STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
UNIVERSITY DIALYSIS ARTIFICIAL ) KIDNEY CENTER, )
)
Petitioner, )
)
vs. ) CASE NO. 84-2299
)
DEPARTMENT OF HEALTH AND )
REHABILITATIVE SERVICES, )
)
Respondent, )
and )
) BROWARD NEPHROLOGY ASSOCIATES, ) INC., )
)
Intervenor. )
) WEST BROWARD ARTIFICIAL )
KIDNEY CENTER, )
)
Petitioner, )
)
vs. ) CASE NO. 84-2634
)
DEPARTMENT OF HEALTH AND )
REHABILITATIVE SERVICES, )
)
Respondent, )
and )
) BROWARD NEPHROLOGY ASSOCIATES, ) INC., AND UNIVERSITY DIALYSIS ) ARTIFICIAL KIDNEY CENTER, )
)
Intervenors. )
)
RECOMMENDED ORDER
Pursuant to notice, the Division of Administrative Hearings, by its duly designated Hearing Officer, William J. Kendrick, held a public hearing in the above-styled cases on February 3-7, 1986, in Fort Lauderdale, Florida.
APPEARANCES
For Petitioner, George N. Meros, Jr., Esquire University Dialysis CARLTON, FIELDS, WARD, EMMANUEL, Artificial Kidney SMITH & CUTLER, P.A.
Center: Post Office Drawer 190
410 First Florida Bank Building Tallahassee, Florida 32302
For Petitioner, E. G. Boone, Esquire West Broward Peter R. Giroux, Esquire Artificial Kidney 1001 Avenida del Circo Center: Post Office Box 1596
Venice, Florida 34284
For Respondent, John F. Gilroy, Esquire Department of Health Department of Health and and Rehabilitative Rehabilitative Services Services: 1323 Winewood Boulevard
Building One, Suite 407 Tallahassee, Florida 32301
PRELIMINARY STATEMENT
Petitioners, University Dialysis Artificial Kidney Center (University) and West Broward Artificial Kidney Center (West Broward) contest the decision of the Department of Health and Rehabilitative Services (Department) to deny their applications for a certificate of need (CON) to establish 7- station kidney dialysis facilities in southwest Broward County.
At hearing University called, as witnesses: Lawrence R. Spira; Steven Zeig, accepted as an expert in internal medicine and nephrology; Joanne Hoover; Vicky Burrier, accepted as an expert in chronic dialysis nursing; Ann Towne; Spiro Moutsatos, accepted as an expert in health planning with emphasis on ESRD services; Herbert Straughn; Christine Collins, accepted as an expert in chronic dialysis nursing; Brenda Braumiller; and Nancy Persily, accepted as an expert in health care planning and gerontology. University Exhibits 1-20 were received into evidence. 1/
West Broward called, as witnesses: Theodore Rosenberg, accepted as an expert in hospital administration; Ronald Schultz, accepted as an expert urban and economic geographer, applied locational analysis; Jim Robinson, accepted as an expert in accounting; Edward Perrine, accepted as an expert in health planning; Harry Burns; Sonia Brown, accepted as an expert in chronic dialysis nursing; Patricia Burgs; Carla Holder; Clementine Odems; Robert Geronemus, accepted as an expert in nephrology; Paul Feinsmith; Roy Gioconda; Lualhati Lawyer; Lawrence R. Spira; Robert Allen, accepted as an expert in ESRD nursing and the administration of ESRD facilities; Neil Schneider, accepted as an expert in nephrology and ESRD medical direction; Robert L. Levinson, accepted as an expert in nephrology; Nolan A. Lerner, accepted as an expert in nephrology; and Steven Zeig. West Broward Exhibits 1-11, 15-17, 19, 20, 27, 32, and 34 were received into evidence. 2/
The Departments called Herbert Straughn, accepted as an expert in health care planning and certificate of need review, as a witness, but offered no exhibits.
The transcript of hearing was filed March 21, 1986. The parties waived the requirement set forth in Rule 28-5.402, Florida Administrative Code, that a recommended order be entered within 30 days after the transcript is filed.
The Department, University, and West Broward have submitted proposed findings of fact, and they have been reviewed and considered. A ruling has been made on each proposed finding in the appendix to this Recommended Order.
FINDINGS OF FACT
University and West Broward filed applications in the same batching cycle to establish 7-station chronic renal dialysis facilities in southwest Broward County. On May 30, 1984, the Department denied their applications, and each filed a timely petition for formal administrative review. The petitions of University and West Broward were subsequently consolidated for comparative hearing.
The proposals of University and West Broward are essentially the same. Each applicant proposes to establish a 7- station free-standing chronic renal dialysis facility within the southwest sector of Broward County to serve patients residing essentially west of the Florida Turnpike, south of West Broward Boulevard, and east of U.S. 27.
The facilities proposed will offer a wide range of chronic dialysis services, including standard chronic hemodialysis, continuous ambulatory peritoneal dialysis (CAPD), home hemodialysis and home CAPD, bicarbonate dialysis, pediatric dialysis, and high-flux dialysis. The applicants also propose to offer comprehensive ancillary services to their patients including dietetic and social services, home dialysis training, laboratory, and blood services.
The Need for the proposed facilities.
Pertinent to this proceeding, Rule 10-5.11(18), Florida Administrative Code, establishes the applicable methodology for calculating numerical need for chronic renal dialysis facilities within a service area. Applying the rule methodology to the service area applicable to this case, District X - Broward County, 3/ establishes that there is an excess of nine End State Renal Dialysis (ESRD) stations in the service area, and no need for the proposed facilities. The availability, quality of care, efficiency, appropriateness, accessibility, extent of utilization, and adequacy of like and existing health care services.
Access to chronic dialysis care is a fundamentally important criterion in the evaluation of applications to establish such facilities. Dialysis is a life sustaining medical procedure whereby an ESRD patient's blood is passed through an artificial kidney to remove the impurities his dysfunctional kidney can no longer remove. ESRD is normally a lifetime form of health maintenance which requires three treatments of four to five hours duration each week. In addition to the life sustaining character of ESRD care, the importance of access is made more critical by the fact that dialysis patients are typically elderly and infirm. The average patient is over 60 years of age and suffers acute
multi-system disease. Because of their age and infirmity, most dialysis patients must depend on family or friends for transportation to and from the facility. Accordingly, ESRD facilities must be sited so their services are available to an ESRD patient within a reasonable period of time.
While the department averred that it had not established a bench mark which it considered a reasonable drive time for ESRD patients, the proof is clear that it consistently adopted the need recommendations of Network 19 which were predicated on a maximum drive time of 30 minutes to receive treatment. The evidence establishes sound medical reasons for Network 19's bench mark, and the Department failed to offer any persuasive proof why its prior application of a 30-minute drivetime standard should not apply in this case. 4/
Network 19 has, for purposes of determining need under its 30-minute accessibility standard, divided Broward County into three catchment areas; northern, central and southern Broward County. The southern catchment area, within which the proposed facilities would be located, currently has 50 approved ESRD stations, together with a 3-station backup at Memorial Hospital, and a projected need for 48 stations. Accordingly, no need exists, under Network 19's established collegiate policy, for the proposed facilities.
While neither the Department's rule methodology nor Network 19's current policy demonstrate a need for the proposed facilities, University and West Broward assert that because of accessibility problems a need exists inn the "sub-area" of southwest Broward County that they have defined. 5/ To establish this "need," each applicant employed Network 19 to do an analysis of their zip code defined "sub area" (catchment area). Using the applicants' catchment area, and applying the rule based methodology to those catchment areas, Network 19 calculated a "need" within the sub-areas for 13-16 ESRD stations. Network 19 offered no opinion, however, as to the propriety of the applicants' catchment areas.
Network 19's analysis does not establish a need for the proposed facilities. All Network 19's analysis establishes is that there exists an adequate ESRD patient base within the applicants' proposed catchment areas to support 13-16 ESRD. 6/ stations. Whether existing facilities are accessible to that patient base is dispositive of the question of need. 7/
To demonstrate that ESRD patients residing in its proposed catchment area were without the 30-minute accessibility standard, University introduced evidence of a drive time study it had commissioned. Utilizing eleven different routes from each ESRD facility serving south Broward County, the study circumscribed for morning, mid-day, and afternoon peak traffic hours a 30-minute drive time from each facility. University then took the data from the drive time studies done from Florida Kidney Center and BMA-Hollywood and superimposed it on a zip code map to demonstrate a 30-minute drive time from each of these facilities to the zip codes within its proposed catchment area. (University Exhibit 17) University asserts that this evidence demonstrates 7-8 ESRD patients must drive more than 30 minutes to receive treatment during the morning peak traffic hour, 8 patients must drive more than 30 minutes during the mid-day peak, and 6-7 patients must drive more than 30 minutes driving the afternoon peak. Therefore, University concludes, the evidence establishes that ESRD patients residing in southwest Broward County suffer an accessibility problem which must be addressed. University's proof is unpersuasive.
University's Exhibit 17 does not purport to locate the residence of any ESRD patient within any zip code zone but, rather, simply indicates the total number of patients residing in each zone. Accordingly, in those circumstances where the 30- minute drive time line passes through a zip code zone the evidence can be as easily interpreted to demonstrate that those patients are within a 30-minute drive time from the selected facilities, as without a 30-minute drive time. Excluding such patients, University's exhibit
only demonstrates that, at the most, 2 patients are without the 30-minute drive time at morning, mid-day, and afternoon peak traffic hours. These two patients, the same in each instance, reside in zip code zone 33332 and 33330.
Network 19's data for November, 1985, reveals no ESRD patients residing in zip code zones 33332 or 33330. The patients University identified are the result of 1986 data. This is significant because Rule 10-5.11(18)(a), Florida Administrative Code, provides:
The base period for determining the need for a proposed facility is one year from the date that the application is deemed complete by the department.
Since the parties' applications were denied by the Department on May 30, 1984, there is no evidence of any ESRD patient residing outside University's 30-minute drive time study for the applicable base period.
Even assuming that utilization of 1986 data were appropriate, University's drive time studies are not credible. University's analysis is predicated upon worst case conditions; peak traffic hours. With the exception of possibly the mid-day hours, ESRD patients will not be required to travel during peak traffic hours. Further, University's drive time studies are uncorroborated hearsay. They were prepared by David Plummer and Associates, Inc., at the request of University's health planning expert Nancy Persily. Not one witness from David Plummer and Associates, Inc., appeared at hearing to authenticate University's exhibits or to offer evidence which would demonstrate the veracity of the facts those exhibits sought to depict. In the absence of such proof, the opinions of Ms. Persily, and the other experts who relied on such studies, are not credited.
In sum, the applicants have failed to establish that there exists any problem with availability, quality of care, efficiency, appropriateness, accessibility, extent of utilization or adequacy of like or existing health care services for ESRD patients residing in their proposed catchment areas. 8/ The availability and adequacy of other health care facilities and services in the service district.
The evidence is clear that there is an excess of 9-ESRD stations in the service district (Broward County), as well as an excess of ESRD stations in south Broward County. These facilities are adequate to serve the ESRD patients residing in southwest Broward County, and their services are readily available to such residents.
Financial feasibility
The applicants have demonstrated that their respective proposals are financially feasible. Such feasibility exists, however, solely because the physicians which will staff their facilities have existing ESRD patients residing in southwest Broward County. The financial feasibility of these proposals is, therefore, at the expense of existing facilities and not an indication of need.
Other criteria
The parties stipulated that the criteria established by Sections 381.494(6)(c)10 and 381.494(6)(d), Florida Statutes, are not applicable to this
case. The need criteria established by Sections 381.494(6)(c) 6, 7, and 11, Florida Statutes, were not shown to be, and are hereby found not to be, applicable to this case. Each applicant has demonstrated that its proposal complies with the provisions of Sections 381.494 (6)(c) 3, 5, 8, 12 and 13, Florida Statutes. 9/
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the parties to, and the subject matter of, these proceedings.
Pertinent to this proceeding, Section 381.494 (6)(c), Florida Statutes, establishes the criteria which must be considered in evaluating applications for a certificate of need. See: Balsam v. Department of Health and Rehabilitative Services, 486 So.2d 1341 (Fla. 1st DCA 1986) and Department of Health and Rehabilitative Services v. Johnson and Johnson Home Health Care, Inc., 447 So.2d 361 (Fla. 1st DCA 1984). The weight to be accorded each criteria and the consequent balancing of the criteria will, however, vary depending on the facts and circumstances of each case. See: Graham v. Estuary Properties, Inc., 399 So.2d 1374 (Fla. 1981).
In the instant case, need as defined by Sections 381.494(6)(0)1 and 2, Florida Statutes, is the key criteria in evaluating the proposals of University and West Broward. Their failure to satisfy that need criteria is dispositive of their request for licensure, and such failure is not outweighed by any other, or combination of any other, criteria.
Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the applications of University and West Broward for a
certificate of need to establish a kidney dialysis facility in Broward County, Florida, be DENIED.
DONE and ENTERED this 30th day of July, 1986, in Tallahassee, Florida.
WILLIAM J. KENDRICK,
Hearing Officer
Division of Administrative Hearings The Oakland Building
2009 Apalachee Parkway
Tallahassee, Florida 32301
(904) 488-9675
Filed with the Clerk of the Division of Administrative Hearings this 30th day of July, 1986.
ENDNOTES
1/ University Exhibits 12 and 13, its application for a certificate of need and revisions, were admitted into evidence over the Department's objection. To the extent it contains uncorroborated hearsay, it may not form the basis for a finding of fact.
2/ West Broward Exhibit 10, its revised application for a certificate of need, was admitted into evidence over the Department's objection. To the extent it contains uncorroborated hearsay, it may not form the basis for a finding of fact.
3/ Both the state and district health plans consider Broward County as the service area. Neither plan has adopted subdistricts within the county for purposes of calculating a numerical need.
4/ Network 19, a short title for ESRD Network 19, was established under the auspices of the Federal Health Care Finance Administration (HCFA). Network 19 performs three major functions: (1) patient ombudsman, (2) planning, and (3) patient tracking. Network 19 has a computer registry that maintains information on every dialysis and transplant patient in Florida, and this information provides the sole data base for ESRD patient information in Florida. At the request of the Department, Network 19 previously provided expert counsel and advice on all new hemodialysis service applications, and its advice was followed on approximately 95 percent of the applications. Currently, however, while the Department utilizes Network 19's data, it does not have the same formal arrangement with Network 19 whereby it once rendered recommendations on all ESRD applications.
5/ The applicants' designated "sub-areas" are essentially the same. University's "sub-area" includes, however, the zip code zone of its existing facility, Plantation AKC, and an adjacent zip code zone. Inclusion of these zip code zones within its proposed "sub-area" results in the expansion of the current patient census by 9 and of the population forecast for November, 1986 by approximately 39,000. This "overlap" significantly inflates University's "need" calculations.
6/ It takes little imagination to gerrymander the boundaries of a "catchment area" so as to include a sufficient patient base which would, when the rule methodology is applied, facially demonstrate need. However, numerical need is established on a district-wide basis, not "sub-areas." Whether there is a need in this case is dependent on the applicants' ability to demonstrate that existing facilities are not accessible to the patient base it proposes to serve.
7/ Section 381.494(6)(c)2, Florida Statutes, requires an evaluation of the availability, quality of care, efficiency, appropriateness, accessibility, extent of utilization, and adequacy of like and existing health care services in the service district. While the gravamen of the applicants' case was 30- minute drive time accessibility, it is significant to note that there is no adverse showing concerning a lack of availability, quality of care, efficiency, appropriateness, extent of utilization or the adequacy of existing facilities.
While there exists over utilization at some facilities, both Broward County and south Broward County have an excess of ESRD stations.
8/ In reaching this conclusion the "informal" drive time study performed by University's personnel has not been overlooked. That study, consisting of one drive from the middle of each zip code zone to the nearest ESRD facility, at an unknown time of day, suffers the same deficiencies, and more, as University's other study. Nor has the testimony of Dr. Zeig that he has "patients" residing in southwest Broward that must drive over 30 minutes for treatment, nor Ms.
Burrier's testimony that she is aware of at least two patients at Plantation that must drive more than 30 minutes, been overlooked. Their testimony is not,
however, compelling; there is no evidence that those patients are utilizing the facility closest to their residence. Notably, neither applicant offered the testimony of one ESRD patient residing in their respective catchment areas who professed to have any accessibility problem.
9/ While each applicant has demonstrated probable economies and improvements in service by virtue of their existing facilities and purchasing arrangements, there is no evidence that they will reduce the level of health care costs in the service districts or that their entry would otherwise improve costs or services because of competition. Further, while each applicant avers that it will offer its services to the indigent, there is no evidence that such a need exists as to override the lack of need demonstrated in this case.
APPENDIX TO RECOMMENDED ORDER IN CASE NOS. 84-2299, 84-2634
University's proposed findings of fact are addressed as follows:
Addressed in paragraph 1.
Addressed in paragraphs 2-3.
3-7. Addressed in paragraph 16, or not necessary to the result reached.
8-14. Addressed in paragraphs 5-6.
15. Addressed in paragraph 12.
16-25. Addressed in paragraphs 7-13 and 15.
26-29. Addressed in paragraphs 4, 7-13.
30-31. Addressed in paragraph 16.
32-36. Addressed in paragraphs 15 and 16, or not necessary to result reached.
37-41. Addressed in paragraph 16.
West Broward's proposed findings of fact are addressed as follows: 1-22. Addressed in paragraphs 4-13.
23-24. Addressed in paragraphs 14-16.
25. Addressed in paragraphs 2-3. 26-36. Addressed in paragraphs 16-17.
37. Addressed in paragraph 16.
38-49. Addressed in paragraphs 16-17.
50-54. Addressed in paragraphs 15-17.
55-71. Addressed in paragraphs 16-17.
72-73. Addressed in footnotes 1-2.
The Department's proposed findings of fact are addressed as follows:
1. Not relevant.
2-4. Addressed in paragraphs 1-2.
5-8. Addressed in paragraphs 5-6.
9-11. Addressed in paragraph 4.
12-23. Addressed in paragraphs 5-13.
24-25. Addressed in paragraph 16.
26-30. Addressed in paragraph 16.
Addressed in paragraph 15.
Addressed in paragraph 16.
Addressed in paragraph 14. 34-36. Addressed in paragraph 16.
COPIES FURNISHED:
George N. Neros, Jr., Esquire CARLTON, FIELDS, WARD,
EMANUEL, SMITH & CUTLER, P.A.
Post Office Drawer 190
410 First Florida Bank Bldg. Tallahassee, Florida 32302
E. G. Boone, Esquire Peter R. Giroux, Esquire 1001 Avenida Del Circo Post Office Box 1596 Venice, Florida 34284
John F. Gilroy, Esquire Department of Health and
Rehabilitative Services 1323 Winewood Boulevard
Building 1, Suite 407
Tallahassee, Florida 32301
William Page, Jr., Secretary Department of Health and
Rehabilitative Services 1323 Winewood Boulevard
Tallahassee, Florida 32301
Steve Huss, General Counsel Department of Health and
Rehabilitative Services 1323 Winewood Boulevard
Tallahassee, Florida 32301
| Issue Date | Proceedings |
|---|---|
| Jul. 30, 1986 | Recommended Order (hearing held , 2013). CASE CLOSED. |
| Issue Date | Document | Summary |
|---|---|---|
| Oct. 20, 1986 | Agency Final Order | |
| Jul. 30, 1986 | Recommended Order | Lack of need under department methodology and failure to demonstrate special circumstances fatal to application of Certificate Of Need to establish dialysis program. |
