The Issue Whether certain forms incorporated by reference into the administrative rules of the Respondent constitute an invalid exercise of delegated legislative authority.
Findings Of Fact Tampa General Hospital ("TGH" or "Petitioner") is a general acute care hospital in Tampa, Florida and is a verified Level I state-approved trauma center. By definition, a Level I trauma center is required to include an adult trauma center and a pediatric trauma referral center. The Department of Health and Rehabilitative Services ("DHRS" or "Respondent") is the state agency with responsibility for certification of trauma centers in Florida. St. Joseph's Hospital ("SJH" or "Intervenor") has filed an application for state approval as a pediatric trauma referral center which is the subject of a separate administrative challenge by TGH. In the instant case, TGH challenges three DHRS forms incorporated by reference into the Florida Administrative Code and which are utilized by applicants seeking certification as state-approved trauma centers. Tampa General has standing to challenge the forms in this proceeding. The three forms challenged by TGH in this case are HRS Form 1840, ("State-Approved Trauma Center Letter of Intent"), HRS Form 1721, ("Application for State-Approved Pediatric Trauma Referral Center"), and the portions of HRSP 150-9, which identify the "critical standards" which must be met by an applicant seeking to obtain approval as a provisional state approved pediatric trauma referral center. The three forms include reference dates of October 1991. The forms were adopted as part of a rule promulgation effort prior to the 1992 Legislative session. Obviously the DHRS did not address the 1992 legislation in the 1991 rules. In relevant part, the 1992 legislation added a requirement that, under conditions set forth in the statute, proposed trauma centers must be certified as consistent with local or regional trauma plans. The forms challenged by TGH fail to reference the requirement. Section 395.4025(2)(a), Florida Statutes, requires submissions of letters of intent from hospitals seeking to become certified as state-approved trauma centers. Section 395.4025(2)(a), Florida Statutes, further requires that "[i]n order to be considered by the department, a hospital that operates within the geographic area of a local or regional trauma agency must certify that its intent to operate as a state-approved trauma center is consistent with the trauma services plan of the local or regional trauma agency, as approved by the department, if such agency exists." The statute states that the requirement is not applicable to hospitals which were provisional or verified trauma centers on January 1, 1992. There are five local or regional trauma agencies in Florida which have been approved by the DHRS. Hillsborough County, where both the Petitioner and the Intervenor operate hospitals, has one of the five local trauma agencies. Rule 10D-66.109(a), Florida Administrative Code provides that the department "shall accept a letter of intent, HRS Form 1840, October 91, State- Approved Trauma Care Center Letter of Intent, which is incorporated by reference and available from the department. " The form letter of intent provided to applicants by the DHRS fails to reference the local plan consistency requirement or the conditions under which the requirement is applicable. Section 395.4025(2)(a), Florida Statutes, relates only to letters of intent. It clearly indicates that the certification of local plan consistency is an issue to be addressed as part of the letter of intent filed by a provider. The form letter of intent does not provide notice to the applicant that such certification may be required, either as part of the completed letter of intent or otherwise. The omission of the certification requirement from the letter of intent form is misleading. It fails to indicate that a hospital should address the issue in its letter of intent. The form contravenes the statute. TGH also challenges HRS Form 1721, October 91, ("Application for State-Approved Pediatric Trauma Referral Center",) and the portions of HRSP 150- 9, October 91, which identify the "critical standards" which must be met by an applicant. Section 395.4025(2)(c), Florida Statutes, (1994 Supplement) provides as follows: In order to be considered by the department, applications from those hospitals seeking selection as state-approved trauma centers, including those current verified trauma centers which seek to be state-approved trauma centers, must be received by the department no later than the close of business on April 1. The department shall conduct a provisional review of each application for the purpose of deter- mining that the hospital's application is complete and that the hospital has the critical elements required for a state approved trauma center. This critical review will be based on trauma center verification standards and shall include, but not be limited to, a review of whether the hospital has: Equipment and physical facilities necessary to provide trauma services. Personnel in sufficient numbers and with proper qualifications to provide trauma services. An effective quality assurance program. Submitted written confirmation by the local or regional trauma agency that the verification of the hospital as a state-approved trauma center is consistent with the plan of the local or regional trauma agency, as approved by the department, if such agency exists. This sub- paragraph applies to any hospital that is not a provisional or verified trauma center on January 1, 1992. Rule 10D-66.109(c), Florida Administrative Code, requires that an applicant for licensure as a provisional state-approved pediatric trauma referral center must submit an application on HRS Form 1721, October 91, Application for State-Approved Pediatric Trauma Referral Center. The form is incorporated by reference in the rule. HRS Form 1721, October 91, Application for State-Approved Pediatric Trauma Referral Center, fails to reference the local plan consistency issue or the conditions under which the requirement is applicable. However, the instructions to the form provide as follows: INSTRUCTIONS: To be eligible for approval as a SAPTRC, a hospital must complete this application and submit all requested information to the HRS, Office of EMS, for review. The following must be used to complete this application: HRS Pamphlet (HRSP) 150-9 entitled "State Approved Trauma Centers and State-Approved Pediatric Trauma Referral Center Approval Standards", Oct 91 (standards document), and the application requirements of Chapter 395, Florida Statutes (F.S.), and Chapter 10D-66, Florida Administrative Code (F.A.C.). Following discussion of a three phase review process, the HRS Form 1721 instructions again state that "HRS Pamphlet (HRSP) 150-9, Oct 91, the application requirements of Chapter 395, F.S., and Chapter 10D-66, F.A.C., will be used as criteria for application review." By reference to the statute and rules, the instructions to the application notify an applicant as to the requirements for certification. The failure of the actual application to specifically restate the potential requirement of certification of local trauma plan consistency does not contravene or modify the requirement. As to the standards document in which the critical standards for provisional approval are set forth, rule 10D-66.109(d)2, Florida Administrative Code, provides as follows: The minimum standards for review for Provisional SAPTRCs are the following portions of HRSP 150-9, October 91; STANDARD Type of Hospital Surgery Department; Division; Services; Sections: A Surgical Specialties Availabilities: A 1, 2, 3 & 4 Non-Surgical Specialties Availabilities: 1, 8 & 13 Emergency Department (ED): A, B, D & H Operating Suite Special Requirements: A IX. Pediatric Intensive Care (P-ICU): A, C, 1 XVI. Quality Management: A, B, C, D, & E It is unnecessary to address each critical standard in this order. Essentially, they relate to the first three "critical elements" set forth as Section 395.4025(2)(c)1-3, Florida Statutes. However, review of the cited portions indicates that there is no reference within the cited sections of HRSP 150-9, October 91, which addresses the possible requirement of local trauma plan consistency certification. The application processing framework set forth by the administrative rules indicates that local plan consistency is to be considered prior to the DHRS's commencement of provisional review. Rule 10D-66.109(d), Florida Administrative Code, provides that "[a]fter considering the results of the local or regional trauma agency's recommendations, the department shall, by April 15, conduct a provisional review to determine completeness of the application and the hospital's compliance with the critical standards for provisional standards." If, as the rule suggests, certification of local plan consistency is considered prior to commencement of provisional review, it would be duplicative to include the requirement in the technical critical standards set forth in the standards document. The failure of the standards document to restate the potential requirement of certification of local trauma plan consistency does not contravene or modify the requirement.
The Issue Whether Florida Administrative Code Rule 64J-2.010 enlarges, modifies or contravenes the specific provisions of law implemented, or is arbitrary or capricious, and thus constitutes an invalid exercise of delegated legislative authority.
Findings Of Fact The Parties Bayfront is a 480-bed tertiary hospital located in St. Petersburg, Pinellas County, Florida. In addition to serving as a teaching hospital, Bayfront is designated as a Level II trauma center pursuant to chapter 395, Part II, Florida Statutes. Bayfront had a $3.6 million operating deficit in 2009 and a positive operating margin below one percent ($1.969 million) in 2010. Due to its financial strife in recent years, Bayfront has been forced to defer needed capital projects due to a poor liquidity position, inadequate borrowing capacity and insufficient cash flow. Tampa General is a major tertiary hospital that is designated by the state as a Level I trauma center. TGH also serves as a teaching hospital for the University of South Florida, College of Medicine ("USF"). TGH is located in Tampa, Hillsborough County, Florida. Like Bayfront, TGH has also experienced significant financial challenges in recent years. For fiscal year 2011, TGH's budget reflected only a $7 million (one percent) operating margin. However, due to subsequent events, including Medicaid cuts and flat utilization year-to-date, TGH now expects to do no better than break-even, and may even incur a $4 million operating loss in FY 2011. This is significant because TGH has reached its borrowing capacity and must rely on its operating margin to build cash that will be used to fund needed capital projects and expenditures. Maintaining a positive and substantial operating margin is therefore critical to TGH's ability to replace equipment and infrastructure. St. Joseph's Hospital has served the Tampa area for 75 years and has approximately 800 licensed acute care beds. SJH offers a broad array of acute care services, including tertiary health care, serves as a comprehensive regional stroke center, and has been repeatedly recognized as a Consumers Choice hospital. SJH operates a Level II trauma center, and in 2010, treated approximately 2,700 trauma patients. SJH also has one of the busiest emergency departments in the state, with approximately 145,000 patient visits in 2010. Shands Jacksonville is an existing Level I trauma center. It is one of only seven such Level I providers in the state of Florida. Located in Jacksonville (Duval County), Shands treats approximately 4,000 trauma victims every year. Respondent Department of Health is the state agency authorized to verify and regulate trauma centers in the state of Florida pursuant to chapter 395, Part II, Florida Statutes and Florida Administrative Code Rule 64J-2.001 et seq. The Division of Emergency Medical Operations, Office of Trauma, oversees the Department's responsibilities with respect to the statewide trauma system. Intervenor Bayonet Point is a general acute-care hospital located in Pasco County, Florida. Bayonet Point is currently seeking to obtain designation as a trauma center. As of the date of the hearing in this matter, Bayonet Point's application for designation as a trauma center was not complete and Bayonet Point was in the process of developing the facilities and retaining the medical staff necessary to meet the standards and criteria required for its application to be deemed complete. Intervenor Blake Medical Center is a general acute care hospital located in Manatee County, Florida. Blake is currently seeking to obtain designation as a trauma center. As of the date of the hearing in this matter, Blake's application for designation as a trauma center was not complete and Blake was in the process of developing the facilities and retaining the medical staff necessary to meet the standards and criteria required for its application to be deemed complete. Although not a party to this case, HCA/Orange Park Medical Center ("Orange Park") is also currently in the process of applying for trauma center designation. Orange Park is located in Clay County, immediately to the south of Duval County. The Florida Trauma System For purposes of organizing a statewide network of trauma services, the Florida Legislature directed the Department to "undertake the implementation of a statewide inclusive trauma system as funding is available." § 395.40(3), Fla. Stat. The statewide trauma network includes not just verified trauma centers, but all other acute care hospitals in the State, as well as ground and air emergency medical services providers, and "every health care provider or facility with resources to care for the injured trauma victim." § 395.40(2), Fla. Stat. The network is premised on the basic principle that a trauma victim who is timely transported and triaged to receive specialized trauma care will have a better clinical outcome. § 395.40(2), Fla. Stat. A trauma victim's injuries are evaluated and assigned an Injury Severity Score ("ISS"). § 395.4001(5), Fla. Stat. Patients with ISS scores of 9 or greater are considered trauma patients. § 395.402(1), Fla. Stat. Trauma experts speak in terms of "a Golden Hour," a clinical rule of thumb that postulates no more than 60 minutes should elapse from the occurrence of an injury to the beginning of definitive treatment. There is, however, no current consensus on what constitutes the "Golden Hour" for transport times. A 1990 Department study recommended travel time of 25-35 minutes as the outside range for optimal outcomes. A 1999 Department study favored a goal of 30 minutes transport time by ground, and a 50-mile radius by helicopter. By contrast, a 2005 study conducted for the Department used 85 minutes "total evacuation time" as "acceptable." Because of the necessity for rapid transport, key components of the trauma network are ground and air EMS transportation. It is important to get the trauma victim to the nearest trauma center as rapidly as possible, because "you can't do surgery in the back of an ambulance." Each EMS provider operates pursuant to Uniform Trauma Transport Protocols and inter-facility guidelines which give guidance for how, where and when trauma patients should be transported. Trauma centers are required to have numerous different kinds of physician specialists at the ready at all times. For instance, with respect to surgical services, a Level I trauma center must have "a minimum of five qualified trauma surgeons, assigned to the trauma service, with at least two trauma surgeons available to provide primary (in-hospital) and backup trauma coverage 24 hours a day at the trauma center when summoned." Further, in addition to having at least one "neurosurgeon to provide in-hospital trauma coverage 24 hours a day at the trauma center," a Level I provider must also have surgeons "available to arrive promptly at the trauma center" in 11 other specialties, including (but not limited to) hand surgery, oral/maxillofacial surgery, cardiac surgery, orthopedic surgery, otorhinolaryngologic surgery and plastic surgery. Level II trauma centers must comply with similar physician specialist standards. Not surprisingly, it is a constant struggle for existing trauma centers to ensure the availability of qualified clinical staff, technicians, specialty physicians and other personnel and resources necessary to continually meet the rigorous programmatic requirements of a trauma center. In general, trauma centers are not profitable due to the intensity of resources necessary to achieve an appropriately functioning trauma program, and the scarcity of such resources. The Challenged Rule In 1992, the Department of Health and Rehabilitative Services ("HRS") adopted Florida Administrative Code Rule 64J- 2.010, (the "Rule"). Respondent Department of Health assumed administration of the Rule in 1996, when the Legislature split HRS into two new agencies, the Department of Health and the Department of Children and Families. The Rule is a statement of need, sometimes referred to as "open slots" for a specific number of trauma centers allocated among 19 geographic service areas ("trauma service areas" or "TSAs") in the state. The current version1/ of rule 64J-2.010, the subject of this rule challenge, reads in its entirety as follows: 64J-2.010 Apportionment of Trauma Centers within a Trauma Service Area (TSA). The number and composition of TSAs shall be in accordance with section 395.402, F.S. The number of trauma centers in each TSA shall be in accordance with the maximum number set forth in the table below. Each trauma service area shall have at least one Level I or Level II trauma center position. The number of trauma center positions for each TSA is as follows: TSA Counties Trauma Centers 1 Escambia; Okaloosa; Santa 2 Rosa; Walton 2 Bay; Gulf; Holmes; Washington 1 3 Calhoun; Franklin; Gadsden; 1 Jackson; Jefferson; Leon; Liberty; Madison; Taylor; Wakulla 4 Alachua; Bradford; Columbia; 2 Dixie; Gilchrist; Hamilton; Lafayette; Levy; Putnam; Suwannee; Union 5 Baker; Clay; Duval; Nassau; St. 2 Johns 6 Citrus; Hernando; Marion 1 7 Flagler; Volusia 2 8 Lake; Orange; Osceola; 3 Seminole; Sumter 9 Pasco; Pinellas 3 10 Hillsborough 2 11 Hardee; Highlands; Polk 3 12 Brevard; Indian River 2 13 DeSoto; Manatee; Sarasota 3 14 Martin; Okeechobee; St. Lucie 1 15 Charlotte; Glades; Hendry; Lee 2 16 Palm Beach 2 17 Collier 1 18 Broward 3 19 Dade; Monroe 6 TOTAL 42 The trauma center will be assigned by the department according to section 395.402(4), F.S. Specific Authority 395.405 FS. Law Implemented 395.401, 395.4015, 395.402, 395.405 FS. History–New 12-10-92, Formerly 10D-66.1075, Amended 6-9-05, 12-18-06, Formerly 64E-2.022. A hospital seeking to establish a new trauma center must file an application with the Department. If a TSA has fewer trauma centers than the number allocated to the TSA in the Rule, the Department deems need to exist without reference to any additional analysis or data. Accordingly, if a hospital's application to establish a new trauma center complies with trauma center programmatic requirements, the Department will approve the application. As will be discussed in greater detail infra, the Department believes it is bound by the determination of need set forth in the Rule and that it does not have authority to deny an application that meets programmatic requirements so long as there is an "open slot" for a new trauma center within a particular TSA. Indeed, the Department has never denied an application that met the programmatic requirements when need existed under the Rule. History of the Rule In 1989, the Legislature directed HRS (DOH's predecessor) to submit a report by February 1, 1990, (the "1990 Report"). The 1990 Report was to include a proposal for funding trauma centers that "will result in funding of the number of strategically placed trauma centers necessary to ensure adequate trauma care throughout the state." Ch. 89-275, § 6, Laws of Fla. The 1990 Report was to include "an estimation of . . . the approximate number and generalized location of state-sponsored trauma centers needed to ensure adequate trauma care throughout the state . . . ." Id. The 1990 Report was prepared by the Committee on State-Sponsored Trauma Centers (the "1990 Committee"). Although HRS timely submitted the Committee's report to the Legislature on February 1, 1990, HRS indicated that it did not "fully support all of the conclusions and recommendations contained in the task force report." In its report, the 1990 Committee recommended the creation of 19 trauma service areas. The boundary of each TSA was drawn to include a "nucleus county" along with its sending (later referred to as "feeder") counties. A nucleus county was one that retained at least 90 percent of its resident trauma alert patients, but also included any county that had a retention rate greater than 75 percent (but less than 90 percent) if no contiguous county had the requisite 90 percent retention rate. Any county that retained less than 75 percent of its trauma alert patients was designated a feeder county. This feeder county was then grouped with the nucleus county that received a majority of the feeder county's outbound patients. After reviewing 1988 patient flow data and applying the above rules, the 1990 Committee created and assigned counties to 19 trauma service areas. Under the 1990 Committee's methodology, a nucleus county was a candidate for a trauma center, but a feeder county was not. Table 3.3 of the 1990 Report set forth the Committee's recommendation as to the number of trauma centers to be allocated to each of the 19 TSAs: Table 3.3 Recommended Trauma Service Areas and Number of Trauma Centers 1988 Number Treated 1988 Number Residing Recommended No. Trauma Centers Service Area ISS Level 9+ ISS Level 16+ ISS Level 9+ ISS Level 16+ Min Max 1 1332 275 | 1166 223 2 3 2 489 117 | 452 105 1 1 3 815 185 | 701 152 1 2 4 1183 269 | 1011 226 2 3 5 2268 662 | 2566 546 2 3 6 869 138 | 877 143 1 2 7 1376 225 | 1286 190 2 3 8 3756 698 | 3329 592 3 4 9 3978 626 | 3709 552 3 4 10 2458 604 | 2222 507 2 3 11 1834 302 | 1665 290 3 4 12 1487 220 | 1433 218 2 3 13 1900 264 | 1810 247 3 4 14 687 105 | 698 102 1 2 15 1455 243 | 1386 236 2 4 16 2310 365 | 2233 371 2 3 17 476 73 | 436 75 1 1 18 4238 670 | 4204 652 4 5 19 7346 1370 | 6633 1176 6 7 Total 40857 7411 | 37817 6603 44 60 Table 3.3 indicates a total trauma center need ranging from 432/ to 60 trauma centers, although only 12 trauma centers were in existence at the time of the report. As the table reflects, the need estimate was apparently based on only one factor: the number of trauma patients residing and treated within each TSA in 1988. However, the 1990 Report indicates that members of the "number and location subcommittee" may have considered other factors in arriving at their recommendation: The study design formulated by the CHSPA called for identification and analysis of trauma patient incidence and patient flow for a one-year period based on the HCCB detailed case mix data. This data analysis effort alone, however, would not specifically identify the number of trauma centers needed in the state, nor their generalized location. The patient incidence and flow information needs to be considered in relation to the following factors in order to reach sound recommendations: . . . The injury severity level for which trauma center care is required; the minimum number of cases which should be treated at a trauma center in order to maintain skill proficiencies consistent with high quality outcomes; appropriate travel times from accident location to a trauma center; and, the existing level of facility resources available in an area upon which one or more trauma centers could be built. While information on certain of these points was available through trauma care literature and previous research, its applicability to Florida’s circumstances was not clear in all instances. Therefore, the Department sought recommendations on these issues from the committee and, especially, from the number and location subcommittee. The subcommittee’s recommendations, as ratified by the full committee, were integral to the development to the approximate number and generalized locations of state-sponsored trauma care throughout the state. However, no methodology was provided within the Report to show how the number of trauma centers was allocated among the TSAs based upon the data considered by the committee. The committee also cautioned that their estimate did not take into account other relevant factors or local conditions within each TSA that should be assessed before deciding how many trauma centers were in fact needed, including resource availability. As stated in the 1990 Report: It was the full committee's feeling that the number of hospitals able to apply to be state-sponsored trauma centers would be limited by the lack of resources in the service area. For instance, the standards require that trauma centers have certain physician specialists committed to the facility for availability 24 hours a day, seven days a week. There are not enough specialists available in any area of the state to staff more than a few trauma centers. The reality of the situation lead the full committee to believe that there cannot be a proliferation of trauma centers. Dialogue between the state and local/regional agency would be essential to making the decision on the number of trauma centers needed. The 1990 Report did not include data or analysis relating to factors such as the availability of physician specialists within geographic areas, existing trauma center patient volumes, patient outcomes, or the capacity and adequacy of existing trauma centers. Following receipt of the 1990 Report, the Legislature amended the trauma statute by adopting the 19 trauma service areas proposed in the 1990 Report. Chapter 90-284, § 5, at 2188-89, Laws of Fla. However, the Legislature did not consider the trauma service area boundaries to be permanent or static. Instead, the Legislature provided that: [t]hese areas are subject to periodic revision by the Legislature based on recommendations made as part of local or regional trauma plans approved by the department . . . These areas shall, at a minimum, be reviewed by the Legislature prior to the next 7-year verification cycle of state sponsored trauma centers. As part of the 1990 trauma statute amendment, the Legislature provided that, in addition to complying with the trauma center standards, a trauma center applicant must "be located in a trauma service area which has a need for such a center." Ch. 90-284, § 6, at 2191, Laws of Fla. In this regard, the Legislature directed HRS to "establish [within each service area] the approximate number of state-sponsored trauma centers needed to ensure reasonable access to high quality trauma services." Id. (emphasis added). This need determination, which must be promulgated via rule, was to be "based on the state trauma system plan and the [1990 Report]." Id.; § 395.402(3)(b) ("[t]he department shall allocate, by rule, the number of trauma centers needed for each trauma service area"). However, the Legislature rejected the 1990 Report's recommended minimum of 43 and maximum of 60 trauma centers. Instead, the Legislature stipulated that there should be a minimum of 19 trauma centers (i.e., one trauma center in each service area) and "no more than" 44 trauma centers. Ch. 90-284, § 5, at 2189-90, Laws of Fla. In 1992, HRS promulgated rule 64J-2.010. The Rule adopted the column in Table 3.3 of the 1990 Report reflecting the "minimum" recommended number of trauma centers, and stated that "[t]he number of trauma centers in each TSA shall be in accordance with the minimum number set forth in the table.3/” The trauma center need allocated by rule 64J-2.010, which merely replicates Table 3.3, has remained unchanged since 1992 with the exception of TSA 18. Subsequent Developments In 1998, the Legislature directed DOH via a committee (the "1999 Committee") to prepare a report by February 1, 1999, (the "1999 Report") "on how best to ensure that patients requiring trauma care have timely access to a trauma center." In furtherance of this objective, the 1999 Committee was required to "study . . . the strategic geographical location of trauma centers . . . ." Id. In its report, the 1999 Committee recommended that "[t]he goal for timely access to trauma centers should be to assure that every trauma victim can be delivered to a trauma center, either by emergency medical ground or air transport, within 30 minutes of beginning transport." As stated in the 1999 Report: There must be an adequate number of trauma centers distributed statewide in order to ensure timely access. . . [T]he ideal trauma system would assure that every trauma victim can be delivered to a trauma center within 30-minute air or ground transport. The geographical locations of the 19 trauma centers either verified or provisional as of July 1998 are shown on Map 1 in Appendix F. The circles around each trauma center location illustrate a fifty-mile flight radius, which translates into an average 30- minutes transport time by helicopter for a trauma victim. Helicopter transport time is used for this illustration because air medical transport allows trauma victims to be transported further distances within the 30-minute timeframe. The 1999 Committee found that some areas in Florida were not within a fifty-mile flight radius of one of the 19 existing trauma centers, which meant residents in these areas could not access a trauma center within 30 minutes. In fact, at that time, only 80 to 85 percent of Florida residents were within 30 minutes of a trauma center.4/ The committee therefore concluded "Florida does not have an adequate number of trauma centers distributed statewide to ensure timely access to appropriate trauma care." As a result of its findings, the 1999 Committee "developed two additional criteria for use by the department: 1) the overall goal of 30-minute transport time to trauma centers, and; 2) its equivalent, 50 miles, for helicopter flight times." The committee stated that these access criteria "should be considered by [DOH] in developing administrative rules for the planning and development of additional trauma centers . . ." The 1999 Committee made no attempt to quantify the number of additional trauma centers that were needed statewide, or within each TSA, to achieve the 30-minute goal.5/ Nor did the committee seek to update the Rule (i.e., Table 3.3) using the 1990 Report's methodology. However, the committee cautioned that: [r]etaining the limit on the number of trauma centers was . . . essential in order to maintain a reasonable volume of patients who are trauma victims as well as to avoid conflicts between competing trauma centers for recruitment of key professional staff. The 1999 Committee recommended giving DOH the "statutory authority to assign counties to trauma service areas" and that DOH "conduct a review of the regional structure of the 19 trauma service areas and the assignment of the counties between these areas and make changes, if found to be appropriate." The 1999 Report offered the following explanation for this recommendation: The committee did recommend that authority to assign counties to trauma service areas should be given to the department. Current authority resides with the Legislature. Shifting this authority to the department will allow flexibility in the system to more quickly respond to changing needs at the local level. Consistent with the 1999 Committee's recommendation, the Legislature repealed the statutory provision that made the trauma service areas subject to periodic review and "revision by the Legislature." Ch. 99-397, § 195, at 164, Laws of Fla. This repealed provision was replaced with an amendment to section 395.402(3) that delegated to DOH the statutory duty to review and revise the TSA boundaries, which stated as follows: Trauma service areas are to be used. The department shall periodically review the assignment of the 67 counties to trauma service areas. These assignments are made for the purpose of developing a system of trauma centers. Revisions made by the department should take into consideration the recommendations made as part of the regional trauma system plans approved by the department, as well as the recommendations made as part of the state trauma system plan. These areas must, at a minimum, be reviewed in the year 2000 and every 5 years thereafter. Until the department completes its initial review, the assignment of counties shall remain as established pursuant to chapter 90-284, Laws of Florida. Ch. 99-397, § 195, at 163-64, Laws of Fla. (Emphasis added). In response to the Legislature's directive, DOH initiated a review of the service areas and prepared a draft report entitled “Trauma Service Area Study-Year 2000” (the "2000 Draft Study"). However, for reasons unknown in this record, DOH apparently never finalized that study, and it was received in evidence in draft form only. In the 2000 Draft Study, DOH noted that the "primary purpose" of the TSA review mandated by section 395.402(3) "is to determine if the 19 trauma service areas . . . continue to be rational service areas." Based on the 1990 Report's methodology, the draft study's tentative recommendation was not to change the trauma service areas, although DOH "should continue to study and review the trauma service areas . . . to determine if different county configurations might lead to more timely access . . . ." At the same time, after analyzing more recent data, the draft study recommended the allocation of a different number of trauma centers to TSAs 9, 10, 11, and 12 as compared to the Rule.6/ Additionally, the 2000 Draft Study made the following finding: Because of the substantial financial commitment made by a hospital to be a trauma center, patient volume becomes an important factor for a hospital in terms of being financially viable and having enough work for trauma surgeons to maintain their skills. The old adage of practice makes perfect is particularly applicable to those treating the seriously injured trauma patient. . . To meet [the American College of Surgeons] caseload recommendations, locating trauma centers in areas where skill levels can be maintained by trauma surgeons is an important factor. Furthermore, to recruit and retain well-qualified surgeons to work in a trauma center, it is important to have a sufficient number of patients to treat, especially to the surgeon. Thus, the 2000 Study emphasized that trauma centers must see enough patients to be financially viable and for trauma surgeons to maintain their skills, and referenced the American College of Surgeons recommendation that Level I trauma centers treat 600 to 1000 patients annually and Level II trauma centers treat 350 to 600 patients annually. The 2000 Study concluded: -No change in trauma service areas should be made at this time. This study found that minimal change occurred in those counties identified as nucleus counties. Furthermore, the relationship between nucleus counties and those identified as sending or "feeder" counties remains intact. -The 19 trauma service areas should continue to serve as the geographical basis for the allocation of the 44 authorized trauma center slots. -The 44 authorized trauma center slots in chapter 395.401 Florida Statutes [now section 395.402(4)(c) should remain as the maximum number required to meet trauma patient care demands. 2004 Amendments to the Trauma Statutes and the 2005 Assessment In 2004, the Legislature made substantial revisions to the trauma statute. Chapter 2004-259, Section 6, Laws of Florida amended section 395.402 to direct the Department to complete a statewide assessment of the trauma system by February 1, 2005 ("the 2005 Assessment"). § 395.402(2), Fla. Stat. The scope of this assessment was defined in paragraphs (2)(a) through (g) and subsection (3) of section 395.402. An appropriation of $300,000 was authorized for the Department to contract with a state university to perform the actions required under the amended statute. Ch. 2004-259, § 10, Laws of Florida. One objective of the 2005 Assessment was to "[c]onsider aligning trauma service areas within [sic] the trauma region boundaries as established in" section 395.4015(1). §395.402(2)(a), Fla. Stat. In a related 2004 amendment, the Legislature added a sunset provision that, upon completion of the 2005 Assessment, ended the statutory mandate to use the service areas created in 1990. See § 395.402(2) ("[t]rauma service areas as defined in this section are to be utilized until [DOH] completes" the 2005 Assessment) (emphasis added); § 395.402(4) ("[u]ntil the department completes the February 2005 Assessment, the assignment of counties shall remain as established in this section.") The obvious intent of the above statutory change was for the section 395.402(4) service areas to be replaced by the service areas DOH established or adopted once it had the results of the 2005 Assessment. "Annually thereafter" (as opposed to every five years per the 1999 version of the statute) DOH was required to "review the assignment of the 67 counties to trauma service areas . . . ." Ch. 2004-259, § 6, at 13, Laws of Florida (amending § 395.402(3)). Another objective of the 2005 Assessment was to "establish criteria for determining the number and level of trauma centers needed to serve the population in a defined trauma service area or region." § 395.402(2)(c), Fla. Stat. Based on these criteria, DOH was then to "[r]eview the number and level of trauma centers needed for each trauma service area to provide a statewide integrated trauma system." § 395.402(2)(b), Fla. Stat. As part of this need assessment, DOH was required to consider the "[i]nventories of available trauma care resources, including professional medical staff," as well as the "[r]ecommendations of the Regional Domestic Security Task Force" and "the actual number of trauma victims currently being served by each trauma center." § 395.402(3), Fla. Stat. However, unlike the situation with the 1990 Report, the Legislature did not intend for DOH to rely on the 2005 Assessment indefinitely. To avoid this, the Legislature therefore required DOH to update the 2005 Assessment by annually reviewing "the requirements of paragraphs (2)(b )-(g) and subsection (3)" of section 395.402. This meant that each annual review, like the initial 2005 Assessment, had to "[r]eview the number and level of trauma centers needed for each trauma service area or region" by, among other things, considering "[i]nventories of available trauma care resources, including professional medical staff." §§ 395.402(2)(b) and (3)(e). The need determinations resulting from these annual reviews would then have to be codified in a rule per section 395.402(4)(b) ("[t]he department shall allocate, by rule, the number of trauma centers needed for each trauma service area"). The 2004 Legislature clearly intended for DOH to rely on the updated need assessments required by section 395.402(4), rather than the need allocation in the 1990 Report (which was incorporated into the Rule). This is evident from the fact that the 2004 Legislature repealed the provision that previously required DOH to establish need based on the 1990 Report. See chapter 2004-259, § 7, at page 14, Laws of Florida (amending section 395.4026(1)), which states in relevant part: Within each service area and based on the state trauma system plan, the local or regional trauma services system plan, and recommendations of the local or regional trauma agency, and the 1990 Report and Proposal for Funding State Sponsored Trauma Centers, the department shall establish the approximate number of state approved trauma centers needed to ensure reasonable access to high-quality trauma services. The Using the guidelines and procedures outlined in the 1990 report, except when in conflict with those prescribed in this section, the department shall select those hospitals that are to be recognized as state approved trauma centers . . . [emphasis added] By repealing the statutory reference to the 1990 Report, the Legislature expressly required the Department to discontinue any reliance on the 1990 Report as a basis for allocating trauma center need. In addition, the 2004 Legislature imposed a moratorium on the submission of applications for new trauma centers in any TSA that already had one trauma center until the 2005 Assessment was complete, regardless of whether the Rule indicated a need for an additional trauma center within the TSA. § 395.4025(14), Fla. Stat. It is reasonable to infer that the imposition of a moratorium notwithstanding unmet need in several of the TSA's under the Rule indicates that the Legislature considered the Rule to be outdated and no longer valid. The moratorium therefore had the effect of maintaining the status quo until the Rule could be updated with a new assessment. The Department timely submitted its 2005 Assessment to the Legislature on February 1, 2005. The assessment itself was conducted by a group of investigators from the University of South Florida and the University of Florida. This group was assisted by a National Steering Committee "composed of recognized experts in the fields of trauma care and trauma system analysis " In its transmittal letter to the Legislature, DOH specifically noted that the assessment included a recommendation regarding “the number and level of trauma centers needed to provide a statewide integrated trauma system. . . .” In contrast with HRS' contemporaneous objections to the 1990 Report, the DOH transmittal letter identified no areas of disagreement with the 2005 Assessment. The 2005 Assessment included 5 "Recommendations", including: 3. Designation of additional trauma centers should be based on the need as determined by trauma region.7/ Deployment of additional trauma centers should take place based not only on the number of patients served per trauma center, but according to a concept of “trauma center capacity,” which would be determined by the staffing levels of medical specialists and other healthcare professionals. An annual regional assessment is also recommended to analyze pre-hospital resources, ICU beds, capacity, trauma center performance including trauma registry data, and other medical resources based on per population estimates to plan for response and improvements. (Emphasis added) Thus, unlike the 1990 Report (and the Rule), the authors of the 2005 Assessment recommended that the availability of existing resources should be taken into account in determining the need for new trauma centers. In evaluating need based on DSTF region, the 2005 Assessment identified an unmet need for only four more trauma centers in the state,8/ which "would provide access to a trauma center for 99 percent of the people in Florida." Given the 20 trauma centers in existence at the time, this meant that the total trauma center need was 24, which is substantially below the need established by the Rule of 42 trauma centers. This lower need determination was due in part to the fact that the 2005 Assessment took "trauma center capacity," and not just the number of patients served per trauma center, into account. According to the 2005 Assessment, the recommended four new trauma centers were needed in DSTF Regions 1, 2, 3 and 5. However, the assessment concluded there was no need for another trauma center in DSTF Region 4 (Tampa Bay), which was found to have "adequate trauma center access at this time." This contrasts with the Rule, which purports to authorize five more trauma centers in the counties assigned to Region 4. In particular, under the Rule, there is a net need for two new trauma centers in Pasco County (TSA 9), two new trauma centers in Manatee County (TSA 13) and one new trauma center in either Citrus or Hernando County (TSA 6). The only legislative response to the 2005 Assessment was an increase in funding to trauma centers. Likewise, the Department has not amended the Rule to implement the recommendations contained in the Assessment. In 2008, the Department held rule development workshops in order for trauma system constituents to indicate whether trauma center allocations contained in the Rule should be changed. Pursuant to stakeholder requests arising out of the workshops, the Department began consideration of an increase in the maximum number of trauma center positions allocated to TSA 1 (Escambia, Santa Rosa, Fort Walton and Okaloosa Counties). Following numerous public workshops and hearings, the Department filed notice of its intent to amend the Rule to increase the allocation of trauma centers in TSA 1 from 2 to 3. However, the amendment did not become final due to matters unrelated to the determination itself and was withdrawn by the Department.9/ The January, 2011 TSA Report In 2011, a study was completed for DOH entitled "Florida Trauma Service Area Analysis" (the "2011 TSA Report") that relied on the 1990 Report's patient flow methodology for assigning counties to trauma service areas. However, this study did not take into account all of the section 395.402(3) criteria. The 2011 TSA Report disclosed this deficiency, stating: This study provides an analysis of TSAs and counties to assess retention of trauma alert patients within the county. Rules for designating counties as nucleus counties for trauma centers and counties for consideration for trauma centers were defined in analyses of TSAs conducted for the office of Trauma in 1990 and 2000. * * * This report analyzes hospital discharges by TSA from 2000 to 2009. Hospital discharge data from [AHCA] is used to analyze the county of residence and treating facility for all trauma patients with an Injury Severity Score (ISS) of 9 or greater, as deemed by statute . . . . Other considerations required, by statute, in the assignment of counties to TSAs include recommendations of regional trauma system plans, stakeholder recommendations, geographical composition to assure rapid access to trauma care, inventories of available trauma care resources, transportation capabilities, medically appropriate travel times, recommendations by the Regional Domestic Security Task Force, and any appropriate criteria. These considerations are not integrated into this analysis of TSAs. (Emphasis added). Although the 2011 TSA Study used the same methodology as the 1990 Report, the 2011 TSA Study supports a different TSA configuration than the one established in the 1990 Report because patient flow patterns have changed since 1990. For example, in the 1990 analysis, the primary treatment county for Manatee County was Sarasota County. Because Manatee served as a feeder county for Sarasota (a nucleus county), it was grouped in the 1990 Report with Sarasota County in TSA 13. However, the updated information in the 2011 TSA study shows that the primary treatment county for Manatee County residents is now Pinellas (TSA 9's nucleus county), which requires that Manatee County be reassigned to TSA 9 per the 1990 Report's methodology. A similar shift in patient flow also dictates the reassignment of Hernando County from TSA 6 to TSA 10 (Hillsborough County). Indeed, it appears that all of the counties in TSA 6 would have to be merged with other trauma service areas since Marion County, which was designated as TSA 6's nucleus county in the 1990 Report, no longer qualifies as a nucleus county. The Department maintains that its employees are continuously reviewing trauma volume, injury severity scores, population and other data and that this activity qualifies as the annual need and trauma service area reviews required by section 395.402(4). However, DOH has not established a need methodology by rule, policy or otherwise that it could apply to this data to quantify the number of trauma centers needed in each TSA. In the absence of an articulable need methodology, it is not possible to verify or replicate any assessment DOH may have done based on the data it claims to have reviewed. More significantly, the Department has itself acknowledged the problem of not having a methodology or process in place for conducting regular assessments. In its "2011-2015 Florida Trauma System Strategic Plan" (the "2011 State Plan"), DOH identified as a "threat" to the achievement of Goal 8 (Regional Trauma System Evaluation) the "[l]ack of effective evaluation criteria, tools and a systematic and periodic process to evaluate trauma service areas and apportionment of trauma centers." In furtherance of Goal 8, DOH also recognized the need to "[c]onduct a statewide comprehensive assessment of the Florida Trauma System access to care based on s. 395.402, F.S., the Western-Bazzoli criteria and other criteria to evaluate access to care and the effectiveness of the trauma service areas/regions." The specified timeline for this future assessment was "December 2011, with annual reviews thereafter as funding is available." On May 19, 2011, the Department's State Surgeon General signed an "Issue Paper" approving a "Florida Trauma System Special Study." This study is intended to "assist the department in developing a process and evidence-based guidelines to be utilized by [DOH] in determining the need for trauma center locations throughout the state." According to the Department's witness, Susan McDevitt (former Director of the Office of Trauma), DOH intends to use this study to develop a formula or methodology for determining the need for new trauma centers in the state. DOH determined this study was needed because the "trauma network has matured and changed" since 2005 when the "last comprehensive assessment of the Florida trauma system" was done. However, December 2011 is the earliest anticipated date for completion of this study, and DOH has no timeline for when this study may result in any rule amendment. As noted, the 1990 Report forms the basis for the configuration of the existing 19 TSA's as well as the need allocated to each of the TSA's within the Rule (with the exception of the reduction in Broward County). However, Dr. Lewis Flint, an expert in trauma surgery and trauma system assessment, credibly explained how Florida's trauma system has "matured and changed" since the 1990 Study was completed: Q. Now, Doctor, can you describe what changes there have been in the trauma system since the 1990 study was completed? A. Well, in 1990, there were fewer trauma centers than there currently are. I believe there were only about 12 designated centers in 1990. There are 22 now. The availability and the efficiency and quality of pre-hospital care has changed in a major way since 1990. We have far more advanced life support staff on ambulances than we had in 1990. We have far more plentiful air evacuation capability than we had in 1990, and the quality and efficiency of the existing trauma centers has changed in a major way as the centers have matured. So that the combination of greatly improved pre-hospital care and significant improvements in efficiency and in-patient outcomes in the existing trauma centers has meant that this system has matured into a very effective trauma system. It is not free of shortcomings, it is not an entire system yet. It has some holes in it, but the system as such has changed in a major way since 1990, such that it was our view at the close of the 2005 comprehensive assessment, that a decision about deployment of trauma centers that was based solely on distance and geography was not going to be an optimum method of determining how the system should be deployed. Whether or not the 1990 Report was valid when issued, its recommended service area configurations and need allocations have been rendered obsolete by the passage of time, changes in patient flow patterns, and significant advances in the trauma care delivery system since the Rule was adopted. Reasonable health planning requires the use of the most recent data available and systematic evaluation of the multiplicity of factors that determine the appropriate number and location of trauma centers in the state. No doubt that is why the Legislature directed DOH to conduct assessments annually. § 395.402(4). Here, the 1990 Report's recommendations were predicated on 1988 information that is now more than two decades old.10/ It is inappropriate to rely on 1988 data to justify the service area configuration or need allocation in 2011, particularly given the major changes and maturation of the trauma system since 1988. The 1990 Report (and rule) also fails to take into account criteria that must now be considered pursuant to the 2004 amendment to section 395.402. In particular, section 395.402(3) as amended, requires the DOH annual need and service area reviews to take into account Regional Domestic Security Task Force recommendations, transportation capabilities (including air transport), and inventories of available trauma care resources (including professional medical staff). The 1990 Report took none of these factors into account in making the need recommendations that were eventually incorporated into the Rule. Notably, had the availability of professional medical staff been factored into the analysis, need would likely have been reduced, as the 1990 Report itself observed, stating: It was the full committee's feeling that the number of hospitals able to apply to be state-sponsored trauma centers would be limited by the lack of resources in the service area. For instance, the standards require that trauma centers have certain physician specialists committed to the facility for availability 24 hours a day, seven days a week. There are not enough specialists available in any area of the state to staff more than a few trauma centers. The reality of the situation lead the full committee to believe that there cannot be a proliferation of trauma centers. (Emphasis added). Standing Petitioners TGH and SJH are located in TSA 10 (Hillsborough County). Petitioner Bayfront is located in Pinellas County in TSA 9 (Pinellas and Pasco Counties). Intervenor Bayonet Point is also located in TSA 9, but in Pasco County. Intervenor Blake is located in Manatee County, in TSA 13 (Manatee, Sarasota, and DeSoto Counties), adjacent to TSA 9. Petitioner Shands is located in TSA 5 (Baker, Clay, Duval, Nassau, and St. Johns Counties). Trauma center applicant Orange Park (a non-party) is located in TSA 5 but in a different county (Clay) from Petitioner Shands (Duval). As noted earlier, because of the intensity of resources that must be devoted to a trauma center, hospitals generally lose money in their operation. Specifically, in FY 2010 Tampa General's Level I trauma center had a $15.7 million net loss, while Bayfront's Level II trauma center had a $3 million net loss. Similarly, Shands lost approximately $2.7 million and SJH lost $8.3 million from the operation of their trauma centers in FY 2010. Of the 42 trauma center positions available statewide, the Rule allocates three to TSA 9 and three to TSA 13. Because TSA 9 currently has one designated trauma center (Bayfront) while TSA 13 has none, the Rule establishes a net need for two more trauma centers in TSA 9 and three more trauma centers in TSA 13. The Intervenors' pending trauma center applications propose to establish Level II trauma centers at Regional Medical Center Bayonet Point in Pasco County, (TSA 9), and at Blake Medical Center in Manatee County (TSA 13). The filing of the Intervenors' applications triggered the application review process set forth in section 395.4025(2). Pursuant to this statute, the deadline for submitting a trauma application is April 1 of each year. § 395.4025(2)(c). The filing of an application triggers a 30-day provisional review period (which in this case is delayed until October 1, 2011, due to an 18-month extension request made by Intervenors). The limited purpose of this provisional review is to determine if the hospital's application is complete "and that the hospital has the critical elements required for a trauma center." Id. The "critical element" portion of the review is based on the trauma center standards and includes a review of whether the hospital meets the equipment, facility, personnel and quality assurance standards. Id. Any hospital that (i) submitted an application found acceptable in the provisional review (i.e., meets the trauma center standards) and (ii) is located in a TSA that has a need for a trauma center may operate as a provisional trauma center after the 30-day provisional review period has concluded. §§ 395.4025(2)(d) and (5). Based upon the facts of record, there is a reasonable probability that the Intervenor hospitals will achieve provisional trauma center status by October 30, 2011, (the end of the 30-day provisional review period that will start October 1, 2011). First, Intervenors' witness James Hurst, M.D. (who is assisting Intervenors and Orange Park in recruiting trauma surgeons and in the application process) testified without contradiction that the HCA applications would be complete and in compliance with the applicable trauma center standards by the extended October 1st application submission deadline. Second, both Intervenor hospitals are located in trauma service areas with a need as established by the Rule. As confirmed by Ms. McDevitt, if the applications meet the programmatic requirements as determined by the provisional review, and there is a need indicated by the Rule, DOH will approve the applications and award the Intervenor hospitals in TSA 9 and 13 provisional trauma center status. Likewise, it is reasonable to expect that the Orange Park application will be approved if it meets the programmatic requirements, given the available slot in TSA 5. Upon receiving the provisional trauma center designation, the EMS providers will be required to treat Bayonet Point, Blake, and Orange Park as trauma centers. This means that the EMS providers will have to revise their protocols to redirect the transport of trauma alert patients from other existing trauma centers to the new centers. See, Fla. Admin. Code R. 64J-2.002(3)(g). A "trauma alert" patient is defined as a "person whose primary physical injury is a blunt, penetrating or burn injury, and who meets one or more of the adult trauma scorecard criteria . . . ." Fla. Admin. Code R. 64J-2.001(14). Pursuant to the DOH Trauma Transport Protocols Manual (which all EMS providers must follow), EMS providers must transport all trauma alert patients to the closest trauma center that is "within 30 minutes by ground or air transport or within 50 miles by air transport." As a result, any trauma alert patient who is closest to Bayonet Point, Blake, or Orange Park will have to be transported to one of those hospitals once they are designated as provisional trauma centers. A provisional trauma center at Bayonet Point would become the closest trauma center for Pasco, Hernando, and Citrus residents (the "northern Tampa Bay region"). Trauma alert patients from these counties would therefore have to be transported to Bayonet Point instead of to the existing trauma centers in Hillsborough (SJH and Tampa General) or Pinellas (Bayfront). Likewise, a provisional trauma center at Blake would become the closest trauma center to Manatee and Sarasota (the "southern Tampa Bay region") requiring transport of their trauma alert patients to Blake rather than to the Hillsborough or Pinellas trauma centers. In 2010, 669 trauma alert patients (16 and over) were transported to Bayfront from the counties in the northern and southern regions of Tampa Bay. This represents 42 percent of all the trauma alert patients (16 and over) transported to Bayfront. From the same area and during the same time period, 120 trauma alert patients (16 and over) were transported to Tampa General. All of these trauma alert patients would be redirected away from Bayfront and Tampa General and transported to the closer Intervenor trauma centers per the EMS transport protocols. The redirection of these trauma alert patients to Bayonet Point and Blake would substantially and adversely affect both Bayfront and Tampa General. In Bayfront’s case, the lost contribution margin caused by the annual diversion of even 400 trauma patients would reduce Bayfront's total margin by at least $2.3 million each year. Likewise, the yearly diversion of 120 trauma patients from Tampa General would result in an annual lost contribution margin and reduction in total margin in excess of $1 million. Notably, for both hospitals this represents the minimum potential loss of trauma patients and revenue as a result of the approval of the Intervenors' trauma centers. Annual losses in excess of a million dollars would be material to both Bayfront and Tampa General given the financial challenges both hospitals are already facing. Although physically located in TSA 10 (Hillsborough County) SJH now receives trauma patients from Hillsborough, Pasco, Citrus, Hernando, and Sumter counties. If approved, the trauma center at Bayonet Point would become the closest trauma center for Pasco, Hernando, and Citrus residents and would likely result in the immediate loss of between 149 and 307 from SJH's trauma program. If the Orange Park trauma center is approved, it is reasonable to expect that all of Shands trauma patients originating from Clay County would instead be redirected to Orange Park. This would represent a loss of approximately 1,000 patients annually, or 25 percent of Shands current trauma volume. With fewer cases to absorb the high fixed costs of trauma preparedness, Shands expects that it would lose $3,400 per case, on a fully allocated basis, rather than the $665/case it now loses. Thus, whereas Shands' trauma center currently loses $2.7 million annually, that loss would increase to approximately $10 million per year. And on a contribution margin basis (where fixed costs are excluded) Shands will experience a decline in contribution margin of $6-7 million annually once the Orange Park trauma center becomes operational. In addition to the direct loss of trauma patients and corresponding revenue, it is reasonable to anticipate that the approval of new trauma centers in relatively close proximity to existing centers will result in increased competition for scarce surgical subspecialists currently associated with the existing trauma programs. Specifically, the opening of new trauma centers in TSA's 5, 9, and 13 are likely to increase the difficulty and escalate the cost of ensuring adequate on-call specialty physician coverage for the Petitioner's hospitals and to adversely affect their ability to retain highly skilled nurses, technicians, and other trauma program staff.
The Issue Whether, when the patient J.B. presented to the Emergency Department of Munroe Regional Medical Center (MRMC) on May 22, 1995, he then had an "emergency medical condition," as defined by Section 395.002(8)(a) F.S. Whether, when the patient J.B. presented to the Emergency Department of Munroe Regional Medical Center (MRMC) on May 22, 1995, MRMC provided to the patient appropriate "emergency services and care," including an appropriate "medical screening, examination and evaluation," as defined by Section 395.002(9) F.S., and as required by Section 395.1041 F.S., and if not, how shall MRMC be disciplined?
Findings Of Fact At all times material, J.B. was a 42 year old male employee of an Ocala music store. In that capacity, he had been moving pianos for years. As a result, he had experienced neck, shoulder and back pain off and on for years. The pain and stiffness was worst upon awaking in the mornings and frequently required two days' bed rest before he could return to work. In the week preceding Monday, May 22, 1995, J.B.'s neck and shoulder pain had intensified. On Friday, May 19, 1995, J.B. went to a walk-in clinic, CARE-ONE, because his primary care physician was out of town. He was examined by a physician; x-rays were taken; he was issued a soft cervical collar; and he was prescribed a muscle relaxer and pain medication, both of which are "scheduled" drugs. The CARE-ONE physician also advised him to see a neurosurgeon for further evaluation and treatment. Despite his use of the prescribed drugs, J.B.'s pain intensified further over the weekend, to the point he was weeping and vomiting on occasion. He also had new pain in his left arm. At all times material, Respondent MRMC in Ocala, Florida, was licensed as a Class I general hospital with an emergency department. MRMC's emergency department handles upwards of 40,000 patient visits annually. At 8:15 a.m. on Monday, May 22, 1995, J.B.'s wife, L.B., took him to the MRMC emergency department. The term, "triage", generally refers to a means of sorting and prioritization of patients based on a superficial initial examination to determine how rapidly they will be seen in a mixture of patients who have differentiated complaints. Emergency department Board-certified physicians established MRMC's medical triage protocols in 1989. In so doing, MRMC has melded the concept of initial patient evaluation and "triage" into one process, and has authorized registered nurses, among other health care professionals, to perform both functions. MRMC's emergency department staff numbers 75 FTEs at all times, plus physician and physician assistant components. Physicians are available on the premises 24 hours a day for any consultation that may be required. At all times material, Geraldine Sweeney was an MRMC Clinical III Emergency Department Triage Nurse. As such, she maintains 24 hours of continuing education units per years (twice the number required to maintain her R.N. license). She also regularly participates in in-service training in emergency department nursing. These courses regularly include neurological topics and she has encountered and assessed numerous neurological cases over her 16 years in MRMC's emergency department, six of them as triage nurse since MRMC established its dedicated triage system in 1989. Ms. Sweeney has both an associate of arts and an associate of science degree in nursing; is a fully licensed Registered Nurse; and has never had any disciplinary action taken against her license. She was accepted as an expert in hospital emergency nursing. At formal hearing, J.B. did not remember being seen by any health care professional at MRMC on May 22, 1995. His wife, L.B., was attending to registration procedures with an MRMC admittance clerk in a different room and was not present when J.B. was assessed at MRMC's emergency department on that date, but she knew he was taken to a different room by a female hospital employee whom L.B. presumed to be a nurse. Geraldine Sweeney, R.N., did not recognize J.B. at formal hearing. She has "triaged" at least 1,000 patients since May 22, 1995. However, despite these three witnesses' lapses in memory or lack of opportunity to observe and/or lack of independent recollection, MRMC's documentation for May 22, 1995, in Ms. Sweeney's handwriting and bearing her signature, shows that Ms. Sweeney is the only MRMC health care professional who performed its initial, and only, assessment of J.B. at MRMC on May 22, 1995. Ms. Sweeney's contemporaneous documentation of her examination of J.B. shows he arrived at MRMC's emergency department at 8:15 a.m. and was "triaged" at 8:15 a.m. She wrote down that subjectively, he presented with a "history of neck problems with spasms; now has pain into left arm; seen at CARE-ONE Friday; had x-rays; given valium and lortab; advised for neurosurgeon." His objective vital signs were recorded by Ms. Sweeney as, "temperature 36.4 C., pulse 62, respiration 20, blood pressure 130/75." No weight was recorded. The only other significant objective triage data Ms. Sweeney recorded was, "Wearing soft collar; ambulates well; grips equal." Ms. Sweeney classified J.B. according to MRMC's physician-established protocols as "Class I, not requiring immediate attention," and he was released from the MRMC emergency department at 8:25 a.m., just ten minutes after his arrival. At that time, he was provided with a written list of other treatment locations to which he could go, including CARE-ONE again, and his personal physician. This list did not name any other hospital emergency department. Richard S. Slevinski, M.D., is Board-certified in emergency medicine and is director of the emergency department at Baptist Hospital in Pensacola, Florida, which includes a Level II Trauma Center. He was accepted as an expert in emergency and general medicine. Dr. Slevinski and Nurse Sweeney testified that a loss of function is a significant phenomenon that should have been recorded in a proper evaluation. Ms. Sweeney testified that if J.B. had identified loss of function as a symptom to her or if she had discovered a loss of function during her examination, she would have noted that and followed up with additional tests, but J.B. did not subjectively describe loss of function and she did not objectively observe any loss of function. Dr. Slevinski and Nurse Sweeney testified that a change in function or location of pain, increase in intensity of pain or recent onset of pain are subjective indicators that should be recorded if related by the patient during an examination and evaluation. Ms. Sweeney testified that she would have recorded any of these subjective symptoms if J.B. had related them to her, but he did not. Nurse Sweeney also testified that none of the objective vital signs she recorded during her examination of J.B. on May 22, 1995 indicated severe or intense pain. This was corroborated by neurosurgeon Dr. Barry Kaplan. (See Finding of Fact 32) I accept Dr. Slevinski's expert opinion that as a medical physician, he has found that if a service was provided in an emergency department it should be documented, and that it is the duty of the emergency department professional who performs patient screenings, examinations and evaluations to inquire adequately of a patient to find out what is going on with him or her and to make a chart so that later someone else can read the chart and see what the examiner did, and I reasonably infer from this expert testimony that, absent some strong evidence to the contrary, if a service has not been documented, the service has not been performed. This analysis, however, does not support a finding that J.B. actually told Nurse Sweeney on May 22, 1995 that his overall pain or his left arm pain was newly onset, that his pain had intensified, or that his pain was more localized in his left arm. J.B. has described his pain as chronic or recurring over a long period of time in testimony and when he saw Dr. Kaplan, a neurosurgeon, on June 1, 1995 (see Findings of Fact 27, 29), and J.B. can remember nothing about what he told Nurse Sweeney on May 22, 1995. Therefore, this is a situation in which Nurse Sweeney's testimony about what J.B. did not tell her is unrefuted, rather than the classic situation, described by Dr. Slevinski, in which a patient testifies as to what symptoms he told a health care professional and the chart shows the health care professional failed to record what the patient said. However, upon the evidence as a whole, it is found that no full neurological evaluation of J.B. was done by anyone at MRMC; that Nurse Sweeney did not individually feel each of his fingers to ascertain if he had sensation and similar temperature in each; and that she did not administer any muscle resistance tests. Rather, she had J.B. perform a "grip test". This "grip test" is performed by having the patient lift and cross his arms and reach out to the examiner. It tests whether the patient is able to maneuver both his own hands forward and grab onto the examiner's fingers with equal pressure, thereby indicating lack of loss of arm function. The test permits skin to skin contact so that any loss of sensation in the patient's hands or any change or inequality of skin temperature in the patient's hands or digits can be noted by the examiner. Upon her education, training, and experience, Nurse Sweeney thereby determined that J.B.'s grips were equal and his skin was a normal temperature, indicating no loss of function, sensation, or failure in circulation. Dr. Slevinski testified that, if J.B. had presented his CARE-ONE x- rays to her, Ms. Sweeney should have had the CARE-ONE x-rays read by a qualified physician, preferably a neurologist. Ms. Sweeney denied that J.B. brought his x-rays with him to MRMC, stating that if he had done so, she would have recorded that on the assessment form and would have had them read by a qualified physician instead of just recording, "had x-rays," which she had meant to show that J.B. had had x-rays taken the Friday before at CARE-ONE. J.B.'s testimony is clear on this single point to the effect that he had his wife take him to get the CARE-ONE x-rays and had them with him at MRMC. Marion Community Hospital documented that J.B. had the CARE-ONE x-rays with him at that facility at 9:23 a.m. (See Findings of Fact 24-25) This is corroborative of J.B.'s testimony on this issue. I therefore find that Ms. Sweeney overlooked those available CARE- ONE x-rays as part of her evaluation of J.B. Dr. Slevinski opined that MRMC, through Nurse Sweeney, did not provide an adequate medical screening examination for J.B.'s presenting complaint on May 22, 1995 because he was not given an appropriately sophisticated neurologic assessment or examination of the involved extremity (left arm) by a physician, preferably a neurologist; because the CARE-ONE x-rays J.B. brought with him were not reviewed by a qualified person; and because his pain was not stabilized. Specifically, Dr. Slevinski faulted Ms. Sweeney's use of a "grips" examination instead of an examination of J.B.'s status of sensation, strength of fingers, or reflex capabilities. He opined that Ms. Sweeney's examination, as documented, was insufficient to rule out that J.B. had a condition that was going to cause him further damage. It was Dr. Slevinski's opinion that "triage", as generally understood by the community of health care professionals, without more, cannot constitute an adequate or appropriate medical screening, examination, and evaluation. In Dr. Slevinski's view, severe pain alone qualifies as an emergent or emergency condition until an adequate examination proves that it is not. However, Dr. Slevinski conceded that pain is highly subjective and is only an "emergency medical condition" if the absence of immediate medical attention could reasonably be expected to result in serious jeopardy to the patient's health, serious impairment to his bodily functions or serious dysfunction to his bodily organs or parts. Upon further questioning, Dr. Slevinski opined that in general, a medical screening examination or evaluation need not always be done by a physician; that it can be done by a nurse or even a psychological case worker in the appropriate circumstances; and that in some, but not necessarily all patient presentations, there is no reason a triage nurse, within the scope of her license, if authorized to do so by the hospital, cannot perform a medical screening examination simultaneously with triage, although that is not his preference and although that was not appropriate in this case or in all cases. Dr. Slevinski commented also that a failure to correctly diagnose and treat after an appropriate screening, examination, or assessment might subject a hospital or individual health care provider to civil liability but would not violate Chapter 395 F.S. After J.B., still in pain, had been returned from the examining room, that is, only after Nurse Sweeney had already finished her evaluation of him and determined that he did not have an emergency medical condition requiring further emergency treatment and care, and while J.B. was standing beside L.B. facing the administrative clerk in the registration area of the MRMC emergency department, L.B. handed her insurance card to the clerk. The clerk then told L.B. that J.B. could not be treated at MRMC because he did not have either a referral from his primary treating physician or a life-threatening condition. An argument ensued, and L.B. demanded to know where else she could get treatment for J.B. She then drove J.B. directly to Marion Community Hospital's emergency department upon the suggestion of MRMC's admissions clerk. J.B. was clocked-in at 9:23 a.m. at the emergency department of Marion Community Hospital a/k/a "Columbia" or "HCA", where he was kept for about five hours. He was examined by an in-house neurologist who performed a limited "hands on" physical examination and a neurological examination. His vital signs were taken. He was injected intramuscularly with 30 milligrams of toradol, a "scheduled" pain killer. He was observed and re-evaluated after several hours. Additional x-rays were taken and reviewed by a radiologist who also reviewed the CARE-ONE x-rays J.B. had brought with him. J.B.'s valium and lortab prescriptions were refilled. He was released from Marion's emergency department with instructions to call and schedule an MRI and also to see his own physician and a neurosurgeon. The only medical "treatment" J.B. received at Marion was for pain. The final result after Marion's extensive and expensive screening examination and evaluation was the same as had occurred at MRMC: that he was released because he had no emergency medical condition requiring further emergency medical treatment in that facility at that time. Barry Kaplan, M.D., is the Board-certified neurosurgeon who eventually performed successful surgery on J.B. Dr. Kaplan first saw J.B. in his office on July 1, 1995. The length of this visit is not clear on the record. J.B.'s general description to him was that of chronic pain. Apparently J.B. had gone back to work for part of the time between May 22, 1995 and seeing Dr. Kaplan on June 1, 1995. On June 1, 1995, Dr. Kaplan did a complete neurologic examination, which included testing J.B.'s muscle actions against resistance. He also felt all of J.B.'s fingers, individually, while asking about sensation in each. These tests revealed only mild weakness or dysfunction in the bicep muscle of J.B.'s left arm and only mild numbness or dysfunction in his left arm. Dr. Kaplan also reviewed an MRI taken of J.B. on May 31, 1995 which demonstrated a chronic arthritic condition of J.B.'s neck, with bone spurs pressing the nerves running to his left arm and spinal cord, which resulted in J.B.'s pain. In Dr. Kaplan's opinion as an expert in neurosurgery and general medicine, J.B.'s condition on June 1, 1995, could not have developed measurably within the time elapsed since his visit to the MRMC emergency department on May 22, 1995 or even within the last month, because on June 1, 1995, J.B. had no acute symptoms of sufficient severity that he then had immediate need of treatment, nor was there any reasonable expectation that lack of treatment could be expected to result in serious jeopardy to his health, serious impairment to his bodily functions or serious dysfunction to his bodily organs or parts. On June 1, 1995, Dr. Kaplan believed that J.B.'s condition could be left alone for another four to six months before any permanent injury would occur to his spinal cord, but due to J.B.'s intense and chronic pain and relative youth, he recommended elective surgical removal of certain discs. Dr. Kaplan did the recommended elective surgery at J.B.'s request on July 12, 1995 at MRMC. J.B. has been pain-free since recovery. Dr. Kaplan's opinion also was that none of the objective vital signs recorded by Nurse Sweeney on May 22, 1995 would be consistent with severe pain. Although he was aware that Nurse Sweeney did not record giving a numbness test, weakness test, or reviewing x-rays on May 22, 1995, Dr. Kaplan also opined that, "Unless somebody has quadriparesis or complete dysfunction of a part from a cervical disc problem, then it is not an emergent condition . . . . Unless they have severe weakness or numbness to go along with the pain, there's no indication for emergency intervention." Dr. Kaplan's opinion also was that no serious jeopardy could have been incurred by J.B. not receiving further emergency services and treatment beyond MRMC's initial assessment on May 22, 1995. No health care witness set a minimum time necessary to conduct an appropriate examination. All indicated that the time involved and appropriate tests varied from case to case.
Recommendation Upon the foregoing findings of fact and conclusions of law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order dismissing the administrative complaint herein. RECOMMENDED this 17th day of December, 1996, at Tallahassee, Florida. ELLA JANE P. DAVIS Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 17th day of December, 1996. COPIES FURNISHED: Thomas W. Caufman, Esquire Agency for Health Care Administration 7827 North Dale Mabry Highway No. 100 Tampa, Florida 33614 Thomas D. Watry, Esquire 1500 Marquis Two Tower 285 Peachtree Center Avenue Northeast Atlanta, Georgia 30303 Douglas M. Cook, Director Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308-5403 Jerome W. Hoffman, Esquire Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308-5403
The Issue Whether the Proposed Rule 64J-2.010 enlarges, modifies or contravenes the specific provisions of law implemented, or is arbitrary or capricious, and thus constitutes an invalid exercise of delegated legislative authority.
Findings Of Fact The Parties Shands operates an 852-bed hospital and Level I trauma center in Gainesville, Alachua County, Florida. Its business address is 1600 Southwest Archer Road, Gainesville, Florida. Shands treats about 2,500 trauma patients each year. Shands is located within trauma service area (TSA) 4, which is comprised of Alachua, Bradford, Columbia, Dixie, Gilchrist, Hamilton, Lafayette, Levy, Putnam, Suwannee, and Union counties. St. Joseph’s is a regional tertiary hospital and has served the Tampa area for 75 years and has approximately 800 licensed acute care beds. St. Joseph offers a broad array of acute care services including tertiary health care, serves as a comprehensive regional stroke center, and has been repeatedly recognized as a Consumers Choice hospital. St. Joseph operates a Level II trauma center and a Level I pediatric trauma center. St. Joseph is located in TSA 10, consisting of a single county, Hillsborough. Tampa General is a major tertiary hospital that is designated by the state as a Level I trauma center. Tampa General also serves as a teaching hospital for the University of South Florida, College of Medicine ("USF"). Tampa General is located in Tampa, Hillsborough County, Florida, TSA 10. Bayfront is a 480-bed tertiary hospital located in Pinellas County, Florida. In addition to serving as a teaching hospital, Bayfront is designated as a Level II trauma center pursuant to chapter 395, Part II, Florida Statutes. It is located in TSA 9, composed of Pinellas and Pasco counties. The Public Health Trust of Miami-Dade County, is an entity which governs and operates the Jackson Health System, including the Ryder Trauma Center at Jackson Memorial Hospital. It is in TSA 19, consisting of Dade and Monroe counties. The Florida Department of Health is the state agency authorized to verify and regulate trauma centers in the state of Florida pursuant to chapter 395, Part II, Florida Statutes, and Florida Administrative Code Rule 64J-2.001 et seq. The Division of Emergency Medical Operations, Office of Trauma, oversees the Department's responsibilities with respect to the statewide trauma system. Osceola is a licensed acute care general hospital, located at 700 West Oak Street, Kissimmee, Florida. Osceola provides a wide array of high quality health services to the residents and visitors within its service area. It is located in TSA 8, consisting of Lake, Orange, Osceola, Seminole, and Sumter counties. The Florida Trauma System For purposes of organizing a statewide network of trauma services, the Florida Legislature directed the Department to undertake the implementation of a statewide inclusive trauma system as funding is available. § 395.40(3), Fla. Stat. The need for a trauma system is premised on the basic principle that a trauma victim who is timely transported and triaged to receive specialized trauma care will have a better clinical outcome. § 395.40(2), Fla. Stat. A trauma victim's injuries are evaluated and assigned an Injury Severity Score ("ISS"). § 395.4001(5), Fla. Stat. Patients with ISS scores of nine or greater are considered trauma patients. § 395.402(1), Fla. Stat. Trauma experts speak in terms of "a Golden Hour," a clinical rule of thumb that postulates no more than 60 minutes should elapse from the occurrence of an injury to the beginning of definitive treatment. There is, however, no current consensus on what constitutes the "Golden Hour" for transport times. A 1990 Department study recommended travel time of 25-35 minutes as the outside range for optimal outcomes. A 1999 Department study favored a goal of 30 minutes transport time by ground, and a 50-mile radius by helicopter. By contrast, a 2005 study conducted for the Department used 85 minutes "total evacuation time" as "acceptable." A trauma center is a hospital that has a collection of resources and personnel who are charged with taking care of trauma patients. They are recognized by the community as a resource for care of severely injured patients. The International Classification Injury Severity Score (“ICISS”) methodology, considered with discharged patient data from the Agency for Health Care Administration database, was used by DOH to determine severely injured patients. An ICISS score is the product of the survival risk ratios (i.e., the probabilities of survival) calculated for each traumatic injury a single patient suffers. Level I trauma centers are generally larger and busier and treat more patients than Level II centers. Level I trauma centers are required to engage in education and research. Trauma centers are required to have several types of physician specialists at the ready at all times. For instance, with respect to surgical services, a Level I trauma center must have a minimum of five qualified trauma surgeons, assigned to the trauma service, with at least two trauma surgeons available to provide primary (in-hospital) and backup trauma coverage 24 hours a day at the trauma center when summoned. Further, in addition to having at least one neurosurgeon to provide in-hospital trauma coverage 24 hours a day at the trauma center, a Level I provider must also have surgeons available to arrive promptly at the trauma center in 11 other specialties, including (but not limited to) hand surgery, oral/maxillofacial surgery, cardiac surgery, orthopedic surgery, otorhinolaryngologic surgery and plastic surgery. Level II trauma centers must comply with similar physician specialist standards. Little if any credible evidence was presented in the present case to suggest that the ability to hire qualified clinical staff, technicians, specialty physicians and other personnel would be severely impacted if the Proposed Rule is implemented. Rather, the existing trauma centers lamented the possibility of reduced case loads which could make it more difficult to retain proficiency. Invalidation of Former Rule 64J-2.010 In 1992, the Department of Health and Rehabilitative Services (HRS), the Department of Health's predecessor, promulgated Florida Administrative Code Rule 64J-2.010, titled "Apportionment of Trauma Centers within a Trauma Service Area," (hereinafter referred to as the “Former Rule”). The Department of Health assumed administration of the Former Rule in 1996, when the Legislature split HRS into two new agencies, the Department of Health and the Department of Children and Families. The Former Rule regulated the number of trauma centers that could be established in Florida. The Former Rule divided the state into TSAs as set forth in section 395.402(4), and for each TSA, announced the number of trauma center "positions" available. In 2004, the Florida Legislature amended section 395.402 to require the Department to complete an assessment of Florida's trauma system, and to provide a report to the Governor and Legislature no later than February 1, 2005 (the 2005 Assessment). The scope of the assessment was defined in paragraphs (2)(a) through (g) and subsection (3) of section 395.402. One objective of the assessment was to consider aligning trauma service areas within the trauma region boundaries as established in section 395.4015(1). It required the Department to establish trauma regions that cover all geographic areas of the state and have boundaries that are coterminous with the boundaries of the Regional Domestic Security Task Forces (“RDSTF”) established under section 943.0312. In a related 2004 amendment, the Legislature added a provision that gave the Department the option to use something other than the trauma service areas codified in section 395.402(4) upon completion of the 2005 Assessment. See § 395.402(2), Fla. Stat. ("Trauma service areas as defined in this section are to be utilized until the Department of Health completes" the 2005 Assessment.) § 395.402(4), Fla. Stat. ("Until the department completes the February 2005 assessment, the assignment of counties shall remain as established in this section."). As part of the 2004 amendments to the trauma statute, the Legislature also required the Department to conduct "subsequent annual reviews" of Florida's trauma system. In conducting such annual assessments, the Legislature required the Department to consider a non-exhaustive list of criteria set forth in section 395.402(3)(a)-(k). Further, the Legislature required the Department to annually thereafter review the assignment of Florida’s 67 counties to trauma service areas. The Department timely submitted its 2005 Assessment to the Legislature on February 1, 2005. With respect to its review of the trauma service areas, the 2005 Assessment recommended against the continued use of the 19 trauma service areas. The 2005 Assessment instead suggested that it may be feasible for the existing trauma service areas to be modified to fit the seven RDSTF regions to facilitate regional planning. Following receipt of the 2005 Assessment, the Department took no action to amend the Former Rule and adopt the recommendations of the 2005 Assessment. As a result, in June 2011, several existing trauma centers challenged the validity of the Former Rule pursuant to sections 120.56(1) and (3). See Bayfront Med. Ctr., Inc. et al. v. Dep't of Health, DOAH Case Nos. 11-2602RX, 11-2603RX, 11-2746RX, 11-2796RX (Fla. Div. Admin. Hear., Sept. 23, 2011). On September 23, 2011, an administrative law judge of the Division of Administrative Hearings entered a final order holding that the Former Rule was an invalid exercise of delegated legislative authority. The administrative law judge concluded that the Former Rule was invalid because it contravened the laws it purportedly implemented, including section 395.402. The judge found: The authority granted by section 395.402 for the use of the [nineteen] identified TSAs existed only until February 2005. After that time, the Department was required to consider the findings of the 2005 Assessment, as well as the recommendations made as part of the regional trauma system plan. Thus, section 395.402 can no longer service as a valid basis for the Rule. However, as set forth below, the authority to utilize the 19 TSAs was not rescinded; rather, the mandated requirement to use only the TSAs was rescinded. The Department was required to review the assignment of Florida’s 67 counties to trauma service areas, taking into consideration the factors set forth in paragraphs (2)(b)-(g) and subsection (3) of section 395.402. Having done so, it was incumbent on the Department to amend its [Former] Rule to allocate the number of trauma centers determined to be needed within each designated area through systematic evaluation and application of statutory criteria. On November 30, 2012, the First District Court of Appeal affirmed the administrative law judge's determination that the Former Rule was an invalid exercise of delegated legislative authority. See Dep't of Health v. Bayfront Med. Ctr., Inc., 134 So. 3d 1017 (Fla. 1st DCA 2012). After noting that the Former Rule claimed to implement sections 395.401, 395.4015, and 395.402, the appellate court held that the Former Rule was invalid because it failed to reflect the substantial amendments to those laws that were enacted in 2004. The appellate court held: Both the pre-and post-2004 versions of the statute require the Department to establish trauma regions that "cover all geographic areas of the state." However, the 2004 amendment requires that the trauma regions both "cover all geographical areas of the state and have boundaries that are coterminous with the boundaries of the regional domestic security task forces established under s. 943.0312." § 395.4015(1), Fla. Stat. (2004). Similarly, the rule fails to implement the 2004 amendments to section 395.402. The version of the statute in effect at the time the rule was promulgated set forth the nineteen trauma service areas reflected in the rule. [T]he 2004 version of the statute required the Department to complete an assessment of Florida's trauma system no later than February 1, 2005. It further provides that the original nineteen trauma service areas shall remain in effect until the completion of the 2005 Assessment. Bayfront, 134 So. 3d at 1019-20 (Emphasis added). It should be noted that the 2004 version of the statute does not specify at what point in time the 19 TSAs could no longer be utilized, only that they would have to be used at least until completion of the 2005 Assessment. Rule Development The Department thereafter initiated rule development workshops to commence construction of a new rule. The first workshop concerning this rule was in Tallahassee, Florida, on December 21, 2012. In January and February 2013, workshops were then held in Pensacola, Tampa, Ocala, Jacksonville, and Miami, as DOH continued working on a new rule. Each of the sessions involved input from interested persons both live and by telephone. Written comments and oral presentations by these persons were considered by the Department. After these first six workshops, held in various regions of the State to make them more accessible to more citizens, DOH then scheduled three more workshops in March 2013, to be held in areas where there were no existing trauma centers, specifically Ft. Walton Beach, Naples, and Sebring. DOH also considered the recommendations of a report issued by the American College of Surgeons (“ACS”), the lead professional group for trauma systems and trauma care in the United States. The ACS sent a consultation team to Tallahassee, Florida, to conduct a three-day site visit and hold public workshops in February 2013. The ACS ultimately issued a report entitled “Trauma System Consultation Report: State of Florida,” in May 2013. The report included as one of its recommendations the use of RDSTF regions as the TSA areas to be used in determining need for additional trauma centers. In November 2013, DOH released a draft proposed rule and a draft of its first TSA Assessment (the January TSA Assessment). The Department then conducted three additional workshops in Pensacola, Orlando, and Miami. Again, DOH solicited comments from interested persons and entered into a dialogue as to what the proposed rule should look like upon publication. On January 23, 2014, DOH conducted a Negotiated Rulemaking Committee meeting at the Department’s headquarters in Tallahassee, Florida. The committee consisted of seven persons: Karen Putnal, Esquire and Dr. Fred Moore--representing existing trauma centers; Steve Ecenia, Esquire and Dr. Darwin Ang-- representing new trauma centers currently under challenge; Dr. Patricia Byers--representative of the EMS Advisory Council; Jennifer Tschetter, Esquire and Dr. Ernest Block--representing DOH. The public was invited to attend the session but was not afforded an opportunity to speak. The Department considered all the input from each of the workshops, the ACS Report, and the negotiated session, as well as all the applicable items enumerated in section 395.402(3)(a)-(k). The Proposed Rule On February 3, 2014, the Department published Notice of Development of Proposed Rule 64J-2.010 (the "Proposed Rule") in Florida Administrative Register, Volume 40, Number 22. The Department's Notice cited section 395.405, as rulemaking authority for the Proposed Rule. The Notice also cited sections 395.401, 395.4015, 395.402, and 395.405 as the laws intended to be implemented by the Proposed Rule. The following day, February 4, 2014, the Department published a Notice of Correction in Florida Administrative Register, Volume 40, No. 23, to correct the history notes of the Proposed Rule. In the corrected Notice, the Department cited section 395.402 as its rulemaking authority in addition to section 395.405. The correction also removed reference to sections 395.401, 395.4015, and 395.405, as laws implemented by the Proposed Rule. Following the Department's correction, the Proposed Rule was intended only to implement section 395.402. The Proposed Rule established 19 TSAs and determined the number of trauma centers to be allocated within each TSA, based upon a scoring system established in the Proposed Rule. Under the scoring system, TSAs were awarded positive or negative points based on data in an annual Trauma Service Area Assessment relating to the following six criteria: (1) population; (2) median transport times; (3) community support; (4) severely injured patients not treated in trauma centers; (5) Level 1 trauma centers; and (6) number of severely injured patients (in each TSA). Ms. Tschetter added the last two criteria (Level I Trauma Centers and Number of Severely Injured Patients) in response to comments received at the negotiated rulemaking session. Subsequent to a final public hearing held on February 25, 2014, DOH revised its January TSA Assessment and the earlier version of the Proposed Rule. The revised TSA assessment (the “March TSA Assessment”) reflected more conservative calculations (as gleaned from input and discussions with stakeholders) and documents the statutory patient volumes for the existing Level I and Level II trauma centers in each TSA. The March TSA Assessment further recalculated the Median Transport times, including all transports from 0-10 minutes (as opposed to only those transports greater than 10 minutes) and only transports to trauma centers (as opposed to transports to all hospitals). On March 25, 2014, a Notice of Change was published in the Florida Administrative Register. The Proposed Rule, as published on that date, is as follows: Notice of Change/Withdrawal DEPARTMENT OF HEALTH Division of Emergency Medical Operations RULE NO.: RULE TITLE: 64J-2.010 Apportionment of Trauma Centers within a Trauma Service Area (TSA) NOTICE OF CHANGE Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 40, No. 22, February 3, 2014 issue of the Florida Administrative Register. 64J-2.010 Allocation of Trauma Centers Aamong the Trauma Service Areas (TSAs). Level I and Level II trauma centers shall be allocated among the trauma service areas (TSAs) based upon the following: The following criteria shall be used to determine a total score for each TSA. Points shall be determined based upon data in the Trauma Service Area Assessment. Population A total population of less than 0 to 600,000 receives 2 points. A total population of 600,001 to 1,200,000 receives 4 points. A total population of 1,200,001 to 1,800,000 1,700,000 receives 6 points. d. A total population of 1,800,000 1,700,001 to 2,400,000 2,300,000 receives 8 points. e. A total population greater than 2,400,000 2,300,000 receives 10 points. Median Transport Times Median transport time of less than 0 to 10 minutes receives 0 points. Median transport time of 101 to 20 minutes receives 1 point. Median transport time of 21 to 30 minutes receives 2 points. Median transport time of 31 to 40 minutes receives 3 points. Median transport time of greater than 41 minutes receives 4 points. Community Support Letters of support for an additional trauma center from 250 to 50 percent of the city and county commissions located within the TSA receive 1 point. Letters of support must be received by the Department on or before April 1 annually. Letters of support for an additional trauma center from more than 50 percent of the city or county commissions located within the TSA receive 2 points. Letters of support must be received by the Department on or before April 1 annually. Severely Iinjured Patients Discharged from Acute Care Hospitals Not Treated In Trauma Centers Discharge of 0 to 200 patients with an International Classification Injury Severity Score (“ICISS”) score of less than 0.85 (“severely injured patients”) from hospitals other than trauma centers receives 0 points. Discharge of 201 to 400 severely injured patients from hospitals other than trauma centers receives 1 point. Discharge of 401 to 600 severely injured patients from hospitals other than trauma centers receives 2 points. Discharge of 601 to 800 severely injured patients from hospitals other than trauma centers receives 3 points. Discharge of more than 800 severely injured patients from hospitals other than trauma centers receives 4 points. Level I Trauma Centers The existence of a verified Level I trauma center receives one negative point. The existence of two verified Level I trauma centers receives two negative points. The existence of three verified Level I trauma centers receives three negative points. Number of Severely Injured Patients If the annual number of severely injured patients exceeds the statutory trauma center patient volumes identified in Section 395.402(1), F.S., by more than 500 patients, the TSA receives 2 points. If the annual number of severely injured patients exceeds the statutory trauma center patient volumes identified in Section 395.402(1), F.S., by 0 to 500 patients, the TSA receives 1 point. If the annual number of severely injured patients is less than the statutory trauma center patient volumes identified in Section 395.402(1), F.S., by 0 to 500 patients, the TSA receives one negative point. If the annual number of severely injured patients is less than the statutory trauma center patient volumes identified in Section 395.402(1), F.S., by more than 500 patients, the TSA receives two negative points. The following scoring system shall be used to allocate trauma centers within the TSAs: TSAs with a score of 5 points or less shall be allocated 1 trauma center. TSAs with a score of 6 to 10 points shall be allocated 2 trauma centers. TSAs with a score of 11 to 15 points shall be allocated 3 trauma centers. TSAs with a score of more than 15 points shall be allocated 4 trauma centers. An assessment and scoring shall be conducted by the Department annually on or before August 30th, beginning August 30, 2015. The number of trauma centers allocated for each TSA based upon the Amended Trauma Service Area Assessment, dated March 24, 2014 January 31, 2014, which can be found at www.FLHealth.gov/licensing- and-regulation/trauma-system/_documents/trauma-area-service- assessment.pdf, is as follows: TSA Counties Trauma Centers 1 Escambia, Okaloosa, Santa Rosa, Walton 1 2 Bay, Gulf, Holmes, Washington 1 3 Calhoun, Franklin, Gadsden, Jackson, Jefferson, Leon, Liberty, Madison, Taylor, Wakulla 1 4 Alachua, Bradford, Columbia, Dixie, Gilchrist, Hamilton, Lafayette, Levy, Putnam, Suwannee, Union 1 5 Baker, Clay, Duval, Nassau, St. Johns 12 6 Citrus, Hernando, Marion 2 7 Flagler, Volusia 1 8 Lake, Orange, Osceola, Seminole, Sumter 3 9 Pasco, Pinellas 23 10 Hillsborough 1 11 Hardee, Highlands, Polk 1 12 Brevard, Indian River 1 13 DeSoto, Manatee, Sarasota 2 14 Martin, Okeechobee, St. Lucie 1 15 Charlotte, Glades, Hendry, Lee 12 16 Palm Beach 1 17 Collier 1 18 Broward 2 19 Dade, Monroe 3 Rulemaking Authority 395.402, 395.405 FS. Law Implemented 395.402 FS. History–New 12-10-92, Formerly 10D-66.1075, Amended 6-9-05, 12-18- 06,Formerly 64E-2.022, Amended . DOH did not incorporate the March TSA Assessment by reference in the rule. After exchanges of communications with the Joint Administrative Procedures Committee (“JAPC”), wherein DOH sought guidance concerning this matter, there was no directive by JAPC that such adoption by reference would be required. DOH revised the population criterion in the Proposed Rule to have even breaks in intervals of 600,000 people. The February proposed rule awarded 6 points in TSAs with a population of 1,200,001 to 1,700,000 people (i.e., a 500,000 person interval), where all other measures were based upon a 600,000 person interval. This discrepancy is corrected in the newly Proposed Rule. DOH revised the community support criterion in the Proposed Rule to no longer award a point to TSAs where 0-50% of the city and county commissions send letters of support, because this could have reflected the need for a trauma center (by awarding points to the TSA) when no letters of support were received. The Proposed Rule now awards a point to TSAs where 25-50% of the county commissions send letters of support. DOH chose twenty-five percent as the minimum necessary community support because the smallest number of city and county commissions in all of the TSAs is four, which ensures everyone has a voice. DOH revised the title of the fourth criterion from “severely injured patients not treated in trauma centers” to “severely injured patients discharged from acute care hospitals,” which more accurately depicts the function of the criterion. DOH revised the sixth criterion to include citations to the statutory minimum volumes for Level I and Level II trauma centers in response to a request by the staff attorney for the Joint Administrative Procedures Committee. DOH also revised the rule to reference the March TSA Assessment in place of the January TSA Assessment. Finally, DOH revised the Proposed Rule’s allocation table based on the revisions to the rule and assessment. The Proposed Rule as amended allocates a total of 27 trauma centers throughout Florida’s 19 TSAs. Each TSA is still allocated at least one trauma center. The Proposed Rule allocates only Level I and Level II trauma centers, not pediatric trauma centers. The rulemaking directive in section 395.402(4) is interpreted by DOH to be limited to the allocation of Level I and Level II trauma centers. In addition, the allocation of stand-alone pediatric centers would not be feasible because pediatric trauma patients make up such a small percentage of the population and all of the Level I and II trauma centers have the ability to become pediatric trauma centers. Currently, all of the existing Level I trauma centers provide pediatric care and there are only two stand-alone pediatric centers in Florida. The Proposed Rule’s allocation of 27 trauma centers is conservative. There are currently 27 verified trauma centers in the state, including two verified trauma centers under administrative challenge. There are several elements of the Proposed Rule which Petitioners have raised as evidence of the Department’s failure to comply with its rulemaking authority. Petitioners maintain that DOH failed to consider all of the items enumerated in section 395.402(3)(a)-(k). Each of those criteria is addressed below. (a) The recommendations made as part of the regional trauma system plans submitted by regional trauma agencies-- There is only one regional trauma agency in Florida. DOH reviewed the regional agency’s plan, but it was devoid of any recommendations related to trauma center allocation within the TSAs. The regional agency did not amend its plan or submit any separate recommendations throughout the year-long, public rulemaking process. (b) Stakeholder recommendations--Petitioners complain that DOH did not do enough to solicit input from everyone who would be affected by the Proposed Rule. The Department, however, obtained stakeholder testimony from 171 individuals and written comments from 166 stakeholders through the course of the 12 rule development workshops conducted around the state. The workshops were held in several cities to allow for geographic access by more residents. Over 400 people attended the workshops. The January TSA Assessment was also modified prior to its publication as a result of the stakeholder discussions at the workshops and the negotiated rulemaking session. The March TSA Assessment was further amended after its publication as a result of testimony at the public hearing for the Proposed Rule. (c) The geographical composition of an area to ensure rapid access to trauma care by patients--While Florida contains no mountains, its geography is unique to other states in that it contains several inlets, bays, jetties, and swamplands. As such, the DOH data unit examined the coastal areas versus non- coastal areas. The unit also analyzed urban versus rural areas. The unit also looked at the communities surrounding Lake Okeechobee. Ultimately, the analysis was not meaningful because the effect geography has on access to trauma centers is captured by Florida’s transport time records for emergency vehicles and helicopters. Thus, by reviewing the Emergency Medical Services Tracking and Reporting System (“EMSTARS”) database, DOH could know the actual effects of Florida’s geography on access to trauma centers. (d) Historical patterns of patient referral and transfer--This item was considered, but the January TSA Assessment does not address it because it was neither measurable nor meaningful. The data was not measurable because of limitations of data quality in the Trauma Registry. Even if the data were measureable it would not have been meaningful because it would have only illustrated the catchment areas--i.e., the geographic distribution of patients served by existing trauma centers. As recommended by the ACS, DOH’s primary focus is on the trauma system as a whole, not individual trauma centers. Moreover, transfer and referral history is not meaningful to an assessment designed to inform an allocation rule because, again, DOH does not have the authority to define where new trauma centers are developed within a TSA. See § 402.395(4)(b), Fla. Stat. (charging DOH with allocating by rule the number of trauma centers in each TSA, not trauma center location within a trauma service area). (e) Inventories of available trauma care resources, including professional medical staff--Petitioners suggest that DOH should have made a determination of existing professional medical staff, but suggest no viable means of doing so. The January TSA Assessment catalogues several trauma care resources within TSAs, including financing, trauma centers, acute care hospitals, and EMS response capabilities. The January TSA Assessment does not catalogue available professional medical staff. DOH is unaware of any database that compiles this information. DOH sent a survey to the existing trauma centers requesting information as to their resources and professional staff, however it was not useful due to the limited responses and potential for bias. The data unit also reviewed the DOH Division of Medical Quality Assurance health professional licensure database (COMPASS), however, it was not helpful because physician specialty reporting is voluntary. Similarly, the data unit reviewed AHCA’s inventory of licensed acute care hospitals and the DOH annual physician workforce survey results, but neither data source provided trauma-specific information. As such, the information was not complete and so was not included in the January TSA Assessment. (f) Population growth characteristics--In response to this criterion, the DOH data unit analyzed the potential for growth in all of the TSAs, but the January TSA Assessment did not include this analysis because it was not meaningful given DOH’s requirement to conduct the assessment annually. The January TSA Assessment does however document the population in each TSA. DOH decided that in light of the continuing change of population in Florida, the best it could do would be to make a finding as to the population in each TSA and use it--year by year--to look at the potential need for additional (or presumably fewer) trauma centers in an area. Obviously the population of an area is not directly commensurate with the number of severely injured patients that might be found. Not all areas have equal percentages of severely injured patients; urban areas would have higher percentages than rural areas, in general. Areas through which a major interstate highway runs would expect a higher percentage. There are a number of factors that could potentially affect an area’s expectation of trauma services. Inasmuch as they could not all possibly be included in an analysis, DOH defaulted to a more general view, i.e., the total population. The total population figure became the first measurement in the Proposed Rule. (g) Transportation capabilities; and (h) Medically appropriate ground and air travel times--DOH considered these two factors together and determined to cover them by way of a determination of median transport time, which was to become the second measurement in the Proposed Rule. The data unit gathered transport capability data by reviewing the COMPASS licensure database and archived paper applications to discern the number of licensed emergency medical stations, helicopters, and vehicles in each TSA. The data unit further calculated the number of ground vehicles per the population in each TSA and every 100 square miles. The January TSA Assessment included this information because it was meaningful and gathered from a reliable database. DOH considered the testimony from a number of trauma surgeons during the 12 workshops regarding transport times and learned that the medically appropriate transport time depends on the nature of injuries and individual patients, which are not always discernable at the scene of an accident. Because of this, the sooner a patient can be transported to a trauma center, the better it is for patient outcomes. In light of the patient-specific realities of establishing a medically appropriate transport time, the data team used EMSTARS to calculate the median emergency transport times in each TSA for the assessment. Granted the EMSTARS is a fairly new system under development, and it reports all 911 calls voluntarily reported (not just trauma patients), so it is not a completely accurate measure. But it is a reasonable approach based upon what is available. Also, the transport times do not reflect whether pre-hospital resources are sufficient for the patient or how far away the closest trauma center may be. It is not an absolutely perfect measurement, but it is reasonable and based on logic. (i) Recommendations of the Regional Domestic Security Task Force--Like Florida’s lone regional trauma agency, the RDSTF did not offer any input throughout the year-long, public rulemaking process. However, DOH considered the testimony of numerous emergency management and law enforcement officials during the rule development process. For example, Chief Loren Mock, the Clay County fire chief and also a member of the Domestic Security Oversight Council, testified at the Jacksonville workshop. There is no evidence DOH directly contacted a RDSTF representative to solicit input. (j) The actual number of trauma victims currently being served by each trauma center--The March TSA Assessment included the annual trauma patient volume reported to the Trauma Registry by the existing trauma centers. When comparing the average patient volume reported to trauma registry from 2010- 2012 to the data unit’s calculation of the average number of severely injured patients treated in trauma centers during this same time span, the volumes reported by the trauma centers were approximately 333% greater. This large disparity prompted DOH to follow the example of many other states and use population as a proxy for the number of potential trauma patients in each TSA in its Proposed Rule. DOH found that: greater population means a greater need for health care; population is a good indicator of need for medical services; population is a reasonable proxy for patient volume; and, more people in a given area results in more trauma cases in a given area. (k) Other appropriate criteria: It was well documented in literature presented to DOH during the rulemaking process that there were a large percentage of severely injured patients in Florida not being seen by trauma centers. The data unit confirmed this by evaluating the AHCA administrative database, which identifies the injuries suffered by patients as well as the type of hospitals discharging those patients, i.e., comparing the total number of severely injured patients with the number of severely injured patients discharged from acute care hospitals in each TSA. This disparity was worrisome to DOH and therefore included in the March TSA Assessment. As pointed out by Petitioners, the Department’s figures include patients who may have received treatment outside the TSA in which the injury occurred. The figures may not have contained patients who needed trauma care but could not access it for other reasons. The Proposed Rule, however, makes as complete an evaluation of the potential patient base for trauma centers as is possible. Notwithstanding complaints about how the Department addressed some of the criteria set forth in the statute, it is clear that all criteria were considered and implemented into the Proposed Rule to the extent feasible and possible. The most credible testimony at final hearing supports the Department’s process. Criticisms of the various elements within the Proposed Rule expressed by Petitioners at final hearing seemed to be based on the concept that the Proposed Rule may allow competition to existing trauma centers rather than real complaints about the elements themselves. All agree, for example, that population, transportation times, number of patients, and the existence of nearby trauma centers are important factors that should be considered. Petitioners just seemed to want those factors expressed in different (though unspecified) terms. Petitioners did enunciate certain shortcomings they felt made the Proposed Rule less than complete. St. Joseph lamented the absence of all the Department’s analysis and background for each of the proposed measurements contained in the Proposed Rule. Jackson Memorial pointed out that pediatric trauma centers were not specifically included in the Proposed Rule. Shands showed that odd or unusual results could arise from implementation of the Proposed Rule. For example, the March TSA Assessment showed a total of 216 severely injured patients in TSA 6, comprised of Marion, Citrus, and Hernando counties. The Proposed Rule called for two trauma centers in that TSA. Although the number of patients necessary to maintain a trauma center’s proficiency was disputed by various experts in the field, it is clear that 108 patients per center would be extremely low. However, the figure appearing in the March Assessment is not absolute or necessarily completely definitive of need. There are other factors concerning population and patients that may affect that figure. The Six Measurement Criteria in the Proposed Rule Petitioners also took exception to the measurement criteria in the Proposed Rule. Each of those six criterion is discussed below. Population The Proposed Rule awards from two to ten points to a TSA, depending on the TSA total population. Two points are awarded for a population of less than 600,000 and ten points are awarded for a popu1ation greater than 2.4 million. The Department used total population as a "proxy" for the actual number of trauma patients in the state rather than using the actual number of trauma victims in the state. The Proposed Rule does not define “population” or “Total Population,” nor are those terms defined in the trauma statute, but those words are subject to their normal definition. The Proposed Rule does not re-state the source of the summary Total Population data; it is already contained in the TSA Assessment. Neither the Proposed Rule nor the March TSA Assessment contains any data or analysis reflecting population by age cohort, population density, or incidence of trauma injury in relation to these factors, and the Department did not specifically conduct any analysis of the significance of any aspect of population data as it relates to the need for new trauma centers, other than determining the total population growth rate in the TSAs. Rather, DOH decided upon total population as the most reliable measure available. Traumatic injury rates and the severity of traumatic injury vary widely based on a number of factors, including whether the area is urban or rural, the population age cohort, and the infrastructure and physical characteristics or features of the geographic area. Thus, the most reasonable way to measure possible need was to look at the total population of an area and extrapolate from that basis. The Department presented no specific data or analysis to support the incremental cutoff points for the Total Population scale contained in the Proposed Rule. Rather, the Department took population as a whole because it was the most readily available, annually updateable, and understandable factor it could access. The use of population as a proxy is not without problems, however. In TSA 19, for instance, the population has increased by about thirty-eight percent in recent decades, but the number of trauma victims has declined by approximately twelve percent. As stated, the Proposed Rule as written is not inerrant. Median Transport Times The Proposed Rule awards from zero to four points to a TSA, depending on the Median Transport Time within a TSA. “Median Transport Time” is not defined in the Proposed Rule, nor is the methodology for determining the summary “Median Transport Time” statistics set forth in the TSA Assessment and relied on in the Proposed Rule. Information concerning transport times is, however, contained within the TSA Assessment. The Median Transport Time used in the Proposed Rule represents the average transport time for all 911 transports voluntarily reported to the state EMSTARS database. EMSTARS is a database that is under development and that collects information voluntarily provided by emergency medical transport providers throughout the state. Although not all EMS providers currently report to EMSTARS (most notably, Miami-Dade County EMS does not participate), the database is useful for research and quality improvement initiatives. The Median Transport Time set forth in the March TSA Assessment and used in the Proposed Rule includes transport time for all patients, regardless of the nature of the emergency, whether the call involved trauma, other types of injury, or illness, and regardless of whether the transport was conducted with the regular flow of traffic or required “lights and siren.” The Median Transport Time used in the Proposed Rule includes all EMS transports of up to two hours in duration. The Median Transport Time excludes transports of patients to trauma centers operating pursuant to the initial stage of trauma center licensure known as “provisional approval.” The Department addressed “medically appropriate air or ground transport times,” as required by section 395.402(3)(h), by its generally accepted conclusion that "faster is better." Not all injured patients, however, benefit from receiving care at a trauma center. Thus, while an existing trauma center is an appropriate destination for all patients with any level of injury who live in the area of a trauma center, the trauma center’s value beyond its immediate area is as a resource for the most severely injured patients whose problems exceed the capabilities of their nearest hospital. The Department did not undertake any analysis to balance its "faster is better" approach to trauma planning against the reality that the resources necessary to provide high quality trauma care are limited, as is the number of severely injured patients. There is a general (but not universal) consensus among trauma experts that access to a trauma center within 30-50 minutes is an appropriate benchmark for access to trauma care. Other than "faster is better," the Department did not determine a medically appropriate travel time for any type of trauma or any geographic area, but recognizes the general consensus as appropriate. The Proposed Rule awards from one to four points that weigh in favor of approval of a new trauma center within a TSA if the Median Transport Time of patients transported in response to any 911 call is between 10 and 42 minutes, i.e., within but faster than the generally accepted consensus. Community Support The Proposed Rule awards from one to two points to each TSA depending on the number of letters of support written by elected city or county commissioners. The Proposed Rule allows for consideration of stakeholder recommendations by way of allowing letters of support from local governments. “Stakeholders” in the state trauma system include existing trauma centers, as well as all acute care hospitals, and pre- and post-hospital care providers, including emergency transport services, air ambulances, and emergency management planning agencies. The Department could find no better way to acknowledge support from those stakeholders, and citizens in general, than to have their elected representatives listen to their constituents and then reflect those people’s desires and comments. Severely Injured Patients Discharged from Acute Care Hospitals The Proposed Rule awards from zero to four points to a TSA, depending on the number of severely injured patients discharged from acute care hospitals (non-trauma centers). The Proposed Rule addresses the number of severely injured patients, i.e., those with an ICISS score of < 0.85, discharged from hospitals other than trauma centers. The Proposed Rule does not specifically define “severely injured patient,” but it is obvious from the context in which that term is used. The summary data in the TSA Assessment labeled "number of severely injured patients” within each TSA is intended to reflect the number of severely injured patients who “didn’t get to trauma care.” The Department's numbers may include patients who received treatment at a trauma center outside of the TSA in which the injury occurred. The Department did not conduct any analysis of the "number of severely injured patients not treated at a trauma center" to determine whether the patients not treated at a trauma center received timely and appropriate care at a non-trauma center hospital with the capability to treat the patient's injuries. The number of “severely injured patients who did not get to trauma care” as reported by the Department is unlikely to reflect the actual number of patients who required care at a trauma center but did not have access, and suggests that this number is far higher than it actually is. The Department, for example (and in response to discussion with stakeholders), excluded from its analysis all patients with isolated hip fractures as well as all patients who were released from the hospital within 24 hours, which resulted in fewer severely injured patients. Neither the Proposed Rule nor the TSA Assessment considers demographics or outcomes for "severely injured patients" treated at general acute care hospitals or outcome data for these patients. The Proposed Rule does not include any method for projecting the actual demand for trauma services in the future; it is used to determine need at a single point in time (and will be done so annually). The Proposed Rule does not include any criteria or method for evaluating whether there are any capacity problems at existing trauma centers, or other barriers that impede access to trauma care. The Department intended this criterion to show a highly conservative estimate of patients who definitely need trauma care. Level I Trauma Centers With respect to “Level I Trauma Centers,” the Proposed Rule awards from negative one to negative three points to a TSA, depending on whether the TSA already has one, two, or three verified Level I trauma center(s), respectively. The Proposed Rule creates the opportunity for establishment of both additional Level I and also additional Level II trauma centers, pursuant to the allocation of need, but the Proposed Rule does not assign or subtract points for the existence of Level II trauma centers. This criterion reflects the recommendations of stakeholders at the rule workshops. It was the consensus of many stakeholders that Level I trauma centers should be protected in order to safeguard the research and teaching missions of those centers. The earlier proposal of a “halo” around existing centers, i.e., not approving a new trauma center within a certain radius of existing centers, was not incorporated into the Proposed Rule. This criterion, however, offers some protection for existing centers. Number of Severely Injured Patients The Proposed Rule awards negative two to two points based on the "number of severely injured patients" in a TSA. The criterion awards points based on the number of Severely Injured Patients which exceed the target trauma center patient volumes as provided in section 395.402(1). If the annual number of Severely Injured Patients exceeds the statutory volumes by more than 500 patients, the TSA will receive two points; if it exceeds it by less than 500 the TSA receives one point; if the number of Severely Injured Patients is less than the statutory volumes by zero to 500 patients, the TSA receives one negative point; if it is less than the volumes by more than 500 patients, the TSA receives two negative points. The Proposed Rule does not include any criterion addressing the actual number of trauma victims currently being served by each trauma center. Instead, Section 6 of the Proposed Rule substitutes the "minimum statutory capacity" of existing trauma centers for the actual capacity of existing trauma centers. The Department could not find “a meaningful” way to measure actual capacity of existing trauma centers. The most accurate way to measure capacity was a contentious topic at rule workshops, and the Department spent a good deal of time working with stakeholders on how to measure capacity in such a way that it could be included as a factor in the Proposed Rule. One suggestion as to how to measure trauma center capacity is by how often existing trauma centers actually divert trauma patients to other facilities. However, trauma centers rarely admit that they are not able to take any more patients, and this is not a realistic method to evaluate capacity. The capacity of an existing trauma center may be measured by various means, including the number of beds at the trauma center, the number of ICU beds, the number of trauma bays, number of operating rooms, as well as the frequency of and reasons for diversion. The trauma center’s clinical staff, including medical and surgical specialists, and supporting clinical personnel, are also indicators of capacity. The Department already routinely collects data reflecting trauma center capacity as part of the quarterly and annual reports that all existing trauma centers are required to submit, and by way of on-site licensure surveys. None of those means, however, provided DOH with sufficiently reliable information and data. The Proposed Rule comports with the DOH Mission to protect, promote, and improve the health of all Floridians through integrated state, county, and community efforts. While by no means perfect, the Proposed Rule is based upon logic and reason derived from an extensive analysis of all relevant factors. History of the Rule The rationale for DOH’s inclusion of those particular six criteria in the Proposed Rule can be better understood by considering some more history of the trauma rule. As stated earlier herein, in 2004 the Legislature made substantial revisions to the trauma statute and ordered the Department to complete an assessment of Florida’s trauma system. The scope of this assessment was defined in paragraphs (2)(a) through (g) and subsection (3) of section 395.402. An appropriation of $300,000 was authorized for the Department to contract with a state university to perform the actions required under the amended statute. Ch. 2004-259, § 10, Laws of Florida. One proposal of the 2005 Assessment was to "[c]onsider aligning trauma service areas within [sic] the trauma region boundaries as established in" section 395.4015(1). § 395.402(2)(a), Fla. Stat. In a related 2004 amendment, the Legislature ended the statutory mandate to use the service areas created in 1990. The obvious conclusion from the above statutory change is that the section 395.402(4) service areas could be replaced by the service areas DOH established or adopted once it had the results of the 2005 Assessment. Unlike the prior statute, there is no mandate for specific new service areas, only the option not to use the prior service areas. The 2005 Assessment included five "Recommendations": Trauma centers should be placed in Tallahassee and in Bay County, which do not currently have a trauma center . . . . It is reasonable to set, as a system goal, that 65 percent of trauma center patients will be treated at a trauma center. . . . Designation of additional trauma centers should be based on the need as determined by trauma region. Deployment of additional trauma centers should take place based, not only on the number of patients served per trauma center, but according to the concept of “trauma center capacity” which should be determined by the staffing levels of medical specialists and other healthcare professionals. . . . The data support the feasibility of transforming the Florida Trauma Services Areas so that these would coincide with the Domestic Security Task Force Regions. . . . It is reasonable to fund trauma centers with public funds, based on the unrecoverable financial burden incurred by trauma centers. The only legislative response to the 2005 Assessment was an increase in funding to trauma centers. The Legislature did not repeal the statute establishing the current 19 TSAs. Likewise, the Department has not amended the Rule to implement the recommendations contained in the 2005 Assessment until the present Proposed Rule. The Department, instead, reviewed existing statutes, interpreted section 395.4015 to mandate the establishment of a trauma system plan (which plan would include trauma regions that have boundaries coterminous with those of the regional domestic security task force boundaries). The development of the trauma system plan is distinct from the determination of need for new trauma systems addressed by the Proposed Rule.
The Issue The issue for determination in this proceeding is whether Respondent is entitled to a refund of $285,648.26 paid for Medicaid services that Petitioner provided during the respective hospitalizations of four psychiatric patients.
Findings Of Fact Petitioner operates two hospitals in the name of Florida Hospital. Each hospital is separately located. Both hospitals participate in the Florida Medicaid program in accordance with Chapter 409, Florida Statutes, 1/ and Florida Administrative Code Rule 59G. 2/ Respondent is the state agency responsible for administering the Florida Medicaid program. In order for the state to receive federal funds, federal statutes and regulations mandate that Respondent control the utilization of services subject to Medicaid payments. 3/ Respondent contracts with a professional review organization to control the utilization of psychiatric services subject to Medicaid payments. 4/ Keystone Peer Review Organization ("KEPRO") retrospectively reviews admissions and lengths of stay for psychiatric patients to determine whether alternative sources of payment exist and whether Medicaid services are medically necessary. Respondent claims that alternative sources of payment existed for two of the four Medicaid recipients at issue in this proceeding. Respondent also claims that the inpatient services Petitioner provided to all four recipients were medically unnecessary. 5/ Alternative Sources Of Payment 5. Medicaid is the payor of last resort. 6/ Irrespective of whether the services provided by Petitioner were medically necessary, Respondent is entitled to a refund if other sources of payment existed for those services. Alternative sources of payment are primary and prior to Medicaid payments ("alternative source(s) of payment"). Medically Necessary Respondent claims that the inpatient services Petitioner provided to all four recipients were medically unnecessary. The terms "medically necessary" or "medical necessity" are not defined by applicable state and federal law. 7/ Medical necessity is determined by applying a two-prong test to the facts and circumstances surrounding each case. 8/ The first prong requires inpatient services during admission and treatment of Medicaid recipients to be consistent with appropriate medical care. 9/ The second prong of the test requires alternative placements to be considered in prescribing inpatient services. 10/ First Prong: Appropriate Medical Care Services that alleviate a harmful medical condition are consistent with appropriate medical care. Services alleviate a harmful medical condition if they are reasonably calculated to prevent, diagnose, correct, cure, alleviate, or prevent the worsening of conditions in the recipient that endanger life, cause suffering or pain, result in illness or infirmity, threaten to cause or aggravate a handicap, or cause physical deformity or malfunction. 11/ Services are consistent with appropriate medical care if they are provided to protect the patient's life, prevent significant illness or disability, or to alleviate severe pain. Services must be consistent with individualized treatment. They must be specific and consistent with symptoms or a confirmed diagnosis of the illness or injury under treatment. 12/ Services are consistent with appropriate medical care if they do not exceed the patient's individual needs. Services may not be primarily intended for the convenience of the recipient or the provider. 13/ KEPRO considers the intensity of service, the severity of illness, and discharge screens in determining medical necessity ("ISD criteria"). 14/ ISD criteria are subdivided into approximately 14 subgroups. ISD criteria represent a list of signs and symptoms and diagnostic and therapeutic services. They are general guidelines for determining the medical necessity of inpatient services. ISD criteria are not dispositive of medical necessity. ISD criteria are not binding on the treating physician. 15/ The treating physician can override ISD criteria based on his or her clinical judgment concerning a particular Medicaid recipient. 16/ The clinical judgment to override ISD criteria must be consistent with appropriate medical care. 17/ The four Medicaid recipients did not improve significantly within the time prescribed by ISD criteria. A patient that fails to make significant improvement in a timely manner does not satisfy ISD criteria for continued inpatient services. 2.1(a) Matters Not At Issue Respondent does not challenge the admission of the four Medicaid recipients. 18/ Their admission to Florida Hospital satisfied applicable ISD criteria and was consistent with appropriate medical care. Respondent does not claim that inpatient services provided before the date each Medicaid recipient failed to satisfy ISD criteria for continued inpatient services were medically unnecessary ("initial treatment"). Initial treatment satisfied applicable ISD criteria and was consistent with appropriate medical care. 2.1(b) Matters At Issue Respondent acknowledges that inpatient services provided after initial treatment of the four Medicaid recipients were consistent with appropriate medical care. 19/ When asked if Respondent challenged the level of services, the quality of care, or the appropriateness of care, Respondent stated: Oh, absolutely [not]. We're not saying that the care was either substandard or . . . rank overutilization . . . . We're not saying there was substandard care or [that] they . . . [tried] . . . to . . . game the system. We certainly don't believe that. Transcript at 172-173. 20/ Respondent claims that inpatient services were medically unnecessary after initial treatment because the recipients no longer satisfied ISD criteria for continued inpatient services. Second Prong: Alternative Placement The second prong of the medical necessity test provides that inpatient services are medically unnecessary if, consistent with appropriate medical care, they could have been effectively furnished more economically either on an outpatient basis or in an inpatient facility of a different type. 21/ Thus, discharge to outpatient care or to an inpatient facility of a different type ("alternative") must be made in a manner that is consistent with appropriate medical care. 22/ In addition, an alternative must be available and suitable for the needs of the individual patient. 23/ An alternative placement exists if several conjunctive requirements are satisfied. An alternative placement exists if inpatient services could have been: effectively furnished; more economically; in an available and suitable alternative; in a manner that is suitable for the needs of the individual patient and consistent with appropriate medical care ("alternative placement"). 24/ The parties agree on two requirements of the alternative placement test. Inpatient services provided by Petitioner could have been provided more economically in an alternative setting. The parties also agree that relevant alternatives were facilities of a different type than Florida Hospital. The parties contest the remaining requirements of the alternative placement test. The contested issues are whether, prior to the respective dates of discharge, the inpatient services provided by Petitioner could have been: effectively furnished; in an available and suitable alternative; in a manner that was suitable for the needs of the individual patient; and in a manner consistent with appropriate medical care. 2.2(a) Matters Not At Issue An alternative placement did not exist when Petitioner admitted the four Medicaid recipients to Florida Hospital. Respondent does not challenge Petitioner's admission of the four recipients. Petitioner used appropriate procedures and due diligence to determine if an alternative placement existed for each of the four Medicaid recipients. 25/ Respondent does not challenge the procedures and diligence used to determine whether an alternative placement existed. 26/ An alternative placement did not exist for the four Medicaid recipients during their initial treatment. Respondent does not challenge the inpatient services provided by Petitioner while the recipients satisfied ISD criteria. 27/ 2.2(b) Matters At Issue As a threshold matter, Respondent asserts that it is not required to consider an alternative placement in determining medical necessity. Respondent argues that it can determine medical necessity solely by applying ISD criteria. Even if Respondent is required to consider an alternative placement, Respondent claims that it is not required to consider the availability or suitability of an alternative. If Respondent is required to consider availability and suitability, Respondent claims that a suitable alternative was available for all four Medicaid recipients on the respective dates that the recipients no longer satisfied ISD criteria. 28/ 2.2(c) A Difficult And Litigious Task The medical determination of the existence of an alternative placement is a difficult task and a risky one for physicians and hospitals in today's litigious society. 29/ It may be suitable for the patient's needs and consistent with appropriate medical care to discharge the patient to an alternative facility. However, an alternative may be unavailable when a patient no longer satisfies ISD criteria. Unavailability of suitable alternatives may be caused by a variety of factors. There may be a shortage of existing facilities. Existing facilities with available space may lack funding to accept new residents. Existing facilities may have the necessary funding but lack available space. Outpatient case loads may be so great that the delay between discharge and the delivery of outpatient services may effectively deny any timely and meaningful availability of outpatient care. In such cases, it may not be suitable for the patient's needs or consistent with appropriate medical care to discharge the patient without an available alternative. When a patient no longer satisfies ISD criteria, alternatives may be available, but available alternatives may not be suitable for the patient's individual needs. The services furnished by an available alternative may not be suitable for the needs of the patient. Conversely, an available alternative may offer suitable services but may not be capable of furnishing those services effectively. It may not be consistent with appropriate medical care to discharge the patient to an available alternative that is either unsuitable or ineffective; or to discharge the patient without an alternative. Even if an alternative is available, suitable, and effective, the condition of the patient may need to improve or stabilize before discharge to an alternative is suitable for the individual needs of the patient and consistent with appropriate medical care. Earlier discharge of such a patient may be inconsistent with appropriate medical care. A provider must determine whether to continue to furnish services during the interim required until the patient can be discharged to an alternative placement or can be discharged with no alternative placement ("interim services"). Interim services are medically necessary if prior discharge of a patient would either violate ISD criteria or be inconsistent with appropriate medical care. 30/ The Four Medicaid Recipients The identity of the patients for which Respondent seeks a refund, the dates of their hospitalization, the contested dates, and the amount of contested payments are set forth in the following table. Patient Dates Of Hosp. Contested Dates Contested Amount J.H. 08/24/92-10/29/92 09/25/92-10/29/92 $ 24,953.96 N.S. 10/18/89-06/14/91 11/18/89-06/14/91 $232,831.16 A.B. 10/04/91-11/04/91 10/12/91-11/04/91 $ 15,808.36 B.W. 05/10/91-06/10/91 05/23/91-06/10/91 $ 12,054.78 TOTAL $285,648.26 Respondent claims that it is entitled to a refund of $257,785.12 because alternative sources of payment existed for the inpatient services provided to J.H. and N.S. after their initial treatment. Respondent does not allege that alternative sources of payment existed for J.H. and N.S. upon admission or during their initial treatment. Respondent does not claim that alternative sources of treatment existed for A.B. and B.W. at any time during their hospitalization. Respondent claims that it is entitled to a refund of $285,648.26 because the inpatient services Petitioner provided to all four recipients was medically unnecessary after their initial treatment. After their initial treatment, none of the four recipients satisfied ISD criteria for continued inpatient services. If Respondent is required to consider alternative placements in determining medical necessity, Respondent alleges that inpatient services Petitioner provided to J.H. and N.S. after their initial treatment could have been furnished more economically in an inpatient facility of a different type. Respondent asserts that inpatient services Petitioner provided to A.B. and B.W. after their initial treatment could have been furnished more economically on an outpatient basis. J.H. J.H. was admitted to Florida Hospital's acute care unit on August 24, 1992. On October 29, 1992, Petitioner transferred J.H. to Daniel Memorial Residential Treatment Center in Jacksonville, Florida. Respondent does not seek a refund of Medicaid payments from August 24, 1992, through September 24, 1992. Respondent seeks a refund of payments made from September 25 through October 29, 1992. Alternative Source Of Payment No alternative source of payment existed for the inpatient services Petitioner provided to J.H. J.H. was involuntarily committed to the hospital on August 31, 1992, pursuant to the Baker Act. 31/ Respondent does not allege that the Baker act provided an alternative source of payment prior to September 25, 1992. 32/ Respondent failed to show why the Baker Act did not provide an alternative source of payment prior to September 25, 1992, but did provide an alternative source of payment on September 25, 1992, and thereafter. 33/ Medical Necessity Once J.H. was admitted to Florida Hospital on August 24, 1992, he did not make significant improvement after 30 days. He did not meet ISD criteria for continued inpatient services. 4.2(a) Appropriate Medical Care ISD criteria were correctly overridden by the treating physician for J.H. Inpatient services Petitioner provided to J.H. after his initial treatment were consistent with appropriate medical care. Although J.H. did not make significant improvement within the time prescribed by ISD criteria, he did make significant improvement during his stay at Florida Hospital. He was successfully treated and timely discharged in a manner that was suitable for his individual needs and consistent with appropriate medical care. 4.2(a)(1) Mental Impairment J.H. was 15 years old when he was admitted to Florida Hospital on August 24, 1992. He had chronic schizophrenia, with borderline intellectual capabilities ("mental retardation"), and a well-documented explosive disorder. 4.2(a)(2) Emotional Impairment J.H. had attention deficit disorder ("ADD"). He could not process information. He had difficulty sitting still and focusing. J.H. had previously been treated in a residential placement setting. He set fires and abused animals. J.H. attempted to choke a dog and had to be restrained. He broke windows and committed acts of mischief. J.H. picked up other children by their neck and ears. He jumped up and down on their toes and punched them in the face. He struck staff and used razor blades to attack authority figures. 4.2(a)(3) Medication The combination of ADD, mental retardation, and schizophrenia made appropriate medical care for J.H. difficult and slow. Medicines used to control the ADD often make schizophrenia more fluid. J.H. had been treated successfully with medications in the past. However, J.H. was noncompliant with medication. More time than that prescribed by ISD criteria was medically necessary to discover the combination of medicines that would be effective for J.H. in this instance. When the right combination was determined, additional time was needed to stabilize the multiple medications. 4.2(b) Alternative Placement Petitioner correctly considered alternative placements in prescribing inpatient services for J.H. after his initial treatment. Petitioner identified an available alternative for J.H. on August 28, 1992. However, no alternative placement existed for J.H. prior to the date he was stabilized and discharged by Petitioner. Discharge before J.H. was stabilized would have been neither suitable for the needs of the individual patient nor consistent with appropriate medical care. Before J.H. was stabilized, he was a danger to himself and others. J.H. was a danger to himself and others when he resided in an alternative facility prior to his admission to Florida Hospital. The services that were medically necessary to stabilize J.H. could only be provided in an acute care facility like Florida Hospital. They could not have been furnished effectively in an alternative facility. Florida Hospital provided J.H. with 24 hour supervision, nursing staff, physicians, and support personnel trained in psychology and psychiatry. N.S. N.S. was admitted through Florida Hospital's emergency room on October 18, 1989, when she was 14 years old. She was discharged on June 14, 1991, to a long term residential treatment facility. Respondent does not seek a refund of Medicaid payments from October 18, 1989, through November 17, 1989. Respondent seeks a refund of payments made from November 18, 1989, through June 14, 1991. Alternative Source Of Payment Respondent alleges that an alternative source of payment existed in a settlement agreement to which neither Petitioner nor Respondent were parties. The settlement agreement resolved a federal law suit filed by the mother of N.S. against the Department of Health and Rehabilitative Services ("HRS") and the Orange County School Board (the "school board"), Case No. 90- 134-CIV-ORL-18. The settlement agreement was executed on November 30, 1990, between the mother of N.S., HRS, the school board, and BRV, Inc., ("BRV"). BRV is a Florida non-profit corporation named after its three directors: Usher L. Brown, Esquire, counsel for N.S.; Wynelle Roberson; and Gregory Valcante. BRV was formed to create an alternative placement that is suitable for N.S.'s individual needs. BRV operates a long term residential facility that effectively furnishes services to N.S. in a manner that is suitable for her needs and consistent with appropriate medical care. The BRV program is designed and supervised by Dr. Ralph Maurer, an expert in the disorders suffered by N.S. Dr. Maurer designs and supervises the protocols, strategies, and approaches utilized in the BRV program. The BRV program provides N.S. with residential and educational components. The program also provides N.S. with components in behavior management and medical care and treatment. HRS paid $60,000 for the residential component and support staff required in the BRV program. The school board paid $100,000 to BRV for the education component. None of the settlement proceeds are allocated to the type of services provided by Petitioner during N.S.'s hospitalization, including behavior management and medical care and treatment. Petitioner did not receive any funds from the settlement agreement. Petitioner is not a party to the settlement agreement. The settlement agreement does not address payment of the Medicaid services provided by Petitioner. The settlement agreement is not an alternative source of payment for the Medicaid services provided by Petitioner. If Respondent is entitled to a refund as a result of the settlement agreement, Respondent must seek its refund from the settlement proceeds. 34/ Applicable law mandates that Respondent, "shall seek recovery of reimbursement from third-party benefits." 335/ Even if Respondent were entitled to a refund from Petitioner as a result of the settlement agreement, the amount of refund would be limited to the portion of the settlement proceeds actually received by Petitioner. 36/ The maximum amount of refund to which Respondent would be entitled is $160,000; not the $232,831.16 sought by Respondent. Medical Necessity Once N.S. was admitted to Florida Hospital on October 18, 1989, she did not make significant improvement after 30 days. She did not meet ISD criteria for continued inpatient services. 5.2(a) Appropriate Medical Care ISD criteria were correctly overridden by the treating physician for N.S. Inpatient services Petitioner provided to N.S. after her initial treatment were consistent with appropriate medical care. Although N.S. did not make significant improvement within the time prescribed by ISD criteria, she did make significant improvement during her stay at Florida Hospital. She was successfully treated and timely discharged in a manner that was suitable for her individual needs and consistent with appropriate medical care. 5.2(a)(1) Mental Impairment N.S. is mentally retarded. She was born missing the right and left temporal lobes of her brain. As a result of her brain damage, N.S. suffers rapid mood changes and can not process certain higher orders of function. 5.2(a)(2) Emotional Impairment N.S. also suffers from agenesis. Agenesis is a brain development problem in which N.S. can not control emotional circuits in her brain. N.S. suffers from animalistic and aggressive patterns of behavior. Her symptoms include stalking, leaping, biting, screaming, spitting, and smashing. 5.2(a)(3) Learning Impairment N.S. has significantly impaired memory. Her memory consists of short term memory from day to day. N.S. has difficulty learning. She can not process certain higher orders of functions. It is difficult for her to pay attention. She has a significant language disorder. The memory disorder dates from birth. N.S. has no period of normal learning to use as a point of reference. N.S. learns differently from others. She does not respond to praise or punishment and does not understand discipline. N.S. does not learn from consequences. She can not store the information necessary to learn from consequences. N.S. reacts to undesired behavior with aggression. As a simplistic example, if one gives N.S. candy, the donor is a nice person. If one withholds candy, that person is not nice. Adverse treatment from others will lead to aggression from N.S. The learning strategies used to teach N.S. are similar to those used to tame a frightened animal. They are comparable to those used to train dolphins at Seaworld. Prior to her admission to Florida Hospital, N.S. was treated at the Children's Mental Health Unit, Shands Teaching Hospital, University of Florida ("Shands"). She was treated by Dr. Maurer, who later set up the program at BRV. 5.2(a)(4) Post Traumatic Stress Disorder N.S. was admitted to Florida Hospital as a result of an incident at the school where HRS placed N.S. at the time. N.S. had been aggressive toward her teacher. Two large males held N.S.'s head between her legs for 45 minutes to teach her not to be aggressive. The inappropriate attempt to discipline N.S. caused post traumatic stress disorder. The disorder required over a year and a half to control. In this type of post traumatic stress disorder, normal antipredator behavior is intensified in a manner similar to that an animal might experience in the presence of predators. Because N.S. is a frail individual, this one incident was sufficient to require hospitalization in the acute care unit at Florida Hospital. N.S. went berserk. At the time of admission, N.S. was grossly psychotic. Her paranoia was global. She was totally out of control with aggressive and violent behavior. She bit a security guard, and had to be restrained. N.S. grunted and did not speak. She neither fed nor dressed herself. She leaped off of chairs, bit others and herself, and did not socialize. She had no sustained attention. Doctors at Shands correctly determined that N.S. needed an acute care facility because N.S. was acutely psychotic and uncontrollable. The objective was to control her, settle her down, and transition her out to a long term residential program. N.S. was treatable. She was appropriately not "warehoused" in an alternative facility that was not suitable for her needs. 5.2(a)(5) Significant Improvement At the time of her discharge on June 14, 1991, N.S. showed dramatic improvement for the severity of impairment that she suffered. She was alert and cooperative. She had learned some language and communication skills. N.S. dressed herself and ate appropriately. Her affect and mood were stable. She did not attack others and was able to socialize. N.S.'s global paranoia was reduced. She was able to go out from seclusion with one-to-one adult supervision. However, the potential to hurt herself and others persists. She requires close adult supervision. 5.2(a)(6) Medication N.S. was a very complex and difficult patient to treat. Her developmental disabilities and severe psychiatric disorders were difficult by themselves. The incident at school superimposed a post traumatic disorder over her existing disabilities and disorders. More time than that prescribed by ISD criteria was medically necessary to discover the combination of medicines that would be effective for N.S. When the right combination was determined, additional time was needed to stabilize the multiple medications. There is no specific medication for the treatment of post traumatic stress disorder. Medicines used for all disorders may be tried on an empirical basis and juggled until the right medication, or combination of medications, is found. N.S. is very fragile. The margin of error for her medication is very small. N.S. was treated with a variety of medications. She had reactions to some medications, and they had to be changed. She did not respond well to others, and they had to be changed. The treating physician conducted an elaborate search for an effective combination of medications. The medications were titrated slowly. A total of nine combinations were tried. Unlike antibiotics that work in 24 to 36 hours, medications for psychiatric disorders and major depression may require two to six weeks before their effectiveness can be determined. During the time that her treating physician was attempting to stabilize N.S.'s medications, N.S. needed the medical care provided by doctors and nurses in a hospital setting. N.S. could not have been discharged to a less restrictive setting due to her level of acuity. Medications for N.S. were not stabilized until April 16, 1991. It was consistent with appropriate medical care to keep N.S. in Florida Hospital until June 14, 1991; approximately two months after her medications were stabilized. 5.2(a)(7) Violence And Seclusion Violent behavior was another reason why it took so much time to stabilize N.S. N.S. was violent throughout much of her treatment. N.S. had to be repeatedly secluded. The seclusion was medically necessary. However, the intervals of seclusion slowed her improvement. 5.2(a)(8) Behavior Modification And Learning Disabilities Even without intervals of seclusion, behavior modification would have been slow because N.S. suffered from memory disorder. She could not store the information necessary to make ordinary means of discipline and learning effective. 5.2(b) Alternative Placement Petitioner correctly considered alternative placements in prescribing inpatient services for N.S. after her initial treatment. No alternative placement existed for N.S. prior to June 14, 1991. The acute care admission and treatment of N.S. at Florida Hospital for approximately 605 days was suitable for the needs of N.S. and consistent with appropriate medical care. Earlier discharge would have been neither suitable for the needs of the individual patient nor consistent with appropriate medical care. Before N.S. was stabilized, she was a danger to herself and others. It would have been unsuitable for the individual needs of N.S. and inconsistent with appropriate medical care to discharge N.S. while she was a danger to herself and others. N.S. was a danger to herself and others when HRS placed her in an alternative facility prior to her admission to Florida Hospital. 5.2(b)(1) Suitable Services Effectively Furnished The services that were medically necessary to stabilize N.S. could only be provided in an acute care facility like Florida Hospital. Florida Hospital provided N.S. with 24 hour supervision, nursing staff, physicians, and support personnel trained in psychology and psychiatry. The inpatient services Petitioner provided could not have been furnished effectively in an alternative facility prior to June 14, 1991. Multiple medications could only be administered in an acute care facility. Nursing staff monitored N.S. for side effects at 15 minute intervals, 24 hours a day. They monitored the effectiveness of multiple medications and the toxicity of those medications. Psychiatric acute care nurses are best equipped to work with patients who are very sick. The doctors and nurses at Florida Hospital know how to handle disturbed, depressive, and psychotic people. N.S. was one of those people for most of her inpatient treatment. N.S. was isolated and safe in Florida Hospital. She became familiar with staff and settled down. Florida Hospital was close enough that N.S.'s mother could visit her regularly. Visitation from her mother was an integral part of the medical treatment and behavior modification that was suitable for N.S. Petitioner effectively treated N.S.'s disorders. Doctors and nurses at the hospital changed N.S.'s behavioral pattern, stabilized her behavior, and taught N.S. the social skills needed for her to function in a residential treatment facility like BRV. 5.2(b)(2) Available And Suitable Alternatives An alternative facility, if it had been available, was not suitable for the needs of N.S. prior to her discharge. Until N.S. was stabilized, she was the type of patient who could not function in a residential setting. N.S. could not use even a word or two. She could not communicate in any intelligible manner. She could not dress or feed herself. Petitioner considered every reasonable alternative in prescribing treatment for N.S. Petitioner reviewed every reasonable alternative in the state and elsewhere, including Texas. One factor that complicated an alternative placement was the need for staff at an alternative facility to be able to consult with doctors at Florida Hospital. As the distance between the two increased, the ability to consult decreased. It was medically necessary for N.S.'s mother to provide support. The ability to provide such support decreased as distance increased. Residential treatment facilities and group homes would not accept N.S. due to her degree of disorganization. Those types of facilities were unable to guarantee N.S.'s safety. Many facilities used treatment plans that were unsuitable for N.S.'s condition. The Montanari and Au Clair Palms programs, for example, were punitive and relied on consequences. Punishment and consequences are ineffective and unsuitable for N.S. Petitioner attempted to place N.S. in the Brown School in Texas. However, that facility refused to accept N.S. N.S. could not be placed in a residential program until her medication was stabilized. None of the residential programs had an acute care psychiatric unit where multiple medications could be administered and monitored until N.S. was stabilized. Petitioner could not return N.S. to Shands. The patients there are younger and severely handicapped. Shands does not have an adolescent unit. Petitioner could not place N.S. in Northeast Florida Mental Health Hospital ("Northeast"). It would not have been consistent with appropriate medical care for Petitioner to make such a placement. Northeast did not have long term acute care for chronically ill children. N.S. did not meet Northeast's criteria. Northeast refused to accept N.S. Petitioner attempted to involuntarily admit N.S. at Medico pursuant to the Baker Act. However, Medico refused to accept N.S. Treating physicians created a facility and program that was suitable for N.S.'s needs and consistent with appropriate medical care. BRV effectively furnishes services in a program that includes a high level of supervision, structure, and behavioral management. N.S. has done well since being placed in BRV. She is functioning well in school. A.B. A.B. was admitted to Florida Hospital on October 4, 1991, and discharged on November 4, 1991. Respondent claims a refund of Medicaid payments for A.B.'s hospitalization from October 12, through November 4, 1991. Alternative Sources Of Payment No alternative sources of payment existed for the inpatient services Petitioner provided to A.B. after her initial treatment. Respondent does not claim that any alternative sources of payment existed for A.B. Medical Necessity After A.B. was admitted to Florida Hospital on October 4, 1991, she did not make significant improvement after eight days. She did not meet ISD criteria for continued inpatient services. 6.2(a) Appropriate Medical Care ISD criteria were correctly overridden by the treating physician for A.B. Inpatient services Petitioner provided to A.B. after her initial treatment were consistent with appropriate medical care. Although A.B. did not make significant improvement within the time prescribed by ISD criteria, she did make significant improvement during her stay at Florida Hospital. She was successfully treated and timely discharged in a manner that was suitable for her individual needs and consistent with appropriate medical care. 6.2(a)(1) Mental Impairment A.B. suffered from multiple medical problems. She had cerebral palsy and was wheel chair bound. She had arthritis. A.B. had a brain injury and suffered seizure disorders. Her arms, hands, and legs were drawn into distorted positions. She was unable to take care of herself. A.B. had a progressive depressive disorder. At the time of admission, A.B. suffered from major depression. She had a history of attempted suicides. 6.2(a)(2) Substance Abuse And Suicide A.B. had a long history of alcohol and drug abuse, including cocaine and crack cocaine. A.B. abused alcohol while on Antabuse. Antabuse is a medicine that makes the patient sick if the patient ingests alcohol. If a patient ingests alcohol in sizeable quantities, Antabuse may cause a severe reaction that can be fatal. A.B. consumed excessive amounts of alcohol while on Antabuse in the hope that she would kill herself. 6.2(a)(3) Medication More time than that prescribed by ISD criteria was medically necessary to discover the combination of medicines that would be effective for A.B. When the right combination was determined, additional time was needed to stabilize the multiple medications. It took approximately 30 days for A.B.'s treating physician to stabilize her with medications. Four to six weeks are usually required before the effectiveness of psychiatric medications can be determined. The patient requires time to adjust to the level of dosage needed to treat the particular impairment. After the appropriate dosage of medication is administered, additional time is needed to determine whether the drug is effective. Eight to ten days are needed for the medication to reach a steady blood level in the patient. Until that time, the medication is not at a therapeutic level. Once the medication has reached a therapeutic level, it takes another 8 to 10 days to determine if the patient is at an appropriate dosage and is responding. Psychiatric medications require longer to work when the level of impairment is high. The level of impairment in A.B. was high because she had to be detoxified. The time needed for the medications to work was greater because they created side affects for A.B.'s brain and other conditions. For example, antidepressant medication increases the risk of seizure. This is particularly true when a patient suffers from cerebral palsy and substance abuse. Side affects had to be monitored to make sure that the medication was not at a toxic level. 6.2(b) Alternative Placement Petitioner correctly considered alternative placements in prescribing inpatient services for A.B. after her initial treatment. No alternative placement existed for A.B. until she was stabilized. Prior to that time, A.B. was a danger to herself. It would have been inconsistent with appropriate medical care for Petitioner to discharge A.B. when she was a danger to herself. 6.2(b)(1) Effective And Appropriate Medical Care Earlier outpatient services would not have been suitable for the needs of A.B. An outpatient clinic could not effectively furnish the services A.B. needed prior to the date of her discharge. A.B. could not be discharged before she was ambulatory and functional. The treating physician prescribed physical therapy. At the time of discharge, A.B. was ambulatory and able to take care of her essential needs. She was timely discharged for outpatient care at the mental health clinic. 6.2(b)(2) No Available And Suitable Alternative It takes approximately six to eight weeks to obtain an appointment as an outpatient at the local mental health clinic. A.B. has no social support network. The risk of suicide is high if patients such as A.B, who have little or no support network, are discharged as soon as they say they are no longer suicidal. A.B. needed to be kept in the hospital until she was in remission from her depression and until she developed some insight into self-medication. B.W. B.W. was admitted to Florida Hospital on May 10, 1991. She was discharged on June 10, 1991. Respondent claims a refund of Medicaid payments for B.W.'s hospitalization from May 23, through June 10, 1991. Alternative Source Of Payment No alternative source of payment existed to pay the medical services Petitioner provided to B.W. Respondent does not assert that any alternative sources of payment were available. Medical Necessity After B.W. was admitted to Florida Hospital on May 10, 1991, she did not make significant improvement after 13 days. She did not meet ISD criteria for continued inpatient services. 7.2(a) Appropriate Medical Care ISD criteria were correctly overridden by the treating physician. Inpatient services Petitioner provided to B.W. after her initial treatment were consistent with appropriate medical care. Although B.W. did not make significant improvement within the time prescribed by ISD criteria, she did make significant improvement during her stay at Florida Hospital. She was successfully treated and timely discharged in a manner that was suitable for her individual needs and consistent with appropriate medical care. 7.2(a)(1) Mental Impairment At the time of admission, B.W. had organic affective disorder with severe depression. She was psychotic and was hallucinating. She heard voices and talked to herself. She was acutely suicidal. B.W. had a history of prolonged depression, multiple hospitalizations, and failed courses of outpatient treatment. This was B.W.'s fifth psychiatric admission. B.W. was last admitted on March 3, 1991, for an overdose of medication. She was hospitalized for four days and discharged. B.W. was obsessed with suicide and how she was going to carry out her suicide. She had a specific plan to kill herself. 7.2(a)(2) Emotional Impairment B.W. was unwashed, unkept, disheveled, and depressed. Her speech was blurred. She suffered from sleep disorder and loss of appetite. B.W. suffered from multiple substance abuse problems and impaired judgment. B.W.'s substance abuse was an attempt to self medicate for anxiety. The anxiety was caused by conditions in her home environment. B.W. was responsible for the care of minor children. She was separated from her husband and living with an elderly mother who could not take care of B.W. Her mother was significantly depressed and was, herself, at risk of suicide. 7.2(a)(3) Medication More time than that prescribed by ISD criteria was medically necessary to discover the combination of medicines that would be effective for B.W. When the right combination was determined, additional time was needed to stabilize the medications. B.W. was on antipsychotic drugs because she was hallucinating and hearing voices. She was also on antidepressants. It takes time for psychiatric drugs to take effect. The treating physician had to gradually increase the dosage administered to B.W. until the medication reached a therapeutic level. B.W. made steady improvement during her hospitalization. As late as June 4, 1991, however, B.W. was nauseated, vomiting, and had headaches. B.W. was treated effectively and timely discharged in a manner that was suitable for her individual needs and consistent with appropriate medical care. 7.2(b) Alternative Placement Petitioner correctly considered alternative placements in prescribing inpatient services for B.W. after her initial treatment. No alternative placement existed for B.W. before she was stabilized and discharged. It was consistent with appropriate medical care for Petitioner to keep B.W. in the hospital until her treating physician stabilized her. It required approximately 30 days for B.W.'s treating physician to stabilize her. Outpatient care would not have been effective before B.W. was stabilized. At the time that Respondent claims B.W. should have been discharged, B.W. was depressed and was hallucinating. She was still in withdrawal from her substance abuse. Earlier outpatient care would have been neither effective nor suitable for the needs of B.W. It would not have been consistent with appropriate medical care to discharge B.W. to her home. B.W. is responsible for the care of two minor children. She has an unstable home environment. It would not have been consistent with appropriate medical care to discharge B.W. to such an environment before she was stabilized.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Respondent enter a Final Order denying its claim for refund of the Medicaid payments at issue in this proceeding. RECOMMENDED this 20th day of December, 1995, in Tallahassee, Florida. DANIEL S. MANRY, 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 December, 1995.
The Issue Does Petitioner, The Public Health Trust of Miami-Dade County, Florida (Health Trust), have standing to challenge Department of Health (Department) proposed rules 64J-2.007, 64J-2.008, and 64J-2.009? Is proposed rule 64J-2.007 an invalid exercise of delegated legislative authority? Is proposed rule 64J-2.008 an invalid exercise of delegated legislative authority? Is proposed rule 64J-2.009 an invalid exercise of delegated legislative authority?
Findings Of Fact The Parties Health Trust is an entity of Miami-Dade County. Health Trust oversees the Jackson Health System, a health care provider functioning as a three-hospital system. One hospital is Jackson Memorial Hospital, a licensed acute care general hospital located in Trauma Service Area (TSA) 19. It operates a verified Level I trauma center, which is a part of the Miami-Dade County trauma system. Health Trust also operates Jackson South Community Hospital (Jackson South), a licensed acute care general hospital in TSA 19. There is no trauma agency in TSA 19. Health Trust is not a trauma agency. It is not attempting to form or to be a part of a coalition to form a trauma agency for Miami-Dade County. Jackson South is committed to obtaining authority to operate a Level II trauma center. In April 2015, it applied to operate a Level II trauma center. The Department denied the application. Jackson South challenged the denial and requested a formal administrative hearing. The Department referred the challenge to DOAH, where it was assigned Case No. 15-3171. Since the hearing in this case, Administrative Law Judge John Van Laningham issued an order recommending approval of Jackson South’s application.3/ As of the date of this Order, the Department has not issued a final order. In September 2015, Jackson South submitted a trauma center letter of intent to the Department expressing its intent to become a Level II trauma center in TSA 19. This was a cautionary filing in the event the Department denies Jackson South’s first application now pending in DOAH Case No. 15-3171. Kendall Healthcare is located in Miami, Florida. It is a licensed acute care general hospital located in TSA 19. Kendall Healthcare is a verified Level II trauma center. Orange Park is located in Orange Park, Florida. Orange Park is a licensed acute care general hospital located in TSA 5. There is no trauma agency in TSA 5. Orange Park submitted a Trauma Center letter of intent to the Department in September 2015, expressing its intent to file an application to become a Level II trauma center. The Department is the state agency authorized to verify and regulate trauma centers and approve the establishment of trauma agencies in the state of Florida. It published the proposed trauma agency rules challenged in this proceeding. The Florida Trauma System Chapter 395, Part II, Florida Statutes, creates a plan to establish an inclusive trauma system to meet the needs of trauma victims. § 395.40(2), Fla. Stat. The Legislature defined “inclusive trauma system” to mean “a system designed to meet the needs of all injured trauma victims who require care in an acute- care setting and into which every health care provider or facility with resources to care for the injured trauma victim is incorporated.” Id. The Legislature placed primary responsibility for the planning and establishment of this statewide inclusive trauma system with the Department. § 395.40(3), Fla. Stat. Section 395.402 establishes trauma service areas. One component of the trauma system is the option for certain local or regional organizations to form and operate trauma agencies to plan, implement, and evaluate trauma services systems in their trauma system area. § 395.401(1)(a), Fla. Stat. Section 395.4001(11) defines a “trauma agency” as “a department-approved agency established and operated by one or more counties, or a department-approved entity with which one or more counties contract, for the purpose of administering an inclusive regional trauma system.” According to Leah Colston, Bureau Chief for the Department’s Bureau of Emergency Medical Oversight, a trauma agency “is the coordinating body for all of the emergency health care systems in a regional area that is designed to evaluate the system and perform its improvement opportunities to better outputs for patients.” (Tr. 34, lines 22-25.) Section 395.401 governs establishment of trauma agencies. It provides that the Department “may approve or not approve trauma agency plans based on the conformance of the plan with [sections 395.401,] 395.4015, 395.404, and 395.4045 and the rules and definitions adopted by the department.” § 395.401(1)(c), Fla. Stat. There are four trauma agencies in Florida. One agency covers 13 rural counties. The other three are for single counties. The counties are Palm Beach, Broward, and Hillsborough. There are no trauma agencies in TSA 19, which covers Miami-Dade and Monroe Counties. The last time the Department received an application to establish a new trauma agency was in 1991. There is no dedicated funding source for trauma agencies. They must find their own funding. Absent a consistent funding source, how and where and when future trauma agencies may develop is unclear. Rulemaking Process Over the past five years, there has been a considerable amount of litigation about the Department’s rules governing the allocation of the trauma centers around the state and applications for new trauma centers. In September 2011, Administrative Law Judge David Watkins issued a Final Order invalidating Department rules governing the allocation of trauma centers throughout the state. The First District Court of Appeal affirmed the Final Order.4/ The Department proposed a new trauma allocation rule in February 2014. Health Trust and other providers challenged that rule. The rule was determined valid.5/ Afterwards, several providers applied for designation as a trauma center in TSA 19, including Jackson South. After adoption of the new rule, the Department undertook review of its trauma center rules, including the rules pertaining to trauma agencies. This was part of the Department’s compliance with its rule reduction mandate. In an effort to reduce the number of Department rules and to align the rules with the statutory requirements, the Department promulgated the proposed rules challenged in this proceeding. As Ms. Colston explained, the Department intended for the proposed rules to align the rule requirements with the statutory provisions governing the formation of a trauma agency and to delete unnecessary or redundant information. During the rulemaking process, the Department conducted several workshops. They were well-attended by representatives of health care providers, including representatives of trauma centers and emergency medical services providers. Health Trust’s representatives and legal counsel participated in the workshops. The Department heard testimony and accepted written comments from the public. The Department thoroughly reviewed the public comments and considered them in finalizing the proposed rules.
The Issue Whether Respondent violated Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes, and, if so, what discipline should be imposed.
Findings Of Fact The Department is the State agency charged with regulating the practice of medicine pursuant to Section 20.43 and Chapters 456 and 458, Florida Statutes. At all times material to this proceeding, Dr. Mationg was a licensed physician in the State of Florida. His license, numbered ME 0028183, was issued on April 13, 1976. Dr. Mationg is the primary care physician of A.A. Dr. Mationg referred A.A. to Dr. Steven Schafer, an orthopedic surgeon, for pain in the right shoulder, which was found to require arthroscopic surgery and repair of a rotator cuff. On January 10, 2000, A.A. was admitted to Regional Medical Center Bayonet Point (Bayonet Point) for surgery. At the time of his admission to the hospital, A.A. was 65 years old and suffered from numerous medical problems. He had cardiomyopathy, meaning his heart was enlarged and not functioning properly. A.A. had high blood pressure and a history of heavy smoking. He had generalized arteriosclerosis and peripheral artery disease. A.A. had previously had surgeries involving the placement of a stint and angioplasty. Based on his medical history, A.A. was subject to a stroke and a heart attack. Prior to his admission to the hospital, A.A. had been taking aspirin daily. Approximately three days prior to surgery, A.A. was directed by Dr. Schafer to discontinue taking aspirin. The aspirin was discontinued to reduce the risk of A.A.'s blood not being able to clot sufficiently. The hospital records of A.A. contain a request for consultation with Dr. Mationg for medical management dated January 10, 2000. The discharge summary shows that the medical evaluation was obtained so that A.A. could be followed by his primary care physician for his hypertension and other medical history. Dr. Schafer performed the surgical procedure on A.A. on January 10, 2000. A.A. had some respiratory problems, and Dr. Mationg ordered a pulmonary consultation with Dr. Patel the afternoon of January 10, 2000. Because of the respiratory problems, A.A. was placed on a ventilator and transferred to the intensive care unit. On January 11, 2000, Dr. Patel extubated A.A., which means that A.A. was taken off the ventilator. On January 11, 2000, Dr. Mationg saw A.A. at 9:00 a.m. and wrote and signed an order for lasix and lanoxin for A.A. Around 3:15 a.m. on January 12, 2000, A.A. was awakened for respiratory therapy and experienced numbness in his left arm and slurring of speech. When A.A. smiled, the left side of his mouth remained flat while the right side turned up. The nurse on duty was called, and he observed A.A.'s symptoms. A.A.'s symptoms indicated that he was having a stroke. Nurse Culligan notified Drs. Schafer and Mationg. Dr. Mationg did not come to the hospital to evaluate A.A. The standard of care would have required him to come to the hospital to evaluate A.A. because A.A. was exhibiting the symptoms of a stroke. Instead of coming to the hospital to do an evaluation, Dr. Mationg gave the following orders telephonically to Nurse Culligan at 4 a.m., on January 12, 2000: T.O. Dr. Mationg/M. Culligan do CT head [without] contrast today a.m. do carotid doppler study today a.m. consult Dr. S. Shah for neuro eval. get speech therapy eval. and video swallow today. Nurse Culligan wrote the orders on A.A.'s chart; Dr. Mationg later countersigned the orders. The term "stat" in medical parlance means immediately or as soon as possible. An order is not presumed to be stat if the order does not specify that it is stat. The tests and consultation which Dr. Mationg ordered at 4 a.m., on January 12, 2000, were not ordered to be implemented stat. The standard of care for treating A.A. required that Dr. Mationg order a stat neurological consultation and a stat head CT scan. Bayonet Point has established policies for its imaging services department, including CT services. The normal hours for CT services are 7 a.m. to 11 p.m., Monday through Sunday. After normal hours, the services are provided on-call. Bayonet Point's call-back procedures include the following: When an emergent radiologic procedure is ordered after hours, the Radiology personnel will contact the appropriate on call technologist via the hospital operator. Once the procedure is complete, the Technologist will call the Radiologist on call and then transmit those images via Teleradiography. Definition of an emergent procedure: In- house STAT, Emergency Department physician requesting radiologist interpretation, any outpatient whose physician requests immediate radiologist interpretation or "wet reading." Prior to A.A.'s experiencing the symptoms of a stroke at 3:15 a.m., no orders had been given for A.A. to resume taking aspirin. At 10 p.m. on January 10, 2000, Dr. Schafer ordered that "till further notified" all medications taken by mouth which could be taken intravenously were to be administered via an IV. Aspirin could not be administered intravenously. Because Dr. Schafer had ordered that aspirin therapy be stopped prior to surgery, it would be the responsibility of Dr. Schafer to order the aspirin to be restarted. Dr. Schafer was at A.A.'s bedside at 8:30 a.m., on January 12, 2000. Dr. Schafer noted that a head CT scan was ordered for that morning and that the patient was on his way down for the test. Dr. Schafer also noted that a neurological evaluation had been ordered for A.A. for that morning. The hospital records show that at 8:50 a.m., on January 12, 2000, a call was made to Dr. Shah's answering service, requesting a neurological consultation. The request for consultation form, which was filled out after Dr. Schafer's visit at 8:30 a.m., indicated that the request was an emergency request. The request for consultation form was filled out by someone other than the nurse who charted Dr. Mationg's verbal order for a neurological consultation. Based on the evidence presented, the request for a neurological consultation was not treated as an emergency request until after Dr. Schafer saw A.A. at 8:30 a.m. Tissue Plaminogen Activators (TPA) are used to dissolve clots which may be causing a stroke. The use of TPA is limited to a three-hour window following the onset of stroke symptoms. Dr. Mationg did consider the use of TPA, but felt that it was contraindicated based on the recent surgery. This opinion was confirmed at final hearing by a neurologist.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding that Dr. Mationg violated Subsection 458.331(1)(t), Florida Statutes; finding that Dr. Mationg did not violate Subsection 458.331(1)(m), Florida Statutes; placing Dr. Mationg on two years probation; imposing an administrative fine of $5,000; and requiring that Dr. Mationg attend ten hours of continuing medical education courses in the diagnosis and treatment of strokes and four hours of continuing medical education courses in risk management. DONE AND ENTERED this 3rd day of July, 2003, in Tallahassee, Leon County, Florida. S ___________________________________ SUSAN B. KIRKLAND 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 3rd day of July, 2003. COPIES FURNISHED: James W. Earl, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 A. S. Weekley, Jr., Esquire Holland & Knight, LLP 400 North Ashley Drive, Suite 2300 Tampa, Florida 33602 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701
The Issue The issue for consideration in this matter is whether Respondent, NME's application for a Certificate of Need to provide comprehensive medical rehabilitation beds in Department District X should be approved.
Findings Of Fact At all times pertinent to the allegations contained herein, the Department was the state agency with the authority to and the responsibility for evaluating and approving CON applications for health care facilities in this state. Department District X is a single county district which encompasses the whole of Broward County, Florida. Broward County consists of two distinct service areas for health care providers; the north and the south. Facilities located in the northern part of the county, for which the dividing line is accepted as State Road 84 and Interstate 595, which run east/west across the county, primarily serve the northern area of the county. By the same token, those providers located south of the dividing line are primarily in service to residents in the southern portion of the county. Legitimate basis exists for the distinction between the north and south county segments. The county is divided into two taxing districts which generally follow the service district boundaries and these taxing districts are utilized to provide and reimburse for health care services. In addition, physician practice patterns show generally that physicians stay, refer, and admit to facilities within that portion of the county where they live and practice. There is little medical intercourse between the sections. A third basis for distinction is the fact that generally patients follow physicians, and will normally present for treatment at those facilities located in the section in which they reside and their practitioner locates. At the present time, of the five providers which offer CMR services in Broward County, (District X), four are located in the northern section of the county, and the fifth, Memorial, is located in the south. Memorial currently has 22 of the 213 existing and approved CMR beds in the District. This constitutes approximately 10% of the total number or approved and existing beds in the District while 32% of the population of the District resides in that service area. By the same token, if one considers the number of CMR beds per 100,000 population, the number in the north service area is approximately 4 times that in the south. Petitioner, Memorial, is a 618 bed acute care regional public hospital providing numerous specialized acute care services to District X as well as adjoining areas in the southeast region of the state. It is operated by the South Broward Hospital District, a taxing entity created by the Florida Legislature in 1947, and has a history of being a disproportionate share provider of medical services to the indigent through Medicare and Medicaid programs as well as other charity care programs. In fact, Memorial provides the sixth highest level of indigent care in this state. Memorial currently has provided CMR services since 1985 and operates a 22 bed CMR unit. It also offers open heart surgery, neurosurgery, pediatric cardiac catheterization, pediatric trauma, pediatric open heart surgery, and pediatric oncology and hematology. The facility has recently submitted a letter of intent to the Office of Emergency Medical Services requesting to be designated as a regional adult trauma center. HMC is a 334 bed acute care hospital also located in the southern service area of District X, in a six story building containing approximately 300,000 square feet and an adjacent five story medical office building. It also offers a broad range of general acute care services as well as specialized programs in the treatment of diabetes, laser surgery, eating disorders and oncology. It also provides intensive care, coronary care, and progressive care beds, though all may not be considered as active tertiary care services. HMC has a large medical staff consisting of over 400 physicians representing almost all medical specialties. More than 90% of the staff are board certified and the rest are board eligible. The medical staff of HMC and Memorial tend to overlap almost in its entirety. HMC's medical staff also includes five physicians who specialize in physical medicine and rehabilitation, (physiatry), all of whom are board certified except for one who has recently taken the board examination. HMC is a subsidiary of NME Hospitals, Inc., a national publicly held health care company which owns, manages or operates more than 150 acute care, rehabilitation, and pediatric hospitals throughout the United States and overseas. NME has a rehabilitation division which specializes in comprehensive rehabilitation services. This division would manage the CMR unit at HMC if approved. HMC is accredited by the Joint Commission of Accreditation of Health Care Organizations and maintains extensive quality assurance activities. On March 11, 1991, HMC filed a Letter of Intent to apply for a CON to convert 30 existing acute care medical surgical beds to 30 CMR beds. Somewhat later, but still during March, 1991, both Memorial and HMC filed applications for a CON for CMR beds. Memorial's application sought the addition of 4 CMR beds to its existing 22 bed unit. Both applications were preliminarily approved by the Department. Thereafter, both Memorial and HMC filed Petitions in opposition to the preliminary approval of the other applicant's application. HMC ultimately dismissed its Petition in opposition to Memorial's 4 beds, and that application is not in issue here. Prior to hearing, the parties agreed that the provisions of Section 381.705(1)(m), Florida Statutes, as they relate to costs of construction and construction methods and itemization and costs of equipment of HMC and its application are not in issue. Memorial, however, did not waive its right to challenge the plan and design of the plan as to quality care considerations in HMC's application. The parties also agreed that Section 381.709(2)(c), Florida Statutes, was in issue but that sup-paragraphs a, b, and d of that section were not. The Hearing Officer's resolution of Petitioner's objections on this matter established that the Letter of Intent was timely filed in the appropriate place and the proper notice published. HMC's Letter of Intent included therewith a resolution of the NME Board of Directors which was accompanied by a certificate as to its accuracy. The corporate resolution certificate, dated March 5, 1991, indicating the resolution was enacted on February 19, 1991, was executed by Mr. McKay, Vice President and Assistant Secretary of NME Hospitals, Inc. Memorial questioned Mr. McKay's authority to sign the certificate as custodian of the corporate records. The evidence presented indicated, however, that Mr. McKay is a keeper of the corporate seal and custodian of corporate records pertinent to the eastern region of NME Hospitals, Inc., and as such he was an appropriate custodian of the records and competent to execute the certificate. The issue as to the date on the certificate appears to be no more than a scrivener's error. The errors which exist are harmless. The documentation contains all certification necessary for a valid Letter of Intent. Daniel J. Sullivan, a consultant in health care management, did a need analysis study of the Broward County District for HMC to determine whether a CMR facility was needed within the District and if so, where. He first looked at the planning area and what services were available, both those in existence and those approved but not yet on line. He also looked at utilization of CMR services in the area and trends toward service utilization, geographic distribution of existing services, the fixed need pool, relevant Department rules relating to numeric need and other factors, and in that connection, any other unusual factors bearing on need. Mr. Sullivan's study clearly established to his satisfaction that HMC does not serve all of Broward County - only, primarily, those patients residing in Hollywood, Hallendale, and Dania, all of which are in the southeast corner of Broward County. The secondary service area goes down into Dade county and up to Ft. Lauderdale. The data for this study and the need analysis comes from the Hospital Cost Containment Board, (HCCB), and is considered to be reliable. Mr. Sullivan also did an analysis of areas served by other providers in the county and determined that Memorial's service area is similar to that of HMC. North Broward Medical Center serves the very northeast part of the county. Holy Cross Hospital serves the lower north to northeast part of the county. Based on this, he concluded that facilities in the northern part of the county serve the northern county area. Only Petitioner and HMC serve the southern part of Broward to any measurable extent. Utilization of CMR beds is very high district-wide, both historically and currently. Occupancy in the District for the relevant period was 91.21% county-wide, with Memorial Hospital having an occupancy rate of 99.32%. This is not, in Sullivan's opinion, a historical aberration. The same trend goes back to the mid 1980's. In 1989 for example, utilization was at 89% and it has gone up since that time. In Sullivan's opinion, the system is now near capacity and the occupancy rate remains high. Both Holy Cross and North Broward Medical Center have 20 new beds each as of the last quarter of 1991. When those beds came on line, the utilization rate still remained very high NBMC's new program was at about 75% occupancy after less than one year operation. These north county beds will be used by north county patients and will not, for the most part, be available to south county residents. Rule 10-5.039, F.A.C., is the Department's rule regarding need determination, and it contains a numeric need formula for projecting future needs for service ((2)(a)). The Department publishes a fixed need pool every six months to identify need. The last one published before this application showed a zero bed need in the fixed need pool. Mr. Sullivan believes, however, this is not an accurate predictor of bed need since the realities of the market place are not related to the Department's fixed need pool. Mr. Sullivan's calculations show a gross bed need in 1990 of 88 beds considering the existing 213 licensed and approved beds. Since these are running at an occupancy rate higher than 90%, this shows the rule grossly underpredicts the need for the service. In fact, the Department has prepared State Agency Action Reports, (SAAR), in both the NBMC and St. Joseph applications and the Memorial application which reflects this trend. Mr. Sullivan believes the need formula is not a good predictor of future needs because it assumes, incorrectly, that the number of patients needing the service is directly related to acute care hospital discharges. Historically, however, this has not been the case. Since 1986, the ratio of CMR discharges to acute care discharges has grown and has never closely approximated the rule's standard ratio of 3.9. Other factors are provided for in subparagraph (2)(b) of the rule. The District's population trends show a relatively older population, (more than 20% of the population is over 64 years old), and by 1996 that percentage will increase somewhat. Since July, 1989 approximately 33% of the people with the top ten conditions utilizing CMR services were from South Broward County. Extrapolating this indicates a net need of 11 beds if an 85% occupancy rate is experienced. Since the actual occupancy rate remains, in fact, higher than 85%, Mr. Sullivan believes this method is accurate. A modification of this need, relating to discharge rates, was done in the Omissions Response herein which shows a need, by 1996, of 39 beds, not including the 4 beds approved for Memorial. As to population, the elderly are most at risk for conditions requiring CMR care since they, by far, experience the largest percentage of strokes and orthopedic related conditions. With the elderly and very elderly percentage of the total population increasing, this would tend to drive the need for CMR services and beds. Mr. Sullivan calculated need for the purposes of the application for the southern portion of the District along, utilizing a method which, though not officially recognized, uses the same criteria for analysis used in the District analysis. Doing so, he concluded there would be a 1990 need for 53 additional beds. Utilizing the 17(a) method to project into the future, he calculates a 1996 need for 57 beds. Concerning subparagraph (2)(B)3 of the rule, considering the growth rate of CMR admissions per 1,000 population, (from 1.41 to 2.24 during the period 1986 through 1990), at HMC, Mr. Sullivan also concluded that the growth rate would be plus or minus 4.5% over the next 5 years. He also concluded that the length of stay will remain at 21 days over the next 5 years and feels this is conservative when compared to the rest of the state and the 28 day figure used in the rule. There is some pressure to have patients discharged as soon as possible which impacts on length of stay. Considering all these factors, Mr. Sullivan expects a District X need as a whole of 65 beds in 1996, not including the 4 beds approved for Memorial. This would result in an actual 61 bed need by 1996. All this means that if the number needed is the same for the South County and the County as a whole, then the number is acceptable and all the need is in the South County. As to trends in the utilization by third-party payees, this factor has driven the growth. Medicare and insurance companies recognize the efficacy of CMR services as opposed to the fragmented treatment otherwise provided. They consider that every dollar spent on CMR saves money for the health care system. Subparagraph (c)1 of the rule requires a unit have at least 20 beds. In the instant application, HMC is seeking 30 beds and this clearly meets the rule criteria. The occupancy standard of 65% in the first year, as outlined in sub- paragraph (c)2 of the rule, is estimated to be met easily, and the 85% requirement for existing providers will also be met. All together, there appears to be a high demand for CMR services in Broward County in general and in the south half of the county in particular, and it is reasonable to assume that the 30 beds for HMC, as well as the additional beds sought by Memorial, could be approved without adversely affecting any existing providers. Regarding the rule's accessibility standard which requires 90% of the target population to reside within 2 hours diving time of the proposed facility, this is clearly met since all of Broward is within 2 hours driving time of both HMC and Memorial. Turning to the provisions of Section 381.705, Florida Statutes, specifically (1)(a), (b) and (2)(a),(b) and (d), all are highly interrelated. While geographic availability may not be of concern, the availability of empty beds is of great concern. Historically, the District has operated well above the 85% occupancy rate for over 3 years. The system currently is clearly inadequate and the existing alternatives, home care and outpatient services, do not replace the services in issue but supplement and are follow-ons to inpatient CMR care. Concerning economies of shared service, Mr. Sullivan feels certain economies will accrue as a result of this conversion if approved. Existing space will be used and can share administrative and overhead expenses; the contractor to be used to accomplish the project is qualified and experienced and knows how to economize. Impacts on competition will be minimal if any, given the high level of need. As to any impact on HMC, the sharing of costs and services between the integrated portions of the facility would generate economies. At the present time there is no existing competition other than the beds at Memorial. If HMC is granted its certificate and becomes an existing provider, the resultant competition should be beneficial to both institutions. There are no alternatives to this service which are less costly or more efficient. Any alternatives would be either more expensive or inappropriate. The facilities are currently being used in a very efficient manner and this would not change. If the application is not approved, according to Mr. Sullivan there are and will be patients who are in need of and who will be denied CMR services in South Broward County. He believes the 1989 Florida State Heath Plan and the District's 1990 Health Plan, those applicable here, are consistent with this application. The preferences called for in the plans will be met and satisfied. HMC agrees to accept Medicaid patients and has committed 1% of its service to the indigent. It should be noted that Memorial's projected need for CMR beds is identical to that of this applicant, and this tends to indicate Memorial also feels there is a need for additional beds in the south county. It's application was filed subsequent to the initial approval of the 30 beds in issue here. It is immaterial at this point that District X has more CMR providers and more licensed CMR beds than any other district in the state. Also not controlling is the fact that under the state's bed need methodology, as outlined in the rule, there is a 125 bed excess projected by 1996 for District X. It must be noticed here that CMR services are defined by rule as tertiary health services which are generally specialized services using specialized equipment and personnel. They should be centralized in a centralized location to encourage better utilization of resources. HMC is a community hospital which does not now have any other tertiary hospital services but Dr. Jay S. Mendelsohn, a psyiatrist testifying on behalf of HMC claims that the majority of rehab problems are not so specialized as to require tertiary services and are mainstreamed. Dr. Mendelsohn, a specialist in physical medicine and rehabilitation, as a physiatrist, coordinates care on a rehabilitation unit including actual treatment, nursing care, and social work relative to the patient's condition. A physiatrist sees, on an inpatient basis, patients with such infirmities as stroke, hip fractures, multiple sclerosis, multiple trauma, and other similar conditions. The patients are usually those with neuromuscular or musculoskeletal problems, though he does, on occasion, see those with arthritis complications. Dr. Mendelsohn has privileges at several hospitals in Broward County including both Memorial and HMC. He practices mostly at Memorial where he was, from 1985 through 1991, Medical Director of the rehabilitation unit. His associate, Dr. Novick, is the current Medical Director. CMR patients are usually referred for this service by other physicians. Hip fractures and strokes are primarily from orthopaedic surgeons and neurologists, but internists, family practitioners, and physicians practicing in other disciplines also refer as appropriate. To Dr. Mendelsohn's knowledge, South Broward County is somewhat unique. Physicians there generally stay in that area and do not practice or draw patients from north of I-595. Another group practices primarily in the northeast portion of the county and a third group practices in the northwest county. Most physicians use the hospitals in the area in which they practice. In the south county, patients needing inpatient rehabilitation can at present, from a practical standpoint, go only to Memorial Hospital since it has the only rehabilitation beds available in the area. His experience indicates substantial difficulty in getting patients admitted to that unit since it generally fills its rehabilitation beds with patients primarily from it own patients already admitted to other services. Patients from other hospitals or from the community normally have great difficulty getting admitted, and this problems has existed for quite some time, (over 5 years). He has encouraged Memorial's staff to apply for more rehabilitation beds. If a Memorial patient is unable to get into the rehabilitation unit at Memorial, that patient then has to obtain the needed rehabilitation treatment on an acute care ward. Patients at other facilities often are not admitted at all, and this situation affects the course of treatment and reduces the amount and the beneficial effects of therapy by approximately one-half. The providers in the northern part of the county are not a good source of therapy to patients from the southern portion of the county because: Since south county physicians normally do not go to the north portion of the county, the patient has to have a different physician who is not familiar with either the patient or the condition and who must, therefore, do repeat tests and other diagnostic procedures. The patients' families find it harder to visit the patients in the north part of the county and therefore do not visit as frequently. Family visits are important to the success of the therapy. When the patient goes home, his family does not know how to help out because they did not receive the training they would have ordinarily have received had they been able to visit in the inpatient facility more frequently. Older patients' spouses often do not drive or, if they do, find the extra distance to the north portion of the county too much to travel. As a result of all the above, the continuity of care concept, which is important from a medical care standpoint, is adversely affected. Patients needing treatment at HMC's facility, if approved, would be much like those treated at the currently existing Memorial facility. Dr. Mendelsohn is familiar with Rehabilitation Hospital Services Corporation, which will be contracted with to run the HMC facility if approved. To his knowledge, the quality of care provided by it is good and comparable with that provided elsewhere. Dr. Mendelsohn anticipates he would refer 5 to 10 patients a week from his and his associate's practice to HMC's CMR facility if approved. He feels he could keep the 30 beds filled without taking any patients from Memorial's unit which would still remain operating at capacity. The 21 day stay average at Memorial is shorter than he would expect to see. This is consistent with Sullivan's conclusion, supra. If more beds were available, the stay at both facilities would probably be longer. This is in part because now the patient is getting therapy on the acute care ward while waiting to get into the rehab unit. This pretreatment would be accomplished on the CMR unit if the space were available. As a result, then, the opening of HMC's CMR unit would, in his opinion, in no way adversely affect Memorial's ability to keep its unit full. Dr. Mendelsohn's comments are not biased by the fact that he is a financial investor in the corporation which will operate HMC's unit. Within the pertinent medical community there is a great deal of frustration and anger over the inability to get patients into a rehabilitation center and keep them there for the appropriate length of time. The alternatives to the proposed facility, such as inpatient treatment on other services or in other hospital facilities in the county, or in nursing homes, are not as good. By the same token, outpatient care is not as good because of the unavailability of sufficient treatment due to Medicare and other financial restraints. The difficulties experienced by physicians practicing in the southern Broward County area who desire to admit their patients for CMR service is typified by that of Dr. Jeffrey A. Crastnopol, an orthopedic surgeon practicing in Hollywood since 1984, and a member of the staff at Memorial, HMC, and other hospitals in the area. Dr. Crastnopol sees a wide range of patients from children to the elderly. His practice deals mostly with trauma in children, sports trauma, and trauma related to bone brittleness in the elderly. Almost all his patients live within the southern Broward area. All hospitals where he is on staff are in that area as well. Dr. Crastnopol has chosen not to take patients from outside his geographical area because he has sufficient patients from in his area to keep him busy. In his experience, of all the other orthopedists he knows, none practicing in the southern Broward area is on staff in any of the hospitals in the northern Broward area. Most are on staff at both Memorial and HMC. Most of Dr. Crastnopol's patients are elderly, suffering hip fractures; pelvic, lumbar and spinal fractures; herniated discs; and the complications of arthritis as well as other symptoms. He and his associate saw between 10 and 15 patients with these conditions in the two weeks prior to the hearing. Of that number, he referred at least 3 for inpatient rehabilitation at Memorial and has an additional 4 or 5 other patients now in acute care services who will need CMR services. His trauma cases usually go to the emergency room first or the patient will call him or their primary care physician. The patients frequently request a particular hospital but, if a patient is already admitted to Memorial, he would try to keep that patient there for rehabilitation services. If the patient is at HMC, and if there were a rehab unit there, he would try for admission at that facility. At the present time, only Memorial has rehab beds available for Dr. Crastnopol to refer to and he often has trouble getting a bed for a patient there since it is usually full. The wait for an opening may be from 4 to 5 days or the patient may not be admitted at all. The delay is controlled by physiatrists at Memorial and though they try to be accommodating, frequently patients from outside that facility cannot be admitted. When that happens he then has to consider other institutions further away or nursing homes with less than full rehabilitation services. According to his experience, patients at Memorial will almost always be admitted to Memorial's rehab unit. Patients at HMC may not, and he, as well as all other physicians testifying, indicate there is a difference in the waiting lists. Dr. Crastnopol believes the best thing for the patient is for the doctor to be able to treat these injuries in a rehab unit. To transfer to one where he cannot come is not as good. He believes that patients on rehab units recover faster than those who are in alternative treatment plans. He also contends that home care and outpatient care are not suitable alternatives to inpatient care, especially for the elderly. He agrees with Dr. Mendelsohn that the northern Broward facilities are generally too far from the families of patients from the south. Since he is not on staff up there, he would not be able to provide the continuity of care which he, and all other physicians testifying, feel is so important. Dr. Crastnopol contends that from a clinical standpoint there is need for additional rehab beds in south Broward County. HMC provides a good service, and he has no doubt that it would provide a rehab service of the highest quality if its unit were approved. He would refer patients to it. He treats Medicaid and indigent patients, and in all fairness to Memorial, that installation has never tried to dissuade him from admitting that category of patient to its facility. Dr. Crastnopol took time from his busy practice to travel to Tallahassee to testify here because he feels there is a need for the service applied for. He, too, is an investor in the limited partnership which owns the building in which the hospital is situated, but in no way would this interest prejudice or bias his testimony. At the present time, only between 30 and 40% of his patients are treated at HMC, whereas between 60 to 70% are treated at Memorial. Similar testimony came from Dr. Jose M. Muniz, an internal medicine specialist practicing in Hollywood, Florida for the past 17 years. Dr. Muniz is on staff at both HMC and Memorial and serves as Chief of Staff at HMC. He is also on the utilization review and quality assurance committees there. As with Dr. Crastnopol, his patients are mainly older, 70% of whom are over 65. The other 30% are adult to middle age. Ninety-eight percent of his patients come from Hollywood and the south Broward area. As a result, Dr. Muniz has no hospital affiliation in the north Broward area. Dr. Muniz refers to rehabilitation patients who experience bone fractures and strokes, and he sees patients at both hospitals. He has had some referral problems at Memorial. He feels very strongly about the necessity for continuity of care and asserts it is important for him to continue to see his patients in a rehabilitation unit because they still have an underlying medical problem which he must continue to treat. It is not good for his patients to go far afield for rehabilitation service due to a lack of availability in the immediate area. He cannot continue to treat the patient who thereby feels abandoned, and the family also has additional difficulties in getting to see the patient. Nursing homes, while an alternative to a rehab unit, are not, in Dr. Muniz' opinion, an acceptable one. They have neither the staff nor the equipment to provide the appropriate treatment, and in his opinion, placing a patient who needs rehabilitative services in a nursing home is no more than warehousing that patient. HMC's application has a high level of support in the local medical community. A second rehab unit has been sought by numerous physicians in the area, and Dr. Muniz believes there is a definite need for additional rehabilitation beds to satisfy the need for rehab availability after the acute care condition has been stabilized. He is satisfied that if HMC gets its rehabilitation unit, its quality of care will be as high as that in the other services already provided there. Dr. Jubran Hoche, a Board certified neurologist at Memorial, HMC, and other facilities in the southern Broward area, often has patients who need inpatient rehabilitation services. Most are elderly stroke victims and younger patients with multiple sclerosis, a demographic consistent with prior evidence considered. He sees between 2 and 3 such patients per week. He begins to evaluate his stroke patients for rehabilitation when they stabilize, somewhere between 7 and 10 days after suffering their stroke. He has found rehabilitation beneficial to recovery and currently refers such patients to Memorial from all facilities where he is on staff. He often has trouble getting beds there, however, and over the years has found that patients already in Memorial have a priority over outsiders when it comes to getting into the inpatient CMR unit. Patients from other facilities face a waiting list and as a result, many are transferred outside the southern part of the county for inpatient rehabilitation. This is not a good alternative because it interferes with the beneficial continuity of care cycle and raises numerous other problems. Noting that Memorial plans to open a satellite facility in southwest Broward County and shift beds there, he contends that this will still increase the need for CMR beds in the county. There is already a clear need for more inpatient CMR beds in south Broward. In his experience, HMC provides a good quality service and would provide the same in any approved CMR unit to which he would refer patients from those who presently he cannot get into Memorial's unit. As with the other physicians who testified here, he has taken the time from his practice to travel to Tallahassee on HMC's behalf because of his sincere concern with continuity of care. Testimony in the form of depositions from Drs. Klotz, Bennett, Petti, and Moskowitz, and Mr. Jensen support and reiterate, fundamentally, the direct testimony of the above physicians and administrators. According to Holly Lerner, Administrator and Chief Operating Officer at HMC for several years, NME Hospitals, Inc. is a wholly owned subsidiary of National Medical Enterprises, an international health care corporation. The local facility is a six story hospital with approximately 300,000 square feet in addition to an adjacent office building. Over 400 physicians are on staff from most medical specialties including 5 physiatrists. HMC practices on an open staff basis meaning any qualified physician can apply. Almost all physicians on staff currently are Board certified and there is an internal requirement that all be at least Board eligible. The hospital is accredited by appropriate accrediting agencies. HMC is located approximately 1 mile from Memorial Hospital. It has an active quality assurance program, and any inpatient rehabilitation unit approved would be subject to the same quality review. HMC pays property and indigent care taxes to the taxing authorities. In contrast to Memorial, however, it gets no funds from those taxing authorities for treating indigent patients. It has a Medicare contract and has never turned away a patient because of an inability to pay. If the requested rehab unit is approved, the hospital's current outpatient physical therapy program will move off-site. The new inpatient rehab unit will have physical therapy capability on site. Management of the facility will be by an experienced firm well qualified to run it. All services required for physical therapy by Department rule are currently available and will continue to be provided. The new unit, if approved, will seek CARF accreditation. All variable services are currently provided and will continue to be provided. All optional services, except therapy for children, will be provided. HMC now has transfer agreements with Memorial and various nursing homes within the area. It also has a rehab agreement with Sunrise Hospital and a contract with the state to treat patients at a Medicaid contract rate. If at all possible, management intends to continue this on an inpatient basis. Discussions have been held with the Dean of a nearby osteopathic medical school to have a residency and intern program at the hospital and though it is still in negotiation, the parties have, in essence, formulated a tentative agreement to effectuate this development. Though disputed by Memorial, manpower requirement estimates are considered adequate to properly staff the facility if approved and the personnel costs are also considered reasonable even with cost of living increases over the next 5 years. In that regard, overhead staff has surveyed salaries within the area and tried to stay at the 70% level. HMC's salary levels are somewhat lower than that of Memorial but, nonetheless, HMC has had no difficulty in getting and retaining qualified support staff. Petitioner's evidence in opposition was not persuasive. According to Paul Echelard, Administrator and Chief Executive Officer of Pincrest Rehabilitation Hospital, and Florida Vice President of Rehabilitation Hospital Service Company, (RHSC), a subsidiary of NME which manages rehab hospitals throughout the country and which will operate the rehab unit at HMC, inpatient rehabilitation assesses an individual who has had a debilitating injury, after medical stabilization, for improvement potential, and helps improve his living capabilities. Inpatient rehabilitation helps to restore both motor and cognitive functions. The minimum requirements for a CMR program include 3 hours per day of speech therapy, occupational therapy, and physical therapy, 5 days a week. The actual program administered is tailored to the patient's individual needs. If, for example, the patient cannot take 3 hours per day, it may be less, if such reduction is documented. RHSC operates 31 rehab hospitals ranging from 60 to 101 beds. The contract management division also operates hospitals for others. All are accredited except those which have not yet been open the required 6 months. The management company brings the expertise of NME's rehab division, which has access to hundreds of experts in numerous fields, and provides program management, program development, and program education. Program Management involves the day to day running of the program. Rehabilitation programs and staffing are different from acute care functions. Management personnel are supplied. Program development defines the methodology to be followed in each type of case. It works with the staff, with physicians, and with the community to develop programs designed to fit the needs of that facility and that community. The program education division provides information on benefits of rehabilitation in areas where such is not well known. It educates hospitals in the area as well as physicians and the community. For these services, the company charges a fee of $105.00 per patient per day which includes the salary of the medical director of the rehab unit and several other supervisory personnel. Though one might see complex, high level cases at HMC, where there is a need for a lot of high level supplemental medical treatment or procedures, the patient probably will not be treated at HMC. If HMC's program is approved, transfer agreements will be entered into with Sunrise or Pinecrest Rehabilitation Hospitals to take care of those patients whose conditions are too severe or too complex for the inpatient CMR unit at HMC. South Florida's normally more elderly population generates a higher need for medical rehab services. Also, medical science now saves people who, before, would not survive their basic illness, and these people generate a greater need for medical rehab services. The utilization of rehab services has increased significantly since 1988 as the result of Medicare, and due to an increased awareness of the service by physicians. Also, insurance companies now recognize the benefits of dollar savings of rehab over acute care treatment. Another factor involves the implementation of DRG's which exempted rehab, among other areas, from the DRG limits. With this development, however, services and personal criteria for inpatient rehabilitation patients were developed to insure against abuses. Not all hospitals can meet these criteria, but the number of providers has grown fivefold due to the recognition of the health and financial benefits to society. In Mr. Echelard's opinion, the payer projections by categories of payer found in the application are reasonable and based upon the applicant's experience. The personnel costs are in addition to the $105.00 per day fee charged by RHSC. The assumed 65% utilization figure for the first year can easily be accommodated by the staff which is more than adequate to meet the requirements of good quality of care. Much the same can be said for the second year with the increase in both patient census and full-time employees. The salaries projected in the application are generally reasonable, though a few may be somewhat low. RHSC would help to recruit personnel for HMC's facility. It has a national recruiting program and sends recruiters to universities and conferences across the country. All RHSC facilities are open to serve as clinical training facilities. They advertise widely for personnel though they do not "head hunt" at other hospitals. As a result, Mr. Echelard feels HMC would have no trouble getting enough qualified personnel, and it is so found. Turning to the unit itself, from a physical standpoint Mr. Echelard has no trouble with the currently existing physical therapy unit being geographically separated from the bedroom area. In fact, this may be beneficial as it tends to simulate the real world and may increase patient mobility skills. He considers the proposed layout to be acceptable and to meet accreditation standards. The proposed patient charges of $1,078 per day is considered reasonable and closely approximates the $1,050 per day charged at Pinecrest as well as other competing providers. Sharon Gordon-Girvin, a health care consultant and formerly the chief of the Department's Office of Community Health Services, reviewed HMC's instant application for Memorial. HMC's application describes it as a provider of primary and secondary services, a general description of a normal acute care hospital. It has no licensed tertiary services. Five hospitals in Broward County are licensed to offer CMR services. They include Petitioner, Holy Cross, North Broward Regional Medical Center, St. Johns Hospital and Sunrise . Only one of these, Memorial, is in the south Broward region. District X, with the 5 providers offering a total of 213 CMR beds, has more CMR beds than districts in the rest of the state with the exception of Dade County. Other districts have greater population with fewer licensed beds, but it must be noted that without information on demographics, that statistic is of little import. Under the pertinent Department rule, the planning horizon for CMR beds is 5 years into the future. Bed need determination is provided for in Rule 10- 5.039, F.A.C., and consistent therewith, the Department did a projection of bed need for 1996 which showed a new need of 88. Because the number of existing beds exceeded that figure it determined the need to be zero. Even if there is a zero need, however, the rule provides 4 other factors for consideration, (Rule 10-5.039(2)(b)1-4), but in her opinion, HMC's application is not consistent with these 4 factors. One of these deals with historic, current and projected incidents of illness. This witness does not believe there is adequate evidence or discussion in the application of any historic incidents of disease sufficient to support any future prevalence. There is no data as to sex or group of patients. The second deals with trends by categories. Here the application, she feels, contains no detail of payment trends shown as to categories of payor. As to the third criterion, dealing with existing and projected inpatients in need of rehabilitation services, the application does contain some information in its Exhibit 17. The fourth criterion relates to availability of specialized staff, and the application discusses how the staff will be recruited, but not the availability of qualified personnel to fill the positions. In that regard, it is well recognized, she contends, that this type of staff is in short supply. Other evidence of record would tend to confirm this opinion. Ms. Gordon-Girvin indicates that the 1989 State Health Plan is pertinent to this application. This plan contains 5 preferences to be used in evaluating applications. These include: Conversion of excess acute beds. Here, the application conforms but Ms. Gordon-Girvin cannot say if the per diem costs would be lower by conversion. Specialty rehab services not currently found in the District. Here, no services not already available were proposed. Teaching hospitals. This is not truly a statutorily mandated teaching hospital even though evidence shows staff may be made available as faculty at the osteopathic medical school with which HMC plans a collaboration. A disproportionate share of charity care. Here, Ms. Gordon-Girvin feels that HMC is not such a provider and that its application is not consistent with this preference. Existing comprehensive outpatient rehab facility. This, again, is not met by the applicant. These preferences are, it must be noted, not mandatory for approval. The 1990 Broward Regional Health Plan is also applicable, and it outlines 3 priorities in its review criteria. These are: The applicant agrees to cooperate and provide data on utilization. In this regard, HMC's application is consistent. Unserved populations. Here, Ms. Gordon-Girvin contends that the instant application does not meet the preference since it is not for construc- tion of a new facility. Situations where the institution's occu- pancy is greater than 85%. Here, clearly HMC does not meet this criteria because it does not have a history of 85% occupancy. Again, however, these are merely guidelines to apply among competing applications and are not preconditions to approval. Ms. Gordon-Girvin points out that the need for CMR services is not considered on a less than district-wide basis, since the rule directs an evaluation of tertiary services on a district-wide basis, and, therefore, the breaking down of the district into north and south services areas is inappropriate. She asserts that in her opinion, the existing rule based on need is not an adequate predictor of need within a district. Instead, she feels the methodology used in Exhibit 17 to the application and omissions response is reasonable. However, she disagrees with HMC's calculations therein because, while the model is credible, the wrong data (the length of stay from 1984, rather than the actual current length of stay) was used. She feels district experience for length of stay (21 days) should be used. Ms. Gordon-Girvin also feels that the methodology used on Application Exhibit 18 is also not appropriate because the variables were not kept constant. It used some date from the sub-area which should not be done because of the rule requirement to treat tertiary services on a district-wide basis. She does not explain, however, that if the rule shows a need for 88 beds and there are already 173 beds licensed, the rationale for a subsequent approval of those excess beds. In that regard, then, the question she does not answer is, if one aspect of the rule is disregarded, cannot another also be disregarded with equal validity? HMC has urged the calculation as set forth in Exhibit 20 of its application, but Ms. Gordon-Girvin does not agree with that because it uses a constant rate of increase in the admissions rate. It also does not ground its assumptions on any existing realities. The initial figure for admissions in 1991, she opines, is overstated, and it, too, does not use accurate real information. If the 3,009 figure were corrected to an "actual" figure, it would result in a net loss of 27 beds and an increase of only 9 additional beds by 1996. She contends that Exhibit 20 is not consistent with the existing rule methodology, because the proposed facility to open in 1993, not 1996. As a result, she sees no need to compute the need in 1996. As to her disagreement with the 4.5% growth in annual admissions, she claims the actual rate shows a decrease from 1990 to 1991. Therefore, the table containing that growth assumption is not justified. She also disagrees with Exhibit 21 because it is applied to a subdistrict and her other objections, (no historical basis for utilization numbers), are also pertinent here. Accepting that the current rule is not a good predictor, she looked at the dispersion of population and beds and determined that there are about twice as many elderly in the northern part of the county as there are in the south. Applying this to the southern area, there should be a total of 46 beds there. Therefore, she asserts, that while there is a need for new beds in District X, all should be in the south, but not as many as requested. If the 30 beds applied for by HMC are approved as well as those approved for Memorial, this would result in 56 beds or 10 too many. In her opinion, based on the incidence model with some adjustment, the actual need is for somewhere between 5 and 20 beds district-wide which should all be located in the south county. Her reasoning and conclusions, however, are not persuasive. Ben F. King, Vice-President for Finance of the Florida Region, Eastern Division of NME, and an expert in health care finances, is satisfied from his familiarity with the application in issue here that the project is financially feasible in both the short and long term. The proforma submitted by HMC in the application, and amended in the omissions response, refers, among other things, to patient day projections. These are converted to revenue by taking the days listed and multiplying by the charge for room and board for each year, and he is satisfied that the rates listed are reasonable. The listed revenues are not what is actually collected, however. They are reduced by deductions for Medicare, Medicaid, indigent, and write-offs (discounts) for health maintenance organizations and insurance companies. In year 1, Medicare contractual is calculated based on reimbursement founded not on cost but on DRG (diagnostic related grouping). This results in no additional reimbursement for patients already in the hospital on an admitting DRG. Therefore, the first year revenues are much lower than in the second and subsequent years. Moving on to year 2, however, the operator gets paid for costs of operation of the unit. Medicare tracks the per-diem costs and income from the hospital, and to be conservative in the preparation of this pro forma, HMC took the existing reimbursement rate of slightly more than $700.00. In calculating reductions, indigents are assumed to be a 100% write-off. Private payments are considered to be a 50% write-off, HMO's a 20% write-off, and insurance an 11% write-off. Mr. King considers all these to be reasonable and consistent with the current experience not only of HMC and NME but of other providers as well. In Broward County, indigent patients are funneled to the county hospitals which receive tax funding for that purpose. This is different from other counties which contract with hospitals to provide indigent care. HMC calculates its revenue estimate in what it considers a conservative manner. Taking off the contractual allowances for Medicare and Medicaid and the other write-offs results in a reduction of more than 50% of gross revenue, and from that figure is taken the expenses, depreciation, interest, etc. to get to the net revenue figure. All the expense categories and the factors they include are considered reasonable by Mr. King. The salary and wages figure includes an add- on of 20% for benefits, which is above the figure for salary and wages found in Table 11 of the application. Supplies includes the provision of housekeeping services, laundry and linen, and dietary services. These, too, he considers reasonable. RHSC's management fee of $105.00 per day includes the personnel provided, the marketing services, the management services, and manuals. This is considered a valuable benefit and the fee is considered comparable with other units. The personnel sent to do the actual work are RHSC employees and not hospital employees. The indigent care assessment is 1.5% of net revenue and is a tax paid to the state. Contract costs are ancillary expenses for ancillary services such as laboratory, pharmacy, etc., already provided by the hospital. The cost listed in the pro forma is only for additional patients generated on the unit in issue. General and administrative - other expenses (joint venture rent, recruitment, insurance, utilities, property taxes, maintenance, education, etc.) are also deducted, and taken together, the above results is an operating revenue net loss for the first year. Depreciation and amortization are self explanatory as is interest expense which is calculated at 10%. Interest rates are anticipated to drop in the future, however, and this will help the picture. The net loss projected for the first year does not necessarily mean that the project is not financially feasible since financial feasibility is calculated over a 5 year basis. In the second year of operation, revenues are projected to increase by 6.5%, a figure considered to be reasonable. Expenses were inflated at 5% except for those not fixed to inflation (indigent care assessment and the joint venture rent). NME has the funds to commit the initial capital and working capital for the first year. The 1989 and 1990 NME financial statements submitted with the application are those most current to filing. These statements, along with the 1991 capital budget, show more than $750,000.00 committed to the start-up of HMC's program. Much of the information presented by Mr. King in his testimony comes from the pro forma and the amendment thereto. Primarily, the difference is only in the amount provided for RHSC's management fee. Any other inconsistencies or errors shown to exist are, for the most part, minor. The entire project is based on 30 beds. The figures assumed for both revenue and expense are reasonable, considering the "other" factors testified to by the physicians and noted previously. This is so notwithstanding the fact that HMC has experienced only a 30% use rate in its acute care beds. However, in light of these other factors, there may not be any correlation between acute care and rehab either from the Medicare or other standpoints. According to Madeline Hellman, Administrative Director of Rehab Services for Memorial, CMR is a high intensity program as well as a high cost program because it uses a large number of professionals to treat the patient in a multi-disciplinary program. Memorial's existing unit has 22 beds in semiprivate rooms. It has an admissions process designed to insure that appropriate patients only are admitted. These patients are made up of a high percentage of stroke, orthopedic, and spinal cord and head injury patients. Memorial's program is a program accredited by the state and the unit is accredited by CARF, a national certifying organization dealing with quality of care. The average length of stay on Memorial's unit is presently just under 25 days which constitutes an increase over time due to the more complicated types of cases taken in. In 1991 the occupancy rate was between 98 and 99%. Memorial gets referrals from both in-house and other facilities. The patients are evaluated by the medical director for the potential to go through the rehab process. If inpatients at Memorial, they are evaluated by the therapy staff and a meeting is held to decide on admission. If the patient comes from another facility, he/she gets priority behind Memorial's patients. In order to be admitted, a patient must have a rehab diagnosis; be able to withstand the 3 hour sessions; be motivated; and have the potential to improve his/her own independence. The refusal to admit a patient does not necessarily indicate a Memorial was too full to accept that patient. It may just be the patient is not an appropriate candidate for rehab, or the patient may die or recover without rehab before getting through the admission process. Some may be referred to nursing home placement instead. Ms. Hellman's figures reflect that in 1990, approximately 42% of those referred to Memorial's unit were admitted. Approximately 35% of those referred were deemed inappropriate. Only 4% were refused admission due to bed unavailability. Many of the non- admittees went home without treatment, went to home care, or came back as outpatients. This witness examined Memorial's admissions records and determined that in 1990/1991, Dr. Hoche, who testified on behalf of HMC's application, referred 9 patients to Memorial of whom 6 were admitted. One went to another facility by choice, 1 was not appropriate, and 1 was not accounted for. Neither Dr. Klotz nor Dr. Pettie referred any patients during that period. Dr. Moscowitz referred 1 in 1990 who was admitted. One patient was referred in 1991 but was not admitted because the patient was not an appropriate candidate. Dr. Bennett referred 1 in 1990 but the patient was not an appropriate candidate. In 1991 he referred 2 but both went to nursing homes instead. During this period Dr. Mendelsohn was the medical director. Dr. Crastnopol referred 12 patients in 1990. Four were admitted; 2 were referred to other facilities; 2 were not considered appropriate candidates, and 2 were not accounted for. In 1991 he referred 17 patients, 8 of whom were admitted. Two of the remainder went to another facility by choice; 1 was refused due to no room; 1 went home; and the rest were unaccounted for. Dr. Manning referred 1 in 1990 who was admitted. Admittedly, according to Ms. Hellman, there is a waiting period of from 1 to 5 days from referral to admission - on the average, probably 3 days. This has decreased somewhat since the summer of 1991. The situation depicted by Ms. Hellman's figures differs radically from that described in the testimony of the physicians to whom she refers. On balance, the physicians' recollections and impressions of the situation are deemed of greater probative value than the bare statistics. Memorial staff salaries went up 9% last year across the board and are anticipated to go up again this year. The ancillary staff devotes 75% of its time to patient care and the other 25% to administration. This extra non- patient time is considered in assessing staffing to insure there is enough staff to do the full therapy load. There is a great deal of competition in the market for both nurses and therapists. A shortage exists which is nationwide and requires heavy recruitment efforts. At Memorial, no contract labor is used to assist in the unit. Benefits constitute an additional 24 - 25% of the salary cost and is not included in Memorial's determination of the salary and wage costs. Ms. Hellman reviewed HMC's proposed staffing as outlined in its application and feels that after taking out 25% clerical time and weekends, the social worker, for example, will only be able to handle 65% of the beds. Speech therapy would require additional people to take up the extra time on other therapies. Taken together, it is her opinion that the staff proposed by HMC is insufficient to provide a quality program. As to salaries, she feels the amount designated by HMC is low. The salaries proposed would be enough to get only new graduates and would force a high turnover. A CMR unit requires an experienced staff, (at least half of the therapy staff), to provide a quality program. Ms. Hellman is of the opinion this cannot be accomplished at the salaries proposed by HMC. In regard to both salaries and staffing level, however, Ms. Hellman's negative comments are offset by those in support of the application, and there is insufficient evidence to the negative to support a finding by a preponderance of the evidence as required that the proposed staffing levels and salaries are insufficient. HMC's 30 bed unit would compete directly with Memorial's existing unit. They are less than a mile apart and use many of the same physicians. They attract the same patients. In addition, Ms. Hellman does not believe HMC's unit will offer any new service not already offered by Memorial, nor will it operate services not already present or offered by existing providers in District X. It is her confirmed opinion that if HMC's unit is approved, it will be difficult for both facilities to attract and retain an adequate professional staff. The majority of patients that Memorial cannot accommodate are referred to Sunrise Hospital, also located in Broward County, which offers a good CMR program. Total referrals in 1990 exceeded 800 patients, and in 1991, in excess of 600 patients. The referral log maintained by Memorial does not include patients who were not referred because their physician felt there was no room anyway. Memorial's records supposedly indicate that in the last two years, only 80 to 90 referrals to its unit came from other institutions. The records were not introduced into evidence, however. Edward J. Maszak, Director of Financial Planning for Memorial, and an expert in health care financing and third party reimbursement, noted that Memorial is a disproportionate share provider under both Medicaid and Medicare. It is a taxing authority which uses funds received in taxes for the care and treatment of indigent patients. It gets $20 million in tax revenue but gives $23 million worth of indigent care in addition to taking $27 million of bad debt write-off. About $10 million of the indigent care cost is funded out of operations. The Hospital Cost Containment Board, (HCCB), statistics submitted by HMC for 1989- 1991 reflect no deduction for charity care in either the 89-90 or 90-91 time-frame. Mr. King, testifying for HMC, indicated there was no advantage to reporting charity care to the HCCB, and it is for that reason that the statistics show no deduction. Mr. Maszak disagrees with Mr. King on this point, and states that to the extent it provides any charity care at all, a facility can raise the prices it charges to some degree. Mr. Maszak reviewed HMC's application and the "incidental cost analysis" basis for the financial pro forma, and in his opinion, HMC's application does not contain a true feasibility study. The projected statement of revenue and expense in the omissions response reflect incremental costs only and do not include the actual, full costs. In a financial statement one looks at a lot of other revenue factors including operating projections and total margins, cash flows and the like, none of which are included in HMC's financial information. The financial feasibility study done by HMC here is not, in Mr. Maszak's opinion, consistent with generally accepted practices and standards. Memorial's CMR unit has lost money over the last 3 years due to the fact that it provides about 70% of its care to Medicare patients. Under that system reimbursement does not fully meet costs. Therefore, the loss has to be covered by income from other payees, (cost shifting). This is not specific to Memorial only, however. Most hospitals experience the same problem. As a result, it is hard to make up the losses from Medicare, Medicaid, and HMO operations from the 9% of patient mix representing full pay patients. In Mr. Maszak's opinion, if HMC gets its approval, in year 3 it would be subject to the same problems experienced by Memorial. Mr. Maszak asserts that with the new beds, HMC's overhead cost allocation will, under Medicare rules, increase by 19% in the first year and by 25% in the second year. This will add at least $570,000.00 additional costs in year 1 and $800,000.00 additional costs in year 2 to expenses. In year 2 the cost will be shifted to Medicare so the expense item in that year will be more by slightly more or less than $200,000.00. With regard to specific defects in HMC's proposal, Mr. Maszak points, with regard to managed care plans, to the HCCB documents which show that the HMC writes off about 65% of its revenue from HMO's. This was for 1991. Pinecrest, for example, wrote off somewhere around 38.5% that year. He believes, therefore, that HMC's figures are inaccurate. Regarding charges for CMR services in District X, HMC's 1993 charges, using its own projections, would be $1,077.00 per day. Sunrise would charge $1,765.00 per day, and Pinecrest, $1,683.00 per day. Memorial will charge $557.00 per day; Holy Cross, $747.00; and North Broward, $564.00 per day. Based on these figures, Mr. Maszak concludes that HMC's HMO estimated income is unreasonable. He contends it will be much less than estimated and more comparable to that of the other providers starting at a discount from $557.00, plus or minus, per day. Mr. Maszak is of the opinion that the insurance estimate indicated by HMC also is unreasonable. The 4% estimated by Mr. King is too low by far, and there are no national HMOs for HMC to contract with for rehab services in District X, he contends. He also believes that as to the salaries and benefits, in 1991 Memorial showed 57.8 full time employees, (FTEs), with an average nursing salary of $27.4 thousand per year. In that regard, benefits as a percent of salary was 32.2%. Sunrise showed an average nursing salary of $29.4 thousand with benefits at 27%. Pinecrest reflected $27.7 thousand and 41% respectively. Based on this, Mr. Maszak believes that the HMC projection of $22.5 thousand for salaries and benefits of 20% are far below current salaries at other NME facilities. It is unreasonable to assume, he asserts, that a provider can start up a competing unit in an open area and attract staff at those figure. Taken together, he considers that the difference between Memorial and HMC's salary figures is a $4 thousand difference for a total of $125 thousand low for HMC without considering inflation for 2 years to 1993. Turning to the issue of payor mix, according to Mr. Maszak, Medicare is reflected at 65% by HMC, but the HCCB data shows only 58% for 1991. The County reports for Memorial showed a rate of 60%. Mr. Maszak believes that HMC's estimate overstates a patient days percentage by 5% which could result in an overstatement of income revenue. Therefore, he believes the entire rehabilitative program, as suggested by HMC, is not feasible in the short term because of a number of expenses which are not figured in. He admits that HMC's current financial position is fair. It is reported to be slow in paying its bills and lost $1 million last year alone. In addition, the interest due NME has not been paid and is increasing. These claims were not supported by actual evidence, however. In addition, 65% of the population in the service area is under Medicare which limits increases to 3.2 % per year. Notwithstanding that, expenses are going up at a higher rate, (5%), and, therefore, he contends, HMC's program is not feasible as well over the long run. According to Mr. Maszak, the opening of HMC's facility would also affect Memorial's status. The staff is much the same for both facilities and many of the physician's on staff at Memorial are also investors in the HMC facility. If HMC gets its unit, Maszak feels many patients will be referred to that facility by its investors instead of to Memorial where they would now go. Based on the number of projected patients, however, this really should not result in a reduction in Memorial's numbers. The rehab service is not the only consideration, however. In addition, the admitting services , (neurology, neurosurgery and orthopedics), would also be impacted. Considering various potential scenarios, from a loss of all HMC business in all services, and no reduction of expense, through others including loss of all services with some expense reduction, loss of rehab only with some expense reduction, to a loss of 50% of all services with some expense reduction, the loss impact on Memorial would extend from a low of $264.5 thousand to $3.1 million. The most likely loss figure, he estimates, would be somewhere around $800 thousand. Therefore, approval of HMC's project, he contends, would have a large impact on Memorial's, operation because of its ongoing expansion plans and their attendant expenses, plus the recent sale of $40 million in revenue bonds. As to the latter, the underwriters of that issue are already unhappy with Memorial's financial picture. Any loss of income might likely result in a need to raise prices, but Memorial is constrained in that regard by the dictates of the HCCB. A second option is to raise taxes in the District, but there the District only has .4 of a mill leeway before reaching its limit of 2.5 mills. A third option is to cut services, but with the economy as it is, and the high level of charity care already being provided, that would be hard to do. Thomas R. Bayless, President of Future Health, Incorporated, a health care consultant and an expert in health care finance, also reviewed HMC's application and omissions response, its audited financial reports, the HCCB reports for HMC and others, and other documents. He believes the cost projections outlined in HMC's omissions response do not account for all contract costs. Thirty new beds would have a greater impact on costs than is estimated. The amount shown on the HCCB cost report for the whole hospital is more than the estimated costs for the whole hospital including the rehab unit in year 1. Mr. Bayless believes that the $366,308.00 figure for the unit in year 1 should be more than $1 million. In year 2 he sees it as $1.3 or $1.4 million as opposed to the $512,602.00 projected. By the same token, the general and administration costs reported at over $6 thousand for the whole hospital in 1991, with the 19% increase for the year, would be over $1 million and a great increase in year 2 over the $394,941.00 projected. Therefore, since all costs were not included to the appropriate degree, he contends in reality there would be a significant increase in the cost of operation of the rehab unit which would result in a much larger net loss than was projected, (plus or minus $2 million) in year 1. In year 2, due to the commencement of reimbursement from Medicare, the impact would be less. Nonetheless, the net income profit would not be as great as projected and might instead result in a loss of some $300 thousand to $400 thousand. Taken together, he concludes that expenses and some allowances are significantly understated. For example, the "other deductions" figure of $477,108.00 should be higher due to the percent of HMO discount which, in Bayless' estimate, should be 60% rather than the 20% utilized. This nearly doubles the amount of the deduction. He also disagrees with HMC's indicated deduction for rent, corporate overhead, salaries and wages, and other expense items, all of which, he believes, should be increased. The "benefits" aspect of salaries should be increased as well since the 20% projected is, in his opinion, insufficient. Memorial's figure, at 24.8%, is the standard for the area, he contends. Making those changes, the year 1 net loss for HMC's operation would be almost $3 million rather than $485,739.00. By the same token, year 2, even with Medicare cost reimbursement would result in a loss of almost $700 thousand rather than a profit of almost $1.4 million as projected. In further years out, ( years 3 - 5 ), due to the limits imposed by TEFRA and projected cost increases of 5%, the loss would be compounded somewhat. This would constitute a continuing loss and Mr. Bayless believes the project is not feasible in either the short or the long term, especially considering the fact that the hospital has been losing money without this unit and, it appears, will continue to do so. The hospital has been living on an infusion of money from the parent corporation, and this does not, to him, appear to be an appropriate use of capital. Mr. Bayless contends that most of what he said about the unit projections applies as well to the consolidated hospital rehabilitative unit projections. The losses from the operation of the rehab unit and the other defects show a loss of $7 million in year 1 and almost $6 million in year 2. Year 3 would also show a loss of almost $6 million. As another problem, Mr. Bayless opines that the statute requirement to provide information on costs during construction and the effect of the project on the applicant's and others' operations was not met. Considering the parties' respective positions, however, it is found that though subject to some debate, HMC's projections as to patient revenue, expenses, and its ability to attract a quality work force without seriously damaging Memorial's ability to provide quality care have not been shown to be unsupportable. They are, therefore, accepted. Morgan Gibson, a review consultant with the Department's Office of Community Medical Facilities, and an expert in health planning, reviewed the instant application in early 1991. When the application was deemed complete, he initiated the formal comparative review of this application and of Memorial's request for 4 beds; did an analysis; and completed the required State Agency Action Report, (SAAR), for each. A fixed need pool was published for this cycle, (January, 1996), showing a "0" numerical need. Gibson's review indicated the project was consistent with the 1990 District X Comprehensive Health Plan which establishes various priorities for the award of CONs. Priority 1 relates to an applicant who demonstrates a willingness to publish information. Both applicants met this priority. Priority 2 relates to applicants who agree to construct additional facilities to provide service to the unserved public. Here, neither application involved new construction, but both applicants were willing to provide charity care with HMC's to be at 1%. Priority 3 applies to those applicants who have a history of operating at greater than 85% utilization. HMC's hospital alone could not meet this level, but the proposed unit was projected to meet it by year 2. Priority 1 of the 1989 Florida State Health Plan relates to facilities which will convert excess beds to comprehensive beds. HMC proposes to do this which is cost effective and gets more beds to the patients. Priority 2 of this plan relates to those who propose specialty services not currently offered. HMC's answer was vague but it agreed to provide a wide range of rehab services, and the fact that it does not focus on a single specialty does not make it less desirable. Priority 3 relates to teaching hospitals. HMC is not a teaching hospital but it has agreed to affiliate with a school of osteopathic medicine in the area. Priority 4 relates to those facilities with a history of providing a disproportionate share of charity and Medicaid. HMC does not now do this but has agreed to provide 1% charity care. Priority 5 relates to those facilities showing a willingness to provide outpatient follow-up rehabilitation services, and HMC has agreed to do this. Mr. Gibson concluded that the HMC project would increase availability and access to services and would improve quality of care. He also reviewed the application against the Rule 10-5 criteria. Existing rehabilitation beds in the area are highly utilized, (Memorial is at a figure close to 100% and is the only provider in the service area). Because of this, he considered the establishment of new beds in South Broward to be better than forcing patients to go to existing beds in the North Broward area. He found that the 30 beds proposed by HMC met the unit size minimum of 20 beds and the projected utilization met the standard of 65% for the first year and 85% for the second year. He concluded that the utilization rates in the district support the program. All but one provider are operating at above 90%. In that regard, since there are only 22 beds currently existing in the south portion of the county, and all providers but one are utilized at over 90%, the new unit could not help but improve the availability to the service in the District. It is so found. The local health council data revealed to Mr. Gibson that while admissions generally decreased by 4.5% from 1985 to 1989, rehab admissions went up 189.4% in the same period. This indicated to him a potential need and increasing utilization. He also concluded that the information provided by HMC was reasonable and not fairly disputable. In that regard, Mr. Gibson concluded that HMC presented information to justify the beds regardless of the rule methodology showing "0" need. The supporting factors for this conclusion were: (1) the high current utilization; (2) the relationship of rehab admissions to discharges; (3) the service pattern; (4) the existing waiting period; (5) the elderly population in the service area; (6) the potential rehabilitation discharges; (7) the conversion of underutilized acute care beds; and (8) the maldistribution of beds between the north and south part of the county. Taken together, Mr. Gibson concluded that the addition of 30 new beds by HMC would have a positive effect, not an adverse one, on the provision of service in the community. HMC indicated its intention to seek CARF accreditation, and it appeared to meet the other quality of care standards. CARF accreditation is important. All the facilities operated by the proposed management corporation are accredited by CARF. In addition, Mr. Gibson saw no adequate alternative to the program. Maintaining the status quo was obviously not effective. Neither was building a new facility. As a result, the conversion of underutilized beds appeared to be the most appropriate resolution of the problem. He also concluded that the proposed plan was reasonable. There was a demonstrated need for additional beds and it appeared this project would meet that need without the necessity to expend millions of dollars to create a new facility. The project did not involve cooperative services or shared facilities, but this is not a disqualifier. By the same token, there is no teaching facility currently available. Neither factor really applies to this project, however. Mr. Gibson determined that HMC had the financial resources to accomplish the proposed project. Its financial statement showed that it and its parent company both were in good financial health. The project cost could easily be met by existing resources. The applicant indicated that staffing levels would be met and the retaining of a management company to operate the facility was a plus factor. Before rendering his opinion, Mr. Gibson consulted with the Department's financial consultants, and based on the applicant's projections and assumptions, if the utilization levels of 65% and 85% for years 1 and 2 respectively were met, the project would be financially feasible in both the short and the long term. Mr. Gibson concluded that the utilization projections were reasonable based on current utilization of existing beds. As to fostering competition and cost effectiveness, Mr. Gibson determined that based on the current high utilization rate, the new beds should have no impact on existing services provided by Memorial in the south and the other existing providers in the north. With regard to charity care, HMC admitted that up until this time it had reported little or no charity care provided. Because HMC admitted that, however, Mr. Gibson was willing to accept its assertion as to what it proposed to do in the area in the future. Turning to the criteria outlined in Section 381.705(2), Florida Statutes, Mr. Gibson found: (1) there was, practically, no less costly or more appropriate alternative to the proposed service; (2) the existing service was being utilized efficiently; (3) there were no reasonable alternatives to conversion; and (4) there was some showing of a shortage of available service and no showing of serious problems existing in providing those services. Based on all the above, Mr. Gibson recommended both this application and Memorial's application be approved conditioned on the provision of a certain percentage of charity care. Mr. Gibson admits there is, on balance, a general shortage of rehabilitation personnel, but cannot say whether or not there is a shortage in Broward County. His conclusion that staff was available to HMC was based on several other factors such as the management contract and the proposed recruitment - all representations by the applicant and not based on his own experience. By the same token, he did not test any of the tables for revenues, costs, salaries, etc. Here again he relied on representations by the applicant. In addition to those aforementioned statutory criteria Mr. Gibson evaluated this application against the Section 381.707 criteria as well, and determined it was complete. It is clear, however, that his evaluation was not done in great detail, nor did he attempt to verify much of the other information submitted in support of the 381.705 criteria. The financial aspects of the project were analyzed by an in-house departmental CPA, Mr. Bell. Gibson's involvement was limited to examining the projected admissions, utilization, charges and the like, and based on those, he relied on Mr. Bell's determination they are reasonable and his opinion on feasibility. Nonetheless, Gibson drew his own positive conclusion of feasibility which was cited above. There appears to be no legitimate reason to reject any of the findings of conclusions drawn by Mr. Gibson. Therefore, they are accepted. Elizabeth Dudek, the Chief of the Department's Office of Community Medical Facilities, met with Mr. Gibson, Mr. Bell, and the architect after reading both the applications and the SAAR and, thereafter recommended the project be approved. After considering the application, the projected utilization, the existing inventory, the state and local health plans, the area where the facility was to be located, and at the provisions of the pertinent statutes and rule, she believed the project proposed was justified. She concluded both HMC and Memorial should be awarded the beds requested. Her reasons therefore conform to the findings of Mr. Gibson regarding existing providers and the high utilization rate. The trade patterns support a division of service between the north and the south. She determined that because this application did not meet all preferences and priorities as outlined in the various health plans did not necessarily mean it should be denied. By the same token, the fact that comprehensive rehab services are considered by the Department to be a tertiary service does not mean that the service must be provided only in teaching hospitals. Ms. Dudek recognizes that Section 381.707(2)(d) requires a detailed statement of income and revenue which includes the two year pro forma assumptions, Table 25, and the list of capital projects. Her review of the matters provided by the applicant and the audit and source of funds referenced led her to the conclusion that requirement was met. There is no basis shown upon which to reject that conclusion or to conclude otherwise.
Recommendation Based on the foregoing Findings of fact and Conclusions of Law, it is, therefore recommended that NME Hospitals, Inc.'s application for a Certificate of Need, Number 6643, for a 30 bed inpatient comprehensive medical rehabilitation unit at Hollywood Medical Center be approved, but that its Motion For Attorney's Fees and Costs be denied. RECOMMENDED this 2nd day of June, 1992, in Tallahassee, Florida. ARNOLD H. POLLOCK, 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 2nd day of June, 1992. APPENDIX TO RECOMMENDED ORDER, CASE NO. 91-5698 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties to this case. FOR THE PETITIONER: 1. Accepted and incorporated herein. 2. - 4. Accepted and incorporated herein. 5. Accepted and incorporated herein. 6. Accepted. 7. & 8. Accepted and incorporated herein 9. Accepted and incorporated herein except for last sentence of first paragraph which is rejected as contra to the evidence. The second paragraph is accepted but is considered irrelevant to the issues. & 11. Accepted and incorporated herein. Accepted. Not a Finding of Fact but a restatement of testimony. First and third sentences are restatements of terstimony. Second and fourth sentences are accepted. Accepted. Accepted. Accepted and incorporated herein. Accepted and incorporated herein. Accepted and incorporated herein. Rejected. Not a Finding of Fact but argument. Accepted as to witness' testimony but not as to an an evaluation of its worth. All but the last sentence is a restatement of the witness' testimony. Last sentence is accepted as Petitioner's position. First two sentences accepted and incorporated herein. Balance, though a restatement of testimony is fundamentally accurate and consistent with the evidence. Though consistent with Petitioner's position, and perhaps factually accurate,this ppoposed Findings is rejected as overlooking the "other basis" provisions of the need rule. Accepted as an accurate statement of the factors involved, but this position was rejected in the Findings of Fact portion of the Recommended Order. - 28. Rejected as contra to the weight of the evidence. All but last sentence accepted and incorporated herein. Last sentence rejected. Accepted and incorporated herein. Rejected as argument and contra to the weight of the evidence. Rejected as argument. - 37. Accepted as an accurate restatement of the evidence, but rejected as to the ultimate factual conclusions drawn. 38. - 40. See next above which is reiterated here. & 42. Accepted as to the testimony presented but rejected as to the efficacy of the analysis. Accepted as to content but not as to analysis. & 45. Contents accepted as an accurate restatement of the testimony but conclusions drawn are rejected. Rejected. First paragraph accepted. Second paragraph rejected as speculation. Accepted and incorporated herein. Accepted. First sentence accepted. Remainder rejected as speculative with no historical basis. FOR THE RESPONDENT, NME: - 8. Accepted and incorporated herein. Accepted and incorporated herein. - 14. Accepted and incorporated herein. - 19. Accepted and incorporated herein. Accepted and incorporated herein. Accepted and incorporated herein. & 23. Accepted and incorporated herein. Accepted. Accepted and incorporated herein. Not a finding of fact but a comment on the evidence. 27. - 29. Accepted and incorporated herein. 30. Accepted and incorporated herein. 31. Accepted. 32. - 34. Accepted and incorporated herein. 35. - 37. Accepted. 38. - 40. Accepted. 41. & 42. Accepted and incorporated herein. 43. Accepted. 44. - 46. Accepted and incorporated herein. 47. & 48. Accepted and incorporated herein. 49. Accepted. 50. - 52. Accepted. 53. & 54. Accepted and incorporater herein. 55. Accepted. 56. - 58. Accepted and incorporated herein. 59. Accepted. 60. Accepted and incorporated herein. 61. - 63. Accepted. 64. - 68. Accepted and incorporated herein. 69. - 75. Accepted and incorporated herein. 76. Accepted and incorporated herein. 77. Accepted. 78. Accepted. 79. Accepted. 80. Accepted and incorporated herein. 81. & 82. Accepted. 83. - 86. Accepted and incorporated herein. 87. Accepted and incorporated herein. 88. Accepted. 89. Accepted and incorporated herein. 90. Accepted. 91. Accepted and incorporated herein. 92. Accepted and incorporated herein. 93. Accepted and incorporated herein. 94. - 97. Accepted and incorporated herein. 98. - 100. Accepted and incorporated herein. 101. & 102. Accepted. 103. - 106. Accepted and incorporated herein. 107. Accepted and incorporated herein. 108. Accepted and incorporated herein. 109. Accepted. 110. Accepted. 111. - 114. Accepted. 115. Accepted and incorporated herein. 116. Accepted. 117. & 118. Accepted but more a comment on evidence than finding of fact. 119. & 120. Not a finding of fact but a comment on evidence. 121. Accepted. 122. - 125. Not findings of fact but comments on the evidence. 126. Accepted. 127. Not a finding of fact. 128. Accepted. 129. Not a finding of fact but more an argument. 130. Accepted. 131. Accepted. 132. - 133. Accepted and incorporated herein. 134. & 135. Accepted. Not a finding of fact but argument. Accepted. Not a finding of fact. Accepted. - 148. Not findings of fact but argument. 149. & 150. Accepted. 151. Not a finding of fact but argument. FOR THE RESPONDENT, DHRS: 1. Accepted and incorporated herein. 2. - 4. Accepted and incorporated herein. 5. - 11. Accepted and incorporated herein. 12. - 15. Accepted and incorporated herein. 16. - 19. Accepted and incorporated herein. 20. Accepted. 21. - 23. Accepted and incorporated herein. 24. Accepted and incorporated herein. 25. - 28. Accepted and incorporated herein. 29. - 35. Accepted and incorporated herein. 36. - 40. Accepted and incorporated herein. 41. Accepted. 42. Accepted and incorporated herein. 43. Accepted. 44. - 46. Accepted and incorporated herein. 47. & 48. Accepted and incorporated herein. 49. Accepted. 50. - 52. Accepted and incorporated herein 53. - 61. Accepted and incorporated herein. 62. & 63. Accepted. 64. Accepted and incorporated herein. 65. Accepted. 66. Accepted and incorporated herein. 67. Accepted. 68. - 75. Accepted and incorporated herein. 76. & 77. Accepted and incorporated herein. Not a finding of fact but a restatement of evidence. Accepted. - 84. Accepted and incorporated herein. Accepted. Accepted and incorporated herein. Accepted and incorporated herein. & 89. Accepted and incorporated herein. Accepted. Accepted and incorporated herein. Accepted and incorporated herein. Accepted and incorporated herein. COPIES FURNISHED: R. Terry Rigsby, Esquire F. Philip Blank, Esquire Blank, Rigsby & Meenan, P.A. 204-B South Monroe Street Tallahassee, Florida 32301 Thomas R. Cooper, Esquire Department of Health and Rehabilitative Services 2727 Mahan Drive - Suite 103 Tallahassee, Florida 32308 C. Gary Williams, Esquire Michael Glazer, Esquire Ausley, McMullen, McGehee, Carothers & Proctor 227 South Calhoun Street Tallahassee, Florida 32302 John Slye General Counsel DHRS 1323 Winewood Blvd. Tallahassee, Florida 32399-0700 Sam Power Agency Clerk DHRS 1323 Winewood Blvd. Tallahassee, Florida 32399-0700
