hope it's cool to post this.. if not, i'll remove it. this is scanned not typed.. i cleaned it up as best i could.
Fax Nov 7 2007 11:25am P002/010
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WellPoint MedIcal Policy
Subject: Parenteral Antibiotics for the Treatment of Lyme Disease
Policy #:MED.00013 Current Effective Date:02/05/2007
Status: Reviewed Last Review Date: 12/07/2006
This policy addresses the use parenteral antibiotics (i.e., intravenous and intramuscular) for the treatment of Lyme disease.
A 4 week course of IV antibiotic therapy usually with ceftriaxone or penicillin is considered medically necessary for patients with Lyme disease meeting ANY of the following criteria:
* Myocarditis associated with third degree heart block; or
* Persistent or recurrent joint swelling (i.e., arthritis) after an initial 1 month trial of oral antibiotics; or
* Acute meningitis or radiculopathy; or
* Late neurological disease affecting the central or peripheral nervous system.
Investigational/Not Medically Necessary:
Other indications for IV antibiotic therapy for Lyme disease are considered investigational/not medically necessary, including, but not limited to ANY of the following:
* Prophylactic treatment of patients who have reported a tick bite but have no clinical findings suggestive of Lyme disease; or
* Treatment of patients with vague systemic symptoms without supporting serologic or cerebrospinal fluid (CSF) studies; or
* Treatment of chronic fatigue syndrome or fibromyalgia attributed to Lyme disease;
* Initial treatment of Lyme arthritis without coexisting neurological symptoms; or
* Treatment of persistent arthritis after 2 prior courses of antibiotic therapy; or
* Treatment of"post-Lyme disease" syndrome; or
* Repeat or prolonged courses (greater than 4 weeks) of intravenous antibiotics.
Intramuscular antibiotics as a treatment of any aspect of Lyme disease are considered investigational/not medically necessary.
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Role of IV Antibiotics
A diagnosis of Lyme disease (LD) requires appropriate epidemiologic data, supporting clinical observation (including
exposure to ixodid ticks in an endemic area), and supporting laboratory findings. However, over diagnosis and over treatment
of LD is common (Hu, 1993; Steere, 1993; Am College of Rheumatology, 1993). Intravenous antibiotic therapy in patients
with presumed LD may be inappropriately recommended in the following situations: an incorrect diagnosis; prolonged or
repeated courses of IV antibiotics; and use of IV antibiotics when oral antibiotics are adequate. An incorrect diagnosis of LD
includes those patients with positive serologies without characteristic signs or symptoms of LD, or those with non-
specific symptoms, but with no known exposure to ticks in an endemic area, or those without supporting serologic evidence. In
1993 the American College of Rheumatology published a position paper on IV antibiotic treatment for LD, which
concluded that "empiric treatment of patients with nonspecific chronic fatigue or myalgia on the basis of positive serologic
results alone will result in many more instances of antibiotic toxicity than cures of atypically symptomatic true Lyme disease.
In patients whose only evidence for Lyme disease is a positive immunologic test, the risks for empiric N antibiotic treatment
outweigh the benefits."(Am College of Rheumatology, 1993). Other studies have also supported the use of oral, not IV,
antibiotics in patients with LD without neurologic involvement (Dattwyler 1997; Eckman 1997).
Published literature suggests that IV antibiotic therapy should be limited to those patients with objective and laboratory evidence
of neuroborreliosis, those patients with carditis and third degree heart block, and in those with well-docwnented severe Lyme
arthritis that does not respond to initial oral antibiotic therapy (Rahn, 1991; Paclmer 1995; Sigal, 1992 and 1995; Steere,
1997). No evidence supports prolonged (greater than 1 month) or repeated courses of IV antibiotic therapy. Practice guidelines
regarding the treatment of Lyme disease have been issued by the Infectious Diseases Society of America (2006). These
guidelines induded the following recommendations for IV antibiotics. Note that none of the recommendations suggest
longer than a I-month course of IV antibiotics:
* Meningitis or radiculopathy; 14~28 days
* 3rd degree heart block; 14-21 days
* Recurrent arthritis after oral regimen; 14-28 days
* CNS or peripheral nervous system disease; 14-28 days
In addition, these guidelines recommend symptomatic treatment for symptoms that persist after appropriate antibiotic therapy.
For example, patients with persistent arthritis may be treated with anti-inflammatory agents or arthroscopic synovectomy.
Finally, these guidelines recommend symptomatic treatment for symptoms that persist after
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appropriate antibiotic therapy. These guidelines do not identifY any role for intramuscular antibiotics.
Lyme disease (LD) is a multisystem inflammatory disease caused by the spirochete Borrelia burgdorjeri and transmitted by the
bite of an infected ixodid tick endemic to Northeastern, North Central, and Pacific coastal regions of the United States. The
disease is characterized by stages, beginning with localized infection of the skin (erythema migrans), followed by
dissemination to many sites. Manifestations of early disseminated disease may include lymphocytic meningitis, facial
palsy, painful radiculoneuritis, atrioventricular nodal block, or migratory musculoskeletal pain. Months to years later, the
disease may be manifested by intermittent oligoarthritis, particularly involving the knee joint, chronic encephalopathy,
spinal pain, or distal paresthesias. While most manifestations of LD can be adequately treated with oral antibiotics, intravenous
(IV) antibiotics are indicated in some patients with neurologic involvement or atrioventricular heart block. However, over
diagnosis and over treatment ofLD is common due to its nonspecific symptoms, a lack of standardization of serologic
tests, and difficulties in interpreting serologic test results. In particular, patients with chronic fatigue syndrome or
fibromyalgia are commonly misdiagnosed as possibly having LD and undergo inappropriate IV antibiotic therapy.
Risk factors in contracting Lyme disease center on people's exposure to outside environments in areas where Lyme disease
occurs. Such activities include working in areas surrounding tick-infested woods and overgrown brush and in outside
occupations. Additionally, people who spend time outside or participate in leisure activities such as hunting, fishing, hiking,
or camping are at high risk for Lyme disease. Any of these activities bring these participants into areas where ticks may be present.
The following paragraphs describe the various manifestations ofLD that may prompt therapy with IV antibiotics.
Neurologic Manifestations of Lyme Disease (Neuroborreliosis)
Lymphocytic meningitis, characterized by head and neck pain, may occur during the acute disseminated stage of the disease.
Analysis of the cerebrospinal fluid (CSF) is indispensable for the diagnosis of Lyme meningitis. If the patient has LD, the CSF will
show a lymphocytic pleocytosis presence of too many cells with increased levels of protein. Intrathecal production of antibodies
directed at spirochetal antigens is typically present. A normal CSF analysis is strong evidence against Lyme meningitis.
Treatment with a 2- to 4-week course of IV antibiotics, typically ceftriaxone or cefotaxime, is reconunended.
Cranial neuritis, most frequently Bell's palsy, may present early in the course of disseminated LD, occasionally prior to the development of antibodies, such that an LD
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etiology luay be difficult to rule in or out. While Bell's palsy typically resolves spontaneously with or without treatment with
oral antibiotics, some physicians have recommended a lumbar plli1cture and a course of IV antibiotics if pleocytosis in the CSF
is identified, primarily as a prophylactic measure to prevent further neurologic symptoms.
A subacute encephalopathy may occur months to years after disease onset, characterized by subtle disturbances in memory,
mood, sleep, or cognition accompanied by fatigue. These symptoms may occur in the absence of abnonnalities in the
electroencephalogram (EEG), magnetic resonance imaging (MRI), or CSF. In addition, the symptoms are nonspecific and overlap
with fibromyalgia and chronic fatigue syndrome. Thus diagnosis of Lyme encephalopathy may be difficult and may be best
diagnosed with a mental status exam or neuropsychological testing. However, treatment with IV antibiotics is generally not
indicated unless CSF abnormalities are identified.
Much rarer, but of greater concern, is the development of encephalomyelitis, characterized by spastic paraparesis, ataxias,
cognitive impairment, bladder dysfunction, and cranial neuropathy. CSF examination reveals a pleocytosis and an
elevation in protein. Selective synthesis of anti-spirochetal antigens can also be identified. A course of IV antibiotics with 3
to 4 weeks of ceftriaxone is suggested when CSF abnormalities are identified.
A variety of peripheral nervous system manifestations of LD have also been identified. Symptoms of peripheral neuropathy include
paresthesias, or radicular pain with only minimal sensory signs. Patients typically exhibit e1ectromyographic (EMG) or nerve
conduction velocity abnormalities. CSF abnonnalities are usually seen only in those patients with a coexistent encephalopathy.
Cardiac Manifestations of Lyme Disease
Lyme carditis may appear during the early dissemination stage of the disease; symptoms include atrioventricular heart block,
tachyarrhythmias, and myopericarditis. Antibiotics are typically given, although no evidence proves that this therapy hastens the
resolution of symptoms. Both oral and IV regimens have been advocated. Intravenous regimens are typically used in patients
with a high degree atrioventricular block or a PR interval on the electrocardiogram (EKG) of greater than 0.3 second. Patients
with milder forms of carditis may be treated with oral antibiotics.
Lyme arthritis is a late manifestation of infection and is characterized by an elevated 19G response to B. burgdoiferi and
intennittent attacks of oligoarticular arthritis, primarily in the large joints such as the knee. Patients with Lyme arthritis may be
successfully treated with a 30-day course of oral doxycycline or amoxicillin, but care must be taken to exclude simultaneous
central nervous system (eNS) involvement, requiring IV antibiotic treatment. In the small subset of patients that do not respond to
oral antibiotics, an additional 30-day course of oral or IV antibiotics may be recommended.
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Fibromyalgia and Chronic Fatigue Syndrome
Fibromyalgia and chronic fatigue syndrome are the diseases most commonly confused with LD. Fibromyalgia is characterized
by musculoskeletal complaints, multiple trigger points, difficulty in sleeping, generalized fatigue, headache, or neck pain. The
joint pain associated with fibromyalgia is typically diffuse, in contrast to Lyme arthritis, which is characterized by marked
joint swelling in one or a few joints at a time, with few systemic symptoms. Chronic fatigue syndrome is characterized by
multiple subjective complaints, such as overwhelming fatigue, difficulty in concentration, and diffuse muscle and joint pain. In
contrast to LD, both of the above conditions lack joint inflammation, have normal neurological test results, or have test
results suggesting anxiety or depression. Neither fibromyalgia nor chronic fatigue syndrome has been shown to respond to antibiotic therapy.
Arthritis: inflammation of the joints
Carditis: inflammation of the heart
Chronic fatigue syndrome: a condition of prolonged and severe tiredness or weariness (fatigue) that is not relieved by rest and is not directly caused by other conditions
Fibromyalgia: a common condition characterized by widespread pain in joints, muscles, tendons, and other soft tissues
Lyme disease: Lyme disease is transmitted through the bite of the deer tick (Ixodes scapularis ) infected with the bacteria Borrelia burgdoiferi , which is the actual cause of the disease
Neurological involvement: when a condition involves the nervous system
Prophylactic antibiotic therapy: using antibiotic medications in order to prevent infection when no infection exists
The following codes for treatments and procedures applicable to this policy are included below for infonnational purposes.
Inclusion or exclusion of a procedure, diagnosis or device coders) does not con... .. titute or imply member coverage or
provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine
coverage or non-coverage of these services as it applies to an individual member.
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CPT 90765 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour
90766 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); each additional hOUT, up to 8 hours
90767 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); additional sequential infusion, up to 1 hour
90768 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); concurrent infusion
HCPCS J0696 Injection, ceftriaxone sodimn, per 250 mg
J2510 Injection, penicillin G procaine, aqueous, up to 600,000 units
S9494 Home infusion therapy, antibiotic, antiviral, or antifungal therapy; administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment, per diem
S9497 Home infusion therapy, antibiotic, antiviral, or antifungal therapy; once every 3 hours
S9500 Home infusion therapy, antibiotic, antiviral, or antifungal therapy; once every 24 hours
S9501 Home infusion therapy, antibiotic, antiviral, or antifungal therapy, once every 12 hours
S9502 Home infusion therapy, antibiotic, antiviral, or antifungal therapy, once every 8 hours
S9503 Home infusion therapy, antibiotic, antiviral, or antifungal therapy, once every 6 hours
S9504 Home infusion therapy, antibiotic, antiviral, or antifungal therapy, once every 4 hours
When services are Investigational/Not Medically Necessary:
For the procedure and diagnosis codes listed above, when criteria are not met or when the code describes a procedure
indicated in the Policy section as investigational/not medically necessary.
When services may be also InvestigationaUNot Medically Necessary:
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90772: Therapeutic, prophylactic or diagnostic injection (specify substance or drug); subcutaneous or intramuscular (when specified as intramuscular antibiotic injection)
088.81 Lyme disease (Erythema chronicum migrans)
Peer Reviewed Publications:
1. Hsu VM, Patella SJ, Sigal LH. "Chronic Lyme disease" as the incorrect diagnosis in patients with fibromyalgia. Arthritis Rheum. 1993; 36(11):1493-1500,
2. Steere AC, Taylor E, McHugh GL~ et a1. The overdiagnosis of Lyme disease. lAMA. 1993; 269(14): 1812-1826.
3. Dattwyler RJ, Luft BJ, Kunkel MJ, et a1. Ceftriaxone compared with doxycycline for the treatment of acute disseminated Lyme disease, N Engl J Med. 1997; 337 (5):289-294.
4. Eckman MH, Steere AC, Kalish RA, et a1 Cost effectiveness of oral as compared with intravenous antibiotic therapy for patients with early Lyme disease or Lyme arthritis. N Engl J Med. 1997; 337(5):357-363.
5. Ralm DW, Malawista SE. Lyme disease: Recommendations for diagnosis and treatment. Ann Intern Med. 1991; 114(6):472-481.
6. Pachner AR. Early disseminated Lyme disease: Lyme meningitis. Am J Merl. 1995; 98(4A):30S-43S.
7. Sigal LH. Early disseminated Lyme disease: cardiac manifestations. Am J Med. 1995; 98(4A):25S-29S.
8. Sigal LH. Current recommendations for the treatment of Lyme disease. Drugs, 1992; 43(5):683-699.
9. Steere AC. Diagnosis and treatment of Lyme arthritis. Med Clin North Am. 1997; 81(1): 179-194,
Government Agency, Medical Society, and Other Authoritative Publications:
1. American Collage of Rheumatology. Appropriateness of parenteral antibiotic treatment for patients with presumed Lyme disease. A joint statement of the American College of Rheumatology and the Council of the Infectious Diseases Society of America. Ann Intern Med. 1993; 119(6):518.
2. Wormser GP, Dattwy1er RJ, Schapiro ED, et al. The Clinical Assessment, Treatment, and Prevention of Lyme Disease, Human Granulocytic Anaplasmosis~ and Babesiosis: Clinical Practice Guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2006; 43:1089-1134.