The Issue 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.
Findings Of Fact 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. 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. 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. 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. 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). 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. A third Notice of Change was published on August 20, 1999, reflecting these amendments approved on August 7, 1999, by the Board. 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. 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. 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. 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. Specifically, Petitioners challenge the following Subsections of Rule 64B8-9.009. Subsection (1)(a) which provides that the rule covers "any elective procedures for aesthetic, reconstructive, or cosmetic purposes;" 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; Subsections (4)(e) and (6)(e) which Petitioners allege impose costly equipment requirements; Subsections (4)(f), (5)(b)2., and (6)(f) which Petitioners allege impose costly personnel requirements; Subsections (3), (4), (5), and (6) which Petitioners allege establish levels of surgery unrelated to any rational classification scheme. 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 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. 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. 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. 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). 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 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 The FSPS and the FSD are comprised of Florida physicians who practice in the areas of plastic surgery and dermatology. The FSA 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. 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 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 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. 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. 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. 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. 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. 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. 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. 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. 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) 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) 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. 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. 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." 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. 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. 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) 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. 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. 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. 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. 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) 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. 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. Petitioners have not presented any persuasive evidence that this requirement is vague, arbitrary, or unreasonable. 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." 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. Physicians attending Dr. Rogers' training course are not required to be certified in Advance Cardiac Life Support. No examination is administered as part of Dr. Rogers' training course, and no certification is issued for completion. 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) 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. Subsection (5) of Rule 64B8-9.009 defines Level II Office Surgery as follows: 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. 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. 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: Intravenous sedation beyond that defined for Level II office surgery; General Anesthesia: loss of consciousness and loss of vital reflexes with probable requirement of external support of pulmonary or cardiac functions; or Major Conduction anesthesia. 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. 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. 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. 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. 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. 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. 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) 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. 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. 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. 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. 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. There is no transfer agreement or hospital privileges requirement for Level I Office Surgery. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Transfer agreements can be a tool for some hospitals to control competition for surgery sites. Office surgery sites compete with hospitals for patients. 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.
The Issue The ultimate issue to be resolved in this proceeding is whether the SSDB's proposal to construct a freestanding ambulatory surgery center in Volusia County, Florida, should be approved or denied. SSDB and the Department contend that the proposal meets statutory criteria and comports with the Department's rules. SSDB and the Department contend that there is a need for the facility and that SSDB is fully competent to construct and operate the facility. OBMH and HHMC contend that there is no need for the proposed facility, that the facility is not likely to be an economically viable venture, that the facility would injure existing businesses, and that the application should be denied because SSDB did not file a letter of intent with the local health council in a timely manner.
Findings Of Fact SSDB is a corporation that is a wholly owned subsidiary of Surgical Inc. Eighty percent of the stock of Surgical Services, Inc., is owned by American Medical International, Inc., a large, multinational health care corporation which owns and operates hospitals and other health care services. American Medical International is the third largest health care provider in the United States. The remaining 20 percent of Surgical Services, Inc., stock is owned by Randall L. Phillips, the company's president. SSDB is proposing to construct and operate a freestanding ambulatory surgery center in Daytona Beach, Volusia County, Florida. The service area for the proposed facility would be Volusia County. This facility would house four operating rooms and would be designed to handle all types of surgical procedures that can be performed on an outpatient basis. SSDB has entered into a contract to purchase land that provides a suitable site for the facility. It is located at the intersection of Clyde Morris Boulevard and Mason Avenue in Daytona Beach. The contract price for the property is $270,000. In addition to the cost of land acquisition, the preopening costs of the project would total $2,080,000. That amount would cover legal and accounting fees, architectural and engineering fees, a site survey, consulting fees, construction costs, movable equipment costs, and other engineering expenses. The preopening cost estimates are less than the $2,500,000 estimated in the original Certificate of Need application. The reduction is attributable to cost efficiencies primarily in selection and purchase of equipment. The costs estimated by SSDB are adequate to cover all preopening expenses and to provide an adequate facility. Financial support for the facility will be provided by American Medical International. This will include an equity contribution, a loan, and all necessary working capital. American Medical International has committed to provide financing adequate to construct and operate the facility. American Medical International has the financial resources to fulfill this commitment. The facility proposed by SSDB would be 15,500 square feet in size. The design is adequate for the proposed use and satisfies applicable health care facility standards and state and federal laws. The equipment proposed for the facility is sufficient to allow the handling of anticipated types of procedures. The facility will be open to all physicians qualified to perform the types of surgery that can be tone within an ambulatory setting. The facility will accept Medicare patients. The facility will admit any patient scheduled by surgeons, and ability to pay will not be a criterion for admission. SSDB has developed a marketing program to attract physicians and patients to the facility. SSDB has proposed adequate staffing for its facility and will be able to fulfill its staff requirements. SSDB is fully competent, given its backing by American Medical International, to construct and operate the proposed facility. OBMH is a Florida nonprofit corporation. It operates a 205-bed hospital in Volusia County, Florida, and renders medical services to residents of Volusia County and surrounding areas. OBMH presently renders ambulatory surgical services on an outpatient basis in connection with its surgery department. MEMO is a special taxing district. It operates a 345-bed hospital in Volusia County, Florida, and services residents of Volusia County and surrounding areas. HEM has a same-day surgery program and renders ambulatory surgical services through this procam on an outpatient basis. Ambulatory surgical services can be performed either in a hospital- based setting such as operated by OBMH and HHMC, or in a freestanding facility such as proposed by SSDB. HHMC presently has 12 general-purpose operating rooms. The HHMC same-day surgery program utilizes these rooms, but has a separate admitting area and waiting room that is utilized for inpatient surgery cases. OBMH has four general-purpose operating rooms. Outpatient or ambulatory surgeries are regularly performed in these rooms. There are presently 41 general-purpose operating rooms in Volusia County's eight hospitals. Outpatient or ambulatory surgical procedures are performed in these rooms. The Florida Health Care Plan is a health maintenance organization located in Volusia County. It has three operating rooms here inpatient or ambulatory surgery procedures are performed for members of the organization. The Neuman Dye Institute is a freestanding ambulatory surgical center licensed by the Department. It is located in DeLand, Volusia County, Florida. It has two operating rooms which are used for treatment of eye disorders. Approximately 15 percent of the surgeries performed in hospitals in Volusia County during the year August 1, 1982, through July 31, 1983, were done on an outpatient basis. The total number of surgical procedures performed in Volusia County has increased only slightly during the past three years. The number of impatient procedures has decreased, while the number of outpatient procedures has increased rather dramatically. This increase reflects a national trend which increasingly favors ambulatory or outpatient surgeries. It is likely that the number of outpatient cases as a percentage of total surgeries will continue to increase in Volusia County. The 15 percent figure for outpatient surgeries relates only to those procedures conducted in a hospital setting. It does not include procedures performed at the health maintenance organization, the Neuman Eye Institute, or in physicians offices. One major source of patients for ambulatory surgery programs is elective plastic surgery procedures. Two of the plastic surgeons who practice in Volusia County have their own operating rooms where ambulatory surgical procedures can be conducted. These physicians are not likely to use a separate, freestanding facility. The remaining plastic surgeons in Volusia County have utilized the same-day surgery facility at HHMC and have expressed satisfaction with that program. Existing facilities in Volusia County are adequate to accommodate the anticipated growth and the number of outpatient or ambulatory surgeries that will be performed during the next three years in Volusia County. Hospital surgical facilities in Volusia County are significantly underutilized at present. Existing facilities have the capacity to accommodate a more dramatic increase in total surgical procedures and in outpatient surgical procedures than is anticipated over the next three years. Given the existence of the hospital facilities, the Neuman Eye Institute, the health maintenance organization, and operating rooms located in physicians' offices, adequate facilities exist to accommodate the increased demand for outpatient surgeries that is anticipated in Volusia County. SSDB is proposing to offer its services to the public during the first year of operation for an average charge of $490 per procedure. The cost would increase to $540 for the second year. The average per-case cost for outpatient surgeries at HHMC is $393. The average per-case cost at OBMH is $439. Given the fact that one case can Involve multiple procedures, it is evident that existing facilities in Volusia County are charging less for ambulatory surgical services than SSDB proposes to charge. While some increases in present charges are likely, given general trends, it is not likely that HHMC or OBMH will charge as much for outpatient surgical procedures as SSDB proposes to charge. It has been asserted that HHMC's charges for outpatient surgeries are inadequate to cover HHMC's costs and that the charges are being kept low artificially. The evidence is to the contrary. HHMC's charges for outpatient surgeries are adequate to meet the facility's expenses. The facility proposed by SSDB does not present any cost savings to patients. Services at the proposed facility would be more expensive than the same services at existing facilities in Volusia County. Freestanding surgical centers have generally presented some advantages to physicians no consumers. In many places, outpatient surgeries are difficult to schedule in a hospital setting because they are susceptible of being bumped by surgeries that are considered more urgent. Furthermore, in many locations, physicians have had difficulty scheduling their outpatient surgeries in blocks of cases so that they can perform them more efficiently. Those problems have not occurred in Volusia County. Physicians who regularly perform outpatient surgeries in hospitals in Volusia County have been able to schedule their cases in blocks and have experienced no difficulties with bumping. SSDB has projected that its proposed facility would experience an acceptable loss during its first year of operation, but that it would show a net profit during its second and third years of operation. These estimates are based upon projections that 2,160 procedures would be performed at the facility at an average rate per procedure of $490 during the first year and 2,640 procedures at an average rate of $540 during the second year. These projections are unrealistic. The projections contemplate that approximately one-third of all outpatient surgeries in Volusia County would be performed at the proposed facility. The projections also contemplate a very dramatic increase in the number of outpatient surgeries and that more than 60 percent of the increased outpatient procedures would be done at the proposed facility. While it is likely that the number of outpatient surgeries performed in Volusia County and elsewhere will continue to increase as a percentage of total surgeries and that eventually as much as 30 percent of all surgeries performed in Volusia County will be done on an outpatient basis, the increase is not-likely to occur in a single year. Even if It did, it is unlikely that local physicians and consumers cold so dramatically reject present facilities as SSDB projects. Indeed, there is no evidence from which it could be concluded that there is any dissatisfaction on the part of physicians or consumers in Volusia County with present facilities. The evidence is to the contrary. A second reason why the projections are inaccurate is that in making the projections SSDB ignored the existence of the Neuman Eye Institute, the health maintenance organization, and operating rooms that have been established in physicians' offices. A third reason is that SSDB proposes to provide services at a higher cost than at existing facilities. A fourth reason is that SSDB has underestimated the proportion of Medicaid and Medicare cases that are likely to be performed at the facility at a cost that is less than the average cost per procedure proposed by SSDB. It is unlikely that SSDB could operate at a profit during its first three years of operation. At the time that SSDB filed its letter of intent and application with the Department of Health and Rehabilitative Services, there was no local health council in existence Volusia County, Florida. SSDB did not file a copy of its letter of intent or application with the local health council and would have had no place to file it if it attempted to do so.
Recommendation That a final order be entered by the Department of Health and Rehabilitative Services denying the Application for Certificate of Need filed by Surgical Services of Daytona Beach, Inc. RECOMMENDED this 31st day of October, 1983, in Tallahassee, Florida G. STEVEN PFEIFFER Assistant Director Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 31st day of October, 1983. COPIES FURNISHED: Fred Baggett, Esq. Michael J. Cherniga, Esq. Post Office Drawer 1838 Tallahassee, Florida 32302 Jay Adams, Esquire Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 Richard B. Orfinger, Esq. 619 North Grandview Avenue Daytona Beach, Florida 32018 Harold C Hubka, Esq. Post Office Box 5488 Daytona Beach, Florida 32018 Mr. David Pingree, Secretary Department of Health and Rehabilitative Services Winewood Boulevard Tallahassee, Florida 32301
Findings Of Fact The applicants, MediVision of Miami, Inc., and MediVision of Northern Dade County, Inc., are wholly owned subsidiaries of MediVision Inc., which maintains its corporate offices in Boston, Massachusetts. MediVision, Inc., was incorporated in January, 1984, to promote the development of outpatient eye surgery, in part through the development and operation of outpatient eye surgery centers. MediVision of Miami, Inc., and MediVision of Northern Dade County, Inc., will each be responsible for the development and operation of the projects proposed in their respective applications. MediVision, Inc., was organized by several individuals in response to a study conducted by Bain and Company, a strategic consulting firms as part of a consulting engagement in which those persons were involved. The study disclosed several demographic and health care delivery trends which prompted MediVision management to pursue the development of outpatient eye surgery centers. Those trends are: an overall movement of all types of surgery from an impatient to an outpatient setting; the increase in the nation's elderly population, and the fact that the likelihood of a person developing cataracts increases dramatically with age; the technological improvements in the provision of cataract surgery; the growth in the number of cataract surgeries performed nationally; and, a change in the manner in which Medicare reimburses a facility for outpatient surgery performed upon Medicare recipients. Medicare, since 1982, has reimbursed licensed freestanding ambulatory surgical facilities at a flat rate for the provision of such surgery, with no cost to the patient. For the same surgical procedures performed in a hospital outpatient setting, Medicare will reimburse the facility its costs of providing the surgery; the patient is responsible to pay the Medicare deductible and 20 percent co-insurance. Various subsidiaries of MediVision Inc., presently operate eight outpatient eye surgery centers nationwide; two are located in Florida. Other MediVision subsidiaries are developing three additional centers in Florida, pursuant to certificates of need issued by the Department of Health and Rehabilitative Services. Both parties employed the same quantitative need methodology. The methodology employs the following steps: acquire data regarding number of impatient and outpatient surgical procedures performed by existing providers; using this data, calculate current overall surgical use rate and outpatient surgical use rate for county; using the projected population for the year in question and the current use rate, calculate projected number of surgeries; multiply total projected surgeries by 40 percent to establish total outpatient surgery pool for year in question; subtract from result of step 4, all outpatient surgical procedures projected to be performed in hospitals and operating freestanding ambulatory surgery centers; subtract financial break-evens of all certificate of need approved freestanding outpatient surgery centers from this pool; and, after subtractions the number of surgical procedures remaining are compared to the break-evens of certificate of need applicant at issue. If the pool is larger than break-evens the condition is satisfied. If the pool is smaller than break-evens the condition is not satisfied. The quantitative methodology provides a reasonable approach to the evaluation of need for ambulatory surgical facilities. The basic methodology has been employed by the Department since 1982; in December, 1985, the Department began to employ a "40 percent outpatient factor" in implementing the policy. Accordingly, looking toward the planning horizon of 1988, the methodology projects that 40 percent of all surgeries in Dade County will be performed on an outpatient basis. The 40 percent outpatient factor is reasonable for use in these proceedings. The prevailing literature suggests that 40 percent of all surgeries can be expected to be performed on an outpatient basis. Within Florida, many counties are already performing in excess of 30 percent of all surgeries on an outpatient basis. Trends in health care delivery and reimbursements including the growth in pre-paid health care organizations, such as health maintenance organizations; professional review organizations, which monitor the appropriateness of hospital admissions; and Medicare reimbursement incentives will contribute to an increase in the percentage of surgeries performed in an outpatient setting. While employing the same quantitative need methodology, the parties' health planning experts arrived at different conclusions as to whether the methodology projects need for the facilities at issue in these proceedings. The differences in outcome are attributable to two issues: (1) the calculation of a base-year use rate; and (2) the calculation of "break-evens" for previously approved, but non-operational, ambulatory surgical facilities. Each expert relied upon the same basic data source in calculating a base-year surgical use rate, employing data collected by HRS and reported in the most current State Agency Action Report prepared by the Department relative to Dade County. Such Action Report (CON Action No. 4095) lacked complete data regarding the total number of surgeries performed in Dade County during the base-year (1984-5), in that six of the thirty-three acute care hospitals in Dade County failed to report. Because it is necessary to have complete data in order to establish an accurate base-year surgical use rate, Mark Druash who was engaged to undertake a need analysis by the applicants, referred to earlier State Agency Action Reports to acquire surgical procedure data for the six hospitals which had failed to report. Such documents are reliable data sources upon which to base a need analysis. In calculating a county's surgical use rate, health planners take into consideration the total population within the county. Accordingly, the total number of surgeries provided within the county must also be considered. In that six Dade County hospitals failed to report data and HRS' health planner did not acquire data relative to those facilities, the surgeries performed at those hospitals were not included in his calculation of a surgical use rate. If the total population of a county is considered in calculating a surgical use rate, but something less than the total number of surgeries is considered, the calculation results in an artificially deflated use rate. As the base-year use rate drives all of the remaining calculations in the quantitative methodology, an error in the calculation of the use rate will be carried through the entire methodology. The ultimate effect of a deflated use rate is to project a smaller number of surgical procedures, as compared to a use rate calculated upon complete data. HRS calculated a base-year surgical use rate for Dade County of 78.2 surgeries/1000 population. MediVision calculated a base-year surgical use rate of 92.8/1000 population. The variance in the use rates is attributable solely to the fact that Druash acquired and employed in his calculations surgical procedure data from all Dade County hospitals previously relied upon by HRS; while HRS relied upon incomplete data. In that Druash's calculations are based on a complete data based the surgical use rate of 92.8/1000 population is found to be more accurate and reliable than the rate of 78.2/1000 population calculated by HRS from incomplete data. The parties differ in their calculation of "break- evens for previously approved, but not yet operational, ambulatory surgical facilities. The break-even calculation is an integral part of the quantitative need methodology. The purpose of subtracting from the available outpatient surgical pool the "break-evens" of approved, but not yet operational ambulatory surgical facilities is to assure that there exists need for the project proposed adequate to allow both such project and previously approved facilities to operate in a financially viable manner. The "break-even" approach is also intended to promote competition; rather than assuming that all of the procedures projected by a facility will be performed in such facility; the approach allocates to the facility only that number of procedures it needs to generate sufficient revenues to cover its expenses. Druash who participated in the development of the quantitative methodology during his tenure with HRS, testified that the "break-even" approach was selected because it would promote competition among providers by approving enough applicants so that they would be "hungry" for the residual surgeries projected by the methodology. The purpose of calculating a financial break-even is to ascertain at what point a project's cash flow will equal its expenditures. The generally accepted method for calculating a financial break-even requires that fixed costs be separated from variable costs. The concept of variable costs is the basis for the computation of a break-even. Fixed costs are those which remain constant regardless of the volume of business conducted by an entity; variable costs are those that change directly with volume. In the operation of an ambulatory surgical facility, virtually all expenses related to medical supplies are variable. If no patients are treated, no medical supplies are needed, and no expenses are incurred. If 100 patients are treated, 100 units of medical supplies are needed, with resultant expense. Certain expenses involved in the operation of an ambulatory surgical center are totally fixed, such as debt service and property taxes. All other expenses are variable to some degree e.g. salaries, utilities, and maintenance. Depreciation and amortization of property and equipment are not considered as expenses in a break-even analysis, as those items do not represent cash expenditures. As mere accounting recognitions of prior investment, depreciation and amortization should not be included in a calculation of a cash flow break-even. HRS' methodology for calculating financial break-evens for ambulatory surgical procedures treats all expenses as fixed, and includes amortization and depreciation among those expenses. By HRS' admissions the Department, "in lieu of attempting to determine what is fixed and what is variable . . . will use a somewhat more crude method". Where a financial break-even is calculated treating all costs as fixed, the resulting break-even number is artificially inflated. By the Department's reckoning, the effect of treating all expenses as fixed is to "add a cushion" to its approvals of prior applications. HRS' expert acknowledged, however, that differentiating between fixed and variable costs in performing a financial break-even analysis is the "preferred methods no question". Lovell Jones, a certified public accountant and expert in health care finance, performed revised break-even analyses for previously approved, but not yet operational, ambulatory surgical facilities. Jones first acquired expense and revenue data from the certificate of need applications submitted by previously approved applicants. Then, treating only medical supplies as variable expenses, and excluding amortization and depreciation from the list of fixed expenses, he calculated the actual financial break-even of each approved, but not yet operational, facility. Jones' analysis finds the collective break- even of all previously approved, but not yet operational, facilities to be 17,996 procedures, whereas the Department's "crude" analysis results in a collective break-even of 25,736. Jones' method of calculating break-even, which was agreed to be technically correct by both parties, is more accurate and reliable than the method employed by the Department. Using the agreed-upon quantitative methodology, the surgical use rate calculated by Druash, and the break-even numbers calculated by Jones, there is projected to exist in 1988 a pool of 5006 outpatient surgical procedures that could be provided by the applicants in these proceedings. Subtracting the break-even numbers of the two proposed facilities, there will exist a residual pool of greater than 3600 procedures. Accordingly, there exists a quantitative need for the two proposed facilities. Furthers the residual pool of greater than 3600 procedures represents an adequate "cushion" to satisfy the concerns of HRS that previously approved facilities be given the opportunity to operate in a financially viable manner. The proposed facilities will improve access to services for both Medicare and indigent patients. Medicare patients receiving surgery at the facilities will be treated free of cost, with the Medicare program having full responsibility for payment. All other patients will be treated at the facilities regardless of ability to pay. The proposed facilities will promote competition in that management intends the charges to commercial patients to be less than the prevailing charges in the community. Where an ambulatory surgical facility enters a market, hospital charges for similar services tend to decrease. The proposed facilities will promote cost containment, as it is more costly to render care in a hospital outpatient department than in a freestanding ambulatory surgical facility. Hospital outpatient departments, which are reimbursed by Medicare for their costs of providing services, do not have the same incentive to reduce costs as do freestanding ambulatory surgery facilities, which are reimbursed at a predetermined flat rate for the provision of services. Accordingly, Medicare has encouraged the use of freestanding ambulatory surgical facilities by incurring all responsibility for payments at no cost to Medicare recipients. The Department's sole concern regarding the financial feasibility of the proposed facilities arises out of its position that there exists no need for the facilities. Accordingly, the Department questions whether the facilities will enjoy utilization sufficient to generate the revenues necessary to their viable operation. In that need for the facilities has been found to exist, it follows that the facilities will be able to generate adequate numbers of surgeries to achieve break-even in their second years of operation. Several other factors indicate that the facilities will experience utilization sufficient to achieve break-even in their second years of operation: The marketing and community education activities proposed by the applicants will encourage utilization. In its existing surgical facility in Orlando, MediVision, Inc., has undertaken similar activities, which have resulted in substantial surgical referrals to the facility; There exists a residual pool of approximately 5,000,000 untreated cataracts nationally; Medicare reimbursement policies which allow Medicare recipients to receive treatment at licensed freestanding ambulatory surgical centers at no cost to the recipient will encourage utilization of the proposed facilities; The applicants' pricing structure, for both Medicare and commercial patients, will encourage utilization of the proposed facilities; and Two local ophthalmology group practices have expressed strong interest in performing surgery at the proposed facilities. Each group presently performs in excess of 1000 surgeries annually, which volume is greater than the break-even volume necessary to be achieved at each facility.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Lawn it is RECOMMENDED that a Final Order be entered approving the applications of Petitioners to establish and operate freestanding ophthalmic ambulatory surgical centers in Dade County, Florida. DONE and RECOMMENDED this 6th day of June, 1986, at Tallahassee, Florida. LINDA M. RIGOT, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 6th day of June, 1986. COPIES FURNISHED: William Page, Jr., Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 Robert A. Weiss, Esquire The Perkins House, Suite 101 118 North Gadsden Street Tallahassee, Florida 32301 Richard A. Patterson, Esquire Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 =================================================================
The Issue This case arises out of Orlando Regional Medical Center's objection to the issuance of a Certificate of Need to Surgical Services of Orlando, Inc., for the construction and operation of an ambulatory surgical center in Orlando, Florida. At the formal hearing, Orlando Regional Medical Center called as witnesses, Herbert E. Straughn, Norton Baker, Terry Weibley, Marlene Mariani, Michael L. Schwartz, Janice Smith, Richard Douglas Signer, Cathy Canniff Gillam, Jack Bradley, Barbara W. Miner, John Bozard and Stephen Haar. The Intervenor, Surgical Services of Orlando, Inc., called as witnesses, Steven Haar, Janice Smith, John Bozard, Michael Means, Jerry Senne, James Leveretee, Stephen Foreman, John S. Lord, Robert C. Klettner, Albert S. Bustamante, Pedro Diaz- Borden, Alberto J. Herran, Marianna Johnson, Richard Toole, Don Newton, Hank Gerken, Gordon Kiester, Leonard J. Levine, Rufus Holloway, Brenda Brinkman, Betty Barker, Wayne Deschambeau, Mark Richardson and Rick Knapp. Department of Health and Rehabilitative Services called as its only witness, Mr. Thomas Porter. Surgical Services of Orlando, Inc., offered and had admitted into evidence 33 exhibits. At the formal hearing, the Hearing Officer reserved ruling upon SSO Exhibit No. 14 and that exhibit is admitted. Orlando Regional Medical Center offered and had admitted into evidence, 9 exhibits. At the formal hearing, the Hearing Officer reserved ruling upon SSO Exhibit No. 14 and that exhibit is admitted. Orlando Regional Medical Center offered and had admitted into evidence, 9 exhibits. At the formal hearing, Orlando Regional Medical Center was given permission to file a late-filed exhibit with Surgical Services of Orlando, Inc., and the Department having the opportunity to object to said exhibit. That exhibit has been filed as Orlando Regional Medical Center Exhibit No. 9 and consists of excerpts from the Department of Health and Rehabilitative Services file relating to this application. That exhibit is admitted. The Department of Health and Rehabilitative Services offered and had admitted into evidence one exhibit. A map of Orlando reflecting the location of the various hospitals in Orange County was admitted as joint exhibit 1. Subsequent to the formal hearing, each of the parties submitted proposed findings of fact and conclusions of law for consideration by the Hearing Officer. To the extent that those proposed findings of fact and conclusions of law are inconsistent with this order, they were considered by the Hearing Officer and rejected as being unsupported by the evidence or as unnecessary to the resolution of this cause.
Findings Of Fact Surgical Services of Orlando, Inc., (hereafter referred to as SSO), is a Florida corporation based in Orlando, Florida. The stock of the corporation is owned in equal shares by Steven Foreman, Dr. Rufus Holloway and Randall Phillips. Mr. Steven Foreman is a life underwriter and financial consultant, and real estate investor in the Orlando area. He is secretary and director of SSO. Dr. Rufus Holloway is an otolaryngologist in the Orlando area and is treasurer and a director of SSO. Randall Phillips is a hospital administrator presently employed by American Medical International, Inc. Orlando Regional Medical Center, Inc. (hereinafter referred to as ORMC) is an existing hospital located in Orlando, Florida. It is a not-for-profit regional tertiary care center with 1035 beds and 24 operating rooms. ORMC has two main divisions, the Orange Division and the Holiday Division and is presently constructing a new facility, Sand Lake Division, which will open sometime in mid 1985. The Sand Lake Division will have 4 operating rooms and 150 beds. Dr. Rufus Holloway and Steven Foreman have committed their personal resources to provide financial support for the complete development and operation of the applicant's proposed ambulatory surgical center. The facility will be constructed by a partnership, the Kaley Avenue Medical Partnership of Dr. Holloway, Mr. Foreman and Richard Toole, a citrus owner in the Orlando area, and will be leased to SSO. Two banks in the Orlando area have given commitments to provide the necessary financing for the proposed facility and start-up expenses. Pan American Bank has committed to provide a $2.5 million loan for the construction and equipping of the building and $750,000 line of credit. Dr. Holloway and Mr. Foreman, and the parties of the Kaley Avenue Partnership have sufficient financial resources to fulfill their commitments to the proposed project. The proposed building will be a one floor building containing 15,000 square feet. The total cost for the project will be $2,737,636. The building is to be constructed and equipped by the Kaley Avenue Medical Partnership and leased to SSO at $16 per square foot. The proposed site of the facility is on Kaley Avenue within two or three blocks of ORMC. Its service area will include all of Orange County. The facility will contain five operating rooms with only three of the rooms being completely equipped initially. These rooms will be used for general and local anesthesia. The remaining two rooms will be equipped as demand requires. The applicant has budgeted $743,000 for initially equipping the facility with an additional $160,000 required to equip the two remaining operating rooms. The equipment proposed by the applicant is adequate to perform those procedures which the applicant proposed to perform at its facility. In addition to the five operating rooms, the center will include laboratory, x-ray, administrative areas, as well as holding and recovery areas for the patients. The applicant projects a total number of procedures in the first year of 1,800 and 2,760 in the second year of operation. Based upon a Medicare utilization rate of 15 percent SSO projects an operating loss in the first year of $223,000 with the facility making a profit in the second quarter of the second year and generating a total profit of $766,000 in the second year. The projected break-even point is 2,448 procedures within a year. Projected revenues are based upon an average charge per case of $575. SSO also intends to accept Medicaid patients. Presently, Medicaid does not reimburse freestanding ambulatory surgical centers. Medicaid charges would be included as charity cases in the projected bad debt of 6 percent of gross revenues. Based upon an inflation rate of 8 percent per annum when SSO begins operation in January, 1986, its average charge per case will be competitive with other facilities in the area providing ambulatory surgical services. Medicare now reimburses 100 percent of the facility charges in a freestanding ambulatory facility and 80 percent for outpatient surgery in a hospital setting. Prior to opening, SSO will implement a marketing program directed to four different target groups: physicians, consumers (patients), employers and insurance carriers. SSO has retained a marketing expert who has prior experience in marketing ambulatory surgical care in Florida. Similar marketing has proven successful for other freestanding ambulatory surgical centers in Florida. SSO has budgeted $20,000 for pre-opening marketing expenses and $35,000 for the first year of operation. It is difficult upon this record to make a truly accurate comparison of outpatient surgical rates in existing facilities to the proposed average charge of SSO. ORMC presented evidence that the present average charge in ORMC and three other hospitals per outpatient case is as follows: ORMC $417.19 Florida Hospital $469.86 Winter Park $512.21 Orlando General $560.81 No average charges were presented into evidence for West Orange Hospital, Lucerne Hospital, or Brookwood Hospital. The evidence established that 8 percent is a reasonable inflation or increase rate for health care charges over the next two years. Applying an 8 percent inflation rate to the above average charges these charges for 1986, SSO's first year of operation would be: ORMC $486.61 Florida Hospital 548.04 Winter Park 597.44 Orlando General 654.13 In calculating its present average charge of $417.19, ORMC did not include those outpatient surgeries performed at the Orange Division which are charged at inpatient rates. A memo dated January 19, 1984, to John Bozard, ORMC Vice President for Finance, from Steve Horr, ORMC Assistant Controller/Reimbursement, reflects that Holiday Division had 484 outpatient surgical cases which are estimated to generate gross revenues of $228,547. This results in an average charge per case for the month of December 1983 of $472.20. It is concluded that in 1986 the SSO projected average charge of $575 will be competitive with those existing facilities in the Orange County area. There is presently no rule which contains a specific methodology for determining need for ambulatory surgery centers. HRS uses a methodology which is based upon policy but has not been proposed or promulgated as a formal rule. The present methodology utilizes the total surgery cases for the most recent 12 month period to determine a surgical utilization rate per 1,000 population. By separating inpatient and outpatient surgeries for the same 12-month period, a percentage ratio of outpatient surgery cases to total surgeries is established. Applying the utilization rate to future projected population, HRS then determines the total projected surgeries for future years and from this number calculates the projected outpatient surgeries which will be performed in existing facilities. Literature relating to ambulatory surgeries projects that 18 to 40 percent of all surgical procedures performed could be performed in an outpatient setting. In calculating total potential surgeries HRS utilizes 29 percent as the potential surgeries that can be performed in an outpatient setting. The 29 percent factor is the mean of 18 percent to 40 percent and appears reasonable in light of the fact ORMC, Holiday Division, Winter Park Memorial and Orlando General had outpatient surgery of 29.4 percent, 30.1 percent and 30.6 percent respectively for 1983. Applying the 29 percent factor to projected total surgeries, HRS calculates the projected potential ambulatory surgery for a given year in the future. Subtracting those outpatient surgeries which will be performed in existing facilities from the total potential outpatient surgeries provides the unmet need for outpatient surgical care. This need is reflected in total cases. In evaluating ambulatory surgical applications, HRS utilizes a two year planning horizon. It is projected that SSO would begin operation January 1, 1986, and therefore under the HRS methodology, 1986 and 1987 become the relevant years for the HRS methodology, 1986 and 1987 became the relevant years for looking at projected need. Using the methodology described above, HRS projects the potential number of outpatient surgical cases which could be performed in other than a hospital setting to be 7,203 and 7,347 for 1986 and 1987, respectively. HRS projects the break-even level of the SSO facility at 2,693 surgical cases per year. Subtracting the SSO break-even factor from 7,203 and 7,347 results in an unmet need even after the SSO facility is in operation of 4,510 and 4,654 surgical cases in 1986 and 1987. HRS calculated the outpatient utilization rate in existing hospitals in 1983 to be 15.3 percent. If the unmet need of 4,510 and 4,654 in 1986 and 1987 was met by these existing facilities, that utilization rate would increase to 24 percent or approximately 1 1/2 times the 1983 rate. The projected utilization for the SSO facility for 1986 and 1987 will constitute only about 20 percent and 30 percent respectively of the unmet need for outpatient surgery in those years. The applicant in projecting need used a five year planning horizon to project need for ambulatory surgical services in Orange County for the year 1989. Under SSO's methodology, an outpatient utilization rate of 30 percent, 35 percent and 40 percent was used to project the total potential outpatient or ambulatory surgeries for the year assuming a total surgical utilization rate of 101.45 cases per thousand. Using these assumptions, the applicant projected unmet need for ambulatory surgeries in Orange County in 1989 as: Percentage of Ambulatory Surgery Unmet Need 30% 6,357 35% 9,246 40% 12,136 Although the projected unmet need is somewhat lower than that projected by HRS, it does reflect a need for the SSO facility. The methodology used by ORMC utilizes what ORMC's experts described as the "excess capacity theory." This methodology is based upon the assumption that no need exists for an ambulatory surgical center until such time as all excess capacity in the existing operating suites in Orange County is utilized. Using this approach, ORMC contends that of the 79 total operating suites in Orange County, there are presently 39 excess operating suites available to perform outpatient surgery. By multiplying total number of hours per day per operating room times 260 days, ORMC calculates the total available hours of operation of an operating suite and by multiplying this number times the total number of suites, the total available hours or operating room time for a facility is determined. The total available hours is then divided by the average operating room time for all procedures performed to determine the total number of potential procedures. Using this approach, ORMC's expert opined that there is potential for 95,513 - 98,980 total surgical cases in the existing 79 operating rooms in Orange County These 79 rooms include the 4 new operating suites in ORMC's Sand Lake facility as well as the 4 suite in Florida Hospital's new freestanding ambulatory surgical center. Subtracting the total procedures of 47,712 from the potential capacity, ORMC projects an available excess capacity for growth of 47,801 to 51,268 surgical cases in Orange County. Also using total available hours, hours per average procedure and total hours required for procedure presently being performed, ORMC's expert calculated the number of operating suites presently required. By subtracting this number from the number of existing suites, the ORMC expert concluded that there are presently 39 excess operating suites in Orange County. Once the ORMC Sand Lake facility and the Florida Hospital Freestanding Ambulatory Center (FAC) open, there will be a total or 79 operating suites in Orange County. These are divided as follows: ORMC, Orange Division 14 ORMC, Holiday Division 10 Winter Park Memorial 10 Orlando General 4 West Orange 3 Lucerne 8 Brookewood 5 Florida Hospital 17 Florida Hospital, FAC 4 ORMC, Sand Lake 4 79 At present, ORMC, Holiday Division, is the only facility operating dedicated ambulatory surgical suites. There are no applications pending for dedicated outpatient facilities within hospitals or for a freestanding ambulatory surgical facility. No such applications have been filed for these types of facilities since the SSO application was filed. Each of the existing facilities listed above performs outpatient surgery to some degree. On August 16, 1982, Florida Hospital was issued a Certificate of Need to construct a freestanding ambulatory surgical center. That facility will contain four operating suites and is expected to begin operation in mid 1984. Once this facility is complete, Florida Hospital will not perform outpatient surgery in its 17 other suites, except when special equipment which is available only in those suites is required. Outpatient surgery at Winter Park Memorial and Orlando General now comprises approximately 30 percent of the total surgeries performed at those facilities. Lucerne Hospital operates no separate ambulatory surgery unit and favors SSO's application. ORMC has been performing outpatient surgery for over 20 years. However, the specific facilities in which outpatient surgery has been performed have changed during this period of time. Prior to August 1979, outpatient surgery was performed at the Five North unit in the Orange Division as well as at the Holiday Division. At that time, Orange Five North was closed for renovation and outpatient surgery was concentrated in Holiday One East. In October 1981, an outpatient surgery review committee was established by ORMC to examine more efficient ways to conduct outpatient surgery and to improve utilization of certain departments at the Holiday Division. The end result was a decision to concentrate outpatient surgery at ORMC in one designated unit to be known as Outpatient Day Surgery ("ODS"), and to provide a financial incentive for physicians and patients to utilize the unit. One of the primary reasons for concentrating outpatient surgery in Holiday One East was the inefficiency and increased cost of staffing the units. Outpatient census counts were resulting in overstaffing the 3 to 11 shift. To encourage doctors and patients to utilize Holiday One East, ORMC reduced the rates for outpatient surgery in the ODS unit by approximately 40 percent. Although some outpatient surgery continues to be performed at the Orange Division the charge for such surgeries is at the inpatient rates rather than the reduced rates utilized by the ODS. The ORMC Board of Directors approved the capital expenditure to renovate the Holiday One East area into the ODS unit on September 20, 1982. The ODS unit was renovated at a cost of approximately $600,000, which was below the Certificate of Need threshold requirement. The ODS unit opened on November 28, 1983. The ODS unit is open Monday through Friday, and utilizes a ten hour day with general anesthesia administered to outpatients from 7:30 a.m. to 1:00 p.m. ODS patients use a separate and distinct entrance to the Holiday Division and have a designated parking area east of the hospital. There are sixteen semi- private holding beds and four recliner chairs located within the ODS unit. The average case load and length of stay are such that holding beds may be used for more than one outpatient per day. As a result of instances where there have been shortages of holding beds for outpatients, ORMC beginning April 2, 1984, established an overflow area of ten beds on the third floor of the Holiday Division. As of May 29, 1984, this overflow area had been utilized on three occasions. The ODS unit contains two dedicated operating rooms where only local anesthesia can be administered. Outpatient procedures requiring general anesthesia are performed in the eight general operating suites of the Holiday Division. These eight operating suites are also used for inpatient surgery. Outpatients are placed in the same holding and recovery areas where inpatients are held. The staff in these areas serve inpatients and outpatients. The ODS unit averages 15 to 16 outpatients per day. In 1983, outpatient surgery comprised 29.4 percent of the total surgeries performed at the Holiday Division. This was a slight increase over the 27.7 percent outpatient percentage for that same division for the previous year. Presently, the two dedicated local anesthesia rooms are being utilized approximately 40 percent of the time. The present utilization rate of the entire Holiday Division is approximately 50 to 55 percent to as much as 80 percent depending upon the particular day of the week. The 80 percent rate is attained on a regular basis at least once per week. ORMC has been issued a Certificate of Need for a children's hospital. As presently designed and approved, the construction of the children's hospital will require the demolition of Holiday One East where the ODS unit is located. It is uncertain where the ODS unit would be relocated. The master facility plan approved by the ORMC Board of Directors includes the construction of a freestanding ambulatory diagnostic center which will include ambulatory surgery. Depending upon the staff and its efficiency and the quality of care provided, a freestanding ambulatory center offers several advantages over outpatient units within hospitals. In such a freestanding facility, only outpatient surgery is performed and the staff and physicians, including anesthesiologists, can be specialized in outpatient surgery. In the freestanding facility, outpatients are not mixed with inpatients. A substantial portion of those patients utilizing outpatient surgery are well patients having elective surgery performed. By specializing in outpatient surgery only, overall operating costs are likely to be less and should result in reduced patient costs. In a hospital setting, there is on occasion a problem with "bumping" elective surgery for emergencies. This would not occur in a freestanding ambulatory surgery facility. Patients will have shorter waits in the facility and Medicare patients will be reimbursed 100 percent rather than the 80 percent reimbursed in a hospital setting. The 550 application is consistent with the applicable criteria enumerated in Section 381.494(6)(c), Florida Statutes and need for its facility exists in Orange County. Of the thirteen governing criteria, the parties have stipulated that the criteria contained in Subsections 6, 7, 10 and 11 of Section 381.494(6)(c), Florida Statutes, are not applicable to this proceeding. In addition, the parties stipulated that Subsection 1 of Section 381.494(6)(c), Florida Statutes, is not applicable to this proceeding to the extent that there is no applicable district health plan or state health plan pertaining to ambulatory or outpatient surgery.
Recommendation Based upon the foregoing findings of fact and conclusions of law, it is, RECOMMENDED That HRS issue a Certificate of Need to Surgical Services of Orlando, Inc., to construct and operate a freestanding, five operating room ambulatory surgery center in Orange County. DONE AND ENTERED this 2nd day of July, 1984, in Tallahassee, Florida. MARVIN E. CHAVIS Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 3rd day of July, 1984. COPIES FURNISHED: Douglas L. Mannheimer, Esq. CULPEPPER, TURNER & MANNERED 318 North Call on Street Tallahassee, Florida 32302-3300 Fred W. Baggett, Esq. ROBERTS, BAGGETT, LaFACE, RICHARD, & WISER P.O. Drawer 1838 Tallahassee, Florida 32302 E. G. Boone, Esq. P.O. Box 1596 Venice, Florida 34284 Steven R. Bechtel, Esq. MATEER, HARBERT, FREY BECHTEL AND PHALIN, PA P.O. Box 2854 Orlando, Florida 32802 P. Joseph Wright, Esq. MURRAH AND DOYLE, P.A. P.O. Box 1328 Winter Park, Florida 32790 David Pingree, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301
The Issue Whether the Petitioner is qualified for licensure as a medical doctor in Florida by examination.
Findings Of Fact Petitioner graduated from the School of Medicine at the University of Pennsylvania in 1955, following which he did a rotating internship at Abington Memorial Hospital before reporting for active duty in the U.S. Navy. Upon release from active duty in the Navy in 1959 he entered a residency program in general surgery at Hospital of University of Pennsylvania followed by thoracic surgery which he completed in 1965. Petitioner was certified by the American Board of Surgery in 1965 and by the Board of Thoracic Surgery in 1966. From 1965 to 1986 Petitioner was engaged in the practice of general, cardiac, thoracic and vascular surgery. In the latter part of this period, he headed a cardiothoracic surgery team at Lankenau Hospital, Philadelphia, which performed some 700-800 open-heart surgeries per year. It was during this period that most of the malpractice suits were filed against Petitioner, the hospital and other doctors on his team. As head of the surgical team Petitioner did the definitive surgery (bypass grafts) while other members of the team opened and closed the chest cavity. Petitioner is currently licensed to practice medicine in Pennsylvania, New York, New Jersey, Delaware and Arizona. At the time he first applied for licensure in Florida in 1988, he was licensed in Pennsylvania, New Jersey and Arizona. No licensing agency has brought any charges against Petitioner's license. Petitioner took and passed the FLEX examination in 1988 scoring 84 and 83 on the two parts of the exam. In the past twenty years, 19 malpractice suits have been filed against Petitioner. Of those suits 9, have been dismissed by Plaintiffs without any recovery from Petitioner, and two were settled on behalf of Petitioner, one in 1979 for $50,000 and one in 1989 for $25,000. Those settlements represented little more than nuisance value. The hospital defendant settled one case for $225,000 and another for $2,500. Of the remaining eight suits the complete medical records of those cases were reviewed by another cardiothoracic and vascular surgeon who opined that five are without merit. For the remaining three, additional evidence is needed to fairly appraise the merits of those suits. This additional information will not be available until discovery is completed. Petitioner's testimony, that these remaining three cases did not involve a failure on his part to practice medicine with that level of care, skill, and treatment which is recognized by a reasonable prudent similar physician as being acceptable under similar conditions and circumstances, corroborates the Affidavit of the risk manager (Exhibit 3) and letters in the file (Exhibit 1) stating those cases are deemed to be without merit and will be vigorously defended. All of these suits were brought in Pennsylvania where the backlog of civil cases is such that civil cases are not scheduled for trial until approximately seven years after the suit is filed. Furthermore, the complaints filed in these cases contain general allegations that the Respondent's negligence, inattention, failure to adequately apprise the plaintiff of possible complications of the surgery, along with the negligence of the hospital and others involved with the surgery, directly resulted in the plaintiff's death, injury, etc. These are catch- all allegations and the specific nature of the malpractice claim cannot be discerned from these pleadings. Cardiothoracic and vascular surgery is a high risk field of medicine in that the patients are frequently very sick and elderly. Accordingly, the success rate for this type surgery is lower than for most surgeries, and this leads to a higher incidence of suits alleging malpractice. Many of these earlier suits were brought before the doctors began paying attention to documenting that they fully explained the risks of the surgery to the patient and thereafter the patient gave informed consent to the operation. Petitioner has been more assiduous in this regard in recent years than he was several years ago. This practice will have the effect of reducing the incidence of malpractice suits against surgeons. It is noted that several of the suits alleged the plaintiffs were not adequately advised regarding the risks involved and, therefore, they did not give informed consent to the surgery.
Recommendation It is RECOMMENDED that Horace MacVaugh III be granted a license to practice medicine in Florida. DONE and ENTERED this 19th day of December, 1990, in Tallahassee, Leon County, Florida. K. N. AYERS Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904)488-9675 Filed with the Clerk of the Division of Administrative Hearings this 19th day of December, 1990. APPENDIX Petitioner's proposed findings are accepted, except: 8. Accepted only insofar as consistent with HO #5 and 6. 15. Rejected. No evidence was presented in this regard. Respondent's proposed findings are accepted except: 17. Second and third sentences rejected as not supported by any competent evidence. COPIES FURNISHED: Roger Lutz, Esquire Robin Uricchio, Esquire HOLLAND & KNIGHT Post Office Box 1526 Orlando, Florida 32802 Allan Grossman, Esquire The Capitol, Suite 1602 Tallahassee, Florida 32399-1050 Dorothy Faircloth, Executive Director Florida Board of Medicine Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, Florida 32399-0750 Kenneth E. Easley, Esquire General Counsel Department of Professional Regulation Northwood Centre, Suite 60 Tallahassee, Florida 32399-0792
The Issue Whether Respondent, a medical doctor, in his treatment of Patient M.A., failed to keep legible medical records in violation of section 458.331(1)(m), Florida Statutes (2007); prescribed or administered inappropriate or excessive quantities of controlled substances in violation of section 458.331(1)(q), Florida Statutes (2007); committed medical malpractice by practicing below the standard of care in violation of section 458.331(1)(t), Florida Statutes (2007); failed to perform a statutory or legal obligation placed upon a licensed physician in violation of section 458.331(1)(g), Florida Statutes (2007); and violated any provision of chapter 458 or chapter 456, or any rules adopted pursuant thereto in violation of section 458.331(1)(nn), Florida Statutes (2007), as Petitioner alleges in the Third Amended Administrative Complaint; if so, whether (and what) disciplinary measures should be imposed.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order: Finding that Paul M. Goldberg, M.D., violated sections 458.331(1)(g) and (nn), Florida Statutes, as charged in Counts IV and V of the Complaint; Dismissing Counts I-III of the Complaint; Imposing $20,000 in administrative fines; issuing a reprimand against Dr. Goldberg's medical license; requiring Dr. Goldberg to complete the "Laws and Rules" Course; suspending Dr. Goldberg's medical license until such time as Dr. Goldberg undergoes a "UF CARES" evaluation; and placing Dr. Goldberg's license on probation for three years under indirect supervision with 100 percent chart review of cosmetic surgery patients and 25 percent chart review of all other patients. DONE AND ENTERED this 4th day of March, 2015, in Tallahassee, Leon County, Florida. S TODD P. RESAVAGE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 4th day of March, 2015.
The Issue The issues for determination are whether Respondent violated Subsections 458.331(1)(f) and (m), Florida Statutes (1997), by assisting an unlicensed person to practice medicine contrary to Chapter 458 and by failing to maintain adequate medical records; and, if so, what discipline, if any, should be imposed against Respondent's license. (All references to chapters and statutes are to those promulgated in Florida Statutes (1997) unless otherwise stated.)
Findings Of Fact Petitioner is the state agency responsible for regulating the practice of medicine in Florida. Respondent is licensed to practice medicine in Florida pursuant to license number ME 0015824. Respondent owns and operates an ambulatory surgical center doing business as the Dermatologic & Cosmetic Surgery Center (Surgery Center). The Surgery Center is located at 2666 Swamp Cabbage Court, Fort Myers, Florida 33901. Respondent is a Board-certified Dermatologist and also performs cosmetic surgery that includes breast augmentation. Dermatology and cosmetic surgery involve similar procedures. The procedures used to remove skin cancers from the face are similar to those used in face-lifts and eyelid surgery. Respondent performs approximately a thousand skin cancer surgeries a year, has been doing cosmetic surgery since 1986, and has practiced breast surgery since 1989. Respondent is a member of the American Board of Cosmetic Surgery. That board is not approved by the American Board of Medical Specialties or the Florida Board of Medicine. Respondent has attended numerous seminars and satisfied relevant continuing education requirements throughout his career. Respondent has never been sued by a patient and has no prior discipline against his license. Prior to August 12, 1997, Respondent performed breast augmentations through the patient's nipple. Respondent made a small incision in the lower part of the binary nipple. He used his fingers to separate the overlying breast tissue from the muscle and create a pocket in which to place an implant. The incision left a scar at the nipple, and Respondent sought to develop competency in a different procedure identified in the record as the axillary method of breast augmentation. The axillary method allows the surgeon to access the breast from the patient's armpit. The surgeon makes a 1.5 inch incision under the armpit, uses an instrument to create a pocket in the breast, inserts a partially inflated implant into the pocket, and repeats the same procedure in the other breast. The surgeon then checks the breasts for symmetry, fills the implants, closes the pockets, and concludes the procedure. In the axillary method, a surgeon must use instruments rather than his fingers to create a pocket for the implant. The initial incision and placement of the implant do not require great skill. The greater skill is required in reaching the proper plane in the breast tissue and in creating the pocket. The brachial plexis is just below the incision in the armpit and contains all of the nerves that make the arm work. From the armpit, the surgeon must proceed over the sternum. If the surgeon applies too much pressure, the surgeon can cross the center of the chest and create a condition known as a unibreast. Respondent developed a basic understanding of the axillary method by watching video tapes for several years and by attending seminars approved for professional education credit in the State of Florida. In May of 1997, Dr. Daniel Metcalf taught one of those seminars in Orlando, Florida. Dr. Metcalf is licensed to practice medicine in Oklahoma. He is qualified by training and experience to perform the axillary method and to teach the method to other physicians. For approximately 25 years, Dr. Metcalf has limited his medical practice to breast surgery and performs approximately 650 surgeries each year. At the time that Dr. Metcalf taught the accredited seminar in Orlando, his license to practice medicine in Oklahoma was suspended. On November 13, 1995, Dr. Metcalf pled guilty to a felony charge that he violated federal interstate commerce law by selling silicon implants during a moratorium on their sale. The federal court fined Dr. Metcalf $5,000 and sentenced him to six months in federal prison beginning on April 5, 1996. The State of Oklahoma suspended Dr. Metcalf's medical license for one year beginning on the date of his release from prison. The suspension expired on or about October 5, 1997. In May of 1997, Respondent discussed the axillary method with Dr. Metcalf during the seminar in Orlando. Respondent and Dr. Metcalf had known each other since the early 1980s, and Dr. Metcalf agreed to come to the Surgery Center and teach the axillary method to Respondent. Respondent scheduled the teaching session at the Surgery Center for August 12 and 13, 1997. Five of Respondent's patients agreed to participate. The patients are identified in the record as B.D., T.R., R.K., M.P., and D.C. Each patient acknowledged in writing that it would be the first time Respondent would perform the axillary method. Neither Respondent nor Dr. Metcalf charged the patients for a surgeon's fee, and Dr. Metcalf did not charge Respondent. However, the patients paid the costs of the implant, the operating room, and the blood work. Respondent conducted a preoperative interview with each patient. He advised the patient that Dr. Metcalf would be in the operating room teaching Respondent. On August 12 and 13, 1997, Respondent introduced Dr. Metcalf to each patient. Respondent and Dr. Metcalf then scrubbed, gloved, and proceeded with the teaching session. Dr. Metcalf performed approximately 60 to 70 percent of the first surgery. Respondent performed progressively more of each successive surgery until Respondent performed the vast majority of the surgery. The surgery that Dr. Metcalf performed included at least one incision and pocket, insertion of an implant, use of the appropriate surgical instruments, and closure of an incision on at least one patient. Neither Respondent nor Dr. Metcalf caused any harm to a patient. The results of all five procedures were positive and without complication. No patients complained about their treatment. Two of Respondent's former employees are the complaining witnesses in this case. The first issue is whether Dr. Metcalf practiced medicine within the meaning of Section 458.305(3). Section 458.305(3) defines the "practice of medicine" as: [T]he diagnosis, treatment, operation, or prescription for any human disease, pain, injury, deformity, or other physical or mental condition. Dr. Metcalf did not diagnose, treat, or prescribe medicine for any human disease, pain, injury, or deformity, or mental condition. The breast augmentations that he participated in were elective and cosmetic and did not treat any disease, pain, injury, or deformity. Dr. Metcalf must have performed an "operation" for some "other physical . . . condition" in order to practice medicine within the meaning of Section 458.305(3). Respondent's counsel argued during the hearing that the issue of whether Dr. Metcalf practiced medicine was an issue of law, rather than fact. Counsel argued that expert testimony would invade the province of the ALJ. If Respondent's counsel were correct, the result could be problematic for Section 90.702. Although a physician would be qualified by training and experience to opine that a peer's activities satisfy the standard of care applicable to the practice of medicine, the physician would not be qualified to know whether he or his peer practiced medicine. In an abundance of caution, the ALJ requested the parties to cite relevant legal authority in their respective PROs. Neither party cited any direct or analogous legal authority that resolves the issue raised by Respondent's counsel or construes the statutory definition of the practice of medicine in Section 458.305(3). Each party submitted expert testimony concerning the issue of whether Dr. Metcalf practiced medicine. As the trier of fact and arbiter of credibility, the ALJ must resolve the evidential conflicts between the experts. Accordingly, the fact finder has carefully considered the substance of the testimony of the two experts and determined the appropriate weight to be accorded the testimony of each. Respondent's expert based his opinion on a custom within the medical profession in which unlicensed persons, such as members of an emergency medical team, medical students, and first year residents, train under a physician. Respondent's expert opined that an unlicensed person does not practice medicine because the person is learning under the auspices of a physician who has responsibility for the unlicensed person. Respondent's expert relied on facts not in evidence. Unlike the custom described by Respondent's expert, the evidence shows that the person teaching was not licensed to practice medicine in the state where the teaching occurred. The person learning was the only person so licensed. While Respondent had ultimate responsibility, Respondent was not teaching Dr. Metcalf. Dr. Metcalf was teaching Respondent. The custom described by Respondent's expert operates within a framework of laws and rules that are inapposite to this case. Residents who are not licensed to practice medicine in Florida may practice under the supervision of a physician only if the residents, and the hospitals in which they work, comply with registration and reporting requirements in Section 458.345 and Florida Administrative Code Rules 648-6.008 and 6.009. None of those provisions apply to the facts in this case. (All references to rules are to those promulgated in the Florida Administrative Code on the date of this Recommended Order.) Respondent's expert also testified that doctors customarily teach other doctors in states where the teaching doctor is not licensed. In Florida, however, that custom is limited by Section 458.303(1)(b) to activities that satisfy the definition of a consultation. A consultation is defined in Rule 64B8-2.001(8) to include the taking of a medical history, the examination of a patient, the review of laboratory tests and x-rays, and the making of recommendations to a person licensed to practice medicine in Florida. A consultation is not a set of activities separate and apart from the practice of medicine. It is a subset of the "practice of medicine" in Section 458.305(3). The opinion of Respondent's expert is limited, by operation of law, to that part of the practice of medicine that is a consultation within the meaning of Section 458.303(1)(b) and Rule 64B8-2.001(8). That part of the practice of medicine that is not a consultation is the practice of medicine that is at issue in Section 458.331(1)(f). Further references in this Recommended Order to the "practice of medicine" refer to those activities described in Section 458.305(3) that are not a consultation within the meaning of Section 458.303(1)(b) and Rule 64B8-2.001(8). Some of the activities engaged in by Dr. Metcalf at the Surgery Center satisfied the definition of a consultation. Other activities comprised the practice of medicine. The proportion of each is not material in this case. Dr. Metcalf performed at least 60 percent of the first "operation" for some "other physical . . . condition" within the meaning of Section 458.305(3). Dr. Metcalf practiced medicine progressively less with each successive operation and performed progressively more consultation. One purpose of the teaching session was for Dr. Metcalf to first demonstrate the axillary method and then to assist Respondent in the practice of that medicine. As it turned out, this purpose was more qualitative than quantitative because Respondent quickly demonstrated competency. However, if it were unnecessary for Dr. Metcalf to first demonstrate the axillary method, Respondent could have gained the competency he sought by reviewing video tapes, attending seminars, and consulting with Dr. Metcalf. Respondent aided, assisted, procured, or advised Dr. Metcalf to engage in the practice of medicine for at least 60 percent the first surgery performed on August 12, 1997. The next issue is whether Dr. Metcalf was an "unlicensed person" within the meaning of Section 458.331(1)(f). Chapter 458 commonly uses the term "licensed" to refer to persons licensed outside of Florida. For example, Section 458.303(1)(b) refers to physicians "licensed" in another state. Section 458.3115(1) authorizes restricted licenses for "foreign- licensed" persons. Section 458.313(1)(c) authorizes licensure by endorsement for those "licensed" in another jurisdiction, and Section 458.315 authorizes a temporary certificate for persons "licensed" in any other state. Dr. Metcalf was a licensed person in Oklahoma when he practiced medicine at the Surgery Center in August of 1997. A person licensed to practice medicine is not an "unlicensed person" while the person's license is suspended. A contrary finding could be problematic under Florida law. If a person with a suspended Florida license were an unlicensed person during the suspension and the person violated the terms of the suspension, the person would have no professional license against which the Board of Medicine could take further disciplinary action, including revocation of the license. Rather, the Board would be required to seek criminal prosecution pursuant to Section 458.327(1)(a). During the period of suspension, Dr. Metcalf was a licensed person in Oklahoma. However, Dr. Metcalf was not authorized to exercise any privileges under the license or to enjoy the benefits of his license until the suspension expired. Section 458.331(1)(f) does not prohibit Respondent from aiding, assisting, procuring, or advising an unauthorized person to practice medicine. Such a statutory prohibition would have been broad enough to proscribe the practice of medicine by a licensed person whose authority to practice was temporarily suspended. Rather, Section 458.331(1)(f) prohibits Respondent from "aiding, assisting, procuring, or advising any unlicensed person" to practice medicine. (emphasis supplied) Relevant terms in Section 458.331(1)(f) must be construed strictly in favor of the licensee because this is a license disciplinary proceeding that is penal in nature. A finding that Dr. Metcalf was a licensed person in Oklahoma does not resolve the issue of whether Dr. Metcalf was an unlicensed person for the purposes of Section 458.331(1)(f). An "unlicensed person" in Section 458.331(1)(f) is properly defined by reference to Section 458.327(1)(a). Section 458.331(1)(f) prohibits Respondent from "aiding, assisting, procuring, or advising an unlicensed person to practice medicine contrary to this chapter " (emphasis supplied). Section 458.327(1)(a) prohibits the practice of medicine without "a license to practice in Florida." When the term "unlicensed person" in Section 458.331(1)(f) is harmonized with Section 458.327(1)(a), an "unlicensed person" means a person not licensed in Florida. 44. Sections 458.327(1)(a) and 458.331(1)(f) operate in concert. The former proscribes the practice of medicine inside this state without a Florida license. The latter prohibits a person licensed inside the state from assisting in the violation of the former. In August of 1997, Respondent violated Section 458.331(1)(f) by assisting an unlicensed person to practice medicine contrary to Section 458.327(1)(a). Respondent did not intentionally violate Section 458.331(1)(f) and had no prior knowledge of the violation. The cause of the violation is rooted in multiple instances of miscommunication, confusing circumstances, and statutory ambiguity that Respondent did not create. Respondent undertook reasonable efforts to comply with Florida law. Prior to the surgeries, Respondent contacted Ms. Anne Dean. Ms. Dean is the licensed risk manager for the Surgery Center and is qualified by training and experience to advise Respondent in matters of regulatory compliance. Ms. Dean owns and operates a risk management company in Deland, Florida. She is the certified risk manager for over 450 domestic and foreign ambulatory surgery centers. Ms. Dean provides a wide range of services including financial feasibility analysis and the processing of certificates of need. She also provides services to ensure that architectural design, equipment lists, inventories, and policies and procedures comply with applicable state and federal regulatory requirements. Ms. Dean also assists ambulatory surgical centers with other license certification, accreditation, and regulatory matters. Since 1988, Ms. Dean has been the risk manager required under state law for the Surgery Center. Ms. Dean was responsible for the Surgery Center's state licensure and Medicare certification. She has been present during each license and risk management survey conducted by the Agency for Health Care Administration (AHCA). AHCA has never cited the Surgery Center for a violation. Ms. Dean has assisted Respondent in ensuring that renovations to the Surgery Center complied with applicable regulations and, except for the calendar year 2000, has advised Respondent in all matters of regulatory compliance and accreditation. Respondent asked Ms. Dean to ensure that the teaching session to be conducted by Dr. Metcalf complied with applicable state law and any accreditation requirements. Ms. Dean spoke by telephone with unidentified representatives of both AHCA and Petitioner. The advice from those representatives was consistent for two areas of concern. The first area of concern involved the accreditation needed for Respondent to be certified to perform the axillary method. Pursuant to the advice of the agency representatives, Ms. Dean created a surgical proctor report and gave the form to Respondent. After the teaching session, Dr. Metcalf completed a report for each patient and provided the reports to Ms. Dean. Ms. Dean reviewed the reports and met with a three-member committee for the Surgery Center. The committee certified Respondent as qualified to perform the axillary method. The second area of concern involved the status of Dr. Metcalf's license to practice medicine. Respondent was specifically concerned that Dr. Metcalf was not licensed to practice medicine in Florida and that Dr. Metcalf's Oklahoma license was suspended. Respondent requested Ms. Dean to ensure that the teaching session complied with Florida law. Ms. Dean conferred with representatives for Petitioner and AHCA. Ms. Dean advised Respondent that if the person teaching were licensed in another state, the person would be entitled to practice medicine in Florida during the teaching session under the auspices of Respondent, a licensed person in Florida. However, if the person teaching were not licensed in another state, the person could not perform any function that required licensure. Ms. Dean conveyed the advice of the agency representatives to Respondent. The advice from those qualified by training and experience in regulatory compliance is consistent with an educational custom among practitioners. It is common for doctors to practice medicine for educational purposes in states where they are not licensed. Before Respondent began cosmetic surgery, Respondent spent four one-week periods with two different cosmetic surgeons in Texas and Virginia. Respondent was not licensed to practice in Virginia. Respondent obtained similar experience in California where he is not licensed. Respondent is 66 years old and did not attempt to become board certified in plastic surgery. That certification would have required two or three years of general surgery and plastic surgery. Respondent would have spent his time learning complex reconstructive procedures, including cleft lips and pallets, rather than simpler cosmetic surgery. The advice from Ms. Dean and representatives for Petitioner and AHCA was incorrect and based on a mistake of law. The statement that a person licensed in another state can do more than consult in Florida purports to amend or modify the limited authority in Section 458.303(1)(b) as well as the prohibitions in Sections 458.331(1)(f) and 458.327(1)(a). An agency cannot amend, enlarge, or deviate from a statute. The mistake of law arose from ambiguity in Chapter 458. Chapter 458 does not define the term "unlicensed person." An "unlicensed physician" is defined in Rule 64B8-6.001 to mean a medical doctor not licensed by the Board of Medicine. However, the term "unlicensed physician" applies only to Section 458.345 and does not apply to Section 458.331(1)(f). The law implemented in Rule 64B8-6.001 is limited to Section 458.345. The rule refers only to interns, residents, and fellows in a hospital setting. Rule 64B8-6.001 does not define an "unlicensed physician" for any purpose in Chapter 458 except Section 458.345. A broader reading of Rule 64B8-6.001 would conflict with the definition of a "physician" in Section 458.305(4). Section 458.305(4) defines a "physician" to mean a person licensed by the Board of Medicine. The rule defines an "unlicensed physician" as a medical doctor not licensed by the Board. Even if the rule were construed to imply that a medical doctor is not a person, for purposes of Section 458.305(4), the implication would not avoid the apparent oxymoron. Any ambiguity between Section 458.305(4) and Rule 64B8-6.001 must be resolved in a manner that effectuates the statute. Section 458.305(4) defines a physician "as used in this chapter. . . ." (emphasis supplied) Neither the definition of an "unlicensed physician" in Rule 64B8-6.001 nor the definition of a "physician" in Section 458.305(4) defines the term "unlicensed person" in Section 458.331(1)(f). Chapter 458 does not expressly state that a person licensed to practice medicine in another state is an "unlicensed person." Moreover, Chapter 458 uses the term "licensed" interchangeably to mean persons licensed inside and outside of Florida. The correct meaning of the term "unlicensed person" is not found in a single provision in Chapter 458. A licensee must glean the meaning from reading Sections 458.427(1)(a) and 458.331(1)(f) in a manner that harmonizes the two provisions. The following hypothetical further illustrates the unintended ambiguity in Chapter 458. If Dr. Metcalf were licensed in Florida in August of 1997, Section 458.331(1)(f) would not have prohibited Respondent from assisting Dr. Metcalf to practice medicine contrary to Chapter 458, including gross and repeated malpractice. Section 458.331(1)(f) does not prohibit Respondent from helping a licensed person to violate Chapter 458. Statutory ambiguity also exists in the distinction between a consultation and other activities defined as the practice of medicine. Although Chapter 458 recognizes a legal distinction between the two kinds of activity, the practical distinctions evidently ebb and flow on a daily basis through a custom in which practitioners teach others in states where the practitioners are not licensed. The ambiguity in Chapter 458 gave rise to, confusion, mistakes of law by individuals qualified by training and experience in regulatory compliance and miscommunications to Respondent. Respondent reasonably relied on the advice of those qualified by training and experience to advise him in his attempt at regulatory compliance. Respondent did not intend to violate Section 458.331(1)(f). The remaining issue for determination is whether Respondent maintained adequate records for the teaching session at the Surgery Center. The statutory requirement for adequate medical records is set forth in Section 458.331(1)(m). In relevant part, Section 458.331(1)(m) provides that Respondent's license is subject to discipline if Respondent fails: [T]o keep . . . medical records that identify the licensed physician or the physician extender and supervising physician by name and professional title who is or are responsible for rendering . . . supervising, or billing for each . . . treatment procedure and that justify the course of treatment of the patient. (emphasis supplied) The parties do not dispute that the medical records adequately identify Respondent. The contested issue is whether the medical records justify the course of treatment by adequately identifying Dr. Metcalf by name and title. The medical records include operative reports that identify Respondent by name but do not identify Dr. Metcalf. Petitioner argues that Section 458.331(1)(m) requires the operative reports to identify both Respondent and Dr. Metcalf. Petitioner argues that Respondent was the "licensed physician" and Dr. Metcalf was the "physician extender and supervising physician." Dr. Metcalf was neither the "physician extender" nor the "supervising physician" during the teaching session. Section 458.305(4) defines a physician as a person who is licensed by the Board of Medicine. Dr. Metcalf was not licensed by the Board and was not a physician under Florida law. Respondent was the "licensed physician." Petitioner admits that the medical records adequately identify the "licensed physician" in accordance with Section 458.331(1)(m). If the definition of a physician in Section 458.305(4) were disregarded, the ALJ agrees with Petitioner that Section 458.331(1)(m) implicitly distinguishes a "licensed physician" from a "physician extender and supervising physician." However, the implicit distinction does not serve the ends that Petitioner seeks. Rather, the implicit distinction suggests that the physician extender and supervising physician may be someone other than a licensed physician. If the implied distinction in Section 458.331(1)(m) were correct, it would need to be construed in pari materia with Section 458.331(1)(f) in a manner that gives force and effect to both subsections. The prohibition in Section 458.331(1)(f) could not prohibit Respondent from assisting an unlicensed person who is "physician extender and supervising physician" without nullifying the implied distinction in Section 458.331(1)(m). The interplay between Subsections 458.331(1)(f) and (m) does not alter the outcome of this case. However, it further elucidates the statutory ambiguity that Respondent, his risk manager, and two different agency representatives faced in attempting to ascertain whether the teaching session complied with Florida law. Assuming arguendo that Petitioner's view of Dr. Metcalf as the physician extender and the supervising physician were correct, Petitioner's statutory interpretation conflicts with the literal terms of Section 458.331(1)(m). Section 458.331(1)(m) requires the medical records to identify either the licensed physician or the physician extender and supervising physician. The statute does not require the medical records to identify the licensed physician and the physician extender and supervising physician. Relevant terms in Section 458.331(1)(m) must be construed strictly in favor of the licensee because this is a license disciplinary proceeding that is penal in nature. If it were determined that Dr. Metcalf could be a physician extender without being a physician defined in Section 458.305(4), no statute or rule cited by the parties defines a "physician extender." Although the term may be a term of art within the medical profession, Petitioner failed to adequately explicate that form of art. The evidence was less than clear and convincing that Dr. Metcalf was a physician extender. If it were determined that Dr. Metcalf could be a supervising physician without being a physician defined in Section 458.305(4), the definitions of "direct supervision and control" and "direct responsibility" in Rule 64B8-2.001(1) and (6) and Rule 64B8-4.026(1) aren't probative. The rules merely define the quoted terms by reference to physical proximity. Both Respondent and Dr. Metcalf were physically proximate. The evidence shows that Respondent was ultimately responsible for the surgeries. Respondent had actual control of each surgery, could have stopped each surgery at any time, and was responsible for billing each patient. Unlike the operative reports, the anesthetist reports identify Respondent and Dr. Metcalf by name and title. The parties agree that the anesthetist reports are part of the medical records. Petitioner argues that the identification of Dr. Metcalf solely in the anesthetist reports is inadequate. Petitioner claims the operative reports must also identify Dr. Metcalf. Each party submitted expert testimony concerning the issue of whether the identification of Dr. Metcalf solely in the nurse anesthetist reports was adequate. Petitioner's expert was tendered and accepted "as a physician, in general, and as a plastic surgeon." Respondent's expert practices emergency medicine, rather than cosmetic or plastic surgery, but is an expert in quality assurance. Respondent's expert is better qualified by training and experience, within the meaning of Section 90.702, to assist the trier of fact in a determination of whether the medical records are adequate. The testimony of Respondent's expert is consistent with the record-keeping requirements in Section 458.331(1)(m) and Rule 64B8-9.003. Neither the statute nor the rule requires medical records to identify Dr. Metcalf in multiple parts of the medical records or to identify Dr. Metcalf in any specific document. The anesthetist reports comprise adequate medical records that identify both Respondent and Dr. Metcalf. Petitioner argues that the patient consent forms do not identify Dr. Metcalf; and that Respondent did not tell his patients that Dr. Metcalf would be operating on them or that Dr. Metcalf's license to practice medicine was suspended. No finding is made concerning these issues because they are not relevant to any allegation contained in the Administrative Complaint. The Administrative Complaint does not allege that Respondent failed to obtain informed consent from his patients. If it were determined that Section 458.331(1)(m) requires the operative reports to identify Dr. Metcalf when the anesthetist reports already do so, Respondent did not cause the omission of Dr. Metcalf's name from the operative reports. Respondent instructed his circulating nurse and surgical supervisor (circulating nurse) to identify Dr. Metcalf in the operative reports that Respondent signed but did not read. The regular duties of the circulating nurse included the identification of surgeons in the operative reports. Respondent reasonably relied on the circulating nurse to perform her assigned duties correctly. The Administrative Complaint does not charge Respondent with failure to supervise his employee or with failure to review the operative reports he signed. The circulating nurse failed to identify Dr. Metcalf in the operative reports she prepared for Respondent. Sometime after the teaching session in August of 1997, the circulating nurse abruptly terminated her employment at the Surgery Center following several employment problems. When Respondent hired the circulating nurse in July of 1996, she was in an impaired physician or nurses (IPN) program for treatment of a previous addiction to Xanex and Demerol that she developed during her divorce. However, representatives of the IPN program assured Respondent that the circulating nurse was successfully completing the program. After the circulating nurse terminated her employment, Respondent discovered that drugs were missing from the Surgery Center. Respondent also learned that the circulating nurse had stopped going to the IPN program in August of 1997 and had stopped taking her urine tests. In October, 1997, the IPN program dismissed the circulating nurse. Sometime between August 13 and September 11, 1997, the circulating nurse told Respondent that she suspected the anesthetist of being addicted to drugs because he was falling asleep during surgeries. The circulating nurse also thought some drugs were missing from the Surgery Center. Respondent barred the anesthetist from further surgeries and asked the circulating nurse to conduct a drug count. Respondent left the next day with his wife on a previously scheduled vacation but stayed in communication with the circulating nurse. The circulating nurse conferred with the risk manager and conducted a drug count but did not comply with prescribed procedures. The circulating nurse entered her drug count on a form but did not make any written findings. The circulating nurse told Respondent that she thought some drugs were missing. Respondent requested the circulating nurse to fax him the portion of the Surgery Center manual that prescribed drug audit procedures. The circulating nurse faxed the material and then terminated her employment. When Respondent returned from his vacation, the office keys used by the circulating nurse were in Respondent's mailbox. The circulating nurse quit her job because she felt Respondent expected too much of her. Prior to January 1998, Respondent requested a pharmacy consultant to assist Respondent and his wife in a second narcotic count. The pharmacy consultant confirmed that some drugs were missing from the Surgery Center. The missing drugs included Versed, Demerol, Tylox, and Valium. Respondent reported the missing drugs to the risk manager, and the risk manager reported the incident to the state. The appropriate state agency began an investigation in January of 1998 that included the potential involvement of the anesthetist and the circulating nurse. The anesthetist died shortly after January 1998, and the agency concluded the investigation without charging the circulating nurse. The circulating nurse and Respondent's former insurance secretary are the complaining witnesses in this case. On September 11, 1997, the insurance secretary altered the computer entrees for the employee manual so that the number of hours needed to be eligible for insurance benefits conformed to the number of hours that the insurance secretary worked. Respondent's wife is the office administrator. She discovered the changes and corrected them. She then instructed the insurance secretary not to come into the Surgery Center while Respondent was on vacation. When Respondent and his wife returned from their vacation, they discovered that the insurance secretary had copied all of the patient charts for August 12 and 13, 1997, and had resigned from her job. Neither Respondent nor his wife could locate any of the copied charts. The proctor forms that had been completed by Dr. Metcalf and reviewed by the risk manager and accreditation committee were missing from their files. Whole parts of the surgery manual were missing. The risk manager conducted an independent search for the missing records without success. The risk manager had helped compile the compliance files, was familiar with the records, and would have recognized any misfiled records.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a Final Order finding Respondent not guilty of violating Subsection 458.331(1)(m), guilty of violating Subsection 458.331(1)(f), and imposing no penalty. DONE AND ENTERED this 3rd day of December, 2002, in Tallahassee, Leon County, Florida. DANIEL MANRY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 3rd day of December, 2002. COPIES FURNISHED: Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 John E. Terrel, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 H. Roger Lutz, Esquire Lutz, Webb & BoBo One Sarasota Tower Two North Tamiami Trail, Fifth Floor Sarasota, Florida 34236
The Issue The issue is whether Florida Administrative Code Rules 64B- 9.0092(2)(f), 64B8-9.0092(4)(a), and 64B8-9.0092(4)(c) constitute invalid exercises of delegated legislative authority as defined by Section 120.52(8), Florida Statutes (2004).
Findings Of Fact In Florida, physicians who perform certain surgical procedures in their offices are required to register the office with DOH. Additionally, DOH must inspect such offices unless a nationally recognized accrediting agency or an accrediting organization approved by the Board inspects and accredits the offices every three years. See § 458.309(3), Fla. Stat. and Fla. Admin. Code R. 64B8-0.0091. Florida Administrative Code Rule 64B8-9.0092, entitled "Approval of Physician Office Accrediting Organizations," establishes requirements that FLACS must meet in order to achieve the Board's approval to operate as an accrediting organization. FLACS is the only organization that the Board has ever approved as an accrediting organization. FLACS is a not-for-profit corporation, organized for the following purposes: (a) to promote office safety through its accreditation activities; (b) to promote cosmetic surgery; and (c) to provide continuing education courses related to office surgery. FLACS was formed in 1999 and, since that time, has participated actively in office surgery issues considered by the Board. FLACS began operating as an approved office surgery accrediting organization early in 2001. In January 2003 FLACS filed a complete renewal application, seeking the Board's approval to continue operating as an office surgery accrediting organization. The Board denied the application and, after a formal administrative hearing, entered a Final Order denying FLACS's application. See Florida Academy of Cosmetic Surgery, Inc. v. Board of Medicine, Case No. DOH-04-0661-FOF-MQA (Final Order, June 18, 2004)(adopting Recommended Order in DOAH Case No. 03-3349, April 15, 2004.) FLACS filed a new application for approval as an office surgery accrediting organization on July 12, 2004. The Board never advised FLACS whether its application was complete or incomplete. There is evidence that a member of the Board's staff, Melinda Grey, reviewed the application, finding it incomplete in many respects. On August 5, 2004, Ms. Grey prepared a spreadsheet entitled "Board of Medicine Staff Issues Regarding FLACS Application." The spreadsheet compared the application with the requirements of the applicable provisions of the Florida Administrative Code, including Florida Administrative Code Rule 64B8-9.0092. Larry McPherson, the Board's Executive Director, was aware that Ms. Grey was reviewing FLACS's application. She did not tell Mr. McPherson that the application was incomplete. Instead, she informed the Board's legal counsel that FLACS had filed the application. Subsequently, Ms. Grey placed the application on the Board's next scheduled meeting agenda. On August 7, 2004, the Board voted to deny the new application. On August 23, 2004, the Board entered an Notice of Intent to Deny FLACS's new application on the following grounds: When participating in accrediting activities in the past, the applicant violated Section 458.331(1)(nn), Florida Statutes, by failing to comply with rules of the Board in the following manner: The applicant failed to provide copies of accreditation reports and corrective action plans to the Board office within 30 days of completion of accrediting activities in violation of Rule 64B8- 9.0092(4)(e), Florida Administrative Code. The applicant failed to immediately report to the Department conditions in physicians' offices that posed a potential immediate threat to patients in violation of Rule 64B8-9.0092(4)(f), Florida Administrative Code. When inspecting and accrediting facilities the applicant ignored its written accreditation standards and failed to provide the Board office with accreditation standards under which it was actually operating. Such facts reveal that the applicant operated in violation of Rule 64B8-9.0092(4)(g), Florida Administrative Code. When inspecting the facilities, the applicant operated with inadequate or applied inconsistently its quality assurance program in violation of Rule 64B8- 9.0092(4)(a), Florida Administrative Code. The applicant failed to provide evidence of an adequate quality assurance program as required by Rule 64B8- 9.0092(4)(a), Florida Administrative Code. The applicant failed to provide evidence of an adequate ongoing anesthesia related accreditation and quality assurance processes as required by Rule 64B8- 9.0092(4)(c), Florida Administrative Code. The applicant failed to submit copies of all incident reports filed with the state that originated at FLACS accredited facilities as required by Rule 64B8-9.0092(4)(f), Florida Administrative Code. Rule 64B8-9.0092(2)(f)--Incident Reports Florida Administrative Code Rule 64B8-9.0092(2)(f) requires an application for approval as an office surgery accreditation organization to include copies of all incident reports filed with the state. The incident reports are defined by Section 458.351(4), Florida Statutes, which reads as follows: (4) For purposes of notification to the department pursuant to this section, the term "adverse incident" means an event over which the physician or licensee could exercise control and which is associated in whole or in part with a medical intervention, rather than the condition for which such intervention occurred, and which results in the following patient injuries: The death of a patient. Brain or spinal damage to a patient. The performance of a surgical procedure on the wrong patient. 1. The performance of a wrong- site surgical procedure; The performance of a wrong surgical procedure; or The surgical repair of damage to a patient resulting from a planned surgical procedure where the damage is not a recognized specific risk as disclosed to the patient and documented through the informed- consent process if it results in: death; brain or spinal damage; permanent disfigurement not to include the incision scar; fracture or dislocation of bones or joints; a limitation of neurological, physical or sensory function; or any condition that required transfer of the patient. A procedure to remove unplanned foreign objects remaining from a surgical procedure. Any condition that required transfer of a patient to a hospital licensed under Chapter 395, Florida Statutes, from any facility or any office maintained by a physician for the practice of medicine which is not licensed under Chapter 395, Florida Statutes. The incident reports are further defined by Florida Administrative Code Rule 64B8-9.001(1)(a), which states as follows in relevant part: . . . an event over which the physician or other licensee could exercise control and which is associated in whole or in part with a medical intervention, rather than the condition for which such intervention occurred, and which results in the following patient injuries: The death of a patient. Brain or spinal damage to a patient. The performance of a surgical procedure on the wrong patient. The performance of a wrong-site surgical procedure, the performance of a wrong surgical procedure; or the surgical repair of damage to a patient resulting from a planned surgical procedure where the damage is not a recognized specific risk as disclosed to the patient and documented through the informed-consent process and if one of the listed procedures in the paragraph results in: death; brain or spinal damage; permanent disfigurement not to include the incision scar; fracture or dislocation of bones or joints; a limitation of neurological, physical or sensory function; or any condition that required transfer of the patient. A procedure to remove unplanned foreign objects remaining from a surgical procedure. Any condition that required transfer of a patient to a hospital licensed under Chapter 395, Florida Statutes, from any facility or any office maintained by a physician for the practice of medicine which is not licensed under Chapter 395, Florida Statutes. FLACS understood that the "incident reports" referenced in Florida Administrative Code Rule 64B8-9.0092(2)(f) are the same as the "reports on adverse incident" defined by Section 458.351, Florida Statutes. FLACS's application specifically references adverse incident reports as defined by Section 458.351, Florida Statutes. FLACS filed two such adverse incident reports with its new application. FLACS has several methods to use in collecting incident reports. First, FLACS requires its accredited physicians and office surgery facilities to attest and acknowledge that they are required to provide FLACS with any and all adverse incident reports related to or following surgery in the accredited offices. Second, FLACS requires the staff of accredited offices to perform self-evaluation surveys after the first and second year of accreditation, said surveys to include such incident reports. Third, FLACS watches for information about adverse incidents as reported by news media or complaints from the public. Most important, FLACS can make quarterly public record searches even though the state system of record keeping for adverse incident reports is not computerized. There is no persuasive evidence that FLACS ever made an oral or written public records request for copies of incident reports related to its accredited practices. There is no statutory or rule requirement for physicians to file copies of incident reports with their accrediting organization. However, at least two of the nationally recognized accrediting agencies, Joint Commission on Accreditation of Healthcare Organizations (JACHO) and American Association for Accreditation of Ambulatory Surgical Facilities (AAAASF), have provisions in their accreditation manuals related to adverse incidents. JACHO's "Accreditation Manual for Office-Based Surgery Practices," Second Edition (2005), defines a "sentinel event" as follows: A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase "or risk thereof" includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. Such events are called "sentinel" because they signal the need for immediate investigation and response. The terms "sentinel event" and "medical error" are not synonymous; not all sentinel events occur because of an error, and not all errors result in sentinel events. JACHO requires each accredited practice to define "sentinel event" for its own purposes in establishing mechanisms to identify, report, and manage these events. JACHO encourages, but does not require, its clients to report "sentinel events" to the accrediting agency within 45 days of the event or of becoming aware of the event. The report should include a root cause analysis and an action plan. If JACHO becomes aware of an unreported "sentinel event," JACHO will advise the accredited practice to prepare and submit the report within a certain time frame. If the accredited practice fails to file an appropriate report within that time frame, JACHO will not revoke accreditation, but will place the accredited practice on an "Accreditation Watch" list. AAAASF's "Standards and Checklist for Accreditaion of Ambulatory Surgery Facilities" contains forms for accredited surgery facilities to use in reporting "unanticipated sequela." The forms refer one to AAAASF's "Quality Assurance and Peer Review Manual" for questions relative to their completion. The record indicates that "unanticipated sequela" are the equivalent of adverse incident reports, including but not limited to, events that result in unplanned hospital admissions. In Florida, physicians are required to file adverse incident reports with DOH's Consumer Services Unit (CSU), which is part of DOH's Medical Quality Assurance Program. On at least a quarterly basis, the Board's staff requests CSU to provide it with copies of adverse incident reports filed during a certain time frame. The staff of the CSU has access to medical consultants who review the incident reports to determine whether there might have been a violation of law or a violation of a standard of care. If so, the matter is referred for further investigation, determination of probable cause, and possible disciplinary prosecution by the Board. The Board's staff places the incident reports in physician registration files and in office surgery inspection/accreditation files. The Board's staff also places copies of incident reports involving physicians or facilities in the respective file of their accrediting agency or accrediting organization. The Board's staff provides copies of adverse incident reports to DOH's state inspectors before they make office inspections of non-accredited facilities or facilities formerly accredited by a national agency or FLACS. The state inspector/risk manager uses the incident reports during inspections to recommend improvements so that such incidents can be avoided in the future. The Board's Surgical Care Committee, uses the incident reports for statistical purposes. The Surgical Care Committee reviews the reports to determine whether changes need to be made in administrative rules, including but not limited to, rules related to standard of care or physician registration. It is important for FLACS to be aware of adverse incident reports filed by its accredited physicians and office- surgery facilities. Such reports are an essential part of any accreditation program. Without such knowledge, FLACS cannot be assured that its accredited physicians and offices are taking steps to prevent such incidents from occurring in the future. Moreover, if FLACS is not aware of the adverse incidents occurring in the offices it inspects, FLACS cannot implement changes in its policies to improve the accreditation process. The Board has no policy or practice for routinely sharing incident reports with accrediting organizations. Nevertheless, requiring FLACS to file copies of incident reports with the Board could alert the Board to incidents that were known to FLACS but never reported to the state and vice versa. As stated above, FLACS could make routine public records requests for copies of reports filed with the Board but not reported directly to FLACS. Rule 64B8-9.0092(4)(a)--Quality Assurance Program Florida Administrative Code Rule 64B8-9.0092(4)(a) requires an accrediting organization to "have a mandatory quality assurance program approved by the Board of Medicine." Though it is not apparent on the face of the rule, this provision relates to an "internal" quality assurance program used by the accrediting organization, not a quality assurance program implemented at a physician's office. The rule does not define a quality assurance program or describe the required contents of a quality assurance program necessary to achieve the Board's approval. There are no forms or instructions to provide guidance in designing an such a program. Mr. McPherson testified that FLACS could have used the quality assurance programs of national accrediting agencies as a reference when designing its own program. The greater weight of the evidence indicates that the "internal" quality assurance programs of national agencies are proprietary and not available to the public. Public information from JACHO and AAAASF relates to the ways that they monitor the quality assurance programs of the offices they inspect. For example, JACHO's manual discusses quality management issues for accredited practices, including standards, elements of participation, and the rationale that supports each. There is no evidence to show what internal steps the national agencies take to assure the quality of their programs apart from monitoring the programs of the accredited practices. Therefore, the Board could not have compared FLACS's "internal" quality assurance program and processes with the "internal" quality assurance programs and processes of the national accrediting agencies. During the hearing, the Board presented expert testimony about quality assurance programs in general. The expert testified that a generic quality assurance program for healthcare providers requires the following: (a) identification of positive outcomes that one desires; (b) identification of undesired negative outcomes based on the service and risk profile of the facility; (c) evaluation of accrued adverse incidents to identify trends; and (d) identification of ways to prevent future problems. The Board's quality assurance expert based his testimony on the standards published by the Center for Medicare and Medicaid Services (CMS). The description of a quality assurance program in the CMS document forms a skeleton for national accreditation programs such as the AAAASF, JACHO, and the Accreditation Association for Ambulatory Health Care (AAAHC). The rule does not reference CMS, JACHO, AAAASF, or AAAHC as having established models for an "internal" mandatory quality assurance program that the Board would approve. FLACS's office quality improvement plan compares favorably to the one established by AAAASF in some respects. For instance FLACS requires its accredited physicians and offices to perform a random chart screen of five cases on a quarterly basis. AAAASF requires a minimum of six cases per surgeon utilizing a facility or two percent of all cases in a group practice every six months. AAAASF requires its clients to engage in a peer review process at least every six months. The review is done by a recognized peer review organization or a medical doctor other than the operating room surgeon. FLACS does not require peer review evaluations due to concerns that peer review documents would be subject to discovery in legal proceedings in Florida. Rule 64B8-9.0092(4)(c)--Ongoing Anesthesia-related Accreditation and Quality Assurance Processes Involving the Active Participation of Anesthesiologists Florida Administrative Code Rule 64B8-9.0092(4)(c) requires an accrediting organization to have "ongoing anesthesia-related accreditation and quality assurance processes involving the active participation of anesthesiologists." The Board did not base its denial on FLACS's anesthesia-related accreditation standards and quality assurance processes required by Florida Administrative Code Rule 64B8-9.0092(4)(b). Instead, the denial is based upon the requirement for "active participation of anesthesiologists." The Board has no standards that describe or define the "active participation of anesthesiologists." There is no evidence that shows how the Board applied this requirement to FLACS's application. There are no forms or instructions to provide guidance for an applicant attempting to show the ongoing active participation of anesthesiologists. There is no evidence regarding the participation of anesthesiologists in ongoing anesthesia-related accreditation and quality assurance processes of national accreditation agencies. FLACS has an Anesthesia Review Committee, which is made up of three participating anesthesiologists, FLACS's inspectors, and FLACS's Executive Director. The committee meets quarterly to discuss current issues involving office surgery anesthesia, any anesthesia incidents involving FLACS's accreditees, new pharmacological agents available for outpatient anesthesia and, when available, additional information such as incident reports involving anesthesia mishaps of physicians who are not FLACS's accreditees. The Anesthesia Review Committee keeps written minutes. FLACS's Board of Directors reviews the minutes during regularly scheduled meeting. The Anesthesia Review Committee is responsible for updating FLACS's Anesthesis Parameters of Care on an annual basis. They also attend FLACS's educational meeting to update members on current practice in outpatient/office surgery anesthesia. The Board's quality assurance expert testified that he could not determine exactly how FLACS's anesthesiologists participated, i.e. what they did and how they came to conclusions. The expert could not say whether the participation of FLACS's anesthesiologists resembled the participation of anesthesiologists in the programs of national accreditation agencies. The expert acknowledged that for a relatively small number of physician's offices with a small number of anesthesia- related problems occurring within those offices, an evaluation of such problems on a quarterly basis might be quite adequate.
The Issue The issue in these cases is whether certain rules proposed by the Agency for Health Care Administration (AHCA) related to adult interventional cardiovascular services are an invalid exercise of delegated legislative authority.
Findings Of Fact By stipulation of the parties, all Petitioners and Intervenors in these cases are acute care hospitals licensed in Florida pursuant to Chapter 395, Florida Statutes; are substantially affected by the proposed rules at issue in these cases; and have standing to participate in this proceeding. AHCA is the state agency responsible for licensure of hospitals pursuant to Chapter 395, Florida Statutes, and responsible for promulgation of the proposed rules at issue in these cases. This dispute specifically involves proposed rules related to the licensure of adult cardiovascular services in Florida hospitals. Such services include percutaneous cardiac intervention (PCI), also referred to as percutaneous transluminal coronary angioplasty (PCTA). PCI involves the insertion of a device placed into an artery and directed to the site of a coronary artery blockage. The device is used to compress or remove the blockage material and restore arterial blood flow to heart tissue. A mechanism called a "stent" may be left in place at the site of the former blockage to reduce the potential for re-blockage ("restenosis") of the artery. The procedure is performed in a cardiac catheterization laboratory ("cath lab"). PCI that is performed on an emergency basis to open an arterial blockage causing myocardial infarction (heart attack) is referred to as "primary" or "emergent" PCI. PCI performed to resolve symptoms of coronary artery disease manifesting in presentations other than through myocardial infarction is referred to as "elective" PCI. Previous law restricted PCI services to those hospitals with onsite cardiac surgery (commonly referred to as "open heart" surgery). Hospitals are required to obtain a Certificate of Need (CON) from AHCA to operate a cardiac surgery program. Accordingly, in order to offer PCI services, a hospital was required to obtain a cardiac surgery program CON from AHCA. As cardiac catheterization procedures have become more widely available and physician training and experience have increased, the relative safety of the procedures has improved. The volume of open heart cardiac surgery has declined as the patient outcomes for non-surgical coronary artery disease treatments have improved, yet Florida hospitals seeking to provide PCI were still operating under the CON-based restrictions. There is an ongoing debate within the medical community related to the issue of whether non-emergent patients should receive PCI services at hospitals which lack cardiac surgery programs. The historic rationale for restricting the availability of elective PCI procedures to hospitals where onsite cardiac surgery was also available was related to the possibility that an unsuccessful PCI would require immediate resolution through surgery. The evidence establishes that PCI-related events requiring immediate access to onsite cardiac surgery have become less frequent, at least in part due to increased training and experience of practitioners, as well as an increased technical ability to resolve some events, such as arterial ruptures or perforations, within the cath lab. Nonetheless, there is also evidence that the outcomes of cardiac catheterization procedures performed in hospitals with onsite cardiac surgery may be superior to those performed in hospitals where onsite cardiac surgery is not available. In 2004, the Florida Legislature adopted two bills that, insofar as are relevant to this proceeding, had an impact on the regulatory process related to adult interventional cardiovascular services. The effect of the legislation was to shift the regulation of PCI programs away from CON-based restrictions and towards a licensing process. Both bills established a two-level classification of hospitals providing adult interventional cardiology services. House Bill 329 limited the provision of PCI at hospitals without onsite cardiac surgery to emergent patients and provided, in relevant part, as follows: In establishing rules for adult interventional cardiology services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult primary percutaneous cardiac intervention for emergent patients without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. (Emphasis supplied) Senate Bill 182 did not limit PCI services on the basis of onsite cardiac surgery availability and provided, in relevant part, as follows: Section 2. Notwithstanding conflicting provisions in House Bill 329, Section 408.0361, Florida Statutes, is amended to read: * * * In establishing rules for adult interventional cardiology services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult percutaneous cardiac intervention without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. (Emphasis added) Both the House Bill and the Senate Bill were signed into law. The legislation was codified as Section 408.0361, Florida Statutes (2004), which provided, in relevant part, as follows: 408.0361 Cardiology services and burn unit licensure.-- * * * In establishing rules for adult interventional cardiology services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult percutaneous cardiac intervention without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. Extensive evidence was offered at the hearing to support both sides of the debate regarding the appropriateness of performing elective PCI in hospitals without onsite cardiac surgery, and it is clear that the debate continues. However, the evidence establishes that the Florida Legislature specifically chose not to restrict non-emergent PCI to Florida hospitals with onsite cardiac surgery units and has determined that properly-licensed Florida hospitals may provide PCI services without regard to the availability of on-site cardiac surgery. It is reasonable to assume that had the Legislature intended to restrict provision of adult PCI in hospitals without cardiac surgery programs to emergent patients, the "notwithstanding" language contained in Senate Bill 182 would not have been adopted. There is no credible evidence that the Legislature was unaware of the continuing debate within the cardiology community at the time the legislation was adopted in 2004. The Legislature has acknowledged the distinction between emergent and elective PCI as indicated by Subsection 408.036(3)(o), Florida Statutes (2008), which provides under certain circumstances that a hospital without an approved "open heart surgery program" can obtain an exemption from CON requirements and provide emergent PCI services to "patients presenting with emergency myocardial infarctions." It is reasonable to assume that had the codification of the 2004 legislation been incorrect, the Florida Legislature would have subsequently amended the statute to reinstate the restriction. In fact, the Legislature has revised the referenced statute without substantively altering the relevant language establishing the two-level licensure designation. Section 408.0361, Florida Statutes (2008), the current statute directing AHCA to adopt the rules at issue in this proceeding, provides, in relevant part, as follows: 408.0361 Cardiovascular services and burn unit licensure.-- Each provider of diagnostic cardiac catheterization services shall comply with rules adopted by the agency that establish licensure standards governing the operation of adult inpatient diagnostic cardiac catheterization programs. The rules shall ensure that such programs: Comply with the most recent guidelines of the American College of Cardiology and American Heart Association Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories. Perform only adult inpatient diagnostic cardiac catheterization services and will not provide therapeutic cardiac catheterization or any other cardiology services. Maintain sufficient appropriate equipment and health care personnel to ensure quality and safety. Maintain appropriate times of operation and protocols to ensure availability and appropriate referrals in the event of emergencies. Demonstrate a plan to provide services to Medicaid and charity care patients. Each provider of adult cardiovascular services or operator of a burn unit shall comply with rules adopted by the agency that establish licensure standards that govern the provision of adult cardiovascular services or the operation of a burn unit. Such rules shall consider, at a minimum, staffing, equipment, physical plant, operating protocols, the provision of services to Medicaid and charity care patients, accreditation, licensure period and fees, and enforcement of minimum standards. The certificate-of-need rules for adult cardiovascular services and burn units in effect on June 30, 2004, are authorized pursuant to this subsection and shall remain in effect and shall be enforceable by the agency until the licensure rules are adopted. Existing providers and any provider with a notice of intent to grant a certificate of need or a final order of the agency granting a certificate of need for adult cardiovascular services or burn units shall be considered grandfathered and receive a license for their programs effective on the effective date of this act. The grandfathered licensure shall be for at least 3 years or until July 1, 2008, whichever is longer, but shall be required to meet licensure standards applicable to existing programs for every subsequent licensure period. In establishing rules for adult cardiovascular services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult percutaneous cardiac intervention without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. For a hospital seeking a Level I program, demonstration that, for the most recent 12-month period as reported to the agency, it has provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations or, for the most recent 12-month period, has discharged or transferred at least 300 inpatients with the principal diagnosis of ischemic heart disease and that it has a formalized, written transfer agreement with a hospital that has a Level II program, including written transport protocols to ensure safe and efficient transfer of a patient within 60 minutes. For a hospital seeking a Level II program, demonstration that, for the most recent 12-month period as reported to the agency, it has performed a minimum of 1,100 adult inpatient and outpatient cardiac catheterizations, of which at least 400 must be therapeutic catheterizations, or, for the most recent 12-month period, has discharged at least 800 patients with the principal diagnosis of ischemic heart disease. Compliance with the most recent guidelines of the American College of Cardiology and American Heart Association guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Establishment of appropriate hours of operation and protocols to ensure availability and timely referral in the event of emergencies. Demonstration of a plan to provide services to Medicaid and charity care patients. In order to ensure continuity of available services, the holder of a certificate of need for a newly licensed hospital that meets the requirements of this subsection may apply for and shall be granted Level I program status regardless of whether rules relating to Level I programs have been adopted. To qualify for a Level I program under this subsection, a hospital seeking a Level I program must be a newly licensed hospital established pursuant to a certificate of need in a physical location previously licensed and operated as a hospital, the former hospital must have provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations for the most recent 12- month period as reported to the agency, and the newly licensed hospital must have a formalized, written transfer agreement with a hospital that has a Level II program, including written transport protocols to ensure safe and efficient transfer of a patient within 60 minutes. A hospital meeting the requirements of this subsection may apply for certification of Level I program status before taking possession of the physical location of the former hospital, and the effective date of Level I program status shall be concurrent with the effective date of the newly issued hospital license. (5)(a) The agency shall establish a technical advisory panel to develop procedures and standards for measuring outcomes of adult cardiovascular services. Members of the panel shall include representatives of the Florida Hospital Association, the Florida Society of Thoracic and Cardiovascular Surgeons, the Florida Chapter of the American College of Cardiology, and the Florida Chapter of the American Heart Association and others with experience in statistics and outcome measurement. Based on recommendations from the panel, the agency shall develop and adopt rules for the adult cardiovascular services that include at least the following: A risk adjustment procedure that accounts for the variations in severity and case mix found in hospitals in this state. Outcome standards specifying expected levels of performance in Level I and Level II adult cardiovascular services. Such standards may include, but shall not be limited to, in-hospital mortality, infection rates, nonfatal myocardial infarctions, length of stay, postoperative bleeds, and returns to surgery. Specific steps to be taken by the agency and licensed hospitals that do not meet the outcome standards within specified time periods, including time periods for detailed case reviews and development and implementation of corrective action plans. Hospitals licensed for Level I or Level II adult cardiovascular services shall participate in clinical outcome reporting systems operated by the American College of Cardiology and the Society for Thoracic Surgeons. As required by Subsection 408.0361(5), Florida Statutes (2004), AHCA created the TAP, which convened and met over the course of two years at a series of public hearings. The TAP also received written materials and comments from interested parties. Thereafter, AHCA convened rule development workshops to formulate the proposed rules at issue in this proceeding. The proposed rules were initially noticed in the September 28, 2007, Florida Administrative Weekly (Vol. 33, No. 39). Subsequent Notices of Changes to the proposed rules were published in the Florida Administrative Weeklies of November 16, 2007 (Vol. 33, No. 46); March 28, 2008 (Vol. 34, No. 13); and May 9, 2008 (Vol. 34, No. 19). There is no evidence that AHCA failed to comply with statutory requirements related to the rule adoption process. As required by Subsection 408.0361(3)(a), Florida Statutes (2008), the proposed rules set forth the procedures by which a hospital may apply for licensure as a Level I or Level II provider of adult cardiovascular services without differentiation based on the availability of on-site cardiac surgery. The proposed rules applicable to a hospital seeking licensure as a Level I provider of adult cardiovascular services are set forth at Proposed Rule 59A-3.2085(16). The proposed rules applicable to a hospital seeking licensure as a Level II provider of adult cardiovascular services are set forth at Proposed Rule 59A-3.2085(17). Subsection 408.0361(3)(b), Florida Statutes (2008), establishes minimum volume reporting requirements for licensure as a Level I program. Accordingly, Proposed Rule 59A- 3.2085(16)(a) provides, in relevant part, as follows: 1. A hospital seeking a license for a Level I adult cardiovascular services program shall submit an application on a form provided by the Agency (See Form 1: Level I Adult Cardiovascular Services License Application Attestation; AHCA Form, Section 18(a) of this rule ), signed by the chief executive officer of the hospital, attesting that, for the most recent 12-month period, the hospital has provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations or, for the most recent 12-month period, has discharged or transferred at least 300 inpatients with the principal diagnosis of ischemic heart disease (defined by ICD-9-CM codes 410.0 through 414.9). Reportable cardiac catheterization procedures are defined as single sessions with a patient in the hospital’s cardiac catheterization procedure room(s), irrespective of the number of specific procedures performed during the session. Reportable cardiac catheterization procedures shall be limited to those provided and billed for by the Level I licensure applicant and shall not include procedures performed at the hospital by physicians who have entered into block leases or joint venture agreements with the applicant. (Emphasis supplied) Subsection 408.0361(3)(c), Florida Statutes (2008), establishes minimum volume reporting requirements for licensure as a Level II program. Accordingly, Proposed Rule 59A- 3.2085(17)(a) provides in relevant part as follows: 1. A hospital seeking a license for a Level II adult cardiovascular services program shall submit an application on a form provided by the Agency (See Form 2: Level II Adult Cardiovascular Services License Application Attestation; AHCA Form , Section 18(b) of this rule ) to the Agency, signed by the chief executive officer of the hospital, attesting that, for the most recent 12-month period, the hospital has provided a minimum of a minimum of 1,100 adult inpatient and outpatient cardiac catheterizations, of which at least 400 must be therapeutic cardiac catheterizations, or, for the most recent 12-month period, has discharged at least 800 patients with the principal diagnosis of ischemic heart disease (defined by ICD-9-CM codes 410.0 through 414.9). a. Reportable cardiac catheterization procedures shall be limited to those provided and billed for by the Level II licensure applicant and shall not include procedures performed at the hospital by physicians who have entered into block leases or joint venture agreements with the applicant. (Emphasis supplied) St. Anthony's asserts that the proposed rule is invalid on the grounds that it fails to provide a clear and reasonable methodology for assessing and verifying the number of diagnostic catheterization procedures performed. St. Anthony's asserts that the exclusion of cardiac catheterization procedures performed within the hospital's cardiac cath lab but not billed by the hospital is arbitrary and capricious, modifies, enlarges, or contravenes the specific provisions of the statute implemented, fails to establish adequate standards for agency decision making, and vests unbridled discretion in the agency. The evidence fails to support these assertions. Although the phrase "block lease" is undefined by statute or rule, the evidence establishes that insofar as relevant to this proceeding, the term refers to a practice by which a group of cardiologists lease blocks of time from a hospital for exclusive use of a hospital's cardiac cath lab. St. Anthony's has a leasing arrangement with a group of cardiologists identified as the "Heart and Vascular Institute South" ("HAVI South") whereby St. Anthony's leases blocks of time in a cardiac cath lab to HAVI South cardiologists. The facility is located in a privately-owned medical office building physically attached to St. Anthony's hospital building. St. Anthony's leases the medical office building from a developer. HAVI South cardiologists perform cardiac catheterization procedures at the St. Anthony's facility during both leased and non-leased time. St. Anthony's provides personnel to staff the cardiac cath lab regardless of whether the procedure is performed during leased or non-leased time. The HAVI South cardiology group develops the schedule of cardiac catheterization procedures to be performed during the leased time and notifies St. Anthony's of the schedule. The HAVI South cardiology group bills for both their professional fees and the facility charges (referred to as the "technical component") for the cardiac catheterization procedures performed during leased time. St. Anthony's does not bill for cardiac catheterization procedures performed during the leased time. For the cardiac catheterization procedures performed during non-leased time, the HAVI South cardiology group bills for professional fees, and St. Anthony's bills for the technical component. Patricia Sizemore, vice-president for patient services at St. Anthony's, acknowledged that other hospitals could have block-leasing arrangements different from those existing between St. Anthony's and the HAVI South group. The proposed rules would preclude St. Anthony's from including the outpatient cardiac catheterization procedures done by HAVI South during the block-leased time within those procedures available to meet the numeric threshold requirements identified in the statute. The evidence fails to establish that the proposed rule fails to provide a clear and reasonable methodology for assessing and verifying the number of diagnostic catheterization procedures performed. The relevant language of Subsection 408.0361(3), Florida Statutes (2008), identifies the hospital as the applicant and requires that the applicant "provide" the procedures or discharges being reported to meet the specified volume thresholds. The applicable definition of hospital is set forth at Subsection 408.032(11), Florida Statutes (2008), which defines a hospital as a health care facility licensed under Chapter 395, Florida Statutes. Subsection 395.002(12), Florida Statutes (2008), sets forth the following definition: (12) "Hospital" means any establishment that: Offers services more intensive than those required for room, board, personal services, and general nursing care, and offers facilities and beds for use beyond 24 hours by individuals requiring diagnosis, treatment, or care for illness, injury, deformity, infirmity, abnormality, disease, or pregnancy; and Regularly makes available at least clinical laboratory services, diagnostic X- ray services, and treatment facilities for surgery or obstetrical care, or other definitive medical treatment of similar extent, except that a critical access hospital, as defined in s. 408.07, shall not be required to make available treatment facilities for surgery, obstetrical care, or similar services as long as it maintains its critical access hospital designation and shall be required to make such facilities available only if it ceases to be designated as a critical access hospital. Physicians are not "hospitals" and are not licensed or regulated by Chapter 395, Florida Statutes. Physicians are not authorized to apply for licensure under the provisions of the statute and proposed rules at issue in this proceeding. Nothing in the statute suggests that entities other than hospitals may apply for licensure of a Level I or Level II adult cardiovascular services program. The rationale underlying the restriction of reportable procedures to those for which the applicant hospital issues bills for payment is based upon AHCA's reasonable intention to validate the procedure volume data submitted by applicant hospitals. Jeffrey Gregg, chief of AHCA's Bureau of Health Facility Regulation and CON Unit, testified that "the only practical, realistic way" for AHCA to routinely verify the accuracy of the procedure volume identified by a hospital's licensure application is through AHCA's ambulatory patient database. The reporting requirements for the ambulatory patient database are set forth at Florida Administrative Code Chapter 59B-9 and include elements such as demographic information, diagnosis codes, and charges. The database provides AHCA with access to patient record documentation and directly allows AHCA to verify the procedure volume identified in the licensure application. Because St. Anthony's has no charges related to the procedures performed by HAVI South cardiologists during the leased time, St. Anthony's has not reported procedures performed during leased time to the ambulatory patient database. St. Anthony's reports far more cardiac catheterization procedures to the local Suncoast Health Council than it does to AHCA's ambulatory patient database and asserts that AHCA could rely on health council data. AHCA has no organizational relationship with the local health council, and the evidence fails to establish that such data is as reliable as that collected by the ambulatory patient database. AHCA asserts that an additional basis to exclude procedures performed by entities other than the applicant hospital is that AHCA has no direct regulatory authority over the non-hospital entity. St. Anthony's asserts that AHCA would have its customary authority over the hospital and, by extension, over the third-party leasing the cardiac cath lab from the hospital. At best, AHCA's authority to obtain records from the non-hospital operator of the hospital's cardiac cath lab is unclear. St. Anthony's position effectively would permit a third-party operator to lease all of the time in a hospital's cardiac cath lab, yet allow the hospital to apply for and receive an adult cardiovascular service license. Nothing in Section 408.0361, Florida Statutes (2008), suggests that the Legislature intended to provide such an option. The proposed rule designating the reportable cardiac catheterization procedures is logical and rational, is not arbitrary or capricious, and does not modify, enlarge or contravene the specific provisions of the statute implemented. The evidence fails to establish that the designation of appropriately reportable cardiac catheterization procedures constitutes a failure to establish adequate standards for agency decision making or vests unbridled discretion in the agency. Subsection 408.0361(3)(d), Florida Statutes (2008), requires that the proposed rules include provisions "that allow for" compliance with the most recent guidelines of the American College of Cardiology and AHA guidelines for "staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety." Subsection 408.0361(5), Florida Statutes (2008), requires that the TAP "develop procedures and standards for measuring outcomes" and that, based thereon, AHCA adopt rules that include a risk adjustment procedure that accounts for variations in severity and case mix, outcome standards specifying expected levels of performance, and "specific steps to be taken by the agency and the licensed hospitals" that fail to meet outcome standards. The statute also requires that licensed hospitals participate in clinical outcome reporting systems operated by the American College of Cardiology and the Society of Thoracic Surgeons. The TAP determined that the appropriate method of measuring outcome was to utilize the data available through the clinical outcome reporting systems referenced in the statute. Accordingly, Proposed Rule 59A-3.2085(16)(a) identifies the guidelines applicable to Level I adult cardiovascular services; identifies the specific provisions of the guidelines with which a Level I hospital must comply; requires that the Level I hospital participate in the statutorily-identified data reporting system; and requires that Level I hospitals document a quality improvement plan to meet performance measures set forth by the data reporting system. The proposed rule provides, in relevant part, as follows: All providers of Level I adult cardiovascular services programs shall operate in compliance with subsection 59A- 3.2085(13), F.A.C., the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214 and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) guidelines regarding the operation of adult diagnostic cardiac catheterization laboratories and the provision of percutaneous coronary intervention. The applicable guidelines, herein incorporated by reference, are the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention). Aspects of the guideline related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. Aspects of the guideline related to the provision of elective percutaneous coronary intervention only in hospitals authorized to provide open heart surgery are not applicable to this rule. Hospitals are considered to be in compliance with the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214 and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) guidelines when they adhere to standards regarding staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Hospitals must also document an ongoing quality improvement plan to ensure that the cardiac catheterization program and the percutaneous coronary intervention program meet or exceed national quality and outcome benchmarks reported by the American College of Cardiology-National Cardiovascular Data Registry. Level I adult cardiovascular service providers shall report to the American College of Cardiology-National Cardiovascular Data Registry in accordance with the timetables and procedures established by the Registry. All data shall be reported using the specific data elements, definitions and transmission format as set forth by the American College of Cardiology-National Cardiovascular Data Registry. Proposed Rule 59A-3.2085(17)(a) identifies the guidelines applicable to Level II adult cardiovascular services; identifies the specific provisions of the guidelines with which a Level II hospital must comply; requires that the Level II hospital participate in the statutorily-identified data reporting system; and requires that Level II hospitals document a quality improvement plan to meet performance measures set forth by the data reporting system. The proposed rule provides in relevant part as follows: All providers of Level II adult cardiovascular services programs shall operate in compliance with subsections 59A-3.2085(13) and 59A-3.2085(16), F.A.C. and the applicable guidelines of the American College of Cardiology/American Heart Association regarding the operation of diagnostic cardiac catheterization laboratories, the provision of percutaneous coronary intervention and the provision of coronary artery bypass graft surgery. The applicable guidelines, herein incorporated by reference, are the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; and ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention; and ACC/AHA 2004 Guideline Update for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery) Developed in Collaboration With the American Association for Thoracic Surgery and the Society of Thoracic Surgeons. Aspects of the guidelines related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. Hospitals are considered to be in compliance with the guidelines in the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; in the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention; and in the ACC/AHA 2004 Guideline Update for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery) Developed in Collaboration With the American Association for Thoracic Surgery and the Society of Thoracic Surgeons when they adhere to standards regarding staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Hospitals must also document an ongoing quality improvement plan to ensure that the cardiac catheterization program, the percutaneous coronary intervention program and the cardiac surgical program meet or exceed national quality and outcome benchmarks reported by the American College of Cardiology-National Cardiovascular Data Registry and the Society of Thoracic Surgeons. In addition to the requirements set forth in subparagraph (16)(a)7. of this rule, each hospital licensed to provide Level II adult cardiovascular services programs shall participate in the Society of Thoracic Surgeons National Database. The Petitioners generally assert that the proposed rules insufficiently identify or establish the minimum standards identified as "guidelines" and "benchmarks" in the rule. The evidence fails to support the assertion. The guidelines are specifically identified and incorporated by reference within the rule. There is no evidence that the documents identified do not constitute the "most recent guidelines of the American College of Cardiology and the American Heart Association" as required by the statute. Hospitals are not obligated to meet all of the requirements set forth in the guidelines. A licensed hospital is deemed to be in compliance when, as specified in the statute, the hospital adheres to the standards related to staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. The Petitioners generally assert that such distinctions between the various compliance elements are unclear. The evidence fails to support the assertion. There is no credible evidence that the guidelines, albeit technical and complex, are not commonly understood by appropriate medical practitioners and hospital administrators. Martin Memorial asserts that the Proposed Rule 59A-3.2085(16)(a)5. is vague on grounds that it requires Level I hospitals to operate in compliance with the referenced guidelines while Proposed Rule 59A-3.2085(16)(a)9. authorizes provision of elective PCI at Level I hospitals. Martin Memorial further asserts that because the proposed rules provide for elective PCI in hospitals without onsite cardiac surgical programs, the proposed rules enlarge, modify or contravene the enacting statute. Subsection 408.0361(3)(d), Florida Statutes (2008), requires that AHCA include "provisions that allow for" the following: Compliance with the most recent guidelines of the American College of Cardiology and American Heart Association guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. (Emphasis supplied) Proposed Rule 59A-3.2085(16)(a)9. provides as follows: Notwithstanding guidelines to the contrary in the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214 and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention), all providers of Level I adult cardiovascular services programs may provide emergency and elective percutaneous coronary intervention procedures. Aspects of the guidelines related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. (Emphasis supplied) Martin Memorial's disagreement with the proposed rule is premised on the following statement in the ACC/AHA/SCAI 2005 Guideline Update: Elective PCI should not be performed at institutions that do not provide onsite cardiac surgery. (Level of Evidence: C) The statement is contained within subsection 4.3 ("Role of Onsite Cardiac Surgical Backup") within Section 4 ("Institutional and Operator Competency"). The statement is defined as a "Class III" standard, meaning within the "conditions for which there is evidence and/or general agreement that a procedure/treatment is not useful/effective and in some cases may be harmful." According to the "Level of Evidence: C" identification, the statement reflects "consensus opinion of experts, case studies, or standard of care." A footnote to the statement provides as follows: Several centers have reported satisfactory results based on careful case selection with well-defined arrangements for immediate transfer to a surgical program (citation omitted). A small but real fraction of patients undergoing elective PCI will experience a life-threatening complication that could be managed with the immediate onsite availability of cardiac surgical support but cannot be managed effectively by urgent transfer. Wennberg, et al., found higher mortality in the Medicare database for patients undergoing elective PCI in institutions without onsite cardiac surgery (citation omitted). This recommendation may be subject to revision as clinical data and experience increase. The guidelines are statements of "best practices" in health care delivery. They are intended to assist practitioners and facility administrators in making appropriate decisions. The cited statement neither prohibits nor requires performance of elective PCI in hospitals without onsite cardiac surgical programs. Whether a practitioner performs elective PCI in a licensed Level I hospital remains a medical decision under the provisions of the enacting statute and proposed rules. The footnote recognizes that elective PCI is available at some hospitals without onsite cardiac surgery through "careful case selection with well-defined arrangements for immediate transfer to a surgical program." The proposed rule specifically establishes staff and transfer requirements designed to facilitate rapid transfer of a patient from a Level I to a Level II facility. There is no evidence that such staff and transfer requirements are insufficient or otherwise inappropriate. Patient selection criteria are those which expressly identify clinical presentations of patients who are appropriate for revascularization through PCI. Section 5 of the referenced ACC/AHA/SCAI 2005 Guideline Update, titled "Clinical Presentations" explicitly addresses such criteria and constitutes the patient selection criteria contained within the document. The patient selection criteria do not regulate the location where PCI procedures are performed. As stated previously, the Florida Legislature, presented with the option of limiting the availability of cardiac catheterization services available at Level I hospitals to emergent patients, rejected the limitation. The evidence fails to establish that Proposed Rule 59A-3.2085(16)(a)5. is vague or that Proposed Rule 59A-3.2085(16)(a)9. enlarges, modifies or contravenes the enacting statute. Martin Memorial and St. Anthony's assert that the proposed rule contravenes Subsection 408.0361(5)(a), Florida Statutes (2008), which provides that AHCA adopt rules that include "at least the following" elements: A risk adjustment procedure that accounts for the variations in severity and case mix found in hospitals in this state. Outcome standards specifying expected levels of performance in Level I and Level II adult cardiovascular services. Such standards may include, but shall not be limited to, in-hospital mortality, infection rates, nonfatal myocardial infarctions, length of stay, postoperative bleeds, and returns to surgery. Specific steps to be taken by the agency and licensed hospitals that do not meet the outcome standards within specified time periods, including time periods for detailed case reviews and development and implementation of corrective action plans. The TAP recommended to AHCA that existing outcome data reporting systems created by the American College of Cardiology and the Society of Thoracic Surgeons be utilized for data collection related to licensed hospital adult cardiovascular services programs. Subsection 408.0361(5)(b), Florida Statutes (2008), requires that hospitals licensed under the proposed rules participate in clinical reporting systems operated by the American College of Cardiology and the Society of Thoracic Surgeons. The requirement was adopted by the 2007 Legislature based on the TAP recommendation. Proposed Rule 51A-3.2085(16)(a)8. requires licensed Level I hospitals to participate in the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR) and sets forth additional directives related to such participation. The ACC-NCDR system is a risk adjusted outcome reporting system that accounts for variation in severity and case mix. It collects approximately 200 data elements and is in use in approximately 2,000 hospitals. Proposed Rule 51A-3.2085(17)(a)6. directs licensed Level II hospitals to participate in the Society of Thoracic Surgeons National Database (STS database) and sets forth additional requirements related to such participation. The STS database provides information generally similar to the ACC-NCDR database. Although Proposed Rule 59A-3.2085(17)(a)5. states that the Level II hospital must meet or exceed the performance standards identified within the ACC-NCDR, there appears to be no specific requirement in the proposed rules that a Level II hospital participate in the ACC-NCDR system. Proposed Rule 59A-3.2085(17)(a)6. contains a citation to Proposed Rule 59A-3.2085 (16)(a)7. The cited paragraph consists of text that is similar to the paragraph preceding the citation. The intent of the reference is unclear. If the reference were intended to incorporate the ACC- NCDR reporting requirements with those applicable to Level II hospitals, the citation in Proposed Rule 59A-3.2085(17)(a)6. should have been to Proposed Rule 59A-3.2085(16)(a)8., where the ACC-NCDR requirements are identified. In any event, the statute requires participation by licensed hospitals in the reporting systems, and, as stated previously, Level II hospitals must document plans to ensure that the cited standards are met; so, it is logical to presume that Level II hospitals will participate in the ACC-NCDR system, in addition to the STS database. Martin Memorial and St. Anthony's assert that the proposed rule does not include the "outcome standards specifying expected levels of performance" required by Subsection 408.0361(5)(a)2., Florida Statutes (2008), and that the proposed rules fail to identify the "national quality and outcome benchmarks" referenced therein. The evidence fails to support the assertions. 93. Proposed Rules 59A-3.2085(16)(a)7. and 59A- 3.2085(17)(a)5. require that each licensed hospital must document a "quality improvement plan to ensure" that the specified cardiac services meet or exceed "national quality and outcome benchmarks" reported by the ACC-NCDR and the STS databases. The word "benchmark" is not defined by statute or rule. Merriam Webster's dictionary defines "benchmark" as "a point of reference from which measurements may be made" or "something that serves as a standard by which others may be measured or judged." The evidence establishes that the "national quality and outcome benchmarks" referenced in the proposed rules are the "expected levels of performance" identified through the ACC-NCDR system. Each hospital participating in the ACC-NCDR system receives a detailed quarterly outcome report indicating the particular hospital's performance relative to all other reporting hospitals on a variety of elements associated with cardiac catheterization and PCI provided at the hospital. Accompanying each periodic report is an "Executive Summary" that identifies the relative performance of the hospital receiving the report on ten specific "PCI and Diagnostic Catheterization Performance Measures," including six "PCI Quality Measures," two "PCI Utilization Measures," and two "Diagnostic Quality Measures." The Executive Summary information visually displays the data through a set of "box and whisker plots" that present the range of data reported by all participating hospitals on each specific measure. The summary received by each hospital identifies its specific performance through an "arrow" and numeric data printed on the plot. The plot visually displays "lagging" and "leading" performance levels. The plot identifies hospitals performing below the tenth percentile of all participating hospitals as "lagging" hospitals. The plot identifies hospitals performing above the 90th percentile as "leading" hospitals. The evidence, including review of the ACC-NCDR data reporting system, establishes that the "expected levels of performance" are rationally those levels within the broad range of hospitals which are neither "leading" nor "lagging" according to the data. It is reasonable to assume that a "leading" hospital is performing at a level higher than expected and that a "lagging" hospital is performing at a level lower than expected. By reviewing the plot for each measure, a hospital can determine its performance relative to other participating hospitals on the ten measures included in the Executive Summary. The additional numeric data contained within the quarterly report permit additional comparison between an individual hospital and all other participating hospitals. Subsection 408.0361(5)(a)2., Florida Statutes (2008), does not require that AHCA establish numeric minimal standards, but only requires that the rule identify "outcome standards specifying expected levels of performance." The ACC-NCDR reporting system required by the statute and adopted by the proposed rules sufficiently identifies expected levels of performance. By their very nature, the outcome standards are not fixed. It is reasonable to presume that as hospital practices change, measurements of relative performance will also change. The rule requires only that each licensed hospital include within a quality improvement plan, documentation to ensure that such outcome standards will be met or exceeded, essentially encouraging a pattern of continual improvement by licensed programs. Subsection 408.0361(5)(a)3., Florida Statutes (2008), requires that the rule include the "specific steps to be taken by the agency and licensed hospitals that do not meet the outcome standards within specified time periods, including time periods for detailed case reviews and development and implementation of corrective action plans." The proposed rule complies with the requirements of the statute. Enforcement of outcome standards requirements applicable to Level I programs is addressed at Proposed Rule 59A-3.2085(16)(f) which provides as follows: Enforcement of these rules shall follow procedures established in Rule 59A-3.253, F.A.C. Unless in the view of the Agency there is a threat to the health, safety or welfare of patients, Level I adult cardiovascular services programs that fail to meet provisions of this rule shall be given 15 days to develop a plan of correction that must be accepted by the Agency. Failure of the hospital with a Level I adult cardiovascular services program to make improvements specified in the plan of correction shall result in the revocation of the program license. The hospital may offer evidence of mitigation and such evidence could result in a lesser sanction. Enforcement of outcome standards requirements applicable to Level II programs is addressed at Proposed Rule 59A-3.2085(17)(e), which provides as follows: Enforcement of these rules shall follow procedures established in Rule 59A-3.253, F.A.C. Unless in the view of the Agency there is a threat to the health, safety or welfare of patients, Level II adult cardiovascular services programs that fail to meet provisions of this rule shall be given 15 days to develop a plan of correction that must be accepted by the Agency. Failure of the hospital with a Level II adult cardiovascular services program to make improvements specified in the plan of correction shall result in the revocation of the program license. The hospital may offer evidence of mitigation and such evidence could result in a lesser sanction. AHCA does not routinely conduct surveys of accredited hospitals. Such surveys are conducted by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). AHCA generally conducts hospital surveys only during the investigation, pursuant to Florida Administrative Code Rule 59A-3.253(8), of a complaint filed against a hospital. AHCA would likely review ACC-NCDR and Society of Thoracic Surgeons data reports associated with the investigation of a specific complaint related to adult cardiovascular services. Assuming that AHCA's review of the data identified a deficiency, the proposed rules provide the licensee a 15-day period to develop a plan of correction acceptable to AHCA, unless the issue poses "a threat to the health, safety or welfare of patients" in which case it is reasonable to expect that a more prompt resolution of a deficiency would be required. Pursuant to Florida Administrative Code Rule 59A- 3.253, a hospital could be sanctioned for failing to submit a plan of correction related to an identified deficiency, or for failing to implement actions to correct deficiencies specified in an approved plan of correction. There is no evidence that AHCA's enforcement authority under the proposed rules differs in any significant manner from the general enforcement authority already available to the agency. There is no evidence that the proposed rules would result in any alteration of AHCA's investigative practices. Martin Memorial notes that, while the proposed rule provides a 15-day period for development of a plan of correction, AHCA's general enforcement rules already provide a ten-day period and asserts that the proposed rule is therefore inconsistent, fails to establish adequate standards for agency decisions, and vests unbridled discretion in the agency. The specific time period set forth in the proposed rule is clearly applicable, and there is no credible evidence of legitimate confusion in this regard. AHCA has suggested that "lagging" hospitals could be specifically regarded as failing to meet the outcome benchmarks identified in the ACC-NCDR data, but the proposed rule makes no specific reference to any systematic classification of hospital performance, and the statute does not require that a minimal performance level be established. Martin Memorial asserts that the Proposed Rule 59A- 3.2085(17)(a)6. is capricious because it requires that "each hospital licensed to provide Level II adult cardiovascular services programs shall participate in the Society of Thoracic Surgeons National Database," but only physicians can participate in the database. The enacting statute requires such participation. Subsection 408.0361(5)(b), Florida Statutes (2008), directs AHCA to adopt rules that require Level I or Level II licensed hospitals to "participate in clinical outcome reporting systems operated by the American College of Cardiology and the Society for Thoracic Surgeons." The proposed rule clearly implements the directive established by the statute. There is no credible evidence that the proposed rule is irrational or that a licensed Level II hospital would be unable to meet the obligations of the rule by requiring that its thoracic surgeons participate in the STS database. Martin Memorial asserts that the requirement that an applicant hospital's chief executive officer attest to compliance with certain guidelines is vague because "it is unclear what guidelines apply and what guidelines will not." The evidence fails to support the assertion. The referenced requirement applicable to a hospital seeking licensure as a Level I facility is set forth at Proposed Rule 59A-3.2085(16)(a)2., which provides as follows: The request [for licensure] shall attest to the hospital’s intent and ability to comply with the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention); including guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. The referenced requirement applicable to a hospital seeking licensure as a Level II facility is set forth at Proposed Rule 59A-3.2085(17)(a)2., which provides as follows: The request [for licensure] shall attest to the hospital’s intent and ability to comply with applicable guidelines in the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-2; in the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention); and in the ACC/AHA 2004 Guideline Update for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery) Developed in Collaboration With the American Association for Thoracic Surgery and the Society of Thoracic Surgeons, including guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Proposed Rule 59A-3.2085(16)(a)6. designates the guidelines applicable to the operation of Level I hospital services. Proposed Rule 59A-3.2085(17)(a) designates the guidelines applicable to the operation of Level II hospital services. The specific elements of the referenced guidelines are identified in both the statute and the proposed rules. Martin Memorial asserts that the proposed rule is vague as to training requirements applicable for physicians performing elective PCI in Level I hospitals. In making the assertion, Martin Memorial references training requirements established at Proposed Rule 59A-3.2085(16)(b)2. and applicable to Level I physicians performing emergent PCI with less than 12 months experience. There is no credible evidence that the proposed rule is vague. Proposed Rule 59A-3.2085(16)(b), in relevant part, provides as follows: Each cardiologist shall be an experienced physician who has performed a minimum of 75 interventional cardiology procedures, exclusive of fellowship training and within the previous 12 months from the date of the Level I adult cardiovascular licensure application or renewal application. Physicians with less than 12 months experience shall fulfill applicable training requirements in the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) prior to being allowed to perform emergency percutaneous coronary interventions in a hospital that is not licensed for a Level II adult cardiovascular services program. The rule provides that a physician with less than 12 months experience working in a Level I facility can perform emergent PCI only if applicable training requirements have been met. The proposed rule does not authorize performance of elective PCI in a Level I hospital by a physician not meeting the minimum annual procedure volume requirements. Proposed Rule 59A-3.2085(17)(b) clearly identifies the requirements applicable to Level II physicians and in relevant part provides as follows: Each cardiac surgeon shall be Board certified. New surgeons shall be Board certified within 4 years after completion of their fellowship. Experienced surgeons with greater than 10 years experience shall document that their training and experience preceded the availability of Board certification. Each cardiologist shall be an experienced physician who has performed a minimum of 75 interventional cardiology procedures, exclusive of fellowship training and within the previous 12 months from the date of the Level II adult cardiovascular licensure application or renewal application. Martin Memorial asserts that the experience requirements set forth at Proposed Rule 59A-3.2085(16)(b)3. (related to Level I hospitals) and Proposed Rule 59A- 3.2085(17)(b)3. (related to Level II hospitals) are arbitrary or capricious. The evidence fails to support the assertion. The text of both proposed rules provides as follows: The nursing and technical catheterization laboratory staff shall be experienced in handling acutely ill patients requiring intervention or balloon pump. Each member of the nursing and technical catheterization laboratory staff shall have at least 500 hours of previous experience in dedicated cardiac interventional laboratories at a hospital with a Level II adult cardiovascular services program. They shall be skilled in all aspects of interventional cardiology equipment, and must participate in a 24-hour-per-day, 365 day-per-year call schedule. Martin Memorial argues that there is no evidence to suggest that 500 hours of experience indicates that appropriate competency levels has been achieved. The evidence establishes that the required experience level was developed by AHCA's hospital licensure unit staff and is the training level currently applicable for hospitals providing emergency PCI services under existing exemptions from CON requirements. The training requirements are not arbitrary or capricious. Martin Memorial asserts that the Proposed Rule 59A-3.2085(16)(c)1. is arbitrary or capricious. The cited rule requires that a Level I hospital make provisions for the transfer of an emergent patient to a Level II hospital, as follows: A hospital provider of Level I adult cardiovascular services program must ensure it has systems in place for the emergent transfer of patients with intra-aortic balloon pump support to one or more hospitals licensed to operate a Level II adult cardiovascular services program. Formalized written transfer agreements developed specifically for emergency PCI patients must be developed with a hospital that operates a Level II adult cardiovascular services program. Written transport protocols must be in place to ensure safe and efficient transfer of a patient within 60 minutes. Transfer time is defined as the number of minutes between the recognition of an emergency as noted in the hospital’s internal log and the patient’s arrival at the receiving hospital. Transfer and transport agreements must be reviewed and tested at least every 3 months, with appropriate documentation maintained. Martin Memorial asserts that the rule is arbitrary or capricious because it does not include a requirement that a Level I hospital make provisions for the transfer of an elective patient to a Level II hospital. There is no credible evidence to support the assertion. There is no evidence that a patient undergoing elective PCI at a Level I would not be regarded as an emergent patient were circumstances such that an emergent transfer to a Level II hospital warranted. There is no credible evidence to suggest a rationale for transferring a non-emergent patient from a Level I to a Level II hospital. Martin Memorial asserts that the proposed rule enlarges, modifies or contravenes the enacting statute on grounds that, although AHCA is directed to adopt rules to ensure compliance "with the most recent guidelines of the American College of Cardiology and American Heart Association Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories," the proposed rule provides that "in case of conflicts between the provisions of this rule and the designated guidelines" the rule provisions "shall prevail." Such provisions appear in Proposed Rule 59A-3.2085(13)(j), Proposed Rule 59A-3.2085(16)(g), and Proposed Rule 59A-3.2085(17)(f). The enacting statute requires that hospitals licensed under the provisions of the proposed rules comply with guidelines "for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety." To the extent that guidelines that relate to elements other than "staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety," the enacting statute does not require compliance by properly- licensed Florida hospitals. Other than as addressed elsewhere herein, the evidence fails to identify any specific conflicts between the guidelines and the proposed rules and, accordingly, fails to establish that the cited proposed rules enlarge, modify or contravene the enacting statute.
