HEALTH SERVICES AND DEVELOPMENT AGENCY MAY 26, 2010 APPLICATION SUMMARY

Transcription

1 HEALTH SERVICES AND DEVELOPMENT AGENCY MAY 26, 2010 APPLICATION SUMMARY NAME OF PROJECT: PROJECT NUMBER: The Proton Therapy Center, LLC CN ADDRESS: 1435 Old Weisgarber Road, Suite 100 Knoxville (Knox County), TN LEGAL OWNER: OPERATING ENTITY: CONTACT PERSON: The Proton Therapy Center, LLC 1450 Dowell Springs Blvd., Suite 250 Knoxville (Knox County), TN Proton Therapy Management, LLC 1450 Dowell Springs Blvd., Suite 250 Knoxville (Knox County), TN John Wellborn (615) DATE FILED: February 12, 2010 PROJECT COST: $118,785, FINANCING: REASON FOR FILING: Commercial Loan and Cash Reserves Establishment of a single specialty ambulatory surgical treatment center limited to radiation therapy, initiation of radiation therapy services and acquisition of proton therapy equipment DESCRIPTION: The Proton Therapy Center, LLC (TPTC), a presently wholly-owned subsidiary of ProVision Trust, is seeking approval to establish a single specialty ambulatory surgical treatment center (ASTC) limited to radiation therapy, initiate radiation therapy services and acquire Ion Beam Applications (IBA) proton therapy equipment at 1435 Old Weisgarber Road, Suite 100 in Knoxville, Tennessee. The applicant will lease 42,982 gross square feet of space from Proton Development, LLC, (another ProVision subsidiary) at ProVision s East Tennessee Healthcare Center (ETHC) (see corporate description below) in its Dowell Springs office park

2 dedicated to cancer treatment and research. TPTC s preliminarily design of the proton therapy treatment facility will consist of two floors. The first floor will contain patient care areas and operations support spaces. The patient treatment areas will consist of four vaults: one containing the proton beam generating cyclotron; a fixed treatment room (where the patient lies on a table with the beam directed into the tumor from a fixed position); a gantry treatment room (where a gantry rotates the beam delivery mechanism around the patient on the table to treat from multiple angles); and a dedicated research room that has access to a proton beam for research projects. Each of the treatment and research vaults will have an adjacent control room. The floor will also have 8 patient examination rooms, a nurse station, a CT treatment simulation room with adjacent control room, work rooms and machine shop, reception and waiting room. The second floor will have six treatment planning spaces, a conference room, medical and facility staff offices, support spaces, IT and telecommunications rooms, storage rooms and electrical and mechanical equipment. Other supportive equipment will include a CT treatment simulator, treatment planning hardware and software. Floor plans of the facility are provided in pages 12 a-12m of the original application. A summary explanation of the construction costs ($465/SF) on pages The TPTC facility will treat patients up to 16 hours per day, 6 AM to 10 PM, five (5) days (80 hours) per week. The TPTC building will be adjacent to an ETHC building which houses the East Tennessee Diagnostic Center, whose PET/CT and other imaging capability will be available to support patient treatment planning and evaluation. The Proton Therapy Center, LLC (TPTC) is a recently created (January 7, 2010) Tennessee limited liability corporation wholly owned by ProVision Trust. The Trust is a 501(c)(3) non-profit foundation established by founder (Terry Douglass, Ph.D.) of CTI Molecular Imaging, Inc., a Knoxville company that developed and commercialized PET and PET/CT technology and delivered the technology globally. The applicant describes ProVision Trust s role as working collaboratively with local providers and funding innovative projects that will advance medical knowledge, improve patient wellness and outcomes, and foster physician hospital relations. TPTC will be managed by another related entity, Proton Therapy Management, LLC (also created on January 7, 2010). Proton Development, LLC, will develop and lease the facility to TPTC. Another ProVision affiliate, ProVision Healthcare, currently provides management services to all five Mercy Health Partners radiation therapy sites along with a joint ventured (between Mercy Health Partners and ProVision) outpatient diagnostic center located in the ETHC complex in Dowell Springs. Note to Agency members: Pages 3-6 of the supplemental response contain more details, an organization chart, and information on the applicant s related organizations. The applicant indicates the project is intended to provide outpatient radiation

3 therapy services utilizing proton therapy technology (and related supportive equipment) at Knoxville s new East Tennessee Healthcare Center (ETHC), located at Dowell Springs office park. ETHC has been developed to provide a state-of-the-art community outpatient healthcare center focused on comprehensive and coordinated services to meet patient needs. The quality of its cancer diagnosis and therapy services, and its patient and physician support service will be, according to the applicant, unsurpassed in the East Tennessee region. A major medical oncology group practice, Tennessee Cancer Specialists, has relocated its largest medical office to Dowell Springs. The Knoxville Comprehensive Breast Center has also relocated their operation to the Dowell Springs center and installing a second dedicated breast MRI (CN A). Letters of Support for the proposed project have been received from the Tennessee Cancer Specialists, the Knoxville Comprehensive Breast Center, The University of Tennessee Medical Center s Cancer Institute and University of Tennessee Medical Center (UTMC). In their letters of support UTMC and its Cancer Institute indicated although it will not be an equity partner in TPTC, UTMC indicates it plans to partner with ProVision in the clinical management and operations of TPTC. UTMC will provide credentialing and physician staffing, and will participate in the recruitment of additional qualified physicians as the need arises. TPTC will be considered an integral component of the UTMC Cancer Institute, and will be included in all research, clinical trials, grants, services, procedures and other functions thereof. The applicant will also establish a TPTC Medical Advisory Board composed of five experienced oncologists with backgrounds and credentials in proton therapy and conventional radiation, academic medicine, surgical oncology, pediatric and adult medical oncology. A description of the purpose of the Medical Advisory Board and summary of the credentials of each of the five members is provided at the end of the HSDA Staff summary. Letters of Support were also received from the University of Tennessee College of Engineering, Department of Nuclear Engineering; East Tennessee Children s Hospital s Department of Pediatric Hematology/Oncology; Blackmon Pediatrics; Pediatric Proton Foundation; The Butterfly Fund; Brotherhood of the Balloon; the American Cancer Society; The National Association for Proton Therapy; Proton Health Partners; IBA Particle Therapy; Elekta Oncology; Siemens Healthcare; The Knox County Mayor; the East Tennessee Economic Development Agency; and 15 patients who have received proton therapy for prostate cancer. Proton therapy is a unique alternative radiation therapy treatment modality which utilizes proton particle beams to irradiate and kill cancer cells and tumors. It is an alternative to the other types of radiation therapy which uses other types of radiation, including photons, electrons and gamma rays which also kill cancer cells. These more traditional radiation therapy modalities deliver radiation to the patient s cancer site via linear accelerators, Cyberknives, and Gamma Knives.

4 The unique feature about photon particle beams is they release their energy directly within the targeted cancer cells, while minimizing damage to healthy tissues as the beams enter and exit the tumor. Thus, according to the applicant, photon beams cause much less collateral damage than other types of radiation. Collateral damage causes, or intensifies, undesirable side effects, including nauseating toxicity, permanently damaged tissues outside the tumor site, and increased risk of subsequent tumor development from the radiation itself. According to the applicant, proton therapy greatly reduces patient discomfort, and substantially reduces risk of subsequent problems, such as additional tumors or loss of function in surrounding tissues. Proton therapy is considered especially promising for treatment of children s cancers, because the escaping radiation with other technologies can have very adverse impacts on children s rapidly growing organs. Proton treatment is also in great demand for prostate cancer, because it substantially reduces subsequent side effects such as impotence, incontinence, and gastric and urinary toxicities. On pages 26 a-26g of the original application, the applicant also shares promising clinical findings in the proton treatment of head and neck, spinal, lung, breast, liver and pancreatic cancers. Various web-sites provide a wealth of information with videos describing proton therapy technology and its diffusion within the United States: and Each of the websites displays links to interviews with clinical experts in the field of radiation oncology. One of the interviews was with Dr. Jay Loeffler, Chairman of the Department of Radiation Oncology at Massachusetts General Hospital in Boston, MA: "In my opinion it's [proton therapy] a better treatment. The bigger issue though is, is the increased costs associated with protons worth it to society? In my opinion it's worth it, if we can reduce the initial costs of building proton centers." Within the time-related scheme of medical technological development, proton therapy cancer treatment is a relatively new cancer treatment technology, although it has been available in the United States for about twenty years. Since the initial proton therapy installation in Loma Linda, California, only six new installations of treatment centers have become operational within the United States. Current operating proton centers include: 1 James M. Slater, M.D. Proton Treatment and Research Center at Loma Linda University Medical Center 2 Frances H. Burr Proton Center at Massachusetts General Hospital, Boston, MA 3 Midwest Proton Radiotherapy Institute at Indiana University, Bloomington, IN 4 The University of Florida Proton Therapy Institute, Jacksonville, FL 5 M.D. Anderson Cancer Center s Proton Center, Houston, TX 6 ProCure Proton Therapy Center, located at the INTEGRIS Cancer Campus Oklahoma City, OK

5 7 The Roberts Proton Therapy Center at the University of Pennsylvania Health System, Philadelphia, PA Several additional centers (5) are currently under construction: 1 Hampton University Proton Therapy Institute, Hampton, VA ($225 million- 5 treatment rooms: 4 gantry, 1 fixed; Completion date ) 2 Northern Illinois University Proton Therapy Center, West Chicago, IL ($159 million: 4 treatment rooms: 2 gantry, 2 fixed, 1 research room; Completion date ) 3 CDH Proton Therapy Center, a ProCure Center, Warrenville, IL ($140 million; Completion date 2011) 4 ProCure Proton Therapy Center in partnership with Princeton Radiation Oncology Group and CentraState Health care System, Somerset, NJ ($160 million: 4 treatment rooms; Completion date 2012) 5 Kling Center for Proton Therapy, Barnes-Jewish Hospital and Washington University, St. Louis, MO ($20 million: 1 treatment room; Completion Date 2011) Thirteen (13) more proton centers are in the feasibility planning stages. The closest to Tennessee proposed Proton Therapy Centers in the developmental stages are located in southeastern Michigan, New Jersey, and southeastern Florida. None will be any closer to Knoxville, Tennessee than Jacksonville, Florida, Bloomington, Indiana and Hampton, Virginia (see driving distances and times on page 21 of the original application and page 14 of the supplemental response). The shortest distance from Knoxville is calculated by Google Map to be about 350 miles (5.8 hours) to Bloomington, IN. A map of the US showing the existing facilities, along with those under construction and in the planning stages of developmental is provided on page 19b of the application. A chart providing more details about the proton therapy centers has been provided on page 20 of the original application. A primary reason for the slow diffusion of proton therapy technology throughout the country is the cost of building a proton therapy treatment facility, and the consequent increased cost of proton therapy treatment versus conventional radiation therapy modalities. Episodes of treatment generally last four to eight weeks and can cost two times more than conventional radiation therapy. For economic reasons, proton therapy treatment facilities must be built within reasonable travel distances of areas of high population density, so that larger volumes of patients may more conveniently be serviced to spread the technology s higher costs over larger patient volumes, thus reducing unit costs. Due to these higher costs, the technology has been diffused quite slowly, which, to-date, is leaving longer travel distances for certain elements of the population. Tennesseans seeking proton therapy treatments must minimally travel several

6 hundred miles to the closest operating centers in Bloomington, Indiana (348 miles from Knoxville), Hampton, Virginia (512 miles), Jacksonville, Florida (523 miles), Chicago, Illinois (538 miles), Oklahoma City, Oklahoma (852 miles) or Houston, Texas (922 miles). The applicant indicates there are no other known proton therapy facilities in the planning stages for development within closer traveling distances to Tennessee than Bloomington, Indiana, Hampton, Virginia or Jacksonville, Florida. Thus, the applicant indicates the proposed facility will be the first proton therapy site in the vast Southeast region of the US, north of Florida. TPTC indicates that proposed service will be provided primarily to patients from 74 counties throughout a five state region in the Southeastern United States (eastern Tennessee, northern Georgia, western North Carolina, southwestern Virginia, and eastern Kentucky. A map of the proposed service area is provided on page 23 of the original application. However, the applicant indicates the experience of the seven other Proton Therapy Centers currently operating in the United States is 50% of the patients will come from a much broader geographic area outside the 150 mile (2.5 hour driving radius) surrounding other Proton Therapy Centers. TPTC estimates 55% of its patients will come from the 74 county, multistate service area. A map of the applicant s primary service area is provided on page 23 of the original application, followed by a chart identifying all 74 counties in the five state region on page 24. Thirty-six (36) of the counties are in east Tennessee, fifteen (15) in southeastern Kentucky, nine (9) in southwestern North Carolina, eight (8) in southwestern Virginia, and six (6) in northwestern Georgia. The applicant indicates the current population of the entire service area is 3,826,895, of which 60% were residents of the 36 Tennessee counties. 15.3% of the primary service area population is 65 years of age and older. This percentage will increase to 17.1% elderly by The applicant notes cancer rates increase steeply in elderly segments of the population and the aging of the population is a major factor in the projected increase in cancer incidence between today and The Tennessee Department of Health indicates the population of the 36 county service area will grow 2.5% from its current overall population of 2,330,677 to 2,388,484 in The estimated age 65 and older cohort for the service area in 2010 is 362,538 and is projected to grow to 405,550 in 2014, an 11.9% increase. The applicant has provided the most recent cancer incidence rate projections ( ) compiled by Thomson Healthcare (a division of Thomson Reuters), based on Medicare s files and the National Cancer Institute s Surveillance Epidemiology and End Results (SEER) data for the 74 county service area on pages of the original application. In summary, the total case projection predicted there would be 23,240 new cancer cases in CY2014. Utilizing various step-down factors, the applicant estimated 55% of these cases (or 12,782 new

7 patients) would very likely be candidates for radiation therapy. Of those that would be eligible to receive radiation therapy, 15-20% would be considered eligible for proton therapy. Using of these step-down factors, the applicant s projection methodology predicted 1,917-2,556 patients in the primary service area would benefit from proton therapy. The applicant indicates the case capacity of the proposed proton therapy facility at 97% utilization, would be approximately 690 patients during the second year of operation. Utilizing the experience of other proton centers of approximately 55% of their patients coming from within their primary service area, the applicant estimates 380 TPTC cases would be patients whose residence would be from within its defined primary service area. Thus, the applicant claims TPTC share of the primary service area radiation therapy market would be only 3% (380 patients/12,782 new cancer patients = 3%). See pages of the original application for details the methodology). Utilizing the HSDA Medical Equipment Registry s information (see page 39b of the original application), there are 32 linear accelerators located within the Tennessee portion (36 counties) of TPTC s declared 74 county primary service area. As reported to the HSDA Medical Equipment Registry, the utilization information shows the entire Tennessee portion of the applicant s declared service area s 32 operating linear accelerators in 2008 were being utilized at an average of 81.2% of the Guidelines for Growth s minimum standard of 6,000 procedures/rt unit/year. The Guidelines for Growth s standard states no additional megavoltage radiation therapy units shall be approved unless every existing unit has performed 6,000 or more procedures per unit annually. Comparing the average utilization (4,878 procedures per linear accelerator) to the Guidelines for Growth s optimal megavoltage therapy unit capacity (9,984 procedures per RT unit per year), the service area-wide utilization is just 48.9% of optimal capacity. With area providers not even performing on the average at minimal capacity of 6,000 procedures per unit per year, there is ample capacity within the current resources to meet present growth trends within the conventional radiation therapy modalities. With three additional megavoltage linear accelerators opening in 2009 and 2010, already approved additional treatment capacity between 18,000-29,952 treatments will be available to service the needs of the conventional radiation therapy market. Most, if not all, have IMRT and IGRT capabilities which also offer the benefits of minimization of collateral damage to surrounding tissue. Note to Agency members: IMRT (intensity modulated radiation therapy is an advanced mode of radiotherapy where the intensity of the beam is computer controlled 3-dimensionally to deliver the most intense dosages to the tumor, while minimizing the intensity of the beam to surrounding tissue). IGRT (image-guided radiation therapy is the process of frequent two and threedimensional imaging, during a course of radiation treatment, used to direct radiation therapy utilizing the imaging coordinates of the actual radiation treatment plan).

8 In addition, there are two (2) Cyberknives (at University of Tennessee Medical Center and Bristol Regional Medical Center and one Gamma Knife at Mercy Baptist-Riverside). These megavoltage machines are also specifically designed to minimize the hazards of collateral damage to surrounding tissue. Whether one type of radiation therapy machine accomplishes the reduction of collateral damage better than the others remains the subject of ongoing clinical evaluations, which have been limited due to the limited supply of proton therapy centers. Note to Agency members: There are no Guidelines for Growth standards for the utilization of the Cyberknives and one Gamma Knife. Both Cyberknives and Gamma Knives have different lengths of treatment time which reduce their annual treatment capacity capabilities from linear accelerators; Cyberknives annual capacity was estimated at 1,800 patients/year by its manufacturer in St. Francis Hospital of Memphis application and the Gamma Knife s capacity was estimated at 850 patients/year by its manufacturer. In its recent application (CN D) for a linear accelerator at the Dowell Springs location, the applicant suggested the annual capacity for the Cyberknife is 1,250 procedures/year and the 750 procedures/year for the Gamma Knife. The most recently reported utilization numbers would indicate their annual utilization is approximately 50% of their annual capacities (as measured by the average of the capacities as stated in previous applications) for the Cyberknives. The Gamma Knife s most recently reported utilization is approximately 11% of its annual capacity (as measured by the average of the capacities as stated in previous applications). The applicant has projected patient volumes of 518 patients and 17,146 treatments in the first year of operation and 690 patients and 22,770 treatments in the project s second year. Per the Projected Data Chart for the photon therapy equipment, the project exhibits positive cash flow equivalent to 6.0% of total gross operating revenues, but unfavorable financial operating margin in the first year of operation in an amount equal to approximately 7.9% of total gross operating revenues. The second year also returns a positive cash flow equivalent of 21.0% of total gross operating revenues, while the unfavorable operating margin improves to approximately 1.0% of total gross operating revenues. The average gross charge per procedure during the first year of operation is $3,182, with deductions from revenue reducing the net charge per procedure to $1,352. The average gross charge per conventional radiation therapy treatment in the Tennessee portion of the primary service area is $856. In comparing the cost differential between the various types of radiation therapy modalities, the applicant points to the comparative research to date which indicate significantly lower rates of treatment complications and recurrence of cancer at later dates. Operating expenses and capital expenses reduce the first year s net operating income less capital expenditures per procedure to -$ The second year s average net operating income less capital expenditures per procedure will be -$ The project s programmed staffing is shown on page 60 on the original application.

9 On page 8 of the DOH Report a chart shows the number of TennCare enrollees in the Tennessee service area counties. There are 416,375 TennCare enrollees in the service area as of 9/7/09. The TennCare enrollee range by county is 14.0% in Blount and Loudon Counties to 32.7% in Hancock County. The Average TennCare enrollment of the Tennessee portion of service area was 17.9%. The applicant indicates it intends to apply for Medicare and TennCare certification and projects (during the initial year of operation) its Medicare revenue (estimated at $16,322,335) will equate to 30% of the total gross revenue and the TennCare revenue (estimated at $5,440,748) will equate to 10.0%. A comparison of how these match with other radiation therapy providers in the services area is shown below. SERVICE AREA LINAC MEDICARE AND TENNCARE PAYOR MIX Service Area Radiation Therapy Providers Facility Type Medicare as a % of Total Gross Revenue TennCare/Medicaid as a % of Total Gross Revenue Baptist of East TN H 52.2% 8.5% Baptist-West H 53.7% 5.7% St. Mary s H 45.2% 2.3% St. Mary s-north H 26.3% 7.3% UT H 49.0% 10.6% Hospital Sub-Total 50.4% 7.9% Thompson CSC- Downtown ASTC 50.9% 8.9% Thompson CSC - West ASTC 53.1% 4.3% ASTC Sub-Total 52.0% 6.6% All Total 50.6% 7.7% 10% Applicant Year #1 ASTC 30.0% +5.0% Charity H=Hospital, ASTC=Ambulatory Surgical Treatment Center, PO=Physician Office Sources: HSDA Medical Equipment Registry The applicant intends to finance the project from a loan from Vision Investments (part of the ProVision Group of companies) and from ProVision Trust (formerly the Douglass Foundation). A February 9, 2010 letter from the Chief Financial Officer of Vision Investments, LLC, attests to Vision Investments ability and intent to loan both the applicant and the project s development company respective amounts to budgeted finance obligations for the project. The Vision Investment s December 31, 2009 Balance sheet shows a balance of Current Assets Cash and Cash equivalents of $20,099,184 and Marketable Securities of $66,787,928. A February 9, 2010 letter from Terry Douglass, Manager of the ProVision Trust, attests to ProVision Trust s ability to and intent to contribute funding to the applicant s portion of the project s capital requirements. The

10 ProVision Trust s December 31, 2009 Balance sheet shows a balance of Current Assets Cash and Cash equivalents of $2,728,993 and Marketable Securities of $11,521,342. The total estimated project cost is $118,785,747.00, of which $92,395,084 is the applicant s and developer s actual capital costs. The construction with contingency costs amount to $16,777,580; $62,570,968 is fixed equipment costs; $26,390,663 in maintenance contract expenses. The lease expense of $8,455,888 is based on fair market value of the leased premises. Interim financing costs $4,495,648. The remainder of the project costs is legal, administrative, and consultant fees ($50,000), and CON filing fees ($45,000). The applicant has submitted the required corporate documents, licensing option agreement, major medical equipment and maintenance quotation with their FDA approvals. Staff will have a copy of these documents available for member reference at the meeting. Copies are also available for review at the Health Services and Development Agency office. The applicant has requested an additional year for completion of the project. Should the Agency vote to approve this project, the CON would expire in three years. CERTIFICATE OF NEED INFORMATION FOR THE APPLICANT: There are no other Letters of Intent or outstanding Certificates of Need for this applicant. Denied Applications East Tennessee Imaging Center, CN D, had an application denied at the September 2006 Agency meeting for the establishment of an outpatient diagnostic imaging center (ODC), the initiation of positron emission tomography (PET) services and the acquisition of a PET/CT unit. The estimated project cost was $4,051,902. Reason for Denial: The applicant did not demonstrate the need for the proposed project. East Tennessee Radiation Therapy Services, LLC., CN D, had an application denied at the December 26, 2009 Agency meeting for the establishment of a single specialty ambulatory surgical treatment center (ASTC) limited to radiation therapy, initiation of radiation therapy services, and acquisition of a linear accelerator at 1415 Old Weisgarber Road, Suite 250, Knoxville (Knox County), TN. The estimated project cost was $5,074, Reason for Denial: The applicant did not demonstrate the need for the proposed project and the project did not contribute to the orderly development of health care.

11 East Tennessee Diagnostic Center-Morristown, CN D, had an application denied at the February 25, 2010 Agency meeting for the establishment of an outpatient diagnostic center (ODC) with MRI, CT and PET/CT and other diagnostic services; and acquisition of MRI & PET/CT units, located on 5 acres within an undeveloped 100 acre tract. The estimated project cost was $11,704,209. Reason for Denial: The applicant did not demonstrate the need for the proposed project and the project did not contribute to the orderly development of health care. CERTIFICATE OF NEED INFORMATION FOR OTHER SERVICE AREA FACILITIES: There are no other Letters of Intent or outstanding Certificates of Need from other health care organizations in the service area for projects similar to this application. Denied Applications Knoxville Urology Clinic, P.C., CN D, had an application denied at the September 23, 2009 Agency meeting for the establishment of a single specialty ambulatory surgical treatment center (ASTC) limited to radiation therapy, acquisition through license of the shared use of a linear accelerator and initiation of radiation therapy services to a 5 county service area. The ASTC was proposed to be located at Parkside Drive in Knoxville, Tennessee. The estimated project cost was $2,182, Reason for Denial: The applicant did not demonstrate the need for the proposed project and it did not contribute to the orderly development of health care in the region. Tennessee Urology Associates, P.C., CN D, had an application denied at the September 23, 2009 Agency meeting for the establishment of a single specialty ambulatory surgical treatment center (ASTC) limited to radiation therapy, acquisition through license of the shared use of a linear accelerator and initiation of radiation therapy services to a 6 county service area. The ASTC was proposed to be located at Parkside Drive in Knoxville, Tennessee. The estimated project cost was $2,505, Reason for Denial: The applicant did not demonstrate the need for the proposed project and it did not contribute to the orderly development of health care in the region. Pending Applications Fort Sanders Regional Medical Center, CN , has a pending application which is due to be heard at the July 28, 2010 HSDA meeting for acquisition of Gamma Knife equipment by lease and associated renovation of existing building space at 1915 White Avenue, Knoxville (Knox County), TN. The estimated project cost is $6,483,

12 PLEASE REFER TO THE REPORT BY THE DEPARTMENT OF HEALTH, DIVISION OF HEALTH STATISTICS, FOR A DETAILED ANALYSIS OF THE STATUTORY CRITERIA OF NEED, ECONOMIC FEASIBILITY, AND CONTRIBUTION TO THE ORDERLY DEVELOPMENT OF HEALTH CARE IN THE AREA FOR THIS PROJECT. THAT REPORT IS ATTACHED TO THIS SUMMARY IMMEDIATELY FOLLOWING THE COLOR DIVIDER PAGE. PMW/ (5/10/10)