STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DAVID MCKALIP, M.D.,

Petitioner,

vs.

AGENCY FOR HEALTH CARE ADMINISTRATION,

Respondent.

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) Case No. 05-1246RP

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FINAL ORDER

Pursuant to notice, a final hearing was held in this case on May 20 and June 8, 2005, in St. Petersburg, Florida, before Susan B. Harrell, a designated Administrative Law Judge of the Division of Administrative Hearings.

APPEARANCES

For Petitioner: David, McKalip, M.D., pro se

1201 5th Avenue, North Suite 210

St. Petersburg, Florida 33705

For Respondent: Tom Barnhart, Esquire

Office of the Attorney General The Capitol, Plaza Level 01 Tallahassee, Florida 32399

STATEMENT OF THE ISSUE

Whether proposed rules 59B-15.001 through 59B-15.007 are an invalid exercise of delegated legislative authority.

PRELIMINARY STATEMENT

On April 5, 2005, Petitioner, David McKalip, M.D.

(Dr. McKalip), filed a Petition to Determine the Invalidity of Proposed Rules, challenging proposed rules 59B-15.001 through 59B-15.007 (Proposed Rules) of Respondent, Agency for Health Care Administration (Agency), as an invalid exercise of delegated legislative authority. The final hearing was originally scheduled for May 13, 2005.

On April 22, 2005, Dr. McKalip filed Petitioner's Motion to Amend Petition. On April 29, 2005, Dr. McKalip filed Petitioner's Second Motion to Amend Petition and Petitioner's Third Motion to Amend Petition. Dr. McKalip filed a Request for Continuance on May 2, 2005. By order dated May 5, 2005, the motions to amend the petition were granted, and Dr. McKalip was given leave to file an amended petition on or before May 13, 2005. Dr. McKalip filed an Amended Petition to Determine the Invalidity of Proposed Rules on May 10, 2005. By order dated May 5, 2005, the motion to continue was granted, and the final hearing was rescheduled for May 20, 2005.

On May 17, 2005, Dr. McKalip filed another request to amend the petition, which was granted by order dated May 19, 2005.

The final hearing was commenced on May 20, 2005, but was not concluded on that date. The final hearing was reconvened on June 8, 2005, and concluded on that date. At the final hearing,

Dr. McKalip testified in his own behalf and called the following witnesses: Dr. Mark Michelman, Dr. Clinton Holder, Dr. Teresa

1. Bradley, Kim Streit, Carolyn Turner, and Lisa Rawlins.

   
   

   Petitioner's Exhibits 1 through 32, 34 through 37, and 39 through 41 were admitted in evidence. Petitioner proffered the hospital policies of Northside Hospital. At the final hearing, the Agency called the following witnesses: Dr. Mark Michelman, Lisa Rawlins, and Carolyn Turner. Respondent's Exhibits 1 through 5 were admitted in evidence.

   On May 11, 2005, Petitioner filed Petitioner's Request for Official Recognition. The request was granted at the final hearing and official recognition was taken of the documents set forth in the request for official recognition. At the final hearing, official recognition was also taken of Sections 408.05, 408.061, and 381.026, Florida Statutes (2004)1; House Bill 1629 of the 2004 session; "State Library Archives of Florida Rulemaking Under Chapter 120," revised February 2005; Subsections 120.54(3)(a), 215.92(4), 815.03(8), 408.07(13) and

   408.15(4), Florida Statutes; and Florida Administrative Code Rule 59A-3.254.

   FINDINGS OF FACT

   
   

   1. The State Center for Health Statistics (State Center) within the Agency collects and disseminates data from hospitals and ambulatory surgery centers. One of the responsibilities of

      the State Center is to produce comparable and uniform health information and statistics through a Comprehensive Health Information System. § 408.05(3), Fla. Stat. The State Comprehensive Health Information System Advisory Council (CHIS) is established within the Agency to assist the State Center in reviewing the Comprehensive Health Information System and to recommend improvements for the system. § 408.05(8), Fla. Stat. In conjunction with CHIS, the agency is to develop and implement a long-range plan for making available performance outcome and financial data that will allow consumers to compare health services. § 408.05(3)(l), Fla. Stat.

   2. In 2004, Section 408.061, Florida Statutes, was amended to require health care facilities to submit hospital emergency department data, data on hospital-acquired infections as specified by rule, and data on readmissions as specified by rule.

   3. On October 20, 2004, a meeting of CHIS was held, and a discussion was held on the collection and dissemination of data relating to infection rates. A motion was approved to consider the adoption of Surgical Infection Prevention (SIP) measures and to form a Technical Workgroup for Hospital Acquired Infections (Technical Workgroup) to make recommendations to the Agency on how to report SIP measures, to review the current systems of

      reporting infection rates, and to determine the appropriate infection measures to report.

   4. On December 1, 2004, CHIS met and heard recommendations from the Technical Workgroup concerning the collection and reporting of SIP measures. The recommendations included developing draft rules. The agency assigned Carolyn Turner, a Government Analyst II with the Agency, to draft rules relating to the collection of SIP Measures. Ms. Turner began drafting the rules in December 2004. Ms. Turner drafted the Proposed Rules.

   5. On January 13, 2005, the Agency held a rule development workshop, which had been noticed in the Florida Administrative Weekly on December 30, 2004. During the workshop and subsequent to the workshop, the Agency received comments and suggestions for modifications to the Proposed Rules, and, as a result, the Agency made some changes to the Proposed Rules. The Proposed Rules were published in the Florida Administrative Weekly on March 11, 2005, and a public hearing was held on the Proposed Rules on April 4, 2005.

   6. The Proposed Rules provide:

      
      

      59B-15.001 Purpose

      The rules in this section describe the requirements for reporting Surgical Infection Prevention (SIP) Measures to the Agency for Health Care Administration (Agency) for the purpose of providing comparative information to consumers.

      
      

      59B-15.002 Definitions

      1. "Hospital" means an entity that is licensed per Section 395.002(13), Florida Statutes.

      2. "Reporting period" means a calendar quarter.

      3. "Eligible patient" means a selected surgical patient 18 years of age or older with no prior evidence of infection as specified by the Center for Medicare and Medicaid Services (CMS) in the Specifications Manual for National Hospital Quality Measures available on the CMS website at: www.cms.hhs.gov/quality/hospital.

         
         

         59B-15.003 Exclusions

         1. State-operated hospitals.

         2. Psychiatric hospitals with no licensed acute care beds other than licensed psychiatric or substance abuse beds.

         3. Specialty rehabilitation as defined in subparagraph 59A-3.52(1)(c)2. F.A.C.

         4. Intensive Residential Treatment Programs for Children and Adolescents as defined in paragraph 59A-3.252(1)(d), F.A.C.

         
         

         59B-15.004 Reporting Requirements

         1. Hospitals shall report Surgical Infection Prevention (SIP) Measures to the Agency for Health Care Administration (Agency) quarterly due on or before December 1, 2005 for the period April 1, through June 30, 2005. Thereafter, data shall be reported for each calendar quarter due 150 days following the end of the quarter.

         2. Hospitals shall report the following measures for all eligible patients regardless of type of payer.

            1. Prophylactic antibiotics received within 1 hour prior to surgical incision;

            2. Prophylactic antibiotic selection for surgical patients;

            3. Prophylactic antibiotics discontinued within 24 hours after surgery end time.

         3. The methodology used to prepare the measures shall meet the standards specified by the Centers for Medicare and Medicaid Services (CMS) in the Specifications Manual for National Hospital Quality Measures available on the CMS website at: www.cms.hhs.gov/quality/hospital. CMS standards include submission of SIP data to the Quality Improvement Organization Clinical Warehouse, providing records required for reabstraction activities, and compliance with other data quality standards as specified by CMS.

         4. Hospitals shall use the SIP methodology specified by the CMS for the applicable reporting period to determine the SIP measures reported to the Agency. If the hospital uses sampling, the hospital must follow the sampling protocol specified by CMS.

         5. Hospitals shall report the population size, rate numerator value, and denominator value as specified by CMS for each type of surgery to include coronary artery bypass surgery (CABG), cardiac surgery, hip arthroplasty, knee arthroplasty, colon surgery, hysterectomy, vascular surgery, and for all of the above surgeries overall.

         6. Hospitals shall report data separately for each location consistent with Rule 59E-7.012, F.A.C. unless reporting separately would be contrary to CMS specifications. If a combined report is submitted, report the name of the hospital and AHCA hospital identification number required in subsection 59B-15.005(1), F.A.C. for each of the hospitals included in the report.

         7. The data shall be submitted in a text file, using a tab between each data element. Start a new line for each type of surgery and for each measure. Order the rows of data by type of surgery as listed in

         subsection (5) with three consecutive rows of data for each measure in subsection (2) above reported for each type of surgery.

         Each line of data shall state the name of the type of surgery or state all of the above surgeries overall as in subsection (5) above and state the name of the type of surgery or state all of the above surgeries overall as in subsection (5) above and state the name of the type of measure as in (2) above. The rate shall be reported as a decimal number greater than or equal to zero

         (0) and less than or equal to one hundred

         (100) using the format X.XX, XX.XX, or

         XXX.XX as required. Report hospital contact information required in Rule 59B-15.005,

         F.A.C. in the order specified starting a new line beginning with contact name and contact telephone number. Hospital contact information should be reported at the beginning of the document.

         (8) Hospitals shall send the SIP measures by electronic mail to SIPReport@ahca.myflorida.com or, if requested in writing by the hospital and approved by the Agency to the Agency's mailing address using a 3.5" diskette or CD- ROM. The mailing address of the Agency is: Agency for Health Care Administration, 2727 Mahan Drive, Mail Stop #16, Tallahassee, Florida 32308 with the statement, "Attention: State Center for Health Statistics." If the hospital has a vendor send the SIP measures to the Agency, the hospital will direct the vendor to copy (cc) the hospital contact when the report is e- mailed to the Agency.

         
         

         59B-15.005 Hospital Contact Information.

         1. Each hospital shall include the following contact information when submitting a report required in this section to the Agency for Health Care Administration:

            1. Name of hospital;

            2. AHCA hospital identification number;

            3. Reporting year in four digits;

            4. Reporting quarter as a 1, 2, 3, or 4 where 1 corresponds to the first quarter of a calendar year;

            5. Contact name;

            6. Contact title;

            7. Contact address;

            8. Contact direct telephone number;

            9. Hospital telephone number;

            10. Contact e-mail address;

            11. Contact FAX number.

         2. The hospital contact information shall be reported in a text file as described in Rule 59B-15.004, F.A.C., using a tab between each data element.

         
         

         59B-15.006 Certification

         1. Each hospital shall provide certification of the accuracy of the Surgical Infection Prevention Measures including all data required in this section as provided in Section 408.061(1)(a), Florida Statutes.

         2. The certification shall be submitted to the Agency for Health Care Administration (Agency) using the Certification of Surgical Infection Prevention Measures from SIP-1, dated 2/01/2005, incorporated by reference. The certification shall be submitted to the Agency for Health Care Administration (Agency) quarterly prior to or concurrent with the submission of the Surgical Infection Prevention Measures as provided in Rule 59B-15.004, F.A.C. The Certification of Surgical Infections Prevention Measures Form will be available from the Agency website at www.ahca.myflorida.com. The signed Certification of Surgical Infections Prevention Measures may be submitted electronically to SIPReport@ahca.myflorida.com. using a pdf file with a scanned signature or mailed to the Agency address provided in Rule 59B- 15.004, F.A.C.

         3. If a combined report is submitted per subsection 59B-15.004(6), F.A.C., a separate Certification of Surgical Infection Prevention Measures Form SIP-1 must be

         submitted for each hospital included in the report.

         
         

         59B-15.007 Administrative Penalties Failure to report as required in this

         section in whole or in part is subject to administrative fines as provided in Section 408.08(2) and 408.08(5), Florida Statutes, unless the hospital has been granted an extension of up to 30 days by the Agency for Health Care Administration for reasons of extraordinary or hardship circumstances such

         as a natural disaster or emergency event impacting the hospital. Hospitals must request the extension, in writing, prior to the due date specified in Rule 59B-15.004, F.A.C.

         
         

   7. The Proposed Rules provide that the specific authority for the promulgation of the Proposed Rules is Subsection 408.06(1)(a)2., Florida Statutes, and the law implemented by the Proposed Rules is Subsection 408.05(3)(l)1., Florida Statutes.

   8. Dr. McKalip is a neurological surgeon practicing in St. Petersburg, Florida. He has hospital privileges at Bayfront Medical Center (Bayfront) and St. Anthony's Health Care

      (St. Anthony's). Both hospitals would be required by the Proposed Rules to report SIP Measures to the Agency. SIP Measures would be required to be reported only on the following surgical categories: coronary artery bypass surgery, cardiac surgery, hip arthroplasty, knee arthroplasty, colon surgery, hysterectomy, and vascular surgery. Dr. McKalip performs vascular surgery of the brain, vascular bypass surgery in the neck, and, as part of his board certification, is required to be

      able to perform carotid artery surgery in the neck. These procedures would be included under the category of vascular surgery in the ICD-9 codes as other (peripheral) vascular shunt or bypass VASC SHUNT and BYPASS NEC.2

   9. The Proposed Rules do not require Dr. McKalip to report the use of SIP measures; they require the hospitals in which he performs the procedures to report the SIP measures. The Proposed Rules do not require the hospitals to implement SIP measures, merely to report whether the SIP measures were implemented. Some hospitals, including Bayfront and

      St. Anthony's, have developed policies which require physicians practicing in those hospitals to implement the SIP measures.

   10. Data collection relating to SIP measures is not a new concept. The Centers for Medicare and Medicaid Services (CMS) have developed a methodology to collect data on SIP measures, and some hospitals are currently voluntarily reporting the use of SIP measures for certain surgical procedures. The Proposed Rules adopt the methodology developed by CMS.

   11. The Proposed Rules are supported by the Florida Hospital Association; Florida Medical Quality Assurance, Inc.; and CMS. The use of SIP measures is supported by many medical societies and organizations.

   12. The Agency views the collection of the SIP measures as the first step in a three-step process for collecting and

       reporting hospital-acquired infection data. The second step will involve the collection of infection rates that are acquired in the inpatient setting, and the third step will involve reporting the infection rates by physicians.

       CONCLUSIONS OF LAW

       
       

   13. The Division of Administrative Hearings has jurisdiction over the parties to and the subject matter of this proceeding. § 120.56(2), Fla. Stat.

   14. Subsection 120.56(2)(a), Florida Statutes, provides:

       
       

       (a) Any substantially affected person may seek an administrative determination of the invalidity of an proposed rule by filing a petition seeking such a determination with the [Division of Administrative Hearings] .

       . . . The petition shall state with particularity the objections to the proposed rule and the reasons that the proposed rule is an invalid exercise of delegated legislative authority. The petitioner has the burden of going forward. The agency then has the burden to prove by a preponderance of the evidence that the proposed rule is not an invalid exercise of delegated legislative authority as to the objections raised.

       
       

   15. In Ward v. Board of Trustees of the Internal Trust

       
       

       Fund, 651 So. 2d 1236, 1237-1238 (Fla. 4th DCA 1995), the court set forth the test to be used in determining whether the petitioner in a rule challenge is substantially affected, stating:

       In order to meet the substantially affected test of section 120.54(4), the petitioner

       must establish: (1) a real and sufficiently immediate injury in fact; and (2) "that the alleged interest is arguably within the zone of interest to be protected or regulated." See All Risk Corp. of Fla. v. State, Dep't of Labor & Employment Sec., 412 So. 2d (Fla. 1st DCA 1982). . . . To satisfy the sufficiently real and immediate injury in fact element, the injury must not be based on pure speculation or conjecture. See, e.g., Professional Firefighters of Fla., Inc. v. Department of Health & Rehabilitative Servs., 396 So. 2d 1194 (Fla. 1st DCA 1981). A real and sufficiently immediate injury in fact has been recognized where the challenged rule or its promulgating statute has a direct and immediate effect upon one's right to earn a living. The clearest example of this is where the challenged rule directly regulates the challenger's occupational field per se by, for example, setting criteria to engage in that profession. See, e.g., Coalition of Mental Health Professions v. Department of Professional Regulations, 546 So. 2d 27 (Fla. 1st DCA 1989); Professional Firefighters, 396 So. 2d at 1196.

       However, even where a challenged rule or its promulgating statute does not regulate the challenger's profession per se by, for example, setting criteria to engage in that profession, but the rule has the effect of directly regulating the professional conduct of persons within such occupation, such challenger has been found to be substantially affected. See State, Dep't of Health & Rehabilitative Servs. v. Alice P., 367 So. 2d 1045, 152 n. 2 (Fla. 1st DCA

       1979). . . . The general rule regarding the zone of interest element of the substantially affected test is that such element is met where a party asserts that a statute, or a rule implementing such statute, encroaches upon an interest protected by a statute or the constitution. Florida Medical Ass'n v. Department of Professional Regulation, 426 So. 2d 1112,

       1117 (Fla. 1st DCA 1983). In the context of a rule challenge, the protected zone of interest need not be found in the enabling statute of the challenged rule, itself. Id. "Since the crux of [a rule change] controversy involves the claim that [the enabling statute] does not authorize the rule, it is obvious the effect of other statutes must be considered in determining standing." Id.

       
       

   16. Dr. McKalip argues that because the hospitals are requiring the physicians to implement the SIP measures that will be required to be reported, he is substantially affected by the Proposed Rules. If the Proposed Rules required the hospitals to implement the SIP measures, Dr. McKalip's argument might have merit; however, the Proposed Rules do not require the hospitals to implement the SIP measures, merely to report them. Hospitals are not required by the Proposed Rules to develop policies requiring the physicians with privileges in the hospitals to use the SIP measures. The hospitals' policies on the implementation of the SIP measures are voluntary. There is no requirement in the Proposed Rules that substantially affect Dr. McKalip per se or indirectly through the regulation of hospitals; thus, Dr. McKalip does not have standing to challenge the Proposed Rules.

   17. Even arguendo if Dr. McKalip had standing to challenge the Proposed Rules, the Proposed Rules are not an invalid exercise of delegated legislative authority. Subsection 120.52(8), Florida Statutes, defines invalid exercise of

       delegated legislative authority as "action which goes beyond the powers, functions, and duties delegated by the Legislature." Dr. McKalip claims that the Proposed Rules are invalid based on the following grounds set forth in Subsection 120.52(8), Florida Statutes:

       1. The agency has materially failed to follow the applicable rulemaking procedures or requirements set forth in this chapter;

       2. The agency has exceeded its grant of rulemaking authority, citation to which is required by s.120.54(3)(a)1;

       3. The rule enlarges, modifies, or contravenes the specific provisions of law implemented, citation to which is required by s. 120.54(3)(a)1;

       * * *

       (e) The rule is arbitrary or capricious. A rule is arbitrary if it is not supported by logic or the necessary facts; a rule is capricious if it is adopted without thought or reason or is irrational[.]

       
       

   18. Dr. McKalip alleged that the Agency materially failed to follow rulemaking requirements set forth in Chapter 120, Florida Statutes, but in his Amended Petition to Determine the Invalidity of Proposed Rules, he did not point to any specific requirements of Chapter 120 that were not followed.3 Dr. McKalip did argue that the advisory panel, which made recommendations to the Agency concerning the reporting of the SIP Measures, did not have consumers or physicians on the panel, and, therefore, the rulemaking was flawed. Whether consumers and physicians were involved in making recommendations to the Agency is immaterial

       to the rulemaking requirements set forth in Chapter 120, Florida Statutes. CHIS may make recommendations to the Agency, but the ultimate responsibility for rulemaking rests with the Agency.

       Additionally, any failure by the Agency to allow input from consumers and physicians was cured by the rule development workgroup and the public hearing which the Agency held on the Proposed Rules.

   19. Dr. McKalip alleged that the Proposed Rules exceeded the Agency's grant of rulemaking authority. The law, which the Proposed Rules cite as specific authority, is Subsection 408.061(1)(a), (2), Florida Statutes, which provides:

       1. The agency shall require the submission by health care facilities, health care providers, and health insurers of data necessary to carry out the agency's duties. Specification for data to be collected under this section shall be developed by the agency with the assistance of technical advisory panels including representatives of affected entities, consumers, purchasers, and such other interested parties as may be determined by the agency.

          1. Data submitted by health care facilities, including the facilities as defined in chapter 395, shall include, but are not limited to: case-mix data, patient admission and discharge data, hospital emergency department data which shall include the number of patients treated in the emergency department of a licensed hospital reported by patient acuity level, data on hospital-acquired infections as specified by rule, data on complications as specified by rule, data on readmissions as specified by rule, with patient and provider-specific identifiers included,

             actual charge data by diagnostic groups, financial data, accounting data, operating expenses, expenses incurred for rendering services to patients who cannot or do not pay, interest charges, depreciation expenses based on the useful life of the property and equipment involved, and demographic data.

             The agency shall adopt nationally recognized risk adjustment methodologies or software consistent with the standards of the Agency for Healthcare Research and Quality and as selected by the agency for all data submitted as required by this section. Data may be obtained from documents such as, but not limited to: leases, contracts, debt instruments, itemized patient bills, medical record abstracts, and related diagnostic information. Reported data elements shall be reported electronically in accordance with rule 59E-7.012, Florida Administrative Code. Data submitted shall be certified by the chief executive officer or an appropriate and duly authorized representative or employee of the licensed facility that the information submitted is true and accurate.

             * * *

       2. The Agency shall, by rule, after consulting with appropriate professional and governmental advisory bodies and holding public hearings and considering existing and proposed systems of accounting and reporting utilized by health care facilities, specify a uniform system of financial reporting for each type of facility based on a uniform chart of accounts developed after considering accepted accounting principles. Such systems shall, to the extent feasible, use existing accounting systems and shall minimize the paperwork required of facilities. This provision shall not be construed to authorize the agency to require health care facilities to adopt a uniform accounting system. As a part of such uniform system of financial reporting, the agency may require the filing of any information relating to the cost to the

          provider and the charge to the consumer of any service provided in such facility, except the cost of a physician's services which is billed independently of the facility.

          
          

   20. Dr. McKalip argues that the Agency does not have authority to require reporting of the SIP measures, because the SIP measures are not data on hospital-acquired infections. The Agency has the authority to collect data which are necessary to carry out the Agency's duties. One of the Agency's duties is to "establish a comprehensive health information system to provide for the collection, compilation, coordination, analysis, indexing, dissemination, and utilization of both purposefully collected and extant health-related data and statistics."

       § 408.05(1), Fla. Stat. The term "data" is not defined in Chapter 408, Florida Statutes.4 Webster's II New Riverside

       University Dictionary (1988) defines "data" as "Information, esp. information organized for analysis or used as the basis for decision-making." Data is a very broad term. Subsection 408.061(1), Florida Statutes, provides a list of specific types of data that may be collected, but the list is not inclusive.

       Subsection 408.061(1), Florida Statutes, provides that data submitted by hospitals "shall include, but not be limited to" specific types of data.

   21. Reading Subsections 408.05(1) and 408.061(1), Florida Statutes, in pari materia, it is clear that the information collected must be health-related and necessary to carry out the Agency's duties. Data on the SIP measures is health-related and will be used in the establishment of a comprehensive health information system, which Subsection 408.05(2)(j), Florida Statutes, requires to include data on the quality of care provided by various health care providers. Additionally, the reporting of the SIP measures is a step in the implementation of a "long-range plan for making available performance outcome and financial data that will allow consumers to compare health care service" as required by Subsection 408.05(3)(l)1., Florida Statutes. It should be noted that Subsection 408.061(1)(e), Florida Statutes, provides that "[a] requirement to submit data shall be adopted by rule if the submission of data is being required of all members of any type of health care facility, health care provider, or health insurer."

   22. The evidence established that the Agency has not exceeded its grant of rulemaking authority in the promulgation of the Proposed Rules.

   23. Dr. McKalip alleged that the Proposed Rules enlarge, modify, or contravene the law implemented, Subsection 408.05(3)(l)1., Florida Statutes, which provides:

       (3) COMPREHENSIVE HEALTH INFORMATION SYSTEM.--In order to produce comparable and uniform health information and statistics, the agency shall perform the following functions:

       * * *

       (l) Develop, in conjunction with the State Comprehensive Health Information System Advisory Council, and implement a long-range plan for making available performance outcome and financial data that will allow consumers to compare health care services. The performance outcomes and financial data the agency must make available shall include, but is not limited to, pharmaceuticals, physicians, health care facilities, and health plans and managed care entities. The agency shall submit the initial plan to the Governor, the President of the Senate, and the Speaker of the House of Representatives by March 1, 2005, and shall update the plan and report on the status of its implementation annually thereafter. The agency shall also make the plan and status report available to the public on its internet website. As part of the plan, the agency shall identify the process and timeframes for implementation, any barriers to implementation, and recommendations of changes in the law that may be enacted by the Legislature to eliminate the barriers. As preliminary elements of the plan, the agency shall:

       1. Make available performance outcome and patient charge data collected from health care facilities pursuant to s. 408.061(1)(a) and (2). The agency shall determine which conditions and procedures, performance outcomes, and patient charge data to disclose based upon input from the council. When determining which conditions and procedures are to be disclosed, the council and the agency shall consider variation in costs, variation in outcomes, and magnitude of variations and other relevant information. When determining which

          performance outcomes to disclose, the agency:

          1. Shall consider such factors, as volume of cases: average patient charges; average length of stay; complication rates, mortality rates; and infection rates, among others, which shall be adjusted for case mix and severity, if applicable.

          2. May consider such additional measures that are adopted by the Centers for Medicare and Medicaid studies, National Quality Forum, the Joint Commission on Accreditation of Healthcare Organizations, the Agency for Healthcare Research and Quality, or a similar national entity that establishes standards to measure the performance of health care providers of other states.

       When determining which patient charge data to disclose, the agency shall consider such measures as average charge, average net revenue per adjusted patient day, average cost per adjusted patient day, and average cost per admission, among others.

       
       

   24. Dr. McKalip argues that Proposed Rules do not require the collection of performance outcomes. Subsection 408.05(3)(l)1.b., Florida Statutes, provides that in determining which performance outcome measures to disclose, the Agency may consider additional measures of performance adopted by CMS, which is what the Agency did. It considered the SIP measures in collecting data that would be disclosed to consumers so that they would be able to compare health care services. The collection of data on the SIP measures is the first step in Agency's collecting and reporting of hospital-acquired infections.

   25. Dr. McKalip argued in his Proposed Final Order that the data on the SIP measures was not risk adjusted as required by Subsection 408.061(1)(a), Florida Statutes. This objection was not raised in the Amended Petition to Determine the Invalidity of Proposed Rules. Pursuant to Subsection 120.56(2), Florida Statutes, the petition is required to raise the objections to proposed rules with specificity; therefore, the risk-adjustment objection will not be considered.

   26. Dr. McKalip contends that the Proposed Rules are arbitrary and capricious. The Proposed Rules are neither arbitrary nor capricious. The Proposed Rules are logical and are supported by facts. Scientific studies support the use of the SIP measures as a means of combating surgical infections. Some hospitals are currently voluntarily reporting the SIP measures to CMS. The Agency gave thought to reporting the SIP measures and considered comments from the public and from CHIS in developing the Proposed Rules.

ORDER

Based on the foregoing Findings of Fact and Conclusions of Law, it is

ORDERED that Petitioner lacks standing to challenge the Proposed Rules, the Proposed Rules are a valid exercise of delegated legislative authority and the Amended Petition to Determine the Invalidity of Proposed Rules is hereby DISMISSED.

DONE AND ORDERED this 26th day of September, 2005, in Tallahassee, Leon County, Florida.

S

SUSAN B. HARRELL

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 26th day of September, 2005.

ENDNOTES

1/ Unless otherwise indicated, all references to the Florida Statutes are to the 2004 version.

2/ Proposed Rule 59B-15.004(3) provides that the methodology used to prepare the measures shall meet the standards of the CMS specified on the CMS website. The current version of the standards requires that discharges from July 1, 2005, through September 30, 2005, be reported using the "Specifications Manual for National Hospital Quality Measures, Version 1.02. Version

1.02 includes other (peripheral) vascular shunt or bypass VASC SHUNT and BYPASS NEC in the list of procedures under vascular surgery.

3/ Dr. McKalip did argue in his Proposed Final Order that the Agency's submission to the Joint Administrative Procedure Committee lacked detail sufficient to justify the Proposed Rules, but that was not included in the Amended Petition to Determine the Invalidity of Proposed Rules as an objection.

Subsection 120.56(2)(a), Florida Statutes, requires that the objections to proposed rules be stated with particularity in the petition; thus, the objection based on the submission to the Joint Administrative Procedure Committee should not be considered. Even if the objection were considered, it is

without merit. The submission accurately describes the Proposed Rules.

4/ The term "audited actual data" is defined in Subsection 408.07(7), Florida Statutes, but this refers to information contained within financial statements which are examined by a Florida-licensed certified public accountant.

COPIES FURNISHED:

David McKalip, M.D. 1201 5th Avenue, North Suite 210

St. Petersburg, Florida 33705

Tom Barnhart, Esquire

Office of the Attorney General The Capitol, Plaza Level 01 Tallahassee, Florida 32399

Richard Shoop, Agency Clerk

Agency for Health Care Administration 2727 Mahan Drive, Mail Station 3

Tallahassee, Florida 32308

William Roberts, Acting General Counsel Agency for Health Care Administration Fort Knox Building, Suite 3431

2727 Mahan Drive

Tallahassee, Florida 32308

Scott Boyd

Executive Director and General Counsel Joint Administrative Procedures Committee

120 Holland Building Tallahassee, Florida 32399-1300

Liz Cloud, Program Administrator Administrative Code

Department of State

R. A. Gray Building, Suite 101 Tallahassee, Florida 32399-0250

NOTICE OF RIGHT TO JUDICIAL REVIEW

A party who is adversely affected by this Final Order is entitled to judicial review pursuant to Section 120.68, Florida Statutes. Review proceedings are governed by the Florida Rules of Appellate Procedure. Such proceedings are commenced by filing the original Notice of Appeal with the agency clerk of the Division of Administrative Hearings and a copy, accompanied by filing fees prescribed by law, with the District Court of Appeal, First District, or with the District Court of Appeal in the Appellate District where the party resides. The notice of appeal must be filed within 30 days of rendition of the order to be reviewed.

Docket for Case No: 05-001246RP

Orders for Case No: 05-001246RP