Appeal type: Medical Necessity
Decision: Upheld

A 56-year-old female has requested coverage for past and future intravenous (IV) ceftriaxone (Rocephin) for treatment of her diagnosis of Lyme disease.   Findings:  The physician reviewer found that the patient has a history of developing pain in her lower extremities starting two years ago. The patients pain was primarily in the feet. She was assessed by a number of providers. An electromyography (EMG) was reportedly normal. The patient was evaluated with a magnetic resonance imaging (MRI) of the lumbar spine and a variety of tests for medical causes of her pain. In the following year, the patient indicated that her pain was in the medial feet and calves bilaterally. She told her provider at that time that she was unable to sit because of pain in her tailbone. A neurological assessment at that time did not reveal any focal neurological deficits. The provider did comment on the patients 30 pound weight loss. The following month, her provider also noted that she had had significant GI upset for some months. She was started on doxycycline for treatment of presumed Lyme disease at that time. Lyme testing was done. The screening EIA test was positive. The IgM Western Blot was positive by Centers for Disease Control (CDC) criteria. A quantitative IgM was negative. The patient was subsequently seen in consultation by an infectious diseases specialist. That provider prescribed ceftriaxone 2gm intravenous (IV) every 24 hours for 4 weeks. The provider noted that the patient had late neurological peripheral disease due to Borrelia. A letter from the patients provider stated that ceftriaxone was medically necessary for treating her symptoms of significant fatigue, arthralgias, paresthesias, seizure-like activity, tingling and decreased energy. Based on review of the available records, there is inadequate clinical history consistent with Lyme disease. The records do not document a tick bite and there is no evidence of the rash seen in a significant proportion of patients with early Lyme disease. In addition, Lyme disease rarely causes peripheral neuropathic pain. As noted in the clinical literature by Wormser and colleagues, patients with Lyme disease have abnormal nerve conduction studies and reduced vibratory sensation in the lower extremities. Moreover, an elevated IgG antibody to Borrelia burgdorferi has been seen in all cases. These findings were not noted in this patients chart. Further, late Lyme disease may be associated with other neurologic disease, but these are usually manifested as encephalopathy or cranial nerve palsies. The positive IgM antibody by Western Blot is a false positive in this patient. The IgG would be expected to be positive in long-standing Lyme disease. An isolated positive IgM has been shown in multiple studies to usually not confirm the presence of Lyme disease. This is especially true in a patient such as with this patient who has had long-standing symptoms. Thus, if the patient in fact had Borrelia infection, it would be expected that the IgG would be positive. A recent study by Seriburi and colleagues reported that 27.5% of patients with a positive IgM Western Blot assessed for Lyme disease had a false positive result. Finally, this patient has been treated with oral doxycycline for an extended period of time. Although she does not have this disease, she has been treated for it. All told, there is no indication for ceftriaxone.