The Issue Whether the Respondent properly denied the Petitioner’s request to be a “recognizing agency” within the parameters of Rule 59R-11.001, Florida Administrative Code.
Findings Of Fact Chelation therapy is the introduction of a man-made amino acid into a patient’s vein. It has been approved by the U.S. Food and Drug Administration and is used for the treatment of heavy medal toxicity and the removal of lead. American Board of Chelation Therapy (ABCT) is an autonomous organization that provides education and certification to any physician who wishes to become knowledgeable in Chelation therapy. ABCT was established in 1982 for the purpose of establishing the criteria necessary for certification in the area of Chelation therapy. The Board of Medicine is a statutory entity, established by Chapter 458, Florida Statutes, as the primary regulatory authority for the practice of allopathic medicine in the State of Florida. Pursuant to section 458.301, Florida Statutes, the legislature recognizes that the practice of medicine is potentially dangerous to the public if conducted by unsafe and incompetent practitioners. The section further provides that the primary legislative purpose in enacting the medical practices act is to “ensure that every physician practicing in this state meets minimum requirements for safe practice.” In keeping with the legislative mandate to ensure that purpose of the medical practices act, the legislature created the Board of Medicine and authorized the Board to create administrative rules for the purpose of implementing chapter 458. Rule 59R-11.001, Florida Administrative Code, is the advertising rule of the Board of Medicine.3 The rule codifies provisions of section 458.331(1)(d), Florida Statutes, and provides criteria for identifying false, deceptive, or misleading advertising. In particular, the rule governs advertising on physician letterhead and limits the use of the term “specialist” unless the specialty is recognized by (1) a specialty board of the American Board of Medical Specialties (ABMS) or (2) a board that meets the requirements of Rule 59R-11.001, Florida Administrative Code. For those specialties recognized by organizations that do not meet the requirements of the rule, the physicians may still advertise their specialty so long as they provide a disclaimer. By rule the disclaimer must state the following “The Specialty recognition identified herein has been received from a private organization not affiliated with or recognized by the Florida Board of Medicine.” ABMS is generally recognized in the United States as the agency that approves allopathic medical specialty boards and the Board of Medicine has historically relied upon ABMS and its standards and, as reflected in the current rule, continues to rely on ABMS and its standards for approving recognizing agencies. On July 17, 1995, the Petitioner, ABCT submitted an application to Florida Board of Medicine for the purpose of being certified as a “recognizing agency” pursuant to rule 59R-11.001. ABCT is not a specialty board of the ABMS. Because ABCT is not a member board of the ABMS, the Board of Medicine looked to the requirements of rule 59R- 11.001(2)(f) to determine whether ABCT met the criteria enunciated in the rule and whether it is therefore a “recognizing agency” capable of bestowing specialty status on a physician. Rule 59R-11.001(2)(f), Florida Administrative Code, provides that non-ABMS Boards may seek recognition as “recognizing agencies” if they meet the following criteria: The recognizing agency must be an independent body that certifies members as having advanced qualifications in a particular allopathic medical specialty through peer review demonstrations of competence in the specialty being recognized. Specialty recognition must require completion of an allopathic medical residency program approved by either the Accreditation Council of Graduate Medical Education (ACGME) or the Royal College of Physicians and Surgeons of Canada that includes substantial and identifiable training in the allopathic specialty being recognized. Specialty recognition must require successful completion of a comprehensive examination administered by the recognizing agency pursuant to written procedures that ensure adequate security and appropriate grading standards. The recognizing agency, if it is not an ABMS board, must require as part of its certification requirement that each member receiving certification be currently certified by a specialty board of the ABMS. The recognizing agency must have been determined by the Internal Revenue Service of the United States to be a legitimate not for profit entity pursuant to Section 501 (c) of the Internal Revenue Code. The recognizing agency must have full time administrative staff, housed in dedicated office space which is appropriate for the agency’s program and sufficient for responding to consumer or regulatory inquiries. The recognizing agency must have written by-laws, and a code of ethics to guide the practice of its members and an internal review and control process including budgetary practices, to ensure effective utilization of resources. However, a physician may indicate the service offered and may state that practice is limited to one or more types of services when this is in fact the case; On April 15, 1996, the Board of Medicine issued an order denying the ABCT’s application for specialty status. As basis for the denial, the order stated that the application of the ABCT failed to establish compliance with the requirements for approval as set forth in Rule 59R-11.001(2)(f), Florida Administrative Code. Specifically, the order stated: The requirements for diplomat status in ABCT do not require advanced qualifications in a particular allopathic medicine specialty; specialty recognition given by ABCT does not require completion of an allopathic medical residency program approved by the ACGME or the Royal College of Physicians and Surgeons of Canada that include substantial and identifiable training in the allopathic specialty being recognized; specialty recognition provided by the ABCT does not require successful completion of a comprehensive examination pursuant to written procedures that ensure adequate security and appropriate grading standards in that ABCT requires only a score of 60% to pass the examination, the examination consists of true false questions and answers, and the examination is not a medically comprehensive examination; ABCT is not an ABMS board and does not require that each member it certifies be currently certified by an ABMS board; and ABCT has not provided evidence that it is a legitimate not-for-profit entity pursuant to Section 501(c) of the Internal Revenue Code as determined by the Internal Revenue Service. Each of the requirements of rule 59R-11.001(2)(f) were addressed at the administrative hearing. With regard to criteria (1) of rule 59R-11.001(2)(f), advanced qualifications in a particular allopathic medical specialty through peer review, the ABCT does not require an advanced qualification in a particular allopathic medical specialty. Furthermore, ABCT admitted that it does not meet the requirement of rule 59R-11.001(2)(f)(1). Criteria (2) of rule 59R-11.001(2)(f) provides that the specialty recognition must require completion of an allopathic medical residency program approved by either the Accreditation Council of Graduate Medical Education (ACGME) or the Royal College of Physicians and Surgeons of Canada. The ACGME is generally recognized as the organization that sets criteria for graduate medical education in the United States. The Board of Medicine has incorporated that recognition in the rule by requiring that the advanced education component of the rule be ACGME approved. The Royal College of Physicians and Surgeons of Canada is ACGME’s counterpart in Canada. With regard to criteria (2) of rule 59R-11.001(2)(f), ABCT does not require completion of an allopathic residency program approved by either the ACGME or the Royal College of Physicians and Surgeons of Canada. In fact, ABCT has no requirement for a residency program. ABCT reasoned that a there is no need for a residency program for Chelation therapists because Chelation therapy does not require overnight hospital stay. The only requirement remotely relating to residency is an ABCT requirement that applicants for diplomat status administer a minimum of 1000 Chelation treatments. There is no requirement that these treatments be supervised and no requirement for verification that the minimum number of treatments were administered. With regard to criteria (3) of rule 59R-11.001(2)(f), requiring successful completion of a comprehensive examination, ABCT does not require all applicants for diplomat status to complete a written examination in order to obtain certification. Specifically, some candidates are grandfathered in without being required to complete the written examination. For those applicants that are required to submit to an examination, Dr. Arthur L. Koch testified that the examination is composed of approximately sixty percent true/false questions. In addition, Dr. Koch testified that another ten percent of the test is not medically oriented but rather addresses the history and politics of Chelation therapy in the United States. At the hearing, ABCT submitted its Spring 1994 examination as an exhibit. That examination contained a majority true/false questions and a few multiple choice questions. To pass the ABCT diplomat examination, the candidate is required to achieve a score of 62.5 percent. In contrast, the Board of Medicine generally requires a passing score of at least 75%. The Board of Medicine expressed concern about the low passing score accepted by ABCT on its certification examination. The Board of Medicine also expressed concern over the large number of true/false questions used in the example examination submitted by ABCT. Uncontroverted testimony was presented at the hearing to support a finding that an examination consisting of a majority of true/false questions is not a viable method of testing knowledge. With regard to criteria (4) of rule 59R-11.001(2)(f), requiring members of non-ABMS boards to also be certified by a specialty board of the ABMS, the ABCT does not require that each physician seeking diplomat status be currently certified by an ABMS specialty board. Furthermore, ABCT admitted that it does not meet the requirement of rule 59R-11.001(2)(f)(4). With regard to criteria (5) of rule 59R-11.001(2)(f), that the recognizing agency must be a legitimate not for profit entity under the Internal Revenue Code, evidence was presented to verify that ABCT is a non-profit, tax-exempt organization. With regard to criteria (6) of rule 59R-11.001(2)(f), requiring the recognizing agency to have full-time administrative staff sufficient to respond to consumer or regulatory inquiries, no evidence was presented at the hearing relating to this criteria. With regard to criteria (7) of rule 59R-11.001(2)(f), requiring the recognizing agency to have written by-laws and a code of ethics to guide the practice of its members, ABCT submitted its Constitution and Bylaws as adopted in March of 1982 and subsequently amended. The Constitution and bylaws, however, did not include a written code of ethics and therefore did not fully comply with the requirements of the rule.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that in Case No. 96-3173, the Board of Medicine enter a Final Order denying ABCT’s application for approval as a “recognizing agency” pursuant to Rule 59R-11.001, Florida Administrative Code.DONE and ENTERED this 5th day of June, 1997, at Tallahassee, Florida. WILLIAM A. BUZZETT Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 5th day of June, 1997.
Conclusions THIS CAUSE came before the State of Florida, Agency for Health Care Administration (“the Agency") for the issuance of a final order. 1. On March 10, 2014, Greystone Hospice of District 7B, LLC, (“Greystone”) requested a formal administrative hearing to contest the preliminary denial of Certificate of Need (“CON”) Application No. 10209, which it submitted to establish a hospice program in the Agency Health Planning Service District 7, Hospice Service Area 7B, and to contest the preliminary approval of Halifax Hospice, Inc.’s (“Halifax”) CON Application No. 10210, to Filed May 15, 2014 4:20 PM Division of Administrative Hearings establish a hospice program in Hospice Service Area 7B. 2. The matter was referred to the Division of Administrative Hearings (CDOAH”) where it was assigned Case No. 14-1368CON. 3. On April 1, 2014, Halifax requested a formal administrative hearing challenging the co-batched applications and supporting the Agency’s preliminary approval of Halifax’s CON Application No. 10210, to establish a hospice program in Service Area 7B, and to support the Agency’s preliminary denial of the co-batched application filed by Greystone. 4. The request was referred to DOAH where it was assigned Case No. 14-1472CON. 5. On April 2, 2014, DOAH issued an Order of Consolidation. 6. On April 18, 2014, Greystone filed a Notice of Voluntary Dismissal. It is therefore ORDERED: 7. The denial of Greystone’s CON Application No. 10209 is upheld. 8. The approval of Halifax’s CON Application No. 10210 is upheld subject to the conditions noted in the State Agency Action Report. ORDERED in Taliahassee, Florida, on this ee day of [hae , 2014. ab hb Ductere Elizabeth Dudek, Secretary Agency for Hegfth Care Administration
Other Judicial Opinions A party who is adversely affected by this Final Order is entitled to judicial review, which shall be instituted by filing one copy of a notice of appeal with the Agency Clerk of AHCA, and a second copy, along with filing fee as prescribed by law, with the District Court of Appeal in the appellate district where the Agency maintains its headquarters or where a party resides. Review of proceedings shall be conducted in accordance with the Florida appellate rules. The Notice of Appeal must be filed within 30 days of rendition of the order to be reviewed. Page 2 of 3 CERTIFICATE OF SERVICE I CERTIFY that a true and correct copy of this Final Order was served on the below- —~—” named persons by the method designated on this [Pine Les , 2014. Richard J. Shoop, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop #3 Tallahassee, Florida 32308 (850) 412-3630 W. David Watkins Administrative Law Judge Division of Administrative Hearings (Electronic Mail) Lorraine M. Novak, Esquire Office of the General Counsel Agency for Health Care Administration (Electronic Mail) Stephen A. Ecenia, Esquire Rutledge, Ecenia and Purnell, P.A. Post Office Box 551 Tallahassee, Florida 32302-0551 Steve@reuphlaw.com (Electronic Mail) Seann M. Frazier, Esquire Parker, Hudson, Rainer and Dobbs, LLP 215 South Monroe Street, Suite 750 Tallahassee, Florida 32301 Sfrazier@phrd.com (Electronic Mail) R. David Prescott, Esquire Rutledge, Ecenia and Purnell, P.A. Jonathan L. Rue, Esquire Parker, Hudson, Rainer and Dobbs, LLP Post Office Box 551 285 Peachtree Center Avenue, Suite 1500 Tallahassee, Florida 32302-0551 Atlanta, Georgia 30303 David@reuphlaw.com jrue@phrd.com (Electronic Mail) (Electronic Mail) | Gabriel F.V. Warren, Esquire James McLemore, Supervisor Rutledge, Ecenia and Purnell, P.A. Certificate of Need Unit Post Office Box 551 Agency for Health Care Administration Tallahassee, Florida 32302-0551 (Electronic Mail) Gabriel@reuphlaw.com (Electronic Mail) Page 3 of 3
The Issue The ultimate issue in this case is whether Respondent's proposed repeal of Florida Administrative Code Rule 64C-4.003, which would deregulate certain pediatric cardiac facilities, constitutes an invalid exercise of delegated legislative authority. Before that issue may be reached, however, it is necessary to determine whether Petitioners have standing to challenge the proposed rule.
Findings Of Fact Respondent Department of Health (the "Department") administers the state of Florida's Children's Medical Services ("CMS") program, which provides financial assistance for medically necessary services, similar to the benefits available under Medicaid, to children with special health care needs who meet the program's eligibility requirements. The Department reimburses health care providers for services rendered through the CMS network, a statewide managed system of care in which providers may participate under contract with the program. The Department is responsible for establishing the criteria for selecting health care providers, including both individuals and facilities, to participate in the CMS network. To that end, the Department has adopted Florida Administrative Code Chapter 64C-4, which comprises rule 64C-4.001, entitled "CMS Physician and Non-Physician Providers"; rule 64C-4.002, entitled "Diagnostic and Treatment Facilities or Services – General"; and rule 64C-4.003, entitled "Diagnostic and Treatment Facilities or Services – Specific." Rule 64C-4.003, whose proposed repeal is the subject of this challenge, provides as follows: CMS Pediatric Cardiac Facilities. CMS Headquarters approves pediatric cardiac facilities for the CMS Network on a statewide basis upon consideration of the recommendation of the Cardiac Subcommittee of the CMS Network Advisory Council. CMS approved pediatric cardiac facilities must comply with the CMS Pediatric Cardiac Facilities Standards, October 2012 . . . . CMS approved pediatric cardiac facilities must collect and submit quality assurance data annually [using the prescribed forms]. CMS Cardiac Regional and Satellite Clinics. CMS Headquarters approves regional and satellite cardiac clinics for the CMS Network on a statewide basis upon consideration of the recommendation of the Cardiac Subcommittee of the CMS Network Advisory Council. CMS regional and satellite clinics must comply with the CMS Cardiac Regional and Satellite Clinic Standards, October 2012. . . . The standards and forms are incorporated herein by reference and are available from CMS Headquarters, 4052 Bald Cypress Way, Bin A06, Tallahassee, FL 32399- 1707. (Emphasis added). The CMS Pediatric Cardiac Facilities Standards and the CMS Cardiac Regional and Satellite Clinic Standards are referred to hereinafter, collectively, as the "Standards." For simplicity's sake, as well, the terms "facility," "clinic," and "hospital" are used interchangeably herein as inclusive of all such places within the purview of rule 64C-4.003. On July 29, 2015, a Notice of Proposed Rule was published in volume 41, number 146, of the Florida Administrative Register. The full text of proposed rule 64C- 4.003, as set forth in this notice, is as follows: 64C-4.003 Diagnostic and Treatment Facilities or Services – Specific. Rulemaking Authority 391.026(18), 391.035(1) FS. Law Implemented 391.026(10), 391.035(1) FS. History–New 1-1-77, Amended 2-11-85, Formerly 10J-5.09, 10J-5.009, Amended 12-20-05, 2-12-13, Repealed. The stated purpose of the proposed repeal of rule 64C-4.003 is to "eliminate imposed regulation of pediatric cardiac facilities, which extends beyond the Department's statutory authority." Each Petitioner is a CMS beneficiary who suffers from a serious heart condition requiring pediatric cardiac services. Each Petitioner has received such services through the CMS program from participating CMS providers, including CMS approved pediatric cardiac facilities that currently must comply with the Standards and report quality assurance data annually to the Department in accordance with existing rule 64C-4.003. Each Petitioner's special health care needs make it likely that he or she will require ongoing pediatric cardiac care in the future from CMS approved providers, including the facilities regulated by rule 64C-4.003. Petitioners are concerned that the repeal of rule 64C- 4.003 would reduce the quality of care available within the CMS program and thereby deprive them of a benefit (high quality pediatric cardiac services) to which they, as enrolled CMS beneficiaries, are entitled. Petitioners have failed to prove, however, that the proposed deregulation of CMS approved pediatric cardiac facilities would, in fact, have a real or immediate effect on the quality of care available through the CMS network.
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.
The Issue Whether the Children's Medical Services Network ("CMSN") Clinical Eligibility Screening Guide (Version 12) constitutes an unadopted rule whose existence violates section 120.54(1)(a), because the statement has not been adopted through formal rulemaking procedures.
Findings Of Fact Parties and Statutory Background CMSN is a statewide managed care system for children with special health care needs. CMSN is part of the Children's Medical Services program established by the Department. §§ 391.021 and 391.025, Fla. Stat. Pursuant to section 391.021(2), Florida Statutes: "Children with special health care needs" means those children younger than 21 years of age who have chronic and serious physical, developmental, behavioral, or emotional conditions and who require health care and related services of a type or amount beyond that which is generally required by children. Pursuant to section 391.021(4): "Eligible individual" means a child with a special health care need or a female with a high-risk pregnancy, who meets the financial and medical eligibility standards established in s. 391.029. Section 391.029 provides as follows: 391.029 Program eligibility.-- Eligibility for the Children's Medical Services program is based on the diagnosis of one or more chronic and serious medical conditions and the family's need for specialized services. The following individuals are eligible to receive services through the program: A high-risk pregnant female who is enrolled in Medicaid. Children with serious special health care needs from birth to 21 years of age who are enrolled in Medicaid. Children with serious special health care needs from birth to 19 years of age who are enrolled in a program under Title XXI of the Social Security Act. Subject to the availability of funds, the following individuals may receive services through the program: Children with serious special health care needs from birth to 21 years of age who do not qualify for Medicaid or Title XXI of the Social Security Act but who are unable to access, due to lack of providers or lack of financial resources, specialized services that are medically necessary or essential family support services. Families shall participate financially in the cost of care based on a sliding fee scale established by the department. Children with special health care needs from birth to 21 years of age, as provided in Title V of the Social Security Act. An infant who receives an award of compensation under s. 766.31(1). The Florida Birth-Related Neurological Injury Compensation Association shall reimburse the Children's Medical Services Network the state's share of funding, which must thereafter be used to obtain matching federal funds under Title XXI of the Social Security Act. Any child who has been provided with surgical or medical care or treatment under this act prior to being adopted and has serious and chronic special health needs shall continue to be eligible to be provided with such care or treatment after his or her adoption, regardless of the financial ability of the persons adopting the child. Medicaid is the medical assistance program that provides access to health care for low-income families and individuals. The Agency for Health Care Administration ("AHCA") is responsible for administering the Medicaid program in Florida. §§ 409.901(2), 409.902, and 409.963, Fla. Stat. Petitioners are Medicaid-eligible minor children who have been enrolled in the CMSN. In 1993, the Florida Legislature passed legislation declaring its intent that the Medicaid program require, to the maximum extent practicable and permitted by federal law, that all Medicaid recipients be enrolled in a managed care program. This intent language was codified in section 409.9121, Florida Statutes, and has remained in effect and unchanged since 1993. In 2011, the Florida Legislature created Part IV of chapter 409, Florida Statutes (codified as sections 409.961 through 409.9841), and directed AHCA to create a statewide, integrated managed care program for all covered services under the Medicaid program, including long-term care services. § 409.964, Fla. Stat. The statewide Medicaid managed care program includes the long-term managed care program and the managed medical assistance program. The law directed AHCA to begin implementation of the long-term care managed care program by July 1, 2012, with full implementation in all regions of the state by October 1, 2013. § 409.978, Fla. Stat. By January 1, 2013, AHCA was required to begin implementing the managed medical assistance program, with full implementation in all regions of the state by October 1, 2014. § 409.971, Fla. Stat. Services in the Medicaid managed care program are provided by eligible plans. § 409.966(1), Fla. Stat. An "eligible plan" means "a health insurer authorized under chapter 624, an exclusive provider organization authorized under chapter 627, a health maintenance organization authorized under chapter 641, a provider service network authorized under s. 409.912(2), or an accountable care organization authorized under federal law." § 409.962(6), Fla. Stat. For purposes of the managed medical assistance program, the term "eligible plan" also includes "the Children's Medical Services Network authorized under chapter 391." Id. Pursuant to sections 409.966 and 409.974(1), AHCA selects a limited number of eligible plans to participate in the Medicaid program using invitations to negotiate. Once selected, the eligible plan becomes a "managed care plan" in the Medicaid program. § 409.962(9), Fla. Stat. (defining "managed care plan" to mean "an eligible plan under contract with [AHCA] to provide services in the Medicaid program"). Managed care plans include "specialty plans" that serve "Medicaid recipients who meet specified criteria based on age, medical condition, or diagnosis." § 409.962(14), Fla. Stat. AHCA is required to enter into a five-year contract with each managed care plan selected through the procurement process. § 409.967(1), Fla. Stat. The Legislature granted AHCA statutory authority to "establish such contract requirements as are necessary for the operation of the statewide managed care program." § 409.967(2), Fla. Stat. AHCA's contracts with the managed care plans must contain the statutorily required provisions outlined in section 409.967(2)(a) through (m), as well as "any other provisions [AHCA] may deem necessary." § 409.967(2), Fla. Stat. Part IV of chapter 409 requires all Medicaid recipients to enroll in a managed care plan, unless they are specifically exempted. § 409.969, Fla. Stat. The law requires Medicaid recipients to have a choice of available plans, unless the plan is restricted by contract to a specific population that does not include the recipient. § 409.969(1), Fla. Stat. Pursuant to s ection 409.974(4), CMSN's participation in the Medicaid managed care program "shall be pursuant to a single, statewide contract with [AHCA] that is not subject to the procurement requirements or regional plan number limits of this section. The [CMSN] must meet all other plan requirements for the managed medical assistance program." The Department's Contract with AHCA In accordance with s ection 409.974(4), the Florida Department of Health, Children's Medical Services, entered into AHCA Contract No. FP031 ("Contract") to serve children with special health care needs through the CMSN Plan. The Contract and its attachments, as referenced in the Contract, contain all the terms and conditions agreed upon by the parties. Section III of Attachment I to the Contract addresses eligibility and enrollment in the CMSN Plan. Section III(B)2. of Attachment 1 to the Contract, provides as follows: 2. Enrollment in the CMSN Plan as a Specialty Plan Specialty Population Identification The [AHCA] shall identify the specialty population eligible for enrollment in the CMSN Plan based on the nightly (Monday through Friday) electronic eligibility data from DOH. The CMSN Plan shall ensure that only the following children are submitted to [AHCA] as children with chronic conditions: Children identified by DOH as having met the clinical criteria specified through an [AHCA]-approved clinical screening tool or having met the clinical criteria for enrollment in another Children's Medical Services program provided the [ACHA] has approved the enrollment criteria as appropriate for enrollment in the CMSN Plan. If a recipient is enrolled in Medicaid under an SSI eligibility assistance category, DOH shall ensure that the clinical screening is still performed for enrollment in the CMSN Plan. The clinical screening must be completed in full and cannot be waived. The agency shall update FMMIS to indicate recipient eligibility for the CMSN Plan on the penultimate Saturday of each month. Plan-Specific Verification and Eligibility The CMSN Plan shall have policies and procedures, subject to [AHCA] approval, to verify the eligibility criteria of each enrolled recipient. The CMSN Plan shall submit policies and procedures regarding screening for clinical eligibility prior to implementation of such policies and procedures and any changes in the [AHCA]-approved clinical screening tool. The DOH shall submit its clinical screening tool and referral policies and procedures for review by the [AHCA] by April 1 of each year. If no changes have been made to the screening tool or the referral policies and procedures, DOH shall include a statement to that effect. Policies and procedures regarding screening for clinical eligibility must include: Timeframes for verification of clinical eligibility criteria; Mechanisms for reporting the results of the clinical eligibility screening to the [AHCA]; Mechanisms for submitting disenrollment requests for enrollees that do not meet specialty population eligibility criteria; and Such other verifications, protocols, or mechanisms as may be required by the [AHCA] to ensure enrolled recipients meet defined eligibility criteria. The Department's CMSN Clinical Eligibility Screening Guide (Version 12) The subject of this proceeding is Joint Exhibit No. 5: CMSN Clinical Eligibility Screening Guide (Version 12)("Screening Tool"). The Department created the Screening Tool to ensure that children enrolled in the CMSN Plan meet the clinical criteria for participation in the plan. CMSN submitted the Screening Tool to AHCA for approval, and it was approved for use pursuant to the Contract. The Screening Tool became effective subsequent to the effective date of Section III of Attachment 1 to the Contract. The Screening Tool does not reference the Contract, and the Screening Tool is not part of the Contract. The Department began using the Screening Tool in May 2015. Pursuant to the Contract, all 77,990 current participants and all potential participants in the CMSN Plan must be screened to determine their clinical eligibility for the CMSN Plan using the Screening Tool. All Petitioners in this proceeding have been screened through use of the Screening Tool. Respondent stipulates that each Petitioner has standing to bring this proceeding. CMSN nurse care coordinators have called parents of children who participate in the CMSN Plan and have asked those parents the questions in the Screening Tool to determine their CMSN eligibility. The Screening Tool is the primary screening tool used to determine clinical eligibility, and the questions in the Screening Tool are not to be altered or amended in any way by the nurse care coordinators. In determining CMSN clinical eligibility, a "[p]arent/guardian must answer yes to all parts of question 3 (functional limitations and chronicity) . . . AND [a] [p]arent/guardian must answer yes to all parts of at least one other question (dependency or service usage and chronicity)." Following the screening of Petitioners, a CMSN nurse care coordinator orally informed Petitioners' parents about their child's continued eligibility based on the responses to the Screening Tool. Since the implementation of the Screening Tool, at least 5,922 children have been determined to be clinically ineligible for the CMSN Managed Medical Assistance specialty plan. The Screening Tool does not contain any language that instructs nurse care coordinators to orally inform the parents of the option to have an additional screening tool. The Screening Tool has not been adopted by the Department as a rule pursuant to section 120.54. No evidence was presented that rulemaking is not feasible or practicable.
The Issue Whether Petitioner meets the requirements for licensure as a Health Care Risk Manager?
Findings Of Fact AHCA is the agency responsible for the licensing and regulation of Health Care Risk Managers in Florida pursuant to sections 395.0971 through 395.0975, Florida Statutes. Petitioner holds a Master of Science Administration from the University of West Florida and is licensed in the state of Florida as a Clinical Laboratory Supervisor. Petitioner filed an application for licensure with AHCA as a Health Care Risk Manager on May 11, 2011. The application was reviewed by Mark Hajdukiewicz, a Health Services and Facilities Consultant employed by AHCA. Section 6 of the application entitled "Qualifications for Licensure" states: "In the appropriate section below, check all of the applicable criteria. Complete only one section." The "sections" on the application are ways or approaches from which an applicant may choose to demonstrate his or her qualifications for licensure as a Health Care Risk Manager. On this initial application, Petitioner completed three sections. By letter dated June 2, 2011 (the Omissions Letter), Mr. Hajdukiewicz notified Petitioner that AHCA received her initial application and, after review, found it to be incomplete. The Omissions Letter further stated: Select one approach to licensure. Resubmit amended pages 4 and 5 of the Health Care Licensing Application form RM-001, Revised 12/2010. Evidence of credentials as a Health Care Administrator as defined in Rule 59A- 10.032(14), F.A.C. An official transcript submitted from the college that satisfies the above rule. The Agency has received the 120 hours certificate. Or Evidence of credentials as a Health Care Professional as defined in Rule 59A- 10.032(15), F.A.C. The application has license SU 3074, a Clinical Laboratory Supervisor, unfortunately that license does not meet the Rule requirements. The Agency has received the 120 hours certificate. Or Official transcripts that include coursework which meets two years of college level studies pursuant to Rule 59A-10.035, F.A.C. Please send the required information no later than 21 days from the receipt of this letter. If the applicant fails to submit all the information required in the application within 21 days of being notified by AHCA of the omissions, the application will be denied and the fees shall be forfeited pursuant to subsection 408.806(3)(b), Florida Statutes. (emphasis in original) Petitioner submitted a revised section 6 of her application on or about June 23, 2011. On this revised portion of her application, Petitioner elected to seek licensure based upon her credentials as a Health Care Administrator as defined in Florida Administrative Code Rule 59A-10.032(14). Petitioner also submitted a copy of her transcript for a Master of Science Administration from the University of West Florida. Mr. Hajdukiewicz reviewed Petitioner's revised application and determined that the documentation submitted by Petitioner in support of her application did not meet the criteria set forth in rule 59A-10.032(14), which defines a health care administrator. Mr. Hajdukiewicz forwarded a recommendation that the application be deemed incomplete to his supervisor, Laura MacLafferty. Ms. MacLafferty concurred with Mr. Hajdukiewicz's recommendation and issued the Notice of Intent to Deem Application Incomplete and Withdrawn from Further Review. Subsequently, Petitioner submitted a copy of her transcript reflecting the curriculum for her master's degree program from the University of West Florida. Although, as a transcript copy, it was extremely difficult to read, Ms. MacLafferty reviewed the curriculum and determined that it was insufficient to warrant reversal of the Agency's decision. At hearing, Petitioner acknowledged that her degree does not say "hospital" as specified in rule 59A-10.032(14) (i.e., hospital administration, hospital finance, hospital management). As Petitioner elected to qualify for licensure pursuant to demonstrating attainment of credentials as a Health Care Administrator as defined in rule 59A-10.032(14), her application was not evaluated pursuant to the other possible ways of demonstrating qualifications for licensure.1/
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law set forth herein, it is RECOMMENDED: That the Agency for Health Care Administration enter a final order denying Petitioner's application for licensure as a Health Care Risk Manager, without prejudice to reapply under the other criteria specified in Florida Administrative Code Rules 59A-10.032(15) and 59A-10.035, and section 6 of the licensure application form. DONE AND ENTERED this 8th day of November, 2011, in Tallahassee, Leon County, Florida. S BARBARA J. STAROS 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 8th day of November, 2011.
The Issue The issue to be determined in this bid protest matter is whether Respondent Department of Health’s (DOH or the Department) intended award of the contract arising out of Invitation to Negotiate No. DOH-17-026 (ITN) for the Children’s Medical Services Managed Care Plan (CMS Plan) to Intervenor Wellcare of Florida, Inc., d/b/a Staywell Health Plan (Staywell), was contrary to its governing statutes, rules, or the solicitation specifications.
Findings Of Fact In 2011, the Florida Legislature created part IV of chapter 409, Florida Statutes, titled “Medicaid Managed Care.” See ch. 2011-134, Laws of Fla.; §§ 409.961 – 409.985, Fla. Stat. In so doing, the Florida Legislature designated the Agency for Health Care Administration (AHCA) as the single state agency authorized to make payments under Title XIX of the Social Security Act. § 409.902(1), Fla. Stat.; see also 42 U.S.C. § 1396-1396v. The Florida Legislature established the Children’s Medical Services Program to “[p]rovide to children with special health care needs a family-centered, comprehensive, and coordinated statewide managed system of care that links community-based health care with multidisciplinary, regional, and tertiary pediatric specialty care.” § 391.016(1), Fla. Stat.6/ The Department oversees and operates the Children Medical Services Network, a statewide managed care service system that includes health care providers. See §§ 391.021(1) and 391.026(8), Fla. Stat. The Department also operates the CMS Plan, which serves approximately 62,000 children with special healthcare needs who are eligible for Medicaid and the Children’s Health Insurance Program under Title XIX and Title XXI of the Social Security Act. The Department operates the CMS Plan under a contract between the Department and AHCA (the Prime Contract), which is part of AHCA’s Statewide Medicaid Managed Care Program (SMMC). Under the Prime Contract, the Department performs certain functions, including care coordination and clinical eligibility determinations. The Department subcontracts out other functions to two integrated care system subcontractors, CCP and Ped-I-Care. CCP and Ped-I-Care provide member services, utilization management, and service authorizations, and contract with medical network providers to deliver services in the areas of the state for which they are responsible. CCP is a provider services network (PSN) owned by the North Broward Hospital District and the South Broward Hospital District.7/ Currently, CCP is the exclusive subcontractor for CMS member services for the state of Florida south of the Interstate 4 (I-4) corridor. Ped-I-Care is the exclusive subcontractor for the portion of the state north of the I-4 corridor. INVITATION TO NEGOTIATE DOH 17-026 On January 20, 2018, the Department issued the ITN for the CMS Plan. On February 28, 2018, the Department issued Addendum 1 to the ITN, which replaced the original ITN in its entirety. Thereafter, the Department issued four additional addenda to the ITN. Cheryl Young, the director and chief executive officer of the CMS Plan, testified that the ITN contemplated a “new” or “improved” healthcare model, after soliciting public input from stakeholders, families, and providers in three public meetings. Ms. Young further testified that the Department engaged with national experts for input on developing health service systems for medically complex patients. Ms. Young also testified that the Department spoke with its 41 medical directors, as well as the Florida Legislature, concerning this healthcare model. Ms. Young testified that the Department’s intention in the ITN was “to help families navigate a complicated healthcare system.” She further stated that “instead of incentivizing fee- for-services payments or where providers get paid, a model where providers are paid for quantity, we wanted to move to a value- based care with the rest of the nation where quality and improved health outcomes for families were incentivized in the model.” Ultimately, under this “new” model contemplated in the ITN, instead of paying network providers a fee-for-service rate (as the Department did under the current CMS Plan), the vendor would receive a per-member per-month capitation rate and have flexibility to negotiate payment of network providers to incentivize overall health outcome goals. Under the “new” model contemplated in the ITN, the Department would subcontract its care coordination function, but the Department’s other previously existing functions with respect to the CMS Plan, including clinical eligibility determinations, would remain the responsibility of the Department. Section 3.3 of the ITN, titled “Specific Goals,” stated: The Department intends to award one state- wide Contract to a Respondent to assist with the administration of the CMS Plan. The Department will award additional contracts only if there is no acceptable state-wide Respondent for all areas of the state. The Department reserves the right to award more than one contract based on regional clusters. Respondents may propose more than one contract based on regional clusters. Respondents may propose statewide or on a regional cluster with either a full risk model or a phased in risk model. Respondents may opt to be full risk in one or two regional clusters and partial risk in others and may submit a statewide and regional cluster reply simultaneously. The ITN identified the “regional clusters” as follows: Northern Florida-AHCA Regions 1-4; Central/Southwestern Florida– AHCA Regions 5-8; and South/Southeastern Florida-AHCA Regions 9-11. Section 3.3 of the ITN further stated: Respondent should offer comprehensive, quality-driven provider networks, streamlined processes that enhance the enrollee and provider experience, expanded benefits targeted to improve outcomes for enrollees, top quality scores, and high rates of enrollee satisfaction to deliver an efficient, high-quality, innovative, cost- effective, and integrated health care delivery model. Additionally, section 3.3 of the ITN stated that the Department intended to award a contract to a Respondent that offers “innovative and evidence-based approaches” in meeting certain requirements set forth in Attachment A-2, Core Provisions, while addressing the following goals under the CMS Plan: Reduce potentially preventable inpatient and outpatient hospital events, and unnecessary ancillary services; Culturally competent, linguistically appropriate, family centered and participant driven care; and Care that is evidence based, where possible and evidence-informed or based on promising practice when evidence-based approaches are not available. Section 3.4 of the ITN, titled “Legal Authority,” stated: Children’s Medical Services Managed Care Plan (CMS Plan, [sic] a Medicaid specialty plan for children with chronic conditions operated by the Department, as further defined in Chapter 391, Chapter 409, Parts II and IV, including section 409.974(4), Florida Statutes, through the AHCA Prime Contract. The ITN instructed Respondents to submit replies through completing Attachment A-1 to the ITN. The ITN stated that the Department “would evaluate and score replies to establish a reference point from which to make negotiation decisions.” After negotiations, the Department would “award [a contract] to the responsible, responsive Respondent determined to provide the best value, based upon the negotiations.” “Criteria #1-Statewide or Regional Reply,” found in Attachment A-1 to the ITN, directly requested whether a Respondent’s reply was statewide or for a regional cluster, the priority of the reply, and whether the reply was risk or non- risk. Attachment A-1 to the ITN requested replies to a total of 57 criteria. Additionally, it requested that Respondents provide a cost reply, provided that the Department would “review and consider the cost replies submitted by Respondents who are invited to negotiations during the negotiation phase[,]” and stated that during negotiations, the Department would evaluate the cost reply “utilizing rates determined by state of Florida actuaries as part of the total reply by the Respondent.” The ITN allowed a prospective Respondent to submit written questions to the Department concerning the ITN prior to submitting replies. For example, Addendum 2 to the ITN was a partial response to questions the Department received on February 21, 2018. Addendum 3 to the ITN was a final response to questions the Department received on February 21, 2018, as well as additional questions the Department received on March 7, 2018.8/ In Question 28 of Addendum 2 to the ITN, CCP asked, and the Department answered, as follows: Q28) 3.3 Specific Goals: The Department intends to award one state-wide Contract to a Respondent to assist with the administration of the CMS Plan. The Department will award additional contracts only if there is no acceptable state-wide Respondent for all areas of the state. If a Respondent in a regional cluster submission outperforms a Respondent in a statewide submission, or otherwise presents efficiencies or other quality advantages to the Department, will the Department retain the discretion to award a regional cluster in lieu of, or in addition to, an acceptable statewide award? A28) Additional points/preference will be given to state-wide bids regardless of risk type. The Department will award contracts by Regional Cluster only if there is no acceptable state-wide Respondent for all areas of the state. The Department reserves the right to award a contract for multiple regional clusters in that instance, or if necessary, a single contract for each regional cluster. In Question 33 of Addendum 2 to the ITN, CCP asked, and the Department answered, as follows: Q33) Criteria 1 Does a Respondent get extra points for each cluster in which it proposes to assume full risk as opposed to proposing as risk phase alternative? A33) Additional points/preference will be given to state-wide bids regardless of risk type. The Department will award contracts by Regional Cluster only if there is no acceptable state-wide Respondent for all areas of the state. The Department reserves the right to award a contract for multiple regional clusters in that instance, or if necessary, a single contract for each regional cluster. As noted in the Evaluation Criteria for #1, additional points are awarded to regional bids on an at-risk basis over regional bids on a non-risk basis. In Question 159 of Addendum 3 to the ITN, CCP asked, and the Department answered, as follows: Q159) Qualification of Respondent Eligibility What is the minimum and maximum number of Plans required per cluster to be awarded? A159) Only one Respondent will be selected per cluster with preference given to Respondents with statewide and multiple cluster proposals. In Question 162 of Addendum 3 to the ITN, CCP asked, and the Department answered, as follows: Q162) PSN Certification Assuming, there is a PSN preference, will there be a minimum or maximum number of PSNs required per cluster? A162) Only one Respondent will be selected per cluster with preference given to Respondents with statewide and multiple cluster proposals. The undersigned finds that the ITN clearly stated that the Department intended to award a single, statewide contract to a single Respondent. The Department answered questions in Addenda 2 and 3 to the ITN that consistently and unambiguously restated this preference for a single, statewide contract to a single Respondent. The ITN further clearly stated that it would award contracts to Respondents with regional cluster proposals if there was no acceptable statewide Respondent. The ITN is silent as to whether the Department would apply a preference for a PSN. In addition to Question 162 to Addendum 3 to the ITN (quoted in paragraph 25, supra), in Question 161 of Addendum 3 to the ITN, CCP asked, and the Department answered, as follows: Q161) PSN Certification Per 609-974(1) [sic] and 409.966, F.S. will the Department apply the PSN preference in the selection process? A161) Requirements are reflected in the ITN. The undersigned finds that the ITN makes no provision for the application of a PSN preference, and that Addendum 3 makes clear that the Department intentionally omitted a PSN preference in the ITN. CCP did not timely protest the specifications in the ITN or any of the Addenda pursuant to section 120.57(3). EVALUATION The Department received replies to the ITN from three Respondents prior to the 3:00 p.m., April 27, 2018, deadline: Staywell; (b) Sunshine; and (c) CCP. Staywell and Sunshine both proposed to enter into a statewide contract with the Department. CCP proposed to enter into a contract for the South/Southeastern Regional Cluster--AHCA Regions 9 through 11-- with the Department.9/ The Department found that the replies from Staywell, Sunshine, and CCP were responsive and responsible. The Department appointed five evaluators to evaluate the replies (evaluation team): (a) Dr. John Curran; Dr. Steven Freedman; (c) Dr. Dennis Kuo; (d) Andrea Gary, the Department’s bureau chief of CMS Plan Administration; and (e) Kelli Stannard, the Department’s director of Clinical Operations and Specialty Programs for CMS. Members of the evaluation team received training, in the form of a power point presentation, that instructed them on the evaluation of the ITN. This training material, inter alia, instructed the evaluation team to evaluate each Respondent’s reply pursuant to section 287.057, Florida Statutes, as well as the criteria contained in the ITN. As provided in the ITN, the point value awarded for a statewide response was worth a maximum of 100 raw points and 200 weighted points, out of a total weighted score of 4,513. The evaluation team scored the replies as follows: (a) Staywell – 3,565.20 points; (b) Sunshine – 3,370.40 points; and (c) CCP – 2,843.20 points. The Department invited all three Respondents to negotiate. As Ms. Young testified: We invited all three respondents because going into negotiations we did not know if we would be able to successfully negotiate with a statewide vendor, so we wanted to have all three at the table and make the same asks of all of them related to the important service delivery components set forth in the ITN and other matters. NEGOTIATIONS The Department appointed seven negotiators to negotiate with the Respondents (negotiation team): (a) Andrea Gary, who served on the evaluation team; (b) Kelli Stannard, who also served on the evaluation team; (c) Cheryl Young; (d) Michele Tallent, the Department’s deputy secretary for Operations; (e) Antonio Dawkins, the Department’s director of Contracts and a Florida-Certified Project Management Professional10/; (f) Stacey Lampkin, a nonvoting member who is an actuary with Mercer Health and Benefits, LLC; and (g) Tom Dahl, a nonvoting member who is an actuary with Mercer Health and Benefits, LLC. Members of the negotiation team received training, in the form of the PowerPoint presentation that the evaluation team also received, that instructed them on their responsibilities as negotiators. The scoring and ranking from the evaluation team did not carry over into the negotiations. Ms. Gary and Ms. Stannard, who also served as members of the evaluation team, testified that they knew only their scores and had no knowledge of the aggregate scores or ranking from the evaluation team. The ITN contained “notes” under various evaluation criteria that stated: Note: Pursuant to section 409.966(3)(c)6., Florida Statutes, reply to this submission requirement will be considered for negotiations. Section 409.966(3)(c)6., which is part of the “Medicaid Managed Care” provisions of Florida’s Medicaid law, and which governs AHCA as the designated single state agency authorized to make payments for medical assistance and related services under Title XIX of the Social Security Act, is not applicable to the Department. Ms. Young testified that these notes in the ITN were typographical errors because the Department is exempt from AHCA’s competitive procurement process. The undersigned finds Ms. Young’s explanation persuasive. See § 409.974(4), Fla. Stat. (“Participation by the Children’s Medical Services Network shall be pursuant to a single, statewide contract with [AHCA] that is not subject to the procurement requirements or regional plan number limits of this section.”). The negotiation team met prior to negotiating with any of the Respondents in a “strategy session” to discuss how they would approach the negotiations. The negotiation team discussed what tools they would use to gather information on what they deemed the best value criteria and outlined a schedule. During this strategy session, the negotiation team developed a document, titled “Best Value Criteria,” which was also referred to throughout this proceeding as the “Best Value Matrix.” As CCP has contended that the Department acted in an arbitrary and capricious manner by its use, and revision, of the best value matrix, its origin and development are set forth below. Ms. Trahan, the Department’s procurement officer for the ITN, testified that, prior to negotiations, she communicated with Ms. Young (and others) via e-mail to provide a document they referred to as the “negotiation topics tool” that Ms. Trahan had recommended to use for this ITN. Ms. Trahan testified that the “negotiation topics tool” was a template that the Department previously used in its procurements. Ms. Trahan testified that she prepared a template that incorporated criteria from the ITN, with space for the negotiators to make notes. In this same e-mail, Ms. Trahan also stated that she would request a best value matrix from AHCA. The best value matrix is a document that differs from the negotiation topics tool. Ms. Young testified that she asked AHCA and other agencies, during planning meetings related to the ITN, about best value matrices that those agencies used during procurements. In particular, Ms. Young stated that she discussed with AHCA the process for negotiating numerous items related to serving applicable populations served by the SMMC and wanted to include those items in the Department’s negotiations with potential vendors, so those vendors would be aware of these items. Additionally, as these items would become components of the new contract, Ms. Young testified that she wanted to review AHCA’s best value matrix template. Ms. Young testified that, while drafting the best value matrix, she did not include criteria contained in section 409.966. Ms. Young testified that section 409.966, which governs AHCA procurements, did not apply to the Department, which is statutorily exempt from AHCA’s procurement requirements. As similarly stated in paragraph 42, supra, the undersigned finds Ms. Young’s testimony persuasive. See § 409.974(4), Fla. Stat. (“Participation by the Children’s Medical Services Network shall be pursuant to a single, statewide contract with [AHCA] that is not subject to the procurement requirements or regional plan number limits of this section.”). Accordingly, the Department’s decision to not use the criteria in section 409.966 in the best value matrix is logical and supported by the statute, and its reference in the ITN was an error and of no consequence in the evaluation or negotiation of the Respondents’ proposals. The best value matrix changed as the Department moved through the negotiation process. The initial best value matrix contained over 200 items, and the final version that the evaluation team used and completed contained 54 items. The items contained in the best value matrix matched the criteria in the ITN. During the negotiations, the negotiation team removed items from the best value matrix that were nonnegotiable and that all Respondents had agreed to. The best value matrix contains a column for each Respondent who responded to the ITN. It also contains rows that provide categories, and items, that matched the criteria from the ITN. The negotiation team placed an “X” in the column for each Respondent who met the particular criteria from the ITN. The negotiation team did not place an “X” in the column if a Respondent did not meet a particular criteria from the ITN. The best value matrix ultimately tallied the overall number of “Xs” each Respondent received from the negotiation team. CCP argues that the Department did not disclose to CCP its use of the best value matrix during negotiations, and that the best value matrix contained criteria not disclosed in the ITN. The negotiation team developed the best value matrix to assist it in the negotiations phase. It did not contain a new set of criteria separate and apart from the ITN. The items listed in the best value matrix all came from the criteria in the ITN. The Department gave all Respondents the opportunity to provide information to the negotiation team and afforded equal amounts of time and opportunities to meet with the negotiation team. The negotiation team held two negotiation meetings with each Respondent. The negotiation team first held in-person negotiation meetings with Sunshine, Staywell, and CCP on June 11, 12, and 13, 2018, respectively. At its first negotiation meeting on June 13, 2018, CCP submitted to the negotiation team a document, titled “CMS Additional Offerings to the Department.” This document listed a variety of additional items and incentives that CCP proposed to provide if selected. At the final hearing, Ms. Lerner, the executive vice president and chief operating officer of CCP, confirmed that CCP presented this document to the Department to demonstrate its willingness to provide “additional offerings” that included items not required in the ITN. Ms. Lerner further testified that CCP presented this document for the Department’s consideration of “additional benefits criteria.” Following the in-person negotiation meetings with each Respondent, the negotiation team met alone and held additional strategy sessions to discuss information received from Respondents and to determine additional information it wanted to request from Respondents. The negotiation team thereafter requested that each Respondent provide clarifications regarding their replies and additional information based on discussions during negotiations. All three Respondents submitted this additional information that the negotiation team requested. The Department also required the Respondents to submit revised cost replies, including an updated actuarial memorandum. All three Respondents submitted the revised cost replies with an updated actuarial memorandum that the negotiation team requested. Staywell’s cost reply submission contained an updated actuarial memorandum that its in-house actuary completed and certified. Attachment D to the ITN, titled “Cost Reply Instructions,” and more specifically, subsection 3, titled “Actuarial Memorandum Requirements,” provides the ITN’s requirements for this submission. After reviewing Attachment D, the undersigned notes the ITN did not require that an independent actuary certify the actuarial memorandum. The negotiation team held a second round of negotiation meetings with the Respondents, via telephone conference call, on June 18, 2018. As part of these second negotiation meetings, the Department provided each Respondent with a document, titled “DOH 17-026 CMS Managed Care Plan Negotiation Topics,” which set forth the rates the Department requested the Respondents use, as well as the contract terms the Department required of the Respondents in order for the Department to consider them for the contract award. The Department asked each Respondent to complete and return this document, indicating whether it agreed or whether it was submitting a counteroffer to the items that were negotiable. CCP agreed to all of the items that the Department requested, including the proposed rates. Staywell agreed to all of the items that the Department requested, including the proposed rates, and offered an enhanced primary care provider ratio. Sunshine submitted counteroffers for several items. The rates that CCP and Staywell agreed to for the South/Southeastern Regional Cluster, AHCA Regions 9-11, were the same. BEST VALUE DETERMINATION AND INTENDED AWARD On June 25, 2018, the negotiation team met for a final time to review the information that the Respondents submitted following the second round of negotiations. At that meeting, the negotiation team finalized the best value matrix, and then proceeded to put an “X” in a Respondent’s column that corresponded to each item (criteria from the ITN) if the Respondent had addressed the item to the negotiation team’s satisfaction. An “X” did not represent a “point” that the negotiation team awarded. The best value matrix, which was a spreadsheet, calculated the number of “Xs” (of the 54 possible) for each Respondent, with Staywell totaling 53, CCP totaling 46, and Sunshine totaling 43. CCP contends that the best value matrix incorporated criteria that were not contained in the ITN--“added value.” CCP contends that the negotiation team’s use of the “added value” criteria was an arbitrary and capricious means to take points away from CCP. Ms. Young testified that “added value” meant that an item was “important to the negotiating team” that was “not consequential” and which did not provide any extra weight to the negotiation process. Ms. Tallent testified that “added value” meant “an item that the team felt added value to the lives of the children and their families[,]” that had “no additional scoring to it.” As stated in paragraph 55, supra, CCP submitted to the negotiation team during the in-person negotiation meeting a document titled “CMS Additional Offerings to the Department.” This document listed a variety of additional items and incentives that CCP proposed to provide if selected. The undersigned finds that the Department did not apply the concept of “added value” in an arbitrary and capricious manner. Rather, the Department’s witnesses credibly testified that “added value” simply reflected the negotiation team’s belief that certain items in the best value matrix (which were ITN criteria) were important. CCP provided the negotiation team with its “CMS Additional Offerings to the Department” that included items CCP hoped the negotiation team would consider. CCP’s argument that the Department considered “added value” as an additional undisclosed criteria, when it submitted a document with “additional offerings” it hoped the negotiation team would consider, is unavailing and unpersuasive. CCP further contends that the negotiation team should have credited it with an “X” for certain items in the best value matrix where it received no “X.” These contentions will be dealt with in the following paragraphs. Care coordination experience relevant to medically complex/CMS comparable employees/added value. Dr. Venereo, CCP’s senior vice president and chief medical officer, testified that CCP was aware of this criteria from the ITN, and addressed it in its response. He testified as follows: We drew upon our experience basically in two lines of business. We currently assist CMS care coordination program because we do utilization management for CMS, and care coordination and utilization management go hand in hand. There is a lot of compatibility and interaction, so we assist CMS in that. We also have a proportionately high number of complex children in our MMA line of business. However, on cross-examination, Dr. Venereo admitted that CCP does not currently provide care coordination under its contract with the Department, and that under its Medicaid Managed Assistance (MMA) contract with AHCA, only provides care coordination in Broward County. The undersigned finds that the Department’s decision to not award an “X” to CCP for this category was neither arbitrary nor capricious.11/ Inclusion of community specific resources available to care coordination and care management and enrollees, including but not limited to Medicaid/CHIP financial eligibility, SNAP, WIC utility payment assistance, referrals to Legal Aid, parenting/wellness classes. Mr. Mink, the chief information officer for CCP, testified that CCP was aware of this criteria, and addressed it in its response. Mr. Mink testified that while CCP certainly addressed some of the resources necessary for this criteria, other resources were not in place during the time of negotiations. For example, Mr. Mink testified that at the time of negotiations, enrollees could not directly access CCP’s Family Resource Database, but that CCP was negotiating a contract with “Aunt Bertha”--a community-based referral platform--to allow access to the database. Ms. Lerner, the Executive Vice President and Chief Operating Officer of CCP, testified that CCP did not have a web page in place at the time CCP was in negotiations that addressed all of the items in this criteria. The undersigned finds that the Department’s decision to not award an “X” to CCP for this category was neither arbitrary nor capricious.12/ Providing additional services above and beyond transition from institutions. Ms. Lerner testified that CCP was aware of this criteria, and addressed it in its response. Ms. Lerner testified, and the undersigned’s review of CCP’s response to this criteria demonstrated, that CCP’s response was that “CCP agrees to provide additional services above and beyond transition from institutions for those services deemed medically necessary.” Further, CCP’s response references its detailed response to evaluation criteria 7, concerning its Disease Management Program. Given CCP’s unremarkable response to this criteria, the undersigned finds that the Department’s decision to not award an “X” to CCP for this category was neither arbitrary nor capricious. Well defined process for ensuring no service breaks when transitioning between XIX and XXI. Mr. Mink testified that CCP was aware of this criteria, and addressed it in its response. CCP’s response during negotiations was: CCP understands the differences between Title XIX and Title XXI benefits since we currently support these two populations. Our eligibility onboarding process will be utilized to assist in transitioning members from one plan to the other explaining the differences to the member of care giver between each plan. Our care managers will facilitate this transition assuring there are no service breaks by coordinating care between the state agency, the member and providers. Mr. Mink further testified that CCP did not include in its response concerning this “well defined process” the utilization of technology, although CCP included the use of technology in its response to the ITN. Given CCP’s unremarkable response to this criteria, which requests a “well defined process,” the undersigned finds that the Department’s decision to not award an “X” to CCP for this category was neither arbitrary nor capricious. Vendor willing to include national standards for transition of care in policy and process for transition? Added value. Dr. Venereo testified that CCP was aware of this criteria, and addressed it in its response. Dr. Venereo testified that the “six core elements of transition in healthcare are embedded into our care coordination model[.]” However, CCP inexplicably failed to reference the applicable national standards in its reply, or when it had the opportunity to address these standards during negotiations. The undersigned finds that the Department’s decision to not award an “X” to CCP for this category was neither arbitrary nor capricious. Extent to which telemedicine will be used to address accessibility in rural areas? (Want specifics from respondents on this question – how they’ll implement the new AHCA requirement) Percentage goals for increasing the numbers of providers using telemedicine in rural areas? ADDED VALUE. Mr. Mink testified that CCP was aware of this criteria, and addressed it in its response. Mr. Mink testified that rural areas are not a large concern for CCP because most of its service area (the South/Southeastern AHCA Regional Cluster) is mostly metropolitan. Mr. Mink also testified that CCP addressed use of telemedicine for its members that may be mobility-challenged or in rural areas. The ITN, which expressed a statewide preference, does not indicate whether the Department would apply different weights in evaluation or determine best value by regional cluster. CCP’s decision to seek only a contract for the South/Southeastern Regional Cluster--AHCA Regions 9 through 11-- necessarily affected its ability to respond to this criteria. The undersigned finds that the Department’s decision to not award an “X” to CCP for this category was neither arbitrary nor capricious. Offers the most [expanded benefits] of relevance to add value to child’s life. Ms. Lerner testified that CCP was aware of the criteria of “expanded benefits,” and addressed it in its response. The ITN contained criteria 17, the expanded benefits tool, and criteria 18, titled “Additional Expanded Benefits,” and an “Additional Expanded Benefits Template.” With respect to criteria 18, the Department asked each Respondent to identify each additional expanded benefit that it proposed to offer its enrollees by eligible population. The negotiation team determined that Staywell listed a higher number of additional expanded benefits than CCP, and thus awarded Staywell an “X.” This is entirely consistent with this criteria, which specifically asks for the response that “[o]ffers the most [expanded benefits] of relevance to add value to child’s life.” The undersigned finds that the Department’s decision to not award an “X” to CCP for this category was neither arbitrary nor capricious. Even if CCP had received an “X” in every category on the best value matrix where it did not receive an “X” (with the exception of the category “Agrees to operate statewide”), CCP and Staywell would have received the same number of “Xs”. Ultimately, the negotiation team determined that Staywell provided the best value to the state. On June 25, 2018, the Department’s procurement officer submitted a Recommendation of Award Memorandum, which the Department’s chief of staff signed, accepting the recommendation to award the CMS contract to Staywell. On June 26, 2018, at 11:00 a.m., the Department posted its Notice of Intent to Award the CMS contract to Staywell. At noon on June 26, 2018, members of the negotiation team briefed the secretary of the Department on the intended contract award.13/ CCP filed a timely notice of intent to protest the Department’s decision to award the CMS contract to Staywell. On July 9, 2018, CCP filed a Formal Written Protest and Petition for Formal Administrative Hearing. On August 6, 2018, CCP filed an Amended Formal Written Protest and Petition for Formal Administrative Hearing. ADDITIONAL ISSUES CCP raises numerous additional issues concerning the ITN. First, CCP argues that the Department’s procurement was biased, raising a contract dispute between the Department and CCP that resulted in a favorable settlement for CCP while the procurement was pending. CCP presented no evidence that any evaluator or negotiator was biased against CCP as a result of that settlement or any other reason. Ms. Lerner testified that nothing that members of the negotiation team did during any of the negotiation team meetings in which she participated indicated that they were biased in any way with respect to CCP. Lupe Rivero, the senior vice president of Government Programs and Business Development for CCP, testified that CCP’s relationship with the Department was as a “true partner.” The undersigned finds no evidence of bias in this procurement process. Second, CCP contends that Staywell’s cost reply is not financially feasible given what Staywell proposed regarding projected managed care savings, administrative cost reductions or efficiencies, and the cost of enhanced benefits. CCP supported this argument through the testimony of Edward Maszak, CCP’s senior vice president of Finance and chief financial officer, who it designated as a “financial expert for managed care organizations.” As detailed in the Preliminary Statement section of this Recommended Order, the undersigned conducted a hearing consistent with section 90.702 and the requirements of Daubert and its progeny, to determine whether Mr. Maszak was qualified to testify as an expert in this designated field. After conducting such a hearing, the undersigned permitted Mr. Maszak to offer his expert testimony in this designated field. The undersigned further cautioned that it was uncertain what extent Mr. Maszak’s expert testimony could aid the trier of fact in this bid protest proceeding, and further noted that the undersigned would gauge the credibility of the testimony and afford such testimony its appropriate weight, given Mr. Maszak’s inherent bias as an executive with CCP. Mr. Maszak’s testimony demonstrated that he is a highly skilled and experienced certified public accountant who has relevant and extensive experience in the healthcare field, particularly with managed care organizations. Mr. Maszak testified that he reviewed the financial information contained in Staywell’s reply, along with achieved savings reports it filed with Florida, and the financial reports of two other large Medicaid companies. Mr. Maszak also reviewed data he could find online, such as analyst reports and SEC reports on Yahoo! Finance. Mr. Maszak stated that he reviewed these various documents to conduct a feasibility study of Staywell’s ability to achieve the savings it provided in its reply. Mr. Maszak testified that he did not know if Staywell or any of its affiliates achieved similar savings elsewhere, and did not have any other information about Staywell’s finances. Mr. Maszak testified as follows as to the standards he followed in preparing this feasibility study: Again, so WellCare in their application said they were going to reduce behavioral health, mental health services by 22 percent. They are going to save the State money. So I looked everywhere I could possibly look where that has been done. So that’s the standard you have to meet when you do a financial feasibility study. You cannot just make a statement. It has to be corroborated with some kind of evidence, right? Just like in this proceeding. So that’s the standard that you have to meet as an accountant, a CPA, to certify, to attest that every single assumption in there is real. So I looked high and low, everywhere I could find information to support that WellCare put in their application, and I could not find good sources to support anything that they made. Mr. Maszak ultimately testified that, in his opinion, the award to Staywell is not financially feasible. He based his opinion on three areas: (a) the medical cost assumptions proposed; (b) the administrative cost reductions or efficiencies proposed; and (c) the amount of benefits, particularly expanded benefits, proposed. Mr. Maszak assumed, to achieve lower administrative costs, that Staywell would have to cut personnel and salaries. However, Mr. Maszak also testified that he had no knowledge of Staywell’s internal operations other than the items and documents he reviewed as detailed in paragraph 90, supra. Mr. Maszak’s feasibility study also failed to take into account the economies of scale in its administrative costs that Staywell may realize through offering services statewide. Staywell offered the testimony of Jeff Skobel, its vice president of Regional Finance, who assisted in the preparation of Staywell’s cost proposal. Mr. Skobel testified that Staywell’s proposed savings, or managed care savings adjustment cuts, did not represent cuts in service, but changes in the utilization cost of the program. Mr. Skobel further testified that Staywell plans to achieve proposed savings by reducing avoidable hospitalizations and appropriate emergency room use through case management, using value-based purchasing to create financial arrangements with providers to incentivize increased qualitative care, and ensuring that behavioral healthcare patients adhere to their prescription schedules. In sum, while Mr. Maszak is a highly qualified CPA who has expansive expertise in the healthcare field, his methodology and assumptions in ultimately opining that Staywell’s cost proposal was not financially feasible is directly rebutted by additional evidence that Staywell presented. Further, the evidence that Staywell presented as to its proposed savings under the ITN was also presented to and reviewed by the negotiation team. The undersigned finds that Mr. Maszak’s expert opinion on the financial feasibility does not assist the undersigned in evaluating the agency’s proposed action, as the Legislature has prescribed in section 120.57(3). CCP proposed the same rates as Staywell for the South/Southeastern Regional Cluster. The undersigned finds there is no credible evidence that demonstrates that Staywell’s proposed rates are not feasible. Third, CCP argues that the proposed contract award to Staywell is contrary to competition because it provides too large a market share of Medicaid managed care procurements in Florida. The undersigned finds no legal basis for this argument, as discussed in the Conclusions of Law, and also finds there is no factual basis for this argument. Mr. Maszak testified that, if Staywell receives all contract awards that the Department and AHCA have awarded it in procurements that are subject to protest, it will have 34.2 percent market share in Florida. Mr. Maszak, in looking at four other states, testified that no other plan in those states has a market share as great as Staywell’s in Florida, with the largest share by any one plan in those states being 27.87 percent. Mr. Skobel testified that Mr. Maszak did not review plans with market shares larger than 27.87 percent, including states where only three plans operate and receive an almost equal market share. Mr. Skobel testified that Staywell’s affiliates have market shares in other states, including Georgia, that are larger than the market share Staywell will have in Florida if it wins all contracts subject to protest. Fourth, CCP argues that if the Department awards the contract to Staywell, it will prevent competition because no other vendor will be able to serve this population and gain experience. CCP’s current contract, which was awarded without competition, establishes it as the exclusive contractor providing integrated care services for the CMS Plan south of the I-4 corridor. The undersigned finds that the intended contract award is not contrary to competition.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, the undersigned RECOMMENDS that the Department of Health enter a final order denying the protest of CCP. The undersigned further RECOMMENDS that the Department of Health award the contract for the Children’s Medical Services Managed Care Plan under Invitation to Negotiate No. DOH-17-026 to Wellcare of Florida, Inc., d/b/a Staywell Health Plan. DONE AND ENTERED this 19th day of November, 2018, in Tallahassee, Leon County, Florida. S ROBERT J. TELFER III Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 19th day of November, 2018.
The Issue Whether or not the Respondents Walter C. Heinrich, as Sheriff of Hillsborough County, Florida and ARA Health Services, Inc. d/b/a Correctional Medical Systems, unlawfully discriminated against Petitioner, Mary Alice Dessasau a/k/a Mary Alice Miller, in March 1991, when Respondent Heinrich revoked Petitioner's identification badge preventing her entry into the Hillsborough County Jails.
Findings Of Fact Petitioner, Mary Alice Dessasau a/k/a Mary Alice Miller, is a black female resident of Hillsborough County, Florida, and was employed by Respondent, ARA Health Services, Inc. d/b/a Correctional Medical Services, Inc. (CMS) as a Director of Nursing (DON) from August 1989 through March 12, 1990. Respondents Heinrich and CMS are employers within the meaning of the Florida Human Rights Act of 1977, as amended by Sections 760.01-760.10, Florida Statutes. As part of its duties as Sheriff, Respondent Heinrich is responsible for the operation and maintenance of the jail system in Hillsborough County. Through its detention department, Respondent Heinrich operated three jail facilities: County Jail East, County Jail West and County Jail Central. Respondent Heinrich is responsible for health care of its inmates in its correctional facilities and these duties are codified in the Florida State Department of Correction Regulations, Chapter 33-8, Florida Administrative Code. Respondent's detention department also operates under its own Standard Operating Procedures (SOP's); Series 913 for inmate health care. Respondent Heinrich operates its jails according to standards established by two accrediting organizations: National Commission on Correctional Health Care ("NCCHC") and American Correctional Association ("ACA"). The head of Respondent's detention department is Colonel Davis Parrish, who reports directly to the Sheriff. In 1989, the detention department had a specific bureau of inmate support services which included, among other functions, a medical services section with responsibility for inmate and staff health care. Respondent's support bureau commander was Captain Carl Barletta. In his chain of command, Captain Barletta reported to Major Steven Saunders, who at times relevant, was commander of Jail Division III. Major Saunders reported directly to Colonel Parrish. In performing his detention responsibilities, Respondent Heinrich utilized outside contractors for some service functions, and since February 1989, has contracted with CMS to provide inmate health care for the jail system and certain health care support staff. The contract between Respondent Heinrich and CMS requires that CMS adhere to Chapter 33-8, Florida Administrative Code, the NCCHC and ACA standards. The contract also provides that Respondent Heinrich has the right to review applicants for CMS positions in its jails and to require CMS to terminate the continued employment of any CMS employee at Respondent's jails. Respondent employs a contract monitor, Joyce Clark, to oversee and monitor inmate health care in the jails and specifically to ensure CMS' compliance with the contract, Chapter 33-8, the accrediting agencies and other community standards. During times material, contract monitor Clark was the contractor monitor involved herein. Clark holds bachelor and master's nursing degrees from the University of Pennsylvania and has 31 years experience in health care. During times material, Clark reported to Captain Barletta and also consulted with Major Saunders and Colonel Parrish. As part of her monitoring duties, Clark report contract problems, including personnel difficulties, to CMS as well as to Barletta, Saunders and Parrish. To provide inmate health services under the contract with Respondent Heinrich, CMS utilizes a nursing staff and independent contractors who are doctors, dentists and psychologists. CMS also employs a program administrator, Carol Shepard, who is the overall supervisor of CMS employees including the independent contractors. Shepard is also responsible for monitoring CMS' contract with Respondent Heinrich. CMS employs two directors of nursing (DONs) who report directly to Shepard. The DONs are responsible for all inpatient nursing functions and for maintaining 24-hour, 7-day a week staffing of the jails by trained nurses. DONs assist the program administrator in the management of the health facility in the development and implementation of policies. DONs function according to specific job functions and are charged with being familiar not only with CMS' policies and procedures, but also with Chapter 33-8, Florida Administrative Code, and the accrediting agencies standards. All of the policies, procedures, standards and regulations are available for review by CMS DONs. Upon Petitioner's employment with CMS during August 1989, Clark arranged a meeting wherein Petitioner was oriented as to all of the procedures, policies and Clark apprised her of what to look for in the different jail facilities. During the orientation meeting with Petitioner on August 29, 1989, Clark explained to Petitioner Chapter 33-8, "histories and physical-physician review, screening forms, sick call, perpetual inventory, NCCHC standards, psych requirements, daily reports and the revisions in Florida Statutes regarding psychologists." Clark specifically explained the NCCHC standards and provided a worksheet for Petitioner's use. Petitioner understood her responsibilities as director of nursing with regards to those standards. Alternatively, Clark advised Petitioner to inquire of her if something should come up that she was unfamiliar with. A number of performance problems surfaced which ultimately led to Petitioner's termination. Alice Claiborne, the other Director of Nursing, encountered some performance problems. However, by contrast, DON Claiborne's performance pale in comparison to these by Petitioner. The first performance problem involved Petitioner's duty as DON pursuant to state law to maintain various records and logs at the jails. Specifically, each jail kept logs of controlled substances, "sharps" (needles, etc.), instruments, segregated inmates' nursing visits, first aid kits, chronic diseases, infirmary admissions, emergency room transfers, hospitalizations, communicable diseases, x-rays, and EKGs. As contract monitor, Clark performed weekly checks of the logs and a pattern of deficiencies were discovered relative to the record keeping of the jails where Petitioner served as DON. Clark filed a complaint of those deficiencies to CMS' program administrator Shepard who verbally counseled Petitioner about the matter. Another performance problem surfaced regarding the manner in which Petitioner conducted inmate histories and physicals ("H & Ps"). Inmate H & Ps are conducted according to standards set forth in Chapter 33-8, the Sheriff's SOPs as well as the NCCHC and CMS guidelines. A paramount deficiency with Petitioner's H & Ps which led to her being counselled came about as a result of what are known as hands on "assessments" and the use of LPNs in the performance of this task. Specifically, the standards require that only physicians, registered nurses, physician assistants or advanced registered nurse practitioners ("ARNPs") perform the hands on assessment portion of an H & P and LPNs are forbidden from doing so by all the pertinent regulations. Notwithstanding Petitioner's familiarity with the standards and availability of the same for review, Petitioner allowed, if not instructed, LPNs to do hands on assessments. Clark became aware of the violation during January 1990, and complained of the breach to administrator Shepard. Shepard counselled Petitioner about the matter during January 1990 and further counselled the nursing staff at County Jail West where Petitioner was then the DON during February 1990. Despite the counselling, a similar occurrence was repeated during March 1990 when Petitioner instructed and/or allowed LPNs to do the hands on assessments. This breach was discovered by Clark who was at County Jail West when she observed an LPN performing an H & P. Clark inquired of the LPN why she was performing the hands on assessment and she advised that she had been assigned H & Ps for that day. This assignment was contrary to the contract, the statutory law and regulatory standards. Clark filed a complaint with program administrator Shepard who reported the matter to her superior, Captain Barletta. Shepard considered Petitioner's actions to be in disobedience of an earlier counselling and she again counselled Petitioner about the matter on or about March 5, 1990, in a meeting attended by CMS's regional manager, Roy Moore. In addition to allowing the wrong personnel to do H & Ps, Petitioner permitted the examinations to be done improperly. Specifically, rather than using scales to weigh inmates, Petitioner permitted her nurses to rely instead on the inmate's estimate of their weight. Similarly, nurses would not use an otoscope to examine eyes and ears and did not use a flashlight and tongue depressor to examine inmate's throats. Likewise, the H & Ps did not include dental exams and lung auscultations (listening to chest sounds through a stethoscope). Petitioner expressed lack of knowledge or confidence regarding certain procedures routinely performed by RNs and particularly a DON. Specifically, Petitioner objected to the procedure for psychiatric (psych") sick call. Under state law, CMS's nurses are required to respond to any inmate request for medical, dental or psychiatric assistance within 24 hours of the request. The procedure is one whereby the request is triaged or sorted, depending on its type and severity. Petitioner, contrary to this triage procedure, instructed her support nurses to direct all psychiatric requests to the psych ARNP, Shuler. This resulted in a potentially dangerous situation wherein such requests could be left overnight without treatment in defiance of the twenty-four (24) hour response requirement.. Petitioner was counselled concerning this by Shepard, Clark, Barletta and the DOC inspector, Pat Terry. Another persistent performance problem CMS and Respondent Heinrich encountered with Petitioner was her ineffective management technique and obstructive personality. Specifically, Respondent presented a management style which was belittling and abusive to nursing personnel under her supervision and prompted a meeting of all black nurses working under her direction. The purpose of that meeting was to air complaints regarding Petitioner's harsh treatment. Not only was this style evident to CMS nurse Joan Harris who called the meeting of the black nurses but also to Captain Barletta who found that although Petitioner initially was very professional, she immediately became argumentative and somewhat insolent. A similar view of Respondent's management style was evident to contract monitor Clark and Major Saunders who reported that Petitioner's management style of "obstructiveness" was a problem. Petitioner's obstructive management style was highlighted when a Florida Department of Corrections inspector, Pat Terry, was making a site inspection of the Hillsborough County Jails on February 27, 1990. Inspector Terry who was accompanied by Shepard, inspected County Jail West where Petitioner was serving on duty as DON. Specifically, Inspector Terry on three occasions inquired about the sharp logs and other documentary logs and on each occasion, Respondent either replied "I don't know where it is; I'm too busy and Bonnie will get it for you". As a result of a complaint filed by Inspector Terry, Program Administrator Shepard counselled Petitioner regarding her attitude this conduct and instructed her on the rather obvious point that the DON should try to assist rather than antagonize the DON inspector. Shepard further explained to Petitioner that her interaction with inspectors was to be a positive experience whereby inspection results could be utilized to improve CMS nursing services to its client. Another example of Respondent's personality difficulties occurred during November, 1989 involving the death of an inmate, Robert King. Specifically, Inmate King was booked into the County Jail on November 19, 1989. King presented flu-like symptoms on November 27 and was transferred to the infirmary on November 29. King was transferred to Tampa General Hospital later that day. Petitioner was on call at the central jail on the evening that King was transferred to Tampa General Hospital. Petitioner reviewed his medical chart that night at approximately 10:00 p.m. At 2:00 a.m. on November 30, CMS nurse Halpin called Petitioner at home to relay a message from King's treating physician at Tampa General, Dr. Combs, that the doctor wished medical information on Inmate King. Petitioner advised nurse Halpin that she did not have Dr. Combs phone number and would not attempt to call him. Petitioner did however, advise Halpin that should the doctor call back, she should take his number and she would then call him the following morning. King died later that day and contract monitor Clark investigated the matter. As part of her investigation, Clark interviewed Petitioner the next morning and she acknowledged receiving the telephone call from nurse Halpin and having refused to make any effort to give the information to the doctor. Petitioner attempted to excuse her actions by claiming that she was required to have a written order prior to releasing the inmate's information. Petitioner was advised by Clark that that was not the case and that her actions were contrary to CMS's policy and good medical practices although she was not the focus of the investigation or that she was the cause of inmate King's death. Upon learning of the incident, Captain Barletta initiated an administrative review of the incident and presented his findings to Major Saunders. Major Saunders recalled this incident as one of two which stood out as examples of Petitioner's refusal to professionally carry out her duties as DON. The other incident which struck Major Saunders as being exemplary of the problematic manner that Petitioner functioned as DON and which culminated in her being barred from Respondent Heinrich's detention facilities involved a court ordered health evaluation of a prostitute inmate housed at County Jail West, one Shannon Harris. It is not unusual for Respondent Heinrich to receive court orders concerning inmates in Respondent's custody and specifically concerning medical care. Typically such orders are referred to the CMS program administrator however on occasion, the courts will sometimes call the sheriff's classification section to direct its order. On March 8, 1990, one of Respondent's classification specialists, Carolyn Walsh, received a call from County Judge Holloway's office ordering Harris' release but qualifying that she must first receive a health test or a "H & P" prior to release. Walsh contacted County Jail West and advised Petitioner that the court had ordered a health examination for Harris and that it had to be as soon as possible. Clark, who was at County Jail West that day performing medical record reviews, witnessed Petitioner taking the call from Walsh. Petitioner told Walsh that she could not do an H & P on an inmate out of sequence and that such tests were done in order. Petitioner then told Walsh that she needed an order in writing which Walsh immediately sent to Petitioner. Petitioner maintained that even with the court order, she would not be able to do the exam that evening and that it would wait until the next day when the H & P nurse(s) were on duty. Clark, who lacked the authority to order the CMS DON to perform the exam, advised Petitioner to call Shepard for clarification. At approximately 3:30 p.m. Petitioner called Shepard and advised her that the court ordered health evaluation had been received whereupon Shepard reviewed the procedure and advised her that she needed to do it and that it had to be done that night. Initially Petitioner indicated to Shepard that she did not understand the order and why it could not wait until the following day. Captain Barletta was advised of this incident later in the afternoon by telephone call from Hall, Walsh's supervisor in Respondent's classification section. Hall advised Barletta that Petitioner had been apprised of the court order but had refused to do the H & P not once, but two times. Barletta then called Petitioner who confirmed that she had refused to do the exam. Barletta then ordered Petitioner to do the exam which was completed at approximately 4:00 p.m. From Barletta's perspective, the court order was clear that a H & P was to be performed on Harris immediately and had been violated by Petitioner. Barletta viewed this as a very serious matter and relayed the incident to his superior, Major Saunders. As a result of the communiques between Barletta, Program Administrator Shepard and Saunders, Barletta requested a meeting the following day with Petitioner. Shepard called Petitioner that evening to advise her of the March 9 meeting with Captain Barletta during the afternoon of March 9 at County Jail West. Because of the seriousness of the matter, Shepard also called CMS Regional Manager Moore because of her concern that if the client was unhappy, as Barletta was, she needed to apprise her superior such that he wouldn't be "blindsided" the next morning if Moore was called by the client raising those concerns. The following morning, Shepard went to County Jail West and talked to the medical secretary and observed the records logs to ascertain whether court ordered medical procedures with inmate prostitutes were being carried out as required. Shepard found a well kept log reflecting that such procedures were routinely conducted. Shepard also questioned the CMS nursing staff about their familiarity with these procedures. Shepard learned that each was aware of the prostitute list and court ordered procedures. Based on her investigation and inquiry of the nursing staff, it became obvious that Petitioner was the only nurse who was unfamiliar (or claimed to be) with the procedure. Shepard attempted to meet with Colonel Parrish who was unavailable but his secretary advised that Parrish was very upset and expected action to be taken. In fact, Barletta had advised Saunders of the incident who in turn advised Parrish. The incident was of great concern to Saunders and they jointly determined that it was the "last straw" for Petitioner as far as Saunders and Respondent Heinrich was concerned as they considered that breach to be simply another in a litany of problems that had surfaced based on Petitioner's performance. Specifically, Barletta, Saunders and Parrish had all discussed Petitioner's performance shortcomings on earlier occasions and Colonel Parrish inquired of Saunders and Barletta "why is this continuing . . . isn't this a problem we're trying to get a handle on . . . we've got to take action". As a result, Saunders exercised Respondent Heinrich's contract perogative and approximately 9:30 a.m. on March 9, Saunders advised Shepard that CMS had until Monday afternoon to terminate Petitioner or Respondent Heinrich would "pull her badge" denying her access to the jails. At the 2:00 p.m. meeting with Captain Barletta, Shepard, and Clark, Petitioner acknowledged her initial noncompliance with the court order although she related that once she got the clarification which she needed, she performed the order as directed. During the meeting, Petitioner was advised by CMS that an investigation would follow and she would be contacted later (regarding her employment status). Respondent Heinrich and CMS's disciplinary treatment of Petitioner were separate and distinct. Specifically, Respondent Heinrich's representative, Major Saunders, advised CMS that Petitioner should be terminated or her access badge would be revoked by Respondent Heinrich. The result of that action was that Petitioner would no longer be able to work at jails however this was not the end of Petitioner's employment with CMS. Specifically, CMS utilized a progressive disciplinary policy and the upshot of all the performance problems was that Petitioner was offered continued employment by Respondent CMS (a transfer) to another location in Pinellas County. However, Petitioner declined CMS' offer of a transfer due to personal reasons i.e. a fear of the water "preventing her from crossing bridges from Tampa to Pinellas County." The transfer offered by CMS was open and continuing at the time of the hearing. However, Petitioner has been employed as a director of nursing at Ambrosia Nursing Home for two years since her separation from employment by the Respondents herein. Respondent's replaced Petitioner by a black employee. Petitioner failed to adduce any racial animus on the part of Respondent Heinrich as relates to her employment relationship. While Petitioner advanced that there was a conspiracy between Captain Barletta, Major Saunders, Joyce Clark and Carol Shepard to "get" her because she was black, the record fails to confirm her claim of a conspiracy and the unsubstantiated allegations of witness Ana Collymore who had little, if any, support for Petitioner's claim since her interaction with Petitioner's employment relationship with Respondent Heinrich was non-existent; they worked in different departments, Collymore's hours were erratic in that she worked part time as a dietician with limited involvement as a member of the executive committee which discussed problems regarding nursing services.
Recommendation Based upon the foregoing findings of fact and conclusions of law, it is RECOMMENDED that: The Florida Commission on Human Relations enter a Final Order dismissing Petitioner, Mary Alice Miller a/k/a Mary Alice Dessasau, charges of discrimination against Respondents Walter Heinrich and Correctional Medical Systems, Inc. DONE and ENTERED this 1st day of May, 1992, in Tallahassee, Leon County, Florida. JAMES E. BRADWELL Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904)488-9675 Filed with the Clerk of the Division of Administrative Hearings this 1st day of May, 1992. APPENDIX TO RECOMMENDED ORDER Rulings on Petitioner's proposed findings of fact: Paragraphs 5, 6 rejected, unnecessary. Paragraph 7, rejected as background material although a similar statement is made in the preliminary section of the Recommended Order. Paragraph 12, adopted as modified, Paragraph 1, Recommended Order. Paragraph 14, rejected, unnecessary. Paragraph 17, rejected, unnecessary. Paragraph 21, adopted as modified, Paragraph 8, Recommended Order. Paragraph 22, rejected, irrelevant and unnecessary. Paragraph 23, rejected, irrelevant. Paragraph 25, adopted as modified, Paragraph 18, Recommended Order. Paragraph 26, adopted as modified, Paragraph 18, Recommended Order. Paragraphs 29, 30, 31 and 32, rejected as recitations of testimony and not findings of fact. Paragraph 33, rejected, irrelevant. Paragraphs 37-60, rejected as being primarily a recitation of testimony and not factual findings and therefore not probative or necessary to resolve the issues posed. Paragraphs 61-155 are, in the main, a recitation of the chronology and testimony of the various witnesses and are not findings of fact which lend themselves to specific rulings as required by Section 120.59(2), Florida Statutes. Copies furnished: GARDNER W BECKETT JR ESQ NELSON BECKETT & NELSON 123 EIGHTH ST N ST PETERSBURG FL 33701 PAUL J MARINO ESQ 2008 EIGHTH AVE TAMPA FL 33601 JAMES M CRAIG ESQ THOMPSON SIZEMORE & GONZALEZ PO BOX 639 TAMPA FL 33601 MARGARET JONES, CLERK FLORIDA HUMAN RELATIONS COMMISSION BLDG F - STE 240 325 JOHN KNOX RD TALLAHASSEE FL 32303-4113 DANA BAIRD ESQ GENERAL COUNSEL FLORIDA HUMAN RELATIONS COMMISSION BLDG F - STE 240 325 JOHN KNOX RD TALLAHASSEE FL 32303-4113
