The Issue Whether the Petitioner is entitled to an award of additional points sufficient to achieve a passing score on the July 1997 optometry exam.
Findings Of Fact Susan J. Summerton-Madison (Petitioner) took the July 1997 examination for licensure as an optometrist in the State of Florida. A portion of the examination tests the clinical skills of the applicant for licensure. Each applicant performs a number of tasks while two examiners observe. Prior to administration of the test, all examiners receive standardization training providing a baseline for grading the individual performance of each applicant. Examiners grade each applicant independently of each other. During the clinical part of the test, a viewing system known as a "teaching tube" is attached to the optometrist's equipment used by the applicant. The applicant performs each task twice because only one examiner at a time can observe the performance through the tube. Prior to beginning the clinical portion of the exam, the applicant and the examiners set the tube focusing mechanism so that both the applicant and the examiner have a clear view of the procedures being demonstrated. By grade report dated August 27, 1997, the Petitioner was advised that she had scored 68.80 on the clinical portion of the examination. A score of at least 75 points is required to pass the clinical portion of the examination for licensure as an optometrist. The Petitioner challenges the grading of the following questions: Section 1, questions 4a and 4b. Section 2, questions 3a, 3b, 5c, 6a, 7b, 10a, 11a, 11b, 12a, 12b, 13a, 14a, 15a, 18a, 18b, 21a, 21b, 24a, 25a, and 26a. The Petitioner asserts that her pregnancy during the examination resulted in ocular changes which caused focusing anomalies. The anomalies allegedly caused the viewing equipment through which the examiners observed her performance to be out of focus. The Petitioner received score deductions related to lack of focus on numerous questions; specifically section 2, questions 3a, 3b, 5c, 6a, 7b, 10a, 13a, 14a, 15a, 18a, 21a, 24a, 25a, and 26a. There are multiple causes of temporary ocular changes, including nervousness. Although there is evidence that pregnancy can result in ocular changes, the evidence fails to establish that any focusing problems which occurred during the Petitioner's performance on the July 1997 examination were related to pregnancy. Refocusing the viewing mechanism takes approximately five seconds. There is no evidence that an applicant is prevented from refocusing the equipment during the clinical examination. Although examiners are under no obligation to advise applicants during the test, one of the examiners observing the Petitioner suggested that she refocus the equipment. The Petitioner asserts that the request caused her to run out of time on section 2, questions 11a, 11b, 12a, and 12b. The evidence fails to establish that any problems related to insufficient time for the examination were related to the examiner's suggestion. The Petitioner asserts that points were deducted for poor focus on tasks which did not include focus as grading criteria. The evidence establishes that because the clinical portion of the test involves examination of ocular systems in a patient, almost all procedures require correct focus. The Petitioner asserts that on section 2, question 21b, ("foveal reflex") she received no points, but that another optometrist's examination of the test patient indicated that the foveal reflex was acceptable. Review of the examination indicates that the Petitioner's score was lowered because of focusing problems. The fact that a qualified optometrist determined the patient to be normal does not entitle the Petitioner to additional points or indicate that the scoring of her performance was unfair. Because examiners view separate procedures, it is not unlikely that examiners may award different scores. It is possible to evaluate the performance of examiners through use of "agreement ratings." Agreement ratings indicate the frequency of which each examiner agrees with the other examiner in testing the same applicant. The Petitioner notes that the examiners grading her performance differed in grading section 1, questions 4a and section 2, questions 3a, 3b, 7b, 10a, 13a, 14a, 15a, 18b, 21a, 21b, and 25a, and asserts that such indicates she was graded unfairly. Although the agreement ratings of the examiners who observed the Petitioner were slightly lower than average, the examiner agreement ratings fail to establish that she was graded arbitrarily or unfairly. The sample size is so small as to be subject to influence by borderline candidates, where one examiner believes an applicant's performance to be more acceptable than does the other examiner. The Petitioner asserts that on section 2, question 18b, the lack of agreement between the examiners reflects arbitrary grading because both supposedly view the same procedure through the viewing tube. The evidence fails to establish that the Petitioner is entitled to additional points or that the scoring of her performance was unfair. The Petitioner asserts that she informed the examiners that she was pregnant prior to administration of the clinical portion of the exam and that she should have received special accommodation of some type based on her condition. Procedures set forth in Rule 61-11.008, Florida Administrative Code, address special assistance to certain persons submitting to examination by the Department of Business and Professional Regulation, Office of Examination Services, which administered the examination in the instant case. Such assistance is available to persons with learning disabilities or physical handicap as defined in the rule. There is no evidence that the Petitioner sought to utilize such procedures. There is no evidence that the Petitioner's condition would have been regarded as a learning disability or physical handicap by the agency. The Petitioner asserts that an examiner exited the room while she was addressing section 1, questions 4a and 4b, and that the confusion of the departure caused the examiners to err. The evidence establishes that the scores reflect the inappropriate performance of the task involved, which involved measurement of the patient's pupil.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is hereby recommended that the Department of Health enter a Final Order dismissing the Petitioner's challenge to the grading of the July 1997 examination for licensure as an optometrist. DONE AND ENTERED this 22nd day of May, 1998, in Tallahassee, Leon County, Florida. WILLIAM F. QUATTLEBAUM 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 Filed with the Clerk of the Division of Administrative Hearings this 22nd day of May, 1998. COPIES FURNISHED: Susan J. Summerton-Madison 559 99th Avenue North Naples, Florida 34108 Anne Marie Williamson, Esquire Department of Health Building 6, Room 102 1317 Winewood Boulevard Tallahassee, Florida 32399-0700 Angela T. Hall, Agency Clerk Department of Health Building 6, Room 136 1317 Winewood Boulevard Tallahassee, Florida 32399-0700 Eric G. Walker, Executive Director Board of Optometry Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue Should the Board of Medicine (the Board) discipline Respondent's license to practice medicine in Florida, based upon an alleged failure in the level of care and treatment of J.P., his patient?
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. The Respondent, whose address of record is 1834 SW 1st Avenue, Ocala, Florida 34474, was issued license number ME 56306. At all times material to this Complaint, the Respondent was a licensed medical physician within the State of Florida. Respondent specializes in pulmonology. Respondent was Patient J.P.'s attending physician. Respondent ordered a bronchoscopy and specimens that revealed possible Mycobacterium Avium-Intracellulare (MAI). The biopsies revealed signs of granulomalous infection as seen in MAI or tuberculosis (TB). During this (his) hospital stay, Patient J.P. was started on the drug ethambutol at 1600 mg daily. It is the manufacturer's recommendation that the dose of ethambutol, if started at 25 mg per kilogram per day, should be reduced to 15 mg per kilogram per day after 60 days. The infections (infectious disease) specialist saw Patient J.P. in his office on or about July 26, and August 8, 2000 and in his August 18, 2000 letter to Respondent, there was no mention or recommendation for a change in Patient J.P.'s dosage after two months on the ethambutol therapy. Patient J.P. was subsequently seen by the Respondent on October 23, and again on December 27, 2000, when Patient J.P. complained of eye problems. At this later visit Respondent immediately discontinued the ethambutol and referred Patient J.P. to an eye specialist. ADDITIONAL FACTS: Patient J.P.: On May 8, 2000, Patient J.P. was seen at Ocala Lung and Critical Care Associates (Ocala Lung and Critical Care) in Ocala, Florida. This practice is Respondent's Professional Association. The patient had been referred by Dr. Dave Metcalf. On that date the patient was seen by Respondent's associate, Poonan Warman, M.D. According to the note in the patient records for that date, the patient reported a complaint of "cough and cold" with no weight loss. (Petitioner's Exhibit No. 1, page 28) On May 23, 2000, the patient returned to Ocala Lung and Critical Care. Again Dr. Warman saw the patient. A note in the patient's chart describes J.P.'s condition on that date. (Petitioner's Exhibit No. 1, page 35) At that time Dr. Warman concluded that the patient had a mass in his left lung with right lung abscess. Dr. Warman scheduled a bronchoscopy and prescribed mediation. On June 13, 2000, Respondent first say Patient J.P. at Ocala Lung and Critical Care. At that time Respondent made notes in the patient's chart concerning the patient's condition. (Petitioner's Exhibit No. 1, page 49) Respondent assessed the condition as a system in the patient's right upper lobe, possible lung abscess. The note refers to the provision of an antibiotic, a CBC differential and CRP that was ordered. This was a follow- up visit for the bronchoscopy that had been performed by Dr. Warman. Cultures in association with the organism found through the bronchoscopy were pending. At that time Respondent's recommendation to the patient was to continue the antibiotic treatment of Augmentin as well as Clindamycin. The patient was to be seen back in a month's time, according to a typed note within the patient's chart bearing Respondent's signature. (Petitioner's Exhibit No. 1, page 48) In that same typed note it was noted that the bronchoscopy and the biopsy that had also been performed did not reveal malignancy but chronic inflammatory cells had developed. The type-written impression entered in the chart was right upper lobe cavitary lesion, most likely lung abscess. On this date Respondent concluded that the patient had bacterial infection in the lung and the lung abscess. Respondent wanted blood work done to monitor the side effects of the antibiotics being given. Respondent discussed the side effects of the medication with the patient as noted in the written entries in the chart. In relation to the antibiotic medications that were provided to Patient J.P., notes were made on June 14 and 20, 2000, in the patient records maintained by Ocala Lung and Critical Care, commenting on the efforts by the practice to assist Patient J.P. in obtaining those medications from that office and other doctors' offices because of his inability to pay for the medicine. (Petitioner's Exhibit No. 1, page 47) On June 27, 2000, Respondent saw Patient J.P. at the Monroe Regional Medical Center (the Medical Center) in Ocala, Florida, for a medical emergency. The Medical Center is a hospital. At that time the patient's chief complaint was a right-side chest pain. The patient was admitted to the Medical Center by Frank E. Reisner, M.D. The patient had called Respondent's office before his admission. Under the circumstances Respondent was concerned that the patient would not receive adequate treatment as an outpatient. It was recommended that the patient be admitted for inpatient hospital treatment of his lung abscess. On June 27, 2000, the emergency department note in the hospital record refers to the admission of Patient J.P. to the service of Dr. Mishra, an internist at the hospital. (Petitioner's Exhibit No. 1, page 354) Dr. Mishra had also spoken to Patient J.P. and told the patient to come to the hospital. Because the Patient J.P. had a lung abscess problem and had been seen by Respondent in the past, Respondent became responsible for the patient in the hospital upon the request of another physician. Respondent's decision to have the patient remain admitted for treatment of the lung abscess was made the same day the patient arrived at the hospital. Under this arrangement Respondent was the attending physician. On June 28, 2000, after receiving the chart for Patient J.P. from Respondent's office, to review the patient history and based upon results at the hospital that revealed the patient had possible MAI present in bronchial washings from a bronchoscopy performed in the hospital, Respondent decided to consult with Lee Prchal, M.D., who specializes in infectious disease and practices in Ocala, Florida. The reason for the consultation was that Respondent does not treat MAI. Decisions about the appropriateness of treatment for MAI, in Respondent's view, would best be made by a physician specializing in infectious diseases. Respondent did not feel comfortable treating MAI, in that he did not have sufficient knowledge about the condition and its treatment. If Dr. Prchal thought that the patient needed to be treated for MAI, Respondent expected that the other physician would be responsible for the care. With this in mind Respondent did not follow the patient as an attending physician would normally during the patient's stay in the hospital. Nonetheless, Respondent was aware that Patient J.P. had been prescribed ethambutol, also referred to as ethambutol hydrochloride or by the generic drug name Myambutol. Respondent understood that the medication had been prescribed initially in a setting in which it was uncertain whether the patient had a problem with MAI or tuberculosis. Dr. Prchal had written the order for ethambutol given to Patient J.P. in the hospital stay. Dr. Prchal intended to address any MAI with the medication. Dr. Prchal did not write orders for ethambutol upon the patient's discharge, although the patient continued to take the medication. Respondent did not order an initial visual acuity test when Patient J.P. was first prescribed ethambutol in the hospital stay. Dr. Prchal did not order visual testing to establish a baseline while the patient was hospitalized. At no point during the time Patient J.P. was treated with ethambutol did Respondent consider himself responsible in addressing MAI. Respondent did not believe that he had the duty to manage the treatment. He believed that Dr. Prchal was responsible while the patient was in the hospital and upon the patient's discharge. On July 19, 2000, following the Patient J.P.'s discharge from the hospital, Respondent saw the patient again in an office visit. Notes concerning that visit were made. (Petitioner's Exhibit No. 1, page 84) The notes reflect that the patient was doing well, and his cough had improved. Respondent's impression was that the patient had atypical TB and COPD. COPD refers to Chronic Obstructive Pulmonary Disease. At the time it was noted that the patient was advised to keep in touch with HRS for atypical TB. HRS refers to Health and Rehabilitative Services. In actuality, the Marion County Health Department was the health organization that Respondent had in mind. The comment on HRS is in association with an adult clinic in Ocala, Florida. According to a note in the patient record made by a member of Respondent's staff, someone previously had spoken to a person from the Health Department, who said that Patient J.P. did not have tuberculosis. This meant that the TB clinic with the Health Department would not follow his case for tuberculosis, but he could be followed in the adult health clinic for the condition he did have and that clinic should be able to help the patient with needed medication. (Petitioner's Exhibit No. 1, page 47) The adult health clinic is a general clinic affiliated with the Department of Health, and if seen in the general clinic Respondent believed that the patient could be provided needed medications. Patient J.P. had experienced difficulties obtaining needed medication in the past. As before, Respondent did not examine Patient J.P. in relation to visual acuity. The patient offered no complaints about his vision at this visit. On the July 19, 2000 visit Respondent did not consider reducing the ethambutol dosage for Patient J.P. The patient was referred to Dr. Prchal for a visit on July 26, 2000, in relation to MAI. Given the referral to Dr. Prchal, Respondent proceeded on the basis that Dr. Prchal was responsible for treating Patient J.P. for MAI. It was intended that the patient return to see the Respondent on October 23, 2000. Patient J.P. saw Dr. Prchal on July 26, 2000. Following that visit Dr. Prchal wrote the Respondent. The letter was dated August 18, 2000. (Petitioner's Exhibit No. 1, pages 87 and 88) In concluding remarks Dr. Prchal stated in the correspondence: Therefore, at this time, I would recommend continued ethambutol and biaxin for treatment of his MAI. The duration of his clindamycin will require your clinical judgment, but in view of his radiographic changes, it may require further prolonged administration. Respondent's reading of the correspondence was that Dr. Prchal would continue to monitor and be responsible for ethambutol therapy while deferring to Respondent to treat the lung abscess with Clindamycin. On October 23, 2000, Respondent saw Patient J.P. in Respondent's office. Handwritten notes were made by the Respondent during the visit, followed by typewritten notes for the patient's record. (Petitioner's Exhibit No. 1, pages 90 and 91) The patient records refer to the Respondent's perception that Dr. Prchal was treating MAI with multiple antibiotics. The note refers to COPD, lung abscess and MAI. Respondent asked the patient to discontinue Clindamycin and to continue Biaxin. Respondent also asked Patient J.P. to continue taking ethambutol. Respondent did not consider himself to be responsible for treating MAI with ethambutol. In the typed document for the patient record pertaining to the October 23, 2000 visit, it is indicated under the section dealing with Respondent's impression that the lung abscess healed resulting from treatment with clindamycin. At the same time the typed notes indicated that MAI would require long-term treatment. Although Respondent contends that Dr. Prchal would follow Patient J.P. routinely for MAI, the typewritten note describes Dr. Prchal's August 18, 2000 correspondence as a "final note." On October 23, 2000, the patient did not complain of any problems with visual acuity and no eye examination was ordered by Respondent. No specific inquiry was made concerning the patient's progress with the MAI. A follow-up appointment was scheduled for December 27, 2000. Patient J.P. kept that appointment. On December 27, 2000, Patient J.P. complained of an eye problem. He told Respondent that he was not able to see and that two weeks before he had seen an eye physician. As the patient record indicates, the patient complained to Respondent whether this problem with his vision was due to medicine. As a record on the patient care states, authored by Respondent, Respondent indicates "In response, [to complaints about the patient's vision] I have stopped his ethambutol." The impression in the patient record that was typed indicates as well "Ethambutol is being stopped today." This patient record is by way of a letter from Respondent to Dr. Prchal. (Petitioner's Exhibit No. 1, page 93) The letter goes on under the portion referred to as "Plan" to say, "I referred him back to you [Dr. Prchal] for evaluation of the disease process and then we will decide how long he will require the Biaxin." The discussion given thus far of the facts, includes the perspective of the Respondent as to his explanation of care for MAI in Patient J.P. The next part of the discussion is in relation to testimony by deposition by Dr. Prchal including his explanation of his care for MAI provided Patient J.P. Dr. Prchal has practiced in Ocala, Florida, since 1987. His primary specialty is infectious disease. His first encounter with Patient J.P. was at the Medical Center when the patient was referred to him by Respondent, the attending physician, to consult as an infectious disease specialist. When Patient J.P. was first seen, the working differential, as Dr. Prchal recalls it, was that the patient had an underlying chronic lung disease with a history of smoking and a family history of lung cancer. The patient had failed outpatient treatment and when seen could have underlying cancer and/or infections in his lung. Following the bronchoscopy performed on the patient in the hospital, Dr. Prchal wrote an order for ethambutol 1600 mg. The order was written on June 28, 2000. He wanted the patient to receive ethambutol because it was an antibiotic that is used for treating MAI. As Dr. Prchal describes, MAI is a germ in the family of tuberculosis. The patient received his first dose of ethambutol on June 29, 2000. The reason for prescribing 1600 mg of ethambutol was in recognition of the patient's weight. The dosage was presented in four tablets of 400 mg. Dr. Prchal's view of the prescription of ethambutol was that he had signed-off on the case before the patient was discharged from the hospital. At the same time, he considered the use of ethambutol to be open-ended and dependent upon the clinical response by Patient J.P. beyond his discharge. The concluding point for using ethambutol was to be decided by Respondent, in Dr. Prchal's perception, in that Respondent was the attending physician and the main person in charge of the case. Dr. Prchal's view of the choice of dosage of milligrams per kilograms of weight ranging from 15 mg to 25 mg per kilogram of weight, depends upon the person's clinical circumstance. The common starting dose is 25 mg per kg, in his view. Dr. Prchal's experience with ethambutol is that he had prescribed ethambutol to more than 50 patients. Dr. Prchal realized that optic neuritis is a potential side effect in the use of ethambutol. Dr. Prchal does not believe that baseline vision testing is necessary before providing ethambutol therapy. Dr. Prchal is familiar with the PDR concerning ethambutol, which he considers to be the manufacturers guidelines for use of that medication. In relation to the PDR reference to monthly testing for visual acuity during the use of ethambutol, particularly in dosages in the amount of 25 mg per kg, Dr. Prchal refers to the difficulty in having an ophthalmologist see patients for screening in the Ocala area and the difference of opinion among members of the medical community concerning screening. He does not believe that there is a specific standard to be followed in the community for screening. When Patient J.P. was in the hospital receiving his first dosage of ethambutol on June 29, 2000, Dr. Prchal indicated that baseline vision testing was not available in that setting and could only be done following the discharge of the patient. The frequency of testing beyond baseline testing would be on a case by case basis. According to Dr. Prchal, visual monitoring is part of the overall monitoring in the use of ethambutol. In Dr. Prchal's physician progress notes for Patient J.P. made on July 1, 2000, at the hospital, pertaining to ethambutol he referred to "appropriate monitoring." He then goes on to say that he "will sign off." He explains the latter reference to indicate that he was signing-off on the case. (Petitioner's Exhibit No. 1, page 121) Dr. Prchal saw Patient J.P. on July 26, 2000. At that time the patient was continuing with ethambutol. Dr. Prchal inquired about any visual symptoms. Patient J.P. responded that he did not have visual symptoms. The patient told Dr. Prchal that he had been referred to the Marion County Health Department. In Dr. Prchal's opinion the patient's medical condition at the time was better and the medicine seemed to be working. This is taken to mean that the ethambutol was working. Dr. Prchal saw Patient J.P. on August 8, 2000. This was their last visit. As with the visit on July 26, 2000, when Dr. Prchal saw Patient J.P. on August 8, 2000, the patient expressed no complaints about his vision. On August 8, 2000, Dr. Prchal had determined that the patient did not have tuberculosis, and medications to treat that disease were not necessary and could be discontinued. The medications for treating tuberculosis were IMH, Tyrazinamide and Rifampin. Dr. Prchal thought that ethambutol for treating MAI was still called for, together with Biaxin. Dr. Prchal did not have in mind a specific dosage of ethambutol. Being persuaded that Respondent was the attending physician overseeing the care, Dr. Prchal made known his views in the correspondence to Respondent on August 18, 2000. (Petitioner's Exhibit No. 1, pages 87 and 88) Dr. Prchal believes that the reason for Patient J.P.'s visits on July 26, 2000, and August 8, 2000, was Respondent's desire to know what medications still needed to be continued in treating the patient. EYE CARE The day before Patient J.P. saw Respondent on December 27, 2000, the patient had been at Ritz Eye Care. The reason for his visit was "check eyes-has trouble seeing." (Petitioner's Exhibit No. 1, page 192). On the visit to Ritz Eye Care he was seen by Daniel L. Ritz, O.D. Dr. Ritz consulted with Robert N. Mames, M.D., specializing in diseases and surgery of the Vitreous and Retina. Dr. Mames performed an ophthalmic examination and diagnosed the Patient J.P.'s condition as (1) decreased visual acuity in both eyes; (2) minimal nuclear sclerosis; and (3) history of lung abscess, Mycobacterium Avium. In his impression Dr. Mames said "etiologies include optic neuropathy secondary to ethambutol versus CAR syndrome (Canon-associated retinopathy), which is unlikely with no history of cancer." These findings were made in the report from Dr. Mames to Dr. Ritz dated January 16, 2001. (Petitioner's Exhibit No. 1, page 199) Patient J.P. was seen at the University of Florida, College of Medicine, Department of Ophthalmology, on March 23, 2001, by M. Tariq Bhatti, M.D., an assistant professor of the Department of Ophthalmology and Neurology. He indicates in correspondence to Mandouh H. Zeini, M.D., practicing in Ocala, Florida, "It appears that Mr. P. has bilateral optic atrophy. As you are aware, ethambutol is a well-known toxin to the optic nerves. However, I think it would be important to rule out other treatable causes of his optic atrophy. Therefore, I have recommended B-12, folate level, sedimentation rate, syphilis serology, ANA and an MRI of the brain and orbits." (Petitioner's Exhibit No. 1, page 224) On April 25, 2001, Dr. Bhatti saw Patient J.P. again. In turn, he corresponded with Dr. Zeini on that date. (Petitioner's Exhibit No. 1, page 227) With the negative work-up on the prior tests given Patient J.P., Dr. Bhatti wrote, "I suspect Mr. P.'s bilateral optic neuropathies are ethambutol- related. He has discontinued the use of ethambutol, therefore this should remain a static process with no visual loss." PHYSICIAN DESK REFERENCE: MYAMBUTOL The PDR in referring to MYAMBUTOL under the heading DESCRIPTION states: MYAMBUTOL ethambutol hydrochloride is an oral chemo-therapeutic agent which is specifically effective against actively growing micro- organisms of the genus mycobacterium, including M. tuberculosis. In the PDR under the heading INDICATIONS it is stated: MYAMBUTOL is indicated for the treatment of pulmonary tuberculosis. The PDR refers to CONTRAINDICATIONS where it states: MYAMBUTOL is contraindicated in patients who are known to be hypersensitive to this drug. It is also contraindicated in patients with known optic neuritis unless clinical judgment determines that it may be used. Under PRECAUTIONS the PDR states: . . . Because the drug may have adverse effects on vision, physical examination should include ophthalmoscopy, finger perimetry and testing of color discrimination. . . . In relation to ADVERSE REACTIONS the PDR states: MYAMBUTOL may produce decreases in visual acuity which appear to be due to optic neuritis and to be related to dose and duration of treatment. . . . Patients should be advised to report promptly to their physician any change of visual acuity. . . . Testing of visual acuity should be performed before beginning MYAMBUTOL therapy and periodically during drug administration, except that it should be done monthly when a patient is on a dosage of more than 15 mg. per kilogram per day. . . . In relation to INITIAL TREATMENT the PDR states: In patients who have not received previous antituberculosis therapy, administer MYAMBUTOL 15 mg. per kilogram. (7 mg. per pound) of body weight, as a single oral dose once every 24 hours. On the related subject of RETREATMENT the PDR states: In patients that have received previous anti- tuberculosis therapy, administer MYAMBUTOL 25 mgs. Per kilogram (11 mg. per pound) of body weight, as a single oral dose every 24 hours. . . . After 60 days of MYAMBUTOL administration, decrease the dose to 15 mg. per kilogram (7 mg. per pound) of body weight, and administer as a single oral dose every 24 hours. During the period when a patient is on a daily dose of 25 mg/kg monthly eye examinations are advised. EXPERT OPINION TESTIMONY: George Andrews Schoonover, M.D. has been licensed to practice in Florida since 1978. He practices pulmonary medicine in Jacksonville, Florida. He is certified in pulmonary medicine as well as internal medicine and has a sub-specialty in critical care medicine. For proposes of this hearing Dr. Schoonover was recognized as an expert in pulmonary diseases. To prepare himself for testimony at hearing he looked at the materials in Petitioner's Exhibit No. 1, which describes the care and treatment received by Patient J.P. during the relevant period. He also looked at the PDR in relation to MYAMBUTOL (ethambutol hydro-chloride). (Petitioner's Exhibit No. 3) His testimony was offered as a consultant for Petitioner. It supports Petitioner's attempt to impose discipline against Respondent's license. In interpreting the physician's progress note entered by Dr. Prchal on July 1, 2000, while Patient J.P. was in the hospital, which states "would sign off," Dr. Schoonover takes this to mean that Dr. Prchal will not be seeing the patient again, either in the hospital or as an outpatient, unless asked to formally consult at a future date. (Petitioner's Exhibit No. 1, page 121) Patient J.P. was discharged from the hospital on July 5, 2000, by Nagesh Kohli, M.D. Dr. Schoonover points out that the discharge summary explained to the patient in the discharge instructions that the patient, if experiencing any recurrence of symptoms, dyspnea, fever or questions or concerns, may call the Respondent. As well, the discharge instructions note that the patient was to follow up with Dr. Mitra in three to four weeks. (Petitioner's Exhibit No. 1, page 77) This instruction tends to coincide with the patient's visit to Respondent on July 19, 2000. Dr. Schoonover commented on the medications that Patient J.P. would continue upon discharge, in particular ethambutol 1600 mg q.d., part of the discharge summary by Dr. Kohli. This is as distinguished from the ethambutol Dr. Prchal had prescribed earlier in the hospital stay. In a patient medication record for Patient J.P. maintained by Respondent's practice, information is contained concerning ethambutol use over time. (Petitioner's Exhibit No. 1, page 9) Dr. Schoonover refers to the dosage of 400 mg four times per day, on July 19, 2000, October 23, 2000, and December 27, 2000, reflected in the patient record. Based upon the record, Dr. Schoonover assumes that Respondent was aware of the dosage of ethambutol for Patient J.P. upon these dates when the patient was seen, indicating a lack of change in the dosage over time. Dr. Schoonover commented upon the correspondence from Dr. Prchal to Dr. Mitra dated August 18, 2000. In his reading, Dr. Schoonover believes that the correspondence points out that Respondent was the physician of record from the standpoint of monitoring Patient J.P., and in treating the patient from the hospital discharge until the patient was seen by Dr. Prchal on July 26, 2000. In this connection notes made by Dr. Prchal concerning Patient J.P. in August 2000 were interpreted by Dr. Schoonover to indicate that the patient was receiving his prescriptions for medication from Respondent. (Petitioner's Exhibit No. 1, page 270) Dr. Schoonover also mentions the August 30, 2000 note in Patient J.P.'s records maintained by Respondent's practice, which describes a call by Dr. Prchal and his office note, taken to mean the correspondence directed to Respondent on August 18, 2000, in which Dr. Prchal requests Respondent to make sure that the patient has plenty of meds (medication) while Dr. Prchal was out of town through September 18, 2000. (Petitioner's Exhibit No. 1, page 89) That note maintained by Respondent in his practice indicates that the request was honored where it states, "Done." Dr. Schoonover assumes that the reference to meds would include ethambutol. Dr. Schoonover commented on the October 23, 2000 visit with Respondent as reflected in the note made on that date by Respondent (Petitioner's Exhibit No. 1, page 90), wherein it indicates that that patient is being continued on ethambutol. Dr. Schoonover believes that Respondent was responsible for monitoring that therapy and potential side effects and drug interactions associated with ethambutol. Dr. Schoonover commented on the December 27, 2000 correspondence from Respondent to Dr. Prchal, in which Respondent describes the complaint by Patient J.P. made December 26, 2000, about some eye problem, and whether the problem was due to medication. As Dr. Schoonover was aware, Respondent responded to those remarks by stopping the ethambutol. Dr. Schoonover was asked about his ability to form an opinion with a reasonable degree of medical certainty, whether the Respondent by his treatment of Patient J.P. practiced 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. He had an opinion. That opinion was that Respondent deviated from the standard of care, that the Respondent fell below the standard of care. Dr. Schoonover feels that deviation was in two areas. The first was the failure to order eye examinations for Patient J.P. The second reason was that the Respondent did not reduce the dosage of ethambutol after two months of therapy. Dr. Schoonover offered his opinion with the belief that Respondent was the attending physician in the hospital and continued to treat the patient beyond the patient's release from the hospital. Dr. Schoonover indicated that had the Respondent not ordered an initial eye examination be done, then at some subsequent point in the care the examination should have been ordered. Concerning reducing the dosage of ethambutol, Dr. Schoonover further explains his opinion that the dosage should have been reduced by Respondent after 60 days or at least determined why the specialist (Dr. Prchal) had not reduced it after 60 days. Dr. Schoonover concludes that Respondent could have taken steps to prevent the permanent visual impairment of Patient J.P. through an initial eye examination or subsequent follow-up eye examination, finding the problem early enough that this discontinuation of the medication would resolve the problem and promote improvement before permanent damage was done. Dr. Schoonover holds the opinion that Dr. Prchal also deviated from the recognized standard of care in his treatment of Patient J.P. in relation to ethambutol. He believes that both Respondent and Dr. Prchal were in a situation wherein they shared the care and they were both equally responsible and failed to meet the standard of care for the same reasons. In essence Respondent was treating the Patient J.P. for MAI as well as Dr. Prchal. In his testimony Dr. Schoonover is less precise in his opinion concerning the responsibility for a physician to order an initial eye examination for Patient J.P., testifying that it was someone's responsibility. He then goes on to say that it was several persons' responsibility and that Respondent and Dr. Prchal were among those persons. They are the persons discussed as well as Dr. Kohli. Finally, in order to find a deviation from the standard of care by Respondent, Dr. Schoonover believes that it is necessary to show that the patient had diminished visual acuity more probably than not connected to ethambutol. His reading of the April 25, 2001 correspondence from Dr. Bhatti in particular, leads him to believe that there was a connection between the use of ethambutol and bilateral optic neuropathies as described by Dr. Bhatti. (Petitioner's Exhibit No. 1, page 227) Raymond L. Parker, Jr., M.D., has been practicing in Florida since 1976. His current practice is with Pulmonary Physicians of South Florida in South Miami, Florida. He specializes in internal medicine, pulmonary disease and critical care. He is board certified in all specialties. He testified by deposition in behalf of Respondent as an expert, in particular, in relation to his specialty in pulmonary diseases. (Petitioner's Exhibit No. 2) In the deposition the parties stipulated that the witness was an expert in pulmonary diseases. That stipulation is accepted. In preparing to offer his opinion concerning the care provided by Respondent to Patient J.P., Dr. Parker had exposure to the deposition of Respondent, the deposition of Dr. Prchal, the deposition of Dr. Kohli, medical records of Dr. Prchal, Frank's Pharmacy records, medical records of Dr. Leslie Husband, medical records of Beatriz X-Ray and Imaging Center, medical records of Dr. Zeini, medical records of Dr. DiLorenzo, medical records of the Marion County Department of Health, medical records of Express Care of Belleview, and medical records of the Monroe Regional Medical Center. Dr. Parker also had exposure to records related to Patient J.P., part of Respondent's office practice. Dr. Parker comments on the bronchoscopy performed by Respondent on June 29, 2000, while Patient J.P. was in the hospital, in which the bronchoscopic specimen showed no endoscopic evidence of malignancy. Based upon the results of the bronchoscopy in the hospital and an earlier bronchoscopy performed a Dr. Warman on June 7, 2000, Dr. Parker was persuaded that the patient was going to be treated for MAI based upon cultures that grew out from the procedures. Further, Dr. Parker refers to the discharge diagnosis when Patient J.P. left the hospital, where it is stated that the patient had atypical tuberculosis, MAI, in addition to a right-upper lobe abscess and COPD. Dr. Parker's refers to the progress note dated July 1, 2000, when Patient J.P. was in the hospital, made by Dr. Prchal, in which Dr. Prchal recommends 400 mg tablets, four times daily of ethambutol, totaling 1600 mg, as being part of a treatment for TB and MAI pending AFB culture results. Dr. Parker's reading of the note by Dr. Prchal calling for "Appropriate monitoring. Will sign off," in the context of other materials reviewed by Dr. Parker, meant that Patient J.P. was being referred to the tuberculosis health center and those persons in that facility would manage the tuberculosis and MAI issue in the future. Dr. Parker refers to information in the patient records where the wife of Patient J.P. contacted a social worker leading to the patient being informed that the tuberculosis unit did not treat MAI but that an attempt was being made to make an appointment for Patient J.P. to be seen at the adult clinic. Ultimately, Dr. Parker interprets the information he reviewed as indicating that Patient J.P.'s wife decided that an appointment needed to be made with Respondent resulting in the appointment on July 19, 2000, between the patient and Respondent. Between July 1, 2000, when Dr. Prchal wrote his "sign off" note and July 19, 2000, when the patient was seen by Respondent, Dr. Parker expressed the opinion that Respondent and Dr. Kohli were the attending physicians for Patient J.P. The prescription recommendations upon discharge would have been the responsibility of Dr. Kohli because he discharged the patient. According to Dr. Parker this included ethambutol. Dr. Parker is familiar with the PDR. He does not consider it to be an authoritative source for information among doctors. He considers that the information contained in the PDR was written years before. Consequently, it is not authoritative or up to date. Dr. Parker prescribes ethambutol for his patients but rarely. He has a special interest in MAI. He is aware of the recommendations within the PDR pertaining to visual testing and dosage for ethambutol. He considers some of the recommendations for using ethambutol to be controversial. For example, he does not recommend his patients get monthly monitoring for their vision. Instead, he recommends that they watch out for problems. He considers that this approach is the general consensus in the community where he treats patients. Specifically, Dr. Parker does not question the prescription of 25 mg per kg of patient weight for the Patient J.P. when ethambutol was first prescribed. The dosage points to the patient loosing weight, fevers and sweats, not doing well and the need to "jump on him or he would just wither away." Dr. Parker does believe that there should have been an eye test when starting the patient on ethambutol. Dr. Parker in his understanding perceives that when Dr. Kohli discharged the patient from the hospital, Dr. Kohli believed that the patient would be attending the TB Clinic for treatment and monitoring, to include baseline studies for visual acuity. Dr. Parker in his opinion looks upon the suggestion in the PDR that the dosage of ethambutol be changed over time as being a guideline and that the proper treatment is in view of the clinical needs of the patient. If the patient is improving the dosage can be reduced. If he remains very sick, he would not necessarily reduce the dose. Concerning the maintenance of 25 mg per kg over periods of three, four, five, or six months Dr. Parker says that under appropriate circumstances the maintenance of 25 mg per kg of patient weight is acceptable. He does not offer his opinion concerning this case. Concerning the prospect for reducing the dosage, Dr. Parker's review of the records does not lead him to a conclusion one way or the other. When patients are maintained on 25 mg. per kg. of patient weight, Dr. Parker expresses the opinion that more frequent eye testing is in order. If the dosage is less than that amount he would not recommend that a patient have repeat eye testing but that the patient be cautioned to quickly advise the doctor about changes in vision and or visual fields or color vision. From his review of the records Dr. Parker was aware that the patient was maintained on ethambutol 25 mg per kg of weight for approximately six months and no eye tests were provided during that period. Dr. Parker interprets the correspondence from Dr. Prchal to Respondent dated August 18, 2000, as a guiding letter for addressing Patient J.P.'s MAI, leading to the belief by Dr. Parker that Respondent deferred to Dr. Prchal in the treatment of MAI with ethambutol following that correspondence. Overall Dr. Parker does not believe that Respondent was treating Patient J.P. for MAI and had no experience with the drug ethambutol as part of that care. This meant that Dr. Parker does not believe that Respondent was addressing the MAI issue or ethambutol. Dr. Parker interprets the note in Respondent's office practice where on August 30, 2000, the call was received from Dr. Prchal referring to the office note of August 18, 2000, from Dr. Prchal. That request asks that the patient have plenty of meds while Dr. Prchal was out of town until September 18, 2000. This indicates that Dr. Prchal could not write the prescriptions and that he was requesting Respondent's office to handle the writing of prescriptions. This is not seen by Dr. Parker as turning over the management of the patient in reference to the prescriptions. In Dr. Parker's view, when consultants prescribe medication, the attending physician does not have a standard of care obligation to hold the knowledge about these drugs prescribed by the consultant for the patient. The attending physician relies upon the consultant for guidance on the drugs and any questions need to be followed up with the consultant, according to Dr. Parker. In this case he goes on to describe the expectation, upon the discharge from the hospital, that the patient would be seen by a clinic where the attending physician felt there would be necessary expertise. Dr. Parker reached an opinion on standard for care issues concerning Respondent's treatment and care of Patient J.P. His opinion is that Respondent met the standard of care because he was the treating physician limited to the lung abscess and COPD. Dr. Parker interprets the results of the July 19, 2000 visit to Respondent to be one in which Respondent realized that the patient was not going to be seen at a tuberculosis health clinic, resulting in Respondent referring the patient back to Dr. Prchal for management of MAI. Dr. Parker attaches importance to the August 18, 2000 letter from Dr. Prchal to Respondent, in which Dr. Prchal indicates a treatment plan for MAI and Respondent defers to that judgment. At the inception Dr. Parker believes Respondent was acting appropriately to refer Patient J.P. to Dr. Prchal, an infectious disease expert. Concerning the need for a baseline eye examination to be performed when ethambutol is being started, Dr. Parker thinks that is necessary. However, the physician managing the care with respect to the MAI and who ordered the medication is responsible for ordering the initial eye examination. In this case that would have been Dr. Prchal. Any follow-up eye examinations on a periodic basis would be the responsibility of the physician with a special interest in management of atypical mycobacterial disease, with some understanding of the various drugs involved, to include ethambutol. Dr. Parker believes that additional eye examinations are needed when continuing the dosage of 25 mg per kg of patient weight. Given the continuing dosage over time, Dr. Parker believes that Dr. Prchal was responsible for ordering subsequent eye examinations. In relation to the suggestion in the PDR that around 60 days the dosage of ethambutol be reduced, Dr. Parker believes that it is dependent upon the clinical response of the patient. Sometimes the dosage would be reduced earlier, sometimes later. The judgments concerning dosage would be that of the expert familiar with the MAI and drugs used to address it. SUMMARIZING FACTS: Respondent's explanation of the availability of the adult clinic in Ocala, Florida, to address Patient J.P.'s need for medications and other services only establishes that availability. It does not establish what was done at the clinic, if anything, in terms of treatment for MAI through the use of ethambutol and related vision tests. There is no proof that anything transpired at the adult clinic to treat MAI, or test for visual acuity. Whatever may have been offered to the patient in treatment and care by the adult clinic, it does not change the fact that Respondent and Dr. Prchal were involved with the treatment for MAI, to include the need to properly use ethambutol. Having considered the facts found concerning the care provided Patient J.P. by Respondent and Dr. Prchal and the opinions by the parties' experts Dr. Schoonover and Dr. Parker, Respondent has failed to practice medicine with the level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. Dr. Prchal was responsible for prescribing ethambutol while Patient J.P. was in the hospital. Consequently Dr. Prchal was responsible for testing initial visual acuity for the patient. The initial treatment provided was upon a request to consult made by Respondent. Dr. Prchal was also responsible for establishing the initial dosage for the patient. When the patient was discharged from the hospital, Dr. Prchal was no longer responsible for the treatment from July 5, 2000, the discharge date until July 26, 2000, when called upon again by Respondent to consult. When Dr. Prchal saw Patient J.P. on July 26, 2000, and August 8, 2000, it reestablished his responsibility but only temporarily. The treatment was turned back to Respondent as established in the correspondence following the second consult. That correspondence was dated August 18, 2000, from Dr. Prchal to Respondent involving ethambutol and its use in treating Patient J.P. Respondent had responsibility for Patient J.P. in relation to ethambutol following the patient hospital discharge and upon the visit by Patient J.P. to Respondent's office on July 19, 2000. Respondent briefly deferred to Dr. Prchal as a consultant on July 26, 2000, until he received the correspondence from Dr. Prchal dated August 18, 2000. Beyond that point in time, Respondent was responsible for Patient J.P.'s use of the medication ethambutol. This responsibility was evidenced in the Respondent's transcribed office note dated October 23, 2000, when the Patient J.P. was seen on a follow-up visit. It refers to the final note from Dr. Prchal dated August 18, 2000 and the continuation of ethambutol for the patient. It describes the need for the patient to continue on ethambutol for a year or so. On December 27, 2000, when Patient J.P. was next seen by Respondent in the office, the patient complained of an eye problem. In response Respondent "stopped his ethambutol" as of that day. During the time that Respondent was responsible for Patient J.P., related to the use of ethambutol by that patient, he was expected to make a clinical judgment about the proper dosage, but not necessarily at a two-month interval. There is no indication that he made any judgment. More significantly, given allegations in the Administrative Complaint, Respondent should have arranged periodic testing of visual acuity, while he was responsible for the use of ethambutol in treating Patient J.P., having failed to reduce the dosage from 25 mg per kg of body weight. Respondent's failure to meet the standard of care is not excused by Dr. Prchal's conduct when treating Patient J.P. with ethambutol. Respondent's belief that Dr. Prchal was all together responsible for treating Patient J.P.'s MAI with ethambutol and other medications is not accepted, realizing that to some degree Respondent undertook the treatment whether capable or not. Finally, there was no proof in this record concerning the local Department of Health, adult clinic providing treatment to Patient J.P. for MAI, to include judgment about the dosage of ethambutol and test for visual acuity. Absent such proof the responsibility fell entirely to Respondent and Dr. Prchal at various times. Their stated assumptions concerning the role, if any, played by the Department of Health, adult clinic in treating Patient J.P. without proof are unavailing and create no defense for their conduct. DISCIPLINARY HISTORY In the case of Department of Health, Petitioner vs. Purushottam Mitra, M.D., Respondent, DOH Case No. 1999-58979, a Final Order was entered. This Final Order was based upon a Recommended Order in Department of Health, Board of Medicine, Petitioner vs. Purushottam Mitra, M.D., Respondent, DOAH Case No. 01-2069PL. The Final Order concluded that Respondent had violated Section 458.331(1)(m), Florida Statutes, pertaining to maintenance of patient records justifying a course of treatment for a patient. It imposed an administrative fine amounting to $5,000.00. Respondent was also reprimanded by the Board. (Petitioner's Exhibit No. 4)
Recommendation Upon consideration of the facts found and conclusions of law reached, it is RECOMMENDED: That a final order be entered finding Respondent in violation of Section 458.331(1)(t), Florida Statutes (2000), imposing an administrative fine of $10,000.00, and issuing a written reprimand. DONE AND ENTERED this 25th day of February, 2005, 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 25th day of February, 2005. COPIES FURNISHED: Irving Levine, Esquire Judith Law, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Michael R. D'Lugo, Esquire Wicker, Smith, O'Hara, McCoy, Graham & Ford, P.A. Bank of America Center, Suite 1000 Post Office Box 2753 Orlando, Florida 32802-2753 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
The Issue The issues in this case are whether Respondent used fraudulent, false, misleading, or deceptive advertising and whether Respondent willfully submitted a claim to a third-party payor for services not rendered to a patient; and, if so, what is the appropriate sanction.
Findings Of Fact Petitioner is the state agency charged with regulating the practice of optometry pursuant to section 20.43, Florida Statutes, and chapters 456 and 463, Florida Statutes. At all times material to this proceeding, Respondent was a licensed optometrist in the State of Florida, having been issued license number OPC 1738. Respondent is the owner of One Price Optical in Cape Coral, Florida, where he practices optometry and sells eyeglasses. He opened his business in 2000. For the first 13 years of his business, Respondent advertised in an area newspaper, offering a free eye exam for glasses. The advertisement that he published in newspapers until sometime in 2013 is in evidence. At the top of the ad, the words “FREE EYE EXAM” appeared in large, white, all capital letters, against a solid black background. Immediately below, also on the black background in smaller white, all capital letters, was the following: FOR YOU • FOR GLASSES • PATIENTS 7 YEARS & UP Below the prominent white-on-black section, the ad contained information about the business in black print against a white background. The name of the business was the only print as large as the “FREE EYE EXAM” message at the top of the ad. Looking at the ad as a whole, the eyes are drawn to two messages: “FREE EYE EXAM” and “ONE PRICE OPTICAL.” The smaller black print on the white background identified Respondent as the optometrist, provided the address, telephone number, and hours, and listed names of third-party payors, including Medicare, vision plans, and insurance plans. The bottom of the ad contained one more very small black banner with tiny white print, setting forth a disclaimer required by statute and Board rule, regarding a patient’s right to a refund. N.P. saw the newspaper advertisement, and on October 4, 2012, he went to One Price Optical to obtain his free eye exam for glasses. N.P. already had glasses, but wanted to get an updated prescription. N.P. brought the ad with him. N.P. was greeted by staff member Hope Fior who asked what brought him to One Price Optical that day. N.P told her that he wanted the free eye exam. Patients are asked to complete a two-sided patient information form provided to them on a clipboard. Ms. Fior does not recall whether she was the staff person who gave N.P. the clipboard paperwork to fill out, but her initials, “HF,” appear at the top of the first page in the blank for “staff,” suggesting that it was her. Just as Ms. Fior did not specifically recall that she was the “staff” initialing N.P.’s paperwork--after all, it has been nearly seven years since the encounter--N.P. also did not recall filling out paperwork, although he remembers that he spoke with a female staff member (and Ms. Fior was the only female staff member). Nonetheless, N.P. was able to identify his handwriting on the form, such as his name, address, and telephone number on the first page (the front of the two-sided page). At the bottom of the first page, the form instructs Medicare patients that they “MUST READ & SIGN THE OTHER SIDE.” (Pet. Ex. 2, handwritten p. 29, lower left corner). The second page (the other side of the two-sided form) was referred to by Respondent as the “how are you going to pay” page, requiring patients to select one of several options, initial and/or sign the selection, and sign at the bottom of the page. One section is designated for “If You Have Medicare.” This section states that if a patient has Medicare, “We will bill Medicare for your eye exam according to the Medicare Laws [CPT code] 92004: New Patient, Comprehensive [or CPT code] 92014: Previous Patient, comprehensive. Please provide the staff with your: 1) Medicare card; 2) Medicare Advantage Card; 3) Any supplemental card; 4) Any other non-governmental health insurance card.” Below these provisions, the Medicare section concludes with the following: “If you do not have all of your insurance cards today, we will not be able to exam [sic] you today and will reschedule you.” (Pet. Ex. 2, p. 30). N.P.’s completed “how are you going to pay” page has a handwritten “X” in the box selecting the “If You Have Medicare” section, with N.P.’s initials next to the “X” (because he was a Medicare patient, and, therefore, required to complete this section as written). A check mark also appears next to “Medicare Advantage Card” in the portion requiring the patient to provide staff with insurance cards. Above the “If You Have Medicare” section, a separate section is provided for “Free Exam For Glasses,” with the following description: “The free eye exam for glasses is free. You do not have to buy anything at all. The free exam does not come with any prescription. If you wish, you may pay an exam fee and get a prescription for eye Glasses to take with you.” (emphasis added). At the bottom of this section, two options are provided, with spaces for the patient’s signature. One option is: “I would like the free exam with no RX”; the other option is: “I would like the $48 exam and get my RX.” On N.P.’s completed form, the “Free Exam For Glasses” section has no “X” in the selection box, and neither of the two options was signed by N.P. However, there are hand-drawn circles around the $48 exam option and the signature space to select that option, suggesting that this option was called to N.P.’s attention. There were no circles around the “free exam with no RX” option--the only option that was truly “free.” That option would not have met N.P.’s objective in coming into One Price Optical, which was to get an updated eyeglasses prescription. Another section on the second page is called “Vision Plans.” This section provides: “We will follow all the procedures, rules, and regulations according to the terms of your plan. The free exam for glasses above can not [sic] be combined with any part of your vision plan. You may not mix and match different coupons, promotions, store discounts, etc. with your Vision Plan.” On N.P.’s completed form, there is no “X” in the box provided to select this section, no initials by N.P., and no hand-drawn circles to indicate that this provision was called to N.P.’s attention as potentially applicable. N.P. signed the bottom of the “how are you going to pay” page (with only the Medicare/Medicare Advantage section initialed), next to the handwritten date, October 4, 2012. According to Respondent, his staff would have carefully walked N.P. through the examination and payment options when he came in and asked for the advertised free eye exam. This would have included asking Respondent whether he was covered by Medicare, whether he had “Medicare supplement” insurance coverage, and whether he had any other “vision plan” coverage. If so, he would have been asked to produce his insurance cards and the staff would have investigated what type of coverage was available for eye examinations. According to Respondent, N.P. made the voluntary election to undergo a comprehensive eye examination, which would be paid for under his Medicare Advantage insurance plan, instead of the “free eye exam.” Respondent acknowledged that a comprehensive eye examination must be completed on a patient in order to write a prescription for eyeglasses. One required component of a comprehensive eye examination is an internal examination of the eyes, to the back of the eyes (examination of the fundus). See Fla. Admin. Code R. 64B13-3.007. Respondent admitted that the so-called free eye exam for glasses offered by the advertisement was actually only a “screening” or a “consultation” with a patient to determine if the patient might need eyeglasses. Respondent admitted that the “free eye exam” (screening/consultation) would not be sufficient to enable Respondent to write a prescription for glasses. The advertisement does not mention this. What is offered for “free” is called an “eye exam for glasses,” not a screening that would be insufficient for Respondent to write a prescription for glasses. Staff person Hope Fior acknowledged that the advertisement caused confusion, not only for N.P., but for others. She blamed their confusion on the failure to read the fine print that she believed was in the ad, which she described as making clear that the offer of a free eye exam for glasses could not be used in combination with vision plans. That language did not appear in the advertisement, in fine print or otherwise. Respondent’s claim that N.P. made the voluntary election to forego the advertised free eye examination is contrary to the credible evidence. What N.P. wanted was a “free eye exam for glasses,” as advertised. N.P. was not offered a free eye exam that would have allowed him to obtain an updated prescription for his glasses. Respondent performed an eye examination on N.P. However, Respondent did not complete all steps required for a comprehensive eye examination. In particular, as the parties stipulated, Respondent did not perform a fundus examination on N.P. A comprehensive eye examination, including fundus examination, can be done with or without dilation. Examination of the fundus, the interior examination to the back of the eyes, is generally done after dilation drops are administered. The fundus examination can be done by other means if the patient does not want dilation, but generally dilation is preferable. In fact, Respondent testified that he “always” administers dilation drops, unless a particular patient asks him not to, in which case he makes them sign a form declining dilation. Respondent administered dilation drops to N.P. There is no persuasive evidence establishing that N.P. was resistant to receiving dilation drops, but there is also no persuasive evidence that N.P. was offered a choice or told that he could decline dilation. More importantly, there is no persuasive credible evidence that N.P. was informed before the drops were administered that he would be charged $39.00 as a dilation fee.3/ Instead, N.P. credibly testified that he was not told he would have to pay any fee until later. After Respondent put dilation drops in N.P.’s eyes, he directed N.P. to go down the hall to the reception/store area where eyeglasses are displayed for purchase, and was told he could wait there and look at glass frames while the drops took effect in 15 to 20 minutes. While N.P. was in the optical area, staff member Todd Dutton spoke with him about whether he might want to purchase glasses. The conversation about glasses did not progress, however, because Mr. Dutton also told N.P. that there was a $39.00 charge for dilation, and asked him to pay. N.P. got very upset with this new information, because up until that point, he was still under the impression that he was getting a free eye exam, as advertised. When Mr. Dutton did not retreat from the position that N.P. would have to pay $39.00 for the dilation drops he had received, N.P. walked out, rather than returning to the examination room for Respondent to complete the comprehensive examination. He did not ever return. Inexplicably, Respondent said he was not aware until much later on October 4, 2012, that N.P. walked out. Respondent did not come back for N.P., or send a staff person to bring N.P. back to the examination room, after the short period of time needed for the dilation drops to have taken effect. No explanation was provided for this lapse. It was not until an hour or two later, when Respondent was going over the patient paperwork for the day, that he realized that he never retrieved N.P. to complete N.P.’s comprehensive examination by performing the fundus examination. Respondent completed the patient record form as best he could, as the form he had created did not have an option to indicate an incomplete comprehensive examination, nor did his form provide the option of recording that an intermediate examination was done (which would not require a fundus examination, but would not be sufficient for writing a prescription for eyeglasses). Respondent selected the option called “No Dilation” and circled “Yes” to indicate that dilation was declined. Then he attempted to clarify in handwriting that there was no internal examination because the patient left the office. Despite not performing a fundus examination, Respondent produced a prescription for N.P. that he said he prepared after the incomplete examination. N.P. testified that he does not recall whether he asked for a prescription before he left the office, but he is sure that no prescription was offered to him. Todd Dutton confirmed that there was no discussion with N.P. about a prescription. The prescription presumably could not have been finalized and actually issued to N.P. before the comprehensive examination was completed, so whatever Respondent prepared must be viewed, at best, as preliminary. Respondent’s advertisement that offered a “free eye exam . . . for glasses” was misleading and deceptive. A reader would have been led to believe, just as N.P. did believe, that there would be no charge to anyone--the patient or the patient’s insurer--for an eye exam that would be sufficient to allow Respondent to prescribe glasses. N.P. was misled and deceived by the advertisement, as were others who were confused by the ad’s offer of a free eye exam for glasses. Respondent testified that he discontinued the advertisement, after 13 years of publishing it in the newspaper, sometime the next year (2013) when it came up for renewal. He said that he discontinued it, in part, in response to N.P.’s complaint to the Department, but also because he did not believe the ad was worth the cost of publication. Respondent did not say that he discontinued the advertisement out of remorse for falsely advertising free eye exams for glasses. He was steadfast in disputing the charge that his advertisement was in any way false, misleading, or deceptive. After N.P.’s incomplete examination, Respondent proceeded to bill N.P.’s vision insurance plan. He submitted a claim under CPT code 92004 in the amount of $139.00, and a claim under CPT code 92019 in the amount of $39.00. Current Procedural Terminology (CPT) codes are used by optometrists to define the services provided to patients in submitting claims to third-party payors for payment. Each CPT code has a definition set forth in a book maintained and distributed by the American Medical Association. The CPT code book has been officially adopted by the Department of Health and Human Services as the standard medical data code set, which must be used by “covered entities” under the Health Insurance Portability and Accountability Act, for physician services and other health care services, including vision services. See 45 C.F.R. §§ 162.1000 and 162.1002(a)(5)(vi) and (b)(1). CPT codes have uniform objective definitions that do not change based upon the type of practitioner or setting in which they are used. CPT code 92004 is defined as a comprehensive ophthalmological examination, including fundus examination. CPT code 92019 is defined as an ophthalmological examination and evaluation under general anesthesia. Respondent admits that he did not complete the comprehensive eye examination of N.P. The parties stipulated that Respondent did not perform the fundus examination. Respondent stated that by submitting a claim to N.P.’s vision insurance plan using CPT code 92004, he intended to bill the vision plan for performing a dilated fundus examination on N.P. He admits to having willfully submitted a claim to a third- party payor for services not provided to a patient. Respondent contends he should be excused for submitting the claim because the reason Respondent did not perform the dilated fundus examination on N.P. is that N.P. walked out. While that explains why Respondent did not provide the service to N.P., it does not justify Respondent’s claim seeking insurance reimbursement for a service he admittedly did not provide. Respondent testified that he was left in a quandary as to how to handle the billing, as there was no option for billing the vision plan for three-quarters or some other fraction of CPT code 92004. Petitioner’s expert, Dr. Kline, offered a viable alternative that would have solved Respondent’s quandary without submitting a claim for a service that was not provided. Dr. Kline testified that Respondent could have submitted a claim under CPT code 92002, for an intermediate eye examination. CPT code 92002 is appropriate to use by an optometrist who has performed a less extensive examination than a comprehensive examination. In particular, the fundus does not have to be examined in an intermediate exam. While an intermediate eye examination was insufficient to meet N.P.’s objective of securing a legal updated prescription (which requires a comprehensive eye examination), the unrebutted evidence in this record shows that submitting a claim using CPT code 92002 would have been accurate in identifying the service actually provided to N.P. Dr. Kline opined that submitting no claim to N.P.’s third-party payor was also an option that would have solved Respondent’s quandary, and in his opinion, would have been the most reasonable course of action under the circumstances. It would have been what he would have done. In light of Respondent’s advertisement for a “free eye exam,” Dr. Kline’s opinion is credited: the most appropriate option would have been to not submit a claim to N.P.’s third-party payor, thereby providing a “free,” albeit incomplete exam. Respondent defended his claim under CPT code 92004 for a comprehensive eye exam, under the guise of it being acceptable practice to perform a comprehensive eye examination in more than one sitting. According to Respondent, as long as the examination is going to be completed, it is acceptable to bill the third- party payor for the entire examination after only part of it has been done. This may be true when (as Respondent was told in a seminar), the completion of the exam is scheduled for the next day, within the next few days, or perhaps as much as a week later. For example, on occasion a patient might request to not be dilated on the day the examination is initiated and mostly completed, and arrangements are made for the patient to return for the dilation and fundus examination on a day when dilated eyes do not present a problem for the patient. However, that is not what occurred with N.P. N.P. never contacted Respondent to complete the examination, nor did Respondent ever attempt to contact N.P. to schedule his return for the fundus examination. It was obvious that N.P never intended to return. Indeed, Respondent admitted that he would not have attempted to contact N.P. because of N.P.’s anger when he left One Price Optical. Respondent’s justification for billing the vision insurance plan under the CPT code for a comprehensive examination could only be accepted if, at the time Respondent submitted the bill, arrangements had already been set for the examination to be completed, either because N.P. had scheduled a return visit before leaving, or because Respondent had called the patient and succeeded, before submitting the bill, in scheduling N.P.’s return visit to complete the exam. Under the circumstances here, at the time Respondent submitted the claim to N.P.’s vision plan, he knew that he had not completed a comprehensive eye examination of N.P., and he knew that no arrangements had been made to complete the examination. A fundus examination is a service that is a required component of CPT code 92004. Respondent willfully submitted a claim to a third-party payor for a service that was admittedly not provided to N.P. Respondent also admitted that he did not provide an eye examination to N.P. while under general anesthesia, which is the service defined by CPT code 92019, but he submitted a claim to the third-party payor using that CPT code. Respondent contended that he intended to use that CPT code to submit a claim for dilation charges. Respondent attempted to explain that some vision plans do not strictly follow the CPT code definitions, and some of them use CPT code 92019 to mean dilation. He testified that he just does his best using their claim forms and the descriptions they use for the CPT codes. Respondent did offer evidence that a different vision plan, not the one administering N.P.’s Medicare Advantage plan’s vision benefits, described CPT code 92019 as “dilation” in its online claim form. If a claim submitted to that other vision plan were at issue here, Respondent’s explanation might be accepted as evidence that Respondent did not willfully submit a claim for a service not provided. However, the evidence does not support Respondent’s explanation in this instance. In the “Explanation of Payment” printed from N.P.’s vision insurance plan’s website, CPT code 92019 was specifically described (in the available space) as “ophthalmological examination and evaluation under general an” and not as dilation. (Pet. Ex. 2, p.35) (emphasis added). Respondent said that he does all of the billing and coding for One Price Optical, and that he has tried to find out what is required. His claim that so-called “vision plans” are not considered insurance and do not strictly follow the CPT code definitions rings hollow, at least as applied to the facts here, where everything in N.P.’s patient records speaks to Medicare Advantage health care insurance. The “how are you going to pay” form completed by N.P. directed him, as a Medicare patient with Medicare Advantage insurance, to authorize billing under that coverage, which Respondent’s form assured would be done in compliance with Medicare laws and rules. The claim processing paperwork calls N.P.’s plan “Universal Health Care – Medicare,” and the plan’s explanation of denied payment for the claim under CPT code 92019 used the code definition from the CPT code book.4/ Respondent testified that he always very carefully checks to see how a particular vision plan uses and defines the CPT codes, and that he submits his claims using the CPT codes as defined by the particular plan. He therefore admitted that he willfully submitted a claim to N.P.’s vision plan under CPT code 92019, defined as “ophthalmological examination and evaluation under general an[esthesia].” The undersigned is not persuaded by Respondent’s assertion that in billing under CPT Code 92019, he should be found to have not willfully submitted a claim for a service not rendered because he knew that the claim would not be paid. The fact remains that Respondent knowingly, intentionally, and willfully submitted a claim to N.P.’s vision insurance plan, coded under CPT code 92019, claiming to have performed an eye exam under general anesthesia on N.P. on October 4, 2012, as explained in the Explanation of Payment. (Pet. Ex. 2, p. 35). Whether Respondent intended to get paid or expected to get paid is not germane to the question of whether he willfully submitted the claim for a service not provided.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health, Board of Optometry, issue a final order finding Respondent guilty of violating section 463.016(1)(f) and (1)(j), Florida Statutes (2012); and, as discipline, imposing a fine of $6,000.00 and issuing a 12-month probationary period on such terms and conditions as the Board deems appropriate. DONE AND ENTERED this 12th day of June, 2019, in Tallahassee, Leon County, Florida. S ELIZABETH W. MCARTHUR Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 12th day of June, 2019.
Findings Of Fact David R. Ness, Petitioner, attended Southern College of Optometry in Memphis, Tennessee, and graduated in May 1990. Part of his training included a three-month externship with James C. Lanier, O.D., an optometrist practicing in Jacksonville, Florida. Dr. Lanier found him a very competent student, thorough in his fact finding and case histories; and satisfactory, if not above average, in his examination of the patients. Dr. Lanier did not participate in the grading of the examination in issue and has no personal knowledge of Petitioner's performance on the examination. Petitioner sat for the September 1990 Optometry licensure examination. He passed the certification portion of the examination and the laws and rules section; he failed the pharm./ocular portion and the clinical portion. After several challenges to the examination, the Board adjusted some scores, but Petitioner's scores in the pharm./ocular section and the clinical sections were still below passing. Written Examination The pharmacology/ocular written portion of the examination consists of a series of case histories, with five questions directed to each. Petitioner explained that he challenged his score on the following specific questions: History #1, question #4; History #5; question #23; History #7, questions #32-35; and History #10, question #48. Case history #1 describes a 19-year old female soft contact lens wearer with symptoms correctly identified by Petitioner as Giant Papillary Conjunctivitis. The patient relies on her contact lenses because she is an actress. The severity of her condition is 3+ on a scale of 1-4, with four being the most severe. Question #4 requires selection from six choices of the initial management course of choice. Petitioner chose "c", Pred Forte suspension, every two hours. Pred Forte is the strongest commercially available steroid and its application every two hours is reserved for very severe cases. While the condition described is moderate to severe, the better answer is "f", "switch to preservative free system, enzyme cleaning 1 time a week". The patient's cleaning solution, described in the case history, is an old solution with a preservative which is known to cause conjunctivitis. While the safest course would be to discontinue contact lens wear, this is a radical option for a patient who must wear the lenses for her work. The preferred course then is to change the solution to see if the condition improves before moving to a less conservative treatment such as Pred Forte. Case history #5 describes symptoms and includes a color photograph of the eye in issue. Petitioner correctly identified the differential diagnosis as "Essential Iris Atrophy" and "Reiger's Anomaly". The next question, #23, states that the fellow eye shows similar findings in a slit lamp examination, and asks which of the differential diagnoses is the final diagnosis. Petitioner selected "Essential Iris Atrophy". The correct answer is "Reiger's anomaly". Essential Iris Atrophy is almost always unilateral and Reiger's is bilateral. The question required the examinee to know this distinction. Case history #7, describes a 37-year old patient with alleged recent vision field loss which occurred after thoracic surgery. The history describes an examination in which the patient remarks that he "isn't going to sue the physician" and where, with coaxing, his vision is much better than he admits. The patient also presented summary results of carotid artery testing and CT studies, which were normal. In his answers to questions 32-35, Petitioner chose diagnoses and treatment based on his conviction that he should try to help anyone who would come to him. He missed the fact that the patient described in the case history is a malingerer who likely is trying to sue his surgeon, and who requires no treatment. Case history #10 describes a 68-year old patient who is being examined for fitting of an extended wear contact lens. The best corrected vision is 20/50 OD, with or without a contact lens. The examination question includes two photographs, one of the fundus examination, the other of a fluorescein angiogram. An angiogram is obtained by injecting dye in the forearm and taking pictures with a special filter as the dye circulates through the blood vessels within the eye. This process is able to reveal abnormalities in the eye. Petitioner missed the question relating to the final diagnosis, which should have been "age-related macular degeneration with secondary choroidal neovascular membrane". Final diagnosis relied, in part, on the fluorescein angiogram. While Petitioner is not arguing that his answer is correct, he contends that the question itself is invalid, because it depends on a process which optometrists are not licensed to perform and it was too technical for recent graduates. People coming out of school have been exposed to live patients and have seen fluorescein angiograms performed and have seen their photographs. Moreover, in Florida, the number of elderly patients makes it necessary that optometrists be proficient in diagnosing age-related macular degeneration. The Practical/Clinical Examination Section 1 of the clinical portion of the practical examination involves the two examiners' review of the examinee's performance of an actual eye examination of a live patient. The two examiners are briefed extensively prior to the examination as to what to look for, but they do not confer during the examination when scoring various functions. For this reason, there may be disagreement between the two examiners. The scores are averaged. On section 1, item #6, with regard to the patient's case history, "follow-up information", the point spread is 0-7, with points being subtracted for failure to follow up on certain information. One examiner gave Petitioner the maximum number of points for the entire case history section. The other examiner gave Petitioner a "no" (0 points) under "personal ocular history", and commented on the examination score sheet that the examinee did not ask ocular history. The same examiner took off 2 points on item #6, "follow-up information" and commented, "did not ask ocular history". At some point during Petitioner's initial challenge, he was given credit for item #3, because it was determined that he did obtain an ocular history. The additional points were not restored to item #6, but should have been; as the failure to obtain that history is the basis for the reduced score. The examiner was not present at hearing to explain any other basis. Section 2 of the clinical portion of the practical examination requires the examinee to perform a series of functions under the scrutiny of two examiners (not the same two as in section 1). Again, the scores are awarded without consultation and there are discrepancies. In each area the examiner marks "yes" or "no" as to whether the procedure is properly performed. A "no" must be supported with the examiner's comment. Two yes marks entitle the examinee to 2 points; a yes/no is worth one point; and two no's are scored zero. For each function, the examinee must demonstrate twice. That is, he says "ready", and the first examinee views the result, then he prepares again and signals, "ready", for the second examiner. For section 2, the candidate is performing techniques or functions on his own patient, a patient whom he brings to the examination and with whom he is familiar. Petitioner is challenging the grading method for Section 2. In 6 out of 16 techniques or functions, the two examinees disagreed; that is, one gave a "yes", and the other, a "no". Petitioner contends that he should get full credit anytime he got one "yes", since that indicates that two people, the examinee and one examiner, agree. There are several reasons why two examiners may disagree on whether the examinee performed a function or technique properly. In some instances one examiner may give the individual the benefit of the doubt; in other cases the patient might move or blink or the examinee might lose his focus. The fact that two examiners independently assess the results gives the examinee two chances to demonstrate his skill. The third section of the clinical examination requires an examination of a live patient where the refractive error of the patient's vision is determined, and a prescription is made. Before being presented to the examinee, the patient is examined independently by three licensed optometrists serving as "monitors". Their examinations give the refraction results against which the examinee's results are compared. Their examinations also determine whether the patient is suitable; that is, the eye must be refracted correctable to 20/20 and the other eye correctable to 20/50. A fourth monitor reviews the results before the patient is presented to the examinee. In this case the patient was examined by the monitors and was found acceptable. Petitioner had problems with the patient; the best he could read was the 20/25 line. Petitioner felt that the patient should have been disqualified and commented in writing on that at the end of his examination, as was appropriate. The comments were reviewed by Dr. Attaway, who considered that the patient had met the criteria when examined by the monitors. Petitioner's refractions varied significantly from the monitors' refractions, which also varied somewhat from each other. Petitioner received a score of 3, out of possible 20, on this portion of the examination. Dr. Attaway did not, himself, examine the patient and the monitors who performed the examinations were not present to testify. The only evidence to rebut Petitioner's findings was the written report of the monitors. Pass Rate for the Examination Out of 130 candidates, approximately 34 percent passed all parts of the September optometry examination. In 1986, 51 percent passed; in 1987, 33.5 percent passed; in 1988, 59.6 percent passed; and in 1989, 52 percent passed. These figures do not, alone, establish that the test is too technical or unfair, nor does the fact that very good students failed. When the examinations are evaluated, when the examinee's performance is rated, there is no established pass rate; the monitors have no idea how close the individual examinee is to passing, either originally or when a challenge is being addressed. Petitioner was a very articulate and candid witness. His two experts were clearly knowledgeable and were sincerely concerned that he should be licensed. None had the experience of Respondent's witnesses, also well-qualified licensed optometrists, in working with the examination. With the exception of the inconsistent score on Section 1, item #6, Petitioner failed to prove that he is entitled to a higher score on any portion of the examination, or that the examination itself was invalid or unfair.
Recommendation Based on the foregoing, it is hereby, recommended that Petitioner's final score on Section 1 of the clinical examination be adjusted to reflect full credit for Item #6; that he be permitted to retake Section 3 of the clinical examination; and that his remaining challenges to the examination be denied. RECOMMENDED this 29th day of May, 1991, in Tallahassee, Leon County, Florida. MARY CLARK 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 29th day of May, 1991. APPENDIX TO RECOMMENDED ORDER, CASE NO. 91-0700 The following constitute specific rulings on the findings of fact proposed by the parties: Petitioner's Proposed Findings 1.-2. Adopted in paragraph 2. 3. Adopted in substance in paragraph 20. 4.-6. Rejected as irrelevant. Adopted in summary in paragraph 2. Rejected as contrary to the evidence. Finding of Fact #15 reflects the grades after adjustment. Rejected as unnecessary. Adopted in paragraph 1. Rejected as unnecessary. Rejected as irrelevant. This fact does not make the examination invalid so long as it fairly evaluates the qualification of the applicant. 13.-14. Rejected as statements of statutory language rather than findings of fact. Respondent's Proposed Findings The Hearing Officer is unable to find where in the record the exact final score of Petitioner is reflected. Adopted in paragraph 1. Rejected as restatement of testimony rather than findings of fact. 4.-5. Rejected as unnecessary. 6.-15. Rejected as restatement of testimony; summary statements, or argument, rather than findings of fact. COPIES FURNISHED: David R. Ness 611 Poinsettia Avenue Titusville, FL 32780 Vytas J. Urba, Esquire Dept. of Professional Regulation 1940 N. Monroe St., Ste. 60 Tallahassee, FL 32399-0792 Patricia Guilford, Exec. Director Dept. of Professional Regulation Board of Optometry 1940 N. Monroe Street Tallahassee, FL 32399-0792 Jack McRay, General Counsel Dept. of Professional Regulation 1940 N. Monroe St., Ste. 60 Tallahassee, FL 32399-0792
The Issue The issues in this case are whether Respondent violated Subsections 458.331(1)(m), 458.331(1)(t), and 458.331(1)(u), Florida Statutes (1997),1 and, if so, what discipline should be imposed.
Findings Of Fact The Department is the state department charged with regulating the practice of medicine pursuant to Section 20.43, and Chapters 456 and 458, Florida Statutes (2006). At all times material to this proceeding, Dr. Geller was a licensed physician within the State of Florida, having been issued license number 35800 on December 18, 1979. Dr. Geller is board-certified in Ophthalmology. Patient P.K. first presented to Dr. Geller's office on February 17, 1998, for evaluation for refractive surgery. At the time of her first visit, P.K. was 56 years old. She had been experiencing difficulty tolerating contact lenses due to dry eyes, seasonal allergies, and some night vision problems, and did not want to wear glasses. Prior to P.K.'s first visit to Dr. Geller, P.K. had been evaluated by Dr. Jonathan Frantz to determine if she was a good candidate for laser refractive surgery. Dr. Frantz informed P.K. that she was not a candidate for laser refractive surgery. Dr. Geller examined P.K.'s eyes on February 17, 1998, at which time he recorded P.K.'s visual acuity with corrective lenses for both eyes. He did not record her uncorrected visual acuity. The evidence did not establish that the failure to determine and record P.K.'s uncorrected visual acuity prior to surgery was below the level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. During the examination on February 17, 1998, Dr. Geller determined P.K.'s anterior chamber depth to be 2.78 by using an optical device and 2.76 - 2.8 by using a sonogram. Dr. Herbert Gould testified as an expert witness for Dr. Geller. It was Dr. Gould's opinion that at least 2.8 millimeters of depth was needed in the anterior chamber for the insertion of a phakic lens. Dr. Osama Omar testified as an expert for the Department. Dr. Omar was of the opinion that an anterior chamber depth of three millimeters was needed for the insertion of a phakic intraocular lens; however, Dr. Omar's opinion was based on a course that he had taken involving an Artisan lens, not a Phakic 6 intraocular lens, which was used in P.K.'s surgery. Dr. Gould's testimony concerning the anterior chamber depth needed for the insertion of a phakic lens is more credible. Dr. Geller measured P.K.'s preoperative endothelial cell count for both eyes by specular microscopy. The reading was more than 2400. Based on his examination of February 17, 1998, Dr. Geller diagnosed P.K. with hyperopia (farsightedness) in both eyes. Dr. Geller told P.K. that he could implant a phakic intraocular lens in each eye that could correct the refractive errors. When a phakic intraocular lens is used, the patient's natural, crystalline lens is left in place, and the intraocular lens is placed either right in front of the iris or in the pupil area plane right behind the iris. Dr. Geller discussed the risks and benefits associated with the insertion of a phakic intraocular lens with P.K. and made a notation of the discussion on P.K.'s medical records for February 17, 1998. His notes established that he had discussed over and under correction, fluctuating vision, corneal disease, and future surgery with her. P.K. was scheduled for the insertion of a phakic intraocular lens in her left eye on March 10, 1998, and in her right eye on March 31, 1998. P.K. signed a consent form for each surgery scheduled to be performed. The consent forms provided: INFORMED CONSENT FOR LENS IMPLANTATION CORRECTION OF REFRACTIVE ERRORS Dear Patient, The South Florida Eye Clinic and Dr. Scott L. Geller have prepared this "informed consent" so that you may understand some of the major details of 'permanent contact lens' intraocular lens implantation. This informed consent naturally is limited in scope and we will just address some major issues related to all ophthalmic surgery. Your discussion with Dr. Geller can elaborate on any of these issues and can touch on other considerations that you may have. Implants performed for correction of refractive error (to get you minimal eyeglass correction, or no eyeglass correction at all) have been performed since the early 1950's. However, in the last ten years, they have been widely performed throughout the world especially in Europe and South America. Lens implants for correction of refractive errors are performed by individual doctors in the United States under 'the scope of medical practice.' At this juncture no FDA approved lenses are available. The lenses being used in our practice have been obtained by Dr. Geller for use in our ongoing clinical studies for correction of errors of refraction. Lens implants have been performed by our office during and after cataract surgery for the past 15 years and Dr. Geller has extensive experience in all lens implant operations. The lens implant operation for the correction of refractive error is very similar to the operation performed for correction of aphakia that has been done by ophthalmologist [sic] worldwide for well over 20 years. Lens implant for refractive error however have [sic] only been performed widely for about the past eight years. We can only predict based on our experience with this and similar surgeries that the operation is safe and effective. However we cannot predict the future and we want you to understand this. The problems that can be associated with any kind of intraocular surgery include [sic] intraocular lens implantations are hemorrhage, infection, cataract, glaucoma, and the necessity for future corneal surgery. We will remind you that these are potential problems that can occur with any similar surgery, and are rarely seen during the career of any ophthalmologist. There have been reported optical aberrations rarely after lens implantation surgery, notably glare or a refractive error that is not exactly as predicted. This may necessitate a change of the lens or a revision of the wound. These problems are extremely rare. Dr. Geller wants to assure you that he is totally confident that this procedure is the most effective for you at this time. In studying this procedure under a world renowned ophthalmologist and has seen patients who have had several years or internal contact lens use. If you should have any further questions, please don't hesitate to ask Dr. Geller directly. Dr. Geller told P.K. that he had done many lens implants. Dr. Geller's assistant also told P.K. that Dr. Geller had been doing lens implants for a long time with good results. Based on the representations from Dr. Geller and his assistant and the information contained in the consent form, P.K. understandably was left with the impression that Dr. Geller had been doing the implantations of Phakic 6 intraocular lenses in his office on a regular basis and that he had done many of the implantations without problems. On March 10, 1998, when Dr. Geller performed the scheduled lens implantation surgery on P.K.'s left eye, he noted her corrected visual acuity, but did not record her uncorrected visual acuity. During the surgery, Dr. Geller inserted a Phakic 6 intraocular lens manufactured by Ophthalmic Innovations into P.K.'s left eye. On March 31, 1998, P.K. presented at Dr. Geller's office for lens implantation in her right eye. Prior to the surgery, Dr. Geller checked the uncorrected visual acuity of P.K.'s right eye, which was 20/150. During the surgery, Dr. Geller inserted a Phakic 6 intraocular lens manufactured by Ophthalmic Innovations into P.K.'s right eye. In March of 1998, the lenses which were inserted in P.K.'s eyes were not approved by the Food and Drug Administration (FDA). The Phakic 6 intraocular lens had been approved for use in Canada and some countries in Europe, Asia, and South America. At the time of P.K.'s surgery, the phakic lenses were not available through standard, mainstream commercial sources within the United States. Dr. Omar opined that the use of a lens which has not been approved by the FDA falls below the standard of care which should be used by a reasonably prudent similar physician. Dr. Herbert Gould and Dr. James Rowsey, who also testified as expert witness for Dr. Geller, opined that the use of a lens which has not been approved by the FDA, by itself, does not equate to a failure to practice 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. The testimony of Drs. Gould and Rowsey are more credible. It should be noted that the FDA did not ban the use of the Phakic 6 lens, but that the lens had not been investigated and approved by the FDA. There have been other products which have not been approved by the FDA, but which physicians use without falling below the standard of care required of the physicians. One such product is glue which was used by physicians in eye surgery. P.K. returned to Dr. Geller's office for postoperative care in March and April 1998. She was in Canada during the summer of 1998 and did not see Dr. Geller from April to October 1998. On October 15, 1998, P.K. presented to Dr. Geller complaining of sensitivity to light and poor visual acuity. Dr. Geller diagnosed P.K. as having iritis. On October 21, 1998, Dr. Geller indicated in P.K.'s medical notes to "get spec micros ou," which indicates a specular microscopy for both eyes. Such a test would indicate P.K.'s endothelial cell count. Dr. Geller's notes indicate a similar entry on November 2, 1998. Dr. Geller's medical notes for P.K.'s visit on November 17, 1998, indicate "spec done ou," but reveal a pachymetry reading of 56/48 and do not indicate an endothelial cell count. Pachymetry is a test which is used to determine the health of a cornea by measuring the thickness of the cornea. The specular microscopy measures the endothelial cell density of the cornea. The testimony of Dr. Omar is credited that a postoperative specular microscopy was required to be done in order to compare the preoperative and postoperative endothelial cell counts. On November 17, 1998, Dr. Geller identified a corneal edema in P.K.'s right eye. He did not refer P.K. to a corneal specialist. Dr. Geller had experience in treating corneal problems, including performing corneal transplants. His experience and training was sufficient to treat P.K.'s corneal edema without having to refer her to a corneal specialist. Dr. Geller treated the edema with anti-inflammatory drugs. The edema continued to be present on subsequent visits on December 1, 3, and 9, 1998. On December 9, 1998, Dr. Geller recommended the removal of the phakic intraocular lens from P.K.'s right eye. He removed the lens on December 15, 1998. Dr. Geller provided postoperative care for P.K. through March 1999. P.K. did not return to see Dr. Geller after March 1999. P.K. returned to Canada and in June 1999 saw Dr. Peter J. Agapitos, who diagnosed her with corneal edema in both eyes and recommended that P.K. return to Florida to have Dr. Geller remove the intraocular lens in the left eye. On June 21, 1999, P.K. called Dr. Geller's office complaining that her left eye was very sensitive to light, crusty, and irritated. Dr. Geller's office referred P.K. to a physician in Canada. P.K. had the intraocular lens in her left eye removed. Additionally, she has required cataract surgery and more than one corneal transplant since Dr. Geller performed the phakic intraocular lens implantations. Dr. Omar was of the opinion that the implantation of a phakic intraocular lens to treat refractive error was experimental in 1998. He defined "experimental" as "a treatment that's currently untested, not developed to the point which can be offered in a mainstream fashion, has not demonstrated safety, ethicacy [sic] in the correction of the problem that the patient may need." Drs. Gould and Rowsey did not feel that the procedure was experimental by 1998. Dr. Rowsey did opine that the procedure was "uncommon" in the United States. Physicians in Europe, Asia, and South America were doing phakic intraocular implants during the 1980's. By 1998, there were peer reviewed literature published concerning phakic intraocular implants and a considerable amount of presentations given concerning the use of phakic intraocular lenses. The production of the Phakic 6 intraocular lens began in 1992, and by the time of P.K.'s surgery, approximately 4,000 to 5,000 implants of the Phakic 6 intraocular lens had been done successfully worldwide. However, few physicians in the United States were performing phakic intraocular lens implantations by 1998, and only a couple of dozen phakic intraocular lens implants had been done in the United States by 1998, representing less than one percent of the total intraocular lens implantations. In 1998, there was no doctor in the United States who was routinely implanting these lenses except as part of a study. In 1997, Dr. Geller went to New York City to the surgery center of Dr. Miles Galin, who was performing implantations of phakic intraocular lenses. Dr. Geller observed several preoperative and postoperative cases on the day he visited Dr. Galin. Dr. Geller also "scrubbed in" and observed at least one implantation being performed by Dr. Galin. Prior to performing surgery on P.K., Dr. Geller had performed less than five implantations of phakic intraocular lenses and had reviewed literature in American and European journals concerning phakic intraocular lenses. The procedures and skills used to insert an intraocular lens implant are substantially similar to those procedures and skills necessary to place an anterior chamber lens after a cataract removal. Dr. Geller's practice involves anterior segment surgery, including cataract surgery. The evidence established that Dr. Geller had adequate education and training to be able to insert phakic intraocular lenses.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Dr. Geller violated Subsections 458.331(1)(m), 458.331(1)(t) and 458.331(1)(u), Florida Statutes; imposing a reprimand; imposing an administrative fine of $1,000 for each violation for a total of $3,000; placing Dr. Geller on probation for one year on the terms to be set by the Board of Medicine; and requiring Dr. Geller to attend continuing medical education courses to be specified by the Board of Medicine. DONE AND ENTERED this 2nd day of November, 2006, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 2nd of November, 2006.
The Issue The issues in this case are presented on the basis of an Administrative Complaint brought by the Petitioner against the Respondent. Allegations set forth in that complaint pertain to the treatment of the patient Helen Gilmore. It is alleged that Respondent failed to record on the patient's records or perform the minimum examination procedures for vision analysis related to that patient in an examination of January 26, 1982. It is further alleged that on May 29, 1982, that the patient requested a duplicate copy of the original prescription obtained from the initial examination but Respondent instead performed a new eye examination and again failed to record on the patient records or perform the minimum procedures for vision analysis concerning this patient. In the face of these factual allegations, Respondent is said to have violated Sections 463.012 and 463.016(1)(g) and (h), Florida Statutes, and Rule 21Q-3.07, Florida Administrative Code.
Findings Of Fact At all times relevant to the Administrative Complaint, Respondent has been licensed as a practicing optometrist in the State of Florida, license No. 40616. During this sequence, Respondent has conducted his practice in Palatka, Florida. Respondent saw the patient Helen Gilmore on January 26, 1982. Ms. Gilmore was having difficulty with her present glasses related to vision in her left eye. Following an examination which took into account the minimum procedures for vision analysis set forth in Rule 21Q-3.07, Florida Administrative Code, Respondent issued a prescription for the patient which deviated from the prescription in the glasses which she was wearing at the time of the examination. Respondent charged $30 for the examination and prescription, which was paid by Gilmore. The prescription was presented to Eckerd's Optical Service in Palatka, Florida, in March 1982, at which time Reid obtained new lenses and frames. Ms. Gilmore paid Eckerd's for the lenses and frames. Having obtained the new frames and lenses from Eckerd Optical, Ms. Gilmore wore those glasses until she started having trouble focusing one of her eyes. Specifically, the patient was having trouble focusing on distant objects. Ms. Gilmore complained to Eckerd Optical about her problem several times. Eckerd Optical was unable to find the duplicate prescription related to the request for prescription by Dr. Reid and Gilmore was advised to return to Dr. Reid and receive a copy of that prescription from his office. In this regard, Dr. Reid's office, in the person of his wife, contacted Gilmore and asked if some problems were being experienced, to which Gilmore indicated that she was having difficulty with her eye and Mrs. Reid stated that Gilmore should return and have her eyes checked again by Dr. Reid. On May 29, 1982, Gilmore was seen by Respondent in his office. The purpose of this visit was to obtain a duplicate copy of the prescription which had been given by Dr. Reid on January 26, 1982 and Gilmore made this known to Respondent. Dr. Reid examined the glasses which Ms. Gilmore had purchased from Eckerd Optical and discovered that the lenses were not in keeping with the prescription which he had given to the patient in that the cylinder correction for astigmatism was not as prescribed and the bifocal had been made up round as opposed to flat. The variance in the prescription given and the prescription as filled was slight. Nonetheless Dr. Reid was of the opinion that it could cause and had caused discomfort to the patient, though not in the way of permanent damage. Having this in mind, instead of providing the duplicate copy of the prescription as requested, Respondent conducted a further vision analysis carrying out those procedures set forth in Rule 21Q-3.07, Florida Administrative Code. On the May 29, 1982 visit, and in the January 26, 1982, examination, Respondent failed to record on the patient's case record the indication that external examination including cover test and visual field testing had been done. Moreover, as established by the testimony of a qualified expert, Dr. Walter Hathaway, who is licensed and practices optometry in the State of Florida, the further examination was not optometrically indicated. This determination was made by Dr. Hathaway based upon the fact that Respondent should merely have provided a duplicate copy of the original prescription of January 26, 1982, as issued by Dr. Reid, having discovered the mistake in the efforts of Eckerd's to fill that prescription and allowed Eckerd's to rectify its error. Per Hathaway, it not being necessary to conduct further examination of the patient, to do so was outside acceptable community standards for the practice of optometry, Again, the opinion of Dr. Hathaway is accepted. As a result of the examination, Dr. Reid prepared a second prescription, which was unlike his January 26, 1982, prescription and the efforts at compliance with that prescription made by Eckerd's in fashioning the lenses. Gilmore was charged $35 for the examination and she paid the bill.
