The Issue DOAH Case No. 02-0949: Whether Respondent's licensure status should be reduced from standard to conditional. DOAH Case No. 02-1299: Whether Respondent committed the violation alleged in the Administrative Complaint dated February 19, 2002, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence adduced at the final hearing, and the entire record in this proceeding, the following findings of fact are made: AHCA is the state Agency responsible for licensure and regulation of nursing homes operating in the State of Florida. Chapter 400, Part II, Florida Statutes. Harbour Health operates a licensed nursing home at 23013 Westchester Boulevard, Port Charlotte, Florida. The standard form used by AHCA to document survey findings, titled "Statement of Deficiencies and Plan of Correction," is commonly referred to as a "2567" form. The individual deficiencies are noted on the form by way of identifying numbers commonly called "Tags." A Tag identifies the applicable regulatory standard that the surveyors believe has been violated and provides a summary of the violation, specific factual allegations that the surveyors believe support the violation, and two ratings which indicate the severity of the deficiency. One of the ratings identified in a Tag is a "scope and severity" rating, which is a letter rating from A to L with A representing the least severe deficiency and L representing the most severe. The second rating is a "class" rating, which is a numerical rating of I, II, or III, with I representing the most severe deficiency and III representing the least severe deficiency. On October 22 through 25, 2001, AHCA conducted an annual licensure and certification survey of Harbour Health, to evaluate the facility's compliance with state and federal regulations governing the operation of nursing homes. The survey team alleged several deficiencies during the survey, only one of which is at issue in these proceedings. At issue is a deficiency identified as Tag F325 (violation of 42 C.F.R. Section 483.25(i)(1), relating to maintenance of acceptable parameters of nutritional status). The deficiency alleged in the survey was classified as Class II under the Florida classification system for nursing homes. A Class II deficiency is "a deficiency that the agency determines has compromised the resident's ability to maintain or reach his or her highest practicable physical, mental, and psychosocial well-being, as defined by an accurate and comprehensive resident assessment, plan of care, and provision of services." Section 400.23(8)(b), Florida Statutes. The deficiency alleged in the survey was cited at a federal scope and severity rating of G, meaning that the deficiency was isolated and caused actual harm that is not immediate jeopardy. Based on the alleged Class II deficiency in Tag F325, AHCA imposed a conditional license on Harbour Health, effective October 25, 2001. The license expiration date was August 31, 2002. The survey allegedly found a violation of 42 C.F.R. Section 483.25(i)(1), which states: Nutrition. Based on a resident's comprehensive assessment, the facility must ensure that a resident-- Maintains acceptable parameters of nutritional status, such as body weight and protein levels, unless the resident's clinical condition demonstrates that this is not possible. . . . This requirement is referenced on Form 2567 as "Tag F325." The survey found one instance in which Harbour Health allegedly failed to ensure that a resident maintained acceptable parameters of nutritional status. The surveyor's observation on Form 2567 concerned Resident 5, or "R-5": Based on observations, record review and staff interviews, the facility failed to maintain acceptable parameters of nutritional status and did not use all possible interventions, to prevent an unplanned, severe weight loss (7.8 percent in a two month period) for 1 (Resident 5) of 20 active sampled residents. The findings include: During her lunch on 10/22/01 at approximately 12:20 P.M., Resident 5 was observed clinching her teeth together making it difficult to get food into her mouth. Resident 5 was observed on 10/23/01 at 12:30 P.M., taking a limited amount of thickened liquids from her nosey cup, and clinching her teeth together making feeding her more difficult. Resident 5 was observed 5:25 P.M. until 5:55 P.M. on 10/23/01, taking small sips from the nosey cup and clinching her teeth together making it very difficult for the Certified Nursing Assistant (CNA) to feed her 25 percent of her meal. These observations were made in the assisted dining room on A-Wing. Record review of Resident 5's chart, documents 5/1/01 she weighed 127 pounds. On 7/2/01 and again on 7/16/01, her weight was documented 117 pounds. This is a severe weight loss of 7.8 percent in a two month period. Review of the resident's care plan dated 7/18/01, revealed the resident's nutrition problem was "Res. is on a puree diet with thickened liquids-- is continuing to lose weight-- is terminal-- weight is down 6 pounds for the month-- on weekly weight-- consumes 25-50 percent of her meals-- small portions at lunch-- super cereal on breakfast tray and Carnation Instant Breakfast on other trays. Resident can be combative during meals-- resists any attempt to assist her with eating-- is very difficult to feed." Approaches to address the problem included consult with Registered Dietician as needed and to monitor labs. Further review of the care plan included the problem: "Resident is on psychotropic meds for dementia with psychosis as evidenced by . . . increased agitation and resisting care." Review of the resident's physician orders reveal the resident began receiving Risperdal in July 2001 for the diagnosis of psychosis. The record also revealed that the resident was given a terminal status in January 2001. During an interview at 5:20 P.M. on 10/23/01, regarding Resident 5's evening meal being delivered after the other 3 residents at her table, the Certified Nursing Assistant stated, "She don't eat nothing anyway." Interview with CDM (Certified Dietary Manager) and Consulting Dietician on 10/23/01 at approximately 4:45 P.M., regarding resident's severe weight loss and limited nutritional intake, revealed that the Consulting Dietician stated she was unaware of this resident. The CDM stated the resident clinches her teeth, refuses food, and they have tried everything else. She stated that the resident was terminal and that the family did not want a tube feeding placed. The resident was put on thickened liquids by a speech therapist in 1998 for dysphagia, but there had been no speech therapy follow-up. They confirmed that no psychiatric consult was ordered since the care plan was developed, despite continued behaviors during feeding. An interview was conducted with the CDM joined by the DON regarding Resident 5's weight loss and possible interventions on 10/24/01 at 3:05 P.M. It was identified that no routine snacks were ordered, no psychiatric follow-up nor speech therapy follow-up, nor medication adjustments had been done during May 2001 through July 2001. The CDM stated that the facility only acknowledges a 5 percent weight loss at an interval of 1 month, and 10 percent at a 6 month interval as significant, but would not look at a 7.5 percent because it would not trigger on the Minimum Data Set. On 10/24/01 at 3:55 P.M., during an interview with the Unit Manager regarding Resident 5, she stated there was no psychiatric or mental health evaluation ordered, it was only on her care plan. Diane Ashworth was the survey team member who recorded the observation of R-5. Ms. Ashworth based her findings on her observations of R-5, a review of the resident's medical records, and interviews with Harbour Health staff. R-5 was a 92-year-old female who had resided at Harbour Health since 1998. She suffered from dementia with psychosis, in particular end-stage Alzheimer's disease. Her worsening condition caused her physician to request a neurological consultation in January 2001. The consulting neurologist diagnosed her condition as terminal. R-5 was severely impaired cognitively, and was completely dependent on Harbor Health staff for all of her care. R-5 was unable to feed herself. For over three years, Harbour Health has implemented a "restorative dining" program for residents with eating problems. In the restorative dining program, the resident is taken to a quiet area and given one-to-one attention by a CNA during meals. R-5 has been in the restorative dining program since its introduction. During her entire stay at Harbour Health, R-5 was very difficult to feed. She would clench her teeth, cover her mouth and push away. At times she would take the food into her mouth, then spit it back into the face of the caregiver. R-5's medical condition made it impossible to reason with her about the importance of maintaining nutrition. The CNA assigned to R-5 as her restorative aide would spend up to two hours feeding one meal to her. The CNA would attempt to feed R-5 until her agitation and resistance made it impossible. The CNA would refrigerate the food, then wait for R-5 to calm down. Then the CNA would reheat the food and begin the process again. Because of her Alzheimer's and her difficult behavior during meals, R-5 was identified as at risk for weight loss and dehydration. Harbour Health's care plan for R-5 identified several strategies for maximizing R-5's caloric intake, and called for consultation with the facility's registered dietician when needed. R-5 was on a no-sodium-added puree diet, taking thickened liquids in place of solid food. Because she tended to consume only 25 to 50 percent of the food offered at meals, the facility offered her 3,252 calories per day at meals, well in excess of the 1,677 to 1,960 calories required to maintain her usual body weight of 120 to 123 pounds. Staff noted that R-5 appeared overwhelmed by large portions of food and began offering her smaller amounts at one time. R-5 was offered fortified cereals and potatoes, and supplements such as Health Shake and Carnation Instant Breakfast. If R-5 showed signs of accepting certain foods, such as eggs, staff would order extra portions of those foods. Snacks were offered between meals, and R-5 was given vitamin C, zinc, and multivitamins with iron to supplement her nutrition. Staff employed items such as a "Nosey Cup," a cup designed to permit its being held near the resident's face without bumping the nose, to ease the feeding process. Harbour Health's standard practice was to weigh residents once per month. If the monthly weights indicated a problem, then Harbour Health would commence weighing the resident on a weekly basis until the problem was resolved. As noted by Ms. Ashworth, R-5 weighed 127 pounds at her monthly weighing on May 1, 2001. At her next monthly weighing on June 1, 2001, R-5 weighed 123 pounds. At the following monthly weighing on July 2, 2001, R-5 weighed 117 pounds. Ms. Ashworth calculated the weight loss from May 1 to July 2, 2001 as 7.8 percent of R-5's body weight. Noting the weight loss, Harbour Health placed R-5 on weekly weights in July 2001. On July 16, 2001, her weight remained at 117 pounds. On July 23, 2001, her weight had increased to 123 pounds. On August 1, 2001, R-5's weight was 125 pounds. Thus, by early August R-5 had regained nearly all of the weight she had lost between May and July 2001. On July 6, 2001, R-5's attending physician prescribed Risperdal, an antipsychotic medication, to calm her severe agitation and constant movement. Risperdal can act as an appetite stimulant. The administration of Risperdal to R-5 coincided with her weight gain in July 2001. When the facility became aware of R-5's weight loss in July 2001, staff began offering R-5 food more often, including more snacks between meals. The attending physician removed the sodium restriction from R-5's puree diet. Aside from those steps, Harbour Health maintained the same nutritional procedures for R-5. The agency alleged that Harbour Health was deficient in not involving the consulting dietician when it became aware of R-5's weight loss. The agency further alleged that Harbour Health should have ordered a psychiatric consultation and a speech therapy consultation. Regular snacks should have been ordered, and R-5's medications should have been adjusted. Harbour Health contended that it was already doing everything possible to ensure R-5's nutritional status. The only alternative to the puree diet would be tube feeding. R-5's son, who acted as her guardian, made it clear to the facility that he would not consent to tube feeding. In May 2001, R-5 suffered from an upper respiratory infection diagnosed as bronchitis by her attending physician. On May 14, 2001, the physician ordered the antibiotic Levaquin; nebulizer treatments with Albuterol and Atrovent, both bronchodilators; and oral administration of Robitussin. All of these medications were ordered and administered for a period of one week. Harbour Health contended that R-5's respiratory infection completely explained her weight loss. The evidence does not entirely support that contention. The medical records indicate that R-5's condition was largely resolved by the latter part of May 2001. R-5 lost four pounds during the month of May 2001. The majority of R-5's weight loss occurred during the month of June 2001, after her bronchitis was treated and apparently resolved. At most, R-5's weight loss was only partially explained by her upper respiratory infection. Dr. Michael Brinson, R-5's attending physician, testified that it is expected that an end-stage Alzheimer's patient will lose weight, because at some point the resident loses the will to live. In Dr. Brinson's opinion, R-5 had reached this point, which explained her refusal to eat. He was aware of R-5's weight loss. Given R-5's clinical condition, the weight loss did not concern Dr. Brinson, who deemed it irrelevant to her care and treatment. Even Ms. Ashworth, the agency RN who performed the survey observation of R-5, agreed that weight loss can be a symptom of end-stage Alzheimer's. R-5 had been provided with a speech consultation and speech therapy in 1998. She was discharged from speech therapy in March 1998 because it was determined that nothing more could be done for her. Dr. Brinson testified that a speech therapy consultation would have been useless in July 2001. Speech therapy is called for if the resident's refusal to eat is related to a swallowing problem. R-5 had no swallowing problem. Catherine Rolin, the restorative nurse who supervised R-5's feedings, confirmed that there were no indications R-5 had difficulty swallowing, or had choked or aspirated during the time she was losing weight. Dr. Brinson opined that R-5's terminal diagnosis with end-stage Alzheimer's disease made a psychiatric consultation of no value. R-5's cognitive impairment would have rendered her unable to participate in any psychiatric examination. Dr. Brinson came to the facility at least once a week. His Advanced Registered Nurse Practitioner ("ARNP"), Vickie Swank, came to the facility several times a week. Dr. Brinson would have had to order any psychiatric or speech therapy consultation, or any laboratory work. Dr. Brinson believed that none of these was appropriate for R-5. The interdisciplinary team overseeing R-5's care included the facility's certified dietary manager. The team was aware of R-5's weight loss as of July 2, 2001, and decided that R-5's status did not trigger a need to consult the registered dietician. Deborah Blackburn, a dietician and expert in nutrition, reviewed R-5's records and concluded that there was no need to consult a registered dietician. Ms. Blackburn opined that the facility was taking all reasonable steps to maintain R- 5's caloric intake and nutritional status. She could not think of a workable approach that Harbour Health had failed to employ. Aside from the weight loss itself, R-5 suffered no skin breakdown or other negative effects. Viewing the evidence in its entirety, it is found that AHCA failed to prove the elements of Tag F325 by a preponderance of the evidence. R-5 lost the weight then quickly gained most of it back with no dramatic changes in Harbour Health's approaches to her feeding and overall nutrition. This fact demonstrates that R-5's weight loss was caused not by Harbour Health's failure to provide adequate nutrition, but by a combination of R-5's terminal Alzheimer's disease and her upper respiratory infection. Once Harbour Health became aware of the weight loss, it reacted appropriately and successfully. The steps that the agency faulted Harbour Health for failing to take--psychiatric consultation, speech therapy consultation, dietician consultation, and medication adjustments--were demonstrated to be unnecessary in light of R-5's condition.
Recommendation Upon the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Agency for Health Care Administration enter a final order dismissing the Administrative Complaint in DOAH Case No. 02-1299, and rescinding the notice of intent to assign conditional licensure status to Harbour Health Center in DOAH Case No. 02-0949 and reinstating the facility's standard licensure status. DONE AND ENTERED this 23rd day of September, 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 23rd day of September, 2002. COPIES FURNISHED: Ursula Eikman, Esquire Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Dennis L. Godfrey, Esquire Agency for Health Care Administration 525 Mirror Lake Drive, North Room 310L St. Petersburg, Florida 33701 Karen L. Goldsmith, Esquire Goldsmith, Grout & Lewis, P.A. 2180 North Park Avenue, Suite 100 Post Office Box 2011 Winter Park, Florida 32790-2011 Lealand McCharen, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Valinda Clark Christian, Acting General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308
The Issue Whether the Respondent committed the violations alleged in the Administrative Complaint dated October 22, 2001, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: The Department is the state agency responsible for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. See Section 455.225, Florida Statutes. The Board of Medicine is the entity responsible for regulating the practice of medicine in Florida and for imposing penalties on physicians found to have violated the provisions of Section 458.331(1), Florida Statutes. See Section 458.331(2), Florida Statutes. Dr. Pliskow is, and was at the times material to this proceeding, a physician licensed to practice medicine in Florida, having been issued license number ME 0054211, and he is Board-certified in Obstetrics, Gynecology, and Forensic Medicine. At the times material to this proceeding, Dr. Pliskow practiced obstetrics and gynecology with three other physicians, Dr. Ackerman, Dr. Herbst, and Dr. Aqua, under the name "Advanced Women's Healthcare." In 1996, Dr. Pliskow, Dr. Ackerman, and Dr. Herbst established the Comprehensive Weight Loss & Nutrition Center ("Center") as a separate corporation. Kimberly Payne, an A.R.N.P., was the administrative director of the Center, and, in addition to administrative duties, her job responsibilities included supervision of the nursing staff working in the Center, direct patient care, and staff training. The four physicians practicing at Advanced Women's Healthcare were the designated supervising physicians for staff of the Center. Bariatrics is the subspecialty dealing with the medical treatment of obesity, and the four physicians supervising the Center, as well as Nurse Payne, were members of the American Society of Bariatric Physicians. As members of this organization, the physicians and Nurse Payne received two monthly journals, a biweekly newsletter, a monthly magazine, and faxes and e-mails containing updates on standard-of-care issues, medication changes, updates from the Federal Drug Administration, and suggested treatment changes and recommendations. The organization also provided educational programs and training opportunities for its members. In accordance with the recommendations of the American Society of Bariatric Physicians, the Center's weight loss program included a behavior modification program; a diet providing between 1200 and 1400 kilocalories per day; and an exercise program designed for each of its patients. In addition, if the patient was an appropriate candidate, the Center prescribed anorectic medications, including the combination of the drugs Phentermine and Fenfluramine commonly known as "Phen/Fen." Weight Loss Protocol At the times material to this proceeding, A.R.N.P.s were allowed under Florida law to practice independently under the general supervision of a physician who was accessible to them if they needed a consultation or evaluation of a patient. See Sections 464.003(3)(c) and 464.012(3), Florida Statutes (1995); Rule 64B8-35.002, Florida Administrative Code. Among other things, A.R.N.P.s were allowed to perform physical examinations of patients, to take medical histories, to initiate treatment programs, to prescribe certain types of drugs, and to evaluate patients for signs and symptoms of side effects associated with medications. A.R.N.P.s could not, however, prescribe drugs that were classified as controlled substances. Nurse Payne, and another A.R.N.P. subsequently hired to work at the Center, practiced under the general supervision of Dr. Pliskow, Dr. Ackerman, Dr. Herbst, and Dr. Aqua and in accordance with a protocol setting forth the respective duties of the A.R.N.P.s and of the physicians in the various areas of practice at Advanced Women's Healthcare. The protocol was filed with the appropriate state agency. Section Four of the protocol dealt with weight loss. Pursuant to the general guidelines, the A.R.N.P.s working at the Center were "responsible for the assessment and management of overweight individuals in a comprehensive weight reduction program including nutritional counseling, exercise management, and use of anorectic medications when appropriate." Patient selection criteria were as follows: Any individual who is over their ideal body weight may participate in the nutrition and exercise portions of the program. In order to qualify to participate in the medication portion of the program, the individual must meet the following criteria: Between the ages of 18 and 65 (any person between the ages of 61 and 65 must have medical clearance from their PCP [primary care physician]). Minimum of 20% over ideal body weight. No present history of heart disease, uncontrolled hypertension, cardiac arrhythmia, glaucoma, uncontrolled diabetes, hyperthyroidism, psychotic illness, drug or alcohol abuse, pregnancy, breastfeeding, or impending surgery requiring general anesthesia. Any deviation from these criteria requires collaboration with physician. The following was the General Condition of the weight loss protocol: The A.R.N.P. should consult with the physician on all patients exhibiting abnormal findings which might affect their weight loss management and refer for physician evaluation as needed. Patient C.B. Patient C.B. learned of the Center's weight loss program from her daughter, who had participated in the program and taken weight loss medication. C.B. had an initial consultation at the Center on October 23, 1996. At the time, as recorded on the Center's Weight Reduction Intake Form, C.B. was 62 years of age, her weight was 165 pounds, her height was five feet and four inches, she had a medium frame, her blood pressure was 138/82, and her pulse was 72 beats per minute. The intake form also included her body measurements as of October 23, 1996. As part of the initial consultation, C.B. completed the Center's Weight Reduction Program Questionnaire, in which she stated that she considered her ideal weight to be 135 pounds, that her biggest obstacle to losing weight was staying on a diet, and that she was interested in using medication in her weight loss program. C.B. indicated that she had no limitations on exercise and played tennis regularly. She disclosed her current medications, and she indicated that she did not then, nor had she ever, had the following conditions: heart disease, irregular heartbeat, high blood pressure, glaucoma, diabetes, psychotic illness, or alcohol or drug abuse. Nurse Payne reviewed the Weight Reduction Program Questionnaire with C.B. and completed the intake form. She noted on the intake form that C.B.'s ideal weight was between 120 and 135 pounds, that her weight goal was 135 pounds, and that her body mass index ("BMI") was 28.1 Nurse Payne reviewed with C.B. the information C.B. provided on the questionnaire, including her medical history, current medications, and drug allergies, and Nurse Payne noted on the intake form that C.B. reported arthritis as her only significant medical history. Nurse Payne and C.B. discussed the 1200-calorie exchange diet that was part of the program, and Nurse Payne developed an exercise plan for C.B. that included walking in the pool twice each week and incorporated C.B.'s usual routine of playing tennis three times each week. Nurse Payne noted on the intake form that Dr. Ira Fine was C.B.'s primary care physician. Nurse Payne also discussed medication options with C.B., including the benefits and risks of medications. The intake form included a printed section on medications, in which the first entry was "Pondimin2 20 mg. po bid and Phentermine 37.5 mg. po qd" and the second entry was "Other." Nurse Payne indicated on the intake form that C.B. would be started on "Phen/Fen pending medical clearance [by] Dr. Fine & EKG." Nurse Payne also advised C.B. that she would need to obtain medical clearance from Dr. Fine before medication would be prescribed. During the initial consultation on October 23, 1996, Nurse Payne provided C.B. with a Consent for Diet Program form and discussed with C.B. in detail the information in the consent form. The consent form contained descriptions of both Phentermine and Fenfluramine, together with the contraindications to their use, and Nurse Payne provided C.B. with an excerpt from the Physician's Desk Reference for Phentermine and the packet insert for Pondimin.3 C.B. signed the consent form on October 23, 1996. A blood specimen was drawn from C.B. on October 23, 1996, and Nurse Payne scheduled C.B. for an EKG on October 26, 1996. Nurse Payne telephoned Dr. Fine's office on October 25, 1996, and spoke with "Betty" about medical clearance for C.B. to participate in the weight loss program; she specifically told Dr. Fine's office the program would include the use of Phen/Fen. Nurse Payne was later advised by Dr. Fine's office that Dr. Fine had medically cleared C.B. to participate in the Center's weight loss program.4 Once medical clearance was obtained for a patient and the results of the blood work and EKG were received, the standard procedure at the Center was for the A.R.N.P. to present the patient's chart to one of the supervising physicians.5 The physician would review the test results and the patient's medical history and determine whether it was appropriate to prescribe medications for the patient. If so, the physician wrote the prescriptions, which were then given to the patient. Neither Dr. Pliskow nor Nurse Payne can recall specifically that this procedure was followed in C.B.'s case, but there is nothing in the record to indicate a deviation from this procedure with respect to C.B. C.B. was cleared for participation in the weight loss program and for the use of Phen/Fen based the results of her blood work and her EKG and on the criteria set out in the weight loss protocol: Her primary care physician had given medical clearance; her weight was 20 percent above her ideal body weight; and she had reported no present history of the conditions identified in paragraph II.B.3 of the protocol. Her blood pressure and pulse were normal. The results of her EKG showed no significant abnormality, and there was nothing in the results of the blood work done on October 23, 1996, that would prevent C.B. from participating in the weight loss program or from taking Phen/Fen. C.B.'s initial prescriptions for Phen/Fen were written on October 28, 1996 and, as noted in her chart, were for Pondimin in the dosage of "20 mg. [milligrams] po [orally] bid [twice daily]" and for Phentermine in the dosage of "37.5 mg. [milligrams] po [orally] qd [daily]."6 The medications and dosage prescribed for C.B. remained the same throughout the time she participated in the Center's weight loss program, and no further notations regarding dosage was included in her chart. C.B. initially visited the Center each week; in late November 1996, the frequency of her visits was decreased to once every two weeks, and then, in early February 1997, to once every four weeks. At each visit, a member of the nursing staff at the Center would note C.B.'s blood pressure, pulse, and weight on the progress forms in her chart, together with the amount of weight lost since her last visit. The chart also contained the notes of Nurse Payne or the other A.R.N.P. working at the Center reporting on C.B.'s success in staying on the diet and exercise plans; noting that her medication was "P/F"; and summarizing C.B.'s general progress, anything unusual she reported, and the plan she would follow until the next visit. C.B. also completed at each visit a Follow-Up Questionnaire in which she was asked to report whether, since her last visit, she had experienced chest pain, shortness of breath, dizziness, light-headedness, visual problems, palpitations, abdominal pain, bowel changes, fatigue, difficulty sleeping, depression, irritability, difficulty concentrating, memory loss, tremors, or increased appetite. The Center's standard procedure was for the A.R.N.P. meeting with the patient to discuss the answers in the questionnaire with the patient and to question the patient regarding any problems he or she might be having with the program. Once the A.R.N.P. had examined the patient and completed the patient's progress report, the A.R.N.P. would take the chart to the supervising physician, who would review the chart and write the prescriptions for Phen/Fen. None of the prescriptions for Phen/Fen dispensed at the Center were pre-signed. Patients in the weight loss program received new prescriptions for Phen/Fen at each visit to the Center. Because Phentermine and Fenfluramine are controlled substances, there could be no refills on a prescription, so the prescriptions were written for a sufficient number of pills to last until the patient's next visit to the Center. Although the prescriptions were written and signed by one of the supervising physicians, the physicians did not sign the patient's chart. After the supervising physician wrote the prescriptions, the A.R.N.P. would take the prescriptions to the patient, who could have them filled at the pharmacy in the offices of Advanced Women's Healthcare or at a pharmacy elsewhere. There is nothing in the record to indicate that this practice was not followed with respect to the prescriptions issued to C.B.7 On November 4, 1996, her first visit after beginning the program, C.B. reported one episode of light-headedness. Otherwise, C.B. reported none of the symptoms identified in the questionnaire and reported no problems with the program. Had C.B. reported experiencing anything abnormal, Nurse Payne would have called in one of the physicians supervising the Center for a consultation. C.B. participated in the Center's weight loss program through April 7, 1997, which was the date of her last visit. C.B. lost weight on the Center's program at a slow but steady rate, usually between one and four pounds between visits, until, on April 7, 1997, she weighed 141 pounds. C.B.'s treatment with Phen/Fen ended before May 1997, when the Florida Board of Medicine published stricter limitations on the use of these medications.8 Although Dr. Pliskow was not present in the office on October 28, 1996, when C.B.'s first prescriptions for Phen/Fen were written, he was present in the office during four of C.B.'s ten visits to the Center. Because at least one other physician was also present in the office during these four visits, Dr. Pliskow may or may not have reviewed C.B.'s chart and written her prescriptions.9 Summary The evidence presented by the Department is not sufficient to support a finding that Dr. Pliskow practiced medicine below the level of care considered acceptable by a reasonably prudent physician under similar circumstances or to support a finding that Dr. Pliskow failed to document in C.B.'s medical records justification for the course of her treatment in the weight loss program and the dosage of the medications prescribed for her. The evidence is not sufficient to establish clearly and convincingly that the prevailing standard of care required the physician supervising the Center's A.R.N.P.s personally to perform a physical examination of C.B. prior to her being cleared for receiving medication as part of her weight loss program or personally to obtain C.B.'s medical history. Rather, it was appropriate for Nurse Payne and the other A.R.N.P. working at the Center to perform physical examinations and to take medical histories of persons seeking to participate in the Center's weight loss program. In addition, the evidence is not sufficient to establish clearly and convincingly that it was inconsistent with the prevailing standard of care for the Center's supervising physicians to rely on C.B.'s primary care physician to provide medical clearance for her to participate in the weight loss program. Dr. Fine was familiar with C.B.'s overall medical condition as a result of his examination of her on September 12, 1996, and he was, therefore, competent to assess the overall risks of her participation in a weight loss program incorporating the use of anorectic medications. Furthermore, the evidence fails to establish that it was inconsistent with the prevailing standard of care to rely on the verbal medical clearance conveyed to Nurse Payne through Dr. Fine's office; rather, the persuasive evidence suggests that it was the normal practice for clearance to be given in this manner.10 And, significantly, Dr. Fine's medical clearance was not the only basis for C.B.'s clearance to take anorectic medications: C.B.'s vital signs were recorded on the intake form by the Center's nursing staff, and Nurse Payne compiled C.B.'s medical history from C.B.'s answers to questions on the Weight Loss Program Questionnaire and from discussions with C.B; an EKG and extensive blood work were ordered for C.B., and a physician reviewed C.B.'s chart and the results of these tests before writing C.B. prescriptions for anorectic medications.11 The evidence is not sufficient to establish that the physicians practicing at Advanced Women's Healthcare failed to provide the appropriate level of supervision to the A.R.N.P.s who worked in the Center. A.R.N.P.s are independent practitioners, and they are subject only to the general supervision of a physician. The evidence failed to establish that the prevailing standard of care for physicians supervising A.R.N.P.s required anything more than that the physician be available for consultation. At least one physician was available in the Advanced Women's Healthcare offices at all times for consultation and/or patient evaluation if an A.R.N.P. working at the Center determined that a patient was experiencing any complications or if a patient reported any unusual symptoms. The evidence is not sufficient to establish clearly and convincingly that the type and scope of information collected during C.B.'s regular visits to the Center and the on-going care provided to C.B. were not appropriate under the prevailing standard of care for monitoring patients on weight loss programs such as C.B.'s. The prescriptions for C.B.'s weight loss medications were written by a physician at each of C.B.'s visits, but only after the physician reviewed her chart, which included the A.R.N.P.'s progress notes and C.B.'s answers on the Follow-Up Questionnaires she completed at each visit, to determine whether it was appropriate to continue C.B. on anorectic medications.12 The evidence also fails to establish that the prevailing standard of care required a supervising physician to sign a chart prepared by an A.R.N.P. to indicate that it had been reviewed.13 The evidence is not sufficient to establish that C.B. was not an appropriate candidate for a weight loss program using Phen/Fen under the prevailing standard of care in 1996 and early 1997.14 Adequate justification for the treatment of C.B. with anorectic medications was included in C.B.'s medical records: She was considered obese by 1996 standards because her weight of 165 pounds was more than 20 percent higher than her ideal body weight of 120-to-135 pounds and because her BMI was 28 and she wanted to lose weight. In addition, nothing in the medical history C.B. provided to Nurse Payne or in her tests results indicated that she would be an inappropriate candidate for anorectic medications, and she reported no complications during her follow-up visits.15 The evidence is not sufficient to establish clearly and convincingly that the dosages of Phen/Fen prescribed for C.B. were inappropriate or excessive under the prevailing standard of care in 1996 and early 1997. Rather, the dosages prescribed for C.B. were in the lower range of dosages recommended at the time by the American Society of Bariatric Physicians and in the medical literature in general for the use of Phentermine and Fenfluramine in combination.16 The dosage of both medications was printed on the intake form completed during C.B.'s initial visit to the Center, and the dosages did not change during the time C.B. participated in the Center's weight loss program; in accordance with normal practice, no further notations were made regarding dosages in C.B.'s chart. New prescriptions were written each time C.B. visited the Center, and no refills were permitted, which is also in accordance with the standard practice in dispensing controlled substances.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order dismissing in its entirety the Administrative Complaint against Steven Pliskow, M.D. DONE AND ENTERED this 30th day of April, 2002, in Tallahassee, Leon County, Florida. PATRICIA HART MALONO Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 30th day of April, 2002.
The Issue Whether Beverly Health Care of North Okaloosa violated certain regulations at the time of two surveys conducted on July 16 and November 29, 2001, so as to justify the Agency for Health Care Administration's decision to issue Beverly Health Care of North Okaloosa Conditional licenses and administrative fines.
Findings Of Fact North Okaloosa is a licensed nursing home located in Crestview, Florida. On July 16, 2001, AHCA conducted a survey of North Okaloosa’s facility. In its survey AHCA found one alleged deficiency relating to Resident No. 5. The deficiency was cited under Tag F-324. Tag F-324 relates to whether a facility has provided sufficient supervision or assistive devices to a resident to prevent injury from falls. The tag does not address assessment, the failure to assess, or maintenance of a care plan. These deficiencies are covered by other tags. Specific to Resident No. 5, the agency surveyor suggested that Resident No. 5 should have been provided a different type of footwear from that which he was wearing or that the facility should have provided additional assistive devices to prevent falls. Resident No. 5 was admitted to North Okaloosa’s facility around April 16, 2001. At the time of admission, he was assessed as being at high risk for falls. Interventions included monitoring medications, laboratory values, steadiness and balance. Resident No. 5 resided on the secured ward at the facility. Resident No. 5 had pain in both feet, but could ambulate. He walked with a shuffling gait due to his foot pain, and he wore slip-on house shoes without non-skid soles. He refused to wear other types of shoes because other types of shoes caused more discomfort. He was also cognitively impaired and refused to sit down or lie down to rest but would ambulate continuously. Restraints were not appropriate for him. Resident No. 5 had been assessed to be at risk for falling and had a care plan in place. He was on the facility’s "Falling Star" program which meant that he was checked on by the staff at least every half hour. The general standard of observation in nursing homes is every two hours. The nurses’ notes contain many entries regarding monitoring the resident while he walked. Since admission, Resident No. 5 fell on June 12, June 25, July 8, and July 14, 2001. The only falls charged as violations by AHCA concerned the falls on July 8 and July 14, 2001. The resident was found on the floor outside the shower on July 8, 2001. He sustained some injury which caused him to be taken to the local hospital. However, there was no indication of inappropriate supervision or that his shoes were involved or contributed to the fall. Indeed, there was very little evidence regarding how Resident No. 5 got down on the floor of the shower. Resident No. 5 fell again on July 14, 2001. On that date, he was being observed by staff who saw him bend over and then lose his balance. At that time, he was being supervised closely, but even so, the fall could not be prevented. Again, there was no indication that the shoes contributed to his fall. Unfortunately, falls are a common occurrence in nursing homes and cannot always be prevented. The goal is to balance the need to prevent falls and the need to keep residents free of restraints given physical, cognitive, and treatment limitations. Falls can result regardless of adequate supervision. There is no standard of care which requires one-on-one supervision of any resident. However, such one-on-one supervision would not necessarily prevent all falls. Although AHCA suggested the resident should have had shoes with non-skid soles, such shoes would have increased the risk of falls, given the resident’s shuffling gait. Non-skid soles were not appropriate footwear for Resident No. 5. There was some indication in the evidence that the facility at times had one C.N.A. on duty for the ward. No schedules or testimony from the facility confirmed this fact. There was insufficient evidence on this point to address the adequacy of the facility's staffing. Moreover, the evidence did not demonstrate any appropriate measures which could have been added to protect Resident No. 5 from falls. Beyond agency speculation, there was no evidence that the standard of care for supervision of a resident in order to prevent falls was violated and no Class II deficiency occurred in relation thereto. On November 29, 2001, AHCA again conducted a survey of North Okaloosa’s facility. In its survey AHCA found several violations related to various residents. The deficiencies cited by AHCA involved Resident No. 3 (Tags F-157 and F-324); Residents No. 2 and 22 (Tag F-221); Resident No. 19 (Tags F-221, F-324 and F-325); Resident No. 7 (Tag F-279); Residents No. 10 and 12 (Tags F-279 and F-325); Resident No. 15 (Tag F-279); Resident No. 16 (Tags F-279 and F-324); Resident No. 24 (Tag F-279); Resident No. 25 (Tag F-324); and Residents No. 1 and 17 (Tag F-325). Tag F-157 represents 42 C.F.R. Section 483.10(b)(11), which in pertinent part requires a facility to immediately inform a physician "when there . . . is a significant change in the resident’s . . . status . . . (i.e., a deterioration in health . . . status in either life threatening conditions or clinical complications) . . ." Not all changes in a resident’s condition trigger the notification provisions of Tag F-157. Notification is required only where the change is significant as outlined above. Resident No. 3 required assistance with her activities of daily living and was cognitively impaired. Resident No. 3 required assistance with ambulation. There was no evidence that she required assistance with toileting. She was diagnosed with dementia and had severe osteoarthritis. Resident No. 3 often complained of back pain and was prescribed Darvocet as a medication for her back pain. She also often refused to ambulate and would remain in her bed. She was prescribed Zyprexa and Haldol. Nursing notes indicate that at 7:23 p.m. on August 31, 2001, Resident No. 3 was assisted to the bathroom and seated. A few minutes later she was found "on the floor no injuries noted." Nurses are trained to assess patients after an accident to determine whether there has been an injury. This is a regular part of practice in a nursing facility. A notification was faxed to the doctor regarding the incident, with the notation that there was no injury, but that the resident had experienced a decline in ability to ambulate. However, the staff did not think the decline was a significant change in status since Resident No. 3 often would stay in bed. AHCA asserts that this notice was insufficient, as it was sent after office hours prior to a weekend. AHCA’s position assumes the doctor would not have received the fax. The nursing notes over the weekend note that the resident complained of back pain, that she had a small bruise on her left shoulder, that she remained in bed but displayed no effects from the fall. Nursing staff continued to monitor her. On Saturday and Sunday, the C.N.A. did range of motion and ambulation exercises with the resident. There was no complaint of pain or "guarding." On the following Tuesday (Monday was Labor Day), while in therapy, the therapist noted pain while doing exercises. The physician was called and an X-ray was ordered which revealed a fracture of the tibia. In this case, the complaint of back pain did not constitute a significant change in condition, as the resident’s record is replete with continuing complaints of back pain prior to August 31, 2001, and a medication prescribed for that particular problem. The resident had also had episodes of staying in bed and a recent decline in ambulation, of which the doctor was aware. Given this history, the clinical records do not reflect any significant change in condition which would warrant an immediate notification of a physician prior to Tuesday, when the doctor was called. Therefore, no Class II violation occurred in relation to Resident No. 3 under Tag F-157. Tag F-324 was also cited as a violation in relation to Resident No. 3. As indicated earlier, Tag F-324 relates to the provision of adequate supervision or assistive devices to prevent falls. The record reflects that the resident had been able to ambulate independently with a recent decline in ambulation and need for some assistance. She could follow instructions. She had a care plan for falls and was on the Falling Star program. She was seen by a neurologist and a physical therapist. Nothing in the record indicated insufficient capacity to be allowed to use the bathroom in private. AHCA's surveyor did not know what the usual routine was for this resident as it related to toileting but suggested that she should not have been left alone while toileting. The evidence does not support this conclusion and there is no other basis under this tag in relation to Resident No. 3, which demonstrates a violation. Tag F-221 corresponds to 42. C.F.R. Section 483.13(a) and prohibits the use of restraints "imposed for discipline or convenience and not required to treat the resident’s medical condition." Again, the tag does not include assessment, failure to assess or maintenance of a care plan. AHCA asserted that three residents had restraints which were not used to treat a medical condition, Residents No. 2, 19, and 22. Resident No. 2 had a history of falls, and a care plan to address his risk of falls. On October 17, 2001, he fell for the third time since September 30, 2001, causing a 3.5 cm laceration to the back of his head. He had been experiencing a decline in cognitive status and disease progression, of which the doctor was aware. The resident had severe mental impairment which caused him to not be aware of safety. As a result of this history and his injury, the doctor assessed and ordered the use of a lap belt while he was in a wheelchair, along with an alarm to notify staff if he attempted to stand. The records reflect a medical need for the restraint to prevent injury to this resident. Resident No. 19 used a front opening lap belt while she was in her wheelchair. The lap belt was assessed and ordered by the physician on August 14, 2001. The clinical record contained an assessment of the device and approval from the family, but the assessment clearly noted that the device was used "for positioning. Not as a restraint." The resident had a care plan for falls, which also stated that the seat belt was for positioning to "prevent her from sliding out of the chair," not to prevent her from getting up. According to the notes of her assessment, the belt also acted as a reminder for her to seek assistance when getting up. AHCA acknowledged that the device was not a restraint because the resident could, and did, open it. Even if it were considered a restraint, however, the record reflects that it was used to address her history of falls and poor safety awareness due to her dementia. In short, the belt was used because of her medical condition and, therefore, had a medical reason underlying its use. Resident No. 22 had a physician’s assessment and order for a roll belt while in bed. A roll belt is attached to either side of the bed and keeps the resident from getting up or out of bed. It is a restraint. The roll belt was ordered because, as acknowledged by AHCA in the survey report, the resident had sustained a fall in which she broke her hip, and then, upon return to the facility, fell from her bed and re-injured her hip. The second fall necessitated a complete hip replacement. She had poor safety awareness, and any further fall would have resulted in severe limitations. The doctor had also ordered cushions to be attached to her legs to keep her hip aligned properly, so that any attempt to get up would necessarily have resulted in a fall. Clearly, this restraint had a medical purpose. As to Tag F-221, there was insufficient evidence that North Okaloosa used restraints in an inappropriate manner. It was clear from the evidence that AHCA’s main concern was a perceived lack of assessment or reassessment of the devices used on these residents. However, assessment is not covered by this tag. Moreover, the record demonstrated some assessment was done by the doctor in ordering the use of these devices for medical reasons. The facility is entitled to rely on that expert's decision. Tag F-279 encompasses 42 C.F.R. Section 483.20(k), which requires a comprehensive care plan for each resident to meet needs identified in a comprehensive assessment. AHCA asserted that the care plans for six residents were defective in varying ways. AHCA's surveyor asserted that the care plan for pressure sores for Resident No. 7 was deficient because it did not mention that the resident was at high risk for pressure sores, that he had sores that opened and healed, or included the changes in the doctor’s orders regarding those sores. A "care plan" as opposed to a "plan of care" is developed pursuant to an assessment called a Minimum Data Set or MDS, which is conducted on admission, then annually with quarterly updates for significant changes. It is not an all- inclusive document and cannot be all-inclusive. As set forth in Rule 59A-4.109, Florida Administrative Code, the overall "plan of care" includes not only the care plan, but physician’s orders and other information relating to the resident. Physician orders are not required to be included in the formal care plan required under Tag F-279 and such orders are not typically reflected on a care plan document. Resident No. 7 was admitted with Stage IV pressure ulcers in February 2001. Resident No. 7 was diagnosed with leukemia, as well as other debilitating conditions. A care plan was developed in March pursuant to an MDS on admission which stated that he had pressure sores and was at high risk for developing such. The plan was amended several times, most recently before the survey on November 14, 2001. Contrary to the surveyor’s assertion, the care plan did mention the resident was at increased risk for pressure sores and noted that, in spite of the resident’s conditions, the pressure sores healed by May and did not reoccur. The care plan was kept in effect to prevent further problems and was obviously effective. Clearly, Resident No. 7 had a care plan which reasonably addressed his needs. AHCA asserted that Resident No. 10 required a care plan for weight loss. However, the resident was admitted at 80 pounds, and at the time of the survey weighed 93.6 pounds, indicating that there was not a weight loss problem. A physician’s assessment in September described her as a "petite, well-developed" 87-year-old, which indicates no problem with her weight. She was within her ideal weight range. She had some history of up and down weights, but the evidence did not demonstrate a need to change or update Resident No. 10’s care plan. Resident No. 10 had also been flagged by the facility as being at risk for weight loss and sometimes refused her meals. However, these facts demonstrate an appropriate ongoing monitoring and assessment of Resident No. 10 by the facility. These facts do not demonstrate a need to immediately amend the formal care plan for Resident No. 10. Resident No. 12 was a Hospice patient. He had metastatic prostate cancer which was likely to result in death within six months. For Hospice residents, the focus is on comfort as opposed to aggressive care. The Hospice agency is a separate entity from the nursing home, and when Hospice comes in to care for a resident, it becomes the care manager and determines the approaches to care. AHCA's surveyor asserted that there did not appear to be coordinated care plans between Hospice and North Okaloosa for Resident No. 12, but the basis for this concern was not made clear. AHCA's surveyor acknowledged that the facility and Hospice had care plans and did not identify any specific concerns except that the facility did not appear to be doing weekly weighings of the resident. However, Resident No. 12 had been assessed to be likely to lose weight due to his medical conditions. He received nutritional supplements, and the family had declined tube feedings, which is consistent with Hospice care. The facility records reflect that the resident did receive the nutritional supplements, and that, while he gradually lost weight as expected, he did not decline significantly in the period prior to survey. The facility did not shirk its duty to continue to monitor Resident No. 12. It coordinated its care with that of Hospice and AHCA’s concerns over such were not born out by the evidence. AHCA’s complaint about Resident No. 15 was that the care plan for weight loss was discontinued when the resident was admitted to Hospice care. At that time, however, the resident continued to have a Hospice care plan regarding nutrition, and a facility care plan regarding hospice care which noted that the resident was to be monitored for abnormal weight loss, appetite, and skin breakdown. Additionally, as a result of an assessment completed November 26, 2001, it was determined that there were concerns about skin breakdown. A separate care plan for nutritional status was to be developed. This assessment demonstrates that the care planning process was working appropriately for Resident No. 15. It also demonstrates coordination between Hospice and the facility. Again, AHCA's concern of coordination of Hospice care with facility care was not born out by the evidence. Resident No. 16 was diagnosed with various dementias, anxiety and depression. The resident had frequent episodes of dizziness with a history of falls. AHCA's surveyor asserted that the care plan for Resident No. 16 should have had particular mention of dizziness and a method of addressing that condition. The care plan did appropriately plan for fall prevention and addressed the reasons for her falls, i.e. vertigo, under that section. The resident’s record demonstrates that the resident received frequent physician attention due to her spells of dizziness or vertigo and that the nurses continuously monitored for that condition. The assessment which resulted in the development of the resident’s care plan indicates that the resident has dizzy spells causing falls. The care plan lists monitoring of the resident for "steadiness and balance." As "dizziness" is a subjective state, it cannot be monitored, and the care plan, which was updated on many occasions, adequately addressed the problem even if it was not in terms AHCA thought should be used. Resident No. 24 was also a Hospice resident. The resident was in a vegetative state. AHCA's surveyor suggested that the Hospice care plans and facility care plans were not "integrated." The resident’s record reflects, however, that the facility developed a care plan noting that the resident was on Hospice care and that Hospice attended care plan meetings. AHCA also suggested that the care plan for pressure sores was deficient because it noted a "risk of" pressure sores and was not updated to reflect actual pressure sores which the resident acquired while in the hospital. AHCA suggested no way in which this would have changed the care given. However, as noted above, physician orders are not typically reflected on the care plan document. Furthermore, Hospice had a care plan for pressures sores as well, and the record reflects that there were numerous physician orders for treatments. The care plans for all the residents cited were developed pursuant to the comprehensive assessment process. The evidence did not demonstrate any Class II violations of Tag F-279. Indeed the evidence demonstrated that confusion by AHCA over a resident’s formal care plan with an ongoing and changing plan of care. Again, in the November survey AHCA charged that North Okaloosa failed to provide adequate supervision to prevent accidents for three residents under Tag F-324. The allegations relating to Resident No. 3 were covered earlier. As indicated earlier, Resident No. 16 experienced dizziness or vertigo. She also had a high risk for falls. AHCA's surveyor speculated that alarms should have been attached to her chair or increased supervision. However, the resident regularly got up and walked, which would render the alarms useless. Indeed, the evidence did not demonstrate that rising from a seated position was the cause of her falls. In fact, the resident had not experienced any falls from August 22 until November 27, 2001, in spite of her episodes of vertigo and dizziness. She received frequent physician evaluations and the nurses’ notes reflect frequent monitoring. The record reflects that there was no warning of her attacks of vertigo. There was no evidence of inadequate supervision or of assistive devices which would reduce the resident’s risk of falling. Resident No. 19 had a history of falls and had been assessed several times for the problem. He was in a wheelchair with a front opening seat belt. A TABS monitor was used while the resident was in bed. The resident had a care plan in place to address such, including restorative care to assist with transfers. She received therapy to address her problem with balance. AHCA's surveyor suggested that her seat belt did not operate as an effective restraint but did not suggest the resident should have been restrained, agreeing that residents generally have the right to be free of restraints. Indeed, restraints were not appropriate for this resident. AHCA also noted that no measures other than a seatbelt and chair alarm had been put in place since August. Those measures had been reviewed through assessment in September, however, and had been effective in preventing falls until November 23, 2001. There was no evidence that there was any lack of supervision of Resident No. 19. Additionally, the resident was in the process of being reassessed to determine if further interventions were appropriate after her fall of November 23, 2001, and that review, though underway, had not been completed at the time of the survey. The evidence did not demonstrate that AHCA failed to adequately supervise or provide assistive devices to these residents. Therefore, no Class II violation under Tag F-324 was established. Tag F-325 requires a facility to ensure that a resident "maintains acceptable parameters of nutritional status" insofar as possible given a resident’s clinical conditions. 42 C.F.R. Section 483.25(i). Guidelines used by AHCA in interpreting this regulation are found in the State Operations Manual and suggest that there are levels of "significant" weight loss which would be unacceptable, if not explained by a resident’s medical circumstances. Weight loss is to be determined by looking to the resident’s usual weight, and significance is measured at one month, three month, and six month intervals, recognizing that a shorter term could be a temporary aberration. Generally, a 5 percent total body weight loss in 30 days or a 10 percent total body weight loss in 180 days is considered significant by AHCA. However, these are simply guidelines and do not necessarily demonstrate a violation of this tag. Other considerations, such as the resident’s medical condition and obesity, must be considered. AHCA asserted that Resident No. 1 had a significant weight loss, from 249 to 222 pounds from September 16 through October 9, 2001. The selection of this time period is inappropriate, however, for two reasons. One, the weight of 249 is clearly, by the weight records, not a usual weight and appears to be a mistake. The resident’s prior weight was 238, and the resident’s usual weight was between 220 and 230 pounds. The resident was obese, which can make weighing difficult and cause inaccuracies. Moreover, it is physically impossible for the resident to have lost 27 pounds in three weeks. The second reason that the noted time frame was inappropriate was that it spanned less than a one month’s time and, therefore, was not necessarily indicative of any trend or condition. The surveyor also opined, though she was not a dietician or physician, that the facility should have increased the resident’s tube feeding level prior to October 9, 2001. The level had been reduced on physician orders on September 24, 2001, due to nausea and vomiting. The resident had metastatic breast cancer and was on Hospice care, making comfort the primary goal of treatment. From that date until October 9, 2001, the clinical record reflects continuing reasons not to increase the feeding level, irrespective of the dieticians recommendations. Medications had been added, and monitoring for their effectiveness would take time. The resident also had a distended abdomen indicating a failure to absorb the feedings she was receiving. Even if there had been a weight loss, it was not inadvisable given the resident’s obesity. There was no evidence that the resident’s nutritional well-being was not being monitored appropriately by the facility. AHCA cited Resident No. 10 under Tag F-325, but did not identify any "parameter of nutritional status" which was not maintained. Again, the surveyor identified a short term (one week) weight loss, which was not significant. The resident was within her ideal range. The surveyor suggested only that she had a history of varying weights and that, during the survey, she did not eat some of her meals. The weight record reflects, however, fairly consistent weights and an overall increase from the time of the resident’s admission. It was not disputed that Resident No. 12 experienced a significant weight loss; however, it was also undisputed that weight loss was to be expected with his metastatic prostate cancer, other medical conditions, and Hospice status. The surveyor was concerned that the resident was seen with a regular meal, rather than a "mechanical soft" meal, as ordered, and that the meal tray did not contain a sugar free shake, as ordered. The description of the meal in the survey report identified a meal which is considered "mechanical soft" by dietary standards. Further the clinical record (medication administration record) demonstrated that the shakes were provided. The shakes were not required to be on the meal tray, as there was a one-hour window around mealtime in which they could be served. Furthermore, the resident’s weight in October and November was relatively stable. The resident’s weight loss and protein levels were the result of his medical condition and the resident was on an adequate diet given the parameters of the resident’s treatment and condition. Resident No. 17 was cited under this tag, though there was no evidence of any significant weight decline or other nutritional deficit. The resident was within her ideal body weight and gained weight during her stay at North Okaloosa. AHCA disputed the tube feeding provided to the resident, but was unaware the resident also received food orally. Resident No. 19 lost weight since her admission in August 2000, to North Okaloosa. However, the trend was noted by the facility when it became significant. The concern was addressed and the weight stabilized after June 2001. The resident remained in her ideal body weight range, so there was no need to recapture the lost weight. In July, a physician review noted that the resident was "well-nourished." The surveyor acknowledged that there had been no significant weight loss from March to September 2001, and that weights were stable from June until the survey. In September, the resident’s psychiatrist noted that there had previously been a weight loss concern but that it had been resolved. The weight loss had occurred due to his medical condition and his need for 15 different medications which affected his appetite and condition. Resident No. 25 had a diagnosis of failure to thrive and was placed on Hospice care. Failure to thrive means an accumulation of factors trending to weight loss. Eating more does not affect weight loss as there is an inability to utilize nutrients. AHCA's surveyor objected to the fact that there was a dietary recommendation on October 23, 2001, for double portions, which had not resulted in an order. A physician’s order is required to make a diet change, and there is no indication of failure to notify the physician. However, the resident already received 3,300 calories, far in excess of her assessed needs, consumed 100 percent of her meals, and continued to lose weight. From a dietary standpoint, there was no reason to believe the addition of more calories would have affected the trend caused by her failure to thrive. The evidence did not demonstrate any Class II deficiencies related to these residents under Tag F-325.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, there was no basis upon which AHCA could have issued Conditional ratings to North Okaloosa on July 12, 2001, or November 29, 2001 or impose a fine. It is RECOMMENDED that the Agency for Health Care Administration enter a final order revising the July 12, 2001, and November 29, 2001, survey reports by deleting the deficiencies described under Tags F-157, F-221, F-279, F-324, and F-325, and issuing Standard ratings to North Okaloosa to replace the previously issued Conditional ratings, and correcting all other records to reflect the absence of any proven deficiencies at North Okaloosa during either survey, and dismiss the Administrative Complaint. DONE AND ENTERED this 3rd day of April, 2003, in Tallahassee, Leon County, Florida. DIANE CLEAVINGER 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 3rd day of April, 2003. COPIES FURNISHED: Jodi C. Page, Esquire Agency for Health Care Administration 2727 Mahan Drive, Mail Station 3 Tallahassee, Florida 32308 Donna H. Stinson, Esquire Broad & Cassel 215 South Monroe Street, Suite 400 Post Office Box 11300 Tallahassee, Florida 32302 Lealand McCharen, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Valda Clark Christian, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308 R. Davis Thomas, Esquire Broad & Cassel 215 South Monroe Street, Suite 400 Post Office Box 11300 Tallahassee, Florida 32302
Findings Of Fact Respondent John Thomas Beckum, a graduate of Bolles Military School and an alumnus of the University of Florida, is a second generation optometrist. His father was chairman of Florida's first Opticians' Board. In 1956, when he earned a B. S. degree and a doctorate of optometry at the Southern College of Optometry in Memphis, Tennessee, respondent graduated salutatorian. On July 31, 1960, respondent obtained his Florida optometrist's license. He worked for an older optometrist in Jacksonville, Florida, before he moved to Gainesville and began his own practice in 1961. It was also about that time he ceased to be a "formal member" (T. 350) of the Optometric Extension Program (OEP), but he has remained active in several other optometric organizations and has attended continuing education courses. He keeps up with the latest in new equipment in chats with the Gainesville ophthalmologist to whom he refers some of his patients. At the time of the hearing, respondent still practiced in Gainesville and held optometrist's license No. 668. He has been licensed by petitioner at all pertinent times. As a result of a complaint unrelated to this case, Ellen Williams, a program monitor in the medicaid office of the Department of Health and Rehabilitative Services (HRS) "requested a printout of [Dr. Beckum's] practice," (T. 85) and examined this computer compilation of information about medicaid claims respondent had submitted. In the period July 1, 1979, to June 30, 1980, Dr. Beckum saw 272 medicaid patients of whom 210 received eyeglasses. Of the 272, there were 112 children ten and under. Of these 112 children, 98 received eyeglasses. Of the 98 bespectacled children, 39 were under age six. At the suggestion of an HRS consultant, Dr. James A. Stephens, some of the respondent's records were examined and copied by HRS investigators., A random group of children's records was copied on the first trip to Dr. Beckum's office and a random group of adult patients' records was gathered, on a second visit. These records, which are in evidence as Petitioner's Exhibits 4A, 4B and 4C, were examined by Dr. ,Stephens, and, eventually, by Drs. Cherdack, Devine and Albert, served as volunteers on a peer review committed of the Florida Optometric Association. MEDICAID FRAMES Catherine Wright, mother of Shawn and Craig Wright and of Farnell and Preston Walker, sent her children to Dr. Beckum in the late '70s at the suggestion of school authorities. Each child received, eyeglasses under the medicaid program. Dr. Beckum told Ms. Wright that the medicaid program would cover the cost of some of the frames but not others. Two of her children chose frames Dr. Beckum told her Medicaid did not cover. On each occasion, Ms. Wright paid respondent's office seventeen dollars ($17.00). Ms. Wright understood she would not have incurred these charges if other frames had been selected; she just wanted to indulge her children by getting them the frames they picked out. After Tracy Boykin started school, her mother to her to Dr. Beckum's office. Eyeglasses were prescribed, and Tracy tried on several frames. She was a medicaid recipient at the time of this visit, in the fall of 1980. None of the "medicaid frames" looked right because her face is real narrow and all the frames that she tried on was small. So, he had a row of frames up on the shelf [and Mrs. Phyllis Smith, Tracy's mother] picked a pair from up there," (T. 134 for which she paid respondent's office seventeen dollars ($17.00). On Tracy's chart appears the pithy comment: "THIN HEAD." Sylvia Webb did not testify at hearing but on the basis of the parties' stipulation that she would have testified as Ms. Smith did, she is found to have paid Dr. Beckum seventeen dollars' ($17.00) for eyeglass frames for herself, while she was a medicaid recipient, some time between the fall of 1978 and the fall of 1980. MEDICAID POLICY? As an optometric consultant to HRS, Dr. Stephens has spoken to more than a hundred optometrists about medicaid policies. It is widely known among Florida's optometrists, he testified, that either "the patient pays for the glasses in their [entirety] or Medicaid pays for it, you cannot charge extra for tints or a special frame or anything of that nature." (T. 86) Elaine Beckum, respondent's wife of 25 years, has worked, for the last five and one half years, as a receptionist at respondent's office. In 1978 or 1979 she spoke to somebody in a Gainesville HRS medicaid program office, "Ms. Uelsmann's office," (T. 150),who told her, she testified, that medicaid patients "are permitted extras [s]uch as tints, better frames, better lenses" and "that if patients wanted these "extras, that they could have them." (T. 150) It was Mrs. Uelsmann herself she talked to (T. 156) She contacted Mrs. Uelsmann; and Mrs. Uelsmann answered her questions [if she's] not mistaken, if [she] remember[s] correctly." (T. 157) She communicated the substance of this telephone call to Dr. Beckum. Why Mrs. Beckum telephoned Mrs. Uelsmann is not clear from the record, because Sylvia Jones, who worked as respondent's receptionist and secretary/bookkeeper, before she left in 1977, had already called Mrs. Uelsmann, at respondent's behest, and inquired about "extras." She was advised that time that the patient could pay a difference and get a different type of frames, if they so chose" (T. 304) which advice she related to respondent. MINIMUM PROCEDURES Rule 21Q-3.07, Florida Administrative Code, took effect on November 13, 1979, and prescribed the following minimum procedures for a vision analysis: Complete case history (recorded); Unaided visual acuity, and acuity with present correction, if any; External examination including cover test and visual field testing (confrontation or other); Ophthalmoscopic examination (direct or indirect) including a study of the media, fundus, blood vessels, cup disc ratio. Biomicroscopy (binocular or monocular); Static retinoscopy or other objective refraction; Test for binocularity; Subjective refraction with recorded visual acuity; Tonometry; Other tests and procedures that may be indicated by case history or objective signs and symptoms discovered during the eye examination; Diagnosis and treatment. Joint Exhibit No. 1. At all pertinent times, even before adoption of the rule, there were minimum standards of prevailing and generally accepted optometric practice. These standards obtained throughout Florida and have not changed significantly in the last four or five years. Just as vision screening with snellen letters entails certain minimal steps, so an optometrist's vision analysis, which is considerably more comprehensive, consists of certain procedures at a minimum. At all pertinent times, generally accepted and prevailing minimum procedures included all those now codified in Rule 21Q-3,07, Florida Administrative Code, except for tonometry on persons younger than 35 years old and visual field testing. The better practice has always been to record the results of every procedure, but not all practitioners did this before the recent amendment to Rule 21Q3.07, Florida Administrative Code, effective April 24, 1980. Generally accepted and prevailing standards of practice have always required recordation, however, of significant or pertinent findings. Members of the Florida Optometric Association's peer review committee asked respondent why so many of his patients' records were devoid of the results of testing required by generally accepted and prevailing standards and, more recently, by formal administrative rule, as well. Dr. Beckum responded that he was familiar with Florida's Optometric Statutes and Rules concerning minimal examination procedures and the necessity for recording their results. Be said he had conducted more of these tests than were recorded, but just had failed to notate it on his records. He also stated that many of the required tests could not be done due to the lack of maturity of the children involved. However he failed to record this reason on his exam record. Dr. Beckum further .explained that in his philosophy of testing, some of the State's mandated tests were unnecessary (and not done) in order for him to do an adequate examination. Exhibit/ Attachment No. 2 to Petitioner's Exhibits Nos. 6 and 7. By his own admission, to the committee, respondent has failed to perform some of the minimum procedures required by Rule 21Q-3.07, Florida Administrative Code, and has failed to record the results of others. The patients' records, as to which these admissions relate, are in evidence as attachments to Petitioner's Exhibits Nos. 6. and 7. Among these records are several examinations that took place after April of 1980. Drs. Albert, Cherdack and Devine were three of the five members of the peer review committee which, as a whole, examined 146 patient records from Dr. Beckum's office and concluded: There was no justified excuse for the lack of recording, in so many cases, the minimum test results, required by the State of Florida. Neglect, or negligence is not a good reason. There was no valid reason given to us for not doing the minimal tests required by the State. Exhibit/Attachment No. 2 to Petitioner's Exhibit Nos. 6 and 7. In these respects, the peer review committee's findings are adopted, without qualification. Of the more than 100 patient records prepared by Dr. Beckum that he reviewed, Dr. James Stephens could not remember a single one on which all the test results that generally accepted and prevailing minimum procedures would have yielded were recorded. Nor was there any record of a reason for not recording these results. The overwhelming majority of these records were made in or after January of 1979 and in or before March of 1981. Some were later than April of 1980. Dr. Stephens did not review the records specifically in order to determine compliance with minimum visual analysis procedures, however. He was not on the peer review committee; he reviewed the records, as a medicaid consultant, for possible fraud and abuse. CASE IN POINT Dr. Beckum saw six year old Tony Baker on February 9, 1981, and wrote down Tony's complaint: His eyes run water all the time. No other information was recorded under the heading "Ocular History." Even though respondent made no record of any near point testing, he prescribed low plus lenses (.25 for each eye) for Tony, and did so without making any, record of having performed the pathology examination that might have uncovered the reason that his eyes watered. The p1us .25 diopter prescription for the optic sphere in each lens would not have alleviated this problem: [A] quarter of optic sphere in each eye would not prevent a patient's eyes from running water There was no slitlamp testing done here, nothing recorded to show that there was a pathology exam done. The thing that concerns me more than whether the glasses were prescribed, which is important, especially to Medicaid when the taxpayers are funding the money, is the lack of pathology testing done. You might have a kid that had some kind of problem that wasn't uncovered. You are not going to harm him by putting on glasses that he does not need. He will lose them or something. But the lack of pathology testing [or at least recordation] does concern me. Deposition of Dr. Stephens, pp. 689. Among others whose visual analysis examinations were performed by Dr. Beckum, but whose examinations did not comport with prevailing and generally accepted minimum requirements, were Kenja Brooks, Carla Michelle Dallas, Eva Mae Dawson, Donia Durden, Twana Evans, Dorothy Jerisesha Farr, Roosevelt Forbes, Sharon Futch, Simeon Griffin, Delores Harrel, Laura Spates, Geneva Tart, Curtis Thorp, Vera Wilson, Elnora Wright, Nicole Young, Andrew Daniels, Christine Neddo, Stephen Cook, Stacey Thomas and Dorothy A. Strickland. LOW, LOW, LOW POWER Respondent has prescribed "low plus" lenses for his own family and for numerous patients, children and adults, including a Joyce Courtney, who came to him in 1973 complaining of difficulty focussing on objects 30 to 40 feet away and who felt that Dr. Beckum resolved her problem by prescribing low plus lenses. A "low plus" lens has an optical sphere of less than one half /1 diopter. A diopter is a unit of the refractive or "focussing" power of a lens. Unlike many optometrists, Dr. Beckum subscribes to the views on stress relieving, low plus lenses held by the OEP of which he was once a member. Optometrists who share these beliefs, like Dr. O.C. Clarke, think low plus lenses should be prescribed for a "number of possible reasons, most of which you will find in near point vision care [and that] low plus lenses reduce the stress of the near-point task." (T. 195) Among the possible indications of a child's need for low plus lenses, according to is the school of optometry that holds there can ever be any need, are when the child is unable to work at his desk for more than a short period of time without becoming restless or fidgety. He may become tense or may work too close to his page; he may turn or cock his head to view the page. He may frequently stare off into space or look out the window. may eyes lid or the conjunctivia may appear reddened. If asked about his vision he may report that the print runs together or blurs after he has been reading for a short time, so that he cannot copy from the blackboard to his desk. Headaches may also be an indication. Sometimes there are no specific symptoms other than the fact that he is a bright child but just getting by in school. Respondent's Exhibit No. 3 But in Developmental Lenses for Children by Richard J. ApeIl, O. D., Respondent's Exhibit No. 3, the author states: Developmental [low plus] lenses are, of course, no panacea for the myriad of visual problems that we find among, school aged children. What are the symptoms that indicate a real need for developmental glasses? It is plain that distance vision is no criterion. Respondent's Exhibit No. 3. Low plus lenses have been advocated since the 1940s. The advocates claim that a prescription for low plus lenses is justified by symptoms of accommodative stress in reading or other near point tasks, but not otherwise. 20 Optometrists who doubt the efficacy of low plus lenses are unlikely ever to prescribe a lens of less than one half diopter. These skeptics, who are in the majority, view such low powered lenses as almost the same as window glass. They point out that prescription errors of a quarter diopter are routinely overlooked, and that a lens of less than one half diopter (a "low- plus" lens) has no measurable effect on visual acuity. Such lenses could be called "low, low, low power," Dr. Stephens testified. Medicaid pays optometrists $25 for examining eligible patients and an additional $7.00 for dispensing eyeglasses. Optometrists like Dr. Beckum who provide the frames get an additional $18.25 for "single vision" eyeglasses and $20.50 for bifocals, about half of which is profit. Dr. Donald Albert, who testified for petitioner on deposition, examined numerous (at least 20) records of examinations Dr. Beckum had prepared. He was amazed at the number of low power prescriptions he saw. On no patient's chart he saw was there a recorded visual acuity with the aid of the low power prescription. " Deposition of Dr. Albert, p. 80. The peer review committee found: Dr. Beckum's examination techniques and prescribing procedures (the magnitude of extremely low power prescriptions) are certainly outside the mainstream of current professional optometric philosophy and practice. This Committee believes that it is not necessarily wrong to be outside a mainstream, but if one is, he must certainly be able to defend this philosophy with complete research, documentation and/or complete testing procedures as well as to provide comprehensive recorded follow up testing to justify or satisfy a peer review and/or State Board Review, if he is not satisfying his State's minimum examination procedures. We find that Dr. Beckum has not documented, explained or provided adequate follow up care to justify to this Committee his questionable examination and prescribing procedures which we believe have resulted in multiple cases of unnecessary eyeglasses being prescribed. However, our Committee does feel that Dr. Beckum honestly believes his techniques and prescriptions are correct and warranted. Our Committee believes when dealing with claims in great numbers it is possible and probable for any doctor to have a small percentage of errors in his billings as to amount and copayments; especially when dealing with third party claims as almost all third party carriers have different and sometimes conflicting rules and regulations on payments, co payments and covered items. However it is out of this Committee's expertise and jurisdiction to deal with possible legal questions that arise concerning possibly nonvalid payments. In accordance with the FOA Professional Standards Review, we recommend to the Florida Department of Health and Rehabilitative Services, the following cou[r]ses of action in this case. Admonish Dr. Beckum in those areas of his misunderstanding and unintentional irregularities in the form of a reprimand. Establish a prepayment review as a corrective/educational device. By this, we mean that if Dr. Beckum is to be allowed to continue seeing Medicaid patients, he must agree to perform and record all tests as required by the State and to evaluate his prescribing and prescriptions in a standard and acceptable manner. Dr. Beckum must further agree to monthly submit copies of his examination records to the Medicaid Optometric Consultant (or this PSRO if payment should be granted. This review procedure should be undertaken for a minimum of six months, at which time, termination of this review may be considered. H.R.S. should have its own staff decide on repayment and/or other actions regarding the eight records where recipients had made payment over and above the Medicaid payment. H.R.S. should have its own staff decide on repayment and/or other actions regarding the three recipients who did not receive eyeglasses for which Medicaid was billed. Copies of this report and other pertinent data in this investigation should be sent to the Department of Professional Regulation for this review. Exhibit/Attachment No. 2 to Petitioner's Exhibits Nos. 6 and 7. The committee acknowledged that respondent's views on low plus lenses are "not necessarily wrong" because they are "outside a mainstream," but concluded that respondent prescribed eyeglasses that were unnecessary under any theory. UNNECESSARY PRESCRIPTIONS Dr. Beckum prescribed low plus (.37 for both eyes) lenses for Samuel Rochelle, Jr. after an eye examination in May of 1980 or January of 1981 in the course of which he recorded unaided acuities at distance, a phoria finding, subjective refraction with recorded acuity and the results of a static retinoscopy, but made no record of any near-point testing, because none was done. Dr. Beckum, made no record of anything that would justify the glasses he prescribed to Samuel Rochelle, Jr. on any theory. Dr. Beckum also prescribed plus (.37 for both eyes) lenses for Tony M. Adkins, a fifth grader, after an examination in November of 1978 or January of 1980 during which various findings were recorded, but nothing that would explain or justify, on any theory, the controversial prescription which Dr. Beckum wrote and Medicaid filled for Tony M. Adkins. In February of 1980, Dr. Beckum prescribed low plus (.25 for both eyes) lenses for 10 year old Joyce E. Rochelle for reasons the record of her examination does not reveal. No near point testing results were recorded either in February or in November of the same year, when Dr. Beckum wrote another low plus prescription (.37 in each eye) for the same child. The patient's record contains nothing to justify or explain, on any theory, the first prescription, the second prescription or the reason for the change. Each of Dr. Beckum's patient records is a form complete with possible symptoms printed on it, for circling, to facilitate the taking of a patient's history. Among those symptoms printed on the form are "Headaches," "Eyes: Ache, Tire," "Blur," "Pains)" "Nausea," and "Nervous." None of these symptoms was circled on the records of Joyce E. Rochelle, Tony M. Adkins, or Samuel Rochelle, Jr. The evidence did not establish that the prescriptions Dr. Beckum wrote for these children were warranted. They would only be justified if written "for the relief of accommodative spasm for subjective symptoms such as headache poor focussing ability, discomfort [and] tiredness of the eyes. Deposition of Joseph R. Devine, pp. 71-72. Dr. Beckum prescribed low plus lenses (.37 in each eye) for Anthony Boykin, a kindergartner, on August 18 or October 5, 1978, and again on November 20, 1979. No history whatsoever appears on this patient's records after August 18, 1980, and there is no record of any near point testing at any time. Similarly Dr. Beckum twice prescribed low plus lenses (.37 in both eyes) for Tracy Boykin, once on October 5, 1978, when she was in first grade, and again on November 20, 1979, after she had broken her first pair of glasses, without recording any history or any near point testing or anything" else that would, on any theory, explain or justify the prescriptions. There is no case history of any sort. There are no points of acuity before or after arriving at the prescription. There is no health testing that is listed here; no corneal curvature measurement, no near point testing, no binocularity testing. Deposition of Leonard Cherdack, p. 52. On March 10, 1980, Dr. Beckum prescribed low plus lenses (.25 for each eye) for Terri Lynn George and later the same year wrote a second, different prescription for low plus lenses (.37 for each eye) for Terri Lynn George. Again the patient's record is devoid of any finding or history that could, on any theory, explain or justify either the first or the second prescription, or account for the change: "No case history, no near point acuities, no health testing, no binocularity testing, no corneal reading," Deposition of Leonard ,Cherdack, p. 66 were recorded. The records Dr. Beckum kept of his two examinations of David Matthew Dixon reveal nothing that could justify or explain, on any theory, the two different low plus lens prescriptions he wrote for this child. In August of 1978, he prescribed .37 for both eyes, but the prescription was changed to .25 for both eyes approximately a year later. "There is no case history. There is no near point acuity recorded. No health history recorded." Deposition of Leonard Cherdack, p. 88. Dr. Beckum wrote two low plus lens prescriptions (both were .25 for each eye) for David Eric Dixon but nothing in David's records would explain or justify these prescriptions. Andrew Daniels saw respondent in February of 1979 and again about a year later. Both times Dr. Beckum prescribed low plus lenses (.25 for each eye), even though nothing in Andrew's records indicates the need for any prescription. He had "excellent distance acuity [20/15]." Deposition of Leonard Cherdack, p. 90. No patient history was recorded. "There is no near point acuity. No health testing no binocularity testing. There is no objective determination which shows nothing, no prescription. There is no subjective determination." Deposition of Leonard Cherdack, p. 90. Dr. Beckum took downs David S. Cooper's complaint when he examined this 8year old on December 20, 1979. "I don't know if I see well," is the complete history recorded on David's chart. But, at the time of the examination, David's unaided visual acuity at distance was 20/15 for both eyes and 20/15 for each. Dr. Beckum nevertheless prescribed glasses (.25 for each eye) which, if they had any effect, could have reduced the unaided acuities at distance. On deposition, Dr. Cherdack testified, "He sees worse with this prescription than he saw before he came into the office p. 95. Dr. Cherdack had not examined David Cooper, however. On March 11, 1981, Dr. Beckum saw Tonya Miller for the second time. When he had first seen her, on August 8, 1979 he had written a low plus (.25 for the right, .50 for the left) lens prescription which Dr. Stephens described as "questionable." Dr. Beckum prescribed new low plus (.25 for each eye) eyeglasses for Tonja Miller in March of 1981 even though her unaided acuities at distance were better than normal, viz., 20/15. Her complaint, which Dr. Beckum recorded, was "I can't see too good," but "when a patient is seeing 20/15 ths, then they are seeing good." Deposition of Dr. Stephens, p. 57. Nothing in Tonya Miller's records justifies or explains, on any theory, the prescription respondent wrote and filled for her on March 11, 1981. In scores of other cases, as well, respondent prescribed low plus eyeglasses for medicaid recipients and others who did not need them, including Tabetha Ann Evans, Betilda Gwenethe George, Andrew Daniels, Stephen Cook, Tammy Richardson and Melinda Cooper.
The Issue The issues in this case are whether the Agency for Health Care Administration ("AHCA") is entitled to repayment of Medicaid reimbursements that it made to Respondent, pursuant to section 409.913(11), Florida Statues; if so, the amount of the repayment; the amount of any sanctions that should be imposed pursuant to subsections 409.913(15) through (17); and the amount of any investigative, legal, and expert witness costs that AHCA is entitled to recoup pursuant to section 409.913(23).
Findings Of Fact The Parties AHCA is the agency responsible for administering the Medicaid Program in the State of Florida, pursuant to section 403.902, Florida Statutes. During all times relevant to this proceeding, Respondent was an enrolled Medicaid provider authorized to receive reimbursement for covered services rendered to Medicaid recipients. AHCA's Agency Action Pursuant to its statutory authority to oversee the integrity of the Medicaid program in Florida, AHCA conducted an audit of Respondent's claims for Medicaid reimbursement for the period from February 1, 2010, to March 1, 2011, to verify that claims paid by AHCA to Respondent under the Medicaid program did not exceed the amount authorized by Medicaid law and applicable rules. As a result of the audit, AHCA determined it was entitled to reimbursement from Respondent for $102,444.33 that it paid to him for services not covered under the Medicaid program. AHCA also sought to impose sanctions consisting of a $20,488.86 administrative fine and investigative, legal, and expert witness costs. Respondent requested an administrative hearing under sections 120.569 and 120.57(1) to challenge the overpayment determination and imposition of sanctions. Evidence Adduced at Final Hearing At the final hearing, AHCA presented the testimony of Robi Olmstead, an administrator with AHCA's Bureau of Medicaid Program Integrity ("MPI"). Olmstead's responsibilities include supervising AHCA's staff performance of MPI audits. As a result of her employment with AHCA in this position for several years, Olmstead is very familiar with, and knowledgeable about, conducting MPI audits. No evidence was presented to show that Olmstead is a licensed physician, has any substantive medical or dental knowledge, or is a medical or dental services expert. Olmstead did not serve as a peer reviewer for AHCA in determining or describing the nature or determining medical necessity of the specific procedures at issue in this proceeding, and she was neither proffered nor accepted as a peer reviewer or expert witness for these purposes at the final hearing. Description of the Audit and Overpayment Determination Olmstead described the audit of Respondent's claims at issue in this case. For reasons unspecified in the record, AHCA initiated an audit of the Medicaid claims for which Respondent had been paid.1/ Using AHCA's data support system, investigator Theresa Mock2/ accessed the complete universe of Medicaid claims paid to Respondent.3/ Mock selected the period from February 1, 2010, to March 1, 2011, as the Audit Period ("Audit Period")4/ and selected a statistically-based claim sampling program——in this case, cluster5/ sampling——to perform the audit. A computer-generated representative sample, consisting of 30 Medicaid recipients for whom Respondent had billed claims during the Audit Period and been paid, was identified. AHCA contacted Respondent by demand letter, requesting that he submit documents to substantiate the claims. In response, Respondent provided documents consisting of his records of service and billing for each claim for each of the 30 recipients. Mock forwarded the records to AHCA's peer review coordinators, who, in turn, forwarded them to Dr. Mark Kuhl, AHCA's peer reviewer for this audit.6/ Kuhl reviewed the records and prepared worksheets reflecting his determination regarding the nature of the service rendered for each claim and whether such claim was eligible for payment under the Medicaid program. Respondent's records and Kuhl's worksheets were sent to Mock, who, based on Kuhl's determination regarding the nature and eligibility of each claim, calculated that Respondent had been overpaid by a total of $85,582.02, or $355.11211618 per claim, for the sampled claims. To extrapolate the total probable overpayment to Respondent for all claims, Mock applied the statistical formula for cluster sampling7/ to the calculated overpayment amount of $85,582.02 for the representative sample. This yielded a total extrapolated overpayment amount of $102,444.33, within a 95 percent probability that the actual overpayment amount was equal to or greater than that amount. In a Preliminary Audit Report ("PAR") dated December 12, 2011, AHCA notified Respondent that it had determined that he had been overpaid by $102,444.33 and gave him the options of paying that amount or submitting further documentation to support the claims identified as overpayments in the PAR. Respondent provided additional information in an effort to support these claims; however, AHCA apparently found the information insufficient to support changes to its previous determination that Respondent had been overpaid by $102,444.33. On March 22, 2013, AHCA issued a Final Audit Report ("FAR") stating its determination that Respondent had been overpaid by $102,444.33. The following explanation in the FAR was provided as the basis for AHCA's overpayment determination: REVIEW DETERMINATIONS A review of your dental records revealed that some services rendered were erroneously coded on the submitted claim. The procedure code that would accurately reflect the service provided is not covered by Medicaid. The payment for those claims is considered an overpayment. Medicaid policy specifies how medical records must be maintained. A review of your medical records revealed that some services for which you billed and received payment were not documented sufficiently. Therefore, the payment for those claims is considered an overpayment. A review of your records indicated that some procedure codes were double billed in error. In those instances, the amount paid for the second (duplicate) procedure is considered an overpayment. The FAR also notified Respondent that AHCA had assessed an administrative fine of $20,488.86 and audit costs of $576.83. In sum, the FAR notified Respondent that he was required to remit a total of $123,510.02. The FAR also notified Respondent that AHCA was entitled to recover all investigative, legal, and expert witness costs. Following issuance of the FAR, Respondent provided additional records to support claims that AHCA asserted were ineligible for payment. After considering these records, AHCA determined that some of these claims had not been overpaid, and on June 17, 2014, performed another calculation of the alleged overpayment for the entire universe of Respondent's claims using the cluster sampling formula. AHCA ultimately determined that Respondent had been overpaid by a total of $102,410.79, the alleged overpayment amount at issue in this proceeding. Requirements for Payment of Claims by Medicaid To be eligible for coverage by Medicaid, a procedure must be "medically necessary," which is defined as follows: “Medical necessity” or “medically necessary” means any goods or services necessary to palliate the effects of a terminal condition, or to prevent, diagnose, correct, cure, alleviate, or preclude deterioration of a condition that threatens life, causes pain or suffering, or results in illness or infirmity, which goods or services are provided in accordance with generally accepted standards of medical practice. § 403.913(1)(d), Fla. Stat. (2010).8/ AHCA is the final arbiter of medical necessity for purposes of determining Medicaid reimbursement. Id. The statute expressly requires that determinations of medical necessity be made by a licensed physician employed by or under contract with the agency——i.e., a peer reviewer——based on information available at the time the goods or services are provided. Id. To ensure that services rendered by a provider are correctly billed to and paid by Medicaid, the provider must identify the services by referring to specific codes corresponding to the specific procedure or service rendered. If services rendered are incorrectly coded on a provider's billing submittals, they may be determined ineligible for payment by Medicaid. Applicable Medicaid Handbooks, Codes, and Fee Schedules To guide and inform providers regarding the types of services that are covered by the Medicaid program and how to correctly bill Medicaid for those services, AHCA has adopted several documents by rule through incorporation by reference. The documents incorporated by reference that are applicable to this case are the Florida Medicaid Provider General Handbook (July 2008)9/; the Florida Medicaid Dental Services Coverages and Limitations Handbook (January 2006)10/; the Florida Medicaid Provider Reimbursement Handbook, CMS-1500 (July 2008)11/; the Dental Oral/Maxillofacial Surgery Fee Schedule (effective January 1, 2010)12/; and the Dental General Fee Schedule (effective January 1, 2010)13/. Additionally, AHCA rule14/ refers to "CPT" codes, which are the Current Procedural Terminology® codes developed and kept up-to-date by the American Medical Association. These codes, which are published, are used by AHCA to identify the specific services rendered by providers for purposes of determining whether the service is covered by Medicaid. In this proceeding, AHCA provided, for admission into evidence, excerpts from the 2010 CPT codes, which were in effect during the Audit Period. AHCA rules adopted in the Florida Administrative Code do not expressly define, incorporate, or otherwise refer to "CDT" codes, which are the Current Dental Terminology© codes published by the American Dental Association. The Florida Medicaid Dental Services Coverages and Limitations Handbook (January 2006) was in effect during the Audit Period. This handbook refers to the Current Dental Terminology© codes, but does not specify the version of the CDT codes by year that were applicable to that version of the handbook.15/ AHCA provided, as exhibits, portions of the 2011/2012 CDT codes.16/ The Specific Claims at Issue Respondent's records and other documentation regarding the services for which he submitted claims for payment under Medicaid were admitted into evidence at the final hearing. The claims at issue in this proceeding are identified on worksheets prepared by Kuhl, who reviewed Respondent's records and documents provided in response to AHCA's demand letter. Kuhl's worksheets were admitted into evidence. These worksheets document, for each claim reviewed, Kuhl's determination regarding the nature of the service rendered by Respondent and whether the claim was eligible for payment under the Medicaid program. As noted above, Kuhl did not testify at the final hearing. Accordingly, the sole evidence in the record regarding Kuhl's determinations consists of the notations on his worksheets and Ms. Olmstead's testimony regarding his conclusions. As discerned from Kuhl's worksheets, Kuhl determined that Respondent had been overpaid for three reasons: (1) for some claims, Respondent did not provide records, such as x-rays or other documents, to support or verify that he had, in fact, rendered the service; (2) for some claims, Respondent billed twice (i.e., duplicate-billed) and was paid twice for the same service rendered to a recipient; and (3) for some claims, Respondent performed, and billed for, procedures that were not medically necessary so were not payable by Medicaid. Each of these bases is addressed below. Lack of Documentation to Support Claims Based on his review of Respondent's records, Kuhl determined that Respondent did not provide adequate documentation to support some claims for which he was paid. For each such claim, Kuhl wrote on the applicable worksheet next to the applicable claim: "not in the record" or "not in record." As noted above, Respondent subsequently submitted additional documentation for some claims. Based on Kuhl's worksheets and this additional documentation, AHCA determined that Respondent had been overpaid a total of $3,091.91 for the sampled claims as a result of his failure to provide supporting information. The table below summarizes AHCA's overpayment determinations for the sampled claims on this basis. Undocumented Claims Recipient No. No. of Claims Overpaid Amount of Overpayment 1 2 $8.00 17 2 $3.00 21 3 $1,120.75 26 1 $4.00 28 3 $1,956.16 Total Amount of Overpayment $3,091.91 Double-billed Claims Kuhl determined that for some claims, Respondent duplicate-billed and was paid twice for the same service. For each such claim, Kuhl wrote on the applicable worksheet next to the applicable claim, what appears to be a notation stating "duplicate charge amt" or "duplicate charge out."17/ Either way, it is clear from the worksheets that Kuhl determined that Respondent had duplicate-billed for certain services rendered to certain recipients. Based on Kuhl's worksheets and Respondent's billing records, AHCA determined that due to duplicate billing, Respondent had been overpaid a total of $30.00 for the sampled claims. The table below summarizes AHCA's overpayment determinations for the sampled claims on this basis. Duplicate-Billed Claims Recipient No. No. of Claims Double-Billed Amount of Overpayment 8 1 $27.00 9 1 $3.00 Total Amount of Overpayment $30.00 Claims for Face Bone Graft and Lower Jaw Graft Three Medicaid billing codes are implicated in this proceeding: CPT codes 21210 and 21215, and CDT code D7953. The 2010 version of CPT code 21210 is defined as "graft, bone; nasal, maxillary, or malar areas (includes obtaining graft)." The notations on AHCA's spreadsheet summarizing its overpayments refer to this procedure, in lay terms, as a "face bone graft." The 2010 version of CPT code 21215 is defined as "mandible (includes obtaining graft)." The notations on AHCA's spreadsheet summarizing its overpayments refer to this procedure, in lay terms, as a "lower jaw bone graft." Respondent billed and was paid for 44 claims under CPT code 21210 for face bone grafts and 25 claims under CPT code 21215 for lower jaw bone grafts. For each claim identified on Kuhl's worksheets as either "21210 ## ## Face Bone Graft" or "21215 ## ## Lower Jaw Bone Graft," Kuhl made the notation "correct code = D7953 = bone graft place in ext site at time of ext" or a similar notation to that effect. For each such claim, Kuhl checked the "deny" option on the worksheet. Below the "deny" option, Kuhl made the following or a similar notation: "as it was stated by Robi Olmstead it is a non-covered procedure" or "if a non-covered procedure." CDT code D7953 is defined in the 2011-201218/ version of the CDT codes as: bone replacement graft for ridge preservation – per site Osseous autograft, allograft, or non-osseous graft is placed in an extraction or implant removal site at the time of the extraction or removal to preserve ridge integrity (e.g., clinically indicated in preparation for implant reconstruction or where alveolar contour is critical to planned prosthetic reconstruction). Membrane, if used, should be reported separately. Olmstead testified that the D7953 procedure is not medically necessary so is not covered by Medicaid. According to Olmstead, the D7953 procedure is not considered medically necessary because "most often sufficient bone will be regenerated or, you know, you won't really need it unless you [are] getting implants are (sic) [or] dentures, and it's just not always——infrequently medically necessary to do this according to some of the literature, and so Medicaid, you know, as they're allowed to do, has decided not to cover this procedure, and it's clearly not covered except for the oral surgeon19/ under these two codes, but again, it still has to be medically necessary." Olmstead testified that the absence of D7953 as a listed procedure on the Dental General Fee Schedule (January 2010) and the Dental Oral/Maxillofacial Surgery Fee Schedule (January 2010) further evidences that D7953 is not covered by Medicaid. Kuhl did not make any express finding on his worksheets that the D7953 procedure is not medically necessary. Indeed, Olmstead acknowledged that Kuhl's worksheets did not state that the D7953 procedure is not medically necessary. Kuhl also did not make any express finding on his worksheets that the CPT code 21210 and CPT code 21215 procedures were not medically necessary. Based on Kuhl's worksheets, AHCA determined that for each claim Respondent billed under CPT codes 21210 or 21215, the claim was not covered by Medicaid, so should not have been paid. The table below summarizes AHCA's determinations of overpayment, on the basis of lack of medical necessity, for the sampled claims for CPT Code 21210 for face bone grafts performed by Respondent. CPT Code 21210 - Face Bone Graft Recipient No. No. of Claims for CPT Code 21210 Total Amount of Overpayment for Recipient 1 1 $1,089.75 2 1 $ 544.88 4 4 $3,814.13 5 2 $1,634.63 6 1 $1,089.75 7 1 $1,089.75 9 3 $2,724.38 10 1 $1,089.75 11 6 $4,903.89 12 1 $1,089.75 17 2 $1,634.63 19 2 $1,634.63 20 1 $1,089.75 21 2 $1,634.6320/ 22 1 $ 544.88 23 3 $1,847.07 24 1 $1,089.75 25 6 $5,448.76 26 3 $3,269.25 29 1 $1,089.75 30 1 $1,089.75 The table below summarizes AHCA's determinations of overpayment, on the basis of lack of medical necessity, for the sampled claims for CPT Code 21215 for lower jaw bone grafts performed by Respondent. CPT Code 21215 - Lower Jaw Bone Graft Recipient No. No. of Claims for CPT Code 21215 Total Amount of Overpayment for Recipient 1 5 $8,591.22 2 1 $1,909.16 4 1 $1,909.16 5 1 $1,909.16 8 3 $4,772.90 11 2 $3,818.32 14 1 $1,909.16 15 1 $1,909.16 16 2 $3,818.32 17 1 $1,909.16 18 2 $3,817.82 22 1 $1,909.16 27 2 $2,863.74 28 2 $1,909.16 Findings Regarding Alleged Overpayment The undersigned determines that the record evidence supports AHCA's determinations that Respondent was overpaid in the amount of $3,091.91 for claims for which he did not provide required documentation. The undersigned determines that the record evidence supports AHCA's determinations that Respondent was overpaid in the amount of $30.00 for claims for which he duplicate-billed Medicaid. As previously noted, the Florida Medicaid Dental Services Coverages and Limitations Handbook (January 2006) was in effect during the Audit Period. However, AHCA did not provide, as part of its evidence, pertinent excerpts of this version of the handbook referencing the CDT codes in effect during the Audit Period. AHCA also failed to provide the version of the CDT codes in effect during the Audit Period. Thus, the undersigned is left without any evidence regarding the nature or description of procedure D7953 as it was defined under the version of the CDT codes in effect during the Audit Period. Accordingly, the undersigned is unable to verify the correctness of Kuhl's notations stating that CDT code D7953, rather than CPT codes 21210 or 21215, was the correct notation for the procedures Respondent performed. As discussed above, AHCA's audit supervisor, Robi Olmstead, testified regarding the nature of the procedure identified in D7953 and distinguished that procedure from the procedures to which CPT codes 21210 and 21215 apply. However, there is no evidence establishing that she was competent to testify about the medical nature of the D7953 procedure, how it substantively differs from the other procedures at issue as defined in CPT codes 21210 or 21215, whether or not the procedures Respondent performed were medically necessary, or whether the D7953 procedure is medically necessary. As such, the undersigned finds her testimony unpersuasive to show that the procedures Respondent performed and billed under CPT codes 21210 and 21215 were not medically necessary and therefore not billable to Medicaid, that D7953 was the correct billing code for the procedures Respondent performed, and that the procedure corresponding with code D7953 is not medically necessary.21/ AHCA chose not to present testimony by its peer reviewer, Dr. Mark Kuhl, at the final hearing.22/ Although Kuhl's worksheets were admitted into evidence, they do not provide a credible, independently verifiable explanation for his conclusion that Respondent incorrectly billed a particular procedure by using either CPT code 21210 or 21215 instead of CDT code D7953. Moreover, the worksheets contain notations, discussed above, which indicate or appear to indicate that Kuhl relied on Olmstead's direction that the bone graft procedures for which Respondent billed were not medically necessary. Olmstead is not competent to determine medical necessity, and Kuhl's apparent reliance on her direction regarding medical necessity is directly contrary to section 409.913(1)(d), which expressly requires that "[d]eterminations of medical necessity must be made by a licensed physician employed by or under contract with the agency." As such, the undersigned finds Kuhl's worksheets unpersuasive to show that the procedures Respondent performed and billed under CPT codes 21210 and 21215 were not medically necessary and therefore not billable to Medicaid, that D7953 was the correct billing code for the procedures Respondent performed, and that the procedure corresponding with code D7953 is not medically necessary. For these reasons, it is determined that AHCA has not proven, by a preponderance of the competent substantial evidence in the record, that Respondent was overpaid for the claims he billed for bone grafts using CPT codes 21210 and 21215. Based on the foregoing, it is determined that AHCA overpaid Respondent in the total amount of $3,121.91. Determination of Administrative Fine As found above, Respondent was overpaid in the amount of $3,091.91 for undocumented claims. Pursuant to Florida Administrative Code Rule 59G- 9.070(7), sanctions are required to be imposed for failure to furnish all Medicaid-related records to be used by AHCA in determining whether Medicaid payments are or were due. Under rule 59G-9.070(7)(d), a $2,500 fine is to be imposed for the first offense23/ of failing to furnish all Medicaid-related records. AHCA proved that Respondent was paid for undocumented claims, and Respondent does not appear to challenge that. Accordingly, it is determined that sanctions consisting of a $2,500 administrative fine should be imposed for this violation. Duplicate-billed Claims As found above, Respondent was overpaid in the amount of $30.00 for duplicate-billing of services. AHCA did not present any evidence that Respondent engaged in a "pattern of erroneous claims." Rather, the evidence indicates that Respondent inadvertently duplicate- billed for services rendered to two recipients for a total of $30.00. Moreover, in its Proposed Recommended Order, AHCA did not cite and otherwise discuss any basis for the imposition of an administrative fine for Respondent's duplicate-billing. Therefore, it is determined that no administrative fine should be imposed for Respondent's violations consisting of two incidents of duplicate billing.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that AHCA issue a final order finding that Respondent was overpaid, and therefore is liable for reimbursement to AHCA, the total amount of $3,121.91; imposing an administrative fine of $2,500; and remanding the matter to the Division of Administrative Hearings for an evidentiary hearing on the recovery of AHCA's costs, if necessary. DONE AND ENTERED this 29th day of May, 2015, in Tallahassee, Leon County, Florida. S CATHY M. SELLERS 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 29th day of May, 2015.
Findings Of Fact The Respondent's name is Maurice L. Kaye. The Respondent's current address is 735-49th Street North, St. Petersburg, Florida 33710. The Respondent is now a licensed osteopathic physician in the State of Florida. The Respondent holds osteopathic license No. OS 0000949. The Respondent was a licensed osteopathic physician in the State of Florida at all times alleged in the Administrative Complaint filed in this cause on August 9, 1983. The Respondent served as the "doctor" at the Florida Medical Weight Loss Clinic from approximately January 15, 1983 until February 10, 1983. The Respondent was employed by Lydia Stein of Florida Medical Weight Loss Clinic. The Florida Medical Weight Loss Clinic placed or caused to be placed an advertisement in the Tampa Tribune dated January 24, 1983. This advertisement failed to conspicuously identify the Respondent by name and failed to conspicuously identify the Respondent as the physician providing medical supervision at the Florida Medical Weight Loss Clinics. The Respondent was vicariously responsible for the dissemination of the advertisement described in the paragraph above. The Respondent caused an advertisement to be placed in the St. Petersburg Times which offered a nonsurgical treatment for cataracts. This advertisement was published on January 10, 1983. This advertisement read as follows: CATARACT TREATMENT NON-SURGICAL FREE CONSULTATION By Dr. Alex Dewart MEDICAL HEALTH CENTER 735-49th Street North 321-3341 The advertisement described above in the St. Petersburg Times failed to conspicuously identify the Respondent by name, failed to identify the Respondent as the responsible physician, and failed to identify the Respondent as an osteopathic physician. The Respondent had no professional or contractual relationship with Dr. Alex Dewart or Alex Duarte, neither of whom were ever employees of Medical Health Center or Respondent at 735-49th Street North, St. Petersburg, Florida. Dr. Alex Duarte is a recognized specialist in non- surgical treatment of cataracts. Evidence was presented concerning the efficacy of non- surgical treatment for cataracts. It is concluded that such treatment may be beneficial and that the extent to which such non-surgical treatment is beneficial is a matter about which reasonable men differ. No believable evidence was presented that the Respondent was unable to assess patients.
Recommendation For failing to identify himself as the responsible osteopathic physician in the Tampa Tribune advertisement contrary to Rule 21R-14.01(2) , Florida Administrative Code and Section 459.015(1)(d), Florida Statutes, it is recommended that the Respondent be fined by the Board the amount of Two Thousand Dollars ($2,000). For having placed the advertisement in the St. Petersburg Times falsely representing that Dr. Alex Dewart was associated with the Medical Health Center contrary to Section 459.015(1)(d) , Florida Statutes, it is recommended that Dr. Kaye's license be suspended for one (1) year and be reinstated upon payment for the fine levied above, and that thereafter Dr. Kaye be placed upon a two (2) year probation period pursuant to Section 459.015(2) , Florida Statutes. DONE and ORDERED this 15th day of January, 1985 in Tallahassee, Leon County, Florida. STEPHEN F. DEAN Hearing Officer Division of Administrative Hearings The Oakland Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 FILED with the Clerk of the Division of Administrative Hearings this 15th day of January, 1985. COPIES FURNISHED: James H. Gillis, Esq. Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Maurice L. Kaye, D.O. 735-49th Street, North St. Petersburg, Florida 33710 Ms. Dorothy Faircloth Executive Director Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Mr. Fred Roche Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 =================================================================
The Issue This is a license discipline case in which the Petitioner seeks to take disciplinary action against the Respondent on the basis of allegations contained in a five-count Administrative Complaint. The charges against the Respondent may be summarized as follows: Count One charges the Respondent with violating Section 458.331(1)(h), Florida Statutes (1985) , by failing to perform any statutory or legal obligation placed on a licensed physician. Count Two charges the Respondent with violating Section 458.331(1)(1), Florida Statutes (1985), by making deceptive, untrue, or fraudulent representations in the practice of medicine when such scheme or trick fails to conform to the generally prevailing standards of treatment in the medical community. Count Three charges the Respondent with violating Section 458.331(1)(n), Florida Statutes (1985), by failing to keep written medical records justifying the course of treatment of the patient. Count Four charges the Respondent with violating Section 458.331(1)(q), Florida Statutes (1985), by prescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including any controlled substance, other than in the course of the physician's professional practice. Count Five charges the Respondent with violating Section 458.331(1)(t), Florida Statutes (1985), by gross or repeated malpractice, or the failure to practice medicine with that level of care, skill, or treatment which is recognized by a reasonably prudent similar physician as acceptable under similar conditions and circumstances. The Respondent filed an answer to the Administrative Complaint. In his answer, the Respondent admits some of the factual allegations in the Administrative Complaint, but denies all allegations of wrongdoing. Following the hearing, a transcript of the proceedings at hearing was filed on September 16, 1987, and the parties were allowed fifteen days from that date within which to file proposed recommended orders. The Respondent filed a proposed recommended order on October 1, 1987, and the Petitioner filed one on October 2, 1987. Careful consideration has been given to the parties' proposed recommended orders, and specific rulings on all findings of fact proposed by the parties are contained in the Appendix which is attached to and incorporated into this recommended order.
Findings Of Fact Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.30, Florida Statutes, Chapter 455, Florida Statutes, and Chapter 458, Florida Statutes. Respondent is, and has been at all times material hereto, a licensed physician in the State of Florida, having been issued license number ME0004527. Respondent's last known address is 463 Emerald Road, Ocala, Florida 32672. Ionamine is a brand name for a scheduled controlled substance as defined by Chapter 893, Florida Statutes. Respondent's treatment of patients for obesity included B-12 vitamin injections. Approximately two-thirds of the Respondent's practice is devoted to the treatment of obesity. The other third of the Respondent's practice is devoted to a general practice of medicine. The Respondent graduated from Indiana University Medical School in 1945, interned in 1946, and became licensed in the State of Florida in 1951. The Respondent served for two years in the Air Force during the Korean War, and then returned to Florida where he established a practice in Miami. He practiced in Miami until 1970, at which time he moved to Ocala, where he has practiced since 1970. The Respondent is a board certified anesthesiologist and graduated at the top 10 percent of his class from Indiana University. The Respondent subscribes to and reads many medical journals and articles, including those concentrating on bariatrics. The Respondent has purchased and reviewed the American Medical Association video and study guide concerning the treatment of obesity. The Respondent also has continued his post graduate studies. When a new patient comes to the Respondent's office for treatment for obesity, the patient is first given a questionnaire to fill out. Subsequently a medical history is obtained from the patient, and the patient is given a thorough physical examination. Usually, but not always, blood and urine samples are obtained from this patient for testing, and the patient is given an EKG. If this patient appears to be in good health, the Respondent puts the patient on a weight loss program consisting of a reduction of calories, an exercise program consisting of a thirty minute walk each day, and an appetite suppressant, usually Phentermine or Diethylpropion. Phentermine and Diethylpropion are both helpful in the treatment of obesity. The Respondent also encourages each patient to take a vitamin injection on a weekly basis, regardless of whether there is any evidence of vitamin deficiency or pernicious anemia. Thereafter, the patient is instructed to return to the Respondent's office once a week, at which time an R.N. or L.P.N. checks their blood pressure, pulse, respiration, and weight. The nurse questions each patient to find out how they are reacting to the weight loss program. If everything appears to be satisfactory, the patient receives another seven-day supply of diet suppressant medication and a vitamin injection. The Respondent sees the patient every fourth visit (once a month) to determine what progress the patient is making. The Respondent routinely commences treatment of obesity patients, including the prescription of or dispensing of Phentermine or Diethylpropion, before reviewing the results of blood and urine tests. The Respondent continues obesity patients on an appetite suppressant (usually Phentermine or Diethylpropion) at the rate of seven 30 mg. pills per week as long as the patient continues to lose one percent of their body weight per week until their ideal weight is reached. In January of 1986, the Respondent saw a patient by the name of Sandy Wilson who came to his office for the treatment of obesity. The Respondent gave Ms. Wilson a thorough physical examination. The Respondent also questioned Ms. Wilson about her medical history. During the course of relating her medical history, Ms. Wilson complained of swelling of her hands and feet. The Respondent did not obtain blood or urine samples from Ms. Wilson, nor did he do an EKG on Ms. Wilson. Following his examination of Ms. Wilson, the Respondent placed her on a 1000 calorie per day diet, recommended that she exercise by walking 30 minutes each day, and dispensed to her a seven-day supply of Ionamine, which is a form of Phentermine. The Respondent also wrote a prescription for Ms. Wilson for thirty tablets of Furosemide 40 mg. Furosemide is a rather potent diuretic. The Respondent also suggested that Ms. Wilson have a vitamin injection, but she refused the injection. Ms. Wilson also refused to have blood drawn, saying she was afraid of needles. The Respondent told Ms. Wilson if she changed her mind she could have the blood drawn and the vitamin injection on her next visit. The Respondent's records of Ms. Wilson's treatment during January of 1986 do not contain sufficient information to show that Ms. Wilson received a thorough physical examination. The Respondent's records of Ms. Wilson's treatment during January of 1986 do not show that an adequate medical, social, or family history was obtained from Ms. Wilson. The Respondent's records of Ms. Wilson's treatment during January of 1986 do not mention that Ms. Wilson had or complained of edema. The Respondent's records of Ms. Wilson's treatment during January of 1986 do not contain the results of any blood or urine tests or the results of any EKG. Ionamine and Furosemide should not be dispensed or prescribed to a patient for obesity and edema without first giving the patient a thorough physical exam, obtaining an adequate medical history, and obtaining the results of laboratory analysis of blood and urine samples and obtaining an EKG. This is in part because a patient may have the beginnings of some illness, such as diabetes or hypothyroidism, that are not detectable by a physical examination alone. The dispensing of Ionamine and the prescription of Furosemide to Ms. Wilson without first obtaining the results of laboratory analysis of blood and urine samples and obtaining an EKG is a failure to practice medicine with that level of care, skill, and treatment which is recognized by reasonably prudent similar physicians as being acceptable under similar conditions and circumstances. A physician's records must be sufficient to justify the treatment given to the patient. In particular such records should contain complete information regarding examinations, histories, and laboratory tests. Because the Respondent's records regarding Ms. Wilson did not contain complete information in this regard, the Respondent has failed to keep written medical records justifying the course of treatment of the patient. Vitamin injections do not have any direct therapeutic effect in the treatment of obesity. They do not cause weight loss, nor do they contribute to weight loss. Nevertheless, periodic vitamin injections are commonly given to patients who are being treated for obesity as a form of "behavior modification." The goal of the behavior modification is to have the patient return for follow- up treatment on a regular basis. Vitamin injections do not pose any significant risk to the patient.
Recommendation Based on all of the foregoing, it is recommended that the Board of Medicine issue a final order in this case to the following effect: Dismissing Counts One and Two of the Administrative Complaint; Finding the Respondent guilty of the violations charged in Counts Three, Four, and Five of the Administrative Complaint; and Imposing the following penalty on the Respondent: (1) an administrative fine in the amount of one thousand dollars ($1,000.00), and (2) placement of Respondent's license on probation for a period of two years under conditions to be prescribed by the Board. DONE and ENTERED this 4th day of February, 1988, at Tallahassee, Florida. MICHAEL M. PARRISH 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 4th day of February, 1988. APPENDIX TO RECOMMENDED ORDER, CASE NO. 86-2031 The following are my specific rulings on all of the findings of fact proposed by the parties. As the parties are well aware, there is a large amount of conflict in the testimony in this case, especially in the expert witness testimony. To the extent that the testimony of the expert witnesses on behalf of the Petitioner (Dr. Clark and Dr. Weiss) conflicts with the testimony of the expert witnesses on behalf of the Respondent (Dr. Haimes and Dr. Asher), I have for the most part been persuaded by, and have incorporated into the findings of fact, the version set forth by the Petitioner's witnesses. Among other things, the version set forth by the Petitioner's expert witnesses more often appeared to be more logical, more reasonable and well reasoned, and more consistent with other evidence in the case. Findings proposed by the Petitioner: Paragraph 1: Accepted. Paragraph 2: Accepted in substance, with some irrelevant details deleted. Paragraph 3: Accepted in substance with some additional findings in the interest of clarity and accuracy. Paragraphs 4 and 5: Accepted. Paragraphs 6 and 7: Accepted in substance with additional clarifying details. Paragraph 8: Rejected as not fully supported by competent substantial evidence. Paragraphs 9 and 10: Accepted in substance with additional clarifying details. Paragraph 11: Accepted. Paragraph 12: Rejected as not supported by persuasive competent substantial evidence. Paragraph 13: Accepted. Paragraphs 14 and 15: Rejected as constituting argument rather than proposed findings of fact. (The failure to include argument in the findings of fact is not a comment upon the merits of the argument.) Paragraphs 16 and 17; Accepted in substance. Findings proposed by the Respondent: By way of clarification of some of the rulings which follow, it is noted that a substantial number of the findings proposed by the Respondent begin with the words "Dr. So-and-so testified" or the words "Dr. So-and-so believes." Such findings are, in most cases, nothing more than summaries of the testimony and might well have been rejected on that basis alone. However, I have chosen to direct attention to the substance of such proposals, overlooking their form, and have treated each such proposal as a proposed finding of the fact testified to or the fact believed by the witness. Accordingly, when such proposals are rejected as being contrary to the greater weight of the evidence, that is not to say that the witness did not so testify or did not so believe, but that the fact testified to or believed by the witness is contrary to the greater weight of the evidence. Paragraphs 1, 2, 3, 4, and 5: Accepted. Paragraph 6: Most of this paragraph has been accepted, but many of the statements have been made subject to additional qualifications to be fully consistent with the evidence. Some details have been omitted as not supported by competent substantial evidence. A major qualification is that the procedures described in this paragraph are performed on many, but not all, of the Respondent's patients. Paragraph 7: Rejected as subordinate and unnecessary details. It has already been found that the Respondent gives thorough physical examinations. Paragraph 8: Accepted. Paragraphs 9 and 10: Rejected as irrelevant. Paragraph 11: Accepted in substance. Paragraph 12: First sentence is accepted in substance. Second sentence is rejected as constituting an opinion which is contrary to the greater weight of the evidence. Paragraphs 13 and 14: Rejected as constituting subordinate and unnecessary details. Paragraph 15: Rejected as constituting subordinate and unnecessary details. Also, last clause of first sentence is not supported by competent substantial evidence. Paragraph 16: Rejected as constituting subordinate and unnecessary details. Paragraph 17: Rejected as irrelevant. Paragraphs 18, 19, 20: Rejected as irrelevant and as constituting subordinate and unnecessary details. Paragraph: 21: Rejected as subordinate and unnecessary details. Also rejected as inaccurate because there were other reasons for the opinion. Paragraphs 22, 23, 24, 25, 26, 27, and 28: Rejected as irrelevant. Paragraph 29: First two sentences rejected as subordinate and unnecessary details. Third sentence rejected as irrelevant because it ignores and omits the context of the statement. Paragraph 30: Rejected as unnecessary. Paragraphs 31 and 32: Accepted in substance with additional clarifying details. Paragraph 33: Rejected because an important detail of the proposal is not supported by competent substantial evidence. Paragraph 34: Rejected as not supported by competent substantial evidence and as contrary to the greater weight of the evidence. Paragraphs 35 and 36: Rejected as irrelevant. Paragraph 37: Rejected as contrary to the greater weight of the evidence. Paragraph 38: Rejected as subordinate and unnecessary details. Paragraph 39: Rejected as irrelevant and as subordinate and unnecessary details. Paragraph 40: Rejected as irrelevant. Paragraph 41: Rejected as subordinate and unnecessary details, because Dr. Haimes did not witness the examination and treatment of the patient. Paragraph 42: Rejected as irrelevant. Paragraph 43: Rejected because the witness's use of vitamin injection is irrelevant in light of other evidence and because the witness's opinion that vitamin injections are acceptable world wide is rejected as not persuasive. Paragraph 44: Rejected as contrary to the greater weight of the evidence. Paragraph 45: Rejected as irrelevant; the witness's beliefs notwithstanding, the greater weight of the evidence is to the contrary. Paragraph 46: Rejected as subordinate and unnecessary. Paragraph 47: First three sentences rejected as irrelevant. Last sentence rejected as contrary to the greater weight of the evidence. Paragraph 48: Rejected as contrary to the greater weight of the evidence. Paragraph 49: The first, second, and fourth sentences are rejected as contrary to the greater weight of the evidence. The third sentence is rejected as irrelevant. Paragraph 50: Rejected as contrary to the greater weight of the evidence. Paragraph 51: First two sentences rejected as contrary to the greater weight of the evidence. Last sentence accepted in substance. Paragraph 52: First sentence is rejected as contrary to the greater weight of the evidence. Second sentence is accepted in substance. Third and fourth sentences are rejected as subordinate and unnecessary details. Paragraph 53: First sentence rejected as irrelevant. Second sentence rejected as contrary to the greater weight of the evidence. Paragraph 54: Rejected as contrary to the greater weight of the evidence. Paragraph 55: Rejected as irrelevant. Paragraph 56: First sentence is rejected as contrary to the greater weight of the evidence. The second sentence is rejected as irrelevant. Paragraph 57: Rejected as subordinate and unnecessary. Paragraph 58: Rejected as contrary to the greater weight of the evidence. Paragraph 59: Rejected as subordinate and unnecessary details. Paragraph 60: Rejected as contrary to the greater weight of the evident. Paragraph 61: Rejected as irrelevant. Paragraph 62: First two sentences rejected gas contrary to the greater weight of the evidence. Third sentence accepted in substance. Last sentence rejected as irrelevant. Paragraph 63: First sentence rejected as irrelevant. Second sentence accepted in substance. Third sentence rejected as contrary to the greater weight of the evidence. Paragraph 64: Rejected as irrelevant. Paragraph 65: Rejected because the opinions in this paragraph are contrary to the greater weight of the evidence. Paragraph 66: First and third sentences rejected as subordinate and unnecessary details. Second and fourth sentences rejected as contrary to the greater weight of the evidence. Paragraph 67: Rejected as contrary to the greater weight of the evidence. Paragraph 68: Rejected as irrelevant. Paragraphs 69 and 70: Rejected as contrary to the greater weight of the evidence. Paragraph 71: Rejected as subordinate and unnecessary details. COPIES FURNISHED: Francine C. Landau, Esquire Inman and Landau, P.A. 2252 Gulf Life Tower Jacksonville, Florida 32207 H. Edward Dean, Esquire 201 Northeast Eighth Avenue Suite 100 Ocala, Florida 32670 William O'Neil, Esquire General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Ms. Dorothy Faircloth Executive Director Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
