ORDERS:
FINAL ORDER AND DECISION
STATEMENT OF THE CASE
This matter arises from a Request for a
Contested Case Hearing by Petitioner MRI at Belfair, LLC (Belfair), in which it
contests a decision by Respondent South Carolina Department of Health and
Environmental Control (DHEC or Department) to approve the Certificate of Need (CON)
application of Respondent Coastal Carolina Medical Center (CCMC) for the
addition of a 1.5 T Magnetic Resonance Imaging (MRI) unit at its Jasper County,
South Carolina hospital facility. A hearing in this matter was held at the
offices of the Court in Columbia, South Carolina on August 23, 2005 through
August 25, 2005.
DISCUSSION
The
ultimate issue in this case is whether to grant a CON to CCMC for one fixed MRI. A CON must be obtained from the Department before a new health service may be added by a
health services provider. The State Certification of Need and Health Facility
Licensure Act (Act) creates a CON program that, among other things, requires
health care facilities to apply for and receive, a CON before undertaking
certain projects. See S.C. Code Ann. §§ 44-7-110 to 44-7-240 (2002).
The purpose of the Act, as set forth in Section 44-7-120, is:
[T[o promote cost containment, prevent
unnecessary duplication of health care facilities and services, guide the
establishment of health facilities and services which will best serve public
needs, and ensure that high quality services are provided in health facilities
in this State.
(Emphasis added). To achieve these ends, the Department is required to
prepare a State Health Plan for use in the administration of the CON program.
The Act requires that the CON must comply with the South Carolina State Health
Plan. S.C. Code Ann. § 44-7-210(C) (2002). The 2003 State Health Plan (2003
Plan) is the applicable State Health Plan for consideration and evaluation of
the CON in this case.
SUMMARY
JUDGMENT
Prior to the hearing in this case, both Respondent CCMC and
Petitioner Belfair filed Motions for Summary Judgment. CCMC filed its Motion
for Summary Judgment on the grounds that the 2003 Plan dictates that, as
a hospital, CCMC should have at least one MRI unit available for the diagnosis
of emergency patients, inpatients and outpatients. Accordingly, CCMC argues
that since it does not have a MRI unit it is unconditionally authorized to
receive a MRI unit and, therefore, there is no genuine issue of material fact
to consider in this case. Respondent DHEC joined in Respondent CCMC’s Motion
for Summary Judgment. Subsequently, Petitioner filed its own Motion for
Summary Judgment on the grounds that the 2003 Plan's provisions for MRI services violate the authorizing statute.
Rule
68 of the Rules of Procedure for the Administrative Law Court provides that
“[t]he South Carolina Rules of Civil Procedure may, where practicable, be
applied in proceedings before the Court to resolve questions not addressed by
these rules.” Rule 56(c), SCRCP, and the accompanying case law set forth that a
party may bring a motion for summary judgment.
Petitioner’s
Motion for Summary Judgment
Petitioner
contends that the MRI Standards of the 2003 Plan do not comply with the
requirements set forth in S.C. Code Ann. § 44-7-180 (2002) and 24A S.C. Code Ann
Regs. 61-15
(Supp. 2004).
Section 44-7-180(B) provides, in part:
The plan at
a minimum must include:
* * *
(2) projections of need for additional health care facilities, beds, health
services, and equipment;
* * *
(4)
a general statement as to the project review criteria considered most
important in evaluating certificate of need applications for each type
of facility, services, and equipment, including a finding as to
whether the benefits of improved accessibility to each such type of
facility, service, and equipment may outweigh the adverse affects caused by
the duplication of any existing facility, service or equipment.
The State
Health Plan must address and include projections and standards
for specified health services and equipment which have a potential to
substantially impact health care costs and accessibility.
(Emphasis
added). As set forth above, at the time the application in the present case
was filed, the 2003 Plan was in effect. That 2003 Plan provides two specific
standards for MRIs as follows:
(1) Each
hospital should have at least one MRI unit available for diagnosis of emergency
patients, inpatients and outpatients.
(2) In order to
promote cost-effectiveness, the use of shared mobile MRI units should be
considered.
Petitioner argues
that the 2003 Plan fails to set forth any projection of need and standards for
MRI services and equipment as required by the CON Act, and, therefore, by
relying on the 2003 Plan in granting the CON to CCMC, the Department exceeded
its statutory authority.
Summary
Judgment is appropriate when it is clear there is no genuine issue of material
fact and the moving party is entitled to judgment as a matter of law. Rule 56,
SCRCP; Vermeer Carolina’s, Inc. v. Wood/Chuck Chipper Corp., 336
S.C. 53, 518 S.E.2d 301 (Ct. App. 1999). In determining whether any triable
issue of fact exists such as to preclude summary judgment, the evidence and all
inferences reasonably drawn therefrom must be viewed in the light most
favorable to the non-moving party. Strother v. Lexington County Recreation Comm’n., 332 S.C. 54, 504 S.E.2d 117 (1998). Moreover, “[s]ummary
judgment is not appropriate where further inquiry into the facts of the case is
desirable to clarify the application of the law.” Middleborough Horizontal Property Regime Council of Co-Owners v. Montedison S.p.A., 320
S.C. 470, 479, 465 S.E.2d 765, 771 (Ct. App. 1995).
Here,
the 2003 Plan sets forth that each hospital should have an MRI unit available
for emergency patients, inpatients and outpatients. Whether that projection is
sufficient and whether the ALC can question the efficacy of the 2003 Plan are
questions that warrant inquiry into the facts of the case to clarify the application
of the law. Accordingly, Petitioner’s Motion for Summary Judgment is denied.
Respondent
CCMC’s Motion for Summary Judgment
The
basis for Respondent CCMC’s Motion for Summary Judgment is that CCMC is a
hospital, and, therefore, pursuant to the 2003 Plan, its application for a CON
for an MRI should be granted. Therefore, Respondent CCMC submits that under
the 2003 Plan there is no need to demonstrate: (a) Community Need
Documentation; (b) Distribution (Accessibility); (c) Acceptability; and (d)
Cost Containment.
Here,
the very language of the 2003 Plan reflects that each hospital have at least
one MRI unit “available for diagnosis of emergency patients, inpatients and
outpatients.”[2] Furthermore, the undisputed evidence established that in the 2003 Plan the DHEC
Board, in keeping with the State Health Planning Committee, made a public
policy decision that each hospital, if it could afford it, should have an MRI.
In other words, each hospital needs an MRI. Moreover, the Board eliminated the
requirement in the 2003 Plan that a hospital applying for a MRI must address
the utilization of existing resources in order to be approved for its first
MRI.
Summary
judgment is appropriate where “the pleadings, depositions, answers to
interrogatories, and admissions on file, together with affidavits, if any, show
that there is no genuine issue as to any material fact and that the moving
party is entitled to a judgment as a matter of law.” Rule 56(c), SCRCP; see also Tupper v. Dorchester County, 326 S.C. 318, 487 S.E.2d 187
(1997). Furthermore, where “plain, palpable and indisputable facts exist on
which reasonable minds cannot differ,” summary judgment in favor of the moving
party is proper. Williams v. Chesterfield Lumber Co., 267 S.C. 607,
610, 230 S.E.2d 447, 448 (1976).
I find that the MRI standards under the 2003 Plan do not
require CCMC to establish: (a) Community Need Documentation; (b) Distribution
(Accessibility); (c) Acceptability; and (d) Cost Containment. Accordingly, since
there is no genuine issue of material fact regarding those criteria, I find
that Respondent CCMC’s Motion for Summary Judgment should be granted, in part.
Nevertheless, there is a question of material fact as to whether CCMC needs an
MRI “available for diagnosis of emergency patients, inpatients and
outpatients,” and whether “the use of shared mobile MRI units should be considered”
in determining availability. Since these issues warrant further inquiry, I
find that summary judgment is not justified regarding those specific issues.
FINDINGS
OF FACT
Having
observed the witnesses and exhibits presented at the hearing and closely passed
upon their credibility, taking into consideration the burden of persuasion of
the Petitioner and the Respondents, I make the following findings of fact by a
preponderance of evidence:
1. Notice
of the date, time, place and subject matter of the hearing was properly given
to all the parties.
2. CCMC is a forty-one (41) bed hospital
located in Jasper County, South Carolina, which opened to the public in
November 2004. The hospital is open twenty-four hours a day, seven days a week.
It has an emergency room which is also open twenty-four hours a day, seven days
a week. The facility is located near Interstate 95 (I-95) and its primary service
area is Jasper and Beaufort Counties. The area serves a full-time population
as well as a large vacation population. Moreover, it is anticipated that by
2006 over 48,000 people will reside full-time in this service area. Additionally,
due to its proximity to I-95, CCMC frequently receives patients injured in traffic
accidents as well as those in need of treatment for other reasons. As a result,
its emergency room is often busy.
After it began its initial operation, CCMC
determined that it needed an MRI scanner. The use of MRI scans is ever
increasing in South Carolina. The scans have become a commonplace diagnostic
modality and are being used by physicians with greater frequency as a
diagnostic tool to analyze conditions of the spine, brain, abdomen and other
parts of the body. The use of an MRI can eliminate the need for other more
invasive tests, in addition to reducing risk and discomfort to the patient. New
uses for MRIs are also continually being discovered. At present, no MRI
services are available in Jasper County.
In accessing its needs for an MRI unit, CCMC
considered the use of a shared mobile MRI unit. CCMC determined, however, that
a shared unit would not meet the needs of its patients. Rather, CCMC concluded
that a fixed base MRI would best meet the needs of its patients and physicians
who utilize the hospital. In making its decision, CCMC considered immediate
accessibility for patients and physicians and convenience for the inpatients
and outpatients. It also considered the number of patients that would be seen
in CCMC’s emergency room, that it was located in a growing community, and the
accessibility of the hospital from I-95, Jasper County, and southern Beaufort County, among other things.
Therefore, on May 7, 2004, CCMC submitted to the
Department an application for a CON to purchase a GE Signa LX 1.5 Tesla MRI to be located in its existing facility. The total project cost is $3.2 million dollars. The
application for the CON was submitted pursuant to the 2003 State Health Plan.
The Department determined that the CCMC CON application was consistent with the
applicable standards in the 2003 Plan and approved the issuance of the CON by
letter dated November 22, 2004.
After the Department issued its decision, Petitioner requested a contested case
hearing by letter dated November 24, 2004.
3. Petitioner
Belfair is a free-standing imaging facility providing MRI services in Bluffton, South Carolina. It is located approximately 13.8 miles from CCMC in Beaufort County. Belfair is a limited liability corporation owned by Albert J. Borelli, Jr., M.D. Dr. Borelli is the sole practitioner. He personally reads the MRI scans at Belfair and is only open for business from 7:00 a.m. to 6:00 p.m., Monday through
Friday. Belfair, however, currently has no on-call responsibilities with any
health care facilities.
4. Petitioner
Belfair contends that the existing MRI facilities provide sufficient capacity
for diagnosis of emergency patients, inpatients, and outpatients without CCMC having
a fixed, in-house MRI unit on-site. Dr. Borelli argues that the hospital would
not have “an overwhelming number of scans” and could, therefore, contract with
providers of mobile MRI services or use existing MRI centers for outpatients. Inpatients
and emergency patients could be accommodated by an on-site mobile unit, or, if
the mobile unit was not there when it was needed, CCMC could have a transfer
agreement with another facility.
However,
Dr. Dean Vincent Moesch, a radiologist with Chatham Radiologists which currently
provides most of the radiology services to CCMC, testified that the MRI needs
to be available 24/7 at CCMC for emergency trauma patients from traffic accidents
alone. Furthermore, the image quality from a mobile unit is generally not as
good as a fixed site scanner. Most of the existing mobile MRI units are older,
lower-cost equipment with smaller magnets. Thus, the mobile and “free-standing”
fixed MRI units are usually less effective diagnostic tools.
Additionally,
although ten (10) MRI units exist in Beaufort County, including both mobile and
fixed MRI units, numerous problems result from a hospital depending on a mobile
unit or having to transfer a patient. CCMC is open twenty-four hours a day,
seven days a week. To the contrary, a mobile unit is usually present only
three days a week and a patient must wait for the unit to return to the
hospital.
Furthermore, the free-standing MRI providers, such as Belfair, are not open
twenty-four hours a day, seven days a week. Other MRI units are in physician
offices and limited to use for patients of those particular practices.
Accordingly, use of such facilities could unreasonably delay the diagnosis by
the physician, which can alter the type of treatment the physician orders in
the interim. The patient’s length of hospital stay may also be extended,
resulting in an increased cost to the patient and his insurer.
Furthermore,
even if another MRI unit is open, transporting a patient has its own risks.
Without an on-site MRI unit, if a CCMC physician determines that an inpatient
should have an MRI scan, the hospital must locate a provider that has the
availability to administer the MRI, determine if the patient is stable enough
to be transported, determine if the patient needs a nurse or other caregiver to
accompany the patient, locate appropriate transportation (either ambulance or
van), load the patient, and then transport the patient. A transferred inpatient
must leave the safety net of services and providers who are on site in the hospital,
which can produce additional stress and harm to the patient. There may also be
an interruption in the patient receiving necessary medications. In addition,
there is always the possibility an ambulance could be involved in an accident
while transporting the patient. Moreover, both CCMC and Belfair are located
near Hilton Head, South Carolina. The area has a substantial increase in
tourist population at different times of the year. The traffic and the travel
time between CCMC and any of the other providers of MRI services depends on a
number of factors, including the time of year, the time of day, traffic
congestion, and highway construction and maintenance. Therefore, transferring
patients interrupts the continuity of care of the patient, delays the patient
receiving services at the hospital, and is inconvenient to the patient and the
family. The process can potentially jeopardize patient care.
Currently,
if a patient presents to the CCMC emergency room and the physician determines
an MRI is necessary, the patient generally will be transferred to hospitals
located in Savannah, Georgia, which is about forty (40) to forty-five (45) minutes
from CCMC. The result is that a Jasper County resident has to leave his home
and family to go out of state to receive medical care. In addition, the
patient will generally be admitted for the rest of the patient’s care at the
receiving facility rather than be transported back to CCMC. Accordingly, only
small, rural hospitals in South Carolina “that absolutely do not have the
funding” are using mobile MRI units.
5. Therefore,
though the current need for urgent MRI scans at CCMC may be limited, I find
that upon considering the impact to CCMC’s emergency patients and inpatients,
the existing MRI facilities in the area do not sufficiently meet the hospital’s
needs of “availability” to warrant disapproving CCMC’s fixed, in-house MRI.
CONCLUSIONS
OF LAW
Based
upon the foregoing Findings of Fact, I conclude the following as a matter of
law:
1. The
Administrative Law Court has jurisdiction over CON contested case proceedings
and consequently over this matter pursuant to S.C. Code Ann. § 44-7-210 (2002)
and § 1-23-600(B) (Supp. 2002). An Administrative Law Judge’s review of an
administrative decision of the Department to grant a CON request is governed by
S.C. Code Ann. § 44-7-210(E) (2002), which provides:
The
department's proposed decision is not final until the completion of
reconsideration or contested case proceedings. The burden of proof in a
reconsideration or contested case hearing must be upon the moving party. The
contested case hearing before the board or its designee is conducted as a
contested case under the Administrative Procedures Act. The issues considered
at the contested case hearing are limited to those presented or considered
during the staff review and decision process.
In contested case hearings, the Administrative Law
Judge is the fact finder. Brown v. S.C. Department of Health and
Environmental Control, 348 S.C. 507, 560 S.E.2d 410 (2002). Furthermore,
Petitioner bears the burden of proving its case by a preponderance of the
evidence. S.C. Code Ann. § 44-7-210(E) (2002); see also Nat’l
Health Corp. v. SCDHEC, 298 S.C. 373, 380 S.E.2d 841 (Ct. App. 1989). In
the present case, Petitioner has the burden of proving by a preponderance of
the evidence that the Department’s recommendation to approve CCMC’s CON
application was in error. Id.
2. As
trier of fact, the Administrative Law Judge (ALJ) is not compelled to accept an
expert’s testimony, but may give it the weight and credibility the ALJ
determines it deserves. Florence County Dep’t. of Social Serv.
v. Ward, 310 S.C. 69, 425 S.E.2d 61 (Ct. App. 1992). Nevertheless, it is
appropriate to give due consideration to the CON staff’s utilization of its
specialized knowledge and expertise in the application of the CON Act and CON
regulations. See S.C. Code Ann. § 1-23-330(4) (Supp. 2002).
3. The
Department administers the CON program for South Carolina pursuant to the State
Certification of Need and Health Facility Licensure Act, S.C. Code Ann. §§
44-7-110, et seq. (2002). Under the Act, before an entity can
operate certain health care facilities and services in South Carolina, the
Department must issue a Certificate of Need to that entity, subject to certain
statutory exemptions. See S.C. Code Ann. §§ 44-7-160 & 44-7-180
(2002). The CON program is also administered under the guidelines of 24A S.C.
Code Ann. Regs. 61-15 (Supp. 2003). Additionally, Section 44-7-210(C) provides
that, “[t]he Department may not issue a Certificate of Need unless an
application complies with the State Health Plan, Project Review Criteria, and
other regulations.” In considering the State Health Plan, the Department’s
decision must be based on the currently approved State Health Plan in effect at
the time such application is accepted. See Regulation 61-15 § 504.
The
Act was enacted to “promote cost containment, prevent unnecessary duplication
of health care facilities and services, guide the establishment of health
facilities and services which will best serve public needs, and ensure that
high quality services are provided in health facilities” in South Carolina.
S.C. Code Ann. § 44-7-120 (2002). Here, CCMC is a health care facility as
defined by the CON Act. S.C. Code Ann. § 44-7-130(10) (2002). Furthermore,
Belfair is an affected party as defined in the CON Act. See S.C. Code
Ann. § 44-7-130(1) (2002).
4. The
CON Act and regulations require that CCMC obtain a CON prior undertaking “the
acquisition of medical equipment which is to be used for diagnosis or treatment
if the total project cost is in excess of that prescribed by regulation.” S.C.
Code Ann. § 44-7-160(6) (2002). A health care facility is required to obtain a
CON before acquiring “medical equipment which is to be used for diagnosis or
treatment if the total project cost is in excess of $600,000” or spending in
excess of $2,000,000 on behalf of a health care facility. S.C. Code Ann. Reg.
61-15 § 102.1(c) and (f)(2002). At the time the Application in the present
case was filed, the 2003 Plan was in effect. The 2003 Plan provides, in
relevant part, as follows:
(1) Each
hospital should have at least one MRI unit available for diagnosis of emergency
patients, inpatients and outpatients.
(2) In order to
promote cost-effectiveness, the use of shared mobile MRI units should be
considered.
The Plan does
not define “available” for purposes of determining whether a CON application
for a MRI unit should be granted. The Department and CCMC interpret the word
“available” in “standard 1” of the 2003 Plan as meaning immediate access
twenty-four hours, seven days a week. Thus, every hospital should be granted a
CON for at least one fixed MRI unit (either within its four walls or in a
permanent facility adjacent to the hospital on its grounds) if the hospital can
afford a unit. In other words, in instances in which a hospital seeks a MRI
unit, the use of shared mobile MRI units is not a consideration.
As
when seeking to determine the meaning of statutes, the rules of statutory
construction apply to the interpretation of the meaning of regulations. See Converse Power Corp. v. South Carolina Dept. of Health and Environment
Control, 350 S.C. 39, 564 S.E.2d 341 (Ct. App. 2002). “Statutes dealing
with the same subject matter must be reconciled, if possible, so as to render
both operative.” Hodges v. Rainey, 341 S.C. 79, 88, 533 S.E.2d 578, 583
(2000). See also Statutes and Statutory Construction, §
46.05, at 154 (6th ed. 2000). (A statute is passed as a whole and not in parts
or sections and is animated by one general purpose and intent. Consequently,
each part or section should be construed in connection with every other part or
section so as to produce a harmonious whole.).[6] The 2003 State Health Plan clearly sets forth the determination that
hospitals need at least one MRI unit available. However, the 2003 Plan
does not set forth that only fixed, in-house units meet the requisite
availability. In other words, the 2003 Plan simply does not set forth a mandatory requirement that “at least one” MRI must be available to all hospitals
without considering shared units.
Furthermore,
there are certainly plausible instances in which both standards would be
applicable to an MRI application by a hospital. Not all hospitals are
necessarily open twenty-four hours, seven days a week or even treat individuals
who would need an MRI. Therefore, “available” as used in the 2003 Plan does
not mean that any hospital is entitled to at least one onsite MRI unit as long
as it can afford the unit. Rather, the application of the above two standards
must be made based upon the facts of the case in light of the MRI needs of the
hospital. Construing “standard 1” as mandatory, without specific language
requiring that reading would render “standard 2” meaningless in all hospital
applications, no matter what the circumstances.
Nevertheless, CCMC is open twenty-four hours a day,
seven days a week. Moreover, CCMC not only treats individuals who would need
MRI scans, but treats individuals who urgently need MRI scans. There are times
when patients are too unstable to be transported off site. Therefore, though “standard
2” may be a consideration, the facts of this case clearly establish that to be
sufficiently “available” to CCMC, it needs a fixed, in-house MRI unit.
ORDER
Based upon the above Findings
of Fact and Conclusions of Law, it is hereby:
ORDERED that the application of CCMC for
its Certificate of Need is granted.
AND IT IS SO ORDERED.
_________________________________
Ralph
King Anderson, III
Administrative
Law Judge
November 10, 2005
Columbia, South Carolina
Prior to approving this MRI project, the
Department required assurances that the project was financially feasible. Wayne
Gower of Province Healthcare Company stated in a letter to the Department that
Province Healthcare Company, owner of CCMC, had “an adequate cash balance on
hand and available for funding the proposed MRI project.”
|