Findings Of Fact Stipulated facts 2/ The Respondent is a licensed physician in the State of Florida and has been licensed in Florida at all times material herein. The Respondent is Board Certified in family practice. The patient B. M., a female born on May 18, 1934, with a history of hypertension, diabetes, and obesity, presented to the Respondent on multiple occasions between August of 1979 and November of 1990. On September 29, 1979, when she was forty-five years old, patient B. M. notified the Respondent that her periods were spreading out and that she was getting hot flashes. On February 18, 1982, patient B. M. indicated that she was having irregular periods every couple of months. The Respondent's medical records indicate that he did not see or treat the patient B. M. between October 1, 1984, and July 3, 1987. On July 3, 1987, patient B. M. presented to the Respondent with complaints of excessive vaginal bleeding for the past three (3) months. The patient indicated the bleeding had stopped approximately three weeks earlier. The Respondent diagnosed patient B. M. with vaginitis, and prescribed her medication for vaginitis, based on the patient's complaints of vaginal discharge. Respondent did not perform a pelvic examination on that day to make that diagnosis. Patient B. M. returned the following week for a pelvic examination. The Respondent did not document the medical history of the patient B. M. during the preceding three years, although she had a history of high blood pressure and diabetes, both conditions that require periodic monitoring and prescription medication. The Respondent also did not document any pertinent information relating to the patient's gynecological history, including, but not limited to, the dates of the patient's last period, how often her periods were occurring, and how much she was bleeding, despite her complaints of excessive bleeding. On August 7, 1987, after several other visits, the patient B. M. returned for an examination. A pelvic examination revealed a vaginal laceration that was bleeding. On January 18, 1988, patient B. M. presented to the Respondent with complaints of irregular bleeding for the prior month. The Respondent suggested a dilation and curettage (scraping of the uterine walls) if patient B. M.'s bleeding continued. On December 21, 1989, patient B. M. presented to the Respondent with complaints of excessive vaginal bleeding with clots since the previous night. The Respondent indicated that the patient had her regular period the previous week, and was using condoms. The Respondent performed a pelvic examination which revealed blood clots, and diagnosed patient B. M. with dysfunctional uterine bleeding and administered progesterone to patient B. M. The Respondent did not document any additional information concerning the patient's menstrual activity, such as how often she had periods, what was meant by uncontrollable vaginal bleeding, where the bleeding was coming from, or why she was using condoms. The patient B. M. continued to complain of occasional bleeding after December 21, 1989, and on January 15, 1990, the Respondent referred the patient B. M. to a gynecologist. On February 5, 1990, the patient B. M. presented to a gynecologist, who took cervical biopsies and subsequently performed a dilation and curettage on the patient B. M. on or about February 23, 1990. The patient was subsequently initially diagnosed with grade two endometrial cancer, and after biopsy was diagnosed with grade three endometrial cancer and was referred to another gynecologist at the University of Miami. 3/ On April 5, 1990, the patient B. M. underwent a total hysterectomy. The patient B. M. was then diagnosed with Stage III-C endometrial carcinoma and underwent intravenous Adriamycin chemotherapy. On December 25, 1990, the patient B. M. expired. Facts based on evidence at hearing At all times material to this case, the subject patient 4/ weighed approximately three hundred pounds. Periods spreading out and hot flashes are signs that a woman may be beginning menopause. The average length of time between the beginning of menopausal symptoms and a cessation of menstruation is six months to one year. Endometrial cancer is cancer of the uterus. It is the most common gynecological cancer in women. Endometrial cancer occurs most often in women who are post-menopausal. About 20 to 25 percent of women are diagnosed with endometrial cancer before menopause. Most patients are diagnosed with endometrial cancer after the age of 50. When diagnosed early, patients with endometrial cancer have a very high survival rate. When diagnosed late, patients with endometrial cancer have a very low survival rate. The subject patient had several of the risk factors associated with endometrial cancer. The first symptom in most cases of endometrial cancer is abnormal bleeding. Any woman with post-menopausal abnormal bleeding should be checked for endometrial cancer. The subject patient was hospitalized in 1982. During that hospitalization she was evaluated by a gynecologist who determined that there was no evidence of abnormal or irregular gynecological problems at that time. After February 18, 1982, through October 1, 1984, there are no references in the Respondent's medical records to the subject patient's menstrual history, and no indication as to whether the patient had regular or irregular menstrual periods during that period of time. The subject patient was not seen by the Respondent on any occasion between October 1, 1984, and July 3, 1987. 5/ The subject patient returned to the Respondent's office on July 3, 1987. On the occasion of that visit she gave a history to the Respondent's office staff which is recorded in the Respondent's medical records as "excessive bleeding vaginal for 3 mos. Stopped 6/13." The Respondent's records for July 3, 1987, do not contain any additional details regarding the nature of the excessive bleeding. The Respondent's medical records for the July 3, 1987, office visit also indicate that at that time the patient had a vaginal infection with a discharge. This information was obtained from the patient. On that day the Respondent did not examine the patient to confirm the condition described by the patient. The Respondent diagnosed the patient as having vaginitis and prescribed Sultrin cream and Betadine douche for the vaginitis. The medical records for the July 3, 1987, office visit note that the patient had high blood pressure. Although the records, standing alone, do not clearly show that any treatment was undertaken on that day for the patient's high blood pressure, during the course of the July 3, 1987, visit, the Respondent prescribed medication for the patient's high blood pressure, as well as syringes for her diabetes. Those prescriptions were recorded in the patient's chart on the front cover. Because the subject patient had returned for a single office visit on July 3, 1987, after an absence of almost three years, the Respondent determined at that time that he needed to do a full physical examination on her, as well as a pelvic exam. Although the Respondent did not perform either examination at the July 3, 1987, office visit, he made plans to do both shortly thereafter. The subject patient returned ten days later, on July 13, 1987, at which time the Respondent performed a complete physical examination of the patient. No pelvic examination was performed that day, because the Respondent was having her period. The Respondent asked the patient to return one week later for a pelvic examination. The subject patient returned on July 20, 1987, at which time a pelvic examination was performed. On that day there was no evidence of any irregular or unusual bleeding. The patient did have a vaginal infection that day. The vaginal infection was treated appropriately by the Respondent. In view of the vaginal infection, the patient was advised to return to the office one week later, at which time she would be examined again. The subject patient returned to the Respondent's office on August 7, 1987, for a follow-up pelvic examination, at which time the Respondent identified a small superficial laceration in the patient's vagina. The laceration was causing some slight bleeding. The Respondent noted that there was no bleeding from the cervical os, which indicated that the small laceration was the sole source of the patient's bleeding that day. As an additional follow-up, the Respondent ordered a sonogram. The sonogram was ordered in part because, due to the patient's obesity, the Respondent was unable to palpate her internal organs. The Respondent did not document any details concerning the vaginal laceration, such as the size of the laceration, the amount the laceration was bleeding, or the precise location of the laceration, because it was a very small laceration with very slight bleeding which was of very little medical significance. The Respondent did not refer the patient to a gynecologist after learning the results of the sonogram he ordered on August 7, 1987. The Respondent concluded that the 1987 sonogram results were not significantly different from the 1982 sonogram results. Such conclusion was reasonable under the circumstances. Accordingly, the 1987 sonogram results did not suggest any need for further investigation. The subject patient returned to the Respondent's office on August 24, 1987, at which time she had no complaints of any type of vaginal bleeding. She was being seen in order to follow up on her other complaints, notably her diabetes and her high blood pressure. The Respondent assumed that the vaginal laceration had healed and did not conduct a pelvic examination of the patient during that visit. After August 24, 1987, and before January 18, 1988, the Respondent saw and treated the subject patient once a month on four more occasions. The medical records for those four office visits do not mention the patient's menstrual history or whether she was bleeding on any of those occasions. During the four monthly visits between August of 1987 and January of 1988, the subject patient did not complain of any episodes of irregular vaginal bleeding. On January 18, 1988, the subject patient returned to the Respondent's office with complaints of irregular vaginal bleeding since having been the victim of a mugging during the previous month. The Respondent did not record any detailed information about the bleeding, such as her current menstrual condition, how much she was bleeding, or how often she was bleeding. The Respondent concluded that the bleeding was probably due to the patient's anxiety about the recent mugging incident. Nevertheless, he wanted to follow up on the irregular bleeding if it did not resolve on its own. To that end he discussed the matter with the patient and told her that if the irregular bleeding did not get better, she should come back and he would do a D & C. The Respondent noted in his record for that visit: "May need D & C if bleeding continues." In view of the patient's intelligence, the Respondent fully (and reasonably) expected she would tell him if she had any further irregular bleeding. The procedure known as D & C, or dilation and curretage, is a procedure wherein a physician obtains a sample of the lining of the uterus to evaluate it for possible abnormalities. The D & C procedure is commonly used to diagnose, or to rule out, endometrial cancer. Following the office visit on January 18, 1988, the subject patient presented to the Respondent's office on three other visits during each of which she did not have any complaints of irregular bleeding. The subject patient did not have any further gynecological complaints until December 21, 1989. On that day she returned to the Respondent's office with complaints of uncontrollable vaginal bleeding since 7:30 p. m. of the previous evening. During the course of the December 21, 1989, office visit, the subject patient told the Respondent that she had had her last regular menstrual period the week before. She also told him she was using condoms. During the course of the December 21, 1989, office visit the Respondent performed a pelvic examination of the patient and made a provisional or working diagnosis of dysfunctional uterine bleeding. He administered an injection of progesterone and instructed the patient to return in three days. He also instructed the patient to have another pelvic sonogram performed. Dysfunctional uterine bleeding is abnormal uterine bleeding not related to or caused by an organic problem such as cancer, polyps, fibroids, or infections. It is usually caused by an hormonal imbalance. In the case of a woman who is not post- menopausal and who presents with complaints of irregular vaginal bleeding, one of the differential diagnoses can be dysfunctional uterine bleeding. In such a case it is appropriate to administer progesterone prior to embarking on additional studies. In such a case the administration of progesterone is useful for two reasons: (1) if the progesterone is successful in stopping the irregular bleeding its success tends to confirm the differential diagnosis of dysfunctional uterine bleeding, and (2) if the progesterone is unsuccessful in stopping the irregular bleeding it tends to rule out the diagnosis of dysfunctional uterine bleeding and confirm the need for further investigation. Under the circumstances that existed on December 21, 1989, it was reasonable and appropriate for the Respondent to administer progesterone on the basis of a provisional or working diagnosis of dysfunctional uterine bleeding, because if the treatment was successful it would tend to confirm the provisional or working diagnosis and it the treatment was not successful it would rule out the provisional or working diagnosis. 6/ The fact that dysfunctional uterine bleeding was only a provisional or working diagnosis is illustrated by the fact that the Respondent at the same time ordered a sonogram in order to investigate other possible causes of the abnormal bleeding. A verbal report of the results of the sonogram ordered on December 21, 1989, was given to the Respondent's office by telephone on December 26, 1989. 7/ A written report of the results was provided shortly thereafter. The report of the sonogram ordered on December 21, 1989, indicated that the subject patient had an enlarged uterus measuring 18.8 x 9.3 x 10.8 centimeters. The 1989 sonogram report revealed that the patient's uterus was substantially larger than it had been at the time of the 1987 sonogram. The report of the December 21, 1989, sonogram included a recommendation for follow up examination of the uterus and the endometrial canal. The subject patient returned to the Respondent's office on December 26, 1989, at which time she told the Respondent that the bleeding had stopped. He asked her to return again in two weeks. When she returned twenty days later on January 15, 1990, she had started to again have occasional episodes of bleeding and spotting. The Respondent thereupon referred the patient for a gynecological consult. The subject patient was seen by a gynecologist, Dr. William Shure, on February 5, 1990. The patient provided Dr. Shure with a history that her last menstrual period had been on December 19, 1989. This last menstrual period history is the same history that was recorded by the Respondent on December 21, 1989. On February 5, 1990, Dr. Shure took cervical biopsies from the subject patient, and subsequently performed a D & C on the patient on February 23, 1990. The patient was then diagnosed with Stage II-B endometrial cancer. Following a total hysterectomy on April 5, 1990, the patient was diagnosed with Stage III-C endometrial cancer. Stage II-B endometrial cancer is cancer of the uterus with extension into the cervix. Stage III-C endometrial cancer is an advanced stage of cancer of the uterus which extends into the cervix and has metastasis to pelvic lymph nodes. The patient underwent chemotherapy for the cancer. The chemotherapy was unsuccessful and the patient expired on December 25, 1990. At all times material to this case the Respondent used a record- keeping methodology in his medical practice known as the SOAP method. This is an appropriate methodology for record- keeping in a medical practice. The Respondent's records regarding the subject patient demonstrate that he kept a running list of all medications prescribed for the patient. The Respondent's records regarding his care and treatment of the subject patient were sufficient to justify his course of treatment of the patient. 8/ The care, skill, and treatment applied by the Respondent in the treatment of the subject patient from July of 1987 through January of 1990 (the only time period at issue here) was reasonable under the circumstances and did not depart from the level of care, skill, and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. The Respondent's treatment of the subject patient did not constitute gross or repeated malpractice. 9/ The Respondent has not been the subject of any prior disciplinary proceedings.
Recommendation On the basis of all of the foregoing, it is RECOMMENDED that the Board of Medicine enter a Final Order in this case dismissing all charges in all three counts of the Amended Administrative Complaint. DONE AND ENTERED this 17th day of May 1996 at Tallahassee, Leon County, Florida. MICHAEL M. PARRISH, 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 17th day of May 1996.
The Issue The central issue in this case is whether Petitioner owes the sum of $51,072 for Medicaid overpayments received through the Department of Health and Rehabilitative Services (Department), now the Agency for Health Care Administration. PRE1IMINARY STATEMENT This case began on November 26, 1990, when the Medicaid Program Integrity Office of the Department completed a review of the Petitioner's Medicaid claims. The notice issued to Petitioner on that date alleged that Petitioner had been overpaid $5Ij072.00 for claims that were, in whole or part, not covered by Medicaid. More specifically, the notice alleged that the procedure codes and descriptions found in the Medicaid Provider Handbook (Rule 10C-7.523, Florida Administrative Code) did not allow for the reimbursements paid to Petitioner, and that Medicaid cannot properly pay claims which do not meet the guidelines. Additionally, the notice alleged that Petitioner had not responded to the letter dated October 1, 1990, which encouraged the submission of information or documentation that would serve to reduce the overpayment claim. In response to the notice of November 26, 1990, the Petitioner filed a petition for formal hearing that maintained Petitioner had documented the medical necessity for services rendered for all procedures in dispute, that radiographs were not required for diagnosis, and that the forms utilized have been approved and previously submitted without issue. The matter was forwarded to the Division of Administrative Hearings for formal proceedings on January 8, 1991. At the hearing, the Department presented the testimony of the following witnesses: Robert V. Peirce, an employee of the Agency for Health Care Administration, Office of the Inspector General, Medicaid Program Integrity Office; Barry Ragone, the Petitioner; Glen Scone, an a by the Department; and, by deposition, Dr. Stanley A. Sheppard, a pediatric dentist. Dr. Sheppard's deposition has been admitted into evidence over Petitioner's objection. The Department's exhibits numbered 1 through 5, 7 and 8 were admitted into evidence. The Department requested and official recognition has been taken, of Chapters 10C-7 and 21G-17, Florida Administrative Code. The Petitioner testified in his own behalf. Petitioner's exhibits numbered 1, 2, and 3 were marked for identification. The transcript of the hearing was filed on August 30, 1993, and the parties were granted ten days to file proposed recommended orders. Specific rulings on the proposed findings of fact are included in the appendix at the conclusion of this order.
Findings Of Fact At all times material to this case, Petitioner, Barry M. Ragone, D.D.S., was a licensed dentist participating in the Medicaid program in Florida. Petitioner's provider number was 0727610 00, his license no. 5079. At all times material to this case, Petitioner had executed an agreement which provided, in pertinent part: The provider agrees to keep such records as are necessary to fully disclose the extent of services provided to individuals receiving assistance under the State Plan and agrees to furnish the State Agency upon request such information regarding any payments claimed for providing these services. Access to these pertinent records and facilities by authorized Medicaid Program representatives will be permitted upon a reasonable request. The provider agrees that claims submitted must be for services rendered to eligible recipients of the Florida Medicaid Program and that payment by the program for services rendered will be based on the payment methodology in the applicable Administrative Rule. The Provider also agrees to submit requests for payment in accordance with program policies. In August, 1990, as a result of an investigation not related to this case, the Office of the Auditor General notified the Department's Medicaid Program Integrity Office (MPIO) that the Petitioner had billed for periodontal scalings, procedure code D4342, for which administrative recoupment might be sought. Subsequently, the MPIO completed a review of Petitioner's Medicaid claims for procedure code D4342 and determined that an overpayment in the amount of $51,072.00 was made. The review covered the period January 1, 1986 through June 30, 1990. On October 1, 1990, the MPIO notified Petitioner of the alleged overpayments and requested additional information or documentation from Petitioner that would either justify the payments or reduce the amount of the overpayment. Having received no response to the October, 1990 letter, the MPIO sent a second notice to Petitioner on November 26, 1990. That notice further claimed the overpayment and alleged that the billing for periodontal scaling did not meet Medicaid criteria. This second notice requested that Petitioner remit the amount of the overpayment, and advised him of his right to an administrative hearing to challenge the decision. According to the rule governing procedure code D4342: Periodontal scaling is allowable only when generalized subgingival accretions are readily visible on radiographs. Periodontal scaling can be billed only one time, at the completion of the procedure, regardless of the number of visits required for completion. Before performing the periodontal scaling procedure, it is customary practice for dentists to document the patient record with an indication as to why the procedure needs to be done. In this case, the records maintained for each of the patients for whom the procedure was allegedly performed contained but one record, form 1014. The form 1014 contained an abbreviated description of the procedure and the area (upper right, upper left, lower left, or lower right quadrant) where the services were rendered. Prior approval of the procedure- was not required to seek payment for the claim for periodontal scaling. When reviewing patient records related to this procedure, the MPIO looks for records which establish the medical necessity for the procedure. Such records were requested from Petitioner, however, only the form 1014 records were submitted. The completion of the form 1014 as submitted by Petitioner inadequately documents the medical necessity for periodontal scaling and inadequately records results of such treatment. For example, such record does not demonstrate the reasons for performing the scaling and does not record the information (such as the pocket depth or calculus score) resulting from such procedure. Periodontal scaling, unlike other dental procedures such as fillings or root canals, cannot readily be detected or confirmed by later observation. For instance, if the child required the procedure, had it, and subsequently returned to poor oral care, a later review of the patient would not confirm the procedure had been performed. Similarly if the child did not require the procedure and did not have it, a later review of the patient would not detect that the procedure had not- been performed. Because periodontal scaling cannot be confirmed or detected after the fact, it is impossible to revisit the patient and create an accurate dental record. Petitioner submitted 4,539 specific claims for periodontal scaling procedures during the period covered in this case. Such procedures were allegedly performed on 866 patients and totalled $51,072.00. Petitioner did not have radiographs or x-rays to support the need for the procedures. In fact, Petitioner did not take x-rays to support the need to perform the procedures. Petitioner did not maintain a medical history with the dental record for the patients who received the periodontal scaling.
Recommendation Based on the foregoing, it is, hereby, RECOMMENDED: That Agency for Health Care Administration enter a final order requiring the Petitioner to reimburse the agency in the amount of $51,072.00 for dental services not appropriately documented as medically necessary. DONE AND RECOMMENDED this 14th day of October, 1993, in Tallahassee, Leon County, Florida. Joyous D. Parrish 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 14th day of October, 1993. APPENDIX Rulings on the proposed findings of fact submitted by the Petitioner: 1. None submitted. Rulings on the proposed findings of fact submitted by the Respondent: Paragraphs 1 through 9, 12 through 16, 18 through 22, 24 through 33 are accepted. Paragraph 10 is rejected as irrelevant or too vague to constitute a statement of fact. Paragraph 11 is rejected as irrelevant. Paragraph 17 is rejected as irrelevant. Paragraph 23 is rejected as irrelevant. COPIES FURNISHED: Gordon B. Scott Senior Attorney HRS Medicaid Office 1317 Winewood Boulevard Building Six, Room 234 Tallahassee, Florida 32399-G700 Jay M. Kolsky 239 N. E. 20th Street- Miami, Florida 33137 Robert L. Powell, Agency Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 Kim Tucker, General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700
The Issue Whether the Respondent committed the violations alleged in the Administrative Complaint dated March 26, 2010, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: The Department is the state agency responsible for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. See § 456.072, Fla. Stat. The Board of Medicine ("Board") is the entity responsible for regulating the practice of medicine and for imposing penalties on physicians found to have violated the provisions of section 458.331(1). See § 458.331(2), Fla. Stat. At the times material to this proceeding, Dr. Genao was a physician licensed to practice medicine in Florida, having been issued license number ME 58604. Dr. Genao was board-certified in pediatrics, and, until he closed his office in 2008, he practiced pediatric medicine and complementary medicine, which consists primarily of nutrition counseling and infusion therapy. From December 2008 to March 2010, Dr. Genao was employed as a physician at the Full Service Pain Management Clinic ("Clinic"). Prior to his employment with the Clinic, Dr. Genao had not practiced medicine in the field of pain management and had not taken any continuing medical education classes in the field of pain management. His knowledge of pain management medicine prior to his association with the Clinic was limited to the writing of an occasional prescription for Oxycodone or Percoset. When Dr. Genao learned that the Clinic was looking for a physician, he contacted the Clinic and was interviewed by one of the owners. After he was hired by the Clinic, he observed and worked with the medical director of the Clinic, Dr. Friedberg, for approximately three weeks. Then, when he began seeing patients at the Clinic on his own, another physician observed him with his first few patients. This was the only formal training he received in pain management medicine. During the time he was observing the medical director of the Clinic and working with patients at the Clinic, Dr. Genao read about pain management medication in textbooks and on the Internet, and he also attended approximately 35 hours of continuing medical education in the field of pain management medicine. During the time he was working at the Clinic, Dr. Genao had an endorsement on his medical license allowing him to dispense drugs on the premises. Dr. Genao began treating patients V.C. and J.S. at the Clinic in December 2008, soon after he began working at the Clinic. They were among his first patients. Dr. Genao prescribed Roxicodone and Xanax for both V.C. and J.S. during the course of their treatment. He also prescribed Soma for V.C. on one occasion, and he prescribed Percocet for J.S. on one occasion. Roxicodone is a rapid release formula of oxycodone. Oxycodone is an opiate (narcotic) analgesic used for the treatment of acute or chronic pain. Oxycodone is a schedule II controlled substance pursuant to section 893.03(2), Florida Statutes, and has a high potential for abuse. Roxicodone is dispensed in 30-milligram and 15-milligram tablets. This medication begins to relieve pain within 30-to-45 minutes after it is ingested, and it continues to act on pain for up to five hours. Percocet is the brand name for a combination of oxycodone and acetaminophen, and it differs from Roxicodone only in the addition of acetaminophen. Xanax, the brand name of alprazolam, is a benzodiazepine sedative hypnotic that is used to treat anxiety. It is a schedule IV controlled substance pursuant to section 893.03(4), and it has a low potential for abuse relative to schedule I, II, and III controlled substances. Soma is the brand name for carisprodol, which is a muscle relaxant commonly prescribed for muscle pain. It is a schedule IV controlled substance pursuant to section 893.03(4), and it has a low potential for abuse relative to schedule I, II, and III substances. Patient V.C. V.C.'s first visit to the Clinic was on December 20, 2008. At that time, he was screened by the Clinic's staff. The screening included completion of forms recording past substance abuse and psychiatric history. V.C. reported that he had no history of drug abuse and no history of a psychiatric diagnosis. V.C. also reported that he had taken, among other drugs, Roxicodone, Valium, Oxydose, Xanax, Lorcet, Percocet, Vicodin, Oxycontin, and Ambien. On December 20, 2008, V.C. also signed the following documents: A Pain Management Agreement, in which he agreed to follow the guidelines set forth in the agreement regarding the use of controlled pharmaceuticals, including submitting himself for blood or urine testing at the request of his physician; A form entitled "Informed Consent to Take Opiate/Narcotic Pain Medication," in which the benefits and risks of taking this type of medication were set out; A form advising V.C. that, pursuant to section 893.13, Florida Statutes, it was a third degree felony to fail to tell a physician prescribing narcotic pain medication that he had received pain medication from another physician since his last visit to the Clinic and/or to possess narcotic medication by misrepresentation, fraud, subterfuge, forgery, or deception; and A non-overdose contract, in which V.C. agreed to take the medication as prescribed and agreed to accept full responsibility if an overdose of pain medications occurred. V.C. also completed an Initial Pain Assessment form on December 20, 2008, in which V.C. reported the following: He tore his rotator cuff at the gym approximately 20 months prior to his first office visit with Dr. Genao; His pain was burning and sharp, and he was stiff in the morning; His pain interfered substantially with his work and made him depressed and irritable; He had been treated in 2006-2007 by a Dr. Taylor, who had treated him with therapy and cortisone shots, among other modalities, and in 2007-2008 by a Dr. Ward, who did nerve conduction testing; and d. X-rays and an MRI had been taken of his shoulder. V.C. was first seen by Dr. Genao on December 23, 2008. At that time, an Initial Medical Evaluation form was completed, in which the following was noted: a. V.C. sought a medical evaluation in order obtain medication refills; b V.C. had previously been seen in a pain clinic in Davie, Florida, in November 2008; The pain medications currently prescribed for V.C. were Roxicodone and Xanax; V.C.'s neck and shoulder were the areas affected by the pain; The level of pain with medication reported by V.C. was three on a scale of ten, while the level of pain without medication was eight on a scale of ten; The pain was constant, burning, aching, and radiating; There was limited range of motion in V.C.'s left shoulder, and he could not raise his left arm; and An MRI scan of the left shoulder was conducted on February 26, 2007. Dr. Genao obtained a copy of the results of the February 26, 2007, MRI scan, which included the following impression: Rotator cuff tendinosis involving the supraspinatus tendon. There is bursal-sided fraying. There is undersurface fraying and some low-grade partial thickness tear in the central distal aspect of the supraspinatus tendon. Fluid in the overlying subdeltoid bursa reflects moderate bursitis. AC joint degenerative change, as noted above with evidence of a type 2 anterior acromion. Labral blunting and fraying along the anterior, anterosuperior, and posterosuperior aspects of the labrum. Changes that appear to suggest some element of chondral thinning along the bony margin of the glenoid, more evident inferior and posteroinferiorly. Dr. Genao's diagnosis, as stated on the Initial Medical Evaluation form, was tendonitis. The blank space on the Initial Medical Evaluation form reserved for a listing of "Non-pharmaceutical pain modifying therapies" was completed with "N/A." The medication treatment plan that Dr. Genao developed for V.C. consisted of prescriptions for 224 30-milligram tablets of Roxicodone; 56 15-milligram tablets of Roxicodone; and 56 two milligram tablets of Xanax3; this treatment plan was included by Dr. Genao in the Initial Medical Evaluation form. The long-term goals Dr. Genao identified on the Initial Medical Evaluation form were to "decrease pain" and to "improve enjoyment of daily life activities and social interaction and function." Dr. Genao completed a History and Physical Examination Form for V.C. on December 23, 2008. Although a small part of the information on the form was illegible, Dr. Genao noted the following: V.C. suffered from severe pain in his left shoulder due to a weight-lifting injury in November 2006, although he continued to exercise with pain; V.C. was first seen for his shoulder pain by a Dr. Taylor, who prescribed exercise and treated him with cortisone shots and Percocet; V.C. continued to experience pain, however, and he was then seen by a Dr. Ward,4 who treated V.C. with 25-to- 30 milligram tablets of Roxicodone; V.C. worked as a cameraman for a television station, which required him to continually push buttons and pull cables, and it was impossible for him to do his work without pain medication; V.C. had been taking pain medications for about a year before his appointment with Dr. Genao; V.C. had not decided whether to have surgery on his shoulder, although he knew it was an option for treating the pain; V.C.'s previous doctor had prescribed Valium, and then Xanax, to relieve anxiety and stress; V.C. had no other health problems and no side effects from the medications; V.C. was divorced and had a young daughter and a 92- year-old mother, for whom he provided care; V.C. smoked but did not use alcohol; V.C.'s current medications were 30-milligram tablets of Roxicodone and two-milligram tablets of Xanax; V.C. may go on work trips and might need prescriptions filled before scheduled. Under the heading "ROS" on the History and Physical Examination Form, Dr. Genao noted that V.C. reported sleepiness but "none" of the following: Gen: Confusion, appetite, weakness Resp: Cough, wheeze, SOB, hemoptysis CVS: CP, palpitations, PND, Syncope, SOBOE, H/O, HTN, Lipid d/o GI: N/V/D/C, dark tarry stool, BRBPR, Liver problems GU: dysuria, urinary retention, frequency urgency, hesitancy, hematuria, kidney problems Neuro: weakness, numbness, tingling, dizziness, memory, cognition, balance, dexterity, agility MSKT: brittle bones, muscle tone, strength, joint pain/deformities/limitation/swelling, carpal tunnel Psych: depression, anxiety, mood, behavioral changes, h/o psychosis Other than the documents discussed above and copies of the prescriptions Dr. Genao wrote for V.C., the only significant items in Dr. Genao's medical records were "Patient Follow Up Sheets" completed by Dr. Genao for each of V.C.'s appointments subsequent to the initial office visit on December 23, 2008. After his initial office visit, V.C. had six appointments with Dr. Genao, on January 21, 2009; February 18, 2009; April 3, 2009; May 4, 2009; June 1, 2009; and June 29, 2009. Dr. Genao assessed V.C.'s condition during each office visit, and each follow-up sheet included the date of the appointment, V.C.'s vital signs, and the following notations: V.C. did not take vitamins, did exercise, and smoked between one-quarter pack to one pack of cigarettes each day; V.C. experienced pain during normal activities of three on a scale of ten with medications and eight on a scale of ten without medications, except that he reported on May 4, 2009, that he experienced pain during normal activities of two on a scale of ten with medications; V.C. had no side effects from the medications, had no new complaints or injuries, and had experienced improvement in mood and daily activities, Lifestyle changes were discussed and notes from previous office visits were reviewed; V.C. was responding well to the medications; Dr. Genao and V.C. discussed reducing his medication amounts and making changes in the medication prescribed for V.C.; and All questions and concerns were addressed in detail; No referral, labs, or diagnostic tests had been ordered. The medication prescribed at each appointment, together with Dr. Genao's notes, are included on the "Patient Follow Up Sheet" for each appointment as follows: January 21, 2009: 224 Roxicodone 30 mg 56 Roxicodone 15 mg 56 Xanax 2 mg "Pt did fine on his prescriptions. Pain well controlled. No side effects reported." February 18, 2009: 224 Roxicodone 30 mg 56 Roxicodone 15 mg 56 Xanax 2 mg "Pt did fine. No side effects reported." April 3, 2009: 224 Roxicodone 30 mg 84 Roxicodone 15 mg 56 Xanax 2 mg "Tendonitis/bursitis L shoulder [illegible] shoulder acting up. Pt feels better ± same" May 4, 2009: 224 Roxicodone 30 mg 84 Roxicodone 15 mg 56 Xanax 2 mg "Pt doing well. No side effects." June 1, 2009: 224 Roxicodone 30 mg 84 Roxicodone 15 mg 56 Xanax 2 mg "Pt doing fine. Active camera man." June 29, 2009: 196 Roxicodone 30 mg 112 Roxicodone 15 mg 56 Xanax 2 mg 56 Soma 350 mg "Pt doing well. Active at job. Doing some painting job which increase his pain. Lot of muscle spasms." Dr. Genao did not conduct a complete physical examination of V.C. during his initial office visit or during subsequent visits. Rather, because V.C. had voiced no other complaints, Dr. Genao performed a limited physical examination on V.C.'s first office visit that focused on his neck and left shoulder, which were the areas of his body that V.C. identified as the sources of his pain. With respect to this limited physical examination, Dr. Genao noted on the Initial Medical Evaluation form that V.C. had a limited range of motion of his left shoulder and was unable to raise his left arm. According to Dr. Genao, the type of examination he gave V.C. on his initial visit usually takes three-to-five minutes. It was Dr. Genao's practice not to touch the patient or conduct any manual manipulation; rather, Dr. Genao would request that the patient perform movements at his direction, and he would measure the amount of rotation and enter the information on the patient's medical records. There is nothing in V.C.'s medical records to indicate that Dr. Genao did any type of physical examination during any of V.C.'s subsequent office visits, although his height, weight, and vital signs were taken and recorded on the "Patient Follow- Up Sheet" for each appointment. Although V.C. reported that he had been seen previously by a Dr. Taylor and a Dr. Ward, neither Dr. Genao nor anyone at the Clinic contacted the offices of these physicians to obtain copies of V.C.'s medical records. Consequently, Dr. Genao did not have any records of V.C.'s prior medical treatment or of the medications that Dr. Taylor and/or Dr. Ward had prescribed for V.C. Nonetheless, Dr. Genao's treatment plan for V.C. was to continue with the medications that V.C. told Dr. Genao he had been taking prior to December 23, 2008. In prescribing 224 30-milligram tablets of Roxicodone, 56 15- milligram tablets of Roxicodone, and 56 two-milligram tablets of Xanax for V.C. at his first office visit, Dr. Genao relied exclusively on the information V.C. provided about the type, strength, and quantities of the medications that Dr. Ward had prescribed. Dr. Genao continued with the medication treatment plan through V.C.'s February 18, 2009, office visit, and he based the strength and quantity of the pain medications he prescribed for V.C. on his assessment of V.C. at each office visit. The strength and quantity of Roxicodone and Xanax prescribed for V.C. remained the same until April 3, 2009, when Dr. Friedberg, the Clinic's medical director, increased to 84 the quantity of 15-milligram tablets of Roxicodone prescribed for V.C. Dr. Genao followed the lead of Dr. Friedberg at V.C.'s May 4, 2009, office visit and increased the quantity of 15- milligram tablets of Roxicodone prescribed for V.C. to 84, deferring to Dr. Friedberg's knowledge and experience in pain management medicine. At V.C.'s May 4, 2009, office visit, Dr. Genao also continued to prescribe the 30-milligram tablets of Roxicodone and the two-milligram tablets of Xanax in the quantities he had previously prescribed. Dr. Genao did not change V.C.'s medications at his office visit on June 1, 2009. At V.C.'s final office visit on June 29, 2009, Dr. Genao prescribed Soma, a muscle relaxant, for V.C. because V.C. reported that he had fallen and was having muscle spasms; Dr. Genao reduced the number of 30-milligram tablets Roxicodone from 224 to 196, and he increased the number of 15-milligram tablets of Roxicodone from 84 to 112. Dr. Genao did this because he wanted to increase the number of 15-milligram tablets of Roxicodone available to V.C. for dealing with "break-through pain"5 and because he wanted to decrease the total milligrams of Roxicodone V.C. was taking each day. According to Dr. Genao, V.C. had decided, after having received other types of treatments, to use pain medication as the modality of treatment for the pain in his shoulder. Dr. Genao did not discuss different modalities of pain management, such as physical therapy, injection therapy, and surgery, with V.C. because, in Dr. Genao's view, V.C. had the right to chose treatment with pain medication. Because V.C. had made his choice of treatments, Dr. Genao did not refer him to other physicians for any other modality of treatment for his pain or treat him with anti-inflammatory medications. Dr. Genao did not doubt the truthfulness of the information V.C. provided about the type, quantity, and strength of the medications he was taking at the time of his first office visit with Dr. Genao on December 23, 2008. He did not order V.C. to submit to urinalysis to determine the amount and type of drugs in V.C.'s system on his first or subsequent visits because Dr. Genao did not consider V.C. to be a patient at high risk of abusing pain medication. Dr. Genao observed that V.C. always kept his appointments, was on time for his appointments, was doing well with his job, and was taking care of his 92-year-old mother and his two-year-old child. In addition, Dr. Genao observed that V.C. behaved in a professional manner during his office visits. Patient J.S. J.S.'s first visit to the Clinic was on December 29, 2008. At that time, he was screened by the Clinic's staff. The screening included completion of forms recording past substance abuse and psychiatric history. J.S. reported that he had no history of drug abuse and no history of a psychiatric diagnosis. J.S. also reported that he had taken, among other drugs, Roxicodone, Percocet, and Lortab. On December 29, 2008, J.S. also signed the following documents: A Pain Management Agreement, in which he agreed to follow the guidelines set forth in the agreement regarding the use of controlled pharmaceuticals, including submitting himself for blood or urine testing at the request of his physician; A form entitled "Informed Consent to Take Opiate/Narcotic Pain Medication," in which the benefits and risks of taking this type of medication were set out; A form advising J.S. that, pursuant to section 893.13, Florida Statutes, it was a third degree felony to fail to tell a physician prescribing narcotic pain medication that he had received pain medication from another physician since his last visit to the Clinic and/or to possess narcotic medication by misrepresentation, fraud, subterfuge, forgery, or deception; and A non-overdose contract, in which J.S. agreed to take the medication as prescribed and agreed to accept full responsibility if an overdose of pain medications occurred. At J.S.'s first office visit with Dr. Genao, on December 29, 2008, an Initial Pain Assessment form was completed, in which J.S. reported the following: His problem started three years prior to his first office visit with Dr. Genao; His pain interfered with his work and his daily routine but did not make him irritable, depressed, or angry; He had been treated in November 2008 by Dr. Beaure, who prescribed 224 30-milligram tablets of Roxicodone, 140 15-milligram tablets of Roxicodone, and 60 two-milligram tablets of Xanax; and He had an MRI in November 2008. An Initial Medical Evaluation form was also completed on December 29, 2007, in which the following was noted: J.S. had been seen in November 2008 by "Dr. Bower" at the AAA pain management clinic; J.S. decided to go to the Clinic because the AAA pain management clinic had closed; J.S. sought a medical evaluation in order to obtain medication refills and medication changes; The pain medications currently prescribed for J.S. were Roxicodone, Xanax, and "Rox 15"; J.S.'s lower back was the area affected by the pain, and it was aggravated by lifting, sitting, standing, walking, and bending; J.S. reported that the level of pain with medication was "N" on a scale of ten and that the level of pain without medication was ten on a scale of ten; J.S. described the pain as constant, sharp, stabbing, throbbing, and radiating; Dr. Genao observed swelling in J.S.'s cervical area, and tenderness, trigger points, and spasms, were observed in his lumbrosacral area; and An MRI scan of the lumbrosacral area was conducted on November 13, 2008. J.S. brought a copy of the November 13, 2008, MRI report to his first office visit with Dr. Genao, and this document was included in Dr. Genao's medical records for J.S. The impression stated in the radiologist's report was that J.S. had a disc protrusion between the L3-4 vertebrae that "touches and mildly effaces the dural sac" and a disc protrusion between the L5-S1 vertebrae that "touches the left exiting S1 exiting nerve root". Dr. Genao's diagnosis, as stated on the Initial Medical Evaluation form, was severe back pain and bulging discs. "No" was filled in the blank space on the Initial Medical Evaluation form reserved for a listing of "Non-pharmaceutical pain modifying therapies." The medication treatment plan that Dr. Genao developed for J.S. consisted of prescriptions for 224 30-milligram tablets of Roxicodone; 56 15-milligram tablets of Roxicodone; and 56 two-milligram tablets of Xanax6; this treatment plan was set forth on the Initial Medical Evaluation form. The long-term goals for J.S. that Dr. Genao identified on the Initial Medical Evaluation form were to "decrease pain" and to "improve enjoyment of daily life activities and social interaction and function." Dr. Genao completed a History and Physical Examination Form for J.S. on December 29, 2008. Although a small part of the information on the form was illegible, Dr. Genao noted the following: J.S. suffered for three years from severe aches and spasms in his lower back, that radiated to his mid-back and neck and went down both legs, especially his right leg, and to his right testicle; J.S. described the pain as ten on a scale of ten; J.S. had been seen by a pain management physician steadily for two years but had to stop this regular pain management treatment because he lacked insurance; J.S. subsequently obtained pain management medications whenever he could afford them, and, when he was last seen in November 2008, he had received prescriptions for both 30- milligram and 15-milligram tablets of Roxicodone; J.S. reported that the pain had become unbearable and interfered with his ability to work and that he had anxiety and problems sleeping; J.S. had no other health problems; J.S. was married with one child; J.S. did not smoke or use alcohol or drugs; J.S.'s current medications were Roxicodone and Xanax; Under the heading "ROS" on the History and Physical Examination Form, Dr. Genao noted that J.S. reported sleepiness; problems with agility, muscle tone, and strength; and anxiety, but he reported "none" of the following: Gen: Confusion, appetite, weakness Resp: Cough, wheeze, SOB, hemoptysis CVS: CP, palpitations, PND, Syncope, SOBOE, H/O, HTN, Lipid d/o GI: N/V/D/C, dark tarry stool, BRBPR, Liver problems GU: dysuria, urinary retention, frequency urgency, hesitancy, hematuria, kidney problems Neuro: weakness, numbness, tingling, dizziness, memory, cognition, balance, dexterity MSKT: brittle bones, muscle tone, strength, joint pain/deformities/limitation/swelling, carpal tunnel Psych: depression, mood, behavioral changes, h/o psychosis Other than the documents discussed above and copies of the prescriptions Dr. Genao wrote for J.S., the only significant items in Dr. Genao's medical records were "Patient Follow Up Sheets" completed for each of J.S.'s appointments with Dr. Genao subsequent to the initial appointment on December 29, 2008. After his initial office visit, J.S. had four appointments with Dr. Genao, on January 26, 2009; February 23, 2009; March 27, 2009, and April 29, 2009.7 Dr. Genao assessed at each office visit, and each follow-up sheet included the date of the appointment, J.S.'s vital signs, and the following notations: J.S. did not take vitamins, did exercise, and smoked between one-quarter pack to one-half pack of cigarettes each day; J.S. experienced pain during normal activities of three on a scale of ten with medications and ten on a scale of ten without medications, except that he reported on April 29, 2009, that he experienced pain during normal activities of nine on a scale of ten with medications; J.S. had no side effects from the medications and had no new complaints or injuries, although he did report at the January 26, 2009, office visit that he had been treated with a "Z-pack" for pneumonia; J.S. experienced improvement in mood and daily activities; Lifestyle changes were discussed and notes from previous office visits were reviewed; J.S. was responding well to the medications; Dr. Genao and J.S. discussed reducing his medication amounts and making medication changes; All questions and concerns were addressed in detail; and No referral, labs, or diagnostic tests were ordered. The medication prescribed at each appointment, together with Dr. Genao's notes, are included on the "Patient Follow Up Sheet" for each appointment as follows: January 26, 2009: 224 Roxicodone 30 mg 112 Roxicodone 15 mg 56 Xanax 2 mg "Pt doing much better. More active at work. Helping [illegible] and performing well at his job. No side effects reported." February 23, 2009: 224 Roxicodone 30 mg 56 Xanax 2 mg 112 Percocet 10/650 mg "Pt did fine. Working almost like a normal person. Pt and wife are happy. Will give Percocet for BTP [breakthrough pain] instead of Roxi 15 mg." March 27, 2009: 224 Roxicodone 30 mg 112 Roxicodone 15 mg 56 Xanax 2 mg Chantix for 2 weeks "Pt doing well. Working some over time and now able to play with daughter. Patient looking to quit smoking asking for Chantix" April 29, 2009: 224 Roxicodone 30 mg 112 Roxicodone 15 mg 56 Xanax 2 mg "Pt very happy with med. Quitting smoking. Did not take Chantix. 2 deaths in the family." Dr. Genao did not conduct a full physical examination of J.S. during his initial office visit or during subsequent office visits. Rather, because J.S. had no other complaints, Dr. Genao performed a limited physical examination on J.S.'s first office visit that focused on his back, which was the area of his body that J.S. identified as the source of his pain. With respect to this limited physical examination, Dr. Genao noted on the Initial Medical Evaluation form that J.S. had muscle spasms and tenderness in trigger points. According to Dr. Genao, the type of examination he gave J.S. on his initial visit usually takes three-to-five minutes. Although it was Dr. Genao's practice not to touch the patient or conduct any manual manipulation, he touched J.S.'s back at several points to determine if it was tender. Otherwise, Dr. Genao requested that J.S. perform movements at his direction, and he noted the results on the Initial Medical Evaluation form. There is nothing in J.S.'s medical records to indicate that Dr. Genao did any type of physical examination during any of J.S.'s subsequent office visits, although his height, weight, and vital signs were taken and recorded on the Patient Follow Up Sheet for each appointment. J.S. reported that he had been seen previously by Dr. Beaure, but neither Dr. Genao nor anyone at the Clinic contacted Dr. Beaure's office to obtain copies of J.S.'s medical records. Consequently, Dr. Genao did not have any records of J.S.'s prior medical treatment or of the medications that Dr. Beaure had prescribed for J.S. Nonetheless, Dr. Genao's treatment plan for J.S. was to continue him on the medications that J.S. told Dr. Genao he had been taking prior to December 29, 2008. In prescribing 224 30-milligram tablets of Roxicodone, 112 15-milligram tablets of Roxicodone, and 56 two- milligram tablets of Xanax, for J.S. at his first office visit, Dr. Genao relied exclusively on the information J.S. provided about the type, strength, and quantities of the medications that Dr. Beaure had prescribed. On February 23, 2009, Dr. Genao substituted 112 10/650-milligram tablets of Percocet for the 112 15-milligram tablets of Roxicodone that he had prescribed on January 26, 2009, at J.S.'s request. J.S. felt that the 15- milligram Roxicodone tablets did not take the edge off of his pain, but the Percocet, which contained ten milligrams of oxycodone and 650 milligrams of acetaminophen, was not as effective as J.S. had expected. Dr. Genao returned to the original prescription of 112 tablets of 15-milligram Roxicodone at J.S.'s March 27, 2009, office visit. Dr. Genao discussed with J.S. different modalities of pain management, such as physical therapy, injection therapy, and surgery, even though he did not note the substance of this discussion in J.S.'s medical records. J.S., however, chose to manage his pain through medication, and Dr. Genao did not refer J.S. to any other physicians for other modalities of treatment for his pain or treat him with anti-inflammatory medications. Dr. Genao did not require J.S. to submit to urinalysis to determine the amount and type of drugs in J.S.'s system on his first or subsequent visits because Dr. Genao did not consider J.S. to be a patient at high risk of abusing pain medications. Dr. Genao did not doubt the truthfulness of the information J.S. provided regarding the type, strength, and quantity of medications J.S. was taking at the time of his first office visit on December 29, 2008. Dr. Genao observed throughout the time that J.S. was his patient that J.S. always kept his appointments, was on time for his appointments, and behaved in a professional and orderly manner. General V.C. and J.S. were among the first patients Dr. Genao treated at the Clinic. He subsequently modified the way in which he approached the treatment of patients seeking help managing pain. He started patients who had not previously taken opioids on small amounts of pain medication and then worked up, or titrated, to the amount that relieved their pain. With V.C. and J.S., however, Dr. Genao prescribed the same type, quantity, and strength of pain medications that they had been taking prior to their first office visits with him because V.C. and J.S. had developed a tolerance for the medications, and Dr. Genao did not want to decrease the amount or change the type of medications and possibly cause them distress or withdrawal symptoms. It was the Clinic's policy to do urine tests to determine what, if any, drugs were in the patient's system at any given time and to obtain copies of patient's medical records. Dr. Genao conceded that he did not order urine tests or ensure that copies of medical records for V.C. and J.S. were obtained by Clinic staff, but, again, he explained that V.C. and J.S. were among his first patients and that he had modified his practices as he became more experienced. Dr. Genao based the type, strength, and quantity of the pain medications he prescribed on his assessment of his patients at each office visit, and he followed the standard procedure of the Clinic in prescribing both 30-milligram and 15- milligram tablets of Roxicodone. Dr. Genao prescribed 224 30- milligram tablets of Roxicodone for both V.C. and J.S.; this amounted to eight tablets a day, and two tablets were to be taken every four-to-six hours.8 Dr. Genao prescribed 15-milligram tablets of Roxicodone to allow V.C. and J.S. to take a 15-milligram Roxicodone tablet for break-through pain rather than having them take a 30-milligram tablet of Roxicodone tablet before the next dose of the greater-strength Roxicodone was due. In this way, Dr. Genao believed that V.C. and J.S. could control their pain with the least amount of medication Dr. Genao used pre-printed prescription forms for Roxicodone and Xanax because those forms were routinely used by the doctors practicing at the Clinic. There were a number of pre-printed forms, and the use of these forms did not mean that Dr. Genao failed to tailor the prescriptions to the specific needs of V.C. and J.S., individually. Summary9 The evidence presented by the Department is not sufficient to establish that Dr. Genao failed to conduct and document appropriate evaluations of V.C. and J.S.10 The Past Substance Abuse and Past Psychiatric History forms, the Initial Pain Assessment forms, the History and Physical Examination Forms, and the Patient's Follow-Up Sheets completed by or for and J.S. included the following: Complete medical histories of these patients relating to their need for pain management; The results of the physical examinations that Dr. Genao performed of the areas related to their complaints of pain to ensure that the symptoms of which they complained correlated with the results of the physical examinations and the information revealed by their MRIs and that there was a medical indication for the use of pain medications; An assessment of the nature and intensity of V.C.'s and J.S.'s pain, with a rating of their pain on a scale of one to ten both with and without medication, together with a description of the nature of their pain; A listing of their current and past treatments for pain, as well as the names of the physicians who had treated them for the pain; A list of underlying or coexistent diseases or conditions that they reported, if any; The effect of the pain on their physical and psychological functioning; A history of their substance abuse, if any; and The diagnoses constituting the medical indications for the prescribing of controlled substances for V.C. and J.S. The evidence presented by the Department is not sufficient to establish that Dr. Genao failed to develop and document appropriate treatment plans for V.C. and J.S. The medication treatment plans were set forth on the Initial Medical Evaluation forms and indicated the type, strength, and quantity of the medications to be prescribed. The short- and long-term goals for V.C. and J.S. were included on the Initial Medication Evaluation form for each of them and included both a decrease in pain and improved enjoyment of daily activities and social interaction as objectives of the treatment plan and the means by which the success of the treatment was to be measured. Dr. Genao indicated on the Initial Medication Evaluation forms for V.C. and J.S. that there would be no non-pharmaceutical pain modifying therapies for either patient. After treatment began, Dr. Genao completed a Patient's Follow-Up Form for each of V.C.'s and J.S.'s office visits, in which he indicated that no new referrals, labs, or diagnostic tests had been ordered; he made notes relating the progress of these patients toward the goals of the treatment plan; and he indicated that he had discussed with V.C. and J.S. reducing the amount of medication or changing medications. The evidence presented by the Department is also insufficient to establish, with the requisite degree of certainty, that Dr. Genao fell below the level of care, skill, and treatment recognized as appropriate by a reasonably prudent physician, in light of all relevant circumstances, with respect to those aspects of the treatment of V.C. and J.S. identified in the Administrative Complaint. The testimony of the Department's expert witness is found to be generally unpersuasive, with the following but a few examples of the basis for this finding: The Department's expert offered a sometimes meandering commentary on what he considered deficiencies in Dr. Genao's treatment of V.C. and J.S., but he neither limited his commentary to the allegations in the Administrative Complaint, nor articulated the standards of care by which he evaluated Dr. Genao's treatment of V.C. and J.S. In several instances, the Department's expert was led by the Department's counsel with questions regarding standards of care to which he was required only to respond with a "yes" or a "no." The testimony of the Department's expert was contradictory in important respects, such as when he testified that treatment of V.C.'s shoulder pain with controlled substances may be needed and then testified that "this kind of medications [sic]" is not what "we use to treat shoulder pain."11 The Department's expert testified in terms of his opinions and his "feelings" about particular matters; used words and phrases such as "seems" and "appears" and "I would state"; and stated conclusions without explanation. Two of the most problematic aspects of the testimony of the Department's expert were his statements that the quantity and dosage of Roxicodone prescribed by Dr. Genao for V.C. and J.S. were excessive and that there was no indication for prescribing both 30-milligram and 15-milligram tablets of Roxicodone.12 These statements are specifically rejected as unpersuasive because the Department's expert did not offer any cogent explanation to support these opinions or articulate any standards of care from which he derived the opinions. Indeed, with respect to the testimony that the quantity of Roxicodone prescribed for V.C. and J.S. was excessive, the Department's expert began discussing the manner in which one would titrate the dosage of opioids for a person who was "opioid naïve" when the medical histories provided by V.C. and J.S. established that they had recently been prescribed Roxicodone by other physicians.13 Furthermore, the only explanation the Department's expert provided to support his opinion that Dr. Genao's prescribing both 30-milligram and 15-milligram tablets of Roxicodone was excessive, "kind of like double dosing almost,"14 was that both 30-milligram and 15-milligram tablets of Roxicodone are immediate release opioids used to treat acute pain. While an accurate statement of fact, this testimony begs the question and did not address Dr. Genao's explanation that he prescribed the 15-milligram tablets of Roxicodone to allow V.C. and J.S. to take a minimal dosage of the drug to combat breakthrough pain, a subject which the Department's expert also failed to address.15 The opinion of the Department's expert that Dr. Genao should have ordered urine drug screens for V.C. and J.S. in order to meet what he would "consider" the standard of care is unpersuasive, first, because the Department's expert never articulated a standard of care related to the routine administration of urine drug screens and, second, because he based his opinion that these patients should have been administered urine drug-screening tests on his assumptions that V.C. and J.S. were at high risk of drug abuse and/or diversion.16 These assumptions, however, were based on nothing more than the amount and type of medications prescribed for V.C. and J.S. With respect to V.C., the Department's expert testified that "[t]he nature of these prescriptions alone place this patient into a high risk category because of the combination that are [sic] very abusable, have a high street value, and are [sic] highly diverted."17 With respect to J.S., the Department's expert testified that "[a] twenty[-]eight year[-]old male on this much medication, that would be a high risk patient"18 and that [t]his is a patient requiring or requesting a very, very high combination of multiple controlled substances. So that alone would be cause for concern. I mean, signs are patients losing their scripts, selling them, knowing that they have other recreational or illicit substances in the urine. So I would say he [J.S.] has the symptoms of potential substance abuse or diversion.[19] The Department's expert did not base his assumptions that V.C. and J.S. were high-risk patients on any evidence in the record that either of them claimed to have lost prescriptions or gave any indication whatsoever that they were diverting and/or abusing the medications Dr. Genao prescribed for them. In addition, by basing his assumption that V.C. and J.S. were at high risk of medication abuse exclusively on the type and amount of medications Dr. Genao was prescribing for them, the Department's expert failed to consider the individual characteristics, circumstances, or conditions of V.C. and J.S. The notes that Dr. Genao included on the Patient Follow Up Sheets for V.C. and J.S. indicated that V.C. and J.S. were both doing well on their medications; that they had no side effects; that their activities of daily were improving; that they were able to perform their jobs better than they could without medication; and, with respect to J.S., that he was able to play with his daughter and that he and his wife were very happy. The testimony of the Department's expert witness is not sufficient to establish that Dr. Genao violated any standard of care by failing to refer V.C. or J.S. for modalities of treatment other than medication to control their pain. First, the Department's expert did not articulate a standard of care with respect to the circumstances in which it would be appropriate for a physician to refer a patient for treatment modalities such as physical therapy, surgery, neuropathic medications, or pain blocks or the circumstances in which it would be appropriate to treat a patient with muscle relaxers or anti-inflammatory medications. In fact, the testimony of the Department's expert was inconsistent with respect to his opinion regarding the appropriate treatment for V.C.'s shoulder pain: He testified that treatment with pain medications would be appropriate for V.C.; he testified that he "could support" Dr. Genao's treatment of V.C. for at least the short term; he testified that pain medications were "not something that we use to treat shoulder pain"; and, finally, he testified, without any supporting explanation, that Dr. Genao should have referred V.C. to an orthopedic surgeon for surgery.20 With respect to J.S., the Department's expert witness merely acknowledged, in response to a question posed by the Department's counsel, that he did not see any recommendations in the medical records for J.S. for treatment modalities other than pain medication; he continued his testimony with a statement regarding his practice of putting patients on opioids only as "a last resort," after having obtained the opinions of surgeons and other clinicians,"21 but this opinion was not given in the context of the standard of care which would be followed by a reasonably prudent similar physician under similar conditions and circumstances. Finally, with respect to a physician's utilizing treatment modalities other than pain medications, the Department's counsel posed the following question: "Is it within the standard of care for a physician to merely recommend that the patient undergo these modalities or should they [a physician] require that they [a patient] undergo them?"22 The Department's expert witness responded: Well, I mean, I think that depends on a physician's judgment. When we talk about prescribing medications like this I think a prudent physician should mandate that a patient at least see some other colleagues to help co-manage a difficult case. It's not mandatory but I think it would be highly recommended.[23] Not only does this testimony fail to address a standard of care relating to utilization of other treatment modalities, the opinion of the Department's expert regarding a practice that he considers "highly recommended" is limited to "a difficult case." The Department's expert witness did not, however, testify that the cases of V.C. and J.S. were difficult cases, so that this opinion is irrelevant to the issues in this case. Finally, and importantly, the Department's expert concedes that a physician should use his or her own judgment with respect to referrals for treatment modalities for pain other than pain medications.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order dismissing the all counts of the Administrative Complaint against Esteban A. Genao, M.D. DONE AND ENTERED this 28th day of January, 2011, in Tallahassee, Leon County, Florida. S Patricia M. Hart 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 28th day of January, 2011.
The Issue At issue in this proceeding is whether Austin Tyler Durand, a minor, suffered an injury for which compensation should be awarded under the Florida Birth-Related Neurological Injury Compensation Plan.
Findings Of Fact Fundamental findings Camilla Durand is the mother and natural guardian of Austin Tyler Durand (Tyler), a minor. Tyler was born a live infant on September 5, 1992, at Memorial Hospital West, a hospital located in Pembroke Pines, Florida, and his birth weight was in excess of 2500 grams. Among the physicians providing obstetrical services during the birth of Tyler was Michael F. Augustino, M.D., who was, at all times material hereto, a participating physician in the Florida Birth-Related Neurological Injury Compensation Plan (the Plan), as defined by Section 766.302(7), Florida Statutes. Ms. Durand's antepartum course and Tyler's birth At or about 7:30 p.m., September 5, 1992, Ms. Durand presented to Memorial Hospital West complaining of contractions. At the time, her estimated due date was noted as September 7, 1992 (by ultrasound), and her antenatal course was without apparent complication. On presentation, contractions were noted as moderate, with a frequency of 3 to 5 minutes and a duration of 60 to 70 seconds. Examination revealed the membranes to be intact, with no apparent bleeding, and the cervix to be at 3 centimeters, effacement at 100 percent, and the fetus at station -1. External fetal monitor revealed a fetal heart tone (FHT) baseline of 140 to 150 beats per minute, with accelerations. Ms. Durand's obstetrician was advised of her progress, and she was admitted to labor and delivery. At about 9:45 a.m., Dr. Augustino evaluated Ms. Durand and noted no change on vaginal examination. He performed an AROM (artificial rupture of the membranes), noting clear fluid. FHT was stable and reactive. At about 10:00 a.m., at Ms. Durand's request, an epidural was placed. At about 10:12 a.m., Ms. Durand was started on Pitocin drip at 1 mu/min., to augment labor. At the time, her contractions were moderate, at 3 to 4 minutes apart and lasting for 60 to 70 seconds. FHT remained stable in the 140 beat per minute range, with good variability. The Pitocin was increased to 2 mu/min. at 10:35 a.m. At 11:30 a.m., vaginal examination revealed the cervix to be at 4 centimeters, effacement at 100 percent, and the fetus still at station -1. Pitocin was increased to 4 mu/min. At 11:30 a.m. Pitocin was increased to 5 mu/min; at 11:45 a.m. Pitocin was increased to 6 mu/min.; at 12:00 (noon) Pitocin was increased to 7 mu/min.; and at 12:15 p.m. Pitocin was increased to 8 mu/min. Vaginal examination at 12:30 p.m. revealed the cervix to be at 5 centimeters, effacement at 100 percent, and the fetus still at station -1. Contractions were noted as moderate to strong, at 3 to 4 minutes apart, and lasting for 60 seconds. FHT continued in the 140 beat per minute range, with good variability. At 1:15 p.m., Ms. Durand was noted to have moderate contractions every 2 to 3 minutes, lasting 40 to 50 seconds. Vaginal examination evidenced no progress. Pitocin was increased to 9, 10, and then 11 mu/min. Vaginal examination at 2:45 p.m. showed slight edema of the cervix, and no progress. FHT tone remained stable in the 150 beat per minute range, with good variability. At about 3:15 p.m., Ms. Durand was noted to have a temperature of 100.1, and she was accorded Tylenol. Vaginal examination at 3:45 p.m. noted no progress, but evidence of head molding. Vaginal culture was done, and antibiotics ordered. FHT remained stable in the 150 beat per minute range, with good variability. At 4:00 p.m., it was resolved to deliver by cesarean section for failure to progress and maternal temperature, and Pitocin was discontinued. FHT remained stable in the 150 beat per minute range, but with decreased variability. At about 4:30 p.m., Ms. Durand was noted to have a temperature of 101.2, and there continued to be no progress in cervical dilatation. The infant's head was described as molded and still poorly applied to the cervix. FHT remained stable in the 150 beat per minute range, but with decreased variability. Between 4:30 p.m. and 4:40 p.m., the fetal monitor was discontinued, and Ms. Durand was transported to the obstetrical operating room (OB/OR). Ms. Durand was noted on the table in the OB/OR at 4:45 p.m., the operation started at 5:00 p.m., and Tyler was delivered at 5:10 p.m. Nuchal cord x 3 was noted. Following delivery Tyler was accorded free flowing facial oxygen for two minutes. Apgars of 8 and 9 were assigned at one and five minutes by the neonatologist. The Apgar scores assigned to Tyler are a numerical expression of the condition of a newborn infant, and reflect the sum points gained on assessment of heart rate, respiratory effort, muscle tone, reflex irritation, and skin color, with each category being assigned a score ranging from the lowest score of 0 through a maximum score of 2. As noted, at one minute Tyler's Apgar score totalled 8, with heart rate, respiratory effort, muscle tone, and reflex irritation being graded at 2 each, and color being graded at 0. At five minutes, Tyler's Apgar score totalled 9, with heart rate, respiratory effort, muscle tone, and reflex irritation being graded at 2 each, and color being graded at 1. Tyler's Apgar scores were essentially normal, suggesting a vigorous infant, and he was transferred to the newborn nursery at 5:30 p.m. On admission to the nursery, Tyler's color was noted as pink, and his breathing as unlabored. Subsequent physical assessment was grossly normal, with the exception of a noted hypospandias (a developmental anomaly in the male in which the urethra opens on the underside of the penis or on the perineum3). However, given the maternal fever at delivery, blood cultures were ordered and Tyler was accorded a regimen of antibiotics to address the risk of sepsis. Tyler's newborn course was otherwise uneventful and he was discharged with his mother on September 8, 1992. Tyler's subsequent development Tyler received routine pediatric care following his discharge from the hospital, and his early infancy was essentially unremarkable, until about two years of age when the mother first became concerned about his development. Tyler was, however, a healthy child, except for pneumonia on two occasions, until on or shortly before February 5, 1995, when he was admitted to Memorial Hospital, Hollywood, Florida. The cause for Tyler's admission to Memorial Hospital, as well as the initial impression regarding his presentation, is stated in the admission summary, as follows: This is the first admission to any hospital in this two year four month old white male who had a temperature since the 3rd, he was seen by Dr. Budowski in the office and i[n] Dr. Samuels office as well and a screening strep test was shown to be positive. Medicine was given but mom did not give it, she took the child home. The patient apparently slept somewhat, mom gave Tylenol and the temperature went down. Apparently the child woke up about 10 o'clock in the evening time and low and behold, we are not sure if there was a spike in the fever but mom said she took the temperature and it was not elevated. Regardless there was a sweating episode, no cyanosis. He became stiff, turned to the right, did not become incontinent and his eyes were staring, this lasted for 10 seconds two episodes within a matter of a few minutes of each other and he was screaming as well before this started. This complex type of possible seizure. He did not turn cyanotic, however, she brought him to the hospital where he was then cared for and admitted. The patient did not have any seizure since that time. There has been no fever, no coughing, no distress, no rash, etc. He had no painful urination, no bowel problems. His appetite was fairly good up until that point. He was exposed from his cousins who had respiratory infections. PAST MEDICAL HISTORY: He was born at Memorial West 7 lbs, breast-fed for three months. He was born hypospadias, was in the hospital seven days because of a questionable sepsis, was delivered by cesarean section. Mom was treated with antibiotic and the baby was treated with antibiotics but apparently did well and there has been no trouble since. There is a history of infection, states that he has had several colds in the past and never a urinary tract infection. A month ago he had probable viral pneumonia treated as an outpatient proven by x-ray. No chicken pox. IMMUNIZATIONS: Up to date. No known allergies. His development history is somewhat delayed, his weight and height his mother says since six months of age has fallen off. He walked after a year of age, his speech is down, his receptive qualities are better than his expressive. He has very poor language skills. He runs stiff, clumsy- like, toes in and falls. He has had no tremors but his hand occasionally shakes when he is sucking his thumb, and his mom thinks that his milestones are delayed based on the children in the family. He is not a toe walker and has never had any other seizures. The patient is a poor eater and a picky eater. * * * PHYSICAL EXAMINATION: * * * NEUROLOGICAL: He walked with a little clumsiness again, this may be due to the chloral hydrate [administered for his CT scan], slight toeing in, no spasticity, no toe walking. 2+ reflexes, no tremors are present, no athetoid movements whatsoever. He did hold his balance pretty well, no clonus whatsoever. He is aware of his surroundings and place. There is an abnormal speech with poor communication skills. Gross hearing and vision seem to be normal. IMPRESSION: Seizure disorder. Seizures could be febrile. Definite positive strep test. Mild development delay ? the CT scan showed borderline lateral ventricle enlargement, could be upper limits of normal. Also speech/language delay, hypospadias, hyponutritution according to weight. As noted, Tyler's CT brain scan showed borderline lateral ventricle enlargement of uncertain significance. More specifically, the CT scan was reported to read, as follows: LATERAL VENTRICLES ARE SOMEWHAT PROMINENT FOR THIS AGE GROUP. THE REMAINDER OF THE VENTRICULAR SYSTEM AND BRAIN SUBSTANCE IS NORMAL. NO MASS NOR MIDLINE SHIFT. NO EXTRA-AXIAL COLLECTION. IMPRESSION: PROMINENT LATERAL VENTRICLES OF UNCERTAIN SIGNIFICANCE. SIGNIFICANCE SHOULD BE CORRELATED WITH THE PATIENT'S CLINICAL STATUS. A chest x-ray, also taken the day of admission (February 5, 1995), was read, as follows; THERE IS EXTENSIVE BILATERAL PERIHILAR INTERSTITIAL INFILTRATE AND BRONCHIAL WALL THICKENING. THERE IS ALSO EXTENSION OF PATCHY INFILTRATE INTO THE RIGHT LOWER LOBE SUGGESTING PNEUMONIA. THERE IS NO PLEURAL EFFUSION. THE MEDIASTINAL CONTOUR IS WITHIN NORMAL LIMITS. IMPRESSION: BILATERAL PERIHILAR DISEASE WITH EXTENSION OF PATCHY INFILTRATE INTO THE RIGHT LOWER LOBE SUGGESTING PNEUMONIA. An electroencephalogram (EEG) taken on February 9, 1995, was noted as "within normal limits for the age." Following his discharge from the hospital, Tyler was referred to Dr. Stuart B. Brown, a pediatric neurologist, to assess the cause of the incident which resulted in Tyler's hospitalization. Dr. Brown's impressions, based on his examination on February 10, 1995, are noted in his report (of February 15, 1995), as follows: The neurological examination revealed this child to be very, very apprehensive and shy. His gait was mildly wide based and unsteady and this was particularly true when he attempted to turn about. Sitting was normal as was crawling and he was able to stand from a sitting position without difficulty. Hand usage appeared to be normal and there was no evidence of striking intention tremor. Muscle tone was normal to decreased in the lower extremities and deep tendon reflexes were only plus one but obtainable and equal in all joint areas. Plantar reflexes were flexor bilaterally. Involuntary movements were not seen. Cranial nerve examination revealed full extraocular movements without nystagmus. The pupils were equal and reactive to light. Optokinetic nystagmus was symmetrical. Fundi were normal with regard to optic discs. Facial musculature appeared normal. He often seemed to have his mouth open but was noted to close it. Tongue appeared normal. Cry was lusty. Hearing appeared intact to tuning fork. The neck was supple and head control was normal. IMPRESSION: I think that this child had a breath holding-like vasovagal episode following being awakened suddenly from sleep causing a persistent screaming and then tonic posturing. We do not have any evidence clinically, by history, or electrically to suggest a seizure problem here. I am concerned however because the child is developmentally delayed from a speech standpoint where he still has basically a jargon speech and from a motor standpoint where he is ataxic. I am not sure as to the basis for this. He also seems to me to be excessively small in stature. I am going to review the MR scans of the brain In the meantime I would suggest getting a wrist x-ray for bone age along with a specific DNA test for fragile x and a chromosome analysis to see if there is any translocation. I would obtain a urine organic acid assay and a plasma amino acid assay and some thyroid studies. I am particularly concerned by the motor and speech problems and less concerned by these episodes which occurred recently. . . . The requested testing was done, and failed to reveal any abnormality. Pertinent to this case, Tyler was seen in neurology consultation on November 17, 1995, by Dr. Roberto F. Tuchman. After considering the perinatal and past medical history, family history, and the results of his neurologic examination, Dr. Tuchman summarized his impressions as follows: . . . we have a 3-year-old boy with developmental delays in language and motor function with ataxia and a tremor without any clear history of regression at this present time. His workup today has only been significant for an MRI showing some mild delay in myelination and we do not have the specific diagnosis to explain his present finding. I do think that we may want to do at least an alpha-fetoprotein for now and I would like to review the rest of his workup and see if I could come up with any further ideas. In addition I am referring him to Dr. Jean A. Cardi who is widely known pediatrist neurologist who is visiting us for the next three months. Once we get this information I will reassess and see if there is anything more that we need to do. . . . After reviewing the history and neurologic examination with Dr. Cardi, it was felt that Tyler "fit the group of children that have been termed cerebral palsy-ataxic type." Also pertinent to this case, Tyler was seen in neurologic consultation on December 28, 1995, by Dr. Robert F. Cullen, Jr. Dr. Cullen's impressions were, as follows: . . . Tyler is a 3-3 1/2 year-old lad with indeed a picture of ataxia, hyperreflexia and up-going toes. While indeed the terminology of an ataxic cerebral palsy might be appropriate I am concerned that he may indeed have the Angelman syndrome or Happy Puppet syndrome. He indeed has a very stiff and jerky gait. He has an abnormality of speech and has had seizures. What we are going to do now is try to get blood for the fish technique and look and see if he has abnormalities in the region of Q11-13 on chromosome 15. I think he should continue with physical, occupational, and speech therapy. I will have the MRI reviewed by Dr. Nolan Altman to see how delayed the myelin is . . . . Tyler's development and the efforts expended to identify the nature of his anomaly, are aptly summarized by Dr. Harvey S. Singer, who documented the results of his September 5, 1996, evaluation, as follows: REASON FOR VISIT: This was the first Pediatric Neurology Clinic visit for this 4-year-old white male referred for further evaluation of developmental delay. The patient is accompanied by his mother. HISTORY OF PRESENT ILLNESS: The patient was the product of a relatively normal pregnancy to a 29-year-old gravida-2, AB-1 mother who gained only 11 pounds during the pregnancy. She had a single exposure to x-ray but was wearing protective garb. Utrasound during the pregnancy showed normal fetal activity. The patient was delivered at 39 weeks by a cesarean section after prolonged labor. Birth weight was 7.5 pounds. Apgars were 8 and 9. Color was described as being slightly dusky and Austin was given oxygen via mask. Since Ms Durand developed a fever prior to delivery and was started on antibiotics, blood cultures were obtained, an LP was unsuccessful, and the patient was treated with antibiotics for 1 week. After discharge, he was breast-fed and was always described as being a poor feeder; in fact, he received breast feedings until the age of 2. The patient appeared to be doing reasonably well until approximately 6 months at which time decreased growth was noted. Subsequently, delays in motor and language areas became more apparent. He sat around 8 months, stood about 12 months, walked at 14 months, and talked at 18 months. Parents first became concerned at about 2 years; especially about delayed language development. There is no history of a loss of an ability once acquired. At present his vocabulary is approximately 75 words though most are not understandable. He conveys his desires pointing and using garbled speech. His receptive abilities exceed his expressive skills. He is able to follow commands and obtain objects. He has had prior formal evaluations: psychometric testing has shown him to be educably handicapped whereas speech and language evaluation showed him to have a level of 22 months and a motor development of 16-18 months. Two months ago he started a special education program but Ms Durand notes no definite improvements. Other described neurologic problems include episodes of breathholding beginning at the age of 2 months and resolving at approximately age 3 years. In addition, in 02/95, he had several seizures. In 01/95 he was hospitalized with pneumonia. One week later he had a temperature to 104 degrees and was continued on antibiotics. At the time of his seizures, he was reportedly afebrile both at home and when evaluated in the emergency ward, although later he did develop a fever. His episodes consisted of crying out, stiffening of all extremities and turning his head to the right, lasting for approximately 10 seconds. This then resolved but later recurred again though for a slightly shorter duration. The patient has had numerous neurologic evaluations by at least 5 pediatric neurologists. He was initially evaluated in 02/95 following the aforementioned seizure- like activity. He has had extensive testing which has included a normal EEG, a CT said to show possibly enlarged ventricles, and an MRI with decreased myelinization. Bone age was normal. A renal ultrasound was normal (obtained to further evaluate the patient's hypospadias). He has had a normal karyotype (46XY), negative DNA testing for fragile X, and negative FISH probes for Angelman's syndrome. He has also had negative urine organic acids, serum amino acids, thyroid screens, normal long chain fatty acids, normal alpha fetoprotein, normal vitamin E, and a serum lactate of 2.6 Thyroid stimulating hormone was slightly increased at 4.76 (normal 0.26 to 4.4), a slightly increased T3 of 2.2 (normal 0.8 to 2.0) and a normal T4. Previous diagnoses have included ataxia cerebral palsy as well as "etiology unknown." Review of systems: Shows short stature, hypospadias, esotropia, an episode of prolonged emesis (etiology undermined with normal laboratory evaluations), and pneumonia X2. Family history: Mother is age 33 in good health. Father is age 42, described as being an alcoholic. Mother's grandmother has hypertension. A maternal cousin is retarded with hearing deficits of unknown etiology. Mother has migraines and sinus problems and an uncle has learning problems. MAJOR FINDINGS: On physical examination, this is a small, thin, youngster in no acute distress. He prefers sitting in his stroller or else in his mother's lap. He follows commands. Vocabulary appears limited and many of his spoken words are indistinct, although some are appropriate and correct. Skin: No neurocutaneous phenomenon. Head: Head circumference was 50.5 cm (approximately the 60th percentile). At times he keeps his head held back. HEENT: The patient has a slightly dysmorphic appearance. He has squared off teeth that are widely spaced. Heart: Regular sinus rhythm. Lungs: Clear. Abdomen: No organomegaly. Extremities: No cyanosis or clubbing. Cranial nerves: The patient has an "A-pattern" esotropia. He tracks by using horizontal saccadic movements and prefers to follow an object by moving his head. To doll's maneuver, one is able to obtain full horizontal extraocular movements. The patient does have slight limitation of upgaze with greater downgaze capabilities. He is able to converge, has normal quick phases, and adequate gaze holding. He has slight ptosis bilaterally. There was no alteration of facial sensation. Corneal reflexes were present. The patient does have slightly decreased spontaneous facial movements. Hearing is grossly intact. Palate is midline. Gag is present. Tongue shows no fasciculations or atrophy. Sensation: grossly intact to touch and pin. Motor: Thin extremities, good strength. The patient has a wide based gait and walks with arms held in an extended upward fashion. In addition to being wide based, he also has some slight circumduction of the right lower extremity as well as a steppage-like component. He is flat footed. Genu recurvatum is present in the standing position. Passive movement shows hypotonia in both upper and lower extremities though there is variability during the exam, especially in the lower extremities. He has dysmetria bilaterally. He sits fairly steadily though with occasional periods of slight titubation. Reflexes were 2-3 in the lower extremities, 2+ in the upper extremities; no crossed adductors. Toes were equivocal though tending to be extensor. There were no frontal release signs. The patient's MRI scan was reviewed with neuroradiology and shows definite evidence of vermal aplasia, a thin corpus callosum and delayed myelination. ASSESSMENTS: This is a 4-year-old with a static encephalopathy [any degenerative disease of the brain] associated with cognitive and motor delays. Examination shows evidence for cerebellar, cranial nerve pathway, and long tract findings. Based upon his history, examination and MRI, I strongly favor a developmental brain disorder as the etiology of this patient's difficulties. As described, his MRI shows partial agenesis of the cerebellar vermis and posterior lobe, a thin corpus callosum, and delayed myelination. A partial or complete defect of the cerebellar vermis may occur sporatically or as a component of the Dandy Walker syndrome, the Dandy Walker varient, or Joubert syndrome. Joubert syndrome is an autosomal recessive inherited condition characterized by retinal dystrophy, oculomotor abnormalities, episodic hyperpnea, ataxia and mental retardation (Lewis et al Am J Med Gen 52: 419, 1994). Austin has a history of breath holding but lacks periods of hyperpnea which alternate with episodes of apnea. Most infants with this syndrome are hypotonic, reflexes can be exaggerated and virtually all are retarded. Adamsbaum et al have described vermal agenesis without a posterior fossa cyst or hemispheric abnormalities with clinical signs of oculomotor dysfunction and developmental delay (Ped Radiol 24: 543, 1994). No specific treatment is available for developmental disorders and ongoing rehabilitative services should be vigorously pursued. I have arranged for Austin to be evaluated in pediatric genetics by Dr. Michael Garrity. . . . Tyler was seen in consultation on September 6, 1996, by Dr. Garrity, who reported the results of his analysis as follows: . . . Of note, Austin has been seen in Miami Children's Hospital by neurology, ophthalmology, genetics, and has had an extensive work-up in the past. His work-up has not found a cause for his problems. His work-up included a chromosome analysis which was normal, a FISH analysis for the Angelman/Prader-Willi locus. This was also negative. He has had normal very long chain fatty acids, normal alpha-fetoprotein, normal plasma amino acids, normal urine organic acids, the latter showed some minor abnormalities, increased pyruvate acid, glutonic acid, and sebacic acid, this does not suggest any diagnostic patterns to me. He has had DNA analysis for Fragile X which was also normal. * * * My overall impression was that Austin had developmental delay, an abnormal neurological examination. By report an MRI of the brain showed a decreased cerebellum, however there was nothing in my examination to suggest a cause for this problem. In view of the minor abnormalities found previously in his urine organic acids, I repeated urine organic acids which were normal. Repeat plasma amino acids were also normal. Blood was taken for analysis of possible carbohydrate deficient glycoprotein syndrome. I am unable to find a record of this sample, and advise it be repeated. At the present time I do not have a specific diagnosis to explain Austin's problems. Ms. Durand had many questions about the cause of Austin's problems, and I indicated to her that there were many causes of cerebellar hypoplasia [incomplete development] including chromosome abnormalities, environmental and infectious exposures during pregnancy, some biochemical disorders, and also some specific genetic developmental syndromes. I indicated that Austin did not really fit any of these at present, and that without a specific diagnosis, it was difficult to give an exact recurrence risk. The dispute regarding compensability Pertinent to this case, coverage is afforded under the Plan when the claimant demonstrates, more likely than not, that the infant suffered an "injury to the brain . . . caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate post- delivery period in a hospital, which renders the infant permanently and substantially mentally and physically impaired." Sections 766.302(2) and 766.309(1)(a), Florida Statutes. Here, there is no dispute that Tyler suffered an anomaly in brain development that has resulted in permanent and substantial mental and physical impairment. What is subject to dispute or, stated differently, at issue, is the cause and timing (genesis) of Tyler's brain anomaly or, pertinent to these proceedings, whether the proof demonstrates, more likely than not, that his neurologic impairment resulted from an "injury to the brain . . . caused by oxygen deprivation or mechanical injury, occurring in the course of labor, delivery, or resuscitation in the immediate post-delivery period," as opposed to some other genesis. With regard to such issue, Petitioner is of the view that Tyler's neurologic impairment is related to some event which occurred during the birth process. In contrast, Respondent is of the view that the proof is not consistent with brain injury having occurred during or immediately following birth and must, therefore, be attributable to another etiology (i.e., prenatal injury or a developmentally-based disorder). Respondent's view of the proof has merit. The genesis of Tyler's impairment To address the genesis of Tyler's neurologic impairment, the parties offered selected medical records and other documents relating to Ms. Durand's antepartum and intrapartum course, as well as Tyler's birth and subsequent development. Portions of those records have been addressed supra, and further portions will be discussed infra. Apart from such documents, Ms. Durand offered her lay observations, and Respondent offered the deposition testimony of Charles Kalstone, M.D., a physician board-certified in obstetrics. The medical records and other competent proof have been carefully considered. So considered, it must be concluded that the proof fails to demonstrate, more likely than not, that Tyler's neurologic impairment resulted from an injury to the brain caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate post-delivery period. In so concluding, it is observed that not one of Tyler's treating physicians attributed the genesis of his impairment to any event which may have occurred during the course of labor, delivery, or resuscitation. Rather, to the extent any of his physicians expressed an opinion as to etiology, they favored a developmentally-based brain disorder as the cause of Tyler's presentation. The clinical evidence also fails to support the conclusion that Tyler's neurologic impairment resulted from an injury to the brain which occurred during the course of birth.4 In this regard, it is observed that the fetal heart rate was monitored by internal heart monitor until approximately 30 minutes before delivery, and detected no evidence of fetal hypoxia or trauma (whether by umbilical cord compression or otherwise), and Tyler's presentation at birth (with normal Apgar scores, suggesting a vigorous infant) and neonatal course (without evidence of injury or neurologic abnormality) were not consistent with an acutely acquired neurologic injury, and it is improbable that he could have experienced an acute injury during labor and delivery, or immediately thereafter, without evidencing any clinical symptoms of such damage. Conversely, the existence of a prenatally acquired, developmentally-based brain disorder would be consistent with Tyler's presentation at birth and subsequent development.
The Issue Did Respondent's failure to intervene in the post-operative period immediately after learning the CT scan results of Patient C.O. near midnight on April 12, 1997, constitute treatment that fell below the standard of care and that he failed to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances, in violation of Section 458.331(1)(t), Florida Statutes?
Findings Of Fact Petitioner is the state agency charged with regulating the practice of medicine in Florida. Respondent is a licensed physician in the State of Florida at all times material to the times alleged in the Complaint, having been issued license number ME 0070668. Respondent, as of May 2001, is board-certified in the area of neurological surgery. On April 3, 1997, Patient C.O., a 50-year-old male, presented to an Otolaryngologist (ear, nose and throat surgeon) with complaints of right side nasal polyps. On April 7, 1997, Patient C.O.'s surgeon ordered a radiological consult and a Coronal CT (up, down, front and back) scan of the right maxillary sinus. The CT scan revealed "complete opacification (blockage) of the left frontal, right ethmoid, right maxillary sinus, as well as the right nasal cavity with complete opacification of right sphenoid sinus." On April 9, 1997, Patient C.O. underwent a surgical procedure to remove nasal polyps. The surgeon removed an extremely large right nasal polyp, measuring approximately 10 cm in length. After removing the large mass, the surgeon noted smaller polyps and removed these also. After removing the polyps, the surgeon noted a "large pulsatile mass," which he biopsied. Biopsy results indicated that the "mass" was brain tissue. During the course of this procedure, the patient's cribriform plate had been pierced. This plate forms a barrier between the nasal cavity and the base of the brain. As a result of this puncture, the surgeon had removed a portion of Patient C.O.'s brain. The surgeon requested an intraoperative consult with Respondent. The surgeon and Respondent talked by telephone and Respondent recommended sealing off the brain tissue with a surgical flap and packing. An arteriogram was performed on Patient C.O. to determine if bleeding was from an artery or vein. It was determined that the bleeding was from a vein. He also, recommended placing Patient C.O. in the neurological intensive care unit, which was done, and the patient was stabilized. A CT scan, ordered by the surgeon, noted a right frontal hemorrhage and pneumoncephalus (air at the top of the skull). On April 10, 1997, drainage was noted from the right nostril of Patient C.O. Respondent noted that drainage was suspicious for cerebrospinal fluid (CSF). Respondent then considered various options in order to stop the leakage of CSF. On April 10, 1997, Respondent performed a surgical procedure which placed a spinal drain in Patient C.O. to control the intracranial pressure and to permit an outlet for the CSF. Respondent was attempting to allow the rupture to the cribriform plate to heal on its own. On April 11, 1997, a CT scan revealed large areas of air in the frontal areas of the skull. On April 12, 1997, it was determined that the rupture of the cribriform plate had not healed on its own. Patient C.O. had persistent drainage from the right nostril. He was taken to the operating room for a direct intracranial surgical repair of the defect. A CT scan demonstrated an increase in the frontal hemorrhage, a large left subdural hematoma, and brain swelling. On the afternoon of April 12, 1997, Respondent performed a bi- frontal craniotomy on Patient C.O. to close off the leaking of spinal fluid from the brain in the area behind the patient's forehead (CSF leak). The surgery began at 12:15 p.m. and anesthesia was initiated at approximately 12:30 p.m. on April 12, 1997, and surgery concluded at about 5:00 p.m. The procedure involved making an incision across the top of the scalp, from ear to ear, gaining access to the brain by making incisions in the cranium, then lifting the brain to allow access to the cribriform plate. This was accomplished without incident. During the post-operative period, the anticipated reaction of the patient was to return to post-operative status, or to improve neurologically beginning within two hours after the surgery ended. During the course of post-operative care, Patient C.O.'s vital signs and neurological statistics were constantly monitored. Patient C.O. did not show any improvements several hours after surgery as would be expected, but began to show signs of neurological deterioration. Because Patient C.O. did not improve neurologically after the surgery, Respondent, at about 9:30 p.m. on April 12, 1997, ordered a CT scan to be done immediately. Patient C.O. was taken for his CT scan around 10:45 p.m. The CT scan report by radiologist at Florida Hospital was called in to the hospital unit at 11:50 p.m. on April 12, 1997. Respondent was at home in bed, sleeping, when he was paged. Respondent called in and was told by telephone of the "wet read" results of the CT scan by the neuroradiologist. After obtaining the CT scan report, Respondent disagreed with the neuroradiologist's recommendations, ordered the continuation of the interventions which he had previously ordered, and issued no new medical orders. The April 12, 1997, CT scan results were reduced to writing and showed the following findings, when compared to the CT scan taken of Patient C.O., on April 11, 1997: Noncontrast examination shows numerous abnormal findings. Compared to the 04/11/97 study acute left subdural hemorrhage is similar. There is a large intraparenchymal frontal hemorrhage that has a similar appearance . . . . DIFFUSE INTRACEREBRAL SWELLING PROBABLY WORSE IN THE POSTERIOR FOSSA. OBLITERATED FOURTH VENTRICLE. VENTRICLE SIZE SIMILAR. INCREASED BLOOD FRONTAL REGION. UNCHANGED SUBDURAL LEFT POSTERIOR PAREITAL REGION. VENTRICULAR SIZE STABLE. PNEUMOCEPHALUS UNCHANGED. INTRAVENTRICULAR BLOOD STABLE. At 5:15 a.m. on April 13, 1997, Patient C.O.'s neurological status took a significant turn for the worse. The patient was interbated, and all appropriate measures were taken to attempt to revive the patient. Patient C.O. lapsed into coma and was unable to breathe sufficiently for himself; he sustained respiratory failure and coma. In the early morning hours of April 13, 1997, Patient C.O's neurological status was discussed with his family, and the decision was made to execute a do-not- resuscitate order. The patient never recovered and died two days later on April 15, 1997. Petitioner alleges that the standard of care required Respondent to take some affirmative or new action to intervene post-operatively on the night of April 12 through 13, 1997, to determine the cause of the deterioration and prevent irreversible brain damage. In support of Petitioner's position with regard to Respondent's standard of care, it presented the testimony of Dean C. Lohse, M.D. Dr. Lohse is a board-certified neurosurgeon who is licensed to practice medicine in the State of Florida. Dr. Lohse is a similar health care provider to Respondent, and he qualifies as an expert witness under Florida law. Dr. Lohse testified that he had several criticisms of the manner in which Respondent managed Patient C.O.'s post-operative care. Dr. Lohse was critical of the manner in which Respondent reacted to the information which was provided to him regarding the CT scan which was taken on the night of April 12, 1997, and which was communicated to Respondent at approximately midnight on that same night. In response to this information, Dr. Lohse was of the opinion that Respondent should have initiated some new intervention, including returning Patient C.O. to surgery, initiating medications to reduce swelling, introducing a pressure monitor, or changing the position of the lumbar drain. However, during the course of cross-examination, Dr. Lohse conceded that he could not say whether a return to surgery would have resulted in a different outcome for Patient C.O. Likewise, he could not state to within a reasonable degree of medical probability whether the introduction of medications to reduce the swelling would have worked. He could not state within a reasonable degree of medical probability whether the placement of a pressure monitor would have created a different result. Finally, he conceded that the issue of changing the lumbar drain was best left to the clinical judgment of the physician who is presiding over the care of the patient. Respondent testified on his own behalf at the final hearing. Respondent explained the April 12, 1997, craniotomy which he performed. He also explained the course of treatment which was followed with Patient C.O. in the hours subsequent to the conclusion of the craniotomy. Respondent explained his rationale behind ordering a stat CT scan, and he described the basis for his response to the information received at that time. Respondent testified that although he considered a return to surgery based upon the information contained within the CT scan, he decided against this option, as performing another surgery would only have been for the purpose of removing additional portions of Patient C.O.'s brain, including areas of the brain which are designed to control significant elements of an individual's personality. Respondent made the determination at that time that performing another surgical procedure would likely have caused more harm than good. Respondent testified that brain swelling reducing medication had been introduced previously and that the introduction of more or different brain swelling-reducing medications would not have addressed Patient C.O.'s condition. Respondent testified that the placement of a pressure monitor would have been pointless, given the information which he was able to obtain during the course of the craniotomy procedure. A pressure monitor is designed to measure increased levels of pressure on the brain. Patient C.O. was suffering from the opposite problem. Patient C.O.'s brain was actually flaccid, suffering from an absence, rather than an overabundance, of pressure. Therefore, the placement of a pressure monitor was never considered, as it would not have been of any use under the circumstances. Respondent testified that there was no need to change the aspect of the lumbar spinal drain. The lumbar spinal drain in this particular case was adequately controlled, at 5 ccs per hour. Thus, the use of the spinal drain was appropriate under the circumstances. Respondent's testimony is credible. Respondent also presented expert testimony, via deposition, of R. Patrick Jacob, M.D. Dr. Jacob is a board- certified neurosurgeon who currently works at the University of Florida in Gainesville. Dr. Jacob testified as to his education, training, and experience. He is a similar health care provider to Respondent, qualifies as an expert under Florida law, and can render expert medical opinions regarding the applicable standard of care in this case. Dr. Jacob testified that in his opinion, to within a reasonable degree of medical probability, Respondent met the applicable standard of care. He addressed each of the specific criticisms raised by Dr. Lohse. He specifically rejected the idea that another surgical procedure should have been performed, stating that to do so would have done more harm than good. He rejected Dr. Lohse's contention that the introduction of additional medications to reduce swelling would have been appropriate. Dr. Jacob disagreed with Dr. Lohse's suggestion that the placement of a pressure monitor would have been appropriate under the circumstances of this case. Finally, Dr. Jacob took issue with Dr. Lohse's opinion that a change in the lumbar spinal drain was warranted given Patient C.O.'s condition. On cross-examination, Dr. Jacob testified that he felt that Respondent's response to the information contained within the April 12, 1997, CT scan was appropriate. He was then presented with hypothetical questioning regarding whether doing nothing in response to the information contained within the CT scan would have been appropriate. Dr. Jacob testified that doing nothing in response to the information contained within the CT scan report may have constituted a deviation from the accepted standard of care. However, according to Dr. Jacob's review of the records, and Respondent's testimony at the final hearing, it is apparent that a decision was made by Respondent to continue with the interventions which had already been initiated, which under the circumstances of this case constitutes an affirmative act by Respondent to address the treatment and care of Patient C.O. Dr. Jacob's testimony is both credible and persuasive. The evidence is not clear and convincing that Respondent failed to intervene in the post-operative period immediately after learning the CT scan results of Patient C.O. around midnight on April 12, 1997. Respondent did not fail to take appropriate action after learning the results of the CT scan at midnight on April 12, 1997. Respondent ruled out several options and elected to continue with the interventions already initiated. Therefore, Respondent did not fall below the standard of care for similarly situated neurosurgeons and his actions on April 12 through 13, 1997, did not constitute a failure to practice medicine with that level of skill, care, and treatment recognized by a reasonably prudent similar neurosurgeon as being acceptable under similar conditions and circumstances.
Recommendation Based on the foregoing, it is RECOMMENDED that the Board of Medicine issue a final order finding that Respondent has not violated Section 458.331(1)(t), Florida Statutes, and dismissing the Administrative Complaint. DONE AND ENTERED this 19th day of July, 2002, in Tallahassee, Leon County, Florida. DANIEL M. KILBRIDE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 19th day of July, 2002. COPIES FURNISHED: Michael R. D'Lugo, Esquire Wicker, Smith, O'Hara, McCoy, Graham & Ford, P.A. Post Office Box 2753 Orlando, Florida 32802-2753 Shirley J. Whitsitt, Esquire Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 39-A Tallahassee, Florida 32308 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
Findings Of Fact Zacari was born on April 2, 2011, at Plantation General Hospital located in Plantation, Florida. Zacari weighed eight pounds two ounces at birth. NICA retained Donald Willis, M.D., as it medical expert specializing in maternal-fetal medicine. In an affidavit dated September 6, 2013, Dr. Willis opined as follows: It is my opinion that labor was indicated at 39 weeks with no fetal distress during labor. Spontaneous vaginal birth resulted in a healthy baby with Apgar scores of 9/9. The newborn hospital course was uneventful. As such, it is my opinion that there was no apparent obstetrical event that resulted in loss of oxygen or mechanical trauma to the baby’s brain during labor, delivery or the immediate post delivery period. Further, in that there was no oxygen deprivation or mechanical injury occurring in the course of labor, delivery or resuscitation in the immediately post- delivery period in the Hospital, then accordingly, there was no causal event which would have rendered Zacari Porter permanently and substantially mentally and physically impaired as a result of same. NICA retained Michael S. Duchowny, M.D., as its medical expert in pediatric neurology. Dr. Duchowny examined Zacari on July 17, 2013, and reviewed his medical records. In an affidavit dated September 4, 2013, Dr. Duchowny opined as follows: It is my opinion that, in summary, Zacari’s neurological examination is significant only for expressive language delay. In contrast, he has well-developed motor abilities, both gross and fine motor skills and has no focal or lateralizing findings. I had an opportunity to review medical records that were sent on June 27, 2013. The records document a relatively uncomplicated perinatal and postnatal course without evidence of either mechanical injury or oxygen deprivation to the brain or spinal cord. The record review together with today’s neurological exam reveals developmentally appropriate motor function and only a mild expressive language delay which suggest that Zacari does not have either a substantial mental or physical impairment. I therefore believe that Zacari should not be considered for inclusion within the NICA program. As such, it is my opinion that Zacari is not permanently and substantially mentally impaired nor is he permanently and substantially physically impaired due to oxygen deprivation or mechanical injury occurring during the course of labor, delivery or the immediate post-delivery period in the hospital during the birth of Zacari Porter. A review of the file does not show any opinion contrary to the opinions of Dr. Willis and Dr. Duchowny that Zacari does not have a substantial and permanent mental and physical impairment due to lack of oxygen or mechanical trauma during labor, delivery, or the immediate post-delivery period are credited.
