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.
Conclusions THIS CAUSE comes before the AGENCY FOR HEALTH CARE ADMINISTRATION (the "Agency") concerning Certificate of Need ("CON") Application No. 10101 to establish a comprehensive medical rehabilitation unit of up to 40 beds which was filed by HALIFAX HOSPITAL MEDICAL CENTER, INC. d/b/a HALIFAX HEALTH MEDICAL CENTER (hereinafter “Halifax”) in the Second Batching Cycle of 2010. The Agency, being otherwise well-advised in the premises and all other matters of record, has entered into a Settlement Agreement (Ex. 1) with Petitioner and concludes as follows: The Agency preliminarily denied Halifax’s CON application. Thereafter, Halifax timely filed a Petition for Formal Administrative Hearing challenging the denial of CON 10101, DOAH Case No. 11-268, which Filed May 12, 2011 4:03 PM Division of Administrative Hearings the Agency Clerk forwarded to the Division of Administrative Hearings (“DOAH’). On February 2, 2011, Memorial Health Systems, Inc. d/b/a Florida Hospital Oceanside (“Oceanside”) filed a petition to intervene in support of the Agency’s denial of Halifax’s CON 10101. On May 3, 2011, Oceanside filed a Notice of Withdrawal, and withdrew the motion to intervene and dismiss its challenge with prejudice. On May 3, 2011, DOAH issued an Order removing Oceanside as an Intervenor and dismissing its challenge. On May 6, 2011, DOAH entered an order which closed the file at the Division. Subsequent to the filing of the Notice of Withdrawal by Oceanside, the Agency has reviewed the merits of this certificate of need and has determined on balance that the issuance of this CON is warranted. It is therefore ORDERED and ADJUDGED: 1. The Notice of Withdrawal filed by Oceanside and the Order Closing File DOAH are hereby acknowledged and accepted. 2. The Agency hereby awards CON 10101 to Halifax and the Agency is directed to issue to Halifax CON 10101. 3. The Parties shall abide by the terms and conditions of the Settlement Agreement. 4. The above-styled case is hereby closed. DONE and ORDERED this _ // day of i, Mar , 2011, in Tallahassee, Florida. ELIZABETH NUDEK, Secretary AGENCY FOR HEALTH CARE ADMINISTRATION
The Issue What administrative sanction should be imposed on the participation of Robert J. Meek, D.O., (Respondent), in the Florida Medicaid program.
Findings Of Fact Petitioner is the agency of the State of Florida charged with the responsibility of administering the Florida Medicaid program. At all times relevant to this proceeding, Respondent has been a provider with the Florida Medicaid program and has had a Medicaid provider number that was issued pursuant to a Medicaid Provider Agreement with Petitioner. "Medicaid" is the medical assistance program authorized by Title XIX of the Social Security Act, 42 U.S.C. §§ 1396 et seq., and regulations thereunder. Respondent holds a doctor of osteopathic medicine degree and was licensed to practice medicine in Florida, Virginia, and Ohio. Because of his criminal conviction, which will be discussed below, his license to practice medicine in Ohio has been revoked and the licenses issued by Virginia and Florida have been suspended. At the time of the formal hearing, Respondent was incarcerated in a federal prison and his license to practice medicine in Florida was suspended. Respondent’s testimony at the formal hearing was taken by telephone. Respondent first became licensed in Florida in 2005. After completing a residency in proctologic surgery, Respondent worked at Colorectal and GI Specialists of South Florida from July 2006 until February 2007. Respondent then worked at The Hemorrhoid Relief Center from April 2007 through June 2009. Respondent practiced proctology five days a week during those periods. In addition to his regular jobs, from the fall of 2007 through the summer of 2009, Respondent worked some weekends at Physicians Immediate Care. Prior to May 2009, Respondent had no background, experience, or training in pain management. Between the middle of May 2009 until the end of February 2010, Respondent worked between one and three days a week at Executive Pain Clinic in Palm Beach County, purportedly in the practice area of pain management. Respondent’s employment at Executive Pain Clinic led to the federal grand jury indictment, dated August 12, 2011, against Respondent and 30 other defendants for multiple charges. Succinctly stated, Executive Pain Clinic was a pill mill. Among the charges brought against Respondent were a count for conspiracy to unlawfully distribute and dispense and possess with intent to distribute a controlled substance in violation of the Controlled Substance Act and a count for conspiracy to commit money laundering. The federal grand jury indictment was related to Respondent’s practice of medicine at Executive Pain Clinic.2/ Of the 31 persons named in the indictment, 13 were licensed to practice medicine in Florida. Of those 13 doctors, 11, including Respondent, entered into a plea agreement to resolve the charges. By his plea agreement, Respondent pled guilty to conspiracy to commit money laundering in exchange for the United States agreeing to dismiss the other charges against him. As part of the plea agreement, Respondent agreed to testify on behalf of the United States in its prosecution of the two medical doctors who were charged by the indictment, but who refused to enter into a plea agreement to resolve the charges. As of the formal hearing, Respondent had so testified, thereby satisfying his obligation under the plea agreement. In addition to the plea agreement, Respondent entered into a "Stipulated Statement of Facts," (Petitioner's Exhibit 4) which contained the following, which are hereby adopted by the undersigned as findings of fact: Had this case proceeded to trial, the government would have presented evidence by way of witness testimony, Court authorized wire interceptions of coconspirators and documentary evidence. The evidence would establish that the defendant was a physician licensed to practice medicine in Florida and maintained a Drug Enforcement Administration registration number which enabled him to order and purchase Schedule II-V controlled substances. The evidence would establish that from in or about 2009 through in or about April 2010, the defendant conspired and agreed with coconspirators to receive monetary compensation from Executive Pain clinic [sic] and to deposit such monetary compensation into a financial institution. The monetary compensation was the proceeds of specific unlawful activity, that is, the illegal distribution of oxycodone pills, a Schedule II controlled substance. The defendant and conspirators [sic] participated in the operation of illegal "pill mills" wherein individuals seeking controlled substances paid for examinations by the defendant and coconspirator physicians based upon alleged complaints of pain. The defendant and coconspirator physicians illegally prescribed large quantities of oxycodone, 30 mg. pills and other controlled substances without a legitimate medical purpose and outside the usual course of professional practice. The defendant and coconspirator physicians prescribed controlled substances without reviewing prior medical records, referring individuals to medical specialists, or recommending alternative treatment modalities. The defendant and coconspirator physicians prescribed a predetermined "cocktail" of controlled substances which contained oxycodone 30 mg. and 15 mg. xanax and/or soma. No individualized or particularization of treatment of care was used, other than to vary the quantity of drugs prescribed in the "cocktail." The evidence established that the pain management clinics wherein the defendant and coconspirator physicians were employed were, in fact, facilities used for the illegal distribution of controlled substances. The defendant and coconspirators engaged in the above-described criminal conduct for a profit motive. The monetary compensation received by the defendant had a value of more than $10,000. During Respondent’s tenure at Executive Pain Clinic, approximately 628,200 dosage units of oxycodone were ordered under his name. Respondent was assigned a large safe at Executive Pain Clinic, in which the dosage units were deposited. Many of the prescriptions written at Executive Pain Clinic were filled on-site. Patients paid cash for the prescriptions filled at Executive Pain Clinic. Respondent was not paid by Medicaid for his work at Executive Pain Clinic. Executive Pain Clinic was not a Medicaid provider. Respondent saw an average of 40 patients per day at Executive Pain Clinic, spending as few as five minutes with some before prescribing pain medication. A very high percentage of those patients left with a prescription for a controlled substance. Respondent prescribed large quantities of oxycodone or other controlled substances in complete disregard to whether the patient was or was not a Medicaid recipient and without knowing whether Medicaid would pay for the prescription. Respondent was not qualified to practice pain management when he practiced at Executive Pain Clinic, and he practiced beyond the scope of his expertise. Respondent testified that in the month of August 2009, he began to question the legality of what he was doing at Executive Pain Clinic. Nevertheless, he did not leave that employment until the end of the following February. As a result of his plea, Respondent was sentenced to be incarcerated for a period of 66 months. As reflected by the plea agreement, that sentence may be adjusted following Respondent’s cooperation in testifying against two of his codefendants. On April 20, 2012, the Florida Department of Health (DOH) filed an Administrative Complaint before the Board of Osteopathic Medicine against Respondent alleging certain facts pertaining to his plea in the federal proceeding. DOH designated that Administrative Complaint as Case No. 2011-15165. The Administrative Complaint alleged that Respondent pled guilty to a crime that "relates to the practice of, or the ability to practice, osteopathic medicine." Respondent did not challenge the factual allegations of the Administrative Complaint. On March 5, 2013, the Board of Osteopathic Medicine entered a Final Order in Case No. 2011-15165. The Final Order found Respondent guilty of the alleged violations, reprimanded his license, administered a fine in the amount of $5,000, restricted his practice, and suspended his license for a period of six years. The Final Order found as a mitigating factor that Respondent had provided free medical services to the underserved community. The restriction on his practice, as set forth in the Final Order under the heading "Permanent Practice Restriction," is as follows: Respondent shall not own, operate, or work in a Pain Management Clinic as defined by Section 459.0137, Florida Statutes. Further, Respondent is permanently restricted from prescribing or dispensing any schedule II controlled substance as defined by Chapter 893, Florida Statutes. The suspension of his license, as set forth in the Final Order under the heading "Suspension," is as follows: Respondent’s license to practice osteopathic medicine in the State of Florida is hereby suspended for a period of six (6) years and until such time as he appears before the Board and can demonstrate that he is clinically safe to practice osteopathic medicine by: 1) submitting evaluations by either the University of Florida CARES program; the Center for Personalized Education for Physicians (CPEP) clinical assessment, or by other Board-approved equivalent, and comply with the prerequisite recommendations of the evaluation. The Board reserves jurisdiction to set terms and conditions, including probation, at the time of reinstatement; or 2) be accepted into and practice only in a residency program and appear before the Board after successful completion of the residency program. The Board reserves jurisdiction to set terms and conditions, including probation, at the time Respondent appears before the Board. Respondent worked part-time at East West Physicians in Broward County from June 2009 to October 2010. Although Respondent prescribed pain medication while employed at East West Physicians, there was no evidence that East West Physicians was a pill mill. Respondent worked at Palm Beach Wellness and Rejuvenation after federal authorities closed Executive Pain Clinic. Respondent testified, credibly, that he worked at Palm Beach Wellness and Rejuvenation for 22 days over a period of five and one-half months. Palm Beach Wellness and Rejuvenation was a pill mill. On September 20, 2011, prior to the Administrative Complaint involving the federal proceeding, DOH filed an Administrative Complaint before the Board of Osteopathic Medicine against Respondent alleging certain facts pertaining to his practice at Palm Beach Wellness and Rejuvenation. DOH designated that Administrative Complaint as Case No. 2011-02478. Respondent did not challenge the factual allegations of the Administrative Complaint. On March 14, 2012, the Board of Osteopathic Medicine entered a Final Order that contained the following under the heading "FINDINGS OF FACT": The allegations of fact set forth in the Administrative Complaint are approved, adopted, and incorporated herein by reference as the findings of fact of the Board. There is competent, substantial evidence to support the Board’s findings and conclusions. The Final Order imposed against Respondent an administrative fine in the amount of $10,000.00; ordered him not to own, operate, or work in a pain management clinic; and suspended his license to practice for a period of one year. The Administrative Complaint in Case No. 2011-024783/ included the following factual allegations in paragraphs 5-76, which were incorporated in DOH's Final Order as findings of fact: At all times material to this Complaint, the Respondent was a dispensing practitioner. At all times material to this Complaint, the Respondent was practicing at Total Medical Express of Boca Raton, which was also known as Palm Beach Pain and Rejuvenation (clinic). The Respondent was practicing pain management while he was at the clinic. The Respondent prescribed controlled substances such as Ambien, Ativan, Flexeril, Lisinopril, oxycodone (also known as Roxicodone), Percocet, Valium and Xanax to his patients. Ambien is the brand name for zolpidem, which is prescribed to treat insomnia. According to Title 21, Section [sic] 1308.14, Code of Federal Regulations, zolpidem is a Schedule IV controlled substance. Zolpidem can cause dependence and is subject to abuse. Ativan is the brand name for lorazepam, which is a benzodiazepine, and is prescribed to treat anxiety. Lorazepam can decrease mental alertness and affect judgment. According to Section [sic] 893.03(4), Florida Statutes, lorazepam is a Schedule IV controlled substance that has a low potential for abuse relative to the substances in Schedule III and has a currently accepted medical use in treatment in the United States. Abuse of lorazepam may lead to limited physical or psychological dependence relative the substances in Schedule III. Flexeril is the brand name for cyclobenzaprine hydrochloride. Flexeril is prescribed as an adjunct to rest and physical therapy for relief of muscle spasms associated with acute, painful musculoskeletal conditions. Flexeril is not a scheduled drug. Lisinopril is the brand name for a drug of the same name. Lisinopril is prescribed to treat hypertension. Lisinopril is not a scheduled drug. Oxycodone is an opioid commonly prescribed to treat pain. According to Section [sic] 893.03(2), Florida Statutes, oxycodone is a Schedule II controlled substance that has a high potential for abuse and has a currently accepted but severely restricted medical use in treatment in the United States. Abuse of oxycodone may lead to severe psychological or physical dependence. Opiate, or opioid, drugs have similar actions as the drug opium and are typically prescribed to treat pain. Opioid drugs are synthetically manufactured, while opiate drugs are naturally occurring, but the terms opioid and opiate are often used interchangeably. Opioid drugs are addictive and subject to abuse. Percocet is the brand name for a drug that contains oxycodone and is prescribed to treat pain. According to Section [sic] 893.03(2), Florida Statutes, oxycodone is a Schedule II controlled substance that has a high potential for abuse and has a currently accepted but severely restricted use in treatment in the United States. Abuse of oxycodone may lead to severe psychological or physical dependence. Roxicodone is the brand name for an immediate release formulation of oxycodone. Valium is the brand name for diazepam and is prescribed to treat anxiety. According to Section [sic] 893.03(4), Florida Statutes, diazepam is a Schedule IV controlled substance that has a low potential for abuse relative to the substances in Schedule III and has a currently accepted medical use in treatment in the United States. Abuse of diazepam may lead to limited physical or psychological dependence relative to the substances in Schedule III. Xanax is the brand name for alprazolam and is prescribed to treat anxiety. According to Section [sic] 893.03(4), Florida Statutes, alprazolam is a Schedule IV controlled substance that has a low potential for abuse relative to the substances in Schedule III and has a currently accepted medical use treatment in the United States. Abuse of alprazolam may lead to limited physical or psychological dependence relative to the substances in Schedule III. Facts Specific to Patient J.W. J.W. was a resident of Irvine, Kentucky. On or about February 24, 2010, J.W. presented to the clinic for the first time with complaints of lower back pain. On or about March 26, 2010, the Respondent saw J.W. and diagnosed him with lower back pain, lumbar spine stenosis, lumbar disk displacement, and chronic pain secondary to trauma. On or about March 26, 2010, the Respondent prescribed 180 tablets of Roxicodone 30 mg, 90 tablets of Roxicodone 15 mg, and 60 tablets of Xanax 1 mg to the patient. People who travel from out-of-state to Florida for pain management are associated with aberrant drug behavior, such as drug abuse or diversion, and are considered high risk patients. The Respondent did not evaluate the patient for drug abuse or drug diversion despite the fact that the patient was from Kentucky. The Respondent inappropriately prescribed multiple immediate release opioids to treat J.W. The Respondent placed J.W. at risk of a drug overdose by prescribing multiple release opioids in conjunction with a benzodiazepine. Facts Specific to Patient W.T. W.T. was a resident of Louisa, Kentucky. On or about January 25, 2010, W.T. presented to the clinic for the first time with complaints of lower back and left shoulder pain. On or about March 25, 2010, W.T. presented to the Respondent, who diagnosed the patient with lower back pain, lumbar disk displacement, chronic pain, and pain in the left shoulder. On or about March 25, 2010, the Respondent failed to perform an adequate physical examination of the patient, or the Respondent failed to document that he performed an adequate physical examination. On or about March 25, 2010, the Respondent failed to offer the patient pain management techniques other than stretching. On or about March 25, 2010, the Respondent prescribed 180 tablets of Roxicodone 30 mg, 90 tablets of Roxicodone 15 mg, and 60 tablets of Xanax 2 mg to the patient. The Respondent inappropriately prescribed multiple immediate release opioids to W.T. The Respondent put W.T. at risk of a drug overdose by prescribing multiple immediate release opioids in conjunction with a benzodiazepine. People who travel from out-of-state to Florida for pain management treatment are associated with aberrant drug behavior, such as drug abuse or diversion, and are considered high risk patients. The Respondent did not evaluate the patient for drug abuse or drug diversion despite the fact that the patient was from Kentucky. Facts Specific to Patient M.P M.P. was a resident of Hancock, Maine. On or about December 30, 2009, M.P. presented to the clinic for the first time with complaints of lower back pain. On or about December 30, 2009, the patient tested positive for tetrahydrocannabinols (THC). THC is the psychoactive ingredients in marijuana, or cannabis. According to Section [sic] 893.03(1), Florida Statutes, THC is a Schedule I controlled substance that has a high potential for abuse and has no currently accepted medical use in treatment in Florida. Its use under medical supervision does not meet accepted safety standards. THC is a central nervous system depressant. On or about March 26, 2010, M.P. presented to the Respondent, who diagnosed the patient with lumbar disk degeneration, chronic lower back pain, degenerative disk disease of the lumbar spine and lumbosacral root lesions. On or about March 26, 2010, the Respondent failed to perform a physical examination of the patient or the Respondent failed to document that he had performed a physical examination of the patient. On or about March 26, 2010, the Respondent prescribed 60 tablets of Valium 10 mg, 30 tablets of Lisinopril 20 mg, 30 tablets of Flexeril 10 mg, 180 tablets of Roxicodone 30 mg, and 60 tablets of Roxicodone 15 mg to the patient. The Respondent inappropriately prescribed multiple immediate release opioids to the patient. The Respondent put the patient at risk of an overdose by prescribing a benzodiazepine and opioids. The Respondent compounded the patient’s risk of an overdose by prescribing Flexeril in addition of a benzodiazepine and opioids. On or about March 26, 2010, the patient tested positive for THC again. The Respondent did not send the patient’s sample out to a laboratory for confirmation to verify that the patient had been positive for THC. The Respondent failed to address the patient’s use of illegal substances in the medical records. The Respondent put the patient at high risk for a drug overdose by prescribing 60 tablets of Valium 10 mg, 30 tablets of Lisinopril 20 mg, 30 tablets of Flexeril 10 mg, 180 tablets of Roxicodone 30 mg, and 60 tablets of Roxicodone 15 mg to the patient while the patient was taking THC. People who travel from out-of-state to Florida for pain management treatment are associated with aberrant drug behavior, such as drug abuse or diversion, and are considered high risk patients. The Respondent did not evaluate the patient for drug abuse or drug diversion despite the fact that the patient was from Maine. Facts Specific to Patient D.S.1 D.S.1 was a resident of Florida, and lived approximately 130 miles away from the clinic. D.S.1 first presented to the clinic on or about March 2, 2010, with a primary complaint of upper, middle and lower back pain and shoulder pain. On or about April 1, 2010, D.S.1 presented to the Respondent, who diagnosed the patient with cervical, thoracic and lumber disk degeneration, lumbar root lesions, chronic pain and muscle spasms. On or about April 1, 2010, the Respondent prescribed 30 tablets of Flexeril 10 mg, 180 tablets of Roxicodone 30 mg and 60 tablets of Roxicodone 15 mg to the patient. The Respondent inappropriately prescribed the patient two immediate release opioids. Facts Specific to Patient D.S.2 Patient D.S.2 was a resident of Middlesboro, Kentucky. On or about March 11, 2010, D.S.2 presented to the clinic for the first time with complaints of lower back pain. On or about April 8, 2010, D.S.2 presented to the Respondent, who diagnosed the patient with thoracic and lumbar disk displacement, chronic lower back pain, degenerative disk disease and lumbar and thoracic spinal stenosis. On or about April 8, 2010, the Respondent prescribed 30 tablets of Ativan 2 mg, 30 tablets of Ambien 10 mg, 180 tablets of Roxicodone 30 mg, and 90 tablets of Roxicodone 15 mg to the patient. The Respondent inappropriately prescribed the patient two immediate release opioids. The Respondent put the patient at risk of overdose by prescribing the patient a combination of Ambien, Ativan, and oxycodone. People who travel from out-of-state to Florida for pain management treatment are associated with aberrant drug behavior, such as drug abuse or diversion, and are considered high risk patients. The Respondent did not evaluate the patient for drug abuse or drug diversion despite the fact that the patient was from Kentucky. Facts Specific to Patient S.F. S.F. was a resident of Florida and lived approximately 24 miles from the clinic. On or about March 10, 2010, S.F. went to the clinic for the first time but his intake form does not indicate what his chief complaint was. On or about April 9, 2010, S.F. presented to the Respondent, who diagnosed the patient with chronic lower back pain, degenerative disk disease and lumbar spinal stenosis. On or about April 9, 2010, the Respondent prescribed 180 tablets of Roxicodone 30 mg and 60 tablets of Roxicodone 15 mg to the patient. On or about April 9, 2010, the Respondent wrote in the medical records that the patient drank a six pack of alcohol a day, five days a week and the patient was "drinking excessively." The Respondent prescribed high doses of opiates to S.F. despite the patient’s excessive use of alcohol. The Respondent put the patient at risk of an overdose by prescribing 180 tablets of Roxicodone 30 mg and 60 tablets of Roxicodone 15 mg when the patient was using alcohol excessively. The Respondent failed to counsel the patient about the dangers of using oxycodone with the levels of alcohol that the patient was imbibing or he failed to document that he counseled the patient. S.F.’s medical records include a magnetic resonance imaging (M.R.I.) study, dated March 20, 2010. S.F.’s M.R.I. indicated that he had an abdominal aortic aneurysm that would be adverse to hypertension. The Respondent failed to refer S.F. to an in-patient detoxification center despite the patient’s use of alcohol and abnormal M.R.I. If his license to practice osteopathic medicine is reinstated in Florida, Respondent intends to practice in South Florida in a practice area other than pain management. Section 409.913(17) contains the factors that Petitioner must consider in determining the length of time a Medicaid provider, such as Respondent, should be terminated from the Medicaid program. Mr. West considered those factors in reaching the conclusions that a termination lasting 20 years is the appropriate sanction to be imposed against Respondent. Petitioner considers the seriousness of the misconduct to be the strongest factor to be considered. Pill mills cause serious problems in the State of Florida, and have been the focus of both regulatory agencies and law enforcement agencies on the state and federal level for several years. Medicaid patients in South Florida are not underserved, and there will be little or no impact on access by recipients to Medicaid services if Respondent is terminated as a provider. The United States Department of Health and Human Services, through its Office of Inspector General, has suspended Respondent's participation in all federally funded health care programs for a period of eight years.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that the Agency for Health Care Administration enter a final order adopting the findings of fact and the conclusions of law set forth in this Recommended Order. It is further RECOMMENDED that the final order terminate Robert J. Meek, D.O., as a Florida Medicaid provider for a period of ten years. DONE AND ENTERED this 28th day of February, 2014, in Tallahassee, Leon County, Florida. S CLAUDE B. ARRINGTON Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 28th day of February, 2014.
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.
Findings Of Fact Respondent is a nursing home licensed by Petitioner pursuant to Chapter 400, Florida Statutes. On December 8, 1980, Petitioner's nurse surveyor, Muriel Holzberger, visited Respondent's facility to review the medical records at Respondent's facility following receipt by HRS of a copy of a newspaper article charging Respondent with patient neglect. Ms. Holzberger reviewed the medical records of patient S and talked with the administrator. After reviewing the records Ms. Holzberger concluded that Respondent had not used the air mattress that accompanied S to the nursing home, that S developed bedsores which were first observed on 1 October, that he was not seen by the doctor until 6 October, that these bedsores worsened until 10 October, that on 10 October an "egg crate" mattress was placed on bed, proper medication was administered to S, and when he left the nursing home near the end of October, the lesions were healed. The three witnesses presented by Respondent, all of whom treated and observed S while he was a patient at the nursing center, testified that the air mattress which accompanied S to the nursing center was inflated and on the bed occupied by S from his admission until replaced by the egg crate mattress on 10 October. At the time of his admission, the patient was recovering from a stroke. He had been cared for by his wife at home following his cardiovascular attack and required total care. He could not communicate or feed himself. Apparently, his wife decided to take a short vacation and placed S in the nursing center to provide the needed care. On 1 October 198 the nurse on the three to eleven shift noted open areas on the patient's buttocks and lower extremities indicating pressure on these areas from lying in bed. On 2 October more open lesions appeared and the attending physician was called but could not be contacted. On 3 October the physician was contacted and he prescribed medication for the bedsores which had developed. On 6 October the patient was seen by the doctor but the open lesions continued to accumulate until around 10 October, after which the lesions abated. Upon delivering S to the nursing center, Mrs. S advised that S was subject to bedsores if not carefully attended and included with his effects a long letter describing treatment she had used to treat bedsores and some Betadine solution which been prescribed by the doctor for treating these lesions. Testimony was unrebutted that during the early part of S's stay at the nursing center (when the bedsores developed) the patient slept on the inflated air mattress, was turned frequently, and appeared despondent due to his wife's absence. He obviously was not as carefully attended to as he could have been, hence the accumulation and subsequent aggravation of the open lesions which healed when the wife returned and more careful attention was given to S. When open lesions were first observed on 1 October, Respondent's duty nurse applied dressings without doctor's orders. When the doctor could not be contacted on 2 October, his office was advised that the doctor would be called the following day. On 3 October the patient's condition was relayed to the doctor and he prescribed medication but, as noted above, did not visit the patient until October 6. The treatment prescribed on 3 October, viz, Betadine and heat lamp apparently was continued until the lesions were healed some four weeks later. The medical records maintained at the nursing center on S did not show the use of the air mattress which accompanied S to the nursing center. Use of this equipment is in the nature of preventive therapy and should have been recorded in the Nurses Notes. The medical records did record S's condition and the treatment given him both before and after receipt of the doctor's orders. No charges were preferred for applying medication to S's lesions before receipt of doctor's orders and this delict will not be considered.
Findings Of Fact Mr. Young has been employed full-time in the field of respiratory care since 1977. He completed training as a respiratory therapy technician at Miami Dade Community College in December, 1977. Mr. Young completed the registry examination of the National Board for Respiratory Care in December, 1985, and became a Registered Respiratory Therapist. This professional title can be somewhat confusing, however, because under the Respiratory Care Act, Section 468.35, Florida Statutes, et seq., it is necessary to apply for registration with the Advisory Council on Respiratory Care to practice as a respiratory therapist. Mr. Young's application for registration as a statutory respiratory therapist by endorsement under Section 468.358(2), Florida Statutes, has given rise to this proceeding. Mr. Young's application for statutory registration was made in June of 1986. The Advisory Council on Respiratory Care issued a Notice of Intent to Deny the application on February 19, 1987, on the grounds that Applicant falsified the reason for termination of employment on his application. Applicant was terminated for being addicted to pain medication and forging prescriptions. See Section 468.365(1)(a), (g), (x), and 468.365(2), Florida Statutes. Applicant is denied without prejudice to reapply for licensure in two years. It is undisputed that Mr. Young meets the education and training requirements for registration as a statutory respiratory therapist. Mr. Young sought a hearing on this denial and in the prehearing stipulation the parties agree the issues of fact are whether Mr. Young's application contained false information amounting to fraudulent misrepresentation, whether he is chemically dependent, and whether his past conduct is cognizable under Section 368.365(1)(g), Florida Statutes. Question 5 on page 3 of the application submitted by Mr. Young, for registration by endorsement as a respiratory therapist, asks Have you ever been terminated, disciplined or allowed to resign from any employment setting where you were employed to deliver respiratory care services? Yes No If "yes", give name of employer or institution, date and reason for such action. Mr. Young answered "yes" and gave as his response "Coral Reef Hospital, January 7, 1983, Seizure Disorder." On the same page of the application Mr. Young stated that he had been addicted to or excessively used alcohol, narcotics, barbiturates or other medication and that he had been treated at South Miami Hospital Addiction Treatment Center. In a letter which Mr. Young wrote to the Advisory Council on September 27, 1986, he stated On March 27, 1981, I was admitted to South Miami Hospital Addiction Treatment Program for chemical dependency. I was instructed to attend aftercare for one year. I attended two (2) months of aftercare and stopped. It was at this time I changed jobs and began to work at Coral Reef Hospital. I did however attend Alcoholics Anonymous meetings in South Miami area twice a month. In December of 1982 I had a grand mal seizure due to medication that I was taking. The medication contained Codine. I was admitted to Coral Reef Hospital January 1, 1983 and evaluated for seizure disorder. I was under the care of Dr. Timothy Grant, a Nurologist. I was placed on Dilantin for two (2) years. After I was released from the hospital I was terminated. From what I now/still understand I was terminated as a "high risk. Mr. Young's account is literally true with respect to the grand mal seizure he suffered, but his version is so shaded in his favor as to be seriously misleading. His explanation that he was terminated from employment because he was a "high risk" is partly true. To fully explain the situation it is necessary to go back to the beginning of Mr. Young's chemical dependency. In 1980 Mr. Young had a laminectomy and was given Percodan for pain control. At this time he had been working at South Miami Hospital. Mr. Young became addicted to Percodan, and began going from physician to physician in order to get Percodan prescriptions. Eventually, his supervisor at South Miami Hospital directed him to the hospital's addiction treatment program where he spent 21 days in inpatient care. The program calls for one year of participation in an aftercare program. After he left the inpatient care, he participated in aftercare for no more than four months, but was drug-free. He thereafter had the opportunity to take a better job at Coral Reef Hospital where he began employment in September 1, 1981. He then developed an upper respiratory infection in the summer of 1982 and his physician prescribed Actifed with Codine. He then began the addiction cycle again, and went to different physicians to get Actifed with Codine from them. In addition, he forged prescriptions on a prescription pad to which he had access at Coral Reef Hospital for Actifed with Codine, but listed the prescription in the name of his wife and his daughter. As the result of the Codine he was taking, either due directly to the Codine, or to the activation of some underlying seizure disorder, Mr. Young had a grand mal seizure December 24, 1982, for which he was treated in the hospital emergency room, and another on December 31, 1982, which led to his hospitalization for a seven- day evaluation. He was given Dilantin for seizure control after the second seizure on December 31, 1982. Mr. Young no longer took the Dilantin after about June of 1983. After the December, 1982, seizures Mr. Young began attending Alcoholics Anonymous on a regular basis, i.e. about twice a month, and has regularly attended those meetings since that time. He attended Alcoholics Anonymous meetings because he was more comfortable there than at Narcotics Anonymous, although these self-help programs are almost identical. Returning to Mr. Young's September 26, 1986, letter to the Council, it was seriously misleading to inform the Advisory Council that he had the grand mal seizure in December of 1982 "due to medication that I was taking." Mr. Young did not merely suffer an adverse reaction to over-the-counter medication or something prescribed by his physician, but as the result of physician shopping, and forging prescriptions accessible to him at the hospital where he worked to obtain preparations containing Codine. Moreover, immediately after he was released from the hospital following the second seizure, he was terminated from his position at Coral Reef Hospital. The hospital's record, which he signed, shows a supervisory contact for Use of controlled substances which were not prescribed by a physician. This potential abuse could have been a contributing factor to two syncopal episodes (12/24, 12/31) had while on duty at the hospital. Mr. Young was terminated the same day. It is clear that Mr. Young was not only terminated for the seizures which interfered with his ability to perform his duties as a respiratory therapist, but also for forging prescriptions for controlled substances. Mr. Young's contention that he did not know his termination was based on the illicit use of controlled substances cannot be credited. Mr. Young has had two bouts of chemical dependency, the first resulting from addiction to Percodan in 1980 which led to his treatment at South Miami Hospital where he did not complete the aftercare program, and the second resulting from addiction to Actifed with Codine in the second half of 1982, which he had dealt with by attending Alcoholics Anonymous meetings approximately every other week, but at least twice a month. The testimony of Dr. Roger Goetz for the Advisory Council on Respiratory Care concerning the need for a highly controlled aftercare program for persons to continue practicing health care professions was generally persuasive. After the completion of an inpatient program for drug dependency, the practitioner must complete an extended care program and continue a period of monitoring. Participation in Alcoholics Anonymous or Narcotics Anonymous, while valuable, is not comparable to a structured aftercare program because those programs involve no - monitoring. Indeed, it is against the philosophies of those programs to monitor participants. Health care practitioners are at particularly high risk for relapse into drug dependency because they are surrounded by and have access to drugs in hospital settings and their jobs involve high levels of stress. Particularly, respiratory care practitioners are subject to stress because they are often the only persons on duty in intensive care wards, and they have access to drugs in critical care areas of the hospital. Although Mr. Young did introduce into evidence two drug screenings, there is no indication whether they were announced or unannounced, or whether the collection of the urine sample was witnessed. Two drug screenings performed over a four-month period is insufficient evidence to determine whether the person is drug free. Moreover, for a person to succeed in long-term recovery, the person should attend at least two meetings of an organization such as Alcoholics Anonymous or other aftercare program each week. Attending one or two meetings a month as Mr. Young has done is "skating on very thin ice" (Tr. 118). The report of the psychiatric evaluation performed by Arthur T. Stillman, M.D., a diplomate of the American Board of Psychiatry, is entitled to little weight. Dr. Stillman did not testify, and it is impossible to determine the accuracy of the information contained in his report, since he was not subject to cross-examination. Similarly, testimony of Gloria Gross does not play an important part in the evaluation of Mr. Young's ability to practice respiratory therapy safely. While he may have been a good employee while a teacher of respiratory care services at Flagler Career Institute since September, 1983, and may generally have a good reputation in the community, that provides very little in the way of predicting whether Mr. Young will be able to deliver respiratory care services with reasonable skill and safety to patients due to Mr. Young's history of addictions.
Recommendation It is recommended that the current application of Mr. Young for registration as a statutory respiratory therapist be denied, but that upon entry into a structured aftercare program with monitoring, Mr. Young be eligible to reapply for licensure after one year's successful participation in such a program. DONE AND ORDERED this 18th day of December, 1987, at Tallahassee, Florida. WILLIAM R. DORSEY, JR. Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 18th day of December, 1987. APPENDIX TO RECOMMENDED ORDER, CASE NO. 87-2641 The following are my rulings on the proposed findings of fact submitted by the parties pursuant to Section 120.59(2), Florida Statutes (1985). Rulings on Petitioner's Proposed Findings: Covered in finding of fact 1. Covered in finding of fact 2. Covered in finding of fact 17 Covered in finding of fact 17. Covered in finding of fact 17. Covered in finding of fact 17. Covered in finding of fact 6. Covered in finding of fact 6. While true, rejected as unnecessary. Rejected. See finding of fact 12. Covered in finding of fact 10. Covered in finding of fact 10 and 12. Rejected for the reasons given in the rulings on documentary evidence. Rejected. See finding of fact 12. Covered in finding of fact 14 and 15. Rejected as unnecessary. Rejected as unnecessary. Rejected because the underlying facts have not been proven, i.e. there is insufficient proof that Mr. Young has actually been drug free for four years, and while he is regularly attending AA meetings, he has not been attending as regularly as the testimony of Dr. Goetz shows is appropriate. Rejected because I am not satisfied that the grand mal seizure resulted in any memory loss to Mr. Young. Rejected as unnecessary. Rulings on Respondent's Proposed Findings: Covered in finding of fact 3. Covered in finding of fact 3. Rejected as unnecessary. Covered in finding of fact 6. Covered in finding of fact 7. Generally covered in findings of fact 8, 10 and 13. Rejected as argument, not a finding of fact. Generally accepted in finding of fact 12. Rejected as argument, not a finding of fact. Rejected as constituting argument, rather than findings of fact. Generally covered in findings of fact 14 and 15. While some monitoring of a person in Mr. Young's position is appropriate, the Hearing Officer is not convinced of the need for lifetime monitoring, nor certain what the intensity of the "lifetime monitoring" Dr. Goetz referred to would be. To condition professional licensure based on lifetime monitoring, rather than monitoring for a period such as one year, is not warranted by this record. Covered in finding of fact 15. Covered in finding of fact 16. Covered in finding of fact 17 to the extent necessary and relevant. COPIES FURNISHED: Rosanne Brady, Esquire 2030 Douglas Road, No. 21 Coral Gables, Florida 33134 M. Catherine Lannon, Esquire Department of Legal Affairs The Capitol, Room 1601 Tallahassee, Florida 32399-1050 Ms. Dorothy Faircloth Executive Director Board of Medicine Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 William O'Neill, Esquire Gereral Counsel Department of Professional Regulation Tallahassee, Florida 32399-0750
