Findings Of Fact On July 18, 1983, Petitioner, under its former corporate name, Deltona General Hospital, Inc., filed a letter pursuant to Rule 10-5.08, Florida Administrative Code, advising DHRS of its intention to file an application for a Certificate of Need to construct and operate a 100-bed acute-care hospital in Volusia County. The letter identifies the nature and scope of the project, the project's location, and the date upon which the application is to be filed. On July 18, 1983, Petitioner advised be Health Planning Council of Northeast Florida of its intention to file an application for a Certificate of Need to construct and operate a 100-bed acute-care hospital in Volusia County. Oral notice was provided by Western Union Mailgram on July 18, 1983. Written confirmation of the mailgram, was received by the Health Planning Council of Northeast Florida on July 20, 1983. On July 18, 1983, Halifax Hospital Medical Center filed a competing letter of intent to establish a 100-bed acute-care general hospital in Volusia County. On August 15, 1983, both Petitioner and Halifax Hospital Medical Center filed applications for a Certificate of Need to construct a 100-bed acute-care hospital in Volusia County. On or about September 9, 1983, Petitioner was advised in a letter from Thomas F. Porter, Supervisor, Medical Facility Consultants, DHRS, that its August 19 application would not be reviewed in the August 19 acute-care batching cycle. DHRS rejected the application due to Petitioner's failure to file a written letter of intent with the local health council on or before July 15, 1983, predicating its decision on Rule 10-5.08 (1)(b), Florida Administrative Code. The application of Halifax Hospital Medical Center will be reviewed by DHRS in the August 15, 1983, batching cycle. Committee Substitute for House Bill 700, effective July 1, 1983, and codified into law at Chapter 83-244, Laws of Florida, amended Section 381.494(5), Florida Statutes, to require DHRS to "provide a mechanism by which providers may enter a batching cycle to compete with all letters of intent filed." DHRS has not, as of this date, developed a mechanism in compliance with this statutory amendment. In 1952, Rule 10-5.08, Florida Administrative Code, provided in pertinent part: In order that applications pertaining to similar types of services, facilties, or equipment affecting the sense health service area may be considered in relation to each other for purposes of competitive review, letters of intent and applications shall be submitted to the appropriate HSA in the Department pursuant to dates prescribed and application schedules (attachments 1-9) developed under the following conditions: (e) In cases where a letter of intent was filed within five working days of the letter of intent dead- line, a grace period of ten days from the deadline date for receipt of intent, shall be established to provide an opportunity for a competing applicant to file a letter of intent. As amended on March 31, 1952, Rule 10-5.08(1)(b) provides, in pertinent part: (b) At least 30 days prior to the filing of an application, a letter of intent respecting the development of a proposal must be actually received by the local health council and by the Department . . . because letters of intent give applicants a right of entry into the Certificate of Need process, failure to file a timely letter of intent and to have it actually received by the Department and by the local health council at least 30 days prior to the filing of an application will prevent the Department from accepting an application. Failure to timely file a letter of intent or to timely file an application will cause a delay in a Certificate of Need project until the next available review cycle. Section 381.494(5), Florida Statutes, is cited in the Florida Administrative Code as the specific authority for Rule 10-5.08. In addition, Section 381.494(5), Florida Statutes, is cited as the law implemented by Rule 10-5.08. During the 1983 legislative session, a number of groups and individuals recommenced that Section 381.494(5), Florida Statutes, be amended to include a grace period provision. Hot DHRS and the Florida Hospital Association supported the requested legislative amendment. The 1983 Legislature in fact amended Section 381.494(5), Florida Statutes, to require DHRS to provide a "mechanism by which providers may enter a batching cycle to compete with all letters of intent filed. Chapter 83-244, Laws of Florida. The amended statute became effective July 1, 1983. DHRS has yet to initiate formal rule-making proceedings under Chapter 120, Florida Statutes, to amend Rule 10-5.08(1)(b) Florida Administrative Code. The amount of time required to develop and adopt an amended version of Rule 10- 5.08, supra, is uncertain. Section 381.494(5), Florida Statutes, as amended, does not specifically require that DHRS promulgate or amend its rule. The statute merely directs DHRS to provide a "mechanism" by which providers may enter a batching cycle to compete with all letters of intent filed. The filing of a letter of intent with the local health councils serves an informational purpose. The letter of intent process gives notice to the community at large as to what particular applications may be submitted during the various batching cycles. The filing of a letter of intent does not trigger any review process at the local level. The local health council does not participate in project review during the Certificate of Need process. The purpose of the letter of intent is simply to put other institutions or interested individuals in the area on notice of the potential for filing of an application at a later date. The Halifax Hospital Medical Center Certificate of deed application is being reviewed in the August 15 batching cycle without reference to any other applications. If Petitioner's application is accepted, it will be reviewed competitively with the Halifax application. There is no evidence of record in this cause to demonstrate that DHRS, Halifax Hospital Medical Center, or any other potentially competitive health care provider was misled or in any way prejudiced by Petitioner's having filed its letter of intent on July 20, 1983, instead of July 18, 1983. Further, there is no evidence to suggest that the interest of the public in containing health care costs and avoiding the unnecessary duplication of health services will not best be served by a competitive review of Petitioner's proposed project and that of Halifax Hospital Medical Center. Finally, there are no facts of record, other than those outlined above, to establish what the agency's policy should be in light of the aforementioned 1983 legislative amendments.
The Issue Whether Respondent violated Subsections 458.331(1)(d), 458.331(1)(n), and 458.331(1)(t), Florida Statutes, and, if so, what discipline should be imposed.
Findings Of Fact Hammesfahr is a licensed physician in the State of Florida, having been issued Florida License ME 52212 on February 8, 1988. He is board-certified in neurology and pain management. Hammesfahr's office is located in Clearwater, Florida, where he maintains a practice treating patients who have had strokes. A stroke is a blockage of an artery in the brain that causes damage to the brain. As a result of the stroke certain cells within the brain will die, and the victim will develop a multitude of deficits, including paralysis, loss of vision, sensory loss, and memory problems. Between 1998 and 2000, Hammesfahr advertised his treatment for stroke patients and included the following statements in some of his advertisements: Using advanced technology, Dr. Hammesfahr has developed a sophisticated method to help restore blood flow to the damaged areas of the brain after a stroke. With increased blood flow to these areas, the brain can heal. Dr. Hammesfahr is the first physician to treat and successfully reverse the effects of stroke using vasodilators. These advertisements have appeared in Florida and in airline magazines, which travel throughout the country. In some of his advertisements, Hammesfahr indicated that based on an evaluation of the first 67 patients who went through the therapy 82 percent had major improvement, 11.9 percent had minor improvement, and 6 percent had no improvement. He further indicated that the study showing these results was peer-reviewed. Generally, Hammesfahr's treatment protocol is based on the concept of dilating blood vessels in the brain to optimize neurological function and neurological recovery. He uses vasodilator medications to dilate blood vessels in the brain and to increase blood flow into the brain. Various methods are used to monitor the therapy and improvement, including ultrasound, physical examinations, neuropsychological and physical therapy testing, EEG, transcranial Doppler, and blood pressure monitoring. Medications used to dilate the blood vessels include ACE inhibitors, calcium channel blockers, nitrates, alpha and beta blockers, and sympatholytics. After a stroke has occurred, brain cells in the center of the stroke are destroyed and cannot be revived. The area next to the stroke center is called the penumbra and consists of brain cells that are damaged and might recover. Hammesfahr does not claim that his treatment protocol can restore the brain cells that have been destroyed. He does claim that by using his protocol there may be some recovery in the damaged areas, where the blood vessels have restricted and narrowed. The medications dilate the vessels and increase the blood flow to the damaged areas. The recovery of a stroke patient consists of three phases: acute, subacute, and chronic. The acute phase occurs from the onset of the stroke to the next few days or weeks thereafter. The subacute phase starts at the end of the acute phase and lasts for approximately six weeks to three months. However, in certain cases it might last as long as 18 months. The chronic phase is the last phase, which commences at the end of the subacute phase and lasts for an indefinite period. Hammesfahr usually treats stroke patients who are in the chronic phase, but has also treated patients in the other phases of stroke recovery. When a patient contacts Hammesfahr concerning his stroke treatment, the patient will be sent a new patient package, which describes the phases of treatment, contains articles written by Hammesfahr concerning his treatment, and includes a fee schedule. Hammesfahr has different treatment plans from which the patient may choose to participate. The costs for the treatment vary according to the plan; the longer the patient is seen in Clearwater by Hammesfahr, the more costly the treatment. The average patient seen by Hammesfahr opts for the three-week plan. If a patient decides that he wants to be treated by Hammesfahr, the patient is required to see his primary care physician, provide the physician with the articles contained in the new patient package, and obtain his medical records from the physician. The primary care physician is to perform certain tests on the patient and give a medical clearance for the patient to travel to Clearwater, Florida, for treatment by Hammesfahr. The patient is also sent a package of materials, which includes a medical history form to be filled out by the patient and brought to Hammesfahr when the patient comes to Clearwater for treatment. When the patient initially presents for treatment at Clearwater, the patient is given an explanation of the treatment by Hammesfahr and his staff. Patients are advised that there are no guarantees that the treatment will be successful. An intake is performed to make sure that the needed forms are properly completed, including a history of the patient to determine that the patient's primary care physician has given the patient a clearance to come to Hammesfahr for treatment, and to review the medical records of the patient. A physical examination is performed on the patient. The patient is given a schedule for the time that the patient will be in treatment in Clearwater, and Hammesfahr's staff reviews the schedule with the patient. Tests are performed on the patient in Hammesfahr's office such as the transcranial Doppler ultrasound to generally determine the blood velocity. The patient is sent to Diane Hartley, a physical therapist, for testing of gross motor function, and to Dr. Alexander Gimon for neuropsychological testing. The tests given by Ms. Hartley and Dr. Gimon are standardized tests, for which the patient normally pays additional fees. The initial tests by Ms. Hartley and Dr. Gimon are given to form a baseline for a comparison with later test results. Those patients who are three-week patients will also have examinations by Ms. Hartley and Dr. Gimon at the end of their treatment period. The test results are compared with the test results taken at the beginning of the treatment period. The patient receives an orientation session in which the patient is informed of the responsibilities that the patient has during the course of treatment. Such responsibilities include taking blood pressure measurements at prescribed times of the day, charting the results of the blood pressure test, and seeing and providing the patient's primary care physician with the blood pressure readings. The patient must drink eight glasses of water a day, unless the patient has a heart disease, and must avoid certain types of foods that are vasoconstrictors. Once the patient completes the treatment at Hammesfahr's office, the primary care physician will take over the medical management of the patient's treatment. Hammesfahr's office will confer with the patient's primary care physician after the patient leaves Hammesfahr's office to discuss the monitoring of the patient and the altering of the patient's medication. One week after returning from treatment in Clearwater with Hammesfahr, the patient must see his primary care physician. In October 1999, a friend of M.T. mailed M.T. one of Hammesfahr's advertisements. As result of receiving the advertisement, M.T. contacted Hammesfahr's clinic and sought treatment from him for a stroke which she suffered in May 1999. Hammesfahr sent M.T. an information package and a videotape. The package contained articles written by Hammesfahr, a description of the different programs available, and a price list for the programs. M.T. decided that she would try a three-day program for $3,000. There was a dispute as to exactly which program M.T. received when she went to Clearwater. The only two programs which Hammesfahr listed as costing $3,000 were the Executive Stroke Prevention Program and the One-Week Evaluation and Treatment Program. The Executive Stroke Prevention Program was described as follows: This is a three (3) day program in which patients will undergo CAT scan and MRI at our facility, state of the art computerized EEG, and transcranial ultrasound to look at the blood vessels of the brain. They will undergo a comprehensive medical review and family review, as well as recommendations for lowering one's chances of a stroke or to treat if there has been a stroke in the past. This program is not covered by insurance. The One-Week Evaluation and Treatment Program was described as follows: This program is designed for those who want to start the stroke program and have the program advanced to a level which makes it significantly easier for the family physicians at home and neurologists to continue the program safely and rapidly. The first days [sic] involved in the initial evaluation, as well as any testing such as EEG and ultrasound testing, if necessary, and CT scans and MRIs as well as blood tests, followed by days two through five being involved in the initiation of medical treatment in that either treating the previous stroke or preventing future strokes. Recommendations are then made to the family physician or neurologists for caring through on this program. There was an additional three-day program, Initial Evaluation and Treatment, which listed for $2,000 and provided the following: This is a three (3) day consultation and evaluation with recommendations for treatment. This program is designed for patients who are interested in treatment of their stroke by their family physicians at home. A comprehensive evaluation will be made by our physicians as well as treatment recommendations. This evaluation will include review of CAT scans or MRIs and blood tests, and when appropriate, computerized EEG testing, neuropsychological testing, and ultrasound evaluations. The program is approximately three days. Prior to traveling to Hammesfahr's clinic, M.T. was directed by Hammesfahr to obtain medical tests from her primary care physician, which she did. The tests included a CT scan of the brain, a CMP, liver profile, CBC with different platelets, Westergren's sed rate, EEG, CVA, and EKG. She was also required to take and write down her blood pressure two times a day for a week before going to Hammesfahr's clinic. M.T. also filled out a medical history form and a system review checklist prior to her visit to Hammesfahr. In a letter dated February 12, 2000, to M.T. on Hammesfahr's letterhead, his office staff described the treatment that M.T. would receive as follows: Your first visits with us will be quite long. So, plan accordingly. On your first day, you will have a consultation with the doctor. The second day you will have diagnostic testing in our office, and an appointment with Dr. Gimon for a neuro- psychological evaluation and Diane Hartley for a physical therapy evaluation. Both of these doctors will be calling you to set up these appointments. The neuro-psychological testing will help us to evaluate any memory changes. You will probably see Dr. Gimon again towards the end of your treatment. On Tuesdays and Thursdays there is an orientation session outlining what we will be doing here in the office and [sic] explaining our treatment program will be given out. Each new patient must attend one of these sessions. Every day thereafter, your visit will be at least two (2) hours long. As you know, our treatment consists of sessions in this office each day Monday through Friday for the duration of your therapy. Please note: No warranties or guarantees can be made regarding the time, the degree, or the duration of improvement with this therapy. On February 20, 2000, M.T. signed a Waiver for Use of Medications, which stated: I am, or my caregiver is, aware that I have had a neurological disease and have failed to respond to other types of medications used in the conservative management of my condition. . . . Options available to me at this time are those now used at the Florida Neurological Institute. I am aware that the medications used in this therapy are medications that have FDA approval. However, I am also aware that the FDA has not approved these medications in the doses and number of medications used here at the Institute. I am aware that Dr. Hammesfahr has published many articles on his therapy. I am aware of the fact that, during the past two years, the Institute has treated many patients with similar conditions and that most have had at least some improvement in the symptoms associated with their problem. I have, and my caregiver has, been counseled regarding this theory under which this therapy is being promulgated. Upon arrival at the Florida Neurological Institute, I and my caregiver, will see and listen to the videotapes available regarding this therapy. I have, or my caregiver has, read this waiver and understands its contents. I am, and my caregiver is, aware that there is no indicated use for this therapy now. I have had all questions I may have concerning the use of these medications answered, I agree to undergo the use of these medications as outlined in the material presented to me. As stated above, I am fully aware of the fact that this therapy probably will not be covered by my insurance, but I wish to continue with this therapy as outlined to me in my training and information sessions. I also understand that no physician, or any other person in this office, can make any guarantees of success from this therapy. (Emphasis in the original) On February 28, 2000, M.T., accompanied by her husband, presented to Hammesfahr's clinic in Clearwater, Florida, for treatment. On her first day at the clinic, she received an orientation. She was required to pay $3,000 for her treatment. A staff member at Hammesfahr's clinic took M.T.'s blood pressure and directed M.T. to take her own blood pressure readings thereafter. On the second day of treatment, February 29, 2000, M.T. was sent to Dr. Alexander Gimon, a neuropsychologist, for a 30-minute evaluation. A staff member of Hammesfahr's clinic gave M.T. a transcranial Doppler, a carotid artery ultrasound, and an electrocardiogram. A Physician's Office Visit History and Physical Examination Form was filled out with a date of "2-28-00" struck through at the top of the form and the date of "2-29-00" placed next to it. At the end of the form appeared a physician's statement signed by Hammesfahr and dated February 22, 2000, a week before M.T. presented for treatment, stating that he had "examined this patient, reviewed his/her history, and consulted with him/her and the caregiver regarding the treatment planned here at Florida Neurological Institute." An Objective (Physical Examination) form was filled out, again with the date of "2-28-00" struck through at the top of the form and the date "2-29-00" placed next to it. The form does not indicate who performed the physical examination. The form does indicate that M.T.'s blood pressure and pulse readings were taken. M.T. met with Hammesfahr, who observed her gait and told her that he would send her back home and would work with her physicians. He did not prescribe any medications at that time and did not give M.T. any medications during her treatment at his clinic. On March 1, 2000, M.T. was supposed to meet with the physical therapist, Diane Hartley, for evaluation at 8:00 a.m. When she arrived at Ms. Hartley's facility, no one was there to let M.T. in the building. When M.T. went into the facility, she did not like the looks of the building, describing it as "shoddy looking." She decided that she did not want to stay for an evaluation and left. The fee Hammesfahr charged M.T. included the fees for Dr. Gimon and Ms. Hartley. On March 1, 2000, M.T. and her husband returned home with the understanding that Hammesfahr would be contacting her doctors in Alabama to arrange for the administering of the medications. M.T. was told to make an appointment with her primary care physician for the week after she returned from Clearwater. Hammesfahr first communicated with M.T.'s physicians by letter, dated April 5, 2000, asking them to administer the vasodilators and magnesium sulfate I.V.'s. M.T.'s physicians in Alabama refused to administer the medications. M.T. did not take the vasodilators, which Hammesfahr wanted her physicians to administer; nevertheless, M.T. improved. Based on the rate schedule presented to M.T. for Hammesfahr's various treatment programs, she should have received either the Executive Stroke Prevention Program or the One-Week Evaluation and Treatment Program. Hammesfahr was adamant that M.T. did not sign up for the Executive Stroke Prevention Program, and the evidence established that she did not receive this program. M.T. was given an itinerary that indicated that she would be treated by Hammesfahr for a week; however the evidence established that she did not receive the treatment that was supposed to be given in the One-Week Evaluation and Treatment Program, which promised that the initiation of medical treatment would be done on days two through five. Hammesfahr did not administer any medications or prescribe any medications for M.T. during her stay in Clearwater. The evidence does show that M.T. received the three-day Initial Evaluation and Treatment Program, for which she should have been charged only $2,000. Hammesfahr presented the expert testimony of Dr. Jacob Green, who is a board-certified neurologist, practicing in Jacksonville, Florida. He has been practicing for over 35 years. Dr. Green has written papers on the use of transcranial Doppler, and he is experienced in the treatment of acute and chronic stroke patients. Dr. Green is familiar with the protocol and procedure utilized by Hammesfahr in treating stroke patients. He has read articles written by Hammesfahr, reviewed patients' records, and spent a day in Hammesfahr's office observing Hammesfahr's practice and treatment protocol which is at issue in this case. While he was at Hammesfahr's clinic, Dr. Green observed Hammesfahr treat patients, reviewed medical records of patients when they first came to Hammesfahr for treatment, and compared the findings in those records to his observations of the patients' abilities. Dr. Green discussed the treatment and protocol with Hammesfahr. Based on his deposition testimony, Dr. Green had a good understanding of the treatment and protocol used by Hammesfahr for stroke patients. Dr. Green described the standard of care for a stroke patient as "to do good by the patient, do no harm." According to Dr. Green, Hammesfahr's care and treatment and protocol complied with the standard of care. Hammesfahr presented the expert testimony of Dr. William Scott Russell, Jr., a retired neurologist with 33 years of experience. In his practice, he had treated thousands of stroke patients. Dr. Russell retired in October 1998. Dr. Russell had first-hand knowledge of the protocol used by Hammesfahr when he treated Dr. Russell for an acute stroke. Prior to Dr. Russell's being treated by Hammesfahr, Dr. Russell had reviewed a paper written by Hammesfahr concerning Hammesfahr's treatment protocol for stroke victims using vasodilators. Dr. Russell considered the treatment protocol espoused by Hammesfahr to not be below the standard of care as of 1998. In 1996, Dr. Russell experienced a stroke. When he awoke one morning, he was confused. He went to work and had difficulty with his abilities to speak and write. Dr. Russell realized that he was experiencing a stroke and had a technician in his office run an EEG. He had peer-reviewed some of Hammesfahr's papers prior to his stroke and was impressed with Hammesfahr's work. So, he contacted Hammesfahr and presented at Hammesfahr's clinic for treatment the day he experienced the stroke. Hammesfahr performed a transcranial Doppler on Dr. Russell and administered nitroglycerine to dilate Dr. Russell's blood vessels. Ten minutes after the nitroglycerine was administered, Dr. Russell's symptoms disappeared. Within a reasonable degree of medical probability, the cause of his recovery was the use of the nitroglycerine. Nitrates are used for acute stroke patients when the patient has an extremely high blood pressure. The nitrates lower the blood pressure and are given intravenously so that the medication can be discontinued immediately if the blood pressure should fall too low. There was no evidence presented to determine whether at the time that Hammesfahr administered nitroglycerine to Dr. Russell that Dr. Russell's blood pressure was high. At the time of the final hearing, Dr. Russell felt that he had total recovery from the stroke deficits. He has reduced his intake of medications prescribed by Hammesfahr and has not had a return of the deficits. The Department presented the testimony of four expert witnesses concerning the standard of care for treatment of stroke victims: Dr. Harold Charles Friend, Dr. Steven Novella, Dr. David F. Scales, and Dr. Thomas Hoffman. Dr. Hoffman has been practicing neurology in Melbourne, Florida, since 1982. Approximately five to ten percent of his patients have had a stroke or a cerebral vascular disease. He has read some of Hammesfahr's advertisements and viewed Hammesfahr's article on Hammesfahr's Internet web site. Dr. Hoffman understands Hammesfahr's protocol to be the use of medications to increase the cerebral blood flow and the use of the transcranial Doppler to direct the medication treatment by measuring the cerebral blood flow. Dr. Hoffman does not agree that the use of vasodilators increases the blood flow to the brain. There is a loss of cerebral autoregulation when a stroke occurs. According to Dr. Hoffman, the use of vasodilators can decrease the blood flow to the brain and worsen neurological functioning in acute stroke patients. It is the opinion of Dr. Hoffman that Hammesfahr's treatment of stroke patients falls below the standard of care for acute, subacute, and chronic stroke patients. Dr. Steven Novella is a neurologist and an assistant professor at Yale University. He received his medical license in Connecticut in 1993 and obtained his board certification in neurology in 1998. He treats stroke patients and is familiar with the appropriate treatment for stroke patients. Dr. Novella understands that the treatment for stroke patients which Hammesfahr advocates is the administration of vasodilators to expand blood vessels which have an insufficient blood supply due to constriction. He disagrees with Hammesfahr's theory, espousing that the blood vessels in the area of the brain that is not receiving enough blood flow will dilate as far as they can go and that the blood vessels will not respond to the vasodilators because the blood vessels are already maximally dilated. Dr. Novella is of the opinion that vasodilators may be used for stroke patients to reduce the risk of another stroke when the patient is hypertensive, but that the vasodilators should not be used as a method of reversing deficits caused by stroke. Dr. Harold Charles Friend is a board-certified neurologist, who has been practicing neurology for 26 years. He practices in Boca Raton, Florida. Approximately five to eight percent of his practice is dedicated to treating stroke patients. He is currently treating in excess of 500 stroke patients. Dr. Friend has reviewed the charts of two patients of Hammesfahr, an article written by Hammesfahr, some of Hammesfahr's advertisements, some newspaper articles, and an article authored by Hammesfahr, which appeared on an Internet site. Dr. Friend also saw a patient in his office that had previously been treated by Hammesfahr. Based on the information from these sources, Dr. Friend incorrectly understood that Hammesfahr's methodology was to basically lower the blood pressure of his patients in an attempt to restore dead cells. He also concluded that the patients seen by Hammesfahr were also receiving physical therapy at the time of treatment. Dr. Friend opined that Hammesfahr's treatment of chronic stroke victims did not comport with the standard of care recognized in the medical community. He further concluded that given the medications that Hammesfahr administers to his patients, that one would expect some adverse effects or no effect on the patients. The only mention in the record of a patient's being harmed by Hammesfahr's treatment was by Dr. Friend. Dr. Friend reviewed a medical chart of a patient who had worsened after treatment by Hammesfahr and had to go to another physician, Dr. Nassar Elmansoury, to correct the problem. The patient had been prescribed Accupril, ten milligrams four times a day, and nitroglycerine cream. Both medications are vasodilators. When the patient presented to Dr. Elmansoury, the patient was feeling worse and experiencing chest pain, dizziness, and disequilibrium. Dr. Elmansoury eliminated the nitroglycerine cream and reduced the amount of Accupril. Within two weeks, the patient was improved. Dr. David F. Scales is a board-certified neurologist, who has been practicing for 34 years. He currently practices in the Jacksonville, Florida, area at the Jacksonville Neurological Clinic. About 50 percent of his in-patient practice consists of stroke patients. Stroke patients comprise about 20 to 25 percent of the entire practice. Dr. Scales has reviewed the medical records of two of Hammesfahr's patients, articles written by Hammesfahr, literature provided by Hammesfahr to his patients, and Hammesfahr's Internet web site. Dr. Scales understands Hammesfahr's theory to be that vasodilators are administered to dilate the blood vessels in the brain so that more blood flows through the penumbra, reactivating neurons that were in a suspended state of activation. He does not agree with Hammesfahr's theory because the blood vessels in the penumbra would be dilated to the maximum and the medications would dilate blood vessels in other parts of the body, which would in turn take away or steal the blood flow from the blood vessels in the penumbra. After reviewing the medical records of two of Hammesfahr's patients, M.T. and M.S., Dr. Scales was of the opinion that the treatment provided by Hammesfahr did not meet the standard of care for the treatment of stroke patients. Having considered the testimony of the experts presented by the parties, it is determined that the standard of care for the treatment of stroke patients varies according to the stage, type, and severity of the stroke. In the acute stage, the patient is admitted to the hospital. A medical history is taken and a physical exam is given, followed by appropriate laboratory and imaging studies to determine the site and cause of the stroke. For patients seen within three hours of the onset of the stroke, certain intravenous medications may be given in an attempt to break up the blood clot. For patients seen beyond the three-hour point, the treatment is maintenance of their blood pressure, monitoring of their vital signs, and treating any complications that may occur such as pneumonia and urinary tract infections. Patients may be given blood thinners to improve the flow of the blood, and medication to increase the blood pressure in the event the blood pressure is too low. Patients with severe hypertension, generally a blood pressure over 220 systolic or 120 diastolic, are given medications to lower their blood pressure. Patients with asymptomatic hypertension are treated judiciously during their hospital stay with anti-hypertensive medications, and the blood pressure is gradually lowered. The standard of care for subacute stroke patients is a continuation of the treatment given in the acute phase. Patients will be started on rehabilitation therapy, which may include speech, occupational, and physical therapy. The standard of care for chronic stroke patients, whom the physician is seeing for the first time, would be to take a history to determine what happened, review the medical records and any imaging studies that may have been done, and review the treatment they have had. The physician should assess the patients' risk factors for stroke such as hypertension, hyperlipidemia, diabetes, and smoking and manage those factors aggressively. Treatment with antiplatelets such as aspirin or an anticoagulation medication might be indicated. An assessment of their neurological functional abilities should be done to determine whether aids, braces, further therapy, or home care could be beneficial. Based upon the evidence presented, the treatment advocated by Hammesfahr is not within the generally accepted standard of care. However, the evidence is not clear and convincing that the treatment used by Hammesfahr is harmful to his patients. There is literature in the medical community that vasodilators can be used in the treatment of stroke as a measure to prevent future strokes. There is evidence that in over 200 patients seen by Hammesfahr that a large percentage improved after being treated by Hammesfahr. Dr. Gimon tested a group of 168 stroke patients seen at Hammesfahr's clinic during the period of November 1999 to May 2000 and another group of 163 stroke patients seen during October 2000 through February 2001. The same battery of tests was administered to both groups. Dr. Gimon evaluated these patients on nine separate neurological evaluations that are standard instruments recognized in neuropsychology. The tests measured identified areas of brain function, including verbal, visual, visual motor, and conceptual thinking. Both groups of patients were tested prior to the treatment by Hammesfahr. The patients were tested again approximately 18 to 21 days after they began treatment at Hammesfahr's clinic. The test results showed that many patients showed improvements in the areas tested. The improvements noted were measured as to a statistical difference so that the findings could not be attributable to testing error. Some patients showed no improvement in all areas. The test results revealed that there was no neuropsychological deterioration of the patients tested. Diane Hartley tested two groups of Hammesfahr's patients, who were treated at his clinic during the period of January to December 2000. Her tests were designed to measure functional motor improvement from a gross motor standpoint. She performed tests on the patients prior to their beginning treatment with Hammesfahr and again approximately two and one half to three weeks after the patients had begun treatment. Of the 242 patients tested by Ms. Hartley, 221 patients demonstrated improvement in one or more of the areas tested and 21 patients showed no improvement. Of the patients tested, ten received physical therapy from Ms. Hartley while they were being treated by Hammesfahr. These ten patients demonstrated a significant amount of improvement, which Ms. Hartley could not attribute solely to the physical therapy they received. The evidence establishes that Hammesfahr informed his patients by the use of videos, orientation sessions, literature, and a web site on the Internet of the nature of the therapy and did not guarantee that the patients would improve as a result of the treatment. Patients were able to make an informed decision on whether to try Hammesfahr' treatment.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Hammesfahr did not violate Subsections 458.331(1)(d) and 458.331(1)(t), Florida Statutes; finding that Hammesfahr did violate Subsection 458.331(1)(n), Florida Statutes; placing Hammesfahr on probation for six months; and imposing a $2,000 administrative fine. DONE AND ENTERED this 20th day of November, 2002, in Tallahassee, Leon County, Florida. _____ SUSAN B. KIRKLAND Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 20th day of November, 2002.
Findings Of Fact On July 18, 1983, Petitioner, under its former corporate name, Deltona General Hospital, Inc., filed, pursuant to Rule 10-5.08, Florida Administrative Code, a letter advising DHRS of its intention to file an application for a certificate of need to construct and operate a 100-bed acute-care hospital in Volusia County. The letter identifies the nature and scope of the project, the project location and the date upon which the application is to be filed. On July 18, 1983, Petitioner advised the Health Planning Council of Northeast Florida of its intention to file an application for a certificate of need to construct and operate a 100-bed acute-care hospital in Volusia County. Oral notice was provided by Western Union Mailgram on July 18, 1983. Written confirmation of the mailgram was received by the Health Planning Council of Northeast Florida on July 20, 1983. On July 18, 1983, Halifax Hospital Medical Center filed a competing letter of intent to establish a 100-bed acute-care general hospital in Volusia County. On August 15, 1983, both Petitioner and Halifax Hospital Medical Center filed applications for a certificate of need to construct a 100-bed acute-care hospital in Volusia County. On or about September 9, 1983, Petitioner was advised in a letter from Thomas F. Porter, Supervisor, Medical Facility Consultants, DHRS, that its August 15 application would not be reviewed in the August 15 acute-care batching cycle. DHRS rejected the application due to Petitioner's failure to file a written letter of intent with the local health council on or before July 18, 1983, predicting its decision on Rule 10-5.08(1)(b), Florida Administrative Code. The application of Halifax Hospital Medical Center will be reviewed by DHRS in the August 15, 1983, batching cycle. Committee Substitute for House Bill 700, effective July 1, 1983, and codified into law at Chapter 83-244, Laws of Florida, amended Section 381.494(5), Florida Statutes, to require DHRS to "provide a mechanism by which providers may enter a batching cycle to compete with all letters of intent filed." DHRS has not, as of this date, developed a mechanism in compliance with this statutory amendment. In 1982, Rule 10-5.08, Florida Administrative Code, provided, in pertinent part: In order that applications per- taining to similar types of services, facilities, or equipment affecting the same health service area may be considered in relation to each other for purposes of competitive review, letters of intent and applications shall be submitted to the appropriate HSA in the Department pursuant to dates prescribed and application schedules (attachments 1-9) developed under the following conditions: * * * (e) In cases where a letter of intent was filed within five working days of the letter of intent deadline, a grace period of ten days from the deadline date for receipt of letters of intent shall be established to pro- vide an opportunity for a competing applicant to file a letter of intent. As amended on March 31, 1982, Rule 10-5.08(1)(b) provides, in pertinent part: At least 30 days prior to the filing of an application, a letter of intent respecting the development of a pro- posal must be actually received by the local health council and by the Department . . . because letters of intent give applicants a right of entry into the Certificate of Need process, failure to file a timely letter of intent and to have it actually received by the Department and by the local health council at least 30 days prior to the filing of an application will prevent the Department from accepting an applica- tion. Failure to timely file a letter of intent or to timely file an appli- cation will cause a delay in a Certifi- cate of Need project until the next available review cycle. Section 381.494(5), Florida Statutes, is cited in the Florida Administrative Code as the specific authority for Rule 10-5.08. In addition, Section 381.494(5), Florida Statutes, is cited as the law implemented by Rule 10-5.08. During the 1983 Legislative Session, a number of groups and individuals recommended that Section 381.494(5), Florida Statutes, be amended to include a grace period provision. Both DHRS and the Florida Hospital Association supported the requested legislative amendment. The 1983 Legislature in fact amended Section 381.494(5), Florida Statutes, to require the Department to provide a "mechanism" by which providers may enter a batching cycle to compete with all letters of intent filed. Chapter 83-244, Laws of Florida. The amended statute became effective July 1, 1983. DHRS has yet to initiate formal rule-making proceedings under Chapter 120, Florida Statutes, to amend the challenged rule. The amount of time required to develop and adopt an amended version of Rule 10-5.08, Florida Administrative Code, is uncertain. Section 381.494(5), as amended, does not specifically require that DHRS promulgate or amend the challenged rule. The statute directs DHRS to provide a "mechanism" by which providers may enter a batching cycle to compete with all letters of intent filed. The filing of a letter of intent with the local health councils serves an informational purpose. The letter of intent process gives notice to the community at large as to what particular applications may be submitted during the various batching cycles. The filing of a letter of intent does not trigger any review process at the local level. The local health council does not participate in project review during the certificate of need process. The purpose of the letter of intent is simply to put other institutions or interested individuals in the area on notice of the potential for filing of an application at a later date. The Halifax Hospital Medical Center certificate of need application is being reviewed in the August 15 batching cycle without reference to any other applications. If Petitioner's application is accepted, it will be reviewed competitively with the Halifax application.
The Issue Whether the Petitioner must reimburse the Respondent for Medicaid overpayments as set out in the Final Agency Audit Report ("FAAR") dated May 8, 2003.
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: At all times material to this proceeding, AHCA has been the state agency charged with responsibility for overseeing the Florida Medicaid system, including the recovery of overpayments to Medicaid providers. § 409.913, Fla. Stat. (1996-2000).1 Dr. Lee was an authorized Medicaid provider during the Audit Period, having been issued provider number 377123700. Dr. Lee had valid Medicaid Provider Agreements with AHCA during the Audit Period. Pursuant to her Medicaid provider agreement, Dr. Lee agreed to: (1) retain for five years complete and accurate medical records "that fully justify and disclose the extent of the services rendered and billings made under the Medicaid program"; (2) bill Medicaid only for services or goods that are medically necessary; and (3) "abide by the Florida Administrative Code, Florida Statutes, policies, procedures, manuals of the Florida Medicaid Program and Federal laws and regulations." AHCA audited the Medicaid claims Dr. Lee submitted for certain specified procedures during the Audit Period. After AHCA issued its Preliminary Agency Audit Report on September 6, 2000, Dr. Lee provided AHCA additional documentation, which was reviewed and which resulted in the issuance of a FAAR dated May 8, 2003, which included an adjustment of the overpayment claimed by AHCA from $131,177.64 to $129,148.49 for services provided between January 1, 1996, and January 9, 1998.2 As a result of adjustments made after issuance of the FAAR on May 8, 2003, AHCA now seeks to recover from Dr. Lee $109,439.77. Dr. Lee is an osteopathic physician who is board- certified in internal medicine by the American Academy of Internal Medicine; three years ago, she earned a sub-specialty in HIV/AIDS medicine from the American Academy of HIV Medicine. During the Audit Period, Dr. Lee specialized in HIV/AIDS, with 85 to 90 percent of her practice devoted to the treatment of patients diagnosed with HIV/AIDS. At the times material to this proceeding, Dr. Lee's offices were located in Ft. Lauderdale, Florida. Joseph W. Shands, M.D., conducted the peer review of the documentation provided by Dr. Lee for purposes of the audit conducted by AHCA. Dr. Shands first reviewed documentation provided by Dr. Lee in 1999; he reviewed additional documentation provided by Dr. Lee subsequent to his deposition in October 2003. Dr. Shands graduated from medical school in 1956, trained in internal medicine, and worked as a microbiologist for approximately 15 years. He served as Chief of Infectious Diseases at the University of Florida for 23 years and also treated patients through the Alachua County Public Health Department and Shands Hospital at the University of Florida. Dr. Shands' practice was devoted almost entirely to the treatment of patients diagnosed with HIV/AIDS. Dr. Shands treated virtually all of the HIV/AIDS patients in Alachua County and the surrounding counties. The area from which Dr. Shands drew his patients is primarily rural, and he has treated approximately 1,000 HIV/AIDS patients. Dr. Shands retired from the practice of medicine in May 2002. For three years prior to his retirement, Dr. Shands practiced medicine part-time. The Medicaid payments sought to be recovered by AHCA for services deemed by Dr. Shands to be medically unnecessary relate primarily to Dr. Lee's use of intravenous immunoglobulin ("IVIG") in the treatment of Patients #4, #5, #6, #7, #9, #13, #15, #16, #21, and #24. All of these patients had been diagnosed with HIV/AIDS prior to the Audit Period, and Dr. Lee prescribed IVIG for these patients based on her diagnoses of either deficiency of humoral immunity ("DHI"), which carries the diagnosis code 279.09, or demyelinating neuropathy, which carries the diagnosis code 357.0. DHI IVIG consists of immunoglobulin precipitated out of human blood and reconstituted for intravenous infusion. IVIG is administered to persons who have low antibodies in an attempt to boost the antibodies in their systems to fight certain diseases, including DHI. There are two immune systems at work in the human body, humoral immunity that is provided by antibodies and cell- mediated immunity that is provided through cells, such as CD4 and CD8 cells. The infusion of IVIG is not covered as a treatment for HIV/AIDS under Florida's Medicaid program because HIV/AIDS compromises a person's cell-mediated immunity by infecting and killing CD4 cells. The use of IVIG to treat properly diagnosed and documented cases of DHI is considered medically necessary and is covered by Florida's Medicaid program. When a person has DHI, the body's antibody-producing cells do not differentiate properly, and the body produces fewer antibodies. As a result, the total level of immunoglobulin, or the level of one or more of the five subclasses of immunoglobulin, is depressed. The infusion of IVIG raises the level of immunoglobulins in the body. A person suffering from DHI must have a history of chronic, severe sinopulmonary infections3 that have persisted over a long period of time and that are so serious that pulmonary function becomes insufficient and death would result without treatment. Even though a person's medical history and symptoms are relevant to a diagnosis of DHI, a confirmed diagnosis of DHI requires documentation of a deficiency in the total level of immunoglobulin in the body or a deficiency in at least one of the five subclasses of immunoglobulin, which are known as IgG, IgM, IgA, IgF, and IgD. Such a deficiency is established by a blood test that measures the total immunoglobulin level in the body, as well as the level of immunoglobulin in the five subclasses. This test was available during the Audit Period and was covered by Florida's Medicaid program. Dr. Lee diagnosed DHI in her patients by relying solely on her training, experience, and diagnostic abilities as a physician. She considered the patient's history of recurring sinopulmonary infections, the results of previous treatment with IVIG, and the status of the patient's CD4 cells as shown by a blood test.4 She did not order tests for any of her patients to determine the level of their total immunoglobulin or the level of the five subclasses of immunoglobulin because she believed that the tests were too expensive. In diagnosing sinusitis, Dr. Lee considered the patient's symptoms and the results of her physical examinations of a patient. Symptoms of sinus congestion, facial pain, and nasal drip do not, however, support a diagnosis of sinusitis; a diagnosis of acute, chronic sinusitis requires that the patient have a chronically stuffy nose with purulent drainage, sinus tenderness, and, perhaps, a high fever. If a patient exhibits these symptoms, the diagnosis could be confirmed with an X-ray of the sinuses, although the test that most accurately established the presence of sinusitis during the Audit Period was a CT scan of the sinuses. In addition, even an appropriate diagnosis of acute, chronic sinusitis does not support a diagnosis of DHI. Acute, chronic sinusitis must be accompanied by severe, chronic pulmonary infections such as frequent episodes of bronchitis, the presence of sputum containing puss, fevers, and occasional episodes of pneumonia. In reviewing Dr. Lee's medical records to evaluate the medical necessity for IVIG treatments for patients diagnosed by Dr. Lee with DHI, Dr. Shands looked first at the patient's symptoms and the results of a physical examination that would show the presence of acute, chronic sinopulmonary infections; he then looked for the results of laboratory tests that would confirm that the patient had a deficiency in total immunoglobulin or a deficiency in one or more of the five subclasses of immunoglobulin. Demyelinating neuropathy Demyelinating neuropathy is a neurological condition in which the peripheral nerves fail to conduct electrical pulses in a normal fashion due to the deterioration or loss of the myelin sheath surrounding the peripheral nerves. General neuropathy, that is, a disruption in the peripheral nervous system, does not respond to IVIG; but neuropathy which involves demyelination, or the loss of the myelin sheath, improves with IVIG treatments, and the use of IVIG to treat properly diagnosed and documented cases of DHI is considered medically necessary and is covered by Florida's Medicaid program. Demyelinating neuropathy is characterized by ascending motor weakness and decreased reflexes. There are several types of neuropathy in addition to demyelinating neuropathy, including sensory neuropathy, which does not respond to treatment with IVIG, and Guillain-Barre, a rare autoimmune neuropathy producing paralysis that starts in the feet and moves up the body, which does respond to treatment with IVIG. Back pain or pain in the legs does not, of itself, support a diagnosis of demyelinating neuropathy, and the neuropathy must be severe in order to support a diagnosis of demyelinating neuropathy. Medical necessity for IVIG treatments Patient #4 Dr. Lee submitted claims to Medicaid for IVIG infusions received by Patient #4 for DHI on September 24, 1997. As a result of the audit, AHCA denied Dr. Lee's Medicaid claims for the IVIG treatment. At the times material to this proceeding, Patient #4 was a 38-year-old man suffering from HIV/AIDS. The medical records provided by Dr. Lee's office cover the period from May 20, 1997, to September 25, 1997, and show that Patient #4's first visit to Dr. Lee's office during the Audit Period was a scheduled visit on May 20, 1997. Although Dr. Lee stated in the medical records of this visit that Patient #4 "denie[d] any recent fevers. Pt state[d] sinus congestion cleared up on Friday - therefore, he didn't need to take Biaxin," Dr. Lee noted in the record that Patient #4 was "complaining once again of sinus congestion, fevers, cough with yellow sputum." The record of the examination of Patient #4's nose indicates "nasal mucosa moist, errythematous [sic], edematous turbinates"5; the record of the examination of Patient #4's lungs indicates "breath sounds are clear to auscultation bilaterally, no rales or rhonchi." In addition to Patient #4's diagnosis of HIV/AIDS, Dr. Lee diagnosed Patient #4 on May 20, 1997, as having acute sinusitis, chronic sinusitis, and DHI, and she noted that "[t]his patient needs IVIG. Sinus infections resolved with increased immunoglobulins by infusion when given in past. Insurance however, refuses to supply this med to the patient. Will continue to treat infections on a PRN basis." Dr. Lee prescribed Rocephin and Biaxin, two antibiotics, for Patient #4 on May 20, 1997. There is no indication in the record of the May 20, 1997, visit that Patient #4 had any pulmonary infection, and there is nothing in the medical records provided to support the notation that IVIG treatments had resolved previous sinus infections. At his scheduled office visit on June 12, 1997, Patient #4 reported sinus congestion and nasal scabbing; Dr. Lee's physical examination of Patient #4's nose again revealed that his "nasal mucosa [were] moist, [with] errythematous [sic], edematous turbinates." The examination of the lungs again did not reveal any abnormalities. On June 17, 1997, Patient #4 visited Dr. Lee's office for a sick visit, reporting "general malaise with diarrhea, night sweats, productive cough." The examination of the nose and lungs did not reveal any abnormalities. On June 26, 1997, Patient #4 visited Dr. Lee's office and complained of boils under both arms. Dr. Lee's physical examination of Patient #4's nose revealed moist nasal mucosa, with erythematous, edematous turbinates; the examination of the lungs again revealed no abnormalities. Patient #4 next visited Dr. Lee's office on September 15, 1997, for a sick visit. Among other complaints, Patient #4 reported that he "is still suffering with chronic sinusitis with increase noted this past week of congestion and post nasal drip. Also noted to be small amount of bleeding from nose." Among the symptoms noted for Patient #4 were "sinus congestion severe, increase in nasal discharge, epistaxis occasionally. . . . Denies fevers or chills." The report of Dr. Lee's physical examination of Patient #4's nose indicated "nasal mucosa moist, extremely errythematous [sic], edematous turbinates, increased nasal discharge, tenacious and greenish"; the examination of the lungs again revealed no abnormalities. Dr. Lee noted on the record of Patient #4's September 15, 1997, office visit that she would "schedule for IVIG monthly." Patient #4 visited Dr. Lee's office on September 24 and 25, 1997, for the infusion of IVIG, but Dr. Lee submitted a Medicaid claim for the IVIG infusion only for September 24, 1997. The diagnoses noted for these visits were DHI and HIV/AIDS. There is no indication in any of the Comparative Laboratory Test Results provided by Dr. Lee's office for Patient #4 that tests were done to measure the level of Patient #4's total immunoglobulin or the level of any of the subclasses of immunoglobulin. The medical records provided by Dr. Lee for Patient #4 do not support Dr. Lee's diagnosis that Patient #4 suffered from DHI. Although the medical records substantiate that Patient #4 had recurrent sinus infections, there was no evidence establishing that Patient #4 had bronchitis or any pulmonary infections; rather, Patient #4's lungs were clear at each of the documented visits to Dr. Lee's office. Dr. Lee testified that she had seen Patient #4 prior to the time covered by the Audit Period and that his history included chronic, recurrent sinus infections and chronic bronchitis. Dr. Lee did not provide documentation of Patient #4's history in the medical records provided by her office, and her testimony is not sufficient, standing alone, to establish that Patient #4 suffered from the severe, chronic sinopulmonary infections necessary to support a diagnosis of DHI. The medical records provided by Dr. Lee fail to support her diagnosis of DHI and, therefore, fail to establish that the infusion of IVIG was medically necessary. The claim submitted to Medicaid for the IVIG infusion given on September 24, 1997, should be denied. Patient #5 Dr. Lee submitted claims to Medicaid for IVIG infusions received by Patient #5 for demyelinating neuropathy and DHI on April 17, 1997, April 18, 1997, and June 11, 1997. As a result of the audit, AHCA denied Dr. Lee's Medicaid claims for these three IVIG infusions. At the times material to this proceeding, Patient #5 was a 31-year-old man suffering from HIV/AIDS. The medical records provided by Dr. Lee cover the period from February 19, 1997, to June 11, 1997, and show that Patient #5's first visit to her office during the Audit Period was a post-hospitalization visit on April 14, 1997. The medical records provided by Dr. Lee do not support a diagnosis of DHI. Patient #5 visited Dr. Lee's office for examination on April 14, 1997, and June 3, 1997. Patient #5 did not complain at either of these visits of a sinopulmonary infection, and the results of the physical examinations of Patient #5's nose and lungs performed during these visits did not reveal any abnormalities: The reports of the examinations of Patient #5's nose indicated that "nasal mucosa moist, normal turbinates," and the reports of the examinations of Patient #5's lungs indicated that "breath sounds are clear to auscultation bilaterally, no rales or rhonchi." In addition, the only dates on which a diagnosis of DHI appeared in Dr. Lee's medical records for Patient #5 were April 17, April 18, and June 11, 1997, the dates on which Patient #5 received infusions of IVIG. The medical records provided by Dr. Lee also fail to support a diagnosis of demyelinating neuropathy. Dr. Mayur Maniar performed a lower extremity nerve conduction study on February 19, 1997, almost two months before Patient #5's first reported visit to Dr. Lee. Dr. Maniar's report contains the following: "IMPRESSION: This is mildly abnormal nerve conduction study of lower extremities, which demonstrates mild sensorimotor, predominately demyelinating type of peripheral neuropathy in lower extremities. Please correlate clinically." The medical records provided by Dr. Lee do not include anything to indicate that a neurological study of Patient #5 was performed. There is no indication in the medical records provided by Dr. Lee documenting Patient #5's April 14, 1997, office visit that Patient #5 complained of weakness in his extremities, and no weakness was noted in Dr. Lee's physical examination performed by Dr. Lee during that office visit. The next two office visits, on April 17, 1997, and on April 18, 1997, were exclusively for the infusion of IVIG. Patient #5 reported at his scheduled office visit on June 3, 1997, that, among other things, that he was experiencing "fatigue, generalized weakness and 'tingling' over all body." Dr. Lee noted that Patient #5's "[n]europathy persists, slight short term improvement with rehab. Will receive second dose of IVIG this month." Patient #5's next visit to Dr. Lee's office, on June 11, 1997, was exclusively for the infusion of IVIG. The medical records she provided to AHCA do not support Dr. Lee's testimony that Patient #5 had "severe profound neuropathy with weakness," and her testimony, standing alone, is not sufficient to establish that Patient #5 suffered from the severe demyelinating neuropathy that responds to IVIG treatment. The medical records provided by Dr. Lee establish only that Patient #5 suffered from mild demyelinating neuropathy. The records, therefore, fail to establish that the infusion of IVIG was medically necessary, and the claims to Medicaid for the IVIG infusions given on April 17 and 18, 1997, and June 11, 1997, should be denied. Patient #6 Dr. Lee submitted claims to Medicaid for IVIG infusions received by Patient #6 for DHI on January 20 and 21, 1997; February 24 and 25, 1997; March 24 and 25, 1997; and April 22 and 23, 1997. As a result of the audit, AHCA denied Dr. Lee's Medicaid claims for these eight IVIG infusions. Dr. Lee's first contact with Patient #6 was on June 5, 1996, when she was asked by another physician to consult as a HIV/AIDS specialist. There is nothing in the record of this consultation to support Dr. Lee's contention that Patient #6 suffered from chronic, recurrent sinusitis and had been previously treated with IVIG. Rather, Dr. Lee noted in the record of the June 5, 1996, consultation that "the patient has had essentially no medical care. He moved from Tennessee in December and had been doing well until then." There is also nothing in the medical records provided by Dr. Lee to confirm that Patient #6 had previously been treated for chronic sinusitis. Patient #6 saw Dr. Lee in her office for a scheduled visit on January 13, 1997. Patient #6 did not complain of sinus or pulmonary problems; the report of Dr. Lee's physical examination of Patient #6's nose and lungs did not reveal any abnormalities. Dr. Lee's diagnoses for the January 13, 1997, office visit did not include DHI or chronic sinusitis. Patient #6 was treated with IVIG on January 20, 1997, with diagnoses that included DHI; Patient #6 was treated with IVIG on January 21, 1997, and the diagnoses for that visit included DHI and both chronic and acute sinusitis. Patient #6 visited Dr. Lee's office on January 27, 1997, with complaints of, among other things, "sinus, nose bleed," and the complaint that "sinus congestion persists." Dr. Lee's physical examination of Patient #6's nose and lungs did not reveal any abnormalities. The diagnoses for the January 27, 1997, office visit included DHI and both chronic and acute sinusitis. Dr. Lee wrote in the record of Patient #6's January 27, 1997, office visit that she would "continue IVIG monthly." Patient #6 visited Dr. Lee's office on February 6, 1997, but the medical records for that visit do not indicate that Patient #6 complained of sinus or pulmonary problems. Dr. Lee's physical examination did not include an examination of Patient #6's nose, but her examination of his lungs did not show any abnormalities. On February 24, 1997, Patient #6 visited Dr. Lee's office for both a physician visit and the infusion of IVIG. Patient #6 complained of "some sinus congestion," and Dr. Lee's physical examination of Patient #6's nose revealed moist nasal mucosa, with erythematous, edematous turbinates. Dr. Lee's physical examination of the lungs did not show any abnormalities. In addition to the physician visit with Dr. Lee, Patient #6 was treated with IVIG on February 24, 1997, with diagnoses that included DHI and chronic sinusitis; Patient #6 was also treated with IVIG on February 25, 1997, with diagnoses that included DHI and chronic sinusitis. Patient #6's next visit to her office was on March 24, 1997, and was solely for infusion of IVIG, with diagnoses that included DHI. On March 25, 1997, Patient #6 visited Dr. Lee's office for a physician visit and for the second infusion of IVIG for the month. Patient #6 reported that his "sinuses [were] better 'already' since IVIG." Dr. Lee's physical examination of Patient #6's nose on March 25, 1997, indicated that he had moist nasal mucosa, with "slightly edematous turbinates"; the examination of Patient #6's lungs did not show any abnormalities. Patient #6 visited Dr. Lee's office on April 1, 11, and 17, 1997. Patient #6 did not complain of any problems with his sinuses or lungs, and no examination was done of Patient #6's nose or lungs on April 1, 1997. Dr. Lee's physical examination of Patient #6's lungs on April 11, 1997, did not reveal any abnormalities; there is no record that Dr. Lee examined Patient #6's nose during the April 11, 1997, office visit. Dr. Lee's physical examination of Patient #6's nose and lungs on April 17, 1997, did not reveal any abnormalities. Patient #6 next visited Dr. Lee's office on April 21, 1997, solely to receive an infusion of IVIG. The nurse was unable to obtain access to Patient #6's vein, and he returned to the office on April 22, 1997, for a physician visit and for the infusion of IVIG. Patient #6 did not complain of any sinopulmonary problems on April 22, 1997, and Dr. Lee's physical examination of Patient #6's nose and lungs did not reveal any abnormalities. IVIG was administered on April 22, 1997, and the following note was included in the record of the April 22, 1997, visit: "IVIG for chronic sinusitis and decreased humoral immunity." Patient #6 returned to Dr. Lee's office on April 23, 1997, solely for the infusion of IVIG. There is no indication in any of the Comparative Laboratory Test Results provided by Dr. Lee's office for Patient #6 that tests were done to measure the level of Patient #6's total immunoglobulin or the level of any of the subclasses of immunoglobulin. The medical records provided by Dr. Lee's office for Patient #6 do not support her diagnosis of DHI. A diagnosis of DHI requires severe, chronic sinopulmonary infections, together with a deficiency in total immunoglobulins or in a subset of immunoglobulins. Dr. Lee did not test Patient #6's total immunoglobulin level or the level of any of the five subclasses of immunoglobulin, and he complained of sinus problems at only two office visits, on January 27, 1997, six days after he received IVIG, and on February 24, 1997, when he complained of "some sinus congestion."6 Additionally, there is nothing in the medical records provided by Dr. Lee to support her testimony that Patient #6's history prior to her treatment of him included chronic recurrent signs of sinus infection or that previous treatment with IVIG had improved his sinus infections. The medical records provided by Dr. Lee, therefore, fail to establish that the infusion of IVIG was medically necessary. The claims to Medicaid for the IVIG infusions given on January 20 and 21, 1997; February 24 and 25, 1997; March 24 and 25, 1997; and April 22 and 23, 1997, should be denied. Patient #7 Dr. Lee submitted claims to Medicaid for IVIG infusions received by Patient #7 for DHI on August 5 and 6, 1997; September 2 and 3, 1997; September 30 and October 1, 1997; and January 8 and 9, 1998. As a result of the audit, AHCA denied the Medicaid claims for these eight IVIG infusions. At the times material to this proceeding, Patient #7 was a 43-year-old man diagnosed with HIV/AIDS. According to the medical records provided by Dr. Lee's office, Patient #7's first office visit of the Audit Period was July 22, 1997. Patient #7 complained of "some cough, but is smoking more." Dr. Lee's physical examination of Patient #7's nose revealed moist nasal mucosa, with "pale, errythematous [sic] turbinates"; the examination of the lungs revealed no abnormalities. Patient #7 next visited Dr. Lee's office on August 4, 1997, when he complained of worsening sinus congestion but denied having fevers. Dr. Lee's physical examination of Patient #7's nose revealed moist nasal mucosa, with erythematous, edematous turbinates; the physical examination of his lungs revealed no abnormalities. Dr. Lee noted in the medical record that she would "start IVIG monthly," and she included diagnoses of chronic sinusitis and DHI. Dr. Lee's office did not provide any medical records documenting Patient #7's August 5, 1997, office visit or the IVIG treatment for which she claimed payment from Medicaid. Patient #7 visited Dr. Lee's office on August 6, 1997, solely for an IVIG infusion. Patient #7's next visits to Dr. Lee's office were on September 2 and 3, 1997. On September 2, 1997, Patient #7 visited Dr. Lee's office for a physician office visit and the infusion of IVIG. Patient #7 reported that his "sinuses are better"; that he was "using saline nasal spray with good results"; and that he had no fevers. Dr. Lee's examination of Patient #7's nose and lungs did not reveal any abnormalities. Dr. Lee's diagnoses included chronic sinusitis and DHI. On September 3, 1997, the only service was the infusion of IVIG, and DHI was among the diagnoses noted in the medical records. Patient #7 next visited Dr. Lee's office on September 30, 1997, to receive an infusion of IVIG, and he was also examined by Dr. Lee. Patient #7 reported "great improvement in sinus congestion since start of IVIG"; Patient #7 denied having any fevers or headaches. Dr. Lee's physical examination of Patient #7's nose and lungs did not reveal any abnormalities, and her diagnoses included DHI and acute sinusitis. Patient #7 returned to Dr. Lee's office on October 1, 1997, solely for the infusion of IVIG; no diagnosis was included in the medical record of this visit. Patient #7 visited Dr. Lee's office on October 28, 1997, for a scheduled visit. He was to receive an infusion of IVIG, but this was not possible, according to Dr. Lee's notes, because of a shortage of the drug. Patient #7 reported "increased sinus congestion for past week." Dr. Lee's physical examination of Patient #7's nose revealed erythematous turbinates; the physical examination of his lungs revealed no abnormalities. Patient #7's next visit to Dr. Lee's office was a follow-up visit on November 11, 1997. Patient #7 reported no major complaints, and Dr. Lee's physical examination of his nose and lungs did not reveal any abnormalities. Neither sinusitis nor DHI was included among the diagnoses. Patient #7 also visited Dr. Lee's office on November 25, 1997, for infusion of "W/B complex." On December 9, 1997, Patient #7 visited Dr. Lee's office for a scheduled visit. He did not complain of sinus problems and denied having any fevers. Dr. Lee's physical examination of his nose and lungs did not reveal any abnormalities. On December 11 and 12, 1997, Patient #7 received only IVIG infusions at Dr. Lee's office; the diagnoses included DHI and chronic and acute sinusitis. Patient #7 also visited Dr. Lee's office on January 8, 1998, solely to receive an infusion of IVIG; the diagnoses for this visit included DHI and chronic and acute sinusitis. On January 9, 1998, Patient #7 visited Dr. Lee's office for a physician's visit and for the infusion of IVIG. The medical records reflect that Patient #7 had been hospitalized on December 23, 1997, "after an acute anterior wall mi[ocardial infarction]" and that he had developed chest pain after increasing his dosage of Zyban. Patient #7 voiced no complaints about his sinuses or lungs during this visit, and Dr. Lee's physical examination of Patient #7's nose and lungs did not reveal any abnormalities. IVIG was infused on January 9, 1998, and the diagnoses included DHI. Dr. Lee also provided medical records documenting Patient #7's office visits prior to the Audit Period to support her diagnosis of DHI: In December 1994, Patient #7 was diagnosed with sinusitis and severe bronchitis, though he denied having fevers; in June 1995, Patient #7 reported no complaints; in September 1995, Patient #7 reported that he had severe pain in his feet and hands, that a physical examination revealed that his "nasal mucosa [was] errythematous [sic], [and] slightly edematous" and that his lungs were clear; in November 1995, Patient #7 reported nasal discharge, and Dr. Lee noted that Patient #7 had chronic sinusitis "resolving with Becanase AQ spray"; in December 1995, Patient #7 reported intermittent sinus congestion but no fevers, and Dr. Lee noted that he had "[c]hronic sinusitis treated with Vancanase." There is no indication in any of the Comparative Laboratory Test Results provided by Dr. Lee's office for Patient #7 that tests were done to measure the level of Patient #7's total immunoglobulin or the level of any of the subclasses of immunoglobulin. Dr. Lee's testimony that she diagnosed Patient #7 with DHI because of his recurrent, chronic sinusitis is not supported by the information in Patient #7's medical records. First, the medical records for office visits and treatments during the Audit Period establish that Patient #7 complained only a few times of sinus congestion that responded well to other, traditional, treatments both before and after Dr. Lee began treating Patient #7 with IVIG infusions. Furthermore, except for the reported bronchitis in December 1994, there is no indication in the medical records that Patient #7 complained of or suffered from any pulmonary infections; all of the physical examinations of Patient #7's lungs done both before and during the Audit Period revealed no abnormalities. Finally, Dr. Lee testified that she based her diagnosis of DHI partly on Patient #7's complaints of headaches, but the only mention of headaches in the medical records is in the record of Patient #7's September 30, 1997, office visit, in which he denied having headaches. The medical records provided by Dr. Lee's office fail to support Dr. Lee's diagnosis of DHI and, therefore, fail to establish that the treatment of Patient #7 with IVIG infusions was medically necessary. The claims to Medicaid for the IVIG infusions given on August 5 and 6, 1997; September 2 and 3, 1997; September 30 and October 1, 1997; and January 8 and 9, 1998, should be denied. Patient #9 Dr. Lee submitted claims to Medicaid for IVIG infusions received by Patient #9 for DHI on July 16 and 17, 1996; August 14 and 15, 1996; September 16 and 17, 1996; October 10 and 11, 1996; November 6 and 7, 1996; December 4 and 5, 1996; December 26 and 27, 1996; January 16 and 17, 1997; February 10 and 12, 1997; March 10 and 11, 1997; April 7, 1997; June 10 and 11, 1997; July 10 and 11, 1997; September 18 and 19, 1997; and January 7 and 8, 1998.7 As a result of the audit, AHCA denied the Medicaid claims for these 29 IVIG infusions. At the times material to this proceeding, Patient #9 was a 30-year-old man who had been HIV positive since 1984. Dr. Lee first saw Patient #9 on May 1, 1996. In the record of Patient #9's May 1, 1996, office visit, Dr. Lee noted that he had a recent history of fungal pneumonia, which resulted from a deficiency in his cell-mediated immunity caused by HIV/AIDS. Patient #9 reported that he was experiencing some shortness of breath with a cough but no sputum, a recurrent sore throat, and chest congestion. Dr. Lee's physical examination of Patient #9's nose and lungs did not reveal any abnormalities, and Patient #9's history, as noted by Dr. Lee, did not include recurrent sinusitis or recurrent pulmonary infections. Dr. Lee diagnosed Patient #9 on May 1, 1996, with HIV/AIDS, gastritis, hypogonadism, weight loss, vitamin B12 deficiency, and fatigue. Patient #9's next office visit was on July 3, 1996, at which time Patient #9 complained of chest congestion with an unproductive cough. Dr. Lee's diagnoses at this office visit were HIV/AIDS and fever. Patient #9's next office visit was on July 15, 1996, at which time he complained of having had a fever above 100 degrees, a cough with blood in the phlegm, and increased sinus drainage. Dr. Lee's physical examination of Patient #9's nose revealed moist nasal mucosa, with erythematous, edematous turbinates; Dr. Lee's physical examination of Patient #9's lungs revealed a scattered respiratory wheeze, but no rales or rhonchi. Dr. Lee diagnosed Patient #9 with bronchitis and chronic sinusitis, and she stated in her treatment plan that she would "start IVIG Q [each] month as soon as possible." Patient #9 visited Dr. Lee's office on July 16 and 17, 1996, solely to receive infusions of IVIG. The diagnoses for these office visits included DHI, bronchitis, and chronic sinusitis. Patient #9 visited Dr. Lee's office on July 18, 1996, complaining of diarrhea, a persistent cough, and a sore throat but no sinus congestion or pulmonary problems. Dr. Lee's physical examination of Patient #9's lungs revealed "slight rhonchi left lung fields. Slight expiratory wheeze"; there is no indication that Patient #9's nose was examined. Dr. Lee saw Patient #9 for a routine office visit on August 1, 1996. Patient #9 reported that he felt fine and had had no fevers. Dr. Lee's physical examination of Patient #9's nose revealed erythematous, edematous turbinates; the examination of his lungs did not reveal any abnormalities. Dr. Lee noted in the medical records of this office visit that Patient #9 needed a full dose of IVIG in 2 weeks for sinusitis. Patient #9 received only infusions of IVIG at the office visits on August 14 and 15, 1996. At his office visit on August 29, 1996, Patient #9 reported no physical complaints, and Dr. Lee's physical examination of his nose and lungs did not reveal any abnormalities. Patient #9 received only infusions of IVIG during the office visits on September 16 and 17, 1996. Dr. Lee examined Patient #9 on September 24, 1996, as a follow-up to surgery to place a port in his chest. He complained of a cough with white sputum, but Dr. Lee's physical examination of Patient #9's nose and lungs did not reveal any abnormalities. Dr. Lee examined Patient #9 at his October 8, 1996, monthly office visit, and her physical examination of his nose and lungs did not reveal any abnormalities. Nonetheless, Dr. Lee noted that she would continue IVIG monthly. Patient #9 received infusions of IVIG at office visits on October 10 and 11, 1996. On October 29, 1996, Dr. Lee saw Patient #9 at her office for a sick visit and a post-hospital visit. Patient #9 complained of congestion and fevers. Dr. Lee's physical examination of Patient #9's nose revealed moist nasal mucosa, with erythematous turbinates; the physical examination of his lungs did not reveal any abnormalities, although an occasional expiratory wheeze was noted. Dr. Lee's diagnoses included chronic sinusitis and acute sinusitis. Patient #9 returned to Dr. Lee's office on November 6 and 7, 1996, solely to receive infusions of IVIG. Dr. Lee examined Patient #9 on November 19, 1996, and there were no abnormalities of the nose and the lungs noted. Patient #9 was treated with an IVIG and Vitamin C infusions on December 4, 1996; he received no other service. The next office visit documented by the medical records provided by Dr. Lee's office was on July 11, 1997, when Patient #9 visited Dr. Lee's office solely for the infusion of IVIG. Patient #9 also visited Dr. Lee's office on August 14, 1997, for a sick visit, when he reported that he was feeling well but was concerned about his quality of life. Dr. Lee's physical examination of Patient #9's nose and lungs did not reveal any abnormalities. Dr. Lee appended the following note to the record of the office visit of August 14, 1997: "Schedule IVIG as soon as possible in light of worsening bleeding gums and rectal bleeding." Patient #9 visited Dr. Lee's office on August 18 and 19, 1997, and on September 18 and 19, 1997, to receive infusions of IVIG. Dr. Lee also saw Patient #9 on September 19, 1997, when Patient #9 reported that he was feeling fairly well, with no fevers or cough. Dr. Lee's physical examination of Patient #9's nose and lungs did not reveal any abnormalities. On September 30, 1997, Patient #9 visited Dr. Lee's office to have a molluscum removed from his face. Patient #9 reported that he was feeling well, with no fevers. Dr. Lee's physical examination of Patient #9's nose and lungs did not reveal any abnormalities. On October 6, 1997, Patient #9 visited Dr. Lee's office for a sick visit. He complained of fever with nasal and chest congestion, sinus congestion for the previous two days, and sneezing clear fluid. Dr. Lee's physical examination of Patient #9's nose revealed moist nasal mucosa, with erythematous turbinates; the physical examination of the lungs did not reveal any abnormalities. Dr. Lee's diagnoses did not include DHI or sinusitis but only HIV/AIDS and "URI." Patient #9 visited Dr. Lee's office on October 16 and 17, 1997, solely for the infusion of IVIG, and the diagnoses for these visits include DHI and chronic and acute sinusitis. Patient #9 visited Dr. Lee's office on October 31, 1997, for a scheduled visit. He reported feeling well, with no fevers; Dr. Lee's physical examination of Patient #9's nose and lungs did not reveal any abnormalities. Patient #9 visited Dr. Lee's office on December 15, 1997, for a doctor's visit and for the infusion of IVIG. Patient #9 reported a tight feeling in his chest with a sore throat and a dry cough for the previous six days. Dr. Lee's physical examination of Patient #9's nose and lungs did not reveal any abnormalities. Patient #9 visited Dr. Lee's office on December 30, 1997, for a "laboratory review." He complained of joint and muscle aches and burning on urination. Dr. Lee's physical examination of Patient #9's nose and lungs did not reveal any abnormalities. Patient #9 visited Dr. Lee's office on January 7 and 8, 1998, for the infusion of IVIG. Dr. Lee also examined Patient #9 on January 8, 1998, at which time he reported that he was feeling fairly well but had esophageal pain. Dr. Lee's physical examination of Patient #9's nose and lungs did not reveal any abnormalities. There is no indication in any of the Comparative Laboratory Test Results provided by Dr. Lee's office for Patient #9 that tests were done to measure the level of Patient #9's total immunoglobulin or the level of any of the subclasses of immunoglobulin. The medical records provided by Dr. Lee do not support her testimony that she prescribed IVIG for Patient #9 because of recurrent sinusitis and bronchitis. Dr. Lee formulated the plan to treat Patient #9 with monthly infusions of IVIG on July 15, 1996, at the time of his third office visit. At that visit, Dr. Lee observed that Patient #9 had a productive cough with flecks of blood and increased sinus drainage, but there is nothing in the records of his May 1, 1996, or July 3, 1996, office visits to indicate that he had sinusitis or bronchitis or anything more than one episode of fungal pneumonia unrelated to DHI. Most of Dr. Lee's physical examinations revealed no abnormalities in Patient #9's nose and lungs, and, contrary to Dr. Lee's testimony, there is nothing in Patient #9's medical records to establish that Patient #9 had a history of recurrent purulent drainage, bloody nose, congestion, or bronchitis. Rather, the medical records for Patient #9 indicate that he was in the advanced stage of AIDS at the time of his first visit to Dr. Lee and that he suffered from numerous infections related to a deficiency of cell-mediated immunity; that he complained of congestion periodically and had a non-productive cough from time to time; that he occasionally had erythematous, edematous nasal turbinates; and that, at a few office visits, Dr. Lee's physical examinations revealed an occasional respiratory wheeze in the lungs. These symptoms are not sufficient to support a diagnosis of DHI, and, therefore, the medical records provided by Dr. Lee's office fail to establish that the infusion of IVIG was medically necessary.8 The claims to Medicaid for the IVIG infusions given on July 16 and 17, 1996; August 14 and 15, 1996; September 16 and 17, 1996; October 10 and 11, 1996; November 6 and 7, 1996; December 4, 1996; June 11, 1997; July 11, 1997; September 18 and 19, 1997; and January 7 and 8, 1998, should be denied because the treatments were not medically necessary. Dr. Lee also submitted claims to Medicaid for infusions of IVIG that purportedly were done on December 5, 1996; December 26 and 27, 1996; January 16 and 17, 1997; February 10 and 12, 1997; April 7, 1997; June 10, 1997; and July 10, 1997. Dr. Lee's office did not provide any medical records to document that IVIG was infused on these dates. Accordingly, Dr. Lee is not entitled to payment for the infusion of IVIG on these dates because of this lack of documentation.9 Patient #13 Dr. Lee submitted claims to Medicaid for IVIG infusions received by Patient #13 for DHI on August 22 and 23, 1996; September 16 and 17, 1996; October 28 and 29, 1996; November 26 and 27, 1996; January 6 and 7, 1997; February 6 and 7, 1997; March 14, 1997; April 8 and 11, 1997; May 12 and 15, 1997; June 10, 1997; July 8 and 9, 1997; August 12 and 13, 1997; and September 10, 1997.10 As a result of the audit, AHCA denied the Medicaid claims for these 23 IVIG infusions. At the times material to this proceeding, Patient #13 was a 39-year-old man who had been diagnosed with HIV/AIDS. The medical records provided by Dr. Lee's office show that Dr. Lee first examined Patient #13 during an office visit on July 26, 1996, when Patient #13 complained of severe fatigue and mild headaches. Dr. Lee's physical examination of Patient #13's nose and lungs did not reveal any abnormalities. Not including the office visits during which Patient #13 received only infusions of IVIG, Patient #13 visited Dr. Lee's office and was examined on August 2 and 20, 1996; September 5 and 24, 1996; October 1 and 24, 1996; November 12, 19, and 26, 1996; December 9, 1996; January 24 and 27, 1997; February 6, 11, and 25, 1997; March 25, 1997; April 15 and 29, 1997; May 20, 1997; June 3 and 24, 1997; July 22, 28, and 31, 1997; August 14 and 18, 1997; September 15 and 29, 1997; October 13, 1997; and November 6 and 20, 1997. On September 24, 1996, Patient #13 complained of headaches, fullness in his ears, and a cough with yellow sputum. On November 12, 1996, Patient #13 complained of an increase in post-nasal drip. On November 26, 1996, Patient #13 reported that he had a cold, with no fever or chills. On February 6, 1997, Patient #13 advised Dr. Lee that he was going to an ear, nose, and throat specialist for hearing tests. On February 25, 1997, Patient #13 reported that he had "sinus symptoms" before his monthly IVIG infusion that were resolved after the second infusion. On July 28 1997, Patient #13 was diagnosed and treated for an infection around the port inserted into his chest; he was also treated on July 31, 1997, and on August 14 and 18, 1997, for the chest-port infection, and the chest port was flushed on September 29, 1997. Dr. Lee's physical examinations of Patient #13's nose on September 24, 1996, and on November 26, 1996, revealed moist nasal mucosa with erythematous turbinates; the physical examinations of Patient #13's lungs on these dates did not reveal any abnormalities. Dr. Lee's physical examinations of Patient #13's nose and lungs conducted at all of the other office visits revealed no abnormalities. There is no indication in any of the Comparative Laboratory Test Results provided by Dr. Lee's office for Patient #13 that tests were done to measure the level of Patient #13's total immunoglobulin or the level of any of the subclasses of immunoglobulin. The medical records provided by Dr. Lee's office do not support her diagnosis that Patient #13 suffered from DHI. None of Dr. Lee's examinations of Patient #13's lungs indicated that that she found any abnormalities, and her physical examinations of Patient #13's nose revealed no abnormalities except on September 24, 1996, and on November 11, 1996, when Dr. Lee found that Patient #13 had erythematous turbinates. Although the medical records do establish that Patient #13 had recurrent infections and extremely low T-cell levels, a diagnosis of DHI must be supported by severe, chronic sinopulmonary infections and low levels of total immunoglobulin or of any of the five subclasses of immunoglobulins. The symptoms and complaints reported by Dr. Lee are not sufficient to support Dr. Lee's diagnosis that Patient #13 suffered from DHI, and, therefore, the medical records provided by Dr. Lee's office fail to establish that the infusion of IVIG was medically necessary. The claims to Medicaid for the IVIG infusions given on August 22 and 23, 1996; September 16 and 17, 1996; October 28 and 29, 1996; November 26 and 27, 1996; January 6 and 7, 1997; February 6 and 7, 1997; March 14, 1997; April 8 and 11, 1997; May 12 and 15, 1997; June 10, 1997; July 8 and 9, 1997; August 12 and 13, 1997; and September 10, 1997, should be denied. The records provided to AHCA include a claim that was submitted to Medicaid for an infusion of IVIG that was purportedly done on June 9, 1997. Dr. Lee's office did not provide any medical records to document that Patient #13 received an infusion of IVIG on this date, and, accordingly, Dr. Lee is not entitled to payment for an infusion of IVIG on June 9, 1997. Patient #15 According to the medical records provided by her office, Dr. Lee treated Patient #15 with IVIG for DHI on February 27 and 28, 1997. As a result of the audit, AHCA denied the Medicaid claims for these 2 IVIG infusions. At the times material to this proceeding, Patient #15 was a 39-year-old female who had been HIV positive since 1991. The medical records provided by Dr. Lee's office establish that Dr. Lee examined Patient #15 once, on January 7, 1997. At that visit, Patient #15 complained of headaches associated with sinus congestion and shortness of breath, which were relieved with nasal steroids. Patient #15 denied that she had fevers, a cough, or sputum production. Dr. Lee's physical examination of Patient #15's nose revealed moist nasal mucosa, with erythematous, edematous turbinates. Dr. Lee's physical examination of Patient #15's lungs revealed no abnormalities. Patient #15 provided Dr. Lee with a history at the January 7, 1997, office visit that included chronic "sinusitis with headaches," but there is no documentation to support this history. Dr. Lee did not include a diagnosis of DHI, but she did recommend treatment for Patient #15 with IVIG "for chronic sinusitis and DHI." Dr. Lee submitted claims to Medicaid for the treatment of Patient #15 with infusions of IVIG on February 27 and 28, 1997, but Dr. Lee's office did not produce any medical records to establish that Patient #15 actually received the infusions. Accordingly, Dr. Lee is not entitled to payment for the infusions of IVIG on these dates. Patient #16 Dr. Lee submitted claims to Medicaid for IVIG infusions received by Patient #16 for DHI on September 3 and 4, 1996; October 2 and 3, 1996; November 4 and 5, 1996; December 9 and 10, 1996; January 7, 1997; February 10 and 11, 1997; and March 17, 1997.11. As a result of the audit, AHCA denied the Medicaid claims for these 12 IVIG infusions. At the times material to this proceeding, Patient #16 was a 35-year-old male who had been HIV positive since 1989. According to notes made by Dr. Lee, she first saw Patient #16 in February 1995, and the first office visit documented by the medical records provided by Dr. Lee's office was on February 9, 1995, which is not within the Audit Period. In the record of that visit, Dr. Lee noted no past history of sinopulmonary infections, and her physical examination of Patient #16's nose and lungs revealed no abnormalities.12 At an office visit on November 27, 1995, Patient #16 complained of "cough, greenish sputum, increased congestion in the sinus region and sinus headaches," but he reported only a low-grade fever. Dr. Lee's physical examination of Patient #16's nose revealed that his nasal mucosa were moist but extremely erythematous and edematous and that there was a "slight increase in nasal discharge"; Dr. Lee's physical examination of Patient #16's lungs revealed that the "[l]ung sounds are clear to auscultation with some scattered faint rhonchi." Sinusitis was included among Dr. Lee's diagnoses, and she prescribed the antibiotic Biaxin, to be taken for 10 days. Patient #16 visited Dr. Lee's office on December 12, 1995. He complained of increased nasal discharge that was clear, and Dr. Lee's physical examination of Patient #16's nose revealed erythematous nasal mucosa, with a "slight increase in post nasal discharge which is clear." Dr. Lee's physical examination of Patient #16's lungs revealed no abnormalities. Dr. Lee's diagnoses included "[m]ild sinusitis, noninfective. Probably allergic rhinitis," and she prescribed Claritin D. Patient #16 visited Dr. Lee's office on January 8, 1996, which is the first documented office visit of the Audit Period. Although Patient #16 did not complain of sinus problems, Dr. Lee's physical examination of Patient #16's nose revealed erythematous nasal mucosa; the physical examination of Patient #16's lungs revealed that they were "clear to auscultation." An X-ray taken on January 9, 1996, indicated that Patient #16's lungs were clear, and a CT scan of Patient #16's head taken the same day was normal. At an office visit on January 15, 1996, Patient #16 complained of a clogged feeling in his ears and increased sinus congestion. Dr. Lee's physical examination of Patient #16's nose revealed that the "[n]asal mucosa is erythematous with edematous turbinates"; the lungs were "clear to auscultation." Dr. Lee's diagnoses on January 8, 1996, did not include sinusitis, but the diagnoses on January 15, 1996, included chronic sinusitis. Dr. Lee examined Patient #16 on February 26, 1996, and on March 18, 1996. Patient #16 did not complain of any sinopulmonary problems at these office visits, and Dr. Lee's physical examination of Patient #16's nose and lungs revealed no abnormalities. On April 19, 1996, Dr. Lee completed a form in which she identified Patient #16's diagnoses as including chronic sinusitis, reported that his medical history included chronic sinusitis and DHI, and indicated that Patient #16's treatment included IVIG "once a month." Patient #16 received infusions of IVIG at Dr. Lee's office on June 11 and 12, 1996, but Patient #16 furnished the IVIG, and Dr. Lee did not submit claims to Medicaid for these infusions. Patient #16 visited Dr. Lee's office on June 17, 1996, and reported that his sinuses were "less bothersome" since IVIG treatments had been "restarted." Dr. Lee's physical examination of Patient #16's nose and lungs revealed no abnormalities; Dr. Lee's diagnoses did not include sinusitis or DHI. Patient #16 received infusions of IVIG at Dr. Lee's office on July 8 and 9, 1996, and on August 5 and 6, 1996, but Dr. Lee did not submit claims to Medicaid for these infusions. Dr. Lee also examined Patient #16 on August 6, 1996, and he complained of a sore throat and fever but no cough. Dr. Lee's physical examination of Patient #16's nose and lungs revealed no abnormalities. Patient #16 received infusions of IVIG at Dr. Lee's office on September 3 and 4, 1996. During the September 3, 1996, office visit, Dr. Lee also examined Patient #16. Patient #16 had no complaints about his sinuses, and the report of a chest X-ray taken that day revealed that Patient #16's lungs and pleural spaces were clear. Dr. Lee's physical examination of Patient #16's nose and lungs revealed no abnormalities. At office visits on September 9 and 24, 1996, Patient #16 had no complaints about his sinuses, and Dr. Lee's physical examinations of Patient #16's nose and lungs revealed no abnormalities. Dr. Lee noted in the treatment plan developed September 24, 1996, that she would "continue IVIG monthly for chronic sinus complaints." Patient #16 received infusions of IVIG at Dr. Lee's office on October 2 and 3, 1996; November 4 and 5, 1996; and December 9 and 10, 1996. Dr. Lee examined Patient #16's nose and lungs on October 3, 1996; November 8, 1996, November 22, 1996; and December 10, 1996. Even though Patient #16 did not complain of sinus problems during the November 22, 1996, office visit, Dr. Lee noted that she would continue to treat Patient #16 with IVIG monthly, but Dr. Lee did not include in the diagnoses for that visit a diagnosis of sinusitis or of DHI. The physical examinations performed by Dr. Lee on all but one of these office visits revealed no abnormalities. During the December 10, 1996, office visit, Patient #16 complained of some increase in sinus pressure with ringing in his ears; Dr. Lee's physical examination revealed that Patient #16's nose had "moist nasal mucosa with erythematous turbinates" and increased nasal discharge that was yellowish- green in color. Dr. Lee's physical examination of his lungs revealed no abnormalities. Dr. Lee submitted claims to Medicaid for IVIG infusions given to Patient #16 on January 7, 1997; February 10 and 11, 1997; and March 17, 1997. Dr. Lee also examined Patient #16 on January 7, 1997, January 20, 1997; February 3, 1997; February 11, 1997; and March 13, 1997. Dr. Lee's physical examination of Patient #16's nose on January 7, 1997, moist nasal mucosa, with erythematous, edematous turbinates, and Dr. Lee's physical examination of Patient #16's lungs during that office visit revealed no abnormalities. On January 20, 1997, Patient #16 reported continued "sinusitis," and Dr. Lee's physical examination of Patient #16's nose on January 20, 1997, revealed that moist nasal mucosa, but with only slightly erythematous turbinates; Dr. Lee's physical examination of Patient #16's lungs on January 20, 1997, revealed no abnormalities. Dr. Lee's physical examinations of Patient #16's nose and lungs on February 3 and 11, 1997, and on March 13, 1997, revealed no abnormalities. Dr. Lee continued to see Patient #16 after March 17, 1997, the date of the last IVIG infusion for which Dr. Lee submitted a claim to Medicaid. On April 3, 1997, Dr. Lee's physical examination of Patient #16's nose revealed moist nasal mucosa, with erythematous turbinates and a large amount of whitish nasal discharge; Dr. Lee's physical examination of Patient #16's lungs revealed no abnormalities. Dr. Lee noted in the medical record of an office visit by Patient #16 on May 1, 1997, that Patient #16's sinus congestion had improved "with IVIG and Claritin D"; Dr. Lee's physical examination of Patient #16's nose and lungs revealed no abnormalities. Dr. Lee noted in the medical record of an office visit by Patient #16 on June 17, 1997, that Patient #16 continued to have sinus drainage, but she attributed this to an error by the pharmacy in giving Patient #16 Claritin Plain rather than Claritin D, resulting in Patient #16's not having taken a decongestant for the previous few weeks. Even so, Dr. Lee's physical examination of Patient #16's nose and lungs revealed no abnormalities. Patient #16 complained of sinus congestion during office visits to Dr. Lee on June 30, 1997; July 15, 1997; and August 12, 1997. The medical record for the August 12, 1997, office visit reflects that Patient #16 reported that his sinus congestion was worsening and that he had had a cough with yellowish sputum for the previous week; Dr. Lee's physical examination of Patient #16 on August 12, 1997, revealed that Patient #16 had moist nasal mucosa, with erythematous, edematous turbinates, and that the breath sounds in Patient #16's lungs were "mildly rhonchorous to auscultation bilaterally, no rales, occasional expiratory wheeze." Patient #16 reported no sinus problems at his visit to Dr. Lee's office on August 29, 1997, and Dr. Lee's physical examination of his nose and lungs revealed no abnormalities. There is no indication in any of the Comparative Laboratory Test Results provided by Dr. Lee's office for Patient #16 that tests were done to measure the level of Patient #16's total immunoglobulin or the level of any of the subclasses of immunoglobulin. The medical records provided by Dr. Lee's office do not support her diagnosis that Patient #16 suffered from DHI. Although Patient #16 routinely complained of sinus congestion from his first documented visit to Dr. Lee on February 9, 1995, through the last documented visit on August 29, 1997, Dr. Lee's medical records contained a diagnosis of acute sinusitis only six times during the Audit Period, on November 4 and 5, 1996, when Patient #16 was not examined but only received infusions of IVIG at Dr. Lee's office; on December 10, 1996, when Patient #16 reported sinus pressure, and Dr. Lee observed a yellowish-green nasal discharge; on March 17, 1997, when Patient #16 was not examined but only received an infusion of IVIG at Dr. Lee's office; on April 3, 1997, when Dr. Lee observed a large amount of whitish nasal discharge; and on August 12, 1997, when Patient #16 reported a cough with yellowish-green sputum. Dr. Lee's notes reflect, however, that Patient #16's sinus congestion was improved when he took a decongestant. Even if these instances of sinusitis could be termed severe and recurrent, there is no evidence in the medical records provided by Dr. Lee's office that Patient #16 suffered from severe, recurrent pulmonary infections. In fact, Dr. Lee's physical examinations of Patient #16's lungs revealed abnormalities only on August 12, 1997, when she observed an occasional expiratory wheeze and mildly rhonchorous breath sounds. Dr. Lee's medical records fail to establish that Patient #16 suffered from the severe, chronic sinopulmonary infections necessary to support a diagnosis of DHI or to establish that Patient #16 had the low levels of total immunoglobulin or of any of the five subclasses of immunoglobulin that are also necessary to support a diagnosis of DHI. Therefore, the medical records provided by Dr. Lee's office fail to establish that the infusion of IVIG was medically necessary, and the claims to Medicaid for the IVIG infusions given on September 3 and 4, 1996; October 2 and 3, 1996; November 4 and 5, 1996; December 9 and 10, 1996; January 7, 1997; February 10 and 11, 1997; and March 17, 1997, should be denied. Patient #21 Dr. Lee submitted claims to Medicaid for IVIG infusions received by Patient #21 for DHI on February 11 and 12, 1997; March 17 and 18, 1997; and April 16, 1997.13 As a result of the audit, AHCA denied the Medicaid claims for these five IVIG infusions. At the times material to this proceeding, Patient #21 was a 38-year-old male who reported that he had contracted HIV in the 1970's. The medical records provided by Dr. Lee's office contain the Progress Report of an emergency visit to Patient #21 on April 29, 1996, by Dr. Allan J. Stein. Dr. Stein noted in the Progress Report that he had first seen Patient #21 on July 7, 1995, and then at a follow-up visit on July 17, 1995, but that he had not seen Patient #21 again until the April 29 1996, visit. Patient #21 reported to Dr. Stein on April 29, 1996, that he had had seven or eight episodes of bronchitis between August and November 1995, while he was living in Tampa, Florida; that he had not received regular medical care while living in Tampa; and that he had been treated for bronchitis with multiple courses of Zithromax prescribed at a hospital emergency room in Tampa. Patient #21 also reported to Dr. Stein that he had been treated by a "Dr. Elbert" in Tampa and had been diagnosed with pneumonia four times between January and April 1996, which was treated each time with various antibiotics. Patient #21 also reported to Dr. Stein that he had never had a bronchoscopy and that he smoked at least one pack of cigarettes per day. The physical examination of Patient #21's nose and lungs performed by Dr. Stein on April 19, 1996, did not reveal any abnormalities. Dr. Stein recommended that Patient #21 arrange to be seen by Dr. Lee because her office was closer to Patient #21's residence than Dr. Stein's, and Dr. Stein ordered a chest X-ray. The report of a chest X-ray signed by Stephen Edelstein, M.D., on July 29, 1996, indicated that Patient #21's lungs were clear and that his chest was normal. Dr. Lee conducted a 23-hour observation of Patient #21 at Pompano Beach Medical Center August 5, 1996, and Dr. Lee noted in the report of that observation that Patient #21 had been "complaining intermittently for the past month of shortness of breath, fevers and chills, [and] sinus congestion." Patient #21 also reported to Dr. Lee on August 5, 1996, that he had chronic bronchitis that usually occurred in the spring and summer of each year. Dr. Lee's physical examination of Patient #21 revealed that he had "tender sinuses in the frontal and bilateral maxillary sinuses," and her physical examination of Patient #21's lungs indicated that they were "[c]lear to auscultation with slightly prolonged expiratory phase. No rhonchi, rales or wheezes." Dr. Lee's diagnoses included "[a]cute severe sinusitis versus bronchitis."14 Patient #21's medical records also include an incomplete report of a consultation with Peter Namnum, M.D., on August 20, 1996,15 in which Dr. Namnum stated that Patient #21 had been ill for the previous six weeks, reporting sweats, fever, chills, and hot flashes, with a cough productive of green sputum and about a tablespoon of blood each day. Dr. Namnum noted that Patient #21 was admitted to Pompano Beach Medical Center about two weeks prior to the consultation and was treated with "broad spectrum intravenous antibiotics" but showed no improvement. Dr. Namnum also reported that Dr. Lee had treated Patient #21 with multiple courses of outpatient antibiotics but that Patient #21 had not responded. Patient #21's first documented visit to Dr. Lee's office was on December 6, 1996, at which time Patient #21 reported symptoms of a cold, with a cough, stuffy head, and congestion but no fever. Dr. Lee's physical examination of Patient #21's nose and lungs revealed no abnormalities. Dr. Lee's diagnoses included "allergic rhinitis." Patient #21 next visited Dr. Lee's office on January 3, 1997, complaining of an ear infection. Dr. Lee observed some congestion in Patient #21's ears, but Dr. Lee's physical examination of Patient #21's nose and lungs revealed no abnormalities. Dr. Lee's diagnoses, however, included chronic sinusitis and allergic rhinitis. Dr. Lee changed Patient #21's prescription from Claritin to Claritin D. On January 21, 1997, Patient #21 visited Dr. Lee's office and reported that he had had a fever of 102 degrees, chills, sweats, nausea, vomiting, a productive cough with green sputum, and wheezes on inspiration and expiration. Patient #21's temperature at the time of the office visit was recorded as 95.8 degrees. Dr. Lee's physical examination of Patient #21's nose revealed no abnormalities, but the physical examination of Patient #21's lungs revealed "scattered wheezes and rhonchi, no rales." Dr. Lee prescribed Rocephin, and her diagnoses included bronchitis, acute sinusitis, and allergic rhinitis. Patient #21 received an infusion of IVIG at Dr. Lee's office on February 11, 1997, at which time he was distraught, complaining of pain "everywhere," and demanding pain medication. Dr. Lee's physical examination of Patient #21 revealed no abnormalities, although the diagnoses for the February 11, 1997, visit included DHI and chronic sinusitis. Patient #21 also received an infusion of IVIG on February 12, 1997, at which time he reported to Dr. Lee that he felt relief after his first dose of IVIG; no physical examination was done during this visit. The diagnoses for the February 12, 1997, visit included DHI, chronic sinusitis, and acute sinusitis. Patient #21 was infused with IVIG at Dr. Lee's office on March 17 and 18, 1997, and on April 16, 1997. The diagnoses for each visit included acute sinusitis, chronic sinusitis, and DHI. There is, however, no record that Dr. Lee performed any examinations of Patient #21 on those dates. Patient #21's last documented office visit was on August 12, 1997. He reported the "usual summer bronchitis" and a cough with clear sputum. Dr. Lee's physical examination of Patient #21's nose revealed moist nasal mucosa, with erythematous, edematous turbinates; the physical examination of Patient #21's lungs revealed no abnormalities. Patient #21 received an infusion of IVIG on August 12, 1997, and the diagnoses included DHI, bronchitis, acute sinusitis, and chronic sinusitis, and Dr. Lee noted that she would continue IVIG monthly. There is no indication in any of the Comparative Laboratory Test Results provided by Dr. Lee's office for Patient #21 that tests were done to measure the level of Patient #21's total immunoglobulin or the level of any of the subclasses of immunoglobulin. Dr. Stein noted that Patient #21's "past medical problems" included negative CMV and toxoid IgG titers, but this was not confirmed by any laboratory tests ordered by Dr. Lee at or about the time she commenced infusion of IVIG. The medical records do not support Dr. Lee's diagnosis that Patient #21 suffered from DHI because there is no documentation of severe, recurrent sinopulmonary infections and low levels of total immunoglobulin or of one of the five subclasses of immunoglobulin. Although Patient #21 reported a history of bronchitis and pneumonia and complained routinely of a cough, the chest X-ray done in July 1996 revealed that his lungs were clear, and abnormalities in Patient #21's lungs were noted on only two occasions, on August 5, 1996, and on January 21, 1997, when wheezing was noted. On August 12, 1997, when Patient #21 reported a cough and his "usual" summer bronchitis, Dr. Lee's physical examination of Patient #21's lungs revealed no abnormalities. Even if the two instances in which Dr. Lee found abnormalities in Patient #21's lungs could be considered indicative of severe, recurrent pulmonary infections, the medical records fail to establish that Patient #21 suffered from severe, chronic sinusitis. The physical examinations done by Dr. Lee establish only that, on August 5, 1996, Patient #21 had tender sinuses and that, on August 12, 1997, four months after the last documentation of an infusion of IVIG, Patient #21 had erythematous, edematous turbinates. The medical records of Patient #21's January 21, 1997, office visit, which took place only a few weeks before the first infusion of IVIG, do not reflect that Patient #21 complained of sinus congestion, and Dr. Lee's physical examination of Patient #21's nose done at that office visit revealed no abnormalities. The medical records provided by Dr. Lee's office, therefore, fail to establish that the infusion of IVIG was medically necessary, and the claims to Medicaid for the IVIG infusions given on February 11 and 12, 1997; March 17 and 18, 1997; and April 16, 1997, should be denied. Patient #24 Dr. Lee submitted claims to Medicaid for IVIG infusions received by Patient #24 on January 9 and 10, 1997; February 6 and 7, 1997; March 6 and 7, 1997; April 7 and 8, 1997; June 16 and 17, 1997; July 14 and 15, 1997; August 11 and 12, 1997; September 8 and 9, 1997; and January 6 and 7, 1998, for DHI and demyelinating neuropathy.16 As a result of the audit, AHCA denied the Medicaid claims for these 18 IVIG infusions. At the times material to this proceeding, Patient #24 was a 32-year-old male who reported that he had been HIV positive since March 1989. Patient #24's first documented office visit to Dr. Lee was on October 7, 1996. Demyelinating neuropathy On October 7, 1996, Dr. Lee noted that Patient #24 complained of "pain c/o neuropathy bilaterally in lower and upper extremities," and she determined that Patient #24 had "moderately severe peripheral neuropathy," with occasional joint pain.17 Dr. Lee's physical examination of Patient #24 revealed that his reflexes were "equal bilaterally upper and lower extremities" and that his "motor/strength" was "4/5 throughout." Dr. Lee did not include neuropathy (diagnosis code 355.9) or demyelinating neuropathy (diagnosis code 357.0) as diagnoses for the October 7, 1996, office visit. Dr. Lee's medical records for Patient #24 include diagnoses of neuropathy for seven office visits between February 11, 1997, and November 21, 1997; for each of the diagnoses, Dr. Lee included the diagnosis code for neuropathy, "355.9," rather than the diagnosis code for demyelinating neuropathy, "357.0." On February 11, 1997, Patient #24 complained of "tingling and numbness in lower extremities that sometimes extends upwards; Dr. Lee noted "neuropathy persists, tolerable." There is no indication in the medical records of Patient #24's April 14, 1997, office visit that he complained of or exhibited symptoms of neuropathy or that Dr. Lee's physical examination of Patient #24 revealed any indication of neuropathy. On July 7, 1997, during a scheduled visit, Patient #24 reported "infrequent episodes of generalized muscle twitching with a feeling of weakness and feeling as though he were going to pass out." The symptoms Patient #24 described included "intermittent episodes of twitching, shaking 'inside'. Feet continue to hurt intermittently." Dr. Lee noted that Patient #24 was to continue to receive IVIG monthly. On September 2, 1997, Patient #24 reported that he had "moderately severe episodes of neuropathy in hands and feet" and that he felt "quite well" except for occasional "pain and persistent neuropathy." At Patient #24's scheduled office visit on October 14, 1997, Dr. Lee noted: "Neuropathy severe, slightly improved since start of IVIG . . . However, sometimes feels as if his feet are 'dead.'" Patient #24 received an infusion of IVIG at Dr. Lee's office on November 3, 1997; Dr. Lee did not examine Patient #24 during this office visit.18 At Patient #24's scheduled office visit on November 21, 1997, he reported "no major complaints," and Dr. Lee noted that he had "only minimal discomfort from neuropathy." Dr. Lee stated that she "would continue IVIG when available." Dr. Lee first diagnosed Patient #24 with demyelinating neuropathy at Patient #24's office visit on January 6, 1998, when Patient #24 received an infusion of IVIG and was examined by Dr. Lee. Dr. Lee did not note in the record of this office visit any complaints or symptoms of demyelinating neuropathy or neuropathy. The diagnosis of demyelinating neuropathy was also included in the diagnoses for Patient #24's January 7, 1998, office visit, but the only service he received on this date was the infusion of IVIG. There is no indication in the medical records provided by Dr. Lee's office that a nerve conduction study and a neurological study were conducted to confirm Dr. Lee's diagnosis that Patient #24 suffered from general neuropathy or demyelinating neuropathy. And, even if Dr. Lee's diagnosis of neuropathy were supported in the medical records, the treatment of peripheral neuropathy by infusions of IVIG is not medically necessary. General neuropathy involving the disruption in the peripheral nervous system does not respond to IVIG. Only neuropathy that involves the loss of or damage to the myelin sheath around the nerves, or demyelinating neuropathy, improves with IVIG treatments. Dr. Lee stated in the medical records of her first visit with Patient #24 that he exhibited the symptoms of "moderately severe peripheral neuropathy," and, without a nerve conduction study and neurological evaluation to confirm a diagnosis of demyelinating neuropathy, there is no medical necessity for Patient #24's IVIG treatments for neuropathy. DHI Patient #24 did not report any complaints or symptoms of sinusitis or pulmonary infection at his first office visit to Dr. Lee on October 7, 1996. He denied fevers, headaches, chest pain, and shortness of breath, although he did report "occasional cough, wheezing, dyspnea, and slight sputum production." Dr. Lee noted that Patient #24's history included chronic "environmental allergies." Dr. Lee's physical examination of Patient #24's nose revealed no abnormalities, and Dr. Lee's physical examination of Patient #24' lungs revealed that they were "clear to auscultation." Dr. Lee included "allergic rhinitis" as one of the diagnoses for the October 7, 1996, office visit. Dr. Lee examined Patient #24 on December 31, 1996, at a scheduled office visit. Patient #24 complained of "severe sinus congestion, worse over past few weeks," but he denied any sputum production. Dr. Lee's physical examination of Patient #24's nose revealed moist nasal mucosa, with "extremely" erythematous, edematous turbinates; the physical examination of Patient #24's lungs revealed no abnormalities. Dr. Lee included among the diagnoses for the December 31, 1996, office visit chronic sinusitis and DHI, and she noted that she would "start monthly IVIG for treatment of chronic sinusitis and decreased humoral immunity." Patient #24 received his first infusions of IVIG on January 9 and 19, 1997; Dr. Lee did not examine Patient #24 during either of these office visits. Patient #24's next office visits were on February 6 and 7, 1997, during which he only received infusions of IVIG. The diagnoses for February 6, 1997, included DHI and acute sinusitis; the diagnoses for February 7, 1997, included DHI. Patient #24 saw Dr. Lee for a scheduled office visit on February 11, 1997, when Dr. Lee noted that Patient #24's "sinus symptoms [were] improved." Dr. Lee's physical examination of Patient #24's nose and lungs revealed no abnormalities. Dr. Lee included DHI and chronic sinusitis among the diagnoses for the February 7, 1997, office visit. Patient #24 received infusions of IVIG at Dr. Lee's office on March 6 and 7, 1997. Dr. Lee did not examine Patient #24 during these visits, but chronic sinusitis and DHI were included among the diagnoses. Dr. Lee examined Patient #24 during an office visit on March 11, 1997, when he complained of neuropathy and diarrhea. There is no indication in the records of this office visit that Patient #24 complained of or had symptoms of sinusitis or pulmonary infection, and Dr. Lee's physical examination of Patient #24's nose and lungs revealed no abnormalities. Patient #24 received infusions of IVIG at Dr. Lee's office on April 7 and 8, 1997. Dr. Lee did not examine Patient #24 during these office visits. Dr. Lee did, however, examine Patient #24 during an office visit on April 14, 1997, and she noted that Patient #24 complained of cold symptoms affecting mainly his chest but denied that he had a fever with the cold. Dr. Lee also noted that Patient #24 "does continue to smoke cigarettes." Dr. Lee's physical examination of Patient #24's nose revealed moist nasal mucosa, with erythematous, edematous turbinates; the physical examination of Patient #24's lungs revealed no abnormalities. Dr. Lee included DHI and allergic rhinitis among the diagnoses for this office visit. Patient #24 visited Dr. Lee's office on May 2, 1997, complaining of a body rash that began after he swam in the ocean. Dr. Lee's physical examination of Patient #24's nose and lungs revealed no abnormalities, and the diagnoses for this office visit included dermatitis and muscle spasm. Patient #24 received infusions of IVIG during office visits on May 5 and 6, 1997. Dr. Lee did not examine Patient #24 during either of these office visits, but he reported on May 5, 1997, that his rash had worsened. The diagnoses for the May 5 and 6, 1997, office visits included DHI and DHI, acute sinusitis, and chronic sinusitis, respectively. Dr. Lee examined Patient #24 on May 8, 1997, when he visited her office for a sick visit and follow-up. Patient #24 reported that the body rash was worsening and that he had slight shortness of breath and a slight cough. Dr. Lee's physical examination of Patient #24's lungs revealed no abnormalities, and Dr. Lee's diagnoses did not include DHI. Patient #24 visited Dr. Lee's office again on May 13, 1997, for treatment of the rash, which Dr. Lee reported was worsening, with lesions appearing in Patient #24's nose and ears. Dr. Lee's physical examination of Patient #24's nose revealed moist nasal mucosa, with "ulcerations bilateral nares"; Dr. Lee's physical examination of Patient #24's lungs revealed no abnormalities. At another office visit on May 21, 1997, Dr. Lee's physical examination revealed no abnormalities. Patient #24 visited Dr. Lee's office for a scheduled visit on June 9, 1997. Dr. Lee noted that Patient #24's rash was almost totally resolved and that he had a "mild cough due to smoking." Dr. Lee's physical examination of Patient #24's nose and lungs revealed no abnormalities. Nonetheless, Dr. Lee included among her diagnoses for the June 9, 1997, office visit DHI and chronic sinusitis. Patient #24 visited Dr. Lee's office on June 16 and 17, 1997, for infusions of IVIG. He was not examined during these office visits. On July 7, 1997, Dr. Lee examined Patient #24 at a scheduled visit. Patient #24's symptoms were related to neuropathy, and Dr. Lee's physical examination of Patient #24's nose and lungs revealed no abnormalities. Patient #24 received infusions of IVIG at Dr. Lee's office on July 14 and 15, 1997, but Dr. Lee did not examine him. The diagnoses for these office visits included acute sinusitis, chronic sinusitis, and DHI. At an office visit on August 4, 1997, Patient #24 complained that he was feeling "stuffy in his head." Dr. Lee noted that his sinus congestion was "slightly worse" and that his roommate had a cold. Dr. Lee's physical examination of Patient #24's nose revealed moist nasal mucosa, with erythematous turbinates; the physical examination of Patient #24's lungs revealed no abnormalities. Dr. Lee's diagnoses included chronic sinusitis and allergic rhinitis. Patient #24 received infusions of IVIG on August 11 and 12, 1997, but was not examined by Dr. Lee. At the office visit on September 2, 1997, Patient #24 reported "pain and persistent neuropathy." Dr. Lee's physical examination of Patient #24's nose and lungs revealed no abnormalities. Patient #24 received infusions of IVIG on September 8 and 9, 1997, with diagnoses of DHI and chronic sinusitis. At an office visit on September 16, 1997, Patient #24 reported "severe fatigue since last IVIG." Dr. Lee's physical examination of Patient #24's nose and lungs revealed no abnormalities. At the scheduled office visit on October 14, 1997, Patient #24 complained of "severe neuropathy." Dr. Lee's physical examination of Patient #24's nose and lungs revealed no abnormalities.19 At an office visit on November 11, 1997, Dr. Lee observed that Patient #24 was "feeling fairly well." Dr. Lee's physical examination of Patient #24's nose and lungs revealed no abnormalities, and she noted that she would "continue IVIG when available." On December 10, 1997, Patient #24 received an infusion of IVIG at Dr. Lee's office but was not examined by Dr. Lee.20 Patient #24 reported that he had a "cough, chest tightness, chills and sweats." The medical records of the office visit include the notation that Patient #24's "lungs [are] clear to auscultation." Dr. Lee notified Patient #24 through her nurse that he should increase his dosage of Bactrim, an antibiotic. Dr. Lee examined Patient #24 on December 11, 1997, at which time Patient #24 received his second infusion of IVIG for the month.21 Dr. Lee noted that Patient #24's "symptoms of shortness of breath slightly improved after increase in Bactrim. Denies fevers or chills. Cough resolving." Dr. Lee's physical examination of Patient #24's nose and lungs revealed no abnormalities, and she included "pneumocystis carinii" in her diagnoses. Dr. Lee noted that "since probable PCP, will start Mephron BID for 3 weeks and will follow closely." At a follow- up visit on December 16, 1997, Dr. Lee noted that Patient #24 was feeling better "since start of Mephron high dose" and had very little cough, though he still had some shortness of breath "on extreme exertion." Dr. Lee's physical examination of Patient #24's nose and lungs revealed no abnormalities. Patient #24 visited Dr. Lee's office on January 6, 1998, for an infusion of IVIG and for a physician visit.22 Patient #24's symptoms included "some slight shortness of breath," but he denied having fevers or a cough. Dr. Lee's physical examination of Patient #24's nose and lungs revealed no abnormalities. There is no indication in the Comparative Laboratory Test Results provided by Dr. Lee's office for Patient #24 that tests were done to measure the level of Patient #24's total immunoglobulin or the level of any of the subclasses of immunoglobulin. The medical records provided by Dr. Lee's office do not support her diagnosis that Patient #24 suffered from DHI because the records do not establish that Patient #24 had the severe, recurrent sinopulmonary infections and low level of total immunoglobulin or one of the five subclasses of immunoglobulin essential to such a diagnosis. Dr. Lee first diagnosed Patient #24 with chronic sinusitis and DHI, and decided to start him on IVIG, at his second office visit on December 31, 1996, when Patient #24 had symptoms of severe sinus congestion. Patient #24 also had symptoms of sinus congestion on August 4, 1997. The reports of Dr. Lee's physical examinations of Patient #24's nose at the December 1996 and August 1997 office visits revealed that Patient #24 had erythematous, edematous turbinates, but her physical examinations of Patient #24's nose and lungs revealed no abnormalities relating to congestion or sinusitis.23 The medical records do not, therefore, establish that Patient #24 had the severe, recurrent sinopulmonary infections that are indicative of DHI. The medical records provided by Dr. Lee's office, therefore, fail to support Dr. Lee's diagnoses of demyelinating neuropathy and DHI, and, therefore, they fail to establish that the infusion of IVIG was medically necessary. Accordingly, the claims to Medicaid for the IVIG infusions given on January 9 and 10, 1997; February 6 and 7, 1997; March 6 and 7, 1997; April 7 and 8, 1997; June 16 and 17, 1997; July 14 and 15, 1997; August 11 and 12, 1997; September 8 and 9, 1997; and January 6 and 7, 1998, should be denied.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order requiring Marah J. Lee to repay the principal sum of $109,439.77. DONE AND ENTERED this 9th day of December, 2004, in Tallahassee, Leon County, Florida. S 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 9th day of December, 2004.
