The Issue Should discipline be imposed against Respondent's license to practice medicine for violation of Section 458.331(1)(t), Florida Statutes (2003)?
Findings Of Fact Stipulated Facts Petitioner is the state department charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 458, Florida Statutes. Respondent was (is) a licensed physician within the state of Florida, having been issued License No. 84357. At all times material to this complaint Respondent's address of record was 68 East Ludlow Place, Citrus Springs, Florida 34434. On or about May 18, 2004, Patient R.D., a 73-year-old male, presented to Citrus Memorial Hospital, Family Care Center in Lecanto, Florida. Patient R.D.'s chief complaint on May 18, 2004, was of constipation and last major bowel movement on May 16, 2004. On or about May 18, 2004, Patient R.D. was physically examined, and the examination revealed normal vital signs, moderately distended abdomen with slowed, but present bowel sounds in all four quadrants, no masses, and a nontender abdomen. On or about May 18, 2004, Respondent ordered an abdominal flat plate and upright X-ray, which showed "obstruction with stool, air fluid levels." On or about May 18, 2004, Patient R.D.'s diagnosis was constipation with partial bowel obstruction. On or about May 18, 2004, the X-rays were interpreted by a radiologist with an impression of marked dilatation of small bowel, likely due to small bowel obstruction. On or about May 18, 2004, Patient R.D. was instructed for treatment of his diagnosis to take Miralax powder as needed and milk of magnesia in between, keep fluid intake up and go to ER (emergency room) if pain increased in the abdomen or fever or vomiting develop. Respondent prescribed Miralax to Patient R.D. Section 458.331(1)(t), Florida Statutes (2003), sets forth grounds for disciplinary action by the Board of Medicine for gross or repeated malpractice or the failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. Respondent's Care of Patient R.D. Respondent received his Doctor of Medicine Degree from George Washington University. He became board certified in family practice in 1980 and was recertified in 1987, 1994, and 2001. Respondent practices at the Allen Ridge Family Care Center, an urgent care facility that is part of Citrus Memorial Hospital. On May 18, 2004, a history was taken from Patient R.D. The patient complained of constant mild abdominal pain. The patient reported that he had not had a stool for two days, that his last bowel movement (bm) had occurred two days earlier. The patient was complaining that he was constipated and that his stomach felt full. When Respondent saw Patient R.D., it was their first encounter. Respondent examined the patient. When Respondent asked the patient if he had blood or black stool, Patient R.D. denied either condition. Having a complaint of GI problems, Respondent was trying to ascertain whether the patient had internal bleeding when inquiring about the condition of the stool. Respondent, when recording information on Patient R.D.'s chart, noted that the distention and constipation were mild and constant. Respondent inquired of the patient concerning diarrhea, chills, vomiting, and issues with his appetite and noted that the patient was not suffering from any of those symptoms, other than to note that the patient's appetite was slightly down. The fluid intake was noted as being adequate for purposes of hydration. A nurse practitioner had noted the nature of the medications the patient was taking. Respondent did discuss those medications with the patient. Respondent was aware of the patient's vital signs and found them to be normal, as taken by a nurse. Respondent noted that the patient was in "no apparent distress," that is, he did not look sick by appearance. Instead the patient appeared well. Respondent noted in the chart that the bowel sounds were slowed but present in all four quadrants. Respondent wanted to determine whether the patient had absent bowel sounds or very rapid sounds that would have alerted Respondent to difficulties experienced by the patient. Absent bowel sounds represent some inflammatory process in the abdominal cavity such as appendicitis or a kidney stone, whereas rapid bowel signs signify a possible obstruction. Respondent noted "negative bruits," referring to the use of the stethoscope on the abdomen to listen for arterial sounds. Respondent found the liver and spleen to be normal upon examination. There was no hernia. There was "no CVA pain," referring to pain in the back that would be accompanied by flank pain. When Respondent palpitated the patient's abdomen light and deep, the patient reported that he experienced no pain. He responded by saying that he "feels full," which Respondent understood was in association with moderate distension. Before the visit, Respondent had experience with the type of patient represented by Patient R.D. Respondent has treated patients over time who have small bowel obstructions and who have constipation. Respondent's working differential diagnosis was that the patient was probably constipated, as had been reported. Respondent decided to have an X-ray made of the patient's abdomen. The decision to order an X-ray was in view of the distension. Respondent reviewed the results of the X-rays. The X-ray series were both flat and upright. The flat X-ray refers to lying flat (supine). That approach was requested in that Respondent was trying to determine how much stool and air were in the abdomen. Respondent was using the results of the X-ray to try to determine if the patient had a potential for obstruction. Respondent's impression of the results of the X-ray was that the rectum area showed stool in it. There was some indication of stool in the colon. Respondent was unsure as to whether there was stool in the small bowel. There were air fluid bubbles in an area that probably reflected the small bowel. Ultimately Respondent reached a diagnosis of constipation with partial bowel obstruction. Respondent, when he looked at the X-rays, went back to discuss the findings with the patient and said: Your x-ray does not look good. It has air fluid levels. You could have a problem here. It does not match up with your exam and your vital signs. You got a bad x-ray. The response by the patient was something to the effect that he did not care if he had a bad X-ray. He was constipated and he wanted something for his constipation. Respondent elected to give the Petitioner Miralax powder and give him precautions if anything developed such as abdominal pain, fever, or vomiting that was not in evidence at the moment, that the patient should go to the emergency room. Based upon the X-ray results, Respondent noted in his testimony that the patient: . . . wasn't out of the woods as far as I was concerned yet. Our standard procedure on a patient like this, is you get these air . . . you get something like that back . . . . probably, went in and recommended that he go to the emergency room. Respondent goes on to say in his testimony: . . . now if everything looked o.k. on this, this guy would have his Miralax prescription, be out of the door, and I wouldn't even see him if he had a normal x- ray. I went in the room and I talked to the guy and I said, look you got this and it could be obstruction, and he goes, 'what's obstruction' I said, well, just what we've been talking about this morning, blah, blah, blah. Pain, increase, bowel sounds, vomiting, 'Do I have any of that?' Respondent then describes the verbal exchange between the patient and Respondent as to the severity of the situation, and Respondent says in his testimony ". . . he won." Respondent indicated that the patient convinced Respondent that he was not ill. In summary, the Respondent told the patient that he could be in trouble or he might be fine. Respondent was also aware of other cases as he describes: . . . a certain percentage of people admitted for partial bowel obstruction like this that go through the hospital and has got to be a significant that go home the next day. They poop and go home the next day, 30 or 40 percent, o.k. So this guy could be that guy easily because he had symptoms so -- and he is not going to the ER because he waited two hours, three hours, whatever it was. I've seen nursing home patient's x-rays twice as bad as that and they are constipated and they are not in pain, so I had experience with these patients that some of them are not in trouble. I told this guy, you could be in trouble and this is -- and he said, 'I just need something for my constipation'. Respondent recognizes that the patient was coming to him for medical care and that he was obligated to determine if the patient was ill and that he could not rely completely upon someone else's ability to convince him of the circumstances. Respondent did not find the patient to look ill and indicated through his testimony that the patient ". . . was not in any trouble." Respondent did not find the patient in acute distress at the time the patient was seen. Respondent believes that had the patient been suffering small bowel obstruction when he was seen, that instead of moderate distension there would have been severe distension, and instead of the bowel sounds slow and present, they would have either been absent or increased. There would have been tenderness in the abdomen. There may have been a mass where none was found on examination. There was no finding of colicky pain, which Respondent considers to be the gold standard of bowel obstruction, crampy abdominal pain in severe waves that "double you over." Respondent called the patient's condition constipation with partial obstruction because of the findings in the X-ray. Respondent recognizes that there was some obstruction. He attributed the bowel obstruction to constipation caused by feces. However, in making his choices for care Respondent recognizes that distension is a symptom of obstruction. The inability to defecate is a symptom of obstruction. Respondent did not rely upon the radiologist's reading and report concerning the X-rays when making his choices for Patient R.D.'s care because he did not have the report at that time. Respondent recognized the Physician's Desk Reference (PDR) available on May 18, 2004, as a reference source and in its discussion of Miralax was an authoritative source and that according to the PDR, it considered Miralax as contraindicated for patients who are known or suspected of having small bowel obstructions. Expert Opinion Dr. James Schaus is licensed to practice medicine in Florida and board certified in family practice. He was offered as an expert to express an opinion concerning Respondent's care provided Patient R.D. on May 18, 2004. To prepare him for that assignment he reviewed investigative materials from the Department, Respondent's records and other available records that pertain to Patient R.D.'s care. When asked to express an opinion concerning whether Respondent met the applicable standards of care as defined by Florida Statutes in the examination, diagnosis and treatment of Patient R.D., Dr. Schaus expressed the opinion that Respondent: . . . deviated from the standard of care in this case by failing to refer the patient to a hospital for immediate further evaluation of the small bowel as indicated on the abdominal x-ray and the physical examination finding of a distension. The abdominal x- ray revealed multiple air and fluid filled loops in the small bowel which are marketedly dilated and associated small bowel air fluid on upright films. A small amount of air, stool, within colon, impression marked dilation of small bowel likely due to small bowel obstruction. Dr. Schaus' view of the definition of "standard of care," is the "failure to practice medicine at a level of care, skill, and treatment which are [sic] recognized by a reasonably prudent similar acting physician as being acceptable under similar conditions and circumstances." Dr. Schaus went on to state the opinion: I believe that these x-ray findings taken together with the fact that the patient was distended on the physical exam and complained of some pain with the distension of abdominal wall obligated Dr. Hopkins for immediate further hospital evaluation of this patient. I also believe that Dr. Hopkins deviated from the standard of care by prescribing Miralax to the patient who had the diagnosis of partial small obstruction. In addition to expressing the opinion that Respondent should have arranged for immediate hospitalization of the patient diagnosed with partial small bowel obstruction, and the problem with Miralax, Dr. Schaus expressed the opinion that there was a deviation from the standard of care for the failure to do a digital rectal exam on the patient. Dr. Schaus expressed an opinion that Respondent should have used a digital rectal exam with this patient to determine the presence of stool, occult blood, and the condition of the prostate and to check for rectal or perianal masses. This was the standard of care that should have been pursued in this case because the patient complained of constipation and possible bowel obstruction. If an impaction of stool were found, this would aid in the diagnosis. It would be properly considered the cause and would constitute the diagnosis. If the digital rectal exam revealed gross blood that is important, or occult blood on the stool sample as detected through a chemical test, those findings would be helpful as well. Gross blood refers to visible blood. It is bright red or darker colored. If a mass is found, it might be an indication of colon cancer. As Dr. Schaus explained, the presence of blood indicates a more serious problem in that the typical constipation does not bleed. Dr. Schaus perceived the case involving Patient R.D. as one in which constipation was the patient's presenting complaint, setting up the possibility that it was in view of constipation as such or could be from bowel obstruction. Dr. Schaus expects the physician to determine that spectrum from the very benign to the very serious. In his review of the record, Dr. Schaus notes that the patient had an obstruction as evidenced by Respondent's diagnosis of obstruction. In particular he emphasizes the diagnosis of "constipation with partial bowel obstruction." In his testimony, Dr. Schaus had referred to small bowel obstruction in his impression of the findings by Respondent but later acknowledged in his testimony that Respondent had described a condition which was "partial bowel obstruction." The obstruction would be found within the intestinal tract. The nature of the blockage in Dr. Schaus' opinion can be a partial blockage that would limit the passage of stool or a complete blockage that can cause more serious problems. In this case, Dr. Schaus believed that it was clearly indicated that the patient had a significant bowel obstruction and that it was a small bowel obstruction and the patient needed to be admitted to the hospital for further evaluation and treatment. Dr. Schaus considers the terms "small bowel" to be synonymous with "small intestine." Dr. Schaus, in expressing his opinion, relies upon Respondent's interpretation of the X-ray where the Respondent notes "abdominal flat and upright obstruction with stool, air fluid levels." Dr. Schaus expressed the opinion that Respondent should have proceeded logically with the next step after discovering the small bowel obstruction, which was to make sure that the patient receives immediate evaluation and treatment in a hospital setting. The treatment that was given was on an out- patient basis with instruction for the patient to use Miralax as needed, with milk of magnesia PRN and to keep his fluid intake up and to report to the emergency room if he had problems with abdominal pain, fever, or vomiting. That approach was not acceptable in Dr. Schaus' opinion given the signs, symptoms, and radiographic findings in relation to Patient R.D. By choosing to have an abdominal X-ray performed on Patient R.D., this was an indication to Dr. Schaus that Respondent believed the patient was experiencing something other than typical constipation. A patient who has only constipation would not be subject to an abdominal X-ray. Concerning the prescription of Miralax, Dr. Schaus noted that this medication is an osmotic agent. It is considered a fairly powerful laxative. It is designed to cause the stool to retain water leading to a softer bowel movement, but it can be a dangerous treatment or contraindicated in a patient with known or suspected bowel obstruction as mentioned in the PDR. Dr. Schaus considers the PDR to be authoritative, and it is a commonly-used reference source for prescribing medications. When explaining the circumstances concerning Miralax, Dr. Schaus commented that the absorption of water is potentially dangerous in the instance where you have a blockage and you are promoting an expansion in the stool. This patient had partial bowel obstruction and Respondent prescribed the medication. Dr. Schaus believed that the patient could have had the entire spectrum from simple constipation to a complete bowel obstruction, because a patient may present with a wide variety of symptoms. In this case, the typical expectation of nausea and vomiting does not overcome the necessity for having a high- end suspicion of serious problems in the interest of not overlooking something. Dr. David A. Weiland, Jr., is licensed to practice medicine in Florida. He is board certified in internal medicine. His practice principally involves care of adult patients. In the past, he has taught family medicine for a period of almost ten years. Patient R.D. was an elderly patient, a type of patient seen in family practice. Dr. Weiland occasionally uses the PDR when he is unaware of a drug, or, if a drug is new, he will look it up in the PDR in discussing dosage or potential drug interactions. He sees the PDR as one reference source. It serves as a guide in prescribing. Dr. Weiland sees the definition of standard of care as being "that practiced by a prudent clinician in similar circumstances, with similar findings." In preparing himself to offer testimony, Dr. Weiland reviewed the Respondent's medical records in association with Patient R.D. He considered those records to be sufficient for him to render an opinion about the care provided Patient R.D. by Respondent. Dr. Weiland in his practice deals with 73-year-old males, such as Patient R.D. He deals with males who have constipation. Dr. Weiland has dealt with patients with distention of the abdomen. At present, Dr. Weiland's predominant practice is in hospice care. Many of his patients are severely constipated because of the use of narcotics due to the nature of their illness in the hospice setting. In deciding the choice of treatment, the choice of medications for addressing a 73-year- old with distention and constipation for two days, in his practice, Dr. Weiland relies on trials and failures or successes with the use of previous medications and an understanding of the illness and the degree of illness. He looks for symptoms such as diarrhea, pain associated with a fecal mass of the rectal wall, nausea, and vomiting, to guide him in deciding where the obstruction may be located and how to address the suspected obstruction. According to Dr. Weiland, you need to encourage the forward motion of the bowels in elderly patients. Dr. Weiland uses Miralax in his practice. He describes it as a promotility agent, an agent that allows the bowel to move more functionally. Miralax is not a drug that Dr. Weiland routinely prescribes. He just does not use the drug often, even though he understands it to be a very popular laxative. Dr. Weiland believes that Miralax is contraindicated for people with mechanical bowel obstruction, meaning anything mechanical that causes the bowel to be obstructed which could be cancer, adhesions, or twisting. The complete bowel obstruction, regardless of the reason, would be contraindicated for use of Miralax. With a partial obstruction, it is not clear to him whether Miralax is contraindicated. If there is stool movement forward, there is no absolute contraindication. The fact that the patient was not vomiting was an indication to Dr. Weiland that the stool was moving forward. With a complete bowel obstruction, the patient would present nausea and vomiting. Dr. Weiland agrees with the PDR warning that Miralax is contraindicated for patients who have known or suspected bowel obstructions. Symptoms suggestive of a bowel obstruction present would be nausea, vomiting, and abnormal distention and should be evaluated to rule out the bowel obstruction before using Miralax therapy, as explained in the PDR. Dr. Weiland thinks the key elements in the evaluation of those symptoms relate to nausea and vomiting and a patient with extreme nausea and vomiting should not be given promotility medication. Therefore, Dr. Weiland's opinion concerning the use of Miralax is conditioned upon those symptoms in relation to nausea and vomiting. Concerning general contraindications for using medications, Dr. Weiland is familiar with a medication by its general use, having looked it up on the PDR, and he has used other texts for medications, pharmacopeia. Dr. Weiland's response to contraindications depends on whether they are considered as absolute contraindications or relative contraindications. He sees the process of determining the use of the medication as dependent of the patient's underlying situation and the whole clinical condition. Dr. Weiland is also familiar with milk of magnesia, which is a chemical laxative. In addressing a patient's condition, Dr. Weiland treats the symptoms about 95 percent of the time. He uses additional testing when he confronts something unusual. For example, severe nausea would lead him to consider the use of X-rays. Other examples of a patient's circumstances in his experience that might cause the use of an X-ray or CT scan would be severe pain that was in association with a history of a particular malignancy known to cause complete obstruction, ovarian cancer or prostate cancer. Dr. Weiland would be impressed with passing significant amounts of blood in the stool, bloody diarrhea, high fever, nausea, and vomiting. But most constipation he treats initially, medically, and it would be necessary that he would have other of the issues that he described going on before it would warrant further investigation. Dr. Weiland explains that most treatments of small bowel obstruction are conservative initially. If the patient presents with a complete bowel obstruction as evidenced by nausea, vomiting, that patient is admitted to the hospital and the management involves bed rest and the provision of IV fluids to see if the patient resolves the situation. To determine whether there is a small bowel obstruction, two factors enter in, according to Dr. Weiland. One is the clinical presentation, which is abdominal pain, marked distension, nausea, and vomiting. If one of those factors is not present, Dr. Weiland does not believe that it would necessarily be considered as being a small bowel obstruction. He thinks that there is the possibility of confusing obstruction, in the sense of whether it is partial or complete. Dr. Weiland understands the differences between patients and the way they present abdominal pain and distension could be explained by lots of things, among them bowel obstruction. Concerning the Patient R.D. in his clinical presentation, considering the patient's appearance, vital signs, lack of nausea and vomiting no symptoms, Dr. Weiland would not have thought he was dealing with a bowel obstruction. The slow bowel that is described would not lead Dr. Weiland to conclude otherwise. The Respondent's impression concerning the bowel obstruction was based on X-ray findings, as Dr. Weiland perceives the matter. Dr. Weiland would not have gotten those X-rays. He believes that X-rays can sway you in the wrong direction and they do not always represent bowel obstruction. If the patient had presented looking "relatively toxin," Dr. Weiland would have ordered films, and, when he got those films, it would have confirmed the condition. Dr. Weiland proceeded with his opinion based upon the belief that Respondent reached the diagnosis of constipation with partial bowel obstruction after the X-ray results were known. Dr. Weiland looked at Patient R.D.'s X-rays. He found them to be abnormal in that there is evidence of dilation in the case because of striations, and there are fluid levels. In his experience, not all fluid levels are obstructions. Sometimes they are caused by other abnormalities. Dr. Weiland expressed the opinion that the standard of care for a patient like R.D. is that you look at the patient, determine the patient's symptoms, and make a clinical recommendation with a follow-up, and, if the patient systems worsen, then the patient should go to the emergency room for care. Dr. Weiland believes that partial small bowel obstruction could be a life threatening condition. If the patient were facing a life threatening condition, Dr. Weiland would hospitalize the patient. Evidence of a life-threatening condition would be nausea, vomiting, inability to keep down oral medications, and abnormal signs none of which were evidenced in this case in the case of R.D. Dr. Weiland considers abdominal distension to be a non-specific symptom in the patient, as well, abdominal distension with pain is non-specific. Dr. Weiland would not have sent the patient to the emergency room on May 18, 2004. The conservative approach was acceptable. The causation of the problem would often times resolve on its own. Dr. Weiland refers to the Respondent having the luxury of looking at the actual patient and the patient's appearance and the vitals did not appear to be toxic. Dr. Weiland agrees with the Respondent that if the patient developed fever or vomiting he should go to the emergency room. That would be evidence that the patient was experiencing a complete bowel obstruction. Dr. Weiland's reading of the Respondent's reference to partial bowel obstruction is that it is based upon information that Respondent had, including the patient had fecal material, and that the patient is obstipated. Dr. Weiland believes that the partial bowel obstruction could be caused by any number of things, that have been mentioned in his testimony and reflected in this discussion and that the patient should be treated conservatively. If the problem resolves then that ends it. If it does not, then a CAT scan should be considered, and only upon the condition becoming a bowel obstruction that is complete will surgery be necessary. Dr. Weiland agrees that the use of a rectal exam can aid in the determination of the cause of an obstruction. Dr. Weiland expresses a preference to have a rectal exam documented in the patient chart. Having considered the opinions of the medical experts in view of the choices Respondent made in caring for Patient R.D., Dr. Schaus' opinions that Respondent fell below the standard of care in prescribing Miralax with a diagnosis of partial obstruction and the opinion by Dr. Schaus that the Respondent's failure to refer the Patient R.D. to the hospital for further evaluation of bowel obstruction fell below the standard of care are accepted. Although the choice to proceed to the hospital or not would have been the patient's decision, Respondent in his approach did not create that option. Rather he deferred to perceived limitations placed on the care by the patient, commenting that he was there principally for difficulties with constipation. That response to the patient's needs was below the standard of care. Respondent left available the choice to proceed to the emergency room if the patient began to have abdominal pain, fever or vomiting. Dr. Schaus' opinion that Respondent fell below the standard of care in not performing a digital rectal examination on Patient R.D. is accepted when addressing the possibility of a bowel obstruction. Mitigation/Aggravation The record does not reveal any adverse outcome attributed to Respondent's care provided Patient R.D. on May 18, 2004. There is no indication that Respondent has ever been disciplined in Florida or other jurisdictions while practicing medicine.
Recommendation Based upon the findings of fact and conclusions of law, it is RECOMMENDED: That a final order be entered finding Respondent in violation of Section 458.331(1)(t), Florida Statutes (2003), placing Respondent on a period of probation for one year, issuing a letter of reprimand and imposing an administrative fine of $5,000.00. DONE AND ENTERED this 1st day of May, 2007, in Tallahassee, Leon County, Florida. S CHARLES C. ADAMS 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 1st day of May, 2007. COPIES FURNISHED: Ephraim D. Livingston, Esquire Dory Penton, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Christopher J. Schulte, Esquire Burton, Schulte, Weekley, Hoeler & Beytin, P.A. 100 South Ashley Drive, Suite 600 Post Office Box 1772 Tampa, Florida 33602-1772 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 Josefina M. Tamayo, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
The Issue The issue is whether Petitioner overpaid Respondent for medical services for 20 patients under the Medicaid Program from February 22, 1997, through February 22, 1999, and, if so, by how much.
Findings Of Fact At all material times, Respondent, who is a licensed physician, was authorized to provide medical services to Medicaid recipients, provided medical services to Medicaid recipients, billed Petitioner for these services, and received payment for these services. The Medicaid program provides for periodic audits of each Medicaid provider, after which Petitioner may seek repayment of amounts revealed by audit to have been overpaid to the provider. After conducting such an audit of Respondent for services rendered from February 22, 1997, through February 22, 1998, and exchanging post-audit information, Petitioner informed Respondent, by letter dated March 1, 2002, that it had overpaid him $238,069.09 for claims that were, in whole or in part, not covered by Medicaid, and demanded repayment of this amount. The letter states that the overpayment was extrapolated from the overpayment amount determined from auditing the records of a random sample of 21 patients for whom Respondent had submitted 423 claims. The actual overpayment amount, before extrapolation is $11,248.14. Petitioner later removed one of the patients from the sample due to a billing error. Among the 21 patients covered by the audit, the deleted patient is identified as Patient 20. The age of each patient set forth below is his or her age at the time of the first office visit during the audit period. Where a series of payments are set forth below, they are listed in the order of the procedures discussed immediately above the payments. Patient 1, who was 17 years old first saw Respondent on March 27, 1998. Petitioner allowed payments for Patient 1's first two visits. On March 27, 1998, Respondent performed an abdominal echogram and other services for abdominal pain of three or four months' duration, and, on April 14, 1998, Respondent performed a doppler echocardiograph and other services for chest pain of three or four days' duration. On April 27, 1998, Patient 1 presented at Respondent's office with fever and chills since the previous day. Patient 1 complained of nausea, frequent and painful urination, and pain in the abdomen and lower back. Without first performing a urinalysis or urine culture, Respondent performed a renal echogram April 27, based on his diagnosis of urosepsis and to rule out a urinary tract infection. Renal echography was not medically necessary to rule out a urinary tract infection, at least until Respondent had first performed a urinalysis and urine culture and considered the results from this laboratory work. Respondent's diagnosis of urosepsis lacks any basis in his records. If Patient 1 had suffered from urosepsis, which is a life-threatening condition that requires urgent treatment--not echography--Respondent should have treated the matter as a medical emergency. Petitioner proved that it overpaid $61.57 for this service. Petitioner allowed a payment for medical services, which did not include any echography, on May 4, 1998. On June 1, 1998, Patient 1 presented at Respondent's office complaining of acute abdominal pain for three or four days. Respondent performed a physical examination and detected an enlarged spleen. He then performed an echogram of the spleen and found a normal spleen without inflammation or cyst. Respondent proceeded with the echography without first performing routine blood work, such as a white blood cell count, to detect infection. The echogram of the spleen was not medically necessary, at least until Respondent had performed routine blood work to confirm or rule out infection. However, as noted in the Preliminary Statement, Dr. Hicks has withdrawn his objection to this payment, so Petitioner did not overpay for this service. Petitioner allowed a payment for a medical service on June 5, 1998. On June 19, 1998, Patient 1 presented at Respondent's office complaining of weakness, fainting, dizziness, fatigue, palpitations, shortness of breath, heartburn, rectal discomfort, and skin rash. After performing a physical examination, Respondent suspected hypothyroidism and performed a thyroid echogram, which revealed a normal thyroid. Again, thyroid echography is not medically necessary without first performing routine laboratory tests of thyroid function. Petitioner proved that it overpaid $45.24 for this service. On August 3, 1998, Patient 1 presented at Respondent's office complaining of weakness in his arms and hands of three to four weeks' duration. A physical examination revealed that Patient 1's grip was weak and his wrists painful upon pressure. Suspecting carpal compression, Respondent conducted three types of nerve conduction velocity tests (NCV), including an H-Reflex test, all of which test nerve function. Patient 1 had a psychiatric diagnosis, as Respondent was aware at the time of this office visit. Before conducting the NCV, Respondent contacted Patient 1's psychiatrist and obtained her approval of the test. Also, before conducting the NCVs, Respondent obtained blood work, so as to determine the blood levels of the psychotropic medications that Patient 1 was taking. Petitioner failed to prove that it overpaid for these services. Patient 1 visited Respondent's office on August 7, August 25, September 16, and October 30, 1998, but Petitioner is not disallowing any of these payments. On November 23, 1998, Patient 1 presented at Respondent's office complaining of pain in his right ankle after tripping and falling the previous day. Respondent conducted a physical examination and found mild swelling, applied an elastic bandage, prescribed Motrin and physical therapy for three weeks, and ordered an X ray. Petitioner claims that Respondent misbilled the procedure. Respondent billed a 73000, which is a procedure under the Current Procedure Terminology manual (CPT), and Petitioner claims that the correct CPT code is 73600, which would generate an overpayment of 59¢. However, as noted in the Preliminary Statement, the evidence fails to support this claim by Petitioner, so Petitioner failed to prove that it overpaid for this service. Patient 2, who was a 57 years old, had seen Respondent for three years. Patient 2 visits the office "constantly," according to Respondent. Petitioner has disallowed payments for services rendered on March 2, March 31, April 28, June 1, August 17, August 28, September 24, October 2, November 3, November 9, December 1, and December 21, 1998, and January 8, 1999. However, as noted in the Preliminary Statement, Dr. Hicks has withdrawn his objection to the aerosol treatment on August 17 and the level of service of the office visit on August 28. On March 2, 1998, Patient 2 presented at Respondent's office with acute onset the previous day of left flank pain, now radiating to the left lumbar and genital areas. Patient 2 denied passing any stones in his urine, although he complained of frequency and pain of urination. Respondent found Patient 2's abdomen distended and liver enlarged. He performed a renal echogram to rule out kidney stones or urinary retention. The results were normal. Respondent's testimony failed to establish the medical necessity of this renal echography. The symptoms are too nonspecific to justify this diagnostic procedure at this time, so Petitioner proved that it overpaid $61.57 for this service. On March 31, 1998, Patient 2 presented at Respondent's office with complaints of leg pain and cramps at night, which arose after walking a block and alleviated with rest. Diagnosing this obese patient with peripheral vascular disease, Respondent performed doppler procedures of the lower extremity veins and arteries. The results revealed mild atheromatous changes in the lower extremities. Petitioner failed to prove that the two procedures billed by Respondent for the March 31 office visit were medically unnecessary, so Petitioner failed to prove that it overpaid for these services. On April 28, 1998, Patient 2 presented at Respondent's office with nausea of three or four days' duration, vomiting associated with indigestion, fatty food intolerance, flatulence, and bitter taste. Patient 2, whom Respondent presumed was alcoholic, had an enlarged liver, as Respondent had noted in previous examinations of Patient 2. Respondent performed a liver echogram, after ordering a laboratory report on January 29, 1998. The results confirmed the presence of liver echogenicity or fatty liver. 26. Petitioner failed to prove that this echography was not medically necessary, so Petitioner failed to prove that it overpaid for this service. On June 1, 1998, Patient 2 presented at Respondent's office with complaints of pain on urination, increased frequency of urination, the need to urinate at night, and chills. Respondent performed an echogram of the prostate to rule out cancer; however, Respondent's records did not disclose any laboratory test, which is more appropriate for detecting prostate cancer. Respondent's testimony establishes that this echogram was not medically necessary, so Petitioner proved that it overpaid $51.34 for this service. On September 24, 1998, Patient 2 presented at Respondent's office with a complaint of low back pain after slipping and falling down three days earlier. Respondent performed three NCVs, including an H-Reflex test. Respondent's notes state an intention to do X rays, although the records fail to reveal whether X rays were ever done. Petitioner failed to prove that the three NCV tests were not medically necessary. Petitioner also downcoded the office visit on this date, but, as noted in the Preliminary Statement, due to the failure to produce a CPT manual, Petitioner failed to prove that it overpaid $10.74 for this service. On October 2, 1998, Patient 2 presented at Respondent's office with a complaint of shortness of breath. Respondent administered an aerosol with Ventolin, which is a drug used to combat asthma. This is the same aerosol that Dr. Hicks decided to allow on August 17 upon further review, and the medical necessity for this aerosol is the same as the earlier aerosol, so Petitioner failed to prove that it overpaid $10.62 for this service. On November 3, 1998, Patient 2 presented at Respondent's office with complaints of malaise, fatigue, weakness, and weight gain. Respondent performed a thyroid echogram in connection with a diagnosis of hypothyroidism, and the test results were normal. Patient 2, who suffered from chronic obstructive pulmonary disease (COPD), had not actually gained weight over 1998. Without the results of other tests of thyroid function, a test to measure the size of the thyroid was not medically necessary, so Petitioner proved that it overpaid $45.24 for this service. On November 9, 1998, Patient 2 presented at Respondent's office with complaints of continuing chest pain and palpitations. Respondent had seen Patient 2 three days earlier for the same complaints and performed an electrocardiogram, whose results were abnormal, although not acute. Based on this test, Respondent had referred Patient 2 to a cardiologist. Given the proper referral of Patient 2 to a cardiologist, the ensuing doppler echocardiogram was not medically necessary. The record is devoid of any evidence that Respondent could adequately care for the cardiac condition suffered by Patient 2, so this diagnostic service performed no useful function. Petitioner proved that it overpaid $117.23 and $51.34 for these services. On December 1, 1998, Patient 2 presented at Respondent's office with chest congestion and cough, with some shortness of breath, of three days' duration. Respondent administered an aerosol with medications to treat Patient 2's bronchial asthma and COPD by functioning as a bronchodilator. This treatment was preceded by a spirometry, which tests respiratory function. Petitioner failed to prove that either the diagnostic or therapeutic service provided by Respondent on December 1 was not medically necessary. On December 21, 1998, Patient 2 presented at Respondent's office with the same complaints from his visit nearly three weeks earlier. Respondent performed two duplex scans of the lower extremities to check his circulatory state, These scans were not medically necessary. Although Patient 2 was also complaining of a slow progression of leg pain and cramps, Respondent had performed a diagnostic procedure for these identical symptoms nine months earlier. The absence of any recorded treatment plan in the interim strongly suggests that diagnostic echography is displacing actual treatment. Respondent also performed another spirometry, less than three weeks after the prior spirometry. There was no medical necessity for this second procedure because Patient 2's symptoms and complaints had remained unchanged. Petitioner proved that it overpaid $97.96, $72.39, and $15.70 for these services. On January 8, 1999, Patient 2 presented at Respondent's office, again with respiratory complaints. Respondent claims to have administered a maximum breathing test, but he submitted no documentation of such a test to Petitioner, so Petitioner has proved that it overpaid $9.82 for this service. Patient 3, who was 13 years old, saw Respondent only one time--April 28, 1998. On this date, she presented at Respondent's office with menstrual complaints, abdominal pain, anxiety, and urinary disorders in terms of frequency and urgency. After performing a physical examination (limited as to the pelvic area due to the demands and cultural expectations of the patient and her family) and ordering blood work, Respondent performed pelvic and renal echograms, choosing not to subject the patient to X rays due to her young age. When Respondent later received the blood work, he found evidence supporting a diagnosis of a urinary tract infection. Although the menstrual history should have been developed in the records, the pelvic echogram could have uncovered an ovarian cyst, and legitimate reason existed to avoid an X ray and an extensive pelvic examination. However, the renal echogram was not medically necessary. The proper means of diagnosing a urinary tract infection is the blood work that Respondent ordered. The records mention the possibility of kidney stones, but this condition did not require ruling out based on the complaints of the patient, findings of the physical examination, and unlikelihood of this condition in so young a patient. Petitioner proved that it overpaid $61.57 for the renal echogram, but failed to prove that it overpaid for the pelvic echogram. Patient 4, who was eight years old, first saw Respondent on November 11, 1998. Patient 4 presented with a fever of two days' duration, moderate cough, and runny nose. His grandmother suffered from asthma, but nothing suggests that Patient 4 had been diagnosed with asthma. After conducting a physical examination and taking a history, Respondent diagnosed Patient 4 as suffering from acute tonsillitis, allergic rhinitis, bronchitis, and a cough. Apparently, Respondent misbilled Petitioner for an aerosol treatment because Respondent testified, and his records disclose, that no aerosol was administered, so Petitioner proved that it overpaid $10.62 for this service. Respondent administered a spirometry, which he justified on the basis of the grandmother's asthma. Although the results of the spirometry indicated pulmonary impairment, the test was not medically necessary, given the history and results of the physical examination, so Petitioner proved that it overpaid $32.06 for this service. On February 15, 1999, Patient 4 presented at Respondent's office with a fever of two days' duration, moderate cough, and clear nasal discharge. Again, Respondent administered a spirometry, which again revealed pulmonary impairment, and, again, the test was not medically necessary. Again, Respondent displayed a fondness for diagnostic procedures that yielded no plan of treatment. Petitioner proved that it overpaid $16.94 for this service. Patient 5, who was 61 years old, presented at Respondent's office with a history of weekly visits, as well as osteoarthritis and high blood pressure. On March 26, 1998, Patient 5 presented at Respondent's office with a complaint of left hip pain of three days' duration, but not associated with any trauma. She also reported dizziness and occasional loss of consciousness after faintness. Patient 5 noted that her neck swelled three or four months ago. Respondent billed for two views of the hip, but nothing in his records indicates more than a single view, so Petitioner proved that it overpaid Respondent $6.68 for this aspect of the X-ray service. Respondent also performed a duplex scan of the carotid artery. The scan, which was justified due to Patient 5's dizziness, faintness, and loss of consciousness, revealed atherosclerotic changes of the carotid arteries, so Petitioner failed to prove that it overpaid for this service. On April 9, 1998, Patient 5 presented at Respondent's office with complaints of left flank pain, nasal stuffiness, headaches, and urinary incontinence on exertion. Interestingly, the report from the thyroid echogram, which was performed on the March 26 office visit and allowed by Petitioner, revealed an enlargement and solid mass at the right lobe, but Respondent's records contain no conclusions, diagnosis, or treatment plan for this condition, focusing instead on cold and other minor symptoms described above. Respondent performed kidney and bladder echograms, to rule out stones, cysts, or masses, and a sinus X ray. However, he did not first perform a urinalysis--instead ordering it simultaneously--to gain a better focus on Patient 5's condition, but his records contain no indication of the results of this important test. Petitioner proved that it overpaid $61.57 and $39.73 for the renal and bladder echograms, both of which were normal, although the left kidney revealed some fatty tissue. Although the results were normal, the sinus X ray was medically necessary, so Petitioner failed to prove that it overpaid for this service. On May 13, 1998, Patient 5 presented at Respondent's office with a complaint of chest congestion, "chronic" cough (despite no prior indication of a cough in Respondent's records), and shortness of breath of two or three days' duration. Respondent administered a spirometry. Respondent justified this test, in part, on Patient 5's "acute exacerbation of COPD," but Respondent's records reveal no other symptoms consistent with a diagnosis of COPD. Administering spirometry when confronted with common cold symptoms is not medically necessary, so Petitioner proved that it overpaid $30.06 for this service. On June 29, 1998, Patient 5, who was diabetic, presented at Respondent's office with complaints of gradual onset of leg pain on exertion, alleviated by resting, and cramping at night. A physical examination revealed no right posterior pedal pulse, grade 2 edema and dermatitis, and bilateral varicose veins. Previous blood work had revealed high cholesterol, triglycerides, and low-density lipoprotein cholesterol. Respondent performed a doppler study of the arteries of the lower extremities, which Petitioner allowed. He also performed a doppler study of the veins of the lower extremities and a duplex scan of the veins of the lower extremities, both of which Petitioner disallowed. Petitioner also downcoded the office visit. Given Patient 5's diabetes and the laboratory work, the disallowed study and scan were justified. Petitioner failed to prove that the services were medically unnecessary or, as noted in the Preliminary Statement, due to the absence of the CPT manual, that the office visit should be downcoded, so Petitioner failed to prove that it overpaid for these services. On July 20, 1998, Patient 5 presented at Respondent's office with complaints of diffuse abdominal pain and nausea without vomiting. Respondent found that her liver was enlarged and tender and performed a liver echogram. Petitioner's disallowance of this service suggests an unfamiliarity with the subsequent report dated August 28, 1998, that states that a CT scan of the abdomen revealed possible metastatic disease of the liver and suggested correlation with liver echography. The liver echogram was medically necessary, so Petitioner failed to prove that it overpaid for this service. On August 13, 1998, Patient 5 presented at Respondent's office with complaints of low back pain of months' duration and related symptoms. Respondent performed three NCVs, including an H-Reflex. The NCVs suggested light peripheral neuropathy. Petitioner failed to prove that these tests were not medically necessary. On August 18 and 28, 1998, Patient 5 visited Respondent's office and received injections of vitamin B12 and iron. However, the medical necessity for these injections is absent from Respondent's records. Respondent testified that the iron was needed to combat anemia, but this diagnosis does not appear in the August 18 records. The August 28 records mention anemia, but provide no clinical basis for this diagnosis. Neither set of records documents the injections. Petitioner proved that it overpaid $94.25 and $37.70 for these services. On October 21, 1998, Patient 5 presented at Respondent's office with complaints of chest congestion, cough, and moderate shortness of breath of one day's onset, although she had visited Respondent one week earlier with the same symptoms. Petitioner allowed an aerosol treatment, but disallowed a maximum breathing procedure. Respondent testified that the service was the administration of oxygen, which is documented in the records and medically necessary. Petitioner's worksheets, which are Petitioner Exhibit 19, contain a handwritten note, "no doc[umentation]," but the shortcomings in Petitioner's evidence, as noted in the Preliminary Statement, prevent Petitioner from proving that it overpaid for this service. On November 11, 1998, Patient 5 presented at Respondent's office with complaints of weakness and fatigue of five or six months' duration. Respondent has previously diagnosed Patient 5 with hypothyroidism, and Respondent believed that she was not responding to her medication for this condition. Without ordering blood work to determine thyroid function, Respondent performed a thyroid echogram. However, this echography was not medically necessary, so Petitioner proved that it overpaid $45.24 for this service. On December 4, 1998, Patient 5 presented at Respondent's office with complaints of left chest and ribs pain and recent faintness. Respondent ordered an X ray of the ribs and conducted a physical examination, which revealed a regular heart rhythm. The following day, Respondent performed an echocardiogram and related doppler study. He had performed these tests seven months earlier, but the results were sufficiently different, especially as to new mitral and aortic valve regurgitation, so as to justify re-testing. Given Patient 5's poor health, these tests were medically necessary, so Petitioner failed to prove that it overpaid for these services. On December 17, 1998, Patient 5 presented at Respondent's office with complaints of cervical pain of three or four days' duration and radiating pain into the arms and hands. Noting a decreased grip on both sides and relevant aspects of Patient 5's history, Respondent performed two NCVs, including an H-Reflex, and ordered a cervical X ray. One NCV revealed abnormalities, but the H-Reflex did not. These tests were medically necessary, so Petitioner failed to prove that it overpaid for these services. On January 12, 1999, Patient 5 presented at Respondent's office with complaints of blurred vision, loss of memory, dizziness, and fainting over several months' duration. Respondent performed a carotid echogram, as he had on March 26, 1998. The results of the new carotid echogram were the same as the one performed nine months earlier. The problem is that, again, Respondent betrays his fondness for diagnosis without treatment, as he never addressed the abnormalities detected in the earlier echogram, except to reconfirm their existence nine months later. Petitioner proved that the second carotid echogram was not medically necessary, so it overpaid $99.14 for this service. On February 1, 1999, Patient 5 presented at Respondent's office with continuing complaints of leg pain and cramps. Respondent responded by repeating the doppler study of the veins of the lower extremities and a duplex scan of the veins of the lower extremities that he had performed only seven months earlier and another duplex scan. The main difference in results is that Respondent had suspected from the earlier tests that Patient 5 suffered from "deep venous insufficiency," but he found in the later tests that "mild vein insufficiency is present." Again, though, the tests performed on February 1 lack medical necessity, partly as evidenced by the failure of Respondent to design a treatment plan for Patient 5 after either set of test results. Petitioner proved that it overpaid $99.14, $37.92, and $110.50 for these services. On December 4, 1998, Patient 6 presented at Respondent's office complaining of leg pain, mild shortness of breath, and a cough. Except for the leg pain, the symptoms were of two days' duration. Patient 6 was 35 years old and had a history of schizophrenia and obesity. Respondent performed a physical examination and found decreased breathing with scattered wheezing in both lungs and decreased peripheral pulses, presumably of the lower extremities, although the location is not noted in the medical records. Respondent also found varices on both sides with inflammatory changes and swelling of the ankles. Respondent ordered duplex studies of the vascular system of the lower extremities and a doppler scan of the lower extremities. The results revealed diffuse atheromatous changes in the left lower extremity. Petitioner failed to prove that these services were not medically necessary. On the same date, Respondent performed a spirometry, which was "probably normal." Petitioner proved that this procedure was not medically necessary because of the mildness of the respiratory symptoms and their short duration. Petitioner overpaid $32.06 for this service. Respondent saw Patient 6 on December 9, 12, and 15, 1998, for abdominal pain, but Petitioner has not disallowed any of these services. On December 28, 1998, Patient 6 presented at Respondent's office with complaints of neck pain with gradual onset, now radiating to the upper and middle back, shoulders, and arms, together with tingling and numbness in the hands. Respondent performed three NCVs, including an H-Reflex, even though the physical examination had revealed active deep reflexes and no sensory deficits or focal signs. The results revealed mild abnormalities, which Respondent never discussed in his notes or addressed in a treatment plan. Petitioner proved that these services were not medically necessary, so Petitioner overpaid $195.12, $73.96, and $21.64 for these services. On February 2, 1999, Patient 6 presented at Respondent's office complaining of three days of chills without fever, left flank pain, and urinary frequency. Without first performing a urinalysis, Respondent performed a kidney echogram to rule out kidney stones. The echogram revealed no abnormalities. Petitioner proved that the renal echogram was not medically necessary, so it overpaid $62.37 for this service. On August 25, 1998, Patient 7, who was 58 years old, presented to Respondent's office with complaints of leg pains and cramps of five or six months' duration and some unsteadiness, as well as progressive numbness in her legs and feet. Patient 7 also complained of moderate shortness of breath, anxiety, and depression. The physical examination revealed decreased expansion of the lungs and decreased breath sounds, limited motion of the legs and back, decreased peripheral pulses (presumably of the legs), edema (again, presumably of the lower extremities), varices, and sensorial deficit on the external aspect of the legs. Blood work performed on August 25 was normal for all items, including thyroid function, except that cholesterol was elevated. Respondent ordered a chest X ray and electrocardiogram, which Petitioner allowed, but also ordered doppler studies of the veins and arteries of the lower extremities, an associated duplex scan, a spirometry, three NCVs (including an H-Reflex), and a somatosensory evoked potential test (SSEP), all of which Petitioner denied. Like the NCV, the SSEP is also an electrodiagnostic test that measures nerve function. The NCVs suggested mild peripheral neuropathy, which required clinical correlation, but the SSEP revealed no abnormalities. The doppler studies produced findings that "may represent some early arterial insufficiency" and "may represent some mild venous insufficiency," but were otherwise normal. The spirometry revealed "mild airway obstruction." The results of the tests do not support their medical necessity, nor do the complaints and findings preceding the tests. Petitioner proved that both doppler studies, the duplex scan, all three NCVs, the SSEP, and the spirometry were not medically necessary. Petitioner overpaid $66.48, $38.75, $108.58, $195.12, $73.96, $21.64, $42.68, and $17.70 for these services. Two days later, on August 27, 1998, Patient 7 presented at Respondent's office with swelling of her anterior neck and pain for two weeks. She complained that her eyes were protruding and large and that she had suffered mild shortness of breath for two days. Respondent ordered an echogram of the goiter, which Petitioner denied. Respondent's records contain no acknowledgement of the fact that, two days earlier, blood work revealed normal thyroid function. Even if the laboratory results were not available within two days of the draw, Respondent had to await the results before proceeding to ultrasound. Petitioner proved that the goiter echogram was not medically necessary, so it overpaid $43.24 for this service. On September 21, 1998, Patient 7 presented at Respondent's office with complaints of chest pain, palpitations, and shortness of breath. The physical examination revealed no abnormalities. Respondent performed an echocardiogram and related doppler study, largely, as he testified, to rule out thyrotoxicosis. However, as noted above, the blood work one month earlier revealed no thyroid dysfunction, and the medical records fail to account for this blood work in proceeding with a thyroid rule-out diagnosis. Petitioner proved that these services were not medically necessary, so it overpaid $117.23 and $51.34 for these services. On October 6, 1998, Patient 7 presented at Respondent's office with complaints of gradual loss of memory, fainting, and blurred vision. Respondent performed a carotid ultrasound, which revealed mild to moderate atheromatous change, but no occlusion. Petitioner failed to prove that this test was not medically necessary. Petitioner also downcoded the office visit, but, for reasons set forth above, its proof fails to establish that the billed visit should be reduced. On the next day, October 7, Patient 7 presented at Respondent's office in acute distress from pain of three days' duration in the legs, swelling, heaviness, redness, and fever. The physical examination revealed swelling of the legs and decreased peripheral pulses. Concerned with thrombophlebitis, Respondent ordered a chest X ray to rule out an embolism and a duplex scan of the lower extremities, neither of which revealed any significant abnormalities. Petitioner failed to prove that these tests were not medically necessary. On November 12, 1998, Patient 7 presented at Respondent's office with complaints of abdominal pain and vaginal discharge. One note states that the pain is in the left upper quadrant, and another note states that the pain is in the lower abdomen. The physical examination was unremarkable, but Respondent ordered echograms of the pelvis and spleen, which were essentially normal. Petitioner proved that the echograms were not medically necessary, so it overpaid $46.03 and $51.34 for these services. On November 30, 1998, Patient 7 presented at Respondent's office with complaints with worsening neck pain radiating to the shoulders and arms and decreased muscle strength on both sides. The physical examination uncovered decreased grip, normal pulses, and no focal findings. Respondent ordered three upper-extremity NCVs, including an H-Reflex, and an SSEP. The tests did not produce significantly abnormal results, such as to require any treatment beyond the anti-inflammatory medications typically used to treat the osteoarthritis from which Patient 7 suffered. Petitioner proved that the tests were not medically necessary, so it overpaid $193.12, $73.96, $21.64, and $42.68 for these services. One month later, on December 28, Patient 7 presented at Respondent's office with continuing complaints of neck pain and decreased muscle strength. Although the same three NCVs had revealed nothing significant only one month earlier, Respondent performed the same three tests. Petitioner proved that these tests were not medically necessary, so it overpaid $195.12, $73.96, and $21.64 for these services. On January 8, 1999, Patient 7 presented at Respondent's office with complaints of right upper quadrant abdominal pain of three days' duration with vomiting and urinary disorders. The physical examination suggested tenderness in the right upper quadrant of the abdomen. Respondent performed liver and renal echograms, which were normal. Petitioner allowed the liver echogram, but not the renal echogram. Petitioner proved that the renal echograms were not medically necessary, so it overpaid $62.37 for this service. On April 7, 1998, Patient 8, who was 48 years old and suffered from diabetes, presented at Respondent's office with an ulcer on her right foot with tingling, numbness, and muscle weakness in both legs. Relevant history included the amputation of the right toe. The physical examination revealed an ulcer on the right foot, but no tingling or numbness. Respondent ordered an electrocardiogram and a doppler study of the arteries of the lower extremities, both of which Petitioner allowed. However, Petitioner denied a doppler study of the veins of the lower extremities and a duplex scan of the veins of the lower extremities and three NCVs of the lower extremities, including an H-Reflex. The venous doppler study disclosed a mild degree of venous insufficiency and suggested a mild to moderate peripheral vascula disease without occlusion. The NCVs showed abnormal sensory functions compatible with neuropathy. In place of a report on the H-Reflex test, a report on an SSEP indicated some abnormalities. At the end of the visit, Respondent sent Patient 8 to the hospital for treatment of the infected foot ulcer. Petitioner failed to prove that the NCVs, including the H-Reflex or SSEP, and the venous doppler study were not medically necessary. For reasons already discussed, Petitioner also failed to prove that the office visit should be downcoded. On August 18, 1998, Patient 8 presented at Respondent's office with complaints of neck pain of two or three weeks' duration, dizziness, blurred vision, and black outs. Respondent ordered a carotid ultrasound, which revealed no abnormalities. Given the compromised health of the patient, Petitioner failed to prove that this service lacked medical necessity. On August 26, 1998, Patient 8 presented at Respondent's office with gastric complaints of three days' duration radiating to the upper right quadrant and accompanied by vomiting and occasional diarrhea. Patient 8 continued to complain of neck pain. Since yesterday, Patient 8 reported that she had had a frequent cough and shortness of breath. Her history includes fatty food intolerance, nocturnal regurgitations, and heartburn. The physical examination revealed a soft, nontender abdomen and normal bowel sounds. With "diagnoses" of epigastric pain, abdominal pain, and shortness of breath, Respondent performed, among other things, a spirometry. Given the short duration of Patient 8's respiratory complaints, Petitioner proved that the spirometry was not medically necessary, so Petitioner overpaid $17.70 for this service. On September 29, 1998, Patient 8 presented at Respondent's office with complaints of low back pain, malaise, chills, fever, and urinary disorders, all of three days' duration. The physical examination was unremarkable, but for unrelated findings in the lower extremities. Respondent performed an echogram of the kidneys, which revealed no significant problems. Petitioner proved that this ultrasound procedure was not medically necessary, so it overpaid $61.57 for this service. Respondent also billed for a diabetes test, but the test results are omitted from the medical records. Petitioner proved a lack of documentation for the diabetes, so it overpaid $11.50 for this service. On December 11, 1998, Patient 8 presented at Respondent's office with complaints of moderate neck pain, numbness and weakness of the shoulders and arms, and tingling of the hands, all of three or four months' duration. Diagnosing Patient 8 with cervical disc disease, cervical radiculitis, and diabetic peripheral neuropathy, Respondent ordered three NCVs, including an H-Reflex. The NCVs revealed some abnormalities, but evidently not enough on which Respondent could make a diagnosis and form a treatment plan. Although this Recommended Order finds an earlier set of NCVs of the lower extremities medically necessary, even though Respondent did not act on them, these NCVs are different for a couple of reasons. First, at the time of the lower- extremity NCVs, Respondent was preparing to send Patient 8 to the hospital, where follow-up of any abnormalities could be anticipated. Second, the lower-extremity NCVs were of the part of the body that had suffered most from diabetes, as Patient 8 had lost her toe. The NCVs performed on December 11 were basically in response to persistent or recurrent complaints about neck pain with an inception, for the purpose of this case, in mid-August. The record reveals that Respondent exerted some effort to diagnose the cause of the pain, but apparently never found anything on which he could base a treatment plan, because he never treated the pain, except symptomatically. From this point forward, Respondent could no longer justify, as medically necessary, diagnostic services for Patient 8's recurrent neck pain, but instead should have referred her to someone who could diagnose any actual disease or condition and provide appropriate treatment to relieve or eliminate the symptoms. Petitioner proved that the three NCVs were not medically necessary, so it overpaid $195.12, $73.96, and $21.64 for these services. On January 12, 1999, Patient 8 presented at Respondent's office with complaints of leg pain and heaviness of "years'" duration. She "also" complained of lower abdominal pain, more to the left side, of mild intensity, "but persistent and recurrent," as well as a burning sensation in the vagina. The physical examination is notable because Patient 8 reportedly refused a vaginal examination. Failing to order a urinalysis, Respondent proceeded to perform a pelvic echogram, as well as a doppler study of the veins of the lower extremities and two duplex scans of the arteries and veins of the lower extremities. The omission of a urinalysis and a vaginal examination--or at least a compelling reason to forego a vaginal examination--renders the pelvic ultrasound, whose results were normal, premature and not medically necessary. Except for the duplex scan of the arteries, Respondent had performed these lower-extremity procedures nine months earlier, just prior to Patient 8's hospitalization. Absent a discussion in the notes of why it was necessary to repeat these tests when no treatment plan had ensued earlier in 1998, these procedures were not medically necessary, so Petitioner overpaid $51.78, $99.14, $37.92, and $110.50 for these services. On January 29, 1998, Patient 9, who was 62 years old, presented at Respondent's office with complaints of weakness and numbness in his legs and fear of falling. A physical examination revealed limited range of motion of both knees. The deep reflexes were normal. Respondent performed three NCVs, including an H-Reflex, and an SSEP, all of the lower extremities. The SSEP was normal, but the NCVs produced results compatible with bilateral neuropathy. Petitioner failed to prove that these services were not medically necessary. On January 31, 1998, Patient 9 presented at Respondent's office with complaints of chest congestion and coughs of three days' duration, accompanied by shortness of breath. This record adds COPD to his history. The physical examination revealed normal full expansion of the lungs, but rhonchis and wheezing on expiration. Respondent ordered a spirometry, which revealed a mild chest restriction. Given the chronic pulmonary disease, Petitioner failed to prove that this service was not medically necessary. On April 14, 1998, Patient 9 presented at Respondent's office with complaints of abdominal pain of three days' duration with vomiting and diarrhea. His history included intolerance to fatty foods. The physical examination found the abdomen to be soft, with some tenderness in the right and left upper quadrants, but no masses, and the bowel sounds were normal. Respondent performed a liver echogram, which was normal. Petitioner proved that the liver echogram was not medically necessary, so it overpaid $44.03 for this service. On May 8, 1998, Patient 9 presented at Respondent's office with complaints of chest pain of moderate intensity behind the sternum, together with palpitations that increased on exertion and eliminated on rest. The physical examination revealed regular heartbeats, a pulse of 84, and blood pressure of 150/90. Respondent performed an electrocardiogram, echocardiogram, and doppler echocardiogram. The electrocardiogram revealed a cardiac abnormality that justified the other procedures, so Petitioner failed to prove that these services were not medically necessary. On June 4, 1998, Patient 9 presented at Respondent's office with complaints of malaise and fatigue, which had worsened over the past couple of weeks. The physical examination showed the lungs to be clear and the heartbeat regular. Patient 9's pulse was 76 and blood pressure was 130/80. Respondent performed a chest X ray and another electrocardiogram, both of which were normal. Petitioner proved that these services were not medically necessary, as the chest X ray was unjustified by the symptoms and physical examination, and an electrocardiogram had just been performed one month earlier, so Petitioner overpaid $18.88 and $15.74 for these services. On July 1, 1998, Patient 9 presented at Respondent's office with complaints of ongoing knee pain. Patient 9 had been re-scheduled for knee surgery and required another clearance. Respondent performed another electrocardiogram, even though he had performed one only three weeks ago, and the results had been normal, as were the results from the July 1 procedure. Petitioner proved that this service was not medically necessary, and it overpaid $15.74 for this service. On August 14, 1998, Patient 9 presented at Respondent's office with complaints of pain in his hands and wrists of three or four months' duration, accompanied by tingling in the fingers and a loss of strength in the hands. Respondent performed two NCVs, which revealed findings compatible with neuropathy, but the records reveal no action by Respondent in forming a treatment plan or referring the patient to a specialist. Petitioner proved that these services were not medically necessary, so it overpaid $195.12 and $73.96 for these services. On March 9, 1998, Patient 10, who was three years old, presented at Respondent's office with a sore throat with fever and malaise. His history included asthma, and he had suffered from mild shortness of breath and a dry cough of three days' duration. The physical examination was unremarkable, except for congested tonsils and scattered rhonchis, but no wheezes. Respondent administered an aerosol, which was appropriate, given the young age of the patient and his asthmatic condition. Petitioner failed to prove that this service was not medically necessary. On the next day, Patient 10 again presented at Respondent's office in "acute distress." Although his temperature was normal, his pulse was 110. The findings of the physical examination were the same as the prior day, except that the lungs were now clear. Respondent billed for another aerosol treatment, but the medical records omit any reference to such a treatment. Petitioner proved that Respondent failed to maintain documentation for this treatment, so Petitioner overpaid $10.03 for this service. On May 21, 1998, Patient 10 presented at Respondent's office with a cough, chest congestion, and mild shortness of breath, but no fever. A physical examination revealed scattered rhonchis, but no wheezes, and the boy's chest expression was full. Diagnosing the patient with acute bronchitis, Respondent administered a spirometry and an aerosol. Again, due to the age of the patient and his asthma, Petitioner failed to prove that the spirometry or aerosol was not medically necessary. On August 18, 1998, Patient 10 presented at Respondent's office with chest congestion, cough, and moderate shortness of breath, all of three days' duration. The physical examination showed that the lungs were free of wheezes. Respondent administered an aerosol and a chest X ray. The aerosol was appropriate given the age of the patient and his asthma. However, the chest X ray was inappropriate given the clear condition of the lungs. Petitioner proved that the chest X ray was not medically necessary, so it overpaid $18.88 for this service. On August 6, 1998, Patient 11, who was three years old, presented at Respondent's office with a fever and sore throat, both since the prior day, as well as abdominal pain of two or three weeks' duration. The physical examination disclosed that the abdomen was normal, as were the bowel sounds. Respondent performed a kidney echogram, which was normal. Given the age of the patient, his overall health, and the lack of confirming findings, Petitioner proved that the echogram was not medically necessary, so it overpaid $61.57 for this service. On October 1, 1998, Patient 12 presented at Respondent's office. Respondent billed an office visit, which Petitioner allowed. This is the only item billed for Patient 12 during the audit period, so there is no dispute as to Patient 12. On March 9, 1998, Patient 13, who was 30 years old, presented at Respondent's office with complaints of back pain, chills, burning urination, and general malaise, all of three days' duration. She also complained of lower abdominal pain, vaginal discharge, and pain during intercourse, but denied abnormal genital bleeding. The physical examination disclosed pain in the cervix on motion, but a normal temperature. Respondent performed echograms of the kidneys and pelvis to address his diagnoses of an infection of the kidneys and pelvic inflammatory disease. However, he ordered no blood work. The ultrasounds of the kidneys and the pelvis were normal. The symptoms and findings justified a pelvic echogram, but not a kidney echogram. Petitioner proved that the kidney echogram was not medically necessary, so that it overpaid $61.57 for this service. Petitioner failed to prove that the pelvic echogram was not medically necessary. On March 17, 1998, Patient 13 presented at Respondent's office with complaints of moderate chest pain behind the sternum with palpitations and anxiety. Diagnosing chest pain, mitral valve prolapse, and anxiety, Respondent ordered an electrocardiogram, which Petitioner allowed, and an echocardiogram and doppler echocardiogram, which Petitioner denied. The results from the latter procedures were normal. Petitioner failed to prove that these two procedures were not medically necessary. On June 12, 1998, Patient 13 presented at Respondent's office with complaints of leg pain of two to three months' duration with heaviness and discomfort, especially at night. Patient 13 also complained of mild shortness of breath and moderate cough. The history included bronchial asthma. The physical examination found normal full expansion of the lungs, but scattered expiratory wheezes in both lungs, as well as a possible enlarged and tender liver. The ankles displayed moderate inflammatory changes. Respondent diagnosed Patient 13 with varicose veins with inflammation and bronchial asthma. Respondent performed a doppler study of the veins of the lower extremities, a duplex scan of these veins, and a spirometry, which Petitioner denied, and an aerosol, which Petitioner allowed. The doppler study suggested a mild degree of venous insufficiency with bilateral varicose veins and edema. The spirometry revealed a moderate chest restriction and mild airway obstruction. Petitioner failed to prove that any of these services were not medically necessary. On March 10, November 16, and December 18, 1998, Patient 14 presented at Respondent's office. On each occasion, Respondent billed an office visit, which Petitioner allowed. These are the only items billed for Patient 14 during the audit period, so there is no dispute as to Patient 14. On March 18, 1998, Patient 15 presented at Respondent's office. Respondent billed an office visit, which Petitioner allowed. This is the only item billed for Patient 15 during the audit period, so there is no dispute as to Patient 15. On March 16 and 19 and April 8,1998, Patient 16 presented at Respondent's office. On each occasion, Respondent billed an office visit, which Petitioner allowed. These are the only items billed for Patient 16 during the audit period, so there is no dispute as to Patient 16. On September 4, 1998, Patient 17, who was 52 years old, presented at Respondent's office with complaints of leg pain after exertion and cold feet, as well as low back pain of several years' duration that had worsened over the past two to three weeks. Patient 17 also complained of low back pain that had persisted for several years, but had worsened over the past two to three weeks. The history included an heart bypass. The only abnormalities on the physical examination were decreased expansion of the chest, edema of the ankles, decreased peripheral pulses, and cold feet. Respondent performed a duplex scan of the arteries of the lower extremities, a spine X ray, and an injection to relieve back pain, all of which Petitioner allowed. Respondent also performed an electrocardiogram, which Petitioner denied. Even though the electrocardiogram revealed several abnormalities, nothing in the symptoms, history, or examination suggests any medical necessity for this procedure. Petitioner proved that the electrocardiogram was not medically necessary, so Petitioner overpaid $15.74 for this service. Four days later, on September 8, Patient 17 presented at Respondent's office with complaints of continuing low back pain, now radiating to the legs. The history and findings from the physical examination were identical to those of the office visit four days earlier. Respondent performed three NCVs, including an H-Reflex, which revealed a mild neuropathy. However, the symptoms and history did not justify these diagnostic procedures focused on the legs when the back was the longstanding problem area, nor did Respondent have any treatment plan for the back problem. Eventually, according to Respondent's testimony, a month or two later, he sent this patient to the hospital, where he could receive treatment for this painful condition. Petitioner proved that the three NCVs were not medically necessary, so it overpaid $195.12, $73.96, and $21.64 for these services. On October 2, 1998, Patient 17 presented at Respondent's office with complaints of chest pain on exertion of three days' duration. The physical examination disclosed decreased breath sounds in the lungs, but a regular rhythm of the heart. Respondent performed an echocardiogram, doppler echocardiogram, and duplex scan of the extracranial arteries. Given the patient's history of coronary artery disease and heart bypass, Petitioner failed to prove that these services were not medically necessary. On December 10, 1998, Patient 17 presented at Respondent's office with complaints of left flank pain and bilateral back pain of three days' acute duration, as well as urinary disorder and nausea. The physical examination was unremarkable. Respondent performed a kidney echogram, which was negative, to address his working diagnoses of urinary tract infection and kidney stones. However, Respondent performed no urinalysis, and the complaints did not justify elaborate diagnostics to rule out the improbable condition of stones. Petitioner proved that the kidney echogram was not medically necessary, so it overpaid $59.57 for this service. On October 9, 1998, Patient 18, who was 35 years old, presented at Respondent's office with complaints of chest pain and palpitations of gradual onset over nearly one year, unrelated to exertion and accompanied occasionally by moderate shortness of breath. Patient 18 reported that she had smoked heavily for several years and suffered from intermittent smoker's cough and phlegms. Relevant history included asthma and bronchitis. The physical examination revealed that the lungs were clear and the chest expanded fully. Petitioner allowed several cardiac diagnostic procedures, but denied a spirometry and aerosol, the former as medically unnecessary and the latter as lacking documentation. The spirometry revealed severe chest restriction. Given the results of the spirometry and the history of Patient 18 as a heavy smoker, Petitioner failed to prove that the spirometry was not medically necessary, but, given the mild symptoms at the time of the treatment, without regard to whether Respondent provided documentation, Petitioner proved that the aerosol was not medically necessary, so it overpaid $10.62 for this service. On October 16, 1998, Patient 18 presented at Respondent's office with complaints of persistent neck pain, radiating to the arms and hands. The physical examination disclosed a substantial limitation in range of motion of the neck, but no focal signs. Respondent performed three NCVs, including an H-Reflex, and an SSEP of the upper extremities, which revealed some abnormalities. Notwithstanding the positive findings, the absence of any treatment plan undermines the medical necessity of these diagnostic procedures. In response to these findings, Respondent merely changed Patient 18's anti- inflammatory medication, which he obviously could have done with negative NCVs and an SSEP. Petitioner has proved that the three NCVs and SSEP were not medically necessary, so it overpaid $195.12, $73.96, $21.64, and $42.68 for these services. On October 17, 1998, Patient 18 presented at Respondent's office with complaints of pelvic pain and vaginal discharge with left flank pain and urinary disorders. She also complained of leg pain and fatigue after standing. A previously performed urinalysis had revealed blood in the urine. The physical examination found vaginal discharge and pain in cervix motion to the right and left sides. It also found normal peripheral pulses and normal movement in all limbs, although some varicosities and inflammatory changes were present. Respondent performed echograms of the kidneys and pelvis and a doppler study and duplex scan of the veins of the lower extremities. Although both echograms were normal, these procedures were justified due to the symptoms and findings. The procedures performed on the lower extremities, which revealed a mild degree of venous insufficiency, were not justified by the complaints or findings. Petitioner failed to prove that the echograms were not medically necessary, but proved that the doppler and duplex procedures were not medically necessary, so it overpaid $38.75 and $108.58 for these services. On November 18, 1998, Patient 18 presented at Respondent's office with complaints of weakness of two to three months' duration and eating disorders. The physical examination uncovered a palpable, enlarged thyroid, even though, one month earlier, the physical examination found the thyroid to be non- palpable. Although the medical records indicate that Respondent ordered laboratory tests of thyroid function, no such reports are in his medical records, and, more importantly, he performed a thyroid echogram, which was normal, prior to obtaining the results of any laboratory work concerning thyroid function. Petitioner proved that the echogram was not medically necessary, so it overpaid $45.24 for this service. On January 21, 1999, Patient 19, who was four months old, presented at Respondent's office with a cough. Eight days earlier, Patient 19 had presented at Respondent's office with the same condition, and Respondent had recommended that the patient's mother hospitalize him if the symptoms worsened. A physical examination revealed that the lungs were clear and the chest fully expanded. Respondent administered an aerosol. Petitioner proved that the aerosol was not medically necessary, so it overpaid $10.97 for this service. On February 2, 1998, Patient 21, who was 46 years old, presented at Respondent's office with complaints of generalized headache and chest discomfort. For the past two weeks, Patient 21 had also suffered from painful urination. The relevant history included non-insulin-dependent diabetes and paranoid schizophrenia. The physical examination indicated that Patient 21's heart beat in regular rhythm. Patient 21's blood pressure was 190/105, and his cholesterol and triglyceride were high. His femoral and popliteal pulses were decreased. Respondent performed an electrocardiogram, which Petitioner allowed, and, after learning that the results were borderline abnormal, an echocardiogram and doppler echocardiogram, which Petitioner denied. Given the symptoms, Respondent was justified in proceeding with additional diagnostic tests, especially given the difficulty of treating a schizophrenic patient. Petitioner failed to prove that the echocardiogram and doppler echocardiogram were not medically necessary. On March 2, 1998, Patient 21 presented at Respondent's office with complaints, of four months' duration, of leg pain when standing or walking a few blocks. The physical examination revealed decreased peripheral pulses. Respondent performed a doppler study and duplex scan of the veins of the lower extremities, which were both normal. Given the diabetes and schizophrenia, these diagnostic procedures were justified. Petitioner failed to prove that these services were not medically necessary. On April 2, 1998, Patient 21 presented at Respondent's office with complaints of worsening leg pain, now accompanied by numbness and tingling in the feet and sensorial deficit on the soles of the feet. The physical examination was substantially the same as the one conducted one month earlier, except that the deep reflexes were hypoactive. Respondent performed three NCVs, including an H-Reflex, on the lower extremities, and they revealed abnormal motor functions. However, the failure of Respondent to prepare a treatment plan or refer Patient 21 to a specialist precludes a finding of medical necessity. Petitioner has proved that these NCVs were not medically necessary, so it overpaid $195.12, $73.96, and $21.64 for these services. On April 30, 1998, Patient 21 presented at Respondent's office with complaints of difficulty urinating for the past three or four days. A physical examination revealed an enlarged, tender prostate. Forming a working diagnosis of prostatitis and chronic renal failure, Respondent performed prostate and kidney echograms, which were both normal, but no laboratory work on the urinary problems. Petitioner failed to prove that the prostate echogram was not medically necessary, but proved that the kidney echogram was not medically necessary, so it overpaid $61.57 for this service. On July 3, 1998, Patient 21 presented at Respondent's office with complaints of visual disorders, dizziness, blacking out, and fainting, all of several months' duration. Respondent performed a carotid echogram, which was normal. Petitioner failed to prove that this service was not medically necessary. On August 4, 1998, Patient 21 presented at Respondent's office with complaints of moderate neck pain of five or six months' duration, radiating to the shoulders and arms and accompanied by tingling and numbness of the hands. The physical examination disclosed decreased femoral and popliteal pulses, limited motion in the neck and shoulders, pain in the shoulders upon manual palpation, pain in the wrists upon passive movements, and decreased grip on both sides. Respondent performed two NCVs, including an H-Reflex, and an SSEP, all of the upper extremities. The NCVs suggested bilateral carpal tunnel syndrome, and the SSEP showed some abnormalities of nerve root function. Respondent responded to these data with a prescription for physical therapy three times weekly. Petitioner failed to proved that the two NCVs and SSEP were not medically necessary. On September 1, 1998, Patient 21 presented at Respondent's office with complaints of "chest oppression" and hypertension since the previous day. Patient 21 also complained of moderate neck pain and urinary discomfort of three days' duration. His blood pressure was 160/100, and his heart was in regular rhythm. Respondent performed an electrocardiogram, which Petitioner allowed, and a 24-hour electrocardiogram with a halter monitor, after learning that the results of the initial electrocardiogram were abnormal. Petitioner disallowed the latter procedure, but failed to prove that it was not medically necessary. On October 6, 1998, Patient 21 presented at Respondent's office with complaints of chest pain, dizziness, fainting, excessive hunger and weight gain, and weakness. His blood pressure was 170/100, and his pulse was 88. His heart beat in a regular rhythm, and his thyroid was enlarged, but smooth. Respondent performed an echogram of the thyroid, even though he had not ordered laboratory work of thyroid function. He performed an echocardiogram and a doppler echocardiogram. All echograms were normal, although Patient 21 suffered from some mild to moderate sclerosis of the aorta. Petitioner proved that these echograms were not medically necessary because the thyroid echogram was not preceded or even accompanied by laboratory work of thyroid function, and the other procedures of repeated diagnostic tests that Respondent had performed eight months earlier and were normal at that time. Petitioner thus overpaid $43.24, $61.96, and $29.31 for these services. On November 6, 1998, Patient 21 presented at Respondent's office. Petitioner downcoded the office visit, but, as discussed above, the failure of Petitioner to produce the CPT manual prevents a determination that Respondent overbilled the visit. On January 4, 1999, Patient 21 presented at Respondent's office with complaints of flank pain of four months' duration accompanied by several urinary disorders, chills, and occasional fever. The physical examination revealed a distended and soft abdomen and tenderness in the flanks and right upper quadrant. Respondent performed a kidney ultrasound, despite having performed one eight months earlier and obtained normal results, but learned this time that the left kidney had a cyst consistent with chronic renal failure. Petitioner failed to prove that this service was not medically necessary. On January 29, 1999, Patient 21 presented at Respondent's office with complaints of moderate back pain of two weeks' duration, radiating to the legs, and weakness in the legs. The physical examination revealed pain on bending backward or forward and muscle spasm. Respondent performed a lumbar X ray, which Petitioner allowed, and three lumbosacral NCVs, including an H-Reflex, which Petitioner denied. The NCVs revealed mild neuropathy, although an SSEP, evidently billed as an H-Reflex, was normal. Petitioner failed to prove that these services were not medically necessary. The total overpayments, before extrapolation, from Petitioner to Respondent are thus $5952.99.
Recommendation It is RECOMMENDED that the Agency of Health Care Administration enter a final order determining that, prior to extrapolation, Respondent owes $5952.99 for overpayments under the Medicaid program. DONE AND RECOMMENDED this 26th day of May, 2006, 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 26th day of May, 2006. COPIES FURNISHED: Alan Levine, Secretary Agency for Health Care Administration Fort Knox Building, Suite 3116 2727 Mahan Drive Tallahassee, Florida 32308 Christa Calamas, General Counsel Agency for Health Care Administration Fort Knox Building, Suite 3431 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Jeffries H. Duvall Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Craig A. Brand Law Offices of Craig A. Brand, P.A. 5201 Blue Lagoon Drive, Suite 720 Miami, Florida 33126 Oscar Mendez-Turino 2298 Southwest 8th Street Miami, Florida 33135
Findings Of Fact Respondent is a physician licensed to practice medicine in Florida. His office is located on Sanibel Island in Lee County. A Sanibel Island tourist, Mrs. Marion Wallace, presented herself as a patient at Respondent's office on the morning of March 2, 1981. She complained of abdominal pain and swelling. Mrs. Wallace was seen by Mr. Kern Barrow, a physician's assistant employed by Respondent. Barrow conducted a physical examination of Mrs. Wallace's abdominal region and took her medical history, noting abdominal distension, abdominal pain, anorexia, nausea, vomiting and dysuria. She had not been feeling well for several days and had experienced some nausea and vomiting in the early morning hours of March 2, 1981. Barrow conducted a routine physical examination that included examination of the abdominal region, neck, mouth and throat. No medical tests were ordered or conducted by Barrow other than a urinalysis. Barrow's preliminary diagnosis was viral gastroenteritis or urinary tract infection. He administered ampicillan and prescribed donnagel for her cramping and gaviscon for the abdominal distension or gas. He administered an injection of compazine to prevent further nausea and vomiting. Barrow could not remember consulting with Respondent concerning Mrs. Wallace on March 2, but told her to come back if her condition did not improve. He described Mrs. Wallace as looking ill, but not mortally ill. Respondent did not see Mrs. Wallace on March 2, but reviewed and initialed the chart prepared by Barrow. Respondent prescribed the medication "Tagamet," but did so only because the patient requested it, claiming to have received relief for gastritus from this medication. Mrs. Wallace returned to Respondent's office on the morning of March 3, continuing to complain of abdominal pain and swelling. Respondent examined the patient at that time, but did not perform a rectal examination. He did not order a blood test, barium enema or x-ray. He noted "observe" on her chart, but did not schedule a return visit. He tentatively diagnosed her condition as diverticulitis. Mrs. Wallace, who did not testify in this proceeding, claimed that her condition had worsened between her visits to Respondent's office on March 2 and March 3. This fact was not established by direct evidence. However, on March 4 she presented herself to another Fort Myers area physician who sent her to the hospital emergency room where her condition was diagnosed as "acute abdomen" necessitating immediate surgery. During the surgery performed on March 4, it was discovered that Mrs. Wallace had a perforated gangrenous appendicitis with abscess formation, peritonitis, and a small bowel obstruction. These are serious and dangerous medical conditions. The testimony of Respondent and the other physicians who testified in this proceeding established that his tentative diagnosis was not inappropriate given the patient's symptoms. However, his failure to perform tests (such as a blood test for white blood cell count, x-ray, rectal examination or barium enema) was a serious lapse in view of her condition and his tentative diagnosis. His prescribing of Tagamet was not shown to have been improper. Respondent's use of a physician's assistant for the initial examination was likewise not shown to have been improper. However, Respondent's inability to note any progression of her symptoms between March 2 and 3 resulted from his overreliance on the physician's assistant and failure to conduct even a minimal examination of her on March 2.
Recommendation From the foregoing, it is RECOMMENDED: That petitioner enter a Final Order (1) finding Respondent guilty of failure to practice medicine with that level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances; and (2) reprimanding and fining Respondent $1,000. DONE and ENTERED this 21st day of January, 1983, in Tallahassee, Florida. R. T. CARPENTER, 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 21st day of January, 1983. COPIES FURNISHED: J. Riley Davis, Esquire Post Office Box 1796 Tallahassee, Florida 32302 Leonard A. Carson, Esquire Post Office Box 1528 Tallahassee, Florida 32302 Dorothy Faircloth, Executive Director Board of Medical Examiners Dept. of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Samuel R. Shorstein, Secretary Dept. of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 ================================================================= AGENCY FINAL ORDER ================================================================= BEFORE THE BOARD OF MEDICAL EXAMINERS DEPARTMENT OF PROFESSIONAL REGULATION, BOARD OF MEDICAL EXAMINERS, Petitioner, vs. CASE NO. 82-815 STANLEY P. WEGRYN, M.D., License Number: 23028, Respondent. /
The Issue The matters presented for consideration in this action are related to an Administrative Complaint brought by the State of Florida, Department of Professional Regulation, against Dr. Lee, accusing him of having violated various provisions of Chapter 458, Florida Statutes, pertaining to his practice of medicine. The complaint accuses the Respondent of violating Section 458.331(1)(t), Florida Statutes, by gross or repeated malpractice or the failure to practice medicine with the level of care, skill and treatment which is recognized by reasonably prudent similar physician as being acceptable under similar conditions and circumstances, related to the treatment of several patients. Respondent is also accused of having failed to keep written medical records justifying the course of treatment for those patients in violation of Section 458.331(1)(n) , Florida Statutes.
Findings Of Fact William J. Lee, M.D., is a physician licensed to practice medicine in the State of Florida through a license issued by the State of Florida, Department of Professional Regulation, Board of Medical Examiners, License No. MEO12345. He has held that license at all times relevant to this case and in that time sequence has practiced general medicine and general surgery in Jacksonville Beach, Florida, in his office and at Jacksonville Beach's Hospital in that same community. Dr. Lee is 51 years old and is a graduate of Emory University in 1958, receiving his M.D. from Emory in 1964. He did an internship at the University of Florida in Gainesville, Florida, followed by a residency in general surgery at the University of Florida from 1965 through 1968 and completed his residency at Duval Medical Center in Jacksonville, Florida, in 1969. The Administrative Complaint, which is the subject of this hearing was filed on February 22, 1983. Proper service of the Administrative Complaint was effected upon the Respondent and Dr. Lee made a timely request for formal hearing pursuant to Section 120.57(1), Florida Statutes. THELMA A. PARKER From August 9 through 13, 1974, Thelma Parker was treated medically at Memorial Hospital of Jacksonville, Jacksonville, Florida, for acute diverticulitis. This treatment was provided by Dr. C. Cooksey. In particular, Dr. Cooksey's medical regime was NOP, IV fluids, and large doses of Fibramycin. A barium enema was done on the patient on August 10, 1974, and revealed diverticulosis of the sigmoid colon and one large acutely inflamed diverticulum of the mid-sigmoid level. This diverticulum was unusually long and Dr. Cooksey was of the impression that the diverticulum produced some edema of the bowel wall with low grade obstruction. Finally, Dr. Cooksey felt that at some point the diverticulum should be resected because of its size. In late August 1978, Ms. Parker, who had become a patient of the Respondent's, began to experience cramping, and diarrhea pain for which she took lomotil to slow down the bowel activity. This relieved her symptoms temporarily. Nevertheless, the symptoms persisted and on September 2, 1978, Ms. Parker went to the emergency room at Jacksonville Beach's Hospital, displaying the same type of pain and showing a mild distention. This pain was a generalized to and fro type of pain of cramping nature across the area of the abdomen. It was not localized. Dr. Lee admitted the patient to that hospital on that date. At that time, Dr. Lee was aware of the prior 1974 bout which the patient had with diverticulitis. Lee obtained an x-ray obstruction series and based upon this information felt that possible explanation was adynamic ileus versus early obstruction. He did not feel that the patient was suffering from diverticulitis in that there was no indication of lower left quadrant abdominal pain, bowel dysfunction such as constipation or obstipation and no indication of temperature elevation, indicators of diverticulitis. The symptoms she did display were not inconsistent with diverticulitis. At admission, the Respondent did note the past history of diverticulitis and the emergency room admission and hospital records indicated chronic lower quadrant abdominal pain and change in bowel habits and diarrhea, which are consistent with diverticulitis. Based upon examination of the patient, x-rays and associated materials, Respondent performed an exploratory laparotomy on September 4, 1978, for the purpose of relieving a small bowel obstruction. In the surgery, he found grossly dilated loops of the small bowel with obvious obstruction of the terminal ileum approximately 15 cm's proximal to the ibocacal valve. He found that area to be "firmly adherent to a mass of scar tissue in the sigmoid colon area of the pelvis with chronic low grade inflammatory reaction present in the region." The portion of the ileum that was involved in this was wound severely upon itself with the massive scar tissue in the area. Given the condition, he determined to resect that portion of the small bowel and effected a repair by anastomosis. No evidence was revealed in the course of the operation of any blockage of the large bowel, based upon his observations and manipulations. Gross examination was also made of the sigmoid colon and this revealed no dilation. No contrast studies were done to examine the lumen of the sigmoid colon, such as barium enema or colonscopy. Those studies would have ruled out diverticulitis in the area of the sigmoid colon. The post operative diagnosis by Dr. Lee was small bowel obstruction, secondary to diverticular disease and upon the discharge date of September 14, 1978, the diagnosis was 1) small bowel obstruction and 2) diverticular disease. The patient was seen in Dr. Lee's office on September 18, 1978 and had a fever and abdominal symptoms. She was told to see the doctor again on the next day and lacking improvement on that date was admitted to the hospital on September 19, 1978. At the time of admission on September 19, 1978, initial impression by Dr. Lee was that the patient was suffering intra-abdominal abcesses, secondary to anastomostic break or leakage in the area of the resection of the small bowel. The patient demonstrated a tenderness in the lower abdomen and had some nausea and vomiting. On rectal examination, the patient demonstrated a fluctuant area in the rectum, at the pelvic basin formed by the peritoneum. This area was determined to be an abscess and on September 26, 1978, Dr. Lee performed a procedure by going through the anus into this area of abscess and making an incision in the wall of the rectum to allow drainage of the abscess through the rectum. There was some improvement but the patient continued to have temperature elevation and abdominal pain and on October 2, 1978, further laparotocy was done and an anastonimotic break was discovered. Reanastomosis was achieved following a second resection in the area of the initial small bowel obstruction. Gross examination during the course of this surgery did not reveal any evident blockage of the large intestine or active diverticulitis. Again, no specific diagnostic work was done to determine the condition of the sigmoid colon related to diverticulitis. During the surgery, in addition to the revision of the ileostomy, abdominal abscesses were also evacuated. The patient was discharged on October 21, 1978. After her release in October 1978, the patient was seen on a number of occasions by the Respondent and indicated occasional episodes of cramping, diarrheal type stool but no localized pain in the left, lower quadrant, constipation or obstipation. The patient developed a ventral hernia in the area of the incision related to the abdominal surgery performed by the Respondent and on June 21, 1979, was admitted to the hospital to attend that condition. Exploratory laparotomy was dome on June 22, 1979 and the Respondent did further resectioning and reanastomosis in the area of the small bowel repair together with repair to the ventral incisional hernia. The large intestine in the area of the previous diverticular disease was examined and no indication, on gross examination, was given as to obstruction of the large bowel or any showing of acute inflammation in the area of the sigmoid colon suggesting diverticulitis. As was the case before, no specific examination of the sigmoid colon by a process of barium enema or otherwise was made at the time of this hospitalization. The patient was seen in the Respondent's office on July 3, 1979, and it was noted that her wound from the most recent operation was healing and that her appetite was good and bowel movements normal. A further visit of July 6, 1979, revealed a pink, serous drainage from the portion of the most recent incision and the abdomen was tender. Eventually, the patient had to be readmitted on July 23, 1979. Upon admission, it was believed that the patient was suffering intra-abdominal abscesses. She demonstrated temperature elevation and abdominal pain. The serous drainage from the incision had subsided. On this admission, particularly July 27, 1979, Dr. Lee did obtain a barium enema for purposes of examining the sigmoid colon and it showed a narrowed portion within the sigmoid colon with a communication to an abscess in the pelvis and from there a fistula to the small bowel at the site of the anastomosis. The abscess described was an abscess that had been addressed by Dr. Lee on September 26, 1978. This narrowing in the sigmoid colon was a partial obstruction, leaving an approximate functional capability of 10 percent. No dilation was observed in the bowel proximal to the area of partial obstruction and there was no distention. The narrowing was caused by the diverticular disease process. No evidence was found of an active condition of diverticulitis in the sigmoid colon. On July 30, 1979, a further surgical course was pursued by Dr. Lee and a segment of the small bowel in the area of the previous attempts at anastomosis was removed and a reanastomosis was done with a cleaning up of the previously described fistula tract and associated repairs. No attention was given to the narrowing of the sigmoid colon. On August 6, 1979, Dr. Lee opened and drained large abscesses in the abdominal wall and this was followed on August 9, 1979, with his notation of a small bowel fistula. On August 10, 1979, the patient requested consultation with another surgeon, Dr. James Corwin and was transferred to his care on August 12, 1979. Corwin advised the patient to have a loop colostomy to try and address continuing problems as described by prohibiting the sigmoid colon from contributing to those difficulties. This procedure was carried out by Dr. Corwin on August 17, 1979. Resection of the sigmoid colon was done by Dr. Corwin on September 17, 1979. (Pathology related to the sigmoid colon showed diverticulosis, indication of diverticular disease. It did not show active diverticulitis.) The patient accepted Dr. Corwin's suggestion that the colostomy and resection of the sigmoid colon were necessary, without hesitation. Respondent's suggestion by testimony or record that he had discussed with Ms. Parker the need to address her diverticular condition and possible resection of the sigmoid colon and her rejection of such diagnosis and treatment is not accepted. These discussions allegedly occurred between her release from the hospital in October 1978, and her hospitalization in June 1979. When examined in light of the facts found, specifically her willingness to submit to all other operations and procedures by Dr. Lee and to accept Corwin's treatment of the colon when suggested, Respondent is not to be believed on this subject. Ms. Parker failed to recover from the series of problems as discussed and died on October 28, 1979. The diverticular disease in the colon contributed to her demise and Dr. Lee failed to diagnose and treat that condition. Notwithstanding the fact that Ms. Parker did not take care of herself in terms of her physical condition, related to her drinking habits, Respondent was not relieved from the necessity to diagnosis and address the problem with the sigmoid colon. Dr. E. R. Woodward testified on behalf of the Petitioner, after being accepted as an expert in medicine with particular emphasis on general surgery. Dr. Woodward is a professor of surgery and former chairman of the Department of Surgery at the University of Florida, College of Medicine, and is a member of various boards, colleges and associations related to the practice of surgery and has written approximately 250 publications and authored two books in the field of general surgery. His testimony was based upon the review of hospital records related to Parker's various hospitalizations under the care of Dr. Lee that have been addressed. Dr. Woodward is of the opinion that the patient suffered diverticulitis in the sigmoid colon at times relevant to the inquiry and finds fault with Dr. Lee's failure to diagnose and treat this condition which Dr. Woodward felt was the underlying cause of the patient's problems pertaining to obstruction in the small bowel and associated anastomotic failures. Even without such diagnoistic procedures as barium enema or otherwise, Dr. Woodward feels that Dr. Lee recognized the diverticulitis of the colon in describing the chronic inflammatory reaction in the area of the sigmoid colon in his September 4, 1978, post operative report. Dr. Woodward revealed that in the September 19, 1978, admission that one of the x-rays showed air fluid levels in the right colon which is indirect evidence of a possible problem of an obstruction in the sigmoid colon. Moreover, given the fact that the intestines heal extremely well, according to Dr. Woodward, the problem with the anastomosis was possibly due to the fact that the lining of the intestine beyond the anastomosis was not open sufficiently and that there was some degree of obstruction as was revealed in the area of the sigmoid colon, which had been caused by chronic diverticulitis. By the time of the June 21, 1979, hospitalization, Dr. Woodward felt that the patient's condition was such that her recovery was not promising. Even in the face of information found after the July 27, 1979, barium enema, Dr. Lee did not address the difficulty with the narrowing in the colon by some process of diverting colostomy or other surgery of the colon. In Dr. Woodward's mind, this was necessary at the time of the September 4, 1978, surgery and continued to be a need at the time of the July 30, 1979, surgery. Risk of mortality increased from 2 percent to as high as 10 percent at the July 30, 1979, operation. Subsequent to that operation, the patient was so ill and the infection so severe that the mortality risk related to surgery was prohibitive, per Woodward. In summary, Woodward felt that the Respondent's failure to diagnose and treat the diverticular condition in the sigmoid colon led to her eventual demise and was such quality of treatment as to constitute gross or repeated malpractice and the failure to practice medicine with a level of care, skill and treatment which is recognized by reasonably prudent similar physicians as being acceptable under similar conditions or circumstances. Dr. Corwin, gave his expert opinion, as a general surgeon, after being accepted in that field. This is the same Dr. Corwin who treated Thelma Parker. Dr. Corwin feels that given a past history of diverticulitis, which the Respondent knew about and the condition which he found upon the original surgery performed in the abdomen, Respondent should have searched for the cause of that condition which most likely was the patient's diverticulitis. This opinion refers to the need for an examination by barium enema or some other form of contrast study to determine the condition of the sigmoid colon. The narrowing or obstruction in the area of the distal colon, as described, was felt by Dr. Corwin to be almost total in that the colon was reduced to an approximate 10 percent function. Corwin felt that the Respondent had made a major mistake in his treatment of the patient in not attempting to ascertain the cause of the abscesses and obstruction and to deal with the problem in the colon which he considered to be the underlying cause of her difficulties. According to Corwin, the quality of that mistake was so severe as to constitute gross mistreatment of the patient. He feels there was malpractice in that the problem in the colon was at least partially responsible for the anastomotic breaks. At minimum, Dr. Corwin felt that a diverting colostomy was necessary to address the problem with the colon and probably a resection of the sigmoid colon, which procedures were done by Corwin subsequent to assuming the case. Dr. Wiley Douglas Fowler, Jr., who is a board certified, general surgeon, practicing in the community where Respondent practices, gave testimony. He too felt that the Respondent had failed to deal with the condition in the sigmoid colon which he considered to be diverticulitis. There was a need to do a diverting colostomy and to do further definitive treatment as necessary to address the diverticular condition, per Fowler. He felt that there was a breakdown in surgical judgment to the point that the doctor was unable to perform the responsibilities of care in the case. Dr. Samuel Stephenson, who is a board certified general surgeon practicing in Jacksonville, Florida, testified. He did not find the quality of Dr. Lee's care to be-substandard related to the patient Parker. He placed emphasis on the fact that in his opinion gross signs such as dilation in the colon or large bowel were not observable and no active condition of diverticulitis was ever discovered during Parker's treatment course from the time of the Respondent's involvement to her demise. He did indicate that the barium enema results of July 27, 1983, might make one wonder if the narrowing in the sigmoid colon had caused some of the other recurring problems associated with anastomotic breaks in the small intestine. He indicated that by July 30, 1979, there might be a need for a colon resection. Stephenson was impressed with the fact that the patient died even after attempts to address the problems with the colon, i.e., the temporary colostomy and resection of the colon done by Dr. Corwin, leading him to wonder if the cause of continuing failure in the area of repair at the small bowel was due to some circumstance other than problems in the sigmoid colon. He believed that in the initial admission of September 1978, that there was a possibility of a problem with diverticulitis as well as the small bowel obstruction but no gross signs indicated an active condition of diverticulitis in the area of the colon, such as dilation. The mass that was discovered at the point of the initial laparotomy in September 1978, might have been from the colon or might not have been in the mind of Dr. Stephenson. The thrust of Dr. Stephenson's testimony seems to be that absent a clear indication that diverticulitis in the colon or the narrowing in the colon was the proximate cause of the anastomotic breaks and attendant processes of infection, there was no duty on Dr. Lee's part to rule out the possible involvement of the sigmoid colon as an explanation for the problems with the healing process in this patient. Upon reflection, the impressions gained by Drs. Woodward, Corwin and Fowler, witnesses for the Petitioner, are more compelling than those of Dr. Stephenson, on the subject of culpability by the Respondent related to the patient's care. Evidence reported establishes that the Respondent should have examined the colon by barium enema or some similar process at the point of the initial surgery and certainly before her final admission in July 1979, and when finally so examined the colon was not treated. This failure is excerbated by the fact that the Respondent knew that the patient had a history of diverticulitis. The diverticular condition in the colon, to include the partial obstruction by narrowing, based upon the opinions of the third party experts, is found to have been a contributor to the continuing problems of anastomotic leakages, abscesses and other conditions which would not allow a successful treatment course for the patient. Even if diverticulitis in the colon or the diverticular condition in that organ did not cause failure in her treatment results, per the physicians, whose opinion is accepted, the circumstance in the colon should have been examined and ruled out at a minimum. The idea expressed by Dr. Stephenson, that in the absence of being able to clearly establish that the colon's condition caused the patient's demise, the Respondent may not be held accountable, is unacceptable. Having determined that the diagnosis should have been made, Respondent should have performed the diverting colostomy to be followed by a resection of the colon if necessary, again in keeping with the opinions of Petitioner's experts. Finally, the opinion related to Respondent's malpractice and failure to perform at an acceptable standard for same or similar physicians, as attributed to Dr. Woodward and supported in concept by Dr. Corwin, is accepted. Respondent is accused of having failed to keep adequate medical records pertaining to the patient Parker. Although there was some demonstrated ambiguity in his record keeping, that ambiguity does not rise to the level of finding facts showing a violation related to record keeping on this patient. JOHN WILLIAM PHILLIPS On July 2, 1979, John William Phillips had an accident in which he fell off of a ladder and came to the emergency room at Beach's Hospital for treatment. An admission was made on July 3, 1979, and Dr. Lee undertook the care of the patient. The patient suffered multiple fractures of the ribs, had a contusion of the left shoulder, was demonstrating slight tenderness in the left flank and evidenced a large swollen and contused area in the left chest wall posterior with tenderness. He showed a normal abdomen with bowel signs present but hypo-active. The patient suffered nausea, abdominal distention and tachycardia. From admission through July 12, 1979, the patient waxed and waned. He received fluids and pain medication and a series of x-rays were taken to better understand his condition. On July 12, 1979, a liver scan was made which demonstrated a cold area in the left lobe of the liver, leaving Dr. Lee in the position of ruling out hemotoma versus tumor versus cyst, though he believed the condition to be benign and unrelated to the accident. The cold spot on the x- ray appeared as a smooth contoured defect. The patient continued to show distention following the liver scan and continued to evidence tachycardia and vomiting for the next several days. Respondent did not choose to verify his preliminary clinical impression of the condition of the liver related to the defect, by use of sonogram or angiogram, electing instead to wait for the patient's condition to change for better or worse. On July 15, the patient showed marked increase in temperature. On that date, a chest x-ray demonstrated plate-like atelectasis in the right lung and an elevated diaphragm. With the advent of the temperature elevation on July 15, the patient was transferred to the CCU unit of the hospital and among other matters prescribed, a broad spectrum antibiotic was ordered. The patient was showing an elevated blood count at that time. Following the liver scan, the patient had also developed rapid pulse and shown mental confusion. By the morning of July 15, the patient's condition was one approaching septic shock if not in that condition. Clinically, there was indication of sepsis or septicemia. The family of the patient requested a second opinion and the patient was subsequently transferred to Dr. Corwin. Dr. Woodward gave his opinion about the treatment of Phillips, expressing the belief that the problems evidenced related to this patient were too long and severe and too related to an abdominal condition to be associated solely with the injury in the chest. Given the location of the injury, Dr. Woodward felt like the defect in the liver, seen on the scan, may have been related to the injury. Dr. Woodward felt that the Respondent should have established whether or not the lesion in the liver was caused by the accident, either by exploratory laparotomy or selective arteriogram. To do otherwise would be less than expected of a prudent general surgeon, according to Dr. Woodward. In essence, Dr. Woodward felt that something should have been done to verify the character of the defect shown on the liver scan and whether that defect was associated with injury suffered by the patient. Dr. Corwin testified about the treatment afforded Phillips. He felt that at the time that he took over the case on July 15, that the quality of the septicemia suffered by the patient was such that he was in septic shock and that an operation was necessary to address the defect in the liver. An operation was undertaken to remove that defect and when first visualized, Dr. Corwin was not sure whether the defect was a cystic hemangioma or not, although it gave an appearance of being that condition. (At the time of the liver scan, given the location of the liver defect, Corwin felt that most probable explanation was hematoma or tear in the left lobe of liver, cystic hemangioma being a rare occurrence in liver.) After removal of this cyst, the patient began to improve and Dr. Corwin believes that the removal of the cyst contributed to that improvement. He thinks that the area of the cyst became a seed bed for the septicemia in the sense of aiding in the circulation of bacteria in the patient's system. Dr. Corwin had criticism of Dr. Lee in the treatment of Mr. Phillips in the sense that once the patient's condition began to decline, approaching the place and time at which Corwin was substituted as the physician, Dr. Lee should have done more to determine the true nature of the patient's problem. He does not feel that the Respondent's treatment can be described as malpractice. He is simply of the opinion that the case was not handled very well and showed poor judgment by the treating physician. Dr. Fowler testified about the care of the patient Phillips after examining the records of hospitalization. He indicated that given the deteriorating condition of the patient, that there was an indecisive action pattern on the part of Dr. Lee but it was not of such proportions as to constitute a breakdown in the care of the patient. He had no specific opinion as to whether this conduct by Dr. Lee constituted gross or repeated malpractice. Stephenson's opinion of the Respondent's treatment of Phillips was to the effect that it was not substandard. Given the appearance of the cold spot on the liver scan, he felt certain that this was a cyst or hemangioma and not a hematoma. He indicated that uncertainty in this regard could have been confirmed by a sonogram. He did not find the necessity to conduct surgery to discover the condition of the liver. Having considered the facts of the treatment of Phillips and the opinions of the experts, while the Respondent's reactions to Mr. Phillips' condition were less than sterling, they did not reach the level of constituting gross or repeated malpractice or care unworthy of a same or similar physician. Again, the records kept by the Respondent related to the care of Mr. Phillips were sufficient. CLIFTON WORCESTER On January 31, 1977, Respondent conducted surgery on Clifton Worcester to patch a perforated duodenal ulcer. Worcester had further hospital admissions on June 21, 1978 and August 1, 1978, for recurrent ulcer symptoms. On these occasions he was treated medically. On December 27, 1978 through January 4, 1979, the patient was admitted for the treatment of pneumonia. On September 6, 1979, Worcester was admitted to the hospital under the Respondent's care for conditions which preliminarily seemed to be related to respiratory and cardiac problems. At that time, the patient was 74 years old and was in a deteriorated condition suffering from a variety of maladies to include cardiac and respiratory conditions as well as the peptic ulcer disease. On September 9, 1979, Respondent after diagnosis determined that the patient was suffering from ulcer disease and an operation was done to repair the perforated pyloric ulcer. A Graham closure was used with omental patch and permanent silk sutures were employed. This ulcer was the same ulcer as had caused problems for the patient in 1977. On the morning of September 12, 1979, blood was visualized from the nasogastric tube which had been placed in the patient and when the patient was later irrigated, a large amount of blood appeared. The initial impression by Dr. Lee was that this blood was either due to the active peptic ulcer or possibly gastritis. To ascertain the source of bleeding, Dr. Corwin was called in to do a gastroscopy. That procedure was done around 7:00 pm. on September 12, 1979. Although the entire area of the stomach could not be visualized, Dr. Corwin was of the impression that the cause of the bleeding was not gastritis, leaving the most probable explanation to be that the patient had a problem of a bleeding ulcer. Dr. Corwin made it known to the Respondent that the bleeding was probably due to an ulcer as explanation for the lesion and Dr. Lee acknowledged that the probable source of bleeding was an ulcer condition. In the early morning hours of September 13, 1979, Dr. Lee again operated on the patient, envisualized the prior pyloric ulcer and was satisfied that the sutures in that ulcer were holding fast. He also discovered a gastric ulcer. The gastric ulcer measured approximately 8 centimeters in diameter. The gastric ulcer was shallow in its depth. There was present in the patient 1200-1500 cc's of old blood and a clot in the duodenum. No active bleeding was seen at that time and no major vessels were present in the ulcer beds. Dr. Lee waited 15 to 20 minutes to see if any active bleeding would occur and failing such appearance, he placed a tube gastrostomy. After cleaning out the blood and placing the gastrostomy tube, the patient was closed. No direct attention was given to the ulcers either in the oversewing of the ulcers or by more definitive surgery addressing both ulcer beds. The reason given for not conducting some form of definitive surgery was to the effect, according to Dr. Lee, that he was worried that the patient would not survive the time it would take to conclude such surgery. The surgery that was done took two hours and twenty minutes to achieve. On reflection, Dr. Lee believes that he should have at least sutured the gastric ulcer by oversewing it like a baseball, being unable to identify a bleeding point. This is in opposition to what he did which was to hope that the patient would not rebleed after the operation of September 13, 1979. That hope was not realized because on September 15, 1979, the patient again experienced massive bleeding between 2:00 and 4:00 p.m. Dr. Lee had tried to treat the ulcers with Tagamet and irrigation through the gastrostomy tube. On September 16, 1979, Respondent operated and performed a vagotomy and antrectomy related to the pyloric and gastric ulcers. At that time, the patient was not better able to tolerate that operation than he would have been on September 13, 1979. In fact, between those two operations, he lost a considerable amount of blood, further weakening his resistance. In view of the relative condition of the patient, that is to say, generally poor health, the effects of the bleeding ulcers and associated insult caused by the surgeries, the patient died on September 27, 1979. Among the problems experienced by the patient, in the waning days of his life, were an anastomotic leak and peritonitis. Dr. Woodward, after review of the patient's hospital records, was of the opinion that the bleeding experienced by the patient on September 13, 1979, was from one of the ulcers and not because of gastritis. This belief is held notwithstanding the failure of the ulcers to bleed in the course of the operation on September 13, 1979. Bleeding sometimes subsides during surgery. Given the patient's circumstance related to bleeding ulcers, the least acceptable approach by the treating physician would have been to oversew and/or excise the ulcer craters. The excision would relate to the gastric ulcer. In addition, if possible, Respondent should have done a vagotomy and antrectomy or vagotomy and pyloroplasty during the September 13, 1979, surgery. Alternatively, the ulcers could have been treated medically after oversewing or excision. Use of Tagamet and irrigation would not stop the ulcers from bleeding, in Woodward's opinion. Woodward felt that a patient such as Worcester, who was in distress during the course of the operation, and had lost a great volume of blood, was a patient in greater need of the aforementioned procedures than the average patient, based upon the patient's inability to tolerate additional blood loss if the ulcer started to rebleed after he had been sewn up. At the time of the September 13, 1979, operation, there was evidence that the patient was in shock, which might cause the surgeon to stabilize the patient before conducting the minimum procedures identified, according to Dr. Woodward, but this would not cause the closure of the patient without addressing the bleeding ulcer or ulcers. The shock in Woodward's opinion was due to blood loss. In summary, in Dr. Woodward's mind, to visualize the ulcers on September 13, 1979, having recognized that they were the source of bleeding and to do nothing to stem that bleeding, was unacceptable Performance by the surgeon. Per Woodward, the procedures of September 16, 1979, a vagotomy and antrectomy, were correct but too late. The risk of mortality on September 13, 1979, as opposed to September 16, 1979, was 10 to 20 percent versus a prohibitive chance for recovery. Dr. Woodward found the treatment of Clifton Worcester to be clearly substandard in the face of the requirement to practice medicine with the level of care, skill and treatment which is recognized by reasonably prudent similar physician as being unacceptable under similar conditions and circumstances. Dr. Woodward's opinions as stated herein are accepted with the exception that pyloroplasty was not an appropriate choice given the location of the pyloric ulcer. Antrectomy would have been the substitute choice. Dr. Corwin, with the knowledge that Dr. Lee had been informed of the results of the gastroscope indicating that the source of bleeding on September 13, 1979, was probably an ulcer, felt that the Respondent, when he opened the patient on September 13, 1979, even though the ulcers were not bleeding, should have dealt with those ulcers to prohibit rebleeding, as opposed to cleaning out the ulcer beds and closing the patient. The minimum response would have been oversewing the ulcers with nonabsorbable sutures, and the aging condition of the patient should not have deterred Dr. Lee in that task. When asked if Dr. Woodward had performed the level of care, skill and treatment which is recognized by reasonably prudent similar physicians as being acceptable under similar conditions and circumstances, Corwin was of the opinion that the patient had received very poor treatment and that most any physician practicing as a surgeon would have done differently. Corwin did not think there was any value to the irrigation of blood within the stomach and the treatment of the ulcers by Tagamet through the gastrostomy tube. The treatment of the patient in failing to correct the bleeding constituted gross malpractice according to Dr. Corwin. The opinions of Corwin are accepted. Dr. Fowler also believed that to simply open the patient on September 13, 1979, and close without treating the bleeding ulcer in the sense of definitive suturing was unacceptable. While the antrectomy and vagotomy were recognized as appropriate responses, in terms of surgical technique, Dr. Fowler felt that in the sense of appropriate judgment, those procedures came too late, having followed another bleeding episode after. the September 13, 1979, surgery. According to Dr. Fowler, when asked the question about whether this conduct by Dr. Lee in his September 13, 1979, operation in his treatment of Worcester was at the level of care, skill and treatment which is recognized by reasonably prudent, similar health care providers as being acceptable under similar conditions and circumstances, he was of the opinion that the breakdown in surgical judgment was to the point that the doctor was unable to fully perform the full responsibilities of care in the case. Dr. Fowler's opinions are also accepted. Dr. Stephenson felt that the choices made on September 13, 1979, to close the patient and treat with Tagament and to irrigate were appropriate. He felt that the source of the bleeding might have been gastritis but was most likely from the ulcers. To him, conservative treatment of the patient in not further addressing the ulcers was acceptable given the condition of the patient. Had the patient been in better health, Dr. Stephenson said he might have taken a chance in addressing the ulcers. He felt that when you cannot visualize the source of the bleeding oversewing isn't particularly helpful because you don't know whether anything is achieved. Given this patient's condition, he felt that the chances were one in three that the patient would not rebleed. Dr. Stephenson's opinion as to the acceptability of the Respondent's conduct at the time of the surgery of September 13, 1979, is not accepted. Even this physician recognized that the patient's source of bleeding was most likely the ulcer beds and that there was a great likelihood that he would rebleed and this considered together with the fact of the tremendous amount of blood that the patient had already lost prior to the September 13, 1979, surgery causes a rejection of the opinion of this physician about Respondent's performance. The related charge of failure to keep written medical records justifying the course of treatment of patient Worcester has not been shown. There is ample information to gain an understanding of the patient's condition, as evidenced by the ability of the experts to give opinion testimony.
Findings Of Fact Respondent was licensed as a dentist in Florida at all times pertinent to this proceeding. He specializes in oral surgery and restricts his dental practice to that specialty. Dr. James Spurling, who practices general dentistry, examined Stephen Rice on March 21, 1980. At that time, Rice mentioned an irritation to his lingual frenum (the tissue which connects the front of the tongue to the floor of the mouth). Spurling diagnosed this condition as ankyloglossia (tongue-tie), and advised Rice that he would refer him to Respondent for consultation. Spurling did not contact Respondent directly, but asked his secretary to complete the referral. Spurling's secretary then called Respondent's secretary who noted the referral as "frenectomy" on her records, but did not specify "lingual frenectomy" which is the procedure to correct the tongue-tie condition. On March 26, 1980, Spurling and Respondent along with several other Melbourne area dentists had lunch together. Spurling mentioned the tongue-tie patient to Respondent at that time and they briefly discussed this condition. Respondent saw Rice on April 4, 1980, for the consultation recommended by Spurling, and determined that Rice required a maxillary labial frenectomy. This procedure involves cutting connective tissue between the upper lip and the upper jaw. Respondent noted that Rice did have ankloglossia, but did not consider a lingual frenectomy necessary. Respondent made an appointment for Rice to have the maxillary labial frenectomy on April 11, 1980. Rice kept the appointment and Respondent performed the maxillary labial frenectomy on that date. Respondent introduced ample evidence to establish that the maxillary labial frenectomy he performed on Rice was beneficial to prevent Rice's front teeth from separating. Similarly, Respondent demonstrated that his reservations regarding the lingual frenectomy in Rice's case were reasonable since Rice did not suffer from a speech impediment. Respondent testified credibly that he explained the maxillary labial frenectomy to Rice in lay terminology and offered to answer any questions Rice had. Respondent did not, however, seek Rice's view on this matter or the error would have immediately become apparent. Rice had confidence in Respondent, who had removed his wisdom teeth several years earlier. Thus, he asked no questions in the belief that Respondent would carry out the procedure for which he had been referred by Spurling. Throughout the consultation and the surgery, Rice believed he was receiving the procedure to correct his tongue-tie condition, and did not realize an entirely different procedure had been performed until he left Respondent's office. This lack of awareness established that he avoided focusing his attention on either the discussion of the surgery or the surgery itself. Thus, Rice is partly responsible for the failure of communication. However, this failure of communication became possible initially because Respondent did not know or did not remember that the consultation referral was specifically for a lingual frenectomy and not merely a frenectomy. Because of this, he did not explain to Rice that the lingual frenectomy was, in his view, inappropriate. Rather, he explained the maxillary labial frenectomy which he believed was required, and which Rice erroneously assumed was the tongue-tie surgery he sought.
Recommendation From the foregoing it is RECOMMENDED that Petitioner enter a Final Order finding Respondent guilty of violating Subsection 466.028(1)(p), Florida Statutes (1979), substantially as charged in Count II of the Administrative Complaint. It is further RECOMMENDED that the Petitioner issue a reprimand as provided in Subsection 466.028(2)(d), Florida Statutes (1979). DONE and ENTERED this 23rd day of July, 1982, in Tallahassee, Florida. R. T. CARPENTER, 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 23rd day of July, 1982. COPIES FURNISHED: Benjamin Y. Saxon, Esquire Saxon and Richardson, P.A. 111 South Scott Street Melbourne, Florida 32901 Salvatore A. Carpino, Esquire Assistant General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Fred Varn, Executive Director Board of Dentistry 130 North Monroe Street Tallahassee, Florida 32301 Honorable Samuel R. Shorstein Secretary, Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue The issue for determination is whether Respondent violated Section 466.028(1)(x), Florida Statutes (2001), by failing to refer patient L.D. to a specialist for evaluation and treatment of numbness of her tongue. (All statutory references are to Florida Statutes (2001) unless otherwise stated.)
Findings Of Fact Petitioner is the state agency responsible for regulating the practice of dentistry in Florida pursuant to Section 20.43 and Chapters 456 and 466. Respondent is licensed as a dentist in Florida pursuant to license number DN9676. Respondent is a general dentist. Respondent practices dentistry in Cape Coral, Florida, and has practiced dentistry for approximately 18 years. Respondent has no prior discipline against his license. The patient at issue is identified in the Administrative Complaint as L.D. The parties stipulated that L.D. is the same person identified in Respondent's medical records as L.V. and in the Transcript as L.W. L.D. is a female who was 19 years old when Respondent removed her four wisdom teeth on February 26, 1998. At the time, Respondent's records correctly identified the patient as L.V. L.V. subsequently married D.D. who was her boyfriend at the time. L.V. is now L.D. L.D. and D.D. were both patients of Respondent. L.D. suffered an injury to her lingual nerve when Respondent extracted her wisdom teeth. Lingual nerve injury is a foreseeable risk of wisdom tooth extraction, and the parties agree that Respondent properly disclosed that risk to L.D. prior to extracting her wisdom teeth. The symptoms of lingual nerve injury include paresthesias, i.e., numbness, of the tongue. The applicable standard of care for lingual nerve injury is observation and, under certain circumstances, referral to an oral and maxillofacial surgeon ("oral surgeon"). Surgery for symptoms of a lingual nerve injury may be exploratory, or it may be undertaken to perform a nerve grafting procedure. One of the risks of such surgery is dyscesthesia, i.e., pain, thereby making the symptoms worse rather than better. Therefore, surgery is not appropriate unless the patient experiences severe or debilitating pain, lip biting and cheek biting, or cannot function. The prudent dentist should observe the patient over time to determine whether the patient is improving and to determine the nature and scope of the patient's symptoms. The Administrative Complaint contains two essential allegations against Respondent. One allegation is that Respondent failed to diagnose the lingual nerve injury. The other allegation is that Respondent failed to refer L.D. to an oral surgeon. Respondent properly diagnosed the lingual nerve injury to L.D. After extracting L.D.'s wisdom teeth on February 26, 1998, Respondent examined L.D. in 1998 on February 27; March 5, 12, and 26; April 30; May 4; and July 8. L.D. did not call or seek an appointment with Respondent between May 4 and July 8, 1998. The first examination on February 27, 1998, was routine. Respondent checked to make sure L.D. had no signs of any complications, gross infection, or pus from the area of the surgery. L.D. had no complaints of numbness. Respondent instructed L.D. to return on March 5, 1998. On March 5, 1998, L.D. complained for the first time of numbness on both sides of her tongue. Respondent properly examined and diagnosed the cause as lingual nerve injury. By using an explorer to identify the areas of paresthesia, or numbness, Respondent determined that the right tip of L.D.'s tongue did not respond to the explorer, the right mid-tongue did respond, the left tip did not respond, and the left mid-tongue did not respond. Respondent also determined that both lingual tissue areas, i.e., the areas toward the tongue, did not respond to the explorer. Respondent properly treated L.D. after diagnosing the lingual nerve injury. Respondent observed L.D. for approximately four months to determine the nature and scope of L.D.'s symptoms. L.D.'s paresthesia of the tongue improved during the four months immediately following the removal of her wisdom teeth. After examining and diagnosing L.D. on March 5, 1998, Respondent explained to L.D. that the numbness may be either transient or permanent and that she was to return in one week for observation. L.D. returned to Respondent's office on March 12, 1998. Respondent stated that the feeling was coming back to her tongue, especially on her left side, and that she felt tingling. L.D. complained only of a tingling sensation on the right side of her tongue. L.D. did not complain that her tongue was numb or that she was biting her tongue. L.D. stated that her tongue was still a little bit numb, and it was tingling a little bit on the right side. A tingling sensation is hyperesthesia or paresthesia. Hyperesthesia can be an indication that the lingual nerve is repairing or healing. It indicates that the nerve is intact, that nerve conduction is occurring, and may indicate a potential for spontaneous self-repair. Respondent instructed L.D. to return for observation in two weeks. L.D. returned to Respondent's office on March 26, 1998. L.D. stated the feeling had returned to the left side of her tongue and that the right side of her tongue was still tingling. Respondent instructed L.D. to return for observation in six weeks. L.D. returned to Respondent's office on April 30, 1998. L.D. stated that she no longer had sensitivity on the right side of her tongue. The comment that she had "no sensitivity" indicated that the patient had none of the tingling sensation that had been her only complaint on March 26, 1998. L.D. returned to Respondent's office on May 4, 1998, for a dental prophylaxis, i.e., cleaning. L.D. did not complain of any numbness or tingling on May 4, 1998. On July 8, 1998, L.D. and D.D. both visited Respondent's office for dental care. D.D.'s visit was routine and not material to this proceeding. L.D. returned to Respondent's office and reported conflicting symptoms. L.D. indicated that she had feeling in her lips, but did not respond to the explorer on the gum in the front or the back of the teeth or in the areas of the tongue in which she had previously indicated that sensation had returned. The symptoms displayed by L.D. on July 8, 1998, included symptoms of buccal nerve damage. The buccal nerve goes to the gum and cheeks and is different from the lingual nerve. Prior to July 8, 1998, L.D. had not previously shown any signs of buccal nerve damage. Because of these conflicting complaints, Respondent referred L.D. to an oral surgeon on July 8, 1998. Respondent referred L.D. to the Southwest Florida Oral Surgery Associates ("Southwest"). Respondent has referred patients exclusively to Southwest for approximately 10 years. Respondent's records for July 8, 1998, do not include an express statement that he was referring L.D. to an oral surgeon. However, the records include a notation, "PTR for records," that indicates L.D. was to return for her records. The notation in the records is consistent with Respondent's longstanding protocol when referring a patient to a specialist. The protocol is to have the patient's records copied and prepared for the patient to pick them up and deliver to the specialist. On July 13, 1998, D.D. obtained copies of the records for L.D. and for D.D. from Respondent's office. The records included a written referral form for L.D. in accordance with Respondent's protocol. Respondent's office staff inadvertently filed Respondent's copy of the written referral form for L.D. in D.D.'s dental records and recovered the form after Respondent was asked to retrieve D.D.'s records during discovery in this proceeding. Respondent informed his office manager on July 8, 1998, that he had referred L.D. to an oral surgeon. Respondent's office manager confirms that Respondent stated to her at the time that he was referring L.D. to an oral surgeon. On March 3, 1999, L.D. saw Dr. Kevin Pollack at Southwest. Dr. Pollack found that L.D. could not perceive touch or pressure on the left side of her tongue. On April 1, 1999, L.D. saw Dr. Timothy Hogan at Southwest. L.D. had improved since she saw Dr. Pollack. Dr. Hogan found that L.D. could perceive light touch and pressure on the left side of her tongue. Petitioner's expert opined that failure to refer L.D. to an oral surgeon failed to comply with the applicable standard of care for lingual nerve injury. However, the issue of whether Respondent referred L.D. to Southwest is an issue of fact for which expert opinion is admissible if: specialized knowledge will assist the trier of fact in understanding the evidence; and the opinion can be applied to evidence at the hearing. Section 90.702. The record does not disclose any specialized knowledge needed to resolve the factual issue of whether Respondent referred L.D. to Southwest. The expert did not testify at the hearing as to why the expert's knowledge, skill, experience, training, or education would assist the trier of fact in making a finding concerning the factual issue of whether Respondent referred L.D. to Southwest. The opinion of Petitioner's expert was not applied to evidence at the hearing. The expert apparently disregarded the entries in Respondent's records that L.D. was to pick up her records, and the expert was not present at the hearing to listen to other evidence and testify as to whether the evidence at hearing altered his opinion. The only other evidence that the expert opinion could be applied to is the testimony by L.D. and D.D. that Respondent did not refer L.D. to Southwest. However, the testimony of L.D. and D.D. is neither credible nor persuasive and is less than clear and convincing. The memories of the two witnesses are not clear and are not without confusion. Most of the facts to which the witnesses testified are not distinctly remembered. The testimony is not precise and explicit. Their testimony lacks certainty and consistency as to specific facts and circumstances and details. Both witnesses testified that they clearly recalled that Respondent did not refer L.D. to Southwest. However, neither witness could recall how L.D. ended up at Southwest. Nor could either witness recall picking up records from Respondent, what was contained in those records, and whether a written referral was included in the records. When asked why L.D. had not returned to Southwest, L.D. refused to answer the question. The testimony of L.D. and D.D. does not produce in the mind of the trier of fact a firm belief or conviction, without hesitancy, as to the truth of the allegation that Respondent failed to refer L.D. to Southwest. The assumption inherent in the testimony of Petitioner's expert that Respondent did not refer L.D. to an oral surgeon is not based on underlying facts or data in evidence and, therefore, is not admissible pursuant to Section 90.705. Even if it were admissible, the underlying facts and data are less than clear and convincing and not persuasive. Petitioner submitted evidence that Respondent failed to meet the applicable standard of care because Respondent did not refer L.D. to an oral surgeon in a timely manner. Without identifying the appropriate time for a referral, Petitioner relies on expert opinion that, "sooner is better than later." The Administrative Complaint does not allege that Respondent failed to meet the applicable standard of care by failing to refer L.D. to an oral surgeon in a timely manner. Rather, the Administrative Complaint alleges that Respondent failed to refer L.D. to an oral surgeon at any time. It would violate fundamental principles of due process to put Respondent on notice in the Administrative Complaint that he must be prepared to defend against the allegations in the Complaint and then prove a different allegation during the administrative hearing. Even if the Administrative Complaint were to allege that Respondent failed to timely refer L.D. to an oral surgeon, the evidence is less than clear and convincing that the referral by Respondent was not timely. Respondent did not refer L.D. to a specialist prior to July 8, 1998, because the numbness in her tongue had been improving. In April of 1999, L.D. had recovered a large percentage of the feeling on the left side of her tongue and was experiencing tingling on her right side. If Respondent had referred L.D. to a specialist during the time that she had been reporting improvement in her parethesias, the referral would have been inappropriate. In the absence of debilitating pain and lip and cheek biting, a dentist need not refer a patient with lingual nerve paresthesia to an oral surgeon. If a patient who experiences lingual nerve parethesias after the removal of wisdom teeth shows signs of improving or if the patient has some feeling in the tongue, the dentist need only observe the patient and need not refer the patient to a specialist.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a Final Order finding that Respondent is not guilty of violating Section 466.028(1)(x) and dismissing the Administrative Complaint. DONE AND ENTERED on this 17th day of December, 2001, in Tallahassee, Leon County, Florida. DANIEL MANRY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 17th day of December, 2001. COPIES FURNISHED: Tracy J. Sumner, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Jay P. Chimpoulis, Esquire O'Connor & Meyers Post Office Box 149022 Coral Gables, Florida 33114-9022 Frank R. Recker, Esquire Frank R. Recker & Associates Company L.P.A. 267 North Collier Boulevard, Suite 202 Marco Island, Florida 34145 Theodore M. Henderson, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 William H. Buckhalt, Executive Director Board of Dentistry Department of Health 4052 Bald Cypress Way, Bin C06 Tallahassee, Florida 32399-1701
The Issue The issue to be resolved in this proceeding concerns whether Respondent's license to practice medicine should be subject to sanctions based upon alleged violations of Section 458.331(1)(m) and 458.331(1)(t), Florida Statutes. Specifically, it must be determined whether he departed from the appropriate standard of medical care and treatment of a patient in the course of his practice of ophthalmology and whether his record keeping with regard to the care and treatment of that patient met appropriate standards.
Findings Of Fact Stipulated Facts The Petitioner is the state agency charged with regulating the practice of medicine, pursuant to Section 20.30, Florida Statutes, and Chapter 455, Florida Statutes. The Respondent is, and at all times material hereto, has been a licensed medical doctor in the State of Florida, having been issued license number ME0004933. The Respondent's address is 820 Prudential Drive, Suite 712, Jacksonville, Florida. On or about September 13, 1989, patient D.P., a 65-year-old-female, presented to the Respondent for evaluation regarding extremely high intra-ocular pressure and severe pain in both eyes. Patient D.P. had undergone abdominal surgery two days prior to the Respondent's examination, which was her second abdominal surgery in two weeks. The Respondent examined patient D.P. and diagnosed her with acute angle closure glaucoma, which had been present since the time of her second abdominal surgery, two days earlier. The Respondent treated patient D.P. with topical medications to decrease the intra-ocular pressure. Patient D.P.'s left eye responded to treatment with decreased pressure. The intra-ocular pressure in the right eye remained extremely high, in excess of 70 millimeters. On or about September 13, 1989, the Respondent performed a vitreous tap of the patient D.P.'s right eye, which immediately relieved the intra-ocular pressure. The Respondent did not consult patient D.P.'s surgeons or internists prior to performing the vitreous tap, regarding the possible use of intravenous medications. On or about September 14, 1989, the Respondent consulted Dr. James Staman, a retinal specialist, due to the patient's diminished vision in her right eye. Dr. Staman examined patient D.P. and diagnosed her with a vitreous hemorrhage. (End of stipulated facts). The Respondent has been licensed to practice medicine in the State of Florida since 1954 and has practiced in the field of ophthalmology since 1966. He has been board certified in the field of ophthalmology since 1969. He has never been investigated or disciplined by the Department of Business and Professional Regulation or any predecessor agency charged with regulating the licensure and practice standards of medical doctors in Florida. The Respondent maintains hospital staff privileges appropriate to his practice and has never had hospital staff privileges denied, revoked, or suspended at any hospital at which he has had privileges. Patient D.P. is a 65-year-old-female, who presented to the Respondent on September 13, 1989 complaining of severe pain in both eyes and with regard to which the Respondent immediately determined the presence of extremely intra- ocular pressure in both eyes. Patient D.P. had recently undergone a gastrectomy, a major abdominal surgical procedure, within 48 hours prior to presenting to the Respondent. This was the second abdominal surgery she had undergone within the past two weeks. When she presented to the Respondent on that date, she was in severe pain from the increased intra-ocular pressure in both eyes and appeared to be weak and in great discomfort. Pursuant to order of her doctors who attended and treated her with regard to the abdominal condition and surgery, the patient was and had been "NPO" for four weeks. This condition or situation means that she was forbidden from taking food or liquids of any type by mouth during this period of time. Upon evaluating the pressure in her eyes, the Respondent determined that the intra-ocular pressure in her left eye was 35 millimeters of mercury and in excess of 70 millimeters of mercury in the right eye. This is because the standard instrument with which her pressure was tested by the Respondent only depicts a maximum pressure of 70 millimeters of mercury. The normal intra- ocular pressure for such a patient would be 17-18 millimeters of mercury. Upon evaluating and examining the patient, the Respondent determined her condition to be bilateral acute angle closure glaucoma. He determined that the condition had been present since her surgery 48 hours earlier. The anesthesia from the surgery had precipitated dilation in both eyes which, in turn, precipitated the acute angle closure glaucoma. This occurred because, upon the dilation of the pupils of both eyes caused by the anesthesia, the iris folded back as the pupil expanded, and the folds of the iris occluded or blocked the drain structure by which fluid can drain from within the eye. The inability of the fluid to drain thus caused the severe increase in intra-ocular pressure and thus the glaucoma condition. The Respondent initially treated the acute angle closure glaucoma in both eyes with glycerin. This is a topical medication designed to reduce the amount of swelling in the cornea and to increase absorption of medication into the eye. The Respondent also initially treated the condition with pilocarpine. This is a topical medication administered to constrict the pupil and thus open the channel in the trabecular meshwork (the drainage structure) in an attempt to break the attack of acute angle closure glaucoma by allowing the eye fluid to drain and thus relieve the pressure. The intent is that by constricting the pupil, the iris will stretch with the pupil's closure so as to remove its folds from the position of blocking the channel in the trabecular meshwork. The Respondent initially administered a "beta blocker" medication in an attempt to open the trabecular meshwork by cutting down on the amount of aqueous fluid produced by the ciliary body. The topical medications, indeed, broke the attack of glaucoma in the left eye and the intra-ocular pressure in that eye returned to normal levels. However, after approximately a four-hour trial of the array of topical medications used by the Respondent, the attack of glaucoma in the right eye had not subsided at all. Prolonged elevated intra-ocular pressure of the magnitude of over 70 millimeters of mercury in the right eye posed a great danger of loss of vision in that eye due to potential occlusion of the ocular artery supplying blood to the eye and concomitant permanent damage to the optic nerve. The artery can be occluded or closed off due to such excessive pressure because the pressure at that level will exceed the blood pressure generated by the heart through the vascular system, including the artery supplying that eye. This results in the ocular pressure overcoming the blood pressure within the artery, thus constricting the artery and, therefore, the blood supply to the eye. The loss of blood supply to the eye in a short time, possibly 90 minutes or less, can cause the eye tissue normally served by the artery to become necrotic (i.e. to die). Necrosis of the internal eye tissue, in turn, can cause complications by weakening the pertinent structures of the eye, such as the tissue by which the retina is attached and held in position. The Respondent observed the patient and performed this clinical treatment for approximately four hours without being able to relieve the elevated intra-ocular pressure in the right eye. The Respondent knew, given the symptoms and history with which the patient presented, that severe pain had been experienced by the patient in her eyes since she awakened from the anesthesia administered for her surgery. Thus, he knew that for approximately two days, the glaucoma condition had been operating on the structures of the eye. Accordingly, he knew that time was of the essence if he was going to be able to relieve the glaucoma and thus save the vision, or some of it, in her eye. After these hours of clinical attempts to cure her condition, and in view of the state of urgency the Respondent recognized in the patient, who had already experienced severely-elevated intra-ocular pressure for two days, the Respondent determined that the emergency nature of the patient's situation precluded use of the time necessary to consult with her surgeon and anesthesiologist, to attempt to hospitalize her, to administer a general anesthetic, and perform an alternative surgical procedure. The Respondent, therefore, elected to perform a "vitreous tap". The vitreous tap involves using a hypodermic needle with a "guarded needle" (meaning that the needle is protected so that only a small portion of the point of the needle projects from the guard structure) to withdraw a small amount of the vitreous fluid. This was done to reduce the pressure, open the angles at the trabecular structure in the eye and thus break the attack of acute angle closure glaucoma and return the eye to normal intra-ocular pressure. The vitreous tap was performed at approximately 4:05 that afternoon and was successful. It immediately broke the attack of acute angle closure glaucoma and the intra-ocular pressure returned to a normal range. However, a vitreous hemorrhage resulted from the vitreous tap caused by the needle striking a small blood vessel in the pars plana area of the eye. This area cannot be visualized when performing the vitreous tap because it is inside the eye. A vitreous hemorrhage is a known and accepted complication or risk of a vitreous procedure. However, it has a low incidence of occurrence of approximately 3-5 percent. Upon determining that the hemorrhage condition was present and on or about September 14, 1989, the Respondent obtained a consultation with Dr. James Staman, a vitreal-retinal surgeon, due to the diminished vision in the patient's right eye. Dr. Staman examined the patient and diagnosed a vitreous hemorrhage in her right eye. The incidence of retinal detachment from a vitrectomy is approximately 5-10 percent. It would have had a higher risk in this patient's case, due to the probability of her already suffering permanent damage to the eye and eye tissue caused by necrosis, which was caused by loss of blood supply to the eye during the extended period of high intra-ocular pressure. This likely damaged the optic nerve and occluded the ocular artery serving that eye or portion of the eye. Dr. Staman performed a vitrectomy and removed the hemorrhage or blood from the patient's eye. Unfortunately, a retinal detachment occurred as a complication of that vitrectomy. This chain of events ultimately resulted in the patient losing the vision in her right eye. This was because of the determination that the retinal detachment could not be repaired without causing the loss of vision itself. Dr. Doyle testified as an expert witness for the Respondent. Dr. Doyle is a board certified ophthalmologist specializing in the field of glaucoma and particularly in the sub-specialty area of glaucoma management, including surgical glaucoma management. Additionally, Dr. Doyle is a holder of a fellowship, involving further specialty training in the field of treatment and management of glaucoma and surgical alleviation and management of glaucoma. He is determined to be the most qualified expert witness by training, education and experience in the particular specialty concerning glaucoma, with which this patient's condition is characterized, as is provided in his testimony depicted in the transcript of this proceeding and in his curriculum vitae in evidence. This depiction of his training, education and experience is adopted, by reference, as fact. According to Dr. Doyle, the loss of vision in the right eye was not caused by the vitreous tap. Rather, the precipitating factor was the retinal detachment which occurred as the result of the direct vitrectomy surgery. A vitreous hemorrhage is a known complication of a vitreous tap and a retinal detachment is a known complication of a vitrectomy. The Respondent and all of the expert witnesses agreed that the patient had probably already suffered permanent damage to the right eye, prior to the performance of the vitreous tap, in the form of corneal decomposition, cataract formation and optic nerve damage. Dr. Doyle's testimony, as corroborated by that of the Respondent, established that, in all likelihood, significant necrosis of the eye tissue involved in the structure by which the retina is attached had occurred due to occlusion of the artery supplying blood to that area of the eye by the 48 hours or more of elevated intra-ocular pressure. The elevated intra-ocular pressure occurred as a result of the anesthesia administered to the patient during her abdominal surgery. The Respondent and all expert witnesses agreed that the Respondent had utilized an appropriate and proper procedure in performing the vitreous tap. However, Drs. Baumann and Berg, testifying for the Petitioner, do not agree that the vitreous tap should have been performed to relieve the attack of acute angle closure glaucoma in the right eye. Standard of Care The Respondent met the standard of care under the circumstances with which this patient presented, in his care and treatment of patient D.P. when he performed the vitreous tap to break the attack of acute angle closure glaucoma in patient D.P.'s right eye. The usual treatment options or alternatives for the treatment of acute angle closure glaucoma were not available to the Respondent due to the extremely unusual set of precipitating circumstances with which the patient presented to him. The patient had already had extreme intra- ocular pressure of approximately 48 hours duration, based upon all of the evidence available to the doctor in performing his diagnosis and examination of treatment options. Dr. Baumann admitted that the situation was "urgent", and Dr. Berg admitted that the situation was an "emergency" and that the Respondent's "back was up against the wall" under the circumstances. Because of this, the treatment, including surgical options preferred by Drs. Baumann and Berg, was not effectively available to the Respondent in an attempt to save the vision in the patient's eye. This is because, in order for a general anesthetic to be administered and the patient prepared, monitored and evaluated for the surgery, she would have had to be hospitalized, with accompanying consultation with her internal medicine physician, her abdominal surgeon, and the anesthesiologist. All of this process would have taken approximately six hours, from the time the decision was made to perform the vitreous tap, which was made when the topical medications failed to alleviate the attack, until the surgery could be performed in the hospital. Even if the patient's eye was not already significantly damaged by the 48 hours of elevated intra-ocular pressure when she presented to the Respondent at his office, substantial damage to her vision would have occurred as a medical certainty if another six hours had elapsed after the unsuccessful conclusion of conservative, clinical treatment between 4:00 p.m. and 4:30 p.m. The first treatment option in an angle closure glaucoma case is topical therapy in an attempt to reduce the production of fluid by the ciliary body in the eye and to cause the iris to constrict and thus open the angle and its drainage structure. The Respondent initially treated the angle closure glaucoma in both eyes with topical medications, including pilocarpine, glycerin and a beta blocker. He repeated this topical therapy for approximately three hours at the appropriate intervals which all testifying physicians, including Dr. Doyle, agree was "normal, appropriate care". Under ordinary circumstances, if the topical medications failed to lower the intra-ocular pressure, the use of diamox or mannitol would be the next treatment alternative to try. However, diamox, a carbonic anhydrase inhibitor, which affects the ciliary body to reduce the production of fluid, would not have produced any greater benefit than the topical medications which had failed already. Mannitol is a hyperosmotic medication. It is ordinarily administered by mouth, which allows the body's stomach and intestines to regulate and gradually accomplish a safe absorption of the medication. However, oral mannitol was not an option to this patient because, under her previous doctor's orders, she was not allowed to take anything by mouth at times pertinent to this proceeding, including the day and times when the Respondent was treating her for the glaucoma. Mannitol reduces vitreous volume by reducing water everywhere in the body, including the eyes. The fluid is drawn into the blood stream, which, however, increases blood volume. Administration of mannitol intravenously would have put the patient at significant risk for an overload of volume in the blood which would have caused readily increased blood pressure with attendant possible medical complications, massive congestive heart failure, or kidney problems. These are life-threatening risks which would have necessitated hospitalization, evaluation and monitoring in the hospital before and during administering of intravenous mannitol. By the time this could have been accomplished, the vision in the eye would have already been lost. Dr. Doyle and the Petitioner's expert, Dr. Baumann, both agreed that administration of intravenous mannitol would have been dangerous for this patient. Intravenous mannitol is only 50 percent effective in such a situation, in any event, and is contra-indicated in patients such as D.P., who are post- gastrectomy surgery. This 65-year-old patient, weakened by her second gastrectomy surgery in a four-week period, involving the use of general anesthetics, was simply not a safe candidate for the administration of mannitol under the risky intravenous method which would have been necessary with the patient. The risk of kidney or heart failure and other complications was simply too great. The Petitioner's expert, Dr. Baumann, admitted that it was reasonable for the Respondent to have these concerns about the use of diamox and intravenous mannitol and further that the Respondent was not negligent in deciding not to use those medications. Under ordinary circumstances, if the topical therapy and the administration of medication failed to relieve an attack of acute angle closure glaucoma, the next course of treatment to be considered would be an argon or YAG laser iridectomy or an irridoplasty in order to place a small hole in the iris to relieve the pressure differential in the eye. A laser is a focused beam of light, at high energy, which can insert the necessary hole in the eye to relieve the intra-ocular pressure. It requires a clear media over the iris in order to penetrate the eye and make the hole in the required position. In this case, due to the extraordinary high intra-ocular pressure over a two-day period, the cornea was very cloudy and hazy. This precluded the laser being effective and created the potential for damage to the cornea had the laser been directed against the eye. Dr. Doyle and the Petitioner's experts, Dr. Berg and Dr. Baumann, all agreed, that in a patient such as D.P., with intra-ocular pressure of over 70 millimeters of mercury extending for 48 hours, the cornea would be very cloudy. The Respondent's testimony confirms this. After the vitreous tap was performed and the intra- ocular pressure relieved, the edema and cloudiness of the cornea resolved itself so that the Respondent was able to perform a successful argon laser iridectomy the following day and a YAG laser irridoplasty in his office five days later, to prevent a recurrence of the problem by providing an additional means of fluid drainage. Under ordinary circumstances where topical therapy, medication therapy, and laser iridectomy had either failed or were not viable options, then surgical treatment would be the next consideration. The surgery would include either surgical iridectomy or a trabeculectomy. A surgical iridectomy creates a small hole in the iris which relieves the pressure. A trabeculectomy creates a secondary drain for the eye. The Respondent was justified in not pursuing a surgical iridectomy or trabeculectomy in that the surgery could not have been done under a local anesthetic and would have required general anesthesia. This is undisputed. This would have required surgery in the hospital operating room, including the necessity for insertion of a tube, which might have caused risk to her recent abdominal surgery. It would have necessitated contacting her surgeon, her internal medicine physician, and her anesthesiologist for pre-surgical evaluation and clearance. This would have taken considerable time, at least six hours, thereby, within reasonable medical certainty causing permanent significant damage or entire loss of vision to the eye. A surgical iridectomy or trabeculectomy are not benign procedures and carry the highest complication rate of any ophthalmic procedure, when used for malignant glaucoma and, indeed, the accepted treatment for malignant glaucoma (albeit a different type of glaucoma condition) is a vitreous tap. Either surgical procedure would have had a risk of complication resulting in loss of vision in the eye of at least 3-5 percent or more, thus, the same or greater level of risk than that attendant to the vitreous tap procedure. Paracentesis, a surgical procedure to make a small hole in the anterior chamber of the eye, was itself not a reasonable treatment alternative under the circumstances. It was simply not feasible because the anterior chamber of the eye had virtually ceased to exist because the iris diaphragm had bulged forward through the space normally occupied by the anterior chamber because of the great pressure behind it. Dr. Doyle established that the Respondent's vitreous tap effected a complete cure of the glaucoma condition in patient D.P. A vitreous tap is a procedure recognized in the medical literature as a treatment for several ophthalmic conditions, including malignant glaucoma, positive pressure during cataract surgery, and for the purpose of obtaining vitreous material for pathological testing (biopsy). The medical literature, indeed, does not address the use of a vitreous tap as treatment for acute angle closure glaucoma because the medical literature and text books tend to deal with more common presentations of all diseases. None of the literature addresses treatment of acute angle closure glaucoma under the unusual set of emergency circumstances presented with this case. The Respondent's expert, Dr. William Doyle, is a board-certified ophthalmologist who has a sub-specialty in glaucoma management and treatment, including surgical management thereof. He is one of only a handful of fellowship-trained glaucoma specialists in the State of Florida and the only one in the North Florida area. He sees patients on referral from other doctors in Florida and South Georgia, who have unusual glaucoma-related problems. Dr. Doyle is an assistant professor of ophthalmology at the University of Florida and is responsible for teaching glaucoma management and treatment. He has authored some twelve article, book chapters, and other publications specifically in the field of glaucoma management and treatment. According to Dr. Doyle, if the vitreous tap procedure had been successful, the Respondent "should have written it out for the literature as a viable, interesting way to cure a disease". The Petitioner's expert, Dr. Berg, in his report attached to his deposition, referenced an article in International Ophthalmology Clinics, by Kevin C. Greenridge, M.D., of the Metropolitan Hospital Center, Department of Ophthalmology, New York, New York, and which Dr. Berg admitted was authoritative in the field of acute angle closure glaucoma. The article specifically states that in cases of acute angle closure glaucoma, for a duration of more than 24 hours, the eyes are more inflamed and have evidence of corneal decomposition, which are relative contra indications to argon laser iridectomy. Since the acute angle closure glaucoma had a duration of 48 hours when the Respondent first saw the patient, corneal decomposition could have been significantly advanced by that point such that the set of conditions requisite to causing the retinal detachment, which ultimately led to the loss of the patient's sight in that eye, were likely already in place. Thus, the vitreous hemorrhage caused by the vitreous tap may not itself have been the cause of the loss of sight. Medical Record Issue The Respondent's office records note "Vitreous tap. 4:30 p.m., immediately patient felt better". The Respondent also made an entry in the patient's hospital chart on the date of the vitreous tap which noted: Acute angle closure glaucoma right eye. Totally unresponsive to treatment. Pressure of 70 unaffected by treatment. Pars plana 1/2 cc vitreous tap done with immediate relief. Both eyes very shallow [referring to anterior chamber]. Started on pilocarpine and both eyes will need argon laser iridectomy soon. A copy of the hospital note was included and contained in the Respondent's records of the patient. In addition, the Respondent obtained a signed, written, informed consent for the procedure. The Respondent's records, including his office records and the note in the hospital chart, adequately document the course of therapy leading up to the vitreous tap and the vitreous tap procedure itself such that the Respondent's medical record keeping would adequately inform the Respondent in the future when reviewing the patient's records with a view toward further follow-up and treatment of the patient's entire status. They would also adequately inform any physician to whom the patient was later referred by the Respondent of her status, the treatment and procedures performed, and the symptoms and diagnosis involved in the patient's care and treatment.
Recommendation Based on the foregoing Findings of Fact, Conclusions of Law, the evidence of record, the candor and demeanor of the witnesses, and the pleadings and arguments of the parties, it is RECOMMENDED that the Respondent be found not guilty of violating Sections 458.331(1)(m) or (t), Florida Statutes, and that the Administrative Complaint against the Respondent be dismissed in its entirety. DONE AND ENTERED this 7th day of September, 1994, in Tallahassee, Florida. P. MICHAEL RUFF 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 7th day of September, 1994. APPENDIX TO RECOMMENDED ORDER, CASE NO. 93-5990 Petitioner's Proposed Findings of Fact 1-16. Accepted, but not necessarily for their purported material import. Rejected, as contrary to the preponderant, probative evidence. Accepted. Accepted, but not itself dispositive of the material issues presented. Accepted. 21-26. Accepted, but not necessarily for their purported material import and subordinate to the Hearing Officer's findings of fact on this subject matter. 27. Accepted, but subordinate to the Hearing Officer's findings of fact on this subject matter and as not probative of the medical records being inadequate as a matter of fact and law. 28-29. Accepted. 30. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter and not entirely in accordance with the preponderant weight of the evidence. 31-41. Accepted, but subordinate to the Hearing Officer's findings of fact on this subject matter and not dispositive of the material issues presented. 42-43. Rejected, as contrary to the preponderant weight of the evidence and subordinate to the Hearing Officer's findings of fact on this subject matter. 44-46. Rejected, as contrary to the preponderant weight of the evidence and subordinate to the Hearing Officer's findings of fact on this subject matter, and for the additional reason that these proposed findings are not dispositive of the material issues presented. 47-50. Accepted, in part, but not as materially dispositive of the issues presented for resolution and as subordinate to the Hearing Officer's findings of fact on this subject matter. Rejected, as contrary to the preponderant weight of the evidence and subordinate to the Hearing Officer's findings of fact on this subject matter. Accepted. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. Respondent's Proposed Findings of Fact 1-55. Accepted, to the extent not rejected by or subordinate to the Hearing Officer's findings of fact. Those proposed findings of fact not treated in the Hearing Officer's findings of fact are rejected as unnecessary or immaterial. COPIES FURNISHED: Alex D. Barker, Esquire Department of Business and Professional Regulation 7960 Arlington Expressway Suite 230 Jacksonville, Florida 32211 Jeptha F. Barbour, Esquire Post Office Box 447 Jacksonville, Florida 32201 Dr. Marm Harris Executive Director Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792 Jack McRay, Esquire Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792
The Issue The issues in this case for determination are whether Respondent Samuel Cox, M.D., committed the violations of Chapter 458, Florida Statutes, as alleged in an Administrative Complaint filed by the Department of Health on November 18, 2006; and, if so, what disciplinary action should be taken against his license to practice medicine in Florida.
Findings Of Fact The Parties. Petitioner, the Department of Health (hereinafter referred to as the "Department"), is the agency of the State of Florida charged with the responsibility for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. § 20.43 and Chs. 456 and 458, Fla. Stat. Respondent, Samuel Cox, M.D., is, and was at the times material to this matter, a physician licensed to practice medicine in Florida, having been issued license number ME 77851 on April 22, 1999. Dr. Cox's mailing address of record at all times relevant to this matter is 2438 East Commercial Boulevard, Fort Lauderdale, Florida 33308. Dr. Cox is a board-certified general surgeon who has specialized his practice to bariatric surgery. He has performed bariatric surgery since 1985, performing approximately 3,000 such surgeries since that time. Dr. Cox has performed approximately 214 Roux-en Y procedures in Florida. No evidence that Dr. Cox has previously been the subject of a license disciplinary proceeding was offered. Bariatric Surgery. Bariatric surgery, also known as gastro-bypass surgery, is a type of surgery performed on morbidly obese patients to assist them in losing weight. In order to be found to be morbidly obese and, therefore, to be considered a candidate for the procedure, a patient must be found to have a Body Mass Index greater than 40. Body Mass Index is a measure of body fat based on height and weight (weight in kilograms divided by the square of height in meters). For example, a six-foot-tall individual weighing 296 pounds would have a Body Mass Index of 40.1. See http://www.nhlbisupport.com/bmi/. A patient with a Body Mass Index of 35 may also be considered a candidate for the surgery if they present with certain comorbidities associated with obesity. Comorbidities are physical problems associated with obesity and include diabetes, lung problems, heart problems, and high blood pressure. The more comorbidities a patient has, the higher the risk is to that patient from bariatric surgery. While there is more than one type of bariatric surgery, at issue in this case is a procedure known as Roux-en-Y gastric- bypass surgery (hereinafter referred to as "RNY Surgery"). RNY Surgery is a surgical method of creating a reduced-sized stomach. This reduced-sized stomach is created by removing a small portion of the stomach, where the esophagus (which brings food from the mouth to the stomach) attaches to the stomach, from the larger remaining portion of the stomach. The small portion of the stomach attached to the esophagus is then formed into a pouch, creating a much smaller stomach. The remaining larger portion of the stomach is completely by-passed. Often a device called a silastic ring is used at the bottom of the newly created stomach to help the pouch maintain the desired size and prevent it from stretching into a larger pouch. A portion of the small intestine is attached to the bottom of the newly created stomach. Approximately 150 centimeters down the small intestine, the excluded or removed portion of the stomach, the liver, and the pancreas are connected back to the intestine. This allows digestion of food to continue, but reduces the amount of digestion that previously occurred in the 150 centimeters of the intestine which are bypassed. RNY Surgery allows a patient to lose weight in two ways: first, by limiting the amount of food the patient can eat; and secondly, by reducing the absorption of nutrients by bypassing part of the intestine. The most common and serious complication of RNY Surgery is a leak at the gastrojejunal anastomosis, or the point where the newly created stomach pouch (the gastro) is connected to the intestine (the jejunal)(a gastrojejunal anastomosis leak will hereinafter be referred to simply as a "Leak"). This complication may be evidenced by several symptoms exhibited by a patient. Surgeons performing bariatric surgery must look for these symptoms. The typical symptoms of a Leak include left shoulder pain (caused by pooling of the leakage under the diaphragm which causes irritation which manifests as left shoulder pain), decreased urine output, fever, shortness of breath, and high heart rate. Some manifestations of a Leak, such as atrial fibrillation, are indirect signs of a Leak in that they are associated with the stress on the body caused by the Leak. Dr. Cox's Treatment of Patient W.T. Patient W.T. presented to Dr. Cox for bariatric surgery. W.T., a male, was 47 years of age at the time and was morbidly obese. W.T. weighed 458 pounds and had a Body Mass Index of Because his Body Mass Index exceeded 50, he was considered "super" morbidly obese. He also had the following comorbidities: high blood pressure, sleep apnea, congestive heart failure, thrombophlebitis, pulmonary eboli, diabetes, and gatroesophageal reflux disease. There is no dispute that W.T. was an appropriate candidate for bariatric surgery. W.T. underwent RNY Surgery on August 31, 2005. During the surgery, Dr. Cox experienced difficulty seeing, due to the size of W.T.'s liver, the staples which he used to connect the intestine to the bottom of the newly formed stomach. Instead of confirming the placement of the staples, he was required to assess the staples with his fingers. This should have made him more sensitive to the possibility of a Leak. Before ending the surgery, Dr. Cox performed a test called a methylene blue test. To perform this test, an anesthesiologist puts medicine down a tube which passes through the patient's nose and into the new stomach. The physician then looks for any sign of a leak where the physician has sewn or stapled the small intestine to the stomach. With W.T., the methylene blue test did not disclose any leaks. The day after W.T.'s bariatric surgery, September 1, 2005, W.T. began to complain of pain in his left shoulder which is an important symptom of a Leak. W.T. also experienced decreased urine output during the night (he had, however, "responded well to fluid increases and diuretics"), and a low- grade fever, which are also indicators of a Leak. Although pain is a normal response to any operation, pain in the shoulder for the type of non-laparoscropic bariatric surgery performed by Dr. Cox should have made Dr. Cox more concerned than he apparently was as to the cause. The normal pain response to the type of operation Dr. Cox performed would be expected where the incision was made, but not in the shoulder. Dr. Cox treated W.T.'s shoulder pain with narcotic analgesia by a patient-controlled analgesia pump. He treated the decreased urine output with increased fluids and a diuretic (Mannitol). The fever was treated with Tylenol. Although the left shoulder pain, decrease in urine output, and low-grade fever could have been indicative of a Leak, Dr. Cox made no note in the patient records that he had considered the possibility that W.T. had a Leak, prematurely ruling out the possibility of a Leak. Dr. Cox suggested that the left shoulder pain was related to a diaphragmatic irritation caused by the use of surgical instruments on the diaphragm and that the urine output decline could have been attributable to the impact on W.T.'s kidneys by his diabetes. While these might have been appropriate considerations at the time, Dr. Cox could have not known for sure what was causing W.T.'s symptoms and, therefore, should have considered all the possible causes of these symptoms, especially the possibility of a Leak. On the second post-operative day, September 2, 2005, W.T. exhibited an abnormal heart rhythm, called atrial fibrillation. With a normal heart rhythm, the atrial (the first two of the four heart chambers) contracts, followed by contraction of the ventricles (the other two heart chambers). Atrial fibrillation is an abnormal heart rhythm characterized by a failure of the atria to completely contract. The fact that W.T., who had no prior history of atrial fibrillation, was evidencing atrial fibrillation on post-operative day two should have raised a concern about what was happening to W.T., including, but not limited to, the possibility of a Leak. W.T. was also experiencing an abnormally high heart rate of 148, which could have also been indicative of a Leak. Dr. Cox continued to treat W.T.'s shoulder pain with narcotic analgesia and the decreased urine output with increased fluids and Mannitol. He treated the elevated heart rate with Cardizem, a medicine used to slow the heart. W.T.'s shoulder pain appeared to decrease, which was to be expected given the course of treatment ordered by Dr. Cox. Dr. Cox had not, however, appropriately determined the cause of the pain. Again, nothing in Dr. Cox's medical records indicates that he considered the possibility that W.T.'s various symptoms might be indicative of a Leak. Nor did he take any action, such as an upper gastrointestinal test, to rule out the possibility of a Leak. To perform a gastrointestinal test, a patient drinks a water-soluble contrast called Gastrografin and a radiologists takes serial pictures of the patient, which show the contrast as it moves down the esophagus and then crosses through the anastomosis of the pouch and intestine. From these pictures, it can be determined whether the anastomosis is open and functioning properly and whether any of the contrast leaks outside of the new stomach-intestine path. The test is not fool-proof, but it is an appropriate diagnostic tool for Leaks. Dr. Cox suggests that the atrial fibrillation and high heart rate could have simply been a recognized complication of any stress W.T., with his borderline cardiac status, was experiencing. Again, while these might have been appropriate considerations at the time, Dr. Cox could have not known for sure what was causing W.T.'s symptoms and, therefore, should have considered all the possible causes of these symptoms, especially the possibility of a Leak. On the third post-operative day, September 3, 2005, air and serosanguinous fluid were observed seeping from W.T.'s abdominal incision. The existence of air may be evidence of a Leak. Although some air gets into the abdominal cavity during surgery, it is usually absorbed by the body very, very quickly. Air coming from an incision on post-operative day three suggests a hole in the intestine. Dr. Cox responded to the finding of air coming from the abdominal incision by ordering a methylene blue swallow, where W.T. swallowed a small amount of blue dye. Blue dye was then seen either coming out of the incision or drains placed in W.T.'s abdomen. Either way, the test was "positive" indicating a leak in W.T.'s intestine. Dr. Cox correctly took W.T. back into surgery. He discovered and corrected a Leak which had been caused by failure of the staples used in W.T.'s surgery. Although much was made as to when the staples failed, that evidence was not conclusive nor is it necessary to resolve the dispute. Whether the staples failed immediately after surgery or at some later time does not excuse Dr. Cox's failure to appropriately react to signs exhibited by W.T. which could have indicated that W.T. had a Leak. This case does not turn on whether a Leak actually existed. It turns on whether Dr. Cox appropriately considered the possibility of a Leak and took the steps medically necessary. With W.T., he did not. Dr. Cox's error was not in failing to find the Leak earlier; it was in failing to properly consider the possibility of a Leak when W.T. exhibited signs that should have prevented Dr. Cox from, with reasonable medical certainty, ruling out the possibility that a Leak was present. For this reason, the fact that a Leak was ultimately found is of little importance in deciding whether the charges leveled against him in the Administrative Complaint are accurate. Even if no Leak had ultimately been found, Dr. Cox's failure to properly respond to the potential of a Leak evidenced by W.T.'s symptoms was inconsistent with the standard of care. Dr. Cox's Treatment of Patient J.L. Patient J.L. presented to Dr. Cox for bariatric surgery. J.L., a male, was 35 years of age at the time and was morbidly obese. J.L. weighed 417 pounds and had a Body Mass Index of Because his Body Mass Index exceeded 50, he was considered "super" morbidly obese. He also had the following comorbidities: high cholesterol, stress incontinence, depression, anxiety, high blood pressure, gastroesophageal reflux disease, and shortness of breath on exertion associated with asthma. There is no dispute that J.L. was an appropriate candidate for bariatric surgery. J.L. underwent RNY Surgery on August 4, 2005. Dr. Cox also removed J.L.'s gallbladder. Before ending the surgery, Dr. Cox performed a methylene blue test. The methylene blue test performed on J.L. did not disclose any leaks. On the first post-operative day, August 4, 2005, J.L.'s heart rate was as high as 155 (anything over 120 is problematic), was experiencing decreased oxygen saturation of 89 percent (95 percent to 98 percent are considered normal saturation levels), had increased BUN and creatinine levels, and his urine output was borderline low. The increased BUN and creatinine, indicative of a problem with the kidneys, were are not being perfused well. J.L. was also complaining of right shoulder pain. Dr. Cox's note concerning the right shoulder pain specifically notes that it was not the "left" shoulder, which suggests that Dr. Cox was aware of the significance of left shoulder pain. J.L.'s high heart rate and low oxygen saturation level were considered significant enough to return him to the intensive care unit. On the second post-operative day, August 5, 2005, J.L.'s BUN and creatinine levels rose higher. That evening J.L. had a high heart rate. His urine output level, which Dr. Cox had treated with a diuretic and increased fluids, had improved. J.L. also became agitated and restless. He began to constantly request water. Dr. Cox eventually ordered, however, that J.L. not be given water. Dr. Cox failed to note in his records that he considered the possibility that J.L. had a Leak. Instead, Dr. Cox focused on the possibility that J.L. was suffering from rhabdomyolysis, a malfunction of the kidneys caused by the breakdown, as a result of surgery, of muscle tissue into cells too large in size for the kidneys to process. Dr. Cox ordered a CK test which found elevated creatine phosphor kinase or CPK, a marker of muscle death. Dr. Cox then consulted with a nephrologists. While the symptoms evidenced by J.L. could have very well been a result of rhadbodmyolysis, they also could have been symptomatic of a Leak. Dr. Cox did not have adequate information on August 5, 2005, to conclusively find that J.L. was suffering from rhadbodmyolysis and, more importantly, not from a Leak. As of the second post-operative day, J.L. was exhibiting a high heart rate, low urine output, pain in his right shoulder, a worsening oxygen saturation level and hunger for air, and a changed mental status (anxiety and combativeness). Due to these symptoms, Dr. Cox should have considered the possibility of a Leak, rather than merely concluding that J.L. was suffering from rhabdomyolysis and treating J.L.'s individual symptoms. On the third post-operative day, August 6, 2005, J.L.'s condition worsened. His agitation and combativeness due to his thirst and air hunger worsened. J.L. was treated with Haldol, a psychiatric medication. Dr. Cox continued to suspect rhadbdomyolysis and to ignore the possibility of a Leak. On the fourth post-operative day, August 7, 2005, at approximately 15:30, pink-tinged fluid was seen draining from J.L.'s incision. A pulmonologist consulting on J.L.'s case was the first to suggest the possibility of a Leak, questioning whether the entire clinical picture pointed to intra-abdominal sepsis due to a Leak. It was not until the drainage from J.L.'s incision that Dr. Cox first considered the possibility of a Leak. Even then, Dr. Cox did not return J.L. to surgery until August 7, 2005, where a Leak was found and repaired. Dr. Cox's error in his treatment of J.L., like his error in his treatment of W.T., was not in failing to find the Leak earlier, but in failing to properly consider the possibility of a Leak when J.L. exhibited signs which should have prevented Dr. Cox from, with reasonable medical certainty, ruling out the possibility that a Leak was present. For this reason, the fact that a Leak was ultimately found is of little importance in deciding whether the charges leveled against him in the Administrative Complaint are accurate. Even if no Leak had ultimately been found, Dr. Cox's failure to properly respond to the potential of a Leak, evidenced by J.L.'s symptoms, was inconsistent with the standard of care. Dr. Cox's explanation at hearing as to why he waited from August 5, 2005, when it was apparent that J.L. had a Leak, until August 7, 2005, to repair the Leak, is not contained in Dr. Cox's medical records. The Standard of Care. The Department's expert, Christian Birkedal, M.D., credibly opined that Dr. Cox failed to practice medicine in accordance with the level of care, skill, and treatment recognized in general law related to health care licensure in violation of Section 458.331(1)(t), Florida Statutes (hereinafter referred to as the "Standard of Care"), in his treatment of W.T. and J.L. In particular, it was Dr. Birkedal's opinion that Dr. Cox violated the Standard of Care as to W.T. by failing to recognize W.T.'s signs and symptoms of a Leak and by failing to perform a post-operative upper gastrointestinal test on W.T. once he evidenced those signs. Dr. Birkedal's opinion is credited and accepted. As to J.L., Dr. Birkedal's opinion that Dr. Cox violated the Standard of Care by failing to recognize the signs and symptoms of a Leak for two days post-operatively is credited and accepted. The opinions to the contrary offered by Dr. Cox and his witnesses as to W.T. and J.L. are rejected as not convincing and as not addressing the issue precisely enough. The opinions offered by Dr. Cox and his witnesses with regard to both patients were essentially that the various symptoms pointed to by Dr. Birkedal were not "evidence" of a Leak. Those opinions do not specifically address the issue in this case. Dr. Cox and his witnesses based their opinions on whether Dr. Cox should have "known" there was a Leak at the times in issue. That is not the charge of the Administrative Complaint or the basis for Dr. Birkedal's opinion. The question was, not whether Dr. Cox should have known there was a Leak, but whether he should have considered a Leak as a possible cause for the symptoms exhibited by W.T. and J.L. Additionally, and finally, Dr. Birkedal based his opinions, not by looking at the record as a whole, as did Dr. Cox and his experts, but by looking at only those records in existence at the times relevant to this matter. In this way, Dr. Birkedal limited himself to a consideration of what Dr. Cox knew about his patients at the times relevant in the Administrative Complaint.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the a final order be entered by the Board of Medicine finding that Samuel Cox, M.D., has violated Section 458.331(1)(m) and (t), Florida Statutes, as alleged in Counts I, II, and III of the Administrative Complaint; issuing a reprimand; placing his license on probation for two years, with terms to be established by the Board; and imposing a fine of $15,000. DONE AND ENTERED this 19th day of June, 2007, in Tallahassee, Leon County, Florida. S LARRY J. SARTIN 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 19th day of June, 2007. COPIES FURNISHED: Patricia Nelson, Esquire Assistant General Counsel Prosecution Services Unit Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3250 Jonathon P. Lynn, Esquire Marci Strauss, Esquire Stephens, Lynn, Klein 301 East Las Olas Boulevard, Suite 800 Fort Lauderdale, Florida 33301 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 Josefina M. Tamayo, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Dr. Ana M. Viamonte Ros, Secretary Department of Health 4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701
