The Issue Whether proposed rules 64J-2.010, 64J-2.012, 64J-2.013, and 64J-2.016 of the Florida Administrative Code (“the Proposed Rules”) are an invalid exercise of delegated legislative authority as defined in section 120.52(8), Florida Statutes (2016).1/
Findings Of Fact Background on Trauma Centers A “trauma center” is “a hospital that has been verified by the department to be in substantial compliance with the requirements in s. 395.4025 and has been approved by the department to operate as a Level I trauma center, Level II trauma center, or [a] pediatric trauma center ” § 395.4001(14), Fla. Stat. Trauma centers must have a wide array of resources at their disposal at all times. For example, a trauma center must have approximately 30 specialists such as trauma surgeons, neurosurgeons, orthopedic surgeons, and anesthesiologists. A trauma center must also have specially trained nurses, advanced imaging and diagnostic equipment, dedicated operating rooms, a blood bank, specialized nursing units, and a helipad. Many of the personnel working in trauma centers have special training. Trauma surgeons have one or two additional years of critical care training followed by another year of training in emergency surgery or acute care surgery. Trauma center nurses typically have three additional years of training/education. In short, a trauma center is a hospital that has made a substantial investment in order to have the resources and personnel capable of caring for trauma patients. Florida Administrative Code Rule 64J-2.001(15) defines a “trauma patient” as “any person who has incurred a physical injury or wound caused by trauma and who has accessed an emergency medical services system.” Trauma injuries commonly occur as a result of motor vehicle accidents, falls from height, gunshot wounds, and stab wounds. See § 395.4001(18), Fla. Stat. (defining a “trauma victim” as “any person who has incurred a single or multisystem injury due to blunt or penetrating means or burns and who requires immediate medical intervention or treatment.”); Fla. Admin. Code R. 64J-2.001(12) (defining “trauma” as “a blunt, penetrating or burn injury caused by external force or violence.”). Trauma injuries are a leading cause of death for those ranging in age from 1 to 45. Hospitals with emergency departments (i.e., acute care hospitals) are capable of treating patients on an emergency basis. However, they would not necessarily have constant access to all of the resources mentioned above. In addition, acute care hospitals have not gone through the statutory process of being approved by the Department to operate as a trauma center. § 395.4001(14), Fla. Stat. (defining a “trauma center” as “a hospital that has been verified by the department to be in substantial compliance with the requirements in s. 395.4025 and has been approved by the department to operate as a Level I trauma center, Level II trauma center, or pediatric trauma center, or is designated by the department as a Level II trauma center pursuant to s. 395.4025(14).”). See also § 395.401(1)(k), Fla. Stat. (mandating that “[i]t is unlawful for any hospital or other facility to hold itself out as a trauma center unless it has been so verified or designated pursuant to s. 395.4025(14).”).3/ In general, a patient in danger of imminent death from a trauma injury is likely to have a better chance of survival if he or she is treated in a trauma center as opposed to an acute care hospital. The Parties The Department is the state agency charged with implementing the laws governing the regulation of trauma centers. See § 395.40(3), Fla. Stat. (noting “[i]t is the intent of the Legislature to place primary responsibility for the planning and establishment of a statewide inclusive trauma system with the department. The department shall undertake the implementation of a statewide inclusive trauma system as funding is available.”); § 395.401(2), Fla. Stat. (mandating that “[t]he department shall adopt by rule, standards for verification of trauma centers based on national guidelines . . . .”); § 395.4015(1), Fla. Stat. (mandating that “[t]he department shall establish a state trauma system plan.”); § 395.402(2), Fla. Stat. (mandating that “[t]he department shall review the existing trauma system and determine whether it is effective in providing trauma care uniformly throughout the state.”). Of particular relevance to the instant case is the legislative mandate that the Department shall adopt rules governing the number of trauma centers that can be operated in Florida. See § 395.402(4)(b), Fla. Stat. (mandating that “[t]he department shall allocate, by rule, the number of trauma centers needed for each trauma service area.”). Those rules (see, e.g., rule 64J-2.010) determine how many trauma centers can be in a particular trauma service area (“TSA”). The Legislature has assigned each county in Florida to a TSA, and there are currently 19 TSAs in Florida. See § 395.402(4), Fla. Stat. With regard to Petitioners, Shands Jacksonville operates a Level I trauma center in TSA 5, which consists of Baker, Clay, Duval, Nassau, and St. Johns Counties. Tampa General operates a Level I trauma center in TSA 10, which consists of Hillsborough County. Lee Memorial operates a Level II trauma center in TSA 15, which consists of Charlotte, Glades, Hendry, and Lee Counties. Bayfront Health operates a Level II trauma center in TSA 9, which consists of Pinellas and Pasco Counties. St. Joseph’s Hospital operates a Level II trauma center and a pediatric trauma center in TSA 10, which consists of Hillsborough County. As for the intervenors, JFK Medical Center is a licensed acute care hospital that has submitted a letter of intent to the Department so that it can apply to operate a Level II trauma center in TSA 17, which consists of Palm Beach County. Orange Park operates a provisional Level II trauma center in TSA 5, and Jackson South operates a provisional Level II trauma center in TSA 19, which consists of Miami-Dade and Monroe Counties. The meaning of the term “provisional trauma center” will be explained below. The Statutory Scheme Governing Trauma Centers As noted above, each of Florida’s 67 counties has been assigned to one of 19 TSAs, and the 19 TSAs play an important role in the location of trauma centers throughout the state. See § 395.4025(1), Fla. Stat. (providing that “[f]or purposes of developing a system of trauma centers, the department shall use the 19 trauma service areas established in s. 395.402. 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, the department shall establish the approximate number of trauma centers needed to ensure reasonable access to high-quality trauma services.”); § 395.402(4)(b), Fla. Stat. (providing that the Department “shall allocate, by rule, the number of trauma centers needed for each [TSA].”). The Florida Legislature has mandated that every TSA “should have at least one Level I or Level II trauma center.” § 395.402(4)(b), Fla. Stat. However, there is a state-wide, statutory cap of 44 trauma centers. § 395.402(4)(c), Fla. Stat. (mandating that “[t]here shall be no more than a total of 44 trauma centers in the state.”). Hospitals seeking approval to operate trauma centers must complete a rigorous review process, and that process begins with a potential applicant submitting a letter of intent to the Department by October 1 of a particular year. See § 395.4025(2)(a), Fla. Stat. (providing that “[t]he department shall annually notify each acute care general hospital and each local and each regional trauma agency in the state that the department is accepting letters of intent from hospitals that are interested in becoming trauma centers. In 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 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. Letters of intent must be postmarked no later than midnight October 1.”). By submitting a letter of intent, a hospital does not become obligated to subsequently file a fully fledged trauma center application. Fla. Admin. Code R. 64J-2.012(1)(a) (providing that “[t]he letter of intent is non-binding, but preserves the hospital’s right to complete its application by the required due date if an available position, as provided in Rule 64J-2.010, F.A.C., exists in the hospital’s TSA.”). “By October 15, the department shall send to all hospitals that submitted a letter of intent an application package that will provide the hospitals with instructions for submitting information to the department for selection as a trauma center.” § 395.4025(2)(c), Fla. Stat. Applications from hospitals seeking to operate trauma centers must be received by the Department by the close of business on April 1 of the following year. Once the Department receives a trauma center application, it conducts “a provisional review of each application for the purpose of determining that the hospital’s application is complete and that the hospital has the critical elements required for a trauma center.” § 395.4025(2)(c), Fla. Stat. The Department’s provisional review includes, but is not limited to, an examination of whether an applicant has: the equipment and facilities necessary to provide trauma services; (b) personnel in sufficient numbers and with proper qualifications to provide trauma services; and (c) an effective quality assurance process. See § 395.4025(2)(c), Fla. Stat. “After April 30, any hospital that submitted an application found acceptable by the department based on provisional review shall be eligible to operate as a provisional trauma center.” § 395.4025(3), Fla. Stat. A hospital that has been approved to operate as a provisional trauma center can immediately begin providing care to trauma victims. From an operational perspective, there is no difference between a provisional trauma center and one that is fully verified. Between May 1 and October 1 of the year following the filing of the letter of intent, the Department conducts an in- depth evaluation of all the applicants that were deemed eligible to operate as provisional trauma centers. § 395.4025(4), Fla. Stat. Then, between October 1 of the year following the filing of the letter of intent and June 1 of the next year, a review team of out-of-state experts assembled by the Department makes “onsite visits to all provisional trauma centers.” The out-of-state experts utilize a survey instrument developed by the Department that includes “objective criteria and guidelines for reviewers based on existing trauma center standards such that all trauma centers are assessed equally.” § 395.4025(5), Fla. Stat. That survey instrument also includes “a uniform rating system that will be used by reviewers to indicate the degree of compliance of each trauma center with specific standards, and to indicate the quality of care provided by each trauma center as determined through an audit of patient charts.” § 395.4025(5), Fla. Stat. Even if a hospital satisfies all of the requirements to operate a trauma center, there must be a need for a trauma center in the relevant TSA. See § 395.4025(5), Fla. Stat. (providing that “hospitals being considered as provisional trauma centers shall meet all the requirements of a trauma center and shall be located in a trauma service area that has a need for such a trauma center.”). (emphasis added). The Department, based on recommendations from the review team, selects trauma centers by July 1 of the second year following the filing of the letter of intent. § 395.4025(6), Fla. Stat. Following this initial approval, “[e]ach trauma center shall be granted a 7-year approval period during which time it must continue to maintain trauma center standards and acceptable patient outcomes as determined by department rule.” Id. An approval, “unless sooner suspended or revoked, automatically expires 7 years after the date of issuance and is renewable upon application for renewal as prescribed by rule of the department.” Id. Also, “[n]otwithstanding any provision of chapter 381, a hospital licensed under ss. 395.001-395.3025 that operates a trauma center may not terminate or substantially reduce the availability of trauma service without providing at least 180 days’ notice [to the Department] of its intent to terminate such services.” § 395.4025(8), Fla. Stat. There are currently 33 approved trauma centers in Florida. Unless the statewide cap of 44 in section 395.402(4)(c) is amended or removed, the Department can only approve 11 more trauma center applicants. Assessment of Need for Trauma Centers under the Current Rules The Department must annually assess Florida’s trauma system, including the number and level of trauma centers needed for each trauma service area. See § 395.402(2)(b), Fla. Stat. (requiring the Department 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(3), Fla. Stat. (mandating that the Department must consider the following during its annual reviews: recommendations of regional trauma agencies; stakeholder recommendations; the geographic composition of an area; historical patterns of patient referral and transfer in an area; inventories of available trauma care resources; population growth characteristics; transportation capabilities; medically appropriate ground and air travel times; recommendations of the Regional Domestic Security Task Force; the actual number of trauma victims currently being served by each trauma center; and other appropriate criteria). As noted above, the Legislature has empowered the Department to adopt rules governing the procedures and process by which it will determine which applicants will be selected for designation as trauma centers. See § 395.4025(13), Fla. Stat. (providing that “[t]he department may adopt, by rule, the procedures and process by which it will select trauma centers. Such procedures and process must be used in annually selecting trauma centers and must be consistent with subsections (1)-(8) except in those situations in which it is in the best interest of, and mutually agreed to by, all applicants within a service area and the department to reduce the timeframes.”). The rules governing trauma centers are set forth in Florida Administrative Code Chapter 64J-2 (collectively referred to as “the Current Rules”). With regard to the instant case, rule 64J-2.010 is particularly relevant and details how Level I and Level II trauma centers will be allocated among the 19 TSAs. On an annual basis beginning on or before August 30, the Department implements the process set forth in rule 64J- 2.010 by conducting the annual assessment mentioned above and assigning a score to each TSA. The process in rule 64J-2.010 begins by evaluating each TSA pursuant to the following criteria: (a) population; median transport times; (c) community support; (d) severely injured patients discharged from acute care hospitals; (e) Level I trauma centers; and (f) number of severely injured patients. For each of the aforementioned criteria, points are assigned to each TSA based on data from the annual assessment. The point scales associated with each criterion are designed to measure the need in each TSA for trauma center services. For example, a TSA with a population of less than 600,000 would receive 2 points, and a TSA with a population of greater than 2,400,000 would receive 10 points. TSAs with populations between those two extremes would receive 4, 6, or 8 points. See Fla. Admin. Code R. 64J-2.010(1)(a)1. As for median transport time, a TSA with a median transport time of less than 10 minutes would receive 0 points. In contrast, if the median transport time in a TSA was greater than 41 minutes, then that TSA would receive 4 points. TSAs with median transport times between those two extremes would receive 1, 2, or 3 points. See Fla. Admin. Code R. 64J- 2.010(1)(a)2. After a TSA’s total score is determined, the Department compares that score to the scale in rule 64J- 2.010(1)(b) which provides that: 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. In the Current Rules, rule 64J-2.010(3) contains a table setting forth the results based upon the March 24, 2014, Amended Trauma Service Area Assessment. For example, the table in rule 64J-2.010(3) indicates that TSA 1 consisting of Escambia, Okaloosa, Santa Rosa, and Walton Counties has a need for one trauma center. In contrast, the table indicates that TSA 19 consisting of Dade and Monroe Counties has a need for three trauma centers. The Department Changes Its Interpretation of “Need” In October of 2014, Orange Park filed a letter of intent indicating its desire to operate a trauma center in TSA 5. Because the Current Rules indicated that there was no need for an additional trauma center in TSA 5, the Department rejected Orange Park’s letter of intent. That action was consistent with a determination that the numeric “need” derived from rule 64J-2.010 establishes the maximum number of trauma centers that are needed in a particular TSA. In 2015, Orange Park submitted another letter of intent to operate a trauma center in TSA 5. The Department accepted that letter of intent even though the numeric “need” derived from rule 64J-2.010 for TSA 5 had not changed. That action was consistent with a determination that the numeric “need” derived from rule 64J-2.010 establishes the minimum number of trauma centers that are needed in a particular TSA. After the Department approved Orange Park’s application to operate as a provisional Level II trauma center in TSA 5, Shands Jacksonville challenged that decision, and Administrative Law Judge W. David Watkins issued a Recommended Order on January 27, 2017, concluding that Orange Park’s application must be denied. In the process of doing so, ALJ Watkins also concluded that “[t]he Department’s policy of accepting letters of intent and trauma center applications irrespective of need as established in rule 64J-2.010, constitutes an unadopted rule and is contrary to its validly adopted rules and statute.” Shands Jacksonville Med. Ctr., Inc., d/b/a UF Health Jacksonville v. Dep’t of Health and Orange Park Med. Ctr., Inc., DOAH Case No. 16-3369 (Recommended Order Jan. 27, 2017). Through the Proposed Rules, the Department is seeking to formalize its new interpretation of the term “need” as meaning the minimum number of trauma centers needed in a particular TSA. Assessment of Need under the Proposed Rules During the final hearing in this matter, Department employees described the Department’s impetus for changing its determination of how the term “need” as that term is used in chapter 395, part II, should be interpreted. For instance, the Department’s mission is to promote, protect, and improve the health of those living and visiting Florida. Because approximately 31 percent of severely injured patients were treated at acute care hospitals rather than trauma centers in 2013, the Department believes that there are an insufficient number of trauma centers in Florida. Also, as one or more trauma centers are added to a particular TSA, the Department observed that the number of trauma centers “needed” in that TSA under rule 64J-2.010 would decrease. This decrease would occur because median transport times and the number of severely injured patients discharged from acute care hospitals would decrease with the addition of trauma centers to that TSA. Accordingly, the Department deems the formula in rule 64J-2.010 to be a “diminishing” formula. As explained by Sue Dick, the Department’s Interim Division Director for the Division of Emergency Preparedness and Community Support (and former Chief of the Tallahassee, Florida Fire Department): [W]e saw the numbers required in a certain trauma service area diminishing because care was better. That’s what led us to go, wait a minute, that can’t be a maximum number because we are going to end up at a point where we say a maximum number is zero. So that’s when we started to look at the allocation and say, what we are really determining is how many more should they have to ensure that all patients are reaching median transport time in less than 10 minutes and very few patients are being discharged from acute care hospitals. That’s what led to the logic behind revisiting this rule and this formula. On September 1, 2016, the Department proposed a series of amendments to rules 64J-2.010, 64J-2.012, 64J-2.013, and 64J- 2.016. The Proposed Rules would implement the Department’s new policy of deeming the calculations pursuant to rule 64J- 2.010(1)(b) to represent the minimum number of trauma centers needed in a particular TSA rather than the maximum number of trauma centers allowed in that TSA. For instance, the Proposed Rules’ version of rule 64J- 2.010(1)(b) would amend the current version of rule 64J- 2.010(1)(b) to read as follows: “[t]he following scoring system shall be used to determine the minimum number of allocate trauma centers needed within the TSAs. Also, the Proposed Rules would add a subsection (4) to rule 64J-2.010, which would state that “[t]he allocation of trauma centers, as described in subsections (1) through (3) of this rule, is the minimum allocation needed and shall not affect existing verified trauma centers seeking renewal of their verification status pursuant to subsection 395.4025(6), F.S., . . . .” (emphasis added). The Proposed Rules would amend rule 64J-2.012(1)(a) to read as follows: “[t]he letter of intent is non-binding, but preserves the hospital’s right to complete its application by the required due date if, subject to the trauma center limit in paragraph 395.402(4)(c), F.S., an available position, is open as provided in Rule 64J-2.010, F.A.C., exists in the hospital’s TSA.” As a result, there would no longer be TSA-specific caps in rule 64J-2.010, and the statewide cap of 44 trauma centers in section 395.402(4)(c) would be the only numeric cap on trauma centers. The same result would flow from the Proposed Rules’ amendment to rule 64J-2.013(7): The department shall make a final determination on whether to approve or deny a hospital’s extension request only after the provisional review of all other trauma center applications in the hospital’s TSA are completed, and it has been determined that the number of trauma centers and Provisional Ttrauma Ccenters, in the hospital’s TSA is less than or equal to the allocated number of trauma centers allowed by paragraph 395.402(4)(c), F.S. positions available for that TSA. Finally, subsection (12) of rule 64J-2.013 would become subsection (11) and be amended as follows: A hospital receiving an extension greater than 12 months shall have its extension denied or terminated if the number of trauma centers and or Provisional Ttrauma Ccenters in the hospital’s TSA equals or is greater than the number of trauma centers provided in paragraph 395.402(4)(c), F.S available positions allocated to the TSA, resulting in the denial of its application and the department will inform the applicant of its right to a Section 120.57, F.S., hearing regarding this denial. Because the Proposed Rules would result in the calculations pursuant to rule 64J-2.010(1)(b) representing the minimum number of trauma centers needed in a particular TSA rather than the maximum number of trauma centers allowed in that TSA, the Department could conceivably approve every applicant in that TSA so long as the statutory cap of 44 trauma centers in section 395.402(4)(c) would not be exceeded. The Proposed Rules also establish a tie-breaker system if the sum of provisional trauma centers found eligible for selection by the Department and the number of existing trauma centers would exceed the statutory limit established in section 395.402(4)(c). The tie-breaking criteria would consider the following: (a) whether the TSA in question already has a Level I or Level II trauma center; (b) the level of service that the applicants propose to provide; (c) the number of severely injured patients treated by the applicants; and (d) approval by a Department-approved trauma agency plan. Chief Dick testified that the Department would exercise discretion to ensure that a TSA that already had the minimum number of trauma centers under the Proposed Rules would not receive an additional trauma center if the statutory cap of 44 would be met or exceeded and another TSA lacked the statutory minimum of one: Q: Now, I want to explore a little bit one of the answers that you gave to Mr. Reynolds regarding how the [Proposed Rules] would work in conjunction with the statutory cap of 44 and the requirement for assignment of a trauma center to each TSA. Let me ask you a hypothetical. If there [are] 43, when you get to the point when there [are] 43 trauma centers that are opened around the state but there is still not one in Collier County, how does it work at that point as a potential new applicant comes in? A: If they are not in Collier County, they won’t be verified. We have a statutory obligation to meet the minimum of one per TSA, so – at a statutory cap of 44. So logic would state then as part of that 44, it includes one per TSA. So if there are 43 and there are none in TSA 17, we would have to reserve that spot until such point as there is one at a minimum in TSA 17, which is Collier, I believe. Q: Would that likewise be the approach if you have a TSA where the methodology calculates there is a need for four, but there [are] only three that are opened, how would it work then? A: I think it would be responsible of the Department, as we view the results of this allocation methodology as setting a minimum need to ensure reasonable access to care, that we would withhold spots until such point as that minimum is met per TSA. So if we are at 42 and there is still not one in TSA 17, which we just spoke to, but in addition there is another TSA that has one but through our methodology, we really think they need a minimum of two, I believe it’s within the Department’s authority to withhold that second one as well. However, Chief Dick acknowledged in subsequent testimony that the discretion she relies upon does not originate from a statute or a rule: Q: I think we had put forth that there’s been some testimony concerning the hypothetical, the what if there’s more applications received by the Department in a cycle than there are statewide slots? So in other words, you’ve got enough applications that its’s going to pop you over the [statutory cap of] 44. Do you understand my hypothetical? ALJ: We are still talking about the [Current Rules]? Q: Under [the Proposed Rules]. ALJ: [Proposed Rules]. Okay. Q: Thank you. A: I understand what you are saying. Q: And would you agree that there’s nothing in the [Proposed Rules] that tells you what happens in that circumstance, if the number received in all of the TSAs will put you over the statewide number? A: There’s nothing in the proposed rule that states that if we receive more applications than there are available spots statewide, what we will do. Q: Correct. There’s no criteria or standards? A: No, those procedures are not outlined in the rule, no. Q: Similarly, there’s nothing in [the Proposed Rules] that would preclude that all of the open positions statewide could be in one TSA or two TSAs to the exclusion of others; there’s nothing that prevents that from occurring? A: Well, I think there is something that prevents that from occurring, and the first thing being that – the first thing we would look at is to ensure there is at least one trauma center in each TSA so we would be able to reserve that. And the other thing I think is where it speaks to a trauma service area, trauma service area that has a need, we would interpret that to mean a minimum need as determined by our allocation methodology. So I would say that if there are – if it were an issue of we were going to go over the 44 and there was a TSA that still did not meet their minimum as we’ve outlined in our proposed rule, that it would be within our prerogative of the Department to hold a spot for that TSA to meet that minimum. Q: When you say it would be within your prerogative, there is nothing in the statute that outlines that procedure you just discussed, that you would hold one in your back pocket and say, I need that one for Collier County? A: No. Q: There’s nothing in [the Proposed Rules] that says that? A: No, there’s been a number of hypotheticals presented, and I just don’t think you can craft a rule that would address every hypothetical. So, no, there’s nothing that speaks specifically to that, what our specific process would be under those specific circumstances. * * * Q: I understand. [The Proposed Rules set] a minimum and all – my only question is, there [are] no standards or criteria in [the Proposed Rules] that would identify how many above the minimum should be approved; the Department’s position is it would approve as many as are applied for, if they meet all the standards? A: And have the endorsement of the regional trauma agency, yes. The Potential Utility Associated with Adopting the Proposed Rules All parties have proceeded under the reasonable assumption that adoption of the Proposed Rules would lead to more trauma centers in Florida. The Department and Intervenors’ primary argument in support of the Proposed Rules is that more trauma centers will result in: (a) increased access to the specialized care available at trauma centers; and (b) less time needed to transport trauma patients to trauma centers. Undertriage occurs when a severely injured patient in need of trauma care is treated by an acute care hospital. In that circumstance, the patient does not receive the benefit of being admitted to a facility dedicated to treating severely injured patients. The January 6, 2016, Amended Trauma Service Area Assessment by the Department indicates that approximately 31 percent of severely injured patients in Florida received care in an acute care hospital rather than a trauma center in 2013. Dr. Mark McKenney, an expert in surgical care and trauma care, characterized undertriage as an access to care problem that could threaten one’s life: I don’t think that any of us would feel good to have a third of us, when we have a life- threatening injury, end up in a hospital that doesn’t have a trauma team, doesn’t have trauma nurses, doesn’t have a trauma intensive care unit, doesn’t have an operating room immediately available, doesn’t have a surgeon in the hospital 24/7 who can take care of this, and doesn’t have subspecialists who routinely take care of the traumatically injured patients. A third is just too high a number. With regard to transport times, trauma care professionals refer to a generally accepted clinical principle for rendering treatment known as “the Golden Hour.” Within one hour after a person is injured, all of the following should occur: (a) emergency personnel are notified, arrive at the injury scene, evaluate the patient, and transport the patient to a trauma center; and (b) the trauma center starts resuscitation; conducts another evaluation of the patient; and performs a life-saving procedure. According to the Department and Intervenors, the increased access to trauma centers and the decreased transport times associated with adoption of the Proposed Rules will save lives.4/ Petitioners’ response to that line of reasoning is that an increase in the number of trauma centers will lead to a decrease in the quality of care rendered to trauma patients. A trauma center needs to treat a certain number of severely injured patients in order for its personnel to remain proficient and for the trauma center’s quality of care to remain high. During the final hearing, Petitioners presented persuasive testimony that “practice makes perfect” with regard to the treatment of trauma patients. For instance, Dr. Steven Epstein, an expert in trauma surgery, credibly testified that trauma injuries require a different level of expertise and that experience acquired through treating less severe injuries does not necessarily translate to the treatment of trauma patients: If you have a set number of patients and you put another trauma center geographically close, what happens is that you will cut the number of patients going to each place, each trauma center. And expertise in the general surgery world, as well as the trauma world, is based on volume. Let me start with the general surgery world and then move toward trauma. We know that in general surgery, residencies right now, they are focusing on different areas of surgery: breast surgery, colorectal surgery, laparoscopic surgery, so that people become experts in these areas. The idea of the general surgeon is going away. The same thing occurs with trauma surgery. Only the expertise there is learned during a fellowship and then with practice. If you take, for instance, a gunshot, the anatomy, any general surgeon can take out a gallbladder, but not any general surgeon can handle a gunshot to the abdomen. The anatomy changes. It’s a much different case. So people who have done this on a regular basis have some idea how to do this. The – what I call the voyeur, you bring in a general surgeon to do some trauma because we don’t have enough trauma surgeons, doesn’t have this same expertise. And you wind up as really – it’s a patient problem. We are talking about it as a problem with hospitals, but this is a patient problem. If the doctor doesn’t know how to treat the patient, then the patient suffers. And I think in the end, that’s what happens when you dilute an expertise. And trauma, with the addition of all these hospitals, winds up diluting an expertise. * * * We, meaning the doctors at our hospital and several other hospitals, have always made an assumption we practice, we practice, we practice, and we get better. If you don’t have the patients – because they call it the practice of medicine. If you don’t have the patients to practice with, you are not going to maintain your expertise. And I use the example, for instance, of a gunshot. But we do blunt trauma where people are in auto accidents, they are in shock, how to get them out of shock. There’s this whole sequence of events that takes place. Nursing, how to take care of these patients. It’s quite complex and I firmly believe that dilution of this knowledge is very detrimental in the end to the patient.5/ In addition, an increase in trauma centers would make it more difficult for a trauma center to acquire and retain the trauma center personnel that must be constantly on site. Dr. Epstein testified that trauma surgeons are already a scarce resource, and that scarcity will only be exacerbated with the addition of more trauma centers. Also, Mark Valler, an expert in trauma center and acute care medical staff administration, credibly testified about how the addition of 10 or 11 trauma centers in Florida would impact an existing trauma center’s ability to retain its staff: But I am concerned that 10 or 11 opening statewide, there are going to be advertisements for trauma surgeons, for neurosurgeons, for trauma orthopedic doctors all over the place. People are going to be recruiting like crazy, and they are going to be recruiting in the state of Florida because the physicians already have a Florida state license, so there is going to be a huge, huge recruiting effort if all those centers actually get approved at one time. However, there was no persuasive evidence presented during the final hearing indicating that any recent openings of new trauma centers have resulted in existing trauma centers experiencing declines in patient volume that would negatively impact quality of care. Accordingly, Chief Dick testified that it would be irresponsible for the Department to not facilitate better access to trauma care when the Department has received no evidence that quality of care had suffered. During the final hearing, Petitioners frequently mentioned the theoretical possibility that adoption of the Proposed Rules could lead to an inordinate number of trauma centers opening in a single TSA. Given the substantial amount of resources needed to open and maintain a trauma center, it is unlikely that a rational hospital administrator would seek to open a trauma center in a particular TSA unless the volume of trauma patients would enable it to operate profitably. Nevertheless, the testimony and the evidence leads to an inference that adoption of the Proposed Rules would likely lead to more trauma centers in well-served TSAs and no increase for TSAs in need of more trauma care. The following testimony from Mark Richardson, an expert in healthcare facility and services planning, illustrates this point: Q: There’s been some suggestion, I think you may have heard this during your deposition, that there may be free market forces that would operate to prevent some of these adverse results that you are describing. Do you have an opinion as to whether free market factors would help to prevent the maldistribution or other issues that you described as being bad consequences? A: I do have an opinion. I think if you look in terms of the folks, whoever have applied via a letter of intent for the development of the additional trauma centers, those centers are not located in areas where there currently are longer transport times. Those centers basically are located in basically metropolitan areas where there are already appears to be good reasonable access to care. Basically it’s adding new programs where there’s already a pretty good network of care provided. * * * My point here is that if you look in terms of where these folks are, they are basically in the Jacksonville area; they are basically in the Miami-Dade, south Florida area; they are in the Orlando area; or they are in the Palm Beach and Broward area, where there already are a number of existing transplant programs, where, for example, specific to the median transport time, there’s no problem in those areas. This is not the Panhandle where there is a problem in terms of transport times. This is not north Florida in terms of north Florida area where portions of the area may have some problems. This is basically adding incremental trauma center capacity to locales where there already is adequate care. It is certainly possible that Petitioners’ fears about lower quality of care could be realized if there is nothing other than the statutory cap to prevent hospitals from opening an unlimited number of trauma centers in TSAs encompassing large metropolitan areas. After considering all of the evidence and testimony, the undersigned is of the opinion that it would be impossible to draft a set of rules that would satisfy the concerns/interests of all the relevant stakeholders.6/ The disagreement over the merit of the Proposed Rules boils down to striking a balance between “practice makes perfect” and providing the earliest opportunity for definitive care. In relation to each other, the Current Rules put more emphasis on “practice makes perfect,” and the Proposed Rules emphasize providing more access to care.
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 Whether the application timely filed with the Department of Health (“Department”) by Memorial Healthcare Group, Inc., d/b/a Memorial Hospital Jacksonville (“Memorial”), met the applicable standards for approval to operate as a provisional Level II trauma center; and whether the Department’s approval of the application was based upon an unadopted rule.
Findings Of Fact The Department is an agency of the State of Florida created pursuant to section 20.43, Florida Statutes. The Department’s mandate is to “promote, protect and improve the health of all people in the state,” and it has a primary responsibility for evaluating provisional trauma center applications submitted by acute care hospitals. §§ 381.001 and 395.40(3), Fla. Stat. Shands is an acute-care hospital located in Trauma Service Area (“TSA”) 5, which lies in Baker, Nassau, Duval, Clay, and St. Johns counties. Shands has been designated by the Department as a Level I trauma center. Memorial is an acute-care hospital also located in TSA 5. Memorial operates a provisional Level II trauma center. The application that was submitted by Memorial and approved by the Department on May 1, 2017, is the subject of this proceeding. 5. Chapter 395, Part II (§§ 395.40 – 395.51), Florida Statutes (“Trauma Statute”), sets forth the statutory framework for the development of a statewide trauma system. The Department is charged with the planning and establishment of the statewide inclusive trauma system. See, § 395.40(3), Fla. Stat. The Legislature recognized the benefits of trauma care provided within an “inclusive trauma system,” that is “designed to meet the needs of all injured trauma victims.” § 395.40(2), Fla. Stat. Section 395.401(2) directs the Department to “adopt, by rule, standards for verification of trauma centers based on national guidelines, including those established by the American College of Surgeons.” The Trauma Center Standards are published in DH Pamphlet (DHP) 150-9, which is incorporated by reference in Florida Administrative Code Rule 64J-2.011 (the “Trauma Standards”). Section 395.4025 (the “Application Statute”) describes the application process for hospitals seeking to become designated as a trauma center. Section 395.4025(2)(c) requires the Department to conduct a “provisional review” of each trauma center application to determine if “the hospital’s application is complete and that the hospital has the critical elements required for a trauma center.” This “critical review” shall be based on “trauma center standards” and shall include a review of whether the hospital has: (1) equipment and physical facilities necessary to provide trauma services; (2) personnel in sufficient numbers and with proper qualifications to provide trauma services; and (3) an effective quality assurance process. Id. Notably, the provisional review described in section 395.4025(1)(c) looks only to the application to determine whether an application “has [met] the critical elements required for a trauma center.” Id. Section 395.4025(13) authorizes the Department to “adopt, by rule, the procedures and processes by which it will select trauma centers.” Pursuant to this authorization, the Department issued rule 64J-2.012, which provides detailed regulations governing the application process. Rule 64J-2.012(1)(d) includes a detailed list of elements that a provisional trauma center applicant must satisfy (the “critical elements”) to receive provisional approval from the Department. The Trauma Standards contain other elements that were not designated by the Department as “critical” (the “non-critical elements”). These standards pertain primarily to ensuring the programmatic integrity of a trauma center. Provisional trauma center applications must eventually establish compliance with the non-critical elements, but the non-critical elements are not examined by the Department until after a provisional trauma center application is granted. See Fla. Admin. Code R. 64J-2.012(1)(h). The process for obtaining designation as a provisional trauma center begins on October 1 each year. By that date, hospitals must submit to the Department a letter of intent to file a provisional trauma center application. See § 395.4025(2)(a), Fla. Stat.; Fla. Admin. Code R. 64J- 2.012(1)(a). If a hospital timely submits a letter of intent, the Department must provide the hospital with a provisional trauma center application and instructions for submitting it to the Department. § 395.4025(2)(b), Fla. Stat. April 1 of the following year is the deadline for the hospital to submit a provisional trauma center application. See Fla. Admin. Code R. 64J-2.012(1)(a). The Department conducts a review of the application to determine whether it is complete and has established compliance with the critical elements. See Fla. Admin. Code R. 64J-2.012(1)(d). The Department does not conduct a site visit until a provisional trauma center application is approved and the trauma center is operational. § 395.4025(2)(d) and (5), Fla. Stat. By April 15, the Department must provide the applicant with written notice of any deficiencies in the critical elements and gives the hospital the opportunity to submit additional clarifying or correcting information. See Fla. Admin. Code R. 64J-2.012(1)(e). Applicants then have five working days to address the identified deficiencies and submit additional information. See Fla. Admin. Code R. 64J-2.012(1)(f). On or before May 1, the Department must send written notification to each applicant hospital advising whether its application was approved or denied. See Fla. Admin. Code R. 64J-2.012(1)(g)1.-2. If a hospital is granted provisional approval, it is required to begin operation as a provisional trauma center on May 1 and becomes a full member of Florida’s integrated trauma system on that day. § 395.4025(3), Fla. Stat.; Fla. Admin. Code R. 64J-2.012(1)(g)1. The Department also immediately notifies EMS providers of the newly operational provisional trauma center. Providers are required immediately to begin transporting “trauma alert” victims, as identified pursuant to field triage criteria, to the newly designated provisional trauma center for trauma care when it is the nearest trauma center to the location of the incident. See Fla. Admin. Code R. 64J-2.002(3)(g). In the summer of 2016, Memorial received a letter from the Department notifying Memorial of the opportunity to submit a letter of intent to become a trauma center. Memorial timely submitted a letter of intent to the Department in September 2016. This letter indicated that Memorial would seek approval from the Department to operate as a Level II trauma center. After Memorial submitted its letter of intent, the Department responded by sending Memorial a notice accepting its letter of intent and providing information on the application process. The notice directed Memorial to the Department’s trauma center application and contained instructions for the completion and submission of the application. Once Memorial received the Department’s notice confirming acceptance of its letter of intent, it began making significant investments of resources and capital to develop its trauma program. It did so to ensure that its application would be compliant with the Trauma Standards. In order to implement its trauma program and meet the required Trauma Standards, Memorial made investments in a number of areas, including the renovation of its emergency department (“ED”) to accommodate two dedicated trauma resuscitation bays; the hiring and recruitment of new physicians and staff; conducting significant staff education; and beginning work towards the construction of a new helipad. By May 1, 2017, Memorial had invested over $4 million to develop its trauma program. This capital investment included approximately $2.5 million in construction and equipment. Memorial also invested $1.7 million in recruiting physicians and staff, as well as trauma-related training and education. Memorial was well positioned to develop its trauma program, since many of the needed surgical specialties were already offered at the hospital. The hospital recruited additional physicians to fill the more than 20 non-surgical specialties required by the Trauma Standards. In addition to new physicians, Memorial recruited many new specialized nurses needed to serve trauma patients. Memorial ultimately provided over 6,000 hours of trauma training before May 1, 2017, and continues to train new nurses. The hospital ensured that over 200 nurses received training in Trauma Nurse Core Competencies, which ensures that nursing staff can provide high quality care for severely injured patients. Memorial made all of the above investments prior to March 31, 2017, the date on which Memorial submitted its application to the Department. Memorial’s Application was prepared by a core team, headed by Eleanor Lynch, senior vice president of operations at Memorial. The key members of the team included Memorial’s trauma medical director, trauma program director, as well as representatives from the intensive care unit (“ICU”) and operating room. In order to ensure Memorial’s Application met the Trauma Standards, the team preparing the application met at least three times each week. Those meetings sometimes consisted of 30 different individuals from a variety of disciplines, including the trauma program director, trauma medical director, registration, respiratory, ICU, and the ED. The process was comprehensive and inclusive to ensure the hospital was fully prepared to address each Trauma Standard in its application. This team reviewed the application before it was submitted to the Department to ensure that it complied with the Trauma Standards. Memorial also received assistance from K.C. Pidgeon, vice president of trauma for HCA South Atlantic Division--which includes Memorial. Mr. Pidgeon, who has significant experience in developing trauma programs in Florida, participated in each of the team meetings. He provided guidance into making sure the hospital and its application met the Trauma Standards, including updating policies and procedures, purchasing equipment, recruiting staff, and development of nurse leaders. The final application submitted to the Department consisted of 32 separate binders encompassing thousands of pages of information. In order to be ready to operate by May 1, 2017, Memorial set an internal deadline of February 27, 2017, for the hospital to meet each of the Trauma Standards. Memorial met this internal deadline and included a letter in its application from Memorial’s CEO confirming this milestone. Memorial timely submitted its trauma center application to the Department on March 31, 2017. In developing its trauma program and preparing its application, Memorial ensured that it met all of the Trauma Standards that are required for provisional approval. After receiving Memorial’s Application, the Department arranged for it to be reviewed by two outside experts, Dr. Marco Bonta and Nurse Marla Vanore. Both Dr. Bonta and Nurse Vanore have reviewed numerous trauma applications on behalf of the Department, and are very familiar with the Trauma Standards. Following their review, Dr. Bonta and Nurse Vanore sent the Department a checklist identifying alleged deficiencies in Memorial’s Application. Both reviewers concluded that the quality of the application on initial review was excellent, and reflected a serious effort to meet the Trauma Standards before beginning operations. On April 14, 2017, the Department sent Memorial a letter notifying it of the deficiencies that Dr. Bonta and Nurse Vanore had identified. The few deficiencies identified by the Department were mainly clerical in nature or required simple clarifications. For instance, one of the noted deficiencies included updating the curriculum vitae of Memorial’s trauma program director. Memorial timely responded to each deficiency identified by the Department on April 22, 2017. Memorial’s deficiency response was also reviewed by Dr. Bonta and Nurse Vanore. Following their review of Memorial’s deficiency response, the expert reviewers concluded that Memorial properly addressed each deficiency identified during the Department’s initial review. On May 1, 2017, the Department informed Memorial that its application was in compliance with the applicable Trauma Standards and directed it to begin trauma operations on that same day. As indicated by the parties’ stipulation, Shands takes issue with only a few of the hundreds of requirements that comprise the Trauma Standards. The only aspects of Memorial’s Application which Shands disputes are the standards related to trauma surgeon call coverage (Standards II.A.4-5, II.B.2, and III.A) and the helipad (Standard V.A.5). Shands does not dispute that the application meets the remaining Trauma Standards. Standard III of the Trauma Standards details the surgical staffing requirements that each trauma center must meet. Standard III.A specifically addresses the requirements for general trauma surgeons. Standard III.A.1 requires that “[t]here shall be a minimum of five qualified trauma surgeons, assigned to the trauma service, with at least two trauma surgeons available to provide primary and backup trauma coverage 24 hours a day at a trauma center when summoned.” Standard III.A.2 requires each trauma surgeon to sign the General Surgeons Commitment Statement, which confirms that each surgeon on primary and backup call will comply with certain conditions, including arriving promptly when summoned. Standard III.A.3 lists the minimum qualifications for each trauma surgeon taking call, such as certifications and hospital privileges. Memorial submitted substantial documentation which demonstrated its compliance with the requirements in Standard III.A. Although the Trauma Standards only require five trauma surgeons, Memorial secured nine trauma surgeons for its program. For each of these surgeons, Memorial provided proof of hospital privileges, board certification, state licensure, Advanced Trauma Life Support (“ATLS”) certification, proof of participation in past trauma cases, completion of continuing medical education courses, attestation by the Chief of Neurosurgery, and the commitment statement, among other documentation. Memorial’s documentation for this section totaled more than 500 pages. Memorial also submitted primary and backup call schedules for February, March, April, and May 2017, indicating when each trauma surgeon was scheduled to take trauma call. In addition, Memorial submitted a number of policies and procedures, including Memorial’s credentialing criteria, which is more stringent than what the Department requires. In order to be credentialed at Memorial, a trauma surgeon must agree to the following requirements for primary trauma call: be physically present in-house to meet all trauma patients in the trauma resuscitation areas at the time of the trauma patient’s arrival; perform no elective surgery or procedures during the on- call period that would render the trauma surgeon unavailable to arrive promptly to a trauma alert patient; and refrain from taking general surgery emergency call at any other facility or trauma call at any other facilities while on trauma call at the primary facility. Similar requirements exist for trauma backup call. Standard II of the Trauma Standards sets forth the trauma call coverage requirements that each trauma center must meet. Specifically, Standards II.A.4 and II.A.5 require “[a]t least one qualified trauma surgeon (as described in Standard III.A) to be on primary trauma call at all times to provide trauma service care” and “[a]t least one qualified trauma surgeon (as described in Standard III.A) to be on backup trauma call at all times to provide trauma service care.” Simply put, there must be one trauma surgeon on primary call and one trauma surgeon on backup call at all times. As part of its application, Memorial submitted detailed information about each of the nine trauma surgeons on its monthly call schedules, including the call schedules themselves. The call schedules detail each of the trauma surgeons scheduled to take primary and backup trauma call for February through May 2017. Memorial secured and submitted commitment statements (DH Form 2043E) from each of the trauma surgeons on its call schedule. These signed commitment letters indicate that each trauma surgeon agreed to commit to the call schedules submitted to the Department and be available as indicated. These letters also indicate that each surgeon pledged not to take trauma call at any other facility while on trauma call at Memorial. Trauma Standard II also includes a requirement that the hospital ensure any new trauma surgeons are appropriately qualified and sign the commitment statement. Specifically, “[a]s surgeons change, the trauma medical director must ensure that the new surgeons have the qualifications delineated in Standard III.A.3 and that they sign the General Surgeons Commitment Statement. The trauma service shall keep a current and up-to- date commitment statement on file in the hospital’s trauma center application at all times for Department of Health review.” In response to this subpart, Memorial appropriately submitted the commitment statements for its initial nine trauma surgeons. Because this was Memorial’s provisional application, none of the new trauma surgeons who have subsequently joined its program after May 1, 2017, were included with this submission. After completing their initial review of Memorial’s Application, the Department’s expert reviewers identified only one issue to be addressed in the above sections. For one of the trauma surgeons, Dr. Alton Parker, there was a question as to whether he had met all the required continuing medical education (“CME”) requirements. As requested, Memorial submitted additional documentation with its Deficiency Response confirming that Dr. Parker had in fact completed the required CME courses. With this concern resolved, the expert reviewers ultimately concluded that Memorial’s Application met every requirement. At hearing, Shands alleged that because some of the trauma surgeons listed in Memorial’s Application do not live in Jacksonville year round, the application did not meet the Trauma Standards detailed above. However, there is no requirement in the Trauma Standards that trauma surgeons must live full time in the same community as the hospital at which they take trauma call. Rather, the Trauma Standards require that trauma surgeons on primary and backup trauma call in Level II trauma centers be available within 30 minutes once summoned. In actuality, Shands’ criticisms appear to be a matter of preference or imagining the ideal situation, rather than substantive questions about compliance with the legal requirements for trauma surgeon call. Memorial has not had any gap in trauma call coverage or similar issues since it began operations on May 1, 2017; every shift has been covered and each trauma surgeon available as required. Memorial’s trauma surgeons are committed members of the trauma team, including active participants in the quality improvement process, regardless of where their permanent residence may be. As part of its mission to ensure high-quality care, Memorial requires its trauma surgeons on primary trauma call to be physically present at the hospital during the entire shift, which is beyond what the Trauma Standards require for Level II trauma centers. Memorial established this requirement in part to ensure that there would be no issues with response time for trauma surgeons. Any trauma surgeons on backup call that do not have permanent residences within 30 minutes response time of the hospital, typically stay at a hotel close to the hospital in order to comply with the Trauma Standards and Memorial’s own requirements. For any trauma surgeons who do not live full time in the Jacksonville area, Memorial requires that they report well in advance of beginning the call coverage to ensure there are no issues, e.g., a trauma surgeon beginning call at 9:00 a.m. Monday morning must report to the hospital by 9:00 p.m. the night before. Memorial’s trauma surgeons have positive working relationships with other team members, like the ED physicians, and have collaborated well with local EMS. Memorial has worked to build a full-time trauma surgeon roster, with the hope that recruited physicians will ultimately decide to make the Jacksonville area their home. Memorial currently has three trauma surgeons, including the trauma medical director, Dr. Michael Samotowka, who live full time in Jacksonville and plans to continue recruiting until all six current spots are filled by full-time residents. Both Dr. Bonta and Nurse Vanore determined that Memorial’s trauma call coverage met the applicable Trauma Standards, including Standards II.A.4-5, II.B.2, and III.A. Both expert reviewers confirmed at hearing that the Trauma Standards only require trauma surgeons on primary and backup call to be readily available--they do not dictate where surgeons must reside full time. Nurse Vanore also testified that many trauma centers across the country utilize physicians who do not live in the immediate vicinity of the hospital. These physicians either stay at the hospital or make arrangements to stay nearby when on call. This reflects a common trend in trauma centers nationwide, which often use the rotation of trauma surgeon (both on- and off-call) shifts to enhance patient care. Most trauma centers do not use trauma surgeons to provide longitudinal care (one surgeon with the patient throughout the care process). Instead, there is a comprehensive patient handoff to the next trauma surgeon. There was no indication in Memorial’s Application that its trauma surgeons would not fulfill their call obligations. The general trauma surgeon call schedules submitted by Memorial adequately demonstrated that Memorial would be able to fulfill its trauma call coverage requirements. Since beginning trauma operations, Memorial has not had any gaps in coverage or other issues related to trauma call. Therefore, Memorial satisfied Standards II.A.4-5, II.B.2, and III.A. The helipad became a central issue at hearing. Standard V addresses the facility requirements relating to the ED, including the helipad. Standard V.A.5 requires that each hospital must have a “helicopter-landing site in close proximity to the resuscitation area.” “Close proximity” is defined to mean that “the interval of time between the landing of the helicopter and the transfer of the patient into the resuscitation area will be such that no harmful effect on the patient’s outcome results.” In addition to this requirement, the helipad must be properly licensed by state and federal authorities, and have appropriate policies and procedures for helipad operations. Memorial has used the helipad in its current location since 1993. Before it began operations as a trauma center, Memorial effectively used its helipad to transport trauma patients out of its ED to Shands and other trauma centers without incident for the entirety of that time period. The helipad is located approximately 1900 feet from Memorial’s ED. To meet this Trauma Standard, Memorial hired Liberty Ambulance Service, a private ambulance service, to staff the helipad 24/7, so that at all times there is an advanced life support ambulance with two paramedics ready to transport patients from the helipad to the ED. In addition, the ambulance driver has received emergency vehicle operations course training. Memorial also provided training to the ambulance crew members to ensure they were proficient in helicopter safety. This training included in-depth interaction with air crew of TraumaOne, which is one of the region’s air transport providers. Memorial hires deputies from the Jacksonville Sheriff’s Office to be present at all times for helicopter arrivals. These deputies can be used to block any pedestrian or vehicle access to the transport route or otherwise provide transport assistance, although this has not been needed. Memorial conducted numerous time studies, almost daily since February 27, 2017, to ensure it could quickly move patients from the helipad to the ED without delaying treatment. The time trials entailed actually loading a stretcher onto an ambulance at the helipad, driving the ambulance to the ED, and unloading the stretcher at the ED. These time trials, which were conducted beginning in December 2016 and continue today, showed an average transport time of two to three minutes. Each time trial was attended by Memorial’s EMS Coordinator, Greg Miller, and signed off by each ambulance crew that participated. These time trials helped familiarize the ambulance crew with the short route from the helipad to the ED, as well as to identify an alternate route that can be used if needed. Admittedly, the trials were performed using hospital personnel posing as patients, rather than actual trauma patients, but the methodology, while presenting a best case scenario, was nonetheless reasonable. In addition to the time trials, actual air transports of non-trauma patients confirm the close proximity of the helipad. It only took five minutes to transport a recent non- trauma patient from the helipad to the ED, as documented by the LifeFlight air crew which transported the patient. Since beginning trauma operations, there have not been any issues with trauma patients arriving by helipad. At the time of hearing, Memorial had only had one trauma patient delivered by helicopter since May 1, 2017. Memorial has only had 24 total non-trauma patients delivered by helipad in 2017. In fact, very few patients are transported by air in TSA 5, generally. As part of ongoing renovations, Memorial is currently constructing a new helipad, which will be situated one floor directly above the ED. The new helipad is scheduled to be completed in July 2018. Shands alleged at hearing that Memorial’s helipad was not optimally located and voiced general concerns about its potential impact on patient care. While 1900 feet from the ED cannot be considered the “optimal location” for the helipad, the claims of adverse impact on patient care were not supported by evidence produced at hearing. None of Shands’ witnesses suggested that the patient transport times reflected in Memorial’s Application would adversely impact patient care, or that any adverse incidents had occurred on Memorial’s helipad. Actually, none of Shands’ witnesses had even reviewed any of the time trials or actual patient transport information included in Memorial’s Application. The time it takes to transport patients from Memorial’s helipad to the ED is not substantially different from other trauma centers in the region. Shands’ own witnesses confirmed that Shands’ helipad sits atop a six-story parking garage across the street from its ED, which requires patients to be transported down an elevator and wheeled on a stretcher across a road while security blocks traffic access. Despite their criticisms, none of Shands’ witnesses knew how long it took to transport patients from Shands’ helipad to the ED. Moreover, with the construction of its new helipad atop the ED, any concerns about the current transport times will be eliminated. Both Dr. Bonta and Nurse Vanore determined that Memorial’s helipad met the applicable Trauma Standard, namely Standard V.A.5. Based on the time studies provided by Memorial which showed the average transport time from the helipad to the ED was only two to three minutes, the expert reviewers determined that the helipad was in “close proximity” to the resuscitation area. Based on their experience, the expert reviewers concluded that two to three minutes was typical of other trauma centers, including hospitals with rooftop helipads. This duration of transport time is actually quite good and would not adversely affect patient care. Memorial’s helipad is in close proximity to the trauma resuscitation area, as the Department properly concluded based on the information provided in Memorial’s Application. The two-to- three minute transport time for trauma patients is well within the acceptable range and demonstrates that Memorial met Standard V.A.5. Memorial elicited testimony from a longtime expert in health care planning, Gene Nelson of Health Strategies, Inc. Mr. Nelson spoke at length in an effort to establish need for an additional trauma center in TSA 5 through a feasibility study employing well recognized health planning concepts. He focused primarily on access to trauma care for patients needing the comprehensive specialized care offered by trauma centers. Mr. Nelson noted that many trauma patients were being treated in general acute care hospitals without trauma centers which fell short of the care provided in centers like Shands and the proposed Memorial trauma center. He concluded that a substantial need exists for another trauma center in TSA 5 and that Memorial would fulfill that need. Shands objected to this discussion of need by Mr. Nelson on behalf of Memorial, and argues that the letter of intent and application filed by Memorial should not have been accepted in the first place, since there was not a documented need for another trauma center in TSA 5. As will be discussed in the Conclusions of Law below, the need for an additional trauma center is not a determination to be made at the time of a hospital’s filing for authority to begin operating a provisional trauma center. Shands testified that Memorial’s operation of a trauma center in TSA 5 has already resulted in injury to its operations and profitability. This injury will only continue in the future as Memorial gains a stronger foothold in the TSA. The negative impacts include fewer trauma patients at Shands resulting in a longer period for trauma nurses to acquire and maintain the specialized skills necessary for operating in a trauma center versus a general acute care hospital. The opening of Memorial’s provisional trauma center has caused the number of severely injured trauma patients at Shands to decrease. Shands predicts an annual loss of 324 trauma cases due to Memorial’s opening, translating to a $2.25 to $2.7 million annual loss of revenues. If outpatient cases are included in this analysis, Shands projects an annual loss in revenues of $12,422 per case over the 324 lost cases, resulting in an annual total loss of approximately $4 million. Memorial argues that sufficient trauma volume exists in TSA 5 for both facilities to operate their trauma centers. Memorial projects that it will treat 1,556 trauma patients per year, well above the American College of Surgeons’ (“ACS”) recommendation of at least 1,200 patients per year as a minimum volume level. Mr. Nelson estimates that, annually, only between 300 and 500 trauma patients will be treated at Memorial that otherwise would have been treated at Shands. The rest likely would have received treatment at an acute care hospital, not a trauma center. Mr. Nelson believes that Memorial’s trauma program has had, at most, a minimal impact on Shands. An analysis produced by Shands demonstrates that Shands’ own projections estimate a loss of only 154 trauma patient admissions, well below the numbers projected by Memorial. Even with Memorial’s trauma program being fully operational, Shands will continue to receive in excess of 2,000 trauma patients admitted annually. That volume is well above the ACS’s recommended minimum patient volume of 1,200 for Level I trauma centers. Shands’ own data shows that it will continue to see over 4,600 total trauma patients annually, including inpatient and outpatient cases. Estimates prepared by Shands’ associate vice president of finance, Dean Cocchi, demonstrate that even with a potential impact from Memorial, Shands will still have a contribution margin of well over $30 million. Mr. Cocchi also testified that Shands’ projected financial impact from Memorial operations will not endanger the continued operation of its trauma program. While the presence of Memorial in the TSA 5 market will have a small negative financial impact on Shands, it is not projected to be substantially adverse. The quality of care provided at Shands has not been impacted by the opening of Memorial’s trauma center. Shands remains a high-quality provider of trauma care.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health enter a final order finding that Memorial met its burden of establishing that its trauma center application met the applicable standards; awarding provisional Level II status to Memorial; and dismissing Shands’ petition. DONE AND ENTERED this 13th day of June, 2018, in Tallahassee, Leon County, Florida. S ROBERT S. COHEN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 13th day of June, 2018. COPIES FURNISHED: Stephen A. Ecenia, Esquire Gabriel F.V. Warren, Esquire Rutledge Ecenia, P.A. 119 South Monroe Street, Suite 202 Post Office Box 551 Tallahassee, Florida 32302-0551 (eServed) Seann M. Frazier, Esquire Marc Ito, Esquire Parker, Hudson, Rainer & Dobbs, LLP 215 South Monroe Street, Suite 750 Tallahassee, Florida 32301 (eServed) Daniel Ryan Russell, Esquire Jones Walker, LLP 215 South Monroe Street, Suite 130 Tallahassee, Florida 32302 (eServed) Michael Jovane Williams, Esquire Prosecution Services Unit Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399 (eServed) Martin B. Goldberg, Esquire Lash & Goldberg, LLP 100 Southeast Second Street, Suite 1200 Miami, Florida 33131 (eServed) Jeffrey L. Frehn, Esquire Radey Law Firm, P.A. 301 South Bronough Street, Suite 200 Tallahassee, Florida 32301 (eServed) J. Stephen Menton, Esquire Rutledge Ecenia, P.A. 119 South Monroe Street, Suite 202 Post Office Box 551 Tallahassee, Florida 32302-0551 (eServed) Nichole Chere Geary, General Counsel Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 (eServed) Shannon Revels, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1703 (eServed) Celeste M. Philip, M.D., M.P.H. State Surgeon General Department of Health 4052 Bald Cypress Way, Bin A-00 Tallahassee, Florida 32399-1701 (eServed)
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 a letter of the Department of Health dated January 15, 2002, violates Section 120.54(1)(a), Florida Statutes?
Findings Of Fact Westside (Petitioner) is an acute care general hospital licensed by the State of Florida, Agency for Health Care Administration, pursuant to Part I of Chapter 395, Florida Statutes. Westside is located at 8201 West Broward Boulevard, Plantation, Florida. Westside's location is in Trauma Service Area ("TSA") 18 comprised exclusively of Broward County as established by Section 395.402(3)(a)18., Florida Statutes. The Department, created pursuant to Section 20.43, Florida Statutes, is the state agency charged with primary responsibility for the planning and establishment of a statewide inclusive trauma system. See Section 395.40(3), Florida Statutes (2001). See also Rule 64E-2.021, Florida Administrative Code. "'Trauma agency' means a department-approved agency established and operated by one or more counties . . . for the purpose of administering an inclusive regional trauma system." Section 395.4001(10), Florida Statutes. The Broward County Trauma Agency ("BCTA") is the local trauma agency established by processes and procedures established, in turn, by rule of the Department. Section 395.401, Florida Statutes. It is the Department-approved trauma agency in TSA 18. Each local trauma agency, such as the BCTA, is directed by Section 395.401(1)(b), Florida Statutes, to "develop and submit to the department plans for local and regional trauma service systems." The plans must include certain components outlined in the statute. Among them are "the number and location of needed state approved trauma centers based on local needs, population, and location and distribution of resources." Section 395.401(1)(b)4., Florida Statutes. The statute also calls for periodic updates of the plans: After the submission of the initial trauma system plan, each trauma agency shall, every 5th year, submit to the department for approval an updated plan that identifies the changes, if any, to be made in the regional trauma system. Section 395.401(1)(n), Florida Statutes. The Broward County Trauma Agency Plan that had been in effect "a little bit longer" than since 1995 or 1996, was updated and submitted for approval to the state in 2001. (Deposition of Danz, p. 6.) Although it may have been somewhat delayed (the record is not clear about the precise amount of time between the approval of the plan in effect prior to the update and the update's approval), the timing of the submission was intended to accord with the statutory requirement that updates be reviewed by the BCTA and submitted for approval "every five years." (Id.) The plan in effect at the time of an update approval process that took place largely in the year 2001 stated: State trauma center planning has resulted in an estimated need for four (4) trauma centers in Broward County. For the purposes of network development this plan envisions the initial establishment of three (3) Level II facilities with additional facilities being placed on line as need and funding requires. Each center will act as the primary receiving facility for a designated geographical catchment area (see maps d1 and d2). (Exhibit 20, Part D, p. 4.) The updated plan, denominated Broward County Trauma Plan 2001 (also referred to as the "2001 Plan" or the "Plan"), made a change to the above language. The 2001 Plan states: The establishment of three (3) facilities (two Level I Adult and Pediatric Centers and one Level II Adult Center) each as the primary receiving facility for a designated geographical catchment area, has been determined to be the correct compliment for the County's current need. (Exhibit 6, p. 50.) George Danz is the chief of operations for the Broward County Medical Examiner's Office. He is also the Director of the BCTA. Director Danz outlined "[i]n a nutshell" (Deposition of Danz, p. 7), the process for approval of the updated trauma plan for TSA 18, Broward County Trauma Plan 2001, as follows: (Id.) The process is fairly lengthy. First of all, the [BCTA] goes through the plan and looks at what areas we need to make revisions and changes to and so forth. We make those changes. We then have a Trauma Advisory Committee. We take those changes to the Trauma Advisory Committee for their recommendations and approval. We then are required by state law to notify all of the hospitals and EMS providers in Broward County that revisions are being drafted. We have to provide public notice, advertise that the changes are being made. We have to have a formal public hearing before the Broward County Commissioners. We have that hearing, and if it's approved by the Board of County Commissioners, we then submit the plan to the State of Florida. The State reviews the plan. If they have any changes that they want us to make to the plan, they let us know. They make the change that the state requires and then the state finally provides us with an approval or denial of the plan. In keeping with the process outlined by him, Director Danz sent a memorandum to "Broward County Hospital Administrators" and "Trauma Care Providers" on January 26, 2001. (Exhibit 1.) The memorandum informed the administrators and providers of trauma care that the BCTA with the aid of the Trauma Advisory Committee and the Regional Health Planning Council, Inc., had updated the Broward County Trauma Plan in accordance with law. The memorandum further advised that the Broward County Commission had directed that notice be given that the updates to the plan would be considered at a public hearing to be held on February 27, 2001. In the meantime, the Broward County Trauma Advisory Committee on February 14, 2001, approved an updated trauma plan for TSA 18. Less than two weeks later, as announced in Director Danz's earlier memorandum to hospital administrators and trauma providers, the 2001 Plan was presented to the Broward County Commission at a public hearing. The Commission voted unanimously at the hearing held as scheduled February 27, 2001, to approve the 2001 Plan. On April 30, 2001, Director Danz submitted the 2001 Plan to the Department. In response, the Department, on May 24, 2001, wrote to Director Danz announcing the conclusion of its "review for completeness of the Broward County Trauma Agency Plan Update that was received May 2, 2001." (Exhibit 3.) Although the Department found the 2001 Plan to include a majority of required elements, it found six "to be missing or incomplete." (Id.) These six elements were listed in the May 24, 2001, letter from the Department to the BCTA Director. On June 26, 2001, Director Danz sent a letter to Program Administrator Frederick A. Williams at the Department's Bureau of Emergency Medical Services. The letter outlined how each of the six deficient elements had been addressed by BCTA. The letter was received June 29, 2001, by the Department. Twelve days later, on July 11, 2001, Bureau of Emergency Medical Services Chief Charles Bement wrote Director Danz: We have completed the review of the Broward County Trauma Agency Plan Update submitted to this office on May 2, 2001, with the changes and additions we had requested in our letter to you May 24, 2001. We are pleased to inform you that your plan update is approved effective as of the date of this letter. (Exhibit 5.) Although the 2001 Plan provided for only three trauma centers in Broward County, and there were already three existing centers, with the plan having been approved for more than two months, on September 26, 2001, Michael Joseph, the Chief Executive Officer of Westside executed a "STATE-APPROVED TRAUMA CENTER LETTER OF INTENT." (Exhibit 17). The letter expressed Westside's "interest in becoming a State-Approved Trauma Center (SATC) or State-Approved Pediatric Trauma Referral Center (SAPTRC), or in upgrading the trauma care services already being provided." (Id.) CEO Joseph's letter was not out of step with the latest thinking of the Department. It crossed in the mail with a letter from the Department dated September 28, 2001. This letter, under signature of Bureau Chief Bement to Director Danz and the BCTA reflected the Department's conclusion that the Broward County Trauma Plan 2001 (although previously approved by the Department) conflicted with a rule of the Department of Health. Accordingly, the letter announced Department action: amendment of the 2001 Plan to bring it into compliance with the rule. The letter stated: It has recently come to my attention that the trauma services system plan approved by the Bureau for the Broward County Trauma Agency conflicts with the provisions of Fla. Admin. Code R. 64E-2.022(3). The plan recommends three state approved trauma centers or pediatric trauma referral centers for trauma service area 18 while the Administrative Code provides for four. The Legislature has assigned responsibility for determining the number of trauma centers allocated to each trauma service area to the Department of Health. See [s.] 395.402(3)(b), Fla. Stat. The Department has allocated, by rule, four centers for your area (sic) therefore, the trauma services systems plan for Broward County Trauma Agency is amended in accordance with the law to provide for four centers. (Exhibit 7, emphasis supplied.) On the same day of the Department's letter announcing the amendment of the 2001 Plan, a memorandum was issued by M. Susan McDivitt, R.N., the Department's Executive Community Health Nursing Director. Bearing a subject line of "Letter of Intent for State Approved Trauma Centers," and dated September 28, 2001, the memorandum informed specific parties of the notice of amendment to the Broward County Trauma Plan. Ms. McDivitt's memo refers to the amendment as one that "provides for four state approved trauma centers or state approved pediatric trauma referral centers for Broward County, as outlined in the [rule]." Exhibit 16. The memorandum goes on, As you may know, [s.] 395.4025(2), Florida Statutes, provides that in order to be considered for approval as a trauma center an applicant must certify that its operation would be consistent with the trauma agency plan. Prior to this amendment, no acute care general hospital in Broward County could make that certification as the trauma agency plan only provided for three centers and Broward County has three centers. The above- referenced notification [by amending the 2001 Plan to provide for four trauma centers] has addressed that situation. (Id.) The following Monday, the Bureau of Emergency Medical Services stamped as received on October 1, 2001, Westside's letter of intent. Two weeks later, on October 15, 2001, the Office of the County Attorney for Broward County responded to the September 28, 2001, letter in writing. This written communication requested reconsideration of the action reflected in the Department's September 28 letter, that is, the amendment of the 2001 Plan to provide for four state-approved trauma centers rather than three. As part of the basis for reconsideration, the County Attorney's office wrote: [s.] 395.401(1)(c), Florida Statutes, provides that the Department must approve or disapprove a trauma plan within one hundred twenty (120) days of submission. Here, the Department approved the plan (which was submitted May 2, 2001) on July 11, 2001. There does not appear to be any statutory authority for the Department of Health to unilaterally "amend" a trauma plan once approved. Moreover, the Department's action here was taken after the 120 day window of consideration had closed, and more importantly, after the Department had already determined that the plan was consistent with Rule 64E-2.-22(3). (Exhibit 8.) On October 23, 2001, Bureau Chief Bement issued a memorandum to Nursing Director McDivitt. It details reasons "[t]here should be three trauma centers in Broward County. " (Exhibit 9.) By letter dated November 5, 2001, Art Clawson, Director of the Division of Emergency Medical Services and Community Health Resources in the Department, notified the Broward County Attorney's Office that Bureau Chief Bement's letter of September 28 amending the 2001 Plan constituted agency action that provided a point of entry into administrative proceedings. The letter further advised that formal administrative proceedings could be initiated within 21 days of receipt of the November 5 letter. On November 29, 2001, NBHD filed a petition for formal administrative hearing pursuant to Sections 120.569 and 120.57(1), Florida Statutes. The case was assigned DOH Case No. 02-0131-FOI-HSEM. In the case, NBHD challenged the authority of the State of Florida to amend the Broward County Trauma Plan 2001 as done in the Department's September 28 letter. Westside moved to intervene in the proceeding. While NBHD's case pended at the Department, Division Director Clawson wrote the letter which contains the statements that Westside seeks to have determined in this proceeding to violate Section 120.54(1)(a), Florida Statutes. The letter, written January 15, 2002, states, in pertinent part, Be advised that this correspondence is the official withdrawal by the Department of Health of its amendment of the Broward County Trauma Agency (BCTA) plan. More specifically, the Department withdraws its letter of September 28th 2001 to the BCTA. Likewise, the Department withdraws its Notice of final agency action of November 5th, 2001. It has been determined that the Department lacked the authority to unilaterally amend the BCTA plan after it had been approved by the Department on July 11th, 2001. (Exhibit 11.) No part of this letter has been promulgated as a rule through the procedures in Section 120.54, Florida Statutes. The effect of the January 15, 2002, letter is to render Westside's letter of intent submitted for a new state-approved trauma center in Broward County inconsistent with the requirement of Section 395.4025(2) that "[i]n order to be considered by the department, a hospital [that submits a letter of intent] . . . must certify that its intent . . . is consistent with the trauma services plan of the local or regional trauma agency, as approved by the department, " On January 24, 2002, the Department issued a final order in DOH Case No. 02-01310FOI-HSEM denying the petition of NBHD challenging the Department's September 28 action of amending the Plan. The basis of the denial is that the relief requested by NBHD had been obtained as the result of the January 15, 2002, letter. Westside now seeks a determination that the January 15, 2002, letter is an agency statement in violation of Section 120.54(1)(a), Florida Statutes, that is, an unpromulgated rule. Such a determination will reinstate the Department's letter of September 28 and its amendment to the 2001 Plan to provide for four (4) trauma centers in TSA 18. The restoration of the amendment, in turn, will open the door to the potential of Department approval of the fourth trauma center in Broward County that Westside hopes to operate as expressed in its letter of intent. North Broward Hospital District, the operator of two trauma centers in Broward County, opposes such a determination because it could lead to approval of a fourth trauma center in Broward County. Approval of a fourth trauma center would have an impact on the currently approved trauma centers, including those of NBHD because the number of patients seen by the existing trauma centers would be reduced. As Dr. Lottenberg testified in his deposition, "[I]n order to effectively have a proficient trauma center, you need to have about 1,000 severely injured patient per trauma center per year. Currently[,] all three trauma centers [in Broward County] are operating somewhat under that number." (Lottenberg, pgs. 26- 27.) Approval of a fourth trauma center would reduce the existing provider's number of severely injured patients when, in Dr. Lottenberg's opinion, the trauma center's in Broward County need more patients to ensure proficiency rather than less.
The Issue The issue in these consolidated cases is whether proposed amendments to Rule 10-5.011(1)(o), and (p) F.A.C. relating to certificates of need for hospital inpatient general psychiatric services, are invalid exercises of delegated legislative authority, as defined in Section 120.52(8), F.S.
Findings Of Fact Metamorphosis of the Rules Prior to 1983, hospitals were not separately licensed, and certificates of need (CON) were not required for the designation of beds for psychiatric and substance abuse services. In 1983, statutory amendments to Chapter 381, F.S. addressed psychiatric beds as reviewable projects in the CON program. In 1983, HRS adopted rules establishing four new categories of beds, now found in Rules 10-5.011(1)(o), (p), and (q), F.A.C.: Short-term psychiatric, long-term psychiatric, and short and long-term substance abuse. At the time that the categories were created, HRS conducted an inventory of the hospitals, asking how many beds were designated in each category. Based on the responses, published in the Florida Administrative Weekly, future projections of need were made and applications were considered for CONs. Another category of psychiatric beds was not included in the 1983 rules. Intensive residential treatment programs for children and adolescents were created by statute in 1982, and are defined in Section 395.002(8), F.S. as: a specialty hospital accredited by the Joint Commission on Accreditation of Hospitals which provides 24-hour care and which has the primary functions of diagnosis and treatment of patients under the age of IS having psychiatric disorders in order to restore such patients to an optimal level of functioning. These facilities, called IRTFs, may become licensed as hospitals pursuant to Section 395.003(2)(f), F.S., but as hospitals they must obtain CON approval pursuant to Sections 381.702(7) and (12), F.S. and Section 381.706(1) (b), F.S. IRTFs have no statutory or regulatory restrictions on length of stay and were approved by HRS at one time under an unwritten policy that there be one such facility available in each HRS planning district, without regard to the availability of other long or short term psychiatric programs. In 1985, HRS proposed a rule amendment which would have eliminated the short and long term distinction, as well as the distinction between psychiatric services and substance abuse services. Six months later, the proposed rule amendment was withdrawn. It was highly controversial; several challenges were filed; objections were made by various local health councils; and a new administrator took over. The agency decided to rework its proposed change~;. The agency next began the process of revision in 1987, and in 1988 convened a workshop group to review an issue paper prepared by agency staff. Another work group met in 1989 to consider the consolidation of psychiatric and substance abuse rules. HRS staff reviewed literature on the subjects of substance abuse and psychiatric services, including literature relating to access by indigent patients and the provision of services to children and adolescents. Staff prepared rule drafts which were circulated in- house, including the alcohol, drug abuse and mental health program office; and to such outside groups as the Association of Voluntary Hospitals of Florida, the Florida Hospital Association and the League of Hospitals. The proposed rule amendments which are the subject of this proceeding were filed on January 19, 1990 (substance abuse), and on January 26, 1990 (inpatient psychiatric services) in the Florida Administrative Weekly. The Parties HRS administers the CON program pursuant to Section 381.701, et seq., F.S. (1989). The CON program regulates entry into the Florida health care market by providers through review and approval of certain capital expenditures, services and beds. The petitioner, Florida League of Hospitals, Inc. is a nonprofit corporation which is organized and maintained for the benefit of investor-owned hospitals which comprise its membership. The remaining petitioners and intervenors are current providers of hospital inpatient psychiatric services, long and short term, and of inpatient substance abuse services, long and short term. The petitioners and intervenors are all substantially affected by the proposed rules and have stipulated to the standing of all parties in this proceeding. Abolishing Distinctions Between Long-Term & Short-Term Psychiatric Beds "Short term hospital inpatient psychiatric services" is defined in existing rule 10-5.011(1)(o)1, FAC, as follows: Short term hospital inpatient psychiatric services means a category of services which provides a 24-hour a day therapeutic milieu for persons suffering from mental health problems which are so severe and acute that they need intensive, full-time care. Acute psychiatric inpatient care is defined as a service not exceeding three months and averaging length of stay of 30 days or less for adults and a stay of 60 days or less for children and adolescents under 18 years. "Long term psychiatric services" is defined in existing rule 10- 5.011(1)(p)1., FAC as a category of services which provides hospital based inpatient services averaging a length of stay of 90 days. Neither rule addresses services to adults with an average length of stay (ALOS) of 30-90 days, or services to children and adolescents with a 60-90 day ALOS. Because of this, and the "averaging" process, long term hospitals legitimately serve "short term" patients and short term hospitals may serve "long term" patients. One party has calculated than a long term facility could legally provide short term services for 80% of its patients, and long term services for only 20% of its patients and still have an ALOS of 90 days. Under the existing rules a facility must file a CON application to convert from long term to short term beds, or vice versa, and is subject to sanctions for failure to comply with the designation on its CON. The proposed changes would repeal rule 10-5.011(1) (p), FAC regarding long term services, and would amend rule 10- 5.011(1) (o), FAC to delete the definition of short term services, thereby permitting facilities to serve patients without regard to length of stay. The proposed changes are supported by several factors upon which a reasonable person could rely. Substantial changes have occurred in the last decade in clinical practices and in third party reimbursement to reduce the ALOS for hospital inpatient psychiatric care. Prior to the 1960s, there was no distinction between long and short term care, as all hospital based care was long term with an emphasis on psychoanalytic therapy. Beginning in the 1960s, the concept of community mental health programs evolved with an emphasis on deinstitutionalization of patients in large public "asylums" and with a goal of treatment in the least restrictive environment. In more recent years the trend has spread to the private sector. Improvements in the availability and use of psychiatric drugs, the use of outpatient care or partial hospitalization, and improved follow up care have led to a dramatic decrease in ALOS. Long term care is costly, and whether third party payors have been a driving force, or are merely responding to the trends described above, long term inpatient reimbursement is virtually nonexistent. During the 19805, most insurance companies imposed a 30-day limit on psychiatric inpatient care or imposed monetary limits which would have effectively paid for less than a 90-day term. CHAMPUS, the program providing insurance to military dependents, was providing long term coverage in 1982, but by 1986 its coverage was rarely available for more than 30-60 days, and today, under CHAMPUS' case management system, 30 days is a "luxurious amount". Other large third-party payors such as Blue Cross/Blue Shield have similar limits or aggressively use case management (the close scrutiny of need on a case by case basis) to limit reimbursement for inpatient care. Of the two or three long term facilities in existence at the time that HRS' rules were originally adopted, only one, Anclote Manor still reported an ALOS of over 90 days by 1989, dropping from an ALOS of 477.9 days in 1986 to 145.4 days in 1989. At the same time its occupancy rate dropped below 50%. There is an interesting dialogue among experts as to whether there still exists a clinical distinction between long term and short term inpatient psychiatric care. Studies at the Florida Mental Health Institute found no difference in rate of rehospitalization over a 12 month period between patients who were in a nine week program and patients from Florida State Hospital with a 500 day length of stay. Some mental health practitioners are looking now at treating the chronic psychiatric patient with repeated short term hospital stays and less intensive care between episodes, rather than a single long term inpatient stay. Other practitioners maintain that a long term psychiatric problem is behavioral in nature and requires a total life readjustment and longer length of stay. Whichever practice may be preferable, the facts remain that fewer and fewer mental patients are being treated with long term hospitalization. The proposed rules would not foreclose any facility from providing long term care, if it finds the need. To the extent that a clinical distinction exists between short and long term care, the existing rules do not address that distinction, except from a wholly arbitrary length of stay perspective. The existing rules no longer serve valid health care objectives. Existing providers with short term CONs are concerned that the allowing long term facilities to convert will further glut an underutilized market and will result in an increase in vacant beds and a rise in the cost of health services, contrary to the intent of the CON program. Intensive residential treatment facilities (IRTFs), which will be folded into the need methodology for children and adolescent beds, have no current restrictions on length of stay and may already compete with impunity with the short term providers. Moreover, long term facilities are also providing substantial short term care as a result of the trends discussed above. HRS has not consistently enforced the length of stay restrictions of long term providers' CONs. Whether those CONs were improvidently granted is beside the point. The capital costs have already been incurred; the beds are available; and the beds are being used, in part, for short term services. Abolishing the distinction is a rational approach to current conditions. And in determining that all existing providers would be placed in the same position regarding length of stay, HRS avoids the regulatory nightmare of trying to enforce limitations on existing providers and approving new beds without limitations. Creating a Distinction Between Adult and Children/Adolescent Beds Rule 10-5.011(1)(o)3.c. creates a CON distinction between general psychiatric services for adults, and those services for children and adolescents. Rule 10-5.011(1)(o)4., as proposed, would create separate need criteria for hospital inpatient general psychiatric services for adults and for children/adolescents. Adolescents are defined in Rule 10- 5.011(1)(o)2.a., as persons age 14 through 17 years. Persons over 17 years are adults, and under 14 years are children. There are valid clinical reasons to distinguish between programs fob the separate age groups. Although there is some overlap, differing therapies are appropriate with different ages. The types of services offered to adults are not the same as those which are offered to children. Children, for example, often receive academic educational services while being hospitalized. Adults receive career or vocational counseling and marriage counseling. The required separation by age categories would remove some flexibility from providers. However, this is offset by the Department's valid need to track for planning purposes inpatient services to children and adolescents separately from those provided to adults. Based on anecdotal evidence, HRS' Office of Alcohol, Drug Abuse and Mental Health Program Office is concerned about the possible overutilization of hospital inpatient services for children and adolescents and the potential that when insurance reimbursement expires they are discharged without clinical bases. Taking Inventory Under the proposed rule, in order to separately regulate adult and children/adolescent beds, HRS will fix an inventory of uses as of the time that the rule takes effect. For facilities with CONs which already allocate beds between the two groups, the proposed rule will have no effect. For facilities without a designation, as long as adults and children/adolescents are kept in separate programs, the allocation can now be mixed and changed at will. The rule amendment will freeze that use in place. HRS has conducted a preliminary survey to determine the existing uses of psychiatric, substance abuse and residential treatment program beds. The survey of approximately 120 facilities is complete, but is not intended to limit those facilities unless their CON already provides a limit. A final inventory will be taken after the proposed rules become effective. The inventory will be published, and providers will be given an opportunity to contest its findings. The ultimate outcome will be amended CONs and licenses which reflect each facility's mix of adult and children/adolescent beds. The process is a fair and reasonable means of commencing separate regulation of services to these age groups. The Definitions Proposed rules 10-5.011(1)(o)2.1., 2.p., and 2.t.) define "hospital inpatient general psychiatric services", "psychiatric disorder" and "substance abuse", respectively. Each of these provisions defines the terms by reference to classifications contained in the Diagnostic and Statistical Manual of Mental Diseases (DSM-III-R Manual) and equivalent classifications contained- in the International Classification of Diseases (ICD-9 Codes). The rule as originally proposed included the phrase "or its subsequent revisions", after incorporating the manuals by reference. In testimony, and in the parties second agreement (Hearing Office exhibit 3) the phrase is deleted. However, it still appears in proposed rule 10-5.011(1) (o)2.1., perhaps inadvertently. The DSM-III-R is a generally recognized manual for the classification of mental disorders and is widely used by clinicians and medical records professionals to categorize the conditions of patients. The ICD-9 codes are broader than just mental disorders, but they have a section on mental disorders with numbers that are identical to those in the DSM-III-R. Although the manuals are complex and subject to interpretation, clinicians are accustomed to their use and they provide a reasonable guide as to the services which may be provided in an inpatient substance abuse program, as distinguished from an inpatient psychiatric program. Advertising Limited Proposed rule 10-5.011(1)(o)3.d. (as amended in the parties second agreement, Hearing Officer exhibit #3), provides: D. Advertising of services. The number of beds for adult or for children and adolescent hospital inpatient general psychiatric services shall be indicated on the face of the hospital's license. Beds in intensive residential treatment programs for children and adolescents which are licensed as specialty hospital beds will be indicated as intensive residential treatment program beds on the face of the hospital's license. Only hospitals with separately-licensed hospital inpatient general psychiatric services, including facilities with intensive residential treatment programs for children and adolescents which are licensed as specialty hospitals, can advertise to the public the availability of hospital inpatient general psychiatric services. A hospital with separately licensed hospital inpatient general psychiatric services that does not have a certificate of need for hospital inpatient substance abuse services may advertise that they [sic] provide services for patients with a principal psychiatric diagnosis excluding substance abuse and a secondary substance abuse disorder. The Department does not currently have CON, licensure, or other rules which limit the ability of a health care provider to advertise its services, and has never used advertising as a factor in conducting CON review for any proposed services. HRS included provisions regarding advertising in its proposed rules because it had evidence that existing facilities have used misleading advertisements. The evidence came from other providers, rather than consumers. However, it is the consumer whom the agency feels may be confused by advertising which implies that services are available when such services cannot be legally provided under the facility's license. The advertising provision is prospective in nature, seeking to prevent licensed providers from advertising services for which they are not licensed. The provisions do not relate to CON review, and the staff is unclear as to how the rule would be implemented. Licensing and CON review are two separate functions within the agency. Although the term is not defined in the proposed rule, advertising broadly includes word of mouth referrals and public presentations by professionals in the community, as well as traditional media and written advertisements. Properly utilized, advertising helps consumers exercise choice and gain access to needed services. Improper advertising is subject to the regulation of federal and state agencies other than the department. New Need Methodology, with Preferences Proposed Rule 10-5.011(1)(o)4., deletes the existing population ratio methodology and creates a need formula based upon use rate, for adult and children/adolescent inpatient psychiatric services. Certain preferences are also described. 34. Rule 10-5.011(1) (o)4.e.(III) provides: In order to insure access to hospital inpatient general psychiatric services for Medicaid-eligible and charity care adults, forty percent of the gross bed need allocated to each district for hospital inpatient general psychiatric services for adults should be allocated to general hospitals. The same provision for children and adolescent services is found in rule 10-5.011(1)(o)4.h.(III). Medicaid reimbursement is not available for inpatient services in a specialty hospital. 35. Rule 10-5.011(1)(o)4.i. provides: Preferences Among Competing Applicants for Hospital Inpatient General Psychiatric Services. In weighing and balancing statutory and rule review criteria, preference will be given to applicants who: Provide Medicaid and charity care days as a percentage of its total patient days equal to or greater than the average percentage of Medicaid and charity care patient days of total patient days provided by other hospitals in the district, as determined for the most recent calendar year prior to the year of the application for which data are available from the Health Care Cost Containment Board. Propose to serve the most seriously mentally ill patients (e.g. suicidal patients; patients with acute schizophrenia; patients with severe depression) to the extent that these patients can benefit from a hospital-based organized inpatient treatment program. Propose to service Medicaid-eligible persons. Propose to service individuals without regard to their ability to pay. Provide a continuum of psychiatric services for children and adolescents, including services following discharge. The preferences are similar to those in CON rules relating to other types of health services and are intended to implement, in part, the legislative mandate that the agency consider an applicant's ". . . past and proposed provision of health care services to medicaid patients and the medically indigent." Section 381.705(1) (n), F.S. Under Medicaid reimbursement general hospitals are paid a set per diem based on a variety of services provided to all Medicaid patients, regardless of actual cost of the individual service. As psychiatric services are generally less costly than other services on a per diem basis, hospitals may recoup a greater percentage of their costs in serving Medicaid psychiatric patients. This and the fact that public hospitals receive some governmental subsidies do not obviate the need for incentives in the CON program. Not all of the charity care provided by these hospitals is funded and a large amount is written off. Although Petitioners argue that the preferences are not needed, or are too generous, none provide competent evidence that the facilities who do not enjoy the preferences are unduly prejudiced. The 40% allocation of bed need to general hospitals is a guideline, not a maximum, as applied by the agency, and presumes that there are general hospitals competing in any batch in question. It is not intended to frustrate a separate section of the rule which allows a hospital with at least an 85% occupancy rate to expand regardless of need shown in the formula and the occupancy rate district-wide. See 10- 5.011(1) (o)4.d. and g. "Evaluation of Treatment Outcomes" The proposed rules contain three provisions relating to a hospital's evaluation of its patients' treatment outcomes. Rule 10-5.011(1) (o)3.i, includes among "required services", ". . . an overall program evaluation of the treatment outcomes for discharged patients to determine program effectiveness." Rule 10-5.011(1)(o)8.j., requires in the application, A description of the methods to be used to evaluate the outcome of the treatments provided and to determine the effectiveness of the program, including any summary evaluation outcome results for hospital inpatient psychiatric services provided at other facilities owned or operated by the applicant in Florida and other states. The data shall exclude patient specific information. Rule 10-5.011(1)(o)9.e., imposes a similar additional requirement in applications from providers seeking more beds: A summary description of any treatment outcome evaluation of the hospital inpatient general psychiatric services provided at the facility for which additional beds are requested, for children, adolescents or adults as applicable to the facility for the 12-month period ending six months prior to the beginning date of the quarter of the publication of the fixed bed need pool. The purpose of these requirements, according to HRS, is to insure that hospitals will know whether its patients are better off when they leave than when they were admitted to the program. Most hospitals have such knowledge. The terms, "outcome determination", "summary evaluation outcome results", "summary description of treatment outcome evaluation" and "overall program evaluation of treatment outcomes", are nowhere defined in the proposed rules, and the department intends to leave to each applicant or provider the methodology for determining whether its patients are "better off" for having been in its program. Hospitals do not routinely evaluate their patients after discharge and such follow up would be difficult and costly. Most hospitals do, however, establish a treatment plan upon admission, continue to review and revise that plan as needed throughout treatment, and determine the patients' readiness for discharge based on the goals successfully attained. This is the process described by Florida Hospital's Center of Psychiatry Administrative Director. The rules require no more than a description similar to that provided by Florida Hospital. The rules set no standards and do not dictate that follow- up of discharged patients be accomplished, even though post discharge evaluation may be of value and is generally accepted as the best tool for measuring treatment effectiveness. The measurement of treatment outcome is an inexact process and relies on a series of subjective standards which need to be described. HRS does not intend to set those standards and, other than have its applicants demonstrate that a process is in place, the agency has no idea how the required information will impact its CON review. Without definitions and standards, the agency will have no way of comparing one applicant's information with another's. Without specificity and more guidance the rules fail to apprise the applicant of what is required and will provide no meaningful information to the agency in its CON review function. Miscellaneous Provisions The Non-Physician Director. The proposed definition of "Hospital Inpatient General Psychiatric Services" in Rule 10-5.011(1) (o)2.1. includes services provided under the direction of a psychiatrist or clinical psychologist In drafting this definition, agency staff relied on advice from experts at their workshops and on advice from the agency's own Alcohol, Drug Abuse and Mental Health Program Office, to the effect that professionals, other than physicians, are qualified to direct the units. Interpretation and Application. It is not the intention of HRS that its rules be interpreted to override good medical practice or the sound judgement of treating physicians. Thus, the rules would not prohibit stabilization of a patient who is presented to the emergency room of a hospital without a CON for substance abuse or psychiatric services. Stabilized Alzheimers patients may be housed in nursing homes. Nor do the rules prohibit or subject to sanctions the occasional admission of a psychiatric or substance abuse patient to a non-substance abuse or psychiatric bed so long as this occurs infrequently in a hospital without psychiatric or substance abuse programs. "Scatter" beds are not eliminated. Those beds would continue to be licensed as acute-care beds, as they would not be considered part of an organized program, with staff and protocols, to provide psychiatric or substance abuse services. Proposed rule 10-5.011(1)(o)4.h.(v) provides that applicants for IRTPs for children and adolescents seeking licensing as a specialty hospital must provide documentation that the district's licensed non-hospital IRTPs do not meet the need for the proposed service. The department is not seeking specific utilization data in this regard, as such is not available. General information on the availability of alternatives to inpatient hospital services is obtainable from local health councils and mental health professionals in the community. Quarterly Reports. Proposed rule 10-5.011(1)(o)10. requires: Facilities providing licensed hospital inpatient general psychiatric services shall report to the department or its designee, within 45 days after the end of each calendar quarter, the number of hospital inpatient general psychiatric services admissions and patient days by age and primary diagnosis ICD-9 code. The Health Care Cost Containment Board (HCCCB) is already collecting similar quarterly data from providers. The reporting system is being updated and improved but in the meantime HRS is experiencing problems with the type and accuracy of the data it receives from HCCCB. One problem is that HCCCB collects its data with regard to all discharges in a psychiatric or substance abuse diagnostic category, whereas HRS is interested only in data from a psychiatric or substance abuse program. Until the system improves, HRS needs the information it seeks from the providers in order to plan and apply the need methodology. The agency intends to designate local health councils to collect the data and has already worked with them to set up a system. If reports provided to the HCCCB comply with the proposed requirement, HRS has no problem in receiving a duplicate of those reports. The Economic Impact Statement Pursuant to Section 120.54(2), F.S., HRS prepared an economic impact statement for the proposed rule. It was authored by Elfie Stamm, a Health Services and Facilities Consultant Supervisor with HRS. Ms. Stamm has a Masters degree in psychology and has completed course work for a Ph.D. in psychology. She has been employed by HRS for 13 years, including the last ten years in the Office of Comprehensive Health Planning. She is responsible for developing CON rules, portions of the state health plan, and special health care studies. It was impossible for Ms. Stamm to determine how the rule could impact the public at large. The economic impact statement addresses generally the effect of abolishing the distinction between long and short term services and acknowledges that the rule will increase competition among short term service providers. The impact statement also addresses a positive impact on current long term providers.
