The Issue The issue for consideration in this hearing was whether Petitioner should be granted additional credit for one or more of questions number 41, 44, 70, or 72 of the National Council for the Certification of Acupuncture, (NCCA), multiple choice examination administered on May 18, 1991.
Findings Of Fact Petitioner, Aaron Benjamin sat for the May 18, 1991 NCCA acupuncture certification examination administered by the Department of Professional Regulation and achieved a passing score on the clean needle technique portion of the examination. However, he received a score of 69 on the written portion of the examination for which a score of no less than 70 was passing. Thereafter, Petitioner challenged four of the written questions on the exam; questions number 41, 44, 70 and 72, alleging that in each case, the question was worded in such a manner as to allow for more than one correct response and that his response, different from the accepted response, was also correct. This allegation was made notwithstanding the written examination instruction that there was "one and only one correct choice for each question." In his challenge, Petitioner also asserted that the examination instructions provided by the NCCA did not limit the textbooks which might be used for preparation for the examination. He claimed that many of these texts encompassed different philosophies of traditional Chinese acupuncture. By the same token, he alleged, the NCCA also did not specify which school of acupuncture should be referenced when answering the challenged questions. There are numerous different acupuncture texts available for reference which are written through different schools of acupuncture and which represent the differing philosophies of acupuncture practitioners. Utilization of differing schools and differing philosophies could affect an examinee's answer choice. Petitioner also asserted as a defect in the examination process the fact that he received his copy of the examination preparation booklet only two weeks prior to the examination rather than the 30 days which should have been provided. He raised these complaints to officials of both the Board of Acupuncture and the NCCA without success. Question 41 in issue reads: If a patient comes to you with a swollen puffy face and complains of scanty urination, which of the Zang-Fu would you first suspect to be disordered? Lung Kidney Spleen Urinary Bladder Petitioner answered this question with "3 - Spleen" while the Department's answer was "1 - Lung." He claims the question does not specify whether the diagnosis of the patient's condition should be from the beginning of the condition or at the time of examination. He asserts, however, that the spleen is an organ with which this condition may be associated since the accumulation of fluid in the interiors causing edema (swelling) is a syndrome of the spleen and incontinence of the urine also relate to that organ. On the other hand, as indicated by the Department's expert, the lung dominates the vital functions of the entire body and greatly influences all its functional activities. It controls and disperses all fluid in the system. The accumulation of water in a patient with a puffy face and scanty urination, therefore, comes from the lung which is responsible for dispersion of water which might, originate from the spleen. Consequently, "Lung" is the correct answer. Question 44 in issue reads: Bouts of dizziness that continue when a patient lies down are attributed to: deficiency excess heat cold Petitioner answered this question with "1 - deficiency", claiming that either excess or deficiency could result in a patient remaining dizzy after lying down. He asserts the wording on the examination question does not provide sufficient information regarding the syndrome to allow the examinee to differentiate whether an excess or deficiency syndrome resulted in the patient's condition. He claims that if an individual suffered from a deficiency syndrome, and the body energy did not stabilize after the patient reclined, the dizziness would continue. The Department's expert notes that the correct answer is "2 - excess" because in a deficiency syndrome, the vital energy, when one lays down, will come back. With an excess, however, even if one lays down, the excess will not go away. Dr. Celpa admits, however, that in western medicine, Petitioner's answer would be correct. However, in traditional Chinese medicine, which deals in philosophy (theory), one has to accept the specifics given by the Chinese. The correct answer, for the purposes of this examination is, therefore, "2 - excess." Question 70 in issue reads: A tight and forceful pulse could indicate: Damp of the Spleen and Stomach. hyperactivity of the Yang of the Heart. penetration of Cold into Liver Channel. Yin deficiency of the Heart. Petitioner answered "1 - Damp of the Spleen and Stomach, while the Department's correct answer was "3 - penetration of Cold into the Liver Channel." He notes that cold is indicated by a slow pulse and penetration of cold into the liver channel is indicated by a deep, wiry and slow pulse. A forceful pulse, he claims, can sometimes mean an accumulation of dampness in the spleen and stomach not allowing the body to metabolize food for distribution to other organs. If one has damp one has an accumulation. Petitioner answered as he did because of the study guide definitions. The study guide directs the examinees to use its definitions and there was no word for forceful included therein. Dr. Celpa, on the other hand, contends "a penetration of cold in the lower channel" is the correct answer as asserted by the NCCA. Most written authorities on the subject indicate that a tight and forceful pulse relates to the liver. Included in these authorities are The Web That has No Weaver; Fundamentals of Chinese Medicine; Acumoxa; and Pulse Diagnosis. Therefore, he concludes that cold in the liver is the closest answer. He asserts, contrary to claims of the Petitioner, that the definition page contained in the examination packet contains all one needs to take the examination. The packet is put together by the Board of Acupuncture and directs definitions outlined in The Web That has No Weaver be used. This gives little room for error. Nonetheless, he admits this question should have more information available in it to assist the examinee and is a poor question. Question 72 in issue reads: Which of the following will cause a foul or offensive smell of the discharge or excretion? Damp disorder combined with Cold. Damp disorder without Cold. Heat disorder of the Xu (deficiency) type. Heat disorder of the Shi (excess) type. Petitioner's answer to this question was "1 - Damp disorder combined with Cold", and the correct answer, as indicated by the Respondent was "4 - Heat disorder of the Shi (excess) type." Petitioner's answer was based on the statement in Traditional Chinese Medicine to the effect that where there is damp there is odor. There is no reference therein to damp heat, so, looking at the remainder of the authoritative statement, he concluded that dampness is associated with odor. On the other hand, Dr. Celpa indicated Petitioner's answer is wrong because damp is not necessary for odor. The heat disorder is the primary one giving an offensive odor. The Shi type adds to it. While damp could have a foul odor, the heat (Shi (excess)) is the only one which gives the discharge. All of the possible answers show something wrong, but the association of heat and excess best meets the test. Consequently, Petitioner's answer could not be correct.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that a Final Order be entered by the Board of Acupuncture denying Petitioner's request for additional credit. RECOMMENDED this 28th day of September, 1993, in Tallahassee, Florida. ARNOLD H. POLLOCK, 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 28th day of September, 1993. APPENDIX TO RECOMMENDED ORDER, CASE NO. 92-926 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties to this case. FOR THE PETITIONER: & 2. Accepted and incorporated herein. Accepted as an accurate description of the thrust of Petitioner's complaint. Accepted. Accepted and incorporated herein. Accepted as Petitioner's justification for his answer but rejected as appropriate authority. Accepted as an accurate description of Petitioner's answer and the correct answer, and as Petitioner's justification for his answer, but rejected as appropriate authority. Accepted and incorporated herein. Accepted as an accurate description of Petitioner's justification for his answer and as a restatement of Respondent's position, but rejected as appropriate authority. Accepted and incorporated herein Accepted as Petitioner's justification for his answer but rejected as appropriate authority. FOR THE RESPONDENT: 1. - 11. Accepted and incorporated herein. COPIES FURNISHED: Arthur J. Springer, Esquire 215 Verne Street, Suite A Tampa, Florida 33601 Vytas J. Urba, Esquire Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792 Jack McRay Acting General Counsel Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792 William Buckhalt Executive Director Board of Acupuncture 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue Whether Kuan-Chu Kuo's application to take the acupuncture examination should be granted or denied.
Findings Of Fact On August 31, 1981, Applicant applied to take the state acupuncture examination administered by the Department. She sought to qualify by reason of her education, indicating that she attended Shanghai Medical College, Shanghai, China, from 1944 to 1950; and that she received her acupuncture education at the Chinese Academy of Medical Science of Jsinan, Shandung, China. (R-1, P-1.) To qualify by reason of education, an applicant must submit a certificate of the dean or director of the acupuncture school which granted the degree. In satisfaction of that requirement, Applicant submitted a certificate, under seal, of the Shanghai Medical College, dated August 11, 1979, which translated under oath reads: Kuo Kuan-Chu, born in Fukien, age 53, was graduated from Shanghai Medical College (6 years curriculum) in 1950. She was with the Shanghai Medical College from Septem- ber 1944 to July 1950. (R-1, P-2.) At Shanghai Medical College from 1944 to 1950, Applicant successfully completed a curriculum including such courses as anatomy, biochemistry, physics, acupuncture, Chinese medicine, surgery, pediatrics, internal medicine, radiology, obstetrics/gynecology, opthalmology, neurology, dermatology, physiology, microbiology, pathology, gross anatomy, epidemiology, and pharmacology. She attended classes six-to-eight hours a day during the first four years; during the last two years of study, she worked in a hospital practicing Chinese medicine, including acupuncture, under the supervision of a resident physician. (Testimony of Kuan-Chu Kuo; P-8.) From 1960 to 1964, she studied at the Academy of Medical Science of Jsinan in Shandung, China. During that five-year program, she investigated the use of acupuncture to treat complications from radiotherapy. She authored several chapters in a textbook on practical gynecology. (Testimony of Kuan-Chu Kuo; R-1.) On February 10, 1982, Applicant supplemented her application by submitting a Certification, dated November 23, 1981, from the president of the Academy of Medical Science of Jsinan. The Certificate states: Dr. Kuo Kuan-Chu had acupuncture education at Jsinan Hospital from 1960 to 1964. She had fulfilled all the Chinese medicine and acupuncture courses and completed her clinical experiences, a thesis was published in Jsinan medical journals. (R-1.) Applicant has been certified by the Educational Commission for Foreign Medical Graduates as qualified to take an examination which would qualify her to take the Florida medical board exam. To obtain such certification, she was required to show that she completed at least four credit-years at a medical school listed in the "World Directory of Medical Schools." (Testimony of Kuan- Chu Kuo; P-5.) In 1979, Applicant was invited to the United States to observe the operations of the University of Miami's Department of Obstetrics and Gynecology. (Testimony of Kuan-Chu Kuo.) According to Jun Wu Xue, M.D., a visiting scholar from China, Shanghai Medical College is one of the most advanced colleges of higher learning in China. He testified that a course of "Medicine of Motherland," including Chinese traditional medicine and acupuncture, is taught at Chinese medical colleges. (Testimony of Jun Wu Xue.) But, Applicant indicated on her application that she received her acupuncture education at the Academy of Medical Science of Jsinan. No detailed information was presented on the courses at the academy, its faculty, and its current accreditation status. On September 22, 1981, the Department wrote Applicant requesting, among other things, an official transcript from her medical school. It relied on Rule 21-12.03, Florida Administrative Code, as providing authority for its request. Chapter 21-12 was filed with the Department of State on September 18, 1981. Applicant has been unable to supply the requested transcript because she attended medical school before the Chinese civil war. Institutional records, such as those kept at medical schools, were lost or destroyed by the war. (Testimony of Kuan-Chu Kuo; R-1.) On September 22, 1981, the Department also wrote the Chinese Academy of Medical Science of Jsinan and asked for their latest catalog of courses and their description, a list of their current faculty members and their curriculum vitae, the name and location of their educational and/or governmental accrediting agency, a copy of their latest accrediting report, and a clearly defined course of study for acupuncture. This request for documentation was made pursuant to the procedure prescribed in Rule 21-12.08 a new rule adopted for evaluating and approving acupuncture schools. As of the date of hearing, the academy had not responded to the Department's request. (R-1.)
Recommendation Based on the foregoing, it is RECOMMENDED: That the application of Kuan-Chu Kuo to take the acupuncture examination be denied. If and when the Department approves the acupuncture school attended by Applicant, she should be allowed to take the examination without further delay. DONE AND RECOMMENDED this 23rd day of March, 1982, in Tallahassee, Florida. R. L. CALEEN, JR. Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 23rd day of March, 1982.
The Issue Whether the Respondent committed the violation alleged in the Administrative Complaint issued October 2, 2006, 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 investigating and prosecuting complaints against persons holding licenses in the health professions and occupations, including chiropractic physicians. See § 456.073, Fla. Stat. The Board of Chiropractic Medicine ("Board") is the entity responsible for imposing penalties against chiropractic physicians for violations of Section 460.413(1), Florida Statutes. See § 460.413(2), Fla. Stat. At the times material to this proceeding, Dr. Falowski was a chiropractic physician licensed to practice chiropractic medicine in Florida, having been issued license number CH 5108. Dr. Falowski was first certified in Florida to practice chiropractic medicine in 1986. Dr. Falowski also is certified to administer propriety drugs. At the times material to this proceeding, Dr. Falowski did business as Rainbow Rehabilitation, and his address of record was 4201 North State Road 7, Lauderdale Lakes, Florida 33319. On or about August 25, 2997, Dr. Falowski submitted an application for acupuncture certification to the Department. He paid a fee and was certified to take the acupuncture certification examination. His application reflects that he completed 105 hours of acupuncture training at the University of Miami. Dr. Falowski took the acupuncture certification examination in November 1997, but he did not pass the examination. On or about April 15, 1998, Dr. Falowski submitted a second application for acupuncture certification to the Department. He paid a fee and was again certified to take the acupuncture certification examination. His application reflects that he completed acupuncture training at the University of Miami. Dr. Falowski took the acupuncture certification examination in May 1998 and attained a passing score. On or about July 7, 1998, the Department mailed an Examination Grade Report to Dr. Falowski, advising him that he had passed the chiropractic certification examination for acupuncture. A Request for Registration Form for the Board of Chiropractic Medicine was included with the Examination Grade Report, and the instructions stated that the form and a check or money order must be returned to the Department within 45 days. The form listed a $100.00 fee for the Chiropractic Acupuncture Certification. There is nothing in the records of the Department indicating that it received the Request for Registration Form or check in the amount of $100.00 from Dr. Falowski, nor do the records reflect that Dr. Falowski has been issued an acupuncture certification.4 On or about December 28, 2005, writing was observed on the window of the Rainbow Rehabilitation office which stated: WE DO PHYSICALS & BLOOD WORK LICENSED ACUPUNCTURE EKG No acupuncture license number was listed on the window. Dr. Falowski intended to perform acupuncture treatments for any member of the public who requested these treatments at Rainbow Rehabilitation.5
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Chiropractic Medicine enter a final order Finding that Francis J. Falowski, D.C., offered to practice acupuncture when he was not certified to do so, in violation of Section 460.413(1)(t); Imposing an administrative fine against Dr. Falowski in the amount of $5,000.00; and Placing Dr. Falowski on probation for a period of two years, under such terms and conditions as the Board deems appropriate. DONE AND ENTERED this 20th day of March, 2008, in Tallahassee, Leon County, Florida. 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 20th day of March, 2008.
The Issue Whether disciplinary action should be taken against Respondent's license as a veterinarian based on alleged violations of Section 474.214, Florida Statutes (1997), as charged in the Administrative Complaints filed against Respondent in this proceeding. Count I of the Administrative Complaint in Case No. 00-2357 charged Respondent with a violation of Section 474.214(1)(r), Florida Statutes (1997): being guilty of incompetence or negligence by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent veterinarian as being acceptable under similar conditions and circumstances. Count II of the Administrative Complaint charged Respondent with a violation of Section 474.214(1)(ee), Florida Statutes (1997): failing to keep contemporaneously written medical records as prescribed by Rule 61G18-18.002(3), Florida Administrative Code. The Administrative Complaint in Case No. 00-2358 charged Respondent with a violation of Section 474.214(1)(r), Florida Statutes (1997): being guilty of incompetence or negligence by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent veterinarian as being acceptable under similar conditions and circumstances.
Findings Of Fact Based on the evidence and testimony of the witnesses presented and the entire record in this proceeding, the following facts are found: At all times material, Respondent was a licensed veterinarian, having been issued license number VM 0003822. Facts relating to Case No. 00-2357 On or about March 5, 1998, Respondent performed a spay on "Midnight," a dog owned by Maryjane Greene and her husband. On or about March 8, 1998, "Midnight" expired at the Greene's home. When Mrs. Greene dropped off "Midnight," she was not sufficiently informed by Respondent about her option to have a pre-anesthesia lab work-up performed. There is no indication of an offer to perform a pre- anesthesia lab work-up, nor an indication that Mr. or Mrs. Greene declined such an offer, nor a consent form declining such a work-up, noted in the medical records kept by Respondent for "Midnight." It is a deviation from the standard of care to fail to offer a pre-anesthesia lab work-up. The anesthetic protocol used by Respondent during the spay of "Midnight" included Xylzine (a.k.a. Rompun) a drug with a profound and potentially deleterious effect on the heart which may cause a first degree or second degree heart block. The anesthetic protocol used by Respondent during the spay of "Midnight" also included Ketamine, which is not approved for use in dogs. When used as an anesthetic protocol, it is considered an extra-label use of the drug. An extra-label use of a drug means that there have been no safety studies completed, and it cannot be adequately predicted what effects the medication will have on an animal on a consistent basis. There is no indication in Respondent's records for "Midnight" that Mrs. Greene was informed regarding the use of Ketamine in her dog's procedure. It is a deviation from the standard of care not to make a client aware of the use of an extra-label drug and not to have the client sign a consent form. Xylazine and Ketamine are both cardiac depressants. When used in combination they each make the other more of a cardiac depressant, thus requiring the administration of another drug, such as Atropine, to minimize the cardiac depressant effect. There is no indication in Respondent's medical records for "Midnight" that Atropine or any other drug was administered, other that the Xylazine and Ketamine. Respondent's failure to administer Atropine or any other drug to minimize the cardiac depressant effects of Xylazine and Ketamine was a deviation from the standard of care. Respondent's failure to administer Atropine or any other drug to minimize the cardiac depressant effects of Xyalzine and Ketamine played a substantial role in "Midnight's" demise. Upon picking up "Midnight," Mrs. Greene was given limited post-operative instructions. She was told not to give "Midnight" water until he could walk a straight line; not to give food until he could hold water down; only leash walks for 10 days; and no baths for 7-10 days. Respondent's post-operative discharge instructions given to Mrs. Greene did not comply with the standard of care in veterinary medicine. Facts relating to Case No. 00-2358 On or about August 25, 1998, Respondent performed surgery to remove a mass from the perineal area of "Snoopy," a nine-year-old obese Beagle belonging to Juan Ferras. There is no indication in Respondent's records for "Snoopy" that the surgery was performed due to an emergency, although the credible testimony indicated that it was an emergency. Given "Snoopy's" age (nine years) and weight (60 lbs.), it would be in the dog's best interest to perform a pre- anesthesia lab work-up, or to at least offer one to the owner. Respondent did not indicate in his medical records that he offered to perform a pre-anesthesia lab work-up on "Snoopy." In view of the emergency nature of the surgery, it was not a deviation from the standard of care to fail to offer a pre-anesthesia lab work-up. The anesthetic protocol used by Respondent during the procedure on "Snoopy" included Ketamine, which is not approved for use in dogs. When used, it is considered an extra-label use of the drug. Ketamine should be used with extreme caution in dogs for which the veterinarian is unaware of the renal function or the liver function of the dog. It is a deviation from the standard of care not to make a client aware of the use of an extra-label drug, and not to have the client sign a consent form. There is no indication in Respondent's records for "Snoopy" that Juan Ferras was informed regarding the use of Ketamine in his dog's procedure. Upon picking up "Snoopy," Mr. Ferras was given limited post-operative instructions. Respondent's failure to give specific post-operative discharge instructions to Mr. Ferras constituted a deviation from the standard of care. After discharge, "Snoopy" began vomiting and was readmitted to Respondent's facility on or about August 27, 1998. On or about August 28, 1998, "Snoopy" expired at Respondent's facility. There is no indication in Respondent's records on "Snoopy" that upon "Snoopy's" readmission to Respondent's facility, on or about August 27, 1998, Juan Ferras refused to pay or was only willing to pay a small portion of any treatment rendered to "Snoopy." Because of this finding it is unnecessary to address whether refusal to pay a fee is an appropriate defense by Respondent. Upon "Snoopy's" readmission to Respondent's facility, on or about August 27, 1998, "Snoopy" was determined to be approximately 11 percent dehydrated and in a state of shock. In order to correct the dehydration and maintain "Snoopy," it would have been required to administer approximately 4300-4400 ccs of fluid. Respondent's records indicate that only 800 ccs of fluids were administered to "Snoopy." This left "Snoopy" with a tremendous deficit of fluids. Respondent's explanation as to the reason for the small amount of fluid shown on "Snoopy's" chart is not credible. Respondent's failure to administer the correct amount of fluids constitutes a deviation from the standard of care. Upon readmission to Respondent's clinic, Respondnet did not draw blood or perform any type of bloodwork on "Snoopy." Respondent's failure to draw blood or perform any type of bloodwork on "Snoopy" after being readmitted for dehydration and vomiting and shock constitutes a deviation from the standard of care. The fluids which were administered to "Snoopy" were administered sub-cutaneously. The failure to insert an IV catheter to administer the fluids, rather than administering them sub-cutaneously, constitutes a deviation from the standard of care. One way of re-hydrating a dehydrated patient is by weighing the dog and then adding enough fluids to get the patient to its normal weight. There is no indication in Respondent's records that "Snoopy" was weighed at the end of the day on or about August 27, 1998, or that "Snoopy" weighed approximately 60 pounds late in the day on or about August 27, 1998. Respondent's records for "Snoopy" contain a notation at 10:00 p.m. August 27, 1998, of "ADR" which means "ain't doing right." A patient whose records indicate "ADR" should be continuously monitored or transferred to an emergency facility. "Snoopy" was not monitored overnight and through the early hours of the next morning. Had Respondent taken appropriate steps with regards to fluid resuscitation upon "Snoopy's" readmission to Respondent's facility, "Snoopy's" chance of survival would have been much higher.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is recommended that a final order be render by the Board of Veterinary Medicine, as follows: Finding Respondent guilty of having violated Section 474.214(1)(r), Florida Statutes (1997), as alleged in Count I of the Administrative Complaint for DOAH Case No. 00-2357 (DBPR Case NO. 98-11323). Finding Respondent guilty of having violated Section 474.214(1)(ee), Florida Statutes (1997), as alleged in Count II of the Administrative Complaint for DOAH Case No. 00-2357 (DBPR Case No. 98-11323). Finding Respondent guilty of having violated Section 474.214(1)(r), Florida Statues (1997), as alleged in the Administrative Complaint for DOAH Case No. 00-2358 (DBPR Case No. 98-21230). In light of these findings of guilt and aggravating circumstances, the following penalties are recommended: A thirty-day suspension of licensure. An administrative fine in the amount of four-thousand dollars ($4000.00). Assessing costs of investigation and prosecution, in the amount of $973.24 for Case No. 00-2357 and $684.29 for Case No. 00-2358. Five years of monitored probation upon such terms and conditions as the Board finds necessary and reasonable. DONE AND ENTERED this 19th day of December, 2000, 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 December, 2000. COPIES FURNISHED: Walter H. Dornbusch, D.V.M. 1117 Malabar Road, Northeast Palm Bay, Florida 32907 Robert H. Hosay, Esquire Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-2202 Barbara D. Auger, General Counsel Department of Business and Professional Regulation Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792 Sherry Landrum, Director Board of Veterinary Medicine Department of Business and Professional Regulation Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue Whether Petitioner's request for authorization for the autologous chondrocyte implantation procedure should be approved pursuant to worker's compensation laws and rules.
Findings Of Fact Petitioner's Injury At all times, the Petitioner has been employed as a Ladies Wear Department Manager for K-Mart Corporation. On July 21, 1998, Petitioner, while in the course and scope of her employment, was injured when she fell on a metal ladder as she attempted to hang clothes on a rail. Her left knee struck a metal bar on the second step of the ladder, causing immediate pain. On August 26, 1998, Petitioner consulted Dr. Jeffery Friedman, M.D., an orthopedic surgeon, who specializes in knee and shoulder surgery. Dr. Friedman was recognized as an expert in the field of orthopedic surgery. On or about September 4, 1998, Petitioner underwent arthroscopic surgery performed by Dr. Friedman to remove a loose body from the knee. Dr. Friedman found grade III chondromalacia and debrided the area using an arthroscopic shaver. He also found loose articular cartilage at the patella. Dr. Friedman's records describe the area of grade III chondromalacia as "fairly large" and involving " the apex of the patella." However, neither the size nor the shape of the injury is disclosed. Dr. Friedman also debrided flake of articular cartilage from the tibial plateau and removed a calcific loose body from the posteromedial compartment. His post-operative diagnosis was left knee loose body, chrondromalacia, and intracruciate ligament strain. Petitioner returned to work with K-Mart after the arthroscopic surgery, and was placed on light duty. While performing her duties, Petitioner is required to stand most of the time, and is unable to sit. Prior to her injury, Petitioner worked 40 hours per week. After her injury, due to her physical limitations resulting from the accident, Petitioner is only able to work 24 hours per week. Petitioner's pain limits her ability to work 40 hours per week. Petitioner cannot put her full weight down on the left knee while going up steps or a ladder or it causes sharp shooting pains. In addition, continuous walking results in continuous aching pain. The reduction in Petitioner's work hours was due to her injury. Petitioner is now unable to perform all of the duties that were required of her before the injury. Dr. Friedman found Petitioner to have reached maximum medical improvement in December 1998. In early 1999, Petitioner sought treatment for continued pain. An MRI was performed on or about March 5, 1999, which suggested a small defect in the articular cartilage, thinning of the patellar cartilage, and narrowing of the medical femoral tibial joint consistent with the early stages of osteoarthritis. In June, 1999, Petitioner underwent steroid injections for continued pain. In September, 1999, Petitioner returned to Dr, Friedman because of continued pain. Dr. Friedman reviewed a video tape that he had made of the arthroscopic surgery and fount that the Petitioner had a fairly large chondral defect of the patella. Dr. Friedman determined that Petitioner was a candidate for ACI, also known as the Genzyme Carticel Procedure (Genzyme Procedure). Dr. Friedman believed that the ACI procedure would benefit Petitioner by providing long-term symptomatic relief with joint pain and mechanical disturbances and improved joint motion function, eliminating the complaints of grinding and catching, and furthering the goal of returning the patient to regular and even strenuous activity. Petitioner then requested authorization for the ACI procedure. The Employer/Carrier denied the request and referred it to the Agency for Health Care Administration for review in accordance with Florida law. The Agency consulted with the University of Florida Faculty Practice Group, and Dr. B. Hudson Berrey, Chair of the Department of Orthopaedics and Rehabilitation, rendered an opinion that the procedure is investigative within the meaning of Rule 59B-11.002(5), Florida Administrative Code. Dr. Berrey further opined that there was not reliable evidence that ACI would provide significant benefit to the recovery and well-being of the injured employee within the meaning of Rule 59B-11.004(3), Florida Administrative Code. The documents and information forwarded to Dr. Berrey by Respondent included Petitioner's medical records provided by Intervenor, K-Mart carrier. Dr. Berrey did not review any actual MRI films, did not review any films taken at the time of the arthroscopic procedure, and in fact only reviewed certain documentation that was supplied to him by the agency. Petitioner was denied her right to present information to Dr. Berrey prior to his forming his opinion for the agency. This was a violation of Rule 59B-11.003, Florida Administrative Code. The agency rendered a decision based upon Dr. Berrey's opinion, declining to order the Employer/Carrier to provide ACI to Petitioner. Autologous Chondrocyte Implantation The ACI procedure was initially developed in Sweden by Dr. Lars Peterson. ACI is a surgical procedure whereby a sample of cartilage is harvested from another area of the joint. The harvesting of the cartilage is performed during an arthroscopic surgical operation. The sample is sent to Boston to the laboratory of Genzyme Tissue Repair, Inc. ("Genzyme"), the owner of the process. Genzyme uses its proprietary process to culture the cells into an estimated 12 million chondrocytes over a period of approximately two months. Genzyme then 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 on the wounded cartilage and covered with the periosteal flap. The ACI procedure thus requires two surgical operations, one arthroscopic procedure and one open procedure. The claimed benefit of ACI is that the cartilage that is generated and implanted onto the knee will be hyaline cartilage or hyaline-like cartilage rather than fibrocartilage. Hyaline cartilage is composed both of the cartilage cells of an extra-cellular matrix. It has greater ability than fibrocartilage to withstand compression and shearing forces. ACI has been shown to produce "hyaline-like" cartilage in some patients. However, it does not reproduce the extra- cellular matrix in which the chondrocytes are found in naturally occurring hyaline cartilage. Alternative Treatments Other available treatments for a defect in articular cartilage of the knees include abrasion chondroplasty, arthroscopic microfracture, and arthroscopic drilling. Many patients get relief with one or more of these alternative procedures and do not need another operation. In addition, a surgical procedure to elevate the tibial tubercle and remove some of the weight from the patella might also alleviate the Petitioner's pain and improve her functioning. Dr. Friedman performed an abrasion chondroplasty during the arthroscopic surgery of September 4, 1998. Dr. Friedman did not offer Petitioner either the microfracture or the drilling procedures. Dr. Friedman had considered performing a tibial tubercle elevation but has not recommended that the Petitioner undergo that procedure either before the ACI is approved or independently of the ACI. Dr. Friedman views the primary purpose of this procedure as assuring the best possible results from the ACI. Dr. Friedman indicated there were no appropriate alternative medical procedures, other then the ACI procedure, available for Petitioner's injury. Dr. Friedman opined that the only viable option of putting back normal articular cartilage underneath the kneecap would be with the ACI procedure. In this opinion, the alternative procedures are not appropriate for and would not benefit Petitioner, as they were merely temporary procedures. Moreover, he emphatically stated that the ACI procedure is the procedure which is appropriate for an would benefit Petitioner. The Evidence That ACI Remains Investigative The Agency for Health Care Administration has not promulgated, endorsed, or approved any particular treatment for injuries to the articular cartilage of the knee in accordance with Sections 440.13(15) or 408.02, Florida Statutes; therefore, there was no Agency-approved protocol for Dr. Berrey to consider in rendering his opinion. Dr. Berrey testified that he could find no articles or publications describing controlled studies in which the effectiveness of ACI compared to any other procedure. Dr. Berrey further testified that he could find no articles about the ACI procedure in peer-reviewed journals in which the authors used objective measures of outcome which compared the patients' condition before and after treatment. The use of blinded or controlled studies is important so that possible confounding factors or variables can be controlled or accounted for and the results measured objectively. Dr. Berrey found that the publications cited by the proponents of the procedure discussed research which was funded by Genzyme, the owner of the process by which the chondrocytes were cultured. The funding of the research by the owner of the process was an additional factor in his determination that the evidence supporting the efficacy of the procedure was not reliable. The Cartilage Repair Registry and the results reported therein do not constitute reliable evidence of the benefits of ACI when compared to other available procedures for two reasons. First, the potentially confounding variables are neither controlled nor accounted for. Second, each surgeon evaluates his or her own work, so that there is no objective, independent measurement or assessment of the condition of each patient before and after surgery. Although the premise on which ACI is based is that the patient's implant will consist of hyaline cartilage rather than fibrocartilage, the available data does not indicate that the results are comprised only, or even primarily, of genuine hyaline cartilage. Rather, the evidence is that some patients develop "hyaline-like" cartilage, or cartilage composed partly of hyaline tissue. It cannot be determined whether hyaline or hyaline- like cartilage has filled a patient's defect without performing a biopsy and a histological evaluation of the tissue. The published reports described in the testimony contain discussions of post-surgical histological performed on very small numbers of patients. The published reports concerning the use of ACI to treat defects of the patella show that the results are not as favorable as those claimed for treatment of the femoral condyle. After the proponents of the procedure began to perform other procedures with the ACI to assure that any defects in the alignment of the patella are repaired, improved results were reported. Dr, Friedman testified about the published results of histological evaluations of 37 patients. Of those, seven underwent ACI to treat defects of the patella. Only one of the seven showed the development of hyaline-like tissue. Further, only two of the seven patella patients reported surgical results classified as good or better. Dr. Friedman opined that the histological data resulting from treatment of defects of the patella had improved since the study described in the preceding paragraph. However, he could not give any reference to the basis for his opinion. Dr. Friedman further testified that the more recent articles discussed the results of patients who had been followed from nine to 15 years. However, the articles and presentations from 1997 to 2000 report on follow-up of the first hundred patients between two and nine years after their surgery. Dr. Billings testified that Dr. Peterson's presentation discussed follow-ups of ACI patients occurring as long as 15 years after surgery. Yet, the March 2000 presentation to the American Academy of Orthopedic Surgeons focused on 40 patients who had been evaluated three or more years after their surgery. The FDA granted an accelerated approval of the Carticel product in 1997. The original accelerated FDA approval was granted for defects of the femoral condyle, the trochlear groove, and the patella. The terms of the approval require that controlled studies be conducted which compare the procedure to other procedures available for the treatment of focal chondral defects, specifically, microfracture and the creation of a periosteal flap without the injection of the cultured chondrocytes. None of the expert witnesses had found in their literature search any published reports of the progress of the controlled studies required under the terms of the accelerated FDA approval. In February, 2000, the FDA approval was modified. Genzyme is no longer permitted to market the ACI procedure or its Carticel product for treatment of defects to the patella. The requirements of Rule 59B-11.004, Florida Administrative Code, differ significantly from those of the accelerated FDA approval process, so that the granting of accelerated approval does not determine the answer to the question whether a treatment is investigative under that rule. The FDA's inquiry addresses the issues of safety and efficacy. However, the accelerated FDA approval process does not address the issues of whether a particular product is more effective than currently existing treatments or is equally cost-effective. Based upon all the evidence, the performance of the ACI procedure on the defects located in the patella is investigative within the meaning of Rule 59B-11.002(5), Florida Administrative Code. The Probability That ACI Would be of Significant Benefit in Returning Petitioner to Work Both of Petitioner's expert witnesses testified that if she does not undergo ACI, it is likely that she will need a total knee replacement. However, neither witness testified that Petitioner currently requires a total knee replacement. No testimony was presented as to when Petitioner might require a total knee replacement. Despite the testimony that ACI has been studied for 20 years, the published reports follow patients only for nine years after surgery. From the current state of the research, it is not possible to conclude that patients who undergo ACI avoid the need for subsequent surgery in ten or more years. The published studies of the results of ACI going out nine years from the date of surgery do not state the number of procedures performed on the patella. No witnesses testified regarding any published studies of the effectiveness of ACI that addressed the extent to which patients had been able to return to work as a result of the procedure. There is insufficient evidence from which to conclude that the ACI is more likely to enable the Petitioner to return to her duties that other available procedures. The Likelihood That the Benefits of ACI Would Outweigh the Risks and the Costs The testimony compared the cost and benefit of ACI with chondroplasty, microfracture or drilling, and, to some extent, a Macquet procedure or tibial tubercle elevation. Each of the other procedures requires only one surgical operation. ACI requires an arthroscopic surgical procedure to harvest cartilage, culturing of the chondrocytes at the Genzyme laboratory in Boston, and followed by an open surgical procedure to create a periosteal flap and to implant the chondrocytes. Petitioner's expert testified that the cost of culturing the chondrocytes alone was between $8,000 and $10,000, in addition to the two surgical procedures. Petitioner's expert compared the cost of ACI to that of a total knee replacement. However, that comparison is not appropriate under the rule because there is no evidence that Petitioner currently needs a knee replacement or that a knee replacement is the treatment generally used to treat her current condition. The cost of the abrasion chondroplasty, the microfracture or drilling procedure would approximate the cost of the first stage of ACI, approximately $2,300. Dr. Billings testified that the cost of the second stage of ACI was greater than that of the first stage. The second stage is an open surgical operation rather than an arthroscopic one. The total cost of the ACI procedure, including therapy, is probably close to the $30,000 required for a total knee replacement, including the therapy required for the total knee replacement. Dr. Berrey testified that published reports of the cost of ACI are as high as $37,000. The ACI requires extensive physical therapy; Petitioner presented no evidence as to the extent to which the cost of this aspect of treatment was included in the total cost of ACI. ACI has been established to be safe, so that the benefits of the procedure outweigh the risks. However, there is insufficient evidence from which to conclude that the benefits of ACI outweigh the additional costs.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order denying approval of the autologous chondrocyte implantation for Petitioner Rebecca Crane. DONE AND ENTERED this 27th day of November, 2000, 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 27th day of November, 2000. COPIES FURNISHED: Jeffrey J. Bordulis, Esquire 570 Crown Oak Centre Drive Longwood, Florida 32750 Lisa J. Hurley, Esquire Pyle, Jones, Hurley & Hand, P.A. 1069 West Morse Boulevard Winter Park, Florida 32789 Michelle L. Oxman, Esquire Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308-5403 Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three, Suite 3431 Tallahassee, Florida 32308 Ruben J. King-Shaw, Jr., Director Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3116 Tallahassee, Florida 32308 Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three, Suite 3431 Tallahassee, Florida 32308
