The Issue The issue in this case is whether the allegations of the Administrative Complaint are correct and, if so, what penalty should be imposed.
Findings Of Fact Respondent's Exception to the first and third sentences contained in paragraph 55 of the Recommended Order is accepted. Respondent's Exception to paragraph 56 of the Recommended Order is accepted. Respondent's Exception to paragraph 67 of the Recommended Order is accepted. The Hearing Officer's Recommended Findings of Fact, as amended, are approved and adopted and incorporated herein. There is competent, substantial evidence to support the Board's finding herein.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the Agency for Health Care Administration enter a Final Order determining that Janet A. Marley, M.D. has violated Section 458.331(1)(t), Florida Statutes, reprimanding the Respondent, placing the Respondent on probation for a period of three years and imposing an administrative fine of $3,000. DONE and RECOMMENDED this 26th day of October, 1994, in Tallahassee, Florida. WILLIAM F. QUATTLEBAUM Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 26th day of October, 1994. APPENDIX TO RECOMMENDED ORDER, CASE NO. 94-1605 To comply with the requirements of Section 120.59(2), Florida Statutes, the following constitute rulings on proposed findings of facts submitted by the parties. Petitioner The Petitioner's proposed findings of fact are accepted as modified and incorporated in the Recommended Order except as follows: 12. Rejected, cumulative. 22, 28-29. Rejected, unnecessary. 33-35. Rejected, subordinate, cumulative. 39. Rejected, evidence does not establish a July 1986 office visit. 40-41. Rejected, subordinate. 44-45. Rejected, subordinate, cumulative. 57. Rejected as to training obtained after the cryocautery performed in this case, irrelevant. 60. Rejected, subordinate. 61-62. Rejected. The theory that "good" cells grow over the "bad" cells is rejected as not supported by the greater weight of credible and persuasive evidence. 70-71. Rejected, cumulative. 90. Rejected, unnecessary. 92-93. Rejected, unnecessary. Respondent The Respondent's proposed findings of fact are accepted as modified and incorporated in the Recommended Order except as follows: 13. Rejected. The greater weight of credible and persuasive evidence establishes that it was below the standard of care for the Respondent to perform cryocautery without making a definitive diagnosis of Patient #1's condition by either biopsy or colposcopy. Rejected, unnecessary. Rejected. There was a small white area on the cervix which the Respondent presumed to be a yeast infection. No confirmatory testing was performed. Rejected, contrary to the greater weight of credible and persuasive evidence. The repeat Pap smear (performed on May 20, 1986) was not performed within six weeks of the April 4. 1986 test. 19. Rejected, irrelevant. There is no evidence that during the time care was provided to Patient #1 any lab other than Accutech was utilized by the Respondent. 22. Rejected, irrelevant. 24. Rejected, not supported by the greater weight of the evidence. A Class II report indicates only that atypical cells are present, that other factors make it impossible to determine whether dysplastic cells are present, and that the test should be redone. It does not establish that there are no dysplastic cells present in the sample. 27, 32. Rejected, subordinate. 33. Rejected, irrelevant. Rejected, not supported by the greater weight of the evidence. It should be noted that the Respondent apparently chose not to rely on the representations of the laboratory after the second Class II report. Although the report suggested re-testing, the Respondent performed cryocautery without confirming a diagnosis. Rejected. The greater weight of the evidence establishes only that the procedure was performed to address the persistent Class II Pap smear. 41. Rejected, not supported by the greater weight of credible and persuasive evidence. Given the two Class II Pap smear reports , and the fact that dysplasia could not be ruled out, it was not reasonable to perform cryocautery without further investigation of the underlying situation. 44. Rejected, cumulative. 49. Rejected. Not supported by the greater weight of credible and persuasive evidence. 51. Rejected. Not supported by the greater weight of credible and persuasive evidence. 53. Rejected, unnecessary. 56. Rejected, irrelevant. COPIES FURNISHED: Douglas M. Cook, Director Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Harold D. Lewis, Esquire Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303-4131 Arthur Skafidas, Esquire Agency for Health Care Administration 1940 North Monroe Street, Suite 60 Tallahassee, Florida 32399-0792 Bruce D. Lamb, Esquire Box 2378 Tampa, Florida 33601
The Issue Whether Respondent performed a wrong-site procedure in violation of section 456.072(1)(bb), Florida Statutes; if so, whether (and what) disciplinary measures should be taken against Respondent's license to practice medicine.
Findings Of Fact At all times relevant to this case, Dr. Lior, M.D., was licensed to practice medicine in the State of Florida, having been issued license number ME 74061, and was board-certified by the American Board of Dermatology. The Department has regulatory jurisdiction over licensed physicians such as Dr. Lior. In particular, the Department is authorized to file and prosecute an administrative complaint against a physician, as it has done in this instance, when a panel of the Board of Medicine has found that probable cause exists to suspect that the physician has committed a disciplinable offense. Here, the Department alleges that Dr. Lior committed one such offense. In the one-count Complaint, the Department charges that Dr. Lior violated section 456.072(1)(bb), "by performing or attempting to perform health care services on the wrong patient, a wrong-site procedure, a wrong procedure, or an unauthorized procedure or a procedure that is medically unnecessary or otherwise unrelated to the patient's diagnosis or medical condition." Dr. Akhtar's Examination On January 11, 2010, Patient S.L., a 74-year-old gentleman, presented to Asfa Akhtar, D.O., a general dermatologist employed by the Cleveland Clinic Florida, for an evaluation of a lesion inside his left ear. It was noted on that date that S.L. had a positive history for skin cancer. Dr. Akhtar performed a physical examination of S.L., and his contemporaneous note provides, in pertinent part, as follows: "Exam of the face, ears and hands reveal a pearly papule with rolled borders on the right helix."1/ On that date Dr. Akhtar's assessment included "R/O BCC-right helix." In other words, Dr. Akhtar wanted to rule out basal cell carcinoma on S.L.'s right helix. Dr. Akhtar's plan was to conduct a "shave biopsy." Prior to performing the biopsy, the location was marked with a pen and photographed. Dr. Akhtar then performed the biopsy by scraping skin cells of the surface skin of the suspicious area. The subsequent surgical pathology report provides, in pertinent part, as follows: Final Pathologic Diagnosis SKIN BIOPSY, RIGHT HELIX: NODULAR BASAL CELL CARCINOMA WITH SURFACE ULCERATION. TUMOR EXTENDS TO THE DEEP AND PERIPHERAL MARGINS OF BIOPSY. In correspondence dated January 20, 2010, Dr. Akhtar advised S.L. that the pathologic findings from the biopsy specimen of S.L.'s right helix confirmed a basal cell carcinoma. Dr. Akhtar recommended that it "be treated by a technique called Mohs Surgery to be certain as possible that it is completely removed." January 26, 2010 Consultation On January 26, 2010, S.L. presented to Dr. Lior for a Mohs surgical consultation. In addition to being board-certified in dermatology, Dr. Lior is qualified as a Mohs surgeon. On that date, Dr. Lior, who is also employed at the Cleveland Clinic, had access to the records of Dr. Aktar's office visit, the biopsy photograph, and the pathology report. Additionally, Dr. Lior's nurse, Diane Donner, LPN, obtained additional history from the patient. Specifically, Ms. Donner noted that, "[p]atient states he has surgery in the area approximately 3 years ago. It has been present for 3 YEAR(S)." Dr. Lior then performed an examination of S.L.'s right helix; however, her examination did not include the entire right helix. Specifically, Dr. Lior did not examine the top of the helix of S.L.'s ear. Instead, Dr. Lior conducted a "focused examination" on an observed scarred pearly papule on the helix of the right ear just superior to (above) the mid-line of the ear. Dr. Lior explained the methodology utilized in limiting her examination to a specific location on the helix, as follows: Q. . . . What information from those records would indicate where on that right helix that you just described that either the biopsy was taken or that there was biopsy- proven carcinoma? A. Right. So when we get that information, patient participation is expected. We ask the patient. We get a history. Then we also need to look at the area and see what looks consistent with the biopsy site as well. And so all of these things, when you actually see a cancer and you see a scar and you see the skin graft area, and the patient tells you that that's the site, you put it together with your biopsy pathology report, as well as your office notes. It's what we use all together. Based on Dr. Lior's experience, the observed papule was consistent with the clinical appearance of basal cell carcinoma. Dr. Lior credibly testified that S.L. pointed to the same area she was palpating and advised her that he had previously undergone Mohs surgery and that the cancer had returned. Dr. Lior discussed treatment options with S.L. and advised that Mohs surgery would be appropriate, to which S.L. agreed. Dr. Lior's record of the consultation provides in pertinent part, as follows: Physical Exam: Right superior helix: There is a 1 cm scarred, crusted, pearly papule. Impression: Biopsy-proven basal cell carcinoma. Patient notes this is recurrent. Plan: Therefore indicated for Mohs surgery. February 11, 2010 Mohs Surgery S.L. returned to Dr. Lior for the scheduled Mohs surgery on February 11, 2010. Upon entering the surgical room, S.L. was engaged in a conversation with Ms. Donner concerning the location of the site. Dr. Lior greeted and approached S.L., obtained the prior photograph, approached S.L.'s ear, and stated, "let's take a look." As she was attempting to match the photograph with the area of the ear, S.L. stated to Dr. Lior, "Don't you see the scar?" while simultaneously pointing to the location of the scar tissue. Dr. Lior indeed observed the scar tissue from the prior skin graft and again, like the January 26, 2010, consultation, noted the area was consistent with recurrent basal cell carcinoma. The location was noted to be just above the scar. Dr. Lior proceeded to palpate or touch the suspicious area. Thereafter, Dr. Lior proceeded to mark the intended surgical location on S.L.'s ear with a marker pen. Subsequently, a photograph of the marked location was obtained, the patient's informed consent was obtained, and an informed consent document was executed by S.L. A time-out was then performed where Dr. Lior and her assistant agreed upon the procedure and location. The surgical site was then sterilized and injected with lidocaine. At no time prior to the surgery did S.L. voice any concerns or objections related to the proposed surgical site. S.L. was not, however, provided a mirror to examine the proposed marked location. Additionally, there was no evidence that S.L. was shown a copy of the photograph obtained by Dr. Lior prior to surgery. Dr. Lior then proceeded to perform the Mohs surgery without incident. After completing the procedure, S.L.'s ear was bandaged and S.L. waited in a separate room while the excised portion of the ear was examined to determine whether there were "clear margins"--the absence of basal cell carcinoma. After completing the examination, Dr. Lior requested that S.L. return to the operating area to discuss the findings. When S.L. returned, Dr. Lior stated, "Good news, it's all clear, the margins are clear, there's no cancer, we're going to repair the area." In response, S.L. replied that, "[t]he site was not here, it was here." S.L. then bent the top of his ear down, and Dr. Lior observed--for the first time--a papule consistent with basal cell carcinoma.2/ It is undisputed that this newly-observed papule was the site of biopsy-proven basal cell carcinoma. Dr. Lior conceded that it was her plan, at the conclusion of the January 26, 2010, consultation, to perform a Mohs surgery on the site of the biopsy-proven basal cell carcinoma. She further conceded that, on February 11, 2010, she performed the Mohs surgery on a location of S.L.'s right helix different from the location that was the subject of the biopsy performed by Dr. Akhtar.3/ Dr. Lior offered to perform a Mohs surgery on the newly-observed/previously-biopsied location; however, S.L. elected to defer the procedure for a later date. Accordingly, Dr. Lior closed the existing excision site and performed a skin graft in the area. Dr. Lior provided S.L. with her contact information and informed S.L. that she would attempt to arrange for the Cleveland Clinic to withhold the charges for the surgical procedure performed. The Cleveland Clinic reversed the charges, as requested. S.L. declined to return to the Cleveland Clinic for suture removal or for any additional procedures.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding Respondent guilty of performing a wrong-site procedure and, therefore, violating section 456.072(1)(bb); and imposing the following penalties: a $1,000.00 fine, a letter of concern, five hours of risk management education, and a one-hour lecture on wrong-site surgery. DONE AND ENTERED this 20th day of May, 2013, in Tallahassee, Leon County, Florida. S TODD P. RESAVAGE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 20th day of May, 2013.
The Issue The issue in this case is whether the Board of Medicine should discipline the Respondent, Carlos C. Soriano, M.D., on allegations contained in an Administrative Complaint filed against the Respondent in DPR Case No. 89-05941: namely, allegations that the Respondent practiced medicine below the acceptable level of care, skill and treatment, in violation of Section 458.331(1)(t), Fla. Stat. (1993), by failing to offer one of his patients the option of radiation therapy or chemotherapy for cancer of the rectum and by inappropriately delaying treatment for the condition.
Findings Of Fact The Respondent, Carlos C. Soriano, M.D., is a physician licensed in the State of Florida, holding license number ME 0024149. In late 1988 and early 1989, the Respondent, Carlos C. Soriano, M.D., was the medical director of a health maintenance organization called Gold Plus. On or about October 24, 1988, a physician at Gold Plus examined the patient in question, a 90 year-old female in apparent good health for her age, and made a preliminary diagnosis of suspected cancer of the rectum. She referred the patient to the Respondent, a surgeon, for further evaluation and treatment. The Respondent examined the patient on October 31, 1988. He confirmed his associate's preliminary diagnosis of cancer of the rectum but pointed out that a flexible sigmoidoscopy with biopsy would be necessary to make a final diagnosis and to determine the kind of cancer involved. The diagnostic procedure was scheduled for November 17, 1988. The Respondent also discussed with the patient that, due to her age and the size and extent of the tumor, surgical removal of the tumor may not be appropriate. The Respondent suggested that the best course might be to perform a palliative colostomy, if necessary, and "let nature take its course." The patient was not pleased with the Respondent's attitude and consulted a nephew, who was a physician, for advice. The nephew referred the patient to another physician, who was a gastroenterologist, for a second opinion. The gastroenterologist examined the patient on or about November 8, 1988, prepared a report for the referring physician, with copies also sent to the patient and to the Respondent. The gastroenterologist's report recommended: a colonoscopy and biopsies like those already scheduled by the Respondent; a complete work-up preliminary to surgical removal of the tumor (including CEA levels, a liver/spleen scan, chest X-ray, and CT scan of the pelvis) to determine whether the cancer had metastasized; and (3) radiation therapy if there was no evidence of metastasis, or palliative radiation prior to snare polypectomy or laser fulguration, to avoid the necessity of a colostomy in the future if there was evidence of metastasis. The Respondent performed the flexible sigmoidoscopy and three biopsies as scheduled on November 17, 1988. He told the patient he would discussed the results with her as soon as they were received from the pathology laboratory. The Respondent received the pathology report and scheduled an appointment to discuss the results with the patient and her family (another nephew, and his wife) on November 30, 1988. The pathology report on the biopsies confirmed that the tumor was malignant. The report stated that the cancer was coacogenic. At the time, and to this day, radiation therapy and chemotherapy is not considered effective curative treatment for coacogenic carcinomas. Assuming the accuracy of the report, the only course of possible effective curative treatment for the patient was surgical removal. Whether or not the cancer had spread, the Respondent did not think surgical removal was appropriate for the patient, due to her age and the size and extent of the tumor. He did not think she would tolerate the kind of surgery that would be required. The decision whether to perform a particular surgery on a particular patient requires the exercise of the physician's professional medical judgment. Such a judgment cannot be made without a knowledge of the patient, through history and physical examination. It is found that, based on all of the evidence, including the Respondent's knowledge of the patient, through history and physical examination, the Respondent's medical judgment not to recommend surgical removal of the patient's tumor was not below the level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. During the meeting with the patient and her family on November 30, 1988, the Respondent explained the results of biopsies and what he considered to be the treatment alternatives. He told them that he would not recommend surgical removal, due to the patient's age and the size and extent of the tumor. He mentioned but did not elaborate on the possibility of radiation therapy because he did not know much about it. He suggested that the patient consider a colostomy to bypass the tumor and to "let nature take its course." He informed the patient and her family that he would be out of the country on vacation for the next four weeks but that she should make an appointment to see him after the holidays. Meanwhile, he would have someone research for him whether radiation or other alternative treatment modes were appropriate. It is found that the Respondent's failure to recommend radiation therapy or chemotherapy was not below the level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. Radiation therapy and chemotherapy is not considered effective curative treatment for coacogenic carcinoma. Assuming the accuracy of the pathology report on the biopsy, the only course of possible effective curative treatment for the patient was surgical removal. Subsequent events revealed that the patient's cancer was not coacogenic but rather squamous cell carcinoma. (It is not uncommon for biopsy reports to make such an error due to the relatively small size of the biopsy sample.) But even if the biopsy report had shown that the patient suffered from squamous cell carcinoma, it could not be found that the Respondent's failure to recommend radiation therapy or chemotherapy was below the level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. In 1988 and 1989, the medical community did not recognize radiation therapy or chemotherapy as an acceptable curative treatment for squamous cell carcinoma of the anus. Once again, the patient became anxious that the Respondent was not offering any curative treatment plan. She asked whether the Respondent should not at least have a liver/spleen scan done to see if the cancer had metastasized. Since the Respondent was not recommending surgery (the only possible curative treatment), he did not think a liver/spleen scan would serve any useful purpose. But to satisfy the patient, and because it was one of the gastroenterologist's recommendations, he agreed to schedule one for the patient before he left for vacation. The patient scheduled a follow-up appointment for January 9, 1989. Meanwhile, the Respondent left for vacation, and the liver/spleen scan was performed on December 8, 1988. In the Respondent's absence, Gold Plus delayed giving the patient the results of the scan. She became more and more anxious as time went by. When the patient called for the results, she initially was told that Gold Plus could not give her the results until the Respondent returned. It took an angry telephone call from the wife of the patient's nephew on the day before Gold Plus closed for the Christmas holiday for Gold Plus to agree to allow another of its physicians discuss the results of the scan. The patient was promised that the physician would call the next day. Still, no call came, and the wife of the patient's nephew called again just hours before the office closed for Christmas. The patient and her family were told that the results of the scan were negative. This distasteful experience further soured the patient's relationship with Gold Plus and, by extension, with the Respondent, and they lost faith in the Respondent and his medical practice. Instead of seeing the Respondent on January 9, 1989, as scheduled, the patient cancelled the appointment and made another appointment to see the gastroenterologist again. By this time, the tumor had grown to some extent and, along with it, the patient's discomfort. It was difficult to even examine the patient's rectum either digitally or by flexible sigmoidoscopy. The gastroenterologist agreed to refer the patient to another surgeon for possible surgical removal of the tumor. The patient initiated disenrollment from Gold Plus so that her Medicare could be reinstated to cover the anticipated surgery. The gastroenterologist asked the Respondent for the patient's medical records. The Respondent's care of the patient and responsibility for the care of the patient effectively ended when the patient cancelled her appointment on January 9, 1989. Another appointment with the gastroenterologist was scheduled for February 1, 1989, in anticipation of imminent surgery. Surgery was scheduled for February 14 but, after the patient's admission, was postponed to February 17, 1989. Initially, the patient's recovery from surgery was slow, and she remained hospitalized until March 14, 1989. Subsequent events raise questions whether the surgery was effective or worth the trauma. It is debatable how well the patient tolerated the surgery. It appears that she did not ever recover the level of physical vigor and energy she had before surgery. During the summer of 1989, the cancer reappeared on her coccyx and had to be treated by radiation. By the fall of 1989, another abdominal perineal resection was necessitated by the reappearance of the cancer in her rectum. Based on the best expert testimony available at the hearing, it cannot be found that the time that went by during the Respondent's treatment of the patient was "substantial," i.e., that it contributed to the spread of the patient's cancer. Notwithstanding the results of the liver/spleen scan, which was not definitive or even very useful in evaluating the patient's cancer for metastasis, it is probable that the patient's cancer already had metastasized by the time the Respondent first saw the patient. The Respondent clearly did not inordinately delay the flexible sigmoidoscopy with biopsy or his discussion of the results and treatment alternatives with the patient. The only questionable delay was the four-week delay caused by the Respondent being out of the country on vacation; by the time he was scheduled to see the patient on his return, she had terminated his care and treatment. There was no evidence on which it could be found that this delay was below the level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Board of Medicine enter a final order dismissing the Administrative Complaint against the Respondent. RECOMMENDED this 21st day of March, 1994, in Tallahassee, Florida. J. LAWRENCE JOHNSTON Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 21st day of March, 1994. APPENDIX TO RECOMMENDED ORDER, CASE NO. 93-5068 To comply with the requirements of Section 120.59(2), Fla. Stat. (1991), the following rulings are made on the parties' proposed findings of fact: Petitioner's Proposed Findings of Fact. 1.-4. Accepted and incorporated to the extent not subordinate or unnecessary. 5.-6. The date of the procedure was November 17, not November 11. Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. 7.-10. Accepted and incorporated to the extent not subordinate or unnecessary. "[A]pproximately four (4) weeks after the Christmas holidays" rejected as not proven and as contrary to the greater weight of the evidence. (He said "in four weeks, i.e., after the Christmas holidays.") Accepted and incorporated. Rejected as not proven and as contrary to the greater weight of the evidence that it was just "for a second opinion." Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. 14.-15. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as not proven and as contrary to the greater weight of the evidence that the gastroenterologist made such a determination; rather, the subsequent surgeon did. Also, rejected as not proven and as contrary to the greater weight of the evidence that the surgery was "successful." In some senses it was, in other senses it was not. Rejected as not proven and as contrary to facts found. 18.-19. Accepted but subordinate to facts contrary to those found, and unnecessary. 20. Both as to the growth of the tumor and as to the evidence of metastasis, rejected as not proven and as contrary to the greater weight of the evidence. (The liver/spleen scan was negative, but the best expert testimony presented as the hearing indicated that subsequent events showed prior metastasis.) 21.-22. Rejected as not proven and as contrary to facts found. (The evidence was that those treatments were not alternative curative treatments. The Respondent was not given an opportunity to use them palliatively.) 23. Rejected as not proven and as contrary to facts found. Respondent's Proposed Findings of Fact. For purposes of these rulings, the Respondent's unnumbered paragraphs of proposed findings of fact are assigned consecutive numbers. 1.-3. Accepted but subordinate and unnecessary. 4.-6. Accepted and incorporated to the extent not subordinate or unnecessary. 7. As to the second sentence, a "transverse colostomy" was discussed, not a "transverse colonoscopy." Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. 8.-9. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as contrary to facts found and to the greater weight of the evidence that there was no delay. Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. Subordinate and unnecessary. COPIES FURNISHED: Barbara Makant, Esquire Steven A. Rothenburg Senior Attorney Department of Business and Professional Regulation 1940 N. Monroe Street Tallahassee, Florida 32399-0792 Hugh Smith, Esquire P. O. Box 3288 Tampa, Florida 33601 Dr. Marm Harris Executive Director Department of Business and Professional Regulation 1940 N. Monroe Street Tallahassee, Florida 32399-0792 Jack McRay, Esquire Acting General Counsel Department of Business and Professional Regulation 1940 N. Monroe Street Tallahassee, Florida 32399-0792
The Issue Whether the Respondent committed the violations alleged in the administrative complaints; and, if so, what penalty should be imposed.
Findings Of Fact The Department is the state agency charged with the responsibility of regulating the practice of medicine pursuant to Florida law. The Respondent is a licensed physician in the State of Florida having been issued license number ME 0043628. In September, 1987, J.B., a patient at Hialeah Hospital, underwent exploratory surgery and was diagnosed with terminal pancreatic cancer. At the time of the surgery, it was estimated that J.B. had six months to live. Dr. Roberto Cruz, J.B.'s doctor at Hialeah Hospital, recommended that the patient undergo chemotherapy; however, J.B.'s wife rejected that proposal. She did not want J.B. to know of the diagnosis. J.B. had told his family that if he had cancer, he would commit suicide. J.B.'s father and brother had had cancer, and the latter had committed suicide. J.B.'s wife and sister believed his threat to be sincere. Based upon the foregoing, J.B.'s wife implored J.B.'s doctors not to disclose his true condition. The families of J.B. and Respondent had been friends for many years going back to their common home in Central America. Respondent knew of J.B.'s diagnosis, and agreed to become his treating physician in November, 1987. Respondent did not tell J.B. of his true medical condition. Instead, Respondent let J.B. presume discomfort and other symptoms were the result of years of heavy drinking. In November, 1987, Respondent had been in private practice only a short time and was unfamiliar with office practices and billing procedures. Respondent did nothing to become familiar with billing practices, and relied on an employee who he mistakenly believed was competent to complete billing from the patient charts. When J.B. first presented at Respondent's office, he complained of abdominal pain. Further J.B. had discovered lumps which concerned him. To pacify J.B., Respondent suggested that a lymph node be removed and biopsied. J.B. and his wife discussed the removal of the lump and agreed that such removal would be appropriate. J.B. wanted to know that the lump was not cancer, and his wife wanted to know that the cancer had not spread or metastasized beyond the original sites. Respondent performed the lump removal in November, 1987, and billed J.B.'s medical insurance for same. At the time of this surgery Respondent was fully aware of J.B.'s medical condition, and knew that the procedure would not affect the medical condition, treatment, or life expectancy of the patient. The only medical result of the procedure was the uplifting of J.B.'s mental attitude since the lump was not cancer. In March, 1988, Respondent performed a colonoscopy with biopsy on J.B. This procedure was suggested as Respondent had presented with rectal bleeding, a symptom common in terminal cancer patients, and was desirous of some diagnosis as to the medical origin of the bleeding. Instead of advising J.B. that the bleeding could be consistent with the known medical condition, Respondent went ahead with the colonoscopy after less intrusive examinations did not establish the origin of the blood. At the time of the colonoscopy, Respondent knew that the procedure would not affect the medical condition, treatment, or life expectancy of the patient. Again, the only beneficial effect from the colonoscopy was an uplifting of J.B.'s mental attitude since the colonoscopy results, which were medically inconclusive, did not disclose cancer to J.B. Even if the colonoscopy had revealed some medical condition which could be treated, it would not have been medically necessary given J.B.'s other, overriding, condition. Anemia, a condition resulting from the loss of blood which is common in terminal cancer patients, could be treated without the colonoscopy procedure. Respondent did not refer J.B. to a psychiatrist for mental evaluation or confirmation as to the suicidal ideation but accepted J.B.'s wife's representations regarding his mental state. Respondent did not allege J.B. had expressed suicidal thoughts to him and did not report same in his medical notes. At all times material to the treatment of J.B., Respondent performed medical services through a company owned by his wife. This company, Sigma Medical Center, submitted bills for the services afforded J.B. on the standard billing forms known as "HCFA 1500." Respondent, as the treating physician, was required to sign all HCFA 1500 forms submitted regarding services for J.B. By executing the HCFA 1500 form Respondent certified that the information was correct and the procedures billed for were medically necessary and appropriate. In this case, Respondent has admitted that numerous billing errors occurred, that the HCFA 1500 forms were incorrect, and that an over-billing regarding services provided to J.B. resulted. For example, consultation visits are billed at a higher rate than regular office visits. Respondent routinely billed J.B.'s visits at the consultation rate even though there was no consultation to be given. Second, Respondent billed post-operative visits which should have been included in the surgical charges separately. Third, J.B. returned for office visits more frequently than would be expected because of the pain management Respondent employed. Because J.B.'s wife would not allow Respondent to prescribe any pain medications which J.B. might associate with cancer, he ended up taking quantities of other prescriptions to manage the pain and to return to Respondent frequently due to the unexplained (to him) reoccurrence of pain. Despite an admission that he reviewed the HCFA 1500 forms before signing them, Respondent maintains he did not, at the time, know that the billing was inaccurate. This assertion has not been deemed credible As to various tests ordered by Respondent for J.B., it is concluded that the following tests were medically unnecessary: the RPR test designed to detect syphilis infection (a STD was the least of this patient's worries), the FTA (a follow-up test to the RPR), and thyroid studies. Given the totality of the circumstances, Respondent's care and treatment of the patient, J.B., fell below the standard of care and skill which a reasonably prudent physician under similar circumstances and conditions would recognize as acceptable. As to DOAH case no. 94-0778 L.G. was an employee in Respondent's office. Unbeknown to Respondent, L.G. took samples of aerobid and proventil without a prescription for the drugs. An aerobid inhaler is used to control the symptoms of bronchial asthma. Proventil is also used to control bronchospasm which may be associated with asthma. L.G. took the samples with the intent that she would forward them to a relative in Cuba who suffers from asthma. L.G. had access to the samples. Respondent had never treated L.G. and there would have been no medical justification to dispense the samples to her. Although somewhat incredulous, Respondent's admission that he had dispensed the samples to L.G. was given, to his understanding, to end the investigation of the matter. He mistakenly believed that if he made the admission the matter would be closed. L.G.'s account as to the events of her removing the samples without Respondent's knowledge has been accepted. Nevertheless, the statement Respondent gave to the Department in connection with this incident was false.
Recommendation Based on the foregoing, it is, hereby, RECOMMENDED: That the Agency for Health Care Administration, Board of Medicine, enter a final order determining the Respondent violated Sections 458.331(1), (n) and (t), Florida Statutes, in the care provided to patient, J.B., suspending his license for a period of one year, placing him on probation for a period of two years thereafter, and imposing an administrative fine in the amount $10,000. DONE AND ORDERED in Tallahassee, Leon County, Florida, this 24th day of December, 1996. JOYOUS D. PARRISH Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 24th day of December, 1996. APPENDIX Rulings on the proposed findings of fact submitted by the Petitioner: Paragraphs 1 through 17, 19 through 39, 42 through 46, 48 through 52, 54 through 65, 69, 70, and 74 are accepted. Paragraph 18 would be rejected as contrary to the weight of the credible evidence IF J.B. had been sincerely suicidal; however, in this case Respondent did not refer J.B. to a psychiatrist, did not make an independent confirmation of J.B.'s mental state, and did nothing to which J.B.'s wife did not agree--therefore, it is impossible under the facts of this case to know whether or not J.B. should have been told. Under most circumstances, J.B. should have been told, and it is accepted that the care afforded to J.B. fell below the standard of care a reasonably prudent similar physician would have provided. Respondent's whole theory of this matter fails because Respondent never independently confirmed and had J.B. properly assessed, by a physician competent to make such assessment, as to whether this major hoax was appropriate. With all due respect to Dr. Blaustein, he merely relied on factual conclusions which are unsupported by medical records in this case. Paragraphs 40 and 41 are rejected as irrelevant because the examination was medically unnecessary regardless of how performed. Paragraph 47 is rejected as contrary to the weight of the credible evidence; this procedure, like others, was medically unnecessary and below the standard of care but its primary purpose was to pacify the patient and his wife regarding the rectal bleeding. Had Respondent been forthright this procedure would not have been performed. The overbilling for the procedure was for financial exploitation of the patient's insurance. Paragraph 53 is rejected as irrelevant because the studies were medically unnecessary anyway. Paragraphs 66 through 68 are rejected as irrelevant since the diagnosis would have always been subservient to the primary diagnosis and Respondent's services in this regard were medically unnecessary. Paragraph 71 is rejected as contrary to the weight of the evidence. L.G. was not Respondent's patient. L.G. stole the drugs and Respondent covered for her with the misguided idea that it would solve the problem and the investigation would be over. Paragraphs 72, 73, 75, 77, and 78 are all rejected since L.G. was not a patient they are irrelevant or contrary to the weight of the credible evidence. Rulings on the proposed findings of fact submitted by the Respondent: 1. Paragraphs 1 through 6, 8, 10, 11, 12, 18, 19, 22, 23, 24, 31, 32, 38 through 48, 51, 55 through 64, 68 through 74, 77, 81, 82, 84, 85, 86, 89 through 92, 100, 107 through 120, 122, and 123 are accepted. Paragraph 7 is rejected as speculation or irrelevant given the overriding issues of this case; further rejected as not credible. Paragraph 9 is rejected in part as contrary to the weight of the credible evidence as to the issue of money; otherwise, as to the families' long- standing friendship accepted. The credible evidence in this case supports the conclusion that Respondent was overpaid for unnecessary services until J.B.'s insurance ran out; that he did not require payment thereafter is irrelevant. It may also have been Respondent's motive for overcharging the insurance before it ran out. Paragraphs 13 through 17 are rejected as irrelevant or contrary to the weight of credible evidence. Respondent was not authorized to delegate the medical decisions regarding J.B.'s care to his wife or family. As the physician he was responsible, regardless of how difficult the situation, to either practice within the standard the care or refer the patient to a physician able to do so. Obviously, any physician would want to keep J.B. comfortable, that is why unpleasant procedures such as the colonoscopic examination were, in part, medically unnecessary. Respondent's highest obligation was to the patient not that person's family or their perceived (and uncorroborated by Respondent) notions as to the patient's mental state. Paragraph 20 is rejected as irrelevant. Paragraph 21 is rejected as contrary to the weight of credible evidence. Paragraphs 25 through 30 are rejected as irrelevant or contrary to the weight of the credible evidence. Paragraph 33 is rejected as contrary to the weight of credible evidence. Paragraphs 34 through 37 are rejected as irrelevant or contrary to the weight of the credible evidence. Paragraphs 49, 50, 52, 53, and 54 are rejected as irrelevant or contrary to the weight of the credible evidence. The fact that J.B. was encouraged by the false or meaningless services performed by Respondent does not justify the performance or billing for same. Respondent could have listed a textbook full of conditions which J.B. did not have to encourage him but it would not have been based on medical reality any more than the colonoscopy was. Lying to a patient to make him fell better and for financial gain is not acceptable practice. Paragraphs 65, 66, and 67 are rejected as irrelevant or contrary to the weight of the credible evidence. Paragraphs 75, 76, 78, 79, and 80 are rejected as irrelevant or contrary to the weight of the credible evidence. 13. Paragraphs 83, 87, 88, 93, 94, 95, 96, 97, 98, 99, 101, 102, 103, 104, and 105 are rejected as irrelevant or contrary to the weight of the credible evidence. Respondent was responsible for all insurance billing for Sigma Medical Center. Paragraph 106 is rejected as contrary to the weight of the evidence as to whether or not L.G. was a patient at the time of the incident complained of, or irrelevant if stating such relationship was at a prior time. Paragraph 121 is rejected as irrelevant. Paragraph 124 is rejected as contrary to the weight of credible evidence. COPIES FURNISHED: Hugh R. Brown Senior Attorney Agency for Health Care Administration Office of the General Counsel Post Office Box 14229 Tallahassee, Florida 32317-4229 Harold M. Braxton, Esquire Suite 400, One Datran Center 9100 South Dadeland Boulevard Miami, Florida 33156-7815 Dr. Marm Harris Executive Director Board of Medicine Agency for Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue Whether Respondent, a medical doctor, violated Section 458.331(1)(m), Florida Statutes, as alleged in Count I of the Administrative Complaint and, if so, the penalty or penalties that should be imposed. Whether Respondent violated Section 458.331(1)(t), Florida Statutes, as alleged in Count II of the Administrative Complaint, and, if so, the penalty or penalties that should be imposed.
Findings Of Fact Effective July 1, 1997, Petitioner is the agency of the State of Florida charged with regulating the practice of medicine pursuant to Section 20.34, Florida Statutes, and Chapters 455 and 458, Florida Statutes. Pursuant to the provisions of Section 20.43(3), Florida Statutes, Petitioner has contracted with the Agency for Health Care Administration to provide investigative and prosecutorial services required by the Division of Medical Assurance, councils, or boards, as appropriate. Respondent is and has been at all times material hereto a licensed physician in the State of Florida, having been issued license number ME 0053773. Respondent has been board-certified in radiology since 1989. In 1995, at the time of the screening mammogram at issue in this proceeding, Respondent was a radiologist at Fisherman's Hospital in the Florida Keys. At the times pertinent to this proceeding, Respondent and Fisherman's Hospital used a classification system to describe the results of mammograms. That classification, developed by the American College of Radiology in 1992, is referred to as BI-RADS, which is an acronym for Breast Imaging Reporting and Data System. The following six categories are used: Category 0: Need Additional Imaging Evaluation: Finding for which additional imaging evaluation is needed. This is almost always used in a screening situation and should rarely be used after a full imaging work up. A recommendation for additional imaging evaluation includes the use of spot compression, magnification, special mammography views, ultrasound, etc. Category 1: Negative: There is nothing to comment on. The breasts are symmetrical and no masses, architectural disturbances or suspicious calcifications are present. Category 2: Benign Finding: This is also a negative mammogram but the interpreter may wish to describe a finding. The interpreter might wish to describe findings while still concluding that there is no mammography evidence of malignancy. Category 3: Probably Benign Finding - Short Interval Follow-Up Suggested: A finding placed in this category should have a very high probability of being benign. It is not expected to change over the follow-up interval, but the radiologist would prefer to establish its stability. Data are becoming available that shed light on the efficacy of short interval follow-up. Category 4: Suspicious Abnormality - Biopsy Should Be Considered: There are lesions that do not have the characteristic morphologies of breast cancer, but have a definite probability of being malignant. The radiologist has sufficient concern to urge a biopsy. Category 5: Highly Suggestive of Malignancy - Appropriate Action Should Be taken: These lesions have a high probability of being cancer. On August 10, 1994, Dr. Sheldon Kushner referred his patient, P. D., to Fisherman's Hospital for a routine screening mammogram. The mammogram was interpreted by Dr. Wayne Moccia, a radiologist. Dr. Moccia's report reflected a dense fibroglandular pattern and scattered microcalcifications in both breasts. No masses or densities were identified. Dr. Moccia recommended a follow-up mammogram in six months for comparison if no prior mammogram was available. On July 21, 1995, Dr. Kushner referred P. D. to Fisherman's Hospital for a follow-up screening mammogram. Respondent was the radiologist who directed the taking of the mammogram views and subsequently interpreted them. Respondent performed two standard screening mammogram views for each breast - the cranial caudial view and the medial lateral oblique view. There is no allegation that these views were inappropriate. Respondent compared the results of the July 1995 mammogram to the results of the August 1994 mammogram and thereafter prepared a report, dated July 21, 1995. 2/ Respondent's report reflects that routine bilateral mammogram views were taken of the patient. The following reflects Respondent's findings: Comparison is from 8-10-94. There are several small clusters of calcifications, particularly in the left breast. The overall breast parenchymal density is increased, as before. No discrete mass. No change in the morphology of the calcifications. Under the part of the report marked "Conclusion", the following appears: Stable calcifications. As some of these are indeterminate in morphology, I would recommend a bilateral follow-up in one additional year to ensure continued stability. (Category 3). The reference to Category 3 is to the BI-RADS classification. According to Dr. Kushner's records, which were admitted into evidence without objection, P. D. was examined by Dr. Kushner on July 27, 1995. Dr. Kushner found P. D.'s breast examination to be within normal limits. P. D. returned to Fisherman's Hospital for a screening mammogram on August 14, 1996. At that time, Dr. Moccia compared the mammogram view taken on that date with the mammogram views taken August 1994 and July 1995. Dr. Moccia detected abnormalities which led him to conclude that there was a strong suspicion for malignancy of P. D.'s left breast. Dr. Moccia classified the 1996 mammogram as a Category 5 and recommended a biopsy. It was subsequently determined that P. D. had cancer in her left breast. There was a conflict in the evidence as to whether Respondent's interpretation of P. D.'s 1995 mammogram fell below the standard of care. Dr. Fueredi, Petitioner's expert, testified that Respondent's interpretation was below the standard of care and explained his reasons for his opinions. Dr. Foley, Respondent's expert, testified that Respondent's interpretation did not fall below the standard of care and explained his reasons for his opinions. Both of these experts are found to be highly qualified, and the testimony of each expert on this issue is found to be credible. There is no basis to credit Dr. Fueredi's testimony over that of Dr. Foley, or vice-versa. Petitioner failed to prove by clear and convincing evidence that Respondent failed to meet the standard of care in classifying P. D.'s July 1995 mammograms as BI-RADS Category 3. Petitioner also failed to establish by clear and convincing evidence that Respondent should have ordered immediate further testing for P. D. BI-RADS Category 3 suggests a short interval follow- up, without defining what constitutes a short interval. Again there was a conflict in the evidence as to whether Respondent's recommendation that P. D. be re-examined in a year fell below the standard of care. Dr. Fueredi testified that the interval for recommended follow-up should have been four to six months, and that Respondent's recommendation for a one-year follow-up fell below the standard of care. Dr. Foley testified that it was acceptable for Respondent to recommend the one-year follow- up. Both of these experts gave lengthy explanations for their opinions. Respondent's testimony as to this issue was conflicting. In his deposition testimony, Respondent testified that he intended to classify the mammogram as Category 3 BI- RADS, which meant to him that there should be a six-month follow-up. In his deposition, Respondent also testified that a recommendation for a one-year follow-up was inconsistent with a Category 3 classification. At the final hearing, Respondent testified that he was confused in his deposition, and that he intended to recommend a one-year follow-up because he knew that Dr. Kushner usually ordered mammograms for patients in P. D.'s age group every two years. This self-serving testimony given by Respondent at the final hearing lacks credibility and is rejected. Dr. Foley and Respondent (at the final hearing) did not convincingly explain how a normal follow-up interval for P. D. could also be appropriately considered to be an appropriate short interval follow-up within the meaning of BI- RADS Category 3. Respondent's deposition testimony that a recommendation for a one-year follow-up is inconsistent with a Category 3 classification is much more persuasive than his testimony on that issue at the final hearing. In resolving the conflicting testimony on this issue, the undersigned has concluded that Respondent's report contains an inconsistency which creates confusion as to the appropriate follow-up interval. The report fails to clearly reflect Respondent's examination results and recommendations for P. D.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a final order adopting the findings and conclusions contained in this Recommended Order. For the violation of Section 458.331(1)(m), Florida Statutes, it is recommended that Respondent be assessed an administrative fine in the amount of $500.00. DONE AND ENTERED this 14th day of November, 2000, in Tallahassee, Leon County, Florida. CLAUDE B. ARRINGTON 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 14th day of November, 2000.
