The Issue The issue is whether the Petitioner, Wellington Regional Medical Center, Inc., meets the criteria for approval of CON application number 9253 to convert 16 substance abuse beds to a seven-bed or ten-bed Level II neonatal intensive care unit.
Findings Of Fact The Agency for Health Care Administration (AHCA) administers the certificate of need (CON) program for health care facilities and services in the state of Florida. Wellington Regional Medical Center, Inc. (Wellington or WRMC) is a 120-bed community-based hospital, with 104 acute care and 16 substance beds. In September 1999, Wellington applied for CON Number 9253 to convert the 16 substance abuse beds into a ten-bed Level II neonatal intensive care unit (NICU). Currently, Wellington transfers newborns requiring Level II care to St. Mary's Hospital, in West Palm Beach, approximately 45 minutes away. The St. Mary's transport team can arrive as quickly as 20 to 30 minutes, but has taken up to four hours to pick up the babies. AHCA reviewed and denied Wellington's application, based on an absence of need in District 9 under criteria applicable to both normal and not normal circumstances, and the absence of any demonstrated problems for patients in getting access to Level II NICU care. For the January 2002 planning horizon used for applications which were, like Wellington's, filed in September 1999, AHCA published a numerical need for zero additional Level II NICU beds in AHCA District 9. The methodology used by AHCA to calculate numeric need, factoring in the existing inventory of 70 licensed and 20 approved beds, and applying the objective for 80 percent district-wide occupancy, resulted in a numeric need for a negative 32 beds. In other words, in District 9, there is a surplus of 32 Level II NICU beds, based on the formula established in AHCA's rules. The NICU II occupancy rate for 1998 was approximately 66 percent in District 9. In the absence of numerical need, Wellington applied for CON approval based on not normal circumstances, and contends it met, on balance, the requirements of the applicable criteria. 59C-1.042(6) - birth volume In Rule 59C-1.042(6), Florida Administrative Code, a not normal circumstance based on minimum birth volume is set forth, in pertinent part, as follows: Hospitals applying for Level II neonatal intensive care services shall not normally be approved unless the hospital had a minimum service volume of 1,000 live births for the most recent 12-month period ending 6 months prior to the beginning date of the quarter of the publication of the fixed need pool. For this application cycle, the fixed need pool was published in July 1999; therefore, calendar year 1998 is the time period for determining birth volume. In 1998, there were 909 live births at Wellington. In 1999, live births at Wellington increased to 1,101, and, in the 12 months prior to the hearing, to 1,152. AHCA permits applicants to use the most recent data in cases involving not normal circumstances. Currently, approximately 100 live births a month occur at Wellington, which justifies the projection of 1,238 total live births for the year 2000. The current level of live births achieved at Wellington, over 1,000, is equaled or exceeded at fewer than 70 of over 200 hospitals in Florida. For the period ending June 30, 1999, 53 of the 70 hospitals also exceeded 1,200 live births. Of the 53 hospitals with over 1,200 live births annually, 48 had Level II NICUs. Six hospitals in Florida range between 1,200 and 1,499 live births a year; five have Level II NICU. 59C-1.042(5) - minimum ten-bed unit size AHCA's CON reviewer testified that she believed that AHCA had only deviated from the ten-bed minimum unit once, for CON Number 9243 to North Collier Hospital, a Medicaid disproportionate share hospital with over 2,000 live births. She also testified that, even though the applicant showed the required occupancy level in fewer than ten beds, CON approval for a ten-bed unit was awarded to Boca Raton Community Hospital (Boca Raton), in part, based on its large number of live births. By contrast, according to the chart on page 19 in AHCA's Exhibit 2, four of the seven Level II NICU providers in District 9 operated fewer than 10 beds at the time Wellington's application was approved. Apparently, unlike in the case of the Boca Raton application, AHCA held Wellington to the requirement of showing that it could reach 80 percent occupancy in the beds, although AHCA's expert health planner testified that the standard was a "benchmark," not an absolute bar to approval. In general, 1.1 Level II NICU patient days result from each live birth. The ratio of 1.1 to 1, when applied to 80 percent occupancy in a ten-bed unit, results in a mathematical necessity for 2,920 patient days a year, or a project volume of at least 2,654 live births a year. The use of the 80 percent district-wide occupancy standard for normal circumstances as a facility-specific standard for not normal circumstances is unreasonable and conflicts with the minimum volume requirement of 1,000 live births in Rule 59C-1.042(6). AHCA's application of the 80 percent occupancy requirement to Wellington is inappropriate and inconsistent with the agency's prior action. For example, in this case, arguably the failure to meet the normal standard for district occupancy might justify requiring a higher than normal facility standard, but AHCA has not done so with any apparent consistency. Only four out of 57 Level II providers in Florida exceed 2,654, the number of live births necessary to achieve the equivalent of 80 percent occupancy in a ten-bed NICU, three of those exceed 3,000 live births a year, and the fourth is in the range between 2,500 to 2,999 live births a year. Applying the 80 percent test with a 1.1 to 1 ratio to project Level II patient days, the six most recently approved Level II NICU applicants fall short, with projected occupancies ranging from 30 to 40 percent. 59C-1.042(8) - quality of care staffing standards Wellington provides obstetrical services in its Department of Maternal Health, also called the Center for Family Beginnings. Seven dedicated beds are used for labor, delivery, recovery, and postpartum care in that Department, with the frequent need to use overflow beds. Despite the screening of mothers prior to delivery to eliminate those whose babies are likely to need Level II or higher care, at least 25 percent of all expected normal deliveries develop into high risk problems. Wellington is already equipped to handle these unexpected, high risk babies, as it must do prior to transferring them. Wellington also provides follow-up care to high risk babies as a result of their agreement with St. Mary's to allow "back transferring" of stabilized babies. Wellington has a neonatologist-perinatologist on call 24 hours a day. It has neonatal intensive care nurses with Level II and Level III experience on staff 24 hours a day. AHCA questioned the adequacy of the staffing proposed in the CON application because a medical director and respiratory therapists are not explicitly listed on Schedule 6. The medical director will be the same neonatologist- perinatologist who is currently on staff and who will continue to receive professional fees for services, but will not be a hospital employee. That arrangement is explained in the notes to Schedule 6. Similarly, the category "Other Ancillary," Wellington explained in the assumptions to Schedule 6, includes two full-time equivalent staff positions for respiratory therapists. Wellington has on staff two perinatologists, who are doctors specializing in high risk maternal-fetal medical care. One of them moved to Wellington when another NICU program in the County was closed. See Findings of Fact 26. 59C-1.030(2) - health care access criteria Rule 59C-1.030(2), Florida Administrative Code, requires consideration of criteria related to the need for the services proposed and the expected accessibility of the services for residents of the district. The criteria largely overlap with those in Subsections 408.035(1)(b), (d), and (f), and (2), Florida Statutes, which are also related to need and access. See Findings of Fact 20-25 below. In addition to more general need and access issues, the rule requires considerations of access for low income, minorities, and other medically underserved patients, including those receiving Federal financial assistance, Medicare, Medicaid, and indigent persons. The parties stipulated that related criteria in Subsection 408.035(1)(n) - evaluating the applicant's past and proposed Medicaid service - is met or not at issue, based on Wellington's commitment to provide 30 percent Medicaid in the NICU, and historical provision of 32.4 percent Medicaid in the obstetrics unit. By stipulating that the criteria are not at issue or are met in Subsection 408.035(1)(a) - need related to district health plan - the parties necessarily agreed that the local health plan requirement for a commitment to provide at least 30 percent Medicaid/Indigent patient days was met, and so, therefore, is the income accessibility concern of the Rule. Wellington addressed the Rule criterion for minority access to NICU services. The only Haitian doctor specializing in obstetrics and gynecology (OB/GYN) in Palm Beach County, who speaks fluent Spanish as well as Creole, delivers 99 percent of his patients' babies at Wellington. From 60 to 80 percent of his patients come from Lake Worth, most of whom are Haitians and Hispanics, including Gualemalans and Mexicans. Another OB/GYN group of four doctors, with privileges at four different hospitals, delivers 30 to 40 babies a month at Wellington, based on their preference for the care provided at Wellington. The only OB/GYN group in Palm Beach County, which has two affiliated perinatologists, both of whom are on staff at Wellington, serves large numbers of patients from Clewiston, Belle Glade, Pahokee, and Okeechobee. These areas are low income, farming communities located, in driving time, from 45 minutes to 1 1/2 hours west of Wellington. Even when predicted to have high risk births, mothers from the low income areas who are told to go to St. Mary's Hospital because it has a Level II NICU are approximately 70 percent non-compliant. St. Mary's is an additional 45-minute drive east of Wellington. 408.035(1)(b) - availability, quality of care, efficiency, appropriateness, accessibility, extent of utilization, and adequacy of like and existing facilities and services; (d) - availability and adequacy of alternatives, such as outpatient or home care; (e) - economics of joint, cooperative, or shared resources; (f) - need for services not reasonably and economically accessible in adjoining areas; and 408.035(2)(a), (b) and (c) - less costly, more efficient or more appropriate alternatives, such as existing inpatient facilities, sharing arrangements; and (d) - serious problems for patients to obtain care without proposed service. In addition to the absence of numeric need under normal circumstances, and the absence of the requisite birth volume which results from the imposition of the district occupancy standard to the hospital, AHCA also determined that Wellington failed to show any problems with patient access to like and existing facilities. Currently, there are 70 licensed and 20 approved Level II NICU beds in District 9. Overall, the occupancy rate for the District is approximately 66 percent. In addition, existing Level II NICU providers are located within two hours driving time for all residents of the district, as required for NICU which is classified as a tertiary service. Seven hospitals in District 9 provided Level II NICU care in 1998 to 1999. These included Lawnwood Regional Medical Center (Lawnwood) in St. Lucie County, Martin Memorial Medical Center (Martin Memorial) in Martin County, and Palm Beach Gardens Medical Center (Palm Beach Gardens) in Palm Beach County, West Boca Raton Hospital (West Boca), St. Mary's Hospital (St. Mary's), Good Samaritan Hospital (Good Samaritan), and Bethesda Memorial Hospital (Bethesda). In addition to the licensed beds, 20 approved beds had been allocated as follows: four for Good Samaritan, ten for Boca Raton Community Hospital, and six for West Boca. All of the existing Level II providers are located in eastern Palm Beach County along the Interstate 95 corridor. The population of Palm Beach County is migrating west. The Wellington community is experiencing significant growth. One indication is approval for the opening of five new schools in Wellington, three elementary, one middle, and a high school approximately 3 miles from the hospital. The number of new residential housing starts in Wellington has increased from 4,332 in 1990 to 6,012 in 1999. The housing starts in Wellington's primary service area represent over 48 percent of the total for Palm Beach County. Approximately 35,000 of the 80,000 women in Palm Beach County aged 35 to 44, who are more likely to have high risk pregnancies, live in the Wellington service area. Births at the three obstetrics providers in western Palm Beach County have increased from 1,441 in 1995 to 2,580 in 1999, including an approximately 200 percent increase at Wellington, from 345 in 1995 to 1,057 in 1999 (for the 12 months ending in August). Prior to October 1, 1999, the two closest hospitals to Wellington with Level II NICU services were Good Samaritan, with seven existing and four approved beds, and St. Mary's, with 22 beds. After Good Samaritan closed its obstetrics and NICU services, the two closest Level II NICU providers to Wellington are St. Mary's and West Boca, with nine licensed and six approved beds. For the 12-month period from July 1998 to June 1999, there were 3,832 NICU II patient days, or 149.98 percent occupancy in the seven operational beds at Good Samaritan; 5,743 patient days, or 71.52 percent in 22 beds at St. Mary's; and 3,210 patient days or 97.72 percent in the nine licensed beds at West Boca. With the closing of Good Samaritan, patients who were using its seven beds were assumed mostly likely to go to St. Mary's, which is owned by the same parent company. AHCA calculated a blended occupancy rate of 84.05 percent for St. Mary's with the addition of nine Good Samaritan beds (seven operational and two of four approved) to its existing 22 beds. Despite the high occupancy in the nearest facilities, the others in the District were relatively low for the same period of time: 39.15 percent in ten Level II NICU beds at Lawnwood, 8.38 percent in five beds at Martin Memorial, 19.23 percent in five beds at Palm Beach Gardens, and 50.46 percent in 12 beds at Bethesda. - immediate or long-term financial feasibility, as related to utilization AHCA rejected Wellington's projection of the volume of babies it would receive as Level II transfers from Glades General Hospital and Palms West Hospital. For the year ending August 1999, there were 737 live births at Glades General and 786 at Palms West. From that, Wellington projected 797 births at Glades General and 850 at Palms West in 2002. From that, Wellington expects to receive 231 transfers from Glades General and 197 from Palms West. The projections are based on historical birth to patient day ratios for the County, reasonable projections of volume, and reasonable market share assumptions. AHCA accepted Wellington's projections of its internal birth volume, which was 1,714 live births by January 31, 2000, resulting in a range between 1,192 and 1,834 Level II days. Based on the reasonableness of the expected transfers and the undisputed reasonableness of internal birth projections, Wellington demonstrated that it will achieve 73.5 percent occupancy in a ten-bed unit, or 75.2 percent in a seven-bed unit, by January 2003. As a result of reasonable utilization projections, as otherwise stipulated by the parties, the project is financially feasible. Factual Summary In general, Wellington demonstrated that the number of live births at Wellington, the closing of the nearest Level II provider, occupancy levels at nearby providers, the distances to other existing providers, particularly from various western areas of its service area, and the demographic and growth patterns within the County are not normal circumstances for the approval of its proposal. On balance, Wellington meets the criteria for approval for approval of CON Number 9253, to convert 16 substance abuse beds to a ten-bed Level II NICU.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order issuing Certificate of Need Number 9253 to Wellington Regional Medical Center, Inc., to convert 16 substance abuse beds to 10 Level II neonatal intensive care beds. DONE AND ENTERED this 25th day of August, 2000, in Tallahassee, Leon County, Florida. ELEANOR M. HUNTER Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 25th day of August, 2000. COPIES FURNISHED: Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308-5403 Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308-5403 Mark S. Thomas, Esquire Richard A. Patterson, Esquire Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308-5403 Robert D. Newell, Jr., Esquire Newell, Terry & Rigsby, P.A. 817 North Gadsden Street Tallahassee, Florida 32303-6313
The Issue Whether Winter Haven Hospital should be authorized for a Level II, neonatal intensive care service with 11 beds via the final inventory of NICU beds for District VI, to be published by the Department of Health and Rehabilitative Services. Whether Lakeland Regional Medical Center should be authorized for more than 14 Level II beds in the same final inventory. Whether University Community Hospital established its right to challenge the number of Level II NICU beds to be authorized for either hospital.
Findings Of Fact Description of the Parties Winter Haven is a 579-bed general hospital in Winter Haven, Florida. Since 1987, it has been authorized to operate 475 acute care, 80 short term psychiatric and 24 comprehensive medical rehabilitation beds. Lakeland is an 897-bed general hospital in Lakeland, Florida. Its licensed bed complement includes the following: 805 acute care, 54 psychiatric short term and 38 substance abuse short term beds. University is a 404-bed acute care hospital in Tampa, Florida. University is seeking a certificate of need for a 10-bed Level II NICU at its facility. In order to obtain the license, University proposes to convert 10 of its existing medical-surgical beds to a 10-bed NICU. HRS is the state agency charged with the duty of regulating tertiary services, including neonatal intensive care. The provision of Level II NICU services in HRS District VI is the subject of this proceeding. All three hospitals are located in the district. University's Standing to Intervene University does not have a program to provide neonatal intensive care services at the present time. However, as part of the hospital's long-range planning goals, it intends to develop a Women's Center, which will include a 10- bed Level II NICU. University applied for the Level II NICU service in the batching cycle of 1990, prior to the effective date of the NICU rule. At the close of evidence on April 15, 1991, the outcome of the application was still pending. Additionally, University filed a Letter of Intent and an application for a 10- bed Level II NICU in the first batching cycle of 1991. That application was also still pending during the evidentiary portion of these proceedings. University's attempt to secure a certificate of need for NICU beds are directly impacted by the number of NICU beds reacknowledged and validated in the District VI inventory of "grandfathered" NICU beds. The number of beds ultimately established by the inventory will directly affect the fixed need pool to be applied to all subsequent certificate of need batching cycles. The NICU Rule The NICU Rule promulgated by HRS went into effect on August 6, 1990. The preliminary inventory of authorized Level II and Level III providers in District VI was published August 24, 1990. According to this inventory, Lakeland was authorized to have 11 Level II NICU beds and Winter Haven was not allocated any Level II beds on the initial preliminary inventory. Winter Haven's Inclusion in a Revised Preliminary Inventory Published September 12, 1990 When the preliminary inventory of Level II NICU beds was published, Winter Haven advised HRS that it had been excluded. Documentation was transmitted to the agency to support Winter Haven's contention that it has continuously developed and now has a operating Level II neonatal intensive care unit based upon past authorization from the agency. The documentation supplied by Winter Haven included past authorizations from the agency, which were relied upon by the hospital before expenditures were made on construction of the NICU and the unit created, and before a personal service contract was entered into for a hospital-based neonatologist in April 1988. Reliance on the agency's approval of the expansion project began on July 9, 1985, and was continuously relied upon throughout the development and establishment of these services at Winter Haven. When the documentation was reviewed by HRS, the decision was made to amend the preliminary inventory to include 11 NICU beds at this hospital. The revised preliminary inventory that included these beds was published on September 12, 1990. HRS decided 11 was the appropriate number of Level II beds to place on the inventory for Winter Haven as the approved construction plans show an isolation room of four beds and a continuing care room with seven beds. The beds in these rooms were described on the plan as "neonatal intensive care centers" and "intensive care bassinets." During the approval period, the square footage for each bed satisfied the draft rules that proposed fifty square feet per each Level II NICU bed. The decision to include Winter Haven on the revised preliminary inventory does not comport with the grandfathering provisions of the NICU Rule. Winter Haven does not meet the threshold requirements specified in sub- subparagraphs 14.a, 14.b or 14.f of the rule deems necessary for grandfathering to occur. During the years in which the NICU Rule was created, HRS did not consider the possibility that some hospitals might have progressed in the development stage of Level II NICU beds to such a level that the promulgated rule would contradict prior agency approvals reasonably relied upon by these hospitals. Before Winter Haven's beds were placed on the revised preliminary inventory, HRS permitted Alachua General Hospital's Level II NICU beds to be placed on the inventory based upon a CON exemption letter and construction plans approved prior to October 1, 1987. There have been no challenges to this decision, therefore, Alachua General can continue these services without a certificate of need as a grandfathered facility. Like Winter Haven, Alachua General did not comport with the grandfathering provisions of the NICU Rule. The decision to place Level II beds on the inventory was based on the approval of construction plans obtained through the licensure process at HRS in effect prior to October 1, 1987. HRS created the construction plans exception to the rule to acknowledge pre-existing bed authorizations not covered by the NICU Rule. Lakeland's Increase to 16 Level II Beds in the Revised Preliminary Inventory Published October 12, 1990 Lakeland was issued a CON exemption by HRS for 16 "Level II neonatal intensive care beds" in a letter dated March 12, 1985. This letter allowed Lakeland to re-designate 16 medical/surgical beds as Level II neonatal intensive care beds. On May 20, 1986, HRS approved Lakeland's construction plans for a 14- bed, Level II NICU. Lakeland did not rely on its opportunity to re-designate all 16 beds as Level II NICU beds when it established its NICU pursuant to the CON exemption. Lakeland was providing Level II NICU services prior to October 1, 1987, and continuously since then under the direction of a neonatologist or group of neonatologists, who were providing 24-hour coverage and who were either board-certified or board-eligible in neonatal-perinatal medicine as the various terms are defined in the NICU Rule. In its 1989 Neonatal Intensive Care Survey response to HRS, Lakeland erroneously underreported its Level II patient days from October 1, 1987 through September 20, 1988. The number reported was different than the 4,412 Level II neonatal intensive care services patient days reported separately to the Hospital Cost Containment Board for the same period, based upon audited data. A third review of the data revealed Lakeland provided, 4,414 Level II patient days in 1987-1988 reporting period for the 1989 survey. Pursuant to the formula set forth in sub-subparagraph 14.c of the NICU Rule, Lakeland should be authorized for 15 Level II beds on the final inventory which lists the established NICU beds that meet the grandfathering provisions of the rule. The inclusion of 16 Level II NICU beds on the revised preliminary inventory published October 12, 1990, went beyond the bed numbers allowed by rule.
Recommendation Based upon the foregoing, it is recommended: A Final Order be entered which excludes Winter Haven from the inventory which lists authorized neonatal intensive care services based on the provisions of sub-subparagraphs 14.a. through 14.g. of the NICU Rule. A Final Order be entered reducing Lakeland's inventory to 15 Level II NICU beds. RECOMMENDED this 6th day of August, 1991, in Tallahassee, Florida. VERONICA E. DONNELLY Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 6th day of August, 1991. APPENDIX TO RECOMMENDED ORDER, CASE NOS. 90-7682 and 90-7683 Lakeland Regional Medical Center's proposed findings of fact are addressed as follows: Accepted. See Preliminary Statement. Accepted. See HO #8, #11, #17 and #22. Accepted. Accepted. Accepted. First two sentences accepted. The rest of the paragraph is rejected. Argumentative. Accepted. Accepted. Accepted. Rejected. Irrelevant. Accepted. See Conclusions of Law. Accepted. Accepted. Accepted. Accepted. Accepted. See HO #13. Rejected. Contrary to law. See Conclusions of Law. Accept the first two sentences. Reject the next sentence. Speculative. The next two sentences accepted. The last sentence is rejected. Contrary to fact. See HO #12. Rejected. Irrelevant. Accept first three sentences. See HO #10. Reject fourth sentence. Incompetent legal conclusion. 21. Rejected. Irrelevant. 22. Rejected. Speculative. 23. Accepted. 24. Accepted. 25. Accepted. 26. Accepted. 27. Accepted. 28. Rejected. Cumulative. 29. Rejected. Irrelevant. 30. Rejected. Irrelevant. 31. Rejected. Irrelevant. 32. Accepted. 33. Rejected. Cumulative. 34. Accepted. See HO #11 and #12. 35. Accepted. See HO #12. 36. Rejected. Contrary to fact. 37. Rejected. Irrelevant. 38. Rejected. Improper summary of testimony. Irrelevant. 39. Accepted. 40. Rejected. Contrary to fact. 41. Rejected. Irrelevant. 42. Accept all but last sentence which is a distinction without substance. See HO #12, #15 and #16. 43. Accepted. See Conclusions of Law. 44. Accepted. 45A. Accepted. 45B. Accepted. 45C. Accepted. 45D. Accepted. 45E. Accepted. 45F. Rejected. Irrelevant. 46A. Accepted. 46B. Rejected. Irrelevant. 47. Rejected. Not evidence. Rejected. Irrelevant to resolution of material fact dispute. Accepted. See HO #17 and #19. Accepted. See HO #22. Accepted. See HO #21. Department of Health and Rehabilitative Services' proposed findings of fact are addressed as follows: Accepted. See HO #12 and Preliminary Statement. Accepted. See Preliminary Statement. Accepted. See Preliminary Statement. Accepted. See HO #8. Accepted. See HO #12 and #22. Accepted. See HO #17. Accepted. See HO #10. Accepted. Accept all but last sentence. See HO #16. The last sentence is improper Conclusion of Law. Winter Haven Hospital's proposed findings of fact are addressed as follows: Accepted. See HO #1. Accepted. See HO #2. Accepted. See HO #3. Accepted. See HO #4. Accepted. See HO #10. Accepted. See HO #8. Accepted. Accepted. See Preliminary Statement. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. Rejected. Irrelevant. Accepted. See Preliminary Statement. Accepted. Accepted. Accepted. See HO #14. Accepted. Accepted. Accepted. See HO #15. Rejected. Improper Conclusion of Law. Accepted. Accepted. Accepted. Accepted. Rejected under current definition. Accepted to the extent the room provided many aspects of Level II care. Accepted. Accepted. Rejected. Contrary to fact. Accepted. Accepted. See HO #10. Rejected. Irrelevant. Rejected. Irrelevant. Accepted. See HO #10. Accepted. See HO #10. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. See HO #12. Accepted. Accepted. Accepted. Accepted. Accepted. Rejected. Improper Conclusion of Law. Accepted. Rejected. Speculative. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. See HO #10. Accepted. Accepted. See HO #15 and #16. Accepted. Accepted. Accepted. Accepted. See HO #11 and #12. Rejected. Improper Conclusion of Law. Rejected. Improper Conclusion of Law. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. See HO #18. Accepted. See HO #21. Rejected. Improper Conclusion of Law. Rejected. Improper Conclusion of Law. See HO #23 - #26. Accepted. Rejected. Contrary to fact. See HO #7. Accepted. Rejected. Incorrect legal conclusion. Accepted. Rejected. Insufficient foundation provided for the opinion to assist Hearing Officer as to weight and sufficiency. Accepted. Accepted. University Community Hospital's proposed findings of fact are addressed as follows: Accepted. See Preliminary Statement. Accepted. Accepted. Accepted. See HO #8. Accepted. See HO #12 and #22. Accepted. See Preliminary Statement. Accepted. See HO #4. Accepted. Accepted. Accepted. Accepted. See HO #5. Accepted. See HO #6 and #7. Accepted. Accepted. See HO #7. Accepted. See HO #7. Accepted. Accepted. Rejected. Speculative. Accepted. Accepted. Accepted. Accepted. Accepted. Rejected. Irrelevant. Rejected. This opinion was rejected by the Hearing Officer as an improper legal conclusion. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. See HO #11 and #12. Accepted. Accepted. Accepted. Accepted. Accepted. Rejected. Contrary to fact. Rejected. Contrary to fact. See HO #12. Rejected. See HO #12. Rejected. Contrary to fact. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. See HO #10. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. See HO #22. Accepted. Accepted. Accepted. Accepted. Accepted. See HO #21. Accepted. COPIES FURNISHED: John H. Parker, Jr., Esquire PARKER HUDSON RAINES & DOBBS 1200 Carnegie Building 133 Carnegie Way Atlanta, Georgia 30303 John M. Knight, Esquire PARKER HUDSON RAINES & DOBBS 118 North Gadsden Street Tallahassee, Florida 32301 Richard A. Patterson, Esquire Assistant General Counsel Department of Health and Rehabilitative Services 2727 Mahan Drive - Suite 103 Tallahassee, Florida 32308 Patricia A. Renovitch, Esquire OERTEL HOFFMAN FERNANDEZ & COLE, P.A. Post Office Box 6507 Tallahassee, Florida 32314-6507 Cynthia S. Tunnicliff, Esquire CARLTON FIELDS WARD EMMANUEL SMITH & CUTLER, P.A. 215 South Monroe Street - Suite 410 Tallahassee, Florida 32301 R. S. Power, Agency Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 John Slye, General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700
The Issue Whether Petitioner should be granted CON No. 6606 to convert 10 medical/surgical beds to 10 neonatal intensive care beds to create a Level II neonatal intensive care unit (NICU).
Findings Of Fact UCH is a licensed acute care hospital with 404 authorized beds. A number of these beds were transferred to the Women's Center, which was exempted from CON review by DHRS. (Exhibit 8) The Women's Center involved the expenditure by UCH of some $11,000,000 to construct and equip a separate building adjacent to the existing hospital. The Women's Center was completed and became operational in September 1991. Accordingly, at the time the Application for NICU beds was submitted through the processing of the Application by DHRS, no births were experienced at this facility. For the first two months the Women's Center was operational, the Women's Center experienced 107 births of which 1 required transfer to a hospital providing Level II neonatal intensive care services. At the time the batching cycle for the September 27, 1990 deadline and January 1993 planning horizon was published (Exhibit 18), the NICU inventory was in litigation, and DHRS did not publish a fixed bed need pool for that batching cycle. Instead, in Florida Administrative Weekly, Vol. 16, No. 34, dated August 24, 1990 (Exhibit 18), an estimated inventory of existing beds was used in the bed need formula calculation. This showed for District VI zero need for additional NICU Level II beds. Subsequent to the issuance of the State Agency Action Report (SAAR), in this case litigation was complete, and DHRS entered a Final Order on September 15, 1991 establishing the bed inventory for neonatal intensive care beds Level II and Level III in District 6. That Order increased the NICU Level II bed inventory by 15 beds by adding four beds to Lakeland Regional Medical Center (LMRC) NICU and 11 beds to Winter Haven's NICU. These additions increased the NICU Level II inventory in District VI from the 61 shown on Exhibit 18 to 76. The SAAR (Exhibit 6) used an inventory of 77 Level II NICU beds in District VI to determine no need after application of the bed need formula showed a need for 70 Level II NICU beds in District VI. Changing the inventory from 77 to 76 NICU beds does not affect this conclusion. Occupancy rates used in the bed need calculation were taken from the reports hospitals are required to submit to local health councils. In some instances in the batching cycle here involved, the hospitals had failed to report to the local health councils their occupancy rate for the period required by the bed need formula, and DHRS contacted these hospitals in District VI for the data needed. Petitioner contends that the occupancy rate data relied upon by DHRS in calculating the need for NICU beds for the 1993 planning horizon is inaccurate and that more reliable data is obtained from using different reports that the hospitals are required to submit to the Hospital Cost Containment Board (HCCB). Petitioner's expert witness opined that the information hospitals are required to submit to the HCCB provides a more accurate method of determining the occupancy rate of the Level II NICU beds at each hospital. Petitioner also contends that at the time the Level II occupancy rates were provided to DHRS there was no finite definition, by rule, of the differences between Levels I, II and III NICUs, and the hospitals did not submit accurate data. However, credible evidence was presented that a proposed definition of Levels I, II and III NICUs had been promulgated to all of the hospitals and, when enacted as a rule, this proposed definition was adopted verbatim or nearly so. Intervenors' witnesses pointed out that the hospital reports to HCCB are based on DRG's (diagnostic related groups), and the same DRG is frequently used on a Level I, II or III NICU admission. Accordingly, from those reports to the HCCB an accurate determination of the Level II occupancy rate cannot be made. Furthermore, the patient, during the hospital stay, is frequently moved from Level III to Level II to Level I care, and this data cannot be obtained from the reports submitted to the HCCB. Accordingly, it is found that the reports submitted by hospitals to the local health councils provide more accurate occupancy rates than can be gleaned from the reports submitted to the HCCB, and the occupancy rate utilized by DHRS to calculate NICU bed need is correct. The average occupancy rate for District VI hospitals providing NICU Level II beds was approximately 70 percent during the most recent 12 months prescribed for this batching cycle. Although discrepancies were noted in the patient days at Humana and Tampa General during this period, when these discrepancies were corrected, the district occupancy rate remained in the vicinity of 70 percent. Rule 10-5.042(3)(d), Florida Administrative Code, provides that regardless of bed need shown (by using the bed need formula) the establishment of new Level II NICU beds within a district shall not normally be approved, unless the average occupancy rate for Level II beds in the district equals or exceeds 80 percent for the most recent 12 month period ending 6 months prior to the beginning date of the quarter of the publication of the fixed bed need pool. Petitioner submitted no evidence to demonstrate a not normal situation existed to waive the 80 percent average District VI occupancy rate required before additional Level II NICU beds will be approved. Petitioner principally relied upon the admissions in Hillsborough County to demonstrate an 80 percent occupancy rate. However, the rule specifically refers to a district rate rather than to a subdistrict or one-county rate. In several areas, Petitioner's estimates used to determine the anticipated number of patients to be served in the proposed NICU are not realistic. To determine the ratio of Level II patients to the number of births, Petitioner relied on data from Lakeland Regional Medical Center (LMRC) as a comparable hospital. However, LMRC is not comparable to UCH in patient payor mix. In excess of 40 percent of LMRC obstetrical cases are Medicaid patients, while UCH projects only 6 percent Medicaid births. A lower income payor such as Medicaid patients have a much higher ratio of ill babies at birth than do more affluent mothers who generally receive better prenatal care. Consequently, the percentage of births needing Level II care in the payor mix expected at UCH is more comparable to the percentage experienced by Humana Women's Hospital, an Intervenor herein. At Humana the percentage of births requiring Level II care is on the order of 6 percent as compared to 15.6 percent at LMRC. This lower ratio is more consistent with UCH experience in its first two months of operations where out of 107 births only 1 required transfer to a Level II NICU. Some question was raised regarding the accuracy of Petitioner's estimate of 1500-1700 births during the first full year of operation. While it would be expected that admissions to a new facility would be lower the start-up year than in subsequent years, hard evidence to support the proposed number of births or a lessor number was not presented. In either case, Petitioner has failed to meet the birth requirement of a minimum of 1000 live births for the most recent 12 month period ending 6 months prior to the beginning date of the quarter of the publication of the fixed need pool needed to qualify for this CON. Petitioner presented no evidence to support the not normal conditions that would provide an exemption to this requirement in Rule 10-5.042(6), Florida Administrative Code, other than the fact that it is patently obvious that a hospital that commenced operations 6 months after submitting its CON application could not demonstrate 1000 live births in the 12 months preceding its application. The protesting providers of Level II neonatal care are both located within one hour driving time of the site of UCH as is All Children's Hospital in St. Petersburg. The other hospitals in District VI providing Level II neonatal care, to wit Manatee Memorial Hospital, Winter Haven Hospital and LMRC, are also within two hours driving time of UCH which is the geographical access guideline established by rules for NICUs. Although UCH contends that its application meets all eight preference items prescribed by the state health plan, the evidence presented established its application conclusively meets only one of these preferences, number 6. Absent a showing of need for the proposed facility as found in finding 6 above, granting this CON will increase the excess NICU beds in District VI and adversely impact existing providers. This includes Tampa General which is a disproportionate share provider (of Medicaid and indigent care). It appears from the evidence presented, that in constructing the Women's Hospital, space for an NICU was provided in the plans and, while awaiting a CON to provide a 10 bed Level II ICU, the space is used for storage. No structural changes will be required to operate a NICU at this location, and costs are related primarily to the equipment that will be needed. Whether the installation of a NICU in this space will improve the physical plant of the Women's Center depends on from which advantage point one looks. From Petitioner's point of view, the NICU would improve the physical plant and comply with Preference 3 of the state health plan. Based upon the premise that the proposed NICU beds will be used at an occupancy rate of 70 percent or greater, the conversion of 10 acute care beds currently operating at less than 50 percent occupancy to NICU beds, the overall occupancy rate will increase and Preference 4 would be met. However, no credible evidence was presented that the proposed 10 bed Level II NICU will operate at 70 percent capacity. If initial utilization of Level II care continues and less than 1 percent of UCH live births require Level II care, this Preference will not be met. Although Petitioner did not address Preference 5 in its application, the SAAR notes that HCB reports show of the three hospitals with a grouping of "05" UCH has lower gross revenues per adjusted admission. Petitioner meets Preference 6. Preference 7 of the State Health Plan pertains to applicants who propose to provide neonatal intensive care services to Children's Medical Services (CMS) and non-CMS patients who are defined as charity care patients. Although UCH proposes to provide 6 percent Medicaid and 5 percent indigent care, past history does not support this level of indigence or low pay care. Under Preference 8 of the State Health Plan, preference is given to applicants who propose to serve substance abuse, pregnant and postpartum women, and coordinate their services with other appropriate social agencies. Although UCH stated in its application that it has developed a referral relationship with the Teen Mom's Program, it did not specifically address coordination of its services with substance abuse, pregnant and postpartum women. The local health plan for District VI provides preference shall be given to an applicant who provides the department with documentation that they provide, or propose to provide, a disproportionate share of Medicaid and charity care patient days in relation to other hospitals in the subdistrict. UCH is not a disproportionate share provider and does not propose to become one. Accordingly, it does not comply with this preference item in the district health plan.
Recommendation It is, therefore, recommended that a Final Order be entered denying the application of University Community Hospital for Certificate of Need No. 6606 to establish and operate a 10 bed Level II neonatal intensive care unit. RECOMMENDED this 16th day of January, 1992, in Tallahassee, Florida. K. N. AYERS Hearing Officer Division of Administrative Hearings The Desoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 16th day of January, 1992. APPENDIX TO RECOMMENDED ORDER, CASE NO. 91-5720 Proposed findings submitted by Petitioner are accepted, except as noted below. Those not noted below and not contained in Hearing Officer findings were deemed not necessary to the conclusions reached. 22. Accepted as the testimony of Hopes, but not as a fact. Accepted only insofar as not in conflict with HO #5. Rejected. 32. Rejected. 34-35. Accepted insofar as not inconsistent with HO #7. 36. Same as 34. Accepted as testimony of witnesses. However, ultimate finding in HO #7 is that when these numbers were corrected, no change in bed need resulted. Rejected. 42. Rejected that Hopes utilization statistic more accurately reflects true utilization of NICU beds. 53-55. Rejected. 56. Rejected as outside the time period here involved. 58-59. Rejected. 62. Rejected insofar as inconsistent with HO #10. Rejected. Second sentence rejected as in conflict with HO #9. 75. Ultimate sentence rejected. 85. Rejected. 92. Accepted, except for the connotation that these patients have geographical access problems to existing facilities. 95. Accepted merely as the testimony of this witness who is currently an employee of UCH. 97-118. Although these preference items were discussed in HO findings #12-19, absent a comparative review these preferences were not considered in determining that a need for 10 more Level II NICU beds did not exist in District VI. Proposed findings submitted by Respondent and the Intervenors are accepted. Those not included in HO findings were deemed unnecessary to the conclusions reached. COPIES FURNISHED: Cynthia S. Tunnicliff, Esquire W. Douglas Hall, Esquire Post Office Drawer 190 Tallahassee, FL 32302 Richard Patterson, Esquire Department of Health and Rehabilitative Services 2727 Mahan Drive Tallahassee, FL 32308 James C. Hauser, Esquire Post Office Box 508 Tallahassee, FL 32302 John Radey, Esquire Post Office Drawer 11307 Tallahassee, FL 32302 Sam Power Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, FL 32399-0700 John Slye General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, FL 32399-0700
The Issue Whether the application of Wuesthoff Memorial Hospital, Inc. d/b/a Wuesthoff Memorial Hospital ("Wuesthoff"), for the conversion of ten acute care beds to ten Level II neonatal intensive care beds meets, on balance, the applicable statutory and rule criteria for approval.
Findings Of Fact Wuesthoff Memorial Hospital, Inc., d/b/a Wuesthoff Memorial Hospital ("Wuesthoff") is a 303 bed acute care hospital in Rockledge, Florida, in Brevard County, District 7. The Agency For Health Care Administration ("AHCA") is the state agency designated by statute to issue, revoke, or deny Certificates of Need ("CON") for health care beds and services. Wuesthoff is the applicant for a CON to convert ten acute care beds to a ten bed Level II neonatal intensive care unit ("NICU"), for total project costs of $1,239,330. By prehearing stipulation, the parties agreed to the following facts: the fixed need pool for Level II NICU beds for District 7 shows zero net numeric bed need; there are 41 licensed and 18 approved Level II NICU beds in District 7, 10 in Brevard County, 49 in Orange County, none in Osceola and Seminole Counties; the letter of intent and CON application were filed timely and properly deemed complete; Wuesthoff does not have any approved Level II NICU beds; the District 7 Health Plan, including the 1991 CON Allocation Factors, are applicable to the review of this application; and the 1989 State Health Plan is also applicable to the review of this application. With regard to the statutory criteria, the parties also agreed that: Wuesthoff's historic record of providing high quality care is not in dispute; Wuesthoff does not maintain that its NICU service will be intended as a research and education facility; the availability of resources, including management personnel and funds for capital and operating expenditures, for project accomplishment and operation, is not in dispute; the immediate and long term financial feasibility of the proposal as demonstrated in Wuesthoff's application are not in dispute, assuming Wuesthoff proves the accuracy of utilization assumptions; Wuesthoff does not provide a substantial portion of services or resources to individuals not residing within the district or in adjacent districts; Wuesthoff's past levels of service to Medicaid and medically indigent patients are not in dispute; the special needs and circumstances of health maintenance organizations are not applicable to this application; and the costs and methods of proposed construction are not in dispute. At issue in this case are the statutory review criteria in Subsections 408.035(1)(a), (b), (d), (e), (f), portions of (h) and (i), (j) and (l), Florida Statutes (1992 supp.). Subsections 408.035(2)(a), (b), (c) and (d) are also in dispute. NEED Subsection 408.035(1)(a) requires consideration of need in relation to state and local health plans. The 1989 State Health Plan and CON allocation factors in the 1991 District 7 Health Plan are applicable to the review of Wuesthoff's CON application. Wuesthoff is not located in Orange County and, therefore, does not meet the District 7 factor favoring Orange County providers who will serve Medicaid newborns. The second factor favors applicants proposing to provide at least 45 percent of all patient days to Medicaid patients and 6 percent to indigent patients. Wuesthoff projected that it would achieve 50.5 percent Medicaid patient days and 4.5 percent to uninsured patients. Despite these projections, Wuesthoff failed to make a commitment to have its CON conditioned on the provision of specified percentages Medicaid and indigent patient days. On this basis, AHCA concluded that Wuesthoff fails to meet the factor. Wuesthoff's position is accepted. Its projections justify favorable consideration under this factor, its historic Medicaid service supports its projections, and AHCA can condition the CON if appropriate. The third factor requires applicants to identify specific services, educational programs, and/or interventions which will provide for an unmet need. This factor is also related to Subsection 408.035(1)(b) - the availability and accessibility of existing and approved Level II NICU beds in the district; (2)(a) - the availability of less costly more efficient facilities; and (2)(c) and (d) - availability and efficiency of existing inpatients facilities, and problems in obtaining existing inpatient care in the absence of the proposed services. There is no dispute that there is zero numeric need for additional Level II NICU beds in District 7. Level II beds exist at Holmes Regional Medical Center ("Holmes") in Melbourne Brevard County, and in Orange County at Winter Park Memorial Hospital ("Winter Park"), Orlando Regional Medical Center ("ORMC") and Florida Hospital. Holmes, the only Level II NICU in Brevard County, is, however, not available because its 10 Level II NICU beds have had occupancy levels not less than 122 percent and up to 147 percent during the past three years. Holmes provided 36.8 percent of the NICU services in District 7, with ten of the 59 licensed or approved beds, or 17 percent of the District beds. There was also evidence that Holmes' physicians do not accept transfers of indigent or Medicaid obstetrics patients from the service area of Wuesthoff and from northern Brevard County. In 1992, district wide occupancy in Level II NICU beds was over 95 percent. All of the other providers, except Holmes, are located in Orange County. Winter Park's 1992 occupancy rate was only 34 percent in its 5 bed unit. Florida Hospital, with a 1992 rate of 87.8 percent in 14 beds, has been approved for 8 additional beds. ORMC, with a 1992 occupancy rate averaging 90.2 percent, has approval for an additional 10 beds. Available beds at Winter Park or Florida Hospital have not historically alleviated overcrowding at Holmes. At hearing, AHCA's expert health planner testified that Holmes reached 122 percent occupancy when Winter Park was at 30 percent and Florida Hospital was 58.2 percent. Wuesthoff has demonstrated that Winter Park, Florida Hospital, and ORMC are geographically and economically inaccessible to Medicaid and indigent patients in Wuesthoff's service area. Expert testimony linked indigency to a greater need for NICU care. Wuesthoff demonstrated that Medicaid and indigent obstetrics patients in its service area cannot and do not use the facilities in Orange County adequately and appropriately for prenatal care or delivery due to transportation and economic difficulties. Indigent patients with high risk pregnancies served by the Brevard County Public Health Unit are referred to ORMC. Experts estimated that fewer than 50 percent of those end up delivering at ORMC. For Medicaid patients who comply with referrals for prenatal care, Medicaid is charged $119 per patient per non-emergency, pre-scheduled trip to ORMC. For infants born in Brevard County in need of Level II care, emergency transportation to ORMC costs $700 by ambulance or over $2000 by helicopter. The number of Public Health medicaid or indigent obstetrics patients referred to ORMC from the Wuesthoff area was reasonably estimated to be 250 patients a year. With 50 percent of the babies needing Level II care, the estimate of 125 neonatal referrals is reasonable. The statutory criterion of need in relation to the State Health Plan also requires consideration of preferences for applicants (1) converting from acute care to NICU beds; (2) proposing to serve Children's Medical Services ("CMS"), Medicaid and charity patients; and (3) proposing to serve substance abusing pregnant and postpartum women. AHCA agreed that the Wuesthoff CON application meets all of the applicable State Health Plan preferences. Wuesthoff is proposing, as also required by AHCA rule, to convert acute care beds, currently utilized at 56.33 percent occupancy. In 1992, Medicaid obstetric patients days accounted for 50.5 percent of the total. A CMS clinic is located on the Wuesthoff campus and receives services from its staff pediatricians. See also, 59C-1.042(3)(j) and (k), F.A.C. Wuesthoff demonstrated the absence of any outpatient alternatives for Level II NICU beds, as required in Subsection 408.035(1)(d), Florida Statutes, (1992 supp.). Wuesthoff fails to comply with the criteria in Subsections 408.035(1)(e), (f), (g), (j) and (k), Florida Statutes, (1992 supp.). It does not plan to jointly operate a NICU with other providers, although it is under consideration as a satellite regional perinatal intensive care center ("RPICC"). The proposed services are available in adjoining areas, including Volusia County to the north, where Level II NICU occupancy was 85 percent in 1992. Wuesthoff does not intend to be a research or educational facility, nor will it serve substantial numbers of individuals residing outside its service district. Wuesthoff is not a health maintenance organization hospital. UTILIZATION AND OPERATIONS Pursuant to Subsections 408.035(1)(h), (i) and (l), and (2)(a), Wuesthoff must be able to staff and fund a Level II NICU that is financially feasible and does not impact negatively health services quality or costs. AHCA presented no evidence at hearing to contradict that presented by Wuesthoff to show that it has the staff and funds for its proposed project. Wuesthoff also has shown that it will profit from the conversion of underutilized acute care beds to Level II NICU beds. Rule 59C-1.042, Florida Administrative Code, includes the methodology for calculating numeric need, among other requirements for approval of Level II NICU programs. Numeric need, under the rule, is zero. In fact, the calculations show that 15 more Level II beds than needed have been approved in District 7. As required by the rule, average occupancy rates in District 7 exceeded 80 percent in the 12 months ending 6 months prior to the quarter in which numeric need was calculated. The rule also favors RPICC's. Wuesthoff is not a RPICC, although it is under consideration as a satellite of the ORMC RPICC. Wuesthoff is not an existing provider of Level II NICU services, and therefore, does not qualify for additional beds under the rule. As required by the NICU rule, Wuesthoff's application seeks the establishment of the minimum size Level II unit of ten beds. The applicant also has on staff a neonatologist, a head nurse with experience and training in neonatal intensive care, registered nurses, respiratory therapists, and social services personnel with the required training. Wuesthoff is capable of performing the blood gas analyses, clinical laboratory support services, and intervention screening. If approved, Wuesthoff would also be eligible to participate in a county grant-funded neonatal developmental disabilities program. Wuesthoff either has installed or has made appropriate plans to obtain the equipment and to make the renovations required by Subsections (9)(b) and (c) of the Rule. Wuesthoff is capable of meeting the data reporting requirements of Subsection 13 of the Rule. The two hour travel time for geographic access to Level II NICU services is met by the existing District 7 providers, and Wuesthoff's proposal is not needed to meet that standard. MINIMUM BIRTH VOLUME Rule 59C-1.042(6), provides in relevant part, as follows: Hospitals applying for Level II NICU services shall not normally be approved unless the hospital had a minimum service volume of 1,000 live births for the most recent 12- month period ending 6 months prior to the beginning date of the quarter of the publication of the fixed need pool. Wuesthoff does not meet the 1000 minimum number of births. In 1991, there were 963 live births at Wuesthoff. From 1988-1990, live birth at Wuesthoff exceeded 1000. In 1992, Wuesthoff had 998 live births. AHCA asserts that the quality of care that volume requirements assure will be adversely affected by the approval of Wuesthoff's application. Wuesthoff has presented competent, substantial evidence that this concern is not well founded, for the following reasons: A privately-owned Birthing Center located on Merritt Island in Brevard County, is staffed by a doctor who owns the facility and has hospital privileges only at Wuesthoff. At the Birthing Center, there were 124 deliveries in 1990, 156 in 1991, and 178 in 1992. The Birthing Center, Jess Parrish Memorial Hospital in Titusville, and Cape Canaveral Hospital, all are Brevard County obstetrics facilities without Level II NICU services. In fact, births at Cape Canaveral exceeded 1000 in 1992. The live births in these three Brevard County facilities, at Wuesthoff, and the overcrowding at the Level II NICU at Holmes, provide a reasonable basis to conclude that Wuesthoff can exceed the minimum birth volume necessary to meet the quality of care objectives of the rule. As required by Subsections (11) and (12) of the NICU rule, Wuesthoff has 24 hour emergency transportation in cooperation with Jess Parrish Memorial Hospital and Cape Canaveral Hospital. Wuesthoff has a transfer agreement with ORMC, which has all levels of NICU care. AHCA also questioned Wuesthoff's utilization assumption and projections. With combined live births at Brevard facilities without Level II NICUs exceeding 3,000 a year, with two of the facilities jointly operating an emergency transportation service with Wuesthoff, and the third staffed by a obstetrician with privileges only at Wuesthoff, Wuesthoff's assumptions that the majority of neonates born at these facilities needing Level II NICU care will be transferred to Wuesthoff are reasonable. As agreed in the prehearing stipulation, because utilization projections are found reasonable, Wuesthoff's proposal is financially feasible.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be issued approving Certificate of Need 7081 to Wuesthoff Memorial Hospital to convert ten acute care beds to a ten bed Level II neonatal intensive care unit condi tioned upon Wuesthoff's providing not less than a combined total of 51 percent Medicaid and indigent patient days in the unit. DONE AND ENTERED this 10th day of November, 1993, in Tallahassee, Leon County, Florida. ELEANOR M. HUNTER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 10th day of November, 1993. APPENDIX TO RECOMMENDED ORDER, CASE NO. 93-0963 To comply with the requirements of Section 120.59(2), Fla. Stat. (1991), the following rulings are made on the parties' proposed findings of fact: Petitioner's Proposed Findings of Fact. Accepted in Finding of Fact 1. Subordinate to Finding of Fact 33. Accepted in Finding of Fact 4. Accepted in Finding of Fact 4. Accepted in Findings of Fact 11, 12, and 13. Subordinate to Finding of Fact 16. Subordinate to Finding of Fact 16. Subordinate to Finding of Fact 16. Subordinate to Findings of Fact 16 and 17. Subordinate to Findings of Fact 15 and 17. Subordinate to Findings of Fact 12 and 13. Accepted in Finding of Facts 15 and 18. Accepted in Finding of Fact 15. Accepted in Finding of Fact 16. Subordinate to Finding of Fact 17. Accepted in Finding of Fact 17. Subordinate to Finding of Fact 16. Accepted in Finding of Fact 17. Accepted in Finding of Fact 15. Accepted in Finding of Fact 17. Subordinate to Finding of Fact 16. Subordinate to Finding of Fact 16. Subordinate to Finding of Fact 16. Subordinate to Finding of Fact 16. Subordinate to Finding of Fact 16. Subordinate to Finding of Fact 16. Subordinate to Finding of Fact 16. Accepted in Finding of Fact 16. Accepted in Finding of Fact 12. Subordinate to Finding of Fact 16. Accepted in Finding of Fact 16. Accepted in Finding of Fact 15. Accepted in Finding of Fact 15. Accepted in Conclusions of Law 40. Accepted in Finding of Fact 15. Subordinate to Finding of Fact 16. Accepted in Finding of Fact 16. Subordinate to Finding of Fact 16. Subordinate to Finding of Fact 16. Subordinate to Finding of Fact 16. Subordinate to Finding of Fact 15. Subordinate to Finding of Fact 16. Accepted in Finding of Fact 12. Subordinate to Finding of Fact 16. Accepted in Finding of Fact 21. Accepted in Finding of Fact 16 and 17. Accepted in Finding of Fact 16. Subordinate to Finding of Fact 12. Accepted in Finding of Fact 28. Subordinate to Findings of Fact 16 and 17. Subordinate to Findings of Fact 16 and 17. Subordinate to Findings of Fact 16 and 17. Subordinate to Findings of Fact 16 and 17. Accepted in Findings of Fact 21 and 26. Accepted in Findings of Fact 21 and 26. Subordinate to Findings of Fact 21 and 26. Subordinate to Findings of Fact 21 and 26. Subordinate to Findings of Fact 21 and 26. Subordinate to Findings of Fact 21 and 26. Subordinate to Findings of Fact 21 and 26. Subordinate to Findings of Fact 21 and 26. Subordinate to Findings of Fact 21 and 26. Subordinate to Findings of Fact 21 and 26. Subordinate to Findings of Fact 21 and 26. Subordinate to Findings of Fact 21 and 26. Subordinate to Findings of Fact 21 and 26. Accepted in Finding of Fact 17. Subordinate to Finding of Fact 16. Subordinate to Finding of Fact 17. Subordinate to Finding of Fact 18. Accepted in Finding of Fact 35. Subordinate to Findings of Fact 35. Subordinate to Finding of Fact 12 and 35. Accepted in Finding of Fact 19. Accepted in Finding of Fact 19. Accepted in Finding of Fact 9. Accepted in Finding of Fact 9. Accepted in Finding of Fact 78. Accepted in Conclusions of Law 39. Accepted in Finding of Fact 12-15. Accepted in Finding of Fact 12. Accepted in Finding of Fact 12. Accepted in Finding of Fact 12-13. Accepted in Finding of Fact 12. Accepted in relevant part in Finding of Fact 32. Accepted in relevant part in Finding of Fact 32. Accepted in relevant part in Finding of Fact 32. Accepted in relevant part in Finding of Fact 32. Accepted in relevant part in Finding of Fact 32. Accepted in Finding of Fact 20. Rejected Conclusion in Findings of Fact 21. Rejected Conclusion in Findings of Fact 21. Rejected Conclusion in Findings of Fact 21. Accepted in Finding of Fact 23. Accepted in Finding of Fact 23. Accepted in Finding of Fact 17. Accepted in Finding of Fact 33. Accepted in Finding of Fact 21. Accepted in Finding of Fact 21. Accepted in Finding of Fact 23. Accepted in Finding of Fact 5. Accepted in Finding of Fact 9. Accepted in Finding of Fact 9. Accepted in Finding of Fact 9. 105. Accepted in Findings of Fact 10-17. 106. Accepted in Finding of Fact 12. 107. Accepted in Finding of Fact 15. 108. Accepted in Finding of Fact 14. 109. Accepted in Finding of Fact 12. 110. Accepted in Finding of Fact 15. 111. Accepted in Findings of Fact 10-17. 112. Accepted in Findings of Fact 10-17. 113. Accepted in Finding of Fact 24. 114. Accepted in Finding of Fact 24. 115. Accepted in Finding of Fact 25. 116. Accepted in Conclusions of Law 42. 117. Accepted in Finding of Fact 19. 118. Accepted in Finding of Fact 19. 119. Accepted in Finding of Fact 28. 120. Accepted in Finding of Fact 28. 121. Accepted in Finding of Fact 33. 122. Accepted in Finding of Fact 31. 123. Accepted in Finding of Fact 28. 124. Accepted in Finding of Fact 29. 125. Accepted in Finding of Fact 34. 126. Accepted in Finding of Fact 34. 127. Accepted in Finding of Fact 30. 128. Accepted in general in Conclusions of Law 42. 129. Accepted in Finding of Fact 11. 130. Accepted in Findings of Fact 13 and 24. 131. Accepted in Finding of Fact 14. Respondent's Proposed Findings of Fact. Accepted in Findings of Fact 1 and 4. Accepted in Finding of Fact 3. Accepted in Finding of Fact 4. Accepted in Finding of Fact 4. Accepted in Finding of Fact 8. Rejected in Findings of Fact 9. Rejected in Findings of Fact 10. Accepted in Finding of Fact 19. Accepted in Finding of Fact 19. Accepted in Conclusions of Law 40. Rejected in Conclusions of Law 41. Accepted in Finding of Fact 4. Accepted in Finding of Fact 4. Accepted in Finding of Fact 24. Accepted in Finding of Fact 13. Accepted in Finding of Fact 25. Accepted in Finding of Fact 13. Accepted in Finding of Fact 4. Accepted in Findings of Fact 21 and 26. Subordinate to Finding of Fact 21. Subordinate to Finding of Fact 21. Subordinate to Finding of Fact 21. Subordinate to Finding of Fact 21. Subordinate to Finding of Fact 21. Subordinate to Finding of Fact 21. Accepted in Finding of Fact 31. Accepted in Findings of Fact 16 and 17. Subordinate to Finding of Fact 16. Accepted in Findings of Fact 15-17. Accepted in Finding of Fact 17. Accepted in Finding of Fact 17. Accepted in Finding of Fact 16. Subordinate to Finding of Fact 16. Subordinate to Finding of Fact 16. Rejected in Findings of Fact 12. Accepted in Finding of Fact 35. Accepted in Finding of Fact 12. Rejected first sentence in Finding of Fact 35. Accepted in Finding of Fact 35. Accepted in Finding of Fact 5. Accepted in Finding of Fact 28. Accepted in Finding of Fact 33. Accepted in Finding of Fact 33. Accepted in Finding of Fact 28. Accepted in Finding of Fact 34. Accepted in Finding of Fact 34. Accepted in Finding of Fact 35. Accepted in Finding of Fact 5. Accepted in Finding of Fact 20. Accepted in Finding of Fact 21. Accepted in Finding of Fact 21. Accepted in Finding of Fact 21. Accepted in Findings of Fact 5 and 22. Accepted in Findings of Fact 5 and 22. Accepted in Finding of Fact 21. Accepted in Finding of Fact 23. Accepted in Findings of Fact 5 and 36. Accepted in Finding of Fact 35. Subordinate to Finding of Fact 35. Accepted in Conclusions of Law 40. Subordinate to Finding of Fact 35. Rejected in Findings of Fact 35. Rejected in Findings of Fact 36. Accepted in Finding of Fact 21. Accepted in Finding of Fact 21. Rejected in Findings of Fact 35. Accepted in Finding of Fact 5. Accepted in Finding of Fact 5. Accepted in Finding of Fact 9. Rejected in Findings of Fact 10-17. Rejected first sentence in Findings of Fact 10-17. Rejected in Findings of Fact 10-17. COPIES FURNISHED: Kenneth F. Hoffman, Attorney Patricia A. Renovitch, Attorney OERTEL, HOFFMAN, FERNANDEZ & COLE, P.A. Post Office Box 6507 Tallahassee, Florida 32302 Lesley Mendelson, Senior Attorney Agency For Health Care Administration The Atrium Building, Suite 301 325 John Knox Road Tallahassee, Florida 32303 Sam Power, Agency Clerk Agency For Health Care Administration The Atrium Building, Suite 301 325 John Knox Road Tallahassee, Florida 32303
The Issue Whether Certificate of Need ("CON") Application No. 9481 by St. Vincent's Medical Center, Inc. ("St. Vincent's"), for a 10- bed Level II neonatal intensive care unit ("NICU") at the hospital proposed in CON Application No. 9484P should be approved?
Findings Of Fact The Acute Care Cases Pursuant to order rendered March 14, 2002, this case (the "NICU Case") was heard in the same final hearing with DOAH Case Nos. 02-0447CON, 02-0882CON, 02-0943CON, and 02-0971CON, (the "Acute Care Cases"). The Order acknowledged overlap between the Acute Care Cases and this case but did not consolidate the cases so that separate recommended orders are required for the Acute Care Case and for this case. The final hearing in the Acute Care Cases and the NICU Case commenced on May 13, 2002, and concluded on June 20, 2002. (The record was reopened in the Acute Care Cases and the hearing on reopening ended October 9, 2002. The proceeding on reopening did not concern the NICU Case.) A Recommended Order was rendered in the Acute Care Cases on February 5, 2003. To the extent relevant, its findings of fact are incorporated into this order. Obstetrics at St. Vincent's St. Vincent's has a significant obstetrical practice that includes neonatal intensive care services. It operates a 17-bed Labor-Delivery-Recovery-Postpartum ("LDRP") Unit that has an adjacent 23-bed unit for overflow postpartum and gynecology patients. In the same area of the hospital is its 10-bed Level II Neonatal Intensive Care Unit ("NICU"). There are 2,300 to 2,400 births annually at St. Vincent's. The NICU has an average daily census of six. St. Vincent's participates in a family practice residency program in which residents rotate through the obstetrical department and "as far as the nurseries go" (tr. 912) the pediatric program. St. Vincent's operates a program unique to Jacksonville in which postpartum services are provided at no cost: the Seton Center. The center's services can be expanded to St. Luke's if acquired by St. Vincent's. St. Vincent's Level II NICU is staffed by the same neonatologists that staff the Level II NICU at St. Luke's. Obstetrics at St. Luke's St. Luke's has an existing 17-bed LDRP unit with 10 antipartum beds. The Obstetrics ("OB") Program is known as the Family Birth Place. Opened in March of 1998, it had approximately 500 deliveries that year. The number of births increased to 1,600 in 2000 and has remained in the range of 1,500 to 1,800. Not part of the original hospital construction but added later to accommodate the new obstetrical service, the Family Birth Place for security has a separate entrance at the hospital. It uses a strong LDRP concept, "meaning that the mothers are admitted to a room where they labor, they deliver and they usually stay there." (Tr. 971) There are two C-section rooms in the LDRP unit. If an obstetrical patient needs an extra day or two, she may be moved to the overflow unit. If not, as in the typical case of other obstetrical patients, the stay is spent in a "well decorated, [private] room that has the ability to take care of the baby, stabilize the baby and stabilize the mother during the birth process." (Tr. 972) There are both Mayo and community obstetricians on staff delivering babies at St. Luke's. In August of 2000, a 10-bed Level II NICU was opened as part of the Family Birth Place. The CON for the unit at St. Luke's was approved without opposition from Memorial. Obstetrics at Memorial Memorial provides OB and NICU level II services to the residents of District 4 at its Woman's Center. The center offers a complement of OB and Level II NICU services in an integrated, multi-floor, single patient tower on the Memorial Campus. The center includes an admitting area, a lactation consultant's office, multiple operative and post operative discharge areas, operating room suites for women's surgery, holding areas for meetings between candidates for surgery and anesthesiologists and other clinicians, labor and recovery beds, an overflow area, an anti-partum testing and triage area, an inpatient unit for C-section patients, and LDRP suites with a full spectrum of obstetrical and GYN services both inpatient and outpatient and the 10-bed Level II NICU. Memorial has invested in a number of improvements to the center. Rooms have been converted from semi-private to private. Hard wood floors and other improvements have been made to enhance the health care environment for OB and NICU patients. The quality of care at Memorial's Women Center is excellent. Relationship of the Proposed Project to Other Applications The 10-bed Level II NICU proposed by St. Vincent's to be located at St. Luke's is related and contingent upon the approval of two other CON applications. The first is St. Luke's CON No. 9483 for a 214-bed replacement hospital on the Mayo Clinic Campus. The second is St. Vincent's CON Application No. 9494P for establishment of a 135-bed facility to be operated at the existing St. Luke's facility. The two other applications are interdependent. Neither can be implemented unless both are approved. If both are not approved or if either is not approved, St. Luke's will continue to operate a Level II NICU at St. Luke's. The status quo will be unaffected vis-à-vis the Level II NICU at St. Luke's. If the two other applications are both approved and this application is approved the outcome vis-à-vis the number and type of NICU beds at St. Luke's will be no different than if the other two applications are not approved. There will continue to be a 10-bed Level II NICU at the St. Luke's facility. Approval of the all applications means that the operators of the NICU beds will be different (St. Vincent's instead of St. Luke's) but the number and type of beds will remain the same. The transfer in control of the NICU from St. Luke's to St. Vincent's, moreover, will be without interruption in the services rendered to the NICU patients. Only if the other two applications are both approved and this application is not approved will there be a change in the status quo vis-à-vis the number and type of the Level II NICU beds at the St. Luke's facility. In such a case, the Level II NICU beds at the St. Luke's facility will cease to exist.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration dismiss the Petition of Memorial Healthcare Group Inc., d/b/a Memorial Hospital Jacksonville for lack of standing. DONE AND ENTERED this 14th day of February, 2003, in Tallahassee, Leon County, Florida. DAVID M. MALONEY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 14th day of February, 2003. COPIES FURNISHED: Lealand McCharen, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Building Three, Suite 3431 Tallahassee, Florida 32308-5403 Valda Clark Christian, General Counsel Agency for Health Care Administration 2727 Mahan Drive Building Three, Suite 3431 Tallahassee, Florida 32308-5403 Kathryn F. Fenske, Esquire Agency for Health Care Administration 8355 Northwest 53rd Street Miami, Florida 33166 Michael J. Cherniga, Esquire Sean M. Frazier, Esquire Greenberg Traurig, P.A. 101 East College Avenue Tallahassee, Florida 32301 Stephen A. Ecenia, Esquire Thomas W. Konrad, Esquire Rutledge, Ecenia, Purnell & Hoffman, P.A. 215 South Monroe Street, Suite 420 Post Office Box 551 Tallahassee, Florida 32302-0551 Stephen C. Emmanuel, Esquire Michael J. Glazer, Esquire Ausley & McMullen 227 South Calhoun Street Post Office Box 391 Tallahassee, Florida 32302-0391 R. Terry Rigsby, Esquire Law Office of R. Terry Rigsby, P. A. 215 South Monroe Street, Suite 505 Tallahassee, Florida 32301 Donna H. Stinson, Esquire Broad and Cassel 215 South Monroe Street, Suite 400 Post Office Drawer 11300 Tallahassee, Florida 32302
The Issue Whether Certificate of Need Application Number 6785 should be approved for the conversion of 10 acute care medical/surgical beds to a 10 bed Level II neonatal intensive care unit at University Community Hospital.
Findings Of Fact On August 9, 1991, HRS published a fixed need pool for Level II and III Neonatal Intensive Care Services in the Florida Administrative Weekly, Volume 17, Number 32. For District 6, HRS published a "Preliminary Estimate of Bed Need" for an additional 10 Level II Neonatal Intensive Care Unit (NICU) beds, with an explanatory footnote which was as follows: "Due to pending litigation regarding the inventory of neonatal intensive care unit beds, no fixed need projection is made." The pending litigation was a challenge to the inclusion of 11 beds at Winter Haven Hospital ("Winter Haven") on the inventory of existing Level II NICUs. Following an amendment of the "grandfathering" rules, Winter Haven's dispute with AHCA was settled. Winter Haven's 11 bed NICU is included on the Level II inventory and its petition in this proceeding, which a Winter Haven witness described as their "fall back position", has been voluntarily dismissed. Humana of Florida, Inc., d/b/a Humana Women's Hospital Tampa ("Humana") intervened in these proceedings. Subsequent to the hearing and filing of proposed recommended orders, Humana entered its notice of voluntary withdrawal of its petition on March 17, 1993. AHCA is the state agency which administers CON laws, following transfer of that responsibility from HRS. See, Chapter 92-33, Laws of Florida. University Community Hospital ("UCH") is a 424 bed hospital in Tampa, Hillsborough County, Florida, AHCA District 6, with services which include open heart surgery, pediatric intensive care, and obstetrics. UCH began obstetrics services on September 2, 1991. In its first full year of operation, there were 1299 deliveries in its 31 bed obstetrics unit. UCH projected that there would be 1500 to 1800 deliveries in its second year of obstetrics services. Numeric Need and Occupancy Levels UCH filed its application to convert 10 acute care beds to establish a 10 bed Level II NICU on September 26, 1991, in response to HRS' August 9, 1991 publication of need. Total project cost was estimated at $765,000. Although HRS described the District 6 publication as a "preliminary estimate," there is no statutory or rule authority for the publication of any numeric need number other than the fixed need. By letter dated December 16, 1991, Tampa General Hospital ("Tampa General") notified HRS that the utilization data for Tampa General, which was used to calculate numeric need was incorrect. Tampa General reported 11,112 Level II NICU patient days for 1987, 11,387 for 1988, and, initially, 10,770 for 1990. Tampa General also reported a 20 percent increase in births from 1988 to 1990, and a 117 percent utilization increase in Level III NICU patient days. Tampa General's revised figures distinguished between services provided in its special care nursery and those provided in Level II NICU beds. The revised report divided the total 10,770 into 4,600 patient days in special care nursery beds and 6,170 in Level II NICU beds, but does not specifically take into account the intensity of nursing care or the severity of infants' conditions. Using 6,170 patient days, rather than 10,770, AHCA recalculated numeric need, determined that the numeric need was zero, and used zero need in reviewing the District 6, Level II NICU applications filed in this batch. AHCA did not publish the revised calculation of zero need. AHCA's policy is to not recalculate a fixed need pool, unless there is time to republish before applications are due. Nevertheless, AHCA takes the position that the need publication in this case may be revised because it was preliminary. Using the August bed need projection published by HRS, Level II NICU beds were reporting 86.5 percent occupancy in the twelve month period ending six months prior to the publication. If Tampa General's utilization rates are decreased from 114.28 percent to 70.43 percent, revised district utilization rates would decrease from 86.5 percent to 72.83 percent. Staffing ratios and costs indicate that some neonates in the Tampa General special care nursery received care consistent with Level II NICU services. There is more credible evidence to support the data used by the agency in its publication of need than there is to support its revised determination of zero need. Minimum 1,000 Births Rule 10-5.042(6), Florida Administrative Code, is, in relevant part, as follows: Hospitals applying for Level II neonatal intensive care services shall not normally be approved unless the hospital had a minimum service volume of 1,000 live births for the most recent 12-month period ending 6 months prior to the beginning date of the quarter of the publication of the fixed need pool. There is no dispute that UCH initiated obstetrics services in September 1991, the same month in which it filed the CON application at issue in this case. Because the August 9, 1991 publication was the time for determination of need, then UCH does not meet the requirements of the rule. Standards For Review The publication of numeric need, minimum district occupancy levels, and minimum birth volumes are factors which determine the standard for review of CON applications. Due to the lack of any statutory or rule authority for the publication of preliminary estimates of numeric need, the nature and only possible effect of the pending litigation, AHCA's untimely revision of the numeric need number, and its failure to publish the revised number to allow a point-of-entry for challenges to the revised numeric need number and occupancy level, UCH is not required to demonstrate not normal circumstances. The failure to meet the minimum birth volume rule does, however, necessitate a showing of not normal circumstances for the approval of the UCH application. UCH assesses that its birth volume, and the number of neonates at UCH in need of Level II NICU care, the absence of available, accessible alternative hospitals, and the standard of care in the district are not normal circumstances which outweigh the minimum birth volume requirement. Available Alternatives Subsection 408.035(1)(b), Florida Statutes, also requires consideration of the availability, quality of care, efficiency, appropriateness, accessibility, extent of utilization, and adequacy of other Level II NICUs in the district. AHCA asserts that its corrected data showing zero need is a major indicator of available alternatives. As noted, however, UCH demonstrated the unreliability of the corrected data. In addition, geographic, economic, and other practical concerns may also affect accessibility. The total District 6 inventory of Level II NICU beds with 1990 occupancy and patient days as published on August 9, 1991, is as follows: Hospital Occupancy Patient Days Humana - Brandon 108.82 1,986 Humana Woman's 72.35 3,961 Tampa General 114.28 10,011 Manatee Memorial 90.23 1,976 Lakeland Regional 75.50 4,409 Winter Haven 49.02 1,968 The inventory is accepted as valid for the same reasons that the original publication of need is accepted as more reliable than the revised estimates. See, Finding of Fact 13. Tampa General's Level II and III nurseries are not available alternatives, because they exceed 90 percent occupancy. See, Findings of Fact 10 and 13. Humana Brandon is not an alternative with its Level II and III NICU beds exceeding capacity. Expert testimony on traffic practice and referral patterns support UCH's assertion that facilities in Winter Haven or Lakeland are not viable alternatives, although within the two hour travel time established by the rule on geographic access. Normal referral patterns are from more rural to more urban areas. Humana Women's, which is seven miles from UCH and has a transfer agreement with UCH, is the most geographically accessible, available alternative. The parties disagree over whether Humana Women's is economically accessible and has the capacity to serve most of the Level II neonates born at UCH. Humana Women's increased its service to 10-11 percent Medicaid obstetrics patients in 1991-1992, in contrast to UCH's level of 7 percent Medicaid obstetrics patients, and therefore, is no longer economically inaccessible to Medicaid patients. Humana Women's has 15 Level II NICU beds, which reported 72 percent occupancy in 1990. The demographic characteristics of the UCH service area include 7.1 percent Medicaid eligible population, and overlaps with the service area of Humana Women's. In addition, UCH and Humana Women's have overlapping medical staffs. For these reasons, Humana Women's experiences provide the most reliable indication of the accuracy of UCH's projections. At Humana Women's 7 percent of neonates require Level II and III care. By contrast, Lakeland Regional Medical Center experiences 12.7 percent neonates requiring NICU care, close to that projected by UCH, however, 30 percent of Lakeland Regional's patients are in the Medicaid payor category. The link between Medicaid and the greater need for NICU care was established by expert testimony. On this basis, the expert projections that 7 percent, not 10-15 percent, of UCH newborns will need Level II NICU care is accepted as reasonable. Average lengths of stay in Humana Women's Level II NICU beds were 6 to 7 days, not 10 days as projected by UCH. That data also supports AHCA's expert's conclusion that the average length of stay in UCH's stabilization unit, 2.3 days, is not indicative of UCH's having provided Level II care to 160 to 170 neonates. According to AHCA's expert planner, total capacity at Humana Brandon, Humana Women's and Tampa General is 14,000 patient days. Using the inventory published by the agency, those hospitals reported a total of 15,958 patient days in 1990. Even assuming that UCH overestimated the number of neonates needing NICU care, the capacity at accessible facilities within the district cannot accommodate the additional patients, and constitutes a not normal circumstance outweighing the minimum birth volume requirement. The fact that UCH is the only obstetrics facility in Hillsborough County without Level II and III NICU beds indicates that, if otherwise in compliance with review criteria, UCH's application should be approved to meet the need for additional Level II NICU beds. UCH's expert also testified that the number of Level II NICU beds in the Tampa area were disproportionately low compared to the population. Tampa has 3.2 Level II beds per thousand births in contrast to 7.6 in Lakeland, and 7.7 in Winter Haven. Given the demographic differences among the hospitals' service areas, the bed to population ratio was not shown to be meaningful as an indication of Level II NICU need. State and Local Health Plans Subsection 408.035(1)(a), Florida Statutes requires an evaluation of need in relation to applicable state and district health plans. The 1989 Florida State Health Plan lists the following general categories of preferences, most of which are applicable to any proposal to transfer or convert acute care beds regardless of the proposed new service: for conversion of acute care beds, for providing indigent care, for providing emergency services, for teaching, research and referral hospitals, and for providing specialized services. The District 6 plan issued in June 1990 by the Health Council of West Central Florida includes only one applicable CON allocation factor, which is related to the state health plan indigent care preferences and is as follows: Preference shall be given to an applicant who provides the department with documentation that they provide, or propose to provide, a disproportionate share of Medicaid and charity care patient days in relation to other hospitals in the subdistrict. The charity care definition shall be consistent with the definition used by the Health Care Cost Containment Board as defined in Chapter 89-275, Laws of Florida. The first group of preferences in the State Health Plan includes the following: Preference shall be given to a bed transfer and conversion application in which the applicant proposes a sizable reduction of excess beds in the existing facility. AHCA argues that the preference is not met. Because UCH has 404 licensed beds with an average occupancy of about 50 percent, or 200 empty beds, AHCA states that the conversion of only 10 medical-surgical beds to 10 Level II NICU beds is not a sizable reduction of excess acute care beds. However, AHCA only projected a need for an additional 10 NICU beds, which is the minimum size allowed by AHCA rules. AHCA's position that no additional Level II beds are needed is inconsistent with penalizing UCH for not proposing to convert more beds in this application. Therefore, this preference must be deemed inapplicable to this case. Similarly, given the size of the published need, the objective of reaching 75 percent occupancy in five years is also inapplicable to this application. The second relevant group of preferences relates to whether the conversion of beds will adversely impact disproportionate share providers. That same issue is also addressed in the group of preferences related to indigent care. AHCA argues that this preference is not met, because Tampa General, the only disproportionate share provider in the District, would be adversely affected. The evidence presented at hearing supports a conclusion to the contrary, that Tampa General will not be affected adversely. UCH and Tampa General have an agreement to cooperate in providing NICU services. UCH proposes to assist Tampa General in the delivery of Level III NICU services, by transfers of Level II neonates back to UCH as soon as possible. The fact that Tampa General's Level III utilization has increased substantially, more than 100 percent since 1988, was not disputted. Tampa General's medical director's testimony on the benefits to Tampa General of the agreement with UCH is persuasive. The next group of relevant preferences is entitled "Indigent care." The only local health plan factor also favors applicants which will provide a disproportionate share of Medicaid and charity care. UCH will not provide a disproportionate share of its services to Medicaid and charity care patients. The Level II NICU providers in District 6 average 40 percent Medicaid participation, and UCH proposes 6 percent. UCH does not meet the disproportionate share preferences in the state or local health plans. The "emergency services" group of preferences apply to applicants who (1)accept indigents for emergency care, (2)have a trauma center, (3) provide a full range of emergency services, and (4) have not been fined for violating emergency service statutes. UCH has an active emergency room, accommodating 45,000 visits in fiscal year 1991, and under expansion to increase its capacity to 60,000 visits a year. UCH, in general, meets the preference for providers of emergency room services. UCH is not a teaching, research, or referral center, nor is its proposed service unavailable within its service area. In response to this group of preferences, UCH has also not demonstrated that patients are leaving the state for this service, that any new physician specialities would be attracted to the area, or that its proposal will expand medical research in Florida. For the group of preferences for specialized services, UCH meets two of three applicable preferences. One for proposing a conversion of medical/surgical beds to NICU beds, another for proposing a commitment to serve 6 percent Medicaid and 5 percent charity care. In 1990, 41 percent of District 6 Level II NICU discharges were Medicaid patients. In 1990, Medicaid services ranged from a high of 61.6 percent of total Medicaid provided by Tampa General to a low of 2 percent by Humana Women's. UCH has shown its 6 percent Medicaid commitment to be reasonable and attainable by demonstrating that 7.1 percent of the population in its service area is Medicaid eligible. The actual Medicaid percentage in the first year for obstetrics services was 7 percent, which coincides with the percentage of Medicaid eligible persons living within the UCH service area. UCH has not emphasized specialized services to substance abusers, other than to have a referral network to community service agencies. The review of UCH's application in relation to state and local health plans results in the conclusion that the proposal is generally supported by preferences for the conversion of excess acute care beds, for not adversely impacting and potentially assisting Tampa General, for having emergency room services, and for providing specialized services with an attainable relatively low, Medicaid commitment. On the negative side are the preferences for applicants serving a disproportionate share Medicaid and charity patients, for teaching, research or referral centers, for services unique to the area, or for specialized service to substance abusing pregnant or postpartum women. On balance, the application of the state and local health plans does not suggest strongly that the UCH application either should or should not be approved, particularly in this case, where comparative review is impossible because UCH is the sole remaining applicant. Other Statutory Criteria Subsection 408.035(1)(c), Florida Statutes, criteria are met by UCH. UCH can provide good quality care in Level II NICU services. It is accredited by the Joint Commission on Accreditation of Health Organizations and has the ability to comply with rule requirements for equipment, staff and physical facilities. UCH already has a board-certified neonatologist on staff. Subsection 408.035(1)(e), favoring joint, cooperative or shared operation of health care services is not a criterion met by the UCH proposal. Although UCH suggests that its transfer agreement with Tampa General complies with the statute and the evidence showed that the two hospitals will cooperate in providing the separate services they each provide, but the transfer agreement does not constitute cooperative operation of the service. Subsection 408.035(1)(f), arguably is a basis for approval of the UCH application, because Level II NICU equipment and services do not exist in the adjoining area of east Pasco County. For District 5, which includes Pasco County, zero need was published for the same batching cycle. Subsection 408.035(1)(g) criterion, related to research and training programs, is not met by the UCH application. UCH meets the criteria in Subsection 408.035(1)(h), by having shown that it has the manpower, personnel and funds to establish and operate a 10-bed Level II NICU. UCH is able to renovate existing space and to acquire the equipment required for the 10-bed NICU for approximately $765,000. AHCA does not dispute UCH's assertion that it has adequate funds to finance this project and that project costs are reasonable. Having already hired a neonatologist, and 6 to 7 of the 11 1/2 to 12 1/2 full time equivalent or FTE's required, UCH has, or can recruit and hire, the necessary staff. Financial Feasibility Under Subsection 408.035(1)(i), the financial feasibility of a project must be considered. UCH estimated that a Level II NICU will generate $290,000 in year one, and $336,000 in year two revenues. The projections were based on providing Level II NICU services to 11 to 12 percent of newborns, or 2290 patient and 2670 patient days in years one and two, respectively. This underlying assumption is rejected. See, Finding of Fact 26. UCH's projection of a 10 day average length of stay in Level II NICU beds is not supported by Humana Women's experience of 6 to 7 days. See, finding of Fact 27. From the testimony and assumptions, attached to UCH's projected revenues and expenses, it is possible to determine that reduced total patient revenues will result from lower than projected numbers of patients and days. It is also apparent that deductions from revenue and some operating expenses will also decrease. There is, however, no testimony from which the relative proportions of adjustments to each item and the effect on charges for NICU services be calculated. Nor is there testimony regarding any minimum utilization necessary for the project to be financially feasible. Therefore, UCH has failed to meet the burden of showing that the proposed Level II NICU at UCH will be financially feasible. On balance, but not excluding all the applicable criteria, the most positive factors of the UCH proposal, the published need and potential benefits to Tampa General, do not outweigh the most negative ones, the failure to demonstrate financial feasibility and to make a more significant commitment compared to the district demand for Medicaid in Level II NICU beds.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the application of University Community Hospital for Certificate of Need 6785 to convert 10 acute care beds to 10 Level II neonatal intensive care beds be DENIED. DONE AND ENTERED this 8th day of October, 1993, in Tallahassee, Leon County, Florida. ELEANOR M. HUNTER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 8th day of October, 1993. APPENDIX TO RECOMMENDED ORDER, CASE NO. 92-1490 To comply with the requirements of Section 120.59(2), Fla. Stat. (1991), the following rulings are made on the parties' proposed findings of fact: UNIVERSITY COMMUNITY HOSPITAL Accepted in Findings of Fact 5 and 36. Accepted in Finding of Fact 6. Accepted in Finding of Fact 7. Accepted in Finding of Fact 2. Accepted in Finding of Fact 2. Accepted in Finding of Fact 3. Accepted in Findings of Fact 1 and 2. Accepted in Finding of Fact 2. Accepted in Finding of Fact 8. Accepted in Findings of Fact 9 and 10. Accepted in Finding of Fact 11. Accepted in Finding of Fact 11. Issue not reached. Issue not reached. Issue not reached. Accepted in Findings of Fact 10 and 11. Accepted in Finding of Fact 13. Subordinate to Finding of Fact 13. Accepted in Finding of Fact 10. Subordinate to Finding of Fact 13. Accepted in Findings of Facts 5 to 13. Subordinate to Finding of Fact 13. Subordinate to Finding of Fact 13. Accepted in Finding of Fact 13. Accepted in Findings of Fact 10 and 13. Accepted in Finding of Fact 47. First two sentences, Subordinate to Finding of Fact 6, Last two sentences, Rejected in Finding of Fact 26. Accepted in Finding of Fact 28. Rejected in Findings of Fact 50 and 51. Accepted in Finding of Fact 27. Rejected. Accepted in Finding of Fact 29. Accepted in Finding of Fact 36. Accepted in relevant part in Finding of Fact 34. Subordinate to Finding of Fact 26. Subordinate to Finding of Fact 26. Conclusion rejected in Finding of Fact 30. Rejected in Finding of Fact 41. Rejected in Findings of Fact 50 and 51. Accepted in relevant part in Finding of Fact 41. Accepted in Finding of Fact 34. Accepted in relevant part in Finding of Fact 38. Accepted in Findings of Fact 20, 22, and 28. Accepted in Finding of Fact 23. Accepted in Finding of Fact 25. Subordinate to Finding of Fact 25. Accepted in Finding of Fact 24. Accepted in Finding of Fact 29. Accepted in Finding of Fact 34. Accepted in Finding of Fact 47. Accepted in Finding of Fact 47. Accepted in Finding of Fact 47. Rejected in Finding of Fact 48. Rejected in Findings of Fact 50. Rejected in Findings of Fact 48. Subordinate to Finding of Fact 50. Subordinate to Finding of Fact 50. Unable to determine. Unable to determine. Accepted. Unable to determine. Rejected in Finding of Fact 45. Accepted in Finding of Fact 47. Accepted in Finding of Fact 47. Accepted in Finding of Fact 47. Accepted in Finding of Fact 47. Accepted in Finding of Fact 47. Accepted in Finding of Fact 47. Accepted in Finding of Fact 28. Issues not reached due to Humana's Voluntary Dismissal. Issues not reached due to Humana's Voluntary Dismissal.
The Issue Whether Trustees of Mease Hospital, Inc., d/b/a Mease Hospital Dunedin ("Mease") is entitled to be included on the Neonatal Intensive Care Unit ("NICU") inventory, as authorized to provide Level III NICU services in five (5) Level III beds in Department of Health and Rehabilitative Services ("HRS") District 5. Whether All Children's established its standing to intervene in Case No. 90-6255, as an existing provider of Level III NICU services in HRS District 5. Whether Morton Plant established is standing to intervene in the consolidated cases, as an existing provider of Level II NICU services in HRS District 5.
Findings Of Fact On September 14, 1990, Mease a 278-bed acute care hospital, located in Dunnedin, Florida, timely challenged the inventory of neonatal intensive care beds published for District 5 (Pasco and Pinellas Counties) by HRS. The preliminary inventory, published on August 24, 1990, authorized five (5) Level II and no Level III beds at Mease. All Children's is a 168-bed specialty children's hospital, which has a 24-bed Level III NICU, located in St. Petersburg, Florida, in Pinellas County. Morton Plant is a 750-bed acute care hospital with Level II NICU beds, located in Clearwater, Florida, in Pinellas County. Of the 2,670 babies delivered at Morton Plant in 1990, 598 came from the Mease area; 569 of the 2,670 were classified as not normal or in need of some NICU services, and 148 of the 569 not-normal newborns came from the Mease service area. HRS is the department with responsibility for promulgating NICU rules pursuant to legislation passed in May 1987, effective in October 1987. See, Section 381.702(20) and 381.706(1)(a), (e), (h), and (m), Florida Statutes (1989). The NICU rule became final in August 1990, and included a "grandfather" provision for providers of NICU services prior to October 1, 1987, to avoid any disruption in the availability of NICU services. The grandfather provision includes, as one of three tests for determining if NICU services were offered prior to October 1, 1987, the requirement that 50% of the neonates admitted to Level II and III units from October 1, 1986 through September 30, 1987, were classified in Diagnostic Related Groups (DRGs) 385, 386, 387 or 388. See, Florida Administrative Code, Rule 10-5.042(14)(f) (2)(b) (III). In August 1987, HRS, in preparation for the promulgation of the NICU rule, mailed surveys to various hospitals, including Mease, requesting information about the provision of NICU services at those hospitals. Using the Guidelines for Perinatal Care to distinguish the level of services it was providing, Mease responded to the August 1987 survey by reporting that it had three (3) Level II beds and no Level III beds. In response to the survey questions, Mease also reported that its NICU services began on April 1, 1987, coinciding with the time that a neonatologist, Mary Newport, M.D., joined the staff at Mease. In March 1987, Board Certified Neonatologist Mary Newport began providing 24-hour coverage at Mease, receiving final approval for active staff privileges in early May 1987, so that Mease could treat rather than transfer sick neonates. Mease resubmitted the August 1987 survey in February 1989, reporting that it had increased from three to six Level II beds, after October 1, 1987, and from one to four Level III beds beginning on October 1, 1987, although such changes required certificate of need ("CON") approval effective October 1, 1987. HRS sent out a second survey in April 1989, to which Mease responded that it currently had six Level II beds and no Level III services, under the more stringent requirements included within the proposed rule as compared to the Guidelines for Perinatal Care standards used in the first survey. In August 1989, Mease resubmitted the second survey and reported a current total of six Level II beds and four Level III beds of which three Level II beds and one Level III bed were operating on September 30, 1987. Mease, in the August resubmittal of the second survey, also reported that 37 neonates were admitted to the Level III bed for 63 patient days and that a total of 188 neonates were admitted to both Level II and Level III beds, from October 1, 1986 through September 30, 1987. Of the 188 neonates admitted to Level II and Level III beds from October 1, 1986 through September 30, 1987, Mease claimed that 87 of those had DRG's 385, 386, 387 or 388. On September 10, 1990, Mease submitted documentation to HRS showing that from October 1, 1986 through September 30, 1987, NICU admissions totaled 122 patients, of which 77 were in DRGs 385, 386, 387 or 388. Subsequently, Mease claimed to have had 18 fewer admissions. On December 18, 1990, Mease claimed to have had 107 NICU patients, of which 69 were in DRGs 385, 386, 387 or 388. At the final hearing, Mease claimed that its review of the available records of 1512 of the 1520 deliveries from October 1, 1986 through September 30, 1987, showed that, when diagnoses and codes were changed retrospectively, there were 126 NICU admissions, of which 74 were in DRGs 385, 386, 387, and 388. The number of neonates in intensive care and the number of neonates in the specified DRGs asserted by Mease are both unreliable. There is no credible evidence to support Mease's claim that it started offering NICU services upon the arrival of Dr. Newport on the courtesy staff on March 28, 1987, or upon her becoming a member of the active staff in early May, 1987. Credible expert testimony was presented that a time lag occurs between the arrival on staff of a neonatologist and the initiation of NICU services. In fact, Dr. Newport testified that after she arrived at Mease, she tried out various rented equipment and evaluated it before making purchases, and altered the locations of the nurseries. The Mease Perinatal Committee Agenda dated May 26, 1987 included an item "Task Force for Development of Level II Facility." Even assuming arguendo that Mease did establish NICU services on April 1, 1987, as reported to HRS in response to the first HRS survey, a substantial number of the neonates Mease claimed to have served in its NICU were, in fact, discharged from Mease prior to April 1, 1987. 1/ Mease has failed to submit documentation that it had neonatal intensive care services from October 1, 1986 through September 30, 1987. Mease has failed to submit documentation that it admitted 126 neonates to intensive care services from October 1, 1986 through September 30, 1987. Mease has failed to submit documentation that 74 neonates were classified into DRGs 385, 386, 387 or 388. Credible expert testimony supports the conclusion that retrospective changes in diagnoses are not reliable, in view of the fact that observation of a patient, not just the patient's record, is significant in making a diagnosis. Mease reported to the Health Care Cost Containment Board that it had no revenue from the operation of a NICU from October 1, 1986 to September 30, 1987.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered: Including Mease on the final inventory as an authorized Level II neonatal intensive care unit with five beds, based on the Summary Recommended Order of April 9, 1991, entered without objection; and Excluding Mease from the final inventory as an authorized provider of Level III neonatal intensive care services. DONE and ENTERED this 1st day of November, 1991, at Tallahassee, Florida. ELEANOR M. HUNTER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 1st day of November, 1991.
The Issue At issue in this proceeding is whether Memorial West should be issued CON 7249 to establish a 10-bed Level II NICU program at its facility in southwest Broward County based on "not normal circumstances." Also at issue is whether the Intervenor, Plantation General Hospital, L.P., has sufficiently demonstrated standing, based on whether its existing NICU service will be substantially adversely affected if Memorial West's proposed project is approved.
Findings Of Fact The agency hereby adopts and incorporates by reference the findings of fact set forth in the Recommended Order except where inconsistent with the rulings on the exceptions.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That Plantation General Hospital, L.P. be dismissed as a party to these proceedings based upon its failure to demonstrate standing, and That Certificate of Need No. 7249 be granted to South Broward Hospital District, d/b/a Memorial Hospital West to establish a 10-bed Level II Neonatal Intensive Care Unit at its Pembroke Pines facility. DONE and ORDERED this 20th day of January, 1995, in Tallahassee, Florida. JAMES W. YORK Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 20th day of January, 1995.
The Issue Whether the Petitioner, Bethesda Memorial Hospital, Inc., (Bethesda) is entitled to a certificate of need (CON) in order to convert three general acute care beds for use as Level III neonatal intensive care unit (NICU) beds.
Findings Of Fact The Agency for Health Care Administration is the state agency charged with the responsibility of reviewing applications such as the one at issue in this proceeding. The parties have stipulated that whether or not the subject application should be approved must be decided upon a weighing and balancing of all pertinent statutory and rule criteria. Bethesda’s letter of intent and application for CON were timely filed in an appropriate batching cycle. Bethesda is a 362-bed acute care hospital located in Boynton Beach, Palm Beach County, Florida. As such, it is located within the Agency’s District 9. The approval of the CON at issue would allow Bethesda to convert three of its existing acute care beds to Level III NICU beds. This approval would expand Bethesda’s existing NICU from 12 beds, which are designated Level II NICU beds, to a total of 15 beds for the combined NICU. Bethesda received a CON for its existing NICU in 1985. From its inception, the unit has been staffed and equipped for the highest level of NICU care and, in fact, performed Level III care until 1995 when the Agency ordered it to stop admitting babies of less than 1000 grams in weight. At the time of the original approval of the Bethesda NICU, the Agency did not distinguish between Level II and Level III NICU beds. Nevertheless, Bethesda staffed and equipped its unit based upon the highest level of care because of the population it has historically served. Later, as the Agency developed more distinct guidelines between Level II and Level III NICU beds (as well as a statewide bed-need methodology), Bethesda found it could not technically continue to do what it had historically done, i.e., serve a Level III newborn. Bethesda has historically served these Level III newborns because it is under contract with the Palm Beach County Public Health Unit (PHU) to care for indigent mothers and at-risk babies. This agreement to serve indigent mothers and at-risk babies has resulted in a significant number of babies being delivered at Bethesda requiring neonatal intensive care at all levels. Until 1989, Bethesda was the only hospital to provide obstetrical care in the southern portion of Palm Beach County, much less make exceptional provision for indigent birth mothers. As it developed, Bethesda provided quality obstetrical, pediatric, and neonatology services in an area of Palm Beach County where other providers were less than enthusiastic about the market. Except for St. Mary’s Hospital in the northern portion of the county, no other provider has extended services to the indigent as demonstrated by Bethesda. Moreover, Bethesda has offered to condition its CON approval on the provision that it render a minimum of 35 percent of the facility’s entire NICU patient days, including Level II and Level III, to Medicaid/charity patients. Thus, a major emphasis of this application is care for the indigent. Of all patients cared for in the south Palm Beach County neonatal programs, ninety-nine percent are indigent. While a provider may receive reimbursement for certain services (from Medicaid or local health district funds), the patients themselves (birth mothers and babies) are indigent. Additionally, one-third of the pregnancies processed through the PHU are high-risk due to diabetes, infectious diseases, or other complications. As a logical consequence of the complications with the birth mother, the babies born through the PHU program tend to be sicker than average. While Palm Beach County has demonstrated a remarkable improvement in providing pre-natal care to birth mothers and thereby improving at-risk results, Bethesda continues to play a critical role in extending care to this needy population. Bethesda is the exclusive hospital used by the PHU in south Palm Beach County. It is utilized because it is geographically located near the patient population. Further, Bethesda’s reputation in this community makes it attractive to those in need. Bethesda is engaged in a three-way partnership with St. Mary's Hospital and the PHU to lower infant mortality in the county. They have created an integrated care plan for south Palm Beach County maternity patients. Bethesda, physicians in the community (including obstetricians, gynecologists, neonatologists and pediatricians), and the PHU have worked together for 11 years to make sure that protocols are available so that pre-natal care is available to all who need it. These parties work closely with Healthy Mothers/Healthy Babies and other voluntary organizations to bring patients to the PHU or to Bethesda. The PHU physicians and midwives deliver between 800 and 1,000 babies a year. About 25 percent of these babies from the southern portion of the county will require some kind of Level II or Level III NICU care during their stay in the hospital. Thus, 200 to 250 babies needing NICU care come through the PHU each year. It would also be expected that non-indigent mothers from the southern portion of the county would deliver babies requiring NICU care. Bethesda plans to open outlying health clinics to enhance services offered to local communities within the Bethesda zip codes. These programs or clinics are expected to result in an estimated 20 percent increase in the volume of indigent pregnant women served by Bethesda. The availability of services to the local communities may also assist patients to keep their scheduled appointments. There is a difference between the number of patients scheduled to see PHU physicians and those who actually show up, due to the inconvenience and financial burden of getting to the health unit. Having the clinic locations readily available may alleviate the inconveniences to the indigent mother. Under the present circumstances, when a Level III baby is delivered at Bethesda it must be transferred to another facility. These transfers create a major burden for the birth mother. Remembering that the mother would not typically be transferred with the child (and would not require the extended stay some neonates demand), the issue of transportation for the parent may be insurmountable. For example, in order to leave a convenient location to visit once or twice a day, an indigent mother must arrange transportation to and from the Level III facility where the baby has been sent. This may entail additional expenses for the parent such as lost wages or extending times for babysitters watching other children in the home. These additional expenses may be more than the indigent family can bear. The nearest Level III NICU provider to whom Bethesda now transfers patients is St. Mary’s Hospital. This facility is, by automobile, approximately 30-40 minutes from Bethesda depending on traffic conditions. Bus transportation directly connecting one site to the other, if it were available (which it is not), would presumably take longer. Currently, even when it is determined that a maternity patient should be sent to St. Mary's Hospital for pre-natal care, the mothers are presenting for delivery at Bethesda. This occurs because Bethesda is geographically located in the area where they live. The baby is born at Bethesda and a decision must be made how best to deal with the health issues of the child. Of the patients referred from Bethesda to St. Mary's Hospital for pre-natal care, only 5 percent deliver at St. Mary's. Ninety-five percent return to Bethesda for delivery even though they were told to go to St. Mary's. The main reason for this failure of patients to follow up at St. Mary's Hospital is the lack of affordable transportation. Many indigent women do not have cars or access to them. The existing facilities in Palm Beach County for Level III care are not reasonably available, appropriate, or accessible alternatives for these patients. AHCA District 9 has only three Level III NICU providers. They are all in Palm Beach County, with St. Mary's Hospital and Good Samaritan Hospital (now owned by the same company) in the northern part of the county (West Palm Beach) and West Boca in the southern part (Boca Raton). West Boca is not a reasonable alternative for the NICU patient population served by Bethesda. West Boca does not serve the lower income patients. In fact, West Boca transfers patients without financial resources to Bethesda. West Boca transfers indigent women in labor early enough so that COBRA regulations are met. Pertinent to this case, historically, West Boca transferred indigent Level III NICU patients to Bethesda until 1994. During the last three years, Level III NICU utilization at Good Samaritan and St. Mary's Hospital has averaged better than 90 percent. To average 90 percent means that the beds are often full or there are more patients than there are beds. Accordingly, these providers are operating at what is essentially capacity. It is, therefore, not surprising that St. Mary's Hospital supports Bethesda's CON application in this proceeding. No existing provider within District 9, including West Boca, formally opposed the instant application. A primary service area is the area from which a hospital draws the overwhelming majority of its patients for a given service and is defined by zip code level information. The primary service area of Bethesda for providing newborn and neonatal services is wholly within what has been described in this record as the southern portion of Palm Beach County. The primary service areas of West Boca and Bethesda for newborn and neonatal services do not significantly overlap. In fact, 40 percent to 45 percent of these services provided by West Boca have been to residents of Broward County. In this regard, West Boca's neonatal services compete more directly with those of Broward General Hospital than Bethesda. Bethesda's NICU is currently staffed and equipped for Level III services. From a medical standpoint, the CON proposal will result in a quality 15-bed dual unit, which is very efficient from the neonatologist's standpoint. The neonatologists staffing the Bethesda NICU are associated with the same group serving St. Mary's Hospital and Broward General Hospital, both Regional Perinatal Intensive Care Centers (RPICC). This helps assure proficiency with large volumes at more than one program. The nursing staff at Bethesda all have at least two years of Level III experience, and no nurse is currently hired for the NICU without that level of experience. From a neonatal nursing care standpoint, the addition of the three Level III beds would result in quality, cost- efficient care. The proposed combined unit would allow for flexibility of making daily staff assignments and would enhance care for the babies. The combined 15-bed NICU is large enough to provide quality, cost-effective Level II and III care. Bethesda has the physician staffing, nurse and therapist staffing, equipment, facilities, and hospital services to provide proper quality tertiary care for these newborns. Since 1993, Mease Hospital in Dunedin, Florida, has operated a five-bed Level III NICU combined with a five-bed Level II NICU in one room. It has proven to be a quality program with a low mortality rate. The five-bed Level III NICU provides cost- efficient care. There is no reason Bethesda cannot duplicate the record Mease has demonstrated. High quality, neonatal intensive care may be easier to achieve with Level II and III beds in the same room than with any other configuration of beds. Bethesda will not be able to treat every sick baby. It cannot care for babies requiring open heart surgery (Bethesda does not have an open heart surgery program), for those needing extra-corporeal membrane oxygenation (ECMO), nor those seeking pediatric cardiac catheterization. None of the three existing Level III facilities in District 9, however, has open heart surgery or ECMO available. Like Bethesda they, too, must transfer out for these services. Fortunately, the Agency rule allows a provider to make written arrangements with other Level III providers to provide those services in the same or nearest service area. AHCA has stipulated that Bethesda has the appropriate written transfer agreements pursuant to Rule 59C-1.042(12), Florida Administrative Code. For the number of babies to be served by Bethesda, the ability to serve Level III babies will improve the quality of care. There are medical risks in transferring babies from one facility to another. When adequate staffing and facilities are available at the hospital of birth, transferring the infant to another provider may pose an unnecessary risk. The risks inherent in transfers do not always outweigh the benefit. For example, transferring the child may delay certain treatments such as use of "surfactants" which protect a baby's lungs. Other risks such as those associated with maintaining the infant's blood pressure or body temperature make transfers difficult and, in some instances, medically questionable. Bethesda’s application for the instant CON meets the applicable local and state health plans. Bethesda has an established record of providing quality care and will be well able to provide quality of care for the services allowed by the proposed addition of three Level III NICU beds. It is unrealistic for Bethesda to refuse admission to patients requiring Level III NICU services given the historical and current patterns of births for this District. Bethesda’s proposed addition of three Level III beds to its NICU is financially feasible both in the short- and long- term. Bethesda’s Level III NICU beds will be programmatically accessible to its patient population. Although 90 percent of the District 9 population is within two hours ground travel time of an existing Level III NICU bed, such accessibility does not consider the unique characteristics of the indigent population the proposed beds at Bethesda will serve. Moreover, the provider who would otherwise serve the Level III patient under such scenario supports this application. The existing facilities providing care to the indigent population operate at capacity and are fully utilized. The only facility not fully utilized (West Boca) has no significant history of providing care to the Medicaid/indigent population. The proposed construction or renovation of the Bethesda unit to accommodate fifteen NICU stations is reasonable. While Bethesda will have to meet certain minimum licensing standards in the configuration of the NICU, it is anticipated that such standards will be met with little difficulty or significant expense to Bethesda. The unchallenged fixed-need pool for the batching cycle applicable to this case was one Level III bed. Bethesda has met all Agency requirements regarding “Emergency Transportation,” “Transfer Agreements,” and “Data Reporting Requirements.” The Agency’s rule regarding minimum unit size for a Level III NICU has not been met. However, this requirement has not been adhered to by the Agency in several instances. In AHCA District 9, there are three hospitals with NICU Level III programs. Not one of these programs has 15 beds. St. Mary's Hospital (a RPICC) has ten beds, Good Samaritan has eight beds, and West Boca has five beds. The quality of care at these providers is presumably adequate despite the fact that they were approved and licensed by the Agency with less than fifteen beds. Moreover, the Agency has never considered the 15-bed minimum an absolute bar to the application for, or the review of, lesser-numbered beds. In fact, the Agency approved new Level III NICU beds at Mease Hospital (a five-bed unit), West Boca Hospital (a five-bed unit), and Miami Baptist Hospital (a seven-bed unit) after the rule was promulgated. Additionally, the total number of all NICU beds at Mease and West Boca is less than fifteen. Thus, as stipulated in South Miami Hospital, Inc. v. Agency for Health Care Administration, Case No. 97-04875, currently pending before the First District Court of Appeal, the Agency has “consistently interpreted those unit size rule provisions as permissive.” Bethesda has presented not normal circumstances supporting this CON application which are hereby accepted. Such circumstances include: accessibility issues for indigent or Medicaid mothers and babies; the lack of Level III beds in the southern portion of the county where 60 percent of all resident live births are delivered; the fact that approximately one-third of the low birth weight mothers reside in the service area for Bethesda yet the majority of the Level III beds are in the northern portion of the county; and the fact that 30 percent of Bethesda’s patients are clients from the PHU. The average occupancy rate for Level III NICU beds for the year applicable to this application was 80.9 percent. As a result, the rule mandated minimum average occupancy rate has been met.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED That the Agency for Health Care Administration enter a final order approving CON application Number 8235 with the condition that Bethesda provide indigent/Medicaid care as proposed in the application. DONE AND ENTERED this 24th day of February, 1998, in Tallahassee, Leon County, Florida. J. D. PARRISH Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 24th day of February, 1998. COPIES FURNISHED: Sam Power, Agency Clerk Agency for Health Care Administration Fort Knox Building 3 2727 Mahan Drive, Suite 3431 Tallahassee, Florida 32308-5403 Paul J. Martin, General Counsel Agency for Health Care Administration Fort Knox Building 3 2727 Mahan Drive, Suite 3431 Tallahassee, Florida 32308-5403 Richard A. Patterson, Esquire Agency for Health Care Administration Fort Knox Building 3 2727 Mahan Drive, Suite 3407B Tallahassee, Florida 32308-5403 Kenneth F. Hoffman, Esquire M. Christopher Bryant, Esquire Oertel, Hoffman, Fernandez & Cole, P.A. Post Office Box 6507 Tallahassee, Florida 32314-6507
