Findings Of Fact Regulation of those practicing acupuncture first became law in Florida with the passage of Chapter 80-375, Laws of Florida (1980). Therein it was declared unlawful for any person to practice acupuncture in this state unless such person has been certified by the Department of Professional Regulation. This statute, as amended, and now contained in Section 468.323, Florida Statutes (1981), requires an applicant for certification to practice acupuncture in this state to pass an examination which tests the applicant's competence and knowledge of the practice of acupuncture and "includes a practical examination of the skills required to practice acupuncture, covering diagnostic techniques and procedures, point/meridian selection, needle insertion, manipulation and removal, patient care, sanitation and antiseptic application." The technique of point/meridian selection, needle insertion, manipulation and removal, which Section 468.323 requires a successful applicant to demonstrate are techniques basic to traditional Chinese acupuncture. All of these Petitioners failed the clinical practical portion of the examination given in August, 1982. The August, 1982, examination was the second examination given in this state to applicants for certification to practice acupuncture. The first examination was given in December, 1981. Due to the lack of known-to-be qualified examiners in Florida, Respondent contacted the State of California, who has licensed acupuncture practitioners since 1976, and arranged to have acupuncturists who have served as examiners in California, serve as examiners for the practical part of the Florida examination for the examinations given in December, 1981, and August, 1982. All of the examiners who administered and graded the practical portion of the August, 1982, examination have practiced acupuncture for at least five years and have served as examiners in California for at least three years. Most of these examiners hold degrees in medicine or oriental medicine and all are highly qualified acupuncturists. All of these examiners were assembled before the commencement of the examination and instructed for twelve to eighteen hours to assure that all were grading on the same scale and their grades would be as consistent as practicable. They were provided with Acupuncture Examiner Manual (Exhibit 14) which contains grading criteria for each task on the practical examination. Petitioners contend that this examiner manual established grading criteria for procedures that are unnecessary and/or not practiced by many acupuncturists, thereby taking from the examiners the initiative to grade the examinees on their overall demonstration of acupuncture techniques. A careful review of Exhibit 14 does not compel this conclusion. To the contrary, Exhibit provides the examiners with examples of techniques that demonstrate competence as well as techniques demonstrating superior performance. As noted below, the areas in which the greatest number failed was in location of acupuncture point and length of needle/angle of insertion/manipulation. In the former a passing grade was given if the candidate needled on the proper meridian. A superior grade resulted if the candidate was less than one-half inch off point and on the meridian. In the latter the candidate received a passing score if he got two of the three, viz, angle of insertion, length of needle and/or manipulation, correct. Either twisting and twirling or lifting and thrusting of the needle was accepted for manipulation for either tonification or sedation. Instructions were mailed to all applicants advising of the time and place of their examination; the format of the examination; the bibliography of books to study for Part II of the examination, Theory and Practice of Acupuncture; how Part IV of the practical examination will be graded and that it will consist of: (1) Needle Insertion, Manipulation and Removal and (2) Patient Care, Sanitation and Antiseptic Application (Exhibit 4). Also forwarded to the applicants were the rules governing acupuncture clinics, Chapter 10D-81, Florida Administrative Code, and Chapter 21-12, Florida Administrative Code, covering licensing procedures for acupuncturists, including scope of the examination. Every examinee's scores for items 6, 11, and 16 on Part IV.1 of the August, 1982, examination intended to test examinees' performance in needle inspection prior to insertion were invalidated by Respondent at the examination because: Candidates did not adhere to this criteria, it would appear that while this is a vital precautionary measure to be utilized in the practice of acupuncture, candidates, however, consistently failed this criteria. The contention is that since applicants used newly purchased pre-packaged needles, disposable needles, and their personal needles, the assumption is that candidates were confident of the "good" condition of needles, and with the exception of one candidate this appears to be true. Prior to the August, 1982, acupuncture licensure examination, Respondent did not specify to Petitioners any text as reference for the clinical practical portion (Part IV) of the examination, nor did Respondent expressly notify Petitioners that they would be tested on points/meridian location in Part IV.1 of the examination. Respondent did not instruct examiners for the August, 1982, examination that they had to determine the accuracy of Petitioners' point/meridian location through the examinees' use of the proportional measurement method, including the comparison of the size of their hand to Petitioners' hands, and then palpation, and the examiners did not use this method of determining the accuracy with which Petitioners located acupuncture points on the clinical practical examination. Respondent did not notify Petitioners expressly in writing prior to the examination that they were required to insert the needle at an angle, either with or against the flow of energy along the meridian, in order to receive a score for "correct angle" on the August, 1982, acupuncture licensure clinical practical examination. Respondent did not notify Petitioners expressly in writing prior to the examination that they had to demonstrate one of the needle manipulation techniques known as "twisting and twirling" or "lifting and thrusting" in order to receive a score for "correct manipulation" on the August, 1982, acupuncture licensure clinical examination. Respondent did not notify Petitioners by rule or otherwise that "needle manipulation" would be graded in two separate items on the grade sheet for each acupuncture point on the examination. Nor did Respondent notify Petitioners expressly in writing prior to the examination that they had to close the hole for tonification and leave the hole open for sedation in order to receive a score for "proper removal" of the needle on this examination. Respondent did not notify Petitioners expressly in writing prior to the examination that they had to cleanse hands by washing with soap or scrubbing with alcohol or an antiseptic solution prior to handling needles and that they had to maintain "sterile hands" when handling any of the needles in order to receive a "pass" score for item 2 of Part IV.2 of the examination. Nor did Respondent so notify Petitioners that they had to use an antiseptic agent, such as betadine solution, hydrogen peroxide, or alcohol, to cleanse the skin area in which needle insertion was to be performed in order to receive a pass score for item 3 of Part IV.2 of this examination. Nor did Respondent so notify Petitioners that once their hands had been cleansed the cleansed hands could not be used to adjust their clothing or in any other manner that would not maintain sterility in order to receive a "pass" score for item 4 of Part IV.2 of the examination. Respondent did not adopt a rule specifying the criteria by which examiners were to be selected prior to the August, 1982, acupuncture examination, nor did Respondent adopt a rule specifying point/meridian location as a grading criterion for the August, 1982, examination. "Superior manipulation" and "extreme care exercised" are not terms of art in the practice of acupuncture. Acupuncture is defined in the statutes and rules to mean "the insertion of needles into the human body, or the treatment of specific skin areas by means of mechanical, thermal, or the electrical stimulation, for the purpose of controlling and regulating the flow and balance of energy in the body." There are numerous "schools" of acupuncture throughout the world where "masters" teach different techniques. However, all of these schools teach the traditional Chinese theory of acupuncture which is to balance the energy in the body by "tonifying" those areas where there is insufficient energy and "sedating" those areas with too much energy. No evidence was presented that different acupuncture "points" are used at the differing schools of acupuncture or that proper results can be obtained if the needle is not inserted accurately on the point to he needled. These "points" are where needles are inserted and manipulated to increase or decrease the flow of energy on that meridian. The differences in these schools of acupuncture, including the western or scientific, consists mainly of techniques used to attain the desired end. Of these techniques, depth of needle, angle of insertion, and how a needle is manipulated to stimulate the point are perhaps the most significant. Of the three texts referred to the applicants for study, two describe the traditional Chinese art of acupuncture, while the third, by Felix Mann, tests the Chinese art of acupuncture against western scientific bases to demonstrate the efficacy or lack thereof of some of these procedures. While a scientific basis for certain of the traditional Chinese theories cannot be demonstrated, Mann, and others in the scientific world, contend these theories to be without merit. Pursuant to the Chinese school of acupuncture, both depth and angle of insertion of the needle are important. For tonification this school teaches that the needle be angled with the flow of energy, and stimulation of the point is attained by: (1) Repeatedly lift the needle gently subtaneously, then thrust it back with force; (2) Twist and twirl the needle back and forth with small amplitudes and slowly; (3) Insert the needle slowly, twirl it gently. When withdrawing, rest the needle just beneath the skin for a short interval, then withdraw it swiftly; and (4) After withdrawing the needle, close the acupuncture hole by applying slight pressure over it, preventing the vital energy from the channel from escaping. For sedation the needle is inserted against the flow and the manipulations above-noted for tonification are, insofar as practicable, reversed and the hole is left open for the excess energy to escape (Exhibit 6). Traditional Chinese acupuncture emphasizes the importance of point location, angle of insertion, depth of penetration of the needle, the type manipulation used and opening or closing of the hole. All schools emphasize the importance of point location. Some schools, finding little scientific basis for angle and depth of insertion, de-emphasize the importance of these techniques. Many contend that there is no basis for angled insertions solely for tonification or sedation, that with adequate stimulation, depth of needle is unimportant and that almost any type of stimulation is adequate for either tonification or sedation. Little scientific basis for leaving the hole open or closing the hole for sedation and tonification, respectively, has been demonstrated. Since many acupuncture practitioners in the western world, particularly medical doctors, attain stimulation by the use of electricity, and electricity will pass through body tissue easier than manually transmitted vibrations of the needle, the depth of penetration for these practitioners using electrical stimulation is not particularly important. Accordingly, those practitioners give little weight to depth of penetration. Manipulation of the needle during and after insertion consists principally of lifting and thrusting or twisting and twirling. The needle can be moved only in three dimensions, but the speed and amplitude of those movements can be varied. Variations of the speed, amplitude and direction of the movement of the needle are obtained by "plucking" the needle, "scraping" the needle, "shaking" the needle, "flying" the needle, and "trembling" the needle. (Exhibit 28) Movements in certain directions with emphasis are specified for tonification and other movements for sedation are important in the practice of traditional Chinese acupuncture. In the instructions given to the applicants, including all of these Petitioners, they were directed to bring acupuncture needles of various sizes they would use in their practice and all material needed for sanitation and antiseptic application. For Part IV of the examination, each applicant was advised prior to the examination (Exhibit 5) that he/she would be required to perform needle insertion, manipulation and removal on themselves for three different acupuncture points, that the examiner will designate the points on which needle insertion, manipulation and removal are to be performed; that they were to demonstrate for the examiners how they would treat a patient in their clinic when performing needle insertion, manipulation and removal; that they are required to demonstrate only the proper sterilization and sanitation procedures and proper needling techniques for the designated acupuncture points; and that minutes is allotted for this portion of the test. The examination was conducted in a motel room having a sink for the applicant to wash his hands, a straight chair and coffee table for applicant to sit on and set up his equipment and two chairs for the two examiners. Upon entry into the room, each applicant was given the information contained in Exhibit 10. Several Petitioners testified Exhibit 10 was not read to them, while all examiners testified that Exhibit 10 was read to each applicant. All Petitioners who testified prepared a lower leg for acupuncture, all acknowledged that they used a different needle for each insertion, and each acknowledged that he/she was directed to tonify or sedate three specific points. Exhibit 10 directs the procedures each Petitioner testified he followed with the possible exception of the words "using correct angle and needle manipulation" following the directions to "tonify spleen 6" or "sedate liver 4." While a few of the Petitioners attributed their failure to use correct needle angle prescribed by traditional Chinese acupuncture to the failure of the examiners to so instruct them, most of the Petitioners who didn't angle the needle testified that they used a perpendicular needle angle of insertion of the needle because they didn't believe in the efficacy of angling the needle; or to the instruction to insert the needle as they would on a patient in their clinic. Since they didn't use angled insertions on their patients or "close the hole" or "leave the hole open" when treating their patients, they didn't demonstrate the use of those techniques on the examination. Petitioners' primary complaints about the examination concern the failure of Respondent to more specifically tell them exactly what they would be required to do on the practical part of the examination to obtain a passing grade. Su Liang Ku was a successful applicant for licensure on the August, 1982, examination and testified as an expert witness in these proceedings. He acknowledged that the instructions that he was given were not all-encompassing and that he did not always "close the hole" when applying tonification procedures to patients in his office; however, he clearly recognized the need to demonstrate to the examiners all of the appropriate techniques when taking an examination. Ku had taken exams in Burma, China and California before taking the Florida examination and was not surprised by the tests he was asked to perform on the practical examination or uncertain whether the needle should be angled, the hole closed or left open, or whether he should demonstrate more than one technique used to stimulate the point. Had some of these Petitioners recognized and kept in mind this innate distinction between adequate clinical procedures and examination procedures, they, too, would have passed this examination. Petitioner William Skelton failed Part IV of the examination largely because he was graded zero by both examiners for "needle manipulation and removal" for two of the three points. He was also given a below average by both examiners on needle length for one point. Skelton understood he would be examined on traditional Chinese acupuncture, and to tonify a point, he angled the needle in the direction of flow. He also understood point location was very important and that when told to tonify Spleen 6 he was expected to insert the needle at the correct point. Despite his acknowledgment that he understood he was being examined in traditional Chinese acupuncture, Skelton closed the hole on one point traditional Chinese acupuncture indicates should be left open. Petitioner Anna Alvarez failed Part IV of the August, 1982, examination largely as a result of the marks she received from both examiners on length of needle/angle of insertion/manipulation. These marks were 2 for both examiners for points 2 and 3 while for point 1 examiner A scored her performance zero and examiner B scored it 2. Had a passing mark from each examiner been awarded for all three points on this item of the examination, she would easily have passed Part IV of the examination. Ms. Alvarez testified that she did not understand she was being graded on point selection; however, she received passing marks in accuracy of location of acupuncture points from both examiners for all three points. Ms. Alvarez also testified that she achieved chi at two points and after receiving chi it is not necessary to manipulate the needle. While this procedure may well be appropriate in practice, the examiner can hardly determine that the applicant is competent as an acupuncturist unless acupuncture techniques are demonstrated. Simply announcing the arrival of "chi" after which additional stimulation may not be necessary, does not demonstrate manipulation. On the third point, Liver 4, she testified that she did not want sedation so she did not try to get chi. She also testified that the needle was inserted perpendicular to the skin for each point. One of the criteria tested on this part of the practical examination is angle of insertion. While the efficacy of angle of insertion is disputed by many, it is entrenched in traditional Chinese acupuncture and all candidates were aware that the examination would be in this field. Applicants were not given a failing score if needle was not angled, but received a higher score if this technique was demonstrated. Petitioner Paul Gonzalez failed Part IV of the August, 1982, examination largely because of the grades he received in accuracy of location of acupuncture point and in length of needle/angle of insertion/manipulation. For point one, Gonzalez was marked zero by both examiners. He testified that he was told to do Liver 8 and he got mixed up and inserted the needle at Kidney 8. He also testified that he had brought only 1-1/2 inch needles to the examination despite instructions received in Exhibit 4. On cross examination he testified that he had other needles with him but used only 1-1/2 inch needles in the examination. Gonzalez expected to he tested on traditional Chinese acupuncture procedures and attempted to demonstrate those techniques and needle insertion and manipulation. However, of the six grades received for each of the four sections on which the candidates were graded (two examiners x three points) Gonzalez received 2 - 3's and 4 - 2's for length of needle/angle of insertion/manipulation. Only on point 3 did his total score for a point reach the passing level of 3. Gonzalez angled the needle against the flow when he was told to sedate Gall Bladder 41. He also testified he was not told to tonify or sedate the other two points; however, this is contrary to the testimony of the examiners that they read Exhibit 5 to all applicants and to the testimony of other witnesses that they were told to tonify or sedate each point to be needled. Petitioner Edward Rumsey failed Part IV of the August, 1982, examination after receiving zeros from both examiners on point selection for point 1, a 3 and a 0 for point selection for point 2, and 2 - 2's for point selection for point 3. For needle manipulation and removal he received zeros from both examiners for points 1 and 2. In each of the 4 techniques tested for the three points, Rumsey received a total score less than 12 which reduces to an average score of less than 3 needed for passing. Rumsey testified he studied the books on Chinese acupuncture listed on Exhibit 4. When told to tonify Stomach 36, he inserted needle perpendicular to the skin. When told to tonify Spleen 10, he inserted the needle at an angle to the flow. When told to sedate Gall Bladder 41, he again inserted needle perpendicular to the skin. Rumsey further testified the only manipulation technique he used was twisting the needle and he didn't demonstrate closing the hole or leaving the hole open. As with other applicants, the examiners who tested Rumsey were seated in chairs facing Rumsey and could observe him clearly. Rumsey, as did several other witnesses, contended the examiners could not ascertain the needle was inserted more than 1/2 inch from the correct point unless they actually measured. The various acupuncture points are located a certain number of "cuns" from an anatomical landmark and there are a specified number of cuns between two anatomical landmarks. For example, Exhibit 9, p 91, shows there are 8 cuns between the nipples on a man's chest. An experienced acupuncturist should be able to locate a point with considerable accuracy by viewing the anatomical landmark and, by eye, selecting the point 3/8, 1/4, etc. of the distance between these landmarks. Petitioner, David Bole, failed part IV of the August, 1982, examination because he received an average score high enough to pass only one of the four criteria graded by the examiners, viz, "condition of needle - handle comes in contact with skin." On needle manipulation and removal, he received for point 1 a 0 and a 3; for point 2 - 3 zeros; and for point 3 - 2 fours. On accuracy of point location, Bole received 2 - 3's for point 1; a zero and a 3 for point 2; and a 4 and a 3 for point 3. For length of needle/angle of insertion/manipulation, he received scores of 3 and 2 for point 1; 2 and 3 for point 2; and 3 and 4 for point 3. Bole also received a mark of at least one fail by both examiners in the sanitation part of Part IV. Any grade of fail in the sanitation portion of the examination results in a final grade of fail. Bole testified he holds a Ph.D. in psychology and has been practicing acupuncture under the supervision of a medical doctor. He studied the recommended texts to prepare for the examination, but relied on his experience, past training and instruction to proceed as he would with a patient in his own clinic, in demonstrating his proficiency in traditional Chinese acupuncture. Bole testified he inserted the needle at an angle with the flow when directed to tonify and against the flow when directed to sedate. He also demonstrated closing the hole or leaving the hole open as appropriate. He used the same swab to clean all points as well as to seal the hole and he used 1-1/2 inch needles for all points. Bole acknowledged that knowing length of needle used allows the examiner to determine the depth the needle is inserted. His principal objection is that insufficient directions were given to applicants for the applicants to understand exactly what they were expected to demonstrate. Harvey J. Kaltsas failed Part IV of the August, 1982, examination by reason of the low scores he received in accuracy of locating acupuncture point and length of needle/angle of insertion/manipulation. On point location Kaltsas received passing grades of 3 by each examiner for points 1 and 2, but for point 3, received grades of 0 and 2. For length of needle/angle of insertion/manipulation he received a 2 from each examiner for point 1, a 3 from each examiner for point 3, and one 2 and one 3 for point 2. Kaltsas testified that in his training, the angle of insertion of the needle is the most important factor in needling. To prepare for the examination Kaltsas studied the texts recommended in Exhibit 10 and assumed the examiners would be looking for methods of tonification and sedation discussed in the books on traditional Chinese acupuncture. For each of the three points he was told to tonify or sedate, he inserted the needle perpendicular to the skin. Kaltsas also testified he didn't think the examiners were looking for point location because they didn't take physical measurements to check the accuracy of each point he needled. Petitioner Marie Burleson failed Part IV of the August, 1982, examination partly as a result of running out of time before point 3 was needled. However, even if the score on point 3 could be ignored, Burleson would have failed all of the criteria except "needle manipulation and removal." For the accuracy of location of the two points needled, Ms. Burleson received two 2's for point 1 and one 2 and one 3 for point 1. Zeros were given for point 3. For length of needle/angle of insertion/ manipulation, Burleson received a score of 3 from one examiner for points 1 and 2, but a score of 1 from the other examiner. For a "condition of needle" Petitioner received a score of 4 from one examiner for points 1 and 2, but received a score of 0 and 3 from the other examiner. Both the examiners scored Burleson zero on point 3. Burleson attributed her difficulty in not completing point 3 to the fact that she had no comfortable place to put her foot while she was needling the leg. She testified that when she started to insert the needle in point 3, her foot slipped off the chair and the needle was bent. Burleson is a graduate of an acupuncture school in California from which she took most of her studies by correspondence. She spent only one month full-time in classrooms before graduation. At the examination, Burleson used a one-inch needle inserted perpendicular to the skin for both points 1 and 2. She demonstrated closing the hole for the two points tonified. Petitioner Henry Meritt failed Part IV of the August, 1982, examination as the result of failing all of the criteria except "condition of needle" for which he was graded a 3 by each examiner for each of the 3 points. He also failed the sanitary part of Part IV with respect to his handling of needles. For accuracy of location of acupuncture point Meritt scored 3's for points 1 and 2 and zero for point 3 by both examiners. For length of needle/angle of insertion/manipulation, Meritt scored a zero and 2 for point 1, two 2's for point 2, and a zero and a 3 for point 3. For "needle manipulation and removal" both examiners scored Meritt zero for points 1 and 2 and he received a 2 and a 4 for point 3. Meritt contends he was not instructed to demonstrate how he located the points to be needled and that he thought, as did others, that point location was to be graded only in Parts II and III of the examination. In view of Finding of Fact 5 above, that point location is the most important element in acupuncture, such contentions are simply not credible. Without inserting the needle on the point or at least on the meridian on which this point is located, the desired results are not obtainable. This Petitioner testified tonification is obtained simply by leaving the needle inserted and without manipulation, that he used 1-1/2 inch needles for all points, that it was immaterial what length needle he used because they were inserted only 1/4 inch and that his two examiners were unprofessional during the time he was in the room taking his practical examination. He graduated from Doctor Dale's Institute in New York and refers to himself as Dr. Meritt although he has no doctoral degree in medicine or anything else. Petitioner Charles McWilliams failed Part IV of the August, 1982, examination by reason of obtaining a total score from both examiners below that required for passing in all of the criteria tested except "condition of needle - handle comes in contact with skin" on which he received a score of 3 from each examiner for each of the 3 points. For accuracy of location of acupuncture points, examiner A gave him a 4 for each of the 3 points, while examiner B awarded him scores of 3, 2 and 0 for points 1, 2 and 3, respectively. For length of needle/angle of insertion/manipulation for point 1 he received scores of 1 and 2; for point 2 scores of 2 and 3; and for point 3 scores of 2 and 2. For "needle manipulation and removal" for point 1 he received scores 2 and 0; for point 2 scores of 2 and 0; and for point 3 scores of 0 and 3. McWilliams testified he understood the practical part of the examination would be based on the texts to which he had been referred in Exhibit 4; that he angled his needle; that a 1-1/2 inch needle was used to tonify Stomach 36 (point 1) and Spleen 10 (point 2) and a 1-inch needle was used to sedate Gall Bladder 41 (point 3); that when he withdrew the needle from point 3, a drop of blood appeared and he put a swab on the hole; and if the latter motion constituted closing the hole, he closed the hole at point 3. McWilliams does not adhere to the theory that closing the hole or leaving the hole open is effective in tonification or sedation. Petitioner James Bissland failed Part IV of the August, 1982, examination because of failing scores received in accuracy of location of acupuncture point and length of needle/angle of insertion/manipulation and because he received a fail score from examiner A on the use of antiseptic solution on the skin prior to needle insertion on all three points needled. Bissland's scores for accuracy of point location were 2's for points 1 and 2 and 3's for point 3. For length of needle/angle of insertion/manipulation he scored a 1 and a 2 for point 1; a 1 and a 2 for point 2; and 2's for point 3. Bissland contends he did not know he would be graded on accuracy of point location but, had he known, he would have done nothing different than he did on the examination. Bissland studied the texts referred to in Exhibit 4 and expected Part IV of the examination to be a demonstration of the knowledge presented in Parts II and III. When told (by Exhibit 5) that he should demonstrate to the examiners the procedures he used in his own clinic, Bissland testified that is what he did. For each point Bissland used a 1-inch needle and a Japanese shallow needle technique with each needle penetrating 1/4 to 1/2 inch. No angling of the needles was performed. Bissland normally provides stimulation by electricity and does not angle the needles unless anatomically necessary. Since he was advised that electrical stimulation would not be allowed on the examination, he demonstrated slow and rapid insertion of the needle, slow and rapid rotation of the needle, and what he considered proper removal of the needle. Petitioners' expert witness, Peter Lu, took and passed the acupuncture examination in August, 1982. His father and grandfather were both Chinese medical doctors and Lu graduated from Hong Kong Western Pacific College where he studied acupuncture and Chinese medicine for four years. He considers point location and depth of needle insertion very important in acupuncture and an examiner can judge the depth of insertion by the length of the needle used. He was taught for tonification to angle the needle with the flow and to close the hole to prevent the escape of energy. For sedation he was taught to angle the needle against the flow and to leave the hole open to release the undesirable energy. Lu would consider a demonstration unsatisfactory if an examinee bent a needle while needling himself. Petitioners presented an expert witness who opined that test results on a practical examination were unreliable when two examiners on a scale of 0 to 4 gave scores 3 or more points apart. Here, the examiners were directed to give the applicant being tested a passing score if they could not clearly see what the applicant was demonstrating. This expert also testified the grades are unreliable where one examiner awards a pass and the other a fail. On the sanitation and antiseptic application part of the examination, the only grades authorized are pass and fail. At one point on the scale on which such performance is weighed there must be a equipoise between pass and fail. Thereafter, whichever way the scale is tilted determines the grade assigned. In this examination, the two examiners agreed on the grade to be assigned for 81 percent of the applicants. Part of the 19 percent on which they disagreed can be attributed to the instructions to award a pass score if the demonstration couldn't be clearly seen by the examiner. Even without this instruction, a difference of only 19 percent is a reasonable deviation in scores assigned by two examiners.
The Issue At issue in this proceeding is whether Petitioner is entitled to a passing score on the Physical Diagnosis portion of the May 2001 chiropractic licensure examination.
Findings Of Fact Pursuant to Chapter 456, Florida Statutes, Respondent is the agency of the State of Florida that develops, administers, scores, and reports scores for licensure examinations, such as the examination at issue in this proceeding. The Board of Chiropractic Medicine is created as a part of Respondent by Section 460.404(1), Florida Statutes. Pursuant to Section 456.013(4), Florida Statutes, this Recommended Order is to be forwarded to the Board of Chiropractic Medicine, which will enter a final order. Section 460.406(1), Florida Statutes, provides that anyone seeking licensure as a chiropractic physician must pass a licensure examination. The Florida Chiropractic Medicine Licensure Examination consists of two portions: (a) a practical examination and (b) a Florida Laws and Rules examination. The practical examination is further subdivided into three areas: (a) interpretation of chiropractic and pathology films (the X-ray portion), (b) physical diagnosis, and (c) technique. A candidate cannot be licensed as a chiropractic physician until he or she has passed all portions of the licensure examination, including the physical diagnosis portion. In May 2001, Petitioner sat only for the physical diagnosis portion, having passed all other portions in a prior examination. The physical diagnosis section is a practical examination that tests a candidate's competency to choose, name, demonstrate, and interpret diagnostic imaging and laboratory reports based on a hypothetical case history. The examination generally presents a case history, including the patient's complaint and vital signs, then asks a series of questions designed to lead to a diagnosis. The examination also asks some separate, stand-alone questions designed to elicit knowledge of specific techniques, such as how to obtain particular diagnostic imaging views. The physical diagnosis section of the May 2001 examination consisted of 26 tasks, for which varying numbers of points were awarded for correct answers. Two examiners evaluated the candidate's performance and independently awarded scores for each task. Petitioner's overall score was the average of the two examiners' scores. The examiners who scored Petitioner's performance on the physical diagnosis section met the criteria for selection as examiners. An examiner must have been licensed in Florida as a chiropractor for at least five years, must not have had a chiropractic or other health care license suspended, revoked, or otherwise acted against, and must not be currently under investigation by the Department or any other state or federal agency. Rule 64B2-11.007(1), Florida Administrative Code. The Department requires each examiner to attend a training session prior to administration of the examination. The training is designed to ensure that scoring standards are uniform and objective among the various examiners. The examiners who scored Petitioner's performance on the physical diagnosis section had successfully completed the training session. The first series of questions on the physical diagnosis section dealt with a female patient in her early thirties whose main complaint was constant, severe pain in her left calf. The patient's temperature was slightly elevated at 99.8ºF, and she had swelling in her left ankle. Ultimately, the candidate was expected to arrive at a diagnosis of thrombophlebitis, inflammation of a vein in the left calf. Tasks 1 and 2, for which Petitioner received full credit, required the candidate to obtain a case history from the patient and to discuss the physical examination the candidate would perform on the patient. Task 3 asked the candidate to identify what laboratory tests or diagnostic procedures, if any, should be used to assist in arriving at a diagnosis. Task 4 asked the candidate to state his reasoning for choosing these tests. The correct answer to Task 3 was that the candidate should order either an erythrocyte sedimentation rate (ESR) test or a C-reactive protein (CRP) test. The correct answer to Task 4 was that the ESR and CRP assess the inflammatory processes that the candidate should suspect in the patient's left calf. On Task 3, Petitioner responded that he would order a complete blood count (CBC) and a urinalysis. On Task 4, Petitioner responded that he chose these tests because the patient's increased temperature indicated that there might be an infection present, and that a CBC and urinalysis are useful tests for infection. Task 3 was worth a maximum of four points. Task 4 was worth a maximum of three points. Each examiner independently awarded Petitioner zero points for Task 3 and for Task 4. The results of the physical examination, particularly "Homan's sign," or pain in the calf with dorsiflexion of the foot, caused Petitioner to suspect thrombophlebitis. Petitioner knew of no laboratory test that returns a specific positive result for thrombophlebitis. He introduced textbook references to establish that the ESR and CRP tests are not specific to diagnosing thrombophlebitis. Petitioner did not believe that Tasks 3 and 4 gave him the option of ordering no laboratory tests at all, so he chose the most common tests that would at least confirm that no infection was present. Dr. Densmore, Respondent's expert, agreed with Petitioner that a positive Homan's sign is specific for diagnosing thrombophlebitis. However, he disagreed with Petitioner's choice of ordering a CBC and urinalysis. Dr. Densmore admitted that many doctors order these tests as a general standard for all patients, but stated that in this case they would do nothing to narrow the diagnosis. The CBC and urinalysis are useful for identifying infections; thrombophlebitis is an inflammatory disease, not an infectious disease. Dr. Densmore conceded that ESR and CRP are not specific to thrombophlebitis. However, Dr. Densmore believed that Petitioner should have chosen ESR or CRP because inflammation is present in 90 percent of thrombophlebitis cases and therefore those tests would assist the practitioner in arriving at a diagnosis. Petitioner should not be awarded credit for his answer to Tasks 3 and 4 because his answers were not the best answers to those questions. The correct answers set forth by the Department were supported by the textbook authorities and expert testimony introduced at the hearing. Task 5 dealt with the same patient discussed above, and asked the candidate to indicate which, if any, diagnostic imaging procedures should be performed. The correct answer, worth four points, was "none" or "A-P & lateral leg." "A-P" stands for anteroposterior, or from the front to the back. On the videotape of the examination, Petitioner appeared confused by the question. He said that he would x-ray the "lower leg." One of the examiners asked him to be more specific as to which views he would take. Petitioner stated that he would x-ray the ankle because of the swelling there. Petitioner then mentioned the swelling in the calf, and stated that he would x-ray the "femur." The femur is the thigh bone, extending from the pelvis to the knee. An x-ray of the femur obviously would reveal nothing about the condition of the patient's calf. The examiner, likely sensing Petitioner's confusion, advised Petitioner to read the question again. Petitioner read the question aloud, then reiterated that he would take x-rays of the patient's ankle and femur. Task 5 was worth a maximum of four points. Each examiner independently awarded Petitioner zero points for Task 5. Petitioner contended that he should have received partial credit for his initial response that he would x-ray the lower leg. However, Task 5 required the candidate to identify the specific views of the x-rays he would take. When the examiner asked him to name the specific views, Petitioner identified the femur. The context of the discussion makes it evident that Petitioner must have been thinking of the fibula or the tibia, i.e., the bones of the lower leg, when he repeatedly named the femur in connection with the patient's calf pain. However, the examiners had no choice but to grade Petitioner on the answer he actually gave. Petitioner should not be awarded any points for his answer to Task 5. Task 18 was a stand-alone question dealing with x- rays. The challenged portion of Task 18, worth two points, asked the candidate what he would do to obtain a quality lumbar spine x-ray of a severely obese patient if his office was equipped with a 300/125 x-ray machine. One of the examiners specified that this patient weighs around 500 pounds. The correct answer was that the candidate would use a higher capacity x-ray machine or refer the patient to a facility that has one. Petitioner's answer was that he would collimate close to the area of injury, decrease milliampere seconds (mAs), increase kilovolt peak (kVp) to increase penetration, and use a rare earth screen. Again, Petitioner appeared to be confused by the question. At the hearing, he testified that Task 18 did not ask what specific view he would take of the obese patient, whether of the arm, the chest, or the skull. Petitioner misread the question. Task 18 clearly states that the required view is of the patient's lumbar spine. Petitioner's misreading of the question led him to treat Task 18 as an x-ray physics question, hence his response, intended to demonstrate how he would maximize the clarity of an x-ray using the equipment at hand. Dr. Densmore stated that an x-ray of a patient this size taken on this equipment would simply be a white picture because of the amount of fatty tissue involved. With a patient of this size, the kVp would have to be increased so much that the practitioner would over-radiate the patient. The practitioner would have no choice but to send the patient out for an x-ray on a higher capacity machine. The examiners independently awarded Petitioner zero points for his response to this portion of Task 18. Their scoring was correct, supported by the textbook authorities and expert testimony introduced at the hearing. Petitioner alleged that the Candidate Information Booklet (CIB) provided him by the Department did not adequately prepare him for format changes that occurred since his first sitting for the examination. Petitioner compared the CIB for the May 2001 examination to that for the November 2001 examination. He found that the detailed sample questions in the November 2001 CIB more closely reflected the examination he took in May 2001, and contended that the May 2001 CIB was outdated at the time it was distributed. All candidates for the May 2001 examination received the same Candidate Information Booklet that Petitioner received. Respondent's psychometrician, Dr. Linda Dean, testified that the passing rate for the May 2001 examination was in the range of 70 percent, consistent with other administrations of the examination. Petitioner's allegation concerning the adequacy of the CIB is not supported by the evidence. Petitioner also alleged that he was placed at a disadvantage by the fact that the examiners appeared to know that he was not taking the examination for the first time. Both Dr. Dean, the psychometrician assigned to the chiropractic licensure examination, and Dr. Densmore, who has served as an examiner many times, testified that examiners are not told the names or the status of the candidates. Dr. Dean testified that nothing is done to segregate first-time candidates from those who are retaking the examination, though an examiner may suspect that a candidate who is sitting for only one section of the examination is retaking that section. Even if Petitioner's allegation were credited, it would not change the result. Petitioner's responses to Tasks 3, 4, 5, and 18 were incorrect. The examiners properly awarded him zero points for those tasks. Their knowledge that he was retaking the physical diagnosis section had no bearing on Petitioner's incorrect responses to the challenged tasks.
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 denying Petitioner additional credit for his responses to Tasks 3, 4, 5, and 18 of the physical diagnosis portion of the chiropractic licensure examination administered in May 2001. DONE AND ENTERED this 18th day of February, 2002, in Tallahassee, Leon County, Florida. LAWRENCE P. STEVENSON Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 18th day of February, 2002. COPIES FURNISHED: Ken Allan Niebrugge 4785 Barkley Circle No. 22 Fort Myers, Florida 33907 Cherry A. Shaw, Esquire Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1703 Theodore M. Henderson, Agency Clerk Department of Health 4052 Bald Cypress Way Bin A02 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
The Issue Whether Respondent was overpaid $237,802.50 for services that in whole, or in part, are not covered by Medicaid because the services were performed by rendering providers who did not have the requisite education or work experience to meet the eligibility requirements in the Behavior Analysis Services Coverage Handbook (“BA Handbook”) to perform the services or for whom documentation was insufficient to determine eligibility; and, if so, the amount of the overpayment to be repaid, the amount of any fine to be imposed against Respondent, and the amount of any investigative, legal, and expert witness costs to be assessed against Respondent.
Findings Of Fact This case involves a Medicaid audit by AHCA of Respondent, which relates to dates of service from November 1, 2017, through December 31, 2018 ("audit period"). During the audit period, Respondent was an enrolled Medicaid provider and had a valid Medicaid provider agreement with AHCA, Medicaid Provider No. 017421300. As an enrolled Medicaid provider, Respondent was subject to the duly- enacted federal and state statutes, regulations, rules, policy guidelines, and Medicaid handbooks incorporated by reference into rule, which were in effect during the audit period. AHCA is designated as the single state agency authorized to make payments for medical assistance and related services under Title XIX of the Social Security Act. This program of medical assistance is designated the "Medicaid Program." See § 409.902, Fla. Stat. AHCA has the responsibility for overseeing and administering the Medicaid Program for the State of Florida, pursuant to section 409.913, Florida Statutes. AHCA’s Bureau of Medicaid Program Integrity (MPI), pursuant to its statutory authority, conducted an audit of Respondent of paid Medicaid claims for services to Medicaid recipients. Medicaid claims are paid under what is known as a “pay and chase” system. Claims are quickly paid under the presumption the provider is billing in accordance with Medicaid law and rules. When paid claims are later audited and AHCA finds non-compliant claims, the payments are deemed overpayments and AHCA requests reimbursement. Section 409.913 allows MPI to audit for fraud and abuse. Abuse includes “[p]rovider practices that are inconsistent with generally accepted business…practices and that result in an unnecessary cost to the Medicaid program….” See § 409.913(1)(a)1., Fla. Stat. All Florida Medicaid providers are required to maintain, for at least five years, “contemporaneous documentation of entitlement to payment, including employment eligibility, compliance with all Medicaid Rules, regulations, handbooks and policies.” This includes business records, Medicaid-related records and medical records. See § 409.913(7)(e) and (f), Fla. Stat. A provider’s failure to document, in accordance with Medicaid handbooks and the Provider Enrollment Agreement, whether its rendering providers met the criteria to provide services, as stated in the promulgated handbook, is inconsistent with generally accepted business practices. Behavior analysis services are “highly structured interventions, strategies, and approaches provided to decrease maladaptive behaviors and increase or reinforce appropriate behavior for persons with mental health disorders, and developmental or intellectual disabilities.”1 Medicaid coverage for these services is limited to children under the age of 21. Behavior analysis 1 See Section 1.0 “Introduction” of Florida Medicaid Behavior Analysis Services Coverage Policy (October 2017); Fla. Admin. Code R. 59G-4.125. recipients are a vulnerable population, consisting of individuals that have mental health disorders, and intellectual and developmental disabilities, including, but not limited to, autism and Down Syndrome. They often have severe deficits in their abilities to complete self-care tasks and communicate their wants and needs. These clients are at a heightened risk of abuse, neglect, and exploitation because of their developmental disabilities and inability to self-preserve. For these reasons, persons entrusted to provided critical services must meet the minimum qualifications. To provide appropriate services to this vulnerable population, BAs are required to meet the criteria set forth in Section 3.2 of the BA Handbook, incorporated by reference in Florida Administrative Code Rule 59G-4.125, “Behavior Analysis Services,” as amended, October 29, 2017. The BA Handbook requires a BA to have “a bachelor’s degree from an accredited university or college in a related human service field” and an agreement to become a Registered Behavior Technician (“RBT”) by 1/1/19; or, alternatively: (1) be at least 18 years old; (2) have a high school diploma; (3) have “at least two years of experience providing direct services to recipients with mental health disorders, developmental or intellectual disabilities”; and (4) have at least “20 hours of documented in-service trainings in the treatment of mental health, developmental or intellectual disabilities, recipient rights, crisis management strategies and confidentiality.” AHCA’S AUDIT This audit was opened in follow-up to AHCA’s statewide review of behavior analysis services. The assessment of these services revealed rampant fraud and abuse within the behavior analysis program including more than twice as many providers as recipients, providers billing unbelievable hours (such as more than 24 hours per day), and unsubstantiated qualifications, meaning that patients were receiving BA services from unqualified providers. Based on information obtained in the statewide behavior analysis review, AHCA issued a moratorium regarding new enrollments in Southeast Florida and chose a number of providers for audits. Respondent was selected for audit. Petitioner audited Respondent's records related to paid claims from November 1, 2017, through December 31, 2018. This audit period was selected because an updated Behavior Analysis Handbook was promulgated and became effective October 29, 2017.2 AHCA’s review of Respondent's records consisted of identifying the rendering providers for whom Respondent provided insufficient or no documentation to support their qualifications to render behavior analysis services. The parties stipulated that none of the rendering providers at issue had both a bachelor’s degree “in a related human services field” and had obtained their RBT by January 1, 2019. Respondent and AHCA also stipulated that the records for each rendering provider indicate they were at least 18 years old and had obtained at least a high school diploma or its equivalent. The only questions that remained was did the BA provider have the requisite two years of experience with the target population and did they have 20 hours or more of the required applicable in-service training. During the Audit Period, Respondent submitted claims for services rendered by 169 rendering providers, for which Medicaid paid Respondent a total of $3,999,828.65. Based on the audit, Petitioner initially determined Respondent had been overpaid in the amount of $1,060,590.41. AHCA issued a Preliminary Audit Report (“PAR”) dated March 25, 2019, notifying Respondent of the rendering providers deemed not qualified and the amount 2 During the MPI audit period, Respondent was placed under pre-payment review by a different section of AHCA. Respondent stopped billing during the audit period and its Medicaid provider number was terminated without cause in October 2018. As such, although the audit period was from November 1, 2017, through December 31, 2018, the last claims reviewed in the audit were for date of service March 28, 2018, as that was the date of the last paid claim. of the overpayment associated with each. Respondent was given the opportunity to pay the PAR amount or submit additional records. In response to the PAR, Respondent submitted additional records. Based on the those additional records, AHCA issued a FAR dated July 19, 2019, alleging Respondent was overpaid $905,838.36 for BA services it billed for 41 BA rendering providers who did not meet the criteria specified in the BA Handbook. In addition, the FAR informed Respondent that AHCA was seeking to impose a sanction of $2,500.00 pursuant to rule 59G-9.070(7)(c), and costs of $1,280.00 pursuant to section 409.913(23)(a). In sum, Petitioner asserted in the FAR that Respondent owed a total of $909,618.36. Kathy Herold is a Senior Pharmacist with AHCA’s MPI unit. In that capacity she assists with MPI audits. She compiles and analyzes data; applies appropriate rules, regulations, policies, and procedures to oversee the activities of Florida Medicaid providers to detect fraudulent or abusive behavior and minimize the neglect of recipients; recovers overpayments; imposes sanctions; and makes referrals as appropriate to the Florida Attorney General’s Medicaid Fraud Control Unit, the Florida Department of Health, and the Florida Department of Business and Professional Regulation. She has over seventeen years’ experience in administrative investigations. She is a Certified Fraud Examiner. Ms. Herold re-reviewed the records provided by Respondent to determine whether the rendering providers for whom behavior analysis services were billed met the qualifications. AHCA did not place any limitations on how Respondent documented the qualifications of its rendering providers. AHCA’s only concern was whether the criteria were met. During the audit, and through the discovery process, Respondent supplied AHCA with copies of employment applications, resumes, letters of recommendation, and training certificates of the BAs in question. At the time of the final hearing, the qualifications of only 14 BAs remained in dispute and the amount sought in overpayment was calculated by AHCA as $237,802.50. Based on the competent, substantial, and persuasive evidence, AHCA demonstrated that the audit was properly conducted. RENDERING PROVIDERS AT ISSUE Eduardo Rodriguez The resume for Eduardo Rodriguez lists work with Abreu Quality (“Abreu”) from 2017 to “present.” It does not indicate a job title or reference any work with the target population in that job. There is no contact information that would have allowed Respondent the opportunity to verify the alleged work experience. The resume also lists “Private Case” work with a child with disabilities from 2010-2014 and 2016-2017. There is no contact information that would have allowed Respondent the opportunity to verify the alleged work experience. The application for Mr. Rodriguez, dated December 27, 2017, Mr. Rodriguez lists BA work with Abreu from February 2017 to “present” (December 27, 2017). While that listing (unlike the resume) contains contact information that would have allowed Respondent the opportunity to verify the alleged work experience, that work, even if verified, did not meet the requisite work experience as it was at most ten months. The application also lists two BA jobs for “Private Case.” There is no information provided that would have allowed Respondent the opportunity to verify the alleged work experience met the requisite work experience or the target population requirements. One private job was from 2010-2014 and the other was from 2016-2017 The documents submitted to AHCA by Respondent contained a letter of recommendation by Felicia Noval. That letter makes no reference to work with the target population. There is no indication who Ms. Noval is or how she knows Mr. Rodriguez. The documents submitted to AHCA by Respondent contained a letter of recommendation by Jose Chao. However, that letter contains no indication of work with the target population. There is no indication of who Mr. Chao is or how he knows Mr. Rodriguez. The documents submitted to AHCA by Respondent contained a background screening requested by Respondent. The background screening indicates that Mr. Rodriguez was not eligible to work with the target population until April 2017. Because Respondent requested the screening, it knew or should have known that Mr. Rodriguez did not have the requisite work experience. Based on conflicting information as to when Mr. Rodriguez worked at Abreu, Ms. Herold reviewed documentation submitted by Abreu to AHCA. This documentation indicates that Mr. Rodriguez only worked for them from May 18, 2017, to June 17, 2017. The documents submitted by Respondent to AHCA for Mr. Rodriguez contained training certificates for both the 20-hour BA course and the 40- hour RBT course. Mr. Rodriguez began working for Respondent on February 8, 2018. The last paid claim for Mr. Rodriguez was March 23, 2018. Based on the documentation provided by Respondent, Mr. Rodriguez did not have documented requisite work experience at the time of hire, at the beginning of the audit period, or by the end of the last paid claim in the audit period. Despite Respondent having documentation that Mr. Rodriguez satisfied the training requirement, payments made by AHCA to Respondent for services billed for him are an overpayment because he did not have the requisite work experience or there is insufficient documentation that he had the requisite work experience. Fanny Vargas The application for Fanny Vargas, dated March 1, 2017, lists work as a BA/AHH for Children’s Home Services (“CHS”) from 2015-2017. There is no indication of how long Ms. Vargas performed each function. There is no indication of work with the target population in the job as an AHH. There is insufficient information to determine how long Ms. Vargas worked for CHS. The application did not provide sufficient information regarding whether Ms. Vargas had the requisite work experience. The resume for Ms. Vargas only lists BA work with CHS from 2015- “still working” (presumably March 1, 2017, the date of the application). There is still insufficient information on the resume to determine when Ms. Vargas began at CHS or if Ms. Vargas worked at CHS for over two years. The resume also lists “private service” for children with special needs from 2012- 2015. The “private service” job was not listed on the application. There is no contact information listed on the resume for the “private service” job that would have allowed anyone to verify it. The resume did not provide sufficient information regarding whether Ms. Vargas had the requisite work experience. The documents submitted to AHCA by Respondent indicate Ms. Vargas was not screened as a Medicaid Provider until January 14, 2017. She was enrolled as a Medicaid provider on April 4, 2017, effective January 9, 2017. She could not have provided services to the target population with CHS before then. The date of service for the last paid claim for Ms. Vargas is December 31, 2017. The documents provided by Respondent to AHCA during the audit and during litigation did not substantiate that Ms. Vargas had the requisite work experience at the time of hire, at the beginning of the audit period or by the end of the audit period, or that she satisfied the training requirement. Javier Collazo Veloz The application for Javier Collazo Veloz, dated May 4, 2017, lists work as Private Practice BA in Miami for Melissa Catano, from “08/01/2016–” (presumably May 4, 2017) and BA work for Fe y Alegria in Ecuador from March 9, 2015–April 3, 2016. Combined, those jobs do not satisfy the requisite work experience. The resume for Mr. Collazo Veloz only lists work as a BA for Fe y Alegria. However, on the resume the dates of employment are listed as July 1, 2013–July 1, 2015. Those dates conflict with the information Mr. Collazo Veloz listed on his application. Based on the conflict regarding the work with Fe y Alegria, Ms. Herold attempted to verify it. She located a website for Fe y Alegria, but the website makes no mention of work with the target population. The last paid claim for Mr. Collazo Veloz was February 16, 2018. The documents provided by Respondent to AHCA during the audit and during litigation did not substantiate that Mr. Collazo Veloz had the documented requisite work experience at the time of hire, at the beginning of the audit period or by the end of the last paid claim in the audit period, or that he satisfied the training requirement. Jorge N. Bernal The application for Jorge N. Bernal, dated March 29, 2017, lists work as an x-ray technician from April 15, 2015, to July 17, 2015. There is no indication of work with the target population and the nature of that work would not contribute to the requisite work experience. Overlapping with the x-ray technician job, Mr. Bernal also lists he was a teacher at Jesus Para Todos from December 1, 2012, to March 15, 2016. The resume makes no mention of work with the target population associated with that job and there is no contact information on the application that Respondent could have used to verify the alleged work experience. The resume for Mr. Bernal only lists the teacher job at Jesus Para Todos, but there is no contact information to verify the employment. The resume indicates that job involved work with the target population. The documents submitted to AHCA by Respondent contained numerous documents indicating Mr. Bernal was born June 16, 1993. That means that Mr. Bernal was purportedly “teaching” when he was only 17. The documents submitted to AHCA by Respondent also contained an honor roll certificate which indicates that Mr. Bernal was attending college while purportedly “teaching.” The documents submitted to AHCA by Respondent post-PAR contained a letter of reference from International Ministry of Jesus for All (“Jesus Para Todos”) dated March 19, 2019. That letter does not clearly corroborate that Mr. Bernal was teaching there. The letter from Jesus Para Todos indicated it was a church, not a school. The letter further indicates that Mr. Bernal “was able to serve to the kid’s ministry and youth groups, teaching kids and youth and serving in our community, and participate in helping special need kids in our church.” Mr. Bernal began work for Respondent on November 7, 2017. The last paid claim for Mr. Bernal is February 17, 2018. Thus, not only could the letter from Jesus Para Todos not have been used to verify work in the hiring process, it also was not created until after the audit period and almost one year after the end of Mr. Bernal’s employment with Respondent. Given the conflicting information regarding Jesus Para Todos, Ms. Herold attempted to verify the facility. She discovered there was no online presence for the facility, and it was not listed in the State’s database of private schools or licensed daycares. The documents provided by Respondent to AHCA during the audit and during litigation did not substantiate that Mr. Bernal had the requisite work experience at the time of hire, at the beginning of the audit period or by the end of the last paid claim in the audit period, or that he satisfied the training requirement. Leyanis Morffi The application for Leyanis Morffi, dated June 30, 2017, lists two cashier jobs. The nature of that work would not contribute to the requisite work experience. The application also lists work as a paid childcare worker at Smiles Childcare from October 2014 to November 2016. However, there is no mention of work with the target population at that job. The resume for Ms. Morffi lists the same work experience that was listed on the application. Again, there is no reference to work with the target population at the childcare job. The resume further indicates that Ms. Morffi “specializes in homes for the elderly and youth detention facilities.” However, there is no listing of that type of work on the application or resume. The documents submitted to AHCA by Respondent contained a background screening requested by Respondent. The screening indicates that Ms. Morffi was not eligible to work with the target population until February 2017. Because Respondent requested the screening, it knew or should have known that Ms. Morffi did not have the requisite work experience. Documents submitted to AHCA by Respondent contained a letter of reference dated September 5, 2017, from Lazaro Noel Suarez. That letter is dated post-hire and was provided to AHCA post-PAR. It references one year of BA work. However, it provides no specific dates or date range, and contains no contact information that could be used to verify the information. Neither the application nor the resume indicates any BA work prior to Respondent to which this letter could correlate. Documents submitted to AHCA by Respondent contained a letter of reference dated July 30, 2017, from Doris Jimenez. That letter is dated post- hire and was provided to AHCA post-PAR. It makes no reference to work with the target population. It makes no mention of the relationship between Ms. Morffi and Ms. Jimenez. The letter does not indicate where the work was performed. Documents submitted to AHCA by Respondent contain a letter of reference dated April 5, 2018. The author is unknown as the signature is illegible. That letter is dated post-hire and was provided to AHCA post-PAR. It references work at Smiles Childcare from October 2014 to May 2017. While the letter mentions work with the target population, there is no way to determine who wrote the letter or the author’s relationship to Ms. Morffi. The letter contains no contact information that could be used to verify the information. The dates of service in the letter conflict with the dates of service listed by Ms. Morffi in her application and resume. The letter indicates that Ms. Morffi was a volunteer, while her application indicates she earned $10.00 per hour. While volunteer work would count toward requisite work experience, the conflicting information undermines the credibility of both this letter and the information provided by Ms. Morffi. Based on the conflicting information regarding Smiles Childcare, Ms. Herold attempted to verify the information. Smiles Childcare had no internet website and was not listed by the State as a childcare facility. The last paid claim for Ms. Morffi is March 16, 2018. Not only could the April 5, 2018, letter not have been used to verify work in the hiring process, it also was not created until after the audit period and over two weeks after the end of Ms. Morffi’s employment with Respondent. The documents provided by Respondent to AHCA during the audit and during litigation did not substantiate that Ms. Morffi had the documented requisite work experience at the time of hire, at the beginning of the audit period or by the end of the last paid claim in the audit period, or that she satisfied the training requirement. Luigui Melendez Tijerino The application for Luigui Melendez Tijerino, dated January 30, 2017, lists overlapping work as a Pharmacy Tech at Walmart from June 2012 to “present” (presumably the date of the application) and as a food prepper at Wendy’s from October 2013 to June 2014. There is no indication of work with the target population and the nature of those jobs would not contribute to the requisite work experience. Overlapping with the Pharmacy technician job, Mr. Melendez Tijerino also listed BA work with ABA Pro Support Services (“ABA Pro Support”) from May 2015 to January 31, 2017. The resume for Mr. Melendez Tijerino lists the same jobs as indicated on the application and also lists work as a server at “The Chelsea” from April 2011 to September 2013. There is no indication of work with the target population and the nature of that job would not contribute to the requisite work experience. Documents submitted to AHCA by Respondent contain a background screening requested by Respondent. The screening indicates that Mr. Melendez Tijerino was not eligible to work with the target population until October 2016. Because Respondent requested the screening, it knew or should have known that Mr. Melendez Tijerino did not have the requisite work experience. Documents submitted to AHCA by Respondent contain an undated letter of reference from Xochilt Povsic.3 That letter was provided to AHCA post-PAR. That letter references work with the target population, but it does not mention any dates that would allow anyone to determine if it satisfied the requisite work experience. The letter does not mention where the BA services were allegedly performed, and the only indication of BA work on Mr. Melendez Tijerino’s application and resume was at ABA Pro Support. Based on the conflicting information regarding work at ABA Pro Support, Ms. Herold looked further into the matter. In response to the letter sent to ABA Pro Support for the BA statewide review, ABA Pro Support advised that Mr. Melendez Tijerino was never an employee. That information was provided to AHCA on January 12, 2018. 3 Ms. Povsic is another rendering provider at issue in the audit. Ms. Povsic may be or may have been related to Mr. Melendez Tijerino as the documents submitted by Respondent for her indicate she used to be called Xochilt Tijerino. Documents submitted to AHCA by Respondent contain a letter of reference dated September 23, 2016, from Walmart, that was provided to AHCA post-PAR. That letter does not reference work with the target population and the nature of the job would not contribute to the requisite work experience. Mr. Melendez Tijerino began working for Respondent on November 1, 2017. The last paid claim for Mr. Melendez Tijerino was January 27, 2018. The documents provided by Respondent to AHCA during the audit and during litigation did not substantiate that Mr. Melendez Tijerino had the requisite work experience at the time of hire, at the beginning of the audit period or by the end of the last paid claim in the audit period, or that he satisfied the training requirement. Maria Oduber The application for Maria Oduber, dated November 29, 2017, lists “young care worker” with “Loyal Resource/CHS” from August 2015 to March 2017. There is no mention of work with the target population associated with that job. Overlapping with that job, the application lists work as client support with HOPWA Housing from March 2010 to January 2017. The application also lists work as an ESOL (English for Speakers of Other Languages) teacher at Greystone Elementary School and as a theater teacher in “Caracas.” There is no indication of work with the target population and the nature of those jobs would not contribute to the requisite work experience. The resume for Ms. Oduber listed the same jobs as listed on the application. There was still no mention of work with the target population for any of those jobs. Ms. Oduber began working for Respondent on January 2, 2018. The last paid claim for Ms. Oduber was March 17, 2018. The documents provided by Respondent to AHCA during the audit and during litigation did not substantiate that Ms. Oduber had the requisite work experience at the time of hire, at the beginning of the audit period or by the end of the last paid claim in the audit period, or that she satisfied the training requirement. Mey Weiss Rodriquez The application for Mey Weiss Rodriguez is dated October 4, 2017, on the front and October 10, 2017, on the back. The application lists work as an assistant at Eliseo Reyes School in “S. Spiritus, Cuba,” from September 2010 to December 2014. There is no mention of work with the target population associated with the job. The application also lists work at Provincial Veterinary Laboratory from August 1997 to August 2010. There is no indication of work with the target population and the nature of that job would not contribute to the requisite work experience. The resume submitted for Ms. Weiss Rodriguez lists the same work on the application, but with less specific information regarding dates, and no information regarding location or contact information. Contrary to the application, work with the target population is listed for Eliseo Reyes School. The resume also claims that Ms. Weiss Rodriguez is an RBT even though Respondent stipulated that none of the rendering providers at issue obtained an RBT by January 1, 2019. The documents submitted to AHCA by Respondent contained a letter of recommendation dated October 4, 2017, from Carmen Yebra. The letter was provided to AHCA post-PAR and makes no mention of work with the target population. Due to the conflict regarding whether there was work with the target population, and the fact there was no documentation of independent verification of that matter, Ms. Herold attempted to verify the work experience. No search engine provided a listing for Eliseo Reyes School and Google Maps, while providing detailed information on Sancti Spiritus, Cuba, indicated the address listed on the application does not exist. The last paid claim for Ms. Weiss Rodriguez was March 17, 2018. The documents provided by Respondent to AHCA during the audit and during litigation did not substantiate that Ms. Weiss Rodriguez had the requisite work experience at the time of hire, at the beginning of the audit period, or by the end of the last paid claim in the audit period, or that she satisfied the training requirement. Sorelys Ferros On her application dated March 14, 2017, Sorelys Ferros lists work as an RBT with MHB Consultants Group (“MHB”) beginning in December 2015 with no end date listed. However, Respondent stipulated that none of the rendering providers at issue obtained an RBT by January 1, 2019. The resume for Ms. Ferros lists the job at MHB and also lists work at Respondent from March 2017 to present. On her resume, Ms. Ferros also indicates that she obtained her RBT certification in December 2015. However, as indicated above, Respondent stipulated that none of the rendering providers at issue obtained an RBT by January 1, 2019. Documents submitted to AHCA by Respondent contain a background screening requested by Respondent. The screening indicates that Ms. Ferros was not eligible to work with the target population until June 2016. As such, she could not have obtained her RBT certification by December 2015. Because Respondent requested the screening, it knew or should have known that Ms. Ferros did not have the requisite work experience and that she was not actually an RBT. The last paid claim for Ms. Ferros was February 2, 2018. The documents provided by Respondent to AHCA during the audit and during litigation did not substantiate that Ms. Ferros had the requisite work experience at the time of hire, at the beginning of the audit period, or by the end of the last paid claim in the audit period, or that she satisfied the training requirement. Teresita Rodriguez The application for Teresita Rodriguez, dated August 10, 2017, lists two jobs as an HHA-BA,4 one with Gifted Health Group, Inc. (“Gifted”), from January 2010 to February 2014, and the other with Nory’s Home Services, Inc. (“Nory’s”), from February 2014 to April 2015. There is no indication of how long Ms. Rodriguez worked in the capacity of an HHA versus as a BA at either job. There is no indication of work with the target population in the HHA job at Gifted or Nory’s. The application also listed work as an HHA at Homecare for Neighborhood Home Health (“Neighborhood”) from April 2015 to “actual” (presumably, the date of the application, August 10, 2017). There is no mention of work with the target population in the job with Neighborhood. The resume for Ms. Rodriguez, lists the same jobs listed on the application; however, the work with Neighborhood is listed on the resume as HHA-BA, and not HHA Homecare. The resume provides more description for each job, and only the job at Gifted describes work with the target population. Documents submitted to AHCA by Respondent contain a background screening requested by Respondent. The screening indicates that Ms. Rodriguez was not eligible to work with the target population until September 2015. Based on the screening, Ms. Rodriguez could not have worked with the target population at Nory’s, Neighborhood, or Gifted before then. Because Respondent requested the screening, it knew or should have known that Ms. Rodriguez did not have the requisite work experience. The documents submitted to AHCA by Respondent contained an undated letter of reference from Josie Vallejo. That letter does not reference any work with the target population but specifically mentions work with Ms. Vallejo’s mother, a senior, although it does not provide any dates. The letter mentioned that Ms. Vallejo had been a friend of Ms. Rodriguez for six years. 4 Presumably, “HHA” as used in applications and on resumes of rendering providers stands for Home Health Aide. The documents submitted to AHCA by Respondent contain an undated letter of reference from Danitza Montero. The letter from Ms. Montero states Ms. Rodriguez cared for Ms. Montero’s son, but does not indicate the son was a member of the target population. Ms. Rodriguez began working for Respondent on December 26, 2017. There is no documentation indicating that Ms. Rodriguez worked for Gifted past August 10, 2017. The last paid claim for Ms. Rodriguez was March 17, 2018. The documents provided by Respondent to AHCA during the audit and during litigation did not substantiate that Ms. Rodriguez had the requisite work experience at the time of hire, at the beginning of the audit period, or by the end of the last paid claim in the audit period, or that she satisfied the training requirement. Xochilt Povsic The application for Xochilt Povsic, dated January 31, 2017, states she worked as a membership coordinator for Sam’s Club, and a dietary aide at Bentley Commons at Paragon Village in New Jersey. There is no indication of work with the target population at either job, and the nature of those jobs would not contribute to the requisite work experience. Overlapping the dietary aide job, on her application Ms. Povsic also indicates work as a BA at two private practice/personal care jobs. Ms. Povsic states she worked for Maria Mora from August 2013 to June 2015 and that she worked for Miriam Ponzano from September 2014 to December 2015. The resume for Ms. Povsic listed the same jobs and dates as listed on the application and also listed another dietary aide job with Fellowship Village in New Jersey. The resume contains descriptions of the type of work performed at each job. There is no mention of work with the target population at either dietary aide job or in the job at Sam’s Club, and those jobs would not be of the type to contribute to the requisite work experience. The work for Ms. Mora was described by Ms. Povsic as providing BA services from August 2013 to June 2015 to a “3-4 [year old child]” with autism, ADHD, and behavior disorders. The work for Ms. Ponzano was described by Ms. Povsic as providing BA services from September 2014 to December 2015 to twin boys, “1-2 years old” with behavior disorders and ADHD. The documents submitted to AHCA by Respondent contained a letter from Miriam Ponzano that is not dated and was provided to AHCA post-PAR. While Ms. Ponzano confirms that Ms. Povsic cared for her boys, there is no indication that the children were part of the target population or that any work performed contributed to the requisite work experience. In addition, the dates of service listed by Ms. Ponzano conflict with the dates listed by Ms. Povsic. Ms. Ponzano indicated the Ms. Povsic cared for her sons from November 2015 to March 2016, not September 2014 to December 2015, as had been asserted by Ms. Povsic on her application and resume. The documents submitted to AHCA by Respondent also contained a letter from Maria Mora, that is not dated, and was provided to AHCA post- PAR. Ms. Mora did not confirm that Ms. Povsic had cared for her 3 to 4-year- old son with autism, ADHD, and behavior disorders, as Ms. Povsic had indicated. Rather, Ms. Mora’s letter indicates that Ms. Povsic was her caretaker, performing personal tasks such as picking up medicines and buying groceries. Ms. Mora does not indicate that she is part of the target population and the services listed are not of the type to contribute to the requisite work experience. In addition, the dates of service listed by Ms. Mora conflict with the dates listed by Ms. Povsic. Ms. Mora indicates that Ms. Povsic cared for her during the winter of 2014 to 2015 (even mentioning that Ms. Povsic shoveled snow for her), not August 2013 to June 2015, as had been indicated by Ms. Povsic on her application and resume. The documents submitted to AHCA by Respondent contained a letter from Maydelis Cruz. The letter is not dated and was provided to AHCA post- PAR. Ms. Cruz indicates she has known Ms. Povsic for 20 years. Ms. Cruz indicates that Ms. Povsic assisted with her son, who has Down Syndrome, from November 2011 to March 2013. Ms. Povsic would only have been 17 years old at that time. The last paid claim for Ms. Povsic was March 17, 2018. The documents provided by Respondent to AHCA during the audit and during litigation did not substantiate that Xochilt Povsic had the requisite work experience at the time of hire, at the beginning of the audit period, or by the end of the last paid claim in the audit period, or that she satisfied the training requirement. Yaima Alvarez The application for Yaima Alvarez, dated August 10, 2017, listed two overlapping HHA jobs: “Faith,” from July 2016 to “present” (presumably August 10, 2017, the date of the application); and Home Health Solutions, from June 2017 to present (August 10, 2017). There is no indication of work with the target population for either job. The resume for Ms. Alvarez lists no work experience, but has listings under “Professional Affiliations” that appear to be a work history. Faith Health Care, Inc., is listed with dates that correspond to the listing for Faith on the application. There is no mention of a job title or work with the target population regarding Faith Health Care, Inc. Solutions Group, Inc., is also listed under “Professional Affiliations.” As with Faith Health Care, Inc., there is no mention of her job title or work with the target population. That listing does not appear to be the same job that is listed as Home Health Solutions on the resume as the dates do not correspond. There is no indication of work with the target population for Faith Health Care, Inc., or Solutions Group, Inc. There is also a listing for “L.G. (R.B.T. patient).” However, as indicated before, Respondent stipulated that none of the rendering providers at issue obtained an RBT by January 1, 2019. Ms. Alvarez began working for Respondent on December 12, 2017. The last paid claim for Ms. Alvarez was February 8, 2018. The documents provided by Respondent to AHCA during the audit and during litigation did not substantiate that Ms. Alvarez had the requisite work experience at the time of hire, at the beginning of the audit period or by the end of the last paid claim in the audit period, or that she satisfied the training requirement. Yudisley Garces The application for Yudisley Garces, dated April 20, 2017, lists overlapping CNA (Certified Nursing Assistant) jobs. One was with AAA Home Health Service (“AAA”) from June 2014 to today (April 20, 2017) and the other is with Alma Care, Inc. (“Alma Care”), from August 2015 to “today” (presumably the date of the application, April 20, 2017). There is no indication of work with the target population for either job. The resume for Ms. Garces only lists the job for AAA. However, the dates listed on the resume for that job (beginning June 2014) conflict with the dates listed on the application (beginning February 2014). There is no indication of work with the target population associated with that job. The resume also listed two jobs (one at a hospital in Cuba and the other at a hospital in Venezuela) performing puncture aspiration biopsies and cervical cancer diagnoses. There is no mention of work with the target population at either of those hospital jobs, and those jobs would not be of the type to contribute to the requisite work experience. The last paid claim for Ms. Garces was March 17, 2018. The documents provided by Respondent to AHCA during the audit and during litigation did not substantiate that Ms. Garces had the requisite work experience at the time of hire, at the beginning of the audit period, or by the end of the last paid claim in the audit period, or that she satisfied the training requirement. Zerelys Lauzerique The resume for Zerelys Lauzerique lists work with “Lenin & Daughter” and Ignite Christian Academy (“Ignite”). There is no indication of work with the target population regarding the job at Ignite. It also lists work as a fitness coach with Beach Body, as a Youth Pastor at Cross Church, and as an Assistant Director at Flames of Fire Bible School (“Flames of Fire”), that is not listed on the application. The Beach Body work overlaps the BA work with Lenin & Daughter. There is no indication of working with the target population associated with the jobs at Beach Body, Cross Church, or Flames of Fire, and those jobs would not be of the type to contribute to the requisite work experience. The application for Ms. Lauzerique, dated December 4, 2017, lists work as a BA with Lenin & Daughter from December 2016 to “current” (presumably the date of the application, December 4, 2017) and as a Teacher Assistant with Ignite from August 2014 to August 2015. There is no mention of work with the target population regarding the job at Ignite. The documents submitted to AHCA by Respondent contained a letter of reference dated December 5, 2016, from Melanie Reyes, a “close friend.” The letter from Ms. Reyes does not indicate any work with the target population and instead pertains to Ms. Lauzerique’s work at Beach Body. The documents submitted to AHCA by Respondent also contained a letter of reference dated December 2016 from Reverend Abram Gomez of Cross Church. The letter indicates that he worked with Ms. Lauzerique for two years, but does not indicate any work with the target population. Ms. Lauzerique began working for Respondent on December 11, 2017. The last paid claim for Ms. Lauzerique was January 6, 2018. The documents submitted by Respondent to AHCA for Ms. Lauzerique contained training certificates for both the 20-hour BA course and the 40-hour RBT course. The documents provided by Respondent to AHCA during the audit and during litigation did not substantiate that Ms. Lauzerique had the requisite work experience at the time of hire, at the beginning of the audit period, or by the end of the last paid claim in the audit period. Respondent's Response The owner of Hour Bliss, Inc., Mr. Perez-Delgado, testified on behalf of Respondent. He is a Board-Certified Behavior Analyst, has a master’s certification in addiction, and is a Licensed Mental Health Counselor. Mr. Perez-Delgado testified that Respondent served populations in Miami that no other company would because of the crime. Mr. Perez-Delgado said that when he enrolled Respondent as a BA provider, many of the rendering providers he hired had worked at other companies where he had also worked, and because of this, he believed they met the qualifications required to serve as BAs. Mr. Perez-Delgado testified that he provided records he thought were relevant to the Medicaid investigation beginning in August 2017, and again in January 2018 and April 2019. If there had been a problem, he would have liked AHCA to institute a corrective action plan. However, he alleges the next communication from AHCA was terminating his Medicaid provider number without cause. Later, he received notice of the audit. Much of the testimony from Mr. Perez-Delgado concerned events that occurred prior to the audit beginning in November 2018, and the issuance of the PAR and FAR in 2019. These events are obviously related to the pre-payment review or other matters with AHCA, and not the audit. Mr. Perez-Delgado testified that several of his rendering providers were parents of children with autism or ADHD. Accordingly, they had more than the requisite experience with the target population. However, he did not document that in the files provided to the Agency. Nor did he timely provide records demonstrating that these same workers met the training requirement. Mr. Perez-Delgado offered no information regarding how or whether he verified prior work experience of these BAs in question. ULTIMATE FINDINGS OF FACT In this case, AHCA presented credible, persuasive evidence establishing that the audit giving rise to this proceeding was properly conducted. AHCA obtained and reviewed records from Respondent, issued a PAR, reviewed additional records submitted after the PAR, issued the FAR, and even then continued to review records and consider evidenced that, by giving Respondent the benefit of the doubt whenever possible, further reduced the overpayment. In this audit, AHCA examined the records provided by Respondent to determine if it maintained business records and Medicaid-related records establishing that its rendering providers met the qualifications set forth in the BA Handbook. The BA Handbook required no special documentation. Respondent, as are all providers who contract to provide Medicaid services, was required to keep contemporaneous records regarding entitlement to payment, including employment eligibility, and compliance with all Medicaid rules, regulations, handbooks, and policies. Respondent failed to provide AHCA with documentation that its rendering providers met the qualifications set forth in the BA Handbook. Of the 14 BA providers in dispute, 12 lacked any documentation of the requisite work experience with the target population and meeting the training requirement. Only two BAs, Mr. Rodriguez and Ms. Lazerique, met the training requirements, but did not meet the required work experience with the target population.
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 incorporating the terms of this Recommended Order as follows: AHCA overpaid Respondent the sum of $237,802.50 for BA services and Respondent must reimburse the Agency for those payments. AHCA is entitled to an administrative sanction in the amount of $2,500.00. AHCA, as the prevailing party in this proceeding, is entitled to recover, from Respondent, costs including all investigative, legal, and expert witness costs. DONE AND ENTERED this 27th day of April, 2020, in Tallahassee, Leon County, Florida. S MARY LI CREASY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 27th day of April, 2020. COPIES FURNISHED: Julio Cesar Perez-Delgado Hour Bliss, Inc. Apartment 406 888 Brickell Key Drive Miami, Florida 33131 (eServed) Susan Sapoznikoff, Esquire Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 (eServed) Kimberly Murray, Esquire Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 (eServed) Richard J. Shoop, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 (eServed) Stefan Grow, General Counsel Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 (eServed) Mary C. Mayhew, Secretary Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 1 Tallahassee, Florida 32308 (eServed) Shena L. Grantham, Esquire Agency for Health Care Administration Building 3, Room 3407B 2727 Mahan Drive Tallahassee, Florida 32308 (eServed) Thomas M. Hoeler, Esquire Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 (eServed)
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
Findings Of Fact The Petitioner, David J. Pennell, is an applicant for licensure by examination to practice acupuncture in the State of Florida. The Petitioner took the acupuncture examination on July 18-20, 1986. He obtained a total overall grade of 68 on the practical portion of the test. A grade of 70 is required to pass the examination. The Petitioner challenges the grading of the answer he gave to the question requiring him to locate the acupuncture point Gallbladder 34. In order to demonstrate the point locations on the examination, applicants are given small round stickers which must be correctly placed on the body of a model. If the sticker is not placed at the correct acupuncture point, the answer is graded incorrect. The Petitioner's placement of the sticker at the acupuncture point Gallbladder 34 was graded incorrect. The Petitioner testified that he had observed his model consuming beer, and that as a result the model's hand was shaking and he was sweating profusely. Consequently, the Petitioner contends that it was difficult to keep the stickers identifying various points on the model's hand. In addition, the Petitioner testified that it took 15-20 minutes for an examiner to arrive at his examination room to grade this portion of the test. Thus, the Petitioner questions the grade he received on the location of the point for Gallbladder 34 because some of the stickers may have fallen off the model or their placement may have been altered. However, there is little evidence presented to support these contentions. For the most part, only speculation was offered by the Petitioner. Both of the Petitioner's witnesses unsuccessfully took the 1986 acupuncture examination with the Petitioner, but neither of them could testify that the models they used were the same model used by the Petitioner. They were also unable to corroborate any of the Petitioner's testimony regarding beer drinking by the model, or shaking or profuse sweating by the model. The Respondent's test development specialist acted as a monitor during the July, 1986, acupuncture examination. All of the monitors for this examination were available to the candidates continuously during the examination. The candidates had the option to go to another exam room if there was any problem. The Petitioner never made any complaint that his model was unsatisfactory. After the candidates finished the practical portion of the examination an examiner came in to grade it within 2-3 minutes. The temperature in the examination rooms was so cold that the models required blankets. The consumption of alcoholic beverages during the examination is prohibited, and no models were seen drinking anything but soft drinks. None of the monitors reported any such complaints. The Respondent's examiner testified similarly regarding the room temperature and the time it took examiners to enter the examination room. He did not observe any of the models drinking beer during the examination. Even if a model had been drinking beer, it would not affect a candidate's placement of the stickers unless a model's drinking caused him to fall off the table.
Recommendation Based upon the foregoing findings of fact and conclusions of law, it is RECOMMENDED that the Board of Acupuncture enter a Final Order dismissing the challenge to and request for review of the Petitioner's score on the July, 1986, practical portion of the acupuncture examination. THIS ORDER entered this 27th day of July, 1987 in Tallahassee, Leon County, Florida. WILLIAM B. THOMAS Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 FILED with the Clerk of the Division of Administrative Hearings this 27th day of July, 1987. COPIES FURNISHED: Mr. David J. Pennell 418 NE. River Drive Deerfield Beach, Florida 33441 Chester G. Senf, Esquire 130 North Monroe Street Tallahassee, Florida 32399-0750 Van Poole Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Joe Sole, Esquire General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Marcelle Flanagan Executive Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
