STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

ST. LUKE'S HOSPITAL ASSOCIATION, ) d/b/a ST. LUKE'S HOSPITAL, )

)

Petitioner, )

)

vs. ) CASE NO. 93-4890

)

STATE OF FLORIDA, AGENCY FOR )

HEALTH CARE ADMINISTRATION, )

)

Respondent. )

)

RECOMMENDED ORDER

This case was heard from September 18, 1995, through September 26, 1995, in Tallahassee, Florida, by David M. Maloney, Hearing Officer of the Division of Administrative Hearings.

APPEARANCES

Petitioner: Michael J. Cherniga, Esquire

Greenberg, Traurig, Hoffman, Lipoff, Rosen & Quentil, P.A.

Post Office Drawer 1838 Tallahassee, Florida 32302

Respondent: John F. Gilroy, Esquire

Agency for Health Care Administration Fort Knox Building 3

2727 Mahan Drive, Suite 3431

Tallahassee, Florida 32308-5403 STATEMENT OF THE ISSUE

Whether the Agency for Health Care Administration should grant or deny CON Application No. 7202, an application by St. Luke's Hospital Association, Inc. for a liver transplantation program at St. Luke's Hospital in Jacksonville, Florida?

PRELIMINARY STATEMENT

On August 18, 1993, the Clerk for the Agency for Health Care forwarded a notice that it had received a request for a formal administrative proceeding from St. Luke's Hospital Association d/b/a St. Luke's Hospital. The notice further requested the Division of Administrative Hearings to assign a hearing officer to conduct all proceedings necessary under law.

After initial assignment, the case was abated to await the outcome of formal administrative proceedings in DOAH Case No. 92-5111 on the ground that the outcome could moot this case. Case No. 92-5111, albeit earlier and different

agency action, concerned, as does this case, the Agency for Health Care Administration's denial of St. Luke's application for a certificate of need proposing the establishment of an adult liver transplantation program at St. Luke's Hospital in Duval County. A recommended order was issued in Case No. 92- 5111 leading to a final order denying the CON application. After rendition of the final order in April of 1994, which did not moot this case as hoped for in the motion to abate, assignment of this case was transferred to the undersigned. The proceeding finally reached hearing in September of 1995.

In this case, St. Luke's tries again. This second application, CON Application 7202, was filed on or about March 24, 1993. Again, St. Luke's liver transplant program would be located at St. Luke's Hospital in Jacksonville, Florida (AHCA District 3, Serving Planning Area One.) And again, the application has been preliminarily denied.

During this proceeding, Shands Teaching Hospital and Clinic, Inc., filed a petition to intervene as a party. Shands is an existing provider of liver transplantation services in Service Planning Area One, but unlike St. Luke's, Shands is in District 4, a different AHCA district. Consequently, Shands petition was dismissed for lack of standing, limiting the parties to just the petitioner, (St. Luke's,) and the respondent, (AHCA).

At hearing, St. Luke's exhibits marked 1a, 1b, 1c, 2, 3, 4 (a, b, c, d, & g), 5, 6, 7, 9, 10, 11 a & b, 13, 15, 18, 19, 20, 24, 28, 29, 30, 33 and 34 were

admitted into evidence. St. Luke's exhibit 14 was admitted for limited purposes stated at hearing. AHCA's exhibits marked 1 - 8 were all admitted.

St. Luke's presented the testimony of seven witnesses: Mark Richardson, health care consultant specializing in the areas of health care planning, accepted as an expert in health planning; Charles Richard Fleming, physician/gastroenterologist at the Mayo Clinic, Jacksonville, accepted as an expert in gastroenterology; James Richard Spivey, physician/gastroenterology, hepatology and liver transplant medicine, accepted as an expert in liver transplant medicine; Richard Knapp, management/consulting business, accepted as an expert in the area of health care facility financial analysis; Ruud Krom, surgeon/liver transplant surgery, accepted as an expert in liver transplantation; Larry Read, administrator of St. Luke's Hospital and administrator for Mayo Clinic, Jacksonville, accepted as an expert in health planning; and, Maria Struss, Chief Financial Officer at St. Luke's.

AHCA presented the testimony of 6 witnesses at hearing: Eugene R. Schiff, professor of medicine at the University of Miami School of Medicine, Chief of the Division of Hepatology, accepted as an expert in hepatology; Robert D. Gordon, professor of surgery at Emory University School of Medicine and co- director of organ transplant services at Emory Hospital, accepted as an expert in liver transplantation and liver transplant surgery and programs; Richard Howard, director of transplantation and medical director of the organ procurement agency at Shands Hospital, accepted as an expert in liver transplant surgery and programs; Gregory Scott Bass, director of business and strategic planning for University of Florida Health Services, Inc., accepted as an expert in health care planning; Tom Prevost, director of budget and planning at Shands/development of the Shands annual operating budget, accepted as an expert in the field of health care budget, accounting and financial analysis; and, Elizabeth Dudek, AHCA bureau chief for the certificate of need and budget review sections, accepted as an expert in health care planning and certificate of need policies and procedures.

A seventh witness was presented by AHCA through deposition: Dr. Joshua Miller, professor of surgery, microbiology, immunology and pathology at the University of Miami, and co-director of the Division of Transplantation at University of Miami and Jackson Memorial Hospital and the Veterans' Administration Hospital in Miami, accepted as an expert in liver transplant surgery and liver transplant programs.

The parties filed their proposed recommended orders on December 12, 1995.

Rulings on the proposed recommended orders are contained in the appendix to this order.

FINDINGS OF FACT

1. The Parties

   
   

   1. With Shands Teaching Hospital prevented by law from participating, there are only two parties to this proceeding: the applicant, St. Luke's Hospital Association d/b/a St. Luke's Hospital, and the Agency for Health Care Administration.

      
      

      St. Luke's

      
      

   2. St. Luke's is a 289-bed not-for-profit hospital located in the southeast part of the City of Jacksonville, Duval County. Jacksonville is in Agency District 4. The District includes Baker, Nassau, Clay, St. John's, Flagler and Volusia Counties as well as Duval.

      
      

   3. St. Luke's is one of a number of affiliates of the Mayo Foundation whose mission it is to provide excellent medical care through practice, education, and research on a multi-campus but unified approach. Other affiliates of the Mayo Foundation are Mayo Clinic Jacksonville (located about 9 miles east of St. Luke's), Mayo Clinic Scottsdale, Arizona and three organizations in Rochester, Minnesota: St. Mary's Hospital, Methodist Hospital and Mayo Clinic Rochester, the famed "Mayo Clinic."

      
      

   4. Founded prior to the turn of the century, Mayo Clinic was the first multi-specialty medical group practice in the country. It delivers health care based on an integrated, team approach to medicine in which specialists from many different areas consult together for the benefit of the patient, and in which a single medical record accompanies the patient through all phases of care, outpatient or inpatient.

      
      

   5. The mission of the Mayo Foundation is also that of Mayo Clinic Jacksonville. Providing outpatient services at its campus, Mayo Clinic Jacksonville employs approximately 170 physicians covering all specialties and sub-specialties for adult patients with the exception of obstetrics.

      
      

   6. The primary role of St. Luke's in the Mayo organization is to provide the inpatient component for the Mayo Clinic Jacksonville medical practice, including provision of tertiary services. In light of this arrangement, St. Luke's patients tend to be more acutely ill than the average hospital patient so that the typical St. Luke's patient has more complex, resource consuming medical problems than the typical hospital patient.

   7. Through the arrangement with Mayo Clinic Jacksonville, St. Luke's has evolved into a tertiary care facility serving Florida and beyond. Among the complex tertiary services provided at St. Luke's that require a certificate of need are open heart surgery and bone marrow transplantation. But liver transplantation is not presently authorized at St. Luke's.

      
      

   8. Others under the Mayo Foundation umbrella, however, have experience in liver transplantation. In fact, Mayo Clinic Rochester operates one of the most successful liver transplant programs in the United States. Its outcome experience, (transplant patient survival rates for one and three years), ranks in the top 3 of the nation's transplant programs, with its 3-year survival rate being ranked first. The Mayo Clinic Rochester program, therefore, has an excellent national and international reputation.

      
      

   9. The St. Luke's program will rely and benefit from the resources, experience, efficiencies and clinical and research protocols of the Mayo Clinic Rochester program. But neither the Rochester program nor the Mayo Foundation, itself, controls St. Luke's. St. Luke's Health System has the controlling interest in the hospital.

      
      

   10. St. Luke's Hospital did not need the approval of any of the Mayo Foundation affiliates or the Foundation, itself, to apply for the CON at issue in this proceeding.

       
       

       The Agency for Health Care Administration

       
       

   11. The Agency for Health Care Administration is the "single state agency [designated by statute] to issue, revoke, or deny certificates of need and to issue, revoke, or deny exemptions review in accordance with the district plans, the statewide health plan, and present and future federal and state statutes." Section 408.034(1), F.S.

       
       

2. The Service Planning Area and Existing Providers in the State.

   
   

   1. In addition to being located in AHCA District 3, St. Luke's is within Service Planning Area One. Described by Rule 59C-1.044, Florida Administrative Code as "district 1, district 2, district 3 excluding Lake County and district 4 excluding Volusia County," Service Planning Area One, from the perspective of land mass, is the largest of the state's four service planning areas. It covers almost half of the state's territory from just north of Orlando through the western panhandle.

      
      

   2. Another liver transplantation center already exists in service planning area one: the Shands Teaching Hospital at the University of Florida, in Gainesville. Elsewhere in the state, Jackson Memorial Hospital (located in Dade County) provides for liver transplantation services. There is a third facility with a certificate of need allowing it to provide liver transplantation services: Tampa General Hospital. But Tampa General's program is inactive and has been for some time.

      
      

3. The Application's Projection for Start-Up

   
   

   1. Originally, St. Luke's projected that its first year of operation would be 1995. Due to litigation, the program would not now begin until sometime in 1997, with the second year in the 1998/1999 time frame.

4. Pre-hearing Stipulation

   
   

   1. The parties stipulated to the findings listed in findings of fact Nos. 16 - 20.

      
      

   2. St. Luke's has a record of providing quality of care and it will provide quality of care in its liver transplantation program.

      
      

   3. The St. Luke's application demonstrates the availability of resources, including health manpower, management personnel, and funds for capital and operating expenditures and for project accomplishment and operation.

      
      

   4. The St. Luke's application proposes reasonable costs and methods of proposed construction to implement the liver transplantation program.

      
      

   5. Rule 59C-1.044, Florida Administrative Code, sets forth standards and need determination criteria for liver transplantation programs. The St. Luke's application satisfies all staffing, other operational and teaching/research requirements set forth therein such as found at (3), (4), (7)(b), and (7)(c). The St. Luke's application also must meet the five transplant minimum volume requirement found at subsection (7)(d).

      
      

   6. The St. Luke's application, to the extent it involves new construction, has considered alternatives to new construction such as modernization or sharing arrangements which have been implemented to the maximum extent practicable.

      
      

5. Considerations Relating to Need

1. History and Current Status of Florida Liver Transplantation Programs Under CON Regulation.

1. On August 7, 1988, AHCA's predecessor, the Department of Health and Rehabilitative Services, adopted what is now the "Organ Transplantation" rule, Rule 59C-1.044, Florida Administrative Code.

   
   

2. The rule provided for a "grandfather" process to recognize programs in existence prior to the date of the legislation requiring certificate of need review for such programs, October 1, 1987. The grandfather process allowed Shands, Jackson and Tampa General to receive certificates of need for liver transplantation programs without the normal certificate of need scrutiny.

   
   

3. Like St. Luke's, Shands is located in Service Planning Area One; Jackson is in Service Planning Area Four, and Tampa General in Service Planning Area Two.

   
   

   1. Shands and Jackson Memorial

      
      

4. Of the three, Shands and Jackson are highly productive, very active liver transplantation programs.

   
   

5. The two transplant programs have been in existence for more than 10 years. Growth of the programs has been slow and gradual. For Shands, growth has been intermittent with stops and starts but toward the end of 1993, it began to experience significant volume. Likewise, after 7 years or so of gradual

   growth, Jackson began to achieve significant volume in late 1993. Today, both have evolved to the point that in addition to active adult programs, they have active pediatric programs as well.

   
   

6. The medical component of the Shands program is provided by the University of Florida and its employed physicians; likewise, the Jackson Memorial program is served by University of Miami physicians. Forty percent of Shands' volume comes from Service Planning Area One, 57 percent from elsewhere in the state, and 3 percent from out of state. Sixty percent of Jackson's liver transplant volume comes from Service Planning Area Four, twenty percent from out of state, ten percent from out of the country and the remainder from Florida outside Service Planning Area Four. There is little, if any, competition between the two.

   
   

7. In fiscal year 1995, Shands performed 43 adult liver transplants and

   11 pediatric transplants. Shands for calendar year 1995 through September 1 performed 49 adult liver transplants and 7 pediatric transplants. For the twelve months ending in August, 1995, Jackson Memorial handled a total volume of

   170 liver transplants, with approximately 148 being adult cases. The volumes of both programs are sustainable. They depict, furthermore, mature and viable programs.

   
   

8. In short, after slow growth until late 1993, both Shands and Jackson Memorial are well on their way to becoming liver transplantation centers of excellence.

   
   

   b. Tampa General

   
   

9. Quite the opposite is the situation for Tampa General. It has performed only seven or eight transplants over the last 5-year period with four of those in 1992. At the time of hearing, three of the 1992 patients had expired. Moreover, no transplants had been performed in 1995. In actuality, Tampa General as of September, 1995, had not added any patients to its liver transplantation wait list through the first three quarters of 1995 and all of 1994, the previous calendar year. There has not been, therefore, an evaluation process in place at Tampa General which would place transplant candidates in a position to receive the service since 1993.

   
   

10. Tampa General's liver transplantation CON is on the verge of being abandoned in fact, if not in law.

    
    

    2. Projected Growth at Shands and Jackson

    
    

11. It is reasonable to assume that 10 to 15 percent of liver transplants at Shands will be performed on pediatric patients in the near future. But, the number of children who have end stage liver disease is not increasing as rapidly as the number of adults. This increase in adult need surpassing the increase in pediatric need will continue so that the ratio of adults to children will increase over the long term.

    
    

12. For calendar year 1995, it was anticipated at time of hearing that Shands will perform 70 total liver transplants, with approximately 60 adult cases.

    
    

13. The current ratio of adult to pediatric cases will hold for 1996 at Shands. It is anticipated that Shands will handle 80 to 90 transplants in 1996, of which 70 to 80 will be adult cases.

14. If the percentage of pediatric cases holds through 1998/1999 (the second year of St. Luke's program, assuming it receives a CON) Shands should handle a total of 90 to 100 liver transplants, with 77 to 90 of those being adult cases.

    
    

15. Approximately 13 percent of Jackson's transplant volume is attributable to pediatric patients.

    
    

16. For the 12 months ending in August of 1995, Jackson handled a total of

    170 liver transplants, with approximately 148 being adult cases.

    
    

17. For calendar year 1995 and annually thereafter, Jackson expects to handle 175 to 200 total transplants, or 153 to 174 adult patients, assuming the current ratio of adult to pediatric cases holds.

    
    

    3. Demand and Florida Resident Outmigration

    
    

18. St. Luke's application, using 1991 data, showed that 598 patients were dying annually in Florida from end-stage liver disease. The figure is minimal however; it excludes those under the age of 15 and over the age of 64. Even more significantly, it excludes patients whose liver damage was caused by alcoholism. It excluded alcoholic liver patients because in 1991 they were not considered good candidates for liver transplantation. Today, however, 25 percent of liver transplants are done on patients with alcoholism. Furthermore, it has become more common for patients older than 64 to be accepted for liver transplantation. In sum, there are well in excess of 600 patients in Florida every year who need liver transplantation services. A great number of those in need of liver transplantation services in Florida, Service Planning Area One and AHCA Districts 3 and 4 are not receiving needed services.

    
    

19. It is undisputed that in the United States there is tremendous number of patients with end stage liver disease who could benefit from liver transplantation services. For example, there are 30,000 deaths per year due to alcoholism-induced liver disease, alone. At the same time, Hepatitis C is on the rise. While not all Hepatitis C patients suffer end-stage liver disease, a stable percentage do. The rise in Hepatis C, therefore, creates an ever- increasing demand for liver transplants. The current system for liver transplantation comes nowhere close to providing services to all of those in need. In short, the nation's current system is overwhelmed by demand. The same is true at the state level for Florida, and at a micro-level for Service Planning Area One and AHCA Districts 3 and 4.

    
    

20. The inability of the Florida liver transplantation centers to meet the needs of Florida's end-stage liver patients has forced some patients to resort to out-of-state services. In 1994, for example, one-third of all Florida residents who received liver transplants did so at an out-of-state program. By sending 10 Florida residents to Mayo Clinic Rochester, four of whom received livers, St. Luke's, itself, has contributed to this outmigration. But its contribution is relatively minor, and if St. Luke's application were granted, St. Luke's will certainly meet the majority of the needs of these patients, itself. Despite the growth of the Shands and Jackson Memorial programs, the number of patients leaving the state for such service has consistently been in the 60's range over the last five years. Indeed, as of July 1995, more than 50 percent of Florida residents awaiting liver transplants were on wait lists maintained by programs located outside the State of Florida. Recent approval by

    Medicare of the Shands and Jackson Memorial programs may decrease the number of patients leaving Florida but by precisely how much did not come to light at the hearing.

    
    

21. Despite the consistency in the numbers of Florida patients seeking liver transplantation out-of-state, the percentage of potential patients doing so has declined in recent years. From 1991, when 54 percent of patients left the state, the percentage declined to 25.3 percent in 1994, the last full year of data available at the time of hearing.

    
    

22. The percentage decline is due, no doubt, to the dramatic improvement in the Shands and Jackson Memorial progress. Recent additions of Drs. Rosen and Tzakis (particularly of Dr. Tzakis), to the programs of Shands and Jackson Memorial, respectively, have enhanced the standings of the programs, and should further propel the decrease in percentage of patients seeking service out-of- state.

    
    

23. But, of course, just how much the percentage will decrease is unknown and even if the percentage continues to drop, the raw number of patients leaving the state is not dropping. Raw numbers are not dropping because the raw number of those seeking liver transplant services of the many in need of such services is rising.

    
    

24. At bottom, outmigration is a problem and demonstrates a need. While the reasons patients leave Florida for liver transplantation services are complex, including the need to be near out-of-state family members, and the effects of managed care contracts and Medicare administration, there is a significant number of patients leaving Florida for liver transplant programs elsewhere. The addition of another program, one that promises to be active as well as of high quality can only assist in meeting the presently unmet need in Florida demonstrated by outmigration.

    
    

    4. Key Issue

    
    

25. The group of patients with end stage liver disease in Florida and elsewhere cannot all be saved, however, because there are not enough organ donors. There are not, therefore, sufficient livers available for transplantation to meet the enormous demand. Thus, the key factual "need" issue in this proceeding is not whether there is an adequate pool of Florida residents with end-stage liver disease who could benefit from access to a new liver transplantation program. The key issue, instead, is whether adequate donor livers are available to meet the increased ability a St. Luke's program would offer to serve the demand overwhelming the current system.

    
    

    1. Likely Increase in the Number of Donors

       1. UNOS

          
          

26. In the 1980's, Congress passed the National Organ Transplantation Act. A task force was set up to look at the issues of organ donation and allocation in the United States. Among the task force's recommendations was to establish a national system for organ allocation. The Executive Branch was authorized by Congress to set up such a national network.

    
    

27. The Department of Health and Human Services opted to contract the responsibility for national organ allocation to a private organization: the United Network for Organ Sharing (UNOS).

28. UNOS has a Board of Directors with both physician and non-physician representatives. The board is composed of members from the public, including patients, representatives of allied health fields (such as the American Hospital Association and the American Nursing Association), and representatives from other walks of life.

    
    

29. UNOS has an extensive committee structure designed to facilitate the development of policy. Allocation programs have been developed. Although they do not yet have the force of law, these programs are generally voluntarily followed nationwide.

    
    

    1. OPOs

       
       

30. An "Organ Procurement Organization," (OPO), set up to serve a specific geographic region, handles the actual organ procurement and distribution. Florida has five OPOs. They are located in Miami, Southwest Florida, Tampa, Orlando and Gainesville.

    
    

31. The Florida OPOs utilize a single statewide liver transplant candidate wait list for determining which patients should receive the next donor liver procured by any one of the five OPOs. Each name on the list is given a ranking, with the allocation decision being based on that priority. The ranking is based on numerous factors, including severity of the patient's condition and length of time on the wait list.

    
    

32. The Florida OPOs are part of UNOS Region 3, which consists of Florida, Louisiana, Arkansas, Mississippi, Alabama and Georgia.

    
    

33. If a procured organ is not suitable for transplant on any patient found on any local or statewide list in a particular state of a UNOS Region, then transplant centers within other states which are a part of the region have the next allocation priority for that donor organ.

    
    

34. If the procured organ is not suitable for use at any transplant center within the region, then the organ is made available on a national network basis.

    
    

    1. Numbers rising

       
       

35. Based on the analysis of forecast ranges which follows, it is reasonable to expect that, at least by 1997, there will be 300 livers retrieved in Florida available for use by Florida's adult programs, including St. Luke's.

    
    

36. Moreover, a conservative minimum of 165 donor livers procured in other states within UNOS Region 3 are available, and will continue to be available, to the Florida programs, including the St. Luke's program.

    
    

37. Current literature projects between 28 and 44 donors per one million population as a reasonable range of expectation for the donor cadaver rate in the United States. A number of OPOs are currently retrieving organs at a rate of over 30 per one million population.

    
    

38. For example, the Orlando OPO, TransLife, achieved an organ donor rate of 33.9 per one million population in 1994. Two of the other Florida OPOs have also experienced organ donor rates in excess of 33 per one million population.

39. In 1994, the State of Florida had 351 organ donor cadavers, which translates to 25 donors per one million population. Historically, there has been a 6 percent annual growth rate in the number of organ donor cadavers.

    
    

40. Based upon the most recent Florida data, the 6 percent annual growth rate assumption for organ donor cadavers is conservative. Florida realized 203 such organ donors for the first six months of 1995 which, on an annualized basis, constitutes a 16 percent increase over 1994.

    
    

41. This annualized data yields a 1995 Florida organ donor rate of 29 per one million population, compared to the 25 per one million population in 1994.

    
    

42. In order to determine the number of donor livers available from any given pool of donor cadavers, it is reasonable to assume a conversion ratio (a percentage representing organs donated which will be suitable for use) of between 70 to 80 percent. In the case of individual OPOs, on occasion, the rate can even be as high as 85 percent but all the experts in this case agreed that

    70 percent is achievable. The most likely point at which the conversion ratio would fall is somewhere between 70 and 80 percent with 80 percent being the maximum if providers were aggressive in using all available organs appropriate for transplantation.

    
    

43. In comparison, the 1994 Florida conversion rate was 66 percent. For the first six months of 1995, the ration was 118 out of 203 making the conversion rate 58 percent.

    
    

44. These lower than normal conversion rates for Florida are indicative of a situation in which there is still a large, untapped pool of donor livers which could be utilized in Florida because only the most ideal livers have been used by Florida's two active programs. In other words, donor livers have been available that programs more aggressive than Shands and Jackson would be able to utilize.

    
    

45. Based upon the annualized 1995 data as a benchmark, but assuming the more appropriate 70 to 80 percent conversion rate range (instead of 50 percent) yields 284 to 325 total adult donor livers that should have been available to Florida programs in 1995.

    
    

46. Applying the TransLife donor rate of 33.9 per one million population, (a reasonable rate to use in this proceeding because of the national range of 28 to 44 per million and since Translife is located in Florida) to a projected 1997 Florida population of 14.5 million yields 334 to 393 total livers.

    
    

47. Accounting for the fact that 85 percent of liver transplants are for adults, adjusting the range of total livers by 15 percent yields 292 to 334 adult livers by 1997.

    
    

48. Given that the 1995 annualized rate is already at 29 per one million population, a 30 per one million population rate is a reasonable expectation for the immediate future. Applying a rate of 30 per million population rate, a rate more conservative than the actual TransLife rate, to the 1997 Florida population projection yields 435 donor livers. Applying the same conversion rate and pediatric adjustment methodology then yields a range of 259 to 296 adult donor livers available to Florida programs by 1997.

49. Applying the historical growth rate of 6 percent to the 1995 base of

    406 total donor organs yields 456 donor livers by 1997. Applying the conversion rate range and pediatric adjustment to this projection then yields 271 to 310 adult donor livers from Florida in 1997, or 319 to 365 total livers.

    
    

    1. Available UNOS Region 3 Livers not Utilized by Florida Programs

    
    

50. Florida programs do not have to rely upon donor livers procured in Florida alone because supply is available from UNOS Region 3, a net exporter of donor livers nationwide.

    
    

51. Shands has used relatively few livers procured in other states in Region 3. For example, 95 percent of the donor livers utilized by Shands were procured in Florida. Jackson has used more from out of state but still the great majority of the livers procured for its program come from within Florida. Between January and June of 1995, 20 percent of the livers used by Jackson came from other states within Region 3.

    
    

52. Of the 505 Region 3 livers retrieved in 1994, 236 were used in the Region 3 state in which they were retrieved. Accordingly 269 livers were used in other states within the Region or elsewhere in the United States. Of these 269 donor livers, 104 were livers generated from Florida that were used at a program outside of Florida. Of the remaining net result, 165 livers, a substantial number could have been used in Florida.

    
    

53. Coincidentally, in 1994 exactly 165 donor livers were exported from Region 3 to transplant centers in other regions.

    
    

54. The 165 pool of donor livers available from other states within UNOS Region 3 is a conservative level. The overall donor rate for Region 3 during 1994 was 20.3 per one million population.

    
    

55. This rate should increase substantially given the fact that it is below Florida and national levels. The number of donors generated in UNOS Region 3 is also growing yearly at a 6 percent rate. Moreover, increased awareness among potential donors is influencing the development of more effective, efficient donor rate levels for Region 3.

    
    

56. Under a reasonable projection that the Region 3 use rate should soon hit at least 29 donors per one million population, applying the 70-80 percent conversion range, Region 3 should reasonably produce at least 131-150 additional livers in comparison to the 1994 level.

    
    

57. Moreover, a driving force in donor organ awareness is promotion by successful transplant patients who become active in supporting such programs in their communities. The increase in Florida programs' transplant volumes indicates that community awareness has increased.

    
    

58. St. Luke's application includes a plan to increase potential donor awareness acceptable to AHCA.

    
    

59. Nationally, the average wait list time for a liver transplant candidate is 8 to 12 months. The Shands and Jackson Memorial programs have significantly shorter wait list times for their patients. The Shands wait list time, for example, is 30 to 60 days with a median of 28 days.

60. These shorter wait list times reveal that the Shands and Jackson programs are not experiencing the pressure necessary to force the Florida programs to expand the criteria for donor liver selection, to thereby increase the donor liver conversion rate, and to take advantage of donor livers available from other states in Region 3. There is, in other words, no strain on the system.

    
    

61. Currently, because the system is functioning so well for Shands and Jackson Memorial, the two are able to utilize only the most ideal donor livers available. But, with experience, it has become common practice to use livers less than ideal. For example, 10 years ago using a liver donated by a person above the age of 70 was considered absolutely unacceptable. Today, these organs are being utilized.

    
    

62. There is room, therefore, in the system for more donor livers to become available.

    
    

63. Being more aggressive in the donor liver selection process and using more high risk donors, thereby increasing the number of donor livers available to the Florida programs, need not have an unacceptable impact upon outcomes. Mayo Clinic Rochester provides an example. The liver transplant wait list there is comparable to the national average. The resulting pressure causes its surgeons to be aggressive in selecting donor livers. Their aggressive selection manifests itself in the 85 percent conversion rate of the OPO serving the clinic. Nonetheless, Mayo Clinic Rochester produces the best outcomes among programs in the United States.

    
    

64. The lack of pressure on Florida explains why Shands and Jackson Memorial are not utilizing to any significant degree organs which become available from other states within Region 3. If wait list pressure builds, UNOS Region 3 should serve as a source of alleviation.

    
    

65. The shorter wait list times and corresponding lack of system pressure, too, given the overwhelming demand for services, demonstrates room for another program to identify and serve those with needs that could be met for liver transplantation services.

    
    

66. In short, there should be enough livers available for an active third program, without compromise to the ability of either Shands or Jackson to continue to strive towards becoming centers of excellence, goals within reach in the near future, whether St. Luke's CON is approved or not.

    
    

    6. Forecast of Transplant Volumes

    
    

67. St. Luke's reasonably projects that it will perform at least 15 transplants in year one and at least 30 in year two of operation. These projections underlie St. Luke's financial feasibility forecast. Although it is not possible to predict with precision, it is reasonable to assume 80 percent of St. Luke's liver transplant patients will be Florida residents with the remaining 20 percent coming from primarily UNOS Region 3, the southeast portion of the United States.

    
    

68. The St. Luke's program will draw patients from throughout the State of Florida. It is expected that roughly 45 percent will be from Service Planning Area One and the remainder from the southern half of the state.

69. The magnitude of demand and the supply of donor livers will allow St. Luke's to reach these start-up volumes, which constitute reasonable market share. In fact, on the demand side, the magnitude of the current outmigration of Florida residents for liver transplantation services is enough, in and of itself, to support these start-up volumes.

    
    

70. Quality and resulting reputation of a liver transplant program has a positive influence on whether physicians refer liver transplants to a facility. The success, efficiency and reputation of the Mayo Clinic Rochester program will enhance the St. Luke's program and promote referrals. Furthermore, St. Luke's will have the ability to tap into Mayo Rochester's proven infrastructure and protocols which will significantly facilitate program implementation.

    
    

71. Since the filing of the application in this case, St. Luke's has secured the services of a hepatologist who conducts a liver pre-transplant and post-transplant program at Mayo Clinic Jacksonville. It has also hired a second hepatologist to build additional program strength. St. Luke's is already developing a significant pool of patients in need of liver transplantation which will enable a rapid start-up for the St. Luke's program. Since 1994, St. Luke's has referred 12 patients for placement on a liver transplant wait list. It is expected that the volume of referrals will double before the St. Luke's program comes on line.

    
    

72. In sum, St. Luke's volume projections are reasonable.

    
    

    7. Financial Feasibility

    
    

73. The St. Luke's program is financially feasible in the near term. St. Luke's itself has over $54 million in liquid assets and its parent, the Mayo Foundation, has over $1 billion in liquid assets and over $1 billion in total assets.

    
    

74. The Foundation fully supports the proposed St. Luke's program from both a start-up and operational standpoint. The Foundation will provide financial support in the unlikely event money is lost in the immediate or long term and St. Luke's finds itself in need of outside support.

    
    

75. In any event, there is little likelihood that there will be a cash shortfall to operate the program as proposed in the application. If there were any shortfalls, St. Luke's itself has more than ample cash on hand to ensure its viability.

    
    

76. The St. Luke's application contains a hospital-wide budget projection for St. Luke's in 1994 of $4,672,000 in net income. The actual St. Luke's experience in 1994 was a net income of $81,000. The reduction of actual income over the projected income was the result of several extraordinary events, not likely to recur. They either will not be perpetuated or have been accounted for in future years.

    
    

77. Indeed, St. Luke's income through the first eight months of 1995 was on the rebound with a net income of $3.8 million.

    
    

78. St. Luke's reasonably and conservatively projected its revenues and costs to demonstrate long-term financial feasibility of its program. The program will make a positive contribution of approximately $900,000 to the St. Luke's hospital-wide margin by the second year of operation.

79. Each of the line-items and underlying assumptions related to the calculation of revenues and costs are reasonable and achievable.

    
    

80. In fact, they are conservative. For example, St. Luke's marginal costs per case are probably overstated in comparison to Shands current costs. Shands marginal cost per case is $58,000, compared to a projected cost of

    $75,000, for St. Luke's.

    
    

81. The results of St. Luke's financial projections for the project would not be materially affected given that the program will not now be implemented any earlier than 1997.

    
    

    8. Medicaid Patients

    
    

82. According to St. Luke's application, the St. Luke's Hospital proposed liver transplant program is being developed to provide care primarily to Florida residents who are medically in need of transplantation. Medicaid and indigent patients who traditionally have trouble accessing this expensive and sophisticated care will be included in the patients expected to be served. In support of this commitment, St. Luke's Hospital commits to provide care to all patients in need of the proposed service, regardless of ability to pay, up to the point that the financial viability of the program is impaired. Translation of this commitment into action is the representation in Table 7 of the application (Utilization By Class of Pay) that three Medicaid/Indigent patients are expected to be served in Year 1 and an additional four Medicaid/Indigent patients are to be served in Year 2. Petitioner's Ex. 1c., Omissions Response, CON Application, Vol. 4, p. 9. St. Luke's application stresses, however, that its commitment is not limited to just three and four Medicaid/Indigent patients in years one and two:

    
    

    It must be understood, however, that as stated above, St. Luke's commits to provide care to all patients, regardless of ability to pay. If additional Medicaid/Indigent patients are identified they, too, will be served. (e.s.) Id.

    
    

    Lest the agency be misled into thinking that St. Luke's will not make serious effort to identify Medicaid and indigent patients in need of liver transplantation services, the application follows with a statement promising beneficial advancement in medicaid and indigent patient access to liver transplantation services:

    
    

    The result of this commitment will be a significant improvement in access to liver transplant care for those with limited financial resources in Florida. Id.

    
    

83. St. Luke's pledge to provide liver transplantation care to medicaid and indigent patients is central to its case that its application be granted. This is because St. Luke's has neither a generous nor dependable history in this regard.

    
    

84. Between 1991 and 1994, St. Luke's provided medicaid and indigent patient days as follows: 0.9 percent in 1991, 1.1 percent in both 1992 and 1993, and 0.8 percent in 1994.

85. Its record with regard to tertiary services is even poorer. Of the

    17 bone marrow transplants done between 1992 and 1994, none was Medicaid. Of the 975 open heart surgeries analyzed since 1992 only five were Medicaid, less than 0.6. St. Luke's record stands in stark contrast to the record of its nearest prospective competitor: Shands. In its most recent year, 31 percent of the bone marrow transplants done at Shands were Medicaid while 17 percent of its open heart surgeries were Medicaid.

    
    

86. Shands, operating five organ transplant programs (heart, liver, kidney, lung and pancreas) is a disproportionate share provider of Medicaid services. Jackson Memorial provides even a larger percentage of its services to Medicaid patients and, in fact, is by far the largest disproportionate Medicaid provider in the state.

    
    

87. Much of Shands' patient care of Medicaid patients is in the areas of obstetrical and general pediatric care, neither of which is provided by St. Luke's. But even with these areas of care excluded, the comparison is not favorable; Shands still provides 13 percent of its care to Medicaid patients, as opposed to St. Luke's 0.8 percent for 1994 and the beginning of 1995.

    
    

88. For 1995, through July (two months prior to hearing), St. Luke's Medicare and Medicaid rates were at even lower levels than its historic levels.

    
    

89. All of the other hospitals in Duval County have higher Medicaid and indigent patient loads than St. Luke's. The lower percentages have been true for St. Luke's even when it has had a strong profit margin.

    
    

90. The decrease in the number of Medicare and Medicaid patients at St. Luke's is due, in part, to its costs increasing at a rate greater than its revenue in recent years. This, in turn, is due, at least in part, to the increase in managed care patients among the number of patients overall. Managed care is a less favorable payor on average than insurance. Hospital patients covered by insurance are decreasing as managed care patients increase.

    
    

91. The percentages for St. Luke's is not likely to increase given data reflecting past performance. Thus, its pledge becomes all important.

    
    

92. Provided St. Luke's satisfies its promise to treat all patients regardless of their ability to pay and as long as St. Luke's identifies patients who fall into this category, then by the second year of the program's operation,

    1. percent of the patient days will be attributable to Medicaid and 87 percent will attributable to patients covered with some type of insurance.

       
       

93. Out of the insurance, approximately 25 percent or 8 cases would be covered by managed care insurance product, with 55 to 60 percent covered by commercial insurance product.

    
    

94. Given the firmness of St. Luke's pledge with regard to Medicaid patients, its financial projections demonstrate reasonable payor mix calculations.

    
    

    9. Improved Access for Florida Residents

    
    

95. Access to a new program at St. Luke's will place the competitive pressure on Florida's system necessary to procure and utilize every possible donor liver from UNOS Region 3 as well as from Florida.

96. The addition of a larger portion of Florida's liver transplant demand pool to a wait list at the St. Luke's program alone will have the positive benefit of creating this pressure.

    
    

97. Since St. Luke's began seeking a certificate of need, both programs have made a significant investment in terms of staff and resources and significantly increased their volumes to evolve into mature, strong programs.

    
    

98. There is no evidence, however, to suggest that the Shands and Jackson Memorial program developments are in reaction to the St. Luke's application.

    
    

99. Nonetheless, given Mayo Clinic's reputation and the quality of care rendered within the Mayo Clinic system, the establishment of a program at St. Luke's will have a material impact on reversing outmigration by Florida residents for liver transplantation services.

    
    

100. Patient outmigration for this type of service is undesirable from a health planning perspective and does not represent optimal or cost efficient care.

     
     

101. This outmigration disturbs the continuity of care for the patient. The patient is unable to maintain close contact with his or her local physician.

     
     

102. This patient outmigration also causes adverse impacts upon the patient's family infrastructure in cases in which outmigration occurs for reasons other than to be with family. The patient not only has to deal with the emotional trauma of having a terminal illness in the absence of a transplant, but also with having to be dislocated from familiar surroundings and the emotional and family support system that may already exist.

     
     

103. This outmigration causes the patient or the patient's third party reimburser to incur significant costs due to transportation, temporary housing, and other expenses attendant to leaving Florida.

     
     

104. The Agency and the 1994 State Health Plan recognize that this patient outmigration is undesirable, and agree that Florida's health planning should encourage an environment to reduce such outmigration.

     
     

105. The level of outmigration for programs located in other states is indicative of inability, for whatever reason, of Florida's two active programs to serve the need in Florida.

     
     

     10. Compliance with State and Local Health Plan Preferences

     
     

106. The St. Luke's application satisfies to a significant degree almost all of the State and Local Health Plan preferences. For the remainder, the application complies with the intent, but not necessarily the letter.

     
     

107. District 4 Local Health Plan contains eight "allocation factors".

     
     

108. There is no dispute that the St. Luke's application satisfies the first criterion that transplant centers be located in a major metropolitan area with a county population of 250,000 or more "so that access to the services would be enhanced".

109. There is no dispute that the St. Luke's application satisfies the second criterion requiring the applicant to document written relationships with a broad spectrum of other health care providers, thereby helping to ensure continuity of care and non-duplication of costly services.

     
     

110. The third Local Health Plan criterion addresses stand-alone regional or national referral centers. The Agency unreasonably found that the St. Luke's application did not satisfy this criterion because the majority of its patients reside in District 4.

     
     

111. The St. Luke's application did demonstrate, however, that St. Luke's/Mayo Clinic Jacksonville is a regional provider. Moreover, affiliation of the St. Luke's liver transplant program with the nationally recognized Mayo Clinic Rochester program would be relevant to this criterion once the program was initiated in Jacksonville.

     
     

112. The District 4 Local Health Council supports approval of the St. Luke's application. The Local Health Council itself agreed that the proposed St. Luke's program "will serve a national clientele whose needs cannot be reflected within a formula designed to serve a portion of a single state".

     
     

113. There is no dispute that the St. Luke's application satisfies the fourth allocation factor which gives preference to hospitals and program which have a significant role in regional or national research efforts. St. Luke's/Mayo Clinic Jacksonville is already substantially involved with and committed to medical research, including research related to liver disease.

     
     

114. That research effort will be even further enhanced because of the leading national and international role of the Mayo Rochester liver transplantation program in research, and the participation of St. Luke's in that research.

     
     

115. The fifth and sixth allocation factors are not applicable because they address regional matters related to pediatric programs.

     
     

116. There is no dispute that the St. Luke's application satisfies the seventh Local Health Plan criterion which prefers applicants "who submit a plan to increase local organ donations."

     
     

117. There is no dispute that the St. Luke's application satisfies the eighth Local Health Plan criterion which prefers applicants who formally commit to charity care in the application.

     
     

118. St. Luke's application was preliminarily reviewed under allocation factors contained in the 1989 State Health Plan.

     
     

119. There is no dispute that the St. Luke's application satisfies the first criterion which requires assurance that it will accept transplant patients regardless of ability to pay.

     
     

120. There is no dispute that St. Luke's satisfies the third State Health Plan criterion preferring applicants with the other organ transplantation programs. St. Luke's has an adult bone marrow transplantation service. As an affiliate of St. Luke's, Mayo Clinic Rochester, in addition to liver transplantation, has heart, kidney, bone marrow, and pancreas transplantation programs.

121. There is no dispute that St. Luke's satisfies the fourth State Health Plan criterion which prefers teaching hospitals for the establishment of any organ transplant program. Although the Agency notes that St. Luke's is not a statutorily-designated teaching hospital, this particular State Health Plan criterion does not impose any such restriction upon the term "teaching hospitals".

     
     

122. The St. Luke's application satisfies the fifth State Health Plan criterion given to a member of UNOS because of its close affiliation with Mayo Clinic Rochester, a member of UNOS.

     
     

123. There is no dispute that the St. Luke's application satisfies the sixth State Health Plan criterion requiring implementation of the Uniform Anatomical Gift Act.

     
     

124. There is no dispute that the St. Luke's application satisfies the seventh State Health Plan criterion preferring teaching hospitals which document the establishment of a residency program related to the proposed transplant program.

     
     

125. The St. Luke's application also satisfies the eighth State Health Plan preference for NIH-approved facilities in Medicare designated centers. Again, affiliation with the Mayo Clinic Rochester program is relevant, with Mayo Clinic Rochester participating in NIH transplant data base research and being Medicare certified.

     
     

126. The more recent 1993 and 1994 State Health Plans adopted most of the criterion found in the 1989 Plan. Moreover, the 1994 Plan addresses a goal of enhancing Florida's health care system.

     
     

127. In that regard, the 1994 Plan addresses the establishment of centers of excellence, stating that "Florida should ensure that its consumers have a choice of outstanding medical and specialized care centers within the State and not be forced to seek better reputation out-of-state". Given the positive attributes of establishing a Mayo Clinic liver transplant program and the benefits to the system which can be achieved, St. Luke's application satisfies this State Health Plan goal.

     
     

128. That same discussion in the 1994 Plan concerning centers of excellence also relies upon the National Opinion Research Center (NORC) mathematical model for measuring the best hospitals in the United States.

     
     

129. The NORC published rankings in July, 1995, which rated Mayo Clinic's gastroenterology program as the number one program in the U.S.

     
     

130. This ranking is relevant to the St. Luke's application because St. Luke's/Mayo Clinic Jacksonville has direct access to that program, and because the Mayo Clinic Rochester liver transplantation program will be installed at St. Luke's.

     
     

131. Moreover, the NORC rating is relevant to support the notion that Mayo Clinic's reputation will give St. Luke's the ability to support its volume forecasts, to redirect outmigration, and to achieve the quality goals of its application.

     
     

132. The 1994 Plan also emphasizes managed care as a means to develop a better Florida health care system.

133. The Mayo Clinic Rochester program is a strong, viable, and aggressive participant in the managed care arena nationwide, presenting a tangible benefit to the St. Luke's program.

     
     

134. Further, the St. Luke's application addresses the legislative approach in Florida which encourages the establishment of integrated systems and programs because they will have the best opportunity to control costs and assure quality and succeed in the market place.

     
     

135. St. Luke's and Mayo Clinic Jacksonville already operate as part of an integrated system with enhanced opportunities to control costs and ensure quality.

     
     

     11. Impact to Existing Providers

     
     

136. The addition of the St. Luke's program will have competitive impact upon the two existing programs.

     
     

137. At their current volumes, both the Shands and Jackson Memorial programs far exceed the quality volume standard of 35 transplants annually as set forth by UNOS, and both are financially healthy.

     
     

138. When assessing the financial performance of a specific program which has been added to hospital operations, the analysis should assess the "contribution margin" performance of the program.

     
     

139. Also known as "incremental analysis," assessment of the contribution margin involves determining the difference between program net revenues and the variable costs of providing the service (i.e., those costs that vary either up or down depending upon volume and which are directly attributable to providing the service.)

     
     

140. Accordingly, the contribution margin analysis appropriately disregards hospital-wide overhead which would already be incurred and absorbed by the hospital in the absence of the specific service and which would be reflected in the hospital-wide profit margin experienced before the new program came on line.

     
     

141. Under this incremental analysis approach, the Shands adult and pediatric programs are profitable, with both making a positive contribution to overall hospital margin.

     
     

142. In the fiscal year 1995, the Shands adult program generated a contribution of $1.7 million and the pediatric program generated a $16,000 contribution to Shands hospital-wide margin. These profitable results are based upon Shands having performed 43 adult cases and 11 pediatric cases.

     
     

143. Hospital-wide, Shands finds itself in a very strong financial position. For example, in fiscal year 1994, Shands' net income was $20.6 million.

     
     

144. For fiscal year 1995, Shands did even better, generating a net income of $21.2 million, with $15 million being attributable to operating profit. In comparison, in its 1995 budget, Shands projected a net profit of $8 million with an operating profit of $4 million to $5 million, so its actual 1995 performance far exceeded its budget expectations.

145. Shands has cash and investments available to it in the amount of $78 million. Its fund balance is $275 million.

     
     

146. The significant degree of Shands' financial health is also emphasized by its intent to purchase five hospitals within the Santa Fe Health System.

     This acquisition is being undertaken with the hospital now being on a more conservative course for the future.

     
     

147. It is possible that Shands will finance the five-hospital acquisition entirely through a bond issue, relying upon the net income of the purchased hospitals to pay back principal and interest on the bonds. Shands will have to incur exposure and risk and pledge its full faith and credit behind this financing as a covenant of the bond issue.

     
     

148. An earlier $265 million 1993 capital expansion project was also to be financed out of bond proceeds. Shands intended, however, to contribute substantial cash to that product in order to reduce the level of exposure and risk that it would incur.

     
     

149. For the Santa Fe Health System acquisition, Shands will not be making any equity contribution to the project, and instead will rely totally upon bond proceeds for financing. Shands' willingness to take risks in regards to the Santa Fe Health System acquisition that it was not willing to take in 1993 is another strong indicator of its financial health.

     
     

150. The Agency has raised a concern over whether the St. Luke's program would divert paying patients and somehow hinder Shands' ability to provide liver transplantation services to Medicaid patients.

     
     

151. It readily appears, however, that Shands enjoys tremendous financial means to continue to carry out any indigent care role it desires in its liver transplantation program.

     
     

152. Achievement by St. Luke's of its second year volumes is not likely to come at unacceptable expense to Shands so long as St. Luke's fulfills its promises with regard to Medicaid and Indigent cases.

     
     

153. Given that Shands' program is already profitable at a volume of 43 adult and 11 pediatric cases, based upon fiscal year 1995 data, there is no evidence to suggest that it would not continue to be profitable with Shands growing to 68 or even 76 adult cases by 1996, prior to the St. Luke's program coming on line.

     
     

154. Likewise, there is no evidence to suggest that the Shands program would not remain profitable assuming it lost 24 cases to St. Luke's in the 1998- 1999 time frame "redirected" from what would be a volume of 77 to 90 adult cases at Shands in the absence of the St. Luke's program.

     
     

155. The St. Luke's program will have the ability to offer liver transplantation at a significantly lower charge than currently available in the market place, thereby resulting in lower costs to the system and enhancing price competition.

     
     

156. The St. Luke's projected charge for its second year of operation at

     $180,000 compares favorably with a projected comparable Shands charge of

     $191,000 per case.

157. The St. Luke's charge at $180,000 per case compares favorably with a projected $257,000 per case at the Jackson Memorial program.

     
     

158. Furthermore, it is likely that the St. Luke's program will achieve a reduction in both costs and charges as the St. Luke's program matures and becomes more "Rochester-like".

     
     

159. St. Luke's also compares favorably with the Jackson and Shands programs on other relevant charges. Major Diagnostic Category (MDC) 7 contains most of the Diagnostic Related Groups (DRGs) related to liver disease.

     
     

160. Shands DRG-specific rates with an MDC-7 are approximately 20 percent higher than St. Luke's charges. Jackson Memorial Hospital's DRG specific rates under MDC-7 are approximately 40 percent higher than St. Luke's charges in MDC- 7.

     
     

161. A "case mix index" adjustment accounts for differences in intensity and resource consumption among hospitals.

     
     

162. For 1994, Shands' overall case mix index adjusted inpatient revenue per admission was approximately 15 percent higher than the comparable benchmark for St. Luke's. Jackson's case mix adjusted inpatient revenue per admission was approximately 41 percent higher than the St. Luke's benchmark.

     
     

163. Shands and Jackson also have higher charges than St. Luke's when comparing tertiary services already offered by each of the three hospitals.

     
     

164. The DRGs applicable to open heart surgery are 104 through 108. Shands' revenues per discharge are significantly higher than St. Luke's revenues per discharge for each of those DRGs, by 54 percent for DRG 107, and by 56 percent for DRG 108.

     
     

165. Jackson's revenues per discharge are significantly higher than St. Luke's revenues per discharge for each of those DRGs, by 97 percent for DRG 104, by 62 percent for DRG 105, by 94 percent for DRG 106, by 86 percent for DRG 107, and by 44 percent for DRG 108.

     
     

166. For DRG 481, bone marrow transplant, Shands' revenues per discharge are 13 percent higher than St. Luke's revenues per discharge.

     
     

167. Unable to fend for itself in this proceeding, Shands' case was left to the agency But in AHCA, Shands finds a worthy ally. The point was well- made by the agency that Shands will suffer if it is left to care for all the Medicaid and indigent patients in need of liver transplantation services without a fair number of such patients being served by a new program at St. Luke's.

     
     

168. Shands, it is true, receives state funds for indigent patient care, under-funded state programs, and non-reimbursable teaching costs. But these funds are susceptible to reimbursement rate declines. Worse, there are no guarantees that these funds will continue.

     
     

169. The loss of commercial paying patient would be a net incremental loss to Shands of $69,000. It is expected that due to the proximity of Shands and St. Luke's, and the overlap in geographic service areas, up to 12 patients could be pulled from Shands in the first year of St. Luke's operation and up to 24 of St. Luke's 30 patients in year two of St. Luke's operation could come from the

     area of overlap with Shands. The impact of these numbers will be lessened by the increase in livers suitable for use and the concomitant increase in the number of procedures performable in Service Planning Area One, as well as statewide. Nonetheless, there will be an adverse impact to Shands, making St. Luke's pledge to identify and treat certain numbers of Medicaid patients all the more important.

     
     

     12. Analysis of Agency Policy Relevant To Review of Application

     
     

170. Since the preliminary denial of the St. Luke's application, the Agency has approved a heart transplant program at University Hospital in Jacksonville, and a kidney transplant program at Florida Medical Center in Broward County.

     
     

171. The Agency preliminarily denied the University application, seeing no need for a fifth heart transplantation program in Florida.

     
     

172. The University Hospital application was approved through litigation settlement just six months prior to the final hearing involving the St. Luke's application.

     
     

173. The University of Florida and Shands supported approval of the University application. They would provide operational and resource support for the University program.

     
     

174. Comparing the heart transplant market place to the liver transplant market place, the justification for approving a new heart transplant program is significantly less than the justification for approving a new liver transplant program.

     
     

175. From a comparative standpoint, the market for heart transplantation in Florida in about half of the size of the market for liver transplantation. The two existing liver transplant programs that perform twice the volume of the four existing heart programs.

     
     

176. The available pool of donor hearts available in Florida is 60 to 70 percent less than the current pool for liver donors. In fact, like donor livers, donor hearts are a scarce resource.

     
     

177. Compared to liver transplantation, there is significantly less outmigration for heart transplant services by Florida residents, and there is significantly less Florida residents on out-of-state wait lists for heart transplantation services.

     
     

178. Through witnesses from Jackson and Shands, the Agency expressed reservations about approving an organ transplantation program at a hospital which did not already have a solid organ transplant program of any other type in existence.

     
     

179. University Hospital, however, prior to receiving approval for its heart transplant program did not have any other type of solid organ transplant program. Like St. Luke's, University does have a bone marrow transplant program.

180. Approval of the University application added a third heart transplantation program to Service Planning Area One. The existing programs are located at Shands and at Tallahassee, Memorial Hospital in Tallahassee, Leon County, Florida.

     
     

181. Rule 59C-1.044 sets forth a requirement that existing programs within the service planning area be performing at least 24 heart transplants a year before approval of a new program. At the time the University program was approved, the Tallahassee program was operating, and has been consistently operating, at below 10 transplants per year.

     
     

182. At the time that the University application was approved, the Shands program was handling 38 heart transplants per year above the minimum, but well below its current liver transplantation volume.

     
     

183. In not opposing approval of the University application, Shands realized that the University program would draw private pay patients away from Shands' heart transplant program. Likewise, in deciding to approve the University application, the Agency recognized the same impact.

     
     

184. A primary factor the Agency relied upon to support approval of the University program was improving access for Medicaid patients.

     
     

185. The health planner from Shands who testified for the Agency explained that University of Florida/Shands found there to be a need for an additional heart transplant program in Service Planning Area One but not for a liver transplant program because "University of Florida physicians...propos[ed] the service," (Tr.1125), and they felt need was demonstrated.

     
     

186. The University heart transplantation program CON contains a condition that, by the second year of operation, three transplants must be provided to charity care/Medicaid patients on an annual basis.

     
     

187. In its application, St. Luke's included a hospital-wide pro forma; the University application did not. The service specific pro forma in the University application projected only a $5,000 profit for its heart transplant program, while St. Luke's projected $900,000.

     
     

188. The settlement agreement entered into between University and the Agency predicted approval upon a "weighing of all applicable statutory and rule review criteria."

     
     

189. The Agency approved a new kidney transplant program at Florida Medical Center in December 1993. The University of Miami transplant program supports, and would specifically provide operational and other resource support to, the Florida Medical Center program.

     
     

190. The Florida Medical Center application projects financial losses for its program, including a $150,000 loss by the second year of operation and a

     $100,000 loss by the third year of operation.

     
     

191. Both Jackson and Florida Medical Center are located within Service Planning Area Four. Rule 59C-1.044 requires that existing programs be handling a minimum volume of 30 cases prior to the approval of new programs.

192. At the time the Florida Medical Center application was approved, the Jackson kidney transplant program was handling 86 kidney transplants annually, well below its current liver transplantation volume.

     
     

193. An Agency witness who opposed the St. Luke's program was Dr. Joshua Miller, director of the JMH/University of Miami transplant program.

     
     

194. Dr. Miller argued that, among other reasons, the St. Luke's application should not be approved because St. Luke's does not have a solid organ transplant program. He also asserted that the St. Luke's program would not increase donor organ awareness and would not improve access.

     
     

195. Dr. Miller joined in the University of Miami's support for the Florida Medical Center kidney transplant application, arguing that it would enhance donor awareness and improve access.

     
     

196. In approving the Florida Medical Center application, the Agency found that the Florida Medical Center program would improve donor organ awareness, improve access, and that it had the capability to bring on line a quality program.

     
     

197. Like St. Luke's, Florida Medical Center did not have any solid organ transplant program.

     
     

198. Florida Medical Center is significantly closer to the existing kidney transplant program at Jackson Memorial Hospital than Shands is to St. Luke's.

     
     

199. Geographically, Service Planning Area One is much larger than Service Planning Area Four.

     
     

200. Subsequent to approval of Florida Medical Center application, Florida Medical Center attempted to transfer the CON to Cleveland Clinic Hospital located in Broward County. The University of Miami transplant program opposed implementation of the project at Cleveland Clinic.

     
     

201. The Agency espoused a planning policy through one of its physician experts that in assessing the need for a new liver transplant program, the Agency should not approve a new program is there is ample capacity already within the system or, alternatively, if the existing programs express a willingness or intent to continue to expand capacity.

     
     

202. This policy is unreasonable because both of the existing programs have the ability to expand their capacity at will and the policy effectively gives the existing providers absolute veto power over any new program.

     
     

203. Moreover, it nullifies the liver transplant rule and its need methodology. Since the rule grandfathered three programs, if capacity controls then the promulgation of the rule was meaningless as to allowing any more programs.

     
     

204. The Agency's original denial of the St. Luke's application was predicated upon the position that allowing a new program to come on line would be "a bit premature". The Agency found that the existing programs had not yet matured.

205. A liver transplantation program is mature when it is handling 50 transplants annually. This total could include pediatric cases as long as the majority are adults.

     
     

206. Under Agency rules, a CON reviewable service which fails to show any utilization for a 1-year period of time must secure a new CON to reactivate. Presumably, this rule applies to Tampa General.

     
     

207. The potential for a new liver transplant program to increase the availability of donor organs is an appropriate factor to be taken under consideration of need for the new program.

     
     

208. The Agency stresses the importance of demonstrating enhanced access for those who require a service but who are unable to obtain it.

     
     

209. On the other hand, fostering competition and the benefits that could be derived through new competition is an irrelevant inquiry for purposes of balancing the statutory and rule criteria when considering the St. Luke's application, according to the Agency.

     
     

210. Florida programs should wait-list as many liver transplant candidates as possible. Even if a patient expires while on the wait list, it was better to have had the individual on a wait list with the opportunity for a transplant.

     
     

211. Once on the wait list, any available organ that is suitable for use in the patient should be obtained for transplantation.

     
     

212. With this background, the Agency urged the adoption of a policy in regards to the St. Luke's application which finds that the existing lack of pressure on the system and the resulting "equilibrium" enjoyed by the Shands and Jackson program was somehow the most desirable, optimal situation.

     
     

213. The Agency believes that when there is "strain" on Florida's liver transplantation system, then it is appropriate to consider the addition of a new program.

     
     

214. With regards to assessing adverse impact on existing programs, the Agency looks at the existing provider's present scheme, health, what impact will not hurt the program, and overlap in the event a new program comes on line.

     
     

215. Moreover, when assessing the need for organ transplantation services, it is not Agency policy to guarantee a particular volume level for existing programs. Instead, it is Agency policy to achieve a comfort level that there is an adequate volume pool under which all programs can operate effectively.

     
     

     CONCLUSIONS OF LAW

     
     

216. The Division of Administrative Hearings has jurisdiction over the parties and the subject matter of this case pursuant to Sections 120.57(1) and 408.039(5), Florida Statutes.

     
     

217. The applicant, St. Luke's, has the burden of demonstrating entitlement to the issuance of a Certificate of Need by compliance with applicable statutory and rule criteria. Boca Raton Artificial Kidney Center v. HRS, 475 So.2d 260 (Fla. 1st DCA 1985).

218. For purposes of the Health Facility and Services Development Act," Sections 408.031-408.45, Florida Statutes, a certificate of need is "a written statement issued by the agency evidencing community need for a new, converted, expanded or otherwise significantly modified health care facility, health service, or hospice." Section 408.032(2), Florida Statutes.

     
     

219. The transplanting of solid organs, such as livers, is a tertiary health service as defined in Section 408.032(19), Florida Statutes and Rule 59- 1.002(65), Florida Administrative code.

     
     

220. By definition a high cost, highly complex, intense and specialized procedure, the transplantation of livers should be concentrated in a limited number of hospitals to ensure quality, availability and the costs effectiveness of that service.

     
     

221. St. Luke's has not challenged the rule establishing the geographic boundaries of the service planning area. When the rule establishing larger tertiary planning areas than agency districts was challenged, the authority of AHCA to utilize such larger geographic areas for tertiary services planning was upheld in the face of an argument that Florida's CON statutes contemplate planning solely on a service district basis. In Humhosco, Inc., et al v. HRS,

     1. FALR 244 (1991), the hearing officer wrote:

     
     

     St. Mary's contends that no statutory authority exists for combining "service district" to create "service areas." However, no prohibi- tion against combining districts 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.

     Id., at 266.

     
     

222. Rule 59C-1.044, Florida Administrative Code, the organ transplantation rule, does not include a minimum volume standard for existing providers. Such minimum volume requirements, like the ones included in the heart and kidney transplantation rules, among others, serve to assure that each existing provider has reached a rule-based minimum volume before consideration will normally be given to approval of a new program. The provision of the liver transplantation rules which sets a minimum of five liver transplants to be performed within two years has been specifically held not to be determinative of need. St. Luke's Hospital Association d/b/a St. Luke's Hospital v. AHCA, 16 FALR 1515, (Final Order, April 21, 1994.) To that extent, the analysis required by rule in this case is not whether the service planning area in question could be expected to absorb or support another liver transplant program, but whether such program is needed to improve patient access to services.

     
     

223. Under a balanced consideration of all relevant criteria, there is a need for the liver transplantation service program applied for by St. Luke's.

     
     

224. There will be beneficial competitive impact for consumers. A program at St. Luke's will help to maximize access at all three programs, inject price competition and could help relieve Shands of some of the financial pressure of providing access to the indigent/Medicaid population.

     
     

225. The St. Luke's application complies with the State and District Health Plans, thereby satisfying Section 408.035(1)(a), Florida Statutes.

226. The St. Luke's program will improve access for a substantial underserved demand, including access to donor organs, when the existing programs have not served that need to the fullest extent possible despite a 10-year history of liver transplantation in Florida. Thus, the St. Luke's application satisfies statutory criteria which require an assessment of the adequacy of like and existing health care services. See, Section 408.031(1),(b),(d),(f),(k) and Section 408.035(2)(a),(b) and (d), Florida Statutes.

     
     

227. The St. Luke's program will have a significant positive effect upon Florida's liver transplantation services. Thus, the application satisfies the criteria which address enhancement of competition and improvements or innovations in the financing and delivery of health services. See, Section 408.035(1)(h) and (l), Florida Statutes.

     
     

228. The St. Luke's program will enhance access to Florida's indigent population, thus satisfying the statutory criteria regarding the provision of services to all residents, regardless of ability to pay. See, Section 408.035(l)(h) and (n), Florida Statutes.

     
     

229. The St. Luke's program will provide medical research and education related to liver transplantation programs. Thus, the St. Luke's application satisfies criteria which assess the need for and encourage research and education. See, Section 408.035(l)(g) and (h), Florida Statutes.

     
     

230. The St. Luke's application, through its affiliation with Mayo Clinic Rochester, promotes economics and improvements and services that may be derived from operation of joint, cooperative, or shared health care resources, thereby satisfying Section 408.035(l)(e), Florida Statutes.

     
     

231. The St. Luke's application satisfies the applicable components of Rule 59C-1.044 in its entirety. It also satisfies the stated intent behind the rule which recognizes that affiliations with medical schools located outside the State are beneficial.

     
     

232. There will not be a negative impact from a St. Luke's program to Jackson Memorial. The Shands and Tampa General programs have little, if any, negative impact upon Jackson Memorial and neither would a St. Luke's program. But St. Luke's poses at least the potential for serious impact to Shands if it takes away commercial and managed health care cases from Shands and leaves Shands with indigent care. See Collier Medical Center vs. Department of Health and Rehabilitative Services, 462 So.2d 83, 85 (Fla. 1st DCA 1985). This negative impact to Shands is overcome so long as St. Luke's lives up to its indigent/Medicaid promise.

     
     

233. Furthermore, if St. Luke's lives up to its pledge to serve indigent and Medicaid patients, a St. Luke's program will improve access to the indigent as well as to non-indigents who are leaving the state for services.

     
     

234. St. Luke's has demonstrated demand for liver transplantation services by Florida residents that is not now being served by Shands and Jackson Memorial. For example, St. Luke's proved that Florida residents in need of liver transplantation are seeking services outside of Florida. While there may be reasons aside from lack of services in Florida for this outmigration, at least some of it is due to lack of service availability at Shands and Jackson

     Memorial. But whether outmigration is happening or not, the agency does not contest that Shands and Jackson cannot meet demand. It is virtually indisputable that demand is overwhelming the current system.

     
     

235. Even with St. Luke's coming on line, there will still be tremendous need in Florida for liver transplantation services. The agency, however, argues that the need question should be considered from more than the direct perspective of need. In addition, the agency argues it is incumbent on St. Luke's to prove that it can serve unmet need. This argument is underscored by the testimony of every expert who testified with regard to the question of organ availability. The key need issue in this case is whether three active programs can be supplied with sufficient suitable organs for liver transplantations.

     
     

236. St. Luke's has proven that there will be a sufficient number of livers available to all three programs, both from Florida and from outside of Florida in UNOS Region 3, should St. Luke's be granted a certificate of need. A sufficient number will be available because of the better jobs being done by OPOs, increased awareness for organ donors among the general population, Florida's and UNOS Region 3's status as net exporters of livers and ultimately because of the resultant rising trend in the numbers of donors. Furthermore, Shands and Jackson Memorial are not presently required to be aggressive in the use of less than ideal livers, a situation that St. Luke's with its relationship with Mayo Clinic Rochester will be able to take advantage of without compromising success in the delivery of liver transplantation services.

     
     

237. In the final analysis, St. Luke's application meets CON statute and rule criteria. The potential for adverse impact to Shands posed by St. Luke's will be acceptable provided St. Luke's fulfills its promises with regard to provision of liver transplantation services in Medicaid and indigent cases. Granting the application will increase the number of active liver transplantation programs to three, no more than were originally envisioned when Rule 59C-1.044, Florida Administrative Code, was promulgated, thereby doing no violence to the limitations necessarily placed upon the numbers of providers of tertiary services. St. Luke's, through affiliation with the Mayo Foundation and connection to Mayo Clinic Rochester, will make more aggressive use of donor livers. The result will be more liver transplantation in Florida, a result that, again due to its affiliation with Mayo Clinic Jacksonville, will not have an unacceptable impact on outcome to recipients of the services. Finally, the ever-increasing numbers of livers suitable for transplantation in Florida and UNOS Region 3 coupled with St. Luke's capacity to make use of "less-than ideal" livers, ensure that the addition at St. Luke's of a third active state program will meet some of the unmet demand with which the liver transplantation system in Florida is now burdened. Most importantly, for Florida, the addition of a liver transplantation program at St. Luke's means benefit to at least some of the needy residents of Service Planning Area One, and Florida citizens elsewhere, presently unable to receive transplantation services in Florida, or unable, perhaps, to receive liver transplantation services at all.

RECOMMENDATION

Based on the foregoing, it is, hereby, RECOMMENDED

1. That St. Luke's CON Application No. 7202 for a liver transplantation program be GRANTED;

   
   

2. That the granting of the application be conditioned upon St. Luke's pledge to provide three Medicaid patients in year 1 and four Medicaid patients in year 2 of operation with liver transplants and that thereafter at least 10 percent per year (averaged every 3 years) of liver transplants performed at St. Luke's be provided to indigent and/or Medicaid patients.

   
   

   DONE AND ENTERED this 29th day of March, 1996 in Tallahassee, Leon County, Florida.

   
   

   
   

   DAVID M. MALONEY, 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 29th day of March, 1996.

   
   

   APPENDIX TO RECOMMENDED ORDER, CASE NO. 93-4890

   
   

   The following rulings are made on the parties, proposed findings of facts: St. Luke's:

   1. Paragraphs 1 - 93, 97 - 113, 115, 116 - 126, 128, 132, 133, 134 - 138,

   140 - 146, 154 - 166, 176 - 182, 188, 190, 193 - 240, 245 - 260, 271 are

   accepted.

   2. Paragraphs 94 - 96, 114, 117, 127, 130, 134, 139, 148, 150 - 152, 167,

   168, 170 - 173, 175, 183, 184, 192, 241 - 244, 262 - 270, 272 are subordinate.

3. Paragraph 129 is rejected on the basis of past performance. This finding of fact is accurate only if St. Luke's meets its pledge to provide liver transplantation services to indigent and Medicaid patients.

4. Paragraph 131 is rejected. A St. Luke's program will have competitive impact that is negative as well as positive. The impact will be detrimental to Shands unless St. Luke's provides its fair share of liver transplantation services to Medicaid and charity cases.

5. Paragraph 147 is accepted in part and rejected in part. Again, competitive impact to Shands will be detrimental unless St. Luke's fulfills its promise to provide an adequate number of Medicaid and charity cases with liver transplantation services.

6. Paragraph 149 is rejected. See Rulings on St. Luke's proposed findings of fact nos. 129, 131 and 147 above.

7. Paragraph 153 is rejected. There is no evidence to support such an assumption.

8. Paragraph 169 is accepted. The second sentence is rejected for lack of evidence.

9. Paragraph 174 is accepted except when patient outmigration is due to the patient's need to be close to family members who reside out of Florida.

10. Paragraph 185 is accepted, provided St. Luke's meets its commitment to provide liver transplantation services to Medicaid patients.

11. Paragraph 186 is accepted as a statement made in the application and therefore as a basis underlying St. Luke's pledge toward treating a fair number of Medicaid patients to alleviate negative competitive impact on Shands. It is rejected, however, as a commitment St. Luke's could, in fact, fulfill. As Dr. Schiff testified, no liver transplant center could take all suitable indigent patients and remain fiscally sound. Vol. V, p. 542 of the transcript.

12. Paragraph 187 is accepted that St. Luke's commitment is the same as Mayo Clinic Rochester's. Rejected otherwise for the same reason in the ruling on Proposed Finding of Fact No. 186, above.

13. Paragraph 189 is rejected as to the first sentence. While not providing obstetrical, pediatrics, mental health, or substance abuse services explains in part St. Luke's low levels of Medicaid cases, it does not explain St. Luke's low levels in other areas of practice and delivery of medical services. To the contrary, not providing these services, since they are areas of medicine tending to generate great numbers of Medicaid cases, is consistent with St. Luke's low level of providing Medicaid services in other areas of service. The second sentence is accepted to the extent it explains Medicaid demand lower than in other areas in Jacksonville. St. Luke's location does not, however, justify its low level of Medicaid cases.

14. Paragraph 191 is rejected.

15. Paragraph 261 is irrelevant.

AHCA:

1. Paragraphs 1, 2, 4, 5, 7 - 10, 14 - 17, 21, 23 - 25, 27 - 30, 32, 34,

38, 44, 47 - 52, 63, 68, 69, 71 - 76, 78 are accepted.

2. Paragraphs 6, 11, 12, 20, 22, 36, 41, 53, 55, 56, 59, 80, 82 are

subordinate.

1. Paragraph 3 is accepted in part. The finances of the Mayo Foundation bear some relationship to the case since they are available if St. Luke's should ever find itself in the unlikely position of needing them.

2. Paragraph 13 is accepted in part. It is rejected as not relevant to the extent that granting the application is conditioned upon requiring St. Luke's to fulfill its pledge to provide liver transplantation services to Medicaid and/or indigent patients.

3. Paragraph 18 is rejected. St. Luke's expectations are legitimately based on performance in years other than in 1993 and 1994, including performance during the months in 1995 for which data was available at the time of hearing.

6. Paragraphs 19, 31, 33, 40, 42 - 45, 66, 67, 54, 58, 60 - 62 are

rejected as against the greater weight of the evidence.

1. Paragraph 26 is rejected. Despite the dramatic development of the Shands and Jackson Memorial program, substantial need exists in Florida for liver transplantation services.

2. Paragraph 35 is rejected in part. That Mr. Richardson's projections were unreasonably optimistic is rejected as against the greater weight of the evidence including the assumptions contained in this proposed findings which are accepted.

3. Paragraph 37 is accepted in part and subordinate in part. Despite agreement as to a 70 percent conversion rate as a minimum, it was not unreasonable for Mr. Richardson to use an 80 percent conversion rate since such a rate is achievable if aggressive use is made of available livers as promised by St. Luke's.

4. Paragraph 39 is accepted in part and rejected in part. The first sentence is rejected. See rulings on AHCA's paragraphs 35 and 37, in 8., and 9., above.

5. Paragraph 46 is rejected in part as argumentative. That St. Luke's approach was a "a sort of hybrid ... between proposing to fill an unmet need, and simply squeezing into the market," is argumentative. Otherwise accepted.

6. Paragraph 57 is rejected as against the greater weight of the evidence.

7. Paragraph 64 is accepted except for the 4th and 6th sentences. No party suggested the building of a hospital to serve liver transplant patients, alone. Each of the existing liver transplantation centers in Florida and St. Luke's have or propose the centers within existing hospitals. The 6th sentence is rejected as opinion without factual support and contrary to the greater weight of the evidence which showed more liver transplantation services could be conducted to serve Florida citizens if the St. Luke's application is granted.

8. Paragraph 65 is rejected as primarily argumentative and reciting conclusions as opposed to findings of fact.

9. Paragraph 70 is rejected.

10. Paragraph 77 is accepted as to the facts with the exception of the last sentence which is against the greater weight of the evidence and with the exception of the implication that having Mayo-trained physicians creates a "Mayo South."

11. Paragraph 79 is rejected as to the first sentence since it is a conclusion rather than a finding of fact. Otherwise, accepted.

12. Paragraph 81 is accepted in part, rejected in part as against the greater weight of the evidence.

COPIES FURNISHED:

Sam Power, Agency Clerk

Agency for Health Care Administration Fort Knox Building 3

2727 Mahan Drive, Suite 3431

Tallahassee, FL 32308-5403

Jerome W. Hoffman, General Counsel Agency for Health Care Administration Fort Knox Building 3

2727 Mahan Drive, Suite 3431

Tallahassee, FL 32308-5403

John F. Gilroy, Esquire

Agency for Health Care Administration Fort Knox Building 3

2727 Mahan Drive, Suite 3431

Tallahassee, FL 32308-5403

Michael J. Cherniga, Esquire Greenberg, Traurig, Hoffman, Lipoff,

Rosen & Quentil, P.A. Post Office Drawer 1838 Tallahassee, FL 32302

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions to this Recommended Order. All agencies allow each party at least 10 days in which to submit written exceptions. Some agencies allow a larger period within which to submit written exceptions. You should contact the agency that will issue the final order in this case concerning agency rules on the deadline for filing exceptions to this Recommended Order. Any exceptions to this Recommended Order should be filed with the agency that will issue the final order in this case.

Docket for Case No: 93-004890CON

Orders for Case No: 93-004890CON