Findings Of Fact Petitioner, Peter P. McKeown, is a graduate of the University of Queensland Medical School in Brisbane, Australia. He holds the degrees of Bachelor of Medicine and Bachelor of Surgery. Doctorates of Medicine, under the British system, are reserved for specialists. Nonetheless, the medical training Petitioner received equates to that leading up to the award of the degree of Doctor of Medicine in the United States, and he is a physician and licensed as such in several states. He has completed residencies in general and thoracic surgery in Australia and the United States and has taken advanced training in cardiovascular and thoracic surgery at Emory University. Immediately before coming to the University of South Florida, (USF), Dr. McKeown was an Assistant Professor of Surgery at the University of Washington. In mid to late 1988, Dr. McKeown responded to an advertisement USF had placed in the Journal of the American Medical Association seeking applicants qualified for appointment at the Associate Professor level "... to join the Department of Surgery at the University of South Florida College of Medicine as the Chief of Cardiothoracic Surgery." He was selected for the position and joined the faculty effective May 1, 1989. All the correspondence leading up to Petitioner's joining the University faculty referred not only to his appointment as Associate Professor but also his assignment as Chief of the Cardiothoracic Surgery Division. Only the actual state employment contract described his employment exclusively as Associate Professor and made no mention of the Chief position. Under these circumstances, Petitioner did not gain any proprietory interest in the position of Chief of the Cardiothoracic Surgery Division. Dr. McKeown held the position of Chief of the Cardiothoracic Surgery Division until April, 1994, when, as a result of a decision made by the Chairman of the school's Department of Surgery, he was replaced as Chief and that position was filled, on a temporary basis, by the Department Chair. Petitioner claims that when he arrived at USF to assume the directorship, an administrative position, he saw an opportunity to develop the position into something significant. He contends he would not have come to USF unless he was to be the Chief of the Division as there was no appeal to him in a position as a general faculty member. He wanted an opportunity to budget, hire people, and develop plans and programs, and in order to advance in academic medicine, one must, at some point, hold an administrative position. Apparently the Department of Surgery had experienced a rapid turnover in faculty. It is not clear whether this caused or was the result of a dispute with administrators and medical staff at Tampa General Hospital, (TGH), where much of the clinical medical school activity is carried on. However, the program was recognized as being weak in cardiothoracic surgery, and this condition offered Petitioner the challenge he wanted. In his five years as Chief, Petitioner increased both the number and quality of personnel and revenues considerably. He developed affiliations with several foreign universities and recruited qualified people, built up the laboratory, secured more grants, developed a program of continuing medical education and raised the examination scores of the school's graduates. He opened new clinical programs and built up both billings and collections to the point where the program revenues were increased at least 2 to 5 times. By 1992- 1993, the Division was making money and generating a surplus and still used clinic funds to support research. During his tenure as Chief of the Division, Petitioner served under two Department of Surgery chairmen. The first was Dr. Connar, the individual who recruited him; and the incumbent is Dr. Carey, the individual who removed him. Petitioner asserts that at no time during his tenure in the position of Chief of the Cardiothoracic Surgery Division was he ever told, by either Department Chairman, that his performance was unsatisfactory. All Division heads within the Department were, from time to time, counseled about personnel costs, and Petitioner admits he had some differences with Dr. Carey about that subject and some other financial aspects of the job, but nothing different than anywhere else in academia. Petitioner was removed by Dr. Carey based in part upon his alleged inability to get along with people. Though he claims this is not true, he admits to three areas of conflict. The first related to his objection to transplants being accomplished by unqualified surgeons which, he alleges, Dr. Carey permitted to further his own ends. The second related to the pediatric heart transplant program for which Petitioner supported one candidate as chair and Dr. Carey supported another. The third related to Petitioner's reluctance to hire a physician whom Dr. Carey wanted to hire but to whom Petitioner purportedly objected. Of the three areas of dispute, only the first two came before his removal, but he contends at no time was he advised his position was a problem for the Department. By the same token, none of Petitioner's annual performance ratings reflected any University dissatisfaction with his performance. At no time was he ever rated unsatisfactory in any performance area; and prior to his removal, he had no indication his position as Chief of the Division was in jeopardy. Dr. Carey indicates he did counsel with Petitioner often regarding his attitude but did not rate him down because he hoped the situation would improve. Dr. McKeown was called to meet with Dr. Carey in his office on April 12, 1994. At that meeting, Dr. Carey was very agitated. He brought up the "Norman" incident and indicated he was going to remove Petitioner as Chief of the Division. Dr. McKeown admits to having made an inappropriate comment regarding Dr. Norman, another physician, to a resident in the operating room while performing an operation. He also admits that it was wrong to do this and apologized to Dr. Norman both orally and in writing shortly thereafter. Dr. Norman accepted his apology and Petitioner asserts that after his removal, Dr. Norman called him and assured him he, Norman, had not prompted the removal action. Dr. Norman did not testify at the hearing. Dr. Carey removed Petitioner from his position as Chief because of the comments he had made regarding Dr. Norman. Almost immediately after the meeting was concluded, Dr. Carey announced in writing his assumption of the Chief's position, in which position he remained until he hired Dr. Robinson as Chief in April, 1995. Petitioner found out that Carey's threat to remove him had been carried out the following day when his nurse told him his removal had been announced at the Moffett Cancer Center. He thereafter heard other reports of his removal from other sources, and based on what had happened, concluded his removal was intended to be and constituted a disciplinary action for his comment regarding Dr. Norman. He was not advised in advance of Carey's intention to impose discipline nor given an opportunity to defend himself before the action was taken. He claims he was not given any reason for his removal before or at the time of his dismissal. It is found, however, that the removal was not disciplinary action but an administrative change in Division leadership. Dr. McKeown at first did nothing about his removal, believing it would blow over. However, after he heard his removal had been publicized, he called several University officials, including a Vice-President, the General Counsel and the Provost, to see how the matter could be handled. He claims he either got no response to his inquiries or was told it was a Medical College problem. He then met with the Dean of the College of Medicine who indicated he could do nothing. After he was removed as Division Chief, Petitioner's salary remained the same as did his supplement from his practice. He claims, however, his removal has had an adverse effect on his reputation in the medical and academic communities. It is his belief that people now feel something is wrong with him. Dr. Carey's blunt announcement of his assumption of the Chief's position, without any reasons being given for that move or credit being given to Petitioner for his past accomplishments has had an impact on his ability to work effectively. After his removal, he received calls from all over the world from people wanting to know what had happened. The removal has, he claims, also made it more difficult for him to get grants and has, thereby, adversely impacted his ability to do productive research. In addition, his removal made it difficult for him to carry out his academic duties. His specialty is still presented in student rotations, only in a different place in the medical curriculum. Dr. McKeown has sought reinstatement to the administrative position of Chief of the Division. He is of the opinion that Dr. Carey's action in removing him from his position as Division Chief was capricious and damaging to the University as well as to his career. Petitioner admits he could have been less confrontational in the performance of his duties as Division Chief, but he knows of no complaints about him from TGH, All Children's Hospital or the VA Hospital. There are, however, letters in the files of the Department Chairman which indicate some dissatisfaction with Petitioner's relationships in some quarters and, as seen below, there were signs of dissatisfaction from both TGH and All Children's Hospitals. Petitioner admits he may have been somewhat overbearing or abrasive, but neither his alleged inability to properly steward finances nor his alleged inability to get along with people were mentioned to him at the time of dismissal or before. After Dr. Carey assumed the Chairmanship of the Department of Surgery in July, 1990, he saw Dr. McKeown frequently on an official basis at first. A Chief, as Petitioner was, has many and varied functions such as administration, teaching, fiscal, research, clinic administration and the like. People skills are important because of the necessary interface with colleagues, faculty, administrators and the public. When Dr. Carey came to USF, Dr. McKeown had not been in place very long, and the Division of Cardiothoracic Surgery was not doing well financially. There were contract negotiations going on with the VA Hospital which were not going well, at least partly because, Dr. Carey asserts, Dr. McKeown had made some major unacceptable demands. As a result, Dr. Carey stepped in, along with Dr. Benke, who was very effective in dealing with the VA, and as a result, an agreement was reached which resulted in somewhere between $275,000 and $300,000 per year coming in which put the Division in the black. Dr. Carey recalls other instances indicating Dr. McKeown's inability to get along with others. One related to the relationship with TGH previously mentioned. TGH had made a decision to use a particular physician as head of its transplant program because, allegedly, Dr. McKeown had so angered private heart patients they would not let him be appointed even though Dr. McKeown was Dr. Carey's choice. As it turned out, Dr. Carey convinced the TGH Director and another physician to agree to a plan whereby Dr. McKeown would be head of the program 50 percent of the time. This would have been good for the University, but Dr. McKeown refused indicating that if he could not be in charge all of the time, he would not be in charge at all. Another incident relates to All Children's Hospital. That institution wanted to initiate a pediatric heart transplant program and a meeting was set up to which Dr. McKeown was invited. Petitioner so infuriated the community surgeons attending that meeting they would not work with him, and without his, Carey's, efforts, Dr. Carey claims the program was doomed to failure. As a result, Carey asked Dr. Nevitsky to help get the program started. This gave the USF an opportunity to participate in the program, but when Nevitsky left, they lost it. Still another example, according to Dr. Carey, is the fact that some surgeons on staff have called to complain about Dr. McKeown's attitude and unwillingness to compromise and negotiate and about his demands for service and staff, all of which creates friction among the hospital staff. A few days before Dr. Carey removed Petitioner as Chief, he spoke with the Dean of the College of Medicine, a Vice-president of the University, and others who would be impacted, about his concern regarding the Cardiothoracic Surgery Division and, in fact, he had had discussions with other officials even before that time. Long before making his decision to remove Petitioner, Carey spoke of his consideration of possibly shifting the emphasis within the Division to non-cardiac thoracic surgery in place of the cardiac program which Dr. Carey felt was not very successful. He believed the program did not do enough procedures to support the medical school affiliation. Dr. Carey chose to dismiss Dr. McKeown as Chief of the Division on April 12, 1994, after learning of McKeown's destructive attack on another surgeon before a junior physician in a public place, an operating room, (the Norman incident). He notes that over the years there was a building concern regarding Dr. McKeown's abilities as an administrator, and this incident with Dr. Norman was the last straw. Dr. Carey had received complaints about Petitioner from other physicians, all of which he discussed with Dr. McKeown. Finally, with the Norman incident, it became abundantly clear that Dr. McKeown's capabilities as a leader had diminished to the point where a change was necessary. Before he dismissed Petitioner, and during the investigation which led up to the dismissal, Dr. Carey admits, he did not give Dr. McKeown any opportunity to give any input to the decision. By the time Carey met with McKeown on April 12, 1994, his mind was made up. The Norman incident was demonstrative of what Carey perceived as McKeown's lack of supervisory ability, and it was that factor which led Carey to the ultimate decision to remove McKeown. He felt it necessary to act then and not leave Dr. McKeown in place during the search for a replacement. Petitioner cites alleged comments made by Carey to others that he would have relieved anyone for doing what Petitioner did in the Norman incident. Dr. Carey cannot recall having made such a statement. He claims he considered disciplinary action against Petitioner for the Norman comments but decided against it. However, it was the last in a series of incidents which caused him to question the propriety of McKeown's placement in the Chief's position, and which ultimately cemented his decision to replace him. Dr. Carey met with Dr. McKeown several times before the dismissal and counseled him about administrative deficiencies in his performance, but he never told Dr. McKeown that unless he improved, he would be dismissed. This is consistent with Petitioner's testimony that he was not warned of his shortcomings or of the administration's dissatisfaction with his performance. Disagreements in conversations between superior and subordinate, meant by the former to be corrective in nature, are not always taken as such by the latter. Dr. Carey did not document any of this in Dr. McKeown's personnel files but put some of the information he received by way of communications from others in the files. These are the letters submitted by the University, pursuant to agreement of the parties, subsequent to the hearing. They contributed to Carey's increasing concern about Dr. McKeown's ability to lead the Division. At no time, however, though he questioned Dr. McKeown's leadership, did Dr. Carey ever question his good faith and sincerity, nor does he do so now. When he finally decided action was necessary, on April 12, 1994, Dr. Carey wrote a memorandum to the Medical College faculty concerning his assumption of the position as Chief of the Cardiothoracic Surgery Division. He also advised Dr. McKeown of his removal. Dr. Carey remained in the Chief's position, holding that title in an administrative capacity and not from a clinical standpoint, for approximately one year, intending to stay in the position only until he could find a fully qualified thoracic surgeon to take the job. After Carey removed Petitioner, he was contacted by the Medical College Dean who asked that he get with McKeown and try to work something out. He thereafter offered Dr. McKeown the position of Chief of the cardiac section of the Division but McKeown declined. Dr. Carey also, on April 26, 1994, wrote to TGH recommending that Dr. McKeown be allowed to have more impact on the hospital's transplant program, pointing out that the change in McKeown's position at the University was occasioned by a need for a change in leadership. According to Dr. Tennyson J. Wright, Associate Provost of the University, disciplinary action against nonunion faculty members is governed by Rule 6C4-10.009, F.A.C., and requires notice of proposed action be given before such disciplinary action is taken. The contract which Dr. McKeown holds and has held since the inception of his tenure at the University, is a standard USF/State University System contract. It reflects Petitioner was hired as an Associate Professor, which is one of the three types of personnel classifications used within the system. These are faculty, administration and support. Petitioner's contract does not refer to his holding the Division Chief position and it is not supposed to. Such a position is an administrative appointment within a Department and a working title used to define the holder's duties, and service in such a position is at the pleasure of the Department Chair. Appointment to or removal from a Chief position is an administrative assignment. The position of Department Chairperson, on the other hand is a separate position and subclassification within the University classification system and is different.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that Petitioner, Peter P. McKeown's, grievance against the University of South Florida School of Medicine arising from his removal as Chief, Cardiothoracic Surgery Division in the Department of Surgery be denied. DONE AND ENTERED this 19th day of January, 1996, in Tallahassee, Florida. ARNOLD H. POLLOCK, 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 January, 1996. APPENDIX TO RECOMMENDED ORDER IN CASE NO. 95-1832 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties to this case. FOR THE PETITIONER: 1. - 7. Accepted and incorporated herein. Though the documents in question refer to appointment, in actuality the personnel action was an appointment to the faculty with an administrative assignment to the position of Director of the Division. & 10. Accepted. 11. & 12. Accepted and incorporated herein. 13. & 14. Accepted and incorporated herein. - 19. Accepted and incorporate herein. Accepted and incorporated herein. Accepted. Rejected as inconsistent with the better evidence of record. Accepted. Accepted and incorporated herein. Rejected as inconsistent with the better evidence of record. & 27. Accepted. & 29. Accepted and incorporated herein. Accepted. Accepted and incorporated herein. 32. - 34. First sentence accepted. Second sentence rejected as inconsistent with the better evidence of record. 35. - 37. Accepted. 38. Rejected as argument. 39. Accepted. FOR THE RESPONDENT: - 9. Accepted and incorporated herein. Accepted. - 14. Accepted and incorporated herein. 15. & 16. Accepted and incorporated herein. COPIES FURNISHED: Benjamin H. Hill, III, Esquire William C. Guerrant, Jr., Esquire Danelle Dykes, Esquire Hill, Ward & Henderson, P.A. Post Office Box 2231 Tampa, Florida 33601 Thomas M. Gonzalez, Esquire Thompson, Sizemore & Gonzalez 109 North Brush Street, Suite 200 Post Office Box 639 Tampa, Florida 33601 Olga J. Joanow, Esquire University of South Florida 4202 East Fowler Avenue, ADM 250 Tampa, Florida 33620 Noreen Segrest, Esquire General Counsel University of South Florida 4202 East Fowler Avenue, ADM 250 Tampa, Florida 33620-6250
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 in this case is whether the challenged portions of the proposed amendments set forth in the Fourth Notice of Change for Rule 64B8-9.009, Florida Administrative Code (FAC), published in the Florida Administrative Weekly on February 18, 2000, constitute an invalid exercise of delegated legislative authority.
Findings Of Fact Background Rule 64B8-9.009, Florida Administrative Code, is the Board's Rule governing the standards of care for office surgery. The Rule was first adopted on February 1, 1994 as a Rule 61F6- 27.009, Florida Administrative Code. It was transferred to Rule 59R-0.009, Florida Administrative Code, and was amended on May 17, 1994; September 8, 1994; and November 15, 1994, and then was finally transferred to Rule 64B8-9.009, Florida Administrative Code. In February of 1998, the Board directed its Surgical Care Committee to evaluate Rule 64B8-9.009 and to make recommendations for any modifications or amendments to the Rule. The 1998 Florida Legislature also addressed the issue of office- based surgery and provided that the Board may "establish by rule standards of practice and standards of care for particular practice settings . . . " including office-surgery environments. As discussed below, hearings were conducted by the Board and its Surgical Care Committee to consider changes to the office surgery rule. The Parties R. Gregory Smith, M.D., Charles Graper, D.D.S., M.D. and Florida Academy of Cosmetic Surgery Petitioner R. Gregory Smith, M.D., is a licensed medical doctor practicing in Ponte Vedra Beach, Florida. Smith practices cosmetic surgery, plastic surgery, and oralmaxillofacial surgery in his office. Smith has a dental degree from Ohio State University College of Dentistry, a residency in oral and maxillofacial surgery and a degree in medicine. Approximately 30 percent of FACS members use general anesthesia (Level III) in their office surgery procedures. At least one representative of FACS has attended each public rulemaking hearing relating to proposed Rule 64B8-9.009, Florida Administrative Code. FACS actively participated in the rulemaking process, expressing concerns relating to transfer agreements, hospital privileges, and the requirement for an anesthesiologist in Level III surgery. FACS' purposes include addressing adverse outcomes in the field of cosmetic surgery and implementing recommended approaches to improve patient safety. Petitioner Charles E. Graper, D.D.S., M.D., is a Florida licensed medical doctor and dentist practicing in Gainesville, Florida. 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. 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. 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. Graper has been practicing cosmetic surgery for 20 years and has been teaching cosmetic surgery for 15 years. Graper has experience in performing Level III office surgery using general anesthesia. The Board of Medicine The Board of Medicine (Board) regulates the practice of medicine in Florida, and is the agency that adopted the rule at issue. The Florida Society of Plastic Surgeons, Inc., Florida Chapter, American College of Surgeons and Florida Society of Dermatologists The FSPS, FCACS, and the FSD are comprised of Florida physicians who practice in the areas of plastic surgery and dermatology. As licensed physicians (M.D.s), members of FSPS, FCACS, and FDS are subject to the regulations promulgated by the Board of Medicine. A substantial number of physician members of the FSPS, the FCACS, and the FSD perform office surgery and are affected by the proposed amendments to Rule 64B8-9.009, Florida Administrative Code. FSPS is a Florida not-for-profit corporation whose 270 members are board-certified plastic surgeons (of the approximately 375 such physicians statewide) licensed in the State of Florida pursuant to Chapter 458, Florida Statutes. FSPS was created and exists for the purposes of promoting plastic surgery as a science and profession. FSPS regularly participates in legislative efforts, rulemaking proceedings, and litigation on behalf of its members, and has participated throughout the rulemaking process with respect to Florida Administrative Code Rule 64B8-9.009. FCACS is a Florida not-for-profit corporation whose 1400 members are surgeons licensed in the State of Florida pursuant to Chapter 458, Florida Statutes. FCACS was created and exists for the purposes of promoting surgery as a science and profession. FCACS regularly participates in legislative efforts, rulemaking proceedings, and litigation on behalf of its members. Members of the Association, including Petitioner Graper, routinely perform office surgery. FSD is a Florida not-for-profit corporation whose 462 members are board-certified dermatologists licensed in the State of Florida pursuant to Chapter 458, Florida Statutes. FSD was created and exists for the purposes of promoting surgery as a science and profession. FSD regularly participates in legislative efforts, rulemaking proceedings, and litigation on behalf of its members. Members of the Association, including David Allyn, M.D., and Diane Calderone, M.D., routinely perform office surgery. The Florida Society of Anesthesiologists, Inc., Florida Hospital Association, Inc. and Association of Community Hospitals and Health systems 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 related to anesthesiology. The FHA and the 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. The Florida Nurses Association (FNA) The Florida Nurses Association is a professional association of approximately 7,500 nurses licensed in the state of Florida, including approximately 1,700 advanced registered nurse practitioner (ARNP) members and a substantial number of CRNAs. Among its many purposes, the FNA represents the legal, legislative, and professional practice interests of the members. The Florida Association of Nurse Anesthetists Petitioner, Florida Association of Nurse Anesthetists (FANA), is a non-profit corporation and professional organization made up of more than 1,600 certified registered nurse anesthetists practicing throughout Florida, many of whom currently provide anesthesia for surgery performed in physicians' offices. As a part of its mission, FANA advocates its members' interests in legal, legislative, and professional practice issues. Rule Challenges by FSA and the Hospitals On July 8, 1999, the FSA filed a Petition for Administrative Determination of Invalidity of Proposed Rule challenging portions of the proposed amendments to Rule 64B- 8.9009 as set forth in the Second Notice of Change. The FSA's Rule challenge was assigned DOAH Case No. 99-2974RP. Also on July 8, 1999, the Hospitals filed a petition for Administrative Determination of the Invalidity of Proposed Rules challenging portions of the proposed amendments to Rule 64B8-9.009 as set forth in the Second Notice of Change. The Hospitals' Rule challenge was assigned DOAH Case No. 99-2975RP. The Board conducted a third public hearing on the proposed Rule amendments on August 7, 1999. The Board published a Third Notice of Change to the proposed Rule amendments in the August 20, 1999, issue of the Florida Administrative Weekly. None of the changes in the Third Notice of Change related to provisions that were in litigation. On January 12, 2000, the Board, the FSA, and the FSPS filed a Joint Stipulation on provisions of Rule 64B8-9.009, Florida Administrative Code (Joint Stipulation) in DOAH Case No. 99-2974RP. The Joint Stipulation released from FSA's Rule challenge, Case No. 99-2974RP, the majority of the proposed amendments to Rule 64B8-9.009 and reserved only the proposed amendments to Subsections (1)(e) and (6)(b)1.a. of Rule 64B8- 9.009 for challenge. On January 26, 2000, the Hospitals filed a Notice of Partial Voluntary Dismissal in DOAH Case No. 99-2975RP, dismissing their challenge to all proposed amendments to Rule 64B8-9.009, except with respect to Subsections (2)(e), (2)(f), (2)(i), (4)(b)1. and 2. and (6)(b)1.a. and b. 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)1., (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. The Board subsequently conducted an additional public meeting and published a fourth notice of change relating to the proposed amendments to Rule 64B8-9.009 still subject to challenge by the FSA and the Hospitals. These changes included the withdrawal of the proposed amendments to Subsection (4)(b)1. which would have changed "transfer agreement" to "transfer protocol." During this public meeting, the Board was informed that those parts of the Rule no longer being challenged had been filed with the Department of State. On January 28, 2000, the Board filed all of its proposed amendments to Rule 64B8-0.009, with the exception of the amendments to Subsections (1)(e), (2)(e), (2)(f), (2)(i), (4)(b)1. and 2., and (6)(b)1.a-b, for adoption with the Florida Secretary of State. The proposed amendments filed for adoption on January 28, 2000, became effective February 17, 2000. The Board voted to modify some of the proposed amendments to Rule 64B8-9.009 still subject to challenge at its public meeting on February 5, 2000. The FSA filed a Notice of Voluntary Dismissal of its Rule challenge in DOAH Case No. 99-2974RP on February 7, 2000. DOAH case No. 99-2974RP was closed on February 8, 2000. The Hospitals filed a Notice of Voluntary Dismissal of their Rule challenge in DOAH Case No. 99-2975RP on March 9, 2000, and the case was closed on March 10, 2000. The Fourth Notice of Change was published in the February 18, 2000, issue of the Florida Administrative Weekly noticing the changes to proposed amendments to Rule 64B8-9.009 voted on by the Board at its February 5, 2000, meeting. On February 25, 2000, the FACS, Graper, and Smith filed a Petition for an Administrative Determination of the Invalidity of a Proposed Rule challenging the Board's proposed changes to Subsection (6)(b)1.a. of Rule 64B8-9.009 as published in the Fourth Notice of Change. This petition was assigned DOAH Case No. 00-0951RP. On March 8, 2000, the FACS, Graper, and Smith filed an Amended Petition for an Administrative Determination of the Invalidity of a Proposed Rule in DOAH Case No. 00-0951RP challenging the Board's proposed withdrawal of the proposed changes to Subsection (4)(b)1. of Rule 64B8-9.009 and the proposed changes to Subsection (6)(b)1.a. of Rule 64B8-9.009 as published in the Fourth Notice of Change. The Board held a public hearing on April 8, 2000, in Orlando, Florida, and received testimony concerning the Fourth Notice of Change. At the conclusion of the hearing, the Board voted to adjourn without making any changes in the Fourth Notice of Change. On April 17, 2000, the FANA filed its petition challenging the Board's Fourth Notice of Change. The FANA's petition was assigned DOAH Case No. 00-1622RP. DOAH Case Nos. 00-0951RP and 00-1622RP were consolidated by Order of the Administrative Law Judge issued May 4, 2000. The Fourth Notice of Change states that "[t]he proposed changes to Subsection (4)(b)1., shall be withdrawn." With respect to Subsection (6)(b)1.a. of Rule 64B8- 9.009, the Fourth Notice of Change states: Proposed Subsection (6)(b)1.a. shall be changed to read, (b) Standards for Level III Office Surgery. In addition to the standards for Level II Office Surgery, the surgeon must comply with the following: Training Required. a. The surgeon must have staff privileges at a licensed hospital to perform the same procedure in that hospital as that being performed in the office setting or must be able to document satisfactory completion of training such as Board certification or Board qualification by a Board approved by the American Board of Medical Specialties or any other board approved by the Board of Medicine or must be able to demonstrate to the accrediting organization or to the Department comparable background, training and experience. In addition, the surgeon must have knowledge of the principles of general anesthesia. If the anesthesia provider is not an anesthesiologist, there must be a licensed M.D., or D.O., anesthesiologist, other than the surgeon, to provide direct supervision of the administration and maintenance of the anesthesia. Petitioners have challenged the Fourth Notice of Change on the following grounds: (1) the requirement that an anesthesiologist be present for all Level III surgeries in physicians' offices will increase the cost and limit surgical procedures and practice opportunities of Petitioners resulting in a substantial adverse financial impact on Petitioners and patients; (2) the Fourth Notice of Change exceeds the Board of Medicine's rulemaking authority by attempting to regulate nurse anesthetists; (3) the Fourth Notice of Change conflicts with existing statutes governing the practice of nurse anesthetists; (4) the rule is arbitrary and capricious and is not supported by competent evidence and is inconsistent with the law and policies of the federal government and of 49 states; (5) the Fourth Notice of Change is not supported by competent substantial evidence and would not have any measurable effect on patient safety; (6) the Rule was improperly adopted; and (7) that the Fourth Notice of Change conflicted with the existing requirement to provide a choice of anesthesia providers. Each of these arguments is addressed below. Final Order in DOAH Case No. 00-1058RX The Final Order in DOAH Case No. 00-1058RX invalidated certain existing Rule requirements related to transfer agreements and hospital staff privileges as a precondition for certain office surgeries. Specifically, that Final Order invalidated Subsection (4)(b) of Rule 64B8-9.009, which required a transfer agreement for any physician performing Level II office surgery who did not have staff privileges to perform the same procedure at a licensed hospital. In addition, the Final Order invalidated Subsection (6)(b) of Rule 64B8-9.009 which required a physician performing Level III office surgery to have hospital staff privileges for the procedure performed in an out-patient setting. As grounds for invalidating the staff privileges requirement, the Administrative Law Judge determined that the Board lacked specific statutory authority to mandate hospital privileges, thereby exceeding its grant of rulemaking authority. The Final Order further determined that the requirement for hospital privileges was arbitrary, deferred credentialing to individual hospitals, and was not supported by competent substantial evidence. During the prior hearing, the parties did not present specific argument related to, nor did the Final Order consider the proposed changes to the staff privileges requirement set forth in the Fourth Notice of Change due to the separate Rule challenge proceedings. The Proposed Rule Regarding Competency Demonstration Notwithstanding, Subsection 4 of the Fourth Notice of Change proposes to change Subsection (6)(b)1.a. of Rule 64B8- 9.009 to include alternatives to hospital staff privileges as a manner of demonstrating sufficient education, training and competency to perform Level III surgery in an office setting. The proposed change provides that a surgeon who seeks to provide Level III surgery in an office setting can demonstrate training as follows: The surgeon must have staff privileges at a licensed hospital to perform the same procedure in that hospital as that being performed in the office setting or must be able to document satisfactory completion of training such as Board certification or Board qualification by a Board approved by the American Board of Medical Specialties or any other Board approved by the Board of Medicine or must be able to demonstrate to the accrediting organization or to the Department comparable background, training, and experience. (emphasis added) The proposed Rule at issue in this proceeding continues to provide for the same mechanism of hospital privileges, previously invalidated. The provision remains invalid for the reasons articulated in the previous Final Order. However, the proposed Rule also provides office surgeons with two alternative methods for objectively demonstrating sufficient training and competency through certification by a recognized medical specialty board or through direct demonstration to the Board of Medicine. That provision of the proposed Rule, provides significant flexibility and meaningful options to physicians seeking to perform office surgery. The Board demonstrated that the options are an appropriate approach for the Board to utilize in exercising its delegated regulatory authority and responsibility to adopt education and training standards for the office setting. The Petitioners adequately challenged the provisions and the Board proved the validity of the proposed alternatives by a preponderance of the evidence. Increased Costs Petitioners contend that the anesthesiologist requirement in the Fourth Notice of Change violates Section 120.52(8)(g), Florida Statutes, by imposing regulatory costs on the regulated person which could be reduced by the adoption of less costly alternatives that substantially accomplish the statutory objectives. Petitioners offered credible evidence indicating that the hourly rates charged by anesthesiologists range from 50 to 100 percent higher than the hourly rates charged by CRNAs for similar procedures. Respondent and Intervenor, FSA, on the other hand, demonstrated that hourly rates varied from market to market within Florida and in a few cases, rates for anesthesiologists were approximately the same as for CRNAs. The evidence is clear, however, that the charges for an anesthesiologist are significantly higher than those for CRNAs for similar procedures. Anesthesiologists possess broader expertise, education, and training. As a result, requiring an anesthesiologist for Level III office surgeries will increase the total cost of a typical in-office plastic or cosmetic surgery procedure between five and ten percent. Furthermore, the evidence demonstrated that although some surgeons periodically use anesthesiologists during Level III office surgery for a variety of reasons, including availability, complexity of procedure, current health of patient and contractual agreements, most surgeons utilize CRNAs due to the considerable cost savings. Petitioners also claimed that the Rule would create a monopoly in the provision of in-office anesthesia for anesthesiologists and would force hundreds of CRNAs out of office practice. The Fourth Notice of Change applies to Level III surgeries, so it is reasonable to conclude that the need for CRNAs to participate in the performance of Level III surgeries under the supervision of an anesthesiologist will be obviated. Their assistance is unnecessary and cost prohibitive. And although nurse anesthetists would still be permitted to provide Level II anesthesia in the office setting under the supervision of the operating surgeon, the proposed Rule imposes a significant increase in the cost of Level III surgeries and severely decreases competition. Rulemaking Authority and Conflicting Law Petitioners mistakenly contend that the proposed anesthesiologists requirement exceeds the scope of the Board of Medicine's rulemaking authority and conflicts with existing law. The authority for the Fourth Notice of Change is contained in part in Section 458.33(1)(v), Florida Statutes, which states in pertinent part: 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 manual in order to establish grounds for disciplining doctors. Specifically, Petitioners allege that the Fourth Notice of Change constitutes an impermissible attempt by the Board of Medicine to regulate nurse anesthetists and conflicts with Chapter 464, Florida Statutes, which permits nurse anesthetists to practice under the supervision of any physician, osteopath, or dentist. The parties have stipulated that Florida-certified registered nurse anesthetists are licensed only by the Florida Board of Nursing and are subject to discipline only by the Florida Board of Nursing. In mandating that office surgeons use an anesthesiologist during in-office Level III surgery, the proposed Rule does not directly regulate any nurse or certified registered nurse anesthetist and does not subject the CRNA to any discipline by the Board of Medicine or by the Board of Nursing. Thus, the Rule on its face does not conflict with the delegated legislative authority to the Board of Medicine for rulemaking in Section 458.331(1)(v). Federal Law, Scientific Evidence, Arbitrary and Capricious, Competent Substantial Evidence Petitioners contend that the Fourth Notice of Change requiring an anesthesiologist be present during Level III surgery is inconsistent with the laws and policies of the federal government and 49 states, contrary to the overwhelming weight of scientific evidence, arbitrary and capricious, and not supported by competent substantial evidence. There is no evidence that the Fourth Notice of Change is inconsistent with the laws and policies of the federal government. There is no federal law or rule which prohibits any state from establishing its own rules governing the rights of various practitioners to administer or supervise the administration of anesthesia in any particular setting. Federal government regulations defer to state law on this subject unless a state establishes a lower standard of care. While it is insignificant whether any other state currently requires an anesthesiologist to be present for the administration or supervision of general anesthesia in an office setting, some states have considered such requirements, including Pennsylvania and New Jersey. With respect to the scientific evidence presented by the parties, it is clear that there is a lack of competent and substantial evidence to demonstrate an increased level of safety for general anesthesia patients who undergo surgery under the care of an anesthesiologist as opposed to a CRNA. CRNAs are advanced registered nurse practitioners. In addition to their nursing training, CRNAs must have at least one year of experience in a critical care setting (such as working in a hospital intensive care unit) prior to beginning their two- to-three year master's level anesthesia training. Nurse anesthetists typically are trained side by side with physician anesthesia residents, use the same textbooks, and are taught by the same instructors. Unlike physician anesthesiologists who receive a general medical-surgical license that may not require any level of training or expertise in the administration of anesthesia, CRNAs must pass a national certifying examination in anesthesia as a condition of state licensure. In addition, CRNAs must complete 40 hours of continuing anesthesia education every two years, and must be recertified every two years to retain their state license. The evidence suggests that the safety of office surgery is comparable to that of hospitals and ambulatory surgery centers. Moreover, under the existing Rule, the office surgeon and patient determine the most appropriate anesthesia provider and setting based on the individual patient's needs. The direct testimony and scientific evidence indicate no significant difference in patient outcomes based on whether anesthesia is administered by an anesthesiologist or CRNA. Hence, Florida law and the existing standard of care in Florida permits a surgeon to supervise a CRNA in the office setting. Nearly forty percent of the 1600 CRNA members of FANA provide anesthesia in physicians' offices. Furthermore, the evidence indicates that anesthesiologist supervision of CRNAs in hospitals is extremely inconsistent. "Supervision" as defined by various hospitals requires the anesthesiologists to be within five to thirty minutes of the hospital. Anesthesiologists are often absent for extended periods and typically "supervise" several operating rooms simultaneously. In fact, Federal Medicare regulations permit an anesthesiologist to receive payment for the "medical direction" of as many as four CRNAs at the same time. Moreover, several smaller and often rural hospitals and ambulatory surgical centers in Florida do not have anesthesiologists on staff. CRNAs provide the anesthesia services in those venues. Dr. David Mackey, an anesthesiologist, testified that he had reviewed information on 28 deaths related to office surgery which occurred between 1987 and 1999. Dr. Mackey concluded that there have been nine deaths resulting from office surgery in the past 12 years in which anesthesia was a cause of death. However, Dr. Mackey was able to confirm that a CRNA provided the anesthesia in only two of the nine cases. Office surgeons and related professional societies agree that an office-based surgeon may safely supervise a CRNA. Currently, there are three national accrediting organizations that may accredit office surgery facilities: Joint Commission on Accreditation for Ambulatory Healthcare Organizations; American Association for Accreditation of Ambulatory Surgery Facilities; and Accreditation Association for Ambulatory Health Care. Rule 64B8-9.0091, Florida Administrative Code. None of these accrediting organizations requires that CRNAs be supervised by an anesthesiologist. No other state currently requires anesthesiologist supervision of CRNAs in an office setting. In fact, Florida's Joint Committee of the Boards of Nursing and Medicine identify specific medical acts that may be performed by ARNPs, and the level of physician supervision required for such acts. Section 464.003(a)(c), Florida Statutes. The Joint Committee does not require anesthesiologist supervision of CRNAs in any setting. The U.S. Armed Forces do not require anesthesiologist supervision of CRNAs in any practice setting. And the American Society of Anesthesiologists' has published its own "Recommended Scope of Practice for Nurse Anesthetists" which provides for CRNAs to administer anesthesia under the supervision of the operating surgeon. Studies of Anesthesia Outcomes and Medical Error Michael B. Pine, M.D., a Board-certified cardiologist, former chief of cardiology at Cincinnati Medical school, and a former professor of medicine at Harvard Medical School and two other medical schools, testified as an expert in healthcare quality assessment and improvement. Dr. Pine has served as a healthcare quality assessment and improvement consultant to the JCAHO, the Health Care Financing Administration (HCFA), the American Medical Association (AMA), the American Osteopathic Association, the Hospital Research and Educational Trust of the American Hospital Association, the American Association of Oral and Maxillofacial Surgeons, the American Association of Nurse Anesthetists, Blue Cross/Blue Shield, and Anthem, among others. Dr. Pine characterized his career transition from clinician to consultant as moving from "dealing with diseased individuals to dealing with diseased organizations to help them assess their problems in delivering health care and help them improve and get better." Dr. Pine assisted in the development of clinical indicators for JCAHO, including indicators in anesthesia care. He has worked with the federal Health Care Financing Administration (HCFA) to measure hospital mortality and adjust for patient severity as an indicator of hospital quality. Dr. Pine's consulting experience includes evaluating outcome data for individual practitioners, groups of providers, and whole systems. Dr. Pine testified that the classic study in anesthesia mortality was a 1950's study by Beecher and Todd of 600,000 anesthetic administrations which were followed by about 8,000 deaths, 325 of which were ultimately determined to be anesthetic related. The study reflects an anesthesia mortality rate of about 1:2,500. In the Beecher and Todd study, nurse anesthetists performed twice as many cases as anesthesiologists, but the number of deaths involving nurse anesthetists was virtually the same as the number of deaths involving anesthesiologists. Beecher and Todd initially hypothesized that the greater mortality rate for anesthesiologists could be explained by the severity of illness of the patients seen by anesthesiologists rather than nurse anesthetists, but after correcting for the difference in severity of illness, they discovered the nurse anesthetists had actually treated patients who were slightly more sick. Beecher and Todd were unable to explain why physician anesthesiologists, who anesthetized only half as many patients as nurse anesthetists, were involved in an equal number of deaths. Dr. Pine testified that a later study, the Bechtoldt, measured outcomes associated with two million anesthetics in North Carolina between 1969 and 1976. The mortality rate was approximately 1:24,000; a mortality rate ten times better than the rate reflected in the Beecher and Todd study 20 years earlier. The Bechtoldt study compared the outcomes of anesthesiologists working alone, nurse anesthetists working alone, and CRNAs and anesthesiologists working together, the surgeon or dentist administering anesthesia him/herself, and deaths in which no provider could be identified. Bechtoldt concluded that: When we calculated the incidence of anesthetic related deaths for each group which administered the anesthetic, we found that the incidence among the three major groups - the CRNA, the anesthesiologist, and the combination of both - to be rather similar. Although the CRNA working alone accounted for about half the anesthesia- related deaths, the CRNA working alone also accounted for about half the anesthetics administered. A 1980 study by Forrest of 17 hospitals and about 10,0000 patents was one of the first studies to make a formal adjustment for the sickness severity of the patients. Using conservative statistical methods, Forrest concluded that "there were no significant differences in outcomes" between the hospitals that predominately used anesthesiologists and the hospitals that predominately used nurse anesthetists. Anesthesia safety continued to improve as indicated by a British study in the early 1980's, that used a procedure similar to that used by Beecher and Todd in the 1950's. The British study looked at 485,000 surgeries in which anesthesia was provided. There were 4000 deaths, only 3 of which were determined to be anesthetic related, reflecting an anesthesia mortality rate of 1:185,000. The Institute of Medicine report entitled "To Err is Human," published in 1999, reflects an even better anesthesia mortality rate of 1:200,000 to 1:300,000 cases. The Institute of Medicine report states: The gains in anesthesia are very impressive and were accomplished through a variety of mechanisms including improved monitoring techniques, the development and widespread adoption of practice guidelines and other systemic approaches to improving errors . . . . the success of anesthesia, was accomplished through a combination of technological changes, new monitoring equipment, standardization of existing equipment, information-based strategies including the development and adoption of guidelines and standards, application of human factors to improve performance such as the use of simulators for training, formation of the Anesthesia Patient Safety Foundation to bring together stakeholders form different disciplines, physicians, nurses, manufacturers, to create a focus for action and having a leader who would serve as a champion for the cause. Dr. Pine also addressed the recent study regarding anesthesia by Silber published in June 2000. This study examined 7,665 deaths following 217,000 hospital procedures for which medical bills were submitted to HCFA for Medicare reimbursement. The study attempted to characterize the type of anesthesia provider based on whether an anesthesiologist submitted a bill for providing anesthesia or supervising the anesthesia. The study assumed that a CRNA administered the anesthesia if either the CRNA billed for it, or if no bill was located. Moreover, instead of reviewing deaths that occurred within 48 hours after the surgery, the study counted all deaths which occurred within 30 days following surgery, and ignored any non-anesthesia related complications and deaths which were included in the 7,665 death toll. Conversely, the 7,665 deaths in 217,000 procedures produce a mortality rate of 1:28, nearly 100 times greater than the mortality rate in the 1950 Beecher and Todd study, and nearly 10,000 times what the 1999 Institute of Medicine study reflected as the anesthetic mortality rate. The greatly inflated and inconsistent death rate is highly questionable and provides little scientific support for the Board's proposed rule. With respect to Petitioners' argument relating to arbitrary and capricious mandate, the proposed Rule would not permit office-based surgeons to provide a choice of anesthesia provider for Level III office surgeries, since only one anesthesia provider is necessary or justified for Level III office surgery, and the proposed rule mandates the participation of an anesthesiologist. It is unreasonable and not economically feasible for the surgeon or the patient to pay for an anesthesiologist and a CRNA for the same procedure. Based on the current Rule's "choice of anesthesia provider" requirement in subsection (2)(b) of the existing Rule, the proposed anesthesiologist mandate for Level III surgery is inconsistent, confusing and illogical to the reasonable person.
The Issue Whether Petitioner should receive a passing grade for the Florida Optometry Licensure Examination taken on July 23 through 25, 2004.
Findings Of Fact Dr. Cook is a licensed optometrist in the State of Michigan. She received her Doctor of Optometry degree in 1985, and became licensed in the same year. Dr. Cook has taken the Michigan, Illinois, and Wisconsin state licensure examinations and passed all three examinations on her first try. For 17 years, Dr. Cook practiced optometry at the University of Michigan Health Services. This was a comprehensive practice, including eye examinations with dilation, treatment of eye diseases, emergency care, and the monitoring and follow-up care of patients with glaucoma, cataracts, and other diseases. Except for providing care to family members, Dr. Cook has not practiced professionally, on a regular basis, since August 2001, when she moved to Florida. Dr. Cook is a Fellow of the American Academy of Optometry. She was accepted at the final hearing as an expert in optometry. Dr. Cook desires to become licensed in Florida to practice optometry. As part of the process to apply for licensure in Florida, Dr. Cook is required to retake parts one and two of the national board examinations and to pass the Florida examination for licensure. She retook the national board examinations and passed on the first try. In August 2003, she took the clinical portion of the Florida examination and failed. In July 2004, Dr. Cook retook the clinical portion of the Florida examination. A passing score on the clinical portion is 80. She scored 75.75 on the July 2004 examination, and, thus, failed the clinical portion. For the clinical examination, Dr. Cook was required to bring her own "patient" upon whom some of the examination's required procedures were required to be performed. Some of the procedures are performed on "patients" brought by other candidates taking the examination. The grading on each procedure in the clinical examination is done by two examiners who are licensed, practicing optometrists. A candidate will be graded by a different set of examiners for the morning and afternoon sessions. The examiners are chosen by the Board of Optometry and trained by the Department's Testing Services Unit and outside practitioner consultants prior to the administration of each examination. The examiners are provided with a set of Grading Standards for their use during the grading of the examination. The purpose of the training and standards is to make the grading process objective and to provide grading uniformity and consistency. The examiners are required to grade and mark their scores independently. They are not to compare or discuss their scoring with other examiners at any time. If both examiners' grades agree, the candidate is given either no credit or full credit, depending on whether the examiners considered the procedures were properly performed. If the examiners disagree on the grading, the candidate is given the average of the two grades actually awarded, which is the sum of the two grades divided by two. If an examiner considers that a procedure is properly performed, the examiner marks the grade sheet with a "Y," indicating a yes. Examiners are taught to give the candidates the benefit of the doubt in borderline cases. If an examiner feels that the performance was borderline, the examiner must indicate "borderline" in the comment section on the grade sheet and specify the reason. If an examiner determines that the candidate did not properly perform the procedure, the examiner marks the grade sheet with an "N," indicating a no. An examiner is required to specify the reason for a no grade in the comment section on the grading sheet. Some of the procedures are performed once for both examiners. Other procedures are performed in groups, meaning that the procedures are performed twice, once before each of the examiners. In grouped procedures, the first examiner will read the directions for a procedure, and the candidate will perform the procedure after the directions are given. The first examiner will read the directions for the next procedure, and the candidate will perform the procedure after the directions are read. This format continues until the grouped segment is completed. The same procedures will then be performed for the second examiner, following the same format used by the first examiner. No records are kept to indicate which examiner graded first or second during any part of the examination. The examination candidate has control over when each examiner grades the candidate. When the candidate is ready to be graded, the candidate is required to say, "Grade me now." Dr. Cook has challenged the grades that she received for the following procedures: confrontational field test; measurement of pupil size; rating patient's response to light; demonstrating the equator and posterior pole during the binocular indirect ophthalmoscopy examination; the anterior vitreous portion of the biomicroscopy examination of the anterior segment; the choroidal crescent, posterior vitreous detachment, A-V three crossings out find and reflex, and hypertensive changes portion of the biomicroscopy examination of the fundus; and measuring eye pressure using a Goldmann Tonometer. A confrontational field test is a gross neurological field test in which the candidate compares her visual field to the patient's to pick up gross neurological defects. The Candidate Information Booklet (CIB) states that the confrontational field test is to be performed as described in Clinical Opthalmology by J.D. Duane. In order to perform this test, the candidate sits in front of the patient about a meter away. The patient covers one eye and looks at the candidate's eye, nose, or other structure so that the patient's gaze is not moving around. The candidate puts her non-moving fingers in different quadrants to test the patient's ability to see the fingers. It is important to keep the fingers stationary while performing the test because moving fingers could be detected by the patient even in a blind field. In other words, a patient who is not able to see a stationary finger may be able to detect a finger that is moving because the motion contributes to the detection. Dr. Cook performed the confrontational field test for both examiners simultaneously. She received .75 points out of a possible 1.5 points for the confrontation field test. Examiner 202 gave Dr. Cook full credit for the examination. Examiner 239 gave Dr. Cook no credit and noted the following in the comment section: "Moving fingers--Init performed 'wiggling fingers' while moving target fingers." Examiner 239 also noted "Did very brief static CF test but fingers moving not stationary." Dr. Cook admitted that she did wiggle her fingers during part of the performance of the examination, claiming that she was testing the patient's peripheral vision, which was not part of the examination. The examination was to be performed within the central 30 degrees. The preponderance of the evidence does not establish that Dr. Cook tested the four quadrants with non-moving fingers. Dr. Cook's score of .75 points is correct. As part of the clinical examination, the candidates are required to measure the size of the patient's pupil. In order to measure the pupil, the candidate must not sit in front of the patient. Sitting in front of the patient creates a stimulus for accommodation, which is a phenomenon where the pupil size changes unless the patient can look and focus on a target at a distance. Dr. Cook measured the pupil size of her patient simultaneously for both examiners. Examiner 202 gave Dr. Cook full credit for her performance in measuring the pupil size, and Examiner 239 did not give Dr. Cook credit for her performance. Examiner 239 noted in the comment section, "candidate sat in front of pt." Dr. Cook received .5 points out of a possible one point for measuring the pupil size during the pupillary examination. Dr. Cook claims that she sat off to the side of the patient, lined up her right eye with the patient's right eye, and asked the patient to sight at a target at a distance. The examiners were off to the side when Dr. Cook performed the procedure. The preponderance of the evidence does not establish that Dr. Cook was in the correct position when she measured the patient's pupil size. Dr. Cook's score of .5 is correct. As part of the examination, candidates are required to rate the patient's pupillary response to light on a pupillary scale. The CIB states, "Pupillary examinations, muscle balance, and motility, should be done on both eyes (including dilated eye)." Examiner 202 gave Dr. Cook full credit for rating the pupil, but indicated that her performance was borderline. Examiner 202 stated in the comment section: "borderline - she was confused about 0 to 4+, but eventually got it." Examiner 239 gave Dr. Cook no credit for her performance, and stated in the comment section: "4+ but did not indicate eye, not used to using 0 to 4 scale." Dr. Cook received .5 points out of a possible one point for rating the pupil on a pupillary scale. She gave the same answer simultaneously to both examiners. When Dr. Cook was asked to rate the pupils of her patient, Dr. Cook was uncertain which scale to use, the Marcus Gunn scale or a true light reflex scale. She indicated that she gave a response for both scales and that one of the responses was 4+. Dr. Cook stated at the final hearing that the left pupil was fixed and dilated, but she did not indicate that she rated the left eye as "0." The preponderance of the evidence does not establish that Dr. Cook advised the examiners of her rating of the left pupil. The score of .5 was correct. The binocular indirect ophthalmoscope (BIO) is an instrument used to examine the fundus, which is the inside back part of the eye. The BIO sits on the candidate's head. There is a small mirror attached, through which another viewer may see the view being seen by the candidate. The candidate holds a condensing lens, which is like a magnifying glass, to evaluate structures in the eye. Examining the fundus with the BIO is a simple procedure, which Dr. Cook performed 14 to 16 times every clinical day for over 17 years. Dr. Cook wore contact lenses during the examination. With the use of contact lenses, Dr. Cook has perfect vision. Dr. Cook adjusted the instrument before the testing procedure started, including adjusting the angle of light and setting the illumination. As part of the examination on the use of the BIO, a candidate is to demonstrate the equator and the posterior pole. In these procedures, the candidate finds the view of the applicable area, one examiner looks through the mirror after the candidate says "Grade me now," and then steps back. The second examiner then looks at the mirror after the candidate again says "Grade me now." Examiner 239 did not give full credit to Dr. Cook in demonstrating the equator. For the portion of the performance which requires the candidate to demonstrate an equator landmark, Examiner 239 gave Dr. Cook a "no" and stated in the comment section: "No clear view through the mirror @ 'Grade me now.'" Examiner 239 also gave Dr. Cook a "no" for an acceptable view of an equator landmark and stated in the comment section: "Dim illumination." Examiner 202 gave Dr. Cook credit for these two performance areas. In the portion of the examination in which the candidate is to demonstrate the posterior pole, the candidate is told that the disc and macula should be seen simultaneously. Examiner 239 did not give Dr. Cook credit for the portion of the examination where the disc and macula are to be viewed simultaneously. Examiner 239 stated in the comment section: "very dim view vis'd ONH not macula." Examiner 202 gave Dr. Cook credit for this portion of the examination. Between the first and second examiners' viewings for the equator and the posterior pole, the patient did not move, Dr. Cook held the focused view still, there was no change in illumination or intensity, and Dr. Cook did not change her position. Thus, it is more likely than not that Examiner 239 was mistaken. Dr. Cook received 3.5 points out of a possible seven points for examining the views of the equator and posterior pole during the binocular indirect ophthalmoscopy examination. She should be credited with an additional 3.5 points. As part of the examination, the candidates were asked to perform an examination using a biomicroscope, which is a microscope combined with a light source that is used to view different structures on the outside and inside of the eye. It is also called a slit lamp. For purposes of the licensure examination, the biomicroscope has a teaching tube attached through the left ocular, and when the examiner looks through the tube she sees the same view the candidate sees through the left ocular. A portion of the examination using the biomicroscope includes grouped procedures. The last procedure on one of the grouped procedures was focusing on the anterior vitreous of the patient's eye. The vitreous is made up of hyaluronic acid and contains vitreal strands made of collagen. As a person ages, the vitreal strands will increase and become more visible. A young patient may have vitreal strands that would be so difficult to see that on viewing the strands the view would appear to be "optically empty." In other words, the vitreous would appear clear on examination. Dr. Cook's patient was a healthy premed student in his early twenties. The patient did not have visible vitreal strands. Before performing the group of procedures, which included the focus of the anterior vitreous, Dr. Cook adjusted the height and width of the light. She set for a direct focal illumination, meaning the light was focused where she was looking. The patient remained still between the procedures, and Dr. Cook did not change the illumination between each grading. Examiner 216 gave Dr. Cook no credit for her focus of the anterior vitreous, stating the illumination was "too dim" and the "vit not seen." Examiner 268 gave Dr. Cook full credit for that part of the examination. Dr. Cook received 1.25 points out of a possible 2.5 points for her performance related to the anterior vitreous portion of the biomicroscopy exam of the anterior segment. Based on the patient's having no visible vitreal strands; the patient not moving between the grading procedures, and Dr. Cook not changing the illumination between grading procedures, it is more likely than not that Examiner 216 was mistaken. Dr. Cook should be awarded 1.25 points for performance of the focus on anterior vitreous. Dr. Cook received 3.5 points out of a possible seven points for her performance related to the choroidal crescent, posterior vitreous detachment, A-V three crossing outs, find and reflex, and hypertensive changes portion of the biomicroscopy exam of the fundus. One of the grouped portions of the examination using the biomicroscope included demonstrating whether a choroidal crescent was present. Determining the presence of a choroidal crescent was the fourth procedure in this grouped segment. A choroidal crescent can be seen when the candidate is looking at the optic nerve and the retina does not come all the way up to the nerve. The choroidal crescent will appear at the edge of the optic nerve. Examiner 268 did not give Dr. Cook any credit for determining whether the choroidal crescent was present, and stated in the comment section, "Did not focus on the edges of the ONH [optic nerve head]." Examiner 216 gave Dr. Cook full credit for the procedure. Dr. Cook did not demonstrate by the greater weight of the evidence that she should be given additional credit for this procedure. Unlike the evidence presented concerning the anterior vitreous, she did not establish that there was no change in illumination, her position, or the patient's position between the grading of the grouped segments. In order to perform the grouped procedures in which she was tested on the presence of the choroidal crescent, Dr. Cook had to move the focus and illumination to different locations related to the optic nerve. The last procedure in the same grouped segment involving the choroidal crescent was demonstrating posterior vitreous separation. Vitreous gel is attached to the back of the eye in several places. When the attachment points for the vitreous are pulled away or become loose, a ring-like structure can be seen where the vitreous pulled loose. Dr. Cook was asked to demonstrate and indicate whether a vitreous separation was present after she performed the procedure involving the choroidal crescent. The proper procedure for checking for posterior vitreous attachment would be to set the proper illumination, focus on the optic nerve, and pull back slightly on the "joy stick." Examiner 268 did not give Dr. Cook any credit for the procedure involving a demonstration of a posterior vitreous separation, stating in the comment section, "Did not pull back." Examiner 216 gave Dr. Cook full credit for the procedure. Again, Dr. Cook failed to establish by a preponderance of the evidence that she should be given additional credit for this portion of the examination. There was no showing that all conditions remained the same when each examiner graded this grouped segment of procedures. Another grouped segment of the examination called for Dr. Cook to start at the optic disc and follow a temporal arcade for a distance of approximately three disc diameters and demonstrate an AV crossing. Dr. Cook was to then indicate whether there were any characteristic hypertensive changes at the crossing. A vascular arcade is a curved shape with blood vessels coming out and arcing toward one another. Most of the blood vessels in the eye are located in this area. Some diseases such as diabetes and hypertension cause changes where the blood vessels in the arcade cross. In order to perform the AV crossing procedure, a candidate has to coordinate the microscope, going up and down and side by side. Lining up is critical on this procedure. Adjustments have to occur separately, once for each examiner. Examiner 268 did not give credit to Dr. Cook for this portion of the examination, stating in the comment section, "No view in the tube." Examiner 216 gave Dr. Cook full credit for the procedure. Dr. Cook has failed to establish that she is entitled to additional points for this portion of the examination. The AV crossing procedure involves making adjustments for each of the examiners as part of the examination, Dr. Cook has not demonstrated by a preponderance of the evidence that all conditions remained the same for each examiner. As part of the examination, candidates are tested on the use of the Goldmann Tonometer, which is a device used to measure eye pressure. The grading on this portion is divided into four categories: illumination at the proper angle, mires alignment, thickness of alignment, and the pressure measurement. Examiner 268 gave Dr. Cook full credit for all categories. Examiner 216 did not give credit to Dr. Cook for having the correct mires alignment, and gave full credit for the remaining categories, indicating that the mires width and the reading of the pressure were borderline. In the comment section, Examiner 216 drew the alignment which he viewed. The mires were not aligned correctly. Dr. Cook received 1.24-1.50 points out of a possible 2.5-3.0 points for the use of the Goldmann Tonometer. Dr. Cook argues that because she was given credit for the pressure reading that it would be impossible for the mires alignment to be incorrect. The reading of the pressure is to test the candidate's ability to read the dial on the tonometer; it is not to determine whether the reading that is on the dial is the actual pressure of the patient. The grading standards require that the examiner put down the reading that he saw during the viewing if it is different from the reading that the candidate gives as a response. Thus, it is possible to be given credit for the pressure reading without having the mires aligned correctly. Dr. Cook has not demonstrated by a preponderance of the evidence that she should be given additional credit for this portion of the examination. None of the examiners testified at the final hearing. The Department did call Dr. Gary McDonald, who was accepted as an expert in optometry.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered awarding Dr. Cook an additional 4.75 points for the clinical portion of the optometry licensure examination given on July 23 through 25, 2004, resulting in a passing grade of 80.25. DONE AND ENTERED this 30th day of June, 2005, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 30th day of June, 2005. COPIES FURNISHED: Edwin A. Bayó, Esquire Gray Robinson 301 South Bronough Street, Suite 600 Post Office Box 11189 Tallahassee, Florida 32302-3189 Allen R. Roman, Esquire Department of Health Office of General Counsel 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1703 Joe Baker, Jr., Executive Director Board of Optometry Department of Health 4052 Bald Cypress Way, Bin C07 Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
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.
Findings Of Fact Petitioner filed an application for certification as a physician assistant pursuant to Section 458.347(7)(b), Florida Statutes, a special avenue of certification as a physician assistant for graduates of foreign medical schools. In furtherance of that application, he appeared before the Physician Assistant Committee of the Board of Medicine. Subsequent to his appearance before that Committee, on August 13, 1992, Respondent sent Petitioner a letter which provides, in pertinent part, as follows: This is to advise that your application for issuance of a temporary certification with the requirement that prior to issuance of temporary certificate you submit within 30 days of date of appearance, a new corrected and complete application to be reviewed by the Board staff. Please complete the enclosed application. You will be required, as a condition to take the examination, 2 new personalized letters of recommendation, specifically recommending you as a physician assistant. The letter did not enclose an application form for Petitioner to complete. Respondent admits that the information in the letter was incorrect because it confused temporary certification with the requirements for examination. It is apparent that the letter is also incorrect because it fails to advise Petitioner if his application was being granted or denied; moreover, the wording of the letter makes no sense. By Order dated August 26, 1992, the Board of Medicine notified Petitioner that his application for temporary certification as a physician assistant was denied pursuant to the Committee's August 1 determination and the Board's August 9 determination that the length of time since Petitioner had last worked in the field of medicine or received significant medical education or training precluded him from being able to establish that he could practice as a physician assistant with reasonable skill and safety to the public. That Order further advised Petitioner, however, that the Board had granted Petitioner's application to sit for the certification examination pursuant to Section 458.347(7)(b), Florida Statutes, because Petitioner was eligible to take the examination to become certified as a physician assistant and that passage of the examination would serve to establish Petitioner's qualifications for practice. The Order specifically provided that the Board's permission for Petitioner to sit for the certification examination was "contingent upon and subsequent to receipt within 30 days" of Petitioner's appearance before the Physician Assistant Committee of (1) a complete and correct application and (2) two more letters of recommendation which specifically recommend Petitioner as a physician assistant. It would have been difficult for Petitioner to timely comply with the Order entered August 26 requiring him to file documents within 30 days of his August 1 appearance before the Committee. By letter dated August 31, 1992, Petitioner requested an extension of one week by which to obtain the second letter of recommendation due to the devastation produced by Hurricane Andrew and Petitioner's inability to communicate with the doctor who would sign it. Petitioner did, however, submit another application which was postmarked August 31, 1992, and received by Respondent early in September. At hearing, Respondent advised that it was waiving the 30-day deadline contained in the August 26, 1992, Order due to the intervention of Hurricane Andrew and because Respondent had not strictly enforced such deadlines as to other applicants. Rather, Respondent simply required that Petitioner comply with its Order within a reasonable period of time. By letter dated December 21, 1992, Respondent advised Petitioner that his application was incomplete because the Board had only received Petitioner's new application, one letter of recommendation, and Petitioner's request for an extension of time for submittal of the second letter. The letter further advised that the Board's staff's review of Petitioner's recent application had revealed some discrepancies requiring an explanation by Petitioner. The letter, therefore, advised Petitioner to submit one more recommendation letter, provide an explanation for six specified areas, and submit pages 8 and 9 of the application regarding Petitioner's clerkships. The letter further advised Petitioner that all information must be received by the Board no later than December 31, 1992. On January 20, 1993, Respondent received an undated letter from Petitioner referencing Respondent's December 21, 1992, letter which was received by Petitioner on December 30. Petitioner's letter enclosed the additional letter of recommendation requested by the Board, responded specifically to the six areas of inquiry, and enclosed pages 8 and 9 of the Board's application form. On January 20, 1993, the Board received a letter from Dr. Jose M. Bermudez, recommending Petitioner as a physician assistant. On January 28, 1993, the Board sent Petitioner a letter advising him that the Board had received the letter of recommendation from Dr. Bermudez and pages 8 and 9 of the application. That letter further provided as follows: However, the Physician Assistant Committee required you to submit a new complete and accurate application, and two (2) additional letters of recommendation which specifically recommend you as a physician assistant. Enclosed you will find a complete physician assistant application. Please fill the application out in its entirety and submit it to the Board of Medicine as soon as possible. In compliance with that request, Petitioner submitted yet another application for certification as a physician assistant, which was received by the Board on February 8, 1993. On February 24, 1993, the Board of Medicine entered its Order denying Petitioner's application for certification as a physician assistant. The Order recited that the denial was based upon the determination made by the Physician Assistant Committee on January 8 and by the Board on January 13 because Petitioner "failed to submit a new and complete and accurate application and one new personalized letter of recommendation within the time frame allotted by the Board." That Order does not mention Petitioner's application to sit for the certification examination, the issue pending before the Board, since the Board had already denied Petitioner's application for certification by Order entered August 26, 1992. That February Order also advised Petitioner of his right to request an administrative hearing regarding the Board's determination. On February 26, 1993, the Board's staff sent Petitioner a letter advising him that he had been certified by the Board to take the examination for licensure as a physician assistant to be administered in September, 1993. On March 10, 1993, the staff sent Petitioner a letter acknowledging Petitioner's "request for a hearing on the denial of your application for certification as a physician assistant," and advising Petitioner that the February letter advising him that he had been certified to take the examination for licensure as a physician assistant had been sent to Petitioner in error. A "corrected" letter was enclosed. That "corrected" letter dated March 10 advised Petitioner that the Board had preliminarily denied him certification to take the examination for licensure as a physician assistant. By letter dated March 18, 1993, the Board's staff sent an additional letter to Petitioner advising Petitioner as to the correct dates for the examination. In applying for temporary certification as a physician assistant and/or to sit for the certification examination, Petitioner has filed an additional application each time he has been instructed to do so by the Board or by the Board's staff and has submitted a letter explaining the information given in his applications each time that the Board's staff has requested that he do so. Petitioner has filed at least three such applications and has responded by letter to inquiries regarding the contents of his applications at least three times. Additionally, Petitioner has personally appeared before the Physician Assistant Committee on August 1, 1992, to be questioned regarding his qualifications. The Board has discovered some "discrepancies" or omissions in analyzing those various documents. Petitioner's August application states that the ending date for medical school, assumedly the date he received his degree, was February 25, 1965. That date appears in three places. Further, the copy of his diploma submitted to the Board reflects that date. Yet, the December 21, 1992, form from the Board to Petitioner advises him that he must explain his ending date for medical school. In response to that indication that he must provide different information, Petitioner's letter received by the Board on January 20, 1993, states that the ending date for medical school was February 29, 1962. At hearing, Petitioner explained that he attempted to differentiate between the date he completed classes and the date he completed all requirements, including internships, in order to receive his diploma. The information contained in Petitioner's application is correct. The August application contains an answer in the negative to question numbered 9 asking Petitioner if he is or has ever been emotionally or mentally ill. Although Petitioner's subsequent February 1993 application contains no answer to that question, the Board did not have before it the February application when it decided in January to deny Petitioner's application. Even so, Petitioner had no intention to be incomplete or inaccurate when he failed to answer that question on the February application. In his August application Petitioner does not list the completion of any social service work in either section inquiring about post-graduate training or practice employment. In an application that Petitioner filed in 1985 requesting licensure as a physician, Petitioner had specifically detailed the social service work performed by him as part of his medical school training. In that application he listed the dates as January 1, 1963 to December 31, 1963. The letter Petitioner wrote to the Board in response to its December 1992 request for a better explanation states that his social service work was done between March 1, 1963 and September 30, 1963. There is no dispute regarding whether Petitioner did in fact complete his social service work requirement as part of his education in order to receive his diploma, and it is clear that such work was done in 1963. Although there is a discrepancy regarding which months during 1963 he did his social work, the discrepancy as to the months during which Petitioner did something 30 years ago does not make his application inaccurate. In fact, the August application may be more accurate than the 1985 application form. The August application required Petitioner to list in chronological order from the date of graduation to the present all practice experience and/or employment. Petitioner advised that from February 28, 1970, to April 30, 1976, he was in private practice in Nicaragua. The Board's December 1992 letter asked for clarification because a prior application indicated additional activity. Petitioner's response letter advised that he was also in pediatric practice at the General Hospital of Managua from 1970 to 1972. His 1985 application did not mention the pediatric practice at General Hospital. At final hearing, Petitioner explained that he was in private practice at the same time that he practiced at the clinic in the hospital. Petitioner's 1985 and February 1993 applications, although not the subject of this proceeding, also contained some minor discrepancies regarding Petitioner's employment experience. For example, one shows Petitioner beginning his employment with the Nicaraguan Red Cross on May 1, 1976, and the other shows Petitioner's employment beginning on May 31, 1976. The parties do not dispute that Petitioner in fact practiced with the Nicaraguan Red Cross during that time period. In further response to the question requiring Petitioner to list all of his practice experience or employment, Petitioner did not list his activities from September 10, 1984, and thereafter. The Board's December 21, 1992, letter to him requested that he account for all his activities for the time period of January 1, 1984, and thereafter. In his response he did not identify those activities except to say that during that time period he was living in Miami. The detailed information had been provided to the Board in response to a letter to Petitioner from the Board dated March 8, 1992, in conjunction with his original application for certification as a physician assistant, although he did not again provide that information when he was ordered by the Board to file a new application. In Petitioner's August application, he listed no ending date regarding his private practice begun on January 1, 1984 in Managua, Nicaragua. Petitioner's 1985 physician license application showed that that employment ended September 10, 1984, whereas his February application showed that practice to have ended on September 15, 1984. Such a discrepancy is not material to Petitioner's application or eligibility. The application form contains a section regarding clerkships and requests that each clerkship be specified. In the August application Petitioner did not specify his four individual clerkships. After being asked pursuant to the Board's staff's December 1992 letter to resubmit pages 8 and 9 as to his clerkships, Petitioner did so by referring to them as a group rather than breaking them down individually. He did the same in the February 1993 application. The parties do not dispute that Petitioner performed the required clerkships. It is unclear how many letters recommending him as a physician assistant Petitioner has submitted to the Board. Petitioner referenced his submittal of photocopies of the "last two" letters of recommendation, the originals of which had previously been submitted to the Board, in a letter that Petitioner sent the Board in March of 1992. In correspondence from the Board to Petitioner in May of 1992 reference is made to the requirement that Petitioner submit another letter of recommendation because the Board did not have the original of that letter in its file. When the Board's staff instructed Petitioner to appear before the Physician Assistant Committee on August 1, 1992, the absence of necessary letters of recommendation was not one of the reasons given. The Board's August 26, 1992, Order requests "two more letters", which indicates that letters had been previously submitted. The staff's December 21, 1992, communication to Petitioner acknowledges receipt of one additional letter but requests another, which request was complied with at least by the submittal of the letter from Dr. Bermudez received by the Board on January 20, 1993. Petitioner applied to be certified as a physician assistant and the Board determined that he was eligible to take the examination. Thereafter, through a series of mistakes and correct acts, the Board's staff requested Petitioner on a number of occasions to file additional applications which he did. When the Board's staff asked for clarification he responded in writing and by telephone call, and the Board agrees that it has telephone slips in Petitioner's file. Each time the Board's staff asked for different information than had been given in Petitioner's previous application(s), Petitioner provided more and/or different information. There is no suggestion that Petitioner attempted to provide inaccurate or false information, and it is found that Petitioner provided correct and complete information to the best of his ability. Petitioner's mistakes are certainly no greater than the mistakes made by the Board's staff in sending Petitioner conflicting instructions, conflicting correspondence, and one letter that did not make any sense.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered permitting Petitioner to sit for the physician assistant examination to be administered during September of 1993. DONE and ENTERED this 12th day of July, 1993, at Tallahassee, Florida. LINDA M. RIGOT 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 12th day of July, 1993. APPENDIX TO RECOMMENDED ORDER DOAH CASE NO. 93-1550 Respondent's proposed findings of fact numbered 1-10 have been adopted in substance in this Recommended Order. Respondent's proposed finding of fact numbered 11 has been rejected as not being supported by the weight of the evidence in this cause. COPIES FURNISHED: Catherine Lannon, Esquire Department of Legal Affairs The Capitol PL-01 Tallahassee, Florida 32399-1050 Enrique Rueda Arguello 9409 Fountainbleau Boulevard, Apt. #101 Miami, Florida 33172 Dorothy Faircloth, Executive Director Department of Professional Regulation, Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792 Jack McRay, General Counsel Department of Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792
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.
Findings Of Fact General Discussion Petitioner is a licensed physician who practices pediatric medicine in Florida. Her practice has been located in St. Augustine, Florida, for 23 years. She has been board-certified in pediatrics since 1972. On November 2, 1982, Petitioner executed a Medicaid Provider Agreement with the State of Florida, Department of Health and Rehabilitative Services, Respondent's predecessor agency. At all times relevant to the inquiry the state agency conducting the Medicaid function in Florida was referred to as the Florida Medicaid Program. The executed Provider Agreement was accepted by the Florida Medicaid Program on December 10, 1982, enrolling Petitioner in the program. In pertinent part, the Provider Agreement states: * * * The provider agrees to keep such records as are necessary to fully disclose the extent of services provided to individuals receiving assistance under the State Plan and agrees to furnish the State Agency upon request such information regarding any payments claimed for providing these services. Access to these pertinent records and facilities by authorized Medicaid Program representatives will be permitted upon a reasonable request. The provider agrees that claims submitted must be for services rendered to eligible recipients of the Florida Medicaid Program and that payment by the program for services rendered will be based on the payment methodo- logy in the applicable Administrative Rule. The Provider also agrees to submit requests for payment in accordance with program policies. * * * 7. The provider and the Department agree to abide by the provisions of the Florida Administrative Rules, Florida Statutes, policies, procedures, manuals of the Florida Medicaid Program and Federal laws and regulations. * * * After being accepted as a Medicaid provider, Petitioner was assigned provider number 052775100. As successor agency to the Department of Health and Rehabilitative Services, Respondent is responsible for the administration of the Florida Medicaid Program. Among Respondent's responsibilities is the operation of a program to oversee the activities of Medicaid providers, to include recovery of overpayments for services given by Medicaid providers to Medicaid recipients. In accordance with its authority, Respondent reviewed information concerning Petitioner's service activities as a Medicaid provider for the period of January 1, 1990 through December 31, 1991. To arrive at the amount claimed as overpayment, Respondent used a representative sampling of randomly-selected recipients for whom Petitioner had requested reimbursement for services provided during the relevant period. The number of recipients utilized in the sample was From its review, and by imposition of a formula and methodology which inferred the overall experience for all recipients who received Medicaid services during the relevant period, Respondent calculated the alleged overpayment. By extending the information found in the audit concerning the 30 recipients for the period of January 1, 1990 through December 31, 1991, Respondent determined that $27,384.82 was owed for overpayment. The results of this preliminary determination (provisional audit report) were made known to the Petitioner through correspondence dated November 4, 1994. Further review of the sample medical records was conducted between persons representing Respondent, counsel for Petitioner, and Petitioner. This meeting took place on February 9, 1995. As a consequence, the overall amount of claimed overpayment was reduced from $27,384.82 to $19,404.89 for the subject time period. From that experience, a final agency audit report was completed. On March 24, 1995, this report was sent to Petitioner. Petitioner contested the proposed final disposition, leading to the hearing conducted to resolve the dispute between the parties over the amount claimed as overpayment. At issue in the present proceeding is the question of whether the records maintained by Respondent are adequate to justify the reimbursement claims made in the instances where the sample group was provided medical services by Respondent. A related question is also raised concerning Petitioner's records, as they pertain to the level of service for which Petitioner claims reimbursement. There is no contention by Respondent that Petitioner has committed fraud or acted dishonestly in submitting the requests for reimbursement for services rendered to Medicaid recipients. In all instances under discussion, where Petitioner sought reimbursement for services rendered, recipients were seen in an office visit. To assist Petitioner in maintaining necessary records to identify the nature of services provided to Medicaid recipients, to identify levels of services provided, and to invoice Respondent for those services, Petitioner had been made aware of the pertinent Florida Statutes and rules, together with Medicaid Provider Handbooks and claims forms. That information was available to Petitioner when submitting claims for reimbursement for services provided for the 30 recipients in the sample for the period of January 1, 1990 through December 31, 1991. Two categories of services by Petitioner are at issue. The first category concerns recipients who present with complaints which are addressed by the provider. The second category concerns EPSDT recipients. This category is a preventive health screening examination for Medicaid-eligible children and young people under the age of 21. Examples of both categories were found within the recipient sample audited by Respondent for the questioned period. The Medicaid Physician Provider Handbook describes Petitioner's record-keeping responsibilities and the opportunity to review the records, wherein it states: Record Keeping You must retain physician records on services provided to each Medicaid recipient. . . . Examples of the type of Medicaid records that must be retained are: Medicaid claim forms and any documents that are attached, treatment plans, prior authorization information, any third party claim information, x-rays, fiscal records, and * * * Medical records must contain the extent of services provided. The following is a list of minimum requirements: history, physical examination, chief complaint on each visit, diagnostic tests and results, diagnosis, a dated, signed physician order for each service rendered, treatment plan, including prescriptions for medications, supplies, scheduling frequency for follow-up or other services, signature of physician on each visit, date of service, anesthesia records, surgery records, copies of hospital and/or emergency records that fully disclose services, and referrals to other services. * * * Authorized state and federal staff or their authorized representatives may audit your Medicaid records. . . . The Medicaid EPSDT Provider Handbook describes the components for the health screening examination. Those components are health and developmental history, unclothed physical assessment or examination, nutritional assessment, updating of routine immunizations, laboratory tests, developmental assessment, vision screening, and hearing screening. EPSDT services also include possible referrals for medical treatment, visual, dental and hearing services. As to immunizations, there is a requirement for accountability for each vaccine administered. This means that the provider must maintain a record when vaccines are administered. In this case Petitioner met this requirement. When a child appears for EPSDT screening the provider must always perform a health and developmental history, physical examination, vision screening, including a check of the eyes, hearing screening, including a check of the ears, developmental assessment and nutritional assessment. This process contemplates the necessity for noting the results obtained in the screenings, normal or abnormal, as a means to track the child's health and development. According to the Medicaid EPSDT Provider Handbook, the record keeping associated with the EPSDT screening process includes the need to be mindful of: The purpose of a health and developmental history is to gather information about those diseases and health problems for which no standard screening test has been developed and to compile historical information about the child and the child's family. The health and developmental history should also provide information on the child's brothers and sisters; growth history; conditions suffered by blood relatives; previous medications; immunizations or allergies; and developmental history of the child and other family members. Unclothed physical examination The physical examination includes specific screening elements as appropriate for the child's age and health history, including: General appearance. Body measurements. Skin examination. Blood pressure. Heart sounds. Ausculation of lungs. Pulse. Palpation of abdomen of musculature, organs, masses. Inspection of genitalia. Vocalization and speech appropriate for age. Facial features. Chest configurations and respiratory movements. Muscle tone. Gross/fine motor coordination. Inspection for scoliosis. Ears, nose, and throat inspection. The Department of Health and Human Services, Health Care Financing Administration, defines a developmental assessment as the range of activities surrounding the exami- nation of the child, adolescent, and young adult in order to determine whether they fall within the normal range of achievement for the child's age group and cultural background. The developmental assessment is performed at the time of screening for all ages. Infor- mation from the parent or other person who has knowledge of the individual, observation, and talking with the individual are utilized in assessing the individual's behavior. The following elements are recommended to be included in the developmental assessment of children of all ages: Gross motor development, focusing on strength, balance, locomotion. Fine motor development, focusing on eye-hand coordination. Communication skills or language development, focusing on expression, comprehension, and speech articulation. Self-help and self-care skills. Social-emotional development, focusing on the ability to engage in social inter- action with other children/adolescents, parents, and other adults. Cognitive skills, focusing on problem solving or reasoning. The assessment of the child's nutritional status, eating habits, including the use of alcohol and tobacco, is taken at the time of the physical examination. The guidelines for visual screening are listed below: Birth through one year. General external examination and evaluation of ocular motility. Gross visual acuity examination with fixation test. Testing light sense with pupillary light reflex test. Intraocular examinations with ophthalmo- scope. Two to five years. Visual acuity for distance should be tested separately for each eye. The illiterate E test, the STYCAR (Screening Test for Young Children and Retardates) or the Lippman Matching Symbol Chart - HOTV may be utilized. Children from two to five years of age should be tested at 10 to 15 feet. To determine muscle balance, a cover test and the Hirschberg test (corneal light reflex) should be given. Parents should be asked whether they notice the child's eyes ever turning in or out. All individuals ages 5 through 20 years should be evaluated for distance visual acuity utilizing the illiterate E or the Snellen letters for a linear fashion. The testing should be at 20 feet. Individuals who wear glasses should be tested while wearing their glasses. Children should be tested using an appropri- ate test such as the Hear Kit, Weber, Rinne, or puretone along with history from the parent or guardian. Beyond the instructions set forth in the Medicaid EPSDT Provider Handbook, which have been referenced, Petitioner has not received additional instructions from Respondent concerning the manner in which records should be maintained related to EPSDT screens performed. In this case, Respondent does not question Petitioner's EPSDT screenings performed, as to the frequency and interval between screening examinations. Respondent has challenged the request for reimbursement for the EPSDT screens in the sample based upon the assertion that inadequate documentation exists to justify reimbursement for the screenings. Having in mind the need to maintain adequate records to justify the treatment and claim for reimbursement for services, the Medicaid Physician Provider Handbook describes the basis for reimbursement for services provided to recipients. That reimbursement scheme is associated with six levels of service. Those levels of service are identified by procedure codes established in the underlying Physician's Current Procedural Terminology, Fourth Edition. The levels of service in contest are limited, intermediate, extended, and comprehensive. The levels of service are defined as follows: Limited is a level of service used to evaluate a circumscribed acute illness or to periodically reevaluate a problem in- cluding a history and examination, review of effectiveness of past medical management, the ordering and evaluation of appropriate diagnostic tests, the adjustments of therapeutic management as indicated and discussion of findings. Intermediate level of service pertains to the evaluation of a new or existing cond- ition complicated with a new diagnostic or management problem, not necessarily related to the primary diagnosis, that necessitates the obtaining of pertinent history and physical or mental status findings, diagnostic tests and procedures, and ordering appropriate therapeutic management; or a formal patient, family or a hospital staff conference regarding the patient's medical management and progress. Extended level of service requires an unusual amount of effort or judgement including a detailed history, review of medical records, examination, and a formal conference with the patient, family, or staff; or a compar- able medical diagnostic and/or therapeutic service. Comprehensive level of service provides for an in-depth evaluation of a patient with a new or existing problem requiring the development or complete reevaluation of medical data. This service includes the recording of a chief complaint, present illness, family history, past medical history, personal history, system review, complete physical examination, and ordering appropriate tests and procedures. The billing number codes set out in the Physician's Current Procedural Terminology, Fourth Edition, are related to new patients and established patients and the coding for the level of service is equated as: New patient: 90010 limited service 90015 intermediate service 90017 extended service 90020 comprehensive service Established patient: 90050 limited service 90060 intermediate service 90070 extended service 90080 comprehensive service To be reimbursed for services provided, consistent with the Medicaid Physician Provider Handbook, Petitioner utilized the Illustration 4-1.VHCFA-1500 Claim Form. To be reimbursed for Medicaid EPSDT screening performed, Petitioner utilized the Illustration 4-1.EPSDT Claim Form. Respondent has not challenged the manner in which Petitioner prepared and submitted the claim forms in its sample audit. For the period of January 1, 1990 through December 31, 1991, in the sample group for 30 recipients, Respondent did not disallow claims for reimbursement for services performed for recipients 6, 8, 20, 22, 23, 24, 27 and 28. In addition, at hearing, Respondent agreed that the payment for services performed for Recipient No. 3, on August 17, 1991, should remain as claimed. Similarly, the payment for services performed for Recipient No. 15, on December 14, 1990, should remain as claimed. The payment for services performed for Recipient No. 21, on December 12, 1990, should remain as claimed. Finally, the payment for services performed for Recipient No. 19, on May 25, 1990, should remain as claimed. At hearing, Petitioner agreed with Respondent that the services provided to Recipient No. 2, on August 17, 1991, should have been billed as a limited level of service. Petitioner conceded that the claim for reimbursement for services to Recipient No. 21 rendered on February 10, 1990 should be as a limited level of service as Respondent contended. Other contested payments must be resolved. In the instance where Respondent has agreed to allow the claims for reimbursement to be honored, this would cause the ultimate claim for overpayment pursuant to the formula and methodology to be adjusted. That adjustment is not made on this occasion based upon the agreement by the parties to bifurcate consideration of the propriety of using the formula and methodology and the need to recalculate the overpayment claim by employing the formula and methodology. Dr. John Sullenberger testified concerning the medical services provided to recipients. He identified the nature of the services. He is an expert in medicine. His practice had been as a board-certified thoracic- cardiovascular surgeon. He has not practiced as a general practitioner or pediatrician. Dr. Sullenberger had reviewed the records in the sample group and assisted Respondent in its determination concerning the appropriate level of service for payment and the adequacy of Petitioner's records. Dr. Sullenberger offered his opinion concerning the care rendered and the records kept, as that would influence assigning the proper level of care for reimbursement purposes and payment for EPSDT screening. Petitioner testified concerning her records and the care provided to the recipients, as a means to address record keeping, assignment of levels of care and payment. She placed emphasis on the fact that in some instances a greater effort was made to attend the recipients due to their age and inability to cooperate in their care. As described in the Medicaid Physicians' Provider Handbook, the levels of care ". . . require varying skills, effort, responsibility and medical knowledge to complete the examination, evaluation, diagnosis, treatment, and conference with the recipient about his illness or promotion of optimal health". In deciding the facts, the physician's insights have been relied upon in determining the extent to which Petitioner exercised these criteria. However, the ultimate determination concerning the proper assignment of level of care has been made by the fact finder, as a means to resolve the factual dispute between the parties and offer recommendations concerning the appropriate legal outcome in this case. Contested Claims Recipient No. 1 (K.H.): K.H. was born August 1, 1981. Petitioner provided services to K.H. on August 28, 1990. The services were billed at an extended level. Respondent asserts that the services should be compensated at an intermediate level. Petitioner's medical records reflect that recipient's height, weight, and temperature, together with blood pressure were observed. The presenting complaint was a stomachache and fever. The temperature was 103 degrees Fahrenheit. According to the medical records, the recipient's ears, throat, neck glands, chest, and cardiovascular system were examined, and a complete blood count was done, with a SMA6 test to check kidney function. A mono spot was done. The recipient was checked for strep. The throat was inflamed. The strep culture revealed a positive result. Consequently, Petitioner prescribed an antibiotic to treat the condition. The child was observed to be somewhat obese. As would be expected, Petitioner explained the child's condition to the parent and the procedures to be followed in dealing with the problems. A urine culture was conducted to rule out possible urinary tract infection, which might be responsible for abdominal pain. The proper billing for this visit was an intermediate level of service. Petitioner rendered services to Recipient No. 1 on October 23, 1991. Her height and weight were recorded. Her blood pressure was taken. The visit was for a checkup based upon trouble which the child was having in school related to her behavior. The clinical examination results in the medical records reflect negative results. However, the records reflect that the child was obese and difficult to evaluate in her abdomen. The medical note refers to difficulty in feeling the liver and spleen and identifying any possible masses. A SMA24 was ordered as a means to address the behavioral problem. A thyroid profile was ordered to exclude the possibility of hyperthyroid condition, which can make the child hyper. The child's urine was checked to see if a urinary tract infection had cleared up from a prior occasion. The SMA24 was a complete examination of the liver function to check lipids and cholesterol, among other things. This test was principally designed to check the child's liver. The clinical examination and tests that were ordered were designed to address possible physical causes for the child's behavior. The medical record reflects that dietary instructions were also given. This was a counseling session with the parent to explain what would be advantageous in the diet and what would not be. At the same time, discussion was given concerning the advantage of exercise in dealing with the obesity. As was customary, the parent or guardian was made aware of the purposes of the tests that were ordered. For these services, the visit was billed as a comprehensive level. Respondent asserts that the level should have been a limited visit. The proper billing for this visit is a limited level of service. Recipient No. 2 (T.S.): This recipient was born on July 7, 1977. On January 17, 1990, Petitioner rendered services to the recipient. Petitioner mistakenly filed a claim for reimbursement for venipuncture, based upon confusion concerning the appropriate code number to be assigned. In fact, a throat culture had been performed, not a blood test. Eventually, this problem was rectified. On January 17, 1990, Petitioner billed under a code related to venipuncture, which was a $2.00 charge. In fact, venipuncture was not performed on the recipient. In addition, the charge for a quick strep test performed on the recipient was miscoded. Instead of a quick strep test, it was coded for a bacterial culture. The bacterial culture code only paid $8.00. The quick strep test code, had it been utilized in requesting reimbursement, paid $11.00. Having used the wrong codes, Petitioner was paid $2.00, to which she was not entitled, for venipuncture. Petitioner was paid $8.00 for the quick strep test, less than the normal $11.00. On the same date, the child was seen by Petitioner complaining of right neck pain, spreading to his right ear. His blood pressure was taken. The reading was 140/85. By history, the recipient was known to have high blood pressure. The child's ears, nose, throat, glands, chest, and heart were checked. A throat culture was performed based upon inflammation which was observed in his throat. He had enlarged lymph nodes in his neck on one side. A strep culture was performed. Antibiotics were prescribed pending the results of the strep test. The blood pressure was considered elevated. Petitioner billed this visit as an intermediate level. Respondent asserts that the level of service is a limited visit. The proper billing for this visit is a limited level of service. Recipient No. 3 (P.J.): The recipient was born on March 15, 1981. Petitioner rendered services to P.J. on April 13, 1991. When the child was seen, she presented a complaint that bumps were on her tongue for a week. This was the first time that the recipient had been seen by Petitioner. Her weight, height, and blood pressure were taken and recorded. The recipient was given a thorough clinical examination. The clinical examination had no findings other than a small one-eighth-inch lesion on the tip of the recipient's tongue. At that time, it was assumed that the child may have bitten her tongue. The child was not believed to have infection, but her gums, tongue, and throat were examined. As part of the physical examination, the chest, heart, and cardiovascular system were also examined. The child's abdomen and genitalia were examined. Petitioner billed the visit as a comprehensive visit based upon the fact that this was the initial visit for the recipient, not based upon the observations concerning the lesion on the tongue, which were not found to be a significant medical problem. Patient history to include a list of illnesses, immunizations, and allergies for the recipient is set forth in a history and immunization record kept by Petitioner. Respondent asserts that the level of service performed on April 13, 1991 was a limited level. The proper billing for this visit was a limited level. Recipient No. 4 (V.K.): V.K. was born on September 25, 1983. Petitioner rendered services to V.K. on March 8, 1990. The child's weight and height were taken. She presented with a low-grade fever and a headache. Her bodily systems were examined. In the examination, Petitioner noted that her tonsils were covered with exudate. Otherwise, her condition was normal based upon a physical examination. A strep screen was performed, which revealed negative results. Petitioner prescribed an antibiotic based upon the appearance of the recipient's tonsils. Petitioner considered recipient's presenting complaints to be vague. The problem with fever could have been based upon problems anywhere in the system. The child did not have a cold and the headache necessitated a good examination. The only findings by Petitioner related to the inflamed tonsils. As was customary, the recipient's condition was discussed with the parent. The services were billed as a comprehensive visit. Respondent asserts that the services should have been billed as a limited visit. The proper billing for this visit was a limited level of service. V.K. was seen on February 6, 1991. Her height and weight were taken. It was noted in the patient records that the presenting complaint was a cold with a lot of coughing. The recipient was also due to have surgery on February 20, 1991. Upon examination, the recipient had inflamed tonsils and nasal congestion. No other significant physical findings were observed. Petitioner prescribed medication for the congestion and an antibiotic for the child's throat condition. The February 6, 1991 visit was billed as an extended service. Respondent asserts that the visit should be billed as a limited service. The proper billing for this visit is a limited level of service. V.K. was seen again on April 13, 1991. As noted in the medical records, the child presented with a cold, low-grade fever, and severe coughing all of the time. A physical examination was made of all systems, and the recipient was found to have an inflamed throat. Otherwise, the physical examination revealed no significant findings. Petitioner prescribed an antibiotic for six days and a cough decongestant to attend the symptoms. Petitioner billed this service as an intermediate visit. Respondent asserts that the proper billing is a limited service. The proper billing for this service is a limited level of service. Recipient No. 5 (L.D.): L.D. was born on May 25, 1983. Petitioner saw the recipient for the first time on September 8, 1990. The recipient's height, weight, and blood pressure were recorded. The child had been sent home from school with inflammation in his eyes. The child's mother also reported that the child was hyperactive. A clinical examination was performed. No significant findings were made concerning the child's eyes. They were not observed to be inflamed. While attending the child, Petitioner did not observe any signs of hyperactivity. Nonetheless, an appointment was made for the child to be seen at the behavior clinic at Nemour's Hospital in Jacksonville, Florida. To perform the examination and observe the child's activities would take approximately 30 minutes. Petitioner billed the visit as a comprehensive service. Respondent asserts that the visit should be billed as an intermediate service. The proper billing for the visit is an intermediate level of service. Recipient No. 7 (T.R.): T.R. was born on September 9, 1984. On March 24, 1990, petitioner rendered services to T.R. The services were billed as an EPSDT screen. In particular, the child was brought to Petitioner to perform a school physical. The child's weight and height and blood pressure were taken and recorded. The child was examined physically and found to be normal. It was also noted that the child was a "healthy boy". On this visit a student health examination form was filled out but not maintained. A copy of that form was retrieved noting the date of examination and information about the physical examination, to include the results of an eye examination. The results of that eye examination are also shown in the Petitioner's medical records for T.R. No information is recorded in the health history portion to the student health examination form. The form notes that T.R. was a "healthy boy". Petitioner contends that the student health examination form, which was executed for T.R., sufficiently responds to the need to address all mandatory screens. The student health examination form is insufficient to meet the requirements for mandatory screens. Information was found in the records maintained by Petitioner related to circumstances at birth, family history, birth and development, feeding history, immunization and skin testing. Growth charts were also in evidence. Rather than completely deny Petitioner reimbursement, Respondent converted the visit to a limited service visit. Sufficient services were provided to justify payment as a limited service visit. On October 18, 1990, Petitioner provided medical services to T.R. At that time, the child's weight and height were taken. As reflected in the records, the child presented with an earache for the past two nights and a fever. A physical examination was performed on the child on this date. The ears were not found to be inflamed. The ears did have wax in them. The throat was inflamed. The child had a postnasal drip causing pressure in the ears, leading to an earache. The child was treated with antibiotics. Petitioner billed for the visit as an extended service. Respondent asserts that the billing should be as a limited level of service. The proper billing for this visit is a limited service. Petitioner saw T.R. on October 22, 1991. At that time, the child's weight and height were taken. He was being seen for a checkup. He was also having a problem holding his urine and had wet his bed the night before. A physical examination was made, with normal findings. The child was subject to a routine urinalysis to rule out bladder or kidney infection. There might be other explanations for the bed-wetting, to include nervousness. Upon examination, there were no obvious explanations for the problem. Petitioner billed for this visit as an extended level of service. Respondent asserts that the level of service was a limited visit. The proper billing for this visit was a limited level of service. Recipient No. 9 (A.N.): A.N. was born on April 27, 1987. Petitioner saw the recipient on February 23, 1990. A.N. was measured and weighed. The presenting complaint was congestion and a cough for a week. A physical examination was performed. His throat showed a little irritation but no inflammation. The nostrils appeared congested. No other significant findings were made concerning the child's condition. Petitioner prescribed medications for the cough and congestion. The child was also given vitamins. As in all cases discussed, the parent was informed of the findings and future treatment. Petitioner billed the visit as a comprehensive service. Respondent asserts that the service was a limited service. The proper billing for this visit was a limited level of service. On November 12, 1990, the child was provided medical services by Petitioner. The child was weighed and his height recorded. The presenting complaint was vomiting and diarrhea for six to seven days. A physical examination was performed. Some tinea infection was found on the skin. Medications were prescribed and the parent instructed concerning those medications as a means to address the vomiting and diarrhea. In addition, a prescription was given for a fungus infection on the face. The parent was instructed concerning the contagious nature of the fungus and its consequences. Petitioner billed this visit as an extended level. Respondent asserts that the service is an intermediate level. The proper billing for this visit is an intermediate level of service. On May 24, 1991, the child was seen by Petitioner for a school physical. The child was also seen for complaints that he had problems with bed- wetting and that his legs hurt. A school physical examination was performed. The child appeared to be healthy. Because the child complained of his legs hurting, Petitioner sent the child for laboratory work to rule out problems with anemia and to also examine his kidney function. A urine culture was also ordered for the child to rule out urinary tract infection. Petitioner filled out the student health examination form but did not maintain it for her records and has not retrieved it for hearing purposes. No other notations were made concerning the examinations for the school physical. Growth charts were maintained. Petitioner billed for an EPSDT screening. Petitioner did not bill for treatments associated with the physical complaints by the child. Respondent asserts that the billing should be for a limited service. For reasons described in discussing the screening for Recipient Number 7, as well as the unavailability of the student health examination form for audit purposes, the billing for an EPSDT screening should not be allowed. In this connection results from vision screening were not available. For reasons that Respondent had allowed a claim for a limited service in substitution for the EPSDT screening reimbursement; and based upon the services provided in addressing the physical complaints, the proper billing is for a limited service. Recipient No. 10 (K.L.): K.L. was born on November 13, 1986. Petitioner provided medical services to K.L. on March 18, 1991. The child was weighed and the height was recorded. In the visit it was indicated the child had been sent home last week from school with a fever. A physical examination was performed. The child was not especially cooperative and was difficult to examine. Significant findings in the examination were inflammation in the ears and throat. Petitioner prescribed antibiotics for the throat condition. Petitioner billed the visit as a comprehensive service. Respondents asserts that the service is an intermediate level. The proper billing is an intermediate level of service. Recipient No. 11 (R.H.): R.H. was born September 21, 1989. Petitioner saw R.H. on January 19, 1990. At that time, the child was weighed, her height and head circumference were also noted. The checkup that was being performed on R.H. was in the series envisioned by the EPSDT screening program. The physical examination conducted on the child indicated that this was a "healthy baby". The information that was recorded concerning the child's height and weight and head circumference was for purpose of charting her growth compared to the expected growth. A document was found with the child's records which related to information concerning her birth date, family history, early birth and development, and feeding history. Growth charts were maintained. The child was seen again on March 19, 1990 for a checkup and shots associated with the EPSDT program. The weight, height and head circumference were recorded. It was noted that the child was not sitting up yet. The physical examination was normal, notwithstanding the observation that the child was not yet sitting. Petitioner billed the January 19, 1990 and March 13, 1990 visits through the EPSDT screening program. Respondent asserts that the billings should not be allowed. The billings were deficient in that necessary information was not provided for the health and developmental history, vision screening, hearing screening, developmental assessments and nutritional assessment. For the January 19, 1990 and March 13, 1990 Respondent asserts that the proper reimbursement is as a limited level of service visit. That position is accepted. Petitioner provided medical services to R. H. on June 6, 1990. At that time there was a complaint concerning the child having diarrhea lasting a week. The diarrhea cleared up and then reoccurred on the date the visit was made. The child was also congested. The physical examination revealed an offensive odor and loose stool in the child's diaper. The chest revealed bilateral rales, meaning there was mucus present. The child had thoracobronchi. Her throat was inflamed. The mother was instructed to take a stool specimen to the laboratory. Medication was prescribed for diarrhea and instructions given concerning its use. The child was provided a bronchodialator. The child was given a cough congestion medication. There was a suspicion the child had bowel infection as well as upper respiratory infection. The visit was billed as an extended service. Respondent asserts that the proper classification is an intermediate service. The proper classification is an intermediate level of service. Recipient No. 12 (F.W.): F.W. was born on February 26, 1990. She was seen by Petitioner on April 17, 1990. At that time the child's weight, height and head circumference were noted. It was noted that the child was receiving a soy formula. The child seemed to have elephant ears. A mild diaper rash was observed, otherwise, the child's physical examination revealed normal results. It was noted that the child was born at University Hospital in Jacksonville and was overdue at birth; however, the child was "ok" at birth. The elephant ears would need treatment at a later date. Medication was prescribed for the diaper rash. The parent was told about the problems with the child's ears and the treatment for diaper rash. Petitioner billed this visit as a comprehensive service. Respondent asserts that the appropriate level of service was limited. The proper billing for the visit was a limited level of service. On May 11, 1990 the child was seen for an EPSDT checkup. The child's weight, height and head circumference were recorded. At that time the child was two months old. A physical examination was performed. It only revealed two lesions on the lower left abdomen which looked like infected bumps or possible scabies. An antibiotic cream was prescribed for this condition and its use was explained to the parent. A document in the records maintained by the Petitioner entitled, Patient History Chart, contains information about the child's date of birth, birth history, family history, nutritional history and illness history. The document describes developmental history at age 16 weeks. A growth chart was also maintained. On June 29, 1990, Petitioner saw the child again and weight, height and head circumference were noted. This was a routine check under the EPSDT program. It was noted that the child was doing well and that there was "no more spitting up". The physical examination revealed "an alert happy baby". There was some reference to the need to repeat a CBC study for blood count. The reason for repeating laboratory tests was based upon laboratory results received by Petitioner for laboratory work done on June 19, 1990. The parent was instructed to bring the child back for follow-up on July 30, 1990. That appointment was not kept. On August 20, 1990, the child was seen for a checkup and to fill out information for referral to the WIC program to qualify for participation in that program. There is a form which is utilized to apply for participation in the WIC program. It concerns an assessment of nutritional risk factors as a means to gain participation in the WIC program. Petitioner indicates that the form was filled out, but it was not maintained by Petitioner in her records. Thus it was not available for examination as part of the audit process involved in this case. On this date the physical examination revealed raised lateral lesions on the upper arm, abdomen and chest. These were reported to be mosquito bites. As noted the parent was advised to keep "an eye" on the condition for a week. It was noted that the physical examination did not reveal any other findings. Petitioner submitted bills under the EPSDT program for the visits on May 11, 1990, June 29, 1990 and August 20, 1990. Inadequate documentation was maintained to qualify for reimbursement for those charges for screens other than the physical examination. It is appropriate for Respondent to have paid for those visits as a limited level of service. On November 21, 1990, Petitioner provided medical services to F.W. The weight of the child was noted. The child presented as having a cold for 2 days. A physical examination was conducted. The throat was found to be inflamed, the nostrils evidence nasal congestion. A yeast diaper rash was found. Antibiotics were prescribed for her throat together with decongestion drops. This visit was billed as an intermediate level visit. Respondent asserted that the proper billing is as a limited level of service. The proper billing is as a limited service. The child was seen again on February 16, 1991. She came for the visit because she had a cold for 2 - 3 days. She was throwing up the formula which she was receiving. Upon physical examination the child was found to have "pus" on her throat surface. A strep screen was conducted and the results were positive. Antibiotics were prescribed together with a decongestant for cough and congestion. Petitioner billed this as an intermediate level service. Respondent asserts that the level of service is a limited level of service. The proper billing is as a limited level of service. On July 24, 1991, a further EPSDT visit was made, together with an examination for WIC qualification. The WIC referral form was not maintained for review. Upon the physical examination, the weight and height were recorded. The physical examination performed showed a mild diaper rash. Otherwise the child was found to be in acceptable health. The child was sent for a hemoglobin hematocrit for the purposes of the WIC qualification. The Petitioner billed this as a EPSDT screening. Petitioner is not entitled to reimbursement for that screening in that the records maintained were insufficient to document the assessment process other than the physical examination. It was appropriate for Respondent to reimburse this visit as a limited level of service. Recipient No. 13 (S.S.): S.S. was born on July 2, 1991. On July 5, 1991 Petitioner provided medical services to the child. The child's weight, length and head circumference were taken. The visit was the first checkup performed by Petitioner. The baby had been delivered at term through a normal delivery. The infant was found to have mild to moderate jaundice. Otherwise the physical examination did not reveal any significant findings. The cord clamp was removed. A test was ordered to determine the level of jaundice in the blood. The results of that test were recorded and discussed with the mother. It was noted that the mother was breast feeding the infant and using formula as well. This visit was billed as a comprehensive service. Respondent asserts that the service was an extended service. The proper billing for the visit was an extended level of service. On July 16, 1991 the baby was brought in for a checkup. The checkup was in accordance with the EPSDT screening program. The child's weight, length and head circumference were taken. A physical examination was made. At that time the child was on formula. It was noted that the weight gain for the child was good. Medication was prescribed for thrush. Thrush is a fungus growth inside the mouth of babies. Within the records maintained by Petitioner is a history and immunization document which reflects the date of birth and limited family history. Information related to the child's condition at birth is noted. In addition, there are growth charts. Given the child's age relating to birth, information contained in the records satisfies the requirement to document information gained in the screens that were conducted on July 16, 1991. Therefore, the EPSDT reimbursement claim should be allowed. Respondent has authorized payment for this visit as a limited service. That is an inappropriate payment for the visit. On August 2, 1991, a further visit was made. This visit was billed as an EPSDT screen. Petitioner believes that the visit was related to problems with the infant not tolerating her formula. This is born out by an office note which describes a change in the formula. That note also reflects the child's weight. The physical examination revealed normal circumstances with good weight gain. Petitioner conceded that the process engaged in addressing the child's needs on this visit might not have been done in the manner in which the July 16, 1991 examination was performed as to comprehensiveness. The August 2, 1991 visit which was billed as an EPSDT screen should not be paid for under that billing code. The emphasis placed in the care rendered by Petitioner does not correspond to the EPSDT screening process. The decision by Respondent to pay for this visit as a limited service is acceptable. On September 3, 1991 the child was brought in for a checkup and shots. The weight, height and head circumference were recorded. The physical examination was noted as normal and the child was described as "a healthy baby". This visit was billed under the EPSDT screening program. There is insufficient documentation to justify reimbursement as an EPSDT screening concerning all screens other than the physical examination. The decision by the Respondent to pay for this visit as a limited service visit is acceptable. On November 4, 1991, the child was seen for a checkup and shots. This visit was billed as an EPSDT screen. At the visit, the weight, height and head circumference were noted. The physical examination was noted as normal. As noted the child was cutting her lower incisors. It was noted that the baby was big for her age. There is insufficient documentation to justify reimbursing Petitioner under the EPSDT program for the visit on November 4, 1991. The decision by Respondent to pay for the visit as a limited service is acceptable. On December 11, 1991 the infant was seen again because she was experiencing a cough and runny nose. She was weighed and a physical exam was performed. It was noted that nostrils were irritated and the throat was irritated. It was noted that the child was drooling and teething. A decongestant was prescribed, together with nose drops and ear drops. This visit was billed as an intermediate service. Respondents asserts that the visit should be billed as a limited service. The proper billing for this visit is as a limited level of service. Recipient No. 14 (B.L.): B.L. was born on August 25, 1987. Petitioner provided medical services to the child on June 18, 1990. At the visit, the child's weight and height were taken. The presenting complaint was fever for 3 or 4 days and sand sores. The physical examination revealed that the child's tonsils were inflamed. Impetigo lesions were also found on the child's legs which corresponded to the description "sand sores". The child was provided an antibiotic by mouth and an antibiotic for the skin lesions. She was also provided vitamin drops. The oral antibiotic was given for inflamed tonsils. The infection on the skin and in the throat was possibly caused by the same process of infection. Explanation was provided to the parent concerning treatment of the impetigo. This visit was billed as an extended service. Respondent asserts that these visits should be reimbursed as an intermediate service. The proper billing for this service is as an intermediate level of service. The child was seen again on August 13, 1990. Her weight and height were recorded. On this visit the mother was worried about the child possibly being deaf. In addition, there was concern about the child being hyperactive based upon the child's discharge from day care for reason that the daycare staff could not control her. The physical examination revealed normal results. However the child was observed to be very hyperactive. The child was referred for a hearing examination and a short course of Ritalin was prescribed to address the hyperactivity. This visit was billed as an extended service. Respondent asserts that the visit should be billed as an intermediate service. The proper billing is as an intermediate level of service. On December 6, 1991, the child was seen again. Her weight and height were recorded. The presenting complaint was a fever since yesterday and a bad cough. Upon physical examination the throat and tonsils were found to be inflamed. A strep screen was performed and the results were negative. Antibiotics were prescribed for the inflammation of the throat and tonsils. A decongestant cough medicine was prescribed. Medication was prescribed for the fever. Petitioner billed this visit as an intermediate service. Respondent asserts that it should be reimbursed as a limited service. The proper billing is as a limited level of service. Recipient No. 15 (D.T.): D.T. was born on November 27, 1990. On December 1, 1990, Petitioner provided services to D.T. This was the first visit for the infant. The weight, height and head circumference were taken. As reported, things went well at birth. The mother was breast feeding the child. Upon physical examination the child was found to be mildly jaundiced Inquiry was made concerning the blood group for the mother and infant. The results did not to prove to be significant. The clamp was removed from the cord. Information was maintained concerning the family history, birth and development and feeding history. This information was recorded on a sheet which related the date of birth that had been mentioned and had space provided for information concerning immunizations. This visit was billed as a comprehensive service. Respondent asserts that it should have been billed as an intermediate service. The proper billing is as an intermediate level of service. On December 11, 1990, the infant was seen again for a checkup. This visit was billed through the EPSDT screening program. The weight, height and head circumference were recorded. It was noted that the mother was still breast feeding the child. It was noted that the child had good weight gain. It was noted that the infant was a "healthy baby". Vitamins were given to the mother in view of her breast feeding. Given the child's age in proximity to birth the documentation provided justifies reimbursement as an EPSDT screening. The decision by the Respondent to reimburse as a limited service was unacceptable. On February 11, 1991, the infant was seen again for a checkup. The basis for the checkup was related to the EPSDT screening program. The weight, height and head circumference were recorded. The mother was still breast feeding the infant. The physical examination revealed that the eyes were matting. Otherwise, the examination revealed no significant findings. Eye drops were prescribed for the problem with the eyes. A growth chart was maintained. The visit was billed as a EPSDT service. That billing is not justified in the documentation was not maintained related to developmental assessment, vision screening, and hearing screening. The decision by Respondent to pay for the services as a limited service is acceptable. Recipient No. 16 (J.M.): J.M. was born on February 13, 1990. On May 26, 1990, Petitioner provided medical services to J.M. At that time the weight, height and head circumference were recorded. The child was experiencing bleeding from his circumcision. The child also had a cold. The circumcision was checked by Petitioner. It appeared well healed with no bleeding. Petitioner prescribed antibiotic cream for the condition. The left eye was found to be crusty upon physical examination. Neosporin was administered for the eye. Nasal congestion drops were provided. This visit was billed as a comprehensive service. Respondent asserts that the service was an intermediate service. The proper billing for this for the visit is an intermediate level of service. Recipient No. 17 (T.V.): T.V. was born on June 23, 1979. Petitioner provided medical services to T.V. on December 18, 1990. This was a visit following hospitalization for acute asthma. It was reported that the child was still having an occasional cough. A physical examination was performed. The mother was instructed concerning the need to continue Ventalin tablets as a bronchial dilator for asthma. Medication was prescribed for the cough. This visit was billed as an extended service. Respondent asserts that the visit was a limited service. The proper billing is as a limited level of service. On October 14, 1991 the child was seen for a school physical. This was billed as an EPSDT screening. At the time the child was seen the blood pressure was recorded. A student health form was filled out, but not maintained in Petitioner's records. At this visit it was reported that the child was having an acute asthma attack for the last 2 or 3 days with symptoms being worse at night. Following the physical examination, Petitioner determined to prescribe Ventalin and cough medicine to address the asthma. Petitioner billed this service as an EPSDT screen. Inadequate documentation was maintained to justify reimbursement as an EPSDT screen other than the physical examination. Respondent's decision to reimburse the visit as a limited level of service is acceptable. Recipient No. 18 (B.K.): B.K. was born on March 23, 1989. On November 22, 1991, Petitioner provided medical services to B.K. The presenting complaints were a cold and ear ache, off and on for a period of 2 months. The child was weighed and measured. The physical examination revealed that the throat was inflamed and the nasal mucus membrane was inflamed. A prescription was given to addresses the child's condition. The visit was billed as a comprehensive service. Respondent asserts that the visit was an intermediate service. The proper billing is as an intermediate level of service. Recipient No. 19 (T.S.): T.S. was born on July 16, 1989. On January 19, 1990, the child was seen for a checkup. This visit was treated as an EPSDT screening. The infant was still on formula. The physical examination revealed no significant findings. The child was described as "healthy baby". It was noted that the child was not sitting up yet. The records contain a document with information related to the date of birth, family history, birth and development information when the child was born and feeding history. Petitioner's records also contain growth charts. The bill for EPSDT screening should not be paid based upon the failure to maintain the records justifying the request, other than the physical examination. The Respondent's choice to reimburse the visit as a limited service is acceptable. On April 23, 1990 the child was seen for a further checkup. This visit was billed under the EPSDT screening. The growth charts that have been described revealed that the child was "under the curve". The chart had been plotted more frequently because the baby had been born premature. On this visit the child was weighed, his height and head circumference were noted. The formula he was receiving was noted. The physical examination was normal. It was noted that the child was a "healthy baby". It was noted that the child would take weight on his feet and was playful. The request to reimburse for this visit as an EPSDT screening is not appropriate in that inadequate records were maintained to justify that billing for the mandated screens, other than the physical examination. The decision by Respondent to pay for this visit as a limited service is acceptable. On May 7, 1990 the child was seen. The presenting complaint was a cold, and his nose would bleed when wiped. During the physical examination the nostrils were checked and found to be irritated but no bleeding was noted. The child's throat was inflamed. Antibiotics was prescribed for the inflamed throat and a decongestant was prescribed for cough. This visit was billed as an intermediate service. Respondent asserts that it was a limited service. The proper billing is a limited level of service. On June 25, 1990, the child was seen for a checkup. The visit was billed as an EPSDT screen. When the child was seen the height, weight and head circumference were recorded. The physical examination revealed normal findings with the exception that it was noted that the child had "not gained adequate weight". A blood test was made. A TB test was administered. These tests were noted in the office notes. The TB test was also noted in the immunization record. The billing as an EPSDT screen is unacceptable based upon inadequate documentation maintained to justify the billing, other than the physical examination. Respondent's decision to reimburse Petitioner for a limited service is acceptable. On October 15, 1990, the child was seen for a checkup. The weight, height and head circumference were recorded. The physical examination showed that the left ear was inflamed. Otherwise no findings were made. The child was described as a "healthy baby". An antibiotic was prescribed for the ear infection as noted. The visit was billed as a EPSDT screen. Inadequate documentation was maintained to justify the billing as an EPSDT screens, other than the physical examination. Respondent's decision to reimburse the visit as a limited service is acceptable. On January 15, 1991, the child was seen for a checkup and shots. The weight, height and head circumference were recorded. Upon physical examination, the left ear was noted to be inflamed, "mild to moderate". Otherwise the examination was normal. This visit was billed as an EPSDT screen. Inadequate records were maintained to justify reimbursement for the mandated EPSDT screens, other than the physical examination. Respondent's decision to reimburse the visit as a limited service is acceptable. Recipient No. 21 (M.C.): M.C. was born on January 17, 1985. On February 2, 1990, Petitioner provided medical services to M.C. The child was weighed and measured. The child was seen because she had been coughing a lot off and on. When the physical examination was made her ears were found inflamed. She had rales in her right chest with poor air expansion of the lung. The left chest showed bronchial breathing which indicated that there was not full expansion when breathing. The child was sent for an x-ray to rule out the presence of pneumonia. The child was prescribed an antibiotic and cough medication and a ventalin elixir to assist in breathing and to open the airways. The antibiotic was for the problem with the ear. Petitioner explained the child's condition to the mother. This visit was billed as a comprehensive service. Respondent asserts that the service was an intermediate service. The proper billing is as an intermediate level of service. On February 6, 1990, the child was seen again as a follow-up. The ears were improved. The throat had improved. The chest still showed bronchial breathing and bilateral wheezing. Therefore, the condition had not completely cleared up. Consequently, the antibiotic was changed. This visit was billed as an extended service. Respondent asserts that it was an intermediate service. The proper billing was as an intermediate level of service. The child had been seen in the emergency room on March 11, 1990 for problems with strep throat. On March 16, 1990 Petitioner provided medical services to the child as a follow-up to the condition observed in the emergency room. At the office visit the mother reported that she had difficulty giving the antibiotic to the child orally. Petitioner observed that the throat appeared improved, but some blisters still were present. Because the child would not take the oral medication Petitioner gave the child an inter-muscular injection of penicillin. This visit was billed as an intermediate level service. Respondent asserts that the service is a limited service. That proper billing for the service is as a limited level of service. The child was seen on July 13, 1990. At that time her height and weight were taken. Her presenting complaint was a cough. The child's throat appeared inflamed. Otherwise the physical findings were unremarkable. The child was given an antibiotic to treat the throat condition as well as a decongestant for the cough. This visit was billed as an intermediate service. Respondent asserts that the service was a limited service. The proper billing was as a limited level of service. The child was seen on November 12, 1990. Her height and weight were recorded. The basis for the visit was a reported cough. The physical examination revealed mild inflammation in her throat. Otherwise the findings were unremarkable. The child was given a decongestant and cough medicine. Petitioner billed this visit as an intermediate service. Respondent asserts that it was a limited service. The proper billing is as a limited level of service. Recipient No. 25 (L.N.): L.N. was born on November 19, 1985. On October 15, 1991, Petitioner provided medical services to the child. The weight, height and blood pressure were recorded. The child presented with a complaint of a sore throat for 2 - 3 days with a fever. When the physical examination was made the throat was found to be inflamed, the tonsils were inflamed and enlarged. The nostrils were congested. A strep screen was performed and found to be negative. Because the throat was quite inflamed and lymph nodes were swollen, indicating severe infection unrelated to strep, a prescription for penicillin was prescribed. This visit was billed as an extended service. Respondent asserts that the service was a limited service. The proper billing was as a limited level of service. The child was seen on December 9, 1991, the presenting complaint was a fever the day before. There was no report of sore throat or cough. Upon the physical examination the tonsils were found to be inflamed, the lymph nodes were markedly enlarged. A strep screen was performed. On this occasion it proved positive. The patient was prescribed an antibiotic. Petitioner billed this visit as an extended service. Respondent asserts that the visit was a limited service. The proper billing was as a limited level service. On December 23, 1991, the child was seen by Petitioner. At this time a complaint was a fever of 24 hours duration with a cough. The tonsils were inflamed. Petitioner prescribed an antibiotic and cough medicine. Petitioner billed for the visit as an intermediate service. Respondent asserts that it was a limited service. The proper billing was as a limited level of service. Recipient No. 26 (Baby Boy T): Baby Boy T was born July 31, 1991. On December 23, 1991 the child was seen for a check up and shots. This visit was an EPSDT screen. The weight, height and head circumference were recorded. A physical examination was conducted. This child had been born premature, at thirty-five weeks gestation. A document concerning the birth, family history and feeding history was maintained. It spoke of the child's condition within the first week. The child had weighed 5 pounds 11 ounces when born. Separate from the document recording birth information, family history, early birth and development, and early feeding history, Petitioner recorded that on December 23, 1991 that the examination was normal with the exception that the child had gained weight, but still not sufficient weight since birth. Another abnormality was a hernia. The child was referred for surgery to address the hernia. A growth chart was maintained in the Petitioner's records. Petitioner billed this visit as an EPSDT screen. Petitioner did not maintain sufficient records to justify payment for the mandated screens, other than the physical examination. Respondent's decision to pay for this visit as a limited service is acceptable. Recipient No. 29 (M.M.): M.M. was born on September 17, 1986. On December 2, 1991, Petitioner provided medical services to M.M. On that date the child's temperature, weight and height were recorded. The presenting complaint was a fever, an earache. A physical examination revealed wax in the ears. The throat and tonsils were inflamed. A strep screen was performed and found to be negative. The child was prescribed an antibiotic for the inflammation and a medication for possible fever. Petitioner billed for this visit as a comprehensive service. Respondent asserts that it is an intermediate service. The proper billing as an intermediate level of service. Recipient No. 30 (R.C.): R.C. was born on March 26, 1970. On August 8, 1990, Petitioner provided medical services to R.C. The reason for seeing R.C. was to perform a college physical. The recipient was blind. She was weighed, her height recorded and blood pressure taken. The physical examination was normal, except for her blindness. During the visit R.C. reported that she had been having headaches behind her eyes. MMR immunization was given to assist in meeting college entry requirements. R.C. was sent to a laboratory for CBC and Differential SMA-25. Petitioner billed this visit as a comprehensive service. Respondent asserts that it was an intermediate service. The proper billing was as an intermediate level of service.
Recommendation Based upon the findings of fact and the conclusions of law reached, it is, RECOMMENDED: That a final order be entered confirming the alleged overpayments described, subject to the adjustments. DONE and ENTERED this 26th day of July, 1996, in Tallahassee, Florida. CHARLES C. ADAMS, 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 26th day of July, 1996.
Findings Of Fact Petitioner applied for certification as a physician assistant by application dated June 29, 1991. Under the statutory scheme regulating physician assistants, in certain circumstances, the Board of Medicine may grant temporary certification to applicants for licensure. The temporary certification is good only until the applicant receives notice of the applicant's scores received on the first available examination. At its meeting of October 30 through November 1, 1992, the Board approved Petitioner for temporary certification contingent upon his completion of specified requirements prior to such temporary certification and his completion of 25 hours of continuing medical education after issuance of such certification. Petitioner completed the specified requirements for issuance of the temporary certification and was issued a temporary certificate. Petitioner was so notified by letter dated October 4, 1993. Petitioner was first notified of the need to pay a required fee for the licensure examination by letter dated February 27, 1993. That letter set forth that the fee must be paid by March 31, 1993. Petitioner did not pay the fee by that deadline. On June 8, 1993, Petitioner was notified that the deadline for payment of the required examination fee had been moved to June 25, 1993. The extension had been given because the Board was still involved with processing applications for this special licensure program. Petitioner did not pay the fee by that deadline. On October 11, 1993, Petitioner was sent another letter notifying him that the deadline had been extended once again. This time the deadline was set for November 15, 1993. The notice sent to Petitioner specified three times that the required examination fee must be received in the office of the Board by November 15, 1993. It specifically informed Petitioner that a postmark of November 15, 1993, would not be sufficient. Furthermore, the notice informed Petitioner that if he failed to submit the required examination fee in a timely fashion, he would not be eligible to take the licensure examination. Although Petitioner testified that he was confused with regard to when the required fee could be sent, it was established that he could read the letter and that he understood that his failure to timely pay the examination fee would result in his not being permitted to take the licensure examination. Petitioner did not have the money for the required examination fee until November 14, 1993. Petitioner mailed the examination fee from Miami to the Board office in Tallahassee by certified United States mail on November 15, 1993. Although Petitioner testified that he believed the fee would be delivered the same day or the next day, Petitioner did not use any type of special delivery to provide same day or next day delivery at the Board's office. The fee submitted by Petitioner in the form of three Travelers Express Company checks was received in the Board's office on December 22, 1993. Petitioner did not submit the required examination fee in a timely manner for any of the three deadlines set by the Board. With the exception of one case involving an applicant with a heart condition, the Board has uniformly denied any request for the late payment of the required examination fee. If he does not take and pass the first available licensure examination, Petitioner will not be able to receive his permanent certification as a physician assistant. The licensure examination for persons in Petitioner's category has not yet been given by the Board. Therefore, none of the applicants for certification as physician assistants through this special licensure program have yet been tested.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is, RECOMMENDED that a Final Order be entered finding that Petitioner is not eligible to take the physician assistant examination and that Petitioner's temporary certification is null and void. DONE and ENTERED this 9th day of February, at Tallahassee, Florida. LINDA M. RIGOT 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 9th day of February, 1995. APPENDIX TO RECOMMENDED ORDER Petitioner's proposed findings of fact numbered 1-4, 7-9, and 13 have been adopted either verbatim or in substance in this Recommended Order. Petitioner's proposed finding of fact numbered 5 has been rejected as being irrelevant. Petitioner's proposed finding of fact numbered 6 has been rejected as being subordinate. Petitioner's proposed findings of fact numbered 10-12 have been rejected as being not supported by any evidence. Respondent's proposed findings of fact numbered 1-17 have been adopted either verbatim or in substance in this Recommended Order. Respondent's proposed finding of fact numbered 18 has been rejected as not constituting a finding of fact. COPIES FURNISHED: Allen R. Grossman, Esquire Office of the Attorney General PL-01, The Capitol Tallahassee, Florida 32399-1050 Alexander J. Alfano, Esquire 45 Southwest 9th Avenue Miami, Florida 33130 Dr. Marm Harris, Executive Director Agency for Health Care Administration, Board of Medicine 1940 North Monroe Street, Suite 60 Tallahassee, Florida 32399-0792 Tom Wallace, Assistant Director Agency for Health Care Administration, Board of Medicine 1940 North Monroe Street, Suite 60 Tallahassee, Florida 32399-0792
The Issue The issue presented for decision herein is whether or not Proposed Rule 10- 5.005(2), Florida Administrative Code, as promulgated by DHRS constitutes an invalid exercise of delegated legislative authority. Based upon the following findings of fact, conclusions and analysis, proposed Rule 10-5.005(2)(a) and (b) is invalid.
Findings Of Fact Based upon my observation of the witnesses and their demeanor while testifying, documentary evidence received and the entire record compiled herein, I hereby make the following relevant factual findings. DHRS' Office of Health Planning and Development is divided into two separate divisions: The Office of Community Medical Facilities, which administers the State Certificate of Need Program and has responsibility for making recommendations regarding CON applications, and (2) the Office of Comprehensive Health Planning, which has primary responsibility for development of rules pertaining to Certificate of Need policy. Mr. Robert Maryanski, Administrator of the Office of Community Medical Facilities, believes his office made no formal comments (perhaps informal comments,) concerning the proposed rule. Mr. Maryanski considered that the proposed rule was objectionable based on his understanding of the statutes. (TR 33, 54). Elfie Stamm is employed by the Office of Comprehensive Health Planning and has primary responsibility for development of Proposed Rule 10-5.005. The text of the proposed rule is as follows: 10-5.005 Exemptions. * * * (2)(a) Physician offices or physician group practices which do not exist for the primary purpose of providing elective surgical care are exempt from certificate of need requirements for ambulatory surgical centers as specified in 10-5.011(30). This certificate of need exemption applies to offices and associated surgical suites maintained by one or more private physicians or a physician group which is used only by the physician or the physicians of the group practice, and in which 50 percent or more of the patients treated annually are non-surgical patients. (b) Physician offices, or physician group practices applying for designation as an ambulatory surgical center (ASC) by the Health Care Financing Administration (HCFA) and who meet the requirements for exemption from certificate of need review under the provisions delineated under paragraph (2), shall submit a request for exemption from certificate of need to the Department. The physician office or physician group practice shall provide the Department with at least 30 day's written notice of the proposed exemption from the certificate of need requirements for ambulatory surgical centers. Within 30 days of receipt of such written notice, the Department shall determine if the physician office or physician group practice is exempt and advise the applicant of its determination in writing. (Petitioner's Exhibit 6). The proposed rule exempts physician offices and physician group practices from CON requirements for ambulatory surgical centers (ASC) when at least 50 percent of the patients treated annually in these facilities are non- surgical patients. The proposed rule purportedly implements the Federal Health Care Financing Administration's (HCFA) policy allowing physician offices which are exempt from State CON and licensure requirements to apply directly (to HCFA) to receive ASC designation for medical facility reimbursement purposes without first obtaining a CON. Currently, "Ambulatory Surgical Center" means a facility, the primary purpose of which is to provide elective surgical care and in which the patient is admitted to and discharged from such facility within the same working day and which is not part of a hospital. However, a facility existing for the primary purpose of performing therapeutic abortions, an office maintained by a physician for the practice of medicine, or an office maintained for the practice of dentistry shall not be construed to be an ASC. Section 395.002(2), Florida Statutes (1985). DHRS is trying to implement what it believes to be a statutory CON exemption for doctor's offices through the proposed rule. In so doing, HRS considers physicians' offices to be indistinguishable from physician group practices. In this regard, the relevant statutes do not reference physician group practices. Historically, HRS would not certify physician offices as medicare providers (in its role as surveyor for HCFA) because such certification entails the requirement that a physician's office comply with the State ASC Law. In short, a physician's office wishing to become an ASC had to satisfy both CON and State licensure requirements in order to be certified as a medicare providing ASC. Prior to promulgation of the proposed rule, DHRS never had a policy that group practices or physicians with operating suites are excluded from the statutory definition of an ASC. DHRS has no exemptions or exclusions for physicians' groups with surgical suites so that they could become ASCs for medicare certification. (Testimony of Tom Porter, previous supervisor for DHRS' Certificate of Need Program). DHRS took the position that it was without authority to grant an exemption to physician group practices and the related offices as an associated surgical suite without such facility having first obtained a CON as an ASC prior to offering such services. DHRS also took the position that a physician wishing to do minor surgical procedures as a sub-part of his office practice would not be required to obtain a CON as an ASC. These services could be done as an ancillary part of the physician's office. (Testimony of Gene Nelson, former Administrator, Office of Comprehensive Health Planning and Administrator of the Office of Community Medical Facilities prior to Mr. Maryanski's tenure with DHRS). Section 381.495, Florida Statutes, provides for several defined exemptions from CON review. As stated above, the proposed rule purports to grant an exemption to physician offices or to physician group practices from State CON requirements. Section 381.493 (3)(a), Florida Statutes (1985), states, in relevant part, that an office maintained by a physician for the practice of medicine is excluded from the definition of an ASC. The referenced statute does not grant an exemption from the ASC regulation nor has DHRS previously exempted a person or entity from CON review under such circumstances. DHRS has historically distinguished between a physician performing minor surgical procedures as an ancillary part of his office versus a full service ASC. HCFA clarified in Memorandum FQA-731, Ambulatory Surgical Center regulations relating to compliance with state licensure requirements and the application of state CON provisions as a prerequisite for medicare certification. (Pet. Exh. 8) In states where ASC licensure laws are in effect, facilities seeking to participate in medicare must meet such licensure requirements. Thus, 42 CFR Section 416.40 states, in pertinent part, that the ASC must comply with state licensure requirements. CON provisions must be met as a prerequisite for medicare licensure certification for an entity to operate legally within a state and CON approval is required before the decision to award a license is made. In instances where licensure is not required either by virtue of the absence of an ASC Licensure Law or the exemption of certain entities from the licensure law, compliance with CON provisions is not necessary for medicare eligibility as an ASC. It is through a series of correspondence between Mr. Robert Streimer of HCFA and Mr. Marshall Kelley, DHRS' Assistant Secretary for Program Planning that affords the proffered "basis" for the proposed rule. (TR 87). The Streimer letter provides that ASC services performed in a physician's office which is not required by state law to be licensed as an ASC and which meets all medicare ASC requirements would be covered and reimbursed by medicare at the ASC rate. As noted, DHRS historically took a different position. Nowhere in Mr. Kelley's letter to Mr. Streimer did HRS identify the specific criteria that would relate to an exemption request in Florida as currently stated in the proposed rule. DHRS, based on the proposed rule, now takes the position that any physician having a operating room and furnishing surgical procedures for less than 50 percent of his or her patients would be entitled to an exemption from CON requirements and in turn be entitled to apply for certification from HCFA as an ASC for ASC reimbursement (facility fee). The proposed rule allows for surgery currently performed in a physician's office to qualify for higher reimbursement from medicare (i.e., a facility fee). DHRS uses as authority for the proposed rule, Section 381.493(3)(a), Florida Statutes. Prior to receipt of Streimer's letter, DHRS considered HCFA's policy to be that if a facility did not have a CON and was not licensed as an ASC, there would be no medicare certification forthcoming from HCFA. The Streimer letter purportedly clarifies HCFA's policy although it does not represent a change in that policy. (Petitioner's Exhibit 6). The proposed rule defines "primary as 50 percent or more of the patients treated annually as being non-surgical patients. However, according to the 1982 federal regulations, an entity seeking application and certification as a medicare ASC must be dedicated exclusively to the provision of Ambulatory Surgical Services (42 CFR Section 416.2). Federal Rules provide that the requirement for ASC's to be certified in order to receive medicare payments was expected to exclude physicians offices. There appears to be no federal regulation dealing with reimbursement for the surgical procedures which are to be done in physicians' offices. To satisfy HCFA's certification requirements, an applicant must satisfy the relevant state licensure requirements if any, and meet federal certification requirements. As presently codified, it is impossible to simultaneously satisfy the proposed rule and the federal ASC definition contained in 42 CFR Section 416.02. Thus, an entity could not "exclusively" provide ASC services and at the same time not exist for the "primary" purpose of providing elective surgical care on an outpatient basis. They are mutually exclusive since the two definitions are inconsistent. The Streimer letter initiated HRS's evaluation of current statutes and the proposed rule is, according to HRS, designed to implement current statutes. HCFA's policy is that if a facility legally provides or is allowed to provide elective surgical procedures in Florida, without having to be licensed as an ASC or having gone through the CON process, it is inappropriate to require the facility to obtain a CON and be licensed as an ASC as a condition of that facility being approved for medicare reimbursement at the ASC rate. Prior to HCFA's correspondence, HCFA required an applicant for medicare ASC certification to meet State Law and also meet its certification requirements. This is still the case and the HCFA's correspondence to DHRS did not change that requirement. The purpose of the Health Facility and Health Services Planning Act, more commonly known as the CON law, (sometimes called the Act) is to protect the public health, safety and welfare of Floridians. These protections are further defined as a necessary increase in health care, minimizing duplication in health services, and minimizing situations where there is an underutilization of existing health care resources. The proposed rule does not relate to or otherwise address any "need" issue or capacity issue and contrary thereto, allows for uncontrolled growth of surgery suites as long as the physician group practice has 50 percent or more of total patients treated as non-surgical patients. It can be expected that there will be a proliferation of physicians, solo or group practices, with physician surgical practices developing in addition to hospital out-patient surgery. Additionally, there is no physical constraint on the location of the physician and a physician's group practice. Adoption of the proposed rule will also increase the cost of the total health care system in Florida as follows: The average cost per procedure increases when procedures are spread out over a greater number of fixed facilities and because of incentives that would be inherent in this additional capacity for additional unnecessary utilization. Physicians would receive a facility fee in addition to a professional fee. Physicians would thereby receive more money for doing the same procedures they are currently doing in their offices without the facility fee. The effect of the introduction of surgery centers where there is already excess capacity in hospitals and in freestanding surgery centers is to increase the cost of health care to the community. With the addition of new facilities, there are added fixed costs placed into the system that would remain until the facility becomes outmoded. With the addition of fewer procedures spread over more fixed costs, the average cost per procedure likewise increases even though the cost to an individual patient might appear to be lower in an alternative setting. Excess capacity leads to underutilization with the resultant increase in the rates for surgery. Without a capacity constraint, there will be more elective surgery performed. With the approval of the proposed rule, a doctor's office will be eligible for medicare reimbursement for a facility fee. Medicare reimbursement for a facility fee is unique to ASCs and does not apply to surgical procedures performed in a doctor's office. The purpose behind reimbursing for facility fees is that there is considerable overhead associated with performing relatively complex surgical procedures which require an operating room. If procedures are so simple as to be safely performed in a doctor's office, the intent of the rule is to distinguish between these two settings. It is desirable for procedures to be done in a doctor's office that are simple because it is the lower cost setting. Procedures performed in a physician's office will not qualify for the facility fee reimbursement and overhead payment because of the simplistic nature of the procedures and the lack of need for sophisticated equipment which is currently being used in ASCs. The federal regulations were intended to remove hospital surgery to ASCs, if appropriate, and to remove minor surgery to doctors' offices in order to avoid reimbursement for procedures which can be done in a less sophisticated setting. If more procedures are shifted to medicare certified ASCs, there would be an additional facility fee and physicians would be eligible for this reimbursement. An example of the operational effect of the proposed rule is the scenario surrounding Doctor Stephen S. Spector and the Presidential Eye Surgery Center in Palm Beach County. Doctor Spector was denied a CON for an ASC based on a lack of need for additional operating suites in Palm Beach County. After DHRS made its initial decision denying Dr. Spector's CON, he petitioned for a formal administrative hearing. A Recommended Order was entered denying Dr. Spector a CON and HRS then issued a Final Order denying a CON to Dr. Spector. Dr. Spector has since simply requested an exemption for a freestanding ASC pursuant to the proposed rule. DHRS will entertain this request and if granted, Dr. Spector will be entitled to medicare certification and a facility fee for surgical procedures performed in his office. The proposed rule will encourage the massive proliferation of outpatient surgery facilities and outpatient surgery suites. 3/ Evidence adduced at final hearing indicates that CON approved and licensed freestanding ambulatory surgery centers are currently underutilized and not operating at optimal capacity. The result will be increased hospital and ASC costs per unit because fixed costs must then be spread over a smaller patient base. It is likely that there will be underutilization of existing facilities. The proposed rule does not foster the purposes of Florida's CON law and it will not restrain increases in health care costs. The proposed rule will enhance or maximize unnecessary duplication and promote underutilization of existing resources. Pursuant to Section 120.54(2), Florida Statutes (1985), the Department is required to prepare an economic impact statement of the proposed rule. For the proposed rule, HRS states, in part, in its economic impact statement as follows: The proposed amendment is expected to have an economic impact on hospital outpatient departments and ambulatory surgical centers licensed by the State. It is expected that some Medicare patients who previously have been referred to hospital outpatient departments or a freestanding ambulatory surgical center licensed by the State may have their elective surgeries performed in the physician's group practice. In addition, the proposed rule may encourage the development of physician group practices with surgical suites since they are exempted from the certificate of need process and State licensure requirements. The fiscal impact on hospitals and ambulatory surgical centers cannot be estimated since the Department has no data regarding the number of potential applicants under this Rule, the location of those applicants, the volume of surgeries which may be performed by these entities, or the number of surgeries which would have been performed in hospital outpatient departments or State licensed ambulatory surgical centers in the absence of these new entities. (Petitioner's Exhibit 7). The economic impact statement for the proposed rule does not provide any data or method used in making the required economic impact estimates. The statement does not include any data to analyze whether the rule will impact ASCs having less than one million dollars net worth and less than 25 employees or whether the proposed rule will have an economic impact on hospitals and ambulatory surgery centers. Although HRS has indicated that the exact amount of the fiscal impact is impossible to estimate due to the unknowns respecting the number of physician offices or group practices that will qualify for the exemptions and therefore no analysis was undertaken or developed, studies could have been made to determine the effect any level of participation would have on hospital costs and utilization of existing facilities. Although the task of compiling such data would, no doubt, be arduous, evidence adduced at final hearing indicates that DHRS could have, with effort, compiled a data base with a stratified sample which would have been reliable and could forecast the likely effect of the proposed rule within an acceptable margin of error. DHRS did not compile data which would provide an estimate as to the number of patients who would choose the physician's office over other facilities that perform Ambulatory Surgery. DHRS never requested input from hospitals or outpatient surgery centers with respect to pay or patient mix. DHRS conducted no surveys with respect to the number of potential applicants under the proposed rule. DHRS considered it not relevant to examine the capacity of existing freestanding surgery centers or hospitals having outpatient surgery facilities. DHRS conducted no studies to determine the accessibility of existing ASCs and hospital ASCs. No studies were done to examine the impact, as to the cost to patients, that the proposed rule is likely to have on existing providers. No studies were done to assess the impact the proposed rule will have on the medicare trust fund. No studies were done to determine the impact, if any, on Florida small and minority businesses. It is true that a great deal of the needed data was not readily available to HRS whereas, on the other hand, it made no attempt to gather such data. DHRS has the ability to assess the number of surgeries that could be performed in hospital outpatient departments and ASC's since DHRS does such compilations on a day to day basis when it projects the need for new ASCs. DHRS could have commissioned studies to determine the effect any level of participation would have on hospital costs and utilization. Development of an adequate data base and a meaningful economic impact of the proposed rule is paramount in view of the legislative mandate (to DHRS) to contain health care costs. Rules are promulgated to further the purpose and objective of the statutes they implement. To accomplish this, they must be consistent with the statute. Here, the purpose of the statute is cost containment. Evidence adduced at final hearing reveals, without contradiction, that the proposed rule will increase health care costs, contrary to the major purpose for its existence. Finally, DHRS compiled no data as to the impact on the ability of hospitals to provide indigent care under the proposed rule. As example, Florida Hospital projects that it will provide $48,000,000 in uncompensated care for fiscal year 1986. If the hospital were to lose revenue as result of this proposed rule, the level of indigent care will also correspondingly be reduced in order to offset the loss of revenue. Other parties herein provide services to indigent persons. The proposed rule does not require these exempt facilities to provide indigent care. In addition to the above economic impact which will be brought about by the proposed rule on the Health Care system as a whole, the proposed rule will have an economic impact on the existing hospitals and ASC's. (TR 276-277; 438-440). As example, one Petitioner herein advises that if one surgery suite were added by an existing physician group or formed near the hospital, the hospital will lose approximately $481,000 per annum. By letter dated August 29, 1986, DHRS forwarded a copy of the purposed rule to the statewide and local health councils requesting comments by September 12, 1986. The public hearing on the proposed rule was scheduled for October 20, 1986. Neither health council (state or local) participated in the public hearing for the proposed rule nor has either council submitted comments respecting the proposed rule. The notice provided to the local and statewide health councils for comments on the proposed rule was adequate and afforded the various councils an opportunity to voice any concerns or provide input about the proposed rule. Dr. Montgomery, an Intervenor herein, will receive additional medicare reimbursements of $500.00 per patient for a facility fee under the proposed rule. Dr. Montgomery approximated that he performed 320 cataract surgeries per year of which approximately 300 patients are paying patients. Approximately 85 percent of those patients are over 65. Therefore, Dr. Montgomery will receive medicare reimbursement for 255 patients or approximately $127,500.00 in additional fees if his office is certified as exempt under the proposed rule.
