STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

FLORIDA ACADEMY OF COSMETIC ) SURGERY, INC.; CHARLES GRAPER, ) M.D., D.D.S, F.A.C.S.; and R. ) GREGORY SMITH, M.D., )

)

Petitioners, )

)

and )

) FLORIDA HOSPITAL ASSOCIATION; ) ASSOCIATION OF COMMUNITY HOSPITAL ) AND HEALTH SYSTEMS; FLORIDA ) SOCIETY OF PLASTIC SURGEONS, INC., ) and FLORIDA SOCIETY OF )

ANESTHESIOLOGISTS, INC., )

)

Intervenors, )

)

vs. ) Case No. 00-1058RX

) DEPARTMENT OF HEALTH, BOARD OF ) MEDICINE, )

)

Respondent. )

)

FINAL ORDER

On June 14-16, 2000 and June 21, 2000, a formal administrative hearing was held in this case in Tallahassee, Florida, before William R. Pfeiffer, Administrative Law Judge, of the Division of Administrative Hearings.

APPEARANCES

For Petitioners: Alfred W. Clark, Esquire

Post Office Box 623

117 South Gadsden Street, Suite 201 Tallahassee, Florida 32301

For Respondent: M. Catherine Lannon, Esquire

Lee Ann Gustafson, Esquire Department of Legal Affairs The Capitol, Plaza Level 01

Tallahassee, Florida 32399-1050

For Intervenor Florida Society of Anesthesiologists:

Jerome W. Hoffman, Esquire Karen D. Walker, Esquire Holland & Knight, LLP

Post Office Drawer 810 Tallahassee, Florida 32302

For Intervenors Florida Society of Plastic Surgery, Inc.,

and Florida Society of Dermatology,Inc.:

Christopher L. Nuland, Esquire

Law Office of Christopher L. Nuland 1000 Riverside Avenue, Suite 200

Jacksonville, Florida 32204

For Intervenors Florida Hospital Association, Inc., and

Association of Community Hospitals and Health Systems of Florida, Inc.:

J. Stephen Menton, Esquire

Rutledge, Ecenia, Purnell & Hoffman, P.A.

215 South Monroe Street, Suite 200 Post Office Box 551

Tallahassee, Florida 32302-0551 STATEMENT OF THE ISSUES

The issue in this case is whether the challenged portions of Rule 64B8-9.009, Florida Administrative Code, constitute an invalid exercise of delegated legislative authority.

PRELIMINARY STATEMENT

On March 3, 2000, Petitioners, Florida Academy of Cosmetic Surgery, Inc. (FACS) Charles Graper, M.D., D.D.S., FACS (Graper), and R. Gregory Smith, M.D. (Smith), filed a Petition for Administrative Determination of the Invalidity of an Existing Rule (Petition). The Petition was assigned DOAH Case No. 00-

1058RX. Leave to intervene was granted to the Florida Society of Anesthesiologists, Inc. (FSA), the Florida Society of Plastic Surgeons, Inc. (FSPS), the Florida Society of Dermatology, Inc. (FSD), and the Florida Hospital Association, Inc., and Association of Community Hospitals and Health Systems of Florida, Inc. (Hospitals).

At final hearing, Petitioners presented the testimony of Smith; Dr, Anthony Rogers, Dr. David Allyn, Barbara Dame, Dr. David Harvey, Graper, and Dr. Ira Schlesinger. Respondent, Florida Board of Medicine (Board) presented the testimony of Liz Cloud, Nancy Murphy, and Tanya Williams. The FSPS and the FSD presented the testimony of Dr. Carl Wildrick Lentz. The Hospitals presented the testimony of Bill Bell and Dr. Brent Amy. The FSA presented the testimony of Matthew Weidner. Petitioners' Exhibits 1, 2, 3, 5, 3.6, 4, 5, 7, 8, 11, 13, and 17 were

received in evidence. Board Exhibits 1-1 through 1-13, 2-1

through 2-16B, 3-1 through 3-6, 4-1 and 4-2 were received in evidence. FSA Exhibits 1, 2, and 3 were received in evidence. The FSPS, the FSD and the Hospitals did not offer any exhibits in evidence.

The Transcript was filed July 10, 2000. Each of the parties submitted Proposed Findings of Facts and Conclusions of Law which have been considered by the Administrative Law Judge.

FINDINGS OF FACT

1. In 1994, Respondent, Florida Board of Medicine promulgated Rule 61F6-27.16, Florida Administrative Code. The Rule was later renumbered twice before being referenced as 64B8- 9.009, Florida Administrative Code.

2. In 1998, the Florida Legislature provided that the Board may "establish by rule standards of practice and standards of care for particular practice settings, including, but not limited to, education and training, equipment and supplies, medications including anesthetics, assistance of and delegation to other personnel, transfer agreements, sterilization, records, performance of complex or multiple procedures, informed consent, and policy and procedure manuals in order to establish grounds for disciplining doctors." Section 458.331(1)(v), Florida Statutes.

3. On March 13, 1998, Respondent published in the Florida Administrative Weekly (FAW) a Notice of Proposed Rule-making concerning the Rule, followed by the first meeting of Respondent's Surgical Care Committee with respect to potential amendments to the Rule. After additional meetings, all of which were properly noticed in the FAW, the Surgical Care Committee presented its recommended amendments to the Rule to the full Board of Medicine from December 4-6, 1998. The full Board did not accept the Surgical Care Committee's recommendation completely, but rather voted to alter the proposed amendments.

   These latter amendments were approved by the Board at its January 6, 1999, conference call. On April 11, 1999 and June 3, 1999, the Board held additional public hearings, leading the Board to publish two Notices of Change, the second of which was published on June 18, 1999.

4. Among the amendments contained in Rule 64B8-9.009 as proposed on June 18, 1999, was a deletion of Section (4)(b) which required those physicians not having staff privileges to perform the same procedure as that being performed in the office to have a "transfer agreement" with a licensed hospital within reasonable proximity. The Board considered replacing this mandate with a "transfer protocol." The June 18, 1999, version also considered a change to Section (6)(b)1., thereby permitting certain physicians to perform Level III surgery without hospital staff privileges and eliminating the mandated presence of a physician anesthesiologist.

5. On July 8, 1999, the Florida Society of Anesthesiologists (FSA) and the Florida Hospital Association, et al. (FHA) filed separate rule challenges seeking to invalidate the proposed Rule (DOAH Case Nos. 99-2974RP and 99-2975RP, respectively).

6. On August 7, 1999, the Board of Medicine held an additional public hearing, where further amendments were made to the Rule, none of which materially affected the above sections.

7. A third Notice of Change was published on August 20, 1999, reflecting these amendments approved on August 7, 1999, by the Board.

8. During the Fall of 1999, the incoming Chairman of the Board of Medicine, Dr. George El-Bahri, held several private settlement negotiations with the parties to the various rule challenges. Nevertheless, as of the Board's December 4, 1999, meeting, no settlement had been reached in either challenge, and the Board voted unanimously to proceed with the rule challenge litigation and make no further changes to the proposed amendments. This course of action was confirmed by the Board during its January 2000 conference call.

9. Following the Board's January conference call, the parties to the pending litigation agreed to "submit to the Department of State for codification" those sections of the proposed amendments which were not at issue in the litigation. As a result, the Board, FSA, and FSPS entered into a joint stipulation on January 26, 2000. The FHA filed a Partial Voluntary Dismissal on January 28, 2000, dismissing their challenge to all proposed amendments to Rule 64B8-9.009, except with respect to Subsections (2)(e), (2)(f), (2)(i), (4)(g)1. and 2.; and (6)(b)1a. and 6., which are not at issue in this case.

   On January 28, 2000, the Board properly filed with the Department of State, portions of the proposed amendments which were no

   longer subject to the pending litigation, with the rule in its current form becoming effective on February 17, 2000.

10. Because any proposed amendments relating to transfer protocols and Level III staff privileges were withdrawn and no longer being considered, they were not filed for adoption on January 28, 2000. Those existing sections remained unchanged in the rule and were renumbered by the Department of State.

11. Petitioners challenge each of the approved amendments to Rule 64B8-9.009 which became effective on February 17, 2000, alleging that the provisions of the existing rule are an invalid exercise of delegated Legislative authority under Section 120.52(8), Florida Statutes.

12. Specifically, Petitioners challenge the following Subsections of Rule 64B8-9.009.

    1. Subsection (1)(a) which provides that the rule covers "any elective procedures for aesthetic, reconstructive, or cosmetic purposes;"

       
       

    2. Subsection (2) which Petitioners allege imposes costly record-keeping requirements;

       
       

       c. Subsections (2)(d), (3), (4), (5), and

       (6) which Petitioners allege limit the types and durations of aesthetic reconstructive and cosmetic procedures which may be performed in Petitioners' office surgical suites;

       
       

       1. Subsections (4)(e) and (6)(e) which Petitioners allege impose costly equipment requirements;

          
          

       2. Subsections (4)(f), (5)(b)2., and (6)(f) which Petitioners allege impose costly personnel requirements;

       3. Subsections (3), (4), (5), and (6) which Petitioners allege establish levels of surgery unrelated to any rational classification scheme.

       
       

13. Petitioners further challenge Subsection (3)(b) and (4)(b) of Rule 64B8-9.009 relating to transfer agreements and staff privileges as they existed prior to February 17, 2000, which contain the exact same language in Subsections (4)(b) and (6)(b) of the current version of the Rule.

    PARTIES

    
    

14. Petitioner R. Gregory Smith, M.D., is a licensed medical doctor practicing in Ponte Vedra Beach, Florida. Petitioner Smith practices cosmetic surgery, plastic surgery, and oral-maxillofacial surgery in his office. Petitioner Smith has a dental degree from Ohio State University College of Dentistry, a residency in oral and maxillofacial surgery, a degree in medicine from the University of Florida College of Medicine, residency at the University of Florida with an internship in general surgery, and served as a faculty member at the University of Florida College of Dentistry in the Department of Oral and Maxillofacial Surgery at Shands Hospital Jacksonville. After specialty training in cosmetic surgery, Petitioner Smith opened his private practice in 1991.

15. Petitioner Smith performs various surgical procedures in his office, including hair transplantation, cosmetic eyelid surgery, functional eyelid surgery, cosmetic and functional nasal surgery, face, neck, and forehead lifts, tumor reconstruction,

    liposuction, abdominoplasties, breast implants, and breast reductions.

16. Petitioner Smith is also President of the Florida Academy of Cosmetic Surgery, Inc. (Academy). Petitioner Academy is an organization of multispecialty physicians who perform both cosmetic and functional surgery in their offices. Functional surgery means surgery being performed as part of a disease process or correcting some deformity and is generally not done for purely cosmetic reasons.

17. Petitioner Charles E. Graper, D.D.S., M.D., FACS, is a Florida licensed medical doctor and dentist practicing in Gainesville, Florida. Petitioner Graper received his doctorate in dental surgery from Emory University in 1971, his medical degree from Hahnemann University Medical School in 1983, and received one year of post-graduate training in general surgery at Orlando Regional Medical Center. Petitioner Graper is Board- certified by the American Board of Oral and Maxillofacial Surgery, Board-certified in general cosmetic surgery, Board- eligible in general plastic surgery, and is a Fellow of the American College of Surgeons (FACS).

18. Petitioner Graper performs in his office cosmetic surgery, functional surgery, and surgery below the head and neck which would not be authorized by his dental license. Petitioner Graper has been practicing cosmetic surgery for 20 years and has been teaching cosmetic surgery for 15 years.

    The Board

    
    

19. The Board regulates the practice of medicine in Florida, and is the agency that adopted the Rule at issue. It is comprised of 15 members appointed by Florida's Governor and confirmed by the Florida Senate.

    The FSPS and the FSD

    
    

20. The FSPS and the FSD are comprised of Florida physicians who practice in the areas of plastic surgery and dermatology.

    The FSA

    
    

21. The FSA is a not-for-profit professional membership organization representing approximately 2,000 anesthesiologists in Florida. FSA members practice in educational institutions, hospitals, ambulatory surgical centers, and physicians' offices.

22. The purpose of the FSA is to provide its members information about anesthesiology and to inform the public about issues particular to anesthesiology.

    The Hospitals

    
    

23. The Florida Hospital Association, Inc. (FHA) and the Association of Community Hospitals and Health Systems (ACHHS) are nonprofit trade associations which represent over 200 hospitals and health systems. FHA and ACHHS represent member hospitals and health systems on common interests before the branches of government, particularly with respect to regulations that impact the members.

    Rule Adoption Procedures

    
    

24. In light of the filing of the Joint Stipulation in DOAH Case No. 99-2974RP, and the filing of the Notice of Partial Voluntary Dismissal in DOAH Case No. 99-2975RP, the proposed amendments to Rule 64B8-9.009 were no longer subject to challenge, with the exception of the proposed changes to Subsections (1)(e), (2)(e), (2)(f), (2)(i), (4)(b)2., (6)(b)1.a. and (6)(b)1.b. Accordingly, on January 28, 2000, the Board filed the proposed amendments to Rule 64B8-9.009 that were no longer subject to challenge with the Department of State for adoption.

25. Liz Cloud is the bureau chief for the Department of State's Bureau of Administrative Code (BAC). Ms. Cloud serves as the filing officer for rules and regulations filed by agencies, all laws passed by the legislature and any advertisements for publication in the Florida Administrative Weekly. She oversees the publishing of the Florida Administrative Weekly and the Florida Administrative Code and has served in that position since 1977.

26. The BAC has rule-making requirements which agencies must follow in order to file a rule for adoption. When the BAC receives a rule that is filed for adoption, specific documents must be included, or the agency is required to resubmit a corrected rule packet. The BAC verifies that the certification from the Joint Administration Procedures Commission has been received and that all the required time frames have been met.

    BAC checks to ensure the rule is filed within the 90-day limit in Section 120.54(3)(e), Florida Statutes, and determines if there is a challenge to the rule. The BAC receives a weekly computer printout from JAPC on which Cloud's staff relies to determine if there are outstanding rule challenges to a rule being filed for adoption.

27. The BAC's role in the rule-making process is not merely ministerial. If, for example, an agency files a rule on which the 90-day time limit has run, the BAC rejects the rule and does not file it for adoption.

28. Nancy Murphy is a research associate at the Office of the Attorney General. With regard to rules and rule promulgation, Ms. Murphy drafts the documents necessary for rule- making, including notices of rule development, notices of rule- making, supporting documents that have to be supplied to JAPC and any documents that have to be prepared for adoption of rule.

29. Prior to filing a rule for adoption, Ms. Murphy verifies that the time frames are correct and she has all the documents that are required for adoption, including the certificate, the additional statement, and the correct copy of the rule text and coded copy, which is the underlined and struck- through version of the rule. Ms. Murphy also determines whether the rule is subject to challenge before it is filed, and if JAPC has received a written response to all correspondence.

30. Ms. Murphy was responsible for filing the amendments to Rule 64B8-0.009 for adoption. In determining which portions of the rule could be filed and which remained under challenge, she reviewed the Joint Stipulation and the Hospitals' Notice of Partial Voluntary Dismissal in DOAH Case Nos. 99-2974 and 99- 2975. Ms. Murphy redrafted and renumbered the proposed amendments to Rule 64B8-9.009 to be filed for adoption, excluding the sections that were still under challenge, after consultation from Ms. Cloud's office.

31. Ms. Murphy also met with Vicky Macintosh at the BAC to review the Rule section-by-section before filing. Ms. Murphy provided a copy of the Joint Stipulation and Notice of Partial Voluntary Dismissal to establish the provisions of the Rule still under challenge. Murphy also consulted with JAPC prior to filing the amendments to Rule 64B8-9.009 for adoption.

32. The BAC's standard operating procedure with regard to a rule challenge that challenges only a portion of a proposed rule is to accept for filing the unchallenged portions of the rule. This procedure has been strictly followed in the past, and approved by the BAC's counsel. Pursuant to that policy, the BAC permitted the Board to file for adoption those portions of Rule 64B8-9.009 not subject to challenge on January 28, 2000. The BAC received a certification from JAPC that permitted the filing of Rule 64B8-9.009 pursuant to Section 120.54(3), Florida Statutes. Based upon the evidence presented, it is concluded that, although

    the Board had considered amendments to Sections (3)(b) and (4)(b) involving transfer agreements and Level III staff privilege requirements, they were withdrawn and no longer subject to the pending litigation in DOAH Case Nos 99-2974 and 99-2975 after the Board agreed to make no change. Petitioners have not met their burden of proving that the Board materially failed to follow the rule-making procedures and requirements of Chapter 120, Florida Statutes.

    Record-Keeping Requirements: Subsection (2)

    
    

33. Petitioners presented no evidence with regard to the record-keeping requirements or the cost of the record-keeping requirements imposed by Rule 64B8-9.009(2). Accordingly, Petitioners have not met their burden of proof in challenging this subsection of the rule.

    Limitation on Types and Duration of Procedures: Subsections (2)(d), (3), (4), (5), and (6)

    
    

34. Subsection (2)(d) of Rule 64B8-9.009 states:

    
    

    In any liposuction procedure, the surgeon is responsible for determining the appropriate amount of supernatant fat to be removed from a particular patient. A maximum of 4000 cc supernatant fat may be removed by liposuction in the office setting. A maximum of 50 mg/kg of Lidocaine can be injected in the office setting.

35. Petitioners claim that a limitation of 4000 cc on liposuction is arbitrary and unreasonable since a physician cannot accurately estimate the amount of fat to be taken out. Notwithstanding, Petitioners' witnesses acknowledged that the

    risk of a liposuction procedure is heightened as the volume of fat removed and the level of anesthesia increase.

36. Petitioners' Exhibit 8, a journal article entitled "Does the Location of the Surgery of the Specialty of the Physician Affect Malpractice Claims in Liposuction?" supports this view. It states: "Large-volume liposuction (over 4000 cc) is inherently risky, but it also involves more aggressive anesthesia, adding to its danger. Risk management for liposuction should stress smaller liposuction procedures using local anesthesia, with minimal sedation."

37. Petitioners' Exhibit 8 also includes the "2000 Guidelines for Liposuction Surgery" of the American Academy of Cosmetic Surgery. Those guidelines recommend volumes of up to 4000 cc of supernatant fat removal in the routine liposuction process.

38. The Board received extensive testimony and information regarding the limitation of removal of tissue in office-based surgery as part of its rule-making process. In setting the volume limit for liposuction, the Board considered the amount of material removed, the Lidocane dosage required, and fluid replaced. The Board considered testimony supporting no limit on liposuction volume, and testimony supporting limitations on volumes as low as 2000 cc. The Board determined that the consensus among experts around the country is that 4000 cc is the appropriate ceiling to ensure the safety of patients undergoing

    liposuction procedures in the office environment. This conclusion is reasonable and amply supported by the rule-making record.

39. Petitioners presented no evidence at hearing regarding other limitations on types or duration of procedures relating to Subsections (3), (4), (5), or (6) of Rule 64B8-9.009. Accordingly, Petitioners have not met their burden of proof with respect to their challenge to these provisions.

    Equipment Requirements: Subsections (4)(e) and (6)(e)

    
    

40. Petitioners presented no evidence at hearing regarding the equipment requirements of subsection (4)(e) of Rule 64B8- 9.009, or the cost thereof. Accordingly, they have not met their burden of proof with respect to these provisions.

41. With regard to Subsection (6)(e) of Rule 64B8-9.009, the only evidence presented by Petitioners at hearing related to the requirement that at least 36 ampules of Dantrolene be available on-site at a physician's office where Level III Office Surgery is being performed.

42. Petitioners claim that the requirement in subsection (6)(e) for 36 ampules of Dantrolene is unreasonable. The cost of

    36 ampules of Dantrolene can be as much as $2,000.00 and the shelf-life of Dantrolene is approximately one to two years.

43. The evidence presented at hearing indicated that the manufacturer of Dantrolene will replace it for free if the shelf-

    life expires, and therefore, shelf-life of Dantrolene is not an economic consideration.

44. The manufacturer of Dantrolene advises that 36 ampules of Dantrolene are necessary to ensure that a patient suffering from malignant hypothermia can be saved. The more persuasive evidence supports the Board's decision to impose a requirement consistent with this recommendation.

    Personnel Requirements: Subsections (4)(f), (5)(b)2., and (6)(f)

    
    

45. Petitioners presented insufficient evidence regarding the cost of additional personnel required by Subsections (4)(f), (5)(b)2, or (6)(f) of the existing Rule. Accordingly, Petitioners have not met their burden of proof with respect to their challenge to these provisions.

46. Petitioners did, however, present some general testimony with regard to Subsection (4)(f) of Rule 64B8-9.009. The evidence was insufficient, however, to prove that Subsection (4)(f) is invalid. That Subsection states:

    Assistance of Other Personnel Required. The surgeon must be assisted by a qualified anesthesia provider as follows: An Anesthesiologist, Certified Registered Nurse Anesthetist, or Physician Assistant qualified as set forth in Rule 64B8-30.012(b)(6), Florida Administrative Code, or a registered nurse may be utilized to assist with the anesthesia, if the surgeon is ACLS certified. An assisting anesthesia provider cannot function in any other capacity during the procedure. If additional assistance is required by the specific procedure or patient circumstances, such assistance must be provided by a physician, osteopathic physician, registered nurse, licensed

    practical nurse, or operating room technician. A physician licensed under Chapter 458 or 459, a licensed physician assistant, a licensed registered nurse with post-anesthesia care unit experience or the equivalent, credentialed in Advance Cardiac Life Support or, in the case of pediatric patients, Pediatric Advanced Life Support, must be available to monitor the patient in the recovery room until the patient is recovered from anesthesia.

47. Petitioners have not presented any persuasive evidence that this requirement is vague, arbitrary, or unreasonable.

48. Evidence was presented that during meetings of the FACS, Dr. Anthony Rogers has held courses in conscious sedation to train non-anesthesiologist physicians to be providers of anesthesia for Level II Office Surgery. Dr. Rogers testified that he does not instruct surgeons on administering anesthesia to patients upon which the surgeons are performing surgery. Rather, he trains the surgeons to serve as anesthesia providers for other surgeons as well as providing them with a better understanding of "what's happening on the other side of the table."

49. The training given by Dr. Rogers consists of approximately six to eight hours of staged administration of anesthesia and discussion of hypothetical scenarios. The training does not involve the actual administration of anesthesia by the physicians-in-training.

50. Physicians attending Dr. Rogers' training course are not required to be certified in Advance Cardiac Life Support.

51. No examination is administered as part of Dr. Rogers' training course, and no certification is issued for completion.

52. Even assuming that some FACS members have completed Dr. Rogers' course, the requirement in Subsection (4)(f) for assistance by a qualified anesthesia provider has not been shown to be unreasonable.

    Levels of Surgery: Subsections (4), (5), and (6)

    
    

53. Petitioners contend that the definitions of the various levels of surgeries provided in the Rule are impermissibly vague. Subsection (4) of Rule 64B8-9.009 defines Level I Office Surgery to include:

    Pre-operative medications not required or used other than minimal pre-operative tranquilization of the patient; anesthesia is local, topical or none. No drug-induced alteration of consciousness other than minimal pre-operative tranquilization of the patient is permitted in Level I Office Surgery.

54. Subsection (5) of Rule 64B8-9.009 defines Level II Office Surgery as follows:

    1. Level II Office Surgery is that in which peri-operative medication and sedation are used intravenously, intramuscularly, or rectally, thus making intra and post- operative monitoring necessary. Such procedures shall include, but not be limited to, hemmorroidectomy, hernia repair, reduction of simple fractures, large joint dislocations, breast biopsies, colonoscopy, and liposuction involving the removal of up to 4000 cc supernatant fat.

       
       

    2. Level II Office Surgery includes any surgery in which the patient is placed in a state which allows the patient to tolerate

    unpleasant procedures while maintaining adequate cardiorespiratory function and the ability to respond purposefully to verbal command and/or tactile stimulation. Patients whose only response is reflect withdrawal from a painful stimulus are sedated to a greater degree than encompassed by this definition.

55. Subsection (6) of Rule 64B8-9.009 defines Level III office surgery as follows:

    Level III Office Surgery is that surgery which involves, or reasonably should require, the use of a general anesthesia or major conduction anesthesia and pre-operative sedation. This includes the use of:

    
    

    1. Intravenous sedation beyond that defined for Level II office surgery;

       
       

    2. General Anesthesia: loss of consciousness and loss of vital reflexes with probable requirement of external support of pulmonary or cardiac functions; or

       
       

    3. Major Conduction anesthesia.

       
       

56. The definitions of the three levels of office surgery are based on definitions developed by the American Society of Anesthesiologists and have been adopted in substantially similar form in other states.

57. The American Society of Anesthesiologists is recognized as a group of specialists in anesthesia. Petitioners acknowledged the expertise of the American Society of Anesthesiologists in developing definitions of levels of office surgery.

58. Petitioners argued that the classifications of levels of surgery in the Rule are irrational and vague because it is

    virtually impossible to differentiate between the various levels of surgery as defined in the Rule. However, the more persuasive evidence establishes that classifications were reasonably based on accepted medical standards.

59. In discussing the potential for a particular patient to drift between what has been defined as Level II anesthesia and Level III, Petitioners' witness, Dr. Rogers testified that medicine itself is vague in this area because there is no machine to tell you if a patient is unconscious. He suggested that anesthesia is a continuum and there is no clear way to define levels of surgery.

60. Dr. Carl Lentz, Board-certified plastic surgeon, supported the Rule's classification scheme. In his opinion, the differences between Levels II and III are clearly understood. When preparing for surgery, a surgeon develops an anesthesia plan. The procedures are distinctly different for each level. If, during surgery, a patient temporarily crosses the line of consciousness, which is apparent if the patient is appropriately monitored, actions to reverse the level can be taken quickly. According to Lentz, if a surgeon does not determine, prior to surgery, the level of anesthesia to be provided, the surgeon should not be performing the surgery.

61. Petitioners complain that the terms "appropriate," "adequate," and "unpleasant" are vague. Although the Petition identifies no other specific terms that are vague, during the

    hearing, Dr. Graper suggested that numerous other terms contained in Rule 64B8-9.009 are vague, including, "preoperative," "medication," "minimal," "tranquilization,," "anesthesia," "local," "drug-induced," "consciousness," "sedation," "intravenously," "intra-operative," "monitoring," "necessary," "procedures," "hernia repair"," "reduction of simple fractures," "large joint dislocation," "colonoscopy," "tolerate," "cardiorespiratory function," and "ability to respond purposefully." His testimony related to vagueness was unpersuasive and not supported by the evidence.

62. After reviewing the rule and considering the evidence, it is concluded that the Rule requirements are not unacceptably vague. The terms "adequate," "appropriate" and "purposeful" have standard meanings in the field of medicine. Likewise, the remaining medical terms in the rule are not unacceptably vague. Transfer Agreements and Staff Privileges:

    Subsections (4)(b) and (6)(b)

    
    

63. Petitioners contend that the transfer agreement and staff privilege requirements found in the rule are vague, fail to establish adequate standards for agency decisions, vest unbridled discretion in the agency, enlarge modify and contravene the

    law, are arbitrary and capricious and not supported by competent substantial evidence.

64. According to Subsection 455.517(4)(a), Florida Statutes, neither the Department of Health, nor the Board of Medicine may take any action:

    . . . that tends to create or maintain an economic condition that unreasonably restricts competition, except as provided by law.

    
    

65. However, Subsection 458.331(1)(v), Florida Statutes, provides that the Board of Medicine may establish rule standards of practice for office surgery settings, including transfer agreements, in order for the Board to determine whether a licensed doctor, subject to discipline, has practiced beyond the scope of the law or beyond his competency level.

66. Subsection (4)(b) of Rule 64B8-9.009, relating to Level II Office Surgery, states:

    Transfer Agreement Required. The physician must have a transfer agreement with a licensed hospital within reasonable proximity if the physician does not have staff privileges to perform the same procedure as that being performed in the out-patient setting at a licensed hospital within reasonable proximity.

67. Subsection (6)(b) of Rule 64B8-9.009, relating to Level III Office Surgery, states;

    Hospital Staff Privileges Required. The physician must have staff privileges to perform the same procedure as that being performed in the out-patient setting at a licensed hospital within reasonable proximity.

    
    

68. There is no transfer agreement or hospital privileges requirement for Level I Office Surgery.

69. Historically, surgeries were typically performed in hospitals, and a large body of regulation has developed to ensure patient safety. As many types of surgeries moved into ambulatory surgical centers, a new body of regulation was developed to ensure health and safety in that setting. Over the past few years, surgeons have increasingly been performing many types of surgeries in office settings with varying degrees of regulation.

70. Among the regulations ensuring safety in hospitals are requirements for an organized medical staff, and staff-developed rules to set criteria for appointment to the staff and delineation of staff privileges. These rules promote quality of care by providing a review of the qualifications of staff physicians.

71. Decisions regarding medical staff privileges are a function of the medical staff of a hospital with support and final approval by the Board of Trustees. Often, national standards and demonstrated competence provide a guide in making medical staff privilege decisions. The medical staff credentialing process is a well-established, but at times, subjective mechanism for evaluating the qualifications of a physician.

72. A transfer agreement is a contract between a hospital and an office surgeon, providing for the transfer and acceptance of a patient in an emergency situation. There is no law or regulation which requires a hospital to enter into a transfer

    agreement with any physician. In addition, there is neither specific nor consistent criteria for the contents of a transfer agreement. Some agreements are very detailed contracts and others are general.

73. During the rule-making process, the Board received testimony regarding surgeons performing Level II as well as Level III Office Surgeries and the requirement of staff privileges and transfer agreements.

74. The Board's stated purpose for the Rule requiring a physician to enter into a transfer agreement is to ensure that steps are taken in advance to care for a patient who experiences a complication during surgery which exceeds the level of care that can be provided in a given facility. However, there is no reliable evidence that transfer agreements improve the quality of patient care. In the rare event an emergency occurs in the office surgery setting, the emergency 911 is called and the patient is delivered to the hospital. The absence of a transfer agreement between the hospital and office surgeon does not delay or impede the patient's admission to the hospital and access to appropriate medical care. Under Florida law, a hospital is required to accept and care for a patient who requires emergency medical attention.

75. At the hearing, Petitioners provided significant testimony demonstrating they have been unable to obtain staff privileges and transfer agreements from certain hospitals. The

    determination of whether to grant staff privileges and/or a transfer agreement is solely the hospital's decision. And the evidence demonstrated that the determination doesn't always depend on the qualifications and reputation of the physician and the resources and circumstances of the hospital.

76. It is undisputed that hospital privileges and transfer agreements may be denied (or revoked) for reasons other than physician competence. The standards for obtaining privileges vary from hospital to hospital.

77. In fact, during the rule-making proceeding, the Board initially approved a change in Level III office surgery to remove the requirement that the surgeon have staff privileges, and recognized that:

    Hospital staff privileges may be denied for reasons other than competency, and that other documented training is comparable demonstration of competency.

    
    

78. Factors other than physician competence enter into the decision of whether hospital privileges or transfer agreements may be approved. For example, turf battles at hospitals and personality conflicts among physicians at hospitals have been considered. Moreover, some physicians have refused to proctor other physicians as a part of the credentialling process. In fact, in some hospitals, competing physicians vote upon the approval or denial of the application of an office surgeon's request for hospital privileges. The evidence further showed

    that a physician's staff privileges can be approved by the medical staff but denied by the board of the competing hospital.

79. Physician competence to perform Level II office surgery procedures is determined by Subsection (4)(d) of the Rule, "Training Required." Under this provision, in order to perform Level II surgery, the surgeon must either have staff privileges for the same procedure, or must be able to document satisfactory completion of training, or must document comparable background training or experience. Nevertheless, a competent office physician who possesses the "training required" to perform an office surgery procedure is precluded unless the physician has received either a transfer agreement or hospital privileges for that procedure.

80. The inability of a qualified office surgeon to secure a transfer agreement or hospital privileges will have a drastic impact on the physician's ability to perform office surgery. The physician's office surgery will be limited to Level I office surgery. The Rule's requirements for either a transfer agreement or hospital privileges for Level II surgeries and hospital privileges for Level III surgeries unreasonably enable a competing hospital to unilaterally refuse a transfer agreement and privileges to a qualified office surgeon for reasons unrelated to physician competence. It has the direct effect of terminating a physician's Level II and Level III office surgery practice, without regard to the fact that the physician otherwise

    meets the "training required" elements of the Rule. It is inconsistent, provides no objective, non-competitive based criteria evaluation and tends to create and maintain an economic condition that unreasonably restricts competition which is inconsistent with and contravenes Section 455.507, Florida Statutes.

81. Barbara Dame (Dame), who is a risk management consultant provided further support. She testified that over the last two years, many of her very qualified physician clients have had applications for transfer agreements summarily denied. Ms. Dame does not get involved in obtaining hospital staff privileges for her clients.

82. Conversely, Bill Bell, General Counsel for the FHA, testified that the Rule requirement for physicians performing office-based surgery to have transfer agreements has existed for a few years and he is not aware of any problems physicians have had obtaining such agreements. The evidence to the contrary is more compelling.

83. Transfer agreements can be a tool for some hospitals to control competition for surgery sites. Office surgery sites compete with hospitals for patients.

84. Dr. Brent Amey is the Vice President of St. Joseph's Baptist Health Care, and has been an emergency room physician since 1974. He is aware of instances involving "economic credentialing", and the denial of transfer agreements and staff

    privileges unrelated to competence, although not at hospitals with which he has been associated.

    CONCLUSIONS OF LAW

    
    

85. The Division of Administrative Hearings has jurisdiction over the parties to, and the subject matter of, this proceeding pursuant to Sections 120.52(8), 120.536.(1), 120.54(3), 120.56(1) and (3), and 120.569 and 120.57, Florida Statutes.

86. Subsections 120.56(1) and (3), Florida Statutes, allow any person who is "substantially affected by an agency rule" to institute a proceeding to determine whether the rule is an "invalid exercise of delegated legislative authority."

87. In order to be deemed a substantially affected person who has standing, the person or entity challenging a rule under Section 120.56 must show that it would suffer a real and sufficiently immediate injury from the challenged rule. See Lanoue v. Florida Dep't of Law Enforcement, 751 So. 2d 94, 96 (Fla. 1st DCA 1999); Board of Optometry v. Florida Soc'y of Ophthalmology, 538 So. 2d 878, 881 (Fla. 1st DCA 1988) (citing Florida Dept. of Offender Rehabilitation v. Jerry, 353 So. 2d 1230 (Fla. 1st DCA 1978)).

88. In addition, a professional association may institute a rule challenge on behalf of its members only when it demonstrates that a substantial number of its members will sustain the requisite direct injury, and thus are substantially affected by

    the challenged rule. Florida Home Builders Ass'n v. Department of Labor and Employment Security, 412 So. 2d 351 (Fla. 1982).

89. Petitioner FACS presented evidence regarding its membership and demonstrated that a substantial number of its members have or will sustain direct injury if Rule 64B8-9.009 is enforced. Therefore, FACS has standing to challenge the Rule at issue in this case.

90. Although Petitioners Graper and Smith each have hospital staff privileges at certain hospitals, they have been denied the same at others and are substantially affected by the requirements for transfer agreements and hospital staff privileges in Subsections (4)(b) or (6)(b) of Rule 64B8-9.009. They have standing to challenge the transfer agreement and staff privileges requirements in Subsections (4)(b) and (6)(b) of the Rule.

91. The evidence presented at hearing demonstrated that the FSA and the Hospitals are "substantially affected" by Rule 64B8-

    9.009. Thus, the FSA and the Hospitals have standing as intervenors in this case.

92. The burden of proof, absent a statutory directive to the contrary, is on the party asserting the affirmative of the issue in a Chapter 120, Florida Statutes, proceeding. See Florida Dep't of Transp. v. J.W.C. Co., Inc., 396 So. 2d 778, 788 (Fla. 1st DCA 1981); see also Department of Banking and Fin. v. Osborne Stern and Co., 670 So. 2d 932, 934 (Fla. 1996) ("The

    general rule is that a party asserting the affirmative of the issue has the burden of presenting evidence as to that issue.")

93. Petitioners have asserted that existing Rule 64B8-9.009 constitutes an invalid exercise of delegated legislative authority. Petitioners, therefore, have the burden of proving the invalidity of the challenged rule by a preponderance of the evidence. See St. Johns River Water Management Dist. v. Consolidated-Tomoka Land Co., 717 So. 2d 72, 76-77 (Fla. 1st DCA 1998).

    Petitioners' Challenge

    
    

94. An "invalid exercise of delegated legislative authority" is defined in Section 120.52(8), Florida Statutes, as "action which goes beyond the powers, functions, and duties delegated by the Legislature. . . ." In particular, an existing Rule will be considered an "invalid exercise of delegated legislative authority" if one or more of the following apply:

    1. The agency has materially failed to follow the applicable rule-making procedures or requirements set forth in [Chapter 120].

       
       

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

       
       

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

       
       

    4. The rule is vague, fails to establish adequate standards for agency decisions, or vests unbridled discretion in the agency;

    5. The rule is arbitrary or capricious;

       
       

    6. The rule is not supported by competent substantial evidence; or

       
       

    7. The rule imposes regulatory costs on the regulated person . . . which could be reduced by the adoption of less costly alternatives that substantially accomplish the statutory objectives.

    
    

    Section 120.52(8)(a)-(g), Florida Statutes (1999). Section 120.52(8) further provides that "An agency may adopt only rules that implement, interpret or make specific the particular powers and duties granted by the enabling statute."

95. The Administrative Law Judge assigned to hear the challenge to an existing rule, may declare all or part of the Rule invalid only if one or more of the circumstances enumerated in Subsection 120.52(8)(a)-(g) are found to exist. See Consolidated-Tomoka Land Co., 717 So. 2d at 77.

    Rule-making Procedures and Requirements of Chapter 120, Florida Statutes

96. Petitioners allege that Rule 64B8-9.009 is an "invalid exercise of delegated legislative authority" because the Board failed to follow the applicable rule-making procedures or requirements of Chapter 120, Florida Statutes. Specifically, Petitioners contend that the Board improperly filed the amendments to Rule 64B8-9.009 for adoption with the Department of State on January 28, 2000, because the rule challenges filed by the FSA and the Hospitals were still pending in DOAH Case Nos.

    99-2974RP and 99-2975RP, respectively.

97. Section 120.52(8)(a) provides that a rule is invalid if the agency has materially failed to follow the rule-making procedures of Chapter 120. Applying the standard that clear and unambiguous language must be given its plain, ordinary meaning, "materially" means: "with regard to matter and not to form, to a significant extent or degree." Webster's Third New International Dictionary (1968). The alleged failure of the Board, if any, to follow the applicable rule-making procedures is not material.

    The purpose of the steps in the rule-making process is to ensure that interested persons are aware of the intentions of the rule- making agency, and are given an opportunity to provide substantive input regarding the proposed regulation. Petitioners have not demonstrated that they were unaware of any portion of the rule-making process for the instant Rule and, indeed, participated in both public and private meetings regarding the Rule.

98. Subsection 120.54(3)(e)3., Florida Statutes, states: "At the time a rule is filed, the agency shall certify that the time limitations prescribed by this paragraph have been complied with, that all statutory rule-making requirements have been met, and that there is no administrative determination pending on the rule." Subsection 120.54(3)(e)4., Florida Statutes, further requires the Department of State to reject any rule "upon which an administrative determination is pending."

99. The evidence demonstrated that the amendments to Rule 64B8-9.009 filed for adoption with the Department of State on January 28, 2000, were no longer subject to challenge by the FSA and the Hospitals due to the Joint Stipulation and the Notice of Partial Voluntary Dismissal in DOAH Case Nos. 99-2974 and 99- 2975. The Board followed the applicable procedure.

    Hospital Privileges and Transfer Agreements Rule 64B8-9.009(4)(b) and (6)(b)

100. Section 120.536(1) provides that "An agency may adopt only rules that implement or interpret the specific powers and duties granted by the enabling statute."

101. In Section 455.517, Florida Statutes, the Florida Legislature has expressed its intent that unreasonable restrictions should not be placed on regulated professions by either the Department of Health or the regulating boards, specifically providing:

     (4)(a) Neither the department nor any board may create unreasonably restrictive and extraordinary standards that deter qualified persons from entering the various professions. Neither the department nor any board may take any action that tends to create or maintain an economic condition that unreasonably restricts competition, except as specifically provided by law.

     
     

     (b) Neither the department nor any board may create a regulation that has an unreasonable effect on job creation or job retention in the state or that places unreasonable restrictions on the ability of individuals who seek to practice or who are practicing a profession or occupation to find employment.

102. The Board relies on the following as "specific" authority" for the Rule: Subsections 458.309(1) and 458.331(1)(v), Florida Statutes; and Sections 92 and 197 of Chapter 99-397, Laws of Florida.

103. Section 458.309(1), Florida Statutes, only provides general rule-making authority and is not sufficient under Section

     120.536 as a "specific" law to be implemented.

     
     

104. Sections 92 and 197 of Chapter 99-397, Laws of Florida, establish requirements for incident reporting and office surgery registration and accreditation, and do not establish "specific authority" for the Board to adopt standards for office surgery.

105. The sole remaining statutory authority relied upon by the Board for its specific authority is:

     Section 458.331(1). The following acts shall constitute grounds for which the disciplinary actions specified in subsection (2) may be taken:

     
     

     (v) Practicing or offering to practice beyond the scope permitted by law or accepting and performing professional responsibilities which the licensee knows or has reason to know that he or she is not competent to perform. The board may establish by rule standards of practice and standards of care for particular practice settings, including, but not limited to, education and training, equipment and supplies, medications including anesthetics, assistance of and delegation to other personnel, transfer agreements, sterilization, records, performance of complex or multiple procedures, informed consent, and policy and procedure manuals. (emphasis supplied)

106. Rule 64B8-9.009, "Standard of Care for Office Surgery," was originally adopted in 1994. While the above underlined portion of Section 458.331(1)(v), relied upon by the Board, was enacted in 1998, an agency may rely on legislative authority enacted subsequent to an existing rule. However, this statutory change does not provide de facto specific authority for the existing Subsections of the Rule.

     Hospital Privileges

     
     

107. There is a complete absence in Subsection 458.331(1)(v), Florida Statutes, in particular, and in Chapter

     458 in general, of any reference to or requirement for hospital privileges as a prerequisite for licensure to practice medicine in any setting or as a standard of practice or care for any practice setting.

108. The range of powers granted to the Board to establish standards for office surgery to determine disciplinary grounds does not include "hospital privileges." The Board does not have "specific" authority to require hospital privileges as a standard for any practice setting.

109. The hospital privileges required by Rule 64B8- 9.009(6)(b) exceed the Board's grant of rule-making authority and enlarge the specific provisions of Section 458.331(1)(v) being implemented.

110. In addition, the practical effect of the requirement for hospital privileges is to authorize each individual Florida

     hospital to unilaterally establish its own standards for physicians who practice office surgery in its area. Subsections 395.0191(4) and (5), Florida Statutes, only confirm the authority of each hospital (and medical staff) to establish its own individual standards and procedures for making decisions relating to hospital privileges at the hospital.

111. There is no specific statutory authority for the Board to delegate the establishment of such standards to each individual hospital in the state. In fact, Section 458.331(1)(v) authorizes only "the Board" to establish those standards.

112. The requirement for hospital privileges is clearly arbitrary because the determination of who may have hospital privileges is left to each hospital's own judgement, and the hospital may exercise its judgement in a manner not related to physician competency. Because each hospital may exercise its own judgement, the requirement for hospital privileges fails to establish adequate standards for agency decisions.

113. The requirement for hospital privileges to perform Level III surgery found in Subsection 4(b) of the 1994 Rule and 6(b) of the January 2000 Rule is an invalid exercise of legislative authority because it violates Section 120.52 (8)(b),(c),(d),(e) and (f).

     Transfer Agreements

     
     

114. Although Subsection 458.331(1)(v) provides that the Board may establish a general requirement for "transfer

     agreements" in order to codify disciplinary standards, an important issue in this proceeding is whether the Board can mandate "a transfer agreement with a licensed hospital" (or, as an alternative, hospital privileges) as the sole means for satisfying a transfer agreement standard.

115. It is undisputed that a hospital has a unilateral right to refuse to enter into a transfer agreement with a physician and that there are no objective or consistent standards or criteria for the establishment of a transfer agreement.

116. As with hospital privileges, the requirement for a transfer agreement effectively authorizes each Florida hospital to establish its own standards for physicians who will practice Level II office surgery in their area. In effect there is no statewide standard.

117. The evidence shows no compelling need for a transfer agreement with a hospital, because a hospital must accept all patients presented to it for emergency care (to the extent that the hospital is capable of providing the care). In the rare instance of an untoward event, the Emergency medical personnel notify and transport the patient to the nearest hospital where care is available, not necessarily to the hospital where the physician practicing office surgery may have a transfer agreement or hospital privileges.

118. Section 458.331(1)(v) does not convey to the Board "specific" or "particular" powers to mandate a transfer agreement

     only with a hospital which has the unrestricted discretion to deny a transfer agreement, or to delegate to a hospital the authority to determine the standards for a transfer agreement.

119. The Board has exceeded its grant of rule-making authority by delegating and deferring to hospitals the discretion to determine whether they will enter into a transfer agreement, and the Rule enlarges the provisions of Section 458.331(1)(v), by requiring a transfer agreement with a hospital (or hospital privileges) as the sole means for meeting the "transfer agreement" provisions of the Rule.

120. In addition, it is noted that Section 458.331(1)(v) does not require transfer agreements to be adopted by the Board as a standard for any practice setting, unlike the representations made to the Board at the February 2000 Board meeting. The statute is clearly permissive.

121. The absence of any standards or criteria in statute or rule for determining whether to approve or deny a transfer agreement or for the contents of a transfer agreement suggests that this requirement is vague, fails to establish adequate standards for agency decisions, and provides unbridled discretion to the hospitals.

122. To the extent that each hospital may exercise its sole discretion to enter into a transfer agreement and thus limit a physician's practice, the rule is irrational and illogical, and therefore arbitrary and capricious.

123. Therefore, it is concluded that the requirement for a transfer agreement with a hospital in Subsection (3)(b) of the 1994 Rule and (4)(b) of the January 2000 Rule are invalid exercises of delegated Legislative authority and violate Subsections 120.52(8)(b), (c), and (d), Florida Statutes. Competent and Substantial Evidence

124. Competent substantial evidence has been described as such evidence as a reasonable person would accept as adequate to support a conclusion. Agrico Chem. Co., 365 So. 2d at 763; see also DeGroot v. Sheffield, 95 So. 2d 912, 915 (Fla. 1957) (defining "competent substantial evidence" as "such evidence as will establish a substantial basis of fact from which the fact at issue can be reasonably inferred" and "such relevant evidence as a reasonable mind would accept to support a conclusion.")

125. Competent substantial evidence is traditionally a standard of review, not an evidentiary standard. See Phillip J. Padavano, Florida Appellate Practice, Section 9.6 at 155 (2d ed. 1997). The competent substantial evidence standard is usually applied to quasi-judicial decisions. See City of Jacksonville Beach v. Coastal Dev. Of North Fla., 730 So. 2d 792 (Fla. 1st DCA 1999).

126. The competent substantial evidence standard is highly deferential to the decision-making body. Thus, a decision will be found to be based on competent substantial evidence if it is based upon evidence that is sufficiently relevant and material

     and that a reasonable mind would accept as adequate to support the conclusion reached. See DeGroot, 95 So. 2d at 916. Under this standard, the reviewing body cannot reweigh the evidence, make determinations as to credibility, or substitute its own judgment for that of the agency, even if the record contains some evidence that may support a view contrary to that of the agency. See Hillsborough Area Reg'l Transit Auth. v. Amalgamated Transit Union Local 1593, 720 So. 2d 1160 (Fla. 1st DCA 1998); Roman v.

     Unemployment Appeals Comm'n, 711 So. 2d 93(Fla. 1st DCA 1998).

     
     

127. Boxes of documentation considered by the Board in adopting the amendments to Rule 64B8-9.009 that became effective on February 17, 2000, and transcripts of numerous days of hearings and meeting conducted by the Board over a 22-month period were admitted into evidence and considered. The evidence shows that the transfer agreement and hospital privileges issues raised by Petitioners in this Rule challenge were very controversial and that the Board was presented with several alternative proposals to mitigate the over-reaching effects of the Rule while ensuring patient safety.

128. While patient safety in Florida is the highest concern, there is no credible evidence that a transfer agreement or privileges with a hospital actually improve the continuity of patient care. It is determined that Subsections (4)(b) and (6)(b) are not supported by competent, substantial evidence and violates Section 120.52(8)(f), Florida Statutes.

129. The evidence in this proceeding clearly establishes the competitive nature of the practice of medicine, including the competition for patients seeking those procedures regulated by the office surgery rule. Physicians compete against each other, and hospitals compete with physicians' offices as surgery sites.

130. By allowing hospitals to unilaterally determine which physicians qualify for transfer agreements and hospital privileges, the Rule allows a hospital and medical staff at a hospital to control the medical practice of physicians against whom the hospital or staff compete. This control "tends to create an economic condition that unreasonably restricts competition," and places "unreasonable restrictions on the ability of individuals who seek to practice," both of which contravene Subsections 455.517(a) and (b), Florida Statutes.

131. Therefore, it is concluded that the requirements for hospital privileges and transfer agreements with hospitals violate Sections 120.52(8) and 455.517, Florida Statutes.

ORDER

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

ORDERED that:

1. Subsection (4)(b) and Subsection (6)(b) of Rule 64B8- 9.009, Florida Administrative Code, are determined to be an invalid exercise of Legislative authority for the reasons stated above.

2. The remaining sections of Rule 64B8-9.009 are not determined to be invalid.

DONE AND ORDERED this 7th day of September, 2000, in Tallahassee, Leon County, Florida.

WILLIAM R. PFEIFFER

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 7th day of September, 2000.

COPIES FURNISHED:

Alfred W. Clark, Esquire Post Office Box 623

117 South Gadsden Street, Suite 201 Tallahassee, Florida 32301

M. Catherine Lannon, Esquire Lee Ann Gustafson, Esquire Department of Legal Affairs The Capitol, Plaza Level 01

Tallahassee, Florida 32399-1050

Jerome W. Hoffman, Esquire Karen D. Walker, Esquire Holland & Knight, LLP

Post Office Drawer 810 Tallahassee, Florida 32302

Christopher L. Nuland, Esquire

Law Office of Christopher L. Nuland 1000 Riverside Avenue, Suite 200

Jacksonville, Florida 32204

J. Stephen Menton, Esquire

Rutledge, Ecenia, Purnell & Hoffman, P.A.

215 South Monroe Street, Suite 420 Post Office Box 551

Tallahassee, Florida 32302-0551

Carroll Webb, Executive Director Administrative Procedures Committee

120 Holland Building Tallahassee, Florida 32399-1300

David Greenbaum

Legislative Research Director Committee on Governmental Rules

and Regulations

218 House Office Building Tallahassee, Florida 32399

Liz Cloud, Chief

Bureau of Administrative Code The Elliott Building Tallahassee, Florida 32399-0250

Tina D. White Legislative Analyst

Senate Governmental Oversight and Productivity Committee

525 Knott Building

Tallahassee, Florida 32399-1100

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 one copy of a notice of appeal with the Clerk of the Division of Administrative Hearings and a second 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: 00-001058RX

Orders for Case No: 00-001058RX