is

undisputed that at the time it submitted its CN application to provide primary

PCI services, CentraState did not operate as a full-service adult diagnostic

cardiac catheterization program. Indeed, CentraState submitted a simultaneous

application on the same date to become a full-service facility.              We are

unpersuaded by the timing of the applications. Again, because CentraState did

not meet the threshold requirement to submit its CN application, the content of

its application was immaterial. And, whether CentraState met the statutory

factors of N.J.S.A. 26:2H-8 is unavailing.

      In DOH's rejection letter relative to PCI services, it aptly stated:

            Please be advised that the above-referenced [CN]
            application to initiate primary angioplasty (PCI)
            without on-site cardiac surgery backup, submitted for
            consideration on August 1, 2017, cannot be accepted
            for processing . . . .        The [DOH] approved

                                                                             A-1605-18T3
                                        37
            [CentraState's] requested six-month deferral of the
            above noted CN application . . . effective January 8,
            2018 through July 8, 2018. Upon the [a]pplicant's
            decision to reactivate the CN application, the [DOH]
            finds the [a]pplicant has failed to document full
            unconditional compliance with the eligibility and
            application review criteria set forth at N.J.A.C. 8:33E-
            2.16.

            In accordance with N.J.A.C. 8:33E-2.16(a)[(1)]
            eligibility to initiate primary angioplasty (PCI) without
            on-site cardiac surgery backup is limited to any general
            hospital having a full[-]service adult diagnostic cardiac
            catheterization program that has been licensed for at
            least six months as a full[-]service adult diagnostic
            cardiac catheterization program prior to the application
            submission date and has documented, to the satisfaction
            of the [DOH], licensure and full compliance with all
            cardiac catheterization program and facility utilization
            for the more recent four quarters. The [a]pplicant has
            not met this eligibility criteria in that it is not currently
            licensed as a full[-]service adult diagnostic cardiac
            catheterization program.

      We are not persuaded by CentraState's argument that the DOH wrongfully

failed to process its application for permission to expand its service line to

include PCI services. CentraState's remaining arguments are without sufficient

merit to warrant discussion in a written opinion. R. 2:11-3(e)(1)(D).

      Affirmed.

                                                                            A-1605-18T3
                                        38