Findings Of Fact On April 27, 1987, Petitioner filed an application for licensure by endorsement with the Board of Chiropractic (the Board.) On September 13, 1988, an Order stating the Board's intention to deny Petitioner's application for licensure by endorsement was filed by the Board. Petitioner timely filed a request for formal proceedings resulting in the above-styled matter being placed before the Division of Administrative Hearings. As a result of attempts to negotiate a settlement between Petitioner and Respondent, Petitioner filed a second application for licensure on or about June 19, 1989. At the July 27, 1989, meeting of the Board, Petitioner's second application for licensure by endorsement was denied. At the time of the final hearing, an Order had not yet been filed, but was to be forthcoming. The grounds for the Board's denial of Petitioner's April, 1987, application were that: Pennsylvania did not require applicants for licensure to receive a score of at least 75% on each portion of the state licensure exam; Pennsylvania did not require completion of continuing education as required of licensees in Florida; and Pennsylvania permitted licenses to be inactive for five years before said licenses became null and void. The Board of Chiropractic determined that the requirements for licensure in Pennsylvania are not substantially similar to, equivalent to, or more stringent than the current requirements of Chapter 460, Florida Statutes. At the hearing, counsel for Respondent waived the grounds regarding inactive licenses and completion of continuing education. The grounds for the Board's denial of Petitioner's June, 1989, application for licensure by endorsement are that the Pennsylvania requirements for licensure are not substantially similar to, equivalent to, or more stringent than the current requirements of Chapter 460, Florida Statutes. Specifically, the licensure examination administered by the Pennsylvania State Board of Chiropractic does not cover physical diagnosis and x-ray interpretation of chiropractic and pathology films, both of which are covered in the practical examination given by the Florida Board of Chiropractic as a requirement for licensure. Petitioner has taken and successfully completed parts I and II of the National Beard written examination. Petitioner has not taken or passed the National Board Written Clinical Competency Examination (which has been administered only since September, 1987). Petitioner has taken and successfully completed the Pennsylvania state licensure examination in chiropractic. Petitioner has been licensed as a chiropractor in Pennsylvania for 6 years. The pertinent Pennsylvania law in effect at the time that the Board considered Petitioner's applications for licensure by endorsement is set out in the following portions of Section 625.501 and Section 625.502, 63 Pennsylvania Statutes: s. 625.501 Applications for license Requirement for licensure.-- An applicant for a license under this act shall submit satisfactory proof to the board that the applicant meets all of the following: (1) Is 21 years of age or older. Is of good moral character. Has a high school diploma or its equivalent. Has completed two years of college or 60 credit hours. Has graduated from an approved college of chiropractic, with successful completion of not less than the minimum number of hours of classroom and laboratory instruction required by regulation of the board, which minimum shall be at least 4,000 hours. Has passed the examination required under this act. Has not been convicted of a felonious act prohibited by the act of April 14, 1972 (P.L. 233, No. 64), known as The Controlled Substance, Drug, Device and Cosmetic Act, or of an offense under the laws of another juris- diction which if committed in this Commonwealth would be a felony under The Controlled Substance, Drug, Device and Cosmetic Act, unless the applicant satisfies all of the following criteria: At least ten years have elapsed from the date of conviction. Satisfactorily demonstrates to the board that he has made sig- nificant progress in personal rehabilitation since the conviction such that licensure of the appli- cant should not be expected to create a substantial risk of harm to the health and safety of his patients or the public or a substantial risk of further criminal violations. Satisfies the qualifica- tions contained in this act. An applicant's statement on the application declaring the absence of a conviction shall be deemed satisfactory evidence of the absence of a conviction, unless the board has some evidence to the contrary. As used in this section the term "convicted" shall include a judgment, an admission of guilt or a plea of nolo contendere. * * * s. 625.502. Examination * * * Nature and content of examination.-- The examination shall be oral, practical and written, upon the principles and technique of chiropractic and shall include the following subjects: anatomy, physiology, histology, chemistry, pathology, physics, bacteriology, diagnosis, hygiene and sanitation, symptomatology, chiropractic analysis, x-ray, chiropractic principles and a practical demonstration of chiropractic technique. * * * Testing organization.-- All written, oral and practical examinations required under this section shall be prepared and administered by a qualified and approved professional testing organization in accordance with section 812.1 of the act of April 9, 1929 (P.L. 177, No. 175), known as The Administrative Code of 1929, except that the oral and practical examinations shall not be subject to section 812.1 until such examinations are available from a testing organization. Score.-- A license shall be granted to an applicant who meets the requirements of this act and who achieves: An overall score of at least 75% on the entire examination; or An average score of at least 75% on the oral and practical examina- tion and a passing score on the written examination administered by the National Board of Chiro- practic Examiners as such passing score is determined by the national board. (Emphasis added.) The Pennsylvania Board of Chiropractic does not have any published rules regarding licensure of applicants in the State of Pennsylvania. The Petitioner did not prove that the Pennsylvania Board of Chiropractic examines applicants in the area of x-ray interpretation and physical diagnosis. The Petitioner did not prove that the Pennsylvania State Board of Chiropractic required applicants to re-take Pennsylvania's entire examination if any portion was failed. The Petitioner did not prove that the requirement of the Florida Board of Chiropractic that applicants for licensure be tested on ability to make physical diagnoses and to interpret chiropractic and pathology x-ray films is unreasonably restrictive or an extraordinary standard that deters qualified persons from entering chiropractic medicine in Florida or that it creates or maintains an economic condition that unreasonably restricts competition. The Petitioner did not prove that the requirement of the Florida Board of Chiropractic that applicants for licensure must re-take the entire licensure examination if any portion of the examination is failed is unreasonably restrictive or an extraordinary standard that deters qualified persons from entering chiropractic medicine in Florida or that it creates or maintains an economic condition that unreasonably restricts competition. The Petitioner did not prove either that it would be unreasonably restrictive or an extraordinary standard that deters qualified persons from entering chiropractic medicine in Florida or that it would create or maintain an economic condition that unreasonably restricts competition for the Florida Board of Chiropractic to decide that "the requirements for licensure in Pennsylvania are [not] substantially similar to, equivalent to, or more stringent than the current requirements of this chapter [460, Florida Statutes.]" Cf. Section 460.4065, Florida Statutes (1987 and Supp. 1988).
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Board of Chiropractic enter a final order denying the applications of the Petitioner, Norman R. Wiedow, D. C., for licensure by endorsement. DONE and RECOMMENDED this 11th day of October, 1989, in Tallahassee, Leon County, Florida. J. LAWRENCE JOHNSTON 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 11th day of October, 1989.
Findings Of Fact The Petitioner, Frederick Norman, is an orthodontist and acupuncturist who is licensed to practice in both disciplines in New York and in Aruba. He is in the process of moving from Long Island to Naples, Florida, and he seeks to become licensed to practice acupuncture in Florida. To this end, the Petitioner took the August, 1982, acupuncture examination in Florida. He passed all parts of this examination except Part IV which he failed. Part IV is the clinical practical portion of the exam, testing needle insertions, manipulation, and removal. In approximately July, 1981, Harriet Williams, employed as an examination development specialist by the Department of Professional Regulation, began the development of the Florida acupuncture examination. She commenced by reviewing the acupuncture statute and rules for the definition of acupuncture, and the general areas to be tested. In order to prepare the examination, Ms. Williams consulted practicing acupuncture experts regarding the scope of knowledge involved in acupuncture, and what activities are critical to the practice, the basic training requirements for the practice, and which skills would have to be demonstrated to show competency and not be dangerous to the public. Ms. Williams then investigated testing feasibility on the different critical areas of acupuncture in order to develop the practical examination. Practical examinations are by definition not referenced to specific textbooks, but are based on the actual practice of a profession. Other states with acupuncture licensure examinations were consulted and, based on the definition in the statute and the practicalities of the situation, it was decided that the Florida acupuncture examination would involve needle insertion into basic common points, and methods of stimulation which are fundamental and basic to the practice of acupuncture, and that the needling would be done on the candidates themselves. Since the State of California had been conducting licensure examinations and had been licensing acupuncturists since 1976, it was decided that examiners would be requested from California for both the December, 1981, and the August, 1982, examinations. Examiners with five years experience, doctorate degrees in Medicine or Oriental Medicine, vast training, California certification, and active acupuncture practices were requested. The regulation of acupuncture is new and unique in Florida because of the State's limited experience with it. In December, 1981, the Department of Professional Regulation gave the first acupuncture examination for licensure in Florida. In August, 1982, prior to the examination which is the subject of this proceeding, California acupuncture licensure examiners were brought into Florida, and were trained to administer the Florida acupuncture licensure performance examination. They were trained extensively as to their responsibilities and the standards which the State of Florida was looking for. The Department did not specify by rule the criteria by which these examiners were to be selected, as required by Section 455.217(1)(b), Florida Statutes. However, the actual qualifications of the examiners were not challenged in this proceeding. The examiners were selected by the Department on the basis of guidelines which required them to be licensed in California and actually treating patients, to have at least five years experience, extensive training in acupuncture, and a degree in Medicine or Oriental Medicine. The examiners were given standards or guidelines to assist them in judging how to grade a candidate's performance, and they administered the practical acupuncture examination August 2-5, 1982, which was taken by the Petitioner. The Petitioner has a fear of needles which he considers a phobia but not a handicap. He could not look at the acupuncture point while he inserted the needle, because of his phobia. Examiners Miles Roberts and Miriam Lee observed the Petitioner's practical acupuncture performance and marked their examination grade sheets accordingly. From one examiner the Petitioner received a barely passing grade on all three points, and from the other examiner, the Petitioner received a barely failing grade on two points and a low failing grade on the third point. Drchi is the needle sensation which indicates that a specific point has been properly stimulated. The Petitioner claimed to have attained drchi on at least two points, but he was not sure on the third one. There is no objective way for the examiners to ascertain whether or not a candidate has achieved drchi. In order to demonstrate acupuncture needling, it is helpful to do it into a human body, and it is necessary to do it into a specific acupuncture point. Angling of the needle with and against the flow of energy, twisting and twirling, lifting and thrusting the needle, and closing the hole or leaving it open for sedation and tonification, are basic fundamental techniques in the practice of acupuncture, but candidates are not penalized for using any auxiliary methods in addition. The grading criteria for the acupuncture examination is contained in Section 21-12.22(5)(a)-(e), Florida Administrative Code. This rule essentially describes how the examiner should reach a decision about how a grade is cast. This particular grading criteria must be applied through the use of expert judgment. The weight for each grading criteria is also given in this rule. The grading criteria are general in nature, rather than specific and detailed, because of the uniqueness of acupuncture as a technique in Florida. The techniques tested by the exam, however, are basic, fundamental, acupuncture techniques which all entry level licensed acupuncturists should know. The examiners agreed on whether a candidate should pass or fail the August, 1982, acupuncture examination on approximately 81 percent of their observations. On their observations of the Petitioner, this agreement was 86 percent. The pass rate for the August, 1982, acupuncture examination was in the range of 30 percent.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the application of Frederick Norman for licensure as an acupuncturist be DENIED, based on his failure to achieve a passing grade on the August, 1982, acupuncture examination. THIS RECOMMENDED ORDER entered this 5th day of April, 1983, in Tallahassee, Florida. WILLIAM B. THOMAS 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 5th day of April, 1983. COPIES FURNISHED: Carlos Alvarez, Esquire, and Carolyn S. Raepple, Esquire Post Office Box 6526 Tallahassee, Florida 32314 Drucilla E. Bell, Esquire 130 North Monroe Street Tallahassee, Florida 32301 Mrs. Ann Mayne Acupuncture, Executive Director 130 North Monroe Street Tallahassee, Florida 32301 Fred Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
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
The Issue Whether Petitioner should receive a passing grade for the Florida Optometry Licensure Examination taken on July 23 through 25, 2004.
Findings Of Fact Dr. Cook is a licensed optometrist in the State of Michigan. She received her Doctor of Optometry degree in 1985, and became licensed in the same year. Dr. Cook has taken the Michigan, Illinois, and Wisconsin state licensure examinations and passed all three examinations on her first try. For 17 years, Dr. Cook practiced optometry at the University of Michigan Health Services. This was a comprehensive practice, including eye examinations with dilation, treatment of eye diseases, emergency care, and the monitoring and follow-up care of patients with glaucoma, cataracts, and other diseases. Except for providing care to family members, Dr. Cook has not practiced professionally, on a regular basis, since August 2001, when she moved to Florida. Dr. Cook is a Fellow of the American Academy of Optometry. She was accepted at the final hearing as an expert in optometry. Dr. Cook desires to become licensed in Florida to practice optometry. As part of the process to apply for licensure in Florida, Dr. Cook is required to retake parts one and two of the national board examinations and to pass the Florida examination for licensure. She retook the national board examinations and passed on the first try. In August 2003, she took the clinical portion of the Florida examination and failed. In July 2004, Dr. Cook retook the clinical portion of the Florida examination. A passing score on the clinical portion is 80. She scored 75.75 on the July 2004 examination, and, thus, failed the clinical portion. For the clinical examination, Dr. Cook was required to bring her own "patient" upon whom some of the examination's required procedures were required to be performed. Some of the procedures are performed on "patients" brought by other candidates taking the examination. The grading on each procedure in the clinical examination is done by two examiners who are licensed, practicing optometrists. A candidate will be graded by a different set of examiners for the morning and afternoon sessions. The examiners are chosen by the Board of Optometry and trained by the Department's Testing Services Unit and outside practitioner consultants prior to the administration of each examination. The examiners are provided with a set of Grading Standards for their use during the grading of the examination. The purpose of the training and standards is to make the grading process objective and to provide grading uniformity and consistency. The examiners are required to grade and mark their scores independently. They are not to compare or discuss their scoring with other examiners at any time. If both examiners' grades agree, the candidate is given either no credit or full credit, depending on whether the examiners considered the procedures were properly performed. If the examiners disagree on the grading, the candidate is given the average of the two grades actually awarded, which is the sum of the two grades divided by two. If an examiner considers that a procedure is properly performed, the examiner marks the grade sheet with a "Y," indicating a yes. Examiners are taught to give the candidates the benefit of the doubt in borderline cases. If an examiner feels that the performance was borderline, the examiner must indicate "borderline" in the comment section on the grade sheet and specify the reason. If an examiner determines that the candidate did not properly perform the procedure, the examiner marks the grade sheet with an "N," indicating a no. An examiner is required to specify the reason for a no grade in the comment section on the grading sheet. Some of the procedures are performed once for both examiners. Other procedures are performed in groups, meaning that the procedures are performed twice, once before each of the examiners. In grouped procedures, the first examiner will read the directions for a procedure, and the candidate will perform the procedure after the directions are given. The first examiner will read the directions for the next procedure, and the candidate will perform the procedure after the directions are read. This format continues until the grouped segment is completed. The same procedures will then be performed for the second examiner, following the same format used by the first examiner. No records are kept to indicate which examiner graded first or second during any part of the examination. The examination candidate has control over when each examiner grades the candidate. When the candidate is ready to be graded, the candidate is required to say, "Grade me now." Dr. Cook has challenged the grades that she received for the following procedures: confrontational field test; measurement of pupil size; rating patient's response to light; demonstrating the equator and posterior pole during the binocular indirect ophthalmoscopy examination; the anterior vitreous portion of the biomicroscopy examination of the anterior segment; the choroidal crescent, posterior vitreous detachment, A-V three crossings out find and reflex, and hypertensive changes portion of the biomicroscopy examination of the fundus; and measuring eye pressure using a Goldmann Tonometer. A confrontational field test is a gross neurological field test in which the candidate compares her visual field to the patient's to pick up gross neurological defects. The Candidate Information Booklet (CIB) states that the confrontational field test is to be performed as described in Clinical Opthalmology by J.D. Duane. In order to perform this test, the candidate sits in front of the patient about a meter away. The patient covers one eye and looks at the candidate's eye, nose, or other structure so that the patient's gaze is not moving around. The candidate puts her non-moving fingers in different quadrants to test the patient's ability to see the fingers. It is important to keep the fingers stationary while performing the test because moving fingers could be detected by the patient even in a blind field. In other words, a patient who is not able to see a stationary finger may be able to detect a finger that is moving because the motion contributes to the detection. Dr. Cook performed the confrontational field test for both examiners simultaneously. She received .75 points out of a possible 1.5 points for the confrontation field test. Examiner 202 gave Dr. Cook full credit for the examination. Examiner 239 gave Dr. Cook no credit and noted the following in the comment section: "Moving fingers--Init performed 'wiggling fingers' while moving target fingers." Examiner 239 also noted "Did very brief static CF test but fingers moving not stationary." Dr. Cook admitted that she did wiggle her fingers during part of the performance of the examination, claiming that she was testing the patient's peripheral vision, which was not part of the examination. The examination was to be performed within the central 30 degrees. The preponderance of the evidence does not establish that Dr. Cook tested the four quadrants with non-moving fingers. Dr. Cook's score of .75 points is correct. As part of the clinical examination, the candidates are required to measure the size of the patient's pupil. In order to measure the pupil, the candidate must not sit in front of the patient. Sitting in front of the patient creates a stimulus for accommodation, which is a phenomenon where the pupil size changes unless the patient can look and focus on a target at a distance. Dr. Cook measured the pupil size of her patient simultaneously for both examiners. Examiner 202 gave Dr. Cook full credit for her performance in measuring the pupil size, and Examiner 239 did not give Dr. Cook credit for her performance. Examiner 239 noted in the comment section, "candidate sat in front of pt." Dr. Cook received .5 points out of a possible one point for measuring the pupil size during the pupillary examination. Dr. Cook claims that she sat off to the side of the patient, lined up her right eye with the patient's right eye, and asked the patient to sight at a target at a distance. The examiners were off to the side when Dr. Cook performed the procedure. The preponderance of the evidence does not establish that Dr. Cook was in the correct position when she measured the patient's pupil size. Dr. Cook's score of .5 is correct. As part of the examination, candidates are required to rate the patient's pupillary response to light on a pupillary scale. The CIB states, "Pupillary examinations, muscle balance, and motility, should be done on both eyes (including dilated eye)." Examiner 202 gave Dr. Cook full credit for rating the pupil, but indicated that her performance was borderline. Examiner 202 stated in the comment section: "borderline - she was confused about 0 to 4+, but eventually got it." Examiner 239 gave Dr. Cook no credit for her performance, and stated in the comment section: "4+ but did not indicate eye, not used to using 0 to 4 scale." Dr. Cook received .5 points out of a possible one point for rating the pupil on a pupillary scale. She gave the same answer simultaneously to both examiners. When Dr. Cook was asked to rate the pupils of her patient, Dr. Cook was uncertain which scale to use, the Marcus Gunn scale or a true light reflex scale. She indicated that she gave a response for both scales and that one of the responses was 4+. Dr. Cook stated at the final hearing that the left pupil was fixed and dilated, but she did not indicate that she rated the left eye as "0." The preponderance of the evidence does not establish that Dr. Cook advised the examiners of her rating of the left pupil. The score of .5 was correct. The binocular indirect ophthalmoscope (BIO) is an instrument used to examine the fundus, which is the inside back part of the eye. The BIO sits on the candidate's head. There is a small mirror attached, through which another viewer may see the view being seen by the candidate. The candidate holds a condensing lens, which is like a magnifying glass, to evaluate structures in the eye. Examining the fundus with the BIO is a simple procedure, which Dr. Cook performed 14 to 16 times every clinical day for over 17 years. Dr. Cook wore contact lenses during the examination. With the use of contact lenses, Dr. Cook has perfect vision. Dr. Cook adjusted the instrument before the testing procedure started, including adjusting the angle of light and setting the illumination. As part of the examination on the use of the BIO, a candidate is to demonstrate the equator and the posterior pole. In these procedures, the candidate finds the view of the applicable area, one examiner looks through the mirror after the candidate says "Grade me now," and then steps back. The second examiner then looks at the mirror after the candidate again says "Grade me now." Examiner 239 did not give full credit to Dr. Cook in demonstrating the equator. For the portion of the performance which requires the candidate to demonstrate an equator landmark, Examiner 239 gave Dr. Cook a "no" and stated in the comment section: "No clear view through the mirror @ 'Grade me now.'" Examiner 239 also gave Dr. Cook a "no" for an acceptable view of an equator landmark and stated in the comment section: "Dim illumination." Examiner 202 gave Dr. Cook credit for these two performance areas. In the portion of the examination in which the candidate is to demonstrate the posterior pole, the candidate is told that the disc and macula should be seen simultaneously. Examiner 239 did not give Dr. Cook credit for the portion of the examination where the disc and macula are to be viewed simultaneously. Examiner 239 stated in the comment section: "very dim view vis'd ONH not macula." Examiner 202 gave Dr. Cook credit for this portion of the examination. Between the first and second examiners' viewings for the equator and the posterior pole, the patient did not move, Dr. Cook held the focused view still, there was no change in illumination or intensity, and Dr. Cook did not change her position. Thus, it is more likely than not that Examiner 239 was mistaken. Dr. Cook received 3.5 points out of a possible seven points for examining the views of the equator and posterior pole during the binocular indirect ophthalmoscopy examination. She should be credited with an additional 3.5 points. As part of the examination, the candidates were asked to perform an examination using a biomicroscope, which is a microscope combined with a light source that is used to view different structures on the outside and inside of the eye. It is also called a slit lamp. For purposes of the licensure examination, the biomicroscope has a teaching tube attached through the left ocular, and when the examiner looks through the tube she sees the same view the candidate sees through the left ocular. A portion of the examination using the biomicroscope includes grouped procedures. The last procedure on one of the grouped procedures was focusing on the anterior vitreous of the patient's eye. The vitreous is made up of hyaluronic acid and contains vitreal strands made of collagen. As a person ages, the vitreal strands will increase and become more visible. A young patient may have vitreal strands that would be so difficult to see that on viewing the strands the view would appear to be "optically empty." In other words, the vitreous would appear clear on examination. Dr. Cook's patient was a healthy premed student in his early twenties. The patient did not have visible vitreal strands. Before performing the group of procedures, which included the focus of the anterior vitreous, Dr. Cook adjusted the height and width of the light. She set for a direct focal illumination, meaning the light was focused where she was looking. The patient remained still between the procedures, and Dr. Cook did not change the illumination between each grading. Examiner 216 gave Dr. Cook no credit for her focus of the anterior vitreous, stating the illumination was "too dim" and the "vit not seen." Examiner 268 gave Dr. Cook full credit for that part of the examination. Dr. Cook received 1.25 points out of a possible 2.5 points for her performance related to the anterior vitreous portion of the biomicroscopy exam of the anterior segment. Based on the patient's having no visible vitreal strands; the patient not moving between the grading procedures, and Dr. Cook not changing the illumination between grading procedures, it is more likely than not that Examiner 216 was mistaken. Dr. Cook should be awarded 1.25 points for performance of the focus on anterior vitreous. Dr. Cook received 3.5 points out of a possible seven points for her performance related to the choroidal crescent, posterior vitreous detachment, A-V three crossing outs, find and reflex, and hypertensive changes portion of the biomicroscopy exam of the fundus. One of the grouped portions of the examination using the biomicroscope included demonstrating whether a choroidal crescent was present. Determining the presence of a choroidal crescent was the fourth procedure in this grouped segment. A choroidal crescent can be seen when the candidate is looking at the optic nerve and the retina does not come all the way up to the nerve. The choroidal crescent will appear at the edge of the optic nerve. Examiner 268 did not give Dr. Cook any credit for determining whether the choroidal crescent was present, and stated in the comment section, "Did not focus on the edges of the ONH [optic nerve head]." Examiner 216 gave Dr. Cook full credit for the procedure. Dr. Cook did not demonstrate by the greater weight of the evidence that she should be given additional credit for this procedure. Unlike the evidence presented concerning the anterior vitreous, she did not establish that there was no change in illumination, her position, or the patient's position between the grading of the grouped segments. In order to perform the grouped procedures in which she was tested on the presence of the choroidal crescent, Dr. Cook had to move the focus and illumination to different locations related to the optic nerve. The last procedure in the same grouped segment involving the choroidal crescent was demonstrating posterior vitreous separation. Vitreous gel is attached to the back of the eye in several places. When the attachment points for the vitreous are pulled away or become loose, a ring-like structure can be seen where the vitreous pulled loose. Dr. Cook was asked to demonstrate and indicate whether a vitreous separation was present after she performed the procedure involving the choroidal crescent. The proper procedure for checking for posterior vitreous attachment would be to set the proper illumination, focus on the optic nerve, and pull back slightly on the "joy stick." Examiner 268 did not give Dr. Cook any credit for the procedure involving a demonstration of a posterior vitreous separation, stating in the comment section, "Did not pull back." Examiner 216 gave Dr. Cook full credit for the procedure. Again, Dr. Cook failed to establish by a preponderance of the evidence that she should be given additional credit for this portion of the examination. There was no showing that all conditions remained the same when each examiner graded this grouped segment of procedures. Another grouped segment of the examination called for Dr. Cook to start at the optic disc and follow a temporal arcade for a distance of approximately three disc diameters and demonstrate an AV crossing. Dr. Cook was to then indicate whether there were any characteristic hypertensive changes at the crossing. A vascular arcade is a curved shape with blood vessels coming out and arcing toward one another. Most of the blood vessels in the eye are located in this area. Some diseases such as diabetes and hypertension cause changes where the blood vessels in the arcade cross. In order to perform the AV crossing procedure, a candidate has to coordinate the microscope, going up and down and side by side. Lining up is critical on this procedure. Adjustments have to occur separately, once for each examiner. Examiner 268 did not give credit to Dr. Cook for this portion of the examination, stating in the comment section, "No view in the tube." Examiner 216 gave Dr. Cook full credit for the procedure. Dr. Cook has failed to establish that she is entitled to additional points for this portion of the examination. The AV crossing procedure involves making adjustments for each of the examiners as part of the examination, Dr. Cook has not demonstrated by a preponderance of the evidence that all conditions remained the same for each examiner. As part of the examination, candidates are tested on the use of the Goldmann Tonometer, which is a device used to measure eye pressure. The grading on this portion is divided into four categories: illumination at the proper angle, mires alignment, thickness of alignment, and the pressure measurement. Examiner 268 gave Dr. Cook full credit for all categories. Examiner 216 did not give credit to Dr. Cook for having the correct mires alignment, and gave full credit for the remaining categories, indicating that the mires width and the reading of the pressure were borderline. In the comment section, Examiner 216 drew the alignment which he viewed. The mires were not aligned correctly. Dr. Cook received 1.24-1.50 points out of a possible 2.5-3.0 points for the use of the Goldmann Tonometer. Dr. Cook argues that because she was given credit for the pressure reading that it would be impossible for the mires alignment to be incorrect. The reading of the pressure is to test the candidate's ability to read the dial on the tonometer; it is not to determine whether the reading that is on the dial is the actual pressure of the patient. The grading standards require that the examiner put down the reading that he saw during the viewing if it is different from the reading that the candidate gives as a response. Thus, it is possible to be given credit for the pressure reading without having the mires aligned correctly. Dr. Cook has not demonstrated by a preponderance of the evidence that she should be given additional credit for this portion of the examination. None of the examiners testified at the final hearing. The Department did call Dr. Gary McDonald, who was accepted as an expert in optometry.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered awarding Dr. Cook an additional 4.75 points for the clinical portion of the optometry licensure examination given on July 23 through 25, 2004, resulting in a passing grade of 80.25. DONE AND ENTERED this 30th day of June, 2005, 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 30th day of June, 2005. COPIES FURNISHED: Edwin A. Bayó, Esquire Gray Robinson 301 South Bronough Street, Suite 600 Post Office Box 11189 Tallahassee, Florida 32302-3189 Allen R. Roman, Esquire Department of Health Office of General Counsel 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1703 Joe Baker, Jr., Executive Director Board of Optometry Department of Health 4052 Bald Cypress Way, Bin C07 Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
Findings Of Fact Petitioner is the state agency charged with regulating the practice of osteopathic medicine pursuant to Section 20.165, Florida Statutes; Chapter 455, Florida Statutes; and Chapter 459, Florida Statutes. Respondent is, and has been at all times material hereto, a licensed osteopathic physician, having been issued license number OS 006021 by the State of Florida. Dispensing practitioner inspections are conducted by Petitioner to evaluate compliance with the legal requirements imposed on dispensing practitioners. The complete legal requirements imposed upon dispensing practitioners are listed on the "Investigative Services Inspection Form for Dispensing Practitioners", with citations to the proper authority. Practitioners subject to inspections are provided with copies of the inspection forms. On July 19, 1991, Jeannie Lewis, a Department investigator, conducted a routine dispensing practitioners inspection of Respondent's office and prepared an inspection form. During the July 19, 1991 inspection, the following violations were discovered and reported: Respondent was not writing prescriptions for dispensed medication; Respondent was not certifying drugs prior to patient receipt; Respondent was not on the premises when dispensing of drugs occurred; Respondent failed to post a generic drug sign; Respondent failed to initial and date all controlled drug prescriptions dispensed; Respondent's controlled substance prescriptions failed to include the patient's address; Respondent's controlled substance prescriptions failed to include Respondent's DEA number; Respondent failed to place dispensed medication in a child proof container; Respondent's controlled substance prescriptions were not properly maintained. Respondent had no prescriptions for controlled substances dispensed. A deficiencies form was issued and signed by Respondent, following the July 17, 1991 inspection. A second inspection of Respondent's office was conducted on December 17, 1992, and a second dispensing practitioners inspection form was completed. During the December 17, 1992 inspection, Investigator Lewis was accompanied by Charles C. Lewis, then Senior Pharmacist for Petitioner. During the December 17, 1992 inspection by Investigator Lewis and Charles C. Lewis, the following violations were discovered and reported: Respondent was not writing prescriptions for dispensed medication; Respondent was not certifying drugs prior to patient receipt; Respondent was not on the premises when dispensing of drugs occurred; Respondent failed to post a generic drug sign; Respondent failed to initial and date all controlled drug prescriptions dispensed; Respondent's controlled substance prescriptions failed to include the patient's address; Respondent's controlled substance prescriptions failed to include Respondent's DEA number; Respondent's controlled substance prescriptions were not properly maintained; Respondent's controlled substance purchase records were not properly maintained or readily retrievable; Respondent's DEA 222 forms were not completed properly and not available. Respondent's nurse refilled and dispensed medications when Respondent was not on the premises. On February 9, 1993, a Final Order of the Board of Osteopathic Medicine was entered in the case of DPR v. Richard Heston Beers, D.O., DPR Case Number 00-95528. This Final Order adopted the provisions of a Consent Agreement signed by Respondent on November 6, 1992, in which Respondent agreed to receive a Letter of Concern, pay a $2,000 fine, attend a Continuing Medical Education course on the ethical prescription of abusable drugs, and to utilize sequentially numbered triplicate prescription forms for a year following the date of the Order. The Consent Agreement, adopted into the Final Order, also provided that copies of the triplicate prescription forms were to be made available to Petitioner's investigators upon request. Following the second inspection of Respondent's office and the issuance of the Final Order, Respondent sent a letter to Lewis dated March 26, 1993, claiming compliance with the dispensing practitioners requirements and inviting her to re-inspect his office at any time. At the request of the Board of Osteopathic Medicine, a third inspection of Respondent's office was conducted on July 7, 1993, and a third dispensing practitioners inspection form was completed. During this third inspection, the following violations were discovered and noted: Respondent failed to properly label medication for dispensing; Respondent was not properly maintaining his controlled substance prescriptions, in that Respondent did not stamp them with a red letter "C" and store them separately from non-controlled drug prescriptions; Respondent's DEA 222 forms were not completed properly (not available). Respondent failed to utilize sequentially numbered triplicate prescription forms when dispensing medications.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that Respondent be found guilty of violating Sections 459.015(1)(g) and (bb), Florida Statutes. It is further RECOMMENDED that: Respondent shall pay an administrative fine in the amount of five thousand dollars ($5,000.00) to the Board of Osteopathic Medicine within one hundred eighty (180) days of the Final Order of the Board. Respondent shall receive a reprimand from the Board of Osteopathic Medicine. Respondent shall surrender his DEA license for a minimum of two (2) years, and not reapply unless or until he appears before the Board and demonstrates that he can prescribe, maintain, and inventory controlled substances with skill, safety, and within the legal requirements imposed upon dispensing practitioners. Respondent's license to practice medicine shall be placed on probation for a period of one (1) year, including indirect supervision, a review of Respondent's medical records by a monitoring physician, and any additional terms deemed reasonable and necessary by the Board. DONE and ENTERED this 12th day of September, 1994, 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 12th day of September, 1994. 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 through 20. Proposed findings of fact submitted by Respondent. Respondent did not submit proposed findings of fact. COPIES FURNISHED: Hugh R. Brown, Esquire Agency for Health Care Administration 1940 North Monroe Street, Suite 60 Tallahassee, Florida 32399-0792 Richard Heston Beers, D.O. 7505 Aloma Avenue Winter Park, Florida 32792 Harold D. Lewis, Esquire Agency for Health Care Administration 325 John Knox Road Tallahassee, Florida 32303 Sam Power, Agency Clerk Agency for Health Care Administration 325 John Knox Road Tallahassee, Florida 32303
Conclusions THE PARTIES resolved all disputed issues and executed a Settlement Agreement. The parties are directed to comply with the terms of the attached settlement agreement. Based on the foregoing, this file is CLOSED. wy DONE and ORDERED on this the day of Napewdot . 2011, in Cg i Mh fo SECRETARY Agency for Health Care Administration Tallahassee, Florida. A PARTY WHO IS ADVERSELY AFFECTED BY THIS FINAL ORDER IS ENTITLED TO A JUDICIAL REVIEW WHICH SHALL BE INSTITUTED BY FILING ONE COPY OF A NOTICE OF APPEAL WITH THE AGENCY CLERK OF AHCA, AND A SECOND COPY ALONG WITH FILING FEE AS PRESCRIBED BY LAW, WITH THE DISTRICT COURT OF APPEAL IN THE APPELLATE DISTRICT WHERE THE AGENCY MAINTAINS ITS HEADQUARTERS OR WHERE A PARTY RESIDES. REVIEW PROCEEDINGS SHALL BE CONDUCTED IN ACCORDANCE WITH THE FLORIDA APPELLATE RULES. THE NOTICE OF APPEAL MUST BE FILED WITHIN 30 DAYS OF RENDITION OF THE ORDER TO BE REVIEWED. Page 1 of 2 Filed November 17, 2011 3:41 PM Division of Administrative Hearings Copies furnished to: Andrew Sheeran, Esquire Agency for Health Care Administration (interoffice Mail) Daniel Leyton, Esquire De La O, Marko, Magolnick & Leyton 3001 SW 3rd Avenue Miami, Florida 33129 (U.S. Mail) Javier Talamo, Esquire Kravitz & Talamo, LLP 7600 West 20th Avenue, Suite 213 Hialeah, Florida 33016 (U.S. Mail) John D. C. Newton II Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Building Tallahassee, Florida 32399-3060 (Electronic Transmission) Michael Blackburn, Medicaid Program Integrity Department of Health Robi Olmstead, Medicaid Program Integrity Heath Quality Assurance Finance and Accounting CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of the foregoing has been furnished to the above named addressees by U.S. Mail on this the /S “day of Vabe—ber, 2011. Richard Shoop, Esquire a? Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Building #3 Tallahassee, Florida 32308-5403 (850) 412-3630 Page 2 of 2
Findings Of Fact Petitioner passed all parts of the acupuncture examination except sections one and two of Part Four, which was the clinical-practical segment of the examination. That portion required the demonstration of various needling techniques and was independently graded by two observer-examiners. Respondent then averaged the two grades to arrive at a single score for each technique Petitioner was required to demonstrate. Respondent administered its first acupuncture examination in December, 1981, and its second in August, 1982 (at issue here). The examinations were developed and administered in consultation with California examiners, since that state had the greatest experience in testing and licensing acupuncturists. Petitioner raised no factual dispute with respect to examiner credentials, qualifications tested, or the scoring system. Rather, Petitioner pointed to alleged errors by the examiners in administering and grading certain questions. Additionally, Petitioner contends the reading list given for the written portion of the examination was misleading in that it was not intended to apply to the practical portion. Petitioner points to several questions where she received full credit from one examiner and a much lower grade from the other. Rather than averaging the two grades, Petitioner believes the lower grades should be thrown out as errors. However, Respondent instructed its examiners to give full credit where they failed to observe a specific technique or were otherwise uncertain of the performance. Thus, there was no showing that these diverse grades were other than a result of an examiner's failure to observe (for which Petitioner was not penalized). Petitioner further challenges the instructions given, contending the examiner erred in administering certain questions. Again, however, it is at least as likely that Petitioner misinterpreted instructions which were properly given. Petitioner also claims one grade was transferred in error from the examination sheet to the score box. However, it does not appear that the letter written by the examiner, as part of a note, was intended to be a letter grade. Rather, the grade as written in the box provided for that purpose must be accepted as the score assigned by the examiner. Petitioner failed the sanitation portion of the examination by breaking the sterile field. She denies she touched the needle to her shoe strap as stated by the examiner and claims she could not have performed the assignment with her shoe on. This contention was demonstrated to be incorrect by Respondent, and it is probable that Petitioner simply failed to notice her error during the examination. Petitioner contends she was misled by the reading list provided in advance of the examination. It was not clear, as Respondent argues, that the reading list was intended only for the written portions of the examination. However, Petitioner did not show that this misunderstanding prevented her from performing satisfactorily on the practical portion of the examination.
Recommendation Based on the foregoing, it is RECOMMENDED that Respondent enter a Final Order denying the petition. DONE and ENTERED this 14th day of July, 1983, in Tallahassee, Florida. R. T. CARPENTER Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 14th day of July, 1983. COPIES FURNISHED: Clarine Smissman, Esquire 217 North Eola Orlando, Florida 32801 Drucilla E. Bell, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Ann Mayne, Executive Director Board of Acupuncture Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue The issue in this case is whether Patrick Dennis (Petitioner) should be granted additional credit for any physical diagnosis practical examination questions which he answered on the May, 1990, chiropractic examination administered by the Department of Professional Regulation (Respondent), or whether, in the alternative, he should be permitted to retake the chiropractic practical examination at no additional charge.
Findings Of Fact Petitioner is a graduate of the New York Chiropractic College, is licensed to practice chiropractic in New York and New Jersey, and is seeking licensure as a chiropractor in the State of Florida. He took the chiropractic practical examination administered by the Respondent in May, 1990, receiving grades of 96.6% in X-ray interpretation, 95.3% in technique, and 63.75% in physical diagnosis. A grade of 75% on each portion of the practical examination is required to pass. After receiving notification that he had failed the examination, Petitioner timely requested a hearing to determine if he should be granted additional credit on this practical exam. It was established that the practical exam was properly administered, appropriate standardization procedures were followed, and each examiner independently graded Petitioner's exam, and was qualified to serve as an examiner. At hearing, the Petitioner solely disputed the score he received in the content areas of general physical examination and laboratory diagnosis. A four point scoring system is used on the practical examination. A score of 4 means that the candidate demonstrated an exceptional knowledge and understanding of the subject area; a score of 3 represents an adequate understanding; a score of 2 indicates an inadequate knowledge of the subject area; and a score of 1 indicates that the candidate would be a danger to the public if allowed to practice in that particular subject area. If a grader feels that the candidate's answer demonstrates a degree of knowledge that is between two of these scores, a .5 credit can be given. This is a subjective, rather than an objective, scoring system that requires each examiner to use his own judgment in evaluating the completeness of a candidate's response; generally, there are no simple right or wrong answers to practical exam questions. In arriving at a candidate's overall percentage score, a score of 4 equals 100 points, a score of 3 equals 75 points, 2 equals 50 points, and 1 equals 25 points. A .5 score equals 12.5 points. For example, a score of 3.5 would equal 87.5 points. Each content area of the practical exam is weighted equally, and there were 5 content areas in the May, 1990, chiropractic practical exam. Two examiners are used to score each candidate's practical examination, and the scores given by each examiner are then averaged to give the candidate's overall grade. In this instance, out of a possible 4 credits, the Petitioner received a grade of 1 and 1.5 from his two examiners in general physical examination, and grades of 1.5 and 2 from the examiners in laboratory diagnosis. In this case, the Petitioner has presented challenges to the grades he received on these two content areas of the practical exam, general physical examination and laboratory diagnosis. Since there are five portions of the physical diagnosis exam, and an average of 75%, or an average score of 3, is required to pass the examination, a cumulative average score of 15 (3 points times the 5 exam areas) is required. The Petitioner's cumulative average score was 12.75, or 2.25 points short of passage. Thus, he would have to receive an increase of 2.25 points in the average of the grades he received from the two examiners on the general physical examination and laboratory diagnosis portions of the exam, in order to receive an overall passing score. Regarding the general physical examination content area, the Petitioner was asked to describe how a prostate examination should be conducted. Petitioner understood that this was a rectal exam, but he testified that he was not trained to perform such examinations at New York Chiropractic College, and he had not seen one performed. Therefore, he could not, and did not, describe how to perform a prostate exam. The evidence is conflicting concerning whether New York Chiropractic College offered instruction in prostate examinations. The Petitioner testified that such instruction was not offered, but Dr. Todd Zazulia, who graduated from that college in 1978 and who is a licensed Florida chiropractor, testified that such instruction was offered at New York Chiropractic College. Documentary evidence received from the Dean of Academic Affairs at New York Chiropractic College, Dr. Anthony Onorato, confirms Dr. Zazulia's testimony. Dr. Salvatore D. LaRusso graduated from this same college in 1984, after Petitioner and Dr. Zazulia, and he testified that instruction in the examination of the prostate was not offered at that time. The Petitioner testified that he was taught to recognize signs and symptoms associated with prostate problems since they cause lower back pains, and that he was taught laboratory tests that would signify prostatic problems. He admitted that he felt an obligation to recognize potential problems from signs and symptoms associated with the prostate. The greater weight of the evidence supports the Respondent's position that the Petitioner was offered instruction in signs and symptoms of prostate problems, as well as rectal prostatic examinations, at New York Chiropractic College. Therefore, the Petitioner has failed to establish that he should not have been asked a question about prostate examinations on his practical examination. The Respondent introduced competent substantial evidence to establish that some chiropractors in Florida do perform prostate examinations, and that this practice is within the recognized scope of practice of chiropractic in Florida. Although a substantial number of chiropractors in Florida do not perform this examination, and although there is evidence that it is a violation of chiropractic licensing statutes and rules in a majority of states for chiropractors to perform prostate examinations, nevertheless there is no evidence that the Florida Board of Chirporactic has adopted any rule or taken any action against any chiropractor in Florida for performing such examinations. In fact, Dr. Phil Leon, a licensed Florida chiropractor and licensure examiner, testified that he has asked a question about prostatic examinations of almost every applicant he has examined over the past five years. Documentary evidence submitted by the Respondent from other examiners confirms Dr. Leon's testimony that such questions are a regular part of the chiropractic practical examination in Florida, and also indicates that prostatic examinations are covered on the exam given by the National Board of Chiropractic Examiners. Even Dr. Thomas P. Toia, who was called on behalf of the Petitioner, testified that the ability to recognize prostate problems is within the scope of the practice of chiropractic, and that prostate examinations are an authorized chiropractic procedure. Based on the evidence in the record, it is found that the Petitioner has not established that the grades he received on the general physical exam content area of the practical examination were arbitrary or capricious. Dr. Leon testified that he gave the Petitioner a grade of 1.5 because he did not know where the prostate was, could not describe how to perform a prostate examination, and did not evidence an awareness or understanding of the fact that pain in the low back area could be related to the prostate. Dr. Zazulia testified that he also would have given the Petitioner a grade of 1.5. Dr. Toia testified that when a candidate has no knowledge about a particular question, a grade of 1 is appropriate. Regarding the exam content area of laboratory diagnosis, the Petitioner was asked to identify the tests that should be given to diagnose gonorrhea and lupus. For gonorrhea, the Petitioner identified the chocolate agar test, and for lupus, the Petitioner identified the antinuclear antibody test (ANA). While these are correct answers, the Petitioner's grades in this content area were lowered to 1.5 and 2 by the two examiners because he failed to mention an additional test which can also detect systemic lupus, the LE prep test, and he failed to describe how the lab samples are taken and how these tests are performed in the laboratory. Based upon the evidence in the record, it is found that Petitioner has not established that the grades he received on the laboratory diagnosis content area were arbitrary or capricious. While Dr. Toia testified that he would have given the Petitioner higher grades on this content area, Dr. Zazulia supported the grades given. Dr. Zazulia testified that the Petitioner's failure to inform the patient about what they were likely to expect at the lab when they had the tests performed, and his inability to differentiate the test for gonorrhea as a smear, swab or blood test would result in a grade of 1.5. Because systemic lupus affects almost every system of the body, the Petitioner's failure to identify the LE prep test for complete screening was significant and would result in a grade of 2. There is competent substantial evidence in the record to support the grades which the Petitioner received on the laboratory diagnosis content area of the practical exam.
Recommendation Based upon the foregoing, it is recommended that Respondent enter a Final Order dismissing the Petitioner's challenge to the grades he received on the May, 1990, chiropractic practical examination in the content areas of general physical examination and laboratory diagnosis. DONE AND ENTERED this 23rd day of April, 1991 in Tallahassee, Florida. DONALD D. CONN Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 Filed with the Clerk of the Division of Administrative Hearings this 23rd day of April, 1991. APPENDIX Rulings on Petitioner's Proposed Findings of Fact: 1. This is a conclusion of law and not a proposed finding of fact. 2-4. Adopted in Finding 1. Adopted in Findings 1 and 5. Adopted in Finding 1. Adopted in Finding 7. Adopted in Finding 11. Adopted in Finding 11, but otherwise Rejected as not based on competent substantial evidence. Rejected as irrelevant and immaterial. Adopted in Finding 3, but otherwise Rejected as irrelevant and immaterial. Rejected as simply an excerpt of testimony and not a proposed finding. Rejected as citations to statutes and rules and not a proposed finding of fact. Adopted and Rejected in part in Finding 9, and otherwise Rejected as irrelevant and immaterial. 15-16. Rejected as irrelevant and immaterial. Rejected in Findings 8-10. Adopted and Rejected in Finding 8. Rejected as irrelevant and immaterial Adopted in Finding 2, but otherwise Rejected as irrelevant and not based on competent substantial evidence. 21-23. Rejected as not based on competent substantial evidence. Rulings on the Respondent's Proposed Findings of Fact: Adopted in Finding 8. Adopted in Finding 9. Adopted in Finding 10. Adopted in Findings 11 and 12. Copies furnished: Lawrence J. Langer, Esquire 400 Executive Center Drive Suite 210 West Palm Beach, FL 33401 Vytas J. Urba, Esquire Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, FL 32399-0792 Jack McRay, Esquire Northwood Centre 1940 North Monroe Street Tallahassee, FL 32399-0792 Patricia Guilford Executive Director Board of Chiropractic 1940 North Monroe Street Tallahassee, FL 32399-0792
