STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
HUMHOSCO, INC., HUMANA, INC., ) COMMUNITY HOSPITALS OF HUMANA ) INC., HUMHOSCO, INC., d/b/a ) HUMANA HOSPITAL BRANDON, and ) HUMANA HOSPITAL - PEMBROKE )
PINES, INC., d/b/a HUMANA )
HOSPITAL - PEMBROKE, )
)
Petitioners, )
)
vs. ) CASE NO. 91-0863RP
)
DEPARTMENT OF HEALTH AND )
REHABILITATIVE SERVICES, )
)
Respondent, )
)
and )
)
NORTH BROWARD HOSPITAL ) DISTRICT and ADVENTIST HEALTH ) SYSTEM SUNBELT, INC., d/b/a ) FLORIDA HOSPITAL, )
)
Intervenors. )
) ST. MARY'S HOSPITAL, INC., )
)
Petitioner, )
)
vs. ) CASE NO. 91-0864RP
)
DEPARTMENT OF HEALTH AND )
REHABILITATIVE SERVICES, )
)
Respondent, )
)
and )
) JFK MEDICAL CENTER, INC. and ) NORTH BROWARD HOSPITAL DISTRICT, ) and ADVENTIST HEALTH SYSTEMS ) SUNBELT INC., d/b/a FLORIDA ) HOSPITAL, )
)
Intervenors. )
)
ADVENTIST HEALTH SYSTEMS ) SUNBELT INC., d/b/a FLORIDA ) HOSPITAL, )
)
Petitioner, )
)
vs. ) CASE NO. 91-0865RP
)
DEPARTMENT OF HEALTH AND )
REHABILITATIVE SERVICES, )
)
Respondent, )
)
and )
) NORTH BROWARD HOSPITAL DISTRICT, )
)
Intervenor. )
)
FINAL ORDER
Pursuant to notice, a formal hearing was conducted in these cases on March 11-13, 1991, in Tallahassee, Florida, before J. Stephen Menton, a duly designated Hearing Officer of the Division of Administrative Hearings.
APPEARANCES
For Petitioners:
Humana James C. Hauser, Esquire George Matlock, Esquire FOLEY & LARDNER
101 North Monroe Street Suite 1050
Post Office Box 508 Tallahassee, Florida 32302
St. Mary's W. David Watkins, Esquire
Hospital OERTEL, HOFFMAN, FERNANDEZ & COLE, P.A.
2700 Blair Stone Road Suite C
Post Office Box 6507 Tallahassee, Florida 32314-6507
Adventist Health Jeffery A. Boone, Esquire Systems John Koda, Esquire
BOONE, BOONE, KLINGBEIL, BOONE & ROBERTS, P.A.
1001 Avenida del Circo Post Office Box 1596 Venice, Florida 34284
For Respondent:
Dept. of Health Lesley Mendelson, Esquire and Rehabilitative Senior Attorney
Services Department of Health and Rehabilitative Services
2727 Mahan Drive, Ste. 103
Tallahassee, Florida 32308
For Intervenors:
JFK Hospital Robert A. Weiss, Esquire
PARKER, HUDSON, RAINER & DOBBS
The Perkins House, Ste. 101
118 N. Gadsden Street Tallahassee, Florida 32301
North Broward
Hospital District Patrick Phelan, Esquire
PARKER, SKELDING, LABASKY & CORRY
Post Office Box 669
318 N. Monroe Street Tallahassee, Florida 32302
St. Anthony's Ivan Wood, Esquire
BAKER & HOSTELLER McCUTCHEN BLACK
2100 Texas Commerce Tower 600 Travis
Houston, Texas 77002
Tampa General Elizabeth McArthur, Esquire
AURELL, RADEY, HINKLE & THOMAS
101 North Monroe Street Suite 1000
Post Office Drawer 11307 Tallahassee, Florida 32302
STATEMENT OF THE ISSUES
Whether the proposed amendments to Florida Administrative Code Rule 10- 5.011(1)(f), the "open heart rule", constitute an invalid exercise of delegated legislative authority.
PRELIMINARY STATEMENT
On January 18, 1991, the Department of Health and Rehabilitative Services ("HRS") noticed by publication proposed amendments to Rule 10-5.011(1)(f), Florida Administrative Code, regulating open heart surgery services. The notice was published in Volume 17, No. 3, Florida Administrative Weekly. In response to written public comment, HRS published a Notice of Change to the proposed rule amendments on February 1, 1991 in Volume 17, No. 5, Florida Administrative Weekly. Challenges to the proposed open heart rule amendments were filed by Martin Memorial Hospital Association, Inc. ("Martin"), Humhosco, Inc., Humana,
Inc., Community Hospitals of Humana, Inc., et. al., Humhosco Inc., d/b/a Humana Hospital Brandon, and Humana Hospital Pembroke Pines, d/b/a Humana Hospital- Pembroke, (collectively "Humana"), St. Mary's Hospital, Inc. ("St. Mary's") and Adventist Health Systems-Sunbelt, Inc., d/b/a Florida Hospital ("Florida Hospital.")
Although there were some overlap in the allegations, each of the Petitions challenging the proposed rule amendments addressed only a portion of the amendments and each of the cases was assigned a separate case number by the Division of Administrative Hearings. The challenge filed by Martin was assigned Case No. 91-0850R. The challenge filed by Humana was assigned Case No. 91- 0863RP. The challenge filed by St. Mary's was assigned Case No. 91-0864RP and the challenge filed by Florida Hospital was assigned Case No. 91-0865RP.
By Order dated February 14, 1991, the four cases were consolidated for purposes of the final hearing. As set forth in an Order entered on March 6, 1991, prior to the final hearing, Martin filed a Notice of Voluntary Dismissal and Case No. 91-0850R was dismissed. In addition, JFK Medical Center, Inc. ("JFK") was granted intervention in Case No. 91-0864RP which was initiated by St. Mary's. The North Broward Hospital District ("North Broward") was granted intervention in all three pending cases and Florida Hospital was granted intervention in Case Nos. 91-0863RP and 91-0864RP.
In its Petition to Intervene, North Broward challenged certain portions of the proposed amendments. On March 7, 1991, North Broward filed North Broward Hospital District's Notice Of Change In Position and Pre-Hearing Statement (the "Notice of Change"). Pursuant to this Notice of Change, North Broward withdrew the portion of its Petition to Intervene which challenged parts of the proposed amendments and asserted its position in favor of the proposed rule.
In addition to the Petitions to Intervene that were addressed in the March 6, 1991 Order, St. Anthony's Hospital ("St. Anthony's") and the Hillsboro County Hospital Authority d/b/a Tampa General Hospital ("Tampa General") filed Petitions to Intervene on March 4 and 5, 1991 respectively. Humana and St.
Mary's filed also Petitions to Intervene in the Florida Hospital case, Case No. 91-0865RP. Argument on all of these Petitions was heard at the commencement of the hearing on March 11, 1991. During argument, counsel for St. Anthony's agreed to withdraw the grounds for intervention set forth in Paragraphs 5(a) and 5(c) of its Petition to Intervene. As a result, St. Anthony's seeks to intervene to challenge the proposed rule amendments only on the grounds alleged in Paragraph 5(b) of its Petition. No objection was voiced to St. Anthony's Intervention on these grounds and its Petition, as amended at the hearing, was granted.
Tampa General sought to intervene in support of all aspects of the proposed rule. St. Mary's opposed the intervention of Tampa General on the basis of the timeliness of the Petition. That objection was overruled at the commencement of the final hearing and Tampa General's Petition for Intervention was granted. In addition, St. Mary's and Humana's Petitions to Intervene in the Florida Hospital case were granted.
On March 4, 1991, JFK filed a Motion To Strike, or in the Alternative, Motion For More Definite Statement. North Broward filed a Motion To Strike and Motion for Official Recognition on March 8, 1991. Ruling on both of these motions was reserved pending presentation of the evidence. The issues raised in the Motions are addressed in the Conclusions of Law in this Final Order.
Prior to the final hearing, the parties jointly stipulated to the standing of all parties challenging the proposed rule amendments and agreed that no evidence would be necessary to prove the factual basis for standing. However, St. Mary's filed a Response objecting to the proposed intervention by JFK. St. Mary's contended that JFK did not have standing to participate in that portion of the case which challenged the proposed amendments dealing with pediatric open heart surgery programs. There is no dispute that JFK does not perform pediatric open heart surgery at its facility nor has it ever applied for such a program.
JFK does have an adult open heart surgery program. St. Mary's objection was noted for the record, but the objection was overruled and JFK was allowed to participate fully in the proceedings.
At the hearing, Humana presented the testimony of Elfie Stamm, a Health Services and Facilities Consultant Supervisor with HRS, and Elizabeth Dudek, the Acting Director and Supervisor of the Office of Community Medical Facilities and Services of HRS. Humana offered two exhibits into evidence, both of which were accepted without objection. St. Mary's presented the testimony of Elfie Stamm, Elizabeth Dudek, and Michael Jernigan, the Director of Planning for Naples Community Hospital and also a private health care consultant. Mr. Jernigan was accepted as an expert in the area of health care planning. St. Mary's had twenty-two exhibits marked for identification at the hearing. St. Mary's Exhibits 7-13 were copies of existing rules of HRS. St. Mary's Exhibit 14 was a copy of Section 20.19, Florida Statutes (1989). St. Mary's Exhibit 17 was a copy of Section 381.704, Florida Statutes (1989) and St. Mary's Exhibits 19-22 were copies of Final Orders entered by HRS in various administrative proceedings. Official recognition was taken of all of these rules, statutes and final orders. St. Mary's remaining Exhibits, 1-6, 15, 16 and 18 were accepted into evidence without objection.
St. Anthony's presented the testimony of Thomas Konrad, a private health care consultant who was formerly the Administrator of the Florida Certificate of Need Program and the former Administrator of the State Office of Health Planning for HRS. Mr. Konrad was accepted as an expert in the area of health planning.
St. Anthony's offered two exhibits into evidence, both of which were accepted.
Florida Hospital presented the testimony of Elfie Stamm, but did not offer any exhibits into evidence. HRS also called Elfie Stamm as its only witness.
HRS offered Ms. Stamm as an expert in health planning. St. Mary's objected to her designation as an expert because she had not been disclosed as an expert witness on the pre-hearing witness list. However, in view of the abbreviated time frame for conducting discovery and the familiarity of all parties with Ms. Stamm's position and background, that objection was overruled. HRS had eight exhibits marked during the hearing. HRS Exhibit 1 was accepted into evidence without objection. HRS Exhibits 2-4 were file folders containing background documents assembled during the development of proposed amendments to the open heart surgery rule in 1989. As discussed below, those proposals were withdrawn in April, 1990. HRS Exhibit 5 was an additional file folder of background documents assembled in connection with the proposed amendments in this case.
Although much of the information contained in these file folders was hearsay, the exhibits were accepted and considered in accordance with Section 120.58(1)(a), Florida Statutes (1989). HRS Exhibits 6-8 were copies of final orders entered in various administrative proceedings. Official recognition was taken of those orders.
Tampa General did not present any witnesses at the hearing. Tampa General had one exhibit marked for identification purposes. That exhibit was a copy of certain amendments to the existing CON rules which have been adopted by HRS. Official recognition was taken of the amendments reflected in this exhibit.
JFK presented the testimony of Mark M. Richardson, a private health care consultant who was accepted as an expert in the field of health care planning. JFK did not offer any exhibits into evidence.
North Broward and Florida Hospital cross-examined some of the witnesses called by the other parties, but did not present any other evidence.
During the course of the hearing, official recognition was taken of the definitions contained in Section 381.702, Florida Statutes, the CON review criteria set forth in Section 301.705, Florida Statutes, Section 120.54, Florida Statutes, and Rules 10D-5.008(1)(A) and 10D-5.018(2), Florida Administrative Code. Finally, official recognition was also taken of the calendar for the year of 1991, in particular the days of January 18 and February 11.
In accordance with a ruling on a Motion For Protective Order filed prior to the commencement of the hearing, the record in this case was left open in order to allow St. Mary's an opportunity to depose certain witnesses employed by JFK and Florida Hospital and possibly submit those depositions as late-filed exhibits to this proceeding. At the conclusion of the hearing, counsel for St. Mary's advised that he no longer intended to depose any of the witnesses from Florida Hospital. However, depositions were subsequently taken of certain witnesses employed by JFK. On March 27, 1991, a hearing was held during which counsel for St. Mary's advised that it would not be submitting those depositions or any other additional evidence. At that hearing, the parties agreed upon a time frame for submitting proposed findings of fact and conclusions of law. All parties timely submitted such proposals.
On May 31, 1991, JFK filed a Motion To Strike the proposed final order submitted by St. Mary's Hospital on the grounds that it did not contain citations to the record as required by Rule 22I-6.031(3), Florida Administrative Code. The Motion did not comport with the requirements of Rule 22I-6.016, Florida Administrative Code. A similar motion was filed with respect to the proposed final order submitted by Humana. On June 5, 1991, St. Mary's filed a Response to Motion to Strike which sets forth citations to the record for many of the proposed findings of fact contained in its proposed final order. On June 12, 1991, Humana filed a Response to Motion To Strike which also sets forth citations to the record for its proposed findings of fact. After reviewing the Motions and the Responses thereto, the Motion To Strike is denied.
On June 28, 1991, Humana filed a Notice of Supplemental Authority. The citation contained in that Notice has been reviewed and considered in the preparation of this Final Order.
A transcript of the proceeding has been filed. A ruling on each of the parties' proposed findings of fact is included in the Appendix attached to this Final Order.
Subsequent to the hearing, counsel for HRS drafted an outline of the various issues raised in this case and submitted the outline to each of the parties as a format for proposed final orders. Most of the parties attempted to stay within that format in submitting proposals and, to the extent appropriate, this Final Order will also follow that outline.
FINDINGS OF FACT
Based upon the oral and documentary evidence adduced at the final hearing and the entire record in this proceeding, the following findings of fact are made.
On January 18, 1991, HRS published proposed rule changes (the "Proposed Amendments") to Rule 10-5.011(1)(f), Florida Administrative Code, in the Florida Administrative Weekly, Volume 17, No. 3 at page 163. These consolidated cases were brought pursuant to Section 120.54, Florida Statutes, to challenge these Proposed Amendments to the administrative rules for the Certificate of Need program.
As a preliminary matter, it is important to understand the background of the rule and the Proposed Amendments. Rule 10-5.011(1)(f), regulates the provision of open heart surgery throughout the eleven HRS service districts in Florida. HRS' stated purpose in promulgating the Proposed Amendments was to "clarify" certain provisions of the existing rule.
The original version of the open heart surgery rule was drafted in 1982, and was modeled after the National Guidelines for Health Planning, (hereinafter the "National Guidelines"). At the time the existing rule was adopted, the Florida Certificate of Need Program closely tracked the National Guidelines. Prior to adopting the existing rule, HRS reviewed the relevant literature regarding open heart surgery programs. In addition, a task force was convened to review numerous issues, including certain criticisms received from the health care industry that the National Guidelines were too restrictive.
In 1985, the open heart rule was amended in response to evidence demonstrating that the incidence rate of adult open heart surgery had increased. The rule was amended to project need based upon the actual use rate experienced. The amended rule provided that the use rate would be adjusted for every batch of applications based on the most recent twelve month data available.
In 1987, the open heart surgery rule was challenged by St. Mary's pursuant to Section 120.56, Florida Statutes. The primary issue in that rule challenge was whether the 350 minimum volume operations standard in the rule was too high. Following a three day hearing which included the presentation of extensive expert testimony, the rule was declared to be a valid exercise of delegated authority. See, St. Mary's Hospital v. Department of Health and Rehabilitative Services, DOAH Case No. 87-2729R, 9 F.A.L.R. 6159. (This subject matter is discussed in more detail in Findings of Fact 91-92 below.)
In 1989, HRS published what it considered to be proposed technical amendments to the open heart surgery rule to resolve certain issues regarding the publication of the fixed need pool and to clarify some other aspects of the rule. No work group was convened for these proposals because HRS did not consider the proposed changes to be substantive. However, a number of challenges were filed to the proposed rule amendments. In April of 1990, HRS decided to withdraw the amendments and seek further input from the health care industry and other affected persons regarding possible changes to the rule.
A work group (the "Work Group") was convened on June 18, 1990 to discuss the issues raised in the various challenges to the 1989 proposed rule amendments and to consider other matters raised by the various industry representatives and other concerned parties. Representatives from numerous Florida hospitals, as well as representatives from the Association of Voluntary
Hospitals, the Florida League of Hospitals and the Florida Hospital Association participated in the Work Group. The participants included hospitals that have open heart surgery programs and those that do not, including several who had applied or who have an interest in offering those services. The minutes of the Work Group Meeting were transcribed and are contained in the rule promulgation file which was accepted into evidence as HRS Exhibit 5.
Elfie Stamm, the HRS planner primarily responsible for the original development and subsequent amendments of the open heart surgery rule was an active participant in the Work Group. She also oversaw the development of Volume 3 of the State Health Plan in 1988 and 1989. This volume deals with certificate of need matters and contains detailed research and analysis of open heart surgery trends and developments. Thus, Ms. Stamm was very familiar with the issues and current research in the area.
Based upon the evidence deduced during the Work Group Meeting and a review of the research in the area, HRS decided to promulgate the Proposed Amendments which it considered to be "technical" changes to the rule that were intended to not change the impact on current and prospective providers. HRS specifically decided not to make any changes that would modify the current overall need projections.
Prior to publication, the Proposed Amendments were circulated for internal review, approval and signoff, and were sent to the House Health Care Committee and the Senate HRS Committee. The Proposed Amendments were also sent to all the members of the Work Group, who were advised that it would be published on January 18, 1991. As noted above, the Proposed Amendments were published in the Florida Administrative Weekly on January 18, 1991.
Only one public comment (dated January 24, 1991, and received by HRS on January 28, 1991,) was submitted in response to the January 18, 1991 publication of the Proposed Amendments. That comment suggested clarifying language to Subparagraph 7(a) II of the Proposed Amendments. In response to this letter, HRS caused to be published a Notice of Change in the February 1, 1991 edition of the Florida Administrative Weekly.
The January 18, 1991 Notice provided that a public hearing on the Proposed Amendments would be conducted on February 11, 1991 at 10:00 a.m. if requested. No public hearing was requested and, therefore, none was held. St. Mary's has insinuated that the Notice was somehow deficient because the public hearing was scheduled more than 21 days after the notice of rulemaking was published in the Florida Administrative Weekly. The evidence indicates that such scheduling is customary in order to assure that a request can be made right up until the last possible moment without the necessity of holding two public hearings.
Overview of the Proposed Amendments
Proposed Section 10-5.011(1)(f) is a new section entitled "Departmental Intent." This section states that certificates of need for open heart surgery programs will not normally be approved unless the applicant meets the relevant statutory criteria, including the need determination criteria in the rule. This Section also provides that separate certificates of need will be required in order to establish either an adult or pediatric open heart surgery program. As discussed in more detail below, the existing rule does not expressly state that separate CONs must be obtained to implement adult and
pediatric programs. The proposed rule amendments do not specifically address the provision of adult and pediatric open heart surgery within the same program.
Proposed Section 10-5.011(1)(f)2 sets forth several new definitions. Subparagraph 2j establishes for the first time pediatric open heart service areas which are made up of combined HRS districts and are thus much larger than adult open heart service areas.
Proposed Section 10-5.011(1)(f)3 mandates that pediatric open heart surgery programs must have the same services and procedures as adult programs, including intraaortic balloon assists. Subparagraph 3c requires that pediatric open heart surgery programs shall only be located in hospitals with inpatient cardiac catheterization programs.
Proposed Section 10-5.011(1)(f)4 contains the travel time standard which applies to adult open heart surgery service accessibility, and the maximum waiting period for open heart surgery team mobilization for adult and pediatric programs. There is no travel time standard for pediatric services in the Proposed Amendments.
Proposed Section 10-5.011(1)(f)4d requires applicants for adult or pediatric open heart surgery programs to document the manner in which they will provide open heart surgery to all persons in need.
Proposed Section 10-5.011(1)(f)7 is entitled "Adult Open Heart Surgery Program Need Determination". Subparagraph (a) essentially recodifies and restates existing Rule 10-5.011(f)11 and provides that each and every adult open heart surgery program within a district should be performing 350 adult open heart surgery operations per year prior to there being a calculated net need for a new program in that district. The section does not contain an explanation or delineation of "not normal" circumstances that HRS will consider in the absence of a net numeric need. Currently, Rule 10-5.011(1)(f)11., provides:
There shall be no additional open heart surgery programs established unless:
The service volume of each existing and approved open heart surgery program within the service area is operating at and is expected to continue to operate at a minimum of 350 adult open heart surgery cases per year or 130 pediatric heart cases per year.
As discussed in more detail in Findings of Fact 89-97 below, from approximately early 1985 through January 22, 1990, HRS interpreted this section to require that the volume of procedures provided by all existing programs in each service district be averaged to determine whether need existed for a new open heart surgery program (the "averaging method"). This averaging method allowed HRS to find numeric need when the average total of procedures per program in the district equaled 350 or more. After this interpretation was rejected in several cases, HRS abandoned the "averaging" approach and has been requiring "each and every" existing program in a district to meet the 350 minimum standard before a new adult program will normally be approved.
Subparagraph (b) of Proposed Section 10-5.011(1)(f)7 mandates that only one program shall be approved at a time, and contains the numeric need calculation formula for adult open heart surgery programs. Subparagraph (c) states that, regardless of whether need is shown according to the formula, if an
incoming provider will reduce an existing provider's volume below 350, the applicant will not normally be approved.
Proposed Section 10-5.011(1)(f)8 contains a new method for calculating need for pediatric open heart surgery programs. Pursuant to this proposal, need would be calculated based on the number of resident live births in a pediatric open heart surgery program service area. The proposal would require at least 30,000 resident live births per pediatric program.
The economic impact statement (EIS) which accompanied the Proposed Amendments states that, other than administrative and word processing costs, there will be no additional annual or operating costs associated with the implementation of the Proposed Amendments. The EIS contains no statement of the impact upon potential applicants or existing providers due to the changes in either the adult or pediatric portions of the rule.
WHETHER PARAGRAPH 1 OF THE PROPOSED AMENDMENT IS INVALID BECAUSE IT REQUIRES A SEPARATE CERTIFICATE OF NEED FOR AN ADULT OPEN HEART SURGERY PROGRAM AND PEDIATRIC OPEN HEART SURGERY PROGRAM.
The existing rule does not expressly require separate certificate of need applications for pediatric and adult open heart surgery programs. However, HRS' policy for at least the last year has been to require hospitals to obtain separate certificates of need for adult open heart surgery programs and pediatric open heart surgery programs. See Findings of Fact 135 below. In other words, the proposed amendment codifies HRS' current interpretation of the existing rule.
The Work Group which assisted in the development of the Proposed Amendments examined the issue of whether HRS should require hospitals to obtain separate CONs for adult open heart surgery programs and pediatric open heart surgery programs. In addition, HRS reviewed the available literature, including the National Guidelines and the Guidelines for Pediatric Cardiology Diagnostic and Treatment Centers (hereinafter the "Pediatric Guidelines"). Comments were also solicited from the Children's Medical Services Program Office which regulates certain aspects of pediatric cardiac surgery. Based upon a review of this information, HRS concluded that (1) pediatric and adult open heart surgery programs are generally and properly operated as separately organized programs and (2) pediatric programs are and should be staffed by personnel specially trained to provide pediatric care.
There are significant differences between providing open heart surgery to adults and providing open heart surgery to children. Adults generally have acquired heart disease, while children generally have congenital heart problems. The transfer process and approach to open heart surgery differs between adults and children. Pediatric open heart patients are more labile in certain situations than adult open heart surgery patients. People who work with adult open heart surgery patients often lack the ability to work with pediatric open heart surgery patients. In sum, the evidence established that pediatric open heart surgery is a complex service which requires a team dedicated to that service.
With the possible exception of one program, all the pediatric open heart surgery programs in Florida are offered in separately organized programs.
The incidence rate of pediatric open heart surgery is significantly lower than that for adult open heart surgery. The latest data reflects that from October 1989 to September 1990 there were only 545 pediatric heart surgeries performed in the state of Florida as compared to nearly 21,000 adult open heart surgeries during the same period.
Nothing in the Proposed Amendments prohibits an applicant from applying for both adult and pediatric open heart surgery. The rule does have separate requirements, including separate need methodologies, which would normally have to be satisfied as a predicate to the award of either program.
St. Mary's voiced a concern that the Economic Impact Statement did not address the additional costs to applicants, (i.e. duplicate application fees) that will result from this provision of the Proposed Amendments which requires separate certificates of need for adult and pediatric programs. As noted above, such costs are already necessary under HRS' interpretation of the existing rules. In any event, St. Mary's has not demonstrated that such additional costs would be other than minimal.
WHETHER THE CLASSIFICATION OF OPEN-HEART SURGERY BY THE DIAGNOSTIC RELATED GROUPS LISTED IN SUB-PARAGRAPH 2.g. OF THE PROPOSED AMENDMENT IS VAGUE, ARBITRARY AND CAPRICIOUS.
Subparagraph 2.g. of the proposed amendments reads as follows: "Open Heart Surgery Operation". Surgery
assisted with a heart-lung by-pass machine that is used to treat conditions such as congenital heart defects, heart and coronary artery diseases, including replacement of heart valves, cardiac vascularization, and cardiac trauma. One open heart surgery operation equals one patient admission to the operating room. Open heart surgery operations are classified under the following diagnostic related groups: DRGs 104, 105, 106, 107, 108
and 110.
Diagnostic related groups or "DRGs", are a health service classification system used by the Medicare System. The existing rule does not include the reference to DRG classifications. Some confusion had been expressed by applicants as to whether certain organ transplant operations which utilized a bypass machine during the operation should be reported as open heart operations or as organ transplantation operations. The amendment was intended to clarify that only when the operation utilizes the bypass machine and falls within one of the enumerated categories should it be considered an open heart surgery operation. The inclusion of the listed DRGs was meant to clarify the existing definition by limiting the DRG categories within which open heart surgery services may be classified.
There is no dispute that the primary factor in defining an open heart surgery procedure is the use of a heart-lung machine. Florida Hospital argued that the proposed definition is ambiguous and vague because not all procedures which fit into the listed DRG categories necessarily involve open heart surgery. Florida Hospital's fear that the new language would seem to indicate that each procedure falling into the listed DRGs qualifies as an open heart surgery
operation is unfounded. While the provision could have been written in a simpler and clearer manner, the definition adequately conveys the intent that the use of a heart-lung by-pass machine is an essential element to classifying an operation as open-heart surgery.
WHETHER SUBPARAGRAPH 2.j. OF THE PROPOSED AMENDMENT IS INVALID BECAUSE IT ESTABLISHES PEDIATRIC OPEN HEART SERVICE AREAS WHICH ARE LARGER THAN ADULT OPEN HEART SERVICE AREAS WHICH MAY RESULT IN DEPRIVATION OF NEEDED OPEN HEART SURGERY PROGRAMS IN SOME SERVICE AREAS.
The Proposed Amendments will regulate pediatric open heart surgery on a regional basis. Five "Services Areas" are created by combining HRS service districts. In establishing these Service Areas, HRS considered the extent to which patients would have geographic access to pediatric open heart surgery services. The Service Areas were organized geographically in a manner intended to result in one pediatric open heart surgery program in each Service Area.
Section 20.19(7), Florida Statutes, provides that "[t]he Department shall plan and administer its programs of health, social, and rehabilitative services through service districts and subdistricts ... ." This statute sets forth the geographic composition of each district and subdistrict through which HRS is to administer its programs. Section 20.19(7)(a), Florida Statutes.
St. Mary's contends that no statutory authority exists for combining "service districts" to create "service areas." However, no prohibition against combining districts for tertiary services exists in the statute and, indeed, the nature of tertiary services mandates such an approach in some instances. As indicated below, HRS has combined districts for other programs.
Section 381.702(20) defines "tertiary health services" and authorizes HRS to establish by rule a list of tertiary health services. Tertiary health care services are complex services which involve high consumption of hospital resources. Due to the low incidence of those medical conditions which require tertiary services, there is a benefit in limiting those services to select facilities in order to maximize volume at those facilities. This approach is known as the regionalization of health care services.
HRS has promulgated a list of tertiary health services in Rule 10- 5.002(66) (previously 10-5.002(40), Florida Administrative Code. Subsection 9 of this Rule includes "neonatal and pediatric cardiac and vascular surgery." Thus, pediatric open heart surgery is a tertiary health care service.
HRS regulates other tertiary services, including burn units, organ transplants programs, and pediatric cardiac catheterization services, on a regional basis. See e.g., Rules 10-5.043, and 5.044 Florida Administrative Code. Regionalization of tertiary services at a central point has been used by HRS to encourage an appropriate volume level at each center.
The evidence established that there is a correlation between volume and outcome in pediatric open heart programs. HRS has concluded that pediatric open heart surgery should be limited to and concentrated in a limited number of hospitals to ensure the quality, availability, and cost effectiveness of the service. No persuasive evidence was presented to rebut this conclusion.
The evidence indicates that pediatric open heart surgery services are currently delivered in Florida on a regional basis. A limited number of hospitals scattered throughout the state are serving the state's population. Of the eight hospitals which are included among the HRS inventory of hospitals providing pediatric open heart surgery services, only 5 perform a significant volume of cases. Each of those five hospitals is either a teaching hospital or a specialty pediatric hospital. The other three hospitals listed on the inventory have large adult open heart surgery programs, but perform a very low volume of pediatric cases. The evidence did not establish that the existing providers are currently unable to meet the need for services in the state.
Based upon a review of the existing research and literature, HRS has concluded that a facility should perform approximately 100 pediatric heart surgeries annually in order to retain proficiency. As discussed in Findings of Fact 132 below, the 30,000 annual live births standard will, over time, result in approximately 100-130 pediatric open heart surgery cases per year among the population base from birth to age 21.
In Service Area 1, the resident live births in 1988 were 16,142. (Service Area 1 combines HRS Districts 1 and 2.) Thus, the number of live births in this Service Area would have to almost double before a new program could meet this standard. While Petitioners object to this result, no persuasive evidence was presented to establish that HRS has acted arbitrarily in establishing the Service Area.
The rule requires a pediatric program in each Service Area. However, only one of the Service Areas established by this Proposed Amendment meets the 30,000 live birth standard. St. Mary's contends that this discrepancy renders the proposed amendment internally inconsistent. However, there are significant countervailing considerations which militate against closing an existing program and justify the continuation of established programs in these areas. These considerations include the need to insure geographic access, the reluctance to disturb existing referral patterns and a reluctance to disturb programs with demonstrated proficiency.
The HRS Work Group which assisted in the development of the Proposed Amendments addressed the issue of regulating pediatric open heart surgery services on a regional basis. No persuasive evidence was presented in opposition to this approach.
WHETHER PARAGRAPH 3 OF THE PROPOSED AMENDMENT IS INVALID BECAUSE IT REQUIRES SERVICES AND PROCEDURES WHICH ARE NOT NECESSARY TO THE SAFE EFFECTIVE PROVISION OF PEDIATRIC OPEN HEART.
The Proposed Amendments will require hospitals seeking to provide pediatric open heart surgery to have the ability to provide certain specified services.
The requirements contained in paragraph 3 of the Proposed Amendments are the same as those contained in the existing rule. They are considered by HRS to be minimum standards for the provision of both adult and pediatric open heart surgery. The evidence established that it is desirable to have those services available, even if they are infrequently used. Dr. Byron testified that some of the procedures such as intra-aortic balloon assists, prolonged myocardial bypass and the repair and replacement of heart valves are performed
less commonly in children. However, he did agree that these procedures are occasionally necessary and a pediatric program should have the ability to provide those services. Requiring a pediatric open heart program to have the capability to provide those services if necessary is consistent with the goal of regionalization of pediatric open heart surgery.
There was no adverse public comment received during development of the Proposed Amendments regarding these requirements and no persuasive testimony or other evidence was offered during the Work Group or the hearing in this cause to establish that these minimum requirements are not appropriate and/or should be deleted.
WHETHER PARAGRAPH 3c VI OF THE PROPOSED AMENDMENT, WHICH REQUIRES THAT IN ORDER TO BE AWARDED A PEDIATRIC OPEN HEART PROGRAM THE APPLICANT MUST ALSO HAVE PEDIATRIC CARDIAC CATH, CREATES A "CATCH 22" WHEN READ IN CONJUNCTION WITH THE CARDIAC CATH RULE WHICH REQUIRES AN APPLICANT FOR PEDIATRIC CARDIAC CATH TO OFFER PEDIATRIC OPEN HEART, AND IS THEREFORE INVALID.
The Proposed Amendments require that in order to be awarded a certificate of need for a pediatric open heart surgery program, an applicant must have a pediatric cardiac catheterization ("cardiac cath") program. A similar requirement can be implied from the current open heart surgery rule and, indeed, HRS has interpreted the current rule is this manner. The cardiac cath rule requires that an applicant for a pediatric cardiac cath program must have a pediatric open heart surgery program.
The Services Areas and the need methodologies in the proposed pediatric portion of the open heart surgery rule and the amended pediatric portion of the cardiac catheterization rule are the same. St. Mary's contention that applicants are placed in a "Catch 22" is rejected. If a facility wants to offer pediatric open heart, it is going to have to simultaneously apply for cardiac cath.
There is nothing in this section, or anywhere else in the rule, which prohibits an applicant from applying for pediatric cardiac cath and pediatric open heart contemporaneously. In fact, such a simultaneous application is exactly what HRS is trying to encourage. The two services, pediatric open heart and pediatric cardiac cath, should only be offered in combination with each other. St. Mary's own witness, Dr. Harry Byron, a pediatric cardiologist, agreed that a facility that offers an open heart surgery program in pediatrics should also have pediatric cardiac cath capabilities.
Every facility in the state of Florida which provides pediatric cardiac cath also provides pediatric open heart surgery. During the hearing, it was suggested that Hollywood Memorial Hospital is performing pediatric open heart without offering pediatric cardiac cath. However, an examination of the CON issued to Hollywood Memorial reveals that it was awarded both services simultaneously.
St. Mary's contends that the Proposed Amendments to the open heart rule are deficient because they cross-reference the cardiac cath rules and there is some question as to the status of the cardiac cath rules. St. Mary's argues that HRS' predecessor cardiac catheterization rule is the current cardiac
catheterization rule because proposed amendments to the cardiac cath rule were prevented from becoming final as the result of timely challenges. As best can be determined from the evidence in this case, there is no inconsistency between the Proposed Amendments and the cardiac cath rules.
The evidence regarding the status of the cardiac cath rules was inconclusive. Amendments to the cardiac cath rule were published on April 22, 1988, but never became effective because of rule challenges which were eventually settled. When the rule amendments were republished on July 29, 1988 with certain agreed upon changes, timely challenges brought pursuant to Section 120.54(4), Florida Statutes, prevented those changes from becoming effective. However, the Final Order in the case challenging the procedural adequacy of the July 29, 1988 amendments upheld a large portion of that proposed rule, including the sections pertinent to this case. See, Florida Medical Center v. Department of Health and Rehabilitative Services, Case No. 88-3970R (DOAH Final Order entered June 30, 1989). Thus, it appears that St. Mary's contention is without merit.
WHETHER SUBPARAGRAPH 4.a. OF THE PROPOSED AMENDMENT IS INVALID BECAUSE IT DOES NOT CONTAIN A TRAVEL TIME STANDARD FOR PEDIATRIC OPEN HEART SURGERY.
The Proposed Amendments do not contain a travel time standard for pediatric open heart surgery services. St. Mary's contends that the proposed rule should include a travel time standard for pediatric patients who need emergency procedures.
There is no dispute that the longer a pediatric patient has to wait to have open heart surgery, the greater the chance of a negative outcome.
Moreover, transporting pediatric patients is often more complicated and dangerous than transporting an adult patient because infants are more labile and closer attention must be paid to their glucose levels, to the environmental temperature and similar matters.
In the course of its deliberations concerning the Proposed Amendments, HRS considered whether it should include a travel time standard relating to pediatric open heart surgery. No persuasive evidence was presented to HRS during the rule development process that an appropriate travel time standard could or should be adopted.
HRS elected not to provide for a travel time standard out of concern that such standard would have suggested a "need" for programs in geographic areas which would not generate a sufficient case load to allow the program to maintain proficiency.
A travel time standard such as that contained in the rule for the provision of adult open heart surgery programs would not be appropriate for the provision of pediatric open heart surgery programs because of the highly tertiary nature of the service. Had HRS used a two-hour travel time standard for pediatrics as it did for adult open heart, a need may have been shown for more programs than the volume of operations could support, resulting in programs with lower volumes than desired from a quality of care standpoint.
Some pediatric patients in need of open heart surgery may have to travel as much as six hours by car if the need methodologies and Service Areas in the Proposed Amendments are adopted. In most instances, however, the travel
time would be substantially less and most areas of the state will be within two to three hours by car to a pediatric open heart surgery center.
Geographical location was one of the factors considered in the establishment of the Service Areas. However, the need to insure an adequate volume of cases for each program was an overriding concern.
While it is certainly desirable to minimize travel and distance for pediatric patients as much as possible, these concerns must be counterbalanced against the need to insure that each center performs enough procedures to maintain proficiency. The evidence was insufficient to establish that HRS was arbitrary and/or capricious in dealing with these sometimes conflicting goals.
WHETHER SUBPARAGRAPH 4.c. OF THE PROPOSED AMENDMENT REQUIRING TEAM MOBILI- ZATION FOR EMERGENCY OPERATIONS WITHIN A MAXIMUM WAITING PERIOD OF TWO HOURS IS CONTRARY TO THE EXCLUSION OF A TRAVEL TIME STANDARD FOR PEDIATRIC OPEN HEART.
As indicated above, there is no travel time standard for pediatric open heart surgery in the Proposed Amendments. There is, however, a requirement that a hospital be able to mobilize an open heart surgery team within a maximum time limit of two hours. Proposed Rule 10-5.011(1)(f)4.
The purpose of the team mobilization standard is to assure rapid mobilization within the hospital once the baby has arrived at the hospital. This requirement is contained in the existing open heart rule and no adverse public comment was received regarding it.
St. Mary's contends that having a two hour team mobilization standard for pediatric open heart surgery but no travel time standard for pediatric patients is inconsistent and reflects a disregard for pediatric accessibility or geographic accessibility. This criticism is rejected. The emergency mobilization standard addresses the applicant facility's ability to render emergency open heart surgery services subsequent to a patient's arrival at the facility. It is an internal requirement. A travel time standard addresses the extent to which the Service Area population has access to services. It is a requirement external to any specific hospital. For the reasons set forth in Findings of Fact 57-60 above, a travel time standard is not appropriate for pediatric open heart programs. However, these reasons do not negate the benefits of an emergency mobilization standard.
WHETHER SUBPARAGRAPH 4.d. OF THE PROPOSED AMENDMENT IS INVALID BECAUSE HRS IS WITHOUT STATUTORY AUTHORITY TO REQUIRE APPLICANTS TO DOCUMENT HOW OPEN HEART WILL BE MADE AVAILABLE TO ALL PERSONS IN NEED.
The existing rule mandates that open heart surgery be available to all persons in need regardless of the ability to pay. This provision remains intact in subparagraph 4.d. of the amended rule, but is clarified in part as follows:
Applicants for adult or pediatric open heart surgery programs shall document the manner in which they will meet this requirement.
HRS currently requires evidence of an applicant's past record with regard to Medicaid and indigent care, as well as statistical projections for the provision of such care upon implementation of its program. In fact, the language added to paragraph 4.d. simply reflects the Department's existing method of reviewing CON applications pursuant to the guidelines of Section 381.705, Florida Statutes, which requires consideration of an applicant's past and proposed provision of health care services to Medicaid patients and the medically indigent.
Section 381.704(4), Florida Statutes (1989) gives HRS the authority to adopt rules necessary to implement Sections 381.701-381.715. Section 381.705, Florida Statutes (1989) requires HRS to review certificate of need applications in context with "(n) The applicant's past and proposed provision of health care services to Medicaid patients and the medically indigent," "(h)... the extent to which the proposed services will be accessible to all residents of the service district", and "(b) the ... accessibility of like and existing health care services and hospices in the service district of the applicant." The Petitioners have not established any inconsistencies between the Proposed Amendments and the statutory standards of review.
WHETHER PARAGRAPH 5 OF THE PROPOSED AMENDMENT, SERVICE QUALITY STANDARDS, IS ARBITRARY AND CAPRICIOUS BECAUSE THE STANDARDS ARE UNRELATED TO PEDIATRIC OPEN HEART.
The standards contained in Subsection 5 are minimum quality of care standards which apply to programs providing pediatric as well as adult open heart surgery. These requirements do not significantly change the existing rule. St. Mary's suggested that the standards were only applicable to an open heart program servicing adults and that pediatric programs should have different standards. No persuasive evidence was provided to establish that any of the requirements are unrelated or unnecessary to pediatric open heart programs. In fact, St. Mary's own witness, Dr. Bryon, testified that he had no objection to the provisions of paragraph 5.
WHETHER PARAGRAPH 7 OF THE PROPOSED AMENDMENT IS INVALID BECAUSE IT DOES NOT PROVIDE AN OPPORTUNITY TO DEMONSTRATE "NOT NORMAL" CIRCUMSTANCES.
Subparagraph 7b of the proposed rule amendments establishes a need determination formula. Application of this formula is governed by minimum volume and utilization standards established under subparts a and c of paragraph 7.
Subparagraph 7e of the proposed amendments provides as follows:
a. A new adult open heart surgery program shall not normally be approved in the HRS District if any of the following conditions exist:
There is an approved adult open heart surgery program in the HRS District;
One or more of the operational adult open heart surgery programs in the HRS District that were operational for at least twelve months as of six months prior to the beginning date of the quarter of the publication of the fixed need pool performed less than 350 adult open heart surgery operations during the twelve months ending six months prior to the beginning date of the quarter of the publication of the fixed need pool; or,
One or more of the adult open heart surgery programs in the HRS District that were operational for less than twelve months during the twelve months ending six months prior to the beginning date of the quarter of the publication of the fixed need pool performed less than an average of 29 adult open heart surgery operations per month.
* * *
(c) Regardless of whether need for a new adult open heart surgery program is shown in subparagraph b. above, a new adult open heart surgery program will not normally be approved for an HRS district if the approval would reduce the 12 month total at an existing adult open heart surgery program in the HRS district below 350 open heart surgery operations. (emphasis added)
The need determination formula includes a presumption against approval of a new provider if there is already an approved program within a district, or any existing program within a district is operating at less than 350 procedures annually. HRS has recognized that the need determination formula cannot take into account all factors within a district which may affect actual need. Accordingly, the rule implicitly allows consideration of "not normal" circumstances in determining need. If circumstances are "normal", then a failure to satisfy the conditions in paragraph 7 will mean that the application is denied. However, by proving that circumstances are "not normal", a new adult open heart surgery program can be approved despite the failure to satisfy the conditions in paragraph 7.
The "not normal" provision is also found in the statement of Departmental Intent, subparagraph 1 of the Proposed Amendments. That provision proclaims that an application will "not normally" be approved unless the applicant meets relevant statutory criteria, including the standards and need determination criteria.
HRS perceived its current rule and the Proposed Amendments as providing applicants with the opportunity to demonstrate need for a new adult open heart surgery program by demonstrating numeric need under paragraph 7 or by demonstrating "not normal" circumstances. HRS can and will approve an application in the absence of quantified need where the other statutory review
criteria are met and the applicant demonstrates that a need for a new program exists.
The current rule provides a similar presumption against approval if there is already an approved program in the district, or if any existing program in the district is operating at less than 350 procedures annually. This rule has been interpreted to allow applicants to demonstrate actual need by demonstrating circumstances that transcend the numeric calculation. For example, an open heart program was recently approved by HRS for Marion County even in the absence of numeric need as determined by the rule.
It is impossible to list all of the circumstances where a new program could be approved even in the absence of "numeric need." Examples of not normal circumstances include a showing of inaccessibility, excessive utilization of a particular facility, or an intentional action by an existing provider to keep its utilization below 350 annual procedures. Other factors may include exceptional circumstances as they relate to the review criteria listed in Section 381.705, Florida Statutes, evidence of an unusual payor mix, established referral patterns among existing providers, or evidence to suggest that an existing program could not reach the 350 minimum procedure volume because of poor quality of care.
In sum, Paragraph 7 of the Proposed Amendments does not preclude an applicant from attempting to demonstrate that its application should be approved in the absence of quantified need. The "not normally" language will enable HRS to consider all the statutory review criteria in its review of applications even in the absence of numeric need under paragraph 7.
The Petitioners challenging the "not normal" language in paragraph 7 of the Rule have failed to provide any credible evidence to demonstrate that the "not normal" provisions are arbitrary or capricious or unduly vague. Similar provisions have been upheld in prior cases. See, Humana, Inc., v. Department of Health and Rehabilitative Services, 469 So.2d 889, 891, (Fla. 1st DCA, 1985); North Broward Hospital District v. Department of Health and Rehabilitative Services, DOAH Case No. 86-1186R (Final Order issued July 18, 1988.)
WHETHER SUBPARAGRAPH 7.a. IS INVALID FOR THE FOLLOWING REASON:
Existing programs could block a proposed program by keeping the number of open heart operations performed in a given year below 350.
As indicated above, the Proposed Amendments provide that a new adult open heart surgery program will not normally be approved in a service district if any of the existing programs in the district performed less than 350 adult open heart surgery operations during the 12 months ending 6 months prior to the beginning date of the quarter of the publication of the fixed need pool.
The challengers claim that the Proposed Amendments to paragraph 7a are invalid because they allow existing programs to bar approval of new programs by keeping their volume below 350. This issue was considered by HRS in its rule amendment promulgation deliberations. No evidence was presented during those deliberations or at the hearing in this cause that there has been a deliberate attempt by any existing provider to keep the number of operations performed below 350 per year. Indeed, such an attempt is unlikely because it would
require physicians to intentionally turn away patients requiring open heart surgery when a facility's numbers reach close to 350 operations on an annual basis.
The existing rule has a similar provision. As discussed in more detail below, a Section 120.56 rule challenge was filed in 1987 against this provision in the existing rule alleging the possibility that an existing provider could block a proposed adult open heart surgery program by deliberately keeping its annual adult open heart surgery volume below 350 cases. These charges were rejected as speculative and unsubstantiated. St. Mary's Hospital
v. Department of Health and Rehabilitative, 9 F.A.L.R. 6159, DOAH Case No. 87- 2729R.
The Proposed Amendments would not prohibit the award of a CON if a deliberate pattern or scheme to keep volume low to lockout new providers was demonstrated.
Because it protects market share which is anticompetitive and contrary to statute; is unconstitutional in that it denies equal protection and due process, and because it is contrary to agency policy through 1989.
Paragraph 7.a. of the Proposed Amendments is based upon a substantially similar provision found in the National Guidelines. The National Guidelines were adopted by the Federal Department of Health, Education and Welfare following an extensive consultation and review process in 1978. The National Guidelines are one of the key resource materials used by local and state health planning agencies in developing certificate of need regulations. The state of Florida conforms to the National Guidelines in most areas.
According to the National Guidelines, a new open heart program should not ordinarily be approved if an existing program is operating at less than 350 operations annually. Specifically, Section 121.107(3) of the "Rules and Regulations" of the National Guidelines, entitled "Open Heart Surgery" published at Vol. 43, No. 60 of the Federal Register, provides at page 262:
There should be no additional open heart units initiated unless each existing unit in the health service area(s) is operating and is expected to continue to operate at a minimum of 350 open heart surgery cases per year in
adult services or 130 pediatric open heart cases in pediatric services.
According to the "Discussion" at Section (b) of the Rules and Regulations for open heart surgery in the National Guidelines:
In order to prevent duplication of costly resources which are not fully utilized, the opening of new units should be contingent upon existing units operating, and continuing to operate, at a level of at least 350 procedures per year. (emphasis added)
The 350 service volume requirement has been a part of HRS' open heart surgery certificate of need rule since its adoption in 1982.
As discussed in more detail below, there is a substantial body of literature which concludes that there is a relationship between volume and outcome in the provision of adult open heart surgery services. The literature contains data which demonstrates that, as a general rule, hospitals which provide higher volumes of adult open heart surgery cases achieve better patient outcomes.
Based upon this research, the optimum efficiency standard, both from quality of care and economy of scale perspective, is believed to be approximately 500 procedures per year.
The 350 minimum volume standard reflects HRS' desire that each existing and approved facility be operating at 75% of this optimum standard before any additional programs are approved within an HRS District.
The 350 standard assumes that each facility can provide an average of seven operations per week, a schedule judged to be feasible in most institutions which provide open heart surgery services. As a matter of health planning policy, HRS adopted the 350-standard in an effort to prevent duplication of costly services which are not fully utilized, both as to facility resources and manpower. This standard is intended to assure both quality of care and efficiency in the operations of adult open heart surgery programs.
For several years after the rule was originally adopted in 1982, the rule was interpreted by HRS to require a showing that each existing program was at or above 350 procedures annually before a new program could normally be approved. However, as discussed below, sometime around 1984 or 1985, HRS began "interpreting" the 350 standard to be an average, i.e., the average utilization of all existing programs in a district had to be at or above 350 before a new program would normally be approved.
From approximately early 1985 through January 22, 1990, HRS interpreted the existing rule in accordance with the "averaging method". This averaging method allowed HRS to find numeric need when the average total of procedures per program in the district equaled 350 or more.
In 1987, a Section 120.56 rule challenge was brought against the then existing open heart rule. In that case, the 350 standard was directly attacked as being too high as a minimum procedure threshold.
In the 1987 challenge to the open heart rule, HRS explained the rule utilizing the averaging approach. St. Mary's Hospital v. Department of Health and Rehabilitative Services, supra, 9 FALR at 6174. HRS witness Elfie Stamm testified during that hearing in support of the rule as it was being interpreted at that time. Extensive testimony was presented regarding the 350 standard. It is not clear whether any of the parties challenged the averaging approach as part of that case. Ultimately the rule, including the 350 standard was, upheld. The Final Order presumes that the averaging approach would be used and does not specifically address the validity of that approach.
None of the Petitioners in this case have provided persuasive evidence that the 350 standard has become obsolete or inappropriate. Indeed, as discussed in more detail below, the evidence indicates that the 350 standard is still the most widely accepted standard.
During 1989, several Orders were entered by the Division of Administrative Hearings rejecting HRS' interpretation that the existing rule permitted the averaging method.
In Lakeland Regional Medical Center v. HRS, 11 FALR 6463 (DOAH Final Order November 15, 1989), a hearing officer declared the HRS "averaging policy" to be inconsistent with the language of the existing rule and an invalid exercise of delegated legislative authority because it had not been adopted in accordance with Section 120.54, Florida Statutes.
In a subsequent 120.57 proceeding involving the proposed issuance of a CON for a new open heart surgery program, the Recommended Order rejected HRS' averaging policy and concluded that it could not be applied because it was inconsistent with the existing rule. Hillsborough County Hospital Authority v. HRS, 12 FALR 785 (Final Order, January 23, 1990). In the Recommended Order in the Hillsborough County case, the hearing officer did not address the relative merits of the averaging policy versus the each and every method. He found that "the incipient policy constitutes an impermissible deviation from the terms of an existing rule and cannot be used in this proceeding. In view of this conclusion, it is unnecessary to determine whether an adequate record foundation exists to support that [averaging approach]."
Although HRS had argued in favor of the averaging policy at the hearing in the Hillsborough County case, the Secretary of HRS in his Final Order in that case accepted the "each and every" interpretation declaring that "it is good health planning to allow newly approved providers to become operational and reach the 350 procedure level as soon as possible and before new programs are authorized." Id. at 787.
In subsequent final orders on other open heart surgery CON applications, HRS has followed this original interpretation of its existing open heart surgery rule and agreed that, as written, the rule requires that the 350 standard be met by each existing and approved facility before a new program can normally be approved. See, Mease Health Care v. Department of Health and Rehabilitative Services, 12 FALR 853 (Final Order dated January 23, 1990); Humana of Florida, Inc. d/b/a Humana Hospital Lucerne v. Department of Health and Rehabilitative Services and Central Florida Regional Hospital Inc. d/b/a Central Florida Regional Hospital. 12 FALR 823 (Final Order dated January 23, 1990), reversed on other grounds 16 F.L.W. 1515 (Fla. 5th DCA 1991); Hospital Development and Services Corporation d/b/a Plantation General Hospital v. Department of Health and Rehabilitative Services, 12 FALR 3462 (Final Order dated July 27, 1990.)
In sum, since January, 1990, the Department has abandoned its former policy of averaging utilization on a district-wide basis and applied the Rule literally to require that "each and every" facility perform the required threshold number of procedures before a new program will normally be approved.
HRS uses the averaging method to determine need for other programs such as cardiac catheterization, nursing homes, rehabilitation services, psychiatric and substance abuse services, and neonatal intensive care.
The challengers contend that it is arbitrary for HRS to use an averaging approach to determine numeric need for some services and not use it for open heart programs. The mere fact that an averaging approach is used for other services does not in and of itself establish that HRS is acting arbitrarily in refusing to follow that approach with open heart surgery
programs. The evidence established that HRS treats open heart surgery services differently because the existing research indicates a direct tie between volume and outcome. HRS has not found a similar demonstrated connection between volume and outcome in any of those other services. In fact, in certain of those services, such as psychiatric care, the volume/quality of care correlation may be a negative one.
The Proposed Amendments do not change the 350 standard in the existing rule, except in the case where an existing program has been operational for less than a year. Whereas the existing rule would not normally authorize a new program before an existing program is providing 350 procedures per year, the Proposed Amendments relax the standard by allowing a new program to be approved if a program that has been operational for less than one year achieves an average monthly volume of 29 operations.
The challengers contend the Proposed Amendments to paragraph 7a are anticompetitive and serve to protect the market shares of existing providers. To the contrary, the more persuasive evidence indicates that the purpose of the
350 standard is not to thwart competition, but, rather, to ensure quality care and efficiency. The Petitioners did not establish that the 350 standard is inappropriate or does not tend to promote quality and efficient care. Without a doubt, HRS' conclusions and the Proposed Amendments reflect a preference for large volume open heart surgery providers and consequently serve to restrict new providers from entering the market. As set forth below, this preference is supported by the existing research in this area.
While the correlation between large volume and quality of care is not absolute, the evidence did not demonstrate that HRS has acted arbitrarily in adopting a policy which is aimed at encouraging all open heart programs an opportunity to grow to the 350 level.
HRS has adopted a rule designating adult open heart surgery as a tertiary health service. See, Rule 10-5.002(66)8. (previously 5.002(41)8,) Florida Administrative Code. A tertiary health service is defined in Section 381.701(20), as follows:
"Tertiary health service" means a health service which, due to its high level of intensity, complexity, specialized or limited applicability, and cost, should be limited to, and concentrated in, a limited number of hospitals to ensure the quality, availability, an cost-effectiveness of such service.
To the extent that the 350 standard may work in some instances to favor greater use of existing providers over approval of a new competitor, that result is consistent with the nature of open heart surgery services as a tertiary health service.
There is no question that several existing adult open heart surgery programs, including the programs of some of the intervenors in this case who are defending the Proposed Amendments, were approved after numeric need was found using the averaging policy. In many, if not all of those cases, need would not have been found if the "each and every" approach was used. See, Central Florida Regional Hospital, Inc. v. Department of Health and Rehabilitative Services, 16
F.L.W. 1515 (Fla. 5th DCA 1991). The challengers contend that they are being denied equal protection and/or that the "each and every" approach is being used
to protect existing providers. As indicated above, the Petitioners have not established that the standards set forth in the National Guidelines are obsolete or inappropriate. The evidence of record in this case was insufficient to conclude that HRS is acting arbitrarily by reenacting standards that are consistent with the National Guidelines. HRS' temporary application of the averaging approach was not consistent with the language of the existing rule or the original interpretation given to the rule by HRS at the time it was adopted. While no evidence was presented that quality of care diminished during the period of time the averaging approach was used, HRS' policy decision to return to standards established in the National Guidelines can not be characterized as arbitrary and capricious.
The research contained in the HRS 1988 and 1989 rule promulgation files supports the 350 standard as set forth in Paragraph 7.a. of the Proposed Rule. Most of this research indicates that there is a strong correlative relationship between the volume of open heart surgery performed by a program and the resulting quality of care, both in terms of morbidity and mortality. Specifically, studies performed by Dr. Harold Luft, suggest a relationship between volume of procedures and quality of care. The Luft studies suggest that mortality and morbidity tend to increase as a percentage of total procedures performed when volume is reduced. In contrast, morbidity and mortality tend to decrease as the annual number of procedures is increased. The Challengers have presented no persuasive evidence to rebut these studies.
Given the undisputed relationship between the quality and economic efficiency of an open heart surgery program and its volume, HRS reasonably concluded that it is sound health planning policy to normally allow approved providers to achieve and sustain the 350 procedure level before new programs are authorized.
The Work Group which assisted in the development of the Proposed Rule Amendments addressed the "each and every" versus "averaging" approach to the 350 standard. Representatives of hospitals which do not offer open heart surgery services were in attendance at the Work Group. No member of the Work Group presented evidence to support the "averaging" approach to the 350 standard nor was any evidence presented to rebut the data contained in the Luft studies.
The evidence presented at the hearing in this matter did not establish that the "averaging approach" would in any way improve or contribute to quality assurance. Indeed, it could lead to problems in districts with established high volume open heart surgery providers. For example, if one provider in a service district performs 600 cases and another performs 100 cases, the service district would meet a "350" average standard However, the lower volume provider would be operating at well below the minimum necessary to insure quality of care. In other words, using an averaging approach, need could be found in a district containing an extremely low volume provider, which would probably inhibit the ability of the struggling existing provider to raise its service volume and could be detrimental to the overall quality of care in the district.
The National Guidelines and Intersociety Study establish a minimum quality of care threshold at 200 annual procedures per open heart team. The existing rule provides, under the heading "Service Quality" for a "Minimum Service Provision" which requires 200 procedures to be performed annually within
3 years of initiation of service by an open heart program. Rule 10- 5.011(1)(f)5.d., Florida Administrative Code. The 200 procedure requirement was
intended to ensure that a new program would operate at a minimum quality of care level. The Proposed Amendments delete this requirement.
The challengers contend that HRS is inappropriately substituting the
350 procedure requirement contained in the Proposed Amendments as a new quality of care standard to be applied to open heart programs. The 350 standard is not intended by HRS to be a per se indicator of quality of care, nor is it intended to create a presumption that a program operating below 350 annual procedures provides poor quality of care.
While the Petitioners claim that the 350 requirement in the National Guidelines was primarily an economic efficiency provision and was not a quality of care issue, the evidence indicates that the 350 standard was developed with both quality of care and efficiency in mind. Efficiency standards are important to allow a program to be doing enough operations to justify the staffing ratios, the inventory of supplies, and the utilization of the rooms themselves. While the challengers believe that the 350 standard is too high, the evidence was insufficient to establish that there is a more reasonable figure let alone that HRS' reliance upon the National Guidelines was arbitrary.
Approximately seven districts would have shown need for a new program in 1993 if an averaging approach was used. However, under the "each and every" interpretation, HRS found there to be zero program need.
The challengers point out that HRS has no authority to revoke a CON for a hospital operating an open heart surgery program with a low service volume. They contend that, due to referral patterns, quality of care problems, a shift in demographics, or similar reason, a hospital may be unable to generate a volume of 350 procedures which could preclude the addition of a new program even if there is a need in the district.
The calculation of numeric need is only one of many criteria which the Department is required to consider under Section 381.705, Florida Statutes when reviewing applications for open heart surgery certificates of need. The Health Facility and Services Department Act sets forth many criteria which the department must consider when making a determination on an application for certificate of need including its need for the proposal, the existing availability of the proposed service of facility, the impact of the proposal on the cost of providing the service, and the quality of care provided by existing providers and proposed by the applicant. These criteria are consistent with the statutory aim as expressed in Title 42 - Public Health, Chapter 1 Public Health Service, Department of Health, Education and Welfare, Part 121 - National Guidelines for Health Planning which provides:
"Equal access to quality health care at a reasonable cost ... Cost savings may be achieved without sacrificing the quality of or access to care through more efficient utili- zation of existing resources and increased emphases on ambulatory and community services. Moreover, limitations of certain resources, such as open heart units, can lead to improve- ments in the quality of care while at the same time containing costs." Federal Register, Vol. 43, No. 60., page 254.
It is important to keep in mind that the 350 standard does not prohibit the approval of a new open heart program if an existing program in the district does not meet this standard. The proposed amendments, as well as existing HRS policy, simply provide that an application for a new program will "not normally" be approved. In other words, the burden of showing need for a new program is shifted to the applicant.
The challengers contend that acquiring a CON when there is no numeric need calculated in accordance with the rule is next to impossible. Without question, an applicant's burden in such a situation would be substantially more difficult. However, the evidence does not support the contention that such approval is impossible.
In conclusion, the 350 standard is a reasonable threshold criterion to presume need under normal circumstances. It is neither anti-competitive nor unconstitutional to require an applicant to allege and demonstrate the existence of not normal circumstances to overcome this presumption.
Because no new program can be added when there is an outstanding approved but yet operational program in existence which could take an undue amount of time coming on line thereby preventing the approval of a new program.
The challengers claim that requiring approved programs to become operational before a new program will normally be approved is unreasonable because of the length of time it could take for a newly approved program to come on line. HRS is generally aware of the length of time it takes an approved program to become operational. HRS reasonably resolved the balance of competing considerations by deciding that it should not approve a second new program in a district while there is still an approved program that has not yet become operational. HRS has concluded that it is preferable to allow programs to grow to a volume of 350 annual operations to assure quality and efficiency before adding a new program. The challengers have not established that this decision was arbitrary or that it would be in any way beneficial to allow simultaneous development of two or more adult open heart surgery programs within a service district.
There are time restrictions on the implementation of a newly approved program and HRS has authority to void a CON when those restrictions are not met. See, Rule 10-5.018(2), Florida Administrative Code. Approved providers may not simply retain their CONs for open heart surgery services indefinitely without implementing them. If for some reason an approved program failed to commence operations within a reasonable time to the point of creating problems of service accessibility, an applicant could raise this issue as a "not normal" circumstance.
The provision in the Proposed Amendments which would normally prevent approval of a new program when there is an outstanding approved but not yet operational program in existence is consistent with HRS' interpretation of the existing rule.
WHETHER SUBPARAGRAPH 7.b OF THE PROPOSED AMENDMENT IS ARBITRARY AND CAPRICIOUS BECAUSE ONLY ONE NEW PROGRAM CAN BE APPROVED AT A TIME.
Paragraph 7.b. of the Proposed Amendments provides that even where the numeric need calculation results in a projected need for more than one new adult open heart program, only one new program per service district may be approved in a given batching cycle. The only evidence presented concerning this issue was the testimony of Ms. Stamm, who asserted that the practice of approving one program at a time ensures that only one new provider will compete with established facilities within a service district and that a new program will have an opportunity for rapid start-up growth in order to reach a safe volume level in a short period of time. By limiting approval to only one new program per planning horizon, the volume and quality of care at existing programs is protected and the continued viability of new providers is assisted. The challengers claim that this provision is arbitrary and capricious because it could prevent the approval of a new open heart surgery program even when numeric need, as determined by the Rule, is present. However, as indicated above, the calculation of numeric need is based upon desired, not maximum levels of operation. Thus, even if numeric need is shown in accordance with the Rule, a new program is not automatically required. Petitioners have not established that HRS' balancing of the conflicting concerns on this issue was arbitrary or capricious.
The requirement that only one new program be approved at a time is consistent with HRS' interpretation of the existing rule.
WHETHER PARAGRAPH 8 IS ANTICOMPETITIVE, UNDULY RESTRICTIVE, ARBITRARY AND CAPRICIOUS.
Paragraph 8 of the Proposed Amendments sets forth a new quantitative need formula for pediatric open heart surgery services programs. It provides:
8.9. Pediatric Open Heart Surgery Program Need Determination. The need for pediatric open heart surgery programs shall be deter- mined on a regional basis in accordance with the pediatric open heart surgery program service areas as defined in sub-subparagraph
2.1. A new pediatric open heart surgery program shall not normally be approved unless the total of resident live births in the pediatric open heart surgery service area, for the most recent calendar year available from the department's Office of Vital Statistics at least 3 months prior to publication of the fixed need pool, minus the number of existing and approved pediatric open heat surgery programs multiplied by 30,000, is at or exceeds 30,000.
The 30,000 live birth standard is based upon and consistent with the standards adopted by the American Academy of Pediatrics, Section on Cardiology, for use by health planning agencies and health service organizations to evaluate existing pediatric cardiac centers and to establish the need for the development of new centers.
The 30,000 live birth standard is set forth in the "Guidelines for Pediatric Cardiology, Diagnostic and Treatment Centers," published in Volume 62, No. 2, American Academy of Pediatrics (1978) (the "Pediatric Guidelines").
Those guidelines were updated in 1990 and the 30,000 live birth standard was
retained in the updated version. The Pediatric Guidelines, like the National Guidelines, is a well-respected and readily available research tool that health planners customarily rely upon in evaluating the need for health care programs.
The 30,000 live birth standard is also contained in the HRS Children's Medical Services administrative rules and this methodology is consistent with the minimum service volume standards found in the National Guidelines.
Unlike the methodology utilized to project need for adult open heart surgery programs, the methodology proposed to project need for pediatric open heart surgery does not utilize a "use rate." This pediatric need methodology assumes a constant use rate and attributes increased need to population growth. St. Mary's argues that the 30,000 live birth standard should not be utilized because the incidence rate of pediatric open heart surgery (the number of procedures per 30,000 births) may change and the standard does not take into account such changes which could be based on advances in medicine, etc. This criticism is highly speculative and does not provide a basis for rejecting the 30,000 live birth standard. While the use rate for adult open heart surgery has generally increased since the open heart rule was adopted in the early 1980s, there is no evidence that the use rate for pediatric open heart surgery programs has increased.
St. Mary's contends that the 30,000 live birth standard only takes into account the pediatric population in the neonatal or newborn time period. However, this contention was not supported by the evidence.
The 30,000 live birth standard assumes that in the years prior to attaining 30,000 live births, a service area experienced something less than 30,000 live births each year and will experience approximately 30,000 live births in subsequent years, so that an age pyramid is building. The Florida data indicates that if this standard is applied over 14 years, approximately 75 pediatric open heart surgery cases per year would be generated based upon multiple years of approximately 30,000 volume base. Approximately 100-130 cases can be expected if the age cohort is increased to 21.
St. Mary's proposed an alternative methodology based upon comments appearing in an article titled "Trends in Cardiac Surgery" from the Journal of Thoracic and Cardiovascular Surgery, 1980. That article suggested that a 380,000 pediatric population base from age 0-14 can be expected to generate 75 pediatric open heart surgery operations. Utilizing the 1970 United States age mix, which indicates that 27.5 percent of all persons are under the age of 14, St. Mary's suggests that the 380,000 pediatric population should be grossed up to a 1.38 million total population base and this total population figure is an appropriate standard for determining when to add a new pediatric program.
Serious questions were raised regarding the validity of St. Mary's proposed standard. For example, it appears that the age mix in Florida is significantly different than the age mix figures used by St. Mary's. In sum, the evidence did not establish that St. Mary's proposed standard was more appropriate to use, let alone that HRS acted arbitrarily in adopting the 30,000 live birth standard. Indeed, the evidence established that the 30,000 live birth standard employed in the Proposed Amendments as a basis to project need for pediatric open heart surgery programs is a reasonable basis upon which to plan for pediatric open heart surgery programs.
WHETHER THE PROPOSED AMENDMENT PROHIBITS AN APPLICANT FROM APPLYING FOR BOTH PEDIATRIC AND ADULT OPEN HEART SURGERY AND FOR THAT REASON IS INVALID.
Proposed Rule 10-5.011(1)(f)1. states that providers must apply for separate certificates of need for adult and pediatric open heart surgery programs. The existing rule does not expressly state that separate certificates of need are necessary. However, Rule 10-5.008(1)(a), Florida Administrative Code, requires separate letters of intent for each type of service having a separate need methodology, even if the projects are within the same facility. Thus, separate applications are necessary under both the present rule and the proposed amendments because a separate need methodology is stated in both.
As discussed above, the Proposed Amendments do not prohibit an applicant from applying for a certificate of need for pediatric open heart surgery services and adult open heart surgery services simultaneously.
WHETHER THE PROPOSED AMENDMENT IS ARBITRARY AND CAPRICIOUS BECAUSE IT DOES NOT SET FORTH A MINIMUM NUMBER OF MIXED PEDIATRIC AND ADULT OPERATIONS WHICH MUST BE PERFORMED IN A MIXED PROGRAM AS A PREDICATE TO THE AWARD OF ANOTHER ADULT PROGRAM.
Neither the existing rule nor the Proposed Amendments to the rule specifically address the minimum number of annual operations which must be performed in a "mixed" program before an additional adult program may be added. Thus, any "mixed" adult/pediatric open heart surgery program would have to be performing at least 350 adult procedures before there would be a calculated need for an additional adult open heart program in the district. St. Anthony's argues that this requirement should not apply to "mixed" programs and/or that a lower volume standard should have been adopted for hospitals that operate "mixed" programs.
There is considerable confusion as to how to define a "mixed" program. St. Anthony's contends that a "mixed" open heart surgery program is any program that provides open heart surgery services to both adult and pediatric patients.
HRS contends that if the programs are separately organized and staffed, the fact that a hospital has both programs is irrelevant to assessing the appropriate volume capacity. HRS considers a "mixed program" as one in which a single team is performing both pediatric and adult open heart surgery. Under this view, a hospital can have both an adult open heart surgery program and a pediatric open heart surgery program without necessarily being considered a "mixed" program. Applying this definition, there is apparently only one program in the state which is a "mixed" program. That program is located at Bayfront/All Children's Hospital.
St. Anthony's contends that there are other programs in this state that offer both pediatric and adult open heart surgery. However, the evidence was insufficient to establish that any of these other programs meets the HRS definition of a mixed program.
St. Anthony's cites to a provision in the National Guidelines which provides that the minimum number of open heart surgery procedures that should be
performed in a "mixed" program is 200, of which 75 should be for children. However, HRS has reasonably concluded that this provision in the National Guidelines was not intended to establish a threshold for the addition of a new adult program. The studies which were the source of this provision did not attempt to address the number of procedures that should be performed in a "mixed" program before a new adult program should be awarded.
In view of the extremely small number of "mixed" programs and the lack of clear evidence regarding the optimal number of procedures that should be performed in such programs, HRS has elected to not address "mixed" programs in the existing rule or the Proposed Amendments. For a true "mixed" program, it may not be reasonable or desirable to expect 350 adult surgeries per year. However, the available data is inconclusive and St. Anthony's has not presented persuasive evidence of a more realistic number. Thus, HRS' decision to not adopt a rule of general applicability to address this issue, is not arbitrary or capricious. An applicant in a district with a "mixed" program that is not performing 350 adult procedures per year can apply on a "not normal" basis.
WHETHER THE PROPOSED AMENDMENTS ARE INVALID BECAUSE HRS HAS FAILED TO PREPARE A DETAILED ECONOMIC IMPACT STATEMENT, AN ESTIMATE OF THE IMPACT ON COMPETITION, OR DETAILED STATEMENT OF THE DATA AND METHODOLOGY USED IN MAKING THE PROPOSED RULES, THE FAILURE
OF WHICH IMPAIRED THE CORRECTNESS OF THE ACTION TAKEN BY THE AGENCY.
Section 120.54(2), Florida Statutes, requires the Department to prepare an Economic Impact Statement (EIS) containing the economic impact of the proposed rule on all persons directly affected.
HRS assessed the economic impact of its proposed amendments and concluded that there would be no impact because the proposed amendments do not change the projected need for either adult or pediatric programs.
As discussed in more detail above, the Proposed Amendments clarify that the 350 target volume must be achieved by each and every existing and approved program before a new program will be approved. The existing rule has been interpreted to require the same thing. While HRS followed an averaging interpretation for a period in the past, that interpretation has been rejected in a series of final orders. Since the averaging interpretation was deemed invalid before these Proposed Amendments, the Proposed Amendments do not change the way need is assessed under the existing rule. Thus, there is no economic impact by reason of the inclusion in the Proposed Amendments of the 350 standard. Likewise, the new methodology for calculating need for pediatric open heart surgery does not change the calculations made under the existing rule.
None of the other changes to the existing rule have been shown to have a significant impact on existing providers or applicants.
None of the challengers showed that they are able to obtain an economic benefit now that they will be deprived of under the rule as amended nor have they demonstrated any prejudice by reason of HRS' conclusion that the Proposed Amendments would not have an adverse economic impact.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction of the subject matter and the parties hereto pursuant to Subsection 120.54(4), Florida Statutes.
The parties stipulated that all Petitioners have standing to challenge the proposed rule amendments. In addition, the parties stipulated that the Intervenors had standing to intervene in the respective cases except St. Mary's argued that, because JFK does not have a pediatric open heart surgery program, JFK should not be allowed to present evidence in support of the pediatric portions of the challenged amendments. That argument was rejected at the hearing.
Pursuant to Section 120.54(4)(a):
Any substantially affected person may seek an administrative determination of the invalidity of any proposed rule on the ground that the proposed rule is an invalid exercise of delegated legislative authority.
A proposed rule is an "invalid exercise of delegated legislative authority" if any one or more of the following apply:
The agency has materially failed to follow the applicable rule-making procedure set forth in Section 120.54;
The agency has exceeded its grant of rule-making authority, citation to which is required by Section 120.54(7);
The rule enlarges, modifies, or contra- venes the specific provisions of law imple- mented, citation to which is required by Section 120.54(7);
The rule is vague, fails to establish adequate standards for agency decisions or vests unbridled discretion in the agency; or
The rule is arbitrary or capricious.
Section 120.52(8), Florida Statutes.
As set forth in Agrico Chemical Co. v. State Department of Environmental Regulation, 365 So. 2d 759 (Fla. 1st DCA 1978), cert. denied, 376 So.2d 74 (Fla. 1979):
...[I]n a 120.54 hearing, the hearing officer must look to the legislative authority for the rule and determine whether or not the proposed rule is encompassed within that grant. The burden is upon one who attacks the proposed rule to show that the agency, if it adopts the rule, would exceed its authority; that the
requirements of the rule are not appropriate to the ends specified in the legislative act;
that the requirements contained in the rule are not reasonably related to the purpose of the enabling legislation or that the proposed rule or the requirements thereof are arbitrary or capricious.
* * *
The requirement that a challenger has the burden of demonstrating agency action to be arbitrary or capricious or an abuse of administrative discretion is a stringent one indeed. 365 So.2d at 763.
The various standards for applying Section 120.52(8) have been established by case law. A rule is vague or fails to establish adequate standards for agency decisions when its terms are so vague that persons of common intelligence must necessarily guess at its meaning and differ as to its application. State v. Cumming, 365 So.2d 153 (Fla. 1978). A rule vests unbridled discretion in an agency when it fails to establish adequate standards and reserves to the agency the arbitrary power to determine private rights. Barrow v. Holland, 125 So.2d 749 (Fla. 1960).
When challenging a rule as "arbitrary or capricious", a petitioner must demonstrate by a preponderance of the evidence that it is not supported by fact or logic, was adopted without thought or reason, or is otherwise not based upon competent, substantial evidence. Humana, Inc., d/b/a Cypress Community Hospital v. Department of Health and Rehabilitative Services, 469 So.2d 889 (Fla. 1st DCA 1985). See, Adam Smith Enterprises v. Florida Department of Environmental Regulation, 553 So.2d 1260, 1274 n.23 (Fla. 1st DCA 1989). Arbitrary and capricious actions were defined in Agrico, supra, as follows:
A capricious action is one which is taken without thought or reason or irrationally.
An arbitrary decision is one not supported by facts or logic, or is despotic.
In Department of Health and Rehabilitative Services v. Framat Realty, Inc. 407 So.2d 238 (Fla. 1st DCA 1981), the court reversed a hearing officer's order invalidating a rule as beyond the department's statutory authority. In reversing, the court made clear that administrative rules must be upheld as long as the rule is within the range of permissible interpretations of the statute, and that it is inappropriate to go further to investigate whether the department's interpretation of the statute is the only possible interpretation or the most desirable one. The court found that great deference to an agency's policy choices that emerge from the formal statutory rule promulgation process was required by the Florida Administrative Procedure Act.
[T]he APA plainly regards rules as a valuable end point in the agency's development of policy. Rules represent an agency's considered decision on issues left to the agency's discretion by a substantive act of the legislature. If we are to regard seriously the incentives for rulemaking under
the APA scheme, and if we are to credit the deliberative process that the legislature has prescribed for the development of agency policy, then surely an interpretative rule emerging from this process should be accorded a most weighty presumption of validity.
Otherwise the elaborate statutory scheme, pressing for rulemaking and prescribing how it shall be accomplished with maximum public and private participation, has no productive purpose, and it has become only a snare for agency action, a device for the evasion, avoidance or postponement of effective agency action in its authorized field of responsi- bility. 407 So.2d at 341-12.
See also, Department of Administration v. Nelson, 424 So.2d 852 (Fla. 1st DCA 1982); Department of Professional Regulation, Board of Medical Examiners v. Durrani, 455 So.2d 515 (Fla. 1st DCA 1984).
In sum, agencies are to be accorded wide discretion in the exercise of their lawful rule making authority. Florida Commission on Human Relations v. Human Development Center, 413 So.2d 1251 (Fla. 1st DCA 1982).
Section 381.702(20) authorizes HRS to establish by rule a list of all tertiary health services. As set forth in Findings of Fact 34-35 and 105 above, both pediatric open heart surgery and adult open heart surgery have been designated tertiary health services. By definition, tertiary health services should be concentrated in a limited number of hospitals to ensure the quality, availability and cost effectiveness of such service.
Pursuant to Section 381.706(1)(c), a certificate of need is required for nonexempt capital expenditures of $1 million or more by a health care facility. Section 381.706(1)(h) requires a certificate of need prior to establishment of inpatient institutional health services or a substantial change in such services involving a capital expenditure or an operating cost of
$500,000 or more per year. HRS has been granted broad rule making authority pursuant to Section 381.031(1)(g)11, and Section 381.704(3) and (4), Florida Statutes (1989) to implement the certificate of need program. Section 381.704(3) requires HRS to adopt rules establishing uniform need methodologies for health facilities.
The parties opposing the proposed rule amendments at issue in this case have not met their burden under Section 120.52(8), Florida Statutes. The Petitioners offered no persuasive evidence that any aspect of the Proposed Amendments was arbitrary or capricious, inconsistent with the enabling statutes, or otherwise invalid.
The proposed rule amendments do not vest unbridled discretion in the agency and are supported by logic and fact. Moreover, the proposed amendments are designed to effectuate the legislative purpose. See, Florida Waterworks Association v. Florida Public Service Commission, 473 So.2d 237 (Fla. 1st DCA 1985), rev. den. 486 So.2d 596 (Fla. 1986).
The Petitioners have not pointed to any portion of the Proposed Amendments that is not supported by the available professional literature. Moreover, both existing providers of open heart surgery services and facilities
which do not have but are interested in providing those services were given an opportunity to participate in a Work Group convened to assist in the development of the Rule. In addition, both groups were provided with an opportunity to request a public hearing on the Proposed Amendments.
It is concluded that HRS complied with each of the procedural standards found in Section 120.54, Florida Statutes. There is no indication that HRS ignored or disregarded any information presented to it. While Petitioners may disagree with some of the policy choices made by HRS, that disagreement is not in and of itself a basis for invalidating the Proposed Amendments.
The evidence established that virtually every issue raised by the challengers in this case was considered by HRS during the rulemaking process. HRS reviewed all of the available research and followed the National Guidelines where appropriate. In sum, HRS "has considered all relevant factors, has given actual, good faith consideration to those factors, and has used reason rather than whim to progress from consideration of these factors to its final decision." Adam Smith, supra, 553 So.2d at 1273.
Many of the objections raised by the Petitioners are based on the contention that the Proposed Amendments are anticompetitive and serve as an entry barrier to new providers. St. Mary's contends that the 1987 amendments to Chapter 381, Florida Statutes, changed the emphasis of the CON law from "planning" restrictions to encouraging "development" of health care resources. See, Chapter 87-92, Laws of Florida. The 1987 amendments deregulated many formerly reviewable projects including ambulatory surgical centers and outpatient cardiac catheterization laboratories. However, both adult and pediatric open heart surgery programs remain subject to CON regulation.
St. Mary's argument ignores the other goals of the statute. Chapter
381 of the Florida Statutes was enacted to improve the health and well-being of the citizens of the state through prudent long-range planning to improve geographic and financial access to healthcare. Section 381.025 Florida Statutes (1989). The goal of the certificate of need portion of the Chapter is to promote access to quality health services in a cost efficient manner. Pediatric and adult open heart surgery programs are tertiary services which, according to the statue, should be "limited to, and concentrated in, a limited number of hospitals to ensure the quality, availability, and cost effectiveness of such service". Section 381.702(20), Florida Statutes (1989).
As indicated above, HRS is required by Section 381.704(3), Florida Statutes, to establish uniform need methodologies for health facilities. HRS must consider in those methodologies, demographic characteristics of the population, the health status of the population, service use patterns, standards and trends, and market economics.
The individual components of the Proposed Amendments and the amendments as a whole, are reasonably related to the statutory requirement that the Department regulate tertiary care services through the certificate of need program, and that it establish uniform methodologies to determine need.
It is clear that HRS has flip-flopped back and forth on whether to apply the 350 minimum service volumn standard for adult open heart programs on an "each and every" or "averaging" basis. While several existing providers were approved based on an averaging interpretation and no evidence was presented to demonstrate that any quality of care problems arose because of that
interpretation, the evidence was insufficient to establish that HRS' decision to return to its original interpretation of the existing rule is arbitrary.
In determining to return to an "each and every" interpretation, HRS relied upon a substantial body of literature which concludes that there is a relationship between volume and outcome in the provision of adult open heart surgery. The literature concludes that, in general, facilities providing higher volumes of open heart surgery achieve better patient outcomes, in terms of mortality and cost efficiency. No persuasive evidence was presented to establish that the quality of adult open heart surgery services provided in Florida hospitals suffers from lack of additional competition, or that the public would be better served if more hospitals provided that service. Cf., Humana, Inc. v. Department of Health and Rehabilitative Services, 469 So.2d 889 (Fla. 1st DCA 1985) (rule may implement a competitive advantage in expansion of a CON regulated service which arises from the statute).
The Fifth District Court of Appeals in Central Florida Regional Hospital, Inc. vs. Department of Health and Rehabilitative Services, 16 FLW D1515, (Fla. 5th DCA 1991), recently overturned an HRS final order which applied the "each and every" approach. That decision, however, did not address the merits of the "each and every" versus the averaging approach. Instead, the court held that HRS was precluded from changing the need standard for a review cycle once the applications are filed. An important factor in that decision was the fact that co-batched applicants had already been approved using the averaging approach. The court did not disturb the holding in Lakeland Regional, supra, that the averaging approach was an invalid exercise of delegated authority because it had not been promulgated as a rule pursuant to Section 120.54, Florida Statutes.
Petitioners point out that HRS does not restrict the addition of surgical suites or teams by existing open heart providers. Petitioners contend that existing providers can add capacity in a district and absorb growth at the expense of both marginal providers and potential applicants.
Petitioners also point out that HRS does not regulate how many open heart surgical teams or suites a hospital has. Because the "each and every" standard does not draw a distinction between hospitals with one surgical team and hospitals with two or more teams, Petitioners contend that one hospital could have three teams performing 150 procedures which would be below the minimum quality of care standard. No evidence was presented to establish that such a situation has or is occurring and/or what the resultant quality of care has been. While these issues point out some possible gaps in the existing rules and Proposed Amendments, they do not invalidate HRS' conclusion that the 350 minimum service volume is a reasonable standard. As pointed out above, the calculation of numeric need under the rule is not determinative in and of itself. At least one Florida facility has been granted approval for an open heart surgery program notwithstanding a lack of numeric need. Further, all appropriate statutory and rule criteria must be taken into account and balanced, regardless of whether the rule provides for an "averaging" or "each and every" approach. Humana of Florida, Inc., supra, 12 FALR at 846.
The challengers have also failed to meet their burden of proving that the economic impact statement is materially deficient in a way that would impair the fairness of the proceedings or the correctness of HRS' actions. Florida Waterworks, supra, 473 So.2d at 247; Humana, supra, 469 So.2d at 890. The absence or insufficiency of an economic impact statement is harmless error if it is established that the proposed action will have no economic impact in that it
merely implements already established procedures, or if it is shown that the agency fully considered the asserted economic factors and impact. Department of Health and Rehabilitative Services v. Wright, 439 So.2d 937 (Fla. 1st DCA 1983); Florida-Texas Freight, Inc. v. Hawkins, 379 So.2d 944 (Fla. 1979). The economic impact statement for the Proposed Amendments is not materially deficient when judged by these standards.
HRS determined that the Proposed Rule would impact neither potential applicants for open heart surgery services nor existing providers of open heart surgery services. This conclusion was reached because the Proposed Amendments' need methodology for adult open heart surgery services renders the same result as the current rule regulating adult open heart surgery services. HRS also determined that the pediatric open heart surgery need methodology contained in the Proposed Rule renders the same result as the methodology contained in the existing rule. The Petitioners have not presented any persuasive evidence to rebut these conclusions.
CONCLUSION
HRS has gathered information from appropriate sources, made a good faith evaluation of that information, and attempted to reconcile different points of view where possible. The rule it has promulgated is not an invalid exercise of delegated legislative authority. Accordingly, it is ordered that the challenges to the proposed amendments to Rule 10-5.011 are dismissed.
DONE AND ORDERED in Tallahassee, Leon County, Florida, this 12th day of December, 1991.
J. STEPHEN MENTON 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 12th day of December, 1991.
APPENDIX TO FINAL ORDER, CASE NOS. 91-0863RP, 91-0864RP AND 91-0865RP
All parties have submitted Proposed Final Orders. The following constitutes my rulings on the proposed findings of fact submitted by the parties.
The Petitioners' Proposed Findings of Fact Humana's Proposed Findings of Fact
Proposed Finding Paragraph Number in the Findings of Fact of Fact Number in the Recommended Order Where Accepted or
Reason for Rejection.
Adopted in substance in Findings of Fact
1 and in the preliminary statement.
Adopted in substance in Findings of Fact 13.
Adopted in substance in Findings of Fact 17.
Adopted in substance in Findings of Fact
18 and 19.
Adopted in substance in Findings of Fact 21.
6-9. Subordinate to Findings of Fact 18 and 91-
96.
Subordinate to Findings of Facts 18 91-
96. Part of this proposal also consti- tutes argument rather than a finding of fact.
The first sentence is rejected as subor- dinate to Findings 18 and 91-96. The second sentence is rejected as consti- tuting argument.
Rejected as constituting argument and as a mischaracterization of the factual developments. As set forth in Findings of Fact 18 and 91-96, HRS' incipient policy interrupting the existing rule as permitting an averaging approach was rejected in the course of litigation. Any interested party who disagrees with the language and interpretation of the existing rule is free to challenge that interpretation in a proceeding pursuant to Section 120.56.
Subordinate to Findings of Fact 104.
The first two sentences are adopted in substance in Findings of Fact 18. The third sentence is rejected as constituting argument. Furthermore, as set forth in Findings of Fact 93, that interpretation has already been rejected as an invalid exercise of delegated legislative authority because it has not been adopted in accordance with Section 120.54, Florida Statutes.
Subordinate to Findings of Fact 87-89.
Adopted in substance in Findings of Fact 110.
Rejected as subordinate to Findings of Fact 81-86 and 111.
Subordinate to Findings of Fact 9 and 142- 144.
Rejected as a mischaracterization of the testimony and subordinate to Findings of Fact 110-111.
Subordinate to Findings of Fact 105-107. In addition, this subject area is addressed in paragraphs 22 and 23 of the
Conclusions 21. Subordinate | of to | Law. Findings | of | Fact | 113. | |
22. Subordinate 142-144. | to | Findings | of | Fact | 113 | and |
23. Subordinate 105. | to | Findings | of | Fact | 104 | and |
24. Subordinate 117. | to | Findings | of | Fact | 116 | and |
25. Subordinate | to | Findings | of | Fact | 81. |
Rejected as unnecessary. The subject matter is addressed in paragraphs 22-24 of the Conclusions of Law.
Subordinate to Findings of Fact 116 and 117.
Adopted in substance in Findings of Fact 114.
Subordinate to Findings of Fact 110 and 111.
Rejected as unnecessary.
Subordinate to Findings of Fact 119.
St. Mary's Proposed Findings of Fact
Proposed Finding Paragraph Number in the Findings of Fact of Fact Number in the Recommended Order Where Accepted or
Reason for Rejection.
Adopted in substance in Findings of Fact 1 and in the preliminary statement.
Subordinate to Findings of Fact 13, 21, and 28.
Adopted in substance in Findings of Fact 14.
Adopted in substance in Findings of Fact 15.
Adopted in substance in Findings of Fact 16.
Adopted in substance in Findings of Fact 17.
Adopted in substance in Findings of Fact
18 and 19.
Adopted in substance in Findings of Fact 20.
Adopted in substance in Findings of Fact 13.
Addressed in the Preliminary Statement and in paragraph 3 of the Conclusions of Law.
The first sentence is adopted in substance in Findings of Fact 22. The remainder is subordinate to Findings of Fact 22 and 28.
The first sentence is subordinate to Findings of Fact 31. The remainder is rejected as vague, ambiguous and constituting argument.
Adopted in substance in Findings of Fact 38.
14. Subordinate | to | Findings | of | Fact | 41 | and | 42. |
15. Subordinate | to | Findings | of | Fact | 39. | ||
16. Subordinate | to | Findings | of | Fact | 43. | ||
17. Subordinate | to | Findings | of | Fact | 50 | and | 51. |
18. Subordinate | to | Findings | of | Fact | 50 | and | 51. |
19. Subordinate | to | Findings | of | Fact | 46 | and | 47. |
20. Subordinate | to | Findings | of | Fact | 53. | ||
21. Subordinate | to | Findings | of | Fact | 53. | ||
22. Subordinate 60. | to | Findings | of | Fact | 52, | 57 | and |
Subordinate to Findings of Fact 60-62.
Subordinate to Findings of Fact 67-75.
Adopted in substance in Findings of Fact 113.
Adopted in substance in Findings of Fact 96.
Adopted in substance in Findings of Fact 87, 91 and 95.
Subordinate to Findings of Fact 88 and 89.
The first sentence is adopted in substance in Findings of Fact 113. The remainder is subordinate to Findings of Fact 142-144.
Adopted in substance in Findings of Fact 104.
Subordinate to Findings of Fact 116 and 117.
Subordinate to Findings of Fact 116 and 117.
Rejected as unnecessary. The subject matter is addressed in paragraphs 22 and
23 of the Conclusions of Law.
Adopted in substance in Findings of Fact 114.
Subordinate to Findings of Fact 110 and 111.
Rejected as unnecessary.
Subordinate to Findings of Fact 119.
Subordinate to Findings of Fact 122 and 123.
The first two sentences are adopted in substance in Findings of Fact 124 and 125. The third sentence is adopted in substance in Findings of Fact 127. The fourth sentence is subordinate to Findings of Fact 130. The remainder of the proposal is subordinate to Findings of Fact 128.
Rejected as contrary to weight of the credible evidence.
Subordinate to Findings of Fact 132.
Adopted in substance in Findings of Fact 133.
Subordinate to Findings of Fact 133.
Adopted in substance in Findings of Fact 21.
Subordinate to Findings of Fact 28.
Florida Hospital's Proposed Findings of Fact
Proposed Finding Paragraph Number in the Findings of Fact of Fact Number in the Recommended Order Where Accepted or
Reason for Rejection.
Adopted in substance in Findings of Fact 2, 4, 5 and 9.
Adopted in substance in Findings of Fact 29.
Subordinate to Findings of Fact 30.
Adopted in substance in Findings of Fact 63.
Adopted in substance in Findings of Fact
64 and 65.
Adopted in substance in Findings of Fact 68.
Adopted in substance in Findings of Fact 73.
Adopted in substance in Findings of Fact 73.
Rejected as unnecessary.
Adopted in substance in Findings of Fact 71, 74 and 75.
The first sentence is rejected as argument and editorial comment. The second sentence is adopted in substance in Findings of Fact 112.
Subordinate to Findings of Fact 88-90.
Adopted in substance in Findings of Fact 82, 84, 85, 107 and 111.
Adopted in substance in Findings of Fact
100 and 101.
Adopted in substance in Findings of Fact 18.
Subordinate to Findings of Fact 76-79.
Subordinate to Findings of Fact 77.
Subordinate to Findings of Fact 78.
Subordinate to Findings of Fact 98-101.
Adopted in substance in Findings of Fact 105-108.
Adopted in substance in Findings of Fact 115-118.
Adopted in substance in Findings of Fact 109.
Adopted in substance in Findings of Fact 104-105.
Rejected as unnecessary.
Rejected as unnecessary.
Rejected as constituting argument. The subject matter is addressed in Findings of Fact 91-96 and Conclusions of Law 20 and 21.
Adopted in substance in Findings of Fact 119-121.
Adopted in substance in Findings of Fact
122 and 123.
Subordinate to Findings of Fact 141-145.
The first sentence is rejected as duplicative. The second sentence is rejected as not supported by the evidence and subordinate to Findings of Fact 29 and 30.
The Respondent's Proposed Findings of Fact
Proposed Finding Paragraph Number in the Findings of Fact of Fact Number in the Recommended Order Where Accepted or
Reason for Rejection.
Adopted in substance in Findings of Fact 2 and 3.
Adopted in substance in Findings of Fact 4.
Adopted in substance in Findings of Fact 5.
Adopted in substance in Findings of Fact 6.
Adopted in substance in Findings of Fact 7.
Adopted in substance in Findings of Fact 8.
Subordinate to Findings of Fact 9.
Adopted in substance in Findings of Fact 10.
Adopted in substance in Findings of Fact 11.
Adopted in pertinent part in Findings of Fact 12.
Adopted in substance in Findings of Fact 23-25.
Adopted in substance in Findings of Fact 26.
Adopted in substance in Findings of Fact 27.
Adopted in substance in Findings of Fact
29 and 30.
Rejected as vague and unnecessary.
Adopted in substance in Findings of Fact 32-34.
Adopted in substance in Findings of Fact
35 and 36.
Adopted in pertinent part in Findings of Fact 35 and 43.
Adopted in pertinent part in Findings of Fact 38.
Adopted in substance in Findings of Fact 45.
Adopted in substance in Findings of Fact 46.
Adopted in substance in Findings of Fact 48.
Adopted in substance in Findings of Fact 49.
Adopted in pertinent part in Findings of Fact 55.
Adopted in substance in Findings of Fact 58.
Adopted in substance in Findings of Fact
62 and 63.
Adopted in substance in Findings of Fact 66.
Adopted in substance in Findings of Fact 66.
Adopted in substance in Findings of Fact 67.
Adopted in substance in Findings of Fact 67.
Adopted in substance in Findings of Fact 69-71.
Adopted in substance in Findings of Fact 69-71.
Adopted in substance in Findings of Fact
73 and 74.
34. | Adopted 81-83. | in | substance | in | Findings | of | Fact |
35. | Adopted 89. | in | substance | in | Findings | of | Fact |
36. | Adopted 94-97. | in | substance | in | Findings | of | Fact |
37. | Adopted | in | substance | in | Findings | of | Fact |
97, 108-109 and 114.
Adopted in substance in Findings of Fact 108, 111, and 120.
Adopted in substance in Findings of Fact 105-106.
Adopted in substance in Findings of Fact 78.
Adopted in pertinent part in Findings of Fact 80.
Adopted in substance in Findings of Fact 117.
Rejected as unnecessary.
Adopted in substance in Findings of Fact
104 and 109.
The first sentence is adopted in substance in Findings of Fact 123. The remainder is addressed in Findings of Fact 121.
46. | Adopted 121 and | in substance 122. | in | Findings | of | Fact |
47. | Adopted 122. | in substance | in | Findings | of | Fact |
48. | Adopted 125. | in substance | in | Findings | of | Fact |
49. | Adopted | in substance | in | Findings | of | Fact |
31 and 126.
Adopted in substance in Findings of Fact 134.
Adopted in substance in Findings of Fact 132.
Adopted in substance in Findings of Fact 127.
Adopted in substance in Findings of Fact 128.
Adopted in substance in Findings of Fact 38.
Adopted in substance in Findings of Fact 129.
Adopted in substance in Findings of Fact 128.
Adopted in pertinent part in Findings of Fact 132.
Adopted in substance in Findings of Fact 130.
Adopted in substance in Findings of Fact 133.
Adopted in pertinent part in Findings of Fact133.
Adopted in substance in Findings of Fact 135.
Adopted in substance in Findings of Fact 137.
Adopted in substance in Findings of Fact 139.
Adopted in substance in Findings of Fact 139.
Adopted in pertinent part in Findings of Fact137-139.
Adopted in substance in Findings of Fact 142.
Adopted in substance in Findings of Fact 141.
Adopted in substance in Findings of Fact 141.
Rejected as unnecesaary.
Adopted in substance in Findings of Fact 144.
Subordinate to Findings of Fact 145-146.
Adopted in substance in Findings of Fact 145.
Adopted in substance in Findings of Fact 145.
Subordinate to Findings of Fact 146.
Adopted in substance in Findings of Fact 135.
The Intervenor's Proposed Findings of Fact Intervenor St. Anthony's Proposed Findings of Fact
Proposed Finding Paragraph Number in the Findings of Fact of Fact Number in the Recommended Order Where Accepted or
Reason for Rejection.
Subordinate to Findings of Fact 138-139.
Adopted in substance in Findings of Fact 137.
Adopted in substance in Findings of Fact 137.
Adopted in substance in Findings of Fact 137.
Adopted in substance in Findings of Fact 39, 126, 137 and 139.
Adopted in substance in Findings of Fact 81.
Adopted in substance in Findings of Fact 81.
Adopted in substance in Findings of Fact
81 and 82.
Subordinate to Findings of Fact 82 and 141.
Subordinate to Findings of Fact 137-139 and 141.
11. Subordinate 142. | to | Findings | of | Fact | 137 | and |
12. Subordinate 142. | to | Findings | of | Fact | 138 | and |
13. Subordinate 140. | to | Findings | of | Fact | 139 | and |
Subordinate to Findings of Fact 139-140.
The first sentence is adopted in substance in Findings of Fact 135. The second sentence is subordinate to Findings of Fact 22-26.
Subordinate to Findings of Fact 138-142.
Subordinate to Findings of Fact 142.
Subordinate to Findings of Fact 138-142.
Subordinate to Findings of Fact 138-142.
Rejected as constituting argument.
Rejected as constituting argument.
Intervenor North Broward Hospital Proposed Findings of Fact
1. - 4. Rejected as unnecessary. As set forth in
the preliminary statement and in paragraph
2 of the Conclusions of Law. The parties stipulated to standing.
Adopted in substance in Findings of Fact 68.
Adopted in substance in Findings of Fact 69.
Adopted in substance in Findings of Fact 70.
Adopted in substance in Findings of Fact
72 and 74.
Adopted in substance in Findings of Fact 73.
Adopted in substance in Findings of Fact 76.
Adopted in substance in Findings of Fact 77.
Adopted in substance in Findings of Fact 81-84.
Adopted in substance in Findings of Fact 86-88.
Adopted in substance in Findings of Fact 88.
Adopted in substance in Findings of Fact 86.
Adopted in substance in Findings of Fact 87.
Adopted in substance in Findings of Fact 108.
Rejected as unnecessary.
Adopted in substance in Findings of Fact 113.
Adopted in substance in Findings of Fact 112.
Adopted in substance in Findings of Fact
109 and 112.
Adopted in substance in Findings of Fact 18 and 95-99.
Adopted in substance in Findings of Fact 78.
Adopted in substance in Findings of Fact 78.
Adopted in pertinent part in Findings of Fact 78.
Adopted in substance in Findings of Fact 80.
Adopted in substance in Findings of Fact 78-80.
Adopted in substance in Findings of Fact 103.
Adopted in substance in Findings of Fact 117.
Adopted in substance in Findings of Fact 120.
Adopted in substance in Findings of Fact 94-99.
Adopted in substance in Findings of Fact 89-99.
Rejected as vague, ambiguous and as constituting argument.
Adopted in substance in Findings of Fact 121.
Adopted in substance in Findings of Fact 122.
Adopted in substance in Findings of Fact 124.
Adopted in substance in Findings of Fact 124.
Addressed in the Conclusions of Law.
Intervenor Tampa General Proposed Findings of Fact
Rejected as unnecessary. As set forth in the Preliminary Statement and in paragraph
2 of Conclusions of Law, the parties have stipulated to standing.
Adopted in substance in Findings of Fact 29-30.
Adopted in substance in Findings of Fact 64-66.
Adopted in substance in Findings of Fact 68-70.
Adopted in substance in Findings of Fact 71.
Adopted in substance in Findings of Fact 72.
Adopted in substance in Findings of Fact 70, 77, 85, 102 and 108.
Adopted in substance in Findings of Fact 81-84.
Adopted in substance in Findings of Fact 89-90.
Adopted in substance in Findings of Fact 95-96.
Adopted in substance in Findings of Fact 97-98.
Adopted in substance in Findings of Fact 102.
Adopted in substance in Findings of Fact 78-80.
Adopted in substance in Findings of Fact 120.
Adopted in substance in Findings of Fact 104.
Adopted in substance in Findings of Fact
105 and 106.
Adopted in substance in Findings of Fact 121.
Adopted in substance in Findings of Fact 122.
Adopted in substance in Findings of Fact 124.
Adopted in substance in Findings of Fact 144-146.
Adopted in substance in Findings of Fact 147.
Intervenor JFK Memorial Proposed Findings of Fact
Adopted in substance in Findings of Fact 24.
Adopted in substance in Findings of Fact 24.
Adopted in substance in Findings of Fact 24.
Adopted in substance in Findings of Fact 24.
Adopted in substance in Findings of Fact 24.
Adopted in substance in Findings of Fact 22 and 135.
Adopted in substance in Findings of Fact 23.
Adopted in substance in Findings of Fact 31.
Adopted in substance in Findings of Fact 34-37.
Adopted in substance in Findings of Fact 26.
Adopted in substance in Findings of Fact 39 and 132.
Adopted in substance in Findings of Fact 31.
Adopted in substance in Findings of Fact 34.
Adopted in substance in Findings of Fact 38.
Adopted in substance in Findings of Fact 42.
Subordinate to Findings of Fact 43-45.
Subordinate to Findings of Fact 43-45.
Adopted in substance in Findings of Fact 47.
Adopted in substance in Findings of Fact 47.
Adopted in substance in Findings of Fact 49.
Adopted in substance in Findings of Fact 50.
Adopted in substance in Findings of Fact 49.
Adopted in substance in Findings of Fact 48.
Adopted in substance in Findings of Fact 53.
Adopted in substance in Findings of Fact
55 and 56.
Adopted in substance in Findings of Fact 26.
Rejected as unnecessary and subordinate to Findings of Fact 54.
Adopted in substance in Findings of Fact 55.
Adopted in substance in Findings of Fact 61-63.
Adopted in substance in Findings of Fact 63.
Adopted in substance in Findings of Fact 63.
Adopted in substance in Findings of Fact 61.
Adopted in substance in Findings of Fact 67.
Adopted in substance in Findings of Fact
70 and 72.
Adopted in substance in Findings of Fact 70, 72 and 73.
Adopted in substance in Findings of Fact 74.
Adopted in substance in Findings of Fact 69.
Adopted in substance in Findings of Fact 78.
Adopted in substance in Findings of Fact 80.
Adopted in substance in Findings of Fact 97-99.
Adopted in substance in Findings of Fact 81.
Adopted in substance in Findings of Fact 104.
Adopted in substance in Findings of Fact 85-108.
Adopted in substance in Findings of Fact
109 and 111.
Adopted in substance in Findings of Fact 110.
Adopted in substance in Findings of Fact 110.
Adopted in substance in Findings of Fact 101.
Adopted in substance in Findings of Fact 124.
49. | Subordinate to Findings | of Fact 124. | |
50. | Adopted in substance in | Findings of | Fact |
126. | |||
51. | Adopted in substance in | Findings of | Fact |
127-129. | |||
52. | Adopted in substance in | Findings of | Fact |
128 and 132. | |||
53. | Adopted in substance in | Findings of | Fact |
135. | |||
54. | Adopted in substance in | Findings of | Fact |
9. |
Adopted in substance in Findings of Fact 99 and 102.
Adopted in substance in Findings of Fact 145.
COPIES FURNISHED:
Carroll Webb, Executive Director Administrative Procedures Committee
120 Holland Building Tallahassee, Florida 32399-1300
Liz Cloud, Chief
Bureau of Administrative Code Room 1802, The Capitol Tallahassee, Florida 32399-0250
James C. Hauser, Esquire George Matlock, Esquire FOLEY & LARDNER
101 North Monroe Street Suite 1050
Post Office Box 508 Tallahassee, Florida 32302
W. David Watkins, Esquire OERTEL, HOFFMAN, FERNANDEZ
& COLE, P.A.
2700 Blair Stone Road Suite C
Post Office Box 6507 Tallahassee, Florida 32314-6507
Jeffery A. Boone, Esquire John Koda, Esquire
BOONE, BOONE, KLINGBEIL, BOONE & ROBERTS, P.A.
1001 Avenida del Circo Post Office Box 1596 Venice, Florida 34284
Lesley Mendelson, Esquire Senior Attorney Department of Health and
Rehabilitative Services 2727 Mahan Drive Ste 103
Tallahassee, Florida 32308
Robert A. Weiss, Esquire PARKER, HUDSON, RAINER
& DOBBS
The Perkins House, Ste. 101
118 N. Gadsden Street Tallahassee, Florida 32301
Patrick Phelan, Esquire PARKER, SKELDING, LABASKY
& CORRY
Post Office Box 669
318 N. Monroe Street Tallahassee, Florida 32302
Ivan Wood, Esquire BAKER & HOSTELLER
McCUTCHEN BLACK
2100 Texas Commerce Tower 600 Travis
Houston, Texas 77002
Elizabeth McArthur, Esquire AURELL, RADEY, HINKLE
& THOMAS
101 North Monroe Street Suite 1000
Post Office Drawer 11307 Tallahassee, Florida 32302
Sam Power, Agency Clerk Department of Health and
Rehabilitative Services 1323 Winewood Boulevard
Tallahassee, Florida 32399-0700
John Slye, General Counsel Department of Health and
Rehabilitative Services 1323 Winewood Boulevard
Tallahassee, Florida 32399-0700
NOTICE OF RIGHT TO JUDICIAL REVIEW
A PARTY WHO IS ADVERSELY AFFECTED BY THIS FINAL ORDER IS ENTITLED TO JUDICIAL REVIEW PURSUANT TO SECTION 120.68. FLORIDA STATUTES. REVIEW PROCEEDINGS ARE GOVERNED BY THE FLORIDA RULES OF APPELLATE PROCEDURE. SUCH PROCEEDINGS ARE COMMENCED BY FILING ONE COPY OF A NOTICE OF APPEAL WITH THE AGENCY CLERK OF THE DIVISION OF ADMINISTRATIVE HEARINGS AND A SECOND COPY, ACCOMPANIED BY FILING FEES PRESCRIBED BY LAW, WITH THE DISTRICT COURT OF APPEAL, FIRST DISTRICT, OR WITH THE DISTRICT COURT OF APPEAL IN THE APPELLATE DISTRICT WHERE THE PARTY RESIDES. THE NOTICE OF APPEAL MUST BE FILED WITHIN 30 DAYS OF RENDITION OF THE ORDER TO BE REVIEWED.
| Issue Date | Proceedings |
|---|---|
| Dec. 12, 1991 | CASE CLOSED. Final Order sent out. Hearing held 3/11-13/91. |
| Jun. 28, 1991 | (Petitioners) Notice of Supplemental Authority filed. (From James C. Hauser) |
| Jun. 12, 1991 | (Petitioners) Response to Motion to Strike filed. (From James Hauser) |
| Jun. 05, 1991 | Response to Motion to Strike filed.(From W. David Watkins) |
| May 31, 1991 | Motion to Strike filed. (From Robert Weiss) |
| May 14, 1991 | Outline for Proposed Final Order filed. (From Lesley Mendelson) |
| May 13, 1991 | JFK`s Proposed Final Order filed. |
| May 13, 1991 | Proposed Final Order filed. (From Elizabeth McArthur) |
| May 13, 1991 | Humana`s Proposed Final Order filed. (from James Hauser) |
| May 13, 1991 | Proposed Final Order filed. (From Lesley Mendelson) |
| May 13, 1991 | St. Anthony`s Hospital`s Proposed Recommended Order filed. (From Erin E. Lunceford) |
| May 13, 1991 | Proposed Findings of Fact, Proposed Conclusions of Law, and Proposed Final Order of Petitioner/Intervenor, Adventist Health System/Sunbelt,Inc., d/b/a Florida Hospital filed. (From Jeffrey A. Boone) |
| May 13, 1991 | North Broward Hospital District`s Proposed Final Order filed. (from P. Pelham) |
| May 13, 1991 | (Respondent) Motion for Leave to File Proposed Final Order in Excess of 40 Pages filed. (From Lesley Mendelson) |
| May 08, 1991 | Order Granting Motion for Extension of Time to File Proposed Final Order sent out. |
| Apr. 17, 1991 | Agreed Motion for Extension of Time to File Proposed Final Order filed. (from Robert A. Weiss) |
| Apr. 15, 1991 | Letter to All Counsel from Lesley Mendelson (re: Open heart rule challenge-proposed outline) without attachment filed. |
| Apr. 10, 1991 | Transcript (Volumes 1-5) filed. |
| Mar. 26, 1991 | Amended Notice of Post-Hearing Conference Call filed. (From W. David Watkins) |
| Mar. 26, 1991 | Notice of Post-Hearing Conference Call filed. (From W. David Watkins) |
| Mar. 19, 1991 | (Intervenor) Motion for Protective Order (Exhibit A) filed. |
| Mar. 13, 1991 | Motion for Clarification filed. |
| Mar. 11, 1991 | Pre-Hearing Stipulation of Adventist Health Systems Sunbelt, Inc., d/b/a Florida Hospital filed. |
| Feb. 14, 1991 | Order of Consolidation sent out. Consolidated case are: 91-0850R, 91-0863R, 91-0864R and 91-0865R |
| Feb. 11, 1991 | Order of Assignment sent out. |
| Feb. 08, 1991 | Petition to Determine Invalidity of a Proposed Rule filed. |
| Feb. 08, 1991 | Letter to Liz Cloud & Carroll Webb from Marguerite Lockard |
| Issue Date | Document | Summary |
|---|---|---|
| Dec. 12, 1991 | DOAH Final Order | Separate certificate of need and need methodology for pediatric open heart surgery upheld. Requirement that each existing provider meet 350 minimum number of procedures valid. |
