ORDERS:
FINAL ORDER AND DECISION
I. STATEMENT
OF THE CASE
This
matter is before the Administrative Law Court (“ALC”) for a final order and
decision following a contested case hearing pursuant to S.C. Code Ann. §
44-1-60 (Supp. 2007) and S.C. Code Ann. § 1-23-600(A) (as amended by 2008 S.C.
Act No. 334). Petitioner
Wando Outpatient Surgery, LLC (“Wando”) challenges the decision of Respondent South
Carolina Department of Health and Environmental Control (“Department” or “DHEC”)
to deny Wando’s Certificate of Need (“CON”) application to establish a freestanding
ambulatory surgery facility (“ASF”) with two operating rooms to be located on the
Cainhoy Peninsula in the Daniel Island area in Berkley County,
South Carolina. The Department denied the application based on its finding
that (1) Wando failed to
establish need for an additional ASF in the area, (2) Wando’s project would
result in an unnecessary duplication of services for the area, and (3) Wando’s
project would have an adverse impact on existing providers. Two of those
existing providers, East Cooper Regional Medical Center (“East Cooper”) and
Healthsouth Corporation (“Healthsouth”), intervened as Respondents in this
matter in support of the Department’s decision to deny Wando’s CON application.
On September 12, 2007, the court granted Healthsouth’s request to withdraw from
this matter.
After
notice to the parties, the court held a hearing on February 25-29, 2008 and
March 14, 2008. All parties appeared at the hearing. Evidence was introduced
and testimony presented. After carefully weighing all of the evidence and
applying the applicable law, the court finds that Wando’s CON application
should be denied.
II. FINDINGS
OF FACT
Having
observed the witnesses and exhibits presented at the hearing and closely passed
upon their credibility, and taking into consideration the burden of persuasion
by the parties, the court makes the following Findings of Fact by a
preponderance of the evidence.
1. Background
On January 9, 2006, Wando
filed a CON application with DHEC’s Bureau of Health Facilities and Services
Development to construct a freestanding multi-specialty surgery center with two
operating rooms in Berkeley County, South Carolina (“Proposed Project”). The
Proposed Project would be located on the Cainhoy Peninsula in the Daniel Island
area of Berkeley County, South Carolina. Wando represented that the total cost
for the Proposed Project would be $7,811,222.
The
application identified ten physicians, representing four physician groups, as
participants in the development and operation of Wando: Peter C. Weber, M.D.;
Robert C. Jordan, M.D.; Mark D. Netherton, M.D.; Timothy G. Allen, M.D.; Joel
R. Cox, M.D.; James J. McCoy, M.D.; James D. Spearman, M.D.; Don O. Stovall,
M.D.; Richard H. Zimlich, M.D.; and David H. Jaskwhich, M.D. Dr. Weber, an
otolaryngology specialist, currently practices in Cleveland, Ohio. He previously practiced in Charleston
and plans to relocate his practice to the Charleston area prior to the development
of Wando. Dr. Jordan also specializes as an otolaryngologist and currently
practices in the Charleston area with offices located in North Charleston. Dr.
Netherton is an anesthesiologist who intended to perform pain management at Wando.
However, subsequent to the Department’s initial staff decision, Dr. Netherton
decided not to participate in the Proposed Project. The remaining seven
physicians currently practice in the Charleston area with a practice group known
as Lowcountry Orthopaedics and Sports Medicine P.A. These physicians
specialize and limit their practice to orthopedics and pain management.
Lowcountry Orthopaedics and Sports Medicine P.A. (“Lowcountry
Practice”) owns and operates an ASF in Dorchester County known as the
Lowcountry Outpatient Surgery Center (“the Lowcountry Center”). The Lowcountry Center
obtained a certificate of need and began providing outpatient services in
2004.
After reviewing the CON
application and conducting a project review meeting with the applicant and
affected persons, DHEC notified Wando on September 25, 2006 of its decision to
deny Wando’s CON application. DHEC based its decision on the following:
1. The
application has been found to be inconsistent with Standard 4 for Ambulatory
Surgical Facilities as outlined in the 2004-2005 South Carolina Health Plan in that the applicant has failed to document the need for an additional
Ambulatory Surgical Facility to serve either its proposed primary or secondary
service areas;
2. Actual
surgical utilization performed by several of the existing licensed Ambulatory
Surgical Facilities in the applicant’s primary and secondary service area that
have the capability of providing similar services to those of the applicant has
declined significantly from FY 2003 to FY 2005. As a result, current
utilization data does not justify the proposed additional freestanding
ambulatory surgical facility to be located within the Trident Area, as it
represents an unnecessary duplication of services for the citizens of these
communities;
3. The
projected surgical utilization for the proposed facility as provided by the
applicant is not consistent with those of its competitors at this time and
would undoubtedly have a negative impact on the patient base and utilization of
existing providers in both the Primary and Secondary Service Areas, without
resulting in any substantial increase in accessibility of services to the
population to be served; and
4. The
proposed project fails to meet one of the primary purposes of South Carolina’s
Certificate of Need Program, which is to “Prevent unnecessary duplication of
health care facilities and services.”
(DHEC Ex. 1-C at 841.)
2. Location of
Proposed Site
The location of the Proposed
Project is in the southern corner of Berkeley County, in the interior area of
the Cainhoy Peninsula. Wando proposes to develop the project on 15.322 acres
of land located on Clements Ferry Road, approximately 3 miles northeast of
Interstate 526, 10.5 miles north of East Cooper, 15.2 miles southeast of
Trident Medical Center, and 33.4 mile from Roper Berkeley Ambulatory Surgery
Center (“Roper Berkeley”).
The location is in a region
that is one of the more sparsely populated areas of Berkeley County. The
Cainhoy Peninsula region contains less than 10% of the population in the
county. Populous areas in Berkeley County exist to the west and northwest of
the Proposed Project site. To the south and southeast across into Charleston
County lies the fastest growing region in the Tri-County area. Berkeley County
is expected to grow by an additional 9,700 people between 2006 to 2011, which
represents a 6% increase in population at an annual growth rate of 1.3%. During
the same time period the population of Charleston County is expected to grow by
an additional 8,000 people and Dorchester County by 10,000 people. The
Tri-County area as a whole is growing at approximately 1% per year, or 4.8%
between 2006 to 2011.
The site of the Proposed
Project is located in a region of Berkeley County known as Wando that consists
of two zip codes: 29492 and 29450. In 2006, the population of zip code 29492 was
6,185. It is projected to increase to 9,292 by 2011. Similarly, zip code 29450
is expected to increase from 4,634 to 5,921 by 2011. The two zip codes are
expected to have a total population of 15,213 by 2011, with a collective
increase of 4,394. By 2015, between 70% and 75% of the population of Berkeley
County will live in the western portion of the county in the communities of
Goose Creek, Ladson, and Moncks Corner, compared to 5.3% of the population on
the Cainhoy Peninsula.
Population density maps
presented by Wando and East Cooper demonstrate that, by 2011, the proposed
location for Wando will remain in a relatively sparsely populated area. Further,
they indicate that Wando will be located considerably closer to more populous
areas of Charleston County, particularly Mount Pleasant, than it will to the more populous areas of Berkeley County.
3. Applicable
Service Area and Outmigration
A. Wando Service
Area
In preparing its original
projections, Wando relied on the historical patient origin data of the
physicians who were identified as intending to practice at Wando. Although
Wando’s utilization projections reflect patient origin from Berkeley County
only, Wando noted in a first set of rebuttal comments during the Department’s project
review that “Charleston and Dorchester are natural secondary service areas due
to the geographic proximity to the purchased site.” (DHEC Ex. 1-C at 720.) The
physicians associated with Wando have a history of serving patients from across
the Tri-County area in facilities throughout that region. Wando stated in its
CON application that the “10 surgeons serve patients throughout the Tri-County
area with seven offices situated across the population of the ‘Lowcountry’ in
Berkeley, Charleston, and Dorchester Counties.” (Id. at 11.)
A large portion of the
patient base for both the Lowcountry Center and the Proposed Project is the
same. The Lowcountry Center is located in the city of Summerville in Dorchester
County near the Berkeley County line. The Lowcountry Center application relied
on the Tri-County area, including Berkeley County, for its patient origin to
establish need for its CON. Wando stated in the second set of rebuttal comments
that the “[p]hysician owners in both facilities have projected that patients
will originate from Berkeley County due to geographical configuration of the
facilities in Dorchester and Berkeley Counties and where their patients come
from day-to-day.” (DHEC Ex. 1-C at 802.) Wando also stated it would be
unrealistic to assume that Wando and the Lowcountry Center would not both
receive patients from all three counties.
A “use rate” is the
utilization of a service relative to the population. A use rate is calculated
by dividing the total number of procedures performed for residents of a
particular area for a given period by the population of that area during that
period. In this case, the applicable use rate can be determined by dividing
the number of outpatient surgical procedures for a designated area in a given
year by the respective population for that area during that year. A use
rate for outpatient surgical services can be used to indicate whether or not
residents of Berkeley County have comparable access to the outpatient surgical
services to residents of urban counties throughout the state.
The great majority of
Berkeley County residents receive ambulatory surgery services from freestanding
centers and hospitals located in Dorchester and Charleston Counties within a
thirty-minute drive time. Because of the relatively close proximity for many
Berkeley County residents to outpatient surgery providers located in Dorchester
and Charleston Counties, the use rate for ambulatory surgery for Berkeley
County residents is consistent with counties in which many more providers are
located. Thus, Berkeley County residents have reasonably good access to
ambulatory surgery services in the area, even though Berkeley County has fewer
ASFs and hospitals than other counties with comparable populations in South
Carolina.
Proximity to outpatient
surgery providers is a factor that affects access. The county designation does
not present a barrier to residents seeking outpatient surgery services.
B. Outmigration
from Berkeley County
During trial, the parties
presented evidence regarding two sources relating to outmigration from Berkeley
County for outpatient surgery services. Wando presented evidence and testimony
concerning the use of Outpatient Surgery Outmigration Reports (“Outpatient
Surgery Reports”) generated by the South Carolina Budget and Control Board’s
Office of Research and Statistics (“ORS”) to determine the extent of
outmigration for outpatient surgery from Berkeley County. Alternatively, East
Cooper presented evidence and testimony concerning the use of Joint Annual
Reports (“JARs”) submitted to DHEC by freestanding providers and hospitals.
The parties’ positions varied as to which data source more accurately
demonstrates outmigration.
DHEC requires certain
facilities, including ASFs and hospitals, to provide the Department with
utilization information annually. The purpose of the data captured by
providers and submitted to DHEC is specifically to measure such utilization and
create the JARs. By contrast, the Outpatient Surgery Reports are based on
billing data ORS collects from hospitals and freestanding centers. The
providers submit the billing data on uniform billing forms the hospitals and
ASFs use to submit reimbursement claims to payors. These billing forms are denominated
as UB-92 or UB-04 forms. The various
procedures performed on a patient are identified by a procedure code, and these
codes are reported on the UB form.
Each record, classified as a “procedure”
on the ORS reports, represents a single “case” or patient. An analysis of the
Outpatient Surgery Reports generated by the ORS reflects that the pool of
patients in the ORS data comprises more than just patients who received
procedures in an operating room. The evidence presented shows that the ORS reports
capture not only procedures performed in operating rooms, but also procedures
performed in other settings within the reporting facilities. The ORS website
contains a list and range of codes reflected in the Outpatient Surgery Reports that
is identical to all of the procedure codes that can be reported on a UB billing
form. Examples of outpatient procedures that are captured on a UB billing form
but not performed in an operating room include: breast biopsy, dialysis,
radiation therapy, and diagnostic cardiac catheterization. All of these
non-operating room procedures are included in the ORS Outpatient Surgery
Reports. As an example, the evidence presented shows that diagnostic cardiac
catheterization procedures are typically performed in a diagnostic
catheterization laboratory rather than an operating room. However, the 2005 Outpatient
Surgery Report for Berkeley County for outpatient surgery includes 392
diagnostic cardiac catheterizations.
Joel Grice, the former
Director of the Bureau of Health Facilities and Services Development at DHEC, illustrated
another example. He testified that Charleston Memorial Hospital did not have
an operating room in 2004 or 2005. However, ORS reported 194 procedures in
2004 and 396 procedures in the 2005 on the Outpatient Surgery Reports for
Charleston Memorial. According to Grice, the reporting of “outpatient
surgeries” for Charleston Memorial by ORS for 2004 and 2005 shows that the Outpatient
Surgery Reports include in their outpatient procedure codes as “outpatient
surgeries” procedures that are not actually performed in a facility’s operating
rooms. The Outpatient Surgery Report cannot be reasonably interpreted to
support the inference that Charleston Memorial was providing outpatient surgical
services.
East Cooper’s expert, David
Levitt, testified that a comparison of the JAR data and ORS data reflects that
the two data sets for ambulatory surgery centers are consistent. However, the
ORS data for hospitals is almost double the volume of outpatient surgeries
reported on the JARs by hospitals. This variance is explained by the fact that
ambulatory surgery facilities predominately provide ambulatory surgery, while
hospitals provide a greater variety of services, including ambulatory surgery
in addition to other outpatient invasive procedures performed in non-operating
room settings. Levitt also demonstrated the reliability of the JAR data by
comparing the utilization rates for South Carolina and two neighboring states,
Georgia and North Carolina. The use rates for outpatient surgery for Georgia
and North Carolina are nearly identical to the use rate for South Carolina
derived by applying the JAR data. The use rate for South Carolina for 2006 is
calculated by dividing 316,000 outpatient surgeries by a population of
4,321,429 for a use rate of 73.1. Georgia’s use rate is 70.89 (652,112
surgeries divided by 9,198,437), and North Carolina’s use rate is 72.1 (638,900
surgeries divided by 8,856,505). In contrast, the outpatient surgery use rate
for South Carolina applying data from the ORS Outpatient Surgery Reports is more
than double the use rate determined by using JAR data. This reflects an
inconsistency with neighboring states and indicates that the ORS data is not an
accurate measure of operating room utilization for the purpose of determining
the need for an ASF in Berkeley County.
Doyle Williams, Wando’s
expert health planner, relied on ORS Outpatient Surgery Reports as the basis
for an opinion that Wando would obtain 2,000 cases in the first year. Williams’s
assertion is based on an assumption that Wando would capture 5% of the Berkeley
County marketplace, which he measured as 24,000 to 25,000 cases that were
outmigrating from Berkeley to primarily Charleston County. However, the
court finds that JARs are a more reliable source than ORS Outpatient Surgery
Reports for measuring utilization of hospital operating rooms and therefore for
determining the volume of outmigration of Berkeley County residents who obtain
outpatient surgery services from healthcare facilities in Charleston and
Dorchester Counties. Because Williams’s projections rely on the ORS Outpatient
Surgery Reports, the court finds that his projections are unreasonably high and
are not as reliable a means for forecasting utilization of Wando for the
purpose of evaluating Wando’s CON application at issue here.
4. Access
There are currently thirteen
existing providers of ambulatory surgery services in the Tri-County area, including
seven freestanding centers and six hospitals. The existing freestanding
centers consist of the Lowcountry Center, Roper Berkeley, HealthSouth, Roper
St. Francis James Island Surgery Center, Roper West Ashley Surgery Center, the
Surgery Center of Charleston, and Trident Surgery Center. The existing hospitals
consist of East Cooper, Trident Medical Center, Summerville Medical Center, the
Medical University of South Carolina (“MUSC”), Roper Hospital, and Bon Secours
St. Francis. A seventh hospital has been approved for Charleston County, the
Roper East facility, and is anticipated to open in or after November 2010. In
addition, a CON for an eighth freestanding center, the Southeastern Spine
Institute (“Southeastern Spine”), has been
approved by DHEC. Only one of
these facilities, Roper Berkeley, is located in Berkeley County.
Experts for all parties generally
agreed that outpatient surgery patients should not be exposed to post-procedure
driving times that exceed thirty minutes. James D. Spearman, M.D., a member of
the Lowcountry Practice and a Wando owner, testified that he is familiar with
the thirty-minute drive time factor that DHEC takes into consideration when
approving ambulatory surgery centers. Dr. Spearman stated that although a
drive time of fifteen to thirty minutes is a reasonable period for a patient to
be confined in a vehicle after an outpatient procedure, he believed that
fifteen minutes is closer to the limit that is generally in the best interests
of patients. Similarly, Williams testified that in his opinion surgical
services should be relatively close to those residents who need it, and that a
distance of nine miles, or a travel time of fifteen or twenty minutes,
represented an optimum service area. Services located farther away than that
standard become increasingly less convenient and less beneficial for patients.
Joel Grice testified that a
majority of the residents of Berkeley County have access to outpatient surgery
services within thirty minutes, including the residents of the Cainhoy
Peninsula. Ten of the thirteen existing ambulatory surgery facilities are
within a thirty-minute drive time to the location of the Proposed Project.
Hanahan, Goose Creek, and Ladson are among the most populated areas of Berkeley
County. Their residents have access to three existing outpatient surgery
providers within a ten-minute drive. Further, two additional outpatient
providers, the Lowcountry Center—owned by a majority of the Wando owners—and
Summerville Medical Center are an average of eighteen minutes away from these three
communities. In contrast, Wando would be an average of twenty-nine minutes
from these same population centers. Roper Berkeley, the only ASF
located in Berkeley County, is historically underutilized, even though it is
accessible to many residents in the center of the county.
East Cooper is one of ten
healthcare facilities that are located within a thirty-minute drive time for
the residents of the Cainhoy Peninsula that live in the vicinity of the Proposed
Project. A comparison of the East Cooper and Wando thirty-minute service areas
reflects that they are largely the same. Only a very small and unpopulated
geographic area in the western reaches of the Cainhoy Peninsula is beyond
thirty minutes of the East Cooper facility. An overlay of the thirty-minute
drive time service areas for the representative providers in the Tri-County
area demonstrates that the great majority of Berkeley County residents live
within thirty minutes of ten of the thirteen Tri-County area outpatient surgery
providers.
Establishment of an ASF at
Wando’s proposed site would improve access only to a very small population,
projected to be no more than 5.3% of the total population of Berkeley County in
2015, with no appreciable effect on accessibility generally for residents of
the Cainhoy Peninsula. With the exception of the Cainhoy Peninsula residents,
the Proposed Project would require longer drive times and would be less
convenient for the great majority of Berkeley County residents than the
thirteen existing facilities in the Tri-County area. Furthermore, the Wando
site is more than a thirty-minute drive time from seven of the ten population
centers in Berkeley County. Moncks Corner, for example, is a fifty-two-minute
drive to the Wando site. While Hanahan and Goose Creek are twenty-seven- and thirty-minute
drives from the Wando site, respectively, residents of these two communities
are closer to no less than seven other outpatient surgery providers than they
are to the Wando site. The only recognized population center in Berkeley
County where residents would have a shorter drive to Wando than to any other
existing provider is the sparsely populated Cainhoy Peninsula community known
as Wando. Even in that case, the new Roper East facility will be a twelve-minute
drive to the town of Wando, which is as close as the Proposed Project would
be.
In addition to the greater
distances from the Wando site to the various Berkeley County population
centers, one of the factors that would compound the inconvenience to Berkeley
County residents is the fact that Clements Ferry Road, the primary artery into
the Cainhoy Peninsula, is a congested, two-lane road in an industrial area. It
is an eleven-minute drive to the Wando site up Clements Ferry Road from
Interstate 526, which runs from Charleston County on the east through the
southern tip of Berkley County to Charleston and Dorchester Counties on the
west of Wando.
From 2003-2006, the average
utilization of freestanding outpatient surgery centers in the Tri-County area declined
from 60.8% to 50.5%, which reflects the extent to which existing ASFs in the
Tri-County area are underutilized. (See East Cooper Ex. 37.) Because
of the underutilization, surgeons have available numerous options to perform
ambulatory surgery for patients at freestanding facilities in the Tri-County
area. More specifically, Roper Berkeley and Healthsouth experienced low
utilization rates during this period. The utilization of HealthSouth, in
particular, dropped from 77.3% in 2003 to 47.7% in 2006. Conversely, the
surgery center affiliated with the Lowcountry Practice increased utilization
during the same period from its opening in 2004 until 2006, when it was at 74.4%
capacity. DHEC, in its Summary Sheet during staff review, noted that in the
year after the Lowcountry Center opened in 2004, utilization at HealthSouth
dropped by 22.5%.
Hospital outpatient surgery
capacity in the Tri-County area during this period also reflected
underutilization of these facilities. The utilization of these hospital-based
services was 58.1% in 2006. Both freestanding and hospital-based outpatient
surgery centers have additional capacity to serve ambulatory surgery patients from
the Tri-County area. DHEC noted in its decision letter that utilization of
several of the existing ambulatory surgery providers significantly declined
between 2003 and 2005. In addition to the existing providers in the area, new
providers including the Roper East facility and Southeastern Spine, as well as
additional capacity at MUSC, will provide further capacity to the Tri-County
area.
Projections of outpatient
surgeries in the Tri-County area in year 2010 reflect that freestanding
facilities will be at less than 50% capacity (47.9%), and hospital-based
outpatient surgery providers will be at 53.1%. Overall, outpatient surgery
providers in 2010 are projected to be at 51% utilization and will have capacity
to serve future demand.
5. Need
The use rate of outpatient
surgery facilities for orthopedic and ENT cases is 27.4 per thousand in South
Carolina. Applying the use rate to the projected population of the Cainhoy
Peninsula in 2011 demonstrates that only 417 cases would be generated from the
area. Only 75% of the 417 cases would utilize a freestanding center (25% are
expected to occur in a hospital setting), yielding an expected 313 cases. Even
if Wando were to capture a 50% share within three years of a geographic market
in which its presence is currently almost non-existent, the potential number of
patients Wando may serve would be approximately only 150. Levitt concluded
that because the Lowcountry physicians and Dr. Jordan do not have sufficient
volume to support a center based on Berkeley County patients, Wando will draw
patients from the more highly populated adjacent areas in Charleston County at
such a level that it will exceed patients drawn from Berkeley County.
Considering the small population and undeveloped infrastructure of the Cainhoy
Peninsula area, the evidence shows that the development of a freestanding
outpatient surgery facility in the Wando area is premature.
Between the time DHEC staff
denied Wando’s CON application and the trial, the ownership of Wando changed.
Peter C. Weber, M.D. and Robert C. Jordan, M.D. were still participating. Mark
D. Netherton, M.D. decided not to participate, and the Lowcountry Practice
physicians remained the same except for the addition of R. Christopher Brooker,
M.D. Due in part to the change of ownership, Wando developed new utilization
projections that relied on different assumptions than had been presented in the
original CON application. At trial, Williams testified that eight Lowcountry
physicians performed a total of 1902 surgery cases in 2007 (excluding pain
management procedures associated with Dr. Netherton) at all locations,
including the Lowcountry Center. Williams identified 686 cases the Lowcountry
surgeons performed for Berkeley County patients in 2007 and assumed that each
of the cases for Berkeley County residents would be moved to the Wando center.
Of the 686 cases Wando
assumed would be shifted to the Proposed Project, 447, or approximately 65%,
were performed at the Lowcountry Center. The court therefore finds that Wando’s
need methodology relies on the same patient base as did the Lowcountry Center
and assumes the redirection of a substantial number of ambulatory surgery cases
from the facility that the Lowcountry Center surgeons opened in 2004. DHEC
originally denied the Wando project in part because patient origin for the
project appeared to be from existing providers, including the Lowcountry Center.
The projected redirection of
the 447 Berkeley County cases from the Lowcountry Center to Wando would also
reduce the Lowcountry Center’s utilization to below 1500 cases per year (from
1902 to 1455). The observation in DHEC’s Summary Sheet that it appeared that a
large portion of the patient base for both the Lowcountry Center and Wando
would be the same is confirmed by Wando’s final projections, even though Wando’s
original CON application failed to acknowledge that a single patient would be
redirected from the Lowcountry Center to Wando.
With regard to the projected
utilization for Dr. Jordan, Wando assumed that all of Dr. Jordan’s Berkeley
County cases would also be shifted to the Proposed Project. With regard to Dr.
Weber, Wando used the cases Dr. Weber performed at the Cleveland Clinic as a
basis for its projections for Dr. Weber’s future productivity at the Proposed
Project. Williams created several budgets for the Proposed Project: one for
the original CON application, a second on January 15, 2008, and a third on
January 28, 2008 which differed to reflect changes in the Proposed Project. See infra Section II.8. All of Williams’s budgets assumed an annual growth
rate of 1.85% and applied that rate to the Berkeley County caseload of its
various surgeon owners. His final budget yielded an annual case utilization of
1137 for 2008, 1159 for 2009, and 1180 for 2010.
Although Wando assumed all of
the Lowcountry Center’s Berkeley County patients would be redirected to the
Proposed Project, the court finds that this assumption is overly optimistic
based on the evidence. Only seven of the Lowcountry Center’s Berkeley County
patients in 2007 were residents of the two Cainhoy zip codes (29492 and 29450)
surrounding the Wando site. In addition, Dr. Spearman and Williams acknowledged
during the hearing that some Berkeley County patients would continue to go to the
Lowcountry Center.
The court finds that Wando’s
projections are also unreasonable in that the projections assume all of
Lowcountry physicians’ and Dr. Jordan’s hospital-based cases involving Berkeley
County patients will be redirected to Wando. Several witnesses testified that
a certain portion of the cases provided on an ambulatory basis are necessarily
done in a hospital setting rather than a freestanding center. Dr. Spearman, in
particular, testified that the Medicare guidelines provide that, as a condition
of payment, certain procedures may not be performed in a freestanding facility
and must be done in a hospital. Dr. Spearman also testified that some patients
need to have their surgery performed in a hospital setting because of risk
factors, such as heart problems, blood thinners, and other conditions that may
complicate surgery. The age of the patient and patient preference are also
factors that may result in a patient having outpatient surgery performed in a
hospital. Certain insurers also require that outpatient procedures be performed
in a hospital setting.
The evidence shows that 25%
of the Lowcountry physicians’ cases were performed in a hospital in 2007. Dr.
Jordan only performed 63.8% of his cases (51 of 80) in a non-hospital setting
in 2006. Wando’s original projections in the CON application do not reflect
any shift of the Lowcountry Center’s patients from hospitals to the Proposed
Project. The court cannot therefore reasonably conclude that all of the
Berkeley County cases of the Lowcountry physicians and Dr. Jordan would be
redirected to Wando. Instead, Levitt calculated that only 549 of 742 cases
generated by the physicians would be appropriate for a freestanding facility,
even assuming all Berkeley County cases shifted to Wando.
Wando’s final utilization
projections also do not account for the proximity of the patients to the Wando
location. Although distance and proximity are not the only factors affecting
utilization, they are important factors. Dr. Spearman testified that one of
his goals in situating the Wando site on the Cainhoy Peninsula was to minimize
travel time for patients and serve residents who live within less than a
thirty-minute drive time from the Wando site. Dr. Spearman recognized that
some Berkeley County residents would be farther than thirty minutes away from
the site. He also acknowledged that patients in other areas of Berkeley County
would choose to have their surgery performed in Summerville, rather than at the
Wando site.
Wando also projected that all
of Dr. Jordan’s Berkeley County cases would be transferred to the Wando
center. Dr. Jordan testified in his deposition that he would be establishing a
satellite office in the Wando area and was not planning to move his patients
from Summerville. The record reflects that in 2006, 75 of the 80 Berkeley
County patients Dr. Jordan treated resided in zip codes for Moncks Corner,
Ladson, and Goose Creek. In contrast, Dr. Jordan saw only one patient that
same year from the Cainhoy Peninsula area. At the hearing, Dr. Jordan
testified on direct that he would shift patients to the Wando facility, but he
admitted on cross-examination that in his deposition he testified that he
intended to establish a “new presence” in the Cainhoy Peninsula and to respond
to the demand in the area. Based on Dr. Jordan’s collective testimony, the
court finds it unreasonable to project that all of his Berkeley County patients
that he had been serving largely in Dorchester County would be shifted to
Wando. Even without Dr. Jordan’s earlier statements, the likelihood that he
would be able to redirect patients who would have to travel more than a thirty-minute
drive time to a more distant site is remote.
Dr. Jordan testified that
occasionally a Berkeley County patient may agree to have a procedure performed
at Wando due to difficulty in getting a surgery slot at the Summerville
facility or another more convenient facility where Dr. Jordan has privileges. However,
these occasions would be the exception, not the rule, and do not form a basis
for a finding that the Proposed Project would customarily serve residents of
western Berkeley County.
Wando used the cases Dr.
Weber performed at the Cleveland Clinic in Ohio as a basis for its final
projections. The volume provided in the projections was based on cases
performed in Cleveland, not on Berkeley County residents. Levitt testified
that the Cleveland data is unreliable because no evidence was presented that
Dr. Weber’s experience there formed a basis for Wando’s assumptions about the
services Dr. Weber would perform when he established a practice in Charleston
County. Wando failed to offer any evidence that established a correlation
between the volume of cases Dr. Weber performed in a nationally renowned
clinical setting in a major urban area and the private practice Dr. Weber
intends to open in Mount Pleasant. Moreover, there is nothing in his Cleveland
experience that was presented as a basis to project the number of cases that
Dr. Weber may be able to generate for Berkeley County residents. Grice
testified that he supported the Department’s analysis of the Wando CON
application that excluded consideration of Dr. Weber’s experience in
Cleveland. In his opinion, a physician’s practice in another state did not, in
and of itself, establish a reasonable basis for projecting what the physician
would actually do in South Carolina.
Wando’s calculations for Dr.
Weber also do not recognize that of the 616 Cleveland cases used as a base for
Dr. Weber’s projections, only 378 were performed in a healthcare facility,
whether a freestanding center (90%) or a hospital-based service (10%). The
remaining 238 cases were performed in an office setting, not in an operating
room. Wando also failed to present any evidence relating to potential referral
sources or marketing strategies to support the assumption that Dr. Weber would
see the same percentage of Berkeley County patients as the Lowcountry
physicians.
Levitt testified that it may
be appropriate to project future volume for a physician who is not present in
the proposed market by reviewing relevant historical experience. Dr. Weber
worked at MUSC from 1999 until 2002. While at MUSC, Dr. Weber performed 345
outpatient cases in 2000, 420 in 2001, and 27 in 2002. Approximately 65% to
70% of Dr. Weber’s cases were from Charleston County. Only 118 cases,
or approximately 15%, of his cases were from Berkeley County patients while he
was at MUSC. Moreover, over 66% of the 118 Berkeley County patients were from
the Moncks Corner and Goose Creek areas. At most, Dr. Weber averaged slightly
less than sixty cases a year from Berkeley County, and, for the entire
three-year period, Dr. Weber had five cases from the two zip codes comprising
the Cainhoy Peninsula.
Levitt performed an overall
analysis of the Wando projections taking into consideration the above mentioned
factors. When the Lowcountry physicians’ cases are reduced by the
hospital-based cases and adjusted for proximity, 176 patients, not 686, of the
Lowcountry Center’s patients would be redirected to the Wando center.
Adjusting Dr. Jordan’s Berkeley County cases to reduce the pool of 80 cases to
include only patients within thirty minutes of Wando, 31 of the 80 patients
might go to Wando. In all, the court finds it more reasonable to project that
the Lowcountry Practice physicians and Dr. Jordan will redirect 207 patients
instead of the 1116 cases Wando projected.
6. Wando’s
Physicians and Shift in Patient Volume
Wando
originally identified ten participating physicians in its CON application: Dr.
Weber, Dr. Jordan, seven Lowcountry Practice physicians, and Dr. Netherton. During
review, Wando identified eleven additional surgeons who would be providing
services at Wando: Lowcountry represented to DHEC that it “plans” to
add four orthopedic surgeons in two years, Dr. Jordan plans to add two ENTs,
and “five (5) additional surgeons who want to practice in the Wando facility when it is completed.” (DHEC Ex. 1-C at 716 (emphasis added); Spearman Test.,
Hearing Day One at 104.) Wando also mentioned that its plans include
additional doctors beyond the eleven.
Wando’s
representations, made through its counsel, were not expressions of potential growth.
They reflected precise and present intent, i.e., Lowcountry “plans” to expand
its practice in the ways described. Its purpose was to persuade DHEC that
Wando would not overlap its patient base with Lowcountry. Wando stated that “[w]e
believe our open medical staff model accommodates additional surgeons and resulting
increases in utilization.” (DHEC Ex. 1-C at 716 (emphasis added)). At no
point during the review process did Wando attempt to project any utilization
data for any of the six physicians that it expected would join Lowcountry and
Dr. Jordan’s practice or provide any information about where the new patients
would come from. Although Wando knew the five unidentified physicians wanted
to practice at the proposed center when it opened, Wando did not provide any
further information about them.
During
discovery, Wando identified many of the additional physicians it alluded to during
review. Wando identified almost fifty additional physicians it expects to
provide services at the proposed center. Dr. Spearman testified that these
individuals had an interest in referring patients and being actively involved
with Wando and/or obtaining ownership interests once the CON was granted.
The
original CON application included physicians who specialized in orthopedics,
ENT, and pain management. The additional fifty physicians’ specialties
included OB-GYN, plastic surgery, general surgery, and unspecified
specialties. As a result, although Wando knew of up to fifty additional providers
would be providing services at the Proposed Project, it did not provide any
projections or patient origin data for them or attempt to project the expected
patient volume from existing providers.
Wando
also did not project the expected shift in patient volume from existing
providers for either Dr. Jordan or Dr. Weber. It was clear from Dr. Jordan’s
testimony that he intended to establish a new presence on the Cainhoy Peninsula
in the form of a satellite office. Dr. Weber’s projections were based on his
experience in Cleveland, but Wando argued Dr. Weber would be returning to South
Carolina and would be treating Berkeley County patients. As with Dr. Jordan,
Wando did not provide any information to demonstrate the providers currently
serving those patients or which existing providers would be impacted by his
re-established presence.
Accordingly,
there is insufficient information available regarding the additional potential
physicians to permit the court to make any determination regarding the
potential impact these physicians will have on projecting Wando’s utilization.
7. Alternatives
to the Addition of Wando
Levitt
testified that there were two particularly viable alternatives that were
superior to Wando’s establishment of a new $8 million facility. The first is
for patients to utilize existing resources in the Tri-County area. The second
is for the Lowcountry physicians to expand the existing Lowcountry facility from
two to four operating rooms.
With
regard to the potential expansion of the Lowcountry facility by adding an
additional two operating rooms to the existing two-operating room center, Grice
testified that it is a good alternative because the Lowcountry physicians
already have ownership interests in an existing facility that is gaining utilization.
Grice also noted that the expansion of the Lowcountry facility could be
undertaken much more cost effectively than the expenditure of $8 million for the
development of Wando. Instead of the $8 million project cost, he believed that
an expansion of the Lowcountry facility could be accomplished for less than $2
million. This is in line with the testimony of Wando’s expert, Williams, stating
that he thought a reasonable estimate for the construction costs for the
expansion of the Lowcountry facility would be a little over $1 million, and he
had been provided with equipment estimates for the expansion at $850,000.
Grice
further testified that the expansion of the Lowcountry facility would be a
better alternative to the Wando project because it would still be an accessible
location for the majority of the residents, would be more convenient for the
Wando physicians, and would add the same capacity for much less cost to the
healthcare system. In contrast, investing the capital needed to develop a potentially
unnecessary facility such as Wando would burden the healthcare system and
ultimately the consumer.
8. Financial
Feasibility
Wando
presented three budgets related to the proposed ambulatory surgery center: a
budget in the original CON application, a second budget on January 15, 2008,
and a third and final budget on January 28, 2008. The January 15 budget
reflects a reduction in number of cases from the original CON budget due to the
removal of Dr. Netherton’s cases. The volume of cases is reduced further in
the third budget. An analysis of the three budgets reflects that the average
charges increased in each of the three budgets presented. The ENT charges were
consistent throughout the budgets and are consistent with the area averages.
The orthopedic charges were consistent with area averages in the original CON
budget. However, the orthopedic charges increased considerably between the
first and the second budget, from $4,749 to $7,102. Between the first and
second budgets, Dr. Netherton’s cases and charges were removed, which partially
accounts for the increase in charges. The increase in charges between the two
budgets is also due to the fact that the original budget used area average
charges, while the January 15 budget used the Lowcountry Center’s charges,
which are not comparable to area charges because they are significantly higher
than the area average. The average charges increase even further in the third
budget. The
budget comparisons also demonstrate that although the volume of procedures in
each budget dropped from the first to the third budget, the gross revenues were
nearly identical. The assumptions relating to the gross revenue figures in the
second and third budgets are due to the fact that the Lowcountry Center’s
charges are significantly higher than the area average. The three budgets
reflect that although the charges went up in each of the budgets, the
contractual adjustments remained the same at 60.6%. Levitt testified it was
unreasonable to hold the contractual adjustments at the same level because many
payors pay a fixed amount regardless of what the charges are. The contractual
adjustment therefore should also have increased as the charges increased.
As
noted previously, projecting utilization based on Dr. Weber’s Cleveland
experience is not a reasonable planning methodology given the evidence
presented at trial. Subtracting Dr. Weber’s cases from the utilization in the
third budget reduces the cases in year number three from 1,181 to 927 cases.
The facility would then be at less that 40% capacity, and Wando would have a
loss of $101,658 in the third year of operation.
The
January 28 budget was based on the assumption that all of the Lowcountry
Practice cases for Berkeley County residents would be redirected to Wando.
Levitt prepared a version of the January 28 Wando budget reflecting the
expected volume of cases reduced to exclude the percentage of cases that would
be performed in a hospital setting, and not at Wando, and to exclude Dr. Weber’s
Cleveland cases. The volume in year three is reduced from 1,181 in the January
28 budget to 580 cases. This reduction in volume would result in a loss of
$758,800 in year three.
Levitt
also adjusted the January 28 Wando budget to reflect the reductions in volume
that should occur when the proximity of the Berkeley County patients is
considered. In this forecast, the volumes in years one through three in the
January 28 budget are reduced from 1,137 to 1,181 to 211 to 219 in the revised
budget when the proximity analysis is applied. The Wando center would incur a
loss of $1,442,455 in year three alone.
East
Cooper’s Exhibit 55 reflects Wando’s January 28 net income pro forma with
Levitt’s adjustments for proximity and area average charges. With these
adjustments, the Wando center would lose $1,496,480 in the third year.
Overall,
Levitt testified that the expense assumptions were consistent with the
decreasing volume changes, but the revenue, gross revenue, and net and
contractual adjustment percentages were not reasonable. Adjusting the final
Wando budget of January 28, 2008 by different factors, including the removal of
Dr. Weber’s Cleveland cases, subtracting the percentage of hospital cases that
will not be performed at Wando, and adjusting the volume figures by the
proximity of the patients, demonstrates that the budget was unreasonable and
that realistic forecasts result in negative net income figures in the third
year of operation.
III. CONCLUSIONS
OF LAW
1. Jurisdiction, Review,
and Burden of Proof
Jurisdiction
over this case is vested with the South Carolina Administrative Law Court
pursuant to S.C. Code Ann. § 1-23-600(A) (as amended by 2008 S.C. Act No. 334),
S.C. Code Ann. § 44-1-60 (Supp. 2007), and 24A S.C. Code Ann. Regs. 61-15, §
403 (Supp. 2007). The weight and credibility assigned to evidence presented at
the hearing of a matter is within the province of the trier of fact. See S.C. Cable Television Ass’n v. S. Bell Tel. & Tel. Co., 308 S.C.
216, 222, 417 S.E.2d 586, 589 (1992). Furthermore, a trial judge who observes
a witness is in the best position to judge the witness’s demeanor and veracity
and to evaluate the credibility of his testimony. See, e.g., Woodall
v. Woodall, 322 S.C. 7, 10, 471 S.E.2d 154, 157 (1996); Wallace v.
Milliken & Co., 300 S.C. 553, 556, 389 S.E.2d 448, 450 (Ct. App.
1990). In presiding over this contested case, the court serves as the finder
of fact and makes a de novo determination regarding the matters at
issue. See S.C. Code Ann. § 1-23-600(B) (Supp. 2007); Marlboro Park
Hosp. v. S.C. Dep’t of Health & Envtl. Control, 358 S.C. 573, 577-79,
595 S.E.2d 851, 853-54 (Ct. App. 2004); Brown v. S.C. Dep’t of Health &
Envtl. Control, 348 S.C. 507, 512, 560
S.E.2d 410, 413 (2002).
The Petitioner, as the party challenging the Department’s decision
to deny the CON application in this matter, bears of the burden of proof. See Leventis v. S.C. Dep’t of Health & Envtl. Control, 340 S.C. 118,
132-33, 530 S.E.2d 643, 651 (Ct. App. 2000) (holding that the burden of proof
in administrative proceedings generally rests upon the party asserting the
affirmative of an issue). Therefore, Wando must demonstrate by a preponderance
of the evidence that the Department’s decision to deny its CON application is
contrary to the applicable regulatory criteria. S.C. Code Ann. §
1-23-600(A)(6) (as amended by 2008 S.C. Act No. 334); S.C. Code
Ann. § 44-7-210(E) (2002); S.C. Code Ann. Regs. 61-15 § 403(1) (Supp. 2007); see also Anonymous v. State Bd. of Med. Exam’rs, 329 S.C. 371, 375, 496 S.E.2d
17, 19 (1998) (holding that the standard of proof in an administrative
proceeding is generally the preponderance of the evidence); Nat’l
Health Corp. v. S.C. Dep’t of Health & Envtl. Control, 298 S.C. 373,
380 S.E.2d 841 (Ct. App. 1989) (stating that preponderance of the evidence
standard is applied in CON disputes).
2. CON Program, State Health Plan,
and Applicable Project Review Criteria
This
matter arises under the South Carolina Certificate of Need regulatory program
for health care facilities and services, which consists of the State
Certification of Need and Health Facility Licensure Act, S.C. Code Ann. §
44-7-110, et seq. (Supp. 2007), the accompanying CON regulations, 24A
S.C. Code Ann. Regs. 61-15 (Supp. 2007), and the 2004-2005 State Health Plan.
The purpose of this regulatory scheme is 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 high quality services are provided in health facilities in
this State.” S.C. Code Ann. § 44-7-120 (2002).
Pursuant
to this regulatory scheme, health care facilities must apply for and receive a
CON from DHEC in order to provide certain new services or undertake certain
projects. S.C. Code Ann. §§ 44-7-120, -160 (2002). In making the
determination whether to grant or deny a CON, DHEC evaluates the project based
on the review criteria found in the CON regulation and under the policies and
standards set forth in the State Health Plan. S.C. Code Ann. § 44-7-210(C)
(2002). DHEC Regulation 61-15, Section 802 lists thirty-three criteria, many
of which contain subsections, by which a CON application may be evaluated.
Some of these criteria that are applicable to this project include:
(1) Compliance
with the State Health Plan – 1
(2) Community
Need Documentation – 2a, 2b, 2c, 2d, 2e
Distribution
(Accessibility) – 3a, 3b, 3c, 3d, 3e, 3f, 3g
(3) Adverse
Effects on Other Facilities – 23a, 23b
Distribution
– 22
Acceptability
– 4a, 4b, 4c
(4) Projected
Revenues/Expenses – 6a, 6b, 7
Net
Income/Financial Feasibility – 9, 15
(5) Alternative Methods – 19.
3. The State Health Plan
The
approval of additional ASFs or the addition of operating rooms/endoscopy suites
to existing ASFs is subject to review under the South Carolina CON program. (DHEC
Ex. 2 at II-77.) The State Health Plan provides that ten standards must be
addressed prior to the approval of additional ASFs, and DHEC listed “Compliance
with the State Health Plan” as the most important criterion for evaluating
Wando’s proposed project. (Id. at II-77 to II-79.) Although a
project does not have to satisfy every review criterion to be approved, a
project may not be approved unless it complies with the State Health Plan. See S.C. Code Ann. §44-7-210; Roper Hosp., Inc. v. S.C. Dep’t of Health &
Envtl. Control, 01-ALJ-07-0378-CC, 2002 WL 31423787 at *13 (S.C. ALJD Sept.
5, 2002).
Of
the ten standards that apply to the Wando project, the court finds that Wando
did not establish that its Proposed Project complies with Standards One, Two,
Three, Four, and Six. Standards Five, Seven, Eight, Nine, and Ten are not in
controversy.
A. Standard One: Proposed Service Area
Standard
One provides that “[t]he county in which the proposed facility is to be located
is considered to be the service area for inventory purposes. The applicant may
define a proposed service area that encompasses additional counties but the
largest percentage of the patients to be served must originate from the county
in which the facility is to be constructed.” (East Cooper Ex. 67 at II-77;
DHEC Ex. 2 at II-77.)
Wando
argues that the first sentence of Standard One limited its ability to present a
project that relied on utilization projections based on patients residing
outside of Berkeley County. The court, however, finds Wando’s argument to be
contrary to the plain language of the first sentence of Standard One. See Hodges v. Rainey, 341 S.C. 79, 85, 533 S.E.2d 578, 581 (2000). Instead,
the first sentence is intended to mean that the county in which the proposed
facility will be located will be used when the facility is placed in the State
Health Plan’s ASF inventory. (Grice Test., Day Four at 139-43.) The inventory
of ASFs, by county, is located in the State Health Plan immediately after the
CON standards for ASFs. (East Cooper Ex. 67 at II-77 to II-85; DHEC Ex. 2 at
II-77 to II-85.) Applying the first sentence to this matter, Wando proposes
its facility will be located in Berkeley County, and thus its service area “for
inventory purposes” would be Berkeley County.
Wando,
in fact, in its CON application lists Berkeley County as its primary service
area and refers to Charleston and Dorchester Counties as its natural secondary
service areas. Furthermore, the proposed owners have a history of serving
patients from across the Tri-County area. This proposed service area is
consistent with the second sentence of Standard One, which clearly allows an
applicant to “define a proposed service area that encompasses additional
counties . . . .” (East Cooper Ex. 67 at II-77; DHEC Ex. 2 at II-77.) The court
finds it is unreasonable in this case and contrary to the evidence presented to
assume that the Wando facility’s service area would be limited to Berkeley County.
Wando
plans to place the Proposed Project in the Cainhoy Peninsula of the southern
tip of Berkeley County. However, the majority of Berkeley County residents do
not live in this area and will not in the foreseeable future. (See Wando
Ex. 24) (reflecting 78.9% of Berkeley County residents in 2015 will reside in
Moncks Corner and Goose Creek-Hanahan areas, while 5.3% of county residents are
projected to live in Wando or Cainhoy Peninsula).
An
analysis of the Wando projections and the participating physicians’ patient
origin also reflects that the Wando owners will not generate enough patients
from Berkeley County to support the proposed center. When Wando’s final
utilization projections are adjusted to remove the hospital-based
cases that cannot be performed in a new freestanding center to (1) reflect the
fact that numerous other facilities, including the Lowcountry Center, are far
more convenient for most of the Berkeley County residents and (2) exclude the
projections based solely on Dr. Weber’s experience in Cleveland, Wando has
failed to prove there is a reasonable basis to project more than 207
Berkeley County patients would be redirected by the Lowcountry physicians and
Dr. Jordan to Wando. This patient volume would be insufficient to support a
surgery center based predominantly upon Berkeley County patients as required by
Standard One of the State Health Plan.
The
court is persuaded by East Cooper’s evidence that the Wando owners under these
circumstances would attract surgeons with practices and patients in the Mount
Pleasant area. Mount Pleasant has the most highly populated and fastest
growing zip codes in the Tri-County area and is closer in proximity to the
Proposed Project than are the communities where the majority of Berkeley County
residents live. For these reasons, the court finds that Wando has not proven
by a preponderance of the evidence that the largest group of patients served by
the Proposed Project would be drawn from Berkeley County instead of the more
highly populated, fast growing, and closer Mount Pleasant area.
B. Standards Two and Three: Identification of Affiliated Physicians
and Projected Shift in Utilization
i. Identification
of Affiliated Physicians, Where They Perform Surgery, and Anticipated Practice
Changes
Standard Two of the State Health Plan provides:
The applicant must identify the physicians
who are affiliated or have an ownership interest in the proposed facility by
medical specialty. These physicians must identify where they currently perform
their surgeries and whether they anticipate making any changes in staff
privileges or coverage should the application be approved.
(East Cooper Ex.
67 at II-78; DHEC Ex. 2 at II-78.) Although Wando originally identified seven
Lowcountry surgeons, Dr. Jordan, Dr. Weber, and Dr. Netherton as participating
physicians, Wando failed to identify numerous other physicians who were
affiliated with its project. During project review, Wando revealed plans to
add eleven surgeons. The evidence conflicts as to whether Wando knew the identities
of the four surgeons it intended to recruit in the next two years or whether
Dr. Jordan knew the identities of the two ENTs he intended to recruit. However,
it is unrefuted that Wando knew the identities of the five additional surgeons
“who want to practice in the Wando facility when it is completed,” but declined
to provide it. Further into Project Review, Wando stated that its “plans call
for additional MDs” and its witnesses discussed up to fifty additional
providers who would be providing services, although whether particular
physicians in this group would practice at Wando is unclear.
Wando
attempted to establish sufficient need for the Proposed Project through the
additional surgeons or physicians. However, without sufficient information
concerning these additional physicians, its utilization data is insufficient.
Standard
Two further requires that an applicant for an ASF must “identify where [the
affiliated physicians or owners] currently perform their surgeries and whether
they anticipate making any changes in staff privileges or coverage should the
application be approved.” (East Cooper Ex. 67 at II-78; DHEC Ex. 2 at II-78.)
At no point did Wando provide any information about where the five surgeons who
expressed a desire to become affiliated with it soon after Wando would be
licensed were performing their surgeries or if they anticipated
making any changes in staff privileges or coverage. While the court
appreciates the desire of these physicians to remain anonymous due to concerns
of reprisal, Wando cannot prove by a preponderance of the evidence the
requirements of Standard Two without the information called for by the State
Health Plan.
ii. The
Interrelation Between Standards Two and Three
Standard
Two is interrelated with Standard Three. Standard Two requires an applicant to
identify the physicians and their current practice locations, and Standard
Three requires an applicant to document the details regarding the physicians’
patients—where the patients will come from, where they are currently being
served, and any expected shift in patient services from existing providers. (East Cooper Ex. 67 at II-78;
DHEC Ex. 2 at II-78.) Thus, when Wando failed to identify other affiliated
physicians during and after the DHEC review process, Wando also did not comply
with Standard Three, because Wando did not document where the physicians’
patients would come from or any expected shift in patient volume. (Levitt
Test., Hearing Day Five at 9-10 and 103.)
The
State Health Plan standards for freestanding surgery centers are predicated on
the Department’s need to know the identities of the physicians affiliated with
the centers, details regarding the physicians’ practices, the number of
potential patients that would be shifted to the new center, and where they will
come from. When assessing whether an ASF applicant has proposed a viable
project, the analysis based on the standards in the State Health Plan should
focus first on whether affiliated physicians identified by the applicant
control a sufficient volume of patients to justify the approval of the center.
The same information is also essential to the assessment the court must
undertake of the potential impact on existing providers that would be caused by
the shift of patients from their facilities to the Proposed Project. Therefore,
if Wando is relying upon the utilization data of a particular physician or
group of physicians to support its Proposed Project, then they must be
disclosed. Without that information, the court cannot make a determination of
the project’s impact.
Standard
Seven of the ASF standards requires that new facilities have open medical
staffs and not restrict the range of surgical specialties offered. (East
Cooper Ex. 67 at II-78; DHEC Ex. 2 at II-78.) However, this requirement does
not obviate the requirement of Standards Two and Three that the physicians and
their specialties be identified, along with expected shifts in patient volume
from existing providers. The burden is on the applicant to comply with
Standards Two and Three. It would not be reasonable to conclude that this
obligation would exist in perpetuity, but it is reasonable to require an
applicant prior to the approval of the CON to provide information within its
knowledge to the Department, as well as to the court, concerning the identity
of physicians who are reasonably likely to become affiliated with a proposed
project during the three-year CON planning projection period. The three-year
projection period ties directly to Standard Four, which mandates that an
applicant document the need for an ASF, including documentation of the
projected number of surgeries performed by medical specialty. DHEC further
requires an applicant to quantify the extent to which a proposed project would
address the need for services through the three-year future utilization
projections, which include volumes, revenues, and expenses.
C. Standard
Four: Need and Existing Resources
Standard
Four requires that an applicant that proposes to establish an ASF document the
need for the facility. The application of Standard Four essentially involves a
two-part analysis: (1)
whether the applicant documented need, including whether existing resources are
adequate to meet the need; and, (2) whether the proposed project meets the
projected need, if it exists.
As
a general rule, a need for an additional ambulatory surgery facility is not
considered to exist unless outpatient surgery providers are operating at 80% of
capacity. Marlboro Park Hosp. v. S.C. Dep’t of Health & Envtl. Control,
et al., 98-ALJ-07-0734-CC, 2000
WL 1274366 at *16 (S.C. ALJD July 27, 2000) (“[T]he appropriate utilization
threshold is that need generally does not exist until existing facilities reach
approximately eighty percent of their total capacity.”) (ultimately affirmed by Marlboro Park Hosp. v. S.C. Dep’t of Health & Envtl. Control, 358 S.C. 573, 595 S.E.2d 851 (Ct. App. 2004)). The
record reflects that there are currently thirteen existing providers of
outpatient surgery services in the Tri-County area, seven freestanding centers,
and six hospitals. The thirteen facilities have the capacity to serve
additional patients and are operating at well below 80% capacity.
Specifically, the utilization of the freestanding centers dropped from 60.8% to
50.5% from 2003-2006, and hospital outpatient surgery capacity during 2006 was
at 58.1%. Thus, both hospital-based and freestanding outpatient surgery
centers have considerable capacity to serve ambulatory surgery patients from
Berkeley County.
In
addition, an analysis of the projected outpatient surgeries in the Tri-County
area in 2010 reflects that freestanding providers will be operating at only
47.9% capacity, and hospital-based providers will be at 53.1% capacity.
Projected utilization in 2010 for all Tri-County providers of outpatient
surgeries will be at 51% overall, with capacity to serve projected future
demand. The existing ambulatory surgery centers in the Tri-County area not
only have the capacity to serve additional patients, but they are also
accessible to the great majority of the residents of Berkeley County.
Expert
witnesses for all parties were generally in agreement that the standard drive
time for an outpatient surgery patient after a procedure should be no greater
than thirty minutes. In fact, Dr. Spearman testified that from a clinical
standpoint he believed that although “15 to 30 minutes is reasonable,” the
drive time should be “closer to 15.” (Dr. Spearman Test., Hearing Day One at 135.)
Grice
testified that a majority of Berkeley County residents have access to
outpatient surgery within thirty minutes. During the review period, DHEC also
noted that the populous areas within Berkeley County are served by multiple
hospital-based and freestanding ambulatory surgery facilities. The drive time
analysis presented by East Cooper confirmed the Department’s observations,
because it demonstrated that a majority of the residents of Berkeley County
have access to ambulatory surgery providers within a thirty-minute drive time.
The
court finds that Wando has not met its burden of demonstrating by a
preponderance of the evidence the need for an additional ASF in Berkeley
County. Furthermore, even if need did exist for an additional ambulatory
surgery center in Berkeley County, Wando has not proven by a preponderance of
the evidence that the Proposed Project would meet the need.
Wando
has proposed to establish an ASF in a remote area of the southern corner of
Berkeley County. The site is located on Clements Ferry Road, along a congested
two-lane road in an industrial area. It is an eleven-minute drive along
Clements Ferry Road from the site to Interstate 536, which cuts across the
Cainhoy Peninsula to connect Charleston County on the east and Charleston and
Dorchester Counties on the west. For this reason, there is limited access into
the Cainhoy Peninsula area, and, as Wando represented during the staff review,
truck traffic and industrial congestion would make travel difficult into and
away from the site. The Proposed Project is therefore not situated to serve
the great majority of residents of Berkeley County who do not reside on the
Cainhoy Peninsula.
In
addition to problems with physical access to the site, the proposed location is
also in one of the least populated regions in Berkeley County. Only 5.3% of
Berkeley County’s population is projected to live in the Cainhoy Peninsula in
2015. The population is concentrated instead in the western region of Berkeley
County, where 70% to 75% of the population resides.
When
compared to existing and approved providers in the Tri-County area, Wando’s
project is the least accessible of the options available to the great majority
of Berkeley County residents. Ten of the thirteen existing Tri-County area
providers already are located within a thirty-minute drive time of the proposed
Wando center’s location. With the exception of a small number of Cainhoy
Peninsula residents, the proposed site would require longer drive times and
would be less convenient for nearly all other Berkeley County residents.
Standard
Four requires that an applicant provide the most current utilization available,
including the projected number of surgeries to be performed by medical
specialty. (East Cooper Ex. 67 at II-78; DHEC Ex. 2 at II-78.) An analysis of
Wando’s projections reflects that Wando has been unable to demonstrate a
reasonable basis for its utilization projections. As discussed in the Findings
of Fact, Wando’s projections unreasonably assume that (1) it would shift all the
Berkeley County patients seen at the Lowcountry Center to Wando; (2) it would
acquire all of Dr. Jordan’s Berkeley County cases; and (3) it could rely on Dr.
Weber’s Cleveland Clinic experience to quantify its projections that Dr. Weber
would perform at Wando. See supra Section II.5. Further,
Wando’s projections rely on ORS Outpatient Surgery Reports in its projections
rather than JAR data, which is a more reliable means for measuring the
utilization of outpatient surgical activity. See supra Section II.3.B.
For all of the foregoing reasons, Wando has not met its burden of documenting
need for its proposed facility.
D. Standard Six: Documentation of the Potential Impact of the
Proposed ASF
Standard
Six provides that “[t]he applicant must document the potential impact that the
proposed new ASF or expansion will have upon the existing service providers and
referral patterns.” (East Cooper Ex. 67 at II-78; DHEC Ex. 2 at II-78.) To
comply with Standard Six, an applicant must provide documentation regarding the
potential impact its proposed project will have on existing providers. Because
of the evidence presented on the underutilization of the existing nearby
facilities and the high probability that Wando will draw patients from Mount
Pleasant, which it did not include in its projections, Wando did not prove by a
preponderance of the evidence that there would not be an adverse impact on the
existing providers.
4. Proposed
Wando Project’s Non-Compliance with Project Review Criteria
South
Carolina Regulation 61-15 contains a list of criteria for project review that
are potentially applicable to a proposed CON project. In this matter, DHEC
specifically listed a number of criteria regarded as most important in
evaluating Wando’s CON application. (See DHEC Ex. 1-C at 581.) Further,
the parties offered testimony concerning an additional criterion. For the
following reasons, in addition to the applicable State Health Plan standards,
the court finds that the Proposed Project did not comply with the project
review criteria identified by DHEC as applicable to the Wando application.
A. Community Need Documentation – 2a, 2b, 2c, 2d, 2e
For
the same reasons discussed related to Standard Four, Wando did not meet its
burden of documenting community need. See supra Section
III.3.A. Wando failed to identify a need of a specific target population or
that its project would meet that need.
B. Distribution
(Accessibility) – 3a, 3b, 3c, 3d, 3e, 3f, 3g
The
project review criteria for distribution (accessibility) involves in part the
principle that an application will not be approved where the effect of doing so
would be the unnecessary duplication of services. 24A S.C. Code Ann. Regs.
61-15, § 802, criteria 3a and 3b (Supp. 2007). As discussed previously, the
existing ambulatory surgery centers in the Tri-County area have capacity to
serve additional patients and are accessible to a great majority of Berkeley
County residents. See supra Section III.3.C. For this
reason, the Proposed Project represents an unnecessary duplication of existing
services.
C. Adverse
Affects on Other Facilities – 23a, 23b
Criterion
23a involves weighing the impact on current and projected occupancy rates or
use rates of existing facilities against increased accessibility offered by the
proposed services. 24A S.C. Code Ann. Regs. 61-15, § 802, criterion 23a (Supp.
2007). In the Tri-County area, the existing providers were well below
80% capacity at 58.1% in 2006 and are projected to be at a 51% utilization
level in 2010. See supra Section III.3.C. The addition
of Wando, another outpatient surgery provider, would necessarily impact and
lower the utilization rates even further and is unwarranted because Wando
offers little increased accessibility.
D. Distribution
– 22
Criterion
22, Distribution, pertains to an identification of the existing distribution of
the health services and the effect of the proposed project upon the
distribution. 24A S.C. Code Ann. Regs. 61-15, § 802, criterion 22 (Supp. 2007). The Tri-County area is currently served by thirteen existing outpatient
surgery providers that are accessible to a great majority of Berkeley County
residents. The Proposed Project would have little positive effect on the
current distribution of ambulatory surgery services because it would be located
in a sparsely populated area of Berkeley County, is not situated so as to
increase accessibility of services to most of the county, and is less
accessible than most of the existing providers to the population centers of the
county.
E. Projected
Revenues/Expenses – 6a, 6b, 7 and Net Income/Financial Feasibility – 9, 15
Criterion
6a states that the proposed charges should be comparable to those charges
established by other facilities for similar services within the service area or
state. 24A S.C. Code Ann. Regs. 61-15, § 802, criterion 6a (Supp. 2007). Criterion 9 provides that a CON project should show an improvement in net revenue
position over time, and Criterion 15 requires that the applicant
must project both the immediate and long-term financial feasibility of the
proposal and that the projections must be reasonable. 24A S.C. Code Ann. Regs.
61-15, § 802, criteria 9 & 15 (Supp. 2007).
Wando
has not proven by a preponderance of the evidence that the Proposed Project is
financially feasible. As explained above, its assumptions on which the budgets
were based are not supported by the evidence. See supra Section
II.8. As a starting point, the orthopedic charges in the final Wando budget
are not comparable with area averages. The charges were based on the
Lowcountry Practice’s charges, which are high compared to the area averages. Moreover,
the contractual adjustments used by Wando remained unchanged even though the
charges significantly increased in each budget. This was an unreasonable
assumption because many payors pay a fixed amount regardless of what is charged
(the contractual adjustment should increase as charges increase). Adjusting
Wando’s final budget by several key factors also demonstrates that its pro
forma budget was unreasonable. Subtracting the cases projected for Dr.
Weber based on his Cleveland experience results in a facility operating at less
than 40% capacity with a loss of $101,658 in the third year of operation. In
addition to the Weber adjustments, reducing the projected volume of cases to
exclude the percentage that would be performed in a hospital setting, rather
than at Wando, produces a net loss of $758,800 in year three. By reducing
the number of patients from all Berkeley County residents to only the number of
residents who live in areas in closer proximity to the Proposed Project site,
Wando’s final budget shows a loss of $1,442,455 in the third year. Finally,
adjusting patient volumes for proximity and reducing the charges to more
accurately reflect area averages shows the Wando center with a loss of
$1,496,480 in the third year. Each of these examples of negative revenue
forecasts demonstrates that Wando’s assumptions overstate the financial
feasibility of the Proposed Project and that, furthermore, it would not be
financially feasible if Berkeley County patients are the predominant patient
group, as required by Standard One.
F. Alternative
Methods - 19
While
not specifically raised by the Department during review, one of the criteria
for project review provides:
a. The applicant should have considered any available or
more effective alternatives which exist to the proposed service such as the use
of less costly alternatives, outpatient services, shared services, or extended
hours of service.
b. For new construction projects, modernization of existing
facilities should be considered as an alternative, and the rejection of this
alternative by the applicant should be justified.
S.C. Code Ann.
Regs. 61-15, § 802.19 (Supp. 2007). Evidence was presented at trial that the Proposed
Project does not satisfy this criterion. Two cost effective alternatives to
the Proposed Project were presented during the course of the hearing that
provide choices consistent with the underlying purpose of the CON program.
First, given the low utilization of existing providers of outpatient surgery services,
both currently and as projected in the future, patients in the Tri-County area
could increase their use of existing resources in the area. The second
alternative would be for the Lowcountry Center to expand its current facility
from two operating rooms to four operating rooms.
Eight
of the ten proposed Wando owners are members of the Lowcountry Practice, and
six of the eight Lowcountry Practice members have an ownership interest in
Lowcountry. The evidence reflects that the Lowcountry Center, which was only
opened in 2004, could be expanded for less than $2 million compared with an $8
million investment in the Proposed Project. In addition to being a less costly
alternative, expanding the existing Lowcountry Center is a superior alternative
because it would still be accessible for a majority of residents. Accordingly,
these alternatives better promote the purposes and objectives of the CON Act. See S.C. Code Ann. § 44-7-110, et seq. (Supp. 2007).
5. Conclusion
Viewing
all of the facts in the record as a whole, the court finds that Wando did not
meet its burden as the petitioner to prove by a preponderance of the evidence
that its CON application to construct and establish a freestanding ambulatory
surgery facility was in compliance with the applicable CON statutes and
regulations and the standards set forth in the 2004-2005 State Health Plan, or
that DHEC erred in denying Wando’s CON application for its Proposed Project.
IV. ORDER
For
all the foregoing reasons, it is
ORDERED that the decision of the South Carolina Department of Health and
Environmental Control to deny the Certificate of Need applied for by
Wando Outpatient Surgery Center, LLC to establish an ambulatory surgery center
in Berkeley County is upheld.
IT
IS SO ORDERED.
___________________________________
PAIGE
J. GOSSETT
Administrative
Law Judge
October 15, 2008
Columbia, South Carolina
Even if credit is given based upon Dr. Weber’s
historical use patterns in the Charleston area, it is still not sufficient to
prevent the Proposed Project from a projected loss in the third year of
operation. As discussed above, while Dr. Weber was at MUSC from 2000-2002, he
had only 118 cases from all of Berkeley County and, of those, only five were
from the Cainhoy Peninsula.
The 2004-2005 State Health Plan was in effect at the
time Wando filed its application for a CON to construct a new ambulatory
surgery center. Accordingly, the standards, policies, and findings set forth
in the 2004-2005 State Health Plan are applicable to review of Wando’s
application.
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