Harvard Pilgrim Health Care Medical Policy

Lyme Disease: Antibiotic Coverage

Subject: Lyme Disease: Antibiotic Coverage

Background: Lyme disease is a multisystem inflammatory, tick-transmitted infection caused by the spirochete bacterium Borrelia burgdorferi. The bacterium is carried and transmitted by deer ticks (Ixodes scapularis). In most cases, Lyme disease is first characterized by the appearance of a red skin lesion (erythema chronicum migrans), which begins as a small elevated round spot (papule) that expands to at least five centimeters in diameter. Symptoms may then progress to include low-grade fever, chills, muscle aches (myalgia), headaches, a general feeling of weakness and fatigue (malaise), and/or pain and stiffness of the large joints (infectious arthritis), especially in the knees. Such symptoms may tend to occur in recurrent cycles. In severe cases, heart muscle (myocardial) and/or neurological abnormalities may occur.

Chronic Lyme disease is a generally unrecognized diagnosis that encompasses \

Please reference appropriate member materials (e.g., Benefit Handbook, Certificate of Coverage) for member-specific benefit information.

• Polymerase Chain Reaction (PCR) based direct detection in cerebral spinal fluid (CSF), synovial tissue or synovial fluid.

A licensed physician may prescribe, administer or dispense long-term (up to 6 months) antibiotic therapy for a therapeutic purpose to eliminate infection or to control a patient’s symptoms upon making a clinical diagnosis that the patient has Lyme disease or displays symptoms consistent with a clinical diagnosis of Lyme disease, if such clinical diagnosis and treatment are documented in the patient’s medical record by the prescribing licensed physician.

Coverage of antibiotics for the treatment of Lyme disease must be expected, based on medical literature, to be effective in the treatment of Lyme disease; any antibiotic used to treat Lyme must have supporting literature showing that it is effective in vitro or in vivo against borrelia burgdorferi). The antibiotics currently known to be effective in the treatment of Lyme disease, and which will be reimbursable are limited to:

• First line agents: doxycycline, amoxicillin, and cefuroxime axetil
• Second line agents: azithromycin, clarithromycin, erythromycin

NOTE: Antibiotics for the treatment of Lyme disease other than those listed above as first and second line agents may be covered provided such drug is recognized for treatment of Lyme disease in one of the standard reference compendia, or in the medical literature. To receive reimbursement, prescribers must submit clinical documentation supporting the drug’s effectiveness in treating Lyme disease, including the applicable literature if appropriate. Payment for Lyme disease antibiotic treatment will not be denied solely because such treatment may be characterized as unproven, experimental, or investigational.

Long-term antibiotics, under this guideline must be prescribed by a licensed physician, not a Registered Nurse Practitioner or a Physician Assistant, as required under applicable law.

Coverage of the treatment of “co-infections” with long-term antibiotics or other treatments not currently supported by the mainstream medical literature will not be covered. Usual standards of medical practice will be used to evaluate the treatment of co-infections and will require demonstrated proof that the member has the infection in question, as documented by appropriate laboratory testing; documentation must be provided by an independent, state credentialed lab. Treatment courses limited to time periods and agents known to be effective based on the usual treatment standards and the current medical literature.

Exclusions:

Harvard Pilgrim Health Care (HPHC) considers antibiotics treatment of Lyme or other Tick-Borne Diseases as not medically necessary when above criteria are not met.

In addition, HPHC does not cover:

• PCR-based direct detection of B. burgdorferi in urine samples
• Genotyping or phenotyping of B. burgdorferi
• Determination of levels of the B lymphocyte chemoattractant CXCL13 for diagnosis or monitoring treatment
• Capture assays for antigens in urine
• Culture, immunofluorescence staining, or cell sorting of cell wall-deficient or cystic forms of B. burgdorferi
• Lymphocyte transformation tests
• Quantitative CD57 lymphocyte assays
• Measurements of antibodies in joint fluid (synovial fluid)
• IgM or IgG tests without a previous ELISA/EIA/IFA
• Treatment of Lyme Borrelia infection when diagnosis is based on invalidated tests including (but not limited to):

Reverse Western blots

Treatment of Lyme Borrelia infection when diagnosis is based on invalidated tests including (but not limited to):

HPHC Medical Policy
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Lyme Disease: Antibiotic Coverage
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HPHC policies are based on medical science, and written to apply to the majority of people with a given condition. Individual members’ unique clinical circumstances, and capabilities of the local delivery system are considered when making individual UM determinations.

Coverage described in this policy is standard under most HPHC plans. Specific benefits may vary by product and/or employer group. Please reference appropriate member materials (e.g., Benefit Handbook, Certificate of Coverage) for member-specific benefit information.

• Positive Western blot in the absence of a positive or equivocal other antibody test (i.e. not using two tier testing)
• Western blot positivity that does not meet CDC criteria
• Repeat PCR-based direct detection of B. burgdorferi is generally considered not medically necessary

Guidelines:

IgG is considered positive only when 5/10 of the following kDa bands are seen: 18, 23, 28, 30, 39, 41, 45, 58, 66, 93. IgM is considered positive only when the IgM is performed within 4 weeks of illness onset, and when 2/3 of the following bands are seen: 23, 39, 41.

For the small proportion of patients who have negative or indeterminate IgM positivity, repeat testing should be performed 2-4 weeks later if suspicion remains high. In those cases, authorization for treatment with parenteral antibiotics will not be delayed pending repeat test results.