The Issue Whether Florida Administrative Code Rule 59C-1.008(4) (Rule) constitutes an invalid exercise of delegated legislative authority because it enlarges, modifies, or contravenes the specific provisions of law implemented.
Findings Of Fact The Parties VRBH is an existing hospital in Sarasota County. In the second batching cycle of 2016, VRBH applied to AHCA for a CON to establish a Class I Acute Care Replacement Hospital of up to 312 beds in AHCA District VIII, Subdistrict 8-6, Sarasota County. The CON application was preliminarily approved by AHCA on December 2, 2016. SMH is a public hospital system serving Sarasota County. In the second batching cycle of 2016, SMH applied for a CON to establish a new acute care hospital with 90 beds in AHCA District 8, Acute Care Subdistrict 8-6, Sarasota County. As with the VRBH application, the SMH application also received preliminary approval from AHCA on December 2, 2016. AHCA is designated as the single state agency responsible for administering the CON program under the Health Facility and Services Development Act, sections 408.031 through 408.045, Florida Statutes. The Challenged Rule In part, Florida Administrative Code Rule 59C-1.008(4) requires that CON applications contain the audited financial statements of the applicant, or the applicant’s parent corporation. The Rule states as follows: Certificate of Need Application Contents. An application for a Certificate of Need shall contain the following items: All requirements set forth in Sections 408.037(1), (2) and (3), F.S. The correct application fee. An audited financial statement of the applicant or the applicant’s parent corporation if the applicant’s audited financial statements do not exist. The following provisions apply: The audited financial statement of the applicant, or the applicant’s parent corporation, must be for the most current fiscal year. If the most recent fiscal year ended within 120 days prior to the application filing deadline and the audited financial statements are not yet available, then the prior fiscal year will be considered the most recent. Existing health care facilities must provide audited financial statements for the two most recent consecutive fiscal years in accordance with subparagraph 1. above. Only audited financial statements of the applicant, or the applicant’s parent corporation, will be accepted. Audited financial statements of any part of the applicant or the applicant’s parent corporation, including but not limited to subsidiaries, divisions, specific facilities or cost centers, will not qualify as an audit of the applicant or the applicant’s parent corporation. To comply with Section 408.037(1)(b)1., F.S., which requires a listing of all capital projects, the applicant shall provide the total approximate amount of anticipated expenditures for capital projects which meet the definition in subsection 59C-1.002(7), F.A.C., at the time of initial application submission, or state that there are none. An itemized list or grouping of capital projects is not required, although an applicant may choose to itemize or group its capital projects. The applicant shall also indicate the actual or proposed financial commitment to those projects, and include an assessment of the impact of those projects on the applicant’s ability to provide the proposed project; and, Responses to applicable questions contained in the application forms. The 2008 CON Legislative Changes In 2008, the Florida Legislature made numerous changes to streamline the CON application process for general hospitals. It is these changes that VRBH asserts removed the requirement for general hospitals to submit audited financial statements with CON applications. Section 408.035 was amended to provide as follows: 408.035 Review criteria.— The agency shall determine the reviewability of applications and shall review applications for certificate-of-need determinations for health care facilities and health services in context with the following criteria, except for general hospitals as defined in s. 395.002: The need for the health care facilities and health services being proposed. The availability, quality of care, accessibility, and extent of utilization of existing health care facilities and health services in the service district of the applicant. The ability of the applicant to provide quality of care and the applicant’s record of providing quality of care. The availability of resources, including health personnel, management personnel, and funds for capital and operating expenditures, for project accomplishment and operation. The extent to which the proposed services will enhance access to health care for residents of the service district. The immediate and long-term financial feasibility of the proposal. The extent to which the proposal will foster competition that promotes quality and cost-effectiveness. The costs and methods of the proposed construction, including the costs and methods of energy provision and the availability of alternative, less costly, or more effective methods of construction. The applicant’s past and proposed provision of health care services to Medicaid patients and the medically indigent. The applicant’s designation as a Gold Seal Program nursing facility pursuant to s. 400.235, when the applicant is requesting additional nursing home beds at that facility. For a general hospital, the agency shall consider only the criteria specified in paragraph (1)(a), paragraph (1)(b), except for quality of care in paragraph (1)(b), and paragraphs (1)(e), (g), and (i). (Emphasis added). Section 408.035 has not been revised since 2008. Additionally, section 408.037 was amended to read as follows: 408.037 Application content.— Except as provided in subsection (2) for a general hospital, an application for a certificate of need must contain: A detailed description of the proposed project and statement of its purpose and need in relation to the district health plan. A statement of the financial resources needed by and available to the applicant to accomplish the proposed project. This statement must include: A complete listing of all capital projects, including new health facility development projects and health facility acquisitions applied for, pending, approved, or underway in any state at the time of application, regardless of whether or not that state has a certificate-of-need program or a capital expenditure review program pursuant to s. 1122 of the Social Security Act. The agency may, by rule, require less- detailed information from major health care providers. This listing must include the applicant’s actual or proposed financial commitment to those projects and an assessment of their impact on the applicant’s ability to provide the proposed project. A detailed listing of the needed capital expenditures, including sources of funds. A detailed financial projection, including a statement of the projected revenue and expenses for the first 2 years of operation after completion of the proposed project. This statement must include a detailed evaluation of the impact of the proposed project on the cost of other services provided by the applicant. An audited financial statement of the applicant or the applicant’s parent corporation if audited financial statements of the applicant do not exist. In an application submitted by an existing health care facility, health maintenance organization, or hospice, financial condition documentation must include, but need not be limited to, a balance sheet and a profit-and-loss statement of the 2 previous fiscal years’ operation. An application for a certificate of need for a general hospital must contain a detailed description of the proposed general hospital project and a statement of its purpose and the needs it will meet. The proposed project’s location, as well as its primary and secondary service areas, must be identified by zip code. Primary service area is defined as the zip codes from which the applicant projects that it will draw 75 percent of its discharges. Secondary service area is defined as the zip codes from which the applicant projects that it will draw its remaining discharges. If, subsequent to issuance of a final order approving the certificate of need, the proposed location of the general hospital changes or the primary service area materially changes, the agency shall revoke the certificate of need. However, if the agency determines that such changes are deemed to enhance access to hospital services in the service district, the agency may permit such changes to occur. A party participating in the administrative hearing regarding the issuance of the certificate of need for a general hospital has standing to participate in any subsequent proceeding regarding the revocation of the certificate of need for a hospital for which the location has changed or for which the primary service area has materially changed. In addition, the application for the certificate of need for a general hospital must include a statement of intent that, if approved by final order of the agency, the applicant shall within 120 days after issuance of the final order or, if there is an appeal of the final order, within 120 days after the issuance of the court’s mandate on appeal, furnish satisfactory proof of the applicant’s financial ability to operate. The agency shall establish documentation requirements, to be completed by each applicant, which show anticipated provider revenues and expenditures, the basis for financing the anticipated cash- flow requirements of the provider, and an applicant’s access to contingency financing. A party participating in the administrative hearing regarding the issuance of the certificate of need for a general hospital may provide written comments concerning the adequacy of the financial information provided, but such party does not have standing to participate in an administrative proceeding regarding proof of the applicant’s financial ability to operate. The agency may require a licensee to provide proof of financial ability to operate at any time if there is evidence of financial instability, including, but not limited to, unpaid expenses necessary for the basic operations of the provider. The applicant must certify that it will license and operate the health care facility. For an existing health care facility, the applicant must be the licenseholder of the facility. (Emphasis added). Section 408.037 has only been amended once since 2008. The revisions are not relevant to the issue presented in this Rule challenge.2/ The Parties’ Positions In support of its argument that the Rule contravenes the statutes, VRBH asserts that the Rule is an invalid exercise of delegated legislative authority because it enlarges, modifies, or contravenes the laws implemented. Simply put, VRBH contends that the Rule is contrary to sections 408.035 and VRBH advances three reasons for its position that the Rule modifies the laws implemented; all three center on the assertion that in 2008, the Legislature removed the requirement for the submission of audited financial statements with general hospital CON applications: Requiring a general hospital to comply with the requirements of section 408.037(1), Florida Statutes, by submitting an audited financial statement with its CON application violates the express provision of the statute which specifically excludes general hospitals from the requirements of subsection (1); Requiring a general hospital to submit an audited financial statement with the CON application directly contradicts the submission requirements set forth in section 408.037(2), Florida Statutes, which only requires a general hospital to provide a statement of intent that it will “furnish satisfactory proof of the applicant’s financial ability to operate” if the CON application is approved by final order of the agency. Requiring a general hospital to submit an audited financial statement with the CON application contradicts the 2008 legislative changes to section 408.035, Florida Statutes, which streamlined the application process for general hospitals by removing the short and long term financial feasibility of the project as a review criteria. (VRBH Petition, ¶¶ 15-17). AHCA’s ultimate position is that the Rule should be interpreted as not requiring audited financial statements for general hospital CON applicants. To reach this conclusion, AHCA relies on 59C-1.008(4)(a), which provides that a CON application must contain “all requirements set forth in Sections 408.037(1), (2), and (3), Florida Statutes.” AHCA interprets the introductory phrase contained in section 408.037(1)--“except as provided in subsection (2) for a general hospital, an application for a certificate of need must contain”--to mean that only subsection (2) of section 408.037 applies to an application for general hospitals. Because section 408.037(2) does not mention audited financial statements, AHCA reasons that they are not required. Therefore, despite the plain language of the Rule, AHCA contends that the Rule does not require the submission of audited financial statements because: the Rule references sections 408.037(1), (2), and (3); AHCA interprets only section 408.037(2) as applying to general hospitals; and section 408.037(2) does not mention audited financial statements. SMH contends that the Rule does not enlarge, modify, or contravene the laws implemented and, therefore, is a valid exercise of delegated legislative authority. Specifically, SMH contends that section 408.037 itself requires general hospital applicants to submit audited financial statements because subsection (2) does not wholesale replace subsection (1) for general hospitals. Subsection (1) applies to general hospitals, unless there is an exception to those requirements listed in subsection (2). Subsection (1) requires the submission of audited financial statements for all CON applicants; nothing in subsection (2) creates an exception to that requirement. SMH also argues that audited financial statements are reliable documents that AHCA can quickly access for relevant information, including an applicant’s provision of health care services to Medicaid patients and the medically indigent, both of which are prominent considerations during the review of a general hospital’s CON application. See § 408.035(1)(i), (2), Fla. Stat. Post 2008 Rule Challenged Rule 59C-1.008(4) does not expressly exclude or differentiate between general hospital CON applications and other CON applications. Instead the Rule cross-references to the statutory requirement. AHCA asserts that by doing so, the Rule incorporates the statutory scheme by reference and does not require a CON application for a general hospital to include audited financial statements. The above-cited statutory provisions clearly state that a general hospital CON application need not include an audited financial statement and that financial condition is not relevant to the CON application review process. Any rule that requires a general hospital CON applicant to provide an audited financial statement with the application would be contrary to the requirements of section 408.037. It follows, therefore, that a rule contrary to the requirements of a statute would be invalid as it would exceed AHCA’s delegated legislative authority. Requiring a general hospital applicant to comply with the requirements of section 408.037(1) would violate the provision of the statute, which expressly excludes general hospitals from the requirements of subsection (1). Further, requiring a general hospital applicant to submit an audited financial statement with its CON application directly contradicts the submission requirements set forth in section 408.037(2). AHCA’s interpretation of rule 59C-1.008 is that it must be read in conjunction with section 408.037, subsections (1), (2), and (3), and accordingly, AHCA does not require that a general hospital applicant submit an audited financial statement as part of its application. AHCA’s interpretation is consistent with the differences in the content of the CON application forms published by AHCA for general hospital applications when compared to non-general hospital applications, for instance, those seeking other beds and services such as comprehensive medical rehabilitation, psychiatric, hospice, and other CON- regulated beds in a hospital. The requirements of each application type correspond to the statutory requirements for each application type. Application forms for projects “except for general hospitals” correspond to the CON application content requirements of section 408.037(1), which requires a statement of financial resources that must include capital projects (Schedule 2 of the CON application); capital expenditures and source of funds (Schedules 1 and 3 of the CON application); and a detailed financial projection, including revenues and expenses for the first two years (Schedules 5 through 8 of the CON application). The general hospital CON application does not have these requirements. General hospitals are not required to submit proof of financial ability to operate at the time of the submission of the CON application. In accordance with rule 59C-1.010(2)(d), general hospitals are required to comply with the requirements of sections 408.035(2) and 408.037(2). Neither of those statutes requires that a general hospital applicant submit proof of financial ability to operate until 120 days after the issuance of the final CON to the applicant. AHCA’s representative, Marisol Fitch, testified that AHCA does not require applicants for general hospitals to submit audited financial statements in the CON application, and that proof of financial ability to operate is required within 120 days after the final approval of the CON application, consistent with the statutory provisions. She testified that the Rule being challenged, when read in conjunction with the AHCA CON application form (incorporated by reference into the Rule) and other AHCA rules, including 59C-1.010 and 59C-1.030, is consistent with the statute, and that no audited financial statements are required. SMH asserts that an audited financial statement for hospitals might contain useful information, such as information on a hospital’s current payor mix. However, the unrefuted testimony is that audited financial statements are not required to include payor mix information, and normally do not since they are typically used to look at an applicant’s financial feasibility to operate. Further, regardless of whether such information might be “useful,” the specific requirement of section 408.037(2) expressly “excepts” general hospitals from the requirement to include such statements in the CON application. Pursuant to rule 59C-1.010(2)(d), “an application for a general hospital must meet the requirements of Sections 408.035(2) and 408.037(2), F.S.,” neither of which require that a general hospital CON applicant provide audited financials or financial feasibility data with the CON application. However, the challenged language in rule 59C-1.008(4) does not contain the “exception” for general hospital applications. Rule 59C-1.008(4) provides, without qualification, that a CON application must contain audited financial statements. Therefore, rules 59C-1.008(4) and 59C-1.010(2)(d) are contradictory. The primary purpose of an audited financial statement in a CON application is to review the short-term and long-term financial feasibility of the proposal. Requiring this financial information is contrary to the clear language of the 2008 changes to section 408.035, which removed the short-term and long-term financial feasibility of the project as review criteria in order to streamline the general hospital CON application process. AHCA has stated that their interpretation of rule 59C-1.008(4) is that it must be read in pari materia with rule 59C-1.010(2)(d) and sections 408.037 and 408.035, therefore, general hospital CON applicants are not required to submit audited financials with the CON application. According to AHCA’s interpretation, rule 59C-1.008(4) does not require a general hospital CON applicant to submit an audited financial statement with the CON application. However, regardless of AHCA’s interpretation, rule 59C-1.008(4) expressly states that a CON application must contain audited financial statements, in contravention of sections 408.035 and 408.037.
The Issue Whether Respondent, Guy Hendricks, III, R.Ph., is subject to discipline pursuant to Subsection 465.016(1)(e), Florida Statutes, for violating Rule 64B16-28.120(2), Florida Administrative Code.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing, the following findings of facts are made: Respondent, Guy R. Hendricks, III, R.Ph., is a Florida-licensed registered pharmacist, so licensed in 1972; he was licensed as a consultant pharmacist in 1974. Registered pharmacists typically dispense medications at a community pharmacy, for example, Eckerds and Walgreen's. Consulting pharmacists oversee a pharmaceutical distribution system in a long-term care nursing home facility with a Class I institutional permit. In addition to his employment at the Arbors in Orange Park (the Arbors), Respondent is engaged in the development of "cutting edge consultant computer programs" and "research and development in the field of software platforms which will lead to a fully integrated consultant software package." (Respondent's vita, Petitioner's Exhibit 2) On August 1, 1996, Respondent became the consulting pharmacist for the Arbors. The AHCA survey, which is the genesis of the allegations of the Amended Administrative Complaint in this case, was conducted later that same month. The Arbors is a sub-acute care facility which has a Class I institutional pharmacy permit. Florida Statutes and Florida Administrative Code rules restrict the type of medicinal drugs and drug preparations allowed in Class I institutional pharmacies. One of the consulting pharmacist's responsibilities is to see that the applicable Florida Statutes and Florida Administrative Code rules are followed within the Class I institutional pharmacies, subject to pharmacist's control. The Arbors utilized a Baxter SureMed Dispensing Machine (SureMed machine) which is a computerized dispensing machine that stores medications and allows the pharmacist to track when medications are taken from the machine, by whom they are taken, what dosage is dispensed, and to whom the medication is administered. It has a complete computerized tracking system. It is a "modern tool of pharmacy" used to provide a high level of pharmaceutical care for nursing home residents. Florida Statutes and Florida Administrative Code rules require that nursing homes, such as the Arbors, provide "reasonable and consistent quality of life for residents" and that "reasonable efforts be made to accommodate the needs and preferences of residents to enhance the quality of life in a nursing home." Florida Administrative Code rules allow the Arbors to adopt policies and procedures regarding drugs to meet the needs of residents and to maintain an Emergency Medical Kit(s), the contents of which shall be determined by the facility's medical director, director of nursing, and pharmacist, and "it (the medical kit) shall be in accordance with facility policy and procedures"; the "emergency medical kit" may contain medicinal drugs and drug preparations which are not otherwise allowed within Class I institutional pharmacies. Respondent testified that the SureMed machine was being used as one of the Emergency Medical Kits of the Arbors. The drugs contained in the SureMed machine were determined by the Arbors staff before Respondent was employed as consulting pharmacist. During the August 27-28, 1996, AHCA Survey, the surveyor concluded that the SureMed machine was being used inappropriately by the Arbors. The survey revealed that the SureMed dispensing unit was used as an emergency medication kit. Review of the SureMed Policy and Procedure stated "Medications stored in SureMed are intended for emergency stat orders, late admission first dose, new orders and missing doses" (part of Petitioner's Exhibit 5) contrary to the approved use of medicinal drugs used in facilities with a Class I Institutional Pharmacy Permit. An inventory list provided by the facility revealed in excess of 300 medications in the SureMed unit and this unit had been accessed 22 times in the 24 hours prior to surveyor review. Further review of the usage log revealed that an unsampled resident received Norixin from the SureMed unit on 8/26/96 at 23:04, 8/27/96 at 22:21 and 8/28/96 at 22:21 instead of receiving a resident specific labeled medication from the provider pharmacy. Respondent suggests that a "typographical error" may have occurred in the facility's SureMed policy and procedure in that, if the word "not" is inserted after the words "emergency stat orders," the policy and procedure would conform to the limitations proscribed for Class I institutional permitees. While this explanation is plausible, it is not accepted as credible. This portion of the Arbors' SureMed policy and procedure, referenced by the AHCA surveyor, does not follow Florida law. If the foregoing policy and procedure language is the only language considered, the surveyor's conclusions may be justified; however, the surveyor failed to note the following language which immediately follows the quote from the same SureMed policy and procedure. "SureMed is not intended to be a routine source of medication. The pharmacy must be informed of all new admissions, new orders, refill orders, and missing doses." When a nursing home resident is first admitted to the Arbors, the admittee does not bring medications but brings new prescription orders which must be filled by the provider or back-up pharmacy. Home Care Pharmacy in Orlando, Florida, provides medications to the Arbors; it is 140 miles from Orlando to Orange Park. Deliveries are made two times a day. There were occasions in 1996 when patients were out of medication or Home Care Pharmacy was not delivering as ordered. While the Arbors has only a Class I institutional permit which limits drugs readily available to residents, the facility accepts residents who are "sub-acute" care patients, for example, patients with chronic disease, post-surgical patients, and patients with "super" infections, all of whom require continuity of pharmaceutical therapy. Frank May, a registered pharmacist and certified HCFA surveyor for AHCA, testified that while the Arbors' SureMed policy and procedure were "out of compliance," nevertheless, it was appropriate to "take a drug out of the machine or out of the emergency medication kit if it cannot be provided by the provider pharmacy or if that provider pharmacy is a long way off or by a back-up pharmacy in a timely manner for the next dosage of that medication." May also testified that "there is nothing wrong" with utilizing the SureMed machine as an emergency medical kit or maintaining drugs, otherwise not permitted in a Class I institution permit, in the machine. May further testified that without examining each instance wherein the SureMed machine was accessed immediately prior to the AHCA survey, it would be impossible to determine whether or not an "emergency" existed warranting the use of the particular drug obtained from the SureMed machine. May testified that in 1996, the use of automated drug dispensing machines was becoming very prominent in nursing homes; and problems, such as addressed in this case, were "fairly prevalent." Respondent maintains that the facility's use of the SureMed machine was on a bona fide emergency basis only. The Arbors' SureMed policy and procedure were changed immediately following the August 1996 survey. Respondent sent AHCA a July 20, 1997, letter in response to the AHCA licensure investigation in which he identified the SureMed machine as a "computerized emergency system," a "modern tool of pharmacy," and "our only solution" "to treat our residents' sub acute conditions" when "some local pharmacies . . . could not provide medications." The SureMed machine was removed from the Arbors in November 1996.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the charges against Respondent in the Amended Administrative Complaint be dismissed. DONE AND ENTERED this 28th day of March, 2001, in Tallahassee, Leon County, Florida. JEFF B. CLARK Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 28th day of March, 2001. COPIES FURNISHED: Guy Hendericks, III Post Office Box 4173 Sebring, Florida 33871 Lawrence F. Kranert, Jr., Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 John Taylor, R.Ph., Executive Director Board of Pharmacy Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 Theodore M. Henderson, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
Findings Of Fact At all times material hereto, Petitioner, R & R Guest Home, Inc., was licensed to operate an adult congregate living facility at 720 Southwest 6th Street, Dania, Florida. On February 5, 1987, the Respondent caused to be conducted an investigation at Petitioner's facility to determine whether a resident, J. T., was appropriately placed. That investigation resulted in the Respondent concluding that the resident needed care beyond that which Petitioner was licensed to provide. Pursuant to the mandate of Section 400.426(7), Florida Statutes, Respondent delivered to Petitioner that day a health assessment form for the resident, with directions that it be completed by the resident's examining physician and returned to Respondent within 30 days. The health assessment form was apparently completed by the resident's examining physician on February 10, 1987, but Petitioner did not submit it to the Respondent until March 30, 1987.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered which sets and levies a $250.00 fine against R & R Guest Home, Inc., for its failure to comply with Section 400.426(7), Florida Statutes. DONE and ENTERED this 6th day of January, 1988, in Tallahassee, Florida. WILLIAM J. KENDRICK Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 904/488-9675 FILED with the Clerk of the Division of Administrative Hearings this 6th day of January, 1988. COPIES FURNISHED: Rholanda Higgs-Rule R & R Guest Home, Inc. 720 Southwest 6th Street Dania, Florida 33004 Leonard T. Helfand, Esquire Department of Health and Rehabilitative Services 5190 Northwest 167th Street Miami, Florida 33014 Gregory L. Coler, Secretary Department of and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 Sam Power, Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700
Findings Of Fact Introduction Tampa General Hospital is a 530-bed short-term general acute care hospital. Hillsborough County Hospital is a 157 bed-general acute-care hospital. Both are divisions of Hillsborough County Hospital Authority, a public hospital system located in Tampa, Florida. T. 25; Hearing Officer Ex. 1. Tampa General Hospital and Hillsborough County Hospital filed timely petitions for formal administrative hearings, and have standing to seek such hearings. Tampa General Hospital and Hillsborough County Hospital historically have provided high levels of uncompensated indigent care. T. 26. If Tampa General Hospital prevails on the RPICC issue and the sales tax issue, it will be due a total of $4,713,108, subject to a final adjustment factor. Hearing Officer Ex. 1, ex. C-4. If Tampa General Hospital prevails only upon the RPICC issue as reported in its April 23, 1987, correction to its fiscal year 1986 actual report, it will be due a total redistribution of $3,806,371, subject to the final adjustment factor. Hearing Officer Ex. 1, ex. C-1. If Tampa General Hospital prevails only upon the sales tax issue, by comparison of exhibits C-1 and C-4 to Hearing Officer Ex. 1, the total redistribution due will be increased by the difference between the two amounts in the last two paragraphs, or by $906,737. The Hospital Cost Containment Board's proposed agency action is contrary to the position urged by Tampa General Hospital on the two issues, and the proposed agency action would result in a total distribution of $3,015,907, subject to the final adjustment factor. T. 29; Hearing Officer Ex. 1, ex. C-5. If Hillsborough County Hospital prevails on the single issue that pertains to it, the sales tax issue, its total redistribution will be $315,543, subject to the final adjustment factor. Hearing Officer Ex, 1, ex. D-2. The preliminary determination of the Hospital Cost Containment Board is that Hillsborough County Hospital should receive $247,883 as a total redistribution, subject to the final adjustment factor. Hearing Officer Ex. 1, ex. D-1. Relevant definitions from the FBURS manual Account 5940, "contractual adjustments-other," of the FHURS manual, providers in part that: These accounts must be used to report the differential (if any) between the amount, based on the hospital's full established rates, of contractual patients' charges for hospital services which are rendered during the reporting period and are covered by the contract, and the amount received and to be received from third-party agencies in payment of such charges, including adjustments made at year end, based upon cost reports submitted. * * * In any instance in which the difference between the amount of a patients' [sic] bill and the payment received by the hospital from a third-party agency is recoverable from the patient, any resulting uncollected amounts should be reported in the appropriate bad debt or uncompensated care category and should not be reported in contractual adjustments. (E.S.) Account 5960, "charity/uncompensated care-other," of the FHURS manual, provides in part that: Account 5960 shall be used to report the differential between the amount, based on the hospital's full established rates, of bills for hospital services to charity/ uncompensated care patients and the amounts to be received from patients or on behalf of patients (including amounts received from voluntary agencies or government agencies on behalf of specific indigent patients) in payment for such services. (E.S.) Account 5960 further requires that the hospital have a verifiable process for determining indigency for each individual patient. Indigency is defined generally as a family income for the preceding 12 months less than 150 percent of the federal poverty guidelines. The instructions for account 5960 further provide that: When the hospital receives lump-sum grants or subsidies (rather than specific payments for individual patient's bills) from governmental or voluntary agencies for the care of medically indigent patients, the amount of the lump-sum grant or subsidy must be reported under "Restricted Donations and Grants for Indigent Care." (Account 5970). (E.S.) Account 5970, "Restricted Donations and Grants for Indigent Care," of the FHURS manual, provides: This account is used to report voluntary and governmental agency grants or subsidies for the care of non-specified medically indigent patients during the current reporting period. (E.S.) Account 9130, "Unrestricted Tax Revenue and Appropriated Funds," of the FHURS manual, provides: This account contains the revenue obtained from assignment of unrestricted tax revenue and funds appropriated by governmental entities. The RPICC issue, Tampa General Hospital The April 23, 1987, revision to Tampa General Hospital's 1986 actual report Tampa General Hospital's fiscal year ends on September 30th. On January 29, 1987, Tampa General Hospital filed its prior year report of its fiscal year 1986 actual experience. P. Ex. 2. As originally filed, Tampa General Hospital reported the following on worksheet C-2: $14,466,596 on line 11 as contractual adjustments-other; nothing on line 13, charity/uncompensated care-other; and ($2,633,338) on line 14, restricted donations and grants for indigent care. Id. Included in the amounts on line 11 of the report as a contractual adjustment-other were the total charges for all patients served by the RPICC program at Tampa General Hospital in fiscal year 1986, and included in line 14 as restricted donations and grants for indigent care were all the amounts received by Tampa General Hospital in fiscal year 1986 from the RPICC program. T. 38. Prior to July 1, 1987, the Hospital Cost Containment Board accepted corrections to prior year reports of actual experience. Dep. (James Bracher), p. 6. On about April 23, 1987, Tampa General Hospital filed a revision to worksheet C-2 of its 1986 report of actual experience. P. Ex. 3. The revision reported $2,067,928 on line 11 as contractual adjustments-other, $32,104,116 on line 13, charity/uncompensated care-other, and made no change to line 14. (A negative $2,633,338 was still reported on line 14 as restricted donations and grants for indigent care.) Id. The April 23, 1987, revision moved the RPICC charges from line 11, contractual adjustment-other, to line 13, charity/uncompensated care-other. There was no change to line 14 since Tampa General Hospital had already reported all amounts received from the RPICC program on line 14 as restricted donations and grants for indigent care. T. 39-40. The fortieth day from April 23, 1987, was June 2, 1987. In the 40 days that followed April 23, 1987, and including a reasonable time thereafter for filing of the April 23, 1987, revision, Tampa General Hospital was given no written notice by the Hospital Cost Containment Board that the April 23, 1987, revision to its fiscal year 1986 report did not conform to the Hospital Uniform Reporting System Manual requirements, or did not otherwise conform to rule or statute. T. 42; Dep. (James Bracher), p. 27. Such written notice was not given until October 28, 1987. James Bracher, Executive Director to the Hospital Cost Containment Board, testified that it was his "understanding" that "we did discuss the possibility with the hospital of having, conducting a site visit to review this information." Dep. (James Bracher), p. 19. But on cross examination, Mr. Bracher qualified the implications of that statement. He was asked: "You earlier testified about some discussions with unnamed hospital people about a site visit on the RPICC issue. When did those discussions occur?" Mr. Bracher testified: "I don't recall that I said I discussed with them. I think I said I discussed with HCCB staff about the need to make site visits as a result of the April submission by Tampa General." (E.S.) Id. at pp. 51-52. The examination continued: Q. So you're not aware of any discussions between staff and the hospital? A. I did not participate in any direct discussions, no. Q. And you're not aware of any? A. I could not give you a date on any specific ones. The only other witness who testified as to oral communications to Tampa General Hospital concerning the issues in dispute in this case was Bill Summers. Mr. Summers was under going examination only with respect to the sales tax issue, not with respect to the RPICC issue. T. 181. Mr. Summers was asked "[W]hat did you do before October 13th, in reviewing this issue. Anything?" He answered in pertinent part: "I made a visit to the facility and reviewed their patient accounting records, in terms of determining medical indigency. I have had numerous conversations with hospital personnel, Mr. Powers, and others." T. 182. In summary, the testimony of Mr. Summers did not clearly pertain to either the April 23, 1987, revision or the RPICC issue. Thus, even if there had been visits or discussions with Tampa General Hospital, there is no evidence that the position of the Hospital Cost Containment Board concerning the RPICC issue was orally conveyed to Tampa General Hospital. Moreover, Mr. Summers provided no dates of such visits or discussions. On this record, one cannot determine if the visits and discussions occurred near the October 13, 1987, the end date used in the question, or in the 40 days following April 23, 1987. Similarly, Mr. Bracher's testimony is insufficient to determine when the Hospital Cost Containment Board orally notified Tampa General Hospital that the April 23, 1987, revision was nonconforming, or, indeed, that such notification in fact did occur. Consequently, there is no credible evidence to infer that within forty days after April 23, 1987, the Hospital Cost Containment Board orally notified Tampa General Hospital that its April 23, 1987, revision was nonconforming. On July 17, 1987, the Hospital Cost Containment Board determined the amount of redistribution due Tampa General Hospital pursuant to section 12, chapter 87-92, Laws of Florida, and advised Tampa General Hospital of its decision by a memorandum of that date. P. Ex. 4. The memorandum states that the redistribution has been determined "based on 1986 actual audited data." The redistribution formula attached to the first page of the memorandum shows the redistribution calculation. One factor accepted by the Hospital Cost Containment Board for its determination of redistribution was the amount of charity care ($32,104,116) contained in Tampa General Hospital's April 23, 1987, revision to its 1986 actual audited data. Id.; T. 40-41. Thus, the initial calculation of redistribution by the Hospital Cost Containment Board was based upon the accounting classifications contained in the April 23, 1987, revision to Tampa General Hospital's 1986 actual report. As a general policy, if, after July 1, 1987, a hospital did not attempt to correct its fiscal year 1986 actual report, the redistribution to that hospital would have been calculated upon the prior actual report of the hospital. T. 174-76. In the case of Tampa General Hospital, however, the magnitude of the change prior to July 1, 1987, was the reason that at some time after July 17, 1987, the staff of the Hospital Cost Containment Board decided to subject the change to scrutiny. The prior year report of actual experience contains two parts. The first is a detailed report containing worksheets and must be prepared pursuant to the uniform financial accounting system of the FHURS manual. The first report is not certified by a certified public accountant. See e.g., P. Ex. 2. The second is a summary report certified by the hospital's certified public accountant. Worksheet C-2 is contained in the first report which is not certified by a certified public accountant. Dep. (James Bracher), p. 4-5; P. Ex. 2. The April 23, 1987, revision to the original 1986 prior year report filed by Tampa General Hospital on April 23, 1987, was only a revision to worksheet C-2, and thus was only a revision to the first detailed report. Consequently, the April 23, 1987, revision was a revision to a report that did not require certification by the hospital's certified public accountant. The Hospital Cost Containment Board has a policy that when a hospital requests that a correction be made to a prior year actual report, the staff of the Hospital Cost Containment Board asks the hospital to have the correction reviewed by its CPA firm to determine why the correction better conforms to the accounting definitions in the FHURS manual. This policy has been in existence for approximately one year preceding December 1987. Dep. (James Bracher), p. 6. The basis for the policy was not explained in the record. Certification by a CPA, however, is not deemed to be sufficiently reliable to result in automatic approval of the proposed change. Dep. (James Bracher), p. 7. The Hospital Cost Containment Board did not apply this policy to Tampa General Hospital until after forty days from the date the April 23, 1987, revision was filed. The policy was not applied until about August 3, 1987. On that date, Mr. Bracher sent a letter to Newell France, Tampa General Hospital's chief executive officer. The letter stated that "the revised worksheets for your 1986 actual report have been received." P. Ex. 6. At that point, the only "revised worksheets" for the 1986 actual report were the April 23, 1987, revisions. Mr. Bracher's letter stated that the revision had to be verified "by the independent auditor who originally prepared the audited financial report for the fiscal year in question." In response to the letter of August 23, 1987, from Mr. Bracher, by letter dated September 28, 1987, Tampa General Hospital filed a revised worksheet C-2 certified by Price Waterhouse, certified public accountants. Price Waterhouse was the independent certified auditor for Tampa General Hospital for fiscal year 1986. T. 89. The amount of a negative $2,633,338, as "restricted donations and grants for indigent care" on line 13 was the same on both the September 28, 1987, and April 23, 1987, revisions. As discussed above, this amount represented the receipts from the RPICC program in 1986. The amount of "charity/uncompensated care-other" reported on the September 28, 1987, worksheet C-2, line 13, changed to $11,457,248. P. Ex. 6. (It was $32,104,116 on the April 23, 1987, report.) Nonetheless, it is clear from the record that the amount of $11,457,248 on the September 28, 1987, revision contained the RPICC charges for 1986 as reported in the April 23, 1987, revision. First, the parties stipulated that exhibit C-3 to Hearing Officer Ex. 1 contained "Tampa General's 9/28/87 submission, which continues to include the RPICC classification." Exhibit C-2 contains $11,457,248 as "charity care," thus reconciling to the September 28, 1987, worksheet C-2. The amount of $11,457,248 of "charity care" could not "continue to include the RPICC classification" unless it contained the same report and classification of RPICC charges as was contained in the immediately preceding report, which was the April 23, 1987, revision. Moreover, having been given the opportunity to deny such continuity, witnesses for the Hospital Cost Containment Board seemed to agree that the September 28, 1987, revision did not change the amounts and classifications of RPICC charges and receipts from the April 23, 1987, revision. T. 200-201; Dep. (James Bracher), p. 64. As a part of the September 28, 1987, revision Price Waterhouse submitted a letter dated September 25, 1987, to Mr. Bracher that stated that it had been asked by Tampa General Hospital to "review the Hospital's original and amended HCCB 1986 Actual Report for its method of presenting deductions from revenue." (E.S.) P. Ex. 6. The letter appended to the September 28, 1987, revision from Price Waterhouse then explicitly states that "the $11,457,248 reclassified from Contractual Adjustments-Other to Charity/Uncompensated Care- Other is arithmetically accurate and represents a correction to the original submission in order to comply with the definitions contained in . . . the FHURS Manual definitions of account numbers 5940 and 5960." (E.S.) The letter from Price Waterhouse further states on page 2 that the RPICC reclassification relates to "unpaid portion of gross bills for services rendered to patients economically eligible for the RPICC grant funds," and demonstrates that this amount, which has been placed into the Charity/Uncompensated Care-Other category, is $6,141,002. In the same calculation, the review shows that Tampa General Hospital received $2,633,338, in RPICC grants in fiscal year 1986. P. Ex. 6. Upon consideration of findings of fact 24 through 27, it is further concluded that on September 28, 1987, Price Waterhouse, as certified public accountants, independently verified and approved the accounting classifications contained in the April 23, 1987, revision. b. The proper FHURS manual accounting classifications of RPICC charges and receipts: characteristics of the RPICC program The RPICC (Regional Perinatal Intensive Care Center) program is a state program administered by the Children's Medical Services (CMS) program office of the Department of Health and Rehabilitative Services. The program is established to provide state funding of services at designated hospitals for high risk pregnant women and infants. These patients typically have long (45 to 50 day) stays in the hospital. T. 29-30. RPICC funds are grant funds. P. Ex. 11; sections 383.17, 383.171, 383.18, and 383.19, Fla. Stat. (1987). RPICC funds do not constitute restricted or unrestricted revenues provided to a hospital by local governments or tax districts. Persons eligible for RPICC services must be indigent, and must be individually qualified. P. Ex. 11, attachment I; T. 75-77. The hospital has to maintain logs of specific patients in the RPICC program, and the patients have to meet certain criteria. Dep. (James Bracher), p. 44. The hospital must maintain detailed records containing information specific to each RPICC patient served. By statute, the procedures for disbursement of RPICC funds must be pursuant to and according to the terms of contracts. Sections 383.117, 383.18, and 383.19(3), Fla. Stat. (1987). These contractual agreements must provide "that parents or guardians of those patients who are financially eligible to participate in the RPICC program shall not be additionally charged for treatment and care which has been contracted for by the [Department of Health and Rehabilitative Services]." Section 383.18, Fla. Stat. (1987). Thus, no hospital bills may be sent to RPICC patients or to their guardians, and these persons may not be charged by the hospital. Tampa General Hospital did not send any bills to its RPICC patients, or to the guardians of those patients. By statute and by contract, a hospital that participates in the RPICC program must serve all patients eligible, regardless of-funding from HRS. T. 35. Tampa General Hospital entered into a contract with HRS to be a Regional Perinatal Intensive Care Center, and received RPICC funds during fiscal year 1986 pursuant to that contract. P. Ex. 11. By contract, Tampa General Hospital was promised what the contract called a "fixed price," subject to availability of state funds. P. Ex. 11. Contracts for administration of RPICC grants do not in effect have a fixed contract price, but provide instead a lump sum that is the maximum amount promised, to be paid according to the conditions of attachment I to the contract. P. Ex. 11, attachment I. Attachment I further provides that the "grant funds" specified in lump sum amount "will be disbursed and accounted for according to the approved RPICC neonatal care (NCG) payment system for hospital services . . . The "payment schedule" requires submission by the hospital of the "expenditure report" which is the form marked exhibit K, P. Ex. 11. Tampa General Hospital was by contract entitled to receive each month the lesser of the prorated portion of the grant or the "total expenditures" for that month. P. Ex. 11. The hospital is normally paid a fixed prorated share of the total grant amount each month. T. 31. The monthly payment does not fluctuate by numbers of patients seen in that month. T. 33-34, 80-81. The RPICC program does not make payments for specific services rendered to specific patients, and does not make payments for specific bills of patients, and thus is not like the Medicaid or Medicare programs, or an HMO contract. Dep. (James Bracher), pp. 47, 60. Instead, the RPICC program has a provision that if certain minimum levels of service are not reached, the total amount of funds will not be disbursed to the hospital. Id. Even when all RPICC funds are not "earned," the result is not patient-specific. Funds which are not earned must, pursuant to the RPICC contract, be paid back to HRS at the end of the year. T. 86; P. Ex. 11, attachment I, paragraph D.1.d. The hospital also has the option of having the shortfall applied to funds due in the next fiscal year. Dep. (James Bracher), pp. 48, 53. The RPICC program requires the submission of a cost report at the end of the year, but monthly payments are not made by cost reports. Dep. (James Bracher), p. 25; T. 32. Medicaid reimbursement is based on cost reports at the end of the fiscal year. T. 33. Under the RPICC program, there is no relationship between actual costs and payments made. Id. With Medicaid and Medicare, the more patients the hospital treats, the more money the hospital receives. The same is true for HMO contracts. Payment is thus made for services rendered to specific patients for these programs. Dep. (James Bracher), p. 47. This is not true in the RPICC program. Although Tampa General was obligated by law and its contract to serve all RPICC eligible patients, the maximum that it would be paid was the fixed price stated in its contract. Tampa General Hospital applied the payments it received from HRS in the RPICC program to its general ledger accounts, not to specific patient accounts. T. 120. A grant may have a contract involved for administration of the grant. Dep. (James Bracher), pp. 44, 46. It is not unusual for a governmental agency that administers a grant program to require the recipient of the grant to substantiate that it used the grant for the purposes intended by the grant program. T. 122. Tampa General Hospital's charges associated with RPICC patients have historically far exceeded the state funding of this program. T. 81; P. Ex. 12. In fiscal year 1986, RPICC charges at Tampa General Hospital were $10,067,448, and Tampa General Hospital received only $2,633,338 in RPICC payments. T. 34; Ex. 12. Tampa General Hospital thus has never had to return overpayments due to unearned funds. The sales tax issue Introduction Pursuant to chapters 84-373 and 85-555, Laws of Florida, Hillsborough County was authorized to enact a 1/4 cent sales tax, the proceeds of which could be allocated to health care providers for certified indigent patients who were residents of the county. Pursuant to this authority, Hillsborough County enacted ordinance 85-2, levying a tax from April 1, 1985, through March 31, 1987. P. Ex. 14. In fiscal year 1986, Hillsborough County Hospital and Tampa General Hospital received funds from this 1/4 cent sales tax. The funds were appropriated to the Hillsborough County Hospital Authority for allocation to both hospitals. Revisions submitted by Hillsborough County Hospital. Hillsborough County Hospital submitted its fiscal year 1986 report of actual experience on January 29, 1987. P. Ex. 22. On worksheet C-2 of that report, Hillsborough County Hospital reported the difference between patient charges and funds received on line 7, bad debts, (FHURS account 5900). T. 52. On about June 9, 1987, Hillsborough County Hospital filed a revision to its fiscal year 1986 report, changing the manner in which the sales tax charges and receipts were accounted on worksheet C-2 of the original prior year report. P. Ex. 23; T. 52. The revision still reported the charges for services provided with sales tax funds on line 7, provision for bad debts, but did not deduct the receipts associated with those services as reported in the original fiscal year 1986 report. Instead, receipts of $647,543 were classified as "unrestricted tax revenue and appropriated funds," FHURS account 9130 (line 39a, worksheet C-4) and were moved to worksheet line 29, non-operating revenue. T. 52. As a result, both lines 7 and 29 increased by $647,543 on the revised worksheet C-2. 55. The June 9, 1987, revision by Hillsborough County Hospital was accompanied by a certification by Price Waterhouse, certified public accountants, verifying the changes in classifications of sales tax patient charges and receipts on worksheet C-2 for Hillsborough County Hospital. P. Ex. Although the verification was submitted by Price Waterhouse in connection with a main penalty issue, the verification concerned only the June 9, 1987, revision as an amendment to the fiscal year 1986 actual report. The verification pertained to the amended report, which itself has multiple uses, including the redistribution at issue in this case. In sum, the verification was not limited to main penalty issues. The Price Waterhouse verification of June 9, 1987, stated that the sales tax funds received by Hillsborough County Hospital were from the special county sales tax that had been appropriated to the Hillsborough County Hospital Authority, and then allocated among both Hillsborough County Hospital and Tampa General Hospital. On June 30, 1987, counsel for Hillsborough County Hospital sent to counsel for the Hospital Cost Containment Board a letter with numerous attachments. P. Ex. 14. The letter was sent in connection with the main penalty issue concerning Hillsborough County Hospital, but generally addressed the sales tax issue from the perspective of the Hillsborough County Hospital Authority, and expressly mentioned both Hillsborough County Hospital and Tampa General Hospital. The documents were received by the Hospital Cost Containment Board shortly after June 30, 1987. Hillsborough County Hospital filed two revisions to worksheet C-2 after June 9, 1987. P. Exs. 25 and 26. Both revisions were filed by Hillsborough County Hospital at the request of staff of the Hospital Cost Containment Board and both contained accounting classifications for the sales tax issue with which Hillsborough County Hospital then disagreed. The September 28, 1987, revision as to the sales tax issue was filed under protest. P. Ex. Likewise, the revision of October 12, 1987, was filed under protest. P. Ex. 26. As to the sales tax issue, neither revision is a revision adopted by, or a revision of, Hillsborough County Hospital. When the September 28, 1987, revision was filed under protest, Price Waterhouse did not renew its verification of the sales tax accounting because the September 28, 1987, submission was incorrect, in its opinion, and because Price Waterhouse believed the June 9, 1987, submission to be correct. P. Ex. 25; T. 91-95. Price Waterhouse has not verified the accounting methods for the sales tax funds in the October 12, 1987, revision, and did not testify during the hearing that those methods are correct. Thus, the Price Waterhouse verification of June 9, 1987, of the classification of sales tax charges and receipts has never changed and remains as the verification of the June 9, 1987, revision relevant to this case. By letter dated October 28, 1987, the Hospital Cost Containment Board notified Hillsborough County Hospital that it rejected Hillsborough County Hospital's method of accounting for sales tax receipts. The letter stated that the FHURS manual required that the difference between indigent patient charges and sales tax receipts be reported as charity/uncompensated care-other, FHURS account 5960. P. Ex. 27. There remains the question of when did the Hospital Cost Containment Board first advise either of the Petitioners that their method of reporting the sales tax issue did not conform to the FHURS manual. Mr. Summers and Mr. Bracher were the only members of the staff of the Hospital Cost Containment Board who worked on the calculations to determine the initial distribution of Public Medical Assistance Trust Fund monies and to review corrections filed by hospitals to their 1986 prior year reports. T. 146-47. No one else testified for the Hospital Cost Containment Board. Thus, their testimony on this issue should be examined closely. Mr. Summers testified that in the middle of the summer he told both hospitals that the sales tax charges and receipts should be "grossed up" rather than "netted down." T. 150. He had previously defined "grossing up" in the context of the sales tax as reporting patient charges on line 13 of worksheet C- 2 (charity/uncompensated care-other) and reduction of those charges by a negative amount on line 14 (restricted donations and grants for indigent care) T. 147. Although the communication did take place, the timing of this communication by Mr. Summers is not supported by the preponderance of the evidence in the record. On September 28, 1987, Hillsborough County Hospital filed the first revision under protest. The amount reported in line 7, worksheet C-2, in the September 28, 1987, revision, was the same as reported in the original fiscal year 1986 actual report filed January 29, 1987, less $148. Compare P. Ex. 22 to P. Ex. 25. The letter transmitting the September 28, 1987, revision stated that the sales tax accounting remained "netted in total deductions from revenue," which is the case since the net was still contained on line 7. The letter of transmittal stated that Hillsborough County Hospital filed the September 28, 1987, revision because "of the position that you and your staff have taken on this issue." It was not until sometime between September 28, 1987, and October 12, 1987, that Mr. Summers changed his position, and told Hillsborough County Hospital to "gross up." P. Ex. 26. In summary, from the testimony of Mr. Summers it is unclear as to when he told Hillsborough County Hospital that its June 9, 1987, revision did not conform to the FHURS manual. Mr. Bracher was asked if he was aware of any written notice to either of the Petitioners that anything in the reports submitted June 9, 1987, was not conforming. He answered that he was not aware of any specific notice. He said he thought the issue was wrapped up in the main penalty case, and would be resolved when that case was heard. Dep. (James Bracher), p. 28-29. It is concluded that there is no evidence that within the forty days following June 9, 1987, the Hospital Cost Containment Board communicated written notice to either Petitioner that the June 9, 1987, revision with respect to sales tax associated charges and receipts was not in conformance with the FHURS manual. Nonetheless, on June 30, 1987, counsel for Hillsborough County Hospital sent a letter to counsel for the Board transmitting a package of information concerning the sales tax. P. Ex. 14. It is inferred from the efforts of counsel for Hillsborough County Hospital that there was disagreement between the parties at this stage. It is also inferred that the package of explanatory documents was sent to the Hospital Cost Containment Board by Hillsborough County Hospital on June 30, 1987, because Hillsborough County Hospital and the Hillsborough County Hospital Authority then knew that the Board disagreed with the June 9, 1987, revision. Moreover, on July 17, 1987, the Hospital Cost Containment Board transmitted to Hillsborough County Hospital its initial calculation of the redistribution. The amount of charity care shown on the accompanying calculation ($2,559,133) is obviously from line 7, worksheet C-2, of the original fiscal year 1986 actual report. P. Exs. 22 and 24. From this it is clear that as of July 17, 1987, the Hospital Cost Containment Board had rejected the accounting on that line contained in the June 9, 1987, revision. Thus, from these activities, it is inferred that within forty days of receipt of the June 9, 1987, revision, the Hospital Cost Containment Board did orally communicate to both Petitioners its disagreement with the June 9th revision with respect to the sales tax question. Revisions submitted by Tampa General Hospital Tampa General Hospital originally reported the differential between charges for patients associated with the sales tax funds and receipts of sales tax funds on line 7, of worksheet C-2, FHURS account 5900, "provision for bad debts." T. 52. On September 28, 1987, Tampa General Hospital filed a "revision" to its fiscal year 1986 actual report. P. Ex. 6. The cover letter from Mr. Powers stated that the sales tax monies "remain netted in total deductions from revenue (lines 7-17)." However, the letter made it clear that Tampa General Hospital disagreed with this accounting method, and that the report was submitted "because of the position that you and your staff have taken on this issue." Like the September 28, 1987, "revision" filed by Hillsborough County Hospital, which was submitted with an identical cover letter, the September 28, 1987, report by Tampa General Hospital was not adopted by Tampa General Hospital. Also as discussed above, the September 28, 1987, revision by Tampa General Hospital as to the sales tax issue was not verified by the hospital's certified public accountant. Thus, it is clear that Tampa General Hospital did not file its own formal written revision to its fiscal year 1986 report with respect to sales tax funds within the ninety-day period following July 1, 1987. Nonetheless, it is inferred from the evidence that the Hospital Cost Containment Board was aware that Tampa General Hospital was seeking within 90 days of July 1, 1987, to change its sales tax reporting in the same manner as Hillsborough County Hospital. This inference is based upon the following: The initial revision submitted by Hillsborough County Hospital on June 9, 1987, contained a discussion by Price Waterhouse, and in that discussion of the nature of the sales tax funds, Price Waterhouse stated that the funds were appropriated to the Hillsborough County Hospital Authority and allocated to both Hillsborough County Hospital and Tampa General Hospital. The letter from Price Waterhouse further stated that Price Waterhouse were the auditors for the Authority. It was thus evident from the June 9, 1987, submission that the sales tax issue applied to the Hillsborough County Hospital Authority, and thus applied equally to Hillsborough County Hospital and to Tampa General Hospital. The letter of June 30, 1987, from counsel for Hillsborough County Hospital to counsel for the Hospital Cost Containment Board, while concerned with the main penalty and Hillsborough County Hospital, stated that the funds went to the Authority, and noted that the Authority was composed of both hospitals. Much of the communication between the parties in this case was with Paul Powers, who is the Chief Financial Officer for the Authority and for both hospitals. As previously discussed, it is evident that staff of the Hospital Cost Containment Board orally advised representatives of the hospitals that the Board disagreed with the June 9, 1987, revision. Both hospitals filed revisions dated September 28, 1987, showing that both hospitals were actively discussing the matter during this period with the Hospital Cost Containment Board. After the September 28, 1987, revisions were filed, staff of the Hospital Cost Containment Board advised both hospitals to resubmit worksheets C- 2, "grossing up" the monies by reporting charges for sales tax patients on line 13, and receipts on line 14. T. 54-57. (Staff of the Hospital Cost Containment Board later determined this advice to have been erroneous.) Both hospitals complied under protest. P. Exs. 7 and 26. Further, while Price Waterhouse did not on June 9, 1987, formally certify that the sales tax funds should be accounted for by Tampa General Hospital in the same manner as reported by Hillsborough County Hospital in its June 9, 1987, revision, the identity of the issues discussed above for both hospitals causes that result in effect. The June 9, 1987, certification made it clear that the funds were appropriated to the Authority, and thus the character of the funds, for accounting purposes, would be the same for both hospitals that compose the Authority. Moreover, certification as to the exact dollar amounts involved in the reclassification for Tampa General Hospital was made by Price Waterhouse during the de novo formal administrative hearing. In sum, the record contains a certification by a certified public accountant as to the sales tax accounting change sought by Tampa General Hospital, both as to amount and as to classification. The proper FHURS manual accounting for sales tax funds: characteristics of the sales tax funds In fiscal year 1986, both Hillsborough County and the Hillsborough County Hospital Authority budgeted and appropriated sales tax funds to Tampa General Hospital and Hillsborough County Hospital for indigent care. T. 44, 101-102. Hillsborough County is a governmental agency. As an appropriation, these sales tax funds were set aside for a specific purpose, indigent care, by Hillsborough County. T. 96-100. The method of distribution of sales tax funds was not specified by statute or by contract. T. 79. As discussed above, the enabling statutes simply stated that the funds were to be used for indigent patients who were county residents. The record does not contain any credible evidence to explain how the fiscal year 1986 sales tax appropriations were supposed to have been distributed to the two Petitioners. It might have originally been based on specific patient bills, or it might have been lump sum distribution, but there is no evidence. At least this is known: the sales tax money was not available until ad valorem appropriations were spent, and those appropriations were not being spent because there were insufficient numbers of patients meeting the ad valorem eligibility requirements. T. 66-67. Midway through the fiscal year, it was determined by Hillsborough County that the appropriated funds were not being transferred to the two Petitioners as originally intended. 44-45, 65-67. In fact, no funds had been transferred by June, 1986, the ninth month of the fiscal year. P. Exs. 17 and 18. Hillsborough County then determined to spend the money by a method other than what was originally envisioned. It did so by arbitrarily and substantially loosening eligibility requirements and expanding the distribution to other programs. T. 67, 69-71, 45. Since there is no clear evidence in the record as to how the sales tax program was originally intended to have operated, and since the only clear evidence in the record is that the County chose drastically to alter the method of transferring the sales tax appropriated funds to the two Petitioners, it must be concluded as a matter of fact that for accounting purposes, the only relevant facts are those facts showing how the sales tax program was changed midway through the fiscal year. In particular, due to the change made by the County, references to earlier plans to transfer the money in the May 22, 1985, minutes of the Board of County Commissions, exhibit 3, P. Ex. 14, are not relevant. It is important to note that the change in the manner of transferring the sales tax appropriations to the Petitioners was caused solely by the fact that the original method did not work. Thus, the County had no underlying basis to determine how to loosen eligibility requirements and to select new programs to cover. Requirements were loosened and new programs were covered until the prior appropriated funds were transferred. The only requirement was that the funds pay for patients who were medically indigent. T. 108. Thus, the method of selection of requirements to loosen and programs to cover was essentially arbitrary. T. 69-74, 103-104, 45, 47-48. At least 25 percent of the sales tax funds was paid on a per diem basis, based upon specific patients and days elapsed. T. 72, 68. But not all was based on per diem, contrary to the testimony of Mr. Summers. T. 152. At least 25 percent of the sales tax funds paid for the specific charges of specific patients who suffered catastrophic illnesses (charges in excess of 125 percent of annual income). T. 72-73. Other sales tax funds paid for amounts not paid (funds exhausted or not yet available) in the RPICC program, the tuberculosis program, the Medicaid program, and the Medicare kidney program. T. 45-46. In fact, payments were superficially made based upon charges submitted by specific patients in all cases, although payment was limited to a set per diem rate for those patients who qualified based upon the original indigency criteria. T. 73-74. Although the method of transfer of sales tax funds to the Petitioners was superficially by payments for charges associated with specific patients, that observation does not go far enough. The context of the payments cannot be ignored. Specific patient charges were identified in the transfer process only to give the County assurance that the money was going for indigent services. T. 109. Moreover, the payments were made for specific charges solely pursuant to the arbitrary change in the sales tax program discussed above, which was motivated solely by the desire of the County to expend all of the sales tax funds (the entire lump sum) previously appropriated to the two Petitioners. T. 73-74. Neither of the two Petitioners had any preexisting contract with the County that establish a system of payment of charges for specific patients. Nor is there any evidence that the County itself, as it shifted gears midway in the fiscal year, established a program to pay charges for specific patients based on reasoned criteria for identification of such patients. Instead, as discussed above, the choices of programs and eligibility requirements was driven only by the desire to spend a prior determined lump sum amount. The observed effect was the transfer to the Petitioners of the entire appropriated amount in only three months, the last three months of the County's fiscal year. P. Exs. 17 and 18. In context, then, the payments for charges associated with specific patients was not fundamentally a series of discrete payments of charges for specific patients, but was merely the mode of transfer of a lump sum payment. Exhibit 12, P. Ex. 14, initially relied upon by Board staff, contains a mixture of payments made by the County from ad valorem tax funds and sales tax funds. Compare to P. Ex. 17 and 18. Thus, for this reason, in addition to the discussion above, one cannot conclude from this exhibit that sales tax funds were transferred to the Petitioners as specific payments for specific patients. The proper accounting classification for the sales tax monies (or the RPICC funds, for that matter) depends upon the nature of the payment mechanism. T. 145. Mr. Summers was of the opinion that if Hillsborough County determined to distribute the sales tax funds by an arbitrary method, totally changing the prior method, with the only criteria that the funds pay for services to indigent patients, then receipts from the sales tax funds should be reported on line 14 of worksheet C-2, FHURS manual account 5970, "restricted donations and grants for indigent care." T. 189-90. That is in fact what occurred. The distribution to the Petitioners with respect to the sales tax issue will be the same whether the receipts of sales tax funds are classified on line 29 or on line 14 of worksheet C-2. T. 94-95.
Recommendation For these reasons, it is recommended that the Hospital Cost Containment Board enter its final order: Confirming that the April 23, 1987, revision by Tampa General Hospital to its 1986 actual report conforms to the FHURS manual by operation of rule 27J- 1.010(3). Due to the definition of charity care in section 12, chapter 87-92, Laws of Florida, denying to Tampa General Hospital recalculation of distribution from the Public Medical Assistance Trust Fund with respect to the RPICC program. Correcting the 1986 actual reports of Tampa General Hospital and Hillsborough County Hospital with respect to sales tax funds, reporting charges on line 13, "charity/uncompensated care-other," and receipts on line 14, "restricted donations and grants for indigent care," and recalculating the redistribution due the two hospitals based upon these corrections. (The result appears to be stated in findings of fact 6 and 8.) DONE and ENTERED this 9th day of March, 1988. WILLIAM C. SHERRILL, JR. Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 9th day of March 1988. APPENDIX TO RECOMMENDED ORDER IN DOAH CASE NUMBERS 87-5207H AND 87-5208H The following are rulings upon findings of fact proposed by the parties which have been rejected or adopted by reference in this Recommended Order. The numbers correspond to the numbers of the proposed findings of fact as used by the parties. Findings of fact proposed by the Petitioner: 9. The last half of the paragraph is an issue of law, not fact. All but the first sentence are cumulative and unnecessary. Irrelevant. 17. The motive of the county is irrelevant. 19. Not supported by the record cited. Mr. Bracher qualified his testimony with the phrase "I guess," and then qualified his opinion. Dep. (James Bracher), p. 27. 24. Irrelevant since the April 23, 1987, revision is operative. These findings of fact are adopted by reference. Irrelevant. The first two sentences are true, but are subordinate to findings of fact adopted in the recommended order. These findings of fact, however, are adopted by reference. The first sentence is not supported by the record. The first sentence is rejected in the conclusions of law. The first sentence is rejected in the conclusions of law. The first sentence is rejected in the conclusions of law. The existence or absence of cost reports is not persuasive that account 5940 is or is not applicable. The phrase "cost reports" in the FHURS manual with respect to account 5940 only appears in a parenthetical, "including adjustments made at year end." As such, it is inclusive of circumstances where adjustments are made at year end based on cost reports, but is not necessarily limited to that circumstance. 38. Blue Cross accounting occurs in account 5930, and thus reference thereto is irrelevant for this case. 40 and 41. Irrelevant. A formal administrative hearing is intended to formulate agency action, not to review prior action. McDonald v. Department of Banking and Finance, 346 So.2d 569, 584 (Fla. 1st DCA 1977). 42 and 43. These proposed findings of fact are true but are not relevant. A formal administrative hearing is intended to formulate agency action, not to review prior action. McDonald v. Department of Banking and Finance, 346 So.2d 569, 584 (Fla. 1st DCA 1977). 44. This is an issue of law, not fact. 50. The last sentence is true, but is subordinate to findings of fact adopted in the recommended order. This finding of fact, however, is adopted by reference. The second sentence is irrelevant. A failure to make the recalculation by October 15, 1987, while a technical violation of the statute, could hardly have been intended by the Legislature to result in no recalculation at all. The last portion of the sentence is incompetent as legislative history. 59. The distributions were initially and superficially calculated on specific patients' charges, but were not ultimately "based" thereon, as discussed in the findings of fact. 63. The second through fifth paragraphs are true, but are subordinate to findings of fact adopted in the recommended order. These findings of fact, however, are adopted by reference. 63-64. These proposed findings of fact are true, but are subordinate to findings of fact adopted in the recommended order. These findings of fact, however, are adopted by reference. Irrelevant for lack of sufficient credible evidence showing identity of-circumstance to justify the comparison. Irrelevant for lack of sufficient credible evidence showing the lack of identity of circumstance to justify the comparison. 68-70. These proposed findings are issues of law, not fact. 71-72. Irrelevant. Findings of fact proposed by the Respondent: 2-4. These are issues of law, not fact. The second sentence is contrary to the record. T. 52, 55-56; P. Exs. 7 and 26. The remainder is irrelevant. These proposed findings have been rejected in findings of fact 79-86. The first four sentences, while true, are not adopted as findings of fact because of little help in resolving the question of which expert to believe. Both parties have submitted proposed findings of fact concerning the shifting bases of expert opinion. About all that can be concluded from these proposed findings, all of which are true, is that the accounting definitions are so unclear and loose that experts have difficulty finding their way. The next sentence is true, and is adopted by reference. Although the testimony cited would lead to the finding that the Petitioners originally classified the sales tax differential on line 13, this is in conflict with testimony at T. 52 that the differential was originally reported in bad debts, line 7. Moreover, there is no entry on line 13 on the original submission. P. Exs. 2 and 22. The proposed finding to this extent is rejected for these reasons. While the basis for Mr. Summer's ultimate opinion is relevant to this case, the path he took to that opinion is not. The formal hearing is de novo, and Mr. Summer's opinion at the hearing is the only one relevant. While the proposed finding of fact is true, and is adopted by reference, the ultimate conclusion has been rejected because the payment mechanism was, in effect, by lump sum. The first paragraph is cumulative to other findings of fact, and thus not necessary. 21. There is not sufficient evidence in the record to adopt the proposed finding that the original RPICC accounting by Tampa General Hospital was "consistent with the manner in which other hospitals report it." This paragraph is an issue of law, not fact. The proposed finding that the Hospital Cost Containment Board notified Tampa General Hospital that it "intended to review Petitioner's records" has been rejected by findings of fact 19-21. Moreover, notice of intent to review records is irrelevant. The notice required by the rule is notice that the report of April 23, 1987, did not conform to FHURS manual accounting classifications. While it is true that the July 17, 1987, memorandum was a preliminary document with respect to the amount of distribution that might be received ultimately by a hospital, it was preliminary only with respect to changes that might occur due to corrections filed by individual hospitals that elected to file such a change pursuant to the opportunity afforded by section 12 chapter 87-92, Laws of Florida. There was no reason for it to be preliminary with respect to reliance by the Hospital Cost Containment Board upon the fiscal year 1986 actual reports filed by hospitals that were already final and would not be changed by a new correction. All sentences after the first two are true, but are subordinate to findings of fact adopted in the recommended order. These findings of fact, however, are adopted by reference. However, the proposed finding that the RPICC cost reports were "like those required by Medicare and Medicaid" is rejected because the RPICC cost reports were not used to settle up at the end of the year. The sentences in this paragraph are true, but are subordinate to findings of fact adopted in the recommended order. These findings of fact, however, are adopted by reference. The record in this case does not explain how the NCG system works. Thus, this proposed finding of fact must be rejected. These proposed findings of fact are not supported by the record. It appears that cost reports were not used to settle up or in the manner used by cost reports in the Medicaid and Medicare programs. 34 and 35. These proposed findings accurately reflect the assumed facts that underlie the opinions at the hearing of Mr. Summers and Mr. Bracher, and are adopted by reference. This is not, however, an adoption as fact of the matters which form the basis of opinions. 36. These proposed findings are essentially arguments of law that have been considered in the conclusions of law. COPIES FURNISHED: John H. Parker, Jr., Esquire 1200 Carnegie Building 133 Carnegie Way Atlanta, Georgia 30303 Gary Walker, Esquire Hospital Cost Containment Board 325 John Knox Road Building L, Suite 101 Tallahassee, Florida 32303 James J. Bracher Executive Director Hospital Cost Containment Board 325 John Knox Road Building L, Room 101 Tallahassee, Florida 32303 Gregory L. Coler, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700
Findings Of Fact HRS is a state agency responsible for the administration of the Florida Medicaid Program provided for in Title XIX of the Social Security Act. The medicaid program was implemented through Section 409.902, Florida Statutes. The peer review aspect of the Florida Medicaid Program involves the responsibility of insuring that hospitals comply with state and federal utilization review requirements. The Petitioner, at all times material hereto, was the treating facility for the four patients involved in the issues in this case. It is assigned Medicaid Provider No. 011976800. The medicaid/medical benefits program for the State of Florida administered by HRS under Title XIX of the Social Security Act reimburses hospitals for "medically necessary" in-patient hospital care provided to medicaid beneficiaries. See Rule 10C-7.039, et. seq. The determination of "medical necessity" is to be made by the hospitals' utilization review committee and by the utilization and quality control PRO which is under contract to provide that service with HRS. Utilization review is defined as "regular prescribed program for the review of each recipient's need for services to insure efficient provision of care". HRS has established procedures for determining the medical necessity and appropriateness of care for use by hospitals and by the PRO's. The procedures include a review of medical record documentation against a list of criteria published by HRS. These criteria are popularly called ISD criteria. "ISD" is an acronym signifying severity of illness, intensity of service, and "discharge screens." Each medicaid recipient must meet ISD criteria for severity of illness before being admitted to a hospital. They must also meet the intensity of service ISD criteria for continued hospitalization. Once a patient meets one of the ISD discharge screens (standards), there is the indication that the patient is ready to be discharged. The ISD criteria are to be used as a "basis for professional determinations of the medical necessity of acute care hospitalizations" by the hospital utilization review (UR) committee and the PRO. These criteria are not an absolute measure of medical necessity. They may be balanced or overridden by a physician during the review process. The severity of illness (SI) criteria are acknowledged by HRS to be set at a high level. The SI criteria need not be met to justify an admission, however. "If treatment has been rendered and the intensity of service criteria are met, or if evidence relevant to more than one severity of illness indicator is available, lower levels than those specified in the criteria may justify certifying the admission. A case presenting marginal findings for certifying an admission will be referred to the physician advisor." See Respondent's Exhibit 4, page 6. According to the policy expressed in the HRS manual for hospitals providing services to medicaid beneficiaries, the hospital UR committee may consider "other supporting data as the committee deems appropriate" and contact the attending physician when determining medical necessity. Similarly, when medical necessity is an issue at the PRO level of review, the attending physician is to be contacted by the PRO and given an opportunity to speak to the physician advisor of the PRO so as to provide additional information going to the question of medical necessity. If the PRO denies coverage, HRS then accepts the PRO determination and does not conduct any independent review. HRS, having charged the hospital UR committee and the PRO with the evaluation of medical necessity, does not conduct its own review of the medical record or undertake any independent evaluation of medical necessity before notifying the relevant physician and hospital if reimbursement is denied. The Petitioner is in compliance with the medicaid program concerning utilization review. The hospital has established a UR plan which has been approved by the PRO and by HRS. The UR plan utilizes the same ISD criteria as the PRO. The UR committee was monitored to make sure that it was complying with the utilization review requirements. The five cases at issue were reviewed by five different physicians on the Center's UR committee and were felt to meet the criteria and to be medically necessary as appropriate admissions and appropriate lengths of stay. The PRO, however, disagreed with the UR committee. The attending physician was contacted by the PRO and asked to call a physician advisor to discuss these cases and to provide additional information to the advisor. The attending physician followed those instructions and attempted numerous times to contact the physician advisor with additional information concerning the cases but was never given the opportunity to do so. These PRO denials included one admission denial following a suicide attempt, despite the fact that "suicide attempt" is included in the ISD criteria as justification for admission. This denial of admission itself is clearly in error. Although this proceeding is a de novo one and not a proceeding designed to simply review the appropriateness and legal efficacy of the HRS initial decision, it is noteworthy, to the extent that HRS' position relies heavily on the PRO review of the patient admissions and lengths of stay in question, that the PRO's work product is of marginal credibility. This is because the PRO which was responsible for the UR and reviewed these cases lost its designation as an approved PRO and became involved in criminal litigation concerning a failure to carry out medical reviews properly. The PRO was unable to meet payroll obligations for its nursing and physician reviewers. The records of the PRO reviews of the five cases at issue in this proceeding were not available to HRS. Consequently, HRS had no information concerning the underlying data or facts relied upon by the PRO nor whether the PRO actually consulted the attending physician or whether its physician advisor did. Thus, the testimony of the attending physician, to the effect that he attempted to contact the physician advisor but was not permitted to as to any of these cases, is uncontraverted. The approved UR committee, in conducting its procedure at the Center, determined that the admission and lengths of stay of the five patients involved was medically necessary and compensable as determined by five physicians taking part in that process. The PRO, although it informed the physicians that they had the right to speak to a physician advisor, did not actually afford them that opportunity. The PRO determination was accepted by HRS without any HRS personnel speaking to the attending physician. Although HRS later allowed one day of an admission immediately following a suicide attempt, it upheld the other PRO determinations without actually knowing or reviewing any underlying information which might have been relied upon by the PRO and without HRS personnel conferring with the attending physician or affording him the opportunity to provide them with additional information. If the PRO, its physician advisor and HRS had given the attending physician the opportunity to explain and provide additional information concerning medical necessity, perhaps this dispute could have been resolved without the necessity and expense of formal proceedings. This is a de novo proceeding and, therefore, the information from the attending physician which was not utilized by the PRO or HRS in the review of these cases can be brought forward at this time providing the attending physician's testimony and evidence is deemed relevant, material, competent and credible. The attending physician named above, in fact, testified in this proceeding. His testimony is deemed competent and credible on the material issues and is not refuted by the Respondent. Based upon the attending physician's testimony, which is accepted, especially since no other physician with knowledge of the facts concerning these patients testified, the following findings of fact are made: Patient M.D.: This patient was treated at the emergency room following a suicide attempt on August 19th and transferred by the police to the Center where she was then admitted. She had previously sought out-patient treatment unsuccessfully. The initial examination showed her to be moderately depressed, avoiding eye contact, showing psycho-motor retardation, and crying easily. She made the statement that her two children would be better off if she were dead. She was placed on the medication prozac but after several days remained depressed and crying and complaining of insomnia. She was then given "Pamelor" which caused some adverse side effects, but she appeared to respond to the medication as to her depression. During her stay, she received an intensive rehabilitation program of at least three encounter therapies per day. On the basis of the medical record alone, patient M.D. met the following criteria: AK11-A (suicide attempt); AK57-B (treatments). These criteria do not require that the patient remain suicidal or admit to being suicidal during the in- patient stay in order to justify further treatment. The HRS representative testified that nursing notes indicated that the patient could perform some self- care functions during her hospitalization ("activities of daily living" or "ADL's"). Because of this and because the physician noted that the patient was denying suicidal ideations, she interpreted that circumstance to mean that the discharge "screen" or standard of "able to function in a non-hospital environment" was met after August 20th, the day of admission. However, HRS also admitted that whether the patient could function in a non-hospital environment was a medical decision to be made on the hospital level and the PRO level. The attending physician testified that records of self-care in a restricted hospital environment do not mean that the patient could function in a non-hospital setting. He further testified that the patient in this instance required treatment and did not meet the discharge standard or "screen" of being "able to function in a non-hospital environment" before August 30th. He testified that the services could not be effectively provided on an out-patient basis prior to August 30th. That testimony is accepted and the fact established. The ISD criteria and explanatory bulletins promulgated by HRS do not contain requirements that a patient remain suicidal during a stay nor a discharge criteria that equates self-care in the hospital environment with the ability to care for oneself safely and adequately in a non-hospital environment. On the basis of the evidence presented, the in-patient admission of M.D. from August 20th to August 30th met the criteria for admission and continued stay. The services provided were shown by unrefuted testimony to be medically necessary and the discharge screens or criteria were not satisfied until August 30, 1991. Patient M.D. (Admission of September 21, 1990 through September 29, 1990): Nineteen (19) days after her first discharge, patient M.D. again attempted suicide. She had been referred for out-patient care after her previous hospitalization but did not follow up and obtain that care and did not continue to take her medication. She wrote a suicide note on the second attempt and was treated in an intensive care unit for three days before being re- admitted to the Center. Throughout her hospitalization, she received intensive rehabilitation therapy as before and remained in a highly-restricted, locked unit, where suicide precautions were in effect. She was assigned to a counselor for "one-on-one" therapy in addition to her group therapy. Her attending physician did not consider her able to function in a non-hospital environment prior to September 29th, and his testimony so establishes. The HRS witness, when asked whether she had an opinion when the patient should have been released, stated a date prior to the actual discharge based upon her opinion that the patient was able to function in a non-hospital environment. That decision, however, is a medical decision which the witness was not qualified to make. In any event, the fact that a patient might be able to perform some "ADL" functions in a highly-supervised, protective hospital setting does not mean that the patient is well enough and responsible enough to perform those functions adequately and safely on her own outside a supervised hospital setting. In summary, based upon the unrefuted evidence presented, particularly the testimony of the attending physician, the in-patient admission of M.D. on September 21, 1990 met the ISD criteria for admission and continued stay. The services were medically necessary and the patient was not appropriately ready for discharge until September 29, 1991. Patient W.P. (Admission of April 11, 1990 to April 16, 1990): This patient suffered a severe psychotic episode a month before her admission and then presented to an emergency room stating that she was "about to lose it" and that it was only her religious beliefs which prevented her from committing suicide. This alarmed the attending physician concerning her suicidal ideation and possibility. The patient had been married five times and was then seeing a married man and also allegedly contemplating a lesbian relationship with that man's wife. She had been blamed by her family for the death of her grandchild. Upon her admission, it took her approximately three days to become aware that she was in a locked psychiatric unit. This indicated to the physician that she did not fully comprehend where she was or what she was doing in terms of her orientation as to reality of time and place. She was severely depressed, out of touch with reality, and not able to perform the affairs of daily living (ADL's). She exhibited anorexia and insomnia at the time of admission. She indicated merely that she was not eating as much as she had previously. She was placed on prozac, to which she responded in approximately five days. The services provided to her after her admission met the intensity of service criteria for a continued stay. The physician testified that she did not meet discharge standards prior to the actual discharge date whereupon she was referred to out-patient care for follow-up treatment. The physician's testimony establishes that necessary medical services could not have been effectively or safely provided on an out-patient basis prior to the discharge date. The physician's testimony establishes that in the artificial environment of a hospital, the notations in medical records that a patient is eating and sleeping does not mean that she is able to perform those functions outside of the hospital safely and adequately or will consistently do so if left to her own devices. The HRS witness admitted that not eating and not sleeping is relevant to the question of whether a patient can perform normal ADL's. The later contention by HRS that inability to perform ADL's requires a patient to be in a "nearly vegetative" state is simply unsupported by medical testimony nor by any definition in evidence. The unrefuted testimony of the attending physician establishes that the in-patient admission of patient W.P. on April 11, 1990 met the ISD criteria for admission and continued stay and that the services were medically necessary. The patient was not recovered sufficiently for appropriate discharge until April 16, 1990. Patient D.G. (Admission of May 4, 1990 to May 11, 1990): This patient had a recent history of heavy drug usage and criminal convictions near the time of her admission. HRS had removed her children from her custody, which created an additional crisis in her life, as did the fact that her husband was then in prison. The attending physician stated that the patient was exhibiting acute withdrawal symptoms from drug usage and delirium tremors from the drugs upon her admission. She was at a high risk of resuming her heroin use and threatened suicide if she did not get help for her addiction. A urine screen performed was positive upon her admission for drug usage and withdrawal symptoms. Impending delirium tremors were exhibited at that time. She was depressed and required acute medication, being placed on a high dose of both librium and anti- depressants. D.G. could not be treated in a de-toxification unit because of her suicidal ideation and attendant depression. She received intensive therapy consisting of three sessions per day while she was hospitalized. Her depression responded to the medication and discharge planning began on her third day of admission, with a view toward placing her in a de-toxification unit. She was discharged to complete her de-toxification as soon as a placement was available. The HRS witness opined that because D.G. was not "comatose" or "impending comatose", she did not meet the admission standards for substance abuse and because she was able to sleep, eat, and dress herself in the hospital, she did not meet the admission criteria concerning performance of ADL's. The attending physician testified, however, that she was in withdrawal from heroin use, needed de-toxification, and could not be admitted to a de-toxification program until her other psychiatric problems had been stabilized. The attending physician, by his training, his experience, and by his personal contact with and treatment of the patient, is best able to evaluate the patient's medical circumstance, need for admission and treatment and the length of treatment required. Consequently, his testimony as to this patient and all the others is accepted over that of the non-physician HRS witness. Based upon the evidence presented at hearing, the in-patient admission and stay of D.G. was medically necessary and could not have been provided effectively in a less-restrictive or out-patient setting. Patient S.R. (Admission of June 20, 1990 to June 29, 1990): Upon this patient's admission, she related not having slept for two months and not having eaten for five days. She had then undergone approximately three years of out- patient treatment unsuccessfully and had no family or community-support system in the area where she lived. She related that her ex-husband had been abusive and had recently abducted her daughter and vandalized her home. She related that her ex-husband had threatened her daughter's life and had had S.R. arrested and supposedly transported to the Palm Beach County Women's Stockade. She testified that she was unable to sleep or eat and was taking 10 to 12 baths per day. She complained of being unable to remember simple tasks, to take care of simple matters such as paying her rent, and was in the habit of wearing the same clothes from three to five days in a row without changing or washing, or being unable to remember whether she had washed or not. The patient was also taking a high dosage of a chronic asthma medication, which includes steroids. This can cause serious problems with depression. The patient was severely depressed and had recently started smoking. The patient met the ADL admissions criteria and while she was in the hospital, she received services which met the intensity of services criteria. The HRS witness admitted that the medical record note which stated "past two months she had not slept at all" constitutes insomnia and the record note "is not eating, has gone five days without food" constitutes anorexia. Based upon the evidence submitted at hearing, the in-patient treatment of S.R. from June 20, 1990 to June 29, 1990 met the criteria for admissions and continued stay and was shown by the treating physician's testimony to be medically necessary. The services could not have been safely and adequately provided on an out-patient basis, and the discharge standards were not satisfied as to this patient until June 29, 1990, when she was discharged.
Recommendation Having considered the foregoing Findings of Fact and Conclusions of Law, the evidence of record, the candor and demeanor of the witnesses and the pleadings and arguments of the parties, it is therefore
The Issue The issue for determination is whether the Petitioner is liable to the Agency for Health Care Administration ("Agency") for Medicaid reimbursement overpayments and related fines, costs, and interest.
Findings Of Fact The Agency is the single state agency charged with administration of the Medicaid program in Florida under Section 409.907, Florida Statutes. The Petitioner provides physician services to Medicaid beneficiaries pursuant to a contract with the Agency under provider number 037381800. The Agency sent the Petitioner a Preliminary Agency Audit report on June 30, 1998, notifying him of a preliminary determination of Medicaid overpayments in the total amount of $21,156.35. The Agency sent the Petitioner a Final Agency Audit Report on October 28, 1998, confirming the Agency's determination of Medicaid overpayments in the total amount of $21,156.35. The Agency's determination of overpayment was based upon findings that obstetrical echography services "were billed and paid in violation of Medicaid policy governing those services." The Agency performed an audit of the Petitioner for the period January 1, 1993, through October 31, 1996. According to the Agency audit report, the Petitioner's records contained violations of two billing policies outlined in the Medicaid Physician Provider Handbook. The first violation was that the Petitioner billed and received payment for more than one initial ultrasound procedure per pregnancy, and the second was that the Petitioner failed to submit documentation of medical necessity for additional procedures. During the years examined by the audit, Medicaid policy allowed providers to bill for more than one complete initial procedure per patient, so long as providers filed supporting documentation of medical necessity. However, the documentation submitted by the Petitioner indicated that the additional ultrasound procedures he conducted were mere follow-up procedures, instead of medically necessary complete procedures. According to the terms of the Medicaid Physician Provider Handbook, "[i]f more than two (or any combination of two) ultrasounds are performed during a pregnancy, they must be billed with modifier-22 and a report documenting the medical necessity for the procedure." The Petitioner submitted bills for more than two ultrasound treatments per recipient without explaining why the procedures were medically necessary. The Agency audit report established that the Petitioner has been overpaid as a result of the Petitioner's erroneous billings. The total overpayment to the Petitioner was calculated as "the difference between what he got paid for a complete procedure and the amount that he should have gotten paid for the follow-up." The Agency records received in evidence and the testimony of the Agency's witness establish that the amount overpaid to the Petitioner totaled $21,156.35. The Petitioner, as an authorized provider of Medicaid services, had signed a Medicaid Provider Agreement. That agreement states, among other things, that the "provider agrees to submit Medicaid claims in accordance with program policies." When the Petitioner became a certified Medicaid provider, he received a handbook outlining billing procedures for the performance of diagnostic ultrasounds. The Petitioner admitted that he knows "little about billing," that he "didn't involve [himself] in the billing at all," and that he has never read the Physicians' Current Procedural Terminology book, which sets forth the universally used billing codes.
Recommendation On the basis of all of the foregoing, it is RECOMMENDED that the Agency issue a final order requiring the Petitioner to reimburse the Agency for overpayments in the total amount of $21,156.35, plus such interest as may accrue as of the date on which payment is made. DONE AND ENTERED this 3rd day of January, 2001, in Tallahassee, Leon County, Florida. MICHAEL M. PARRISH Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 3rd day of January, 2001.
The Issue Kindred Hospitals East, LLC ("Kindred") and Select Specialty Hospital-Palm Beach, Inc. ("Select-Palm Beach"), filed applications for Certificates of Need ("CONs") with the Agency for Health Care Administration ("AHCA" or the "Agency") seeking approval for the establishment of long-term care hospitals ("LTCHs") in Palm Beach County, AHCA District 9. Select-Palm Beach's application, CON No. 9661, seeks approval for the establishment of a 60-bed freestanding LTCH in "east central" Palm Beach County about 20 miles south of Kindred's planned location. Kindred's application, CON No. 9662, seeks approval for the establishment of a 70-bed LTCH in the "north central" portion of the county. The ultimate issue in this case is whether either or both applications should be approved by the Agency.
Findings Of Fact Long Term Care Hospitals Of the four classes of facilities licensed as hospitals by the Agency, "Class I or general hospitals," includes: General acute care hospitals with an average length of stay of 25 days or less for all beds; Long term care hospitals, which meet the provisions of subsection 59A-3.065(27), F.A.C.; and, Rural hospitals designated under Section 395, Part III, F.S. Fla. Admin. Code R. 59A-3.252(1)(a). This proceeding concerns CON applications for the second of Florida's Class I or general hospitals: LTCHs. A critically ill patient may be admitted and treated in a general acute care hospital, but, if the patient cannot be stabilized or discharged to a lower level of care on the continuum of care within a relatively short time, the patient may be discharged to an LTCH. An LTCH patient is almost always "critically catastrophically ill or ha[s] been." (Tr. 23). Typically, an LTCH patient is medically unstable, requires extensive nursing care with physician oversight, and often requires extensive technological support. The LTCH patient usually fits into one or more of four categories. One category is patients in need of pulmonary/respiratory services. Usually ventilator dependent, these types of LTCH patients have other needs as well that requires "complex comprehensive ventilator weaning in addition to meeting ... other needs." (Tr. 26). A second category is patients in need of wound care whose wound is life-threatening. Frequently compromised by inadequate nutrition, these types of LTCH patients are often diabetic. There are a number of typical factors that may account for the seriousness of the wound patient's condition. The job of the staff at the LTCH in such a case is to attend to the wound and all the other medical problems of the patient that have extended the time required for care of the wound. A third category is patients with some sort of neuro-trauma. These patients may have had a stroke and are often elderly; if younger, they may be victims of a car accident or some other serious trauma. They typically have multiple body systems that require medical treatment, broken bones and a closed head injury for example, that have made them "very sick and complex." (Tr. 27). The fourth category is referred to by the broad nomenclature of "medically complex" although it is a subset of the population of LTCH patients all of whom are medically complex. The condition of the patients in this fourth category involves two or more body systems. The patients usually present at the LTCH with "renal failure ... [and] with another medical condition ... that requires a ventilator ..." Id. In short, LTCHs provide extended medical and rehabilitative care to patients with multiple, chronic, and/or clinically complex acute medical conditions that usually require care for a relatively extended period of time. To meet the definition of an LTCH a facility must have an average length of inpatient stay ("ALOS") greater than 25 days for all hospital beds. See Fla. Admin. Code R. 59A-3.065(34). The staffs at general acute care hospitals and LTCHs have different orientations. With a staff oriented toward a patient population with a much shorter ALOS, the general acute care hospital setting may not be appropriate for a patient who qualifies for LTCH services. The staff at a general acute care hospital frequently judges success by a patient getting well in a relatively short time. It is often difficult for general acute care hospital staff to sustain the interest and effort necessary to serve the LTCH patient well precisely because of the staff's expectation that the patient will improve is not met in a timely fashion. As time goes by, that expectation continues to be frustrated, a discouragement to staff. The LTCH is unlike other specialized health care settings. The complex, medical, nursing, and therapeutic requirements necessary to serve the LTCH patient may be beyond the capability of the traditional comprehensive medical rehabilitation ("CMR") hospital, nursing home, skilled nursing facility ("SNF"), or, the skilled nursing unit ("SNU"). CMR units and hospitals are rarely, if ever, appropriate for the LTCH patient. Almost invariably, LTCH patients are not able to tolerate the minimum three (3) hours of therapy per day associated with CMR. The primary focus of LTCHs, moreover, is to provide continued acute medical treatment to the patient that may not yet be stable, with the ultimate goal of getting the patient on the road to recovery. In comparison, the CMR hospital treats medically stable patients consistent with its primary focus of restoring functional capabilities, a more advanced step in the continuum of care. Services provided in LTCHs are distinct from those provided in SNFs or SNUs. The latter are not oriented generally to patients who need daily physician visits or the intense nursing services or observations needed by an LTCH patient. Most nursing and clinical personnel in SNFs and SNUs are not experienced with the unique psychosocial needs of long-term acute care patients and their families. An LTCH is distinguished within the healthcare continuum by the high level of care the patient requires, the interdisciplinary treatment model it follows, and the duration of the patient's hospitalization. Within the continuum of care, LTCHs occupy a niche between traditional acute care hospitals that provide initial hospitalization care on a short-term basis and post-acute care facilities such as nursing homes, SNFs, SNUs, and comprehensive medical rehabilitation facilities. Medicare has long recognized LTCHs as a distinct level of care within the health care continuum. The federal government's prospective payment system ("PPS") now treats the LTCH level of service as distinct with its "own DRG system and ... [its] own case rate reimbursement." (Tr. 108). Under the LTCH PPS, each patient is assigned an LTC- DRG (different than the DRG under the general hospital DRG system) with a corresponding payment rate that is weighted based on the patient diagnosis and acuity. The Parties The Agency is the state agency responsible for administering the CON Program and licensing LTCHs and other hospital facilities pursuant to the authority of Health Facility and Services Development Act, Sections 408.031-408.045, Florida Statutes. Select-Palm Beach is the applicant for a free-standing 60-bed LTCH in "east Central Palm Beach County," Select Ex. 1, stamped page 12, near JFK Medical Center in AHCA District 9. Its application, CON No. 9661, was denied by the Agency. Select-Palm Beach is a wholly owned subsidiary of Select Medical Corporation, which provides long term acute care services at 83 LTCHs in 24 states, four of which are freestanding hospitals. The other 79 are each "hospitals-in-a- hospital" ("HIH" or "LTCH HIH"). Kindred is the applicant for a 70-bed LTCH to be located in the north central portion of Palm Beach County in AHCA District 9. Its application, CON No. 9662, was denied by the Agency. Kindred is a wholly owned subsidiary of Kindred Healthcare, Inc. ("Kindred Healthcare"). Kindred Healthcare operates 73 LTCHs, 59 of which are freestanding, according to the testimony of Mr. Novak. See Tr. 56-57. Kindred Healthcare has been operating LTCHs since 1985 and has operated them in Florida for more than 15 years. At the time of the submission of Kindred's application, Kindred Healthcare's six LTCHs in Florida were Kindred-North Florida, a 60-bed LTCH in Pinellas County, AHCA District 5; Kindred-Central Tampa, with 102 beds, and Kindred-Bay Area- Tampa, with 73 beds, both in Hillsborough County, in AHCA District 6; Kindred-Ft. Lauderdale with 64 beds and Kindred- Hollywood with 124 beds, both in Broward County, ACHA District 10; and Kindred-Coral Gables, with 53 beds, in Dade County, AHCA District 11. The Applications and AHCA's Review The applications were submitted in the first application cycle of 2003. Select-Palm Beach's application is CON No. 9661; Kindred's is CON No. 9662. Select-Palm Beach estimates its total project costs to be $12,856,139. Select-Palm Beach has not yet acquired the site for its proposed LTCH, but did include in its application a map showing three priority site locations, with its preferred site, designated "Site 1," located near JFK Medical Center. At $12,937,419, Kindred's estimate of its project cost is slightly more than Select-Palm Beach's. The exact site of Kindred's proposed LTCH had not been determined at the time of hearing. Kindred's preference, however, is to locate in the West Palm Beach area in the general vicinity of St. Mary's Hospital, in the northern portion of Palm Beach County along the I-95 corridor. This is approximately 15 to 20 miles north of Select's preferred location for its LTCH. There is no LTCH in the five-county service area that comprises District 9: Indian River, Okeechobee, St. Lucie, Martin, and Palm Beach Counties. There are two LTCHs in adjacent District 10 (to the south). They have a total of 188 beds and an average occupancy of 80 percent. The Agency views LTCH care as a district-wide service primarily for Medicare patients. At the time of the filing of the applications, the population in District 9 was over 1.6 million, including about 400,000 in the age cohort 65 and over. About 70 percent of the District 9 population lives in Palm Beach County. More than 70 percent of the District's general acute care hospitals are located in that county. Kindred's preferred location for its LTCH is approximately 40 to 50 miles from the closest District 10 LTCH; Select-Palm Beach is approximately 25 to 35 miles from the closest District 10 LTCH. The locations of Select Palm-Beach's and Kindred's proposed LTCHs are complementary. The SAAR Following its review of the two applications, AHCA issued its State Agency Action Report ("SAAR"). Section G., of the report, entitled "RECOMMENDATION," states: "Deny Con #9661 and CON #9662." Agency Ex. 2, p. 43. On June 11, 2003, the report was signed by Karen Rivera, Health Services and Facilities Consultant Supervisor Certificate of Need, and Mr. Gregg as the Chief of the Bureau of Health Facility Regulation. It contained a section entitled "Authorization for Agency Action" that states, "[a]uthorized representatives of the Agency for Health Care Administration adopted the recommendations contained herein and released the State Agency Action Report." Agency Ex. 2, p. 44. The adoption of the recommendations is the functional equivalent of preliminary denial of the applications. In Section F. of the SAAR under the heading of "Need," (Agency Ex. 2, p. 40), the Agency explained its primary bases for denial; it concluded that the applicants had not shown need for an LTCH in AHCA District 9. The discussions for the two, although not precisely identical, are quite similar: Select Specialty Hospital-Palm Beach, Inc.(CON #9661): The applicant's two methodological approaches to demonstrate need are not supported by any specific discharge studies or other data, including DRG admission criteria from area hospitals regarding potential need. The applicant also failed to provide any supporting documentation from area physicians or other providers regarding potential referrals. It was further not demonstrated that patients that qualify for LTCH services are not currently being served or that an access problem exists for residents in District 9. Kindred Hospitals East, L.L.C. (CON #9662): The various methodological approaches presented are not supported by any specific DRG admission criteria from area hospitals suggesting potential need. The applicant provided numerous letters of support for the project from area hospitals, physicians and case managers. However, the number of potential referrals of patients needing LTCH services was not quantified. It was further not demonstrated that patients that qualify for LTCH services are not currently being served or that an access problem exists for residents in District 9. Id. At hearing, the Agency's witness professed no disagreement with the SAAR and continued to maintain the same bases contained in the SAAR for the denials of the two applications The SAAR took no issue with either applicant's ability to provide quality care. It concluded that funding for each applicant was likely to be available and that each project appeared to be financially feasible once operating. The SAAR further stated that there were no major architectural concerns regarding Kindred's proposed facility design, but noted reservations regarding the need for further study and revision of Select Palm-Beach's proposed surgery/procedure wing, as well as cost uncertainties for Select Palm Beach because of such potential revisions. By the time of final hearing, however, the parties had stipulated to the reasonableness of each applicant's proposed costs and methods of construction. The parties stipulated to the satisfaction of a number of the statutory CON criteria by the two applicants. The parties agreed that the applications complied with the content and review process requirements of sections 408.037 and 409.039, Florida Statutes, with one exception. Select reserved the issue of the lack of a Year 2 of Schedule 6, (Staffing) in Kindred's application. The form of Schedule 6 provided by AHCA to Kindred (unlike other schedules of the application) does not clearly indicate that a second year of staffing data must be provided. The remainder of the criteria stipulated and the positions of the parties as articulated in testimony at hearing and in the proposed orders that were submitted leave need as the sole issue of consequence with one exception: whether Kindred has demonstrated that its project is financially feasible in the long term. Kindred's Long Term Financial Feasibility Select-Palm Beach contends that Kindred's project is not financially feasible in the long term for two reasons. They relate to Kindred's application and are stated in Select Palm Beach's proposed order: Kindred understated property taxes[;] Kindred completely fails to include in its expenses on Schedule 8, patient medical assistance trust fund (PMATF) taxes [citation omitted]. Proposed Recommended Order of Select-Palm Beach, Inc., p. 32, Finding of Fact 97. Raised after the proceeding began at DOAH by Select- Palm Beach, these two issues were not considered by AHCA when it conducted its review of Kindred's application because the issues were not apparent from the face of the application. AHCA's Review of Kindred's Application Kindred emerged from a Chapter 11 bankruptcy proceedings on April 20, 2001, under a plan of reorganization. With respect to the events that led to the bankruptcy proceeding and the need to review prior financial statements, AHCA made the following finding in the SAAR: Under the plan [of reorganization], the applicant [Kindred] adopted the fresh start accounting provision of SOP 90-7. Under fresh start accounting, a new reporting entity is created and the recorded amounts of assets and liabilities are adjusted to reflect their estimated fair values. Accordingly, the prior period financial statements are not comparable to the current period statements and will not be considered in this analysis. Agency Ex. 2, p. 30. The financial statements provided by Kindred as part of its application show that Kindred Healthcare, Kindred's parent, is a financially strong company. The information contained in Kindred's CON application filed in 2003 included Kindred Healthcare's financial statements from the preceding calendar year. Kindred Healthcare's Consolidated Statement of Operations for the year ended December 31, 2002, showed "Income from Operations" to be more than $33 million, and net cash provided by operating activities (cash flow) of over $248 million for the period. Its Consolidated Balance Sheet as of December 31, 2002, showed cash and cash equivalents of over $244 million and total assets of over $1.6 billion. In light of the information contained in Kindred's CON application, the SAAR concluded with regard to short term financial feasibility: Based on the audited financial statements of the applicant, cash on hand and cash flows, if they continue at the current level, would be sufficient to fund this project as proposed. Funding for all capital projects, with the support of its parent, is likely to be available as needed. Agency Ex. 2, p. 30 (emphasis supplied). The SAAR recognized that Kindred projected a "year two operating loss for the hospital of $287,215." Agency Ex. 2, p. Nonetheless, the SAAR concludes on the issue of financial feasibility, "[w]ith continued operational support from the parent company, this project [Kindred's] is considered financially feasible." Id. The Agency did not have the information, however, at the time it reviewed Kindred's application that Kindred understated property taxes and omitted the Public Medicaid Trust Fund and Medical Assistance Trust Fund ("PMATF") "provider tax" of 1.5 percent that would be imposed on Kindred's anticipated revenues of $11,635,919 as contended by Select-Palm Beach. Consistent with Select Palm-Beach's general contentions about property taxes and PMATF taxes, "Kindred acknowledges that it likely understated taxes to be incurred in the operation of its facility." Kindred's Proposed Recommended Order, paragraph 50, p. 19. The parties agree, moreover, that the omitted PMATF tax is reasonably projected to be $175,000. They do not agree, however, as to the impact of the PMATF tax on year two operating loss. The difference between the two (approximately $43,000) is attributable to a corporate income tax benefit deduction claimed by Kindred so that the combination of the application's projected loss, the omitted PMATF tax, and the deduction yields a year two operating loss of approximately $419,000. Without taking into consideration the income tax benefit, Select-Palm Beach contends that adding in the PMATF tax produces a loss of $462,000. Kindred and Select-Palm Beach also disagree over the projection of property taxes by approximately $50,000. Kindred projects that the property taxes in year two of operation will be approximately $225,000 instead of the $49,400 listed in the application. Select-Palm Beach projects that they will be $50,000 higher at approximately $275,000. Whether Kindred's or Select-Palm Beach's figures are right, Kindred makes two points. First, if year two revenues and expenses, adjusted for underestimated and omitted taxes, are examined on a quarterly basis, the fourth quarter of year two has a better bottom line than the earlier quarters. Not only will the fourth quarter bottom line be better, but, using Kindred's figures, the fourth quarter of year two of operations is profitable. Second, and most importantly given the Agency's willingness to credit Kindred with financial support from its parent, Kindred's application included in its application an interest figure of $1.2 million for year one of operation and $1.03 million for year two. Kindred claims in its proposed recommended order that "[i]n reality ... this project will incur no interest expense as Kindred intends to fund the project out of cash on hand, or operating capital, and would not have to borrow money to construct the project." Id., at paragraph 54, p. 20. Through the testimony of John Grant, Director of Planning and Development for Kindred's parent, Kindred Healthcare, Kindred indicated at hearing that its parent might, indeed, fund the project: A ... Kindred [Healthcare] would likely fund this project out of operating capital. Like I said, in the first nine months of this year Kindred had operating cash flow of approximately $180 million. So it's not as if we would have to actually borrow money to complete a project like this. Q And what was the interest expense that you had budgeted in Year Two for this facility? A $1,032,000. Q ... so is it your statement then that this facility would not owe any interest back to the parent company? A That's correct. Tr. 221-222 (emphasis supplied). If the "financing interest" expense is excluded from Kindred's statement of projected expenses in Schedule 8 of the CON application, using Kindred's revised projections, the project shows a profit of approximately $612,0002 for the second year of operation. If Select-Palm Beach's figures and bottom line loss excludes the "finances interest" expense, the elimination of the expense yields of profit for year two of operations in excess of $500,000. If the support of Kindred's parent is considered as the Agency has signaled its willingness to do and provided that the project is, in fact, funded by Kindred Healthcare rather than financed through some other means that would cause Kindred to incur interest expense, Kindred's project is financially feasible in the long term. With the exception of the issue regarding Kindred's long term financial feasibility, as stated above, taken together, the stipulation and agreements of the parties, the Agency's preliminary review contained in the SAAR, and the evidence at hearing, all distill the issues in this case to one overarching issue left to be resolved by this Recommended Order: need for long term care hospital beds in District 9. Need for the Proposals From AHCA's perspective prior to the hearing, the only issue in dispute with respect to the two applications is need. This point was made clear by Mr. Gregg's testimony at hearing in answer to a question posed by counsel for Select-Palm Beach: Q. ... Assuming there was sufficient need for 130 beds in the district is there any reason why both applicants shouldn't be approved in this case, assuming that need? A. No. (Tr. 398). Both applicants contend that the application each submitted is superior to the other. Neither, however, at this point in the proceeding, has any objection to approval of the other application provided its own application is approved. Consistent with its position that both applications may be approved, Select-Palm Beach presented testimony through its health care planner Patricia Greenberg3 that there was need in District 9 for both applicants' projects. Her testimony, moreover, rehabilitated the single Kindred methodology of three that yielded numeric need less than the 130 beds proposed by both applications: Q ... you do believe that there is a need for both in the district. A I believe there's a need for two facilities in the district. Q It could support two facilities? A Oh, absolutely. Q And the disagreement primarily relates to the conservative approach of Kindred in terms of not factoring in out-migration and the narrowing the DRG categories? A Correct. ... Kindred actually had three models. Two of them support both facilities, but it's the GMLOS model that I typically rely on, and it didn't on the surface support both facilities. That's why I reconciled the two, and I believe that's the difference, is just the 50 DRGs and not including the out-migration. That would boost their need above the 130, and two facilities would give people alternatives, it would foster competition, and it would really improve access in that market. Tr. 150-51. Need for the applications, therefore, is the paramount issue in this case. Since both applicants are qualified to operate an LTCH in Florida, if need is proven for the 130 beds, then with the exception of Kindred's long term financial feasibility, all parties agree that there is no further issue: both applications should be granted. No Agency Numeric Need Methodology The Agency has not established a numeric need methodology for LTCH services. Consequently, it does not publish a fixed-need pool for LTCHs. Nor does the Agency have "any policy upon which to determine need for the proposed beds or service." See Fla. Admin. Code R. 59C-1.008(2)(e)1. Florida Administrative Code Rule 59C-1.008(2), which governs "Fixed Need Pools" (the "Fixed Need Pools Rule") states that if "no agency policy exist" with regard to a needs assessment methodology: [T]he applicant will be responsible for demonstrating need through a needs assessment methodology which must include, at a minimum, consideration of the following topics, except where they are inconsistent with the applicable statutory or rule criteria: Population demographics and dynamics; Availability, utilization and quality of like services in the district, subdistrict or both; Medical treatment trends; and Market conditions. Fla. Admin. Code R. 59C-1.008(2)(e)2. The Fixed Need Pools Rule goes on to elaborate in subparagraph (e)3 that "[t]he existence of unmet need will not be based solely on the absence of a health service, health care facility, or beds in the district, subdistrict, region or proposed service area." Population, Demographics and Dynamics The first of the four topics to be addressed when an applicant is responsible for demonstrating need through a needs assessment methodology is "population, demographics and dynamics." The Agency has not defined service areas for LTCHs. Nonetheless, from a health planning perspective, it views LTCH services as being provided district-wide primarily for Medicare patients. Consistent with the Agency's view, Select-Palm Beach identified the entire district, that is, all of AHCA District 9, as its service area. It identified Palm Beach County, one of the five counties in AHCA District 9, as its primary service area. In identifying the service area for Select-Palm Beach, Ms. Greenberg drew data from various sources: population estimates for Palm Beach County and surrounding areas; the number of acute care hospital beds in the area; the number of LTCH beds in the area; the types of patients treated at acute care hospitals; and the lengths of stay of the patients treated at those hospitals. AHCA District 9 has more elderly than any other district in the State, and Palm Beach County has more than any other county except for Dade. Palm Beach County residents comprise 71% of the District 9 population. It is reasonably projected that the elderly population (the "65 and over" age cohort) in Palm Beach County is projected to grow at the rate of 8 percent by 2008. The "65 and over" age cohort is significant because the members of that cohort are most likely to utilize hospital services, including LTCH services. Its members are most likely to suffer complications from illness and surgical procedures and more likely to have co-morbidity conditions that require long- term acute care. Persons over 65 years of age comprise approximately 80 percent of the patient population of LTCH facilities. Both Select-Palm Beach and Kindred project that approximately 80 percent of their admissions will come from Medicare patients. Since 90 percent of admissions to an LTCH come from acute care facilities, most of the patient days expected at Select-Palm Beach's proposed LTCH will originate from residents in its primary service area, Palm Beach County. When looking at the migration pattern for patients at acute care facilities within Palm Beach County, the majority (90 percent) come from Palm Beach County residents. Thus, Select- Palm Beach's projected primary service area is reasonable. Just as Select-Palm Beach, Kindred proposes to serve the entire District. Kindred proposes that its facility be based in Palm Beach County because of the percentage of the district's population in the county as well as because more than 70% of the district's general acute care hospitals are in the county. Its selection of the District as its service area, consistent with the Agency's view, is reasonable. Currently there are no LTCHs in District 9. Availability, Utilization and Quality of Like Services The second topic is "availability, utilization and quality of like services." There are no "like" services available to District residents in the District. Select-Palm Beach and Kindred, therefore, contend that they meet the criteria of the second topic. There are like services in other AHCA Districts. For example, AHCA District 10 has at total of 188 beds at two Kindred facilities in Fort Lauderdale and Hollywood. The Agency, however, did not present evidence of their quality, that they were available or to what extent they are utilized by the residents of AHCA District 9. Medical Treatment Trends The third topic is medical treatment trends. Caring for patients with chronic and long term care needs is becoming increasingly more important as the population ages and as medical technology continues to emerge that prolongs life expectancies. Through treatment provided the medically complex and critically ill with state of the art mechanical ventilators, metabolic analyzers, and breathing monitors, LTCHs meet needs beyond the capability of the typical general acute care hospitals. In this way, LTCHs fill a niche in the continuum of care that addresses the needs of a small but growing patient population. Treatment for these patients in an LTCH, who otherwise would be cared for without adequate reimbursement to the general acute care hospital or moved to an alternative setting with staff and services inadequate to meet their needs, is a medical trend. Market Conditions The fourth topic to be addressed by the applicant is market conditions. The federal government's development of a distinctive prospective payment system for LTCHs (LTC-DRG), has created a market condition favorable to LTCHs. General acute care hospitals face substantial losses for the medically complex patient who uses far greater resources than expected on the basis of individual diagnoses. Medicare covers between 80 and 85 percent of LTCH patients. The remaining patients are covered by private insurance, managed care and Medicaid. LTCH programs allow for shorter lengths of stay in a general acute care facility, reduces re-admissions and provide more discharges to home. These benefits are increasingly recognized. Numeric Need Analysis Kindred presented a set of needs assessment methodologies that yielded numeric need for the beds applied for by Kindred. Select-Palm Beach did the same. Unlike Kindred, however, all of the needs assessment methodologies presented by Select-Palm Beach demonstrated numeric need in excess of the 130 beds proposed by both applications. Select-Palm Beach's methodologies, overall, are superior to Kindred's. Select-Palm Beach used two sets of needs assessment methodologies and sensitivity testing of one of the sets that confirmed the methodology's reasonableness. The two sets or needs assessment methodologies are: (1) a use rate methodology and (2) length of stay methodologies. The use rate methodology yielded projected bed need for Palm Beach County alone in excess of the 130 beds proposed by the two applicants. For the year "7/05 - 6/06" the bed need is projected to be 256; for the year "7/06 - 6/07" the bed need is projected to be 261; and, for the year "7/07 - 6/08" the bed need is projected to be 266. See Select Ex. 1, Bates Stamp p. 000036 and the testimony of Ms. Greenberg at tr. 114. If the use rate analysis had been re-computed to include two districts whose data was excluded from the analysis, the bed need yielded for Palm Beach County alone was 175 beds, a numeric need still in excess of the 130 beds proposed by both applicants. The use rate methodology is reasonable.4 The length of stay methodologies are also reasonable. These two methodologies also yielded numeric need for beds in excess of the 130 beds proposed. The two methodologies yielded need for 167 beds and 250 beds. Agency Denial The Agency's general concerns about LTCHs are not without basis. For many years, there were almost no LTCH CON applications filed with the Agency. A change occurred in 2002. The change in the LTCH environment in the last few years put AHCA in the position of having "to adapt to a rapidly changing situation in terms of [Agency] understanding of what has been going on in recent years with long-term care hospitals." (Tr. 358.) "... [I]n the last couple of years long-term care hospital applications have become [AHCA's] most common type of application." (Tr. 359.) At the time of the upsurge in applications, there was "virtually nothing ... in the academic literature about long- term care hospitals ... that could [provide] ... an understanding of what was going on ... [nor was there anything] in the peer reviewed literature that addressed long-term care hospitals" id., and the health care planning issues that affected them. Two MedPAC reports came out, one in 2003 and another in 2004. The 2003 report conveyed the information that the federal government was unable to identify patients appropriate for LTCH services, services that are overwhelmingly Medicare funded, because of overlap of LTCH services with other types of services. The 2004 report gave an account of the federal government decision to change its payment policy for a type of long-term care hospitals that are known as "hospitals-within- hospitals" (tr. 368) so that "hospitals within hospitals as of this past summer [2004] can now only treat 25 percent of their patients from the host hospital." Id. Both reports roused concerns for AHCA. First, if appropriate LTCH patients cannot be identified and other types of services overlap appropriately with LTCH services, AHCA cannot produce a valid needs assessment methodology. The second produces another concern. In the words of Mr. Gregg, The problem ... with oversupply of long-term care hospital beds is that it creates an incentive for providers to seek patient who are less appropriate for the service. What we know now is that only the sickest patient ... with the most severe conditions are truly appropriate for long-term care hospital placement. * * * ... [T]he MedPAC report most recently shows us that the greatest indicator of utilization of long-term care hospital services is the mere availability of those services. Tr. 368-369. The MedPAC reports, themselves, although marked for identification, were not admitted into evidence. Objections to their admission (in particular, Kindred's) were sustained because they had not been listed by AHCA on the stipulation required by the Pre-hearing Order of Instructions.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be issued by the Agency for Health Care Administration that: approves Select-Palm Beach's application, CON 9661; and approves Kindred's application CON 9662 with the condition that financing of the project be provided by Kindred Healthcare. DONE AND ENTERED this 18th day of April, 2005, in Tallahassee, Leon County, Florida. S DAVID M. MALONEY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 18th day of April, 2005.
The Issue Whether under Section 381.494(6)(c)-(d), Florida Statutes, and Rule 10-5.11, Florida Administrative Code, Respondent, Martin Memorial Hospital Association, Inc., is entitled to a Certificate of Need ("CON") authorizing a proposed 75-bed satellite hospital in Port Salerno, Martin County, Florida.
Findings Of Fact Background Respondent, Martin Memorial Hospital Association, Inc. ("Martin Memorial"), seeks a CON to construct and operate a 75- bed satellite hospital in Port Salerno, Florida. Of the proposed 75 acute-care beds, 50 will be new and 25 will be transferred from Mar in Memorial's existing hospital in Stuart, Florida. The proposed satellite hospital will have six intensive care beds, 69 medical-surgical beds, and two operating rooms. Respondent, Department of Health and Rehabilitative Services ("DHRS"), preliminarily issued the applied-for CON. After Petitioner, Palm Beach-Martin County Medical Center ("PBMC"), owner of nearby Jupiter Hospital in northern Palm Beach County, requested a Section 120.57 hearing to contest issuance of the CON, DHRS forwarded this case to the Division of Administrative Hearings for assignment of a hearing officer. This case, in its earlier stages, was a consolidated proceeding with numerous parties and party-applicants. In the fall of 1984, several parties withdrew or were dismissed. One of the them, American Healthcorp., dismissed its challenge of DHRS' denial of its application to construct a 120-bed new hospital in Vero Beach, Florida. Prior to that dismissal, American Healthcorp. had filed a mandamus action in Leon County Circuit Court to require DHRS to issue a CON. The writ of mandamus was issued and that order was appealed by DHRS to the First District Court of Appeal. On June 18, 1985, the First District reversed the Circuit Court's order. DHRS never issued a CON to American Healthcorp., as the writ of mandamus was stayed during the pendency of the appeal. Initially, PBMC, another party-applicant, contested DHRS' denial of a proposed 66-bed addition to its existing hospital in Jupiter, Palm Beach County, Florida. Later, PBMC dropped its opposition to the denial after concluding that, due to a dramatic drop in patient census during 1984, additional beds in the area were not needed.1 On Martin Memorial's unopposed motion to dismiss, PBMC was dismissed as a party. Other nonapplicant intervenors subsequently withdrew. In the earlier consolidated proceeding, Martin Memorial had contested the denial of its initial application (filed in 1983) for a CON to construct a 150-bed satellite hospital in Port Salerno, on the same site as now proposed for the 75-bed hospital. In October, 1984, Martin Memorial revised its application, within a deadline for submittal of amended applications set by prehearing order. This revised application, now the subject of this proceeding, reduced the number of beds in the proposed hospital from 150 to 75: 50 were to be new and 25 were to be transferred from Martin Memorial's existing hospital in Stuart.2 This 75-bed application was then preliminarily approved by DHRS, as part of an effort to settle the pending consolidated proceeding. After notice of the approval was published on December 7, 1984 in the Florida Administrative Weekly, PBMC timely requested a hearing to contest it. PBMC's position is, generally, that another hospital in the area is not needed and will result in an unnecessary duplication of services and that, if built, the hospital would draw patients who would otherwise use Jupiter Hospital, to the economic injury of PBMC. The remaining party-applicant in the consolidated proceeding was Lawnwood Medical Center, whose proposed 50- bedexpansion of its hospital in Fort Pierce (St. Lucie County), was preliminarily approved by DHRS. Martin Memorial requested a Section 120.57(1) hearing to contest the approval. By stipulation dated May 15, 1985, Lawnwood Medical Center was dismissed as a party. Martin Memorial II. The Parties The applicant, Martin Memorial, operates a not-for- profit community hospital in Stuart, Florida, which has served the health care needs of the area since 1939. At that time, it had 25 beds and the site consisted o eight acres. In subsequent years, Martin Memorial added five additional acres of land, and the hospital now has 336 beds, including 26 new beds: nearing completion. Martin Memorial is a subsidiary of Coastal Health Corporation, a not-for-profit holding company. One of the holding company's other non-profit subsidiaries, Coastal Care Corporation, provides services such as ambulatory surgery and primary or emergency care at medical treatment centers. Martin Memorial and its parent corporation, Coastal Health Corporation, are governed by boards comprised of full- time residents of Martin County who serve without compensation. Martin Memorial Hospital has a proven record of providing health care to indigents. Its policy is to provide health services without regard to race, religion, national origin, or a patient's ability to pay. It has always participated in the Medicare/Medicaid Programs and participates in the county indigent program. It proposes to follow the same policy at the proposed satellite hospital. Martin Memorial Hospital, in Stuart, is adjacent to the St. Lucie River on the north, bounded by the Heida-Brad Park residential development on the east, by the St. Mary's Episcopal Church on the south, and by various businesses and residences on the west. It would be difficult for Martin Memorial Hospital to expand to meet anticipated future demand. It has found it impractical to buy additional land adjacent to its existing facility. (It does not nave eminent domain power.) Under current zoning, its height is limited to the existing six floors. Other obstacles include problems with parking access and compliance with fire safety codes. Palm Beach-Martin (PBMC) PBMC is a non-profit corporation, organized in 1973, with the stated purpose of serving tee health care needs of residents of northern Palm Beach County and southern Martin County. It operates a community not-for-profit hospital, known as Jupiter Hospital, in Jupiter, Florida. A 156-bed acute care hospital, it is the northern most hospital in Palm Beach County and provides health care services to the residents of northern Palm Beach and southern Martin Counties. Over 10% of Jupiter Hospital's patients come from the Hobe Sound area of Martin County, and another 20% come from the Tequesta area of Martin County. The boards which operate PBMC and Jupiter Hospital are made up of volunteers; one-half of whom are doctors on the hospital's medical staff, and the other half are lay-members from the community. All policy decisions are made by the boards. The hospital is managed, under contract, by hospital Corporation of America Management Company (owned by Hospital Corporation of America) which supplies only the hospital administrator and finance director, all other personnel are employees of PBMC. Like Martin Memorial, PBMC has a practice of providing health care to indigent patients. It has a Medicaid contract at its convalescent pavilion and treats Medicaid patients requiring care. (Since it has not had a Medicaid contract with the state, PBMC "writes-off" the cost of care provided to Medicaid and indigent patients. But due to an increasing number of Medicaid patients, PBMC has applied for a Medicaid contract.) It has a current contract with Palm Beach County to treat indigents in its out-patient facility. Department of Health and Rehabilitative Services (DHRS) DHRS is designated by statute as the single state agency charged with issuing and denying CONs in accordance with district plans, DHRS rules, and state and federal statutes. See, Section 381.494, Florida Statutes (1983). Geographic Facts The proposed satellite hospital would be located in Port Salerno, Martin County, 5 1/2 miles south of Martin Memorial Hospital and 15 miles north of Jupiter Hospital. The site of the proposes hospital is 35 acres in size, and is located approximately 1/4 mile east of Highway U.S. 1, on Port Salerno Road. Jonathan Dickinson State Park, abutting Highway U.S. 1 for five miles, is situated between the site of the proposed satellite hospital and PBMC's Jupiter Hospital. The area of Hobe Sound is just north of this State Park. The proposed hospital would be adjacent to the Martin County Campus of Indian River Community College. III. Standing of PBMC: Expected Impact of Proposed Hospital on PBMC. Since it is physicians who admit patients to hospitals, the extent to which medical staffs overlap is one factor used to project how a new hospital will affect an existing one. Martin Memorial Hospital and Jupiter Hospital have distinct medical staffs and there is no material overlap. Neither has it been shown that Jupiter Hospital physicians will seek staff privileges at the proposed satellite hospital. It is reasonably expected that the proposed hospital will be staffed, for the most part, by physicians who are also on the staff of Martin Memorial Hospital. Nevertheless, the proposed satellite hospital would draw away a substantial portion of Jupiter Hospital's patient base and is intended to reduce Jupiter Hospital's market share in the Hobe Sound area to near zero. (Indeed, this is a result projected in Martin Memorial's Long Range Plan.) Martin Memorial (in its Long Range Plan) estimates Jupiter Hospital's current market share to be 65%. Jupiter Hospital's primary service area includes Hobe Sound, from which it draws approximately 10% of its patients. The northern boundary of the Hobe Sound area is 20 minutes driving time from Jupiter Hospital. Hobe Sound is also within the primary service area of the proposed satellite hospital. The proposed hospital would be in the same DHRS Service District as Jupiter Hospital and both hospitals would have overlapping primary service areas. The projected loss of 10% of its patient base to the proposed satellite hospital would have a significant adverse financial impact on PBMC. It has not been shown, however, this impact would imperil the continued financial feasibility of Jupiter Hospital. IV. Numerical Bed-need Projected by Applying DHRS Rule-Based Bed-need Methodology. The proposed satellite hospital would be located in DHRS Health District 9, which consists of Indian River, St. Lucie, 55artin, Okeechobee, and Palm Beach Counties. The state acute care bed-need methodology is a complex formula contained in Rule 10-5.11(23), Florida Administrative Code. It projects bed-need, on a district-wide basis, five years into the future, creating what is referred to as a "five-year planning horizon" for assessing acute care bed-need. The formula requires several district-specific inputs, including population forecasts in four age groups, the average fertility rate in the district for the three most recent years, the average historical utilization rate in the district for the three most recent years, together with specific factors used to determine the net flow of elderly patients. Three other input factors are applied uniformly to all districts: discharge rates by service and by age cohort for Florida residents, average length of stay by service and by age cohort, and occupancy standards by service and by age cohort. Application of the formula entails seven steps: Project patient days by service and by age cohort using the formula: Patient days = projected population x discharge rate x average length of stay Adjust the projected patient days for the 65 and over age cohort to account for patient flows. Calculate bed-need by applying service- specific occupancy standards to projected patient days. Calculate the district bed allocation by summing the beds needed by service. Calculate the projected occupancy of these beds using the district's historical utilization rate. If the projected occupancy. rate is less than 75 percent or greater than 90 percent, apply specified formulas to adjust the district bed allocation (downward or upward, respectively. Check to ensure that each district will be able to meet peak demand based on the adjusted allocation. (R-l8l/, Testimony of Kolb) Population projections used in the methodology are: "for age- specific cohorts residing in the relevant district projected five years into the future," Rule 10-5.11(23)(f)1., Florida Administrative Code. These age-specific cohort projections (of county populations) must be "those developed by the State Health Planning Agency, and will be based on the latest mid-range projections published by the Bureau of Economic and Business Research of the University of Florida [BEBR]." Id. There are currently 4,695 licensed or approved acute care beds in District 9, which includes the 50 additional beds (preliminarily) approved for the proposed satellite hospital and the 45 beds approved in a subsequent batching cycle. For July, 1989, application of the bed-need methodology shows a district wide gross need of 4,621 beds. This is based on population forecasts for July, 1939, released by the Governor's Budgeting and Planning Office on- January 1, 1985.This office interpolates and publishes population forecasts based on figures received from BEBR. Since later 1934 (when Rule 27E-2.01-.04 was adopted requiring state agencies to use, in their planning, population projections provided by the Governor's Office), DHRS's Office of Health Planning and Development has used such forecasts to project bed-need under the methodology. These forecasts are appropriate for such use since they are "developed" by the State Health Planning Agency and based on the latest mid-range projections published by BEBR. When the licensed or approved bed total of 4,645 (excluding 50 beds for the proposed satellite hospital) are subtracted from the district wide gross need, there is a net surplus of 24 beds. If the 50 beds of the proposed satellite hospital are included, the net surplus increases to 74 beds. A planning horizon of January, 1990, however, is more appropriate. It more closely conforms to the methodology's requirement that need be projected five years into the future. (At hearing, all parties agreed or acquiesced to the proposition that the five year planning horizon should begin to run, to the extent possible, from the date of final hearing in June, 1985.) The latest county-wide projections released by the Governor's Office for state agency use, projects population by age and sex cohorts for January 1, 1990 and July 1, 1990. The July 1, 1990 projections are beyond the five year horizon and so less suitable for use in the methodology. Applying, then, the bed-need methodology to project bed-need for January, 1990, shows a gross need of 4,702 beds, resulting in a total district wide net need of 57 beds (excluding the proposed 50-beds satellite hospital). Hence the methodology shows (just barely) a January, 1990 need for the 50- beds sought for the proposed satellite hospital. Because of projected increases in district population, the methodology predicts a significant growth in bed-need between July, 1989 and January, 1990: bed-need grows by 81 beds or by more than 10 beds per month. PBMC contends that a planning horizon of July 1, 1989, and no later, must be used since DHRS has, historically, updated bed-need projections only on July 1 of each year. Annual updates were limited to once a year because updated population figures were received only in July. Now, however, -he situation has greatly improved. DHRS receives updated population forecasts from the Governor's Office twice a year--in January and July. There is no reason why these updated and, presumably, more accurate population forecasts cannot be used to project bed-need Martin Memorial, on the other hand, argues for a more distant planning horizon--April 1, 1990. This horizon, however, requires use of BEBR projections recently received but not yet released or interpolated by the Governor's Office, until released, such projections are not appropriate for use by state agencies. See, Rule 27E-2.01-2.04, Fla. Admin. Code. V. Consideration of Other CON Review Criteria [A CON may be denied even though the bed- need methodology projects a need for the proposed beds five years into the future. Rule 10-5.11(23)(b): "An unfavorable Certif- icate of Need determination may be made when a calculated bed-need exists, but other criteria specified in Chapter 3Bl.494(6)(c), Florida Statutes, are not met." DHRS must consider CON applications in light of all statutory and rule criteria. See, Department of Health and Rehabilitative Services v. Johnson & Johnson, 447 So. 2d 361 (Fla. 1st DCA 1984).] Subdistrict Need: Allocation of District Wide Bed-need to|-. Relevant Subdistrict In 1983, the Local Health Council divided District9 into five subdistricts: (1) Indian River County, (2) Martin and St. Lucie Counties, (3) Okeechobee County, (4) northern Palm Beach County, and (5) southern Palm Beach County. Each subdistrict "is an area where the co-unity, by itself, uses the facilities in an area. It is supposed to be a sort of natural boundary that separates the different communities." (TR-413) The council also adopted a methodology for allocating acute care beds among the five component subdistricts. (R.-19) Although DHRS has not yet adopted, by rule, District9's subdistricts and subdistrict bed-need allocation methodology, both are part of District 9's Local Health Plan, adopted after a series of workshops and public hearings. The subdistricts were identified pursuant to a protocol furnished by DHRS which required consideration of whether an area was urban or rural, or comprised a standard metropolitan statistical area (SMSA). Under the protocol, an SMSA must be designated a separate subdistrict. Since Martin and St. Lucie Counties form a SMSA, they form a separate subdistrict. The five subdistricts of District 9 were identified in a rational manner, have a factual basis, and are useful tools for health care planning purposes. The methodology for allocating district wide bed-need to the subdistricts, also part of the Local Health Plan, has also been shown to be supported by reason and accepted health care planning concepts. DHRS cannot rationally determine the need for additional acute care beds, at least in =he context of this case without looking at subdistrict need or lack of need. In this way, local needs and conditions are considered in the decision- making process. District 9 is too large to serve as a useful unit for acute care bed planning purposes. Applying the Local Health Plan's sur5istrict bed-need allocation methodology to the July, 1989 planning horizon, indicates a net acute care bed-need for the Martin/St. Lucie-- County Subdistrict (not counting the 50 beds at issue) of 103beds. If the proposed hospital were approved, the subdistrict bed-need methodology would show a remaining subdistrict need for53 acute care beds. (R-18, TR-249) When applied to the January, 1990 planning horizon, preferred to the July, 1999 horizon., the subdistrict methodology shows a net acute care bed-need of 119 beds for the Martin/St. Lucie County Subdistrict (not counting the 50 beds at issue). Thus, the bed-need allocation methodology contained in District 9's Local Health Plan, shows a need for the proposed 50-acute care beds, with a 69-bed margin. (T-18, TR-248) Since the total number of licensed and approved beds (excluding the 50-beds at issue) for the subdistrict is 761, the projected need for 119 new acute care beds in January, 1990, is considered to be substantial. But the subdistrict bed allocation methodology assumes, incorrectly, that patients do not "cross-over" from one subdistrict to another. It fails, therefore, to consider or take to account the significant number of patients residing in the Martin/St. Lucie Counties Subdistrict who use acute care beds at Jupiter Hospital, located in the subdistrict to the south. This failure in the subdistrict methodology detracts from the weight to be given the resulting bed-need calculation. Availability, Accessibility and Adequacy of Like and Existing Facilities. Section 384.494(6) (c) 2.; Florida Statutes, requires review of CON applications in context with the "availability . . . accessibility and adequacy of like and existing health care services . . . in the district of the applicant."] Excess or under-utilized acute care bed capacity is a problem because it contributes to higher health costs. There are fixed overhead costs associated with acute care beds, whether empty or filled by a patient. These costs must ultimately be borne by the patients, or their insurers In reviewing a CON application, DHRS considers the number of available unoccupied beds at the facility and in the county or subdistrict for the most recent calendar year, determines actual occupancy rates, and compares them against an 80% occupancy standard, a standard generally accepted by health care planners. For example, one stated reason for DHRS' denial of Martin Memorial's initial 150-bed application was the availability of 20 unoccupied medical-surgical beds at Martin Memorial in 1982, on an average daily basis. Similarly, the average daily availability of 73 unoccupied medical-surgical beds in the five hospitals within PBMC's service area, plus additional approved but not licensed beds in the area, were stated reasons for DHRS' denial of PBMC's initial 1983 application for additional beds. (R-13) Applying the 80% occupancy standard to 1984 bed utilization statistics in the Martin/St. Lucie County Subdistrict, there were 111 unoccupied acute care beds on an average daily basis, not counting the 50 new beds recently approved for Lawnwood Hospital and the 26 new beds soon to be available at Martin Memorial. This is a 63.7% occupancy rate. Moreover, there were 47 unoccupied licensed beds on an average daily basis at Martin Memorial Hospital (not counting the 26 new beds under construction). The same calculation using only medical-surgical beds shows that in 1984, on an average daily basis, Martin Memorial had 36 unoccupied medical-surgical beds or an occupancy rate of 661. At Jupiter Hospital and Port St. Lucie Medical Center, the two hospitals having overlapping service areas with Martin Memorial, there were 31 (58.2% occupancy rate) and 49 (43.7% occupancy rate) unoccupied medical-surgical beds, respectively, on an average daily basis. (HRS-4) There is an ample supply of available beds: there is not a shortage of acute care hospital beds at Martin Memorial Hospital or in the Martin/St. Lucie Subdistrict. Martin Memorial has shown only that there may be, or could be, bed availability problems during certain peak months at Memorial Hospital in 1990, based on seasonal considerations. At most, it has shown that, without the proposed satellite hospital, the average occupancy for its highest occupancy month in 1990 would reach 91%. (TR-263-265) However, it is possible to operate a hospital at such an occupancy level for several months and yet maintain an acceptable level of service. (Moreover, Martin Memorial's analysis fails to take into account acute care beds which would be available in 1990 at Port St. Lucie Medical Center and Jupiter Hospital, where occupancy rates would be much lower.) Martin Memorial does not assert that in 1990 its average daily occupancy rate will exceed 80%. Indeed, assuming the validity of its average length of stay and hospital utilization assumptions (which are questionable), Martin Memorial forecasts an average daily occupancy rate of 79.4%. The State Health Plan states that "the issue of surplus beds is expected to be an even greater problem in the future because of the growth of alternative delivery systems"-- (R-20, p.22)--a proposition with which Martin Memorial's expert generally agrees. (TR-287-288) The State Health Plan concludes that "the combined effect of ambulatory surgery, HMOs, DRGs, and other innovations could reduce acute care bed-need by 15% or more." Id. Thus it becomes more likely that there will be an ample supply of available unoccupied beds in the subdistrict through 1990. The proposed satellite hospital would improve or enhance the accessibility of hospital services, since it would be located closer to some patients than either Martin Memorial or Jupiter Hospital. However, it has not been shown that geographic accessibility has been or will be a serious problem without construction of the proposed satellite hospital. The proposed hospital would be located about 5 miles from Martin Memorial and about 15 1/2 miles from Jupiter Hospital. Patients in the southern part of Martin County, residing south of the northern part of Hobe Sound, can be driven to Jupiter Hospital in 20 minutes or less. The definitive standard, commonly used by DHRS and.generally accepted by health care planners to detect geographical bed-access problems, is the 30 minute drive-time standard. Under this standard, if acute care hospital beds are available and accessible, within an automobile travel time of 30 minutes under average traffic conditions to at least 90% of the population, there is no cause for concern about geographic accessibility. It is undisputed that hospital beds are now available well within 30 minutes travel time to all residents of Martin County during all relevant periods, and will continue to be so through 1990. In short, geographic accessibility is not a current or projected problem and although the satellite hospital would make in-patient services more geographically accessible to some residents, such a result could be expected whenever a new hospital is constructed, whatever its location. As to adequacy of existing and licensed and approved facilities, there is no showing that the quality or extent of health care provided is inadequate. Extent of Utilization of Like and Existing Facilities. [Under Section 3Bl.494(6)(c)2., Florida Statutes, CON applications must also be reviewed in context with the "extent of utilization . . . of like and existing health care services . . . in the service district of the applicant."] During the last two years, the health care industry has undergone major changes resulting in a sudden and dramatic decline in the use of hospital in-patient services. The main cause of this decline was the shift, in October 1983, to the Medicare prospective payment system, otherwise known as Diagnostic Related Groupings (DRGs). The DRG payment system changed Medicare reimbursement from a cost basis to a set reimbursement based on diagnosis. It has caused a sharp decline in the average length of stay of Medicare patients as well as a decrease in Medicare admissions, and a resulting decline in hospital occupancy levels. For example, in calendar year 1984, the average length of stay for hospital patients in District 9 dropped from approximately 6.8 to 6.1. (DHRS-4) Another recent development contributing to the general decline in hospital utilization .is the increasing emphasis on providing out-patient services such as out-patient surgery and home health services. In many areas of the country, the advent of Preferred Provider Organizations (PPOs) and Health Maintenance Organizations (HMOs) have significantly impacted hospital occupancy rates, not only by encouraging shorter lengths of stay, but also by greatly lowering admission rates. (TR-604-05, 773: P-3, p.l8) According to the State Health Plan, "the emergence of [these] alternative delivery systems . . . [has] exacerbated declining occupancy rates." (R-20, Vol. 1, p.26) Martin Memorial has developed free-standing medical treatment centers in Hobe Sound and Port St. Lucie, which can provide up to 80% of the services required by patients in hospital emergency rooms. (TR-56-59 R-1, Vol. II at 73) In addition, Martin Memorial is merging with VNA in Martin County to provide home health care. These alternative delivery systems, along with the expected increasing effects of PPOs, HMOs and prospective payment systems, will contribute to further declines in hospital utilization and tend to extend the time during which the existing inventory of acute care beds will be adequate to meet the needs of a growing population. Although witnesses for Martin Memorial suggest that this steady decline in bed utilization at Martin Memorial will soon bottom out and that the average length of stay will fall no further, the weight of credible evidence shows that hospital utilization in District 9, as well as in the country as a whole, is still declining and that no one can say, with any reasonable degree of certainty, just when the decline (or "nose dive," TR- 682) in average length of stay and overall utilization will stop. The Executive Director of the District 9 Health Council predicts that the average length of stay in the district may fall from its current level of 6.1 or 6.2 to 5, and a recent survey of southeastern hospitals predicts at least a 5% further decline in average length of stay from 1984 levels. Hospital admission or discharge rates in District 9 fell slightly in 1984, but on the whole have remained relatively constant. The decline in hospital utilization has been chiefly caused by the unprecedented drop in average length of stay. Several factors causing declines in hospital admissions as well as utilization in other areas of the state and country have not yet begun to significantly affect northern Palm Beach, Martin, and St. Lucie Counties. It is, however, reasonably expected that these factors, such as out-patient or ambulatory surgical centers, and home health services (which are becoming increasingly used), will continue to grow and further decrease hospital in-patient surgery and care, admissions, and utilization. (TR-39-40, 578) As stated earlier, the most recent State Health Plan predicts that the combined effect of ambulatory surgery and other alternative health care delivery systems will be to reduce hospital discharges (or admissions) by 15% or more by 1989. (R-20, Vol. 2, p.72) Another factor which will contribute to the further decline in hospital utilization in Florida will be the required adoption of prospective payment programs by hospitals and private insurers for non-;5edicare patients. Under the Florida Health Care Access Act of 1984, hospitals are required to negotiate a prospective payment arrangement with each health insurer representing 10% or more of the hospital's private pay patients (R-20, Vol. 1, p. ll) To date, the only active HMOs in District 9 are found in southern Palm Beach County and their impact has not been felt elsewhere in the district. It is reasonably anticipated, however, that HMOs will expand throughout the district in the next several years and will contribute to a further decline in admissions. (Some commentators predict HMOs will reduce hospital admission rates by as much as 40%.) (TR-605-06, 679-80) Even without these factors, the extent of the decline in hospital utilization in District 9 has been dramatic. Overall hospital utilization i., 1984 declined from a level of 73.7% in 1983 to 65.R% in 1984. (HRS-4; R-~9: P-5) The District 9 medical-surgical utilization rate dropped from 76.3% in 1983 to 67.3% in 1984. The decline in hospital utilization in the Martin/St. Lucie Subdistrict and at specific hospitals in the area have been even more pronounced: 1983-84 Subdistrict and Specific Hospital Utilization Rates Overall Rate Med-Surg Rate 1983 1984 1983 1984 Martin/St. Lucie Subdistrict 76.9%1 63.7% 78% 63.8% Martin Memorial 74.1% 65.1%4 74.8% 66.0% Port St. Lucie5 38.9% 44.1% 37.6% 43.7% Jupiter Hospital 67.7% 55.7% 71.4% 58.2% Although experts disagree on how long the decline in hospital utilization will continue and how far it will fall, it is apparent that hospital utilization is continuing to decline in District 9 in 1985. By January and February 1985, the Martin/St. Lucie Subdistrict medical-surgical utilization declined about 1% from the same period in 1984. However, the most recent data for March, 1985, shows a decline in monthly medical-surgical utilization from 73.2% in 1984 to 68.8%. Martin Memorial's patient days in 198; are less than the corresponding number of patient days .when compared to the same periods in 1984. In addition, in no single month during Martin Memorial's 1985 fiscal year, beginning on October 1, 1984, has Martin yet achieved its budgeted patient days or admissions. In fact, Martin Memorial's bed utilization is more than 10% under budget for fiscal year 1985. (TR-66-69 P-1) Martin Memorial contends that the projected increase in the population and the aging in population in the Martin/St. Lucie Subdistrict will offset the decline in average length of stay and gradually increase the in-patient population. Although it is reasonable to expect that such factors would increase utilization, over the last year in District 9, use rates have gone down and admission rates have decreased slightly even though population increased and aged. In addition, it is reasonably anticipated that the future negative impact of HMOs on use and admissions will offset these population changes and contribute to further decline in utilization. Projected Utilization of Martin Memorial Hospital and the Proposed Satellite Hospital. In projecting- utilization for its existing and proposed facilities, Martin Memorial used 1984 District 9 use rates and a constant to increasing average length of stay. (R- 18) Use and admission rates have declined steadily for several years for the under-65 population and, in the first year of DRGs, dropped by over 3% for the over-65 population. Vet, despite this t-end and projections of decreasing use and admission rates in the future due to alternative delivery programs, Martin Memorial's utilization forecast uses admission rates slightly higher than the 1984 actual admission rates. (R- 18) In projecting the average length of stay for the proposed Port Salerno Hospital, Martin 'Memorial discounted 10% from its 1984 average length of stay. This discount, however, was due to projections of lower Medicare utilization and lower intensity of services at the new hospital, and makes no allowance for any further decreases in average lengths of stay. Similarly, in projecting utilization for Martin Memorial Hospital, Martin Memorial assumed an increase over the 1984 average length of stay of 6.0 days to 6.1 days in 1990. These assumptions are unreasonable in that they 'ail to fully into account the current and projected continuing decline in hospital admissions and utilization. Consequently, little weight is assigned to Martin Memorial's forecast of future bed utilization—that the satellite hospital would experience 58% occupancy in 1990, the first year of operation. Martin Memorial projects that without the proposed Port Salerno Hospital, Martin Memorial would achieve an occupancy rate of 79.4% in 1990. This utilization projection was based on population projections for Martin County done in 1984 by Dr. Stanley Smith it fails to take into account Dr. Smith's recent revision downward of the 1990 population projections for Martin County from 100,900 to 98,700. (TR-95-96, 294-95 R-6) The decline in average length of stay and hospital use rates will have a major impact on the number of empty beds in District 9 and, at least as applied to this District, the bed- need methodology of Rule 10-5.11(23), over-states the need for additional beds in 1990. The methodology uses a constant average length of stay derived from prior years. It is not an accurate predictor of future occupancy when, as now, use rates and utilization are declining and are reasonably expected to continue to decline. (TR-639-41: TR-614, 621-22 P-5) Martin Memorial's projected 79.4% occupancy rate in 1990 is overstated because it fails to fully take into account continuing declines in average length of stay and use rates, and because the 1984 population figures used to derive the 1984 use rate may be understated, thereby overstating the use rate. Similarly, using the same assumptions, an occupancy rate of 69.7% was projected for Jupiter Hospital (without the proposed Port Salerno Hospital). This projection is also overstated for the same reasons. If the Port Salerno Hospital were approved, the 1990 occupancy figures for both Martin Memorial and Jupiter Hospital would, in all likelihood, be much lower. (TR-627 P-5) 21 A more credible projection of ,Martin Memorial Hospital's 1990 occupancy rate was offered by Thomas W. Schultz, PSMC's health care planning expert. By reducing the 1984 Dis- trict 9 use rate by 2.9% to account for declining utilization at Martin Memorial during the first three months of 1985, as well as the general continuing decline in hospital utilization, Mr. Schultz projected Martin Memorial's 1990 occupancy (without the new facility) to be only 72.6%. Similarly, because use rates are still declining and because the 1985 population numbers used to calculate the rates may have been understated, this projected occupancy is overstated. (TR-628-30, 635-38; P-5) The State Health Plan and the District 9 Local Health Plan [Section 381.494(6) (c)l. requires that CON applications be reviewed "in relation to the applicable district plan and state health plan "] Several specific utilization and occupancy standards are contained in the State Health Plan and the District 9 Local Health Plan. A major stated goal of the State Health Plan is to promote the efficient utilization of acute care services by raising the occupancy rates or acute care hospitals. (R-20) It identifies 80% as the appropriate minimum occupancy level for acute care hospitals: an average annual occupancy rate of at least 80% is made an objective. As conceded by Debra S. Kolb, Ph.D., Martin Memorial's expert health planner, the 80% occupancy standard is an appropriate minimum standard which should be "looked at as a hurdle before beds are added." (TR- 289) She adds, however, that "there are other factors, such as . . . size of the facility, seasonality issues, age problems. . . that would warrant special cases." (T?.-289) By policy and practice, DHRS considers current occupancy levels to be an important criterion and has applied this 80% occupancy standard in reviewing CON applications. Its use of these standards is illustrated by its initial action on the various applications which were once part of this proceeding. DHRS granted Lawnwood Hospital's application for several stated reasons, one of which was a 1982 occupancy rate of 90%. Martin Memorial's initial 150-bed application and PBMC's 60-bed application (later dropped) were denied, in substantial part, because of low utilization rates in 1982 and because there was an adequate supply of beds currently available. (Interestingly, both Martin Memorial and PBMC had 1982 occupancy rates exceeding 70%.) As stated by Gene Nelson, then supervisor of DHRS' CON review section, in the State Agency Action Report denying PBMC's application: "Overall utilization for Palm Beach Martin County Medical Center for 1982 was 72.3% and medical/surgical utilization was 76.4%, neither being sufficiently high to justify additional beds." (R-13) The Acute Care portion of District 9's Local Health Plan (1984), contains "Recommendations by Priority Ranking" reflecting policies and priorities which, according to the local health council, should be used (in addition to the DHRS bed-need methodology) in planning and allocating acute care bed-need. Priority I delineates the subdistricts for purposes of allocating acute care hospital beds: Priority II establishes the_ subdistrict allocation methodology: Priority III establishes an occupancy rate which must be met before additional beds may approved: Before needed beds, as determined by Rule 10-5.11(23), may be approved, applicants requesting additional acute care beds should demonstrate that certain occupancy thresholds have been achieved relative to medical/surgical, obstetric, pediatric and ICU/CCU beds. The average annual occupancy rate (most recent calendar year) in the applying facility and its corresponding subdistrict average, should equal or exceed the following levels (inclusive of CON approved beds): Medical/Surgical 75% Obstetrical 65% Pediatric 65% ICU/CCU, Monitored & Intermediate Care 75% (e.s.) (R-10, pp.48-49) The rationale for this standard is set forth in the plan: With the advent of the Medicare prospective reimbursement system, there is literally no way to estimate the magnitude of impact that this reimbursement mechanism will have on hospital admissions, occupancy rates, and average lengths of stay. Therefore, relying upon the national standard of 4 beds/1000 population was not adequate. There is a need for an indicator based solely on utilization for the elderly. Since the reimbursement mechanism for non-Medicare patients has not changed, a resource based methodology has been utilized for this population group. Moreover, the program goals of the Local Health Plan state that the overall occupancy rate in District 9--as a whole--for licensed acute care beds as well as the occupancy rate for medical/surgical beds should equal or exceed 756. (Id. at 47) These minimum annual district and subdistrict occupancy rates take seasonality and age considerations into account. Bed utilization or occupancy standards are the only bed-need criteria that look to actual, verifiable data reflecting current conditions as opposed to forecasts, which look to the future.6 Failure to achieve the occupancy standards of Priority III A of the Local Health Plan creates, at least, a strong presumption against the approval of the project. In exceptional situations, however, additional beds may be approved even though the occupancy standard is not met. A typical example projected continuing decline in hospital admissions and utilization. Consequently, little weight is assigned to Martin Memorial's forecast of future bed utilization--that the satellite hospital would experience 58% occupancy in 1990.the first year of operation would be where there was a geographical access problem.7 Both the State and District 9 Health Plans cite the high cost of unused hospital beds which add to the cost of hospitalization. (R-20, p.70: R-10, p.10) A primary goal of both plans is to raise occupancy rates and eliminate excess beds. With this in mind, it is reasonable to give considerable weight to current utilization rates even though a numerical "need" for the beds is projected by the DHRS bed-need methodology.8 1984 bed utilization at Martin Memorial, Port St. Lucie and Jupiter Hospitals, as well as average utilization for District 9 and the Martin/St. Lucie Subdistrict, fall well below the minimum occupancy standards normally applied by DHRS and set out in the State and Local Health Plans. These minimum occupancy standards have not been met and are not reasonably projected to be met by 1990. Considerable weight should be accorded this factor since that is the effect of the State and Local Health Plans and DHRS' normal practice. Moreover, since occupancy rates are based on actual current conditions, they are less subject to manipulation, and inject a healthy measure of reality into CON decision-making during a time of great change in the health care industry. Economies and Improvement Services Derived From Operation of Joint, Cooperative or Shared Resources. [Another CON criterion is whether there will be "[p]robable economies and improvements in service that may be derived from the operation of joint, cooperative, or shared health care resources." Section 3fll.494(6)(c)5., Florida Statutes.] Because the proposed project is a satellite hospital, there will be economies and improvements in services realized from the operation of joint, cooperative or shared health care resources, as compared to the operation of a wholly separate free-standing hospital. The satellite hospital will not offer obstetrics or a defined pediatric unit. It will not have a CAT Scanner, a -- personnel office similar to Martin Memorial's, or a hospital laundry. It will have an emergency room, normal operating room suites, and radiology and lab services, although the more complex lab tests will be performed at Martin Memorial Hospital. The Need for Research and Educational Facilities. [CON applications are also reviewed in context with the "need for research and educational facilities . . .." Section 381.494 (6)(c)7, Florida Statutes.] The proposed satellite hospital will be located directly adjacent to the Martin County campus of Indian River Community College ("IRCC"). The IRCC campus has an Allied Health Building with approximately nine classrooms, a nursing 120 and an emergency medical technician lab. IRCC has a contract with Martin Memorial Hospital which allows IRCC students to use Martin Memorial facilities for clinical training. Clinical training is an important part of the allied health curriculum at IRCC. Construction of the satellite hospital next to the IRCC campus would benefit the Allied Health Programs since there could be joint use of equipment, facilities, and personnel, and a better opportunity to invite doctors, nurses, and other health care professionals to the classroom. The satellite hospital would also be more convenient to students, in terms of scheduling and transportation, than Martin Memorial Hospital, where they now receive clinical training. Although the proposed satellite hospital would enhance the IRCC health care training programs, there is no evidence that the clinical training programs now provided at Martin Memorial Hospital are inadequate. The proposed facility is not predicated on a claim that its primary purpose will be to serve as a research or educational facility. Financial Feasibility of the Proposed Satellite Hospital. [Another CON criterion is "[t]he immediate and long-term financial feasibility of the proposal." Section 381.494 (6)(c)9, Florida Statutes.] Estimated Project Costs The estimated costs of the movable equipment for the proposed satellite hospital are reasonable. (Stipulation, P.3) The real property in Port Salerno where the proposed satellite hospital would be located, is owned by Martin Memorial and is of adequate size and otherwise appropriate for the proposed project. (Stipulation, p.3) The estimated cost of construction and fixed equipment is $7,490,625.00, which amounts a cost of $117.50t per square foot. (The hospital will have 850 square feet per bed: $117.50 X 850 X 75 = $7,490,625.00.) his is a reasonable cost for bidding the project in the spring of 1986. Estimates of the architect's fee ($545,317.00), the cost for surveys and borings ($25,000.00j, the 3% contingency cost ($251,000.00), the developmental costs ($195,000.00), the site work and utilities ( $960, 000.03 ), the actual land costs.($595,000.00), and the financing and refinancing costs($3,100,770.00) have also been shown to be reasonable. Short-Term Financial Feasibility Martin Memorial has sufficient funds to make the equity contribution necessary to obtain financing. It also has the ability to raise $16,370,000.00 through the sale of tax exempt bonds, which appear to be marketable. It is likely that Martin Memorial would be able to secure the necessary funds for construction. The proposed satellite hospital would be financially feasible in the short-term. Martin Memorial has proven its ability to operate a hospital efficiently and profitably. Even with the advent of the DRG payment system, Martin Memorial Hospital has continued to operate profitably. During the initial DRG phase-in year of 1984, Martin Memorial benefited financially from the use of the new prospective payment schedule. Even if bed use at the satellite hospital is less than projected, or desired, during the start-up years, it is likely that Martin Memorial would be able to subsidize its operation until, with expected population growth, utilization increases and it becomes financially self- sustaining. Long-Term Financial Feasibility The proposed satellite hospital is also financially feasible in the long-term his conclusion is supported by a financial analysis utilizing reasonable assumptions based on Martin Memorial Hospital's historical experience an t financial costs obtained from a qualified securities analyst. The financial analyst also used bed utilization projections supplied by Martin Memorial's qualified earth care planner. Although the reliability of the 1990 utilization forecast is questionable, over the long-term--with projected increases in population9 is likely that the proposed hospital would become financially feasible, self-sustaining, and able to meet its operating expenses and debt service payments. I. Availability of Manpower and Resources [Another CON criterion is "[t]he availability of resources, including health manpower . . .." Section 381.494 (6)(c)8, Florida Statutes.] Martin Memorial has an in-place recruiting department which, in the past, has successfully recruited new employees for expansion programs. It has the capability of recruiting, training, and staffing the 175 full-time equivalent medical personnel shown in its CON application. There has been no showing that the hiring of employees for the satellite hospital will significantly impact other facilities or that there is a shortage of health manpower and resources. III. Need for the Proposed Hospital (using a planning horizon of January, 1990) Based on a Balanced Consideration of all CON Criteria_ ["Need" for a proposed facility, under CON law, is determined by "a balanced consideration of all the statutory [and rule] criteria." Department of Health and Rehabilitative Services v. Johnson & Johnson, 447 So. 2d 361, 363 (Fla. 1st DCA 1984) See, Section 381.494(6)(c), Florida Statutes. DHRS may not adopt a rule allowing it to "ignore some statutory criteria and emphasize others." Id. Nor may it adopt a methodology, in rule form, which "rigidly control[s] the granting or withholding of [CON] approval." Humana, Inc. et al. v. Department of Health and Rehabilitative Services, So. 2d (Fla. 1st DCA Case No. AY-422, Opinion filed May 16, 1985), 10 F.L.W. 1222.] (a) The foregoing evidentiary findings support an ultimate finding that the proposed satellite hospital is not needed, either now or within the planning horizon of January, 1990. When measured against all pertinent statutory and rule criteria, the factors favoring approval of Martin Memorial's application are outweighed by the factors supporting denial. The DHRS numerical bed-need methodology projects a January, 1990 "need", but barely so. Further, the methodology, as one criterion among many, is assigned less weight since it is a less accurate predictor of "need" in times, such as these, when in-patient bed use is steadily declining. This decline is pervasive, has continued, unabated, for over 13 months and has not yet bottomed-out. The methodology uses bed-need figures rooted in the past and does not adequately reflect this decline. Allocation of bed-need to the Martin/St. Lucie Subdistrict shows a more substancial "need" (103 beds), but this figure is, in part, also derived from the DHRS methodology. There is an adequate current supply of available acute care beds at existing facilities, similar in nature. No geographical access problem has been shown. The existing hospitals which serve the area proposed to be served by the satellite hospital, as well as the subdistrict and district, have 1984 occupancy rates considerably below the,30% occupancy standard generally applied by DHRS and health care planners. There is not a current shortage of beds. In January, 1990, it is likely that the supply of acute care beds will continue to be adequate. In all likelihood, daily occupancy rates at Martin Memorial and in the subdistrict will still be below the 80% standard. At best, Martin Memorial has shown that during two or three peak winter months, its own institution-specific occupancy rate will exceed 90%.10 But on a short-term basis, such a rate is doable and consistent with quality health care. Current bed utilization, a readily ascertainable criterion which reflects actual conditions, should be accorded considerable weight on the scale of criterion when, as now, the health care industry is in rapid flux and past trends have been disrupted, or even displaced. With declining average lengths of stay and anticipated growth in alternative delivery systems, it is reasonably expected that acute care bed use will continue to decline. The steady drop in bed use makes it more likely that the currently existing and licensed or approved beds in the area will be adequate through January 1990. Martin Memorial's utilization forecast failed to fully take into account the steady decline in bed use. Approval of the proposed hospital would be inconsistent with the State Health Plan, which identifies 80% as a minimum occupancy rate for acute care hospitals and, more particularly, with the Local Health Plan (Priority III) which, with few exceptions, does not allow new beds (irrespective of the DHRS methodology numbers) until specified occupancy thresholds have been met. These thresholds have not yet been met. The proposed hospital would be financially feasible in the short-and-long-term, enhance competition, and improve the education of health care students at the adjacent Indian River Community College. These benefits, however, are outweighed by the other factors which support a conclusion that the proposed hospital will not be needed by January, 1990. Construction of an unneeded hospital would have the effect of reducing occupancy rates at nearby hospitals and exacerbating the problem of excess bed capacity.
Recommendation Based on the foregoing, it is RECOMMENDED: That Martin Memorial's application or a CON to construct and operate the Port Salerno Hospital be DENIED. DONE and ORDERED this 4th day of October, 1985, in Tallahassee, Florida. R. L. CALEEN, J . Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, FL 32301 (904)488-9675 Filed with the Clerk of the Division of Administrative Hearings this 4th day of October, 1985.
The Issue The issue in these cases is whether certain rules proposed by the Agency for Health Care Administration (AHCA) related to adult interventional cardiovascular services are an invalid exercise of delegated legislative authority.
Findings Of Fact By stipulation of the parties, all Petitioners and Intervenors in these cases are acute care hospitals licensed in Florida pursuant to Chapter 395, Florida Statutes; are substantially affected by the proposed rules at issue in these cases; and have standing to participate in this proceeding. AHCA is the state agency responsible for licensure of hospitals pursuant to Chapter 395, Florida Statutes, and responsible for promulgation of the proposed rules at issue in these cases. This dispute specifically involves proposed rules related to the licensure of adult cardiovascular services in Florida hospitals. Such services include percutaneous cardiac intervention (PCI), also referred to as percutaneous transluminal coronary angioplasty (PCTA). PCI involves the insertion of a device placed into an artery and directed to the site of a coronary artery blockage. The device is used to compress or remove the blockage material and restore arterial blood flow to heart tissue. A mechanism called a "stent" may be left in place at the site of the former blockage to reduce the potential for re-blockage ("restenosis") of the artery. The procedure is performed in a cardiac catheterization laboratory ("cath lab"). PCI that is performed on an emergency basis to open an arterial blockage causing myocardial infarction (heart attack) is referred to as "primary" or "emergent" PCI. PCI performed to resolve symptoms of coronary artery disease manifesting in presentations other than through myocardial infarction is referred to as "elective" PCI. Previous law restricted PCI services to those hospitals with onsite cardiac surgery (commonly referred to as "open heart" surgery). Hospitals are required to obtain a Certificate of Need (CON) from AHCA to operate a cardiac surgery program. Accordingly, in order to offer PCI services, a hospital was required to obtain a cardiac surgery program CON from AHCA. As cardiac catheterization procedures have become more widely available and physician training and experience have increased, the relative safety of the procedures has improved. The volume of open heart cardiac surgery has declined as the patient outcomes for non-surgical coronary artery disease treatments have improved, yet Florida hospitals seeking to provide PCI were still operating under the CON-based restrictions. There is an ongoing debate within the medical community related to the issue of whether non-emergent patients should receive PCI services at hospitals which lack cardiac surgery programs. The historic rationale for restricting the availability of elective PCI procedures to hospitals where onsite cardiac surgery was also available was related to the possibility that an unsuccessful PCI would require immediate resolution through surgery. The evidence establishes that PCI-related events requiring immediate access to onsite cardiac surgery have become less frequent, at least in part due to increased training and experience of practitioners, as well as an increased technical ability to resolve some events, such as arterial ruptures or perforations, within the cath lab. Nonetheless, there is also evidence that the outcomes of cardiac catheterization procedures performed in hospitals with onsite cardiac surgery may be superior to those performed in hospitals where onsite cardiac surgery is not available. In 2004, the Florida Legislature adopted two bills that, insofar as are relevant to this proceeding, had an impact on the regulatory process related to adult interventional cardiovascular services. The effect of the legislation was to shift the regulation of PCI programs away from CON-based restrictions and towards a licensing process. Both bills established a two-level classification of hospitals providing adult interventional cardiology services. House Bill 329 limited the provision of PCI at hospitals without onsite cardiac surgery to emergent patients and provided, in relevant part, as follows: In establishing rules for adult interventional cardiology services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult primary percutaneous cardiac intervention for emergent patients without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. (Emphasis supplied) Senate Bill 182 did not limit PCI services on the basis of onsite cardiac surgery availability and provided, in relevant part, as follows: Section 2. Notwithstanding conflicting provisions in House Bill 329, Section 408.0361, Florida Statutes, is amended to read: * * * In establishing rules for adult interventional cardiology services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult percutaneous cardiac intervention without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. (Emphasis added) Both the House Bill and the Senate Bill were signed into law. The legislation was codified as Section 408.0361, Florida Statutes (2004), which provided, in relevant part, as follows: 408.0361 Cardiology services and burn unit licensure.-- * * * In establishing rules for adult interventional cardiology services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult percutaneous cardiac intervention without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. Extensive evidence was offered at the hearing to support both sides of the debate regarding the appropriateness of performing elective PCI in hospitals without onsite cardiac surgery, and it is clear that the debate continues. However, the evidence establishes that the Florida Legislature specifically chose not to restrict non-emergent PCI to Florida hospitals with onsite cardiac surgery units and has determined that properly-licensed Florida hospitals may provide PCI services without regard to the availability of on-site cardiac surgery. It is reasonable to assume that had the Legislature intended to restrict provision of adult PCI in hospitals without cardiac surgery programs to emergent patients, the "notwithstanding" language contained in Senate Bill 182 would not have been adopted. There is no credible evidence that the Legislature was unaware of the continuing debate within the cardiology community at the time the legislation was adopted in 2004. The Legislature has acknowledged the distinction between emergent and elective PCI as indicated by Subsection 408.036(3)(o), Florida Statutes (2008), which provides under certain circumstances that a hospital without an approved "open heart surgery program" can obtain an exemption from CON requirements and provide emergent PCI services to "patients presenting with emergency myocardial infarctions." It is reasonable to assume that had the codification of the 2004 legislation been incorrect, the Florida Legislature would have subsequently amended the statute to reinstate the restriction. In fact, the Legislature has revised the referenced statute without substantively altering the relevant language establishing the two-level licensure designation. Section 408.0361, Florida Statutes (2008), the current statute directing AHCA to adopt the rules at issue in this proceeding, provides, in relevant part, as follows: 408.0361 Cardiovascular services and burn unit licensure.-- Each provider of diagnostic cardiac catheterization services shall comply with rules adopted by the agency that establish licensure standards governing the operation of adult inpatient diagnostic cardiac catheterization programs. The rules shall ensure that such programs: Comply with the most recent guidelines of the American College of Cardiology and American Heart Association Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories. Perform only adult inpatient diagnostic cardiac catheterization services and will not provide therapeutic cardiac catheterization or any other cardiology services. Maintain sufficient appropriate equipment and health care personnel to ensure quality and safety. Maintain appropriate times of operation and protocols to ensure availability and appropriate referrals in the event of emergencies. Demonstrate a plan to provide services to Medicaid and charity care patients. Each provider of adult cardiovascular services or operator of a burn unit shall comply with rules adopted by the agency that establish licensure standards that govern the provision of adult cardiovascular services or the operation of a burn unit. Such rules shall consider, at a minimum, staffing, equipment, physical plant, operating protocols, the provision of services to Medicaid and charity care patients, accreditation, licensure period and fees, and enforcement of minimum standards. The certificate-of-need rules for adult cardiovascular services and burn units in effect on June 30, 2004, are authorized pursuant to this subsection and shall remain in effect and shall be enforceable by the agency until the licensure rules are adopted. Existing providers and any provider with a notice of intent to grant a certificate of need or a final order of the agency granting a certificate of need for adult cardiovascular services or burn units shall be considered grandfathered and receive a license for their programs effective on the effective date of this act. The grandfathered licensure shall be for at least 3 years or until July 1, 2008, whichever is longer, but shall be required to meet licensure standards applicable to existing programs for every subsequent licensure period. In establishing rules for adult cardiovascular services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult percutaneous cardiac intervention without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. For a hospital seeking a Level I program, demonstration that, for the most recent 12-month period as reported to the agency, it has provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations or, for the most recent 12-month period, has discharged or transferred at least 300 inpatients with the principal diagnosis of ischemic heart disease and that it has a formalized, written transfer agreement with a hospital that has a Level II program, including written transport protocols to ensure safe and efficient transfer of a patient within 60 minutes. For a hospital seeking a Level II program, demonstration that, for the most recent 12-month period as reported to the agency, it has performed a minimum of 1,100 adult inpatient and outpatient cardiac catheterizations, of which at least 400 must be therapeutic catheterizations, or, for the most recent 12-month period, has discharged at least 800 patients with the principal diagnosis of ischemic heart disease. Compliance with the most recent guidelines of the American College of Cardiology and American Heart Association guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Establishment of appropriate hours of operation and protocols to ensure availability and timely referral in the event of emergencies. Demonstration of a plan to provide services to Medicaid and charity care patients. In order to ensure continuity of available services, the holder of a certificate of need for a newly licensed hospital that meets the requirements of this subsection may apply for and shall be granted Level I program status regardless of whether rules relating to Level I programs have been adopted. To qualify for a Level I program under this subsection, a hospital seeking a Level I program must be a newly licensed hospital established pursuant to a certificate of need in a physical location previously licensed and operated as a hospital, the former hospital must have provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations for the most recent 12- month period as reported to the agency, and the newly licensed hospital must have a formalized, written transfer agreement with a hospital that has a Level II program, including written transport protocols to ensure safe and efficient transfer of a patient within 60 minutes. A hospital meeting the requirements of this subsection may apply for certification of Level I program status before taking possession of the physical location of the former hospital, and the effective date of Level I program status shall be concurrent with the effective date of the newly issued hospital license. (5)(a) The agency shall establish a technical advisory panel to develop procedures and standards for measuring outcomes of adult cardiovascular services. Members of the panel shall include representatives of the Florida Hospital Association, the Florida Society of Thoracic and Cardiovascular Surgeons, the Florida Chapter of the American College of Cardiology, and the Florida Chapter of the American Heart Association and others with experience in statistics and outcome measurement. Based on recommendations from the panel, the agency shall develop and adopt rules for the adult cardiovascular services that include at least the following: A risk adjustment procedure that accounts for the variations in severity and case mix found in hospitals in this state. Outcome standards specifying expected levels of performance in Level I and Level II adult cardiovascular services. Such standards may include, but shall not be limited to, in-hospital mortality, infection rates, nonfatal myocardial infarctions, length of stay, postoperative bleeds, and returns to surgery. Specific steps to be taken by the agency and licensed hospitals that do not meet the outcome standards within specified time periods, including time periods for detailed case reviews and development and implementation of corrective action plans. Hospitals licensed for Level I or Level II adult cardiovascular services shall participate in clinical outcome reporting systems operated by the American College of Cardiology and the Society for Thoracic Surgeons. As required by Subsection 408.0361(5), Florida Statutes (2004), AHCA created the TAP, which convened and met over the course of two years at a series of public hearings. The TAP also received written materials and comments from interested parties. Thereafter, AHCA convened rule development workshops to formulate the proposed rules at issue in this proceeding. The proposed rules were initially noticed in the September 28, 2007, Florida Administrative Weekly (Vol. 33, No. 39). Subsequent Notices of Changes to the proposed rules were published in the Florida Administrative Weeklies of November 16, 2007 (Vol. 33, No. 46); March 28, 2008 (Vol. 34, No. 13); and May 9, 2008 (Vol. 34, No. 19). There is no evidence that AHCA failed to comply with statutory requirements related to the rule adoption process. As required by Subsection 408.0361(3)(a), Florida Statutes (2008), the proposed rules set forth the procedures by which a hospital may apply for licensure as a Level I or Level II provider of adult cardiovascular services without differentiation based on the availability of on-site cardiac surgery. The proposed rules applicable to a hospital seeking licensure as a Level I provider of adult cardiovascular services are set forth at Proposed Rule 59A-3.2085(16). The proposed rules applicable to a hospital seeking licensure as a Level II provider of adult cardiovascular services are set forth at Proposed Rule 59A-3.2085(17). Subsection 408.0361(3)(b), Florida Statutes (2008), establishes minimum volume reporting requirements for licensure as a Level I program. Accordingly, Proposed Rule 59A- 3.2085(16)(a) provides, in relevant part, as follows: 1. A hospital seeking a license for a Level I adult cardiovascular services program shall submit an application on a form provided by the Agency (See Form 1: Level I Adult Cardiovascular Services License Application Attestation; AHCA Form, Section 18(a) of this rule ), signed by the chief executive officer of the hospital, attesting that, for the most recent 12-month period, the hospital has provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations or, for the most recent 12-month period, has discharged or transferred at least 300 inpatients with the principal diagnosis of ischemic heart disease (defined by ICD-9-CM codes 410.0 through 414.9). Reportable cardiac catheterization procedures are defined as single sessions with a patient in the hospital’s cardiac catheterization procedure room(s), irrespective of the number of specific procedures performed during the session. Reportable cardiac catheterization procedures shall be limited to those provided and billed for by the Level I licensure applicant and shall not include procedures performed at the hospital by physicians who have entered into block leases or joint venture agreements with the applicant. (Emphasis supplied) Subsection 408.0361(3)(c), Florida Statutes (2008), establishes minimum volume reporting requirements for licensure as a Level II program. Accordingly, Proposed Rule 59A- 3.2085(17)(a) provides in relevant part as follows: 1. A hospital seeking a license for a Level II adult cardiovascular services program shall submit an application on a form provided by the Agency (See Form 2: Level II Adult Cardiovascular Services License Application Attestation; AHCA Form , Section 18(b) of this rule ) to the Agency, signed by the chief executive officer of the hospital, attesting that, for the most recent 12-month period, the hospital has provided a minimum of a minimum of 1,100 adult inpatient and outpatient cardiac catheterizations, of which at least 400 must be therapeutic cardiac catheterizations, or, for the most recent 12-month period, has discharged at least 800 patients with the principal diagnosis of ischemic heart disease (defined by ICD-9-CM codes 410.0 through 414.9). a. Reportable cardiac catheterization procedures shall be limited to those provided and billed for by the Level II licensure applicant and shall not include procedures performed at the hospital by physicians who have entered into block leases or joint venture agreements with the applicant. (Emphasis supplied) St. Anthony's asserts that the proposed rule is invalid on the grounds that it fails to provide a clear and reasonable methodology for assessing and verifying the number of diagnostic catheterization procedures performed. St. Anthony's asserts that the exclusion of cardiac catheterization procedures performed within the hospital's cardiac cath lab but not billed by the hospital is arbitrary and capricious, modifies, enlarges, or contravenes the specific provisions of the statute implemented, fails to establish adequate standards for agency decision making, and vests unbridled discretion in the agency. The evidence fails to support these assertions. Although the phrase "block lease" is undefined by statute or rule, the evidence establishes that insofar as relevant to this proceeding, the term refers to a practice by which a group of cardiologists lease blocks of time from a hospital for exclusive use of a hospital's cardiac cath lab. St. Anthony's has a leasing arrangement with a group of cardiologists identified as the "Heart and Vascular Institute South" ("HAVI South") whereby St. Anthony's leases blocks of time in a cardiac cath lab to HAVI South cardiologists. The facility is located in a privately-owned medical office building physically attached to St. Anthony's hospital building. St. Anthony's leases the medical office building from a developer. HAVI South cardiologists perform cardiac catheterization procedures at the St. Anthony's facility during both leased and non-leased time. St. Anthony's provides personnel to staff the cardiac cath lab regardless of whether the procedure is performed during leased or non-leased time. The HAVI South cardiology group develops the schedule of cardiac catheterization procedures to be performed during the leased time and notifies St. Anthony's of the schedule. The HAVI South cardiology group bills for both their professional fees and the facility charges (referred to as the "technical component") for the cardiac catheterization procedures performed during leased time. St. Anthony's does not bill for cardiac catheterization procedures performed during the leased time. For the cardiac catheterization procedures performed during non-leased time, the HAVI South cardiology group bills for professional fees, and St. Anthony's bills for the technical component. Patricia Sizemore, vice-president for patient services at St. Anthony's, acknowledged that other hospitals could have block-leasing arrangements different from those existing between St. Anthony's and the HAVI South group. The proposed rules would preclude St. Anthony's from including the outpatient cardiac catheterization procedures done by HAVI South during the block-leased time within those procedures available to meet the numeric threshold requirements identified in the statute. The evidence fails to establish that the proposed rule fails to provide a clear and reasonable methodology for assessing and verifying the number of diagnostic catheterization procedures performed. The relevant language of Subsection 408.0361(3), Florida Statutes (2008), identifies the hospital as the applicant and requires that the applicant "provide" the procedures or discharges being reported to meet the specified volume thresholds. The applicable definition of hospital is set forth at Subsection 408.032(11), Florida Statutes (2008), which defines a hospital as a health care facility licensed under Chapter 395, Florida Statutes. Subsection 395.002(12), Florida Statutes (2008), sets forth the following definition: (12) "Hospital" means any establishment that: Offers services more intensive than those required for room, board, personal services, and general nursing care, and offers facilities and beds for use beyond 24 hours by individuals requiring diagnosis, treatment, or care for illness, injury, deformity, infirmity, abnormality, disease, or pregnancy; and Regularly makes available at least clinical laboratory services, diagnostic X- ray services, and treatment facilities for surgery or obstetrical care, or other definitive medical treatment of similar extent, except that a critical access hospital, as defined in s. 408.07, shall not be required to make available treatment facilities for surgery, obstetrical care, or similar services as long as it maintains its critical access hospital designation and shall be required to make such facilities available only if it ceases to be designated as a critical access hospital. Physicians are not "hospitals" and are not licensed or regulated by Chapter 395, Florida Statutes. Physicians are not authorized to apply for licensure under the provisions of the statute and proposed rules at issue in this proceeding. Nothing in the statute suggests that entities other than hospitals may apply for licensure of a Level I or Level II adult cardiovascular services program. The rationale underlying the restriction of reportable procedures to those for which the applicant hospital issues bills for payment is based upon AHCA's reasonable intention to validate the procedure volume data submitted by applicant hospitals. Jeffrey Gregg, chief of AHCA's Bureau of Health Facility Regulation and CON Unit, testified that "the only practical, realistic way" for AHCA to routinely verify the accuracy of the procedure volume identified by a hospital's licensure application is through AHCA's ambulatory patient database. The reporting requirements for the ambulatory patient database are set forth at Florida Administrative Code Chapter 59B-9 and include elements such as demographic information, diagnosis codes, and charges. The database provides AHCA with access to patient record documentation and directly allows AHCA to verify the procedure volume identified in the licensure application. Because St. Anthony's has no charges related to the procedures performed by HAVI South cardiologists during the leased time, St. Anthony's has not reported procedures performed during leased time to the ambulatory patient database. St. Anthony's reports far more cardiac catheterization procedures to the local Suncoast Health Council than it does to AHCA's ambulatory patient database and asserts that AHCA could rely on health council data. AHCA has no organizational relationship with the local health council, and the evidence fails to establish that such data is as reliable as that collected by the ambulatory patient database. AHCA asserts that an additional basis to exclude procedures performed by entities other than the applicant hospital is that AHCA has no direct regulatory authority over the non-hospital entity. St. Anthony's asserts that AHCA would have its customary authority over the hospital and, by extension, over the third-party leasing the cardiac cath lab from the hospital. At best, AHCA's authority to obtain records from the non-hospital operator of the hospital's cardiac cath lab is unclear. St. Anthony's position effectively would permit a third-party operator to lease all of the time in a hospital's cardiac cath lab, yet allow the hospital to apply for and receive an adult cardiovascular service license. Nothing in Section 408.0361, Florida Statutes (2008), suggests that the Legislature intended to provide such an option. The proposed rule designating the reportable cardiac catheterization procedures is logical and rational, is not arbitrary or capricious, and does not modify, enlarge or contravene the specific provisions of the statute implemented. The evidence fails to establish that the designation of appropriately reportable cardiac catheterization procedures constitutes a failure to establish adequate standards for agency decision making or vests unbridled discretion in the agency. Subsection 408.0361(3)(d), Florida Statutes (2008), requires that the proposed rules include provisions "that allow for" compliance with the most recent guidelines of the American College of Cardiology and AHA guidelines for "staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety." Subsection 408.0361(5), Florida Statutes (2008), requires that the TAP "develop procedures and standards for measuring outcomes" and that, based thereon, AHCA adopt rules that include a risk adjustment procedure that accounts for variations in severity and case mix, outcome standards specifying expected levels of performance, and "specific steps to be taken by the agency and the licensed hospitals" that fail to meet outcome standards. The statute also requires that licensed hospitals participate in clinical outcome reporting systems operated by the American College of Cardiology and the Society of Thoracic Surgeons. The TAP determined that the appropriate method of measuring outcome was to utilize the data available through the clinical outcome reporting systems referenced in the statute. Accordingly, Proposed Rule 59A-3.2085(16)(a) identifies the guidelines applicable to Level I adult cardiovascular services; identifies the specific provisions of the guidelines with which a Level I hospital must comply; requires that the Level I hospital participate in the statutorily-identified data reporting system; and requires that Level I hospitals document a quality improvement plan to meet performance measures set forth by the data reporting system. The proposed rule provides, in relevant part, as follows: All providers of Level I adult cardiovascular services programs shall operate in compliance with subsection 59A- 3.2085(13), F.A.C., the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214 and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) guidelines regarding the operation of adult diagnostic cardiac catheterization laboratories and the provision of percutaneous coronary intervention. The applicable guidelines, herein incorporated by reference, are the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention). Aspects of the guideline related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. Aspects of the guideline related to the provision of elective percutaneous coronary intervention only in hospitals authorized to provide open heart surgery are not applicable to this rule. Hospitals are considered to be in compliance with the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214 and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) guidelines when they adhere to standards regarding staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Hospitals must also document an ongoing quality improvement plan to ensure that the cardiac catheterization program and the percutaneous coronary intervention program meet or exceed national quality and outcome benchmarks reported by the American College of Cardiology-National Cardiovascular Data Registry. Level I adult cardiovascular service providers shall report to the American College of Cardiology-National Cardiovascular Data Registry in accordance with the timetables and procedures established by the Registry. All data shall be reported using the specific data elements, definitions and transmission format as set forth by the American College of Cardiology-National Cardiovascular Data Registry. Proposed Rule 59A-3.2085(17)(a) identifies the guidelines applicable to Level II adult cardiovascular services; identifies the specific provisions of the guidelines with which a Level II hospital must comply; requires that the Level II hospital participate in the statutorily-identified data reporting system; and requires that Level II hospitals document a quality improvement plan to meet performance measures set forth by the data reporting system. The proposed rule provides in relevant part as follows: All providers of Level II adult cardiovascular services programs shall operate in compliance with subsections 59A-3.2085(13) and 59A-3.2085(16), F.A.C. and the applicable guidelines of the American College of Cardiology/American Heart Association regarding the operation of diagnostic cardiac catheterization laboratories, the provision of percutaneous coronary intervention and the provision of coronary artery bypass graft surgery. The applicable guidelines, herein incorporated by reference, are the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; and ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention; and ACC/AHA 2004 Guideline Update for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery) Developed in Collaboration With the American Association for Thoracic Surgery and the Society of Thoracic Surgeons. Aspects of the guidelines related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. Hospitals are considered to be in compliance with the guidelines in the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; in the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention; and in the ACC/AHA 2004 Guideline Update for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery) Developed in Collaboration With the American Association for Thoracic Surgery and the Society of Thoracic Surgeons when they adhere to standards regarding staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Hospitals must also document an ongoing quality improvement plan to ensure that the cardiac catheterization program, the percutaneous coronary intervention program and the cardiac surgical program meet or exceed national quality and outcome benchmarks reported by the American College of Cardiology-National Cardiovascular Data Registry and the Society of Thoracic Surgeons. In addition to the requirements set forth in subparagraph (16)(a)7. of this rule, each hospital licensed to provide Level II adult cardiovascular services programs shall participate in the Society of Thoracic Surgeons National Database. The Petitioners generally assert that the proposed rules insufficiently identify or establish the minimum standards identified as "guidelines" and "benchmarks" in the rule. The evidence fails to support the assertion. The guidelines are specifically identified and incorporated by reference within the rule. There is no evidence that the documents identified do not constitute the "most recent guidelines of the American College of Cardiology and the American Heart Association" as required by the statute. Hospitals are not obligated to meet all of the requirements set forth in the guidelines. A licensed hospital is deemed to be in compliance when, as specified in the statute, the hospital adheres to the standards related to staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. The Petitioners generally assert that such distinctions between the various compliance elements are unclear. The evidence fails to support the assertion. There is no credible evidence that the guidelines, albeit technical and complex, are not commonly understood by appropriate medical practitioners and hospital administrators. Martin Memorial asserts that the Proposed Rule 59A-3.2085(16)(a)5. is vague on grounds that it requires Level I hospitals to operate in compliance with the referenced guidelines while Proposed Rule 59A-3.2085(16)(a)9. authorizes provision of elective PCI at Level I hospitals. Martin Memorial further asserts that because the proposed rules provide for elective PCI in hospitals without onsite cardiac surgical programs, the proposed rules enlarge, modify or contravene the enacting statute. Subsection 408.0361(3)(d), Florida Statutes (2008), requires that AHCA include "provisions that allow for" the following: Compliance with the most recent guidelines of the American College of Cardiology and American Heart Association guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. (Emphasis supplied) Proposed Rule 59A-3.2085(16)(a)9. provides as follows: Notwithstanding guidelines to the contrary in the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214 and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention), all providers of Level I adult cardiovascular services programs may provide emergency and elective percutaneous coronary intervention procedures. Aspects of the guidelines related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. (Emphasis supplied) Martin Memorial's disagreement with the proposed rule is premised on the following statement in the ACC/AHA/SCAI 2005 Guideline Update: Elective PCI should not be performed at institutions that do not provide onsite cardiac surgery. (Level of Evidence: C) The statement is contained within subsection 4.3 ("Role of Onsite Cardiac Surgical Backup") within Section 4 ("Institutional and Operator Competency"). The statement is defined as a "Class III" standard, meaning within the "conditions for which there is evidence and/or general agreement that a procedure/treatment is not useful/effective and in some cases may be harmful." According to the "Level of Evidence: C" identification, the statement reflects "consensus opinion of experts, case studies, or standard of care." A footnote to the statement provides as follows: Several centers have reported satisfactory results based on careful case selection with well-defined arrangements for immediate transfer to a surgical program (citation omitted). A small but real fraction of patients undergoing elective PCI will experience a life-threatening complication that could be managed with the immediate onsite availability of cardiac surgical support but cannot be managed effectively by urgent transfer. Wennberg, et al., found higher mortality in the Medicare database for patients undergoing elective PCI in institutions without onsite cardiac surgery (citation omitted). This recommendation may be subject to revision as clinical data and experience increase. The guidelines are statements of "best practices" in health care delivery. They are intended to assist practitioners and facility administrators in making appropriate decisions. The cited statement neither prohibits nor requires performance of elective PCI in hospitals without onsite cardiac surgical programs. Whether a practitioner performs elective PCI in a licensed Level I hospital remains a medical decision under the provisions of the enacting statute and proposed rules. The footnote recognizes that elective PCI is available at some hospitals without onsite cardiac surgery through "careful case selection with well-defined arrangements for immediate transfer to a surgical program." The proposed rule specifically establishes staff and transfer requirements designed to facilitate rapid transfer of a patient from a Level I to a Level II facility. There is no evidence that such staff and transfer requirements are insufficient or otherwise inappropriate. Patient selection criteria are those which expressly identify clinical presentations of patients who are appropriate for revascularization through PCI. Section 5 of the referenced ACC/AHA/SCAI 2005 Guideline Update, titled "Clinical Presentations" explicitly addresses such criteria and constitutes the patient selection criteria contained within the document. The patient selection criteria do not regulate the location where PCI procedures are performed. As stated previously, the Florida Legislature, presented with the option of limiting the availability of cardiac catheterization services available at Level I hospitals to emergent patients, rejected the limitation. The evidence fails to establish that Proposed Rule 59A-3.2085(16)(a)5. is vague or that Proposed Rule 59A-3.2085(16)(a)9. enlarges, modifies or contravenes the enacting statute. Martin Memorial and St. Anthony's assert that the proposed rule contravenes Subsection 408.0361(5)(a), Florida Statutes (2008), which provides that AHCA adopt rules that include "at least the following" elements: A risk adjustment procedure that accounts for the variations in severity and case mix found in hospitals in this state. Outcome standards specifying expected levels of performance in Level I and Level II adult cardiovascular services. Such standards may include, but shall not be limited to, in-hospital mortality, infection rates, nonfatal myocardial infarctions, length of stay, postoperative bleeds, and returns to surgery. Specific steps to be taken by the agency and licensed hospitals that do not meet the outcome standards within specified time periods, including time periods for detailed case reviews and development and implementation of corrective action plans. The TAP recommended to AHCA that existing outcome data reporting systems created by the American College of Cardiology and the Society of Thoracic Surgeons be utilized for data collection related to licensed hospital adult cardiovascular services programs. Subsection 408.0361(5)(b), Florida Statutes (2008), requires that hospitals licensed under the proposed rules participate in clinical reporting systems operated by the American College of Cardiology and the Society of Thoracic Surgeons. The requirement was adopted by the 2007 Legislature based on the TAP recommendation. Proposed Rule 51A-3.2085(16)(a)8. requires licensed Level I hospitals to participate in the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR) and sets forth additional directives related to such participation. The ACC-NCDR system is a risk adjusted outcome reporting system that accounts for variation in severity and case mix. It collects approximately 200 data elements and is in use in approximately 2,000 hospitals. Proposed Rule 51A-3.2085(17)(a)6. directs licensed Level II hospitals to participate in the Society of Thoracic Surgeons National Database (STS database) and sets forth additional requirements related to such participation. The STS database provides information generally similar to the ACC-NCDR database. Although Proposed Rule 59A-3.2085(17)(a)5. states that the Level II hospital must meet or exceed the performance standards identified within the ACC-NCDR, there appears to be no specific requirement in the proposed rules that a Level II hospital participate in the ACC-NCDR system. Proposed Rule 59A-3.2085(17)(a)6. contains a citation to Proposed Rule 59A-3.2085 (16)(a)7. The cited paragraph consists of text that is similar to the paragraph preceding the citation. The intent of the reference is unclear. If the reference were intended to incorporate the ACC- NCDR reporting requirements with those applicable to Level II hospitals, the citation in Proposed Rule 59A-3.2085(17)(a)6. should have been to Proposed Rule 59A-3.2085(16)(a)8., where the ACC-NCDR requirements are identified. In any event, the statute requires participation by licensed hospitals in the reporting systems, and, as stated previously, Level II hospitals must document plans to ensure that the cited standards are met; so, it is logical to presume that Level II hospitals will participate in the ACC-NCDR system, in addition to the STS database. Martin Memorial and St. Anthony's assert that the proposed rule does not include the "outcome standards specifying expected levels of performance" required by Subsection 408.0361(5)(a)2., Florida Statutes (2008), and that the proposed rules fail to identify the "national quality and outcome benchmarks" referenced therein. The evidence fails to support the assertions. 93. Proposed Rules 59A-3.2085(16)(a)7. and 59A- 3.2085(17)(a)5. require that each licensed hospital must document a "quality improvement plan to ensure" that the specified cardiac services meet or exceed "national quality and outcome benchmarks" reported by the ACC-NCDR and the STS databases. The word "benchmark" is not defined by statute or rule. Merriam Webster's dictionary defines "benchmark" as "a point of reference from which measurements may be made" or "something that serves as a standard by which others may be measured or judged." The evidence establishes that the "national quality and outcome benchmarks" referenced in the proposed rules are the "expected levels of performance" identified through the ACC-NCDR system. Each hospital participating in the ACC-NCDR system receives a detailed quarterly outcome report indicating the particular hospital's performance relative to all other reporting hospitals on a variety of elements associated with cardiac catheterization and PCI provided at the hospital. Accompanying each periodic report is an "Executive Summary" that identifies the relative performance of the hospital receiving the report on ten specific "PCI and Diagnostic Catheterization Performance Measures," including six "PCI Quality Measures," two "PCI Utilization Measures," and two "Diagnostic Quality Measures." The Executive Summary information visually displays the data through a set of "box and whisker plots" that present the range of data reported by all participating hospitals on each specific measure. The summary received by each hospital identifies its specific performance through an "arrow" and numeric data printed on the plot. The plot visually displays "lagging" and "leading" performance levels. The plot identifies hospitals performing below the tenth percentile of all participating hospitals as "lagging" hospitals. The plot identifies hospitals performing above the 90th percentile as "leading" hospitals. The evidence, including review of the ACC-NCDR data reporting system, establishes that the "expected levels of performance" are rationally those levels within the broad range of hospitals which are neither "leading" nor "lagging" according to the data. It is reasonable to assume that a "leading" hospital is performing at a level higher than expected and that a "lagging" hospital is performing at a level lower than expected. By reviewing the plot for each measure, a hospital can determine its performance relative to other participating hospitals on the ten measures included in the Executive Summary. The additional numeric data contained within the quarterly report permit additional comparison between an individual hospital and all other participating hospitals. Subsection 408.0361(5)(a)2., Florida Statutes (2008), does not require that AHCA establish numeric minimal standards, but only requires that the rule identify "outcome standards specifying expected levels of performance." The ACC-NCDR reporting system required by the statute and adopted by the proposed rules sufficiently identifies expected levels of performance. By their very nature, the outcome standards are not fixed. It is reasonable to presume that as hospital practices change, measurements of relative performance will also change. The rule requires only that each licensed hospital include within a quality improvement plan, documentation to ensure that such outcome standards will be met or exceeded, essentially encouraging a pattern of continual improvement by licensed programs. Subsection 408.0361(5)(a)3., Florida Statutes (2008), requires that the rule include the "specific steps to be taken by the agency and licensed hospitals that do not meet the outcome standards within specified time periods, including time periods for detailed case reviews and development and implementation of corrective action plans." The proposed rule complies with the requirements of the statute. Enforcement of outcome standards requirements applicable to Level I programs is addressed at Proposed Rule 59A-3.2085(16)(f) which provides as follows: Enforcement of these rules shall follow procedures established in Rule 59A-3.253, F.A.C. Unless in the view of the Agency there is a threat to the health, safety or welfare of patients, Level I adult cardiovascular services programs that fail to meet provisions of this rule shall be given 15 days to develop a plan of correction that must be accepted by the Agency. Failure of the hospital with a Level I adult cardiovascular services program to make improvements specified in the plan of correction shall result in the revocation of the program license. The hospital may offer evidence of mitigation and such evidence could result in a lesser sanction. Enforcement of outcome standards requirements applicable to Level II programs is addressed at Proposed Rule 59A-3.2085(17)(e), which provides as follows: Enforcement of these rules shall follow procedures established in Rule 59A-3.253, F.A.C. Unless in the view of the Agency there is a threat to the health, safety or welfare of patients, Level II adult cardiovascular services programs that fail to meet provisions of this rule shall be given 15 days to develop a plan of correction that must be accepted by the Agency. Failure of the hospital with a Level II adult cardiovascular services program to make improvements specified in the plan of correction shall result in the revocation of the program license. The hospital may offer evidence of mitigation and such evidence could result in a lesser sanction. AHCA does not routinely conduct surveys of accredited hospitals. Such surveys are conducted by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). AHCA generally conducts hospital surveys only during the investigation, pursuant to Florida Administrative Code Rule 59A-3.253(8), of a complaint filed against a hospital. AHCA would likely review ACC-NCDR and Society of Thoracic Surgeons data reports associated with the investigation of a specific complaint related to adult cardiovascular services. Assuming that AHCA's review of the data identified a deficiency, the proposed rules provide the licensee a 15-day period to develop a plan of correction acceptable to AHCA, unless the issue poses "a threat to the health, safety or welfare of patients" in which case it is reasonable to expect that a more prompt resolution of a deficiency would be required. Pursuant to Florida Administrative Code Rule 59A- 3.253, a hospital could be sanctioned for failing to submit a plan of correction related to an identified deficiency, or for failing to implement actions to correct deficiencies specified in an approved plan of correction. There is no evidence that AHCA's enforcement authority under the proposed rules differs in any significant manner from the general enforcement authority already available to the agency. There is no evidence that the proposed rules would result in any alteration of AHCA's investigative practices. Martin Memorial notes that, while the proposed rule provides a 15-day period for development of a plan of correction, AHCA's general enforcement rules already provide a ten-day period and asserts that the proposed rule is therefore inconsistent, fails to establish adequate standards for agency decisions, and vests unbridled discretion in the agency. The specific time period set forth in the proposed rule is clearly applicable, and there is no credible evidence of legitimate confusion in this regard. AHCA has suggested that "lagging" hospitals could be specifically regarded as failing to meet the outcome benchmarks identified in the ACC-NCDR data, but the proposed rule makes no specific reference to any systematic classification of hospital performance, and the statute does not require that a minimal performance level be established. Martin Memorial asserts that the Proposed Rule 59A- 3.2085(17)(a)6. is capricious because it requires that "each hospital licensed to provide Level II adult cardiovascular services programs shall participate in the Society of Thoracic Surgeons National Database," but only physicians can participate in the database. The enacting statute requires such participation. Subsection 408.0361(5)(b), Florida Statutes (2008), directs AHCA to adopt rules that require Level I or Level II licensed hospitals to "participate in clinical outcome reporting systems operated by the American College of Cardiology and the Society for Thoracic Surgeons." The proposed rule clearly implements the directive established by the statute. There is no credible evidence that the proposed rule is irrational or that a licensed Level II hospital would be unable to meet the obligations of the rule by requiring that its thoracic surgeons participate in the STS database. Martin Memorial asserts that the requirement that an applicant hospital's chief executive officer attest to compliance with certain guidelines is vague because "it is unclear what guidelines apply and what guidelines will not." The evidence fails to support the assertion. The referenced requirement applicable to a hospital seeking licensure as a Level I facility is set forth at Proposed Rule 59A-3.2085(16)(a)2., which provides as follows: The request [for licensure] shall attest to the hospital’s intent and ability to comply with the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention); including guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. The referenced requirement applicable to a hospital seeking licensure as a Level II facility is set forth at Proposed Rule 59A-3.2085(17)(a)2., which provides as follows: The request [for licensure] shall attest to the hospital’s intent and ability to comply with applicable guidelines in the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-2; in the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention); and in the ACC/AHA 2004 Guideline Update for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery) Developed in Collaboration With the American Association for Thoracic Surgery and the Society of Thoracic Surgeons, including guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Proposed Rule 59A-3.2085(16)(a)6. designates the guidelines applicable to the operation of Level I hospital services. Proposed Rule 59A-3.2085(17)(a) designates the guidelines applicable to the operation of Level II hospital services. The specific elements of the referenced guidelines are identified in both the statute and the proposed rules. Martin Memorial asserts that the proposed rule is vague as to training requirements applicable for physicians performing elective PCI in Level I hospitals. In making the assertion, Martin Memorial references training requirements established at Proposed Rule 59A-3.2085(16)(b)2. and applicable to Level I physicians performing emergent PCI with less than 12 months experience. There is no credible evidence that the proposed rule is vague. Proposed Rule 59A-3.2085(16)(b), in relevant part, provides as follows: Each cardiologist shall be an experienced physician who has performed a minimum of 75 interventional cardiology procedures, exclusive of fellowship training and within the previous 12 months from the date of the Level I adult cardiovascular licensure application or renewal application. Physicians with less than 12 months experience shall fulfill applicable training requirements in the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) prior to being allowed to perform emergency percutaneous coronary interventions in a hospital that is not licensed for a Level II adult cardiovascular services program. The rule provides that a physician with less than 12 months experience working in a Level I facility can perform emergent PCI only if applicable training requirements have been met. The proposed rule does not authorize performance of elective PCI in a Level I hospital by a physician not meeting the minimum annual procedure volume requirements. Proposed Rule 59A-3.2085(17)(b) clearly identifies the requirements applicable to Level II physicians and in relevant part provides as follows: Each cardiac surgeon shall be Board certified. New surgeons shall be Board certified within 4 years after completion of their fellowship. Experienced surgeons with greater than 10 years experience shall document that their training and experience preceded the availability of Board certification. Each cardiologist shall be an experienced physician who has performed a minimum of 75 interventional cardiology procedures, exclusive of fellowship training and within the previous 12 months from the date of the Level II adult cardiovascular licensure application or renewal application. Martin Memorial asserts that the experience requirements set forth at Proposed Rule 59A-3.2085(16)(b)3. (related to Level I hospitals) and Proposed Rule 59A- 3.2085(17)(b)3. (related to Level II hospitals) are arbitrary or capricious. The evidence fails to support the assertion. The text of both proposed rules provides as follows: The nursing and technical catheterization laboratory staff shall be experienced in handling acutely ill patients requiring intervention or balloon pump. Each member of the nursing and technical catheterization laboratory staff shall have at least 500 hours of previous experience in dedicated cardiac interventional laboratories at a hospital with a Level II adult cardiovascular services program. They shall be skilled in all aspects of interventional cardiology equipment, and must participate in a 24-hour-per-day, 365 day-per-year call schedule. Martin Memorial argues that there is no evidence to suggest that 500 hours of experience indicates that appropriate competency levels has been achieved. The evidence establishes that the required experience level was developed by AHCA's hospital licensure unit staff and is the training level currently applicable for hospitals providing emergency PCI services under existing exemptions from CON requirements. The training requirements are not arbitrary or capricious. Martin Memorial asserts that the Proposed Rule 59A-3.2085(16)(c)1. is arbitrary or capricious. The cited rule requires that a Level I hospital make provisions for the transfer of an emergent patient to a Level II hospital, as follows: A hospital provider of Level I adult cardiovascular services program must ensure it has systems in place for the emergent transfer of patients with intra-aortic balloon pump support to one or more hospitals licensed to operate a Level II adult cardiovascular services program. Formalized written transfer agreements developed specifically for emergency PCI patients must be developed with a hospital that operates a Level II adult cardiovascular services program. Written transport protocols must be in place to ensure safe and efficient transfer of a patient within 60 minutes. Transfer time is defined as the number of minutes between the recognition of an emergency as noted in the hospital’s internal log and the patient’s arrival at the receiving hospital. Transfer and transport agreements must be reviewed and tested at least every 3 months, with appropriate documentation maintained. Martin Memorial asserts that the rule is arbitrary or capricious because it does not include a requirement that a Level I hospital make provisions for the transfer of an elective patient to a Level II hospital. There is no credible evidence to support the assertion. There is no evidence that a patient undergoing elective PCI at a Level I would not be regarded as an emergent patient were circumstances such that an emergent transfer to a Level II hospital warranted. There is no credible evidence to suggest a rationale for transferring a non-emergent patient from a Level I to a Level II hospital. Martin Memorial asserts that the proposed rule enlarges, modifies or contravenes the enacting statute on grounds that, although AHCA is directed to adopt rules to ensure compliance "with the most recent guidelines of the American College of Cardiology and American Heart Association Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories," the proposed rule provides that "in case of conflicts between the provisions of this rule and the designated guidelines" the rule provisions "shall prevail." Such provisions appear in Proposed Rule 59A-3.2085(13)(j), Proposed Rule 59A-3.2085(16)(g), and Proposed Rule 59A-3.2085(17)(f). The enacting statute requires that hospitals licensed under the provisions of the proposed rules comply with guidelines "for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety." To the extent that guidelines that relate to elements other than "staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety," the enacting statute does not require compliance by properly- licensed Florida hospitals. Other than as addressed elsewhere herein, the evidence fails to identify any specific conflicts between the guidelines and the proposed rules and, accordingly, fails to establish that the cited proposed rules enlarge, modify or contravene the enacting statute.