STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

MARAH J. LEE, )

)

Petitioner, )

)

vs. ) Case No. 03-2251MPI

)

AGENCY FOR HEALTH CARE )

ADMINISTRATION, )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, a formal hearing was held in this case on January 7 through 9, 2004, in Tallahassee, Florida, before Patricia Hart Malono, a duly-designated Administrative Law Judge of the Division of Administrative Hearings. The continuation of the formal hearing was held on March 26, 2004, by video teleconference, with the Petitioner appearing in Ft. Lauderdale, Florida, and the Respondent appearing in Tallahassee, Florida, before Patricia Hart Malono, who presided in Tallahassee, Florida.

APPEARANCES

For Petitioner: Joanne Fanizza, Esquire

Law Offices of Joanne Fanizza, P.A. 1995 East Oakland Park Boulevard Suite 210

Fort Lauderdale, Florida 33306

For Respondent: Anthony L. Conticello, Esquire

Garnett W. Chisenhall, Esquire Agency for Health Care Administration 2727 Mahan Drive, Mail Station 3

Tallahassee, Florida 32308 STATEMENT OF 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.

PRELIMINARY STATEMENT

In a FAAR dated May 8, 2003, the Agency for Health Care Administration ("AHCA") notified Marah J. Lee, D.O., that it had determined that she was overpaid $129,148.49 during the period extending from January 1, 1996, through August 11, 2000, ("Audit Period") for "claims that in whole or part are not covered by Medicaid." AHCA articulated the reason for its determination that an overpayment had been made to Dr. Lee as follows:

Medicaid requires that services performed be medically necessary for the diagnosis and treatment of an illness. You billed and received payments for services for which the diagnosis codes and medical records, when reviewed by a Medicaid physician peer review consultant, indicated that the services provided did not meet the Medicaid criteria for medical necessity. The claims that were considered medically unnecessary were disallowed and the money you were paid for these procedures is considered an overpayment.

Dr. Lee timely requested an administrative hearing to resolve disputed issues of fact, and AHCA transmitted the matter

to the Division of Administrative Hearings for assignment of an administrative law judge. Pursuant to notice, the final hearing was originally scheduled for September 9 through 11, 2003.

After two continuances and a period of time during which the case was held in abeyance pending settlement negotiations, the final hearing was held on January 7 through 9, 2004, and on March 26, 2004.

At the hearing, AHCA presented the testimony of Joseph W. Shands, Jr., M.D., and of Margerite Johnson, R.N. Respondent's Exhibits 1; 2a, 2a1, and 2a2; 2b, 2b1, and 2b2; 2c, 2c1, and 2c2; 2d, 2d1, and 2d2; 2e, 2e1, and 2e2; 2f, 2f1, and 2f2; 2g, 2g1, and 2g2; 2h, 2h1, and 2h2; 2i, 2i1, and 2i2; 2j, 2j1, and 2j2; 3; 10; 12; 13; 15; 22; 23; and 26 through 28 were offered and received into evidence. Respondent's Exhibit 26 consists of the transcript and videotape of the deposition of Dr. Shands taken September 19, 2004; Respondent's Exhibit 27 consists of the transcript of the deposition of Dr. Lee taken October 3, 2003. Dr. Lee testified in her own behalf and presented the testimony of Kimberly Kopacz. Petitioner's Exhibits 1, 2,

4 through 6, and 8 were offered and received into evidence.

AHCA presented the testimony of Dr. Shands on rebuttal, and Dr. Lee testified in her own behalf on sur-rebuttal. Subsequent to the final hearing and without objection from Dr. Lee, AHCA filed a copy of all versions of Florida Administrative Code

Rules 59G-4.230 and 59G-5.020 in effect during the Audit Period; a copy of excerpts from all versions of the Physician Coverage and Limitations Handbook in effect during the Audit Period; and excerpts from all versions of the Medicaid Provider Reimbursement Handbook in effect during the Audit Period.

In their pre-hearing stipulation of facts, AHCA and Dr. Lee agreed that the amount AHCA seeks to recover decreased from

$129,148.49 to $128,666.22. In addition, during the final hearing, AHCA stated that it no longer sought to recoup an overpayment for services provided by Dr. Lee to Patient #27. Accordingly, the amount AHCA seeks to recover is now

$109,439.77.

Volumes 1 through 6 of the transcript of the proceedings were filed with the Division of Administrative Hearings on January 26, 2004, and volume 7 of the transcript of the proceedings was filed on April 8, 2004. The parties timely filed proposed findings of fact and conclusions of law, and AHCA filed a separate memorandum of law. These submissions have been considered in the preparation of this Recommended Order.

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:

1. 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

2. 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."

3. 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.

4. 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.

5. 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.

6. 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.

7. Dr. Shands retired from the practice of medicine in May 2002. For three years prior to his retirement, Dr. Shands practiced medicine part-time.

8. 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

   
   

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. 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

    
    

17. 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.

18. 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

19. 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.

20. 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."

21. 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.

22. 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.

23. 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.

24. 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.

25. 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.

26. 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."

27. 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.

28. 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.

29. 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.

30. 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

    
    

31. 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.

32. 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.

33. 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.

34. 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.

35. 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.

36. 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."

37. Patient #5's next visit to Dr. Lee's office, on June 11, 1997, was exclusively for the infusion of IVIG.

38. 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

    
    

39. 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.

40. 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.

41. 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.

42. 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.

43. 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."

44. 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.

45. 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.

46. 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.

47. 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.

48. 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.

49. 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.

50. 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.

51. 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.

52. 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

    
    

53. 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.

54. 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.

55. 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.

56. 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.

57. 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.

58. 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.

59. 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.

60. 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."

61. 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.

62. 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.

63. 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.

64. 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."

65. 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.

66. 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.

67. 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

    
    

68. 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.

69. 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.

70. 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.

71. 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."

72. 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.

73. 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.

74. 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.

    
    

75. 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.

76. 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.

77. 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.

78. 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.

79. Dr. Lee examined Patient #9 on November 19, 1996, and there were no abnormalities of the nose and the lungs noted.

80. Patient #9 was treated with an IVIG and Vitamin C infusions on December 4, 1996; he received no other service.

81. 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."

82. 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.

    
    

83. 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.

84. 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.

85. 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.

86. 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.

87. 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.

88. 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.

89. 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.

90. 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.

91. 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.

92. 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

    
    

93. 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.

94. 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.

95. 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.

    
    

96. 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.

97. 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.

98. 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.

99. 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.

100. 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.

101. 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

     
     

102. 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.

103. 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."

104. 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

     
     

105. 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.

106. 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

107. 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.

108. 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.

109. 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.

     
     

110. 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.

111. 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.

112. 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."

113. 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.

114. 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.

115. 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.

116. 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."

117. 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.

118. 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.

119. 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.

120. 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.

121. 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."

122. 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.

123. 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.

124. 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.

125. 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

     
     

126. 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.

     
     

127. 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.

128. 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.

129. 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.

130. 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

131. 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.

132. 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."

     
     

133. 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.

134. 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.

135. 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.

136. 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.

137. 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.

138. 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.

139. 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.

140. 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.

141. 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

     
     

142. 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.

143. 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.

     1. Demyelinating neuropathy

        
        

144. 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.

145. 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."

     1. On February 11, 1997, Patient #24 complained of "tingling and numbness in lower extremities that sometimes extends upwards; Dr. Lee noted "neuropathy persists, tolerable."

     2. 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.

     3. 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.

        
        

     4. 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."

     5. 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.'"

     6. 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

     7. 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."

146. 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.

147. 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.

     1. DHI

     
     

148. 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.

149. 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.

     
     

150. 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.

151. 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.

152. 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.

153. 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.

154. 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.

155. 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.

156. 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.

157. 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.

158. 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.

159. 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.

160. 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."

161. 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.

162. 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.

163. 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.

164. 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.

165. 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.

166. 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.

     CONCLUSIONS OF LAW

     
     

167. The Division of Administrative Hearings has jurisdiction over the subject matter of this proceeding and of the parties thereto pursuant to Sections 120.569 and 120.57(1), Florida Statutes (2004).

168. AHCA is empowered to "recover overpayments . . . as appropriate." § 409.913, Fla. Stat. An "overpayment" is defined to include "any amount that is not authorized to be paid by the Medicaid program whether paid as a result of inaccurate or improper cost reporting, improper claiming, unacceptable practices, fraud, abuse, or mistake." § 409.913(1)(d), Fla. Stat. Specifically, as well, AHCA is authorized to "require repayment for inappropriate, medically unnecessary, or excessive goods or services from the person furnishing them, the person under whose supervision they were furnished, or the person causing them to be furnished." § 409.913(10), Fla. Stat.

169. AHCA has the burden of proving an alleged Medicaid overpayment by a preponderance of the evidence. South Medical

     Services, Inc. v. Agency for Health Care Admin., 653 So. 2d 440,

     
     

     441 (Fla. 3d DCA 1995); Southpointe Pharmacy v. Department of Health and Rehabilitative Services, 596 So. 2d 106, 109 (Fla. 1st DCA 1992). Section 409.913(21), Florida Statutes, provides, however, that "[t]he audit report, supported by agency work papers, showing an overpayment to the provider constitutes

     evidence of overpayment." Consequently, although it has the ultimate burden of persuasion by the greater weight of the evidence, AHCA can make a prima facie case of overpayment through the introduction into evidence of the audit report; the provider is then required to respond by producing evidence to support its Medicaid claims. See Maz Pharmaceuticals, Inc. v.

     Agency for Health Care Administration, DOAH Case No. 97-3791, 1998 WL 870139, *2 (Recommended Order issued Mar. 20, 1998); see also Full Health Care, Inc. v. Agency for Health Care Administration, DOAH Case No. 00-4441, 2001 WL 729127, *8-9 (Recommended Order issued June 25, 2001)(adopted in toto, Sept. 28, 2001, AHCA Rendition No. 01-262-FOF-MDO).

170. The pertinent statutes, rules, Physician Coverage and Limitations Handbooks, and Medicaid Provider Reimbursement Handbooks that were in effect during the Audit Period govern this dispute. See Toma v. Agency for Health Care Administration, DOAH Case No. 95-2419, 1996 WL 1059900, *23 (Recommended Order issued July 26, 1996) (adopted in toto, Sept. 24, 1996, 18 F.A.L.R. 4735).

171. Section 409.913(7), Florida Statutes, spells out the duties of providers who make claims under Medicaid:

     1. When presenting a claim for payment under the Medicaid program, a provider has an affirmative duty to supervise the provision of, and be responsible for, goods and services claimed to have been provided,

        to supervise and be responsible for preparation and submission of the claim, and to present a claim that is true and accurate and that is for goods and services that:

        
        

        1. Have actually been furnished to the recipient by the provider prior to submitting the claim.

           
           

        2. Are Medicaid-covered goods or services that are medically necessary.

           
           

        3. Are of a quality comparable to those furnished to the general public by the provider's peers.

           
           

        4. Have not been billed in whole or in part to a recipient or a recipient's responsible party, except for such copayments, coinsurance, or deductibles as are authorized by the agency.

           
           

        5. Are provided in accord with applicable provisions of all Medicaid rules, regulations, handbooks, and policies and in accordance with federal, state, and local law.

           
           

        6. Are documented by records made at the time the goods or services were provided, demonstrating the medical necessity for the goods or services rendered. Medicaid goods or services are excessive or not medically necessary unless both the medical basis and the specific need for them are fully and properly documented in the recipient's medical record.

           
           

172. The terms "medical necessity" and "medically necessary" are statutorily defined to mean

     any goods or services necessary to palliate the effects of a terminal condition, or to prevent, diagnose, correct, cure, alleviate, or preclude deterioration of a condition that threatens life, causes pain or

     suffering, or results in illness or infirmity, which goods or services are provided in accordance with generally accepted standards of medical practice. For purposes of determining Medicaid reimbursement, the agency is the final arbiter of medical necessity.

     Determinations of medical necessity must be made by a licensed physician employed by or under contract with the agency and must be based upon information available at the time the goods or services are provided.

     
     

     § 409.913(1)(d), Fla. Stat.; see also § 409.9131(2)(b), Fla. Stat.

173. Pursuant to Section 409.9131(5), Florida Statutes, when the AHCA makes a determination of overpayment with respect to a physician, it must:

     1. Use accepted and valid auditing, accounting, analytical, statistical, or peer-review methods, or combinations thereof. Appropriate statistical methods may include, but are not limited to, sampling and extension to the population, parametric and nonparametric statistics, tests of hypotheses, other generally accepted statistical methods, review of medical records, and a consideration of the physician's client case mix. Before performing a review of the physician's Medicaid records, however, the agency shall make every effort to consider the physician's patient case mix, including, but not limited to, patient age and whether individual patients are clients of the Children's Medical Services network established in chapter 391. In meeting its burden of proof in any administrative or court proceeding, the agency may introduce the results of such statistical methods and its other audit findings as evidence of overpayment.

        
        

     2. Refer all physician service claims for peer review when the agency's preliminary analysis indicates a potential overpayment, and before any formal proceedings are initiated against the physician, except as required by s. 409.913.

     
     

174. "Peer review," as that term is used in Section 409.9131(5), Florida Statutes, is defined in

     Section 409.9131(2)(d), Florida Statutes, as

     
     

     an evaluation of the professional practices of a Medicaid physician provider by a peer or peers in order to assess the medical necessity, appropriateness, and quality of care provided, as such care is compared to that customarily furnished by the physician's peers and to recognized health care standards, and to determine whether the documentation in the physician's records is adequate.

     
     

175. "Peer," as that term is used in Section 409.9131(5), Florida Statutes, is defined in Section 409.9131(2)(c), Florida Statutes, as "a Florida licensed physician who is, to the maximum extent possible, of the same specialty or subspecialty, licensed under the same chapter, and in active practice." "Active practice," as that term is used in Section 409.9131(5), Florida Statutes, is defined to mean that "a physician must have regularly provided medical care and treatment to patients within the past 2 years." § 409.9131(2)(a), Fla. Stat.

176. Based on the findings of fact herein, AHCA has established that Dr. Shands satisfies the statutory criteria of

     a peer, and, therefore, AHCA has satisfied the requirement of Section 409.9131(5)(b), Florida Statutes, that a peer review be conducted of all physician claims that, on preliminary review, may be a potential overpayment.

177. Based on the findings of fact herein, AHCA has met its burden of proving by proving by a preponderance of the evidence that Dr. Lee's treatments of Patient #4, Patient #5, Patient #6, Patient #7, Patient #9, Patient #13, Patient #15, Patient #16, Patient #21, and Patient #24 with infusions of IVIG were not medically necessary. Accordingly, Dr. Lee is liable to AHCA for Medicaid overpayments in the amount of $109,439.77, which is the amount AHCA sought to recoup as of the date of the final hearing.

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.

ENDNOTES

1/ Because the Audit Period covers the period from January 1, 1996, through August 11, 2000, references to the Florida Statutes shall be to the 1996 through 2000 editions, unless otherwise specified.

2/ AHCA issued a FAAR dated August 9, 2001, in which it identified the calculated overpayment as $130,749.44. Dr. Lee disputed the material facts stated in the FAAR, and the case was referred to the Division of Administrative Hearings and assigned DOAH Case No. 01-4077. Prior to hearing, the parties requested that the file be remanded to AHCA to allow the parties an opportunity to resolve the matter through settlement, and the case was closed and the matter remanded to AHCA.

Settlement negotiations were not successful, and AHCA withdrew its August 2001 FAAR and issued another FAAR dated May 8, 2003, in which it alleged an overpayment of $129,148.49. This FAAR was forwarded to the Division of Administrative Hearings, and the instant case was opened. Meanwhile, Dr. Lee filed with the Division of Administrative Hearings a Motion to

Reopen DOAH Case No. 01-4077, which was denied. Dr. Lee appealed this order to the District Court of Appeal for the Fourth District of Florida, and the instant case was placed in abeyance pending the decision of the district court. On

August 1, 2003, the district court denied Dr. Lee's petition for review, and this case was scheduled for final hearing.

3/ A sinopulmonary infection involves both the sinuses and the lungs.

4/ Although Dr. Lee looked at the level of CD4 cells when diagnosing DHI, she conceded during cross-examination that "the lack of -- or the CD4 counts is not a factor to be used in determining deficiency of humoral immunity." Transcript at page 592.

5/ Dr. Shands testified that "erythematous, edematous turbinates" describe a "red nose." Transcript at volume 1, page

108. Nothing was found in Dr. Lee's testimony to contradict Dr. Shands' testimony on this point.

6/ Dr. Lee ordered two CT scans of Patient #6's brain, but she did not order a CT scan of the sinuses, which could have provided a definitive diagnosis of chronic, acute sinusitis.

7/ According to the medical records provided by Dr. Lee's office, Patient #9 received infusions of IVIG on December 15 and 16, 1997, but it appears that Dr. Lee did not file claims with Medicaid for these infusions.

8/ It must also be noted that, in the records of the August 14, 1997, office visit, Dr. Lee indicated that Patient #9 needed IVIG treatments because of bleeding gums and rectal bleeding.

9/ Dr. Lee would not be entitled to payment for the infusion of IVIG on these dates for the reasons stated in paragraph 91, above.

10/ The medical records provided by Dr. Lee's office indicate that Patient #13 received infusions of IVIG on July 30 and 31, 1996; March 12, 1997; September 12, 1997; October 13 and 14,

1997; and November 11 and 12, 1997, but it appears that Dr. Lee did not file claims with Medicaid for these infusions.

11/ The medical records provided by Dr. Lee's office indicate that Patient #16 received infusions of IVIG on July 8 and 9,

1996; August 5 and 6, 1996; January 6, 1997; March 18, 1997;

April 15, 1997; May 19 and 20, 1997; June 16 and 17, 1997;

July 14 and 15, 1997; August 11 and 12, 1997; and September 8 and 9, 1997, but it appears that Dr. Lee did not file claims with Medicaid for these infusions.

12/ Although Dr. Lee's notes reflect that Patient #16 had recurrent sinus infections dating from 1992, when he was treated by a Dr. Sutherland, Dr. Lee provided no supporting documentation.

13/ The medical records provided by Dr. Lee's office indicate that Patient #21 also received an infusion of IVIG on August 12, 1997, but it appears that Dr. Lee did not file a claim with Medicaid for this infusion.

14/ Dr. Lee also indicated in the medical report of the

August 5, 1996, examination that she had ordered "sinus films," but there is no further mention of these films in the medical records.

15/ Only page one of three was included in the medical records provided by Dr. Lee.

16/ The medical records provided by Dr. Lee's office indicate that Patient #24 also received infusions of IVIG on May 5 and 6, 1997; October 6 and 7, 1997; November 3 and 4, 1997; and December 10 and 11, 1997, but it appears that Dr. Lee did not file claims with Medicaid for these infusions.

17/ Dr. Lee indicated in the notes she prepared on this case that her determination that Patient #24 suffered from peripheral neuropathy was based on information she received from a physician in Pittsburgh, Pennsylvania, who had previously treated Patient #24. There is, however, no documentation confirming Patient #24's treatment in Pennsylvania or the diagnosis of neuropathy.

18/ Neuropathy was not included as a diagnosis when Patient #24 returned to Dr. Lee's office for the second infusion of IVIG on November 4, 1997, but Dr. Lee did not submit claims to Medicaid for the November 3 and 4, 1997, IVIG infusions.

19/ Patient #24 received infusions of IVIG at Dr. Lee's office on October 6 and 7, 1997, and on November 3 and 4, 1997, but

Dr. Lee apparently did not submit claims to Medicaid for these infusions.

20/ Dr. Lee apparently did not submit a claim to Medicaid for this infusion.

21/ Dr. Lee apparently did not submit a claim to Medicaid for this infusion.

22/ Dr. Lee apparently did not submit a claim to Medicaid for this infusion.

23/ On December 11, 1997, Patient #24 reported a cough and tightness in his chest, but these symptoms responded almost immediately to an increase in the dosage of an antibiotic. And, on December 16, 1997, Dr. Lee noted that Patient #24 had a pulmonary infection that responded to Mephron.

COPIES FURNISHED:

Joanne Fanizza, Esquire

Law Offices of Joanne Fanizza, P.A.

1995 East Oakland Park Boulevard, Suite 210 Fort Lauderdale, Florida 33306

Anthony L. Conticello, Esquire Garnett W. Chisenhall, Esquire

Agency for Health Care Administration 2727 Mahan Drive, Mail Station 3

Tallahassee, Florida 32308

Charlene Thompson, Acting Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Station 3

Tallahassee, Florida 32308

Valda Clark Christian, General Counsel Agency for Health Care Administration Fort Knox Building, Suite 3431

2727 Mahan Drive

Tallahassee, Florida 32308

Alan Levine, Secretary

Agency for Health Care Administration Fort Knox Building, Suite 3116

2727 Mahan Drive

Tallahassee, Florida 32308

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions within

15 days from the date of this recommended order. Any exceptions to this recommended order should be filed with the agency that will issue the final order in this case.

Docket for Case No: 03-002251MPI

Orders for Case No: 03-002251MPI