The Issue Whether Rule 64B8-9.009(6)(b)1.a., Florida Administrative Code, is an invalid exercise of delegated legislative authority pursuant to Section 120.52(8), Florida Statutes.
Findings Of Fact Stipulated Facts Section 458.331(1)(v), Florida Statutes, authorizes the Board to adopt rules establishing the standards of practice and care for particular physician practice settings. The Board is the agency that adopted Rule 64B8-9.009, Florida Administrative Code, regarding standards of care for office surgery. Petitioner, Victor Ortiz, is a Certified Registered Nurse Anesthetist (CRNA), and is licensed by the Board of Nursing pursuant to Chapter 464, Florida Statutes. Mr. Ortiz is not a member of the Florida Association of Nurse Anesthetists or the Florida Nurses Association. Mr. Ortiz provides anesthesia care to patients in various settings under the supervision of physicians licensed pursuant to Chapters 458 and 459, Florida Statutes. Among other functions, Mr. Ortiz orders preanesthetic medications; administers regional, spinal, and general anesthesia under protocol and the supervision of a physician; provides life support functions; and monitors patient condition during surgery and in the recovery room. Prior to April 15, 2002, the effective date of Rule 64B8-9.009(6)(b)1.a., Florida Administrative Code (the Rule), Mr. Ortiz administered anesthesia under the supervision of operating physicians for all types of office surgeries, including surgical procedures classified by the Board of Medicine as "level III." Mr. Ortiz provided anesthesia services to patients in level III office surgeries under the supervision of M.D. or D.O. operating physicians four or five days per week on average. The Rule requires that if the anesthesia provider is a CRNA, 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 in level III office surgeries. Since the adoption of the Rule, the physicians for whom Mr. Ortiz previously provided anesthesia services will no longer employ him for level III office surgeries because they believe that it is unnecessary and cost-prohibitive to pay Mr. Ortiz to provide the actual anesthesia services and an anesthesiologist to directly supervise him. Consequently, Mr. Ortiz' revenues have been reduced and his office practice has been substantially and adversely affected.
Findings Of Fact Respondent, Patricia Major, M.D., graduated from Harvard undergraduate school with honors; graduated with honors from New York University School of Medicine; served her internship at Yale New Haven Hospital, as well as completing a residency program and fellowship program in pulmonary diseases at Yale in 1974. She was certified in 1974 by the American Board of Internal Medicine. She was a teaching fellow at Yale during her pulmonary fellowship and had a faculty appointment thereafter at that same school. She was Assistant Director and Educational Coordinator at the Family Practices Residency Program for the University of Connecticut and from 1974 through 1976 had teaching appointments there. In 1976, she left New England and returned to Florida to practice internal medicine in Key West where she had grown up. During the period from 1976 to 1980, when she practiced medicine in Key West, she also worked with Emory University and the University of Miami as a clinician teaching medical students who were placed in Key West on rotating clerkships. She served as an emergency room physician at Florida Keys Memorial Hospital and was an admitting physician on the staff. In 1978 she was selected as one of five physicians to become the first civilians to go through the Navy's Diving Medical Officers Training Program and served as a civilian diving medical officer for the Navy in Key West. In 1980, the Board of Medical Examiners of the State of Florida brought charges against Respondent that resulted in a stipulation being entered into between Respondent and the Board that she would voluntarily cease practicing in Florida and relinquish her Florida license. The stipulation was signed in December, 1981, and her license was relinquished by Order of the Board in February, 1982. The charges that resulted in the initial suspension of Respondent's license and in the stipulation between the Respondent and the Board dealt with charges based on impairment due to drugs and alcohol. Respondent moved to Massachusetts where she practiced medicine under a temporary license and voluntarily participated in the Impaired Professionals Program for two years. From 1982 to 1984 she had twice-weekly urine screens under her contract between the assigned Massachusetts monitoring physician and herself. In no instance was there evidence of impairment or a positive urine screen during her Massachusetts stay. In 1984, Respondent returned to Florida and applied to the Board of Medical Examiners for permission to return to practice. On March 14, 1984, the Board of Medical Examiners entered an order reinstating Respondent's medical license for the State of Florida, placing her on probation for a period of three years and setting up a monitoring agreement under which Dr. John Buckner of the Island Clinic would serve as supervising physician for Respondent. From March, 1984, until April, 1986, Respondent worked at the Island Clinic with Dr. Buckner, seeing 15 to 25 patients a day. During that period of time, she only missed one working day, in September, 1985, when she was moving from one house to another and during the period of time immediately before and during her October, 1985 stay at South Miami Hospital. Respondent, and all of the witnesses who had personal knowledge of her contact with patients, denied that she ever treated or dealt with patients while under the influence of drugs or alcohol from 1984 until the current time. Iris Carleen Cervantes, who served as secretary to Dr. Buckner and is currently on the staff of Dr. Davidson, Respondent's current monitoring physician, has had the opportunity over two and one-half years to observe Respondent on a regular basis in her dealings with patients. She has been with Respondent socially as well. She has never seen Respondent drink alcoholic beverages. She uses Respondent as her personal physician and for all other members of her family. She is aware of the Respondent's regular visits to her psychiatrist, Dr. Jerrold Weinstock, and takes those into account in doing the scheduling for Dr. Major. She is similarly aware of Respondent's regular attendance at Alcoholics Anonymous meetings, has never heard Respondent disparage A.A.; and in fact, has a brother whom Respondent helped get into A.A. At no time has Cervantes ever seen any indication, even when Respondent has returned to the office late at night, of any use of drugs or alcohol. Linda Susan Park, a counselor at the Delphus Drug and Alcohol Treatment Center at Florida Keys Memorial Hospital for the last three and one-half years, knows Respondent both personally and professionally. She has never seen Respondent under the influence of any mood-altering chemicals. Although they go out socially together, she has never seen Respondent order an alcoholic beverage. When they are together, they talk program, i.e., A.A. steps. Parks has regularly seen Respondent at A.A. meetings, and they attend a number of the same groups including a Wednesday night women's group called The New Beginnings Group. Parks is aware of the interest Respondent has shown in drug and alcohol-impaired nurses at Keys Memorial and of her attendance at the impaired nurses Caducues meetings. Respondent has worked with the Delphus Program at Florida Keys Memorial Hospital referring a number of patients to the program. Park has seen the Respondent under extremely stressful situations, particularly in the past year; and has seen her act only appropriately. With the Board's approval, Respondent has also worked with indigent patients at the Health Care Center at Florida Keys Memorial Hospital since August, 1986. The Director of that program, Thomas C. Puroff, testified regarding her employment there. Respondent was originally hired on a temporary basis to cover for the primary care physician for three weeks. The Director's assessment of her initial period of employment at the Health Care Center is as follows: The staff was very, very pleased with her performance, and I was very pleased with her performance. The staff felt that they were learning a lot from her, that she was an exemplary doctor who explained why she was doing things with patients and it became a learning process for our nurse practitioners and nurses. Her interaction with the receptionist, administrative assistant was very high level, very positive, and the patients loved her. And both--well, later on when we did hire her on a one day per week basis to fill in when the regular doctor could not be there, a lot of patients would call and specifically request an appointment when she was going to be there. (Transcript, P. 199) The Health Care Center ultimately hired the Respondent for one to two days a week when the other physician was not there. She works the longest day of the stretch, which is a ten-hour day. The Director describes the job as a high stress one in which he has seen no difficulty in handling stress on Respondent's part. He has never seen any indication of impairment of faculties or inability to handle her job in any fashion on Respondent's part. When he hired Respondent, Puroff had full knowledge that she had problems with the Board of Medical Examiners, had been assigned a monitoring physician, had been brought in restraints to the emergency room at Florida Keys Memorial Hospital and had been committed under the Baker Act in September of 1985, that she was an alcoholic who attended A.A., and that she regularly visited a psychiatrist. None of these matters were kept secret from him. Karl Michael Davidson, M.D., who became Respondent's monitoring physician after Dr. Buckner abruptly left town in April, 1986, has similarly seen no sign of any kind of impairment during the time he has worked with her. He has never seen her indulge in any drugs or alcohol. He knows that she regularly sees her psychiatrist. He has received no complaints from anyone in the medical community, the patient community, or the general community of Key West with regard to Respondent since he has served in a monitoring capacity for her. Even Sally Parr who testified on behalf of the Petitioner denied that Respondent ever used alcohol when she was in a situation in any way connected with patients. Regarding the change of monitoring physicians in April, 1986, the testimony of Respondent and her witnesses was consistent and uncontradicted, with Petitioner presenting no facts other than those stipulated. The individual having the most knowledge regarding the circumstances under which Dr. Buckner left Key West, was his secretary, Iris Cervantes. She, like the other witnesses, was aware that he had gone to look at a number of schools and other medical positions. He would say he was going to leave, but he always came back. On April 6, 1986, Buckner's wife told Respondent the Island Clinic was being closed and Buckner was leaving. On April 7, the locks on the doors to the Island Clinic were changed. Cervantes was one of two people to have a new key; Respondent and the other doctors practicing with Dr. Buckner were not given keys. This left Respondent in a position where she could not write some pharmaceutical prescriptions, all appointments had to be cancelled, and there was no way to treat ongoing patients who were ill at the time. When the locksmiths changed the locks, Respondent contacted Buckner to ask if he knew what he was doing and if he were going to be gone permanently. He indicated that he had started working in California, but he did not know whether it would be permanent. He said that he had spoken with Dr. Davidson and asked him to act as a temporary supervising physician in addition to himself. Respondent spoke with Dr. Davidson who said that she was welcome to see patients at his office and that he would monitor until Buckner decided what he was doing. They spoke about immediately notifying the Board of the change in her office location. It was her impression that Dr. Davidson had actually notified the Board with a handwritten memo the first day she was there and that was how the investigator from the Department knew how to find her when the investigator came to see Respondent at Davidson's office on April 18, 1986. On that date Davidson also discussed with the investigator Buckner's abrupt departure which might be permanent. Respondent ultimately wrote the Board herself. That correspondence dated April 22, 1986, was received by the Department of Professional Regulation on April 28, 1986, the same day on which the Department received from Davidson his notification letter dated April 17, 1986. Four to six weeks after that letter, Dr. Davidson and Respondent were advised that the Board had received the information and would consider Dr. Davidson as her supervisor. On August 2, 1986 Davidson and Respondent appeared before the Board of Medical Examiners and received formal approval. The remaining allegations involve two separate incidents occurring during the week of September 16, 1985. At that time, and since January of that year, Respondent was living in the home of Sally Parr, an Assistant State Attorney for Monroe County. It was Parr's testimony that several months after Respondent moved in, Respondent began to drink wine on a regular basis sometimes to the point of intoxication. Parr is the sole person to testify to having seen Respondent drink alcoholic beverages. Other witnesses testified to Parr's own problems with alcohol. The emotional relationship between Parr and Respondent from March, 1985, until September, 1985, was "stormy" and "tremendously emotional." The two of them attended therapy with Dr. Jerrold Weinstock. On September 16-17, 1985, all of this emotionalism culminated in Parr calling the emergency number 911. During the evening of Monday, September 16, Parr's sister arrived in town. There were highly controverted scenes which both Parr and Respondent described. The two participants were clearly emotionally charged, angry, and upset. It was Parr's testimony that Respondent walked into the back bedroom and with a syringe in her hand with a pale yellow fluid in it, lifted her shirt and injected that material into her chest under her left breast Saying she was going to kill herself. According to Parr, Respondent said the fluid was 100 percent xylccaine and she would die in one minute. Parr then called 911, Respondent told her she was a fool to believe that, and Respondent left the house and drove away. Parr also confusedly describes a later scene that night with Respondent and another syringe and more light yellow fluid. Officer Cynthia Tingley responded to that call from Parr. The report was treated as one for an "attempted suicide". At no time did Ms. Parr tell the officer that Respondent was not in danger or that Respondent had told Parr that she was "a fool" to believe that this was a way to kill oneself. In the opinion of the investigating officer, Parr had an odor of alcoholic beverage on her breath. The officer had no personal knowledge that Respondent had administered the legend drug to herself. She did note an empty bottle of xylocaine in the room but no syringe was found. Later the officer was called to where another officer had stopped Respondent and had given her a citation for careless driving. Respondent was cooperative and did not seem to be having health problems, although she did appear to be under a lot of stress and appeared anxious. Neither officer made any attempt to detain Respondent after the stopping. Under Parr's version of this event, it ended with Respondent refusing to go to sleep in the back bedroom and only agreeing to go to sleep if she could sleep in Parr's room. That occurred and ended the evening. Respondent continued to live at the house, and on Thursday Parr and her sister left for a short vacation. Parr testified that she called from out-of-town to tell Respondent that she was not coming back to the house unless Respondent had moved out. Respondent agrees that Parr called and told her that but adds that Parr had promised to go on vacation with Respondent and told Respondent to arrange that vacation while Parr and her sister were gone. Respondent specifically denies that she made a suicide attempt or attempted to give the impression she was trying to commit suicide on September 16-17, 1985, or any other time. She denies that the events described by Parr occurred but agrees that it was a very confusing, emotional night. She denies that there was any further incident when she returned that night and only recalls them both being pretty tired and having gone to bed. Dr. Jerrold Weinstock, Respondent's treating psychiatrist and the individual to whom Parr and Respondent had gone for counselling, testified that the only description of the xylocaine/suicide incident he received came from Parr, not from Respondent. No information that Weinstock gained from his psychotherapy of Respondent indicated that Respondent's version of the event (or non-event) was incorrect. It is specifically found based upon the credibility of the witnesses that Respondent did not inject herself or attempt to inject herself with anything and specifically not with xylocaine. The second incident of that week occurred on Friday evening, September 20-21, 1985. This was the evening when Parr called Respondent and told her to move out of the house. Respondent describes that scene as follows. She [Parr] called. We had arranged that she would call at that time. I had seen my last patient about 5:30 or 5:45 and I was waiting at home for her call . . . She started screaming at me to get out of her home, that she did not want me there when she got back. I was stunned because I was making arrangements for vacation. I said, "What about the vacation?" She said, "I lied to get out." And I said, "Well, what will you do." "Call the police," she said. "I know people on the police force and I won't hesitate to use them." And then she hung up on me. (Transcript, P. 248) Respondent had taken steps during the day to arrange a trip to New York and Connecticut because Parr had never been to New York. An acquaintance came by while Respondent was still sitting stunned and asked her if she wanted to go to the Black Angus and have a drink. Respondent went with this individual to the Black Angus and had three very strong drinks there. She realized that she was feeling intoxicated after the third drink. She asked the woman, who was driving, to drop her off at Sally's house, but the woman wanted to go downtown to a few more bars. Respondent pleaded to be dropped off, and her companion became belligerent. Ultimately, the acquaintance assaulted Respondent tearing her shirt off, punching her in the face, hitting her about the head, grabbing her purse and pulling it away from her. During the scuffle, Respondent even lost her sandals. Petitioner has not controverted this account. Cervantes and Buckner both confirmed the bruises and scratches from the fight. Cervantes also described an incident a few days later whereby the same woman came into the Clinic, gave Cervantes some earrings she said she had taken out of Respondent's purse, and slashed the tires on Respondent's car on her way out. Respondent was left intoxicated, running, frightened, with no top on and three miles from Parr's house. She did not have her keys which had been in her purse and could not get into the clinic but felt she could get into Parr's house if she could get there. She felt intoxicated and becoming more so, uncertain whether it was the alcohol or being beaten that was affecting her. She was disoriented and embarrassed to be running down the street wearing only a pair of shorts. She crawled under a garage on the side of the road to sleep to clear her head to find a solution to her predicament. She was awakened by police officers but said nothing in response to questioning. Respondent was taken by the police to Florida Keys Memorial Hospital. When the police officers tried to transport Respondent, she became physically violent, kicking at the officers and attempting to kick out the windows of the patrol car. When she arrived at the hospital, she was physically restrained with arm and leg restraints. A drug analysis performed on Respondent at the hospital showed her blood alcohol level to be 0.235 percent. Respondent was next transported to Marc House in Marathon, Florida. She was involuntarily committed under the Baker Act for that one night. The next morning, Dr. Jesse Sewell, Director of Marc House, spoke with Respondent, determined there was absolutely no reason for Respondent to be there, and called Buckner to pick up Respondent and transport her back to Key West. Dr. Buckner did and took Respondent to Parr's house so she could move out her belongings. Respondent and Buckner discussed the episode at great length and she got in touch with Dr. Weinstock. Buckner and Respondent called her probation officer with the Department of Professional Regulation, a Diane Robie, who advised them to contact Dr. Roger Goetz, head of the Florida Impaired Physicians Program. Buckner called Goetz and described the incident that resulted in Respondent being committed overnight. He told Goetz that Respondent had moved out of the place where she had been living which seemed to have precipitated the disturbance; that she was in daily contact with her psychiatrist; that she had started attending A.A. meetings daily as recommended to someone who has had an episode of drinking; and that she would bring her support systems together. Goetz suggested going for evaluation at South Miami Hospital with Dr. Lynn Hankes. When Respondent was evaluated by Hankes, he recommended entry into South Miami's treatment program. Respondent went back to Key West and conferred with Buckner, Weinstock, and Goetz. Although Weinstock believed the inpatient program at South Miami would be therapeutically counterproductive, Respondent followed the recommendations of Goetz and Hankes and entered the treatment program on October 6, 1985. Buckner (whose deposition was taken prior to his departure from Key West in April, 1986) considers Respondent the best internal medicine doctor in Monroe County. Since he had noticed nothing wrong with Respondent through Friday afternoon, September 20, 1985, he was surprised by the telephone call from Dr. Sewell at Marc House on Saturday morning. When Buckner spoke with Weinstock that day, Weinstock explained that Respondent completely removes her emotional problems from her professional self. After the Friday/Saturday Marc House incident, Respondent finished her weekend move from Parr's house on Monday and came back to work on Tuesday. From Tuesday until she entered South Miami's treatment program, her performance as a practicing physician remained exemplary, analytical and calm. Respondent entered the program committed to making the program work and seeking insights into the nature of her disastrous interpersonal relationships as well as the episode that led to her admission to Marc House. Dr. Lynn Hankes testified that Respondent is a chronic alcoholic who will always be an impaired physician. He described in detail the South Miami Treatment Program beginning with the first phase of detox and assessment. He admitted that Respondent did not require detoxification and that she suffered no abstinence syndrome or withdrawal syndrome. She became immediately oriented to the program and began interacting with her counselor. However, Dr. Hankes believes that Respondent only intellectually admitted to the problem and that she was preoccupied with only interacting with the other medical professionals on the unit. He described at some length Respondent's "negative limit testing" and her preoccupation with the medical professionals on the unit. He regarded her as "sabotaging her own treatment". For example, Respondent did not initially tell program personnel that she sometimes had a glass of wine at dinner over the last several months or that she shared a marijuana cigarette on her way from Key West to admit herself into South Miami Hospital although she did disclose that information during her stay in the program. It is his opinion that there is a clear medical indication for extended treatment in a secondary facility for many reasons. Basically, in his opinion, it was a bottom line of an intellectual admission of the disease with only minimal acceptance. He administratively discharged Respondent from the program on October 31, 1985 just prior to her completing the program because she refused to accept his recommendation for extended care for an indefinite period of time. Dr. Hankes did not see Respondent after October 31, 1985 in any capacity. All of his testimony was based on information which he had prior to October 31, 1985. Dr. Hankes admitted that the only limit testing, rule breaking that Respondent had engaged in was that she spoke to other medical professionals, she spoke to male patients in their room while she stood at the door, and she walked a friend to the lobby of the hospital but did not leave the premises. He also observed isolation tendencies on her part. His dire predictions of doom have not proven accurate. In the subsequent year and a quarter Respondent has stayed sober and practiced medicine successfully with no further incident. It was Buckner's impression that the major reason Respondent was being required to go into the hospital for the inpatient treatment was because other impaired physicians in the Key West area had had to go through the program, and they were unhappy that she had somehow missed it. Buckner encouraged Respondent to enter the treatment program, even against the advice of her psychiatrist, so that the Board would be on her side after she "completed the drill." Buckner spoke with her counselor and therapist regularly during the time she was at South Miami Hospital and got indications that everything was progressing well and that she would be back to Key West to practice at the scheduled time. Buckner went to South Miami Hospital three weeks after Respondent's admission to meet with Dr. Hankes on a Saturday. Hankes did not show up for the appointment, but Buckner later reached him by phone. Hankes told Buckner that Respondent was progressing fine, although she still had some problems. Hankes said Respondent would be back in Key West practicing the next week and could have outpatient treatment with Dr. Weinstock. Buckner returned to Key West and told his staff to schedule Respondent for patients the next week when she would return. On Monday Respondent telephoned to tell him that Hankes had changed his mind, that they were not going to release her, and that she was going to have to sign herself out. No explanation has been offered as to why Hankes changed his mind between Saturday and Monday so radically from outpatient treatment with Respondent's treating psychiatrist to indefinite inpatient hospitalization. Buckner and Weinstock agreed the best treatment for Respondent was to get her back practicing medicine. Buckner contacted Cecilia Bradley, the attorney representing the Department and the Board, asking for direction. Bradley advised Buckner that he would have to personally decide whether Respondent was a threat to the community. He saw no such threat. Respondent returned to the Island Clinic and resumed her practice. Buckner saw her there on a daily basis, and her performance was, in his opinion, the same as before, "absolutely flawless." When Respondent did not accept Hankes' recommendation of indefinite long-term treatment in Mississippi, she became, in Dr. Goetz's opinion, in noncompliance with the Florida statute on impaired physicians. Dr. Goetz subsequently reported her to the Department of Professional Regulation for her failure to continue satisfactorily in the program. Goetz admitted that his role as Director of the program was one of an administrative officer, and he has offered no opinion as to whether Respondent is in fact impaired. Goetz has received no information that Respondent's impairment, if any, has in any way affected her practice or patient contact. All the information that Goetz relies on is information prior to Respondent's discharge from South Miami Hospital on October 31, 1985. It was Buckner's understanding, and that of Respondent, that she had not violated the Order of the Board in having an instance where she "slipped" with regard to drinking. Dr. Goetz agreed with that assessment a "slip" can be a part of a rehabilitation program. Linda Parks, Diane Robie, and Dr. Weinstock agree with that assessment. Respondent could not have financially afforded the Mississippi program. Despite the testimony of Hankes and Goetz that Respondent could have gone there for free, Goetz did not tell her that, Hankes did not know what the financial arrangement was, and the Director of that program whom Respondent personally contacted regarding the program did not mention such a possibility. Jerrold Weinstock has been Respondent's treating psychiatrist since 1984. His opinion is that there is no basis for the allegation that Respondent be considered an impaired physician incapable of rendering safe, quality, and competent services to her patients. In fact, Weinstock refers members of his own family to her. That opinion is shared by two independent psychiatrists, Stanley I. Holzberg, M.D., and Milton Burglass, M.D. Dr. Holzberg examined Respondent initially on behalf of the Florida Impaired Physicians Program in 1983; reexamined her at the request of the Department in February, 1984; and saw her for a third time at her own request in November, 1985, following Respondent's discharge from South Miami Hospital. On all of the occasions when he examined Respondent, Holzberg opined that she could practice medicine with skill and safety with the conditions that she have treatment and monitoring. Holzberg considers the treatment she is receiving from Weinstock, including the prescription of an antidepressant, as appropriate long-term treatment. He agrees with Weinstock and Buckner that long-term inpatient hospitalization would not be helpful to Respondent. Holzberg further agrees with Weinstock that Respondent's major illness is chronic depression, the affective disorder. Dr. Milton Burglass evaluated Respondent on March 25 and April 2, 1986, and reached the same conclusion. Burglass administered a full series of psychological tests to Respondent, including the Minnesota Multi-Phasic' Personality Inventory; the Beck Depression Inventory; the Cattell Use for Tension and Anxiety Survey Schedule; the Rotter Incomplete Sentences Blank; the Cattell Assertive Behavior Survey Schedule; the Cattell Thought Stopping Survey Schedule; and the Standardized Medical and Personal History Form. He spent, in addition, a total of five hours interviewing Respondent, and he went over all the records from other psychiatric and related medical evaluations that she had had from 1980 forward. Burglass found nothing to suggest that Respondent is incapable of practicing medicine with skill and safety. Burglass believes that people can, in fact, function normally and be able to perform professionally in their chosen profession after recovering from a chemical dependency, be it drug or alcohol. Burglass specifically opined that Respondent is not impaired.
Recommendation Based upon the foregoing Findings of Facts and Conclusions of Law, it is RECOMMENDED that a final order be entered: Dismissing with prejudice the complaint filed against Respondent in DOAH Case NO. 86-0469; Finding Respondent guilty of the allegation contained in the Administrative Complaint filed in Case No. 86-2065 but taking no disciplinary action against her, and Allowing Respondent to continue to practice medicine under reasonable monitoring conditions until the period of her probation has been completed on March 15, 1987. DONE AND ORDERED this 5th day of March, 1987, in Tallahassee, Florida. LINDA M. RIGOT Hearing Officer Division of Administrative Hearings The DeSoto Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 5th day of March, 1987. APPENDIX TO RECOMMENDED ORDER DOAH Case Nos. 86- 0469 and 86-2065 Rulings are made as to each of Petitioner's proposed findings of fact as follows: 1-2. Adopted. 3. Rejected as irrelevant. 4-5. Adopted. 6-7. Rejected as not supported by the weight of the credible evidence. Rejected as being contrary to the weight of the credible evidence. Adopted. Rejected as not supported by the weight of the credible evidence. Adopted. Rejected as being a statement taken totally out of context. Adopted. Rejected as being contrary to the weight of the credible evidence. 15-17. Adopted. Rejected as not supported by the weight of the credible evidence. Adopted. Rejected as not supported by the weight of the credible evidence. First two sentences adopted; third sentence rejected as being contrary to the weight of the credible evidence. 22-23. Adopted. Rejected as being secondary. Adopted. First sentence rejected as being contrary to the weight of the credible evidence. Second sentence adopted. Rejected as being contrary to the weight of the credible evidence. 28-29. Adopted. 30-32. Rejected as not supported by any evidence. Rejected as being secondary. Rejected as being contrary. Rejected as being irrelevant. Rejected as being secondary. Adopted. Rejected as not supported by any evidence. Rejected as being irrelevant. 40-45. Adopted. Rejected as being irrelevant. Adopted. Rulings are made as to each of Respondent's proposed findings of fact as follows: 1-27. Adopted. 28. Rejected as being redundant. 29-32. Adopted. 33. Rejected as being redundant. 34-39. Adopted. 40-41. Rejected as being unnecessary. 42-43. Adopted. COPIES FURNISHED: Leslie Brookmeyer, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Elizabeth Du Fresne, Esquire 2950 S.W. 27th Avenue, Suite 10 Coconut Grove, Florida 33133 Nathan Eden, Esquire 417 Eaton Street Key West, Florida 33040 Van Poole, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Dorothy Faircloth Executive Director Board of Medical Examiners 130 N. Monroe Street Tallahassee, Florida 32301
The Issue The issue in this case is whether notice was accorded the patient, as contemplated by section 766.316, Florida Statutes (2012).
Findings Of Fact Ashley Lamendola first presented to Gulf Coast OB/GYN on the morning of December 16, 2011, for a prenatal visit. This visit constituted the beginning of her professional relationship with the physicians who were part of the Gulf Coast OB/GYN group, which included Dr. Calderon and Dr. Shamas.1/ Violet Lamendola, Ms. Lamendola’s mother, accompanied Ms. Lamendola to that visit. When she arrived at Gulf Coast OB/GYN, Ms. Lamendola was given information and forms to fill out by the receptionist. According to both Ms. Lamendola and her mother, the materials included a NICA brochure in Spanish and an acknowledgment of receipt of the NICA form. While reviewing the materials, Ms. Lamendola, who does not speak Spanish, noted that the NICA brochure given to her was in Spanish. She asked her mother to take the brochure back to the receptionist. When Ms. Lamendola’s mother asked the receptionist about the Spanish brochure, the receptionist told her that the office had run out of NICA brochures printed in English, but that she would obtain one from another office and give it to Ms. Lamendola at the end of her appointment. Ms. Lamendola was instructed to sign and did sign the acknowledgment form so that she could see the physician. The acknowledgment form advised that all physicians in the Gulf Coast OB/GYN, P.A., were participating physicians in the NICA program. Ms. Lamendola received a black-and-white facsimile copy of the NICA brochure on her way out of the office along with other materials relating to prenatal and infant care. The brochure, received by Ms. Lamendola from Gulf Coast OB/GYN, bears a facsimile transmission header dated December 16, 2011, at 9:47 a.m. The brochure prepared by NICA is a color brochure which contains the following text in white letters on a light-to-medium green background on the back of the brochure: Section 766.301-766.316, Florida Statutes, (“NICA Law”) provides rights and remedies for certain birth-related neurological injuries and is an exclusive remedy. This brochure is prepared in accordance with the mandate of Section 766.316, Florida Statutes. A copy of the complete statute is available free of charge to completely inform patients of their rights and limitations under the application provision of Florida law. Since 1989, numerous court cases have interpreted the NICA law, clarifying legislative intent. The above-quoted language is absent from the facsimile copy of the brochure that Ms. Lamendola received from Gulf Coast OB/GYN. Apparently because the letters in the original brochure were white, the letters did not transmit. It is noted that on the front of the brochure, white lettering that appears on the green background of the color brochure did not transmit on the copy that Ms. Lamendola received. The majority of the information contained in Ms. Lamendola’s facsimile copy of the brochure is contained in the color copy of the brochure. The facsimile copy informed Ms. Lamendola that the statutes provide an exclusive remedy and a copy of the statutes may be obtained from NICA. The facsimile outlined the rights and limitations provided in the statutes. The only things that are not contained in the original brochure are that a copy of the statutes is available free of charge, the preparation of the brochure was mandated by section 766.316, and court cases have interpreted the statutes. St. Petersburg General Hospital offers a tour of its obstetrical department to expectant mothers and their families. Ms. Lamendola’s mother called St. Petersburg General Hospital to register for a tour. The hospital employee who was scheduling the tour asked to speak to Ms. Lamendola to obtain pertinent biographical information. Ms. Lamendola provided the information to the hospital employee. The tour is an informational tour and attendance at the tour does not constitute pre-registration at St. Petersburg General Hospital for the delivery of a baby. Ms. Lamendola and her mother, along with 12 other couples, attended the tour on March 22, 2012. During the tour, Ms. Lamendola received a tour packet, which contained a document titled Preadmission and Financial Information. This document instructed Ms. Lamendola to fill out the pre-admission form and return it to the hospital. Ms. Lamendola filled out the pre- admission form, but did not return it to St. Petersburg General Hospital. Ms. Lamendola did not pre-register for admission to the hospital. On April 3, 2012, Ms. Lamendola presented to St. Petersburg General Hospital with complaints of vaginal bleeding. Ms. Lamendola was told by a hospital employee that she was already in the system and that additional information would not be necessary. Ms. Lamendola signed a “Consent to Treat” form and was treated in the labor and delivery unit of the hospital. A short time later, she was given informational materials relating to prenatal and infant care and released. She was not given a NICA brochure during the visit on April 3, 2012. It was the hospital’s policy to give a NICA brochure to a patient only when the patient was being admitted as an inpatient for delivery of her baby. Ms. Lamendola’s professional relationship with St. Petersburg General Hospital relating to her pregnancy began with her visit on April 3, 2012. At 20:19 on June 26, 2012, Ms. Lamendola presented to St. Petersburg General Hospital. She had been experiencing contractions for six hours prior to her arrival at the hospital. She had been placed on bed rest for gestational hypertension five days prior to coming to the hospital. When she arrived at the hospital, she had hypertension. Normally when a patient is 37 to 39 weeks gestation, her physician will bring the prenatal records to the hospital or the physician’s office will send the records to the hospital by facsimile transmission. When Ms. Lamendola arrived at St. Petersburg General Hospital, her prenatal records from her physicians’ office were not on file. Megan Muse, R.N., was on duty when Ms. Lamendola presented at St. Petersburg General Hospital. Because Ms. Lamendola’s records were not on file, Ms. Muse requested that Bayfront Hospital send Ms. Lamendola’s records to St. Petersburg General Hospital. The evidence did not establish how Ms. Muse knew that the prenatal records were at Bayfront Hospital. Ms. Lamendola’s prenatal records, consisting of 11 pages, were sent by facsimile transmission to St. Petersburg General Hospital beginning at 21:35 on June 26, 2012. Ms. Muse recorded in her notes that Ms. Lamendola’s prenatal records were received from Bayfront Hospital at 21:45 on June 26, 2012. Although Ms. Lamendola’s prenatal records may have been sent to Bayfront Hospital, it was never Ms. Lamendola’s intention to deliver her baby at Bayfront Hospital. She took the informational tour offered by St. Petersburg General Hospital and went to St. Petersburg General Hospital in April 2012 when she had a problem related to her pregnancy. At 20:33, Dr. Javate admitted Ms. Lamendola to St. Petersburg General Hospital for the delivery of her infant. Ms. Lamendola was examined by Emanuel Javate, M.D., at approximately 21:35. At 22:02, Ms. Lamendola signed the hospital’s Condition of Admission form. At 22:10 the hospital gave Ms. Lamendola the brochure prepared by NICA, and Ms. Lamendola signed the acknowledgment form, acknowledging that she had received the brochure. Ms. Lamendola gave birth to Hunter Lamendola (Hunter) on June 27, 2012, at St. Petersburg General Hospital, which is a licensed Florida Hospital. At birth, Hunter weighed in excess of 2,500 grams and was a single gestation. Ashley Lamendola received obstetrical care from Guillermo Calderon, M.D. Dr. Calderon was a “participating physician” as defined in section 766.302(7). Christina Shamas, M.D., provided obstetrical services in the course of labor, delivery, and resuscitation in the immediate post-delivery period. Dr. Shamas was a “participating physician” as defined in section 766.302(7).
The Issue The issues are whether Petitioner overpaid Medicaid reimbursements to Respondent for inpatient hospital services due to the lack of medical necessity for such services and, if so, the amount of the overpayment.
Findings Of Fact Respondent is a 226-bed community hospital in Sanford. It is an acute-care hospital with an emergency department. At all material times, Respondent has been an authorized Medicaid provider. For inpatient services, Respondent receives, under Medicaid, an all-inclusive per diem rate for all goods and services provided during a 24-hour period, less any third-party payments. Petitioner is the state agency responsible for the regulation of the Medicaid program in Florida. Petitioner is required to perform Medicaid audits of providers and to recover any overpayments. Pursuant to this authority, Petitioner conducted an audit of Respondent for the period from January 1, 2001, through March 31, 2002. Pursuant to its procedures, Petitioner duly informed Respondent of the audit, obtained from Respondent relevant medical and hospital records, issued a Provisional Agency Audit Report on January 24, 2006, obtained additional information from Respondent pertinent to the provisional findings, and issued a Final Agency Audit Report on October 19, 2006, which claimed a total overpayment of $286,357.54 based on Medicaid payments made to Respondent on behalf of 35 different recipients. (The report indicates two separate denials for each of four recipients, so 39 total transactions are listed.) The dispute in this case concerns the medical necessity of the inpatient hospitalization of each recipient. The Florida Medicaid Hospital Services Coverage and Limitations Handbook (Handbook) states that the purpose of the Medicaid program is "to provide medically necessary inpatient and outpatient services to recipients in the hospital." Handbook, page 1-1. This case involves paid claims for inpatient, not outpatient, services. The Handbook defines inpatient services as those services "rendered to recipients who are admitted to a hospital and are expected to stay at least 24 hours and occupy a bed, even though a bed is not actually utilized because the recipient is discharged or transferred to another hospital." Handbook, page 1-1. The Handbook provides that the day of admission is covered, but the day of discharge is not covered, unless it is also the day of admission. Handbook, page 2-22. The Handbook defines "grace days" as non-medically necessary days following the day of formal discharge when the recipient continues to occupy a hospital bed until an outside facility or residence can be found. These days are not reimbursable by Medicaid except for children under 21 years of age on "Department of Children and Families hold . . .." Medicaid will pay up to 48 hours of inpatient stay beyond the formal discharge day for these children while an alternative placement is located. The Handbook incorporates the limitation of medical necessity as follows: Medicaid reimburses for services that are determined medically necessary, do not duplicate another provider's service, and are: individualized, specific, consistent with symptoms or confirmed diagnosis of the illness or injury under treatment, and not in excess of the patient's needs; not experimental or investigational; reflective of the level of services that can be safely furnished, and for which no equally effective and more conservative or less costly treatment is available statewide; furnished in a manner not primarily intended for the convenience of the recipient, the recipient's caretaker, or the provider. The fact that a provider has prescribed, recommended, or approved medical or allied care, goods, or services does not, in itself, make such care, goods or service medically necessary or a covered service. Note: See Appendix D, Glossary, in the Florida Medicaid Provider Reimbursement Handbook, UB-92, for the definition of medically necessary. Handbook, pages 2-1 to 2-2. The Florida Medicaid Provider Reimbursement Handbook, UB-92, Appendix D, defines "medically necessary" as follows: Means that the medical or allied care, goods, or services furnished or ordered must: Meet the following conditions: Be necessary to protect life, to prevent significant illness or significant disability, or to alleviate severe pain; Be individualized, specific, and consistent with symptoms or confirmed diagnosis of the illness or injury under treatment, and not in excess of the patient's needs; Be consistent with generally accepted professional medical standards as determined by the Medicaid program, and not experimental or investigational; Be reflective of the level of service that can be safely furnished, and for which no equally effective and more conservative or less costly treatment is available; statewide; and Be furnished in a manner that is not primarily intended for the convenience of the recipient, the recipient's caretaker, or the provider. "Medically necessary" or "medical necessity" for inpatient hospital services requires that those services furnished in a hospital on an inpatient basis could not, consistent with the provisions of appropriate medical care, be effectively furnished more economically on an outpatient basis or in an inpatient facility of a different type. The fact that a provider has prescribed, recommended, or approved medical or allied care, goods, or services does not, in itself, make such care, goods or services medically necessary or a medical necessity or a covered service. The Florida Medicaid Provider Reimbursement Handbook, UB-92, Appendix D, page D-10. E. A. was admitted on January 6, 2001. Petitioner does not contest the medical necessity of inpatient services to treat E. A.'s acute exacerbation of chronic bronchitis from January 6-8. The parties' dispute concerns the medical necessity of the remaining ten days of E. A.'s hospitalization. (All calculations of duration of hospitalizations omit the day of discharge, pursuant to the above-cited provision from the Handbook. In this case, for instance, E. A. was discharged on January 19.) E. A., a 60-year-old male, presented to the emergency department with shortness of breath and a history of chronic obstructive pulmonary disease (COPD), emphysema, and hypertension. He had been unable to eat for the preceding four days due to respiratory distress. At the time of his admission, E. A. had been living for a short while with his sister, who was suffering from cancer. His relevant history included a shotgun wound to the left lung 30 years earlier. Respondent states in its proposed recommended order that E. A.'s chest X-rays showed acute infiltrate demonstrating pneumonia, although the discharge summary reveals that chest X-rays fail to reveal this condition, but acknowledged that sputum grain stains revealed a polymicrobial infection. More to the point, the X-ray reports dated January 6 and 8 note: "no focal infiltrate." However, the discharge summary described E. A.'s prognosis as poor because he was in "end-stage lung disease." In the emergency department, after treatment with bronchodilators, E. A.'s oxygen saturation rate was only 87 percent--not 94-100 percent, as mistakenly stated by Petitioner's expert, Dr. Ellen Silkes, an otolaryngologist whose practice is largely limited to outpatients. This low rate of oxygen saturation evidences hypoxia. E. A.'s arterial blood gases bore a pH of 7.28, evidencing, on the facts of this case respiratory acidosis, which results from excessive retained carbon dioxide due to poor lung function. E. A. was started on Albuterol and Atrovent by nebulizer at four-hour intervals, as well as a corticosteroid intravenously every six hours to relieve the swelling in the lungs. He received oxygen by nasal cannula. On January 10, the physician's notes state that E. A. still suffered from "severe COPD" secondary to smoking with bronchospasms. According to the notes, the first day that E. A. showed any improvement was January 12. On January 14 and 16, E. A. was still retaining excessive carbon dioxide and remained hypoxic, but showed some improvement by January 16 in terms of arterial blood gases. The physician's note for January 17 states that E. A. could be discharged as soon as arrangements for home health care were completed. E. A.'s hospitalization was medically necessary from January 6-17. His hospitalization after January 17 was not medically necessary. Petitioner improperly denied January 9-16, given that the day of discharge is excluded. Thus, for E. A., Petitioner should have denied two days, not all ten days. A. A. was admitted on June 19, 2001. Petitioner does not contest the medical necessity of inpatient services to treat A. A.'s gastrointestinal bleeding from June 19-20. The parties' dispute concerns the medical necessity of the remaining 12 days of A. A.'s hospitalization. (Some of Petitioner's calculations are incorrect. For instance, in this case, Petitioner does not deny July 2-5, even though, undoubtedly, its position as to the lack of medical necessity as to the earlier dates would mandate the same position as to the later dates. This recommended order does not disturb Petitioner's implicit acceptance of the medical necessity of any dates, even when it appears to be in error.) A. A., a 51-year-old male, presented to the emergency department with abdominal pain, diarrhea, and black tarry stools. His recent history included bloody vomit and a diagnosis, a few months earlier, of a pulmonary embolism. A. A. had discontinued taking Coumadin, a blood thinner, due to nosebleeds. A. A. had been diagnosed with AIDS in 1998 and had lost 30 pounds in one month. At admission, A. A.'s hemoglobin and hematocrit levels were critically low at 5.1 and 15.5, respectively, and remained critically low the following day when, after A. A. received transfusions of two units of packed red blood cells, his hemoglobin and hematocrit levels were only 6.8 and 20.0, respectively. Dr. Silkes denied the hospitalization after June 20 because an upper gastrointestinal endoscopy revealed, on June 19, no acute bleeding, and a bleeding scan the following day was negative. However, according to the physician's notes, A. A. was continuing to experience diarrhea on June 20, even though he was starting to feel better. The course of treatment of A. A. was complicated by his recent history of pulmonary embolism and his inability to report an accurate history. By June 21, A. A.'s severe anemia had been corrected, but he was diagnosed with candida, an opportunistic fungal infection common in AIDS patients. This diagnosis would explain the vomiting of blood. Generally, the treatment dilemma posed by A. A. was that efforts to increase his clotting time to stop the bleeding raised the risk of pulmonary embolism. The physicians debated whether to install a Greenfield filter to stop the passage of a blood clot. The filter is introduced under X-ray control through the femoral vein into the inferior vena cava, where it is anchored, so that it allows the passage of blood, but not the passage of a blood clot. But the Greenfield filter is contraindicated in the presence of A. A.'s fever of 101 degrees and elevated white blood counts. Physicians introduced Coumadin to minimize the risk of clots, but A. A.'s low platelet count required the discontinuation of Coumadin on June 30. A. A.'s International Normalization Ratio (INR) was 4.2, which is well above the range of 2.0-3.0 and thus indicative of the fact that A. A.'s blood was taking too long to clot. The standard of care in 2001 precluded safe outpatient management of a complicated patient such as A. A., given his twin risks of pulmonary embolism and bleeding, either of which could result in his death. A. A.'s Coumadin could not safely have been adjusted on an outpatient basis. The physicians restarted the Coumadin on June 24 and doubled its dosage the following day. As they were working on adjusting the blood thinner, though, A. A. continued to suffer nightly fevers of 103 degrees, and the physicians needed to monitor him closely for the next week for this reason too. On June 28, A. A. reported that he was feeling better, but the physicians needed to monitor him for a recent reduction in his Coumadin dosage. A. A. was reported as "alert and comfortable" on July 2. A. A.'s hospitalization was medically necessary from June 19 through at least July 2. Petitioner improperly denied all ten days of this hospitalization. T. B. was admitted on May 15, 2001. Petitioner does not contest the medical necessity of inpatient services to treat T. B.'s esophageal cancer and tuberculosis from May 15-17 and The parties' dispute concerns the medical necessity of the ten days that Dr. Silkes denied of the remaining 14 days of T. B.'s hospitalization. (It is unclear why Petitioner denied only ten days when Dr. Silkes denied May 18-20 and May 22-June 1--a total of 14 days, or 13 days exclusive of the day of discharge. But, as noted above, in cases such as this, the recommended order will consider only whether up to ten days within this period are allowable as medically necessary.) T. B., a 47-year-old male, presented to the emergency department with difficulty swallowing. He had visited a physician in February 2001 with the same complaint, and the physician had recommended an upper gastrointestinal series. Due to financial constraints, T. B. did not undergo this procedure until late April, when he was found to have a high-grade obstruction consistent with a tumor. T. B.'s recent history included the loss of 25 pounds. An endoscopy with biopsy performed on May 16 revealed a high-grade carcinoma of the esophagus. The physician planned to commence preoperative chemotherapy and radiation therapy to shrink the lesion, but, based on sputum collected on May 18, it was discovered that T. B. had mycobacterium tuberculosis. Physicians had suspected the tuberculosis from the time of admission when they placed T. B. in a negative airflow isolation room. Treatment of the tuberculosis necessarily preceded the preoperative chemotherapy recommended for T. B.'s carcinoma. The sputum sample revealed rare acid-fast bacilli, for which the standard of care in 2001 typically required two to three weeks of treatment before isolation precautions could be discontinued. T. B. remained in isolation at least through May 31. In addition, T. B. suffered significant pain from the carcinoma. By May 23, he was on patient-controlled analgesia in the form of a morphine pump, which is not available outside of an acute-care hospital. T. B.'s hospitalization was medically necessary from May 15 through at least June 1. Petitioner improperly denied all ten days of this hospitalization that it denied. R. B. was admitted on December 3, 2001. Petitioner does not contest the medical necessity of inpatient services to treat R. B.'s respiratory failure from December 3, 2001, to January 2, 2002, and January 8, 2002. Based on Petitioner's prehearing stipulation, the dispute concerns only seven days' hospitalization. R. B., a 59-year-old female, presented to the emergency department with acute respiratory distress and respiratory failure. She was immediately intubated. Her family insisted upon aggressive treatment of, among other things, her bilateral pneumonia caused by a virulent staph infection. R. B. required a tracheotomy on December 20 due to the difficulty in weaning her from the ventilator. She required the placement of a percutaneous endoscopic gastrostomy (PEG) tube on January 1. The discharge summary describes R. B. as "very frail and fragile" and her hospitalization as "very prolonged and complicated." On December 23, when R. B. was finally weaned from the ventilator, her family agreed to a do-not-resuscitate (DNR) code for her. The dispute arises from an incident on January 3 when R. B. fell when trying to get out of bed. Her mental status deteriorated, probably due to malignant disease. Physicians ruled out sepsis in the bloodstream, but X-rays revealed multiple nodules in the lung and liver. On January 8, a CT- guided lung biopsy of one of the nodules confirmed malignant disease. Two days later, the physician stated that a consultation with hospice was indicated. Upon the agreement of the family, R. B. was discharged to her home under hospice care on January 12. Dr. Silkes is substantially correct in her opinion. The diagnostic work after January 2 only supported the poor prognosis that had become obvious to R. B.'s family ten days earlier and certainly was not palliative in nature. R. B.'s hospitalization after January 2, 2002, was not medically necessary--except for January 8, which Dr. Silkes initially conceded, and an additional two days, which Petitioner conceded in its prehearing stipulation. Petitioner properly denied seven days of this hospitalization. J. B. was admitted on January 5, 2002. Petitioner does not contest a 23-hour observation on January 5, but this would generate a reimbursement considerably smaller than that sought by Respondent for inpatient services for that day, so Petitioner has essentially denied the entire hospitalization, which consists of 16 days. J. B., a 59-year-old male, presented to the emergency department with shortness of breath and atrial fibrillation with fast ventricular rate. He had been diabetic for 25 years. He had been laid off from construction work in August 2001, and had arthritic knees which prevented his return to work. Since losing his job, J. B. had been feeling poorly and had lost 20 pounds. J. B.'s pulse at the time of his arrival was 165, and it dropped to 105 within his first six hours at the hospital. J. B.'s relevant history included congestive heart failure, edema of the extremities, and nocturnal dyspnea. A chest X-ray on the day of admission revealed a dense mass in the left lobe. Physicians started a calcium channel blocker to regulate J. B.'s rapid heart beat and a diuretic to eliminate his excess fluids and swelling. J. B. was feeling much better by January 7, as the physicians had controlled his rapid heart beat. On that day, J. B. underwent a stress test, which was negative. However, a CT scan performed on January 8 and reported the following day revealed a left hilum mass that proved to be advanced carcinoma. The physicians decided that J. B. needed a bronchoscopy to biopsy the lung mass and a thoracentesis, in which a needle is inserted between the ribs to extract fluid for the purpose of determining the fluid's source. However, J. B.'s atrial fibrillation complicated their plans. On January 8, J. B. remained in atrial fibrillation, and the physicians were considering starting him on Coumadin because patients with atrial fibrillation are at high risk of clotting due to the poor expulsion of blood into the ventricle. Introduction of this blood-thinning agent before other invasive procedures requires first that the physicians stabilize the patient. This dilemma delayed the introduction of the blood- thinning agent and prevented treating J. B. as an outpatient. Once stabilized on Coumadin, J. B. underwent the two diagnostic procedures on January 11. They revealed that he was suffering from stage IV squamous cell carcinoma, according to a physician's report dictated on January 14 and transcribed the following day. The physician ordered additional CT scans to determine the extent of the metastatic disease before deciding on a course of treatment. A whole body bone scan was performed on January 15 and was essentially negative. However, the carcinoma had metastasized to the left hilum and, by report dated January 15, a physician noted that J. B. would not benefit from surgery, chemotherapy, or radiation, although palliative radiation could offer him some relief. An IV port for chemotherapy (not radiation) was placed on January 16--not January 6, as noted by Dr. Silkes in her report. Coumadin had been discontinued in advance of the procedure and resumed on the day of the procedure, but required adjustment for the next several days, as J. B.'s INR was too low, indicative of excessive clotting. Although the administration of the chemotherapy through the IV port could have been done on an outpatient basis, J. B. was comfortable at all times after January 15, and with no effective treatment possible, his hospitalization remained medically necessary until the physicians were able to adjust his Coumadin so that his INR reached the normal range. J. B.'s hospitalization was medically necessary from January 5 through January 22, on which date he was discharged. Petitioner improperly denied the 16 days of inpatient services. N. C. was admitted on February 8, 2002. Petitioner does not contest the medical necessity of inpatient services to treat N. C.'s intracranial hemorrhage from February 8-10. The parties' dispute concerns the medical necessity of the remaining 21 days of N. C.'s hospitalization. N. C., a 40-year-old female, presented to the emergency department with a complaint of passing out and no significant medical history. N. C. was a single mother of a developmentally disabled child. Her father resided in a nursing home and suffered from dementia, so her siblings were her decisionmakers concerning care. At admission, N. C. was already in a vegetative state, suffering from a massive intracranial hemorrhage. Her blood pressure was 213/107. She was immediately intubated and given Mannitol to reduce intracranial pressure and Dilantin to prevent seizures. On February 8, a neurologist evaluated N. C. and found her a poor candidate for surgery to evacuate the intracranial hematoma due to the likelihood of extensive consequent neurological deficits. The neurologist discussed the possibilities and the "extremely poor" prognosis with the siblings, who decided not to pursue surgery and instead allow N. C. to be "managed medically." The physicians asked the siblings to consider a DNR code for N. C. N. C. made no meaningful progress in the following days. Respondent was unable to contact her siblings until February 19, and they asked for two days within which to make the decision whether to place N. C. on a DNR code. On February 22, they decided to place N. C. on a DNR code and withdraw the ventilator. Three days later, the physician discussed with the siblings the possibility of placement in a nursing home. Three days after this discussion, the siblings agreed on inpatient hospice care for N. C. On March 4, IV fluids and medications and the nasogastric feeding tube were withdrawn, and N. C. was transferred to a nursing home under hospice care. N. C.'s hospitalization was medically necessary through February 22 because a nursing home cannot accept a patient on a ventilator, N. C.'s course following the stroke could reasonably be observed for a couple of weeks to determine if improvement--however unlikely--might take place, and the siblings reasonably required this long to make this difficult decision. From February 23 through discharge, the inpatient services provided N. C. were no longer medically necessary, so Petitioner properly denied nine days of the 21 days that it denied for this recipient. N. Ch. was admitted on May 23, 2001. Petitioner does not contest the medical necessity of inpatient services to treat N. Ch.'s cellulitus and osteomyelitis from May 23 to June 24. The parties' dispute concerns the medical necessity of the remaining 46 days of N. Ch.'s hospitalization. N. Ch., a 38-year-old male, presented to the emergency department with wounds to both legs and loss of feeling in both feet and a history of fractures to both tibias 20 years ago followed by osteomyelitis four years ago. Despite considerable hospital treatment to both legs, consisting of antibiotics, hyperbaric oxygen, debridement, and skin grafts, drainage of the wounds persisted. Four grainy wounds on both legs penetrated to the bone, and N. Ch. had suffered some bony damage from the persistence of these infected wounds. A physician performed a surgical debridement of the wounds on May 26, and a vacuum- assisted closure device was applied to the wound on the following day. This device produces negative air pressure to stimulate a chemical change in the tissues to enhance the migration of new blood vessels and granulation tissue over the area of the wound. The pump was changed often. On June 22, N. Ch. underwent a second debridement and a pump was reapplied to the wounds on June 24. The issue in this case involves the use of hyperbaric oxygen treatment on an inpatient basis. On June 7, a physician reasonably recommended 20, 90-minute hyperbaric oxygen treatments. The treatments, which accelerate wound healing, began the next day. Dr. Silkes correctly finds no medical necessity after N. Ch. became stable after the second debridement. Although he later suffered some fever, apparently from his reaction to an antibiotic, and gastroesophagael reflux, as well as some adverse reactions to IV and peripherally inserted central catheter lines, N. Ch. could have been managed as an outpatient after June 24. Nothing suggests that the vacuum-`assisted closure device requires hospitalization, and hyperbaric oxygen treatment clearly does not require hospitalization. Respondent contends that inpatient services remained medically necessary after June 24 because Medicaid would not pay for hyperbaric oxygen treatment on an outpatient basis. Medical necessity is driven by medical, not legal, considerations. If the sole reason for hospitalization is to obtain a medically necessary good or service that Respondent has restricted to the inpatient setting, then the provider community improperly circumvents Petitioner's restriction. If there is no other reason to continue to hospitalize a recipient, such as N. Ch., the decision to do so in order to obtain for him a concededly medically necessary service--that does not otherwise require hospitalization--is unwarranted. Petitioner properly denied the 46 days of inpatient services for N. Ch. after June 24. J. C. was admitted on February 24, 2002. Petitioner does not contest the medical necessity of inpatient services to treat J. C.'s coronary artery disease and lymphoma on February 24 and March 3-8. In its proposed recommended order, Respondent does not contest Petitioner's denial of the "last two days," which apparently are March 9-10. The parties' dispute concerns the medical necessity of the remaining six days of hospitalization from February 25 through March 2. J. C., a 61-year-old female, presented to the emergency department with worsening chest pain over the past two weeks and a history of coronary artery disease. She also had an undiagnosed mass on her neck. She had previously failed outpatient treatment and was admitted to the hospital. Two weeks earlier, J. C. was to have had an outpatient biopsy of the neck mass, but the anesthesiologist declined to administer anesthesia until her unstable angina was addressed. J. C. went to her primary care physician, who referred her to a cardiologist, but, prior to seeing him, J. C. went to the emergency department. On February 25, the physician's notes indicate that J. C. was stable and without chest pain. The cardiologist performed a cardiac catheterization on February 26 and found 100 percent blockage of the left anterior descending artery, 80 percent blockage of the proximal circumflex, and other narrowings that were not amenable to angioplasty and stenting, so he recommended coronary artery bypass grafting. Heart surgery could not proceed until physicians learned the nature of the neck mass. A biopsy was performed on February 28, which revealed B-cell malignant lymphoma. The oncologist preferred to commence chemotherapy after the bypass operation, so this was performed on March 3. J. C. was extubated on March 4, but developed acute respiratory distress on March 5 and required a transfusion the following day. However, Dr. Silkes is correct in finding the hospitalization from February 25 through March 2 medically unnecessary. The procedures performed during this period could have been done on an outpatient basis. The record does not support Respondent's argument that her unstable angina required inpatient management. Petitioner properly denied these six days of inpatient services. R. LaB. was admitted on April 2, 2001. The parties' dispute concerns the medical necessity of the last day of inpatient service on April 12. This is the first case considered in this recommended order handled by Dr. Alan Yesner, an internist whose practice is more evenly divided between inpatients and outpatients than is Dr. Silkes' practice. R. LaB., a 47-year-old female, presented to the emergency department with abdominal pain of two days' duration and a history of COPD, hypertension, and diabetes. She was rushed to abdominal surgery to reduce an incarcerated hernia. The surgery was long. R. LaB. suffered respiratory failure and required intubation. Dr. Yesner is correct in opining that R. LaB.'s hospitalization after April 11 was not medical necessary. She was stable and on appropriate medication, so Petitioner properly denied one day of inpatient service for R. LaB. J. L. was admitted on June 12, 2001. The parties' dispute concerns the medical necessity of the seven days of inpatient services. J. L., a 47-year-old male, presented to the emergency department with complaints of a gradual increase of abdominal girth and was found to have blood in his stool. Lab work indicated an elevated INR, elevated bilirubin, and bacteria in his urine. The physician concluded that J. L. suffered from primary biliary cirrhosis, for which he had been treated since at least 1998. J. L. admitted that he had become noncompliant with his medication after a divorce. A CT scan revealed a probable stone obstructing the right ureter, causing urine to back up and flood the right kidney. A successful laser lithotripsy was performed on June 17 with the complete fragmentation of the stone and the installation of a stent, which would facilitate drainage, to be removed a few days later. J. L. tolerated the procedure well, and on the next day he reported feeling better without any pain in his flank. Dr. Yesner notes the "late schedule" of the lithotripsy, but Respondent did not have a lithotripter in 2001 and had to schedule it for use at the hospital. The hospitalization was medically necessary through June 17 due to the pain, advanced kidney disease, and potential kidney problems presented by the blockage, prior to its surgical fragmentation. Petitioner should have denied two days, not seven days. C. M. was admitted on April 2, 2001. Petitioner does not contest the medical necessity of admission for 23-hour observation only on April 2 for end-stage sarcoidosis, pneumonia, and gastrointestinal bleeding. The parties' dispute concerns the medical necessity of the remaining 31 days of C. M.'s hospitalization, which concluded with her death. C. M., a 55-year-old female, presented to the emergency department with shortness of breath and weakness. She is a Jehovah's Witness, so she declines blood transfusions on religious grounds. By April 4, C. M.'s blood gases, although not within normal ranges, were out of critical ranges. C. M. suffered respiratory failure and required intubation on April 16. Her hemoglobin gradually dropped after this, but treatment was limited to iron and vitamins due to the refusal of the patient to accept a blood transfusion. This treatment was unsuccessful. The family supported C. M.'s decision not to accept a blood transfusion, but insisted on full, aggressive treatment, including CPR. C. M. went into cardiac arrest on May 3 and CPR failed to revive her. Dr. Silkes states that Respondent should have arranged for hospice care during the first day of hospitalization. C. M. was not then on a ventilator, so a hospice would not have objected to taking C. M. on that ground, but her respiration was critically impaired for the first three days of her hospitalization and her prognosis was not such as to render hospital care medically unnecessary. It was medically necessary to stabilize C. M.'s respiration during these first three days, but her hemoglobin issues could have been addressed by home health care for the next 11 days. The medical necessity of inpatient services resumes, though, after C. M.'s respiratory failure of April 16 and continues to the end of her hospitalization. The first three days of inpatient services were medically necessary, the next 11 days of inpatient services were not medically necessary, and the last 17 days of inpatient services were medically necessary, so Petitioner should have denied 11 days, not 31 days. M. M. was admitted on March 3, 2001. Petitioner does not contest the medical necessity of inpatient services to treat acute asthmatic bronchitis with a history of coronary artery bypass graft, asthma, sarcoidosis of the lung, and diabetes from March 3-12, which Petitioner later extended to March 13. The parties' dispute concerns the medical necessity of the remaining three days of M. M.'s hospitalization, which Respondent's expert frankly conceded was difficult to justify. As Dr. Yesner noted, M. M. was stabilized on oral medication by March 11, and he allowed a couple of additional days to monitor her. M. M. experienced hypoglycemia on March 16, but this is a condition that, according to Dr. Yesner, is not unusual with the Prednisone that M. M. was taking, and hypoglycemia is typically managed on an outpatient basis. Petitioner properly denied the last three days of M. M.'s hospitalization. J. P. S. was admitted on January 4, 2001. Petitioner does not contest the medical necessity of inpatient services to treat J. P. S.'s obstruction of the common bile duct. The parties' dispute concerns the medical necessity of the last three days of his hospitalization. J. P. S., a 54-year-old male, presented to the emergency department with severe jaundice and a history of diabetes, congestive heart failure, and triple coronary artery bypass graft performed in 1997, although he displayed no significant cardiac abnormalities during this hospitalization. During the initial examination, J. P. S. went into respiratory arrest and required intubation. The gastroenterologist found J. P. S. ready for discharge, from a gastroenterological perspective, on January 13. but J. P. S. immediately developed COPD symptoms, including shortness of breath and edema. According to the physician notes, J. P. S. was sufficiently stable for discharge on January 15, but a note for the next day says to hold the discharge pending cardiac evaluation. Respondent discharged J. P. S. three days later, after physicians could monitor the level of Digoxin to ensure that J. P. S. was safe for discharge. P. S.'s entire hospitalization was medically necessary. Petitioner improperly denied the last three days of inpatient services. J. P. was admitted on December 8, 2001. Petitioner does not contest the medical necessity of services to treat J. P.'s fever from December 8-12. The parties' dispute concerns the medical necessity of the remaining 14 days of J. P.'s hospitalization. J. P., a 27-year-old male, presented to the emergency department with high-grade fevers and severe headaches and a history of AIDS. Dr. Silkes approved the treatment of the fever until it ended on December 12. The fever was likely caused by J. P.'s toxoplasmosis of the central nervous system. This is an opportunistic condition not unusual in immunocompromised patients. Candida fungal infection likely caused J. P.'s complaints of pain on swallowing, as this too is an opportunistic condition. Additionally, a blood culture revealed a staph infection. Through December 18, J. P. was continuing to experience fevers of up to 101 degrees. At the same time, it was necessary to address the toxoplasmosis before it extended to other organs. This required the sequential administration of IV antibiotics and careful, continual monitoring of the patient for his clinical response to treatment. On December 20, J. P. underwent a bone marrow biopsy to rule out the extension of toxoplasmosis in the bone marrow or the presence of tuberculosis. This test was negative, which was a precondition for discharge. The pathology report was "received" on December 21, but not "printed" until December 27. However, J. P. did not complete his IV administration of Doxycycline until December 23, when the medical necessity for his inpatient services ended. Petitioner should have denied three days, not 14 days. W. P. was admitted on June 18, 2001. Dr. Silkes would allow only a 23-hour observation on the day of admission for the treatment of lung cancer and tuberculosis. The parties' dispute concerns the medical necessity of 13 days of his hospitalization from June 18 through July 1 (even though he was not discharged until July 13). W. P., a 59-year-old male, presented to the emergency department with severe coughing up of blood and a recent loss of 40 pounds. A chest X-ray at admission revealed a large mass in the upper left lobe of the lungs. Lab work suggestive of anemia correlated with a malignancy as its source. Sputum to test for acid fast bacillus was taken, and a consult was immediately arranged with a pulmonary specialist to consider a bronchoscopy and to take a biopsy. A CT scan of the chest on June 18 revealed abnormal soft tissue density filling the right upper lobe, two tumors, and numerous nodes. The bronchoscopy on June 19 revealed 80 percent obstruction of the right main bronchus secondary to an endobronchial lesion and 100 percent obstruction of the right upper lobe. A biopsy of the right mainstem bronchus revealed a squamous cell carcinoma. A physician noted in his consultation report that W. P. was to complete his metastatic survey on the day of the report--June 22--after which they would discuss palliative treatment. The report states that the patient understands that he will unlikely live more than six months. Subsequently, acid fast bacillus, which had originally not been detected, was found, so W. P. was placed in isolation on June 26. He had been experiencing elevated white blood counts and fevers. He was placed on antituberculosis treatment, which, as noted above, typically takes two or three weeks until the patient can be removed from isolation. July 10 was W. P.'s first day without fever. On this date, Respondent sent his records to the Health Department to facilitate a transfer to a tuberculosis hospital. He was discharged on July 13. W. P.'s entire hospitalization was medically necessary. Petitioner should not have denied any of the 13 days that it denied. M. Pr. was admitted on December 18, 2001. Petitioner does not contest the medical necessity of inpatient services to treat M. Pr.'s coronary artery disease from December 18-27. The parties' dispute concerns the medical necessity of the remaining seven days of M. Pr.'s hospitalization. M. Pr., a 58-year-old male, presented to the emergency department with a recent cardiovascular accident while out of state. A cardiac catheterization revealed severe triple vessel coronary artery disease. On December 19, M. Pr. underwent a four-vessel bypass. Post-operatively, however, M. Pr. fell while on the commode. The dispute in this case arises due to the unavailability of rehabilitation facilities that would take M. Pr. after his fall. He was suitable for discharge on December 28, but no facility could be found to receive him. These are "grace days," as noted in the Handbook and are available, on a limited basis, for persons under 21 years of age, but, by negative implication, are unavailable for adults. Thus, medical necessity dictated that Respondent discharge M. Pr. on December 27, so the inpatient services are not reimbursable after December 28, given that the day of discharge is not allowable. Dr. Silkes' determination was correct in this case. Petitioner properly denied seven days' inpatient services for M. Pr. A. R. was admitted on December 30, 2001. Petitioner has denied the entire 14 days of A. R.'s hospitalization, although Dr. Silkes approved one day's inpatient services, on the day of admission, for the treatment of ovarian cancer. A. R., a 63-year-old female, presented to the emergency department with vomiting on the day of admission, progressive abdominal distension, anorexia, weight loss over the past month, and a 15-year history of bronchial asthma. A CT scan of A. R.'s thorax at the time of admission revealed a large collection of fluid in the abdominal cavity. At this time, a physician removed 4.5 liters of fluid from the cavity, and A. R., not surprisingly, began to feel much better. A report on January 3--delayed probably due to the holidays-- indicated the presence of scattered malignant cells in the withdrawn fluid compatible with carcinoma. Metastatic ovarian cancer was subsequently confirmed. A. R.'s case was complicated by the withdrawal of this large volume of fluids, which required continual monitoring of her electrolytes, and the sudden exacerbation of her dementia on January 2, which would impede outpatient services, as well as the initiation of chemotherapy. The dementia, which had been progressive for the past six months, was likely a reaction to the carcinoma. By January 11, a physician recommended hospice placement given A. R.'s incurable tumor. A. R.'s daughter agreed on this day to hospice placement. This is the day that medical necessity for inpatient services ended. Petitioners should have denied three days, not 14 days. The remaining days were medically necessary. E. S. was admitted on May 4, 2001. Petitioner does not contest the medical necessity of inpatient services to treat E. S.'s pancreatitis and multisystem failure from May 4-23. The parties' dispute concerns the medical necessity of the remaining 24 days of her hospitalization, which ended with her death. E. S., a 64-year-old female, presented to the emergency department with nausea and abdominal pain and a history of hypertension and abuse of alcohol and tobacco. She was found to have elevated pancreatic enzymes. On May 8, E. S. underwent a laparoscopic removal of her gallbladder, which she tolerated well, but soon afterwards suffered respiratory failure. E. S. was then placed on a ventilator. Problems with malnourishment and then kidney failure precluded a successful weaning her off the ventilator. On May 23, the family agreed to a DNR code. May 23 marks the last day that Dr. Silkes found that E. S.'s hospitalization was medically necessary. Care after this date was entirely supportive and not medically necessary; however, no hospice or skilled nursing facility would take E. S. because she could not be weaned off the ventilator. The unavailability of an alternative, less costly setting does not automatically render the inpatient care of a recipient medically necessary. The circumstances dictate whether inpatient services to such a patient are medically necessary. Here, it is impossible to find that services after May 23 were medically necessary. Dr. Silkes was correct in her opinion. Petitioner properly denied all 24 days of inpatient services for E. S. D. S. was admitted on March 24, 2001. Petitioner does not contest the medical necessity of inpatient services to treat D. S.'s osteomyelitis of the right foot from March 24-25 and March 30-April 10. (Originally, Dr. Silkes allowed only March 24-25 and March 30-April 6, but, on February 7, 2007, she revised her opinion to allow the additional four days to April 10.) In its prehearing statement, Petitioner conceded that only three of the original ten denied days remained at issue, as it was agreeing that an additional seven days were medically necessary. The parties' dispute concerns the medical necessity of the remaining three days, although it is not clear what three days Petitioner is contesting. D. S., a 57-year-old female, presented at the emergency department with a "hole in the right foot" and a history of diabetes. She dropped a can of juice on her foot on January 1, and the foot had become progressively infected since that time. On the day of admission, she underwent surgery for the removal of fourth and fifth metatarsal bones and toes of the right foot. She did not heal properly and required followup surgery on April 7 to trim some of the necrotic flap, as the physicians considered the possibility of a below-knee amputation. On April 13, the surgeon probed the wound, found no hidden pockets, and discharged D. S. Regardless what three days that Petitioner continues to find were not medically necessary, the entire hospitalization was medically necessary. J. W. was admitted on August 20, 2001. Petitioner does not contest the medical necessity of inpatient services to treat J. W.'s multiple organ failure from August 20 to September 14. The parties' dispute concerns the medical necessity of the remaining two days of J. W.'s hospitalization, at which time he died. J. W., a 48-year-old male, presented to the emergency department with a two or three-day history of progressive congestive heart failure with pulmonary edema, atypical chest pain, and increasing abdominal girth. His history included nonischemic cardiomyopathy with minimal coronary artery disease, chronic alcohol abuse, pulmonary hypertension, chronic atrial fibrillation requiring anticoagulation therapy, hepatitis B and C, chronic renal insufficiency, and chronic congestive heart failure with multiple hospitalizations. On admission, his INR was 6.6, indicative of very slow clotting. Despite the care of numerous consultants, J. W. suffered increased respiratory failure on September 5, at which time he was intubated. He received a Greenfield filter on September 7 to prevent further pulmonary clots. Starting September 10, and continuing everyday thereafter, J. W. required dialysis due to renal failure. J. W. was on total parenteral feeding as of September 14. The family, whose availability had been a problem, agreed to a DNR code on September 17. Respondent claims in its proposed recommended order that a DNR code is a precondition to hospice care, but no competent evidence establishes this fact. Dr. Silkes and Petitioner properly denied the last two days because they were not medically necessary. M. W. was admitted on June 10, 2001. Petitioner does not contest the medical necessity of inpatient services to treat M. W.'s ventricular fibrillation and complications from June 10- The parties' dispute concerns the medical necessity of the remaining seven days of M. W.'s hospitalization. M. W., a 31-year-old male, presented to the emergency department with cardiopulmonary arrest after his wife found him slumped on the sofa, seizing. On arrival, he was found to be in ventricular fibrillation, and he was intubated. Physicians restored a normal rhythm, but M. W. suffered a seizure in the emergency department, so he was given large doses of Dilantin. M. W. had suffered brain damage from cerebral anoxia. M. W. was extubated on June 13, and his breathing remained stable. He remained in normal sinus rhythm. M. W. began to receive Librium on June 13 to sedate him. The cardiologist proposed a cardiac catheterization, but M. W. refused. An EKG on June 15 found a conduction defect in M. W.'s heart that was suggestive of Wolff Parkinson White syndrome. The cardiologist then determined, on June 16, that M. W. required an electrophysiology study to rule out Wolff Parkinson White syndrome. In 2001, Respondent lacked the equipment to perform this study, for which M. W. remained too confused to participate on June 18 anyhow. Physicians continued to monitor M. W.'s cardiac rhythm, and, when a bed opened at Florida Hospital, Orlando, which had the necessary equipment, Respondent promptly transferred M. W. on June 22. During the transfer, the cardiac monitor continued to check M. W.'s rhythm due to the risk of another cardiac incident until the underlying cardiac abnormality was assessed and treated. Petitioner improperly denied the final seven days of M. W.'s hospitalization. M. W. had suffered a serious cardiac event. Physicians had not yet ruled out all possible reasons for the event and needed to address a promising possibility of Wolff Parkinson White syndrome, so M. W. remained at risk for another event. He was confused from the brain damage. All of these factors militate in favor of finding that the remaining seven days of inpatient services were medically necessary. E. A. $1666.62 R. B. $5703.18 N. C. $7332.66 N. Ch. $38,332.26 J. C. $4888.44 R. LaB. $833.31 J. L. $1666.62 C. M. $9166.41 M. M. $2499.93 The total overpayment is $104,309.97, which breaks down as follows: J. P. $2444.22 M. Pr. $5703.18 A. R. $2444.22 E. S. $19,999.44 J. S. $1629.48
Recommendation It is RECOMMENDED that the Agency for Health Care Administration enter a final order finding overpayments totaling $104,309.97 during the audit period and requiring that Respondent repay this amount, imposing an administrative fine of $1000, requiring Respondent to prepare a corrective action plan, and reserving jurisdiction to remand the case to the Division of Administrative Hearing for a determination of Petitioner's entitlement to statutory costs, if any. DONE AND ENTERED this 6th day of June, 2007, in Tallahassee, Leon County, Florida. S ROBERT E. MEALE 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 6th day of June, 2007. COPIES FURNISHED: Richard J. Shoop, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Craig H. Smith, General Counsel Agency for Health Care Administration Fort Knox Building, Suite 3431 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Dr. Andrew C. Agwunobi, Secretary Agency for Health Care Administration Fort Knox Building 3116 2727 Mahan Drive Tallahassee, Florida 32308 Richard M. Ellis, Esquire Rutledge, Ecenia, Purnell & Hoffman, P.A. 215 South Monroe Street, Suite 420 Post Office Box 551 Tallahassee, Florida 32304-0551 William Blocker, Esquire Agency for Health Care Administration Fort Knox Building III, Mail Stop 3 2727 Mahan Drive, Building 3 Tallahassee, Florida 32308 Daniel Lake, Esquire Agency for Health Care Administration 2727 Mahan Drive, Suite 3431 Fort Knox Building III, Mail Stop 3 Tallahassee, Florida 32308 Tracy Cooper, Esquire Agency for Health Care Administration Fort Knox Building III, Mail Stop 3 2727 Mahan Drive Tallahassee, Florida 32308
Findings Of Fact Each of the Petitioners qualified and took the State of Florida examination in July 1987 for licensure as a podiatrist. Initially, there were nine Petitioners in these proceedings, but four were subsequently given a passing grade on review of their examinations, and these four Petitioners were dismissed. Each of the Petitioners successfully passed national board examinations for podiatrists prior to sitting for the July 1987 examination here at issue, and all failed to receive an average grade of 75% on the nine subjects on which they were examined. The questions included in the July 1987 examination were taken from a large group of questions assembled into each category or subject on which the applicant for licensure is tested. To compile these questions and put together an examination, a group of experts in the field of podiatry was assembled to determine the subjects to be included on the examination. These subjects were subsequently enacted in Rule 21T-11.002, Florida Administrative Code. These subjects were referred to "item writers", generally academicians in the field of podiatric medicine, each of whom prepared a minimum of 50 questions on each subject. Upon return of these questions to Respondent, these items were reviewed by five content specialists on the Board of Podiatry to insure the validity of the questions and then placed in the item bank from which a certain number from each subject is withdrawn for the examinations. Not all of the items submitted by the item writers are found valid in this review and added to the item bank. For the 1987 examination, no new items were entered, and all questions used were taken from the item bank. Accordingly, most of the questions had been used on earlier examinations. In selecting questions for the 1987 examination, certain questions used on the 1986 examination were used so the group being examined in 1987 can be compared to the group examined in 1986. Comparing the correct answers given by the 1986 group of examinees to these questions common to both examinations, with the correct answer given by the 1987 examinees, showed the earlier examinees performed better than the group in which these Petitioners were examinees. Projecting that percentage to the entire examination shows the 1986 examinees scored five to eight points higher than the 1987 group overall. When the 1987 examinations were scored initially, only some 31% of those taking the examination received a passing grade. These scores were obtained from a computer scoring of the answer sheet submitted. Following receipt of these results, those questions which were marked incorrectly by the highest number of examinees were reviewed and submitted to the Board for review. As a result of this review, some of those questions were credited as being correct if another choice than the correct choice were selected by the examinee or if the exam key was in error. The tests were regraded, and those scores were sent out to the candidates with a notice of their right to challenge questions and answers. Following the candidates being given an opportunity to review the questions and answers on their individual examination with DPR personnel, the Test Development Specialist at DPR, Mrs. Hall, who is in charge of preparing the podiatry examination, again reviewed the questions and answers and presented to the Board a list of questions (by number) for which a large number of examinees had submitted an incorrect answer, to have the Board reconsider to determine if these questions were too difficult and to give credit for any answers as correct. As a result, the Board gave additional credit to all examinees, and four of the original nine Petitioners received a passing grade. A total of 57 adjustments were made in these scorings involving miss-keys, ambiguous questions and too difficult questions. Petitioner presented two witnesses who purported to testify to the merits of this challenge. Dr. Black is a podiatrist at Bay Pines Veterans Administration Hospital near St. Petersburg who operates a residency program in which he has trained four residents each year for the past five years. Petitioner Ellison is the only resident in Dr. Black's program who failed the Florida Podiatry examination, and Dr. Black considers Ellison to be as fully qualified for licensure as the other residents who completed the program and passed the examination. Petitioners' other witness, who was also not a Petitioner, was James F. Pruchniewski. This witness was an original Petitioner who received a passing grade on a regrading of the examination and withdrew his petition for hearing. Dr. Pruchniewski opined that the July 1987 podiatry examination was "inferior". He had earlier been a science teacher in high school and had frequently checked examinations prepared by fellow teachers. He has never been involved in preparing professional examinations, but considers the initial 31% passing rate to be outrageously lopsided. In view of this witness' lack of experience or training in preparing or grading professional examinations, his opinions are given little weight.
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.
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, as well as the facts stipulated to by the parties, the following relevant facts are found: Petitioner Frank Robert Gentile was born in New York on August 14, 1942, and is a citizen of this country. He attended St. John's Preparatory School in New York from 1956 through 1960, and received his undergraduate degree from Seton Hall University in New Jersey in 1964. His medical degree was received from the University of Bolgona, Bolgona, Italy, in 1972. In 1973, petitioner's credentials were evaluated by the Educational Commission for Foreign Medical Graduates and he received a passing grade on the examination administered by that organization. Between July, 1972 and June, 1973, petitioner trained as a clinical clerk at Maimonides Medical Center and Wyckoff Heights Hospital in Brooklyn, New York. From July, 1973 through January, 1974, petitioner completed his medical externship at the Veteran's Administration Hospital in Brooklyn, New York. From January, 1974 through January, 1975, petitioner completed an approved internship at Jersey Shore Medical Center in Neptune, New Jersey. From July, 1975 through June, 1978, petitioner completed his residency at Methodist Hospital in Brooklyn, New York. Petitioner received a passing grade in the examination administered by the Federation of State Medical Boards of the United States, Inc. (FLEX) in September of 1977. From July, 1978 through June, 1979, petitioner trained as a Hematology Fellow I at Cabrini Medical Center, New York, New York. From July, 1979 through June, 1980, petitioner trained as a Hematology Fellow II at Downstate Medical Center-Kings County Hospital Center in Brooklyn, New York. From July, 1980 through June, 1981, petitioner trained as a Medical Oncology Fellow at Downstate Medical Center-Kings County Hospital Center in Brooklyn, New York. Petitioner has been continuously and actively engaged in the practice of medicine, specializing in the fields of hematology and oncology, from June, 1981 to the present. Petitioner currently holds licenses to practice medicine in the states of New York and North Carolina. These licenses are in good standing, have never been revoked or suspended and petitioner is not under investigation in either state. From July, 1981 through January, 1982, petitioner was employed by Memorial Hospital of Alamance County, Burlington, North Carolina, as a hematologist and oncologist. He considered this employment to be temporary and so informed the Chief of Staff. While at Memorial Hospital, petitioner treated patients, did consultations and trained the oncology nurse. During the first part of his work there, his patients and charts were reviewed by a panel of doctors. He never received any complaints from his patients or from his fellow physicians concerning his medical skills. The Medical Staff Bylaws required a six-month review. In January, 1982, petitioner was informed by the Chief of Medicine that the review board had met, that petitioner's charts were not complete enough and that the board felt that petitioner should immediately resign from the Hospital. When petitioner inquired as to the problems the board found with respect to his charts, he was not given a specific answer. Petitioner received no prior warning and he considered his charts acceptable. Rather than contesting the charges against him, petitioner resigned from Memorial Hospital inasmuch as he had no intention of remaining there on a permanent basis. On March 17, 1982, petitioner applied to the Florida Board of Medical Examiners for licensure by endorsement pursuant to Section 458.313, Florida Statutes (1981). His application was complete in all respects and was accompanied by the required application fee. During the application process, petitioner was requested to furnish additional information as to what he was doing from June, 1981 to the present. He responded that he had finished his training near the end of June and then had been trying to find a place to start a private practice. He further explained that he took over a doctor's practice while that doctor was on vacation and that he had worked in the emergency rooms in the North Carolina area. No mention was made by respondent of his employment with the Memorial Hospital of Alamance County. Upon a standard inquiry to the North Carolina State Board of Medical Examiners, the respondent board learned of petitioner's affiliation with the Memorial Hospital of Alamance County. That Hospital was requested to complete a form regarding petitioner. The form was completed by "Susan Denault, Assistant Administrator," and was returned to the respondent and placed in petitioner's application file. To the question "Does he perform competently?" the answer "Questionable" appears on the form. To the question "Have any restrictions ever been placed on him beyond the original period of probation?" the following answer appears: On January 18, 1982, the Department of Medicine reviewed the work of Dr. Frank R. Gentile acting in accordance with the Medical Staff Bylaws, Rules and Regula- tions which require a six-months review. At that meeting the Department of Medicine decided the work of Dr. Frank R. Gentile had not been up to the standards expected by the department, and was not in accordance with that standard that should be appropriate for practice in the Memorial Hospital of Alamance County. Before further action could be taken, Dr. Frank R. Gentile voluntarily resigned his membership and clinical privileges to the Medical Staff of Memorial Hospital of Alamance County, Inc. Dorothy Faircloth, the Executive Director of the Florida Board of Medical Examiners, in response to petitioner's inquiry as to the status of his application, informed petitioner that the Board had received the form from the Memorial Hospital of Alamance County and related the contents to him. She advised petitioner that the normal procedure of her office was to request further information from an institution providing such information and also to request the applicant to provide a written response to such a report. However, petitioner indicated that he wished to personally address the Board on this matter at its upcoming Board meeting. Petitioner did appear at the Board meeting but felt that the Memorial Hospital matter was not fully addressed by the Board and that he was not given the opportunity to speak to the Board on that matter. By Order dated June 24, 1982, the Board of Medical Examiners denied petitioner's application for licensure by endorsement, finding that The Petitioner has not demonstrated to the Board that he is capable of safely engaging in the practice of medicine with reasonable skill and safety to his patients based upon his voluntary resignation of his membership and clinical privileges at Memorial Hospital of Alamance County, Inc., Burlington, North Carolina, just prior to disciplinary action taken by the hospital. Based on this finding, the Board concluded that petitioner had not demonstrated that he meets the statutory requirements of Sections 458.313 and 458.331(3), Florida Statutes.
Recommendation Based upon the findings of fact and conclusions of law recited above, it is RECOMMENDED that petitioner's application for licensure by endorsement be GRANTED. Respectfully submitted and entered this 17th day of January, 1983, in Tallahassee, Florida. DIANE D. TREMOR, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 17th day of January, 1983. COPIES FURNISHED: Edward P. de la Parte, Jr., Esquire de la Parte & Gilbert 705 East Kennedy Boulevard Tampa, Florida 33602 Chris D. Rolle, Esquire Assistant Attorney General Department of Legal Affairs Suite 1602, Capitol Tallahassee, Florida 32301 Dorothy Faircloth Executive Director Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301 Fred Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 ================================================================= AGENCY FINAL ORDER ================================================================= DEPARTMENT OF PROFESSIONAL REGULATION BOARD OF MEDICAL EXAMINERS FRANK ROBERT GENTILE, M.D. Petitioner, vs. DOAH CASE NO. 82-1994 DEPARTMENT OF PROFESSIONAL REGULATION and BOARD OF MEDICAL EXAMINERS, Respondent. /
