Appeal type: Medical Necessity
Decision: Upheld Decision of Health Plan

The patient is a 47-year-old woman reported to have Lyme disease and fibromyalgia. There is no documentation of the latter diagnosis in the submitted records. She apparently was initially assessed because of fatigue in late May 2005. In June 2005, a note stated that she had erythema migrans in 1988. In mid-July 2005 she was begun on Ketek. The note also reports that the Health Plan had denied Zithromax. In August 2005, her dose of Ketek was increased. The patient was noted to be edgy, dizzy and having problems concentrating. She also had similar symptoms in August 2005 and was additionally bothered by sleeplessness. On two visits in September 2005, she noted problems with sleep. She reported overall improvement while on vacation during which time she was under less stress. At the end of September 2005 she asked for intravenous antibiotics and noted that she had input overload and had been anxious and crying. In November 2005, the patients provider reported the patient had less intensity in radiating and vibration feeling inside of her and had improved. She was receiving IV Rocephin at this time. The patient noted that she gets sick when under stress. She was seen also in mid-December 2005 and in January 2006; on both visits she was reported to be on IV Rocephin and to be improving.The submitted laboratory studies were largely normal. However, a glucose test in November 2005 was abnormal at 165mg%. In addition, an unexplained report sheet included an IgM Borrelia sensu strict of 2.5 with a normal range of 0-2.  There is also an IgM Bartonella peptide of 2.9 listed with 0-2 again in the normal range. These are single tests of an unknown type. The Lyme IgG Western Blot is negative; the Lyme IgM Western Blot is positive. This is a single positive test with no recent history of clinical Lyme disease and most probably represents a false positive.At issue is whether IV antibiotic therapy beyond a 30-day period is medically necessary for treatment of the patients condition.The evidence provided does not make a diagnosis of Lyme disease. The CDC approach [screening test followed by Western Blot Studies] remains the accepted route to a serological confirmation of Lyme disease. In this case there was a positive IgM Western Blot in the face of a negative IgG Western Blot. Given the lack of any clinical evidence of acute Lyme disease in prior months, this most likely represents a false positive result. Because the diagnosis of Lyme disease has not been substantiated, treatment with the intravenous antibiotic Rocephin was not necessary. Even if there was sufficient evidence of Lyme disease, there is no support for a period of over 30 days of treatment with IV antibiotics. Indeed, except for documented cardiac or neurological disease, there is no indication for a months treatment with Rocephin. The paper by Krupp, et al. is a blinded randomized trial of 28 days of antibiotic therapy for post Lyme disease fatigue. The group that received the antibiotic did have improvement in fatigue but no improvement in measures of cognitive function. Because there were significant adverse effects associated with the antibiotic therapy, the authors concluded that there was no indication for Rocephin therapy for patients with Lyme disease who report fatigue.Based upon the information set forth above, I have determined the requested therapy is not medically necessary for treatment of the patients medical condition. The Health Plans denial should be upheld.