The Issue The issue is whether Respondent failed to practice medicine at the level of care, skill, and treatment that is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances and, if not, the penalty.
Findings Of Fact Respondent is a licensed physician, holding license number ME 0026784. He is Board-certified in radiology. On January 30, 1997, T. D., a 30-year-old female who was eight months pregnant, presented to the emergency room of the Columbia Largo Medical Center complaining of pain in the left flank radiating to the left groin, together with nausea and vomiting. She also reported a prior history of kidney stones. A urologist diagnosed T. D. as suffering from kidney stones and severe hydronephrosis, which is the dilation of the kidney due to an obstruction in the flow of urine. The urologist was unable to pass a stent and catheter by the stones to drain the urine and relieve the pressure on the kidney, so he asked Respondent to perform a left percutaneous nephrostomy. A percutaneous nephrostomy is a procedure in which a physician places a tube through the skin and into the collecting system of the kidney to drain the kidney. The tube remains in place until the obstruction is removed. On February 1, Respondent performed a left percutaneous nephrostomy under local anaesthesia. For guidance in placing the tube, Respondent used ultrasound, rather than ultrasound and a flouroscopy. Respondent has performed 100-150 nephrostomies. As is the common practice, he normally does not rely exclusively ultrasound in guiding the placement of the tube in the kidney. In this case, the urologist asked that he not use a flouroscopy, in deference to the patient's pregnancy and the duration of x-ray exposure in a flouroscopy. Respondent was comfortable doing the procedure in this manner, although he decided that, if he encountered any problems in placement, he would resort to flouroscopy. Respondent proceeded to perform the percutaneous nephrostomy in the morning. As is typical, the radiology technician helped position T. D. on the table for the procedure. T. D.'s advanced pregnancy necessitated a slight adjustment to the normal posture of patients being prepared for this procedure, so T. D. lay slightly more up on her side than is usual. However, this did not change the point of entry chosen by Respondent. And, regardless of her precise position, the location of the spinal canal relative to the kidney relative to the point of entry into the skin remains constant: an imaginary line from the kidney to the spinal canal is perpendicular to an imaginary line from the point of entry to the kidney. The point of entry is on the lower back of the patient. T. D. is thin and her pregnancy did not manifest itself on her back, so the length of tube used by Respondent was relatively short. T. D.'s thin build makes it less likely that Respondent would have placed sufficient excess tube into the patient so as to permit the tube to run from the kidney to the spinal cord. Upon placement of the tube, at least 100 cc of fluid drained through the tube. This is well within the range of urine that would be expected under the circumstances. The color was well within the range of color for urine. The preponderance of the evidence indicates that the fluid was urine and that Respondent had placed the tube correctly in the kidney. At the end of the procedure, T. D. appeared a lot more comfortable. Late in the afternoon, someone called Respondent and told him that the drainage had slowed to a very small amount or nothing at all. This is not uncommon, as moving the patient or over-energetic nurses may accidentally dislodge the stent in the kidney. It is also possible that the tube has rested in a part of the kidney that does not facilitate maximum drainage. Using ultrasound, Respondent confirmed that the tube remained in place in the kidney, although he could not tell whether the stent had come to rest in a narrow place in the kidney or possibly even against a stone. Even with this uncertainty, Respondent still was able to determine that the stent was predominantly in the collecting system. Because T. D. was resting comfortably, she said that she felt fine, her fever was going down, and the hydronephrosis had decreased, Respondent decided to do nothing until after re-examining T. D. the next morning. However, at about 11:00 p.m. or midnight, Respondent, who was visiting a nearby patient, dropped in on T. D. The nurse said that she was fine and her kidney was draining a little better. T. D. also said that she was feeling fine. About three or four hours later, T. D. reported a feeling of some paralysis. Petitioner's expert testified that this was linked to the misplacement of the stent in the spinal canal, but he was unaware that T. D. had undergone a spinal block for the percutaneous nephrostomy and that a problem with the first anaesthetic procedure had necessitated a second. It is more likely that T. D.'s paralysis was in response to the two spinal blocks. At 9:00 a.m. the next day, Respondent returned and examined T. D. He found that she was still doing better, and her urologist was preparing to discharge her from the hospital. She looked better, and her urine flow had improved. He told her to call him if she had any problems, but he never heard from her again or even about her until he learned from the urologist that T. D. had been admitted to another hospital where a radiologist had inserted contrast material into the tube to locate the stent and found it in the spinal canal. The father of the baby picked up T. D. at the Columbia Largo Medical Center. He picked her up out of the wheelchair and placed her in the car. Her condition deteriorated once she got home. A hospital nurse directed the father to change the collection bag, if it filled prior to the visit of the home health care nurse. In the three or four days that T. D. remained at home, he changed the bag several times. He daily checked the site at which the tube entered T. D.'s skin and noticed that it had pulled out a little bit. However, he testified that he did not try to adjust the length of tube inside T. D., nor did he change the setting on the tube, which had "open" and "closed" settings for the pigtail at the end of the tube. The proper setting was closed, as the pigtail is not to be open once the stent has reached its destination in the kidney. On February 5, the father took T. D. to the emergency room of the Columbia St. Petersburg Medical Center, where she presented with complaints of severe back pain. An ultrasound confirmed the presence of kidney stones, whose removal had been deferred until the delivery of the baby. In an effort to locate the end of the tube, a radiologist inserted radiographic contrast dye, which showed that the end of the tube was in the intrathecal space of the spine. A urologist removed the tube. However, T. D. suffered a seizure. Another physician attempted an emergency C-section, but the baby did not live. There are two alternatives to explain how the stent at the end of the tube found its way into the spinal canal. First, Respondent placed it there during the procedure. Second, it migrated from the kidney, where Respondent placed it, to the spinal canal. If not unprecedented, both alternatives are extremely rare. The drainage during the procedure and initial improvement of the distended kidney are consistent with the proper initial placement of the stent. The difficulty of inadvertently turning a relatively short length of tube 90 degrees from the kidney to the spinal canal also militates against a finding that Respondent misinserted the tube. Problems with the first spinal tap may have contributed to some of the complaints, such as paralysis, that T. D. experienced after the procedure. Although unlikely, the migration alternative would be consistent with well-intended, but incorrect, attempts by the baby's father or a home health care nurse to ensure that the tube did not travel too far in or our of the point of entry. Migration would be facilitated if either the father or nurse misread the "open" and "closed" settings and turned to "open," in the hope of improving drainage, when such a setting opens the pigtail, which would increase the possibility that the stent could migrate into the spinal canal. In a case requiring proof that is clear and convincing, it is impossible to find that Petitioner has adequately proved that Respondent misinserted the tube during the procedure. Likewise, the evidence is not clear and convincing that Respondent should have recognized at anytime prior to T. D.'s discharge from the Columbia Largo Medical Center that something was wrong with the procedure that he had performed or that he needed to confirm by x-ray the location of the stent at the end of the tube.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order dismissing the Administrative Complaint. DONE AND ENTERED this 2nd day of August, 1999, in Tallahassee, Leon County, Florida. ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 2nd day of August, 1999. COPIES FURNISHED: Britt Thomas, Senior Attorney Agency for Health Care Administration Fort Knox Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308 William B. Taylor, IV Macfarlane, Ferguson & McMullen Post Office Box 1531 Tampa, Florida 33601-1531 Angela T. Hall, Agency Clerk Department of Health Bin A02 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701 Pete Peterson, General Counsel Department of Health Bin A02 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0750
The Issue The ultimate issues in this case are whether Respondent violated Section 458.331(1)(m) and (t), Florida Statutes (1997), respectively, by failing to keep medical records that justify the course of treatment and by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances; and, if so, what penalty, if any, should be imposed against Respondent's license to practice medicine. (All chapter and section references are to Florida Statutes (1997) unless otherwise stated.)
Findings Of Fact Petitioner is the state agency responsible for regulating the practice of medicine in Florida pursuant to Sections 20.165 and 20.43 and Chapters 455 and 458. Respondent is licensed as a medical physician in Florida pursuant to license number ME0050478. Respondent has been a Board-certified plastic surgeon at all times material to this proceeding. The Administrative Complaint involves one patient who undertook elective plastic surgery. The record identifies the patient as E.O. in order to preserve the patient's confidentiality. In summary, the Administrative Complaint alleges that Respondent departed from the acceptable standard of care by: failing to perform the surgical procedure elected by E.O.; performing a surgical procedure other than the procedure E.O. authorized; failing to document a reason for changing the procedure; failing to advise the patient of the risks associated with the procedure performed; performing breast augmentation with implants that were too large; and failing to document a reason for using the larger implants. On December 31, 1997, E.O. presented to Respondent for consultation regarding reconstruction of her left breast. At the time, E.O. was approximately 48 years old. E.O.'s medical history included an abdominal hysterectomy, a biopsy of the right breast, two biopsies of the left breast, and a diagnosis of cancer in the left breast. A partial mastectomy of the left breast and radiation therapy resulted in significant scarring. The left breast had a concave, depressed area in the left side. The depressed area extended from the upper part of the breast, near the outer pectoral muscle, halfway to the nipple. The nipple on the left breast was pulled to the outside toward the depressed area. E.O. also suffered ptosis, i.e., the appearance of drooping, that was not related to her medical history. The radiation therapy to the left breast had caused a burn injury that left internal scar tissue. The scar tissue was not pliable and was not suitable for manipulation during plastic surgery. During E.O.'s initial visit with Respondent on December 31, 1997, Respondent noted E.O.'s prior medical history and radiation treatment. He noted the bilateral ptosis and the left breast deformity. Respondent recommended bilateral implants for the purposes of reconstructing the left breast and for achieving symmetry between the breasts. Respondent and E.O. did not agree on a plan of treatment during the initial visit but did agree to a second visit. On January 16, 1998, E.O. presented to Respondent for her second visit. After further consideration of E.O's case, Respondent made a specific recommendation of bilateral augmentation with prostheses, in the form of implants, and a latissimus dorsi flap (LDF) procedure to correct the depression in the left breast. An LDF procedure would have resected, or removed, the scarring in the left breast and would have replaced the resulting divot with healthy tissue. Respondent would have obtained healthy tissue by moving a flap of tissue and muscle from the patient's back underneath the patient's outer tissue layers and placing the flap internally in the left breast. E.O. agreed with Respondent's recommendation. E.O. agreed to the bilateral augmentation because Respondent advised her that an implant in her right breast was necessary to achieve appropriate symmetry. E.O. did not agree to the augmentation because she wanted larger breasts. Respondent assured E.O. that her breast size would increase only about one-half cup. Respondent's records do not include a reference to the size of the implants to be used. Respondent indicated he would seek preauthorization from the insurer for the LDF procedure with prosetheses. The LDF procedure required E.O. to stay overnight in the hospital following surgery. Surgery that omitted the LDF procedure could have been performed in "same-day" surgery. Respondent and E.O. did not discuss or agree upon any plan of treatment. On January 21, 1998, E.O. presented to Respondent for a third time. E.O.'s husband, L.O., was also present. Respondent discussed the LDF procedure with E.O. and L.O. Respondent stated that he believed the LDF procedure was necessary to fill-in the left breast after Respondent resected the radiated tissue as part of the reconstruction of E.O.'s left breast. Respondent, E.O., and L.O. did not discuss other treatment options. On January 21, 1998, Respondent requested authorization from E.O.'s insuror for breast reconstruction surgery that included an LDF procedure with the use of a prosthetic implant. On February 12, 1998, E.O. presented to Respondent for a fourth time. E.O. had additional questions about the surgery that included questions regarding the insurance coverage for the surgery. E.O. and Respondent did not discuss the LDF procedure or other treatment options. Respondent scheduled the surgery for February 26, 1998, at the Columbia Regional Medical Center Southwest Hospital ("Columbia" or the "hospital"). On February 24, 1998, E.O. presented to Columbia for a preoperative workup. At the preoperative workup, E.O. executed a written informed consent document that authorized Respondent to perform a, "Lat Flap with implant left Breast and Right endoscope augmentation." Respondent also signed the informed consent. E.O. did not consent to another procedure different from that stated in the informed consent. Nor did E.O. and Respondent agree upon a different procedure. Hospital records, including the Short-Stay History and Physical completed on the day of surgery and signed by Respondent, show that the procedure to be performed was an LDF procedure with implants. The hospital records are devoid of any indication that E.O. did not wish to undergo the LDF procedure or that E.O. expressed any reservations about the procedure. On the morning of February 26, 1998, E.O. fully expected to undergo the LDF procedure. E.O. presented to Columbia anticipating an overnight hospitalization that was consistent with an LDF procedure. E.O. brought with her the personal belongings she would need for an overnight hospitalization. The applicable standard of medical care required Respondent to perform the LDF procedure so long as it was medically reasonable to do so. On February 26, 1998, Respondent performed surgery on E.O. that included an implant in each breast. However, Respondent did not perform the LDF procedure. Rather, Respondent created breast flaps by incising existing scar tissue and utilizing the incised scar tissue to fill in the depression in the left breast. Respondent did not resect the scar tissue and replace it with healthy tissue. Immediately after the surgery, Respondent advised L.O., without explanation, that Respondent did not perform the LDF procedure and that E.O. was doing well. Columbia discharged E.O. on the same day of surgery. During the trip home in their car, L.O. advised E.O. that Respondent did not perform the LDF procedure. E.O. was surprised but groggy from medication. No medical reason prevented Respondent from performing the LDF procedure. Respondent encountered no difficulties or complications during surgery that precluded the LDF procedure. Moreover, there were medical reasons not to incise the scar tissue and use it to fill in the depression in the left breast. Irradiated scar tissue is not well vascularized, is not pliable, and is not easy to manipulate. The only reason that Respondent offered for failing to perform the LDF procedure was that E.O. expressed concern over the procedure. Respondent testified that E.O. expressed her concern to Respondent when Respondent was in the holding area marking E.O.'s breasts for surgery. The holding area is an area that is physically separate from the operating room. E.O. did not expressly ask Respondent not to perform the LDF procedure. Rather, Respondent inferred that E.O. did not want him to perform the LDF procedure. As Respondent testified during cross examination: Q. And you had a conversation with her wherein she expressed some concern about the latissimus dorsi flap procedure; is that correct? A. The tenor of her conversation indicated some concern. She did not say to me please don't do it, but the tenor of her conversation was that there was concern when I was marking her for it. Transcript (TR) at 624. Respondent claims that the conversation with E.O. occurred when Respondent was in the holding area marking E.O. for surgery. Respondent's testimony during cross examination is illustrative. Q. And your testimony is that, is the holding area an area different than the actual operating room. A. Yes. * * * Q. I would like for you to look to the first line of this operative report, under procedures. It says the patient was brought to the operating room, and marked in the sitting position, then laid supine. A. Yes. Q. Doesn't that note say that you did not mark this patient in the holding area, but you marked her in the operating room? A. It sure does. And are you telling me today that this is in error? A. That is absolutely in error. I have never marked a patient in the operating room. TR at 625. Respondent's claim that he had a conversation with E.O. in the holding area before surgery is refuted by E.O. The testimony of E.O. concerning this factual issue is credible and persuasive. The testimony of E.O. is consistent with the operative report stating that E.O. was marked in the operating room rather than in the holding area. Respondent did not see E.O. in the holding area prior to surgery and did not have a conversation with E.O. in which E.O. expressed some concern over the LDF procedure. E.O. received preoperative medication in the holding area and was not capable of carrying on a conversation with Respondent in the operating room and was not capable of making an informed consent to a different procedure. If it were determined that Respondent had a conversation with E.O. in the holding area while marking her for surgery, there was ample time to amend the informed consent document to reflect a different treatment plan agreed to by E.O. and Respondent. The actual surgery performed by Respondent was a procedure that was different from the LDF procedure authorized by E.O. The actual surgical procedure performed by Respondent was not a lesser included procedure of the LDF procedure. The applicable standard of care would have required Respondent to amend the informed consent document under the facts and circumstances testified to by Respondent. An informed consent should include all anticipated treatment options. The informed consent signed by E.O. and Respondent did not include any options to the LDF procedure. Even if it were determined that the actual procedure performed is a lesser included procedure of the LDF procedure, E.O. did not consent to the lesser included procedure. The performance of a lesser included procedure for which E.O. was not informed and to which E.O. did not consent departs from the applicable standard of care. The procedure performed by Respondent during surgery increased the risk of failure and the need for subsequent surgery by using scar tissue rather than resecting the scar tissue and using healthy tissue to fill in the left breast. Respondent failed to inform E.O. of the increased risk of the procedure actually utilized by Respondent. Respondent failed to practice medicine with the level of care, skill, and treatment recognized by a reasonably prudent similar physician as acceptable under similar conditions and circumstances. First, Respondent failed to perform the procedure that E.O. authorized. Second, Respondent performed a procedure that placed implants in E.O.'s irradiated left breast without resecting the irradiated scar tissue. Third, Respondent failed to inform E.O. of the increased risk associated with the procedure Respondent utilized during surgery. Finally, Respondent failed to document in the records a reason or rationale for performing a surgical procedure other than the LDF procedure authorized by the patient. Prior to surgery, Respondent agreed to use the smallest implants possible. During surgery, Respondent placed very large implants in E.O.'s breasts. Respondent used a 480 cc implant in the left breast and a 460 cc implant in the right breast. Respondent used the large implant in the left breast, rather than the LDF, in an attempt to stretch the tissue, including the scar tissue, and to fill in the depression in the left breast. Respondent used the large implant in the right breast for symmetry. E.O. did not consent to the use of large implants in either breast. Rather, E.O. authorized the smallest implants possible. Respondent utilized implants that increased E.O.'s cup size from a small C cup to a DD cup. The weight and volume of the large implants stretched E.O.'s skin and exacerbated her ptosis. After surgery, E.O.'s clothes did not fit. A DD cup size was sometimes too small. An accepted method of determining the effect of implants is to sit the patient up on the operating table prior to completing surgery. Respondent did not sit E.O. up on the operating table to view the effect of the implants. Respondent had a complete range of implant types and sizes available for use during surgery. Respondent failed to practice medicine with the level of care, skill, and treatment recognized by a reasonably prudent similar physician as acceptable under similar conditions and circumstances. Respondent utilized implants that were not authorized by E.O. by placing overly large implants in E.O.'s breasts. Respondent failed to utilize the implants authorized by E.O. by failing to use the smallest implants possible. Respondent failed to document in the records a reason or rationale for using implants other than those authorized by E.O. Respondent's failure to practice medicine in accordance with the applicable standard of care caused substantial harm to E.O. At the first postoperative visit on March 2, 1998, E.O. asked Respondent why he did not perform the LDF procedure. Respondent stated that he had determined that E.O. could do without the LDF procedure. E.O. also expressed concern over the large size of her breasts. Respondent explained that the large size was attributable to swelling and that it would take several months for the swelling to dissipate. Until that time, it was impossible to assess the final result. During subsequent visits on March 11 and 18 and on April 3, 1998, E.O. expressed concern over the size and appearance of her breasts. However, she continued to trust Respondent and to accept his assurances that she needed to be patient and allow the swelling to go down before forming any final opinions regarding the outcome of the surgery. During a visit on May 1, 1998, Respondent examined E.O. and acknowledged that the procedure actually performed on February 26, 1998, did not produce the desired result. The implant and incised scar tissue had not stretched and filled in the left breast. Respondent advised E.O. that she needed the LDF procedure. E.O. elected for Dr. Brueck to perform reconstruction surgery on her. However, problems with insurance coverage delayed the surgery until July 11, 2000. The surgery included bilateral reconstruction with bilateral implant and mastopexy. E.O.'s breast size was a B cup after surgery. E.O. was very pleased with the results of the surgery.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED, in accordance with the terms of Petitioner's PRO, that Petitioner enter a Final Order finding Respondent guilty of violating Section 458.331(1)(m) and (t); issuing a written reprimand; imposing a fine of $5,000; and requiring Respondent to complete, within one year, 20 hours of continuing professional education above and beyond that required to maintain licensure. DONE AND ENTERED this 18th day of March, 2002, in Tallahassee, Leon County, Florida. DANIEL MANRY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 18th day of March, 2002. COPIES FURNISHED: William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Britt Thomas, Esquire Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Carol A. Lanfi, Esquire 1000 Riverside Avenue, Suite 800 Jacksonville, Florida 32204 Albert Peacock, Esquire 8554 Congressional Drive Tallahassee, Florida 32312 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
The Issue Whether disciplinary action should be taken against Respondent's license to practice as a physician, license number ME 0060427, based on violations of Sections 458.331(1)(j) Florida Statutes, by exercising influence within a patient-physician relationship for purposes of engaging a patient in sexual activity and Section 458.331(1)(x), Florida Statutes, by violating any provision of this Chapter, in that he violated Section 458.329, Florida Statutes, and Rule 59R-9.008, Florida Administrative Code, by committing sexual misconduct in the practice of medicine.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that Respondent be found guilty of violating Sections 458.331(1)(j) and (x), Florida Statutes as to Patients T.S. and A.A. As discipline therefore, it is FURTHER RECOMMENDED: Respondent's license be suspended for a period of one year, commencing December 12, 1994, with his reinstatement upon demonstration that he can practice with skill and safety and upon such conditions as the Board of Medicine shall deem just and proper. Respondent pay an Administrative fine in the amount of $6,000.00. Respondent be placed on probation for a period of three years. DONE and ENTERED this 9th day of May, 1995, in Tallahassee, Florida. DANIEL M. KILBRIDE 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 9th day of May, 1995. APPENDIX The following constitutes my specific rulings, in accordance with section 120.59, Florida Statutes, on proposed findings of fact submitted by the parties. Proposed findings of fact submitted by Petitioner. Accepted in substance: paragraphs 1, 2, 3, 4, 5, 6, 8, 9 (in part), 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 29 (in part), 30, 3, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 49, 50, 51, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88. Rejected as subsumed or irrelevant and immaterial: paragraphs 7, 9 (in part), 17 (in part), 28, 29 (in part), 59, 61, 65. Rejected as not proven by clear and convincing evidence: paragraphs 52, 53, 54, 55, 56, 57, 58, 60, 62, 63, 64, 66, 67. Proposed findings of fact submitted by Respondent. Accepted in substance: paragraphs 1, 2, 3, 4, 5, 6, (in part), 7, 8, (in part), 9, 10 (in part), 12, 18 (in part), 19 (in part), 20 (in part), 21 (in part), 22 (in part) 27 (in part), 31, 44 (in part), 46 (in part), 47 (in part), 48 (in part), 49 (in part), 53 (in part), 57 (in part), 58 (in part). Rejected as subsumed or irrelevant and immaterial: paragraphs 6 (in part), 8 (in part), 10 (in part), 13, 15, 16, 18 (in part), 20 (in part), 21 (in part), 23, 24, 25, 26, 28, 29, 30 (in part), 34, 35, 36, 38, 39, 43, 44 (in part), 50, 55, 57 (in part), 58 (in part). Rejected as a restatement or commentary on the evidence: paragraphs 11, 14, 17, 22 (in part), 23, 27 (in part), 29, 30, 34, 35, 36, 37, 48, 40, 41, 42, 44 (in part), 45, 46 (in part), 47 (in part), 48 (in part), 49 (in part), 50, 51, 52, 53 (in part), 54, 55, 56. Rejected as not supported by the evidence: 19 (in part), 20 (in part), 32 and 33. COPIES FURNISHED: William Frederick Whitson, Esquire Senior Attorney Agency for Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0792 Lee Sims Kniskern, Esquire 2121 Ponce de Leon Blvd. Suite 630 Coral Gables, Florida 33134 Dr. Marm Harris Executive Director Department of Business and Professional Regulation 1940 North Monore Street Tallahassee, Florida 32399-0792 Tom Wallace Assistant Director Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303
The Issue Whether Petitioner, Jupiter Outpatient Surgery Center ("Petitioner"), is entitled to additional reimbursement from the carrier in the amount of $4,210.50 for Rotation Medical surgical implants pursuant to section 440.13, Florida Statutes (2017).
Findings Of Fact Petitioner is a Florida ambulatory surgical center ("ASC") with its principal office located at 2055 North Military Trail, Suite 100, Jupiter, Florida 33458. Lucia Alcira is Petitioner's business office manager. Petitioner is a health care provider as defined in section 440.13(1). Sedgwick Claims Management Services and Ace American Insurance Company are carriers as defined in section 440.13(1). On May 25, 2017, a representative of Rotation Medical, Inc. ("Rotation Medical"), arrived at Petitioner's surgical facility and delivered to Petitioner the Rotation Medical implants that are the subject of this dispute. The implants are described on a Rotation Medical acquisition form (inventory slip) (Dep't Composite Ex. 1, p. 13), provided by the manufacturer representative to Petitioner on the date of surgery. The form describes the Rotation Medical implants in pertinent part, as follows: Rotation Medical Implant Set REF 2516-1, $1,000.00 Rotation Medical Reconstituted Collagan Scaffold-Arthroscopic, Medium, REF 2169-2, $2,600[.] The acquisition form, which is not an invoice, identifies Dr. Ryan Simovitch as the physician, and a service date of May 25, 2017.1/ On May 25, 2017, a patient presented to Dr. Simovitch at Petitioner's facility for a right shoulder rotator cuff arthroscopic surgical repair. Dr. Simovitch performed the surgical repair of the patient's right shoulder on May 25, 2017. Dr. Simovitch's operative report reflects the insertion of "a single 5-5 Cayenne anchor double loaded" into the patient. In addition, an "additional 4.5 mm titanium tipped cayeene knot-less anchor" was utilized. The report further reflects that Dr. Simovitch subsequently "assembled the guide and nitinol wire for the Rotation Medical graft insert." (Emphasis added). According to Dr. Simovitch, "[w]e did this in order to augment the tendon because of the tendinopathy." Dr. Simovitch's report goes on to state, in pertinent part: We inserted the pin. We then inserted the gun device in order to deploy the graft. Passing through a 10x3 passport cannula, we deployed the graft. Once we held it, we it with soft tissue staples and accessory superior portal. Multiple soft tissues samples were placed stapling the graft back down to the supraspinatus tendon. Once that was completed, the lateral edge of the graft tensioned over the greater tuberosity and was secured with two PEEK anchors one anterior and one posterior into the bone. The graft showed good tension. We then debrided all soft tissue and bony debris in the subacromial space. We then closed the arthroscopic portals with 3-0 Monocryl inverted subcutaneous followed by Mastisol and Steri-Strips. A sterile compressive dressing was applied. The patient was awakened from anesthesia and transferred to PACU in stable condition. On June 9, 2017, Petitioner submitted its bill charges to the carrier for reimbursement for the Rotation Medical implants, Cayenne implants, disposable items, and services provided to the patient. However, Rotation Medical did not invoice Petitioner for the Rotation Medical implants until June 24, 2017. (Dep't Composite Ex. 1, p. 10). The invoice identifies the Rotation Medical implants by the same item numbers and prices as those in the acquisition form. The invoice required payment by Petitioner within 30 days. On July 5, 2017, the carrier initially denied payment to Petitioner for all of the items requested. On July 14, 2017, Petitioner filed the petition disputing the carrier's denial for reimbursement of the implants. Petitioner timely provided the Rotation Medical invoice and Cayenne implants invoices to the Department in response to a Notice of Deficiency, which the Department considered in making its Reimbursement Dispute Determination. The Department issued its Reimbursement Dispute Determination on August 1, 2017. Out of the total of $6,589.00 that was requested by Petitioner for reimbursement, the Department awarded Petitioner an additional $2,379.00 for the Cayenne implants. The Department awarded Petitioner this amount because it determined Petitioner had provided invoices showing it purchased the Cayenne implants and the operative report specifically referenced them. At hearing, Petitioner acknowledged it is not seeking reimbursement for the disposable items in the amount of $266.76. These disposable items are not reimbursable under the reimbursement manual because they were not on the same invoice as the implants. Consequently, the total amount Petitioner seeks to recover as reimbursement in this proceeding is $4,210.50, for the Rotation Medical implants.2/ The Department contends that reimbursement should be disallowed for the Rotation Medical implants because "there was no substantiation that documented the Rotation Medical implants were, in fact, used" during the surgery of the patient on May 25, 2017. In support of its position, the Department contends the operative report does not specifically note the use of bioinductive implants or an implant set. Although the operative report makes no specific mention of the phrases "bioinductive implants" or "implant set," no specific language in the operative report is required to allow for reimbursement. Page two of the report specifically notes the use of the "the Rotation Medical graft insert" during the surgery. On page one, the graft is specifically described as a "rotational medical allograft." Moreover, Petitioner's Implant Charge Sheet, prepared by a nurse in the operating room at the time of the patient's surgery, specifically identifies the use of the Rotation Medical Implant Set, Ref 2516-1, and Rotation Medical/Reconstituted Collagan Scaffold-Arthroscopic, Medium, Ref 2169-2, during the patient's surgery. (Dep't Composite Ex. 1, p. 6). The persuasive and credible evidence adduced at hearing demonstrates that the Rotation Medical implants were inserted into the patient's body during the May 25, 2017, surgery, with the intent to remain in the patient's body.3/ The Department also contends that reimbursement for the Rotation Medical implants should not be allowed because the billing was not done in accordance with the reimbursement manual. Specifically, the Department argues that the implants were not "purchased" before they were billed to the carrier because Petitioner did not pay for them before the items were billed to the carrier. Petitioner purchased the Rotation Medical implants prior to billing the carrier. In sum, the persuasive and credible evidence adduced at hearing demonstrates that Petitioner is entitled to additional reimbursement in the amount of $4,210.50 for the Rotation Medical surgical implants.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Financial Services, Division of Workers' Compensation, enter a final order granting Petitioner's request for additional reimbursement from the carrier in the amount of $4,210.50 for the Rotation Medical surgical implants pursuant to section 440.13, Florida Statutes. DONE AND ENTERED this 2nd day of March, 2018, in Tallahassee, Leon County, Florida. S DARREN A. SCHWARTZ Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 2nd day of March, 2018.
The Issue The issues in this case are whether Respondent violated Subsection 458.331(1)(t), Florida Statutes (2004),1 and, if so, what discipline should be imposed.
Findings Of Fact The Department is the state agency charged with regulating the practice of medicine pursuant to Section 20.43 and Chapters 456 and 458, Florida Statutes. Dr. Patel is a licensed physician within the state of Florida, having been issued license number 54617. He has been board certified in general surgery since 1990 and has been practicing medicine in Florida since 1989. For the past 20 years, S.A. has had yearly gynecological examinations and mammograms. In 1994, a mammogram revealed a lump in her left breast. She was referred to a specialist, who removed the lump. The biopsy revealed that the lump was a fibroadenoma, which is a common, benign tumor of the female breast with unknown etiology. In 2004, S.A. found a lump in her right breast during a self-examination. She consulted her gynecologist, Dr. Hae Soo Lim, who had been prescribing Clomid for S.A. Dr. Lim advised S.A. that the Clomid could be causing the lump. S.A. discontinued taking Clomid, but the lump did not dissipate. In August 2004, Dr. Lim ordered a mammogram for S.A. The mammogram did not reveal an abnormality in the right breast. Because a lump could be felt on examination, S.A. was advised to have a supplemental bilateral breast sonography. A sonogram was performed on the same date as the mammogram and revealed the following as it related to the right breast: In the area of palpable abnormality, there is a solid hyperechoic nodule that has a central cleft. It is more ethogenic than the adjacent breast parenchyma and could therefore represent a focal fatty deposit or area of breast tissue fibrosis. This measures approximately 1.5 cm x 1.2 cm. This is 5 mm beneath the skin surface and is readily palpable. This is 5 cm away from the nipple in the 12 o'clock position. Using color flow Doppler imaging, no vascular flow is demonstrated within the lesion. This would further support probable benign etiology. This does not have the appearance of a complicated cyst or of a typical fibroadenoma or malignancy. CONCLUSION: Hyperechoic nodule accounting for palpable abnormality. This is not seen mammographically. This has indeterminate characteristics and most likely represents a focal fatty deposit and/or area of breast tissue fibrosis. A biopsy or excision would be needed to establish pathology. It is noted that the patient states that this fluctuates in size during the course of her period. Dr. J.M. Swalchick, who prepared the report of the sonogram findings, recommended a surgical consultation for the palpable abnormality in the right breast. Dr. Swalchick noted in his report that he discussed his findings with S.A. at the time of the performance of the sonogram. His discussion was limited to telling S.A. that she should follow up with a surgical consultation and that he would send the report to Dr. Lim. On or about August 12, 2005, S.A. presented to Dr. Patel for a surgical consultation and evaluation of the mammogram and breast ultrasound reports upon referral from Dr. Lim. Dr. Patel reviewed the mammogram, ultrasound, and the accompanying radiology reports. In his office notes, which were dictated within 24 hours of S.A.'s visit, Dr. Patel made the following findings during his examination of S.A.'s right breast: Patient has a small palpable nodule in the right breast at 12:00 to 11:00 position and appears to be right under the skin. Appears to be more likely a simple fibroadenoma without any skin dimpling or any nipple or skin retraction. Patient did not have any axillary adenopathy. Dr. Patel made the following notation of S.A.'s August 12, 2004, office visit: Patient was explained regarding her mammogram, regarding her ultrasound exam and also regarding various breast problems with the help of the booklet on the breast disorders and was advised that what appears to be a palpable nodule seen on the ultrasound is a fibroadenoma and she can be followed clinically and will advise her to be seen again in six months in follow up. Patient explained that if she wants this to be removed, it can be removed either in the office or in outpatient surgery and the patient is agreeable to have simple follow up done and will be seen again in six months. Dr. Patel does not have a specific recollection of S.A.'s office visit on August 12, 2004, other than what he wrote in the patient's chart. Dr. Patel's office notes comport with S.A.'s testimony that he told her that she had a fibroadenoma. He did not tell S.A. that the lump was indeterminate. Based on Dr. Patel's representation that the lump was a fibroadenoma, S.A. elected to wait and return to Dr. Patel in six months for a follow-up visit. There is conflict between S.A.'s testimony and Dr. Patel's office notes concerning whether he explained the mammogram and ultrasound to her and whether he showed her a booklet on breast disorders. I credit Dr. Patel's office notes in that he did discuss the mammogram and ultrasound tests with S.A. and that he did go over a booklet with S.A. on various breast disorders. Additionally, I credit Dr. Patel's notes that he told her that he could remove the nodule in his office if she desired. However, I credit S.A.'s testimony that Dr. Patel told her that she had a benign fibroadenoma and had nothing to worry about. Had Dr. Patel told her that the lump was indeterminate, S.A. could have made an informed decision concerning the removal of the mass versus waiting six months to see what would happen. On February 22, 2005, S.A. returned to Dr. Patel's office for a follow-up visit. The lump was still present. Based on Dr. Patel's office notes, he was still under the impression that the lump was a benign fibroadenoma. He told her that he would remove the lump in his office under local anesthesia. Another office visit was scheduled to remove the lump. On or about March 8, 2005, Dr. Patel excised the breast mass in his office using local anesthesia. A biopsy of the excised tissue revealed that S.A. had an infiltrating ducal carcinoma (breast cancer). On or about March 14, 2005, Dr. Patel performed a right partial mastectomy on S.A. Dr. Armand H. Katz testified as an expert for the Department. Dr. Katz's testimony is credited that the standard of care required that Dr. Patel tell S.A. that the lump was indeterminate and could be cancerous.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that: A Final Order be entered finding that Dr. Rameshibhai P. Patel violated Subsection 458.331(1)(t), Florida Statutes; placing him on probation for one year with indirect supervision, with the terms to be set by the Board of Medicine; requiring completion of five hours of continuing medical education in risk management; and imposing an administrative fine of $1,000. DONE AND ENTERED this <day> day of <month>, <year>, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this <day> day of <month>, <year>.
Findings Of Fact The Respondent, Charles P. Shook, M.D., is a medical doctor having been issued license number 0020414, pursuant to Chapter 458, Florida Statutes. He is board certified in the areas of general and peripheral vascular surgery and practices in those specialty areas in Fort Myers, Lee County, Florida. He has been practicing in Lee County since 1973. The Petitioner is an agency of the State of Florida, charged with enforcing the licensure and practice standards embodied in Chapter 458, Florida Statutes and related statutes and rules and imposing disciplinary measures for departure from those standards by physicians licensed in Florida when such are proven. Mrs. Betty A. Fiore, at times pertinent hereto, was an obese, 47-year old female, with a history of thrombo-phlebitis and progressively enlarging and painful bilaterial varicosities of the veins in her right and left legs. She was admitted to Fort Myers Community Hospital on January 28, 1979, by the Respondent, for performance of a bilateral "vein-stripping" surgical procedure. Her medical history reflected that she had had a similar vein-stripping procedure performed over 20 years previously. The patient was operated on by the Respondent on January 29, 1979, beginning at approximately 9:25 a.m. The procedure was quite lengthy due to certain complications and lasted until 1:25 p.m. that day. After normal preparations, under general anesthesia, the Respondent began the operation by performing an oblique groin incision on the left leg just below the inquinal liagment, approximately ten centimeters in length. The incision penetrated the subcutaneous tissue and, as the "fossa-ovalis" was approached, the Respondent noted a significant amount of scar tissue, apparently related to the earlier surgical procedure, which obliterated and concealed much of the normal anatomy and structure in the area of surgery. It was of such a dense nature that only a faintly palpable pulse could be felt in the vessel. The Respondent dissected out the various venous branches in the area and individually ligated them. During his dissection process, the distal common femoral artery was injured by being slightly nicked with the surgical instrument. Repair procedures for the injury to the artery were carried out as will be described below. In any event, the "codman stripper" was employed in carrying out the stripping operation on the vein in question and additionally, several incisions were made around the calf of the leg to alleviate smaller varicosities. One large perforating vein in the malleolar area had to be ligated after the superficial portion had been stripped away. The Respondent then began to perform a similar procedure on the right leg, in spite of the initial difficulties he had had on the left leg, because he did not expect such severe scar tissue involvement with the anatomical structures in the area of incision on both legs. When he carried out the incision on the right leg however, he found that the anatomy of the right leg was essentially the same as that of the left and that substantial scar tissue reaction had occurred, related to prior surgery, with obliteration of much of the normal anatomy, including concealment of the femoral artery. Due in large part to these anatomical changes and complications involved in dissecting out the various venous branches involved in the stripping procedure, the right femoral artery was also slightly nicked by the scalpel. The Respondent attempted to suture the femoral arteries nicked in both legs at the time these injuries occurred, but the sutures would not hold in the arteries due to some then unknown, medical condition. After the same failure to hold sutures was encountered with regard to both femoral arteries, the Respondent sent samples of the arteries to the pathologist for evaluation. The pathologist report indicated that the arteries were "normal." Parenthetically it should he noted that the "complaining witness," Mrs. Fiore, has been found to exhibit symptoms of diabetes mellitus. Her testimony was somewhat evasive concerning the degree to which she may suffer from this malady, which can have a detrimental effect on the vascular system. In any event, when working first on the left leg, the Respondent elected to resect back along the artery for approximately a half-inch on each side of the wound and after that resection, to repair the femoral artery with the insertion of a 6 millimeter gortex graft. Likewise, with regard to the right leg, the Respondent found the sutures would not hold in the damaged artery (which was of a "cheese-like" consistency). He therefore performed a similar resection and insertion of a 6 millimeter gortex graft to repair the injury. The surgical procedure was then successfully concluded. Post-operatively the patient encountered some complications involving infection in the groin area, requiring two additional admissions to Fort Myers Community Hospital. Subsequently, she was transferred to Methodist Hospital in Houston, Texas, where she underwent two additional surgical procedures. The Petitioner presented the opinions of two expert witnesses, Dr. Alexander Braze and Dr. E. William Reiber. Dr. Braze's expert opinion is predicated on the review of Mrs. Fiore's office records from the Respondent's office, the hospital charts for her three admissions to Fort Myers Community Hospital, and summaries of her two admissions to the Methodist Hospital in Houston, Texas. His opinion is not based on any examination of the patient involved. Dr. Braze thus opined that because of the previous surgery on the greater saphenous vein, bilaterally, there would be obvious and considerable scarring and scar tissue in the subcutaneous area which would distort and conceal the individual anatomical structures. He himself has never nicked a femoral artery while doing a vein-stripping operation but, although he acknowledges it is an "uncommon complication, he has heard of it occurring. He was unable to render an opinion concerning whether or not the operation was performed properly because this was not a typical vein ligation and stripping procedure, due to the presence of extensive scar tissue, and resulting difficulty involved. The dense scar tissue precluded identification of the structures in the area of the surgical incision and meant that the Respondent had to proceed slowly and very meticulously with a careful dissection, deviation from which careful procedure could cause difficulty. The doctor's procedure was slow and meticulous. The procedure (for both legs) took approximately four hours. Although the Respondent proceeded with care, he nicked the arteries anyway. Dr. Braze could not state that such a complication, albeit uncommon, constituted a departure from standards normally recognized in the medical community. With regard to the doctor's judgmental decision to proceed to the right leg after nicking and repairing the artery in the left leg and completing the vein stripping procedure in the left leg. Dr. Braze opined that he was acting as a reasonable physician in proceeding to the other leg since he had already corrected the initial injury, especially since it was the leg in which she was having her chief complaints. In any event, Dr. Braze was unable to render an opinion as to whether or not the procedure up to the point of nicking the artery was properly or improperly done, although he acknowledged that the lengthy time taken to perform the total procedure indicates that the doctor was proceeding slowly and with greater than normal difficulties. In any event, after the arteries were nicked, the procedure followed by the Respondent was excellent and the repair work was competently and efficiently performed. Dr. Reiber, Petitioner's other expert witness, testified by deposition, which was stipulated into evidence. His expert opinion was based on a review of the deposition of the Respondent, the Fort Myers Community Hospital records of the patient, and the depositions of the patient, Betty Fiore, Arnold Flare and Quillen Jones. Additionally, he reviewed the records dealing with Mrs. Flare's treatment in Houston, Texas. He thus opined that the Respondent made two technical errors when he injured the arteries in each leg and he felt that it was an error in judgment to have performed the procedure on the right leg after having encountered difficulty in the initial procedure on the left leg. He was unable to opine however, that the treatment rendered the patient by Respondent fell below the appropriate standard of care accepted by similar physicians in the community. Moreover, he also opined that the Respondent's treatment after nicking the arteries affirmatively met the standard of care for reasonably prudent physicians in such circumstances. The expert witnesses presented on behalf of the Respondent were Drs. Peter M. Sidell and Luis A. Ruilova. Both witnesses opined, in effect, that, given the obesity of the patient and the difficult surgical process that alone entailed, coupled with the significant involvement of scar tissue in the area of the incision, that the complications associated with this procedure could occur in the hands of even the most renowned surgeon. The fact that the Respondent experienced these complications does not render his practice in this regard to be below the standard of care for vascular surgeons in that community or area of practice. They further opined that it is a matter of personal judgment on whether to proceed to the other leg after encountering these difficulties. A reasonable judgment would have been to explore the groin area on the other side, after accomplishing repair of the first injured artery, which was done. The initial arterial injury having been repaired in a successful manner, both of the Respondent's experts opined that, the patient then being stabilized, the Respondent was justified in proceeding to the other leg and performing the procedure on that side. The main purpose of the operation was to remove the veins of the patient since the patient was symptomatic with varicosities. It therefore would be poor judgment to simply repair the nicked artery and proceed no further, since the symptomatic vein would remain uncorrected. In short, both experts for Respondent opined that neither the vein-stripping procedure, the repair of the damaged arteries nor post-operative management for which Respondent was responsible were performed in a manner below the appropriate standard of care of reasonably prudent physicians in the community. Thus, although the patient unfortunately experienced difficulties during a procedure involving the accidental nicking of her femoral arteries and, after the grafts repairing those injured arteries were performed, later suffered an infection at the operative site necessitating further hospitalization, no expert witness could describe the treatment and care afforded this patient as being below the appropriate standard of care exercised by a reasonably prudent physician performing such vascular surgical practice in the Fort Myers community or area. The Respondent has never encountered this difficulty either before or since this occasion in his practice, which is characterized by frequent vascular surgical procedures. Additionally, Dr. Ruilova established that the nicking of the femoral arteries during such a procedure, although not a common occurrence, is well documented in the literature and not at all unheard of. Indeed, Dr. Ruilova, when assisting a distinguished surgeon who was chief of surgery at the Mayo Clinic at the time, observed that expert surgeon nick a femoral artery in a vein- stripping procedure on two occasions. Finally, it is noted that the Respondent's practice has been characterized by a high level of professional expertise, competence and compassion in caring for his patients, both before and since the occasion in question. He has never before been subjected to disciplinary action.
Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law, the evidence of record, the candor and demeanor of the witnesses and the pleadings and arguments of the parties, it is, therefore RECOMMENDED that a Final Order be entered by the Board of Medical Examiners dismissing the complaint in its entirety. DONE and ENTERED this 11th day of October, 1984, in Tallahassee, Florida. P. MICHAEL RUFF Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904)488-9675 FILED with the Clerk of the Division of Administrative Hearings this 11th day of October, 1984. COPIES FURNISHED: Barbara K. Hobbs, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301 Patrick Geraghty, Esquire HENDERSON, FRANKLIN, STARNES & HOLT Post Office Box 280 Fort Myers, Florida 33902 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue The issues for resolution, as provided in an Order Finding Probable Cause dated March 11, 1992, are whether Respondent, as a member of the State Board of Acupuncture: violated section 112.313(7)(a), F.S., by having an employment or contractual relationship with The Healing Center which created a continuing or frequently recurring conflict between his private interest and the performance of his public duties; and violated section 112.3143(2), F.S. by voting on a measure which inured to his or his wife's special private gain without disclosing the nature of his interest in the matter.
Findings Of Fact Harvey Kaltsas served on the Board of Acupuncture from February, 1987 through April 3, 1991. As a member of the Board of Acupuncture, his duties included regulation of the practice of acupuncture, and the promulgation of rules to implement Chapters 455, 457, and 120, Florida Statutes. Mr. Kaltsas has been a licensed acupuncturist in the State of Florida since 1984, and was registered as an apprentice prior to licensure. Since 1989, Harvey Kaltsas has been married to Cynthia O'Donnell, who is the sole officer and shareholder of a business, The Healing Center, Inc., which was incorporated in April of 1989. In addition to providing other health services, The Healing Center, Inc. has sold sterile, disposable acupuncture needles since October, 1990. Gross sales of needles have averaged one to two thousand dollars per month from October 1990 until the present. Harvey Kaltsas was not and is not a shareholder or stockholder in The Healing Center, Inc. Harvey Kaltsas has had no interest in The Healing Center, Inc. At all times pertinent to the complaints at issue, The Healing Center, Inc. was located at 430 North Tamiami Trail, Suite C, Sarasota, Florida 34236. The lease for such property remained in the name of Harvey Kaltsas during this period. Although Harvey Kaltsas was ultimately responsible for lease payments on the property, lease payments were made by The Healing Center, Inc. to the landlord. Harvey Kaltsas, as well as other tenants of the property, paid rent to The Healing Center, Inc. The utilities account for the leased property was in the name of Harvey Kaltsas. Although he was ultimately responsible for utilities payments, such payments were made by The Healing Center, Inc. From April, 1989 through December 1990, Harvey Kaltsas was both a tenant of and an independent contractor with The Healing Center, Inc. As a tenant, Mr. Kaltsas paid rent of approximately $300.00 per month to The Healing Center, Inc. As an independent contractor, Mr. Kaltsas performed thermographic examinations on several patients of The Healing Center, Inc. These services were performed from time to time on an ad hoc basis. For these services, Mr. Kaltsas received $3625.00. No contract existed between Mr. Kaltsas and the Healing Center, Inc., regarding performance of these services. Other individuals provided similar thermographic services. On January 1, 1991, Harvey Kaltsas became a salaried employee of The Healing Center, Inc. At the time he vacated his seat on the Board of Acupuncture in April 1991, he was still a salaried employee of The Healing Center, Inc. On December 14, 1990, Harvey Kaltsas moved for consideration of, and voted for, an amendment to Rule 21AA-8.002, Florida Administrative Code, which would have required all licensed acupuncturists in the State of Florida to use only sterile, disposable acupuncture needles. The matter had been raised in an earlier meeting of the board by Luis Celpa, another acupuncturist member. The proposed amendment to Rule 21AA-8.002, Florida Administrative Code, was noticed and published in the Florida Administrative Weekly on February 15, 1991 (Vol. 17, No. 7, p.645). The proposed amendment deleted existing language with regard to sterilization procedures and substituted language requiring disposable needles for one-time use only. The proposed ruled was subsequently withdrawn by the Board of Acupuncture and never became effective. The Joint Administrative Procedures Committee challenged the authority for the rule since Chapter 457, F.S. provides for resterilization of needles. Prior to voting on the measure to amend Rule 21AA-8.002, Florida Administrative Code, Mr. Kaltsas did not disclose to the Board of Acupuncture his interests in or relationship with The Healing Center, Inc. On or about March 7, 1991, The Healing Center, Inc. mailed a letter signed by Cynthia O'Donnell-Kaltsas to licensed Florida acupuncturists advising them of the proposed rule change requiring the use of sterile, disposable needles and offering such needles for sale at a discounted price. Ms. O'Donnell was aware of the board's action, and the letter was mailed after publication of the proposed rule change in The Florida Administrative Weekly. After the rule was withdrawn Ms. O'Donnell sent a follow up letter stating that the rule did not go through and apologizing for any misinformation. Even though she does not use the husband's name, Ms. O'Donnell signed the letters, "O'Donnell-Kaltsas", as her husband had been president of the Florida Acupuncture Association and she was raising money for the association with a 2 percent contribution from needle sales. There are a significant number of potential vendors offering sterile, disposable needles for sale to Florida practitioners of acupuncture. There are a minimum of at least fifteen such vendors in Florida, as well as a minimum of eleven practitioners who sell needles. In addition, Chinese practitioners have direct access to needle suppliers in China from whom they can purchase needles. Florida practitioners receive solicitations from needle vendors across the country and from needle vendors located in Canada, England, Taiwan and Hong Kong. There are no barriers to interstate sale and shipment of needles into the State of Florida by any company or person. The Board of Acupuncture does not regulate the sellers of acupuncture needles. No barriers to entering this market have been established by the Board of Acupuncture. The Board does not license persons or entities which sell needles, nor does it inspect facilities of such persons or entities. The Board does not regulate the types of needles which can be sold, nor does it subject sellers of needles to any kind of disciplinary action. For all intents and purposes, Mr. Kaltsas and his wife maintain separate financial identities. They maintain separate bank accounts, with the exception of a $30.00 credit union account. They do not have signing privileges on each other's banking accounts. In business transactions involving The Healing Center, Inc., Mr. Kaltsas did not receive any special consideration with respect to the amount of rent or with respect to making of rent payments. Although the couple resides in a house owned by Ms. O'Donnell, Harvey Kaltsas makes payments to her to offset the household expenses. There is no evidence that the vote of December 14, 1990 regarding the proposed attachment to Rule 21AA-8.002, Florida Administrative Code, inured to the special private gain of Mr. Kaltsas or to the special private gain of Cynthia O'Donnell. There is no evidence that any matter came before the Board of Acupuncture on a continuing or frequently recurring basis which created a conflict between Mr. Kaltsas' private interests and the performance of his public duties. The sterile, disposable needle rule was formally addressed on two occasions while Mr. Kaltsas was on the Board; it was approved by the Board on December 14, 1990; and it was subsequently withdrawn by the Board on April 3, 1991. Most acupuncturists use disposable needles already. The low cost of such needles compared to the cost of effective sterilization created a legitimate concern for the safety and welfare of the needle handlers and their patients. This concern, rather than any private interest or benefit motivated Harvey Kaltsas' action as a board member.
Recommendation Based on the foregoing, it is, hereby RECOMMENDED: That the Commission on Ethics enter its final order and public report finding that Harvey Kaltsas did not violate Sections 112.3143(2), Florida Statutes (1989) and 112.313(7)(a), Florida Statutes, as alleged, and dismissing the complaints. DONE AND ORDERED this 31st day of August, 1993, in Tallahassee, Florida. MARY CLARK Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 31st day of August, 1993.
The Issue Whether Petitioner's request for authorization for the autologous chondrocyte implantation (ACI) procedure should be approved pursuant to worker's compensation laws and rules.
Findings Of Fact Witherspoon is a 41-year-old police officer. He has worked in law enforcement for 20 years and is currently employed as a police officer for the City of Fort Lauderdale. Witherspoon was injured in an employment-related accident on September 14, 1999. The accident significantly aggravated a pre-existing injury to his left knee. At the time of the accident, Witherspoon had already had two arthroscopic surgical procedures to treat his pre- existing knee injury. He underwent a third arthroscopic surgery following the accident, and returned to work in the Spring of 2000. In addition to surgery and physical therapy, Witherspoon has been treated continuously with injections and medications in an effort to alleviate his symptoms, to no avail. At all times relevant to this case, Witherspoon has two separate injuries to the articular cartilage of his knee: one in the trochlea and one in the medial femoral condyle. Because of these injuries, Witherspoon's articular cartilage, which is necessary for proper functioning of the knee joint, has been degrading and flaking off and will continue to do so. The injuries cause him to walk with a significant limp. He is in constant pain and constant danger of his knee buckling. Witherspoon's situation is complicated by a defect in the articular cartilage of his patella. ACI was not recommended for this defect, and it is unknown how debilitating the patella injury would continue to be, if and when ACI treatment is successfully completed. Because of his injuries, Witherspoon is unable to perform the duties of a uniformed police officer. He is presently assigned to desk work, at a significantly reduced salary. Witherspoon is on an accelerated course to advanced degenerative arthritis, for which a complete knee replacement is the standard recommended treatment. Because Witherspoon is relatively young and knee replacements do not last indefinitely, the unanimous weight of medical opinion is that knee replacement should be postponed as long as possible. Witherspoon's treating physician, having exhausted all viable treatment options, referred Witherspoon to Dr. Douglas Stringham (Stringham), a Board-certified orthopedic surgeon. After reviewing Witherspoon's arthroscopic photographs and medical records, Stringham recommended that he undergo ACI. Witherspoon requested authorization for the ACI procedure, which was denied by his Employer/Carrier City of Fort Lauderdale (Employer). The dispute was referred to AHCA for review in accordance with Subsection 440.13(1)(m), Florida Statutes. AHCA consulted with Dr. Peter Indelicato (Indelicato), a Board-certified orthopedic surgeon. Indelicato rendered an opinion that the procedure is investigative within the meaning of Rule 59B-11.002(5), Florida Administrative Code. He further opined that there was not reliable evidence that ACI would provide significant benefit to Witherspoon's recovery and well being within the meaning of Rule 59B- 11.004(3), Florida Administrative Code. Relying exclusively upon Indelicato’s opinion, AHCA declined to order the Employer to provide ACI to the Petitioner. Upon the filing of this petition, Witherspoon was advised by the Employer that neither ACI nor any other form of intervention would be offered to him. AHCA has not promulgated, endorsed, or approved any particular treatment for injuries to the articular cartilage of the knee in accordance with Subsection 440.13, Florida Statutes. The ACI procedure which has been recommended to Witherspoon was initially developed in Sweden. Over the course of two separate surgical procedures, a sample of cartilage is first harvested arthroscopically from another area of the patient's knee joint. The sample is sent to the Boston Laboratory of Genzyme Tissue Repair, Inc. (“Genzyme”), which owns the rights to the process. Genzyme uses its proprietary process to culture the cells into an estimated five million chondrocytes over a period of approximately five weeks. Genzyme returns the cultured chondrocytes to the surgeon. The surgeon then performs an open surgical operation. The surgeon creates a periosteal flap. In addition, the injury is debrided and the chondrocytes are implanted in the wounded cartilage and covered with the periosteal flap. The claimed benefit of ACI is that the cartilage that is generated and implanted into the knee will approximate natural human cartilage to an extent significant enough to provide substantial benefit to the patient. Because ACI is in its infancy, questions remain about the long-term efficacy of the procedure. Other available treatments for a defect in articular cartilage of the knee include, abrasion chondroplasty, arthroscopic microfracture or drilling, osteochondral autograft surgery or “plugs”, and an osteochondral allograft using transplanted tissue from a cadaver (collectively, "conventional interventions"). Each of these procedures is, standing alone, less expensive than ACI. Each of these procedures, whether used singly or in combination, is not appropriate for Witherspoon at this time. Individually and collectively, conventional interventions afford no realistic hope of providing any noticeable relief for his symptoms, nor will they forestall the deterioration of his knee. The evidence establishes that there are no viable alternatives to ACI in the facts and circumstances of this case. Witherspoon is either not a candidate for conventional interventions, or has had such treatments and they have failed. Of the three Board-certified orthopedic surgeons who testified, AHCA's expert, who has never performed ACI, opined that Witherspoon could be treated by conventional interventions and Witherspoon's experts, who do perform ACI, testified that conventional interventions have failed and will continue to fail. There is no evidence to suggest that the testimony of any of the doctors was tainted by personal financial considerations of any kind. The ACI procedure, if successful, would be less expensive than a continuing course of short-term "housekeeping" treatments. Conventional interventions would, at most, stave off the inevitable knee replacement. They would not alleviate Witherspoon's disability in any way. Reliable evidence establishes that the ACI procedure presents the only possibility of providing Witherspoon with significant benefits toward recovery and well being. AHCA stipulates and the evidence establishes that ACI has been established to be safe. Under the facts and circumstances of this case, the benefits of the ACI procedure outweigh the risks to Witherspoon.
Recommendation Based upon the foregoing, it is RECOMMENDED that the Agency for Health Care Administration enter a Final Order approving the proposed ACI for the Petitioner. DONE AND ENTERED this 24th day of April, 2001, in Tallahassee, Leon County, Florida. FLORENCE SNYDER RIVAS 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 24th day of April, 2001. COPIES FURNISHED: Barry A. Pemsler, Esquire 307 Ros Centre 770 Ponce de Leon Boulevard Coral Gables, Florida 33134 Michelle L. Oxman, Esquire Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Mail Stop 3 Tallahassee, Florida 32308 Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308 Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308
