The Issue Whether the Proposed Rule 64J-2.010 enlarges, modifies or contravenes the specific provisions of law implemented, or is arbitrary or capricious, and thus constitutes an invalid exercise of delegated legislative authority.
Findings Of Fact The Parties Shands operates an 852-bed hospital and Level I trauma center in Gainesville, Alachua County, Florida. Its business address is 1600 Southwest Archer Road, Gainesville, Florida. Shands treats about 2,500 trauma patients each year. Shands is located within trauma service area (TSA) 4, which is comprised of Alachua, Bradford, Columbia, Dixie, Gilchrist, Hamilton, Lafayette, Levy, Putnam, Suwannee, and Union counties. St. Joseph’s is a regional tertiary hospital and has served the Tampa area for 75 years and has approximately 800 licensed acute care beds. St. Joseph offers a broad array of acute care services including tertiary health care, serves as a comprehensive regional stroke center, and has been repeatedly recognized as a Consumers Choice hospital. St. Joseph operates a Level II trauma center and a Level I pediatric trauma center. St. Joseph is located in TSA 10, consisting of a single county, Hillsborough. Tampa General is a major tertiary hospital that is designated by the state as a Level I trauma center. Tampa General also serves as a teaching hospital for the University of South Florida, College of Medicine ("USF"). Tampa General is located in Tampa, Hillsborough County, Florida, TSA 10. Bayfront is a 480-bed tertiary hospital located in Pinellas County, Florida. In addition to serving as a teaching hospital, Bayfront is designated as a Level II trauma center pursuant to chapter 395, Part II, Florida Statutes. It is located in TSA 9, composed of Pinellas and Pasco counties. The Public Health Trust of Miami-Dade County, is an entity which governs and operates the Jackson Health System, including the Ryder Trauma Center at Jackson Memorial Hospital. It is in TSA 19, consisting of Dade and Monroe counties. The Florida Department of Health is the state agency authorized to verify and regulate trauma centers in the state of Florida pursuant to chapter 395, Part II, Florida Statutes, and Florida Administrative Code Rule 64J-2.001 et seq. The Division of Emergency Medical Operations, Office of Trauma, oversees the Department's responsibilities with respect to the statewide trauma system. Osceola is a licensed acute care general hospital, located at 700 West Oak Street, Kissimmee, Florida. Osceola provides a wide array of high quality health services to the residents and visitors within its service area. It is located in TSA 8, consisting of Lake, Orange, Osceola, Seminole, and Sumter counties. The Florida Trauma System For purposes of organizing a statewide network of trauma services, the Florida Legislature directed the Department to undertake the implementation of a statewide inclusive trauma system as funding is available. § 395.40(3), Fla. Stat. The need for a trauma system is premised on the basic principle that a trauma victim who is timely transported and triaged to receive specialized trauma care will have a better clinical outcome. § 395.40(2), Fla. Stat. A trauma victim's injuries are evaluated and assigned an Injury Severity Score ("ISS"). § 395.4001(5), Fla. Stat. Patients with ISS scores of nine or greater are considered trauma patients. § 395.402(1), Fla. Stat. Trauma experts speak in terms of "a Golden Hour," a clinical rule of thumb that postulates no more than 60 minutes should elapse from the occurrence of an injury to the beginning of definitive treatment. There is, however, no current consensus on what constitutes the "Golden Hour" for transport times. A 1990 Department study recommended travel time of 25-35 minutes as the outside range for optimal outcomes. A 1999 Department study favored a goal of 30 minutes transport time by ground, and a 50-mile radius by helicopter. By contrast, a 2005 study conducted for the Department used 85 minutes "total evacuation time" as "acceptable." A trauma center is a hospital that has a collection of resources and personnel who are charged with taking care of trauma patients. They are recognized by the community as a resource for care of severely injured patients. The International Classification Injury Severity Score (“ICISS”) methodology, considered with discharged patient data from the Agency for Health Care Administration database, was used by DOH to determine severely injured patients. An ICISS score is the product of the survival risk ratios (i.e., the probabilities of survival) calculated for each traumatic injury a single patient suffers. Level I trauma centers are generally larger and busier and treat more patients than Level II centers. Level I trauma centers are required to engage in education and research. Trauma centers are required to have several types of physician specialists at the ready at all times. For instance, with respect to surgical services, a Level I trauma center must have a minimum of five qualified trauma surgeons, assigned to the trauma service, with at least two trauma surgeons available to provide primary (in-hospital) and backup trauma coverage 24 hours a day at the trauma center when summoned. Further, in addition to having at least one neurosurgeon to provide in-hospital trauma coverage 24 hours a day at the trauma center, a Level I provider must also have surgeons available to arrive promptly at the trauma center in 11 other specialties, including (but not limited to) hand surgery, oral/maxillofacial surgery, cardiac surgery, orthopedic surgery, otorhinolaryngologic surgery and plastic surgery. Level II trauma centers must comply with similar physician specialist standards. Little if any credible evidence was presented in the present case to suggest that the ability to hire qualified clinical staff, technicians, specialty physicians and other personnel would be severely impacted if the Proposed Rule is implemented. Rather, the existing trauma centers lamented the possibility of reduced case loads which could make it more difficult to retain proficiency. Invalidation of Former Rule 64J-2.010 In 1992, the Department of Health and Rehabilitative Services (HRS), the Department of Health's predecessor, promulgated Florida Administrative Code Rule 64J-2.010, titled "Apportionment of Trauma Centers within a Trauma Service Area," (hereinafter referred to as the “Former Rule”). The Department of Health assumed administration of the Former Rule in 1996, when the Legislature split HRS into two new agencies, the Department of Health and the Department of Children and Families. The Former Rule regulated the number of trauma centers that could be established in Florida. The Former Rule divided the state into TSAs as set forth in section 395.402(4), and for each TSA, announced the number of trauma center "positions" available. In 2004, the Florida Legislature amended section 395.402 to require the Department to complete an assessment of Florida's trauma system, and to provide a report to the Governor and Legislature no later than February 1, 2005 (the 2005 Assessment). The scope of the assessment was defined in paragraphs (2)(a) through (g) and subsection (3) of section 395.402. One objective of the assessment was to consider aligning trauma service areas within the trauma region boundaries as established in section 395.4015(1). It required the Department to establish trauma regions that cover all geographic areas of the state and have boundaries that are coterminous with the boundaries of the Regional Domestic Security Task Forces (“RDSTF”) established under section 943.0312. In a related 2004 amendment, the Legislature added a provision that gave the Department the option to use something other than the trauma service areas codified in section 395.402(4) upon completion of the 2005 Assessment. See § 395.402(2), Fla. Stat. ("Trauma service areas as defined in this section are to be utilized until the Department of Health completes" the 2005 Assessment.) § 395.402(4), Fla. Stat. ("Until the department completes the February 2005 assessment, the assignment of counties shall remain as established in this section."). As part of the 2004 amendments to the trauma statute, the Legislature also required the Department to conduct "subsequent annual reviews" of Florida's trauma system. In conducting such annual assessments, the Legislature required the Department to consider a non-exhaustive list of criteria set forth in section 395.402(3)(a)-(k). Further, the Legislature required the Department to annually thereafter review the assignment of Florida’s 67 counties to trauma service areas. The Department timely submitted its 2005 Assessment to the Legislature on February 1, 2005. With respect to its review of the trauma service areas, the 2005 Assessment recommended against the continued use of the 19 trauma service areas. The 2005 Assessment instead suggested that it may be feasible for the existing trauma service areas to be modified to fit the seven RDSTF regions to facilitate regional planning. Following receipt of the 2005 Assessment, the Department took no action to amend the Former Rule and adopt the recommendations of the 2005 Assessment. As a result, in June 2011, several existing trauma centers challenged the validity of the Former Rule pursuant to sections 120.56(1) and (3). See Bayfront Med. Ctr., Inc. et al. v. Dep't of Health, DOAH Case Nos. 11-2602RX, 11-2603RX, 11-2746RX, 11-2796RX (Fla. Div. Admin. Hear., Sept. 23, 2011). On September 23, 2011, an administrative law judge of the Division of Administrative Hearings entered a final order holding that the Former Rule was an invalid exercise of delegated legislative authority. The administrative law judge concluded that the Former Rule was invalid because it contravened the laws it purportedly implemented, including section 395.402. The judge found: The authority granted by section 395.402 for the use of the [nineteen] identified TSAs existed only until February 2005. After that time, the Department was required to consider the findings of the 2005 Assessment, as well as the recommendations made as part of the regional trauma system plan. Thus, section 395.402 can no longer service as a valid basis for the Rule. However, as set forth below, the authority to utilize the 19 TSAs was not rescinded; rather, the mandated requirement to use only the TSAs was rescinded. The Department was required to review the assignment of Florida’s 67 counties to trauma service areas, taking into consideration the factors set forth in paragraphs (2)(b)-(g) and subsection (3) of section 395.402. Having done so, it was incumbent on the Department to amend its [Former] Rule to allocate the number of trauma centers determined to be needed within each designated area through systematic evaluation and application of statutory criteria. On November 30, 2012, the First District Court of Appeal affirmed the administrative law judge's determination that the Former Rule was an invalid exercise of delegated legislative authority. See Dep't of Health v. Bayfront Med. Ctr., Inc., 134 So. 3d 1017 (Fla. 1st DCA 2012). After noting that the Former Rule claimed to implement sections 395.401, 395.4015, and 395.402, the appellate court held that the Former Rule was invalid because it failed to reflect the substantial amendments to those laws that were enacted in 2004. The appellate court held: Both the pre-and post-2004 versions of the statute require the Department to establish trauma regions that "cover all geographic areas of the state." However, the 2004 amendment requires that the trauma regions both "cover all geographical areas of the state and have boundaries that are coterminous with the boundaries of the regional domestic security task forces established under s. 943.0312." § 395.4015(1), Fla. Stat. (2004). Similarly, the rule fails to implement the 2004 amendments to section 395.402. The version of the statute in effect at the time the rule was promulgated set forth the nineteen trauma service areas reflected in the rule. [T]he 2004 version of the statute required the Department to complete an assessment of Florida's trauma system no later than February 1, 2005. It further provides that the original nineteen trauma service areas shall remain in effect until the completion of the 2005 Assessment. Bayfront, 134 So. 3d at 1019-20 (Emphasis added). It should be noted that the 2004 version of the statute does not specify at what point in time the 19 TSAs could no longer be utilized, only that they would have to be used at least until completion of the 2005 Assessment. Rule Development The Department thereafter initiated rule development workshops to commence construction of a new rule. The first workshop concerning this rule was in Tallahassee, Florida, on December 21, 2012. In January and February 2013, workshops were then held in Pensacola, Tampa, Ocala, Jacksonville, and Miami, as DOH continued working on a new rule. Each of the sessions involved input from interested persons both live and by telephone. Written comments and oral presentations by these persons were considered by the Department. After these first six workshops, held in various regions of the State to make them more accessible to more citizens, DOH then scheduled three more workshops in March 2013, to be held in areas where there were no existing trauma centers, specifically Ft. Walton Beach, Naples, and Sebring. DOH also considered the recommendations of a report issued by the American College of Surgeons (“ACS”), the lead professional group for trauma systems and trauma care in the United States. The ACS sent a consultation team to Tallahassee, Florida, to conduct a three-day site visit and hold public workshops in February 2013. The ACS ultimately issued a report entitled “Trauma System Consultation Report: State of Florida,” in May 2013. The report included as one of its recommendations the use of RDSTF regions as the TSA areas to be used in determining need for additional trauma centers. In November 2013, DOH released a draft proposed rule and a draft of its first TSA Assessment (the January TSA Assessment). The Department then conducted three additional workshops in Pensacola, Orlando, and Miami. Again, DOH solicited comments from interested persons and entered into a dialogue as to what the proposed rule should look like upon publication. On January 23, 2014, DOH conducted a Negotiated Rulemaking Committee meeting at the Department’s headquarters in Tallahassee, Florida. The committee consisted of seven persons: Karen Putnal, Esquire and Dr. Fred Moore--representing existing trauma centers; Steve Ecenia, Esquire and Dr. Darwin Ang-- representing new trauma centers currently under challenge; Dr. Patricia Byers--representative of the EMS Advisory Council; Jennifer Tschetter, Esquire and Dr. Ernest Block--representing DOH. The public was invited to attend the session but was not afforded an opportunity to speak. The Department considered all the input from each of the workshops, the ACS Report, and the negotiated session, as well as all the applicable items enumerated in section 395.402(3)(a)-(k). The Proposed Rule On February 3, 2014, the Department published Notice of Development of Proposed Rule 64J-2.010 (the "Proposed Rule") in Florida Administrative Register, Volume 40, Number 22. The Department's Notice cited section 395.405, as rulemaking authority for the Proposed Rule. The Notice also cited sections 395.401, 395.4015, 395.402, and 395.405 as the laws intended to be implemented by the Proposed Rule. The following day, February 4, 2014, the Department published a Notice of Correction in Florida Administrative Register, Volume 40, No. 23, to correct the history notes of the Proposed Rule. In the corrected Notice, the Department cited section 395.402 as its rulemaking authority in addition to section 395.405. The correction also removed reference to sections 395.401, 395.4015, and 395.405, as laws implemented by the Proposed Rule. Following the Department's correction, the Proposed Rule was intended only to implement section 395.402. The Proposed Rule established 19 TSAs and determined the number of trauma centers to be allocated within each TSA, based upon a scoring system established in the Proposed Rule. Under the scoring system, TSAs were awarded positive or negative points based on data in an annual Trauma Service Area Assessment relating to the following six criteria: (1) population; (2) median transport times; (3) community support; (4) severely injured patients not treated in trauma centers; (5) Level 1 trauma centers; and (6) number of severely injured patients (in each TSA). Ms. Tschetter added the last two criteria (Level I Trauma Centers and Number of Severely Injured Patients) in response to comments received at the negotiated rulemaking session. Subsequent to a final public hearing held on February 25, 2014, DOH revised its January TSA Assessment and the earlier version of the Proposed Rule. The revised TSA assessment (the “March TSA Assessment”) reflected more conservative calculations (as gleaned from input and discussions with stakeholders) and documents the statutory patient volumes for the existing Level I and Level II trauma centers in each TSA. The March TSA Assessment further recalculated the Median Transport times, including all transports from 0-10 minutes (as opposed to only those transports greater than 10 minutes) and only transports to trauma centers (as opposed to transports to all hospitals). On March 25, 2014, a Notice of Change was published in the Florida Administrative Register. The Proposed Rule, as published on that date, is as follows: Notice of Change/Withdrawal DEPARTMENT OF HEALTH Division of Emergency Medical Operations RULE NO.: RULE TITLE: 64J-2.010 Apportionment of Trauma Centers within a Trauma Service Area (TSA) NOTICE OF CHANGE Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 40, No. 22, February 3, 2014 issue of the Florida Administrative Register. 64J-2.010 Allocation of Trauma Centers Aamong the Trauma Service Areas (TSAs). Level I and Level II trauma centers shall be allocated among the trauma service areas (TSAs) based upon the following: The following criteria shall be used to determine a total score for each TSA. Points shall be determined based upon data in the Trauma Service Area Assessment. Population A total population of less than 0 to 600,000 receives 2 points. A total population of 600,001 to 1,200,000 receives 4 points. A total population of 1,200,001 to 1,800,000 1,700,000 receives 6 points. d. A total population of 1,800,000 1,700,001 to 2,400,000 2,300,000 receives 8 points. e. A total population greater than 2,400,000 2,300,000 receives 10 points. Median Transport Times Median transport time of less than 0 to 10 minutes receives 0 points. Median transport time of 101 to 20 minutes receives 1 point. Median transport time of 21 to 30 minutes receives 2 points. Median transport time of 31 to 40 minutes receives 3 points. Median transport time of greater than 41 minutes receives 4 points. Community Support Letters of support for an additional trauma center from 250 to 50 percent of the city and county commissions located within the TSA receive 1 point. Letters of support must be received by the Department on or before April 1 annually. Letters of support for an additional trauma center from more than 50 percent of the city or county commissions located within the TSA receive 2 points. Letters of support must be received by the Department on or before April 1 annually. Severely Iinjured Patients Discharged from Acute Care Hospitals Not Treated In Trauma Centers Discharge of 0 to 200 patients with an International Classification Injury Severity Score (“ICISS”) score of less than 0.85 (“severely injured patients”) from hospitals other than trauma centers receives 0 points. Discharge of 201 to 400 severely injured patients from hospitals other than trauma centers receives 1 point. Discharge of 401 to 600 severely injured patients from hospitals other than trauma centers receives 2 points. Discharge of 601 to 800 severely injured patients from hospitals other than trauma centers receives 3 points. Discharge of more than 800 severely injured patients from hospitals other than trauma centers receives 4 points. Level I Trauma Centers The existence of a verified Level I trauma center receives one negative point. The existence of two verified Level I trauma centers receives two negative points. The existence of three verified Level I trauma centers receives three negative points. Number of Severely Injured Patients If the annual number of severely injured patients exceeds the statutory trauma center patient volumes identified in Section 395.402(1), F.S., by more than 500 patients, the TSA receives 2 points. If the annual number of severely injured patients exceeds the statutory trauma center patient volumes identified in Section 395.402(1), F.S., by 0 to 500 patients, the TSA receives 1 point. If the annual number of severely injured patients is less than the statutory trauma center patient volumes identified in Section 395.402(1), F.S., by 0 to 500 patients, the TSA receives one negative point. If the annual number of severely injured patients is less than the statutory trauma center patient volumes identified in Section 395.402(1), F.S., by more than 500 patients, the TSA receives two negative points. The following scoring system shall be used to allocate trauma centers within the TSAs: TSAs with a score of 5 points or less shall be allocated 1 trauma center. TSAs with a score of 6 to 10 points shall be allocated 2 trauma centers. TSAs with a score of 11 to 15 points shall be allocated 3 trauma centers. TSAs with a score of more than 15 points shall be allocated 4 trauma centers. An assessment and scoring shall be conducted by the Department annually on or before August 30th, beginning August 30, 2015. The number of trauma centers allocated for each TSA based upon the Amended Trauma Service Area Assessment, dated March 24, 2014 January 31, 2014, which can be found at www.FLHealth.gov/licensing- and-regulation/trauma-system/_documents/trauma-area-service- assessment.pdf, is as follows: TSA Counties Trauma Centers 1 Escambia, Okaloosa, Santa Rosa, Walton 1 2 Bay, Gulf, Holmes, Washington 1 3 Calhoun, Franklin, Gadsden, Jackson, Jefferson, Leon, Liberty, Madison, Taylor, Wakulla 1 4 Alachua, Bradford, Columbia, Dixie, Gilchrist, Hamilton, Lafayette, Levy, Putnam, Suwannee, Union 1 5 Baker, Clay, Duval, Nassau, St. Johns 12 6 Citrus, Hernando, Marion 2 7 Flagler, Volusia 1 8 Lake, Orange, Osceola, Seminole, Sumter 3 9 Pasco, Pinellas 23 10 Hillsborough 1 11 Hardee, Highlands, Polk 1 12 Brevard, Indian River 1 13 DeSoto, Manatee, Sarasota 2 14 Martin, Okeechobee, St. Lucie 1 15 Charlotte, Glades, Hendry, Lee 12 16 Palm Beach 1 17 Collier 1 18 Broward 2 19 Dade, Monroe 3 Rulemaking Authority 395.402, 395.405 FS. Law Implemented 395.402 FS. History–New 12-10-92, Formerly 10D-66.1075, Amended 6-9-05, 12-18- 06,Formerly 64E-2.022, Amended . DOH did not incorporate the March TSA Assessment by reference in the rule. After exchanges of communications with the Joint Administrative Procedures Committee (“JAPC”), wherein DOH sought guidance concerning this matter, there was no directive by JAPC that such adoption by reference would be required. DOH revised the population criterion in the Proposed Rule to have even breaks in intervals of 600,000 people. The February proposed rule awarded 6 points in TSAs with a population of 1,200,001 to 1,700,000 people (i.e., a 500,000 person interval), where all other measures were based upon a 600,000 person interval. This discrepancy is corrected in the newly Proposed Rule. DOH revised the community support criterion in the Proposed Rule to no longer award a point to TSAs where 0-50% of the city and county commissions send letters of support, because this could have reflected the need for a trauma center (by awarding points to the TSA) when no letters of support were received. The Proposed Rule now awards a point to TSAs where 25-50% of the county commissions send letters of support. DOH chose twenty-five percent as the minimum necessary community support because the smallest number of city and county commissions in all of the TSAs is four, which ensures everyone has a voice. DOH revised the title of the fourth criterion from “severely injured patients not treated in trauma centers” to “severely injured patients discharged from acute care hospitals,” which more accurately depicts the function of the criterion. DOH revised the sixth criterion to include citations to the statutory minimum volumes for Level I and Level II trauma centers in response to a request by the staff attorney for the Joint Administrative Procedures Committee. DOH also revised the rule to reference the March TSA Assessment in place of the January TSA Assessment. Finally, DOH revised the Proposed Rule’s allocation table based on the revisions to the rule and assessment. The Proposed Rule as amended allocates a total of 27 trauma centers throughout Florida’s 19 TSAs. Each TSA is still allocated at least one trauma center. The Proposed Rule allocates only Level I and Level II trauma centers, not pediatric trauma centers. The rulemaking directive in section 395.402(4) is interpreted by DOH to be limited to the allocation of Level I and Level II trauma centers. In addition, the allocation of stand-alone pediatric centers would not be feasible because pediatric trauma patients make up such a small percentage of the population and all of the Level I and II trauma centers have the ability to become pediatric trauma centers. Currently, all of the existing Level I trauma centers provide pediatric care and there are only two stand-alone pediatric centers in Florida. The Proposed Rule’s allocation of 27 trauma centers is conservative. There are currently 27 verified trauma centers in the state, including two verified trauma centers under administrative challenge. There are several elements of the Proposed Rule which Petitioners have raised as evidence of the Department’s failure to comply with its rulemaking authority. Petitioners maintain that DOH failed to consider all of the items enumerated in section 395.402(3)(a)-(k). Each of those criteria is addressed below. (a) The recommendations made as part of the regional trauma system plans submitted by regional trauma agencies-- There is only one regional trauma agency in Florida. DOH reviewed the regional agency’s plan, but it was devoid of any recommendations related to trauma center allocation within the TSAs. The regional agency did not amend its plan or submit any separate recommendations throughout the year-long, public rulemaking process. (b) Stakeholder recommendations--Petitioners complain that DOH did not do enough to solicit input from everyone who would be affected by the Proposed Rule. The Department, however, obtained stakeholder testimony from 171 individuals and written comments from 166 stakeholders through the course of the 12 rule development workshops conducted around the state. The workshops were held in several cities to allow for geographic access by more residents. Over 400 people attended the workshops. The January TSA Assessment was also modified prior to its publication as a result of the stakeholder discussions at the workshops and the negotiated rulemaking session. The March TSA Assessment was further amended after its publication as a result of testimony at the public hearing for the Proposed Rule. (c) The geographical composition of an area to ensure rapid access to trauma care by patients--While Florida contains no mountains, its geography is unique to other states in that it contains several inlets, bays, jetties, and swamplands. As such, the DOH data unit examined the coastal areas versus non- coastal areas. The unit also analyzed urban versus rural areas. The unit also looked at the communities surrounding Lake Okeechobee. Ultimately, the analysis was not meaningful because the effect geography has on access to trauma centers is captured by Florida’s transport time records for emergency vehicles and helicopters. Thus, by reviewing the Emergency Medical Services Tracking and Reporting System (“EMSTARS”) database, DOH could know the actual effects of Florida’s geography on access to trauma centers. (d) Historical patterns of patient referral and transfer--This item was considered, but the January TSA Assessment does not address it because it was neither measurable nor meaningful. The data was not measurable because of limitations of data quality in the Trauma Registry. Even if the data were measureable it would not have been meaningful because it would have only illustrated the catchment areas--i.e., the geographic distribution of patients served by existing trauma centers. As recommended by the ACS, DOH’s primary focus is on the trauma system as a whole, not individual trauma centers. Moreover, transfer and referral history is not meaningful to an assessment designed to inform an allocation rule because, again, DOH does not have the authority to define where new trauma centers are developed within a TSA. See § 402.395(4)(b), Fla. Stat. (charging DOH with allocating by rule the number of trauma centers in each TSA, not trauma center location within a trauma service area). (e) Inventories of available trauma care resources, including professional medical staff--Petitioners suggest that DOH should have made a determination of existing professional medical staff, but suggest no viable means of doing so. The January TSA Assessment catalogues several trauma care resources within TSAs, including financing, trauma centers, acute care hospitals, and EMS response capabilities. The January TSA Assessment does not catalogue available professional medical staff. DOH is unaware of any database that compiles this information. DOH sent a survey to the existing trauma centers requesting information as to their resources and professional staff, however it was not useful due to the limited responses and potential for bias. The data unit also reviewed the DOH Division of Medical Quality Assurance health professional licensure database (COMPASS), however, it was not helpful because physician specialty reporting is voluntary. Similarly, the data unit reviewed AHCA’s inventory of licensed acute care hospitals and the DOH annual physician workforce survey results, but neither data source provided trauma-specific information. As such, the information was not complete and so was not included in the January TSA Assessment. (f) Population growth characteristics--In response to this criterion, the DOH data unit analyzed the potential for growth in all of the TSAs, but the January TSA Assessment did not include this analysis because it was not meaningful given DOH’s requirement to conduct the assessment annually. The January TSA Assessment does however document the population in each TSA. DOH decided that in light of the continuing change of population in Florida, the best it could do would be to make a finding as to the population in each TSA and use it--year by year--to look at the potential need for additional (or presumably fewer) trauma centers in an area. Obviously the population of an area is not directly commensurate with the number of severely injured patients that might be found. Not all areas have equal percentages of severely injured patients; urban areas would have higher percentages than rural areas, in general. Areas through which a major interstate highway runs would expect a higher percentage. There are a number of factors that could potentially affect an area’s expectation of trauma services. Inasmuch as they could not all possibly be included in an analysis, DOH defaulted to a more general view, i.e., the total population. The total population figure became the first measurement in the Proposed Rule. (g) Transportation capabilities; and (h) Medically appropriate ground and air travel times--DOH considered these two factors together and determined to cover them by way of a determination of median transport time, which was to become the second measurement in the Proposed Rule. The data unit gathered transport capability data by reviewing the COMPASS licensure database and archived paper applications to discern the number of licensed emergency medical stations, helicopters, and vehicles in each TSA. The data unit further calculated the number of ground vehicles per the population in each TSA and every 100 square miles. The January TSA Assessment included this information because it was meaningful and gathered from a reliable database. DOH considered the testimony from a number of trauma surgeons during the 12 workshops regarding transport times and learned that the medically appropriate transport time depends on the nature of injuries and individual patients, which are not always discernable at the scene of an accident. Because of this, the sooner a patient can be transported to a trauma center, the better it is for patient outcomes. In light of the patient-specific realities of establishing a medically appropriate transport time, the data team used EMSTARS to calculate the median emergency transport times in each TSA for the assessment. Granted the EMSTARS is a fairly new system under development, and it reports all 911 calls voluntarily reported (not just trauma patients), so it is not a completely accurate measure. But it is a reasonable approach based upon what is available. Also, the transport times do not reflect whether pre-hospital resources are sufficient for the patient or how far away the closest trauma center may be. It is not an absolutely perfect measurement, but it is reasonable and based on logic. (i) Recommendations of the Regional Domestic Security Task Force--Like Florida’s lone regional trauma agency, the RDSTF did not offer any input throughout the year-long, public rulemaking process. However, DOH considered the testimony of numerous emergency management and law enforcement officials during the rule development process. For example, Chief Loren Mock, the Clay County fire chief and also a member of the Domestic Security Oversight Council, testified at the Jacksonville workshop. There is no evidence DOH directly contacted a RDSTF representative to solicit input. (j) The actual number of trauma victims currently being served by each trauma center--The March TSA Assessment included the annual trauma patient volume reported to the Trauma Registry by the existing trauma centers. When comparing the average patient volume reported to trauma registry from 2010- 2012 to the data unit’s calculation of the average number of severely injured patients treated in trauma centers during this same time span, the volumes reported by the trauma centers were approximately 333% greater. This large disparity prompted DOH to follow the example of many other states and use population as a proxy for the number of potential trauma patients in each TSA in its Proposed Rule. DOH found that: greater population means a greater need for health care; population is a good indicator of need for medical services; population is a reasonable proxy for patient volume; and, more people in a given area results in more trauma cases in a given area. (k) Other appropriate criteria: It was well documented in literature presented to DOH during the rulemaking process that there were a large percentage of severely injured patients in Florida not being seen by trauma centers. The data unit confirmed this by evaluating the AHCA administrative database, which identifies the injuries suffered by patients as well as the type of hospitals discharging those patients, i.e., comparing the total number of severely injured patients with the number of severely injured patients discharged from acute care hospitals in each TSA. This disparity was worrisome to DOH and therefore included in the March TSA Assessment. As pointed out by Petitioners, the Department’s figures include patients who may have received treatment outside the TSA in which the injury occurred. The figures may not have contained patients who needed trauma care but could not access it for other reasons. The Proposed Rule, however, makes as complete an evaluation of the potential patient base for trauma centers as is possible. Notwithstanding complaints about how the Department addressed some of the criteria set forth in the statute, it is clear that all criteria were considered and implemented into the Proposed Rule to the extent feasible and possible. The most credible testimony at final hearing supports the Department’s process. Criticisms of the various elements within the Proposed Rule expressed by Petitioners at final hearing seemed to be based on the concept that the Proposed Rule may allow competition to existing trauma centers rather than real complaints about the elements themselves. All agree, for example, that population, transportation times, number of patients, and the existence of nearby trauma centers are important factors that should be considered. Petitioners just seemed to want those factors expressed in different (though unspecified) terms. Petitioners did enunciate certain shortcomings they felt made the Proposed Rule less than complete. St. Joseph lamented the absence of all the Department’s analysis and background for each of the proposed measurements contained in the Proposed Rule. Jackson Memorial pointed out that pediatric trauma centers were not specifically included in the Proposed Rule. Shands showed that odd or unusual results could arise from implementation of the Proposed Rule. For example, the March TSA Assessment showed a total of 216 severely injured patients in TSA 6, comprised of Marion, Citrus, and Hernando counties. The Proposed Rule called for two trauma centers in that TSA. Although the number of patients necessary to maintain a trauma center’s proficiency was disputed by various experts in the field, it is clear that 108 patients per center would be extremely low. However, the figure appearing in the March Assessment is not absolute or necessarily completely definitive of need. There are other factors concerning population and patients that may affect that figure. The Six Measurement Criteria in the Proposed Rule Petitioners also took exception to the measurement criteria in the Proposed Rule. Each of those six criterion is discussed below. Population The Proposed Rule awards from two to ten points to a TSA, depending on the TSA total population. Two points are awarded for a population of less than 600,000 and ten points are awarded for a popu1ation greater than 2.4 million. The Department used total population as a "proxy" for the actual number of trauma patients in the state rather than using the actual number of trauma victims in the state. The Proposed Rule does not define “population” or “Total Population,” nor are those terms defined in the trauma statute, but those words are subject to their normal definition. The Proposed Rule does not re-state the source of the summary Total Population data; it is already contained in the TSA Assessment. Neither the Proposed Rule nor the March TSA Assessment contains any data or analysis reflecting population by age cohort, population density, or incidence of trauma injury in relation to these factors, and the Department did not specifically conduct any analysis of the significance of any aspect of population data as it relates to the need for new trauma centers, other than determining the total population growth rate in the TSAs. Rather, DOH decided upon total population as the most reliable measure available. Traumatic injury rates and the severity of traumatic injury vary widely based on a number of factors, including whether the area is urban or rural, the population age cohort, and the infrastructure and physical characteristics or features of the geographic area. Thus, the most reasonable way to measure possible need was to look at the total population of an area and extrapolate from that basis. The Department presented no specific data or analysis to support the incremental cutoff points for the Total Population scale contained in the Proposed Rule. Rather, the Department took population as a whole because it was the most readily available, annually updateable, and understandable factor it could access. The use of population as a proxy is not without problems, however. In TSA 19, for instance, the population has increased by about thirty-eight percent in recent decades, but the number of trauma victims has declined by approximately twelve percent. As stated, the Proposed Rule as written is not inerrant. Median Transport Times The Proposed Rule awards from zero to four points to a TSA, depending on the Median Transport Time within a TSA. “Median Transport Time” is not defined in the Proposed Rule, nor is the methodology for determining the summary “Median Transport Time” statistics set forth in the TSA Assessment and relied on in the Proposed Rule. Information concerning transport times is, however, contained within the TSA Assessment. The Median Transport Time used in the Proposed Rule represents the average transport time for all 911 transports voluntarily reported to the state EMSTARS database. EMSTARS is a database that is under development and that collects information voluntarily provided by emergency medical transport providers throughout the state. Although not all EMS providers currently report to EMSTARS (most notably, Miami-Dade County EMS does not participate), the database is useful for research and quality improvement initiatives. The Median Transport Time set forth in the March TSA Assessment and used in the Proposed Rule includes transport time for all patients, regardless of the nature of the emergency, whether the call involved trauma, other types of injury, or illness, and regardless of whether the transport was conducted with the regular flow of traffic or required “lights and siren.” The Median Transport Time used in the Proposed Rule includes all EMS transports of up to two hours in duration. The Median Transport Time excludes transports of patients to trauma centers operating pursuant to the initial stage of trauma center licensure known as “provisional approval.” The Department addressed “medically appropriate air or ground transport times,” as required by section 395.402(3)(h), by its generally accepted conclusion that "faster is better." Not all injured patients, however, benefit from receiving care at a trauma center. Thus, while an existing trauma center is an appropriate destination for all patients with any level of injury who live in the area of a trauma center, the trauma center’s value beyond its immediate area is as a resource for the most severely injured patients whose problems exceed the capabilities of their nearest hospital. The Department did not undertake any analysis to balance its "faster is better" approach to trauma planning against the reality that the resources necessary to provide high quality trauma care are limited, as is the number of severely injured patients. There is a general (but not universal) consensus among trauma experts that access to a trauma center within 30-50 minutes is an appropriate benchmark for access to trauma care. Other than "faster is better," the Department did not determine a medically appropriate travel time for any type of trauma or any geographic area, but recognizes the general consensus as appropriate. The Proposed Rule awards from one to four points that weigh in favor of approval of a new trauma center within a TSA if the Median Transport Time of patients transported in response to any 911 call is between 10 and 42 minutes, i.e., within but faster than the generally accepted consensus. Community Support The Proposed Rule awards from one to two points to each TSA depending on the number of letters of support written by elected city or county commissioners. The Proposed Rule allows for consideration of stakeholder recommendations by way of allowing letters of support from local governments. “Stakeholders” in the state trauma system include existing trauma centers, as well as all acute care hospitals, and pre- and post-hospital care providers, including emergency transport services, air ambulances, and emergency management planning agencies. The Department could find no better way to acknowledge support from those stakeholders, and citizens in general, than to have their elected representatives listen to their constituents and then reflect those people’s desires and comments. Severely Injured Patients Discharged from Acute Care Hospitals The Proposed Rule awards from zero to four points to a TSA, depending on the number of severely injured patients discharged from acute care hospitals (non-trauma centers). The Proposed Rule addresses the number of severely injured patients, i.e., those with an ICISS score of < 0.85, discharged from hospitals other than trauma centers. The Proposed Rule does not specifically define “severely injured patient,” but it is obvious from the context in which that term is used. The summary data in the TSA Assessment labeled "number of severely injured patients” within each TSA is intended to reflect the number of severely injured patients who “didn’t get to trauma care.” The Department's numbers may include patients who received treatment at a trauma center outside of the TSA in which the injury occurred. The Department did not conduct any analysis of the "number of severely injured patients not treated at a trauma center" to determine whether the patients not treated at a trauma center received timely and appropriate care at a non-trauma center hospital with the capability to treat the patient's injuries. The number of “severely injured patients who did not get to trauma care” as reported by the Department is unlikely to reflect the actual number of patients who required care at a trauma center but did not have access, and suggests that this number is far higher than it actually is. The Department, for example (and in response to discussion with stakeholders), excluded from its analysis all patients with isolated hip fractures as well as all patients who were released from the hospital within 24 hours, which resulted in fewer severely injured patients. Neither the Proposed Rule nor the TSA Assessment considers demographics or outcomes for "severely injured patients" treated at general acute care hospitals or outcome data for these patients. The Proposed Rule does not include any method for projecting the actual demand for trauma services in the future; it is used to determine need at a single point in time (and will be done so annually). The Proposed Rule does not include any criteria or method for evaluating whether there are any capacity problems at existing trauma centers, or other barriers that impede access to trauma care. The Department intended this criterion to show a highly conservative estimate of patients who definitely need trauma care. Level I Trauma Centers With respect to “Level I Trauma Centers,” the Proposed Rule awards from negative one to negative three points to a TSA, depending on whether the TSA already has one, two, or three verified Level I trauma center(s), respectively. The Proposed Rule creates the opportunity for establishment of both additional Level I and also additional Level II trauma centers, pursuant to the allocation of need, but the Proposed Rule does not assign or subtract points for the existence of Level II trauma centers. This criterion reflects the recommendations of stakeholders at the rule workshops. It was the consensus of many stakeholders that Level I trauma centers should be protected in order to safeguard the research and teaching missions of those centers. The earlier proposal of a “halo” around existing centers, i.e., not approving a new trauma center within a certain radius of existing centers, was not incorporated into the Proposed Rule. This criterion, however, offers some protection for existing centers. Number of Severely Injured Patients The Proposed Rule awards negative two to two points based on the "number of severely injured patients" in a TSA. The criterion awards points based on the number of Severely Injured Patients which exceed the target trauma center patient volumes as provided in section 395.402(1). If the annual number of Severely Injured Patients exceeds the statutory volumes by more than 500 patients, the TSA will receive two points; if it exceeds it by less than 500 the TSA receives one point; if the number of Severely Injured Patients is less than the statutory volumes by zero to 500 patients, the TSA receives one negative point; if it is less than the volumes by more than 500 patients, the TSA receives two negative points. The Proposed Rule does not include any criterion addressing the actual number of trauma victims currently being served by each trauma center. Instead, Section 6 of the Proposed Rule substitutes the "minimum statutory capacity" of existing trauma centers for the actual capacity of existing trauma centers. The Department could not find “a meaningful” way to measure actual capacity of existing trauma centers. The most accurate way to measure capacity was a contentious topic at rule workshops, and the Department spent a good deal of time working with stakeholders on how to measure capacity in such a way that it could be included as a factor in the Proposed Rule. One suggestion as to how to measure trauma center capacity is by how often existing trauma centers actually divert trauma patients to other facilities. However, trauma centers rarely admit that they are not able to take any more patients, and this is not a realistic method to evaluate capacity. The capacity of an existing trauma center may be measured by various means, including the number of beds at the trauma center, the number of ICU beds, the number of trauma bays, number of operating rooms, as well as the frequency of and reasons for diversion. The trauma center’s clinical staff, including medical and surgical specialists, and supporting clinical personnel, are also indicators of capacity. The Department already routinely collects data reflecting trauma center capacity as part of the quarterly and annual reports that all existing trauma centers are required to submit, and by way of on-site licensure surveys. None of those means, however, provided DOH with sufficiently reliable information and data. The Proposed Rule comports with the DOH Mission to protect, promote, and improve the health of all Floridians through integrated state, county, and community efforts. While by no means perfect, the Proposed Rule is based upon logic and reason derived from an extensive analysis of all relevant factors. History of the Rule The rationale for DOH’s inclusion of those particular six criteria in the Proposed Rule can be better understood by considering some more history of the trauma rule. As stated earlier herein, in 2004 the Legislature made substantial revisions to the trauma statute and ordered the Department to complete an assessment of Florida’s trauma system. The scope of this assessment was defined in paragraphs (2)(a) through (g) and subsection (3) of section 395.402. An appropriation of $300,000 was authorized for the Department to contract with a state university to perform the actions required under the amended statute. Ch. 2004-259, § 10, Laws of Florida. One proposal of the 2005 Assessment was to "[c]onsider aligning trauma service areas within [sic] the trauma region boundaries as established in" section 395.4015(1). § 395.402(2)(a), Fla. Stat. In a related 2004 amendment, the Legislature ended the statutory mandate to use the service areas created in 1990. The obvious conclusion from the above statutory change is that the section 395.402(4) service areas could be replaced by the service areas DOH established or adopted once it had the results of the 2005 Assessment. Unlike the prior statute, there is no mandate for specific new service areas, only the option not to use the prior service areas. The 2005 Assessment included five "Recommendations": Trauma centers should be placed in Tallahassee and in Bay County, which do not currently have a trauma center . . . . It is reasonable to set, as a system goal, that 65 percent of trauma center patients will be treated at a trauma center. . . . Designation of additional trauma centers should be based on the need as determined by trauma region. Deployment of additional trauma centers should take place based, not only on the number of patients served per trauma center, but according to the concept of “trauma center capacity” which should be determined by the staffing levels of medical specialists and other healthcare professionals. . . . The data support the feasibility of transforming the Florida Trauma Services Areas so that these would coincide with the Domestic Security Task Force Regions. . . . It is reasonable to fund trauma centers with public funds, based on the unrecoverable financial burden incurred by trauma centers. The only legislative response to the 2005 Assessment was an increase in funding to trauma centers. The Legislature did not repeal the statute establishing the current 19 TSAs. Likewise, the Department has not amended the Rule to implement the recommendations contained in the 2005 Assessment until the present Proposed Rule. The Department, instead, reviewed existing statutes, interpreted section 395.4015 to mandate the establishment of a trauma system plan (which plan would include trauma regions that have boundaries coterminous with those of the regional domestic security task force boundaries). The development of the trauma system plan is distinct from the determination of need for new trauma systems addressed by the Proposed Rule.
The Issue The issue is whether Respondent's medical license should be disciplined for alleged violations of Chapter 458, Florida Statutes.
Findings Of Fact Respondent is, and has been at all times material hereto, a licensed physician in the State of Florida, having been issued license number ME 0027368. Respondent is board certified in family practice; however, he is not board certified in emergency medicine. On May 30, 1994, Dr. Dulay was on call in the hospital emergency room at Madison County Memorial Hospital (MCMH) in Madison, Florida. On May 30, 1994, Patient T.H. an obese, forty-eight year-old male was found unconscious on the floor of the bathroom by his brother, Wallace. T.H. had an arteriovenous malformation (AVM) in his brain. An AVM is a weakened area of a blood vessel which can fill with blood, expand and/or burst. AVMs located in the brain are very dangerous since a ruptured AVM can damage the brains tissue. The amount of damage depends on the amount and rapidity of the bleeding. Under any circumstances, a ruptured AVM is an emergency medical condition where time is of the essence in diagnosing and treating usually with some neurosurgical intervention. On May 30, 1994, at approximately 4:56 a.m., Carol Wells a Madison County 911 Operator received an emergency call regarding T.H. The call was originally received as a fall. An Advanced Life Support (ALS) ambulance was dispatched to T.H.'s location in Cherry Lake Garden Trailer Park. An ALS unit is intended to be a mobile critical care unit, able to render critical care and stabilization to a patient enroute to an appropriate hospital. An Advanced Life Support unit contains equipment needed for insertion of a chest tube, a lab, and an x-ray, as well as equipment and medications for cardiac emergencies. The equipment and medications needed for T.H.'s case were present. The ALS unit arrived at T.H.'s location at 5:19 a.m. Jimmy Kent was an EMT and driver of the ALS unit that responded to the 911 emergency call on T.H. Richard Kline was the paramedic on the ambulance. Mr. Kline was trained in ALS care and could administer certain drugs, including Procardia without a physician's order. Paramedic Kline found patient T.H. on the floor of the trailer. He observed T.H. to be comatose, unresponsive to painful stimuli, and exhibiting snoring-type respirations. His skin was hot and dry, and his face was red. T.H. scored a three on the Glasgow Coma Scale, the lowest possible score. T.H.'s vital signs were blood pressure estimated at 300 plus over 150, respiratory rate of 40, heart rate "tacking" at approximately 170, with raspy breathing. T.H. was considered in critical condition. At the scene, Paramedic Kline was having problems with his cardiac monitor, which became non-functional due to battery problems. However, patient T.H. could still be adequately monitored manually. Additionally, within twenty-five minutes of beginning the run, the cardiac monitor on the ALS unit was non- functional due to failure of the primary and back-up batteries. The lack of the units equipment did not significantly impact the paramedic's ability to monitor or treat T.H.'s condition. Paramedic Kline was informed by T.H.'s family that he had a history of Arterial Venous Malformation, paralysis on the right side, and strokes. T.H.'s sister was called and she advised that T.H. not be brought to Madison County Memorial Hospital (MCMH) because they usually don't have a doctor available. She wanted T.H. to go to South Georgia Medical Center (SGMC) in Valdosta, Georgia. The paramedic thought that they needed to take T.H. to MCMH because of the serious vital statistics that T.H. had. The paramedic felt T.H. could go into cardiac arrest. After being advised by the paramedic that T.H. needed immediate assistance at MCMH, T.H.'s sister agreed to have T.H. taken to MCMH. There are two hospital emergency facilities to choose from when transporting an emergency case in the Madison, Florida, area, MCMH and SGMC. In driving terms MCMH is slightly, but not significantly, closer to Cherry Lake Garden Trailer Park than SGMC. However, the facilities are very different in the services each can offer in an emergency situation. MCMH is not a trauma center. MCMH does not have any neurosurgical facilities, neurosurgical consults, diagnostic MRI's, diagnostic CT scans, or cerebral monitoring equipment available. MCMH cannot treat a cerebral vascular accident or bleeding in the brain. On the other hand, SGMC is a tertiary care facility. It has neurosurgical facilities, neurosurgical consults, diagnostic CT scans, and cerebral monitoring equipment available. SGMC can treat a cerebral vascular accident and is the closest facility which can provide such care. The ambulance was en route to MCMH when it contacted the hospital by radio; Joanie Cruce, R.N., spoke to the ambulance driver over the radio. Paramedic Kline informed Nurse Cruce of T.H.'s history, including the presence of T.H.'s AVM and vital signs. He also informed Nurse Cruce that he was bringing the T.H. to MCMH. Nurse Cruce relayed T.H.'s information to Joe Jaime, R.N. Nurse Jaimie was on the telephone to Dr. Dulay who was in another room at the hospital. Nurse Jaimie relayed over the telephone to Dr. Dulay the information Nurse Cruce gave her. At no time did Dr. Dulay speak directly with the paramedic. Dr. Dulay was informed that the patient had high blood pressure, was unconscious, and had a history that included an arterial venous malformation. Due to the patient being unconscious, he suspected a cerebral vascular accident/stroke (CVA). At approximately 5:40 a.m., while en route to MCMH, the paramedic asked for advice on whether to administer Procardia. Procardia is used to reduce blood pressure. Respondent advised that it was appropriate to administer 10mg of Procardia. There was some uncertainty in the testimony as to whether the administration of Procardia was requested by the paramedic and approved by Dr. Dulay, or ordered by Dr. Dulay. Either person could have authorized the use of the drug. In any event, 10mg of Procardia was the appropriate medication for the patient's condition and met or exceeded the appropriate standard of care for an emergency room physician under the circumstances. At some point, Dr. Dulay advised the ambulance to have T.H. taken to the nearest appropriate facility. The ALS unit was one to two miles from MCMH when Joanie Cruce, R.N., advised the ambulance driver to take T.H. to the nearest appropriate facility. Either Nurse Cruce misspoke and said Tallahassee or Richard Kline misunderstood her to say Tallahassee. Richard Kline questioned the direction to take T.H. to Tallahassee. He told nurse Cruce that the family wanted T.H. to go to the hospital in Valdosta. The information was passed to Dr. Dulay. He agreed that SGMC was an appropriate facility for T.H. and in fact SGMC was the closest appropriate facility for T.H.'s condition. Dr. Dulay never informed the nursing staff that T.H. could not be brought to MCMH and indeed the nurses thought that the ambulance was on its way even after the conversation about Valdosta. Patient T.H. was not in respiratory or cardiac arrest at the time the ambulance was turned around to go to Valdosta. After the change of direction, which is always within the discretion of the ambulance crew, there was no further contact with MCMH. Therefore Dr. Dulay was never informed of the results of the Procardia. Additionally, T.H. was never admitted to MCMH and never became a patient of Dr. Dulay or the hospital. Therefore, since T.H. was not a patient of the hospital no transfer from one facility to another facility occurred. While en route to SGMC, the ambulance contacted SGMC's emergency room. The staff advised the paramedic to give T.H. sodium nitroprusside. However, the ambulance did not carry sodium nitroprusside. Instead the paramedic was advised by SGMC staff to administer Lasix IV and nitroglycerine. Patient T.H. suffered respiratory arrest just outside the city limits of Valdosta. Efforts to intubate and revive him were unsuccessful. Patient T.H. arrived at SGMC in full arrest. The ambulance arrived at SGMC at 6:25 a.m. Attempts to revive the patient at the hospital were unsuccessful. T.H. was pronounced deceased shortly after his arrival at SGMC. T.H.'s cause of death was cardiopulmonary arrest with an underlying cause of intracranial hemorrhage, probably due to an aneurysm. In short, all of T.H.'s symptoms were caused by a rapidly expanding and bleeding cerebral vascular incident from his AVM. T.H.'s condition was not due to a cardiac problem. The medical condition of T.H. at the time he was transported by Madison County ALS was indicative of an intracranial hemorrhage. Such a condition could only be evaluated for surgical treatment through the utilization of an MRI and CT scan, and required the immediate consultation of a neurosurgeon. None of which were available at MCMH. Moreover, it would generally be preferable to transport a patient with a score of three on the Glasgow Coma Scale to a trauma center. SGMC was the closet facility to Cherry Lake at which a neurosurgical consult was available, and which had the capability of treating an intracranial hemorrahage; therefore, patient T.H. was appropriately diverted to that facility. Dr. Dulay did not open a chart on T.H., and could not recall whether he made written notes during T.H.'s emergency. However, it is not customary practice that a medical chart be opened for an emergency case when consults are made via radio and the person is diverted or otherwise delivered to a separate facility. Generally, neither the hospital nor the doctor know the name of the person being transported. If the person does not arrive at the hospital, that facility has no information on which to open a patient record. Under such circumstances, the person's history, vital signs, and medication administration are recorded in the ALS run sheet, which accompanies the person to his or her ultimate destination. The radio communications are recorded by audiotape. In this case, the history, vital signs, and medication administration to T.H. were in fact recorded in the ALS run sheet. The run sheet appropriately accompanied T.H. to SGMC. The radio communications were recorded by audiotape. These documents are adequate records in emergency situations. Given these facts, there was no deviation by Dr. Aldolfo Dulay from the applicable standard of care for a physician under the circumstances presented in this case or that there was a failure to keep adequate written medical records justifying the course of treatment of the patient.
Recommendation Based upon the findings of fact and conclusions of law, it is, RECOMMENDED: That the Board of Medicine enter a final order finding that Adolofo Dulay, M.D. did not practice below the accepted standard of care in his handling of the diversion of patient T.H. to a tertiary care facility, that there was no transfer of patient T.H. and that the records maintained were appropriate under the circumstances and that the Administrative Complaint be dismissed. DONE AND ENTERED this 2nd day of June, 1998, in Tallahassee, Leon County, Florida. DIANE CLEAVINGER Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 2nd day of June, 1998. COPIES FURNISHED: John Terrell, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Richard B. Collins, Esquire Ryan Garrett, Esquire Collins and Truett, P.A. 2804 Remington Green Circle, Suite 4 Tallahassee, Florida 32308 Angela T. Hall, Agency Clerk Department of Health Building 6, Room 136 1317 Winewood Boulevard Tallahassee, Florida 32399-0700 Pete Peterson, Esquire Department of Health Building 6, Room 102-E 1317 Winewood Boulevard Tallahassee, Florida 32399-0700 Dr. James Howell, Secretary Department of Health Building 6, Room 306 1317 Winewood Boulevard Tallahassee, Florida 32399-0700 Dr. Marm Harris, Executive Director Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue The issue for determination in this proceeding is whether Respondent is entitled to a refund of $285,648.26 paid for Medicaid services that Petitioner provided during the respective hospitalizations of four psychiatric patients.
Findings Of Fact Petitioner operates two hospitals in the name of Florida Hospital. Each hospital is separately located. Both hospitals participate in the Florida Medicaid program in accordance with Chapter 409, Florida Statutes, 1/ and Florida Administrative Code Rule 59G. 2/ Respondent is the state agency responsible for administering the Florida Medicaid program. In order for the state to receive federal funds, federal statutes and regulations mandate that Respondent control the utilization of services subject to Medicaid payments. 3/ Respondent contracts with a professional review organization to control the utilization of psychiatric services subject to Medicaid payments. 4/ Keystone Peer Review Organization ("KEPRO") retrospectively reviews admissions and lengths of stay for psychiatric patients to determine whether alternative sources of payment exist and whether Medicaid services are medically necessary. Respondent claims that alternative sources of payment existed for two of the four Medicaid recipients at issue in this proceeding. Respondent also claims that the inpatient services Petitioner provided to all four recipients were medically unnecessary. 5/ Alternative Sources Of Payment 5. Medicaid is the payor of last resort. 6/ Irrespective of whether the services provided by Petitioner were medically necessary, Respondent is entitled to a refund if other sources of payment existed for those services. Alternative sources of payment are primary and prior to Medicaid payments ("alternative source(s) of payment"). Medically Necessary Respondent claims that the inpatient services Petitioner provided to all four recipients were medically unnecessary. The terms "medically necessary" or "medical necessity" are not defined by applicable state and federal law. 7/ Medical necessity is determined by applying a two-prong test to the facts and circumstances surrounding each case. 8/ The first prong requires inpatient services during admission and treatment of Medicaid recipients to be consistent with appropriate medical care. 9/ The second prong of the test requires alternative placements to be considered in prescribing inpatient services. 10/ First Prong: Appropriate Medical Care Services that alleviate a harmful medical condition are consistent with appropriate medical care. Services alleviate a harmful medical condition if they are reasonably calculated to prevent, diagnose, correct, cure, alleviate, or prevent the worsening of conditions in the recipient that endanger life, cause suffering or pain, result in illness or infirmity, threaten to cause or aggravate a handicap, or cause physical deformity or malfunction. 11/ Services are consistent with appropriate medical care if they are provided to protect the patient's life, prevent significant illness or disability, or to alleviate severe pain. Services must be consistent with individualized treatment. They must be specific and consistent with symptoms or a confirmed diagnosis of the illness or injury under treatment. 12/ Services are consistent with appropriate medical care if they do not exceed the patient's individual needs. Services may not be primarily intended for the convenience of the recipient or the provider. 13/ KEPRO considers the intensity of service, the severity of illness, and discharge screens in determining medical necessity ("ISD criteria"). 14/ ISD criteria are subdivided into approximately 14 subgroups. ISD criteria represent a list of signs and symptoms and diagnostic and therapeutic services. They are general guidelines for determining the medical necessity of inpatient services. ISD criteria are not dispositive of medical necessity. ISD criteria are not binding on the treating physician. 15/ The treating physician can override ISD criteria based on his or her clinical judgment concerning a particular Medicaid recipient. 16/ The clinical judgment to override ISD criteria must be consistent with appropriate medical care. 17/ The four Medicaid recipients did not improve significantly within the time prescribed by ISD criteria. A patient that fails to make significant improvement in a timely manner does not satisfy ISD criteria for continued inpatient services. 2.1(a) Matters Not At Issue Respondent does not challenge the admission of the four Medicaid recipients. 18/ Their admission to Florida Hospital satisfied applicable ISD criteria and was consistent with appropriate medical care. Respondent does not claim that inpatient services provided before the date each Medicaid recipient failed to satisfy ISD criteria for continued inpatient services were medically unnecessary ("initial treatment"). Initial treatment satisfied applicable ISD criteria and was consistent with appropriate medical care. 2.1(b) Matters At Issue Respondent acknowledges that inpatient services provided after initial treatment of the four Medicaid recipients were consistent with appropriate medical care. 19/ When asked if Respondent challenged the level of services, the quality of care, or the appropriateness of care, Respondent stated: Oh, absolutely [not]. We're not saying that the care was either substandard or . . . rank overutilization . . . . We're not saying there was substandard care or [that] they . . . [tried] . . . to . . . game the system. We certainly don't believe that. Transcript at 172-173. 20/ Respondent claims that inpatient services were medically unnecessary after initial treatment because the recipients no longer satisfied ISD criteria for continued inpatient services. Second Prong: Alternative Placement The second prong of the medical necessity test provides that inpatient services are medically unnecessary if, consistent with appropriate medical care, they could have been effectively furnished more economically either on an outpatient basis or in an inpatient facility of a different type. 21/ Thus, discharge to outpatient care or to an inpatient facility of a different type ("alternative") must be made in a manner that is consistent with appropriate medical care. 22/ In addition, an alternative must be available and suitable for the needs of the individual patient. 23/ An alternative placement exists if several conjunctive requirements are satisfied. An alternative placement exists if inpatient services could have been: effectively furnished; more economically; in an available and suitable alternative; in a manner that is suitable for the needs of the individual patient and consistent with appropriate medical care ("alternative placement"). 24/ The parties agree on two requirements of the alternative placement test. Inpatient services provided by Petitioner could have been provided more economically in an alternative setting. The parties also agree that relevant alternatives were facilities of a different type than Florida Hospital. The parties contest the remaining requirements of the alternative placement test. The contested issues are whether, prior to the respective dates of discharge, the inpatient services provided by Petitioner could have been: effectively furnished; in an available and suitable alternative; in a manner that was suitable for the needs of the individual patient; and in a manner consistent with appropriate medical care. 2.2(a) Matters Not At Issue An alternative placement did not exist when Petitioner admitted the four Medicaid recipients to Florida Hospital. Respondent does not challenge Petitioner's admission of the four recipients. Petitioner used appropriate procedures and due diligence to determine if an alternative placement existed for each of the four Medicaid recipients. 25/ Respondent does not challenge the procedures and diligence used to determine whether an alternative placement existed. 26/ An alternative placement did not exist for the four Medicaid recipients during their initial treatment. Respondent does not challenge the inpatient services provided by Petitioner while the recipients satisfied ISD criteria. 27/ 2.2(b) Matters At Issue As a threshold matter, Respondent asserts that it is not required to consider an alternative placement in determining medical necessity. Respondent argues that it can determine medical necessity solely by applying ISD criteria. Even if Respondent is required to consider an alternative placement, Respondent claims that it is not required to consider the availability or suitability of an alternative. If Respondent is required to consider availability and suitability, Respondent claims that a suitable alternative was available for all four Medicaid recipients on the respective dates that the recipients no longer satisfied ISD criteria. 28/ 2.2(c) A Difficult And Litigious Task The medical determination of the existence of an alternative placement is a difficult task and a risky one for physicians and hospitals in today's litigious society. 29/ It may be suitable for the patient's needs and consistent with appropriate medical care to discharge the patient to an alternative facility. However, an alternative may be unavailable when a patient no longer satisfies ISD criteria. Unavailability of suitable alternatives may be caused by a variety of factors. There may be a shortage of existing facilities. Existing facilities with available space may lack funding to accept new residents. Existing facilities may have the necessary funding but lack available space. Outpatient case loads may be so great that the delay between discharge and the delivery of outpatient services may effectively deny any timely and meaningful availability of outpatient care. In such cases, it may not be suitable for the patient's needs or consistent with appropriate medical care to discharge the patient without an available alternative. When a patient no longer satisfies ISD criteria, alternatives may be available, but available alternatives may not be suitable for the patient's individual needs. The services furnished by an available alternative may not be suitable for the needs of the patient. Conversely, an available alternative may offer suitable services but may not be capable of furnishing those services effectively. It may not be consistent with appropriate medical care to discharge the patient to an available alternative that is either unsuitable or ineffective; or to discharge the patient without an alternative. Even if an alternative is available, suitable, and effective, the condition of the patient may need to improve or stabilize before discharge to an alternative is suitable for the individual needs of the patient and consistent with appropriate medical care. Earlier discharge of such a patient may be inconsistent with appropriate medical care. A provider must determine whether to continue to furnish services during the interim required until the patient can be discharged to an alternative placement or can be discharged with no alternative placement ("interim services"). Interim services are medically necessary if prior discharge of a patient would either violate ISD criteria or be inconsistent with appropriate medical care. 30/ The Four Medicaid Recipients The identity of the patients for which Respondent seeks a refund, the dates of their hospitalization, the contested dates, and the amount of contested payments are set forth in the following table. Patient Dates Of Hosp. Contested Dates Contested Amount J.H. 08/24/92-10/29/92 09/25/92-10/29/92 $ 24,953.96 N.S. 10/18/89-06/14/91 11/18/89-06/14/91 $232,831.16 A.B. 10/04/91-11/04/91 10/12/91-11/04/91 $ 15,808.36 B.W. 05/10/91-06/10/91 05/23/91-06/10/91 $ 12,054.78 TOTAL $285,648.26 Respondent claims that it is entitled to a refund of $257,785.12 because alternative sources of payment existed for the inpatient services provided to J.H. and N.S. after their initial treatment. Respondent does not allege that alternative sources of payment existed for J.H. and N.S. upon admission or during their initial treatment. Respondent does not claim that alternative sources of treatment existed for A.B. and B.W. at any time during their hospitalization. Respondent claims that it is entitled to a refund of $285,648.26 because the inpatient services Petitioner provided to all four recipients was medically unnecessary after their initial treatment. After their initial treatment, none of the four recipients satisfied ISD criteria for continued inpatient services. If Respondent is required to consider alternative placements in determining medical necessity, Respondent alleges that inpatient services Petitioner provided to J.H. and N.S. after their initial treatment could have been furnished more economically in an inpatient facility of a different type. Respondent asserts that inpatient services Petitioner provided to A.B. and B.W. after their initial treatment could have been furnished more economically on an outpatient basis. J.H. J.H. was admitted to Florida Hospital's acute care unit on August 24, 1992. On October 29, 1992, Petitioner transferred J.H. to Daniel Memorial Residential Treatment Center in Jacksonville, Florida. Respondent does not seek a refund of Medicaid payments from August 24, 1992, through September 24, 1992. Respondent seeks a refund of payments made from September 25 through October 29, 1992. Alternative Source Of Payment No alternative source of payment existed for the inpatient services Petitioner provided to J.H. J.H. was involuntarily committed to the hospital on August 31, 1992, pursuant to the Baker Act. 31/ Respondent does not allege that the Baker act provided an alternative source of payment prior to September 25, 1992. 32/ Respondent failed to show why the Baker Act did not provide an alternative source of payment prior to September 25, 1992, but did provide an alternative source of payment on September 25, 1992, and thereafter. 33/ Medical Necessity Once J.H. was admitted to Florida Hospital on August 24, 1992, he did not make significant improvement after 30 days. He did not meet ISD criteria for continued inpatient services. 4.2(a) Appropriate Medical Care ISD criteria were correctly overridden by the treating physician for J.H. Inpatient services Petitioner provided to J.H. after his initial treatment were consistent with appropriate medical care. Although J.H. did not make significant improvement within the time prescribed by ISD criteria, he did make significant improvement during his stay at Florida Hospital. He was successfully treated and timely discharged in a manner that was suitable for his individual needs and consistent with appropriate medical care. 4.2(a)(1) Mental Impairment J.H. was 15 years old when he was admitted to Florida Hospital on August 24, 1992. He had chronic schizophrenia, with borderline intellectual capabilities ("mental retardation"), and a well-documented explosive disorder. 4.2(a)(2) Emotional Impairment J.H. had attention deficit disorder ("ADD"). He could not process information. He had difficulty sitting still and focusing. J.H. had previously been treated in a residential placement setting. He set fires and abused animals. J.H. attempted to choke a dog and had to be restrained. He broke windows and committed acts of mischief. J.H. picked up other children by their neck and ears. He jumped up and down on their toes and punched them in the face. He struck staff and used razor blades to attack authority figures. 4.2(a)(3) Medication The combination of ADD, mental retardation, and schizophrenia made appropriate medical care for J.H. difficult and slow. Medicines used to control the ADD often make schizophrenia more fluid. J.H. had been treated successfully with medications in the past. However, J.H. was noncompliant with medication. More time than that prescribed by ISD criteria was medically necessary to discover the combination of medicines that would be effective for J.H. in this instance. When the right combination was determined, additional time was needed to stabilize the multiple medications. 4.2(b) Alternative Placement Petitioner correctly considered alternative placements in prescribing inpatient services for J.H. after his initial treatment. Petitioner identified an available alternative for J.H. on August 28, 1992. However, no alternative placement existed for J.H. prior to the date he was stabilized and discharged by Petitioner. Discharge before J.H. was stabilized would have been neither suitable for the needs of the individual patient nor consistent with appropriate medical care. Before J.H. was stabilized, he was a danger to himself and others. J.H. was a danger to himself and others when he resided in an alternative facility prior to his admission to Florida Hospital. The services that were medically necessary to stabilize J.H. could only be provided in an acute care facility like Florida Hospital. They could not have been furnished effectively in an alternative facility. Florida Hospital provided J.H. with 24 hour supervision, nursing staff, physicians, and support personnel trained in psychology and psychiatry. N.S. N.S. was admitted through Florida Hospital's emergency room on October 18, 1989, when she was 14 years old. She was discharged on June 14, 1991, to a long term residential treatment facility. Respondent does not seek a refund of Medicaid payments from October 18, 1989, through November 17, 1989. Respondent seeks a refund of payments made from November 18, 1989, through June 14, 1991. Alternative Source Of Payment Respondent alleges that an alternative source of payment existed in a settlement agreement to which neither Petitioner nor Respondent were parties. The settlement agreement resolved a federal law suit filed by the mother of N.S. against the Department of Health and Rehabilitative Services ("HRS") and the Orange County School Board (the "school board"), Case No. 90- 134-CIV-ORL-18. The settlement agreement was executed on November 30, 1990, between the mother of N.S., HRS, the school board, and BRV, Inc., ("BRV"). BRV is a Florida non-profit corporation named after its three directors: Usher L. Brown, Esquire, counsel for N.S.; Wynelle Roberson; and Gregory Valcante. BRV was formed to create an alternative placement that is suitable for N.S.'s individual needs. BRV operates a long term residential facility that effectively furnishes services to N.S. in a manner that is suitable for her needs and consistent with appropriate medical care. The BRV program is designed and supervised by Dr. Ralph Maurer, an expert in the disorders suffered by N.S. Dr. Maurer designs and supervises the protocols, strategies, and approaches utilized in the BRV program. The BRV program provides N.S. with residential and educational components. The program also provides N.S. with components in behavior management and medical care and treatment. HRS paid $60,000 for the residential component and support staff required in the BRV program. The school board paid $100,000 to BRV for the education component. None of the settlement proceeds are allocated to the type of services provided by Petitioner during N.S.'s hospitalization, including behavior management and medical care and treatment. Petitioner did not receive any funds from the settlement agreement. Petitioner is not a party to the settlement agreement. The settlement agreement does not address payment of the Medicaid services provided by Petitioner. The settlement agreement is not an alternative source of payment for the Medicaid services provided by Petitioner. If Respondent is entitled to a refund as a result of the settlement agreement, Respondent must seek its refund from the settlement proceeds. 34/ Applicable law mandates that Respondent, "shall seek recovery of reimbursement from third-party benefits." 335/ Even if Respondent were entitled to a refund from Petitioner as a result of the settlement agreement, the amount of refund would be limited to the portion of the settlement proceeds actually received by Petitioner. 36/ The maximum amount of refund to which Respondent would be entitled is $160,000; not the $232,831.16 sought by Respondent. Medical Necessity Once N.S. was admitted to Florida Hospital on October 18, 1989, she did not make significant improvement after 30 days. She did not meet ISD criteria for continued inpatient services. 5.2(a) Appropriate Medical Care ISD criteria were correctly overridden by the treating physician for N.S. Inpatient services Petitioner provided to N.S. after her initial treatment were consistent with appropriate medical care. Although N.S. did not make significant improvement within the time prescribed by ISD criteria, she did make significant improvement during her stay at Florida Hospital. She was successfully treated and timely discharged in a manner that was suitable for her individual needs and consistent with appropriate medical care. 5.2(a)(1) Mental Impairment N.S. is mentally retarded. She was born missing the right and left temporal lobes of her brain. As a result of her brain damage, N.S. suffers rapid mood changes and can not process certain higher orders of function. 5.2(a)(2) Emotional Impairment N.S. also suffers from agenesis. Agenesis is a brain development problem in which N.S. can not control emotional circuits in her brain. N.S. suffers from animalistic and aggressive patterns of behavior. Her symptoms include stalking, leaping, biting, screaming, spitting, and smashing. 5.2(a)(3) Learning Impairment N.S. has significantly impaired memory. Her memory consists of short term memory from day to day. N.S. has difficulty learning. She can not process certain higher orders of functions. It is difficult for her to pay attention. She has a significant language disorder. The memory disorder dates from birth. N.S. has no period of normal learning to use as a point of reference. N.S. learns differently from others. She does not respond to praise or punishment and does not understand discipline. N.S. does not learn from consequences. She can not store the information necessary to learn from consequences. N.S. reacts to undesired behavior with aggression. As a simplistic example, if one gives N.S. candy, the donor is a nice person. If one withholds candy, that person is not nice. Adverse treatment from others will lead to aggression from N.S. The learning strategies used to teach N.S. are similar to those used to tame a frightened animal. They are comparable to those used to train dolphins at Seaworld. Prior to her admission to Florida Hospital, N.S. was treated at the Children's Mental Health Unit, Shands Teaching Hospital, University of Florida ("Shands"). She was treated by Dr. Maurer, who later set up the program at BRV. 5.2(a)(4) Post Traumatic Stress Disorder N.S. was admitted to Florida Hospital as a result of an incident at the school where HRS placed N.S. at the time. N.S. had been aggressive toward her teacher. Two large males held N.S.'s head between her legs for 45 minutes to teach her not to be aggressive. The inappropriate attempt to discipline N.S. caused post traumatic stress disorder. The disorder required over a year and a half to control. In this type of post traumatic stress disorder, normal antipredator behavior is intensified in a manner similar to that an animal might experience in the presence of predators. Because N.S. is a frail individual, this one incident was sufficient to require hospitalization in the acute care unit at Florida Hospital. N.S. went berserk. At the time of admission, N.S. was grossly psychotic. Her paranoia was global. She was totally out of control with aggressive and violent behavior. She bit a security guard, and had to be restrained. N.S. grunted and did not speak. She neither fed nor dressed herself. She leaped off of chairs, bit others and herself, and did not socialize. She had no sustained attention. Doctors at Shands correctly determined that N.S. needed an acute care facility because N.S. was acutely psychotic and uncontrollable. The objective was to control her, settle her down, and transition her out to a long term residential program. N.S. was treatable. She was appropriately not "warehoused" in an alternative facility that was not suitable for her needs. 5.2(a)(5) Significant Improvement At the time of her discharge on June 14, 1991, N.S. showed dramatic improvement for the severity of impairment that she suffered. She was alert and cooperative. She had learned some language and communication skills. N.S. dressed herself and ate appropriately. Her affect and mood were stable. She did not attack others and was able to socialize. N.S.'s global paranoia was reduced. She was able to go out from seclusion with one-to-one adult supervision. However, the potential to hurt herself and others persists. She requires close adult supervision. 5.2(a)(6) Medication N.S. was a very complex and difficult patient to treat. Her developmental disabilities and severe psychiatric disorders were difficult by themselves. The incident at school superimposed a post traumatic disorder over her existing disabilities and disorders. More time than that prescribed by ISD criteria was medically necessary to discover the combination of medicines that would be effective for N.S. When the right combination was determined, additional time was needed to stabilize the multiple medications. There is no specific medication for the treatment of post traumatic stress disorder. Medicines used for all disorders may be tried on an empirical basis and juggled until the right medication, or combination of medications, is found. N.S. is very fragile. The margin of error for her medication is very small. N.S. was treated with a variety of medications. She had reactions to some medications, and they had to be changed. She did not respond well to others, and they had to be changed. The treating physician conducted an elaborate search for an effective combination of medications. The medications were titrated slowly. A total of nine combinations were tried. Unlike antibiotics that work in 24 to 36 hours, medications for psychiatric disorders and major depression may require two to six weeks before their effectiveness can be determined. During the time that her treating physician was attempting to stabilize N.S.'s medications, N.S. needed the medical care provided by doctors and nurses in a hospital setting. N.S. could not have been discharged to a less restrictive setting due to her level of acuity. Medications for N.S. were not stabilized until April 16, 1991. It was consistent with appropriate medical care to keep N.S. in Florida Hospital until June 14, 1991; approximately two months after her medications were stabilized. 5.2(a)(7) Violence And Seclusion Violent behavior was another reason why it took so much time to stabilize N.S. N.S. was violent throughout much of her treatment. N.S. had to be repeatedly secluded. The seclusion was medically necessary. However, the intervals of seclusion slowed her improvement. 5.2(a)(8) Behavior Modification And Learning Disabilities Even without intervals of seclusion, behavior modification would have been slow because N.S. suffered from memory disorder. She could not store the information necessary to make ordinary means of discipline and learning effective. 5.2(b) Alternative Placement Petitioner correctly considered alternative placements in prescribing inpatient services for N.S. after her initial treatment. No alternative placement existed for N.S. prior to June 14, 1991. The acute care admission and treatment of N.S. at Florida Hospital for approximately 605 days was suitable for the needs of N.S. and consistent with appropriate medical care. Earlier discharge would have been neither suitable for the needs of the individual patient nor consistent with appropriate medical care. Before N.S. was stabilized, she was a danger to herself and others. It would have been unsuitable for the individual needs of N.S. and inconsistent with appropriate medical care to discharge N.S. while she was a danger to herself and others. N.S. was a danger to herself and others when HRS placed her in an alternative facility prior to her admission to Florida Hospital. 5.2(b)(1) Suitable Services Effectively Furnished The services that were medically necessary to stabilize N.S. could only be provided in an acute care facility like Florida Hospital. Florida Hospital provided N.S. with 24 hour supervision, nursing staff, physicians, and support personnel trained in psychology and psychiatry. The inpatient services Petitioner provided could not have been furnished effectively in an alternative facility prior to June 14, 1991. Multiple medications could only be administered in an acute care facility. Nursing staff monitored N.S. for side effects at 15 minute intervals, 24 hours a day. They monitored the effectiveness of multiple medications and the toxicity of those medications. Psychiatric acute care nurses are best equipped to work with patients who are very sick. The doctors and nurses at Florida Hospital know how to handle disturbed, depressive, and psychotic people. N.S. was one of those people for most of her inpatient treatment. N.S. was isolated and safe in Florida Hospital. She became familiar with staff and settled down. Florida Hospital was close enough that N.S.'s mother could visit her regularly. Visitation from her mother was an integral part of the medical treatment and behavior modification that was suitable for N.S. Petitioner effectively treated N.S.'s disorders. Doctors and nurses at the hospital changed N.S.'s behavioral pattern, stabilized her behavior, and taught N.S. the social skills needed for her to function in a residential treatment facility like BRV. 5.2(b)(2) Available And Suitable Alternatives An alternative facility, if it had been available, was not suitable for the needs of N.S. prior to her discharge. Until N.S. was stabilized, she was the type of patient who could not function in a residential setting. N.S. could not use even a word or two. She could not communicate in any intelligible manner. She could not dress or feed herself. Petitioner considered every reasonable alternative in prescribing treatment for N.S. Petitioner reviewed every reasonable alternative in the state and elsewhere, including Texas. One factor that complicated an alternative placement was the need for staff at an alternative facility to be able to consult with doctors at Florida Hospital. As the distance between the two increased, the ability to consult decreased. It was medically necessary for N.S.'s mother to provide support. The ability to provide such support decreased as distance increased. Residential treatment facilities and group homes would not accept N.S. due to her degree of disorganization. Those types of facilities were unable to guarantee N.S.'s safety. Many facilities used treatment plans that were unsuitable for N.S.'s condition. The Montanari and Au Clair Palms programs, for example, were punitive and relied on consequences. Punishment and consequences are ineffective and unsuitable for N.S. Petitioner attempted to place N.S. in the Brown School in Texas. However, that facility refused to accept N.S. N.S. could not be placed in a residential program until her medication was stabilized. None of the residential programs had an acute care psychiatric unit where multiple medications could be administered and monitored until N.S. was stabilized. Petitioner could not return N.S. to Shands. The patients there are younger and severely handicapped. Shands does not have an adolescent unit. Petitioner could not place N.S. in Northeast Florida Mental Health Hospital ("Northeast"). It would not have been consistent with appropriate medical care for Petitioner to make such a placement. Northeast did not have long term acute care for chronically ill children. N.S. did not meet Northeast's criteria. Northeast refused to accept N.S. Petitioner attempted to involuntarily admit N.S. at Medico pursuant to the Baker Act. However, Medico refused to accept N.S. Treating physicians created a facility and program that was suitable for N.S.'s needs and consistent with appropriate medical care. BRV effectively furnishes services in a program that includes a high level of supervision, structure, and behavioral management. N.S. has done well since being placed in BRV. She is functioning well in school. A.B. A.B. was admitted to Florida Hospital on October 4, 1991, and discharged on November 4, 1991. Respondent claims a refund of Medicaid payments for A.B.'s hospitalization from October 12, through November 4, 1991. Alternative Sources Of Payment No alternative sources of payment existed for the inpatient services Petitioner provided to A.B. after her initial treatment. Respondent does not claim that any alternative sources of payment existed for A.B. Medical Necessity After A.B. was admitted to Florida Hospital on October 4, 1991, she did not make significant improvement after eight days. She did not meet ISD criteria for continued inpatient services. 6.2(a) Appropriate Medical Care ISD criteria were correctly overridden by the treating physician for A.B. Inpatient services Petitioner provided to A.B. after her initial treatment were consistent with appropriate medical care. Although A.B. did not make significant improvement within the time prescribed by ISD criteria, she did make significant improvement during her stay at Florida Hospital. She was successfully treated and timely discharged in a manner that was suitable for her individual needs and consistent with appropriate medical care. 6.2(a)(1) Mental Impairment A.B. suffered from multiple medical problems. She had cerebral palsy and was wheel chair bound. She had arthritis. A.B. had a brain injury and suffered seizure disorders. Her arms, hands, and legs were drawn into distorted positions. She was unable to take care of herself. A.B. had a progressive depressive disorder. At the time of admission, A.B. suffered from major depression. She had a history of attempted suicides. 6.2(a)(2) Substance Abuse And Suicide A.B. had a long history of alcohol and drug abuse, including cocaine and crack cocaine. A.B. abused alcohol while on Antabuse. Antabuse is a medicine that makes the patient sick if the patient ingests alcohol. If a patient ingests alcohol in sizeable quantities, Antabuse may cause a severe reaction that can be fatal. A.B. consumed excessive amounts of alcohol while on Antabuse in the hope that she would kill herself. 6.2(a)(3) Medication More time than that prescribed by ISD criteria was medically necessary to discover the combination of medicines that would be effective for A.B. When the right combination was determined, additional time was needed to stabilize the multiple medications. It took approximately 30 days for A.B.'s treating physician to stabilize her with medications. Four to six weeks are usually required before the effectiveness of psychiatric medications can be determined. The patient requires time to adjust to the level of dosage needed to treat the particular impairment. After the appropriate dosage of medication is administered, additional time is needed to determine whether the drug is effective. Eight to ten days are needed for the medication to reach a steady blood level in the patient. Until that time, the medication is not at a therapeutic level. Once the medication has reached a therapeutic level, it takes another 8 to 10 days to determine if the patient is at an appropriate dosage and is responding. Psychiatric medications require longer to work when the level of impairment is high. The level of impairment in A.B. was high because she had to be detoxified. The time needed for the medications to work was greater because they created side affects for A.B.'s brain and other conditions. For example, antidepressant medication increases the risk of seizure. This is particularly true when a patient suffers from cerebral palsy and substance abuse. Side affects had to be monitored to make sure that the medication was not at a toxic level. 6.2(b) Alternative Placement Petitioner correctly considered alternative placements in prescribing inpatient services for A.B. after her initial treatment. No alternative placement existed for A.B. until she was stabilized. Prior to that time, A.B. was a danger to herself. It would have been inconsistent with appropriate medical care for Petitioner to discharge A.B. when she was a danger to herself. 6.2(b)(1) Effective And Appropriate Medical Care Earlier outpatient services would not have been suitable for the needs of A.B. An outpatient clinic could not effectively furnish the services A.B. needed prior to the date of her discharge. A.B. could not be discharged before she was ambulatory and functional. The treating physician prescribed physical therapy. At the time of discharge, A.B. was ambulatory and able to take care of her essential needs. She was timely discharged for outpatient care at the mental health clinic. 6.2(b)(2) No Available And Suitable Alternative It takes approximately six to eight weeks to obtain an appointment as an outpatient at the local mental health clinic. A.B. has no social support network. The risk of suicide is high if patients such as A.B, who have little or no support network, are discharged as soon as they say they are no longer suicidal. A.B. needed to be kept in the hospital until she was in remission from her depression and until she developed some insight into self-medication. B.W. B.W. was admitted to Florida Hospital on May 10, 1991. She was discharged on June 10, 1991. Respondent claims a refund of Medicaid payments for B.W.'s hospitalization from May 23, through June 10, 1991. Alternative Source Of Payment No alternative source of payment existed to pay the medical services Petitioner provided to B.W. Respondent does not assert that any alternative sources of payment were available. Medical Necessity After B.W. was admitted to Florida Hospital on May 10, 1991, she did not make significant improvement after 13 days. She did not meet ISD criteria for continued inpatient services. 7.2(a) Appropriate Medical Care ISD criteria were correctly overridden by the treating physician. Inpatient services Petitioner provided to B.W. after her initial treatment were consistent with appropriate medical care. Although B.W. did not make significant improvement within the time prescribed by ISD criteria, she did make significant improvement during her stay at Florida Hospital. She was successfully treated and timely discharged in a manner that was suitable for her individual needs and consistent with appropriate medical care. 7.2(a)(1) Mental Impairment At the time of admission, B.W. had organic affective disorder with severe depression. She was psychotic and was hallucinating. She heard voices and talked to herself. She was acutely suicidal. B.W. had a history of prolonged depression, multiple hospitalizations, and failed courses of outpatient treatment. This was B.W.'s fifth psychiatric admission. B.W. was last admitted on March 3, 1991, for an overdose of medication. She was hospitalized for four days and discharged. B.W. was obsessed with suicide and how she was going to carry out her suicide. She had a specific plan to kill herself. 7.2(a)(2) Emotional Impairment B.W. was unwashed, unkept, disheveled, and depressed. Her speech was blurred. She suffered from sleep disorder and loss of appetite. B.W. suffered from multiple substance abuse problems and impaired judgment. B.W.'s substance abuse was an attempt to self medicate for anxiety. The anxiety was caused by conditions in her home environment. B.W. was responsible for the care of minor children. She was separated from her husband and living with an elderly mother who could not take care of B.W. Her mother was significantly depressed and was, herself, at risk of suicide. 7.2(a)(3) Medication More time than that prescribed by ISD criteria was medically necessary to discover the combination of medicines that would be effective for B.W. When the right combination was determined, additional time was needed to stabilize the medications. B.W. was on antipsychotic drugs because she was hallucinating and hearing voices. She was also on antidepressants. It takes time for psychiatric drugs to take effect. The treating physician had to gradually increase the dosage administered to B.W. until the medication reached a therapeutic level. B.W. made steady improvement during her hospitalization. As late as June 4, 1991, however, B.W. was nauseated, vomiting, and had headaches. B.W. was treated effectively and timely discharged in a manner that was suitable for her individual needs and consistent with appropriate medical care. 7.2(b) Alternative Placement Petitioner correctly considered alternative placements in prescribing inpatient services for B.W. after her initial treatment. No alternative placement existed for B.W. before she was stabilized and discharged. It was consistent with appropriate medical care for Petitioner to keep B.W. in the hospital until her treating physician stabilized her. It required approximately 30 days for B.W.'s treating physician to stabilize her. Outpatient care would not have been effective before B.W. was stabilized. At the time that Respondent claims B.W. should have been discharged, B.W. was depressed and was hallucinating. She was still in withdrawal from her substance abuse. Earlier outpatient care would have been neither effective nor suitable for the needs of B.W. It would not have been consistent with appropriate medical care to discharge B.W. to her home. B.W. is responsible for the care of two minor children. She has an unstable home environment. It would not have been consistent with appropriate medical care to discharge B.W. to such an environment before she was stabilized.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Respondent enter a Final Order denying its claim for refund of the Medicaid payments at issue in this proceeding. RECOMMENDED this 20th day of December, 1995, in Tallahassee, Florida. DANIEL S. MANRY, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 20th day of December, 1995.
The Issue The issue in this case is whether the application filed with the Department of Health (“Department”) on March 31, 2017, by Galencare Inc., d/b/a Northside Hospital (“Northside”), to operate as a provisional Level II trauma center met the applicable criteria and standards under Part II, Chapter 395, Florida Statutes (2017),1/ and Florida Administrative Code Chapter 64J-2.
Findings Of Fact Parties 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. Northside is a 288-bed acute-care hospital located in TSA 9, Pinellas County, Florida. Northside provides a wide range of services, including inpatient cardiovascular and neuroscience services. Northside has developed a trauma program and submitted an application to operate as a provisional Level II trauma center in March 2017. The Department’s preliminary determination to deny Northside’s application on May 1, 2017, is the subject of this proceeding. Bayfront is an acute-care hospital located in TSA 9, Pinellas County, Florida. Bayfront has been designated by the Department as a Level II trauma center. Northside’s Trauma Center Application Northside Submitted a Timely Letter of Intent In the summer of 2016, Northside received a letter from the Department notifying Northside of the opportunity to submit a letter of intent to become a trauma center. Northside timely submitted a letter of intent with the Department in September 2016. This letter indicated that Northside would seek approval from the Department to operate as a Level II trauma center. Northside was well-situated for a trauma center because of the resources and services already in place at the hospital. Moreover, Northside was prepared to open a trauma program because it already had extensive experience treating critically ill patients. After Northside submitted its letter of intent, the Department responded by sending Northside a notice accepting its letter of intent and providing information on the application process. The notice directed Northside to the Department’s trauma center application and contained instructions for the completion and submission of the application. Northside Established a Full Trauma Program after the Department Accepted its Letter of Intent Once Northside 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 forthcoming application was compliant with the requirements set forth in DOH Pamphlet (DHP) 150-9 (the “Trauma Standards” or “DHP”), which is incorporated by reference in rule 64J-2.011. As part of the development of its trauma program, Northside hired Doreen Gilligan in October 2016 to serve as director of Trauma Services. The hospital also worked with Angie Chisolm to draw on resources from other approved trauma centers, such as trauma-related policies and procedures and best practices for trauma center operations. Northside’s expertise in advanced, life-saving care, including cardiovascular and neuroscience programs and its intensive care unit (“ICU”), made it a well-qualified candidate to open a new trauma center. Between October 1, 2016, and April 1, 2017, Northside invested over $4 million to develop its trauma program. Northside invested $2.5 million in physical plant improvements and equipment. These improvements included: A helipad, which is properly licensed by the Department of Transportation and FAA. The helipad is operational and Northside is already receiving patients from helicopters on a daily basis in its capacity as an acute- care hospital. Two state-of-the-art trauma resuscitation bays in the emergency department (“ED”) that are in immediate proximity to the helipad. These new trauma bays can accommodate up to four trauma patients at the same time. The expansion of the ICU to include 12 beds that are specifically designated for trauma patients. The expansion of one of the operating rooms because trauma patients often require care from multiple doctors simultaneously. The purchase of new equipment, including new ICU monitors, operating room equipment, and equipment to support physician subspecialists. The purchase of a blood track machine for the emergency department. This machine dramatically reduces the amount of time it takes for patients to receive blood transfusions. The purchase of a platelet function testing machine and a thromboelastography machine. These machines help identify where a trauma patient is bleeding. These machines also play a critical role in quickly stopping bleeding – one of the key functions that every trauma center must perform. The purchase of a second computed tomography (“CT”) machine dedicated solely to the provision of radiology services needed by trauma patients. Northside invested approximately $1.7 million in physician and staff employment and recruitment. This investment has enabled Northside to do the following: Provide continuous, around-the-clock trauma surgeon coverage, 7 days a week (beginning February 16, 2017). Provide continuous, around-the-clock anesthesiology coverage. Provide hospital coverage for the required 19 physician sub-specialty groups. These physicians are able to arrive at the hospital within 30 minutes or less. Hire more than 30 additional full-time nurses to meet the staffing requirements in the Trauma Standards. These hires have allowed Northside to provide a continuous, in-house presence of operating room nurses and technicians. Hire specialized administrative staff for the trauma program, including Doreen Gilligan (Director of Trauma Services), a trauma registrar, and a performance improvement coordinator dedicated solely to ensuring Northside’s trauma patients receive high quality care. Once Northside’s trauma program becomes operational, Northside plans to hire a second trauma performance improvement coordinator. Between January and March 2017, Northside provided over 5,000 hours of trauma training to its staff, including the CEO and CFO of the hospital. The major focus of this training was the Trauma Nursing Core Course (“TNCC”) for nursing staff, which is the foundation of emergency nursing education and ensures that the nursing staff can provide high-quality care for the most severely injured patients. The hospital implemented nursing education requirements which exceeded the Trauma Standards. Some of this training included actual operational practice using simulations and mock trauma drills. Northside implemented over 200 new facility policies related to trauma during this period. Northside subsequently trained its staff on these new programs. Northside made all of these investments prior to March 31, 2017, the date on which Northside submitted its application to the Department. Northside Timely Assembled and Submitted Its Trauma Center Application and Deficiency Response to the Department Northside’s application was prepared by a core team whose mission was to ensure that the application fully complied with the Trauma Standards. The key members of that team were Peter Kennedy, chief operating officer; Doreen Gilligan, director of Trauma Services; Dr. Erik Barquist, interim trauma medical director; and Angie Chisolm, assistant vice president of Trauma Services for HCA East and West Florida Divisions. The final application submitted to the Department encompassed over 10,000 pages of information. Because the application was too voluminous for any one person to prepare alone, each of the team members played an important role in ensuring the application addressed each Trauma Standard. Preparation of the application involved thousands of staff hours and required close cooperation with the physicians, staff, and community members. Northside timely submitted its trauma center application (“Northside Application”) to the Department on March 31, 2017. After receiving the Northside Application, the Department arranged for it to be reviewed by two outside experts, Dr. Lawrence Reed and Nurse Susan Cox. Both Dr. Reed and Nurse Cox have reviewed trauma applications on behalf of the Department in the past. On April 14, 2017, the Department sent Northside a letter notifying it of the deficiencies that Dr. Reed and Nurse Cox had identified (the “Deficiency Notice”). The Department provided a checklist (Department of Health Initial Provisional Review Checklist for Northside, April 5, 2017, hereafter referred to as the “Initial Checklist”) based on the Trauma Standards with boxes marked “Yes” or “No” to indicate whether the reviewers found evidence to demonstrate that each particular Trauma Standard and subpart was met. The checklist also contained written comments from the reviewers for subparts which were checked “No.” Of the more than 350 subparts that make up the Trauma Standards, the reviewers only identified 35 about which they had concerns or additional questions. Most of the comments from the reviewers consisted of simple requests for clarification. In some cases, the reviewers asked for information that Northside had already submitted with the initial application on March 31, 2017. Northside timely responded to each deficiency identified by the Department on April 21, 2017 (the “Deficiency Response”), five business days after receipt of the Deficiency Notice. The Deficiency Response was prepared by the same team that prepared the initial application. Much like the initial application, the team’s role was to ensure that each concern was addressed and that the application demonstrated that the hospital met the Trauma Standards. The Deficiency Response included 78 supporting exhibits consisting of hundreds of pages. The Deficiency Response was divided in two sections: (1) a narrative table; and (2) supporting exhibits to the narrative table. In the narrative table, Northside addressed each Trauma Standard subpart identified in the Initial Checklist as an area not met or an area of concern. The table was organized into three columns: the first reciting the subpart language; the second copying the reviewer concern from the Initial Checklist; and the third detailing Northside’s narrative response or explanation to each comment. The Deficiency Response was also reviewed by Dr. Reed and Nurse Cox. These reviewers determined that Northside addressed and corrected the vast majority of deficiencies identified in the initial review. Only three Trauma Standard subparts were identified as remaining areas of concern: Standard V(B)(3)(a)(1), Standard V(B)(3)(d), and Standard XVIII(G). Each of these issues was identified by Dr. Reed. Neither Dr. Reed nor Nurse Cox recommended to the Department that Northside’s application be denied. On May 1, 2017, the Department informed Northside that its application was not in compliance with the applicable Trauma Standards and would be denied (“Denial Letter”). The Denial Letter did not identify which (if any) of the Standards that the Department believed that Northside had not met. Instead, the Denial Letter attached a checklist indicating concerns with only three subparts. The Department now takes the position that Northside’s application is deficient because it did not satisfy Standard V(B)(3)(a)(1), Standard V(B)(3)(d), and Standard XVIII(G), although the Department has not stated whether each one of these Standards, standing alone, would have (in its view) warranted denial of the application. The Denial Letter did not afford Northside any opportunity to address the potential issues identified with respect to the three Standards. Instead, it informed Northside that its only options were to seek an administrative hearing challenging the Department’s denial or to submit a trauma center application the following year. Northside therefore did not submit any additional documentation to the Department. Northside’s Evidence Establishes That It Satisfied Each of the Three Standards the Department Claimed Were Deficient Standard V(B)(3)(a)(1) Standard V addresses the facility requirements relating to the emergency department. It includes requirements for a trauma resuscitation area, helipad, emergency physicians, support staff, and trauma flow sheet, among other criteria. This Standard also details the required qualifications for emergency room physicians who may provide care to trauma patients. Emergency room physicians must be board certified in emergency medicine or meet stringent alternate criteria demonstrating their qualifications. There are two ways to meet the alternate criteria. The first includes attestation from the trauma medical director that there is a critical need for the physician, completion of an accredited residency training program, documentation that the physician participated in the Advanced Trauma Life Support (“ATLS”) program, 48 hours of trauma-related continuing medical education in the past three years, evidence that the physician attends at least 50 percent of the trauma performance improvement meetings, evidence of membership or attendance at regional or national trauma meetings during the past three years, and attestation by the trauma medical director and emergency department director that the physician compares favorably with other physicians on the trauma call schedule. The second way for a physician to meet the alternate criteria is by providing evidence of board certification in a primary care specialty and attestation by the emergency department director that the physician has worked as a full-time emergency physician for three of the last five years. As part of its initial application, Northside provided the Department with staffing schedules for March, April, and May 2017, which documented the physicians on staff in the emergency room during those months and the shift times they would cover. Northside also submitted substantial evidence regarding the qualifications of each of these emergency room physicians. One of these emergency room physicians was Dr. Abraham Wilks. At the time it submitted its initial application, Northside believed Dr. Wilks met both paths of the alternate criteria. In preparation for the initial application, Dr. Wilks, working with Northside, went to extraordinary lengths to secure the seven required components under the first alternate criteria path. Northside also provided evidence that Dr. Wilks qualified under the second alternate criteria path since he was board eligible for family medicine and had been working as an emergency physician for the past five years. The staffing schedules submitted with Northside’s application on March 31, 2017, showed that Dr. Wilks was scheduled to be the sole physician provider for short periods of time on a limited number of days. During his review of the initial application, Dr. Reed concluded that Dr. Wilks did not meet either of the alternative criteria because he did not complete an emergency medicine residency and was no longer board-certified in family medicine. Because Dr. Wilks did not meet these qualification requirements in Standard V(B)(3) as an emergency department physician, he could not be the sole physician provider in the emergency department. After receiving the Deficiency Notice and Initial Checklist, Northside immediately took steps to address Dr. Reed’s comments. Northside’s leadership worked with the director of the emergency department to ensure that Dr. Wilks would not be the sole physician provider in the emergency room. After April 18, 2017, Dr. Wilks never served as the sole physician provider in the emergency room. The emergency department physician staffing schedule for April and May 2017, was updated to reflect these changes (“Updated Staffing Schedule”). The other physicians listed on the staffing schedule were appropriately qualified, and the staffing schedule provided for appropriate physician coverage. In its Deficiency Response, Northside noted these operational changes regarding Dr. Wilks and specifically addressed Dr. Reed’s concerns. Northside informed the Department that “Dr. Wilks has been removed from the ED Trauma assignment and will never be the single provider in the ED, effective immediately.” Dr. Reed agreed at his deposition that if Dr. Wilks were removed from the staffing schedule, Northside would be in compliance with Standard V(B)(3)(a)(1). The Deficiency Response also referenced a related exhibit, which Northside intended to be the amended staffing schedule. However, due to a clerical error, Northside’s Deficiency Response included the old staffing schedule from the initial application, which incorrectly showed Dr. Wilks as the sole provider for limited periods. The old staffing schedule contradicted the narrative explanation of Northside’s operational changes included in the Deficiency Response and was clearly submitted in error. Dr. Reed himself noted this contradiction: The response document also states that “Dr. Wilks has been removed from the ED Trauma assignment and will never be the single provider in the ED, effective immediately. However, it appears that Dr. Wilks is the only ED physician on site from 6a-8a on May 4, May 7, May 20, and May 21. Please clarify this contradiction.” The Department did not follow Dr. Reed’s recommendation. It never contacted Northside to ask why the staffing schedule listed Dr. Wilks as the sole provider for limited periods of time when Northside’s submission expressly stated that Dr. Wilks would no longer be the sole provider. Had the Department contacted Northside, it would have learned that the “old” staffing schedule had been submitted rather than the current and correct staffing schedule, i.e., the one that did not include Dr. Wilks as the sole provider. Thus, there can be no dispute that, as of April 18, 2017, (1) Northside’s operative emergency department staffing schedule was updated to reflect that Dr. Wilks would never be the sole provider; and (2) at all times, Northside’s emergency department was fully staffed by properly qualified emergency department physicians. Under these circumstances, the Department erred in taking the position that Northside did not satisfy Standard V(B)(3)(a)(1) simply because it mistakenly submitted an outdated staffing schedule to the Department in conjunction with its clear narrative explanation. Standard V(B)(3)(d) The physician qualifications included in Standard V also require that each physician maintain a current ATLS provider certification. The ATLS certification is required only of emergency department physicians and trauma surgeons because these are the physicians who treat trauma patients when they first arrive at the trauma center. One of the emergency department physicians included in Northside’s application is Dr. Joseph Nelson. Dr. Nelson also serves as the emergency department’s pre-hospital trauma care expert for the Committee of Emergency Preparedness and Readiness, meaning that he is the state’s expert on issues relating to the emergency care provided on-site before patients are brought to the hospital. Northside’s application included an extensive set of documents that established Dr. Nelson’s credentials, including the following: a compilation of Dr. Nelson’s certifications, proof of his osteopathic board certification, his Florida Department of Health medical license, his physician profile with the American Medical Association, proof of his continuing medical education hours, his letter of privileges at Northside, and his most recent ATLS certificate. Dr. Nelson’s ATLS certificate included a letter from ATLS that recognized Dr. Nelson for high scores on his written and practical tests and recommended that he apply to be an ATLS course instructor, an honor that is accorded only to doctors who attain the best performances at the training course. At the time Northside submitted its initial application, Dr. Nelson’s ATLS certification had recently expired and he was planning to take a course to renew his certification. Dr. Nelson was aware of the expiration before the submission and made a concerted effort to complete the course in advance by registering for a course in February 2017. However, the course Dr. Nelson was originally scheduled to take in February 2017 was cancelled due to a snowstorm. Because ATLS courses are in high demand and often full, Dr. Nelson was not able to immediately reschedule for a course in his region. After working with Northside and Angie Chisolm, he registered for another course to be held in Tallahassee on April 23, 2017. Northside included proof of his course registration with its initial application. In the Deficiency Notice and Initial Checklist provided by the Department, Dr. Reed noted that Dr. Nelson’s ATLS certificate had expired and acknowledged that he was scheduled to take his ATLS course on April 23, 2017. Dr. Reed asked the hospital to “provide evidence of successful completion of the ATLS course he is scheduled to take on 4/23/2017.” Dr. Reed did not ask the hospital to submit any further documentation before the certificate arrived. On multiple occasions, Northside sought clarification from the Department regarding how it should establish that Dr. Nelson was in compliance with Standard V(B)(3)(d). Before Northside submitted its initial application to the Department, it informed the Department that Dr. Nelson was registered for and planned to take the ATLS course on April 23, 2017, and asked for guidance regarding how it should establish that Dr. Nelson was in compliance with Standard V(B)(3)(d). The Department advised Northside to provide proof of registration with its initial application, and Northside did just that. Northside returned to the Department for guidance after receiving the Deficiency Notice and reminded the Department that Dr. Nelson planned to complete the ATLS course on April 23, 2017. Once again, the Department directed Northside to submit documentation of course registration and to later submit Dr. Nelson’s updated ATLS certificate when available. In its Deficiency Response, Northside reiterated that Dr. Nelson was registered for and scheduled to complete the ATLS certification course on April 23, 2017, just two days later. Based on the Department’s guidance, Northside also included Dr. Nelson’s ATLS course registration, which demonstrated that he was scheduled to take the course in Tallahassee on April 23, 2017, as well as email communication from the course host confirming that Dr. Nelson paid for and secured a seat at that course. Northside further indicated that it would provide evidence to the Department of Dr. Nelson’s ATLS recertification following successful completion of the course. Northside also informed the Department that if Dr. Nelson did not attend and pass the course on April 23, 2017, he would be removed from the call schedule effective May 1, 2017. Dr. Nelson successfully completed the course on April 23, 2017, and thus satisfied his ATLS requirement that day. Northside immediately confirmed with the ATLS coordinator that Dr. Nelson had passed the course and concluded that he was in compliance with Standard V(B)(3)(d). Dr. Reed’s review of Northside’s Deficiency Response stated: “Upon receipt of a copy of Dr. Nelson’s updated ATLS certification, compliance with this standard will have been met.” Northside subsequently received Dr. Nelson’s updated ATLS certification. It did not arrive at Northside until after May 1, 2017, due to normal delays in processing by the American College of Surgeons. At hearing, Northside presented Dr. Nelson’s updated ATLS certification reflecting his successful completion on April 23, 2017. In sum, Dr. Nelson was ATLS-certified as of April 23, 2017, which is before the Department’s May 1, 2017, deadline. Northside also provided a litany of information to the Department with its initial application and Deficiency Response detailing Dr. Nelson’s efforts to secure his ATLS certification. Northside therefore satisfied Standard V(B)(3)(d). Standard XVIII(G) Standard XVIII addresses quality management, which is one of the core requirements of a trauma program. Since the time that Northside began building its trauma program, it has prioritized quality management. Northside began developing its trauma quality management program in early December 2016. As part of this effort, Northside developed a trauma quality management plan, which is essential for any quality management program. Following the beginning of limited trauma-related operations on February 16, 2017, Northside held its first peer review meeting on February 22, 2017, to discuss patient treatment issues. Dr. Barquist attended these meetings and minutes were kept. Northside also began to hold nursing and ancillary staff meetings, known as trauma quality management (“TQM”) meetings, during this time. The directors of each department at the hospital attended these meetings, as well as the chief operating officer and chief financial officer. The objective of these meetings was to operationalize the more than 200 trauma-specific policies and procedures put in place during the trauma program development. Any issues identified in these meetings were addressed immediately with the whole trauma staff to ensure program-wide compliance. To demonstrate compliance with this Standard, Northside submitted nearly 400 pages of documents with its initial application. These included Northside’s Trauma Performance Improvement and Patient Safety Plan, policies and procedures, and peer review minutes. As part of its application, Northside submitted the minutes of its peer review meetings at which quality management issues were discussed. Even though Northside was not receiving trauma alert patients from local emergency medical services (something it could not do prior to becoming a provisionally approved trauma center), it routinely conducted quality management activities with regard to patients in the hospital with trauma injuries. With this patient population, Northside employed its trauma improvement processes to identify areas in which there was room for improvement in care, and to determine how education, training, and equipment could be enhanced to improve care for similar patients in the future. In his review of Standard XVIII(F), Dr. Reed affirmed that Northside held quality management meetings at which the following issues were discussed: The subject matter discussed, including an analysis of all issues related to each case referred by the trauma service medical director to the trauma program manager, cases involving morbidity or mortality determining whether they were disease related or provider related and the preventability, and cases with other quality of care concerns. A summary of cases with variations not referred to the committee. A description of committee discussion of cases not requiring action, with an explanation or each decision. Any action taken to resolve problems or improve patient care and outcomes. Evidence that the committee evaluated the effectiveness of any action taken to resolve programs or improve patient care and outcomes. Northside also submitted documents addressing Standard XVIII(G). This subpart addresses a quarterly report prepared by the trauma quality management committee which must be submitted to the Department by approved trauma centers 15 days after the end of each quarter. If approved as a provisional trauma center, Northside would have submitted its first quality report to the Department on August 15, 2017. The report, which is only submitted by provisionally approved and verified trauma centers, must include information related to patient case reviews, select clinical indicators, and patient complications. The report is only made available by the Department to approved trauma centers; it is not provided to applicants. The report form is not referenced in any Department rule, the Trauma Standards, or the Department’s website. However, to establish that Northside was prepared to provide the required report once it received provisional approval, Northside obtained a copy of the template from an affiliated operating trauma center and included that template in its application. Because it was not an approved trauma center, Northside ultimately submitted a detailed template of the quality report to be submitted following approval as required. The detailed template included blank fields with the quality indicators selected by the Department and the hospital, benchmarking data points, patient complications, and case review information. The fields in the report regarding patient complications and case review information can be taken directly from the peer review minutes, which Northside submitted with its initial application and were located directly in front of its detailed template. In his review of Northside’s initial application, Dr. Reed concluded that Northside provided much of the required evidence, demonstrating “an active and effective trauma quality improvement program” and met the vast majority of subparts in this Standard. However, regarding Standard XVIII(G), Dr. Reed identified deficiencies on the basis that “[a] template of a report was submitted, but there were no cases recorded.” Dr. Reed confirmed that he reviewed the peer review minutes Northside submitted with its application. In response to Dr. Reed’s comment, Northside submitted updated templates with additional information. The quality indicator and benchmarking templates were populated with data from its trauma registry regarding the patients with traumatic injuries that the hospital had treated since February 16, 2017. In addition to these documents, which specifically addressed Standard XVIII(G), Northside also submitted more peer review minutes from subsequent meetings since the initial application, which were included directly in front of Exhibit 75. Dr. Reed ultimately concluded that Northside had not demonstrated compliance with Standard XVIII(G)(1)-(3). That conclusion, however, is unsupportable by the evidence at hearing. Dr. Reed acknowledged that Northside’s Deficiency Response provided the “quarterly data regarding the state required indicators and the additional institution-specific indicators.” The only reason he believed that Northside’s application remained deficient was that it did not “address the individual case quality review issues required in Standard XVIII.G.1-3.” This conclusion is undermined by Dr. Reed’s recognition-–as reflected in his review of Standard XVIII(F)-–that Northside was conducting case quality reviews. In his deposition, Dr. Reed agreed that Northside’s Deficiency Response “did include information regarding the number of cases and indicators and that sort of thing.” Indeed, Dr. Reed’s true concern appears to have been that Northside’s “numbers,” i.e., the number of patient cases reviewed by Northside, were “still kind of thin.” But Dr. Reed himself recognized that prior to the time that a trauma center application is provisionally approved and the trauma program begins treating trauma alert patients, a trauma program is unlikely to have a large number of patient cases to review. The Department’s view that Northside did not satisfy Standard XVIII(G) is not supported by the evidence. The section of the quality report addressing individual case reviews is simply a summary of the information contained in the hospital’s peer review minutes-–and Northside conducted the required peer review meetings. Northside demonstrated at hearing that it was capable of preparing a table summarizing its peer review cases and the corrective action taken for each case. All the information contained in the completed table was taken verbatim from the peer review minutes that Northside submitted with its initial application and Deficiency Response. If approved, Northside was prepared to submit the quarterly report as required on August 15, 2017. Thus, at worst, Northside did not copy and paste information from one place to another. To the extent possible, Northside complied with this Standard. The Department’s review of an earlier trauma center application confirms that the Department should not have determined that Northside did not satisfy Standard XVIII(G). In April 2016, the Department approved an application to operate as a provisional Level II trauma center submitted by Jackson South Community Hospital. As part of its approval, the Department-- based on a review by Dr. Reed--determined that Jackson South met each of the requirements in Standard XVIII(G). However, Jackson South only submitted hospital policies, promising to prepare and submit the required quality report if approved. Jackson South did not submit any quality report or even a template of such a report. Despite submitting far less evidence demonstrating compliance, Dr. Reed did not note any deficiencies for this Standard with regard to Jackson South’s application. The Department ultimately approved the application. Dr. Reed confirmed that Northside’s quality management program was significantly more developed than the one for Jackson South Community Hospital that Dr. Reed himself had recommended be approved only two years earlier. At hearing, Chief Dick could not explain the inconsistency. In sum, the Department erred in concluding that Northside had not satisfied Standard XVIII(G) because Northside had an active and effective quality management program that involved thorough case reviews and Northside demonstrated that it was capable of submitting the required forms once its program was approved and its fully operational. Contemporaneous Emails Demonstrate That the Department Denied Northside’s Application for Reasons Having Nothing to Do with the Merits of Northside’s Program The Department’s decision to deny Northside’s application was not made in a vacuum. On April 28, 2017-–only two days before the Department sent Northside the Denial Letter-– a circuit judge in Leon County entered an order (“Injunction Order”) temporarily enjoining Northside from operating as a trauma center and enjoining the Department from permitting Northside to operate as a provisional trauma center. This injunction was based exclusively on issues of administrative law and did not in any manner address the merits of Northside’s application. In fact, the Department strongly opposed the injunction. The injunction did not prevent the Department from approving Northside’s application. The Department’s internal correspondence demonstrates that the injunction led the Department to deny Northside’s application, presumably because it was concerned about the ramifications of provisionally approving Northside’s application while the injunction was pending and Northside could not begin trauma center operations. On April 28, 2017, just hours before the Injunction Order was issued, Kate Kocevar, head of the Department’s Trauma Section, emailed Dr. Reed’s final conclusions to Chief Dick and informed her that in her opinion “Northside Hospital appears to have passed the reviewers [sic] survey and will be granted Provisional status.” Chief Dick confirmed at hearing that her initial impression based on Ms. Kocevar’s email was that Northside passed the survey. Later that day, Chief Dick received the injunction order and immediately emailed other Department personnel, “[l]ooks like the letter to Northside will not be going out on Monday as originally written.” Three days later, on May 1, 2017, the Department sent Northside the Denial Letter, notifying the hospital that its application had not met the Trauma Standards and would be denied. Given the looming injunction order, the Department’s internal correspondence, and the fact that the three alleged deficiencies are minor, at the very most, the Department’s decision to deny the application was apparently motivated by an administrative decision that it should not approve an application while the injunction was in place-–not by any genuine concerns regarding the merits of Northside’s program. Northside Has Expended, and Continues to Expend, Millions of Dollars to Maintain an Operational Trauma Program Northside has continued to maintain its trauma service capability, including retaining physicians and staff, while proceeding with its challenge of the Department’s preliminary denial. As part of its readiness efforts, Northside’s quality management program remains in place, meaning that Northside is still holding peer review and quality improvement meetings. Maintaining a continued state of readiness to initiate operations as a provisional Level II trauma center will cost Northside approximately $13 million this year.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department enter a final order finding that Northside met its burden of establishing that its trauma center application met the applicable standards, and awarding provisional Level II status to the applicant. DONE AND ENTERED this 20th day of December, 2017, 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 20th day of December, 2017.
The Issue The issue presented is whether Respondent is guilty of the allegations contained in the Administrative Complaint filed against him, and, if so, what disciplinary action should be taken against him, if any.
Findings Of Fact At all times material hereto, Respondent has been a physician licensed to practice in the State of Florida, having been issued license number ME 0025685. For 18 years prior to the event complained of herein, Respondent worked at Indian River Memorial Hospital, where he practiced as an anaesthesiologist. Also prior to the event complained of herein, Respondent was a tri- athlete, training in swimming, biking, and running. During the summer of 1992 he competed in five or six tri-athalons and did quite well in his age class. Respondent was also a snow skier. In accordance with his physical fitness values, Respondent does not drink alcoholic beverages or smoke cigarettes. He is also a vegetarian. Peter G. Wernicke is an orthopedic surgeon in the Vero Beach area. After arriving there, he and Respondent became social friends and went on ski trips together. He also became Respondent's treating physician, caring for Respondent when Respondent suffered broken bones, strains, and sprains as a result of his sporting activities. In early winter of 1992 Respondent seriously injured his knee while snow skiing. Respondent discussed his need for surgery with Wernicke after Respondent returned to the Vero Beach area. Wernicke was insistent that he perform Respondent's knee surgery, but Respondent wanted to have the surgery performed by Dr. Richard Steadman in Vail, Colorado, since he believed that Dr. Steadman was probably the best in the world at taking care of that particular kind of knee injury. Wernicke then insisted that Respondent allow Wernicke to perform the knee surgery with Respondent awake, and once the knee was opened up, Wernicke and Respondent would look at it and decide whether it was something Wernicke was able to take care of or if the knee should be closed and Respondent would then go to whomever he wanted to have the surgery performed. Respondent would not agree to that approach since he well understood that opening the knee twice would double Respondent's risk of infection in that injured knee. Up to the time that Respondent left to travel to Vail for his knee surgery, Wernicke maintained that he was not giving Respondent his blessing for having the surgery performed by someone else. Respondent went to Vail and had Dr. Steadman perform the surgery in early December of 1992. Respondent remained in Vail post-operatively undergoing physical therapy which commenced within hours of surgery being completed to increase his chances of obtaining full range of motion with that knee by keeping it moving and preventing scarring. Respondent returned to Vero Beach on December 13 and returned to work the next morning, working a full shift that day. After his shift was over, he drove himself to Orlando for a meeting. While in Orlando, Respondent began to have very severe pain and swelling in his knee. He drove back to Vero Beach, arriving at his home at approximately 9:30 p.m. Upon his arrival, he telephoned Wernicke, told Wernicke he was in a great deal of pain, and begged Wernicke to help him by meeting him at the hospital and looking at Respondent's knee. Wernicke told Respondent that he would not go to the hospital to meet Respondent, that Respondent should elevate his knee and apply ice, and then see Wernicke in the morning. Respondent elevated his leg and applied ice for the next few hours. By approximately midnight the pain had become "absolutely excruciating," unlike any Respondent had experienced with all of his broken bones and other sports injuries. Although Respondent's tolerance for pain was high enough that he had gone through the surgery performed by Dr. Steadman without pain pills and had tolerated getting on an exercise bike 12 hours after that surgery, Respondent knew that he could no longer endure the pain, that he had a serious problem with his post-operative knee, and that he needed to get help immediately. Respondent got himself up with crutches and got in the car to drive himself to the emergency room. While driving, he telephoned the emergency room at Indian River Memorial Hospital and told the staff he was on his way there and asked the name of the orthopedist who was on call. He was advised that Dr. Wernicke was not only on call, but was present in the emergency room at that moment. Respondent told the emergency room staff to tell Wernicke to wait for him. Respondent then called the operating room at Indian River Memorial Hospital and asked if an anaesthesiologist were there so he could get something to relieve his pain. He was told that Dr. Brennan had just finished with surgery and had taken the patient to the intensive care unit. Respondent then asked for two things: (1) to have Dr. Brennan go to the emergency room to take care of Respondent and (2) to bring Respondent's anaesthesia cart to the emergency room. The operating room staff agreed. Respondent's requests resulted from his experience with that hospital's emergency room staff and procedures. He knew he needed medication for his knee and for his pain. He knew that Dr. Brennan was not employed by the hospital and did not have his own anaesthesia cart there. He knew that the emergency room staff were notoriously slow in responding to patient needs or doctor requests. Therefore, over the years, Respondent had learned that whenever he was called to the emergency room, the patient was better served if Respondent took his own anaesthesia cart and supplies with him. As a result of his telephoning ahead, Respondent's arrival was expected. Dr. Wernicke waited for him. Someone took Respondent's anaesthesia cart to the emergency room and placed it next to a stretcher. Dr. Brennan was paged and told that Respondent needed him in the emergency room, and Dr. Brennan went to the emergency room to assist his colleague. When Brennan got there, Respondent had not yet arrived, but Wernicke was present. Brennan told Wernicke he was there to help with Respondent. For whatever reason, Wernicke told Brennan that Brennan was not needed and told him to leave. Before leaving the emergency room, Brennan told Wernicke that if he were needed he would be nearby in the intensive care unit and to please summon him. Respondent arrived at the hospital emergency room on crutches. The emergency room was currently under construction and had no dividing walls or partitions so that it was simply one room in which everyone could see everything occurring. There were no patients in the emergency room when Respondent arrived, but there were three or four nurses and the emergency room doctor at the nurses' station. Respondent went to the nurses' station to be admitted. He was told that he should wait in the lobby and he would be called when they were ready to begin the admission process. Respondent refused to do that, told them he was in excruciating pain, and insisted that he be given the emergency room release form and financial responsibility form to sign and be taken to one of the emergency room stretchers. He was given the forms to sign, which he did, and he was then escorted to the stretcher next to his anaesthesia cart. For the remainder of his time in the emergency room, Respondent remained on that stretcher which was no more than 30 feet from the nurses' station. No chart for his emergency room visit was prepared by the hospital personnel. Further, no one took his vital signs; no one took his blood pressure; no one asked what his problem or complaints were which caused his visit; and no one asked whether Respondent had any allergies or had recently eaten. Respondent lay on the stretcher waiting for Wernicke to return to the emergency room for approximately five minutes. When Wernicke came in, he was wearing a big smile. He remarked to Respondent that Wernicke could see that Respondent had a problem with his knee. Wernicke then gave one swipe across Respondent's knee with an alcohol swab and prepared to jab an 18 gauge needle into the knee to aspirate it, i.e., to drain the fluid. Respondent became terrified and told Wernicke to stop. Respondent's terror was caused by two fears. First, it was apparent that his knee was full of blood. He knew that blood outside of its normal confines is an irritant which causes inflammation and he knew that it was also the perfect medium in which bacteria could grow. He also knew that the risk of infection in his knee was substantial because it was a post-operative knee. Infection in such a knee presents a best-case scenario of a damaged knee and a worst-case scenario of rendering him a cripple, requiring a total knee replacement. Yet, Respondent saw that Wernicke intended to stick the needle into Respondent's dirty knee without even using a Betadine preparation to remove bacteria from the skin. Second, Respondent was in "unbelievable" pain from the significant swelling in his knee. The surgical incisions above and below his knee had ruptured from the pressure caused by the swelling. In order for Wernicke to aspirate Respondent's knee, it would be necessary for him to poke his fingers into the swollen knee area in order to locate the right place to stick the needle, and it was impossible for Respondent to hold his leg still for Dr. Wernicke to palpate, let alone insert the needle in the correct location. Respondent told Wernicke that he needed an I.V. started; that he needed Kefzol, an I.V. antibiotic, to prevent infection; that he needed Toradol intravenously for its anti-inflammatory effect; and that he was in very, very severe pain and needed pain medication so he could hold his leg still for Wernicke to aspirate. Although Wernicke recognized that Respondent was in significant, severe pain, he told Respondent he would agree to the antibiotic and he would agree to the anti-inflammatory, but that he didn't think Respondent needed anything for pain. Respondent's anaesthesia cart was not equipped with I.V. fluids. Someone brought an I.V. bag and set-up. Respondent does not know who brought the I.V. and whether it was on Dr. Wernicke's order or ordered by the emergency room doctor, but Respondent did not order the I.V. brought. No one offered to start Respondent's I.V. for him, and Wernicke did not tell Respondent that Dr. Brennan had come to the emergency room, had been sent away by Wernicke but was nearby, and had told Wernicke to summon him if he were needed. Wernicke kept telling Respondent to hurry up because it was late and he wanted to go home. He told Respondent that they needed to get finished because Wernicke was doing Respondent a favor just by being there. Respondent, while still lying on his stretcher, started his own I.V. Wernicke assisted Respondent by handing him tape for the I.V. since Respondent was performing the task with one hand. Respondent then removed his medication box from the bottom of his anaesthesia cart. He took out an ampule of Kefzol, a dry powder. He took a syringe and drew fluid from the I.V. that was running into him and mixed up that dry powder antibiotic by flushing it back and forth. He then gave the antibiotic to himself. He attempted to delay Wernicke from inserting the needle into his knee until after the antibiotic could circulate through his system and get to his knee before any bacteria was introduced, a process which would take approximately six minutes to complete enough circulations. Respondent next prepped his own knee with Betadine solution while Dr. Wernicke continued to stand there by his side, watching him. Respondent then took an ampule of Toradol, a new anti-inflammatory medication, and gave himself 60 milligrams intravenously, while Wernicke stood and watched. Although that anti-inflammatory medication would also serve to reduce Respondent's pain, Toradol is a slow-acting medication in that regard, having a slow onset but thereafter lasting for a number of hours. Respondent then removed from his medication box a 5 cc ampule of Alfenta. That ampule is a 2 1/2 inch object made of glass with its name in blue lettering on the outside, large enough to read. Alfenta is a Schedule II controlled substance and is a narcotic. Alfenta has a fast onset and a fast offset; it works in 30 to 60 seconds, and its effect lasts for approximately 10 minutes. While Dr. Wernicke watched, Respondent filled a needle and gave himself 1 cc of Alfenta which is a very conservative test dose for a man weighing 190 pounds who is in good condition. Respondent then waited a minute or a minute and a half to see what effect it had on his pain level and trembling leg. It had very little effect. Therefore, Respondent injected an additional 1/2 cc and waited. That additional amount was sufficient. Wernicke watched as Respondent gave himself the Alfenta, standing, as he had been, within inches of Respondent. As he injected the medications, Respondent filled out the chart on his anaesthesia cart, noting the medication, the dosage, and that he was the patient. Respondent then laid back on the stretcher, closed his eyes, and then told Wernicke he was ready. Wernicke then palpated Respondent's knee and inserted the needle to aspirate Respondent's knee. The pressure in his knee was so high that it blew the syringe back. Wernicke commented that he had never before seen that happen and had never seen pressure like that. Wernicke withdrew approximately 100 ccs of fluid from Respondent's knee, commenting that he did not think he'd seen one with more volume. Although initially Wernicke had said that he did not agree that Respondent needed any pain medication, Wernicke totally acquiesced in everything Respondent did to assist Wernicke in treating Respondent. Wernicke accepted Respondent's judgment and watched Respondent execute step by step the course of treatment Respondent said was needed to render proper medical treatment. Wernicke totally agreed and acquiesced with the use of Alfenta as much as he did the antibiotic and the anti-inflammatory as evidenced by Wernicke's own conduct. Wernicke never told Respondent to stop doing Wernicke's work for him. Wernicke never told him not to administer the medications. Wernicke never suggested that he or someone else perform the administration. Wernicke could have easily stopped Respondent who was laying on a stretcher but did not. Wernicke knew that Alfenta was a pain killer and a narcotic. He did nothing to stop or prevent Respondent from injecting a medication Respondent needed. Further, Wernicke continued to treat Respondent after the administration of Alfenta by thereafter performing the aspiration. After he completed the aspiration, Wernicke left. Respondent lay on the stretcher for a little while. The nurses and the emergency room doctor remained at the nurses' station, and there were still no other patients in the emergency room. Respondent asked if someone would bring him a wheelchair so he could leave, and he was told that they were too busy. Respondent took his crutches and hobbled out of the emergency room. The next morning Respondent reported to work for his regular shift which began at 7:00 a.m. After Respondent completed the first case on his shift that day, at approximately 10:30 to 11:30 a.m. he called Haynes McDaniel, the hospital's pharmacist, and told him what had happened the night before, what medications Respondent had used, and that he had used the medications on himself. Respondent said he needed to do whatever paperwork the pharmacist wanted and specifically asked the pharmacist to bill him for the medications he had used. McDaniel told Respondent that there was no problem regarding the Kefzol and the Toradol and that he would simply send Respondent a bill for those medications; however, as to the Alfenta, the pharmacist needed a prescription for his records. McDaniel asked Respondent who the attending physician had been, and Respondent told him that Peter Wernicke was the attending doctor. McDaniel told Respondent to get a prescription from Wernicke for the Alfenta so that the hospital record keeping would be proper. Respondent went to Wernicke and asked him for a prescription for the Alfenta that had been used, and Wernicke refused. Respondent then personally went to McDaniel and told him that Wernicke would not write the prescription and told McDaniel why, i.e., that Wernicke was still mad that Respondent had not considered him good enough to do Respondent's surgery. McDaniel asked Respondent who could write the prescription because Respondent needed a prescription from somebody and Respondent could not write the prescription for himself. Respondent told McDaniel that he had asked Dr. Brennan to be there to give him the pain medication, that Dr. Brennan had never showed up, but that Brennan was in the hospital at the time the medication was administered. McDaniel suggested that Respondent see if Brennan would sign a prescription. Respondent went to Brennan's office and told Brennan exactly what had happened. He told Brennan he had given himself 1 1/2 ccs of Alfenta and that Wernicke was the attending physician. He told Brennan that Respondent had self- administered and why, that Wernicke had refused to write the prescription and why, and that Haynes McDaniel had suggested that Brennan could sign the prescription for the hospital's records. Dr. Brennan became upset that he had not been there to help when his colleague needed him, agreed to sign the prescription, and offered Respondent pain pills or anything else Respondent needed for what remained a painful knee and leg. Respondent declined the offer of any additional medication. In good faith and in the course of his professional practice, Dr. Brennan signed a prescription for 1 1/2 ccs of Alfenta for Respondent. Respondent then hand- delivered that prescription to the pharmacist. After receiving the prescription from Respondent, the pharmacist wrote an Unusual Occurrence Report dated December 16, 1992. In January of 1993 the hospital summarily suspended Respondent's privileges, and he has been unable to practice medicine since that time. Respondent's emergency room visit happened on a Monday evening. On the following Thursday, Respondent and Wernicke's partner Dr. Jim Cain were in the doctor's lounge together. Respondent told Cain that his leg really hurt him and was swollen, and Cain offered to look at it. Respondent pulled up his scrub suit and showed Cain his calf which was twice its normal size and "hot". Cain suggested that Respondent get an ultrasound and get some blood thinner since it looked as though Respondent had developed phlebitis, a dangerous condition. Respondent immediately went to the x-ray department and had an ultrasound performed. The ultrasound revealed that Respondent had compartment syndrome in his calf, four days after the aspiration was performed. Dr. Wernicke's office notes regarding Respondent's emergency room visit, supposedly dictated that same evening or the following day, discussed the ultrasound that Respondent had. Accordingly, Dr. Wernicke did not dictate his notes regarding his treatment of Respondent on Monday evening or on Tuesday. Those notes, however, do bear Tuesday's date and are included in the hospital's medical record for Respondent's emergency room visit. The medical chart created by the hospital was likely created on December 21, 1992, the date stated on the Unusual Occurrence Report as the date the chart was initiated. The chart which thereafter purports to be Respondent's emergency room record is actually a composite of different patients' charts. To the extent it purports to be Respondent's chart, the entries contained therein are false. The Alfenta used by Respondent was an appropriate drug for the purpose for which it was used. It is a rapid but short-acting narcotic analgesic when given in the amount in which it was given. Further, the amount of Alfenta administered was an appropriate dose. Respondent used the Alfenta because it was an appropriate drug for immediate relief so he could endure the palpation and aspiration of his knee and so he could stop his leg from trembling allowing Wernicke to aspirate it. He knew the Alfenta would be worn off even before the analgesic effect of the anti- inflammatory medication was felt. It is noteworthy that all physicians who testified in this proceeding rated the pain Respondent was in as between eight and ten on a pain scale where ten is the worst. Respondent did not use Alfenta as a result of any addiction, and his use of the drug under the circumstances in this case was not related to any abuse of narcotics. Respondent has not exhibited any of the behavior of a drug user. Respondent did not engage in any attempt to "cover up" his administration of Alfenta to himself. He called the hospital and requested his anaesthesia cart be brought and that an anaesthesiologist come to the emergency room to administer the medication. The administration occurred with the implicit consent of Wernicke and it took place in front of Wernicke, in front of three or four emergency room nurses, and in front of the emergency room doctor. At the time, he filled out the narcotics record on his anaesthesia cart and telephoned the hospital's pharmacist the following day to tell him what had occurred and request that he be billed for the medication he used. His giving the hospital a prescription from Dr. Brennan was caused by Wernicke's refusal to document the treatment he rendered to Respondent, by Respondent's inability to write his own prescription, and was in response to the hospital's specific request that a prescription be written for the purpose of the hospital's record keeping. Further, Dr. Wernicke knew what had happened, as did the other emergency room personnel present that evening, and Respondent fully disclosed the events that had occurred to both Dr. Brennan and to the hospital pharmacist. Respondent's use of Alfenta on December 14, 1992, was not in any way related to patient care and had no impact on any patient care rendered by Respondent.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding Respondent not guilty and dismissing the Administrative Complaint filed against him in this cause. DONE and ENTERED this 28th day of March, 1995, at Tallahassee, Florida. LINDA M. RIGOT Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 28th day of March, 1995. APPENDIX TO RECOMMENDED ORDER Petitioner's proposed findings of fact numbered 2-6 and 9-12 have been adopted either verbatim or in substance in this Recommended Order. Petitioner's proposed finding of fact numbered 1 has been rejected as not constituting a finding of fact but rather as constituting argument of counsel, conclusions of law, or recitation of the testimony. Petitioner's proposed findings of fact numbered 7, 8, 13, 14, and 16 have been rejected as not being supported by the weight of the competent evidence in this cause. Petitioner's proposed finding of fact numbered 15 has been rejected as being subordinate to the issues herein. Respondent's proposed findings of fact numbered 1, 3-19, 21-31, 33-35, 38-40, 42, 43, and 45 have been adopted either verbatim or in substance in this Recommended Order. Respondent's proposed findings of fact numbered 2, 20, 32, 36, 37, and 44 have been rejected as not constituting findings of fact but rather as constituting argument of counsel, conclusions of law, or recitation of the testimony. Respondent's proposed finding of fact numbered 41 has been rejected as being subordinate to the issues herein. COPIES FURNISHED: Arthur B. Skafidas, Esquire Agency for Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0792 Joseph L. Mannikko, Esquire 215 South Federal Highway, Suite 100 Stuart, Florida 34994 Dr. Marm Harris, Executive Director Agency for Health Care Administration Board of Medicine 1940 North Monroe Street Tallahassee, FL 32399-0792 Tom Wallace, Assistant Director Agency for Health Care Administration Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792
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.
