3-200) STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION «= Florida Health Sciences Center, Inc., dba Tampa General Hospital; Lakeland Regional Medical Center, Inc.; St. Joseph’s Hospital, Inc.; and University Community Hospital, Inc., Petitioners, VS. Agency for Health Care Administration and Galencare, Inc., dba Brandon Regional Hospital, Respondents. Case nos. 00-0481, 00 0 00-0484 and 00-0485 - . CON no. 9239 re Rendition no. AHCA-01-2O9-FOF-CON bmm-CUs FINAL ORDER This cause was referred to the Division of Administrative Hearings for a formal administrative hearing. At issue in this proceeding is whether Galencare, Inc., d/b/a Brandon Regional Hospital, should.be granted a Certificated of Need (CON) to establish an additional open heart surgery program in Hillsborough County, Florida. The assigned Administrative Law Judge (ALJ) has submitted a Recommended Order to the Agency for Health Care Administration (Agency). The Recommended Order of March 30, 2001, entered herein is incorporated by reference. ULINGS ON EXCEPTIONS RULINGS ON EXCEPTIONS Exceptions were filed by all parties to this proceeding. Petitioners filed joint exceptions. | I. AGENCY Counsel for the Agency excepts to the AL’s conclusions of law in paragraphs 225 and 227 establishing a fixed need pool (numeric need number) of three for the planning horizon addressed in this proceeding. The fixed need pool is the numeric: need for new programs, also known as the Rule need. The methodology for determining Rule need for new open-heart surgery programs is set forth in Rule 59C-1.033(7), Florida Administrative Code. All elements of the Rule methodology are considered together to derive the numeric need number for the district and planning horizon. Pursuant to the Rule methodology, the numeric need number is zero for the district and planning horizon under consideration. The numeric need number of zero was properly published and was not challenged. See Fla. Admin. Code R. 59C-1.008(2). The exception is” therefore granted.' . II. GALENCARE Galencare objects to the ALJ’s use of the word “typical” as an adjective modifier of the CON term of art “not normal circumstances.” As stated above, the methodology for determining Rule need for new open-heart surgery (OHS) programs is prescribed in Rule 59C-1.033(7), Florida Administrative Code. The rule, which is based on demographic and utilization data for the district and a fixed planning date in the future ! This clarification also addresses Galencare’s and Petitioners’ concerns expressed in their exceptions to the ALI’s comments regarding the fixed need pool. : (planning horizon), generates a number representing the number of new OHS programs needed in the clistrict (numeric need or Rule need). Rule 59C-1.033(7)(b) allows only a net need for one additional OHS program in a district. The need number is calculated and published periodically (batching cycle). The absence of numeric need under the need formula establishes, in effect, a rebuttable presumption of no need. Thus, where, as here, there is no numeric neeci for the planning horizon at issue, a proposal for a new OHS program nevertheless may be approved if there are “not normal” circumstances justifying approval of a new program; i.e., there is nead for a new program due to “not normal” circumstances within the district. See Belsam, v. Dep't of Health and Rehab. Servs., 486 So. 2d 1341 (Fla. 1st DCA 1986); Humhosco v. Dep't of Health and Rehab. Servs., 476 So. 2d 258 (Fla. ist DCA 1985). . The Agency’s determination whether considerations other than Rule need constitute “not normal” circumstances sufficient to justify approval despite a lack of numeric need is a conclusion of law and a matter left to the sound discretion of the Agency. See Federal Property Mgmt. v. Dep’t of Health and Rehab. Servs., 482 So. 2d 475 (Fla. 1st DCA 1986); Humana v. Dep't of Health and Rehab. Servs., 492 So. 2d 388 (Fla. 4th DCA 1986). “Not normal” circumstances and the weight to be given them are determined on a case-by-case basis. See Halifax Hosp. v. Agency for Health Care Admin., 19 F.A.L.R. 2484, 2487 (AHCA), aff'd per curiam, 698 So, 2d 841 (Fla. 1st DCA 1997). By their nature, then, “not normal” circumstances cannot be classified as typical. As such, the word “typical” is inappropriate as used by the AL). Accordingly, the exception is granted. Galencare also excepts to several findings of fact favorable to Petitioners or, by remote implication, adverse to Galencare “. . . to preserve its right to address such rulings and conclusions in the event an appeal is taken.” Specifically, Galencare excepts to findings in paragraphs 84 regarding economic access, paragraph 97 regarding the effectiveness of thrombolytic therapy, paragraph 160 regarding transfer of patients from Brandon for OHS, and, in whole or in part, findings in paragraphs 12, 20, 33, 48, 69, 70, 71, 73 through 75, 82, 88, 136, 140, 145, 166, 167, 168, 174, 175, and 178 through 196. The challenged findings are supported by the record, and the exceptions are denied See Heifetz v. Dep't of Bus. Reg., 475 So. 2d 1277, 1281 (Fla. ist DCA 1985). . III. PETITIONERS A. Petitioners’ Exceptions to Factual Findings Petitioners except on the grounds of factual and legal relevance to paragraph 4 wherein the ALJ found that the three OHS providers in Hillsborough County are located east of Interstate 75. Brandon Regional Hospital is just west of Interstate 75. The finding is marginally relevant in light of the findings on the accessibility of the three providers. Additionally, the argument that receiving such evidence is a de facto subdistricting has been rejected. See South Broward Hosp. Dist. v. Agency for Health Care Admin., 17 F.A.L.R. 3539, 3540 (AHCA 1995); South Broward Hosp, Dist. v. Dep’t of Health and Rehab. Servs., 14 F.A.L.R. 3163, 3164 (HRS 1992). The exception is denied. Likewise, the exceptions to paragraphs 47 through 50, 52, and 53 are denied. 4 Petitioners’ exceptions to paragraphs 51, 95, 110, 112, 114, 117, 151, 152, 203, 210 and 220 are denied as those findings are supported by competent, substantial evidence, and the Agency cannot reweigh conflicting evidence. See Heifetz. Petitioners’ exceptions to paragraphs 55 and 58 regarding numeric or Rule need are denied. See the clarification given in response to Agency counsel's exceptions, supra. Petitioners except on the grounds of relevance to the finding in paragraph 59 that Manatee Memorial, according to the latest data. “. . . has ‘hit the mark’ of 350 procedures annually.” The challenged finding falls under the ALJ’s heading “No Impact on Manatee County Providers” and is marginally relevant on that issue. The exception is denied. Petitioners’ exception to paragraph 63 is denied. The finding therein simply addresses one basis for CON application #9169 and neither contradicts nor is inconsistent with other findings that the application set forth two bases for approval. Petitioners except to paragraphs 64 through 66 on the grounds that the AU failed to sufficiently explicate the Agency's reasons for denying Galencare’s application for OHS at Brandon based on “not-normal” circumstances in an earlier batching cycle. As previously noted, whether sufficiently significant “not normal” circumstances exist must necessarily be decided on a case-by-case basis. In any event, the explanation Petitioners seek appears in paragraph 217 of the Recommended Order. That finding Petitioners except to by highlighting conflicting testimony which the Agency cannot reweigh. See Heifetz. The exceptions are therefore denied. The previous discussion of Galencare’s exceptions regarding the nature of “not normal” circumstances answers Petitioners’ exception to paragraph 68 regarding the ALJ's use of the word “typical.” Petitioners except on the grounds of relevance to the ALJ's findings in paragraph 79 that travel times between Brandon and Petitioners’ hospitals are generally 30 minutes or less. The challenged findings are merely follow-up to the more general finding in paragraph 77 that there is no geographic access problem in District 6. The exceptions are denied. Petitioners except to the ALJ’s finding in paragraph 92 that the dispersal of the six providers of OHS within the district is inconsistent with the tertiary status of OHS in that the six providers are not “regional centers.” OHS is a tertiary service and the Agency addresses whether there is need for a new program on a district wide basis. See Rule 59C-1.033(2)(b). The legislative policy regarding the placement of tertiary programs is as follows: ‘Tertiary health service” means a health service which, due to its high level of intensity, complexity, specialized or limited applicability, and cost, should be limited to, and concentrated in, a limited number of hospitals to ensure the quality, availability, and cost-effectiveness of such service... § 408.032(17), Fla. Stat. (2000). The dispersal of the six providers is consistent with the statutory mandate; therefore, the exception is granted. Petitioners contend that the ALJ failed to make findings on certain rnatters Petitioners evidently consider relevant (exception nos. 41 and 42), and on that basis also except to the factual findings in paragraphs 101, 113, 118, 123, 134 and 138. The Agency has no authority to make supplemental findings of fact. See Friends of Children v. Dep't of Health and Rehab. Servs., 504 So. 2d 1345 (Fla. 1* DCA 1987). If a possibly dispositive finding were not made, the Agency could remand the proceeding to the Division of Administrative Hearings (Division) for additional fact finding. Remand is neither requested nor required here; therefore, the exceptions are denied. Petitioners except to the findings in paragraphs 107 and 108 regarding the number of patients over a recent two-year period that may have benefited from receiving angioplasty at Brandon had it been available there. The finding is relevant to the issue of “not normal” circumstances, and the Agency has no authority to reweigh conflicting evidence. The challenged finding is supported by competent substantial evidence; the exception is denied. See Heifetz. Petitioners except to the findings in paragraphs 119 and 120 regarding the impact on the patient of delay encountered in inter-facility transfer on the grounds that such findings are inconsistent with the legislative policy regarding the placement of tertiary programs. In other words, Petitioners maintain that transfer delay, as a matter of law, cannot constitute a “not normal” circumstance justifying the approval of a new tertiary program. In the same vein, Petitioners except to the findings in paragraphs 158 and 159 regarding the large number of cardiac patients transferred from Brandon to other hospitals with open-heart capability. They maintain that as a matter of law a large number of transfers cannot constitute a “not normal” circumstance. See the Agency’s response above to Galencare’s exception to the AL's use of the word “typical” to describe “not normal” circumstances. The exceptions are denied. The exceptions to paragraphs 149 and 150 are denied as the findings therein are supported by competent, substantial evidence. See Heifetz. However, the last sentence in paragraph 149 is amended, for clarification, to read: “The patient recently showed an injection fraction of 45 percent, below the minimum for normal of 50 percent.” To the extent Petitioners point to evidence on which the ALJ made no findings, the Agency cannot make supplemental findings of fact. See Friends of Children. Petitioners except on the grounds of relevancy to findings in paragraph 156 and 157 regarding cther cardiac patients who required transfer. Galencare seeks a CON based on “not normal” circumstances involving the need to transfer certain cardiac patients. There is relevance; the exception is denied. Petitioners exception to paragraph 161 is denied as the finding is supported by competent, substantial evidence and does not implicate the Agency’s rule or policy regarding tertiary health services. The factual findings in paragraph 162 also are supported by the record. Petitioners assert that paragraph 162 is irrelevant in light of the definition of tertiary services and the expectation that patients will have to be transferred to a facility offering such services. However, Galencare’s CON application urges “not normal” circumstances in District 6 which justify establishing an OHS program in Brandon. The findings in paragraph 162 are relevant to determining whether the problems attendant to transferring patients from Brandon Regional Hospital to other hospitals rise to the level of “not normal” circumstances. B. Petitioners’ Exceptions to Conclusions of Law Petitioners’ exceptions to paragraphs 224 through 227 are denied based on the previous discussion of Agency counsel’s exception. Petitioners except to the conclusions of law in paragraphs 228 and 230 through 237 as being unsupported by the record. On the contrary, the evidence in the record amply supports the ALJ‘s conclusions. Petitioners also contend that these conclusions of law are inconsistent with the definition of “tertiary services” and prior Agency rulings. See the earlier discussion of “not normal” circumstances, supra. The exceptions are denied. Finally, Petitioners complain that the ALJ erred by denying their Motion in Limine to prohibit certain witnesses from testifying about specific incidents in which Brandon Regional Hospital encountered difficulty transferring patients to other hospitals in Hillsborough County for OHS. The Agency may only reject or modify conclusions of law over which it has substantive jurisdiction. See § 120.57(1)(/, Fla. Stat. (2000). Whether a motion in limine should be granted or denied is not an issue of law the Agency is authorized to address. See Deep Lagoon Boat Club, Ltd. v. Sheridan, 784 So. 2d 1140, (Fla. 2d DCA 2001). This exception is therefore denied. FINDINGS OF FACT The Agency hereby adopts the findings of fact set forth in the Recommended Order as modified and except where inconsistent with this Final Order. CONCLUSIONS OF LAW The Agency rejects the AL’s conclusion of law in paragraph 226 that the lack of impact on the OHS programs of the two Manatee County providers is not a “not normal” circumstance. The Agency has previously ruled that such lack of impact is a “not normal” circumstance, see Halifax v. Agency for Health Care Admin., supra, and the foregoing discussions regarding numeric need and the ALJ’s inappropriate use of the word “typical” to describe “not normal” circumstances also render the conclusion of law, and its supporting reasoning, incorrect. The Agency otherwise adopts the conclusions of law set forth in the Recommended Order, except where inconsistent with this Final Order. Based on the foregoing, CON application 9239, submitted by Galencare, Inc., d/b/a Brandon Regional Hospital, for open heart surgery is granted. 4% DONE AND ORDERED this 6 day of Nuss _, 2001 in Tallahassee, Leon County, Florida. Robert G. Brooks, M.D., Secretary Department of Health A PARTY ADVERSELY AFFECTED BY THIS FINAL ORDER IS ENTITLED TO JUDICIAL REVIEW, WHICH IS INITIATED BY FILING A NOTICE OF APPEAL WITH THE AGENCY CLERK OF THE AGENCY FOR HEALTH CARE ADMINISTRATION AND A COPY, ALONG WITH THE FILING FEE, WITH THE DISTRICT COURT OF APPEAL IN THE APPELLATE DISTRICT WHERE THE AGENCY MAINTAINS ITS HEADQUARTERS OR WHERE THE PARTY RESIDES. THE NOTICE OF APPEAL MUST BE FILED WITHIN 30 DAYS OF THE RENDITION OF THIS ORDER. 10 CERTIFICATE OF SERVICE I certify that a copy of this final order was served on ~ Gust. q 2001, as follows: Richard Patterson for AHCA, CON Office, and DOAH by interoffi ice mail; Robert Weiss for Tampa General Hospital and St. Joseph's Hospital, Jon Rue, for Lakeland Regional Medical Center, James Hauser for University Community Hospital, and Stephen Ecenia for Brandon Regional Hospital, by U.S. Mail. O yi bre Tapa _ LOER'S, Power, Agency Clerk, 2727 Mahan Drive Tallahassee, Florida 32308 (850) 922-5873 . 11

Docket for Case No: 00-000481CON

Orders for Case No: 00-000481CON