NO DATE FOR THIS OUTSTANDING ARTICLE!!! ****************************************
HEALTH CENTERS OF AMERICA WEBSITE **********************************
Insurance Reimbursement and Lyme Disease ******************************************
Lyme Disease and Insurance Reimbursement
This document is to address the concerns presented by insurance companies and their lack of reimbursement coverage for the treatment of Lyme disease.
The first and most difficult task however, is to get the medical director for the insurance company to ``READ and REVIEW'' this documentation and references.
The arguments against reimbursement by most insurance companies fall within two major areas:
First is: Diagnosis is not within standard guidelines.
Lyme diagnosis is not within standard of care There is not such thing as Lyme disease (in this area).
Lyme testing used are not FDA approved or CDC approved i.e. Bowen, MDL, etc.
There is no clinical evidence of Lyme disease with this patient (based on being ill informed and lack of understanding of the stages and symptoms of Lyme disease).
Second is: Treatment is not medically necessary because of one of the two following reasons:
1) Not adequate data supporting diagnosis and/or
2) the treatment is not within the standard of care for Lyme disease
Treatment with IV's for Lyme disease is not within standard of care ***************************
Length of treatment is not standard of care
Antibiotic used is not standard of care
Supplements are not within standard of care
Third and most significant: The insurance company does not want to pay for the treatment of Lyme disease and the medical directors/review board of the insurance company serves to implement that position.
The hurdle once again is to get a fair hearing.
There are several levels of confronting the insurance company once they have rejected the initial claim.
The first step however, is to make sure that the patient's insurance policy does provide coverage for claims.
It is best to have some indication at the beginning of treatment.
Remember that even though the insurance company may say they will cover treatment, they always state they reserve the right to review the claim before reimbursement.
Make sure the patient understands that coverage is always within the limits of the individual policy and they coverage is always what is ``usual and customary.'' **************************
Responses to arguments ***********************
First Response: responding to requests for more information and patient notes following billing to the insurance company.
Second Response: responding to the first rejection letter.
Send Letter of Medical Necessity with copies of test results and summary of clinical data.
Third Response: After the patient or physician has received a second letter of rejection send a more detailed response about diagnosis (clinical);
lab results that support Lyme disease and secondary conditions and
copies of the patients chart and possible detailed information about Lyme disease, diagnosis and treatment.
This letter must address ``not medically necessary'' and ``standard of care'' and present a detailed description of clinical data to support the diagnosis. ****************************
Fourth Response: When a third letter of rejection is sent to the patient or physician, the patient must request a face to face hearing with the insurance company. ************************************************
The insurance company must grant this request.
At this time, someone from the physicians office must provide material to support the diagnosis and treatment of Lyme disease
and may even have to be on the phone with the insurance company giving supportive information about diagnosis and treatment.
This can be the patient's physician, nurse or someone in the office who understands the diagnosis and treatment of Lyme disease.
They key is to be sufficiently armed with refutable information. ///////////////////////
In the end however, there is no guarantee that the insurance company will respond by reimbursement of treatment.
We have found however, that most of the time the insurance company will respond in a positive manner at this point. **********************
Facts to be considered are:
Currently, there are two approaches to the diagnosis and treatment of Lyme disease.
Two sets of diagnostic and treatment guidelines, reflecting the different approaches, are available in peer review literature.
Thus, two community standards of practice exist.:
both diagnosis and treatment of Lyme disease recognized by most state boards.
When considering whether standard of care is within guidelines of medical practice, the insurance company must understand there are two standards of care.
The two standards of care are:
1) traditional - Lyme disease is rare, and if a person does have Lyme disease 2-4 weeks with oral antibiotics for early Lyme disease will solve the problem.
Most of the time Lyme disease is not recognized unless there is a EM (bulls eye rash) on the patient.
2) Growing standard that Lyme disease is widespread and treatment should be a minimum of 4-6 weeks of oral antibiotics for early Lymes
and IV antibiotics for late stages of Lyme with treatment lasting 4-6 weeks followed by oral treatment of up to 1 year.
The primary difference being that with the second frame of reference, physicians believe that Lyme disease should be treated aggressively and for a long period of time.
This is especially true for late stage Lyme disease.
Most physicians and insurance companies are not up to date on the diagnosis and treatment of Lyme disease.
Their judgment is based on archaic information, misinformation and an unwillingness to update Lyme disease.
Most states have committees or boards who are looking at the diagnosis and treatment of Lyme disease.
Their focus is on accurate reporting, better testing and standards of treatment for Lyme disease.
Must consider what stage of Lyme disease the patient is in that is being treated.
Late stage of Lyme disease or chronic Lyme disease is treated with IV Infusion treatment.
Definitions by the CDC and FDA regarding Lyme disease, diagnosis and treatment.
Problems with current Lyme disease testing
Definitions ***************
Medical Necessity -
Increasingly across the US , in insurance cases, the term ``medical necessity'' is being interpreted by the courts as the standard of community care for the illness involved.
There are two legally accepted approaches to diagnosis and care of Lyme disease.
In cases of recurrent or long-term chronic Lyme disease, treated with IV antibiotics, insurers have been quick to shield themselves behind the standard enabling them to reject or restrict a claim for reimbursement of treatment.
Therefore, ``medically necessity'' by most insurance companies is the traditional definition. *******************************
The growing definition of ``medical necessity'' accepted is that Lyme disease is best diagnosed clinically by a physician who is understands Lyme disease.
That testing for Lyme disease is not necessary for diagnosis but encouraged as supportive documentation.
Increasingly many state medical boards and the legal system, is recognizing that Lyme disease is on the increase,
that the definition of Lyme disease is much broader than previously considered
by ``traditional standards'', more research must be done, more accurate Lyme disease testing developed, and better treatment methods for Lyme disease patients.
There is growing support by the legal system that insurance companies reimburse for the chronic treatment of Lyme disease.
The ``key'' then, in this latter definition of ``medical necessity'' is to diagnose Lyme disease ``clinically'' based on an accurate and detailed medical history that is well documented. ******************************
Lyme testing is an important validation but when current testing does not support Lyme disease, the clinical evaluation by the physician takes precedence over the blood test. *************************************
CDC Definition of Lyme disease - ********************************
in 1996 the CDC recommends that to properly diagnose Lyme disease you must
1) identification by a physician of EM (rash) in the early stage, or a major system involvement with positive serology;
2) recognition by evaluating physicians of characteristic clinical sign,
a history of exposure in an area endemic for Lyme-transmitting ticks, and
the use of laboratory tests as an adjunct to diagnosis.
The CDC further states that on the Western Blot there must be 5 of 10 bands for IgG and 2 of 3 for IgM.
It is important to note that this 1996 definition of Lyme disease, excludes bands for OspA and OspB, the 31kDa and 34kDa bands, respectively, which are very specific in Lyme disease.
The ELISA is the second test the CDC recommends for Lyme disease.
Problems with the CDC definition are: *************************************
Most tick bites do not produce an EM (rash) Lyme disease is spreading rapidly throughout the US thereby conflicting with the CDC statement that a tick caring Lyme disease is limited to and area they define as endemic for Lyme-transmitting disease.
Both the ELISA and Western Blot measure the immune system's response to the Lyme spirochete -
that is - looking for the immune systems reaction within the blood for antibodies.
The believe that is there are no antibodies there is no Lyme disease.
What these tests cannot pick up, is that spirochetes have a slow growth rate, can remain dormant for a lengthy period of time, and can invade cellular walls and therefore do not produce an immune system response of antibodies.
Therefore there is a high rate of false negative is produced on these tests. ****************************************
There is a problem of standardization of these tests among labs.
FDA Definitions: ***************
In 1997 the FDA says that physicians should use blood testing ``only to support a clinical diagnosis''.
This is extremely important for insurance companies to understand and especially when insurance companies take the position that the only way to diagnose Lyme disease is with a positive Western Blot or ELISA test.
The FDA goes on to say that the results of Lyme tests (WB and ELISA primarily) ``may be easily misinterpreted.''
Bb is difficult to detect by most laboratory methods in use today, and a little known fact is that there isn't currently a test approved by the FDA for Lyme Disease.
The Diagnosis of Lyme Disease - Must be made Clinically by a qualified physician.
Diagnosis of Lyme Disease from John's Hopkins Medical School ***************************
The diagnosis of Lyme disease is clinical, and the diagnostician must consider many types of evidence.
The history is very important to the diagnosis of the disease
(e.g., opportunity for tick exposure? live or work in endemic area? recent tick bites?).
The temporality and pattern of the development of symptoms is critical to the diagnosis.
Diagnosis of Lyme Disease by Joseph Burrascano Jr., M.D. ************************************
Lyme is diagnosed clinically, as no currently available test, no matter the source or type, is definitive in ruling in or ruling out infection with these pathogens, or whether these infections are responsible for the patient's symptoms.
The entire clinical picture must be taken into account, including a search for concurrent conditions and alternate diagnoses, and other reasons for some of the presenting complaints.
Often, much of the diagnostic process in late, disseminated Lyme involves ruling out other illnesses and defining the extent of damage that might require separate evaluation and treatment.
>b>Diagnosis of Lyme Disease by Brian A. Fallon, MD; Columbia University ***********************
The criteria for diagnosing Lyme disease vary depending upon the purpose.
For surveillance studies (3), the diagnosis requires a history of exposure in an endemic area and either:
(1) a physician-diagnosed erythema chronicum migrans rash, or,
(2) serologic evidence of exposure to Borrelia burgdorferi and one of the following: ***********************************
(a) arthritic symptoms-recurrent brief attacks of joint swelling or joint pain;
(b) neurologic symptoms-such as lymphocytic meningitis, cranial neuritis, radiculoneuropathy, and/or encephalomyelitis; or
(c) cardiac conduction defects-second or third degree AV block.
This definition, while useful for research purposes, is unduly restrictive because about one-third of patients do not recall a rash and because current serologic testing is generally considered inadequate, producing false negatives and false positives (5).
Thus, the diagnosis of Lyme disease at this point remains clinical not serologic. *****************************************
Because Lyme borreliosis is multisystemic, the differential diagnosis has to be broad, including
If treated early, the disease may be limited to an asymptomatic rash or only a few days to a week of flu-like symptoms.
In its later stages, patients may have multisystemic disease, leading to an inability to work for months to years. The simplest tasks may become insurmountable.
Report by the FDA in October 1997 ***********************************
The Western blot is a supplemental test only; it is NOT a confirmatory test.
No confirmatory serological test exists at this time **************************************
Do not make the diagnosis of Lyme disease based on the results of serological lab tests.
The diagnosis must be based on a high index of clinical suspicion before laboratory testing.
Do not use seiological tests for Lyme disease for screening asymptomatic patients.
The diagnosis must be made clinically.
Serological tests for B. burgdorferi are only an aid to establish the diagnosis in the presence of strong clinical suspicion.
(The most definitive diagnostic procedure is biopsy and isolation of the organism in culture, which frequently yields the spirochete, but is often not practical.
Definitions of Testing for Lyme disease:
In the February 15 issue of the American Journal of Medicine, Mark S. Klempner, M.D., of NEMC and his scientific collaborators in New York , Connecticut and Washington , D.C. , report their findings about the reliability of two Lyme disease tests: **********************
an IgG Western blot blood test and the Lyme urine antigen test, or LUAT.
The IgG Western blot is a licensed test used to screen blood samples for antibodies to the Lyme bacterium, Borrelia burgdorferi.
The LUAT detects proteins derived from the bacterium in urine samples.
Although the LUAT has NOT been approved by the Food and Drug Administration as a valid diagnostic test for Lyme disease, it is widely used, and the NIAID Lyme Disease Advisory Panel asked that it be further evaluated.
Serologic testing is thus not very helpful in a patient with classic erythema migrans, who will be treated for Lyme disease regardless of the serologic test result.
The specificity of serologic testing is approximately 90-95% for all stages of the disease.
John's Hopkins University Medical School *****************************************
Primary Tests for Lyme Disease and validation of results:
The ELISA Lyme test is unreliable, and misses 35% of culture proven Lyme (only 65% sensitivity!) and is unacceptable as the first step of a two step screening protocol. *************************************
(By definition a screening test should have 95% sensitivity.)
Of patients with acute culture proven Lyme disease, 20-30% remain seronegative on serial Western Blot sampling.
Antibody titers also appear to decline over time; thus, the IgG Western Blot is even less sensitive in detecting chronic Lyme infection yet the IgM Western Blot may work.
For "epidemiological purposes" the CDC eliminated from the Western Blot analysis the reading of bands 31 and 34.
These bands are so specific to Borrelia burgdorferi that they have been chosen for vaccine development. ***************************
However, for patients not vaccinated for Lyme, a positive 31 or 34 band is highly indicative of Borrelia burgdorferi exposure.
When used as a part of a diagnostic evaluation for Lyme disease, the Western Blot Lyme test should be performed by a laboratory that reads and reports on all 16 bands as part of their routine comprehensive analysis. *********************************
Laboratories (such as SmithKline) that use FDA approved kits (for instance, Mardex's Marblot) are restricted from reporting all of the bands, as they must abide by the rules of the manufacturer. ********************************
These rules are set up in accordance with the CDCs surveillance criteria. and increase the risk of false negative results.
These kits may be OK for surveillance purposes, but offer too scanty of an analysis to be useful in patient management.
PCR assay testing and detection of pieces of the spirochete through antigen assays both give stronger indication of the presence of the Lyme pathogen; but currently these tests don't conclusively prove that live Bb spirochete are present and causing active illness. ************************************
PCR tests are now available, and although they are very specific, sensitivity remains poor, possibly less than 30%.
This is because Bb causes a deep tissue infection and is only transiently found in body humors.
Therefore, just as in routine blood culturing, multiple specimens must be collected to increase yield; a negative result does not rule out infection, but a positive one is significant.
Bowen "Rapid Identification of Borrelia burgdorferi" (RIBb). ****************************
The Bb antigen is identified by the presence of fluorescing structures upon microscopy.
At Bowen Research & Training Institute, Inc., located in Palm Harbor , Florida , ongoing research is being conducted using the Bowen Q-RIBb (Quantitative Rapid Identification of Borrelia burgdorferi) test developed by Dr. JoAnne Whitaker.
Originally a CLIA approved lab until April of 2003, the institute, lacking in vital grant funding, changed its status from that of a clinical lab to a research facility under the State of Florida Health Department.
Since its inception, the main focus at the institute has been the development of an accurate test for the Borrelia burgdorferi (Bb) antigen, the causative agent of Lyme disease.
The Bowen Q-RIBb test just recently received its preliminary US Patent approval. Although the Bowen Q-RiBb Test is not presently approved by the FDA for Lyme disease; an application for FDA approval is now pending.
General Statements from John's Hopkins about Diagnosis of Lymes Disease. *********************************
``Within weeks to months of becoming infected, early disseminated Lyme disease may occur (formerly termed stage 2).
Approximately 4-10% of patients in the U.S. develop cardiac manifestations, including conduction defects
(e.g., atrioventricular block, complete heart block, bundle branch block, fascicular block), tachyarrhythmias (e.g., atrial due to pericarditis, uncommonly ventricular as an escape rhythm), myopericarditis, and mild myocardial dysfunction.
Involvement of the central or peripheral nervous systems may occur in up to 10 to 20% of cases, ******************************************
may be manifested by headache, fatigue, stiff neck, and malaise, and
includes such diagnoses as
Lyme meningitis, neuroborreliosis, cranial neuropathies (especially facial nerve palsy, which can be bilateral),
peripheral neuropathy, radiculitis, myelopathy, or brachial plexopathy.
Lyme disease may also involve the eye (e.g., follicular conjunctivitis, keratitis, and rarely uveitis or vitritis).
Musculoskeletal manifestations of Lyme disease are very common.
During early infection, migratory arthralgias and pain in bursae, tendon, muscle, or bone occur in the majority of patients.
Weeks to months later, frank arthritis, most commonly mono- or oligoarticular and involving large joints (most commonly knees, but also shoulders, ankles, elbows, and other sites), may develop.
Lyme arthritis is one manifestation of persistent or late Lyme disease (previously termed state 3).
In the United States , approximately 60% of untreated patients will develop intermittent episodes of joint pain and swelling, months to years after the infecting tick bite.
The most common presentation is a single involved knee but can involve both knees and be migatory, but both large and small joints may be affected, and usually only one or two joints at a time.
Over time, the frequency and severity of attacks can decline, and, on average, the proportion of patients with recurrent attacks declines by 10-20% annually.
Approximately 10% of untreated patients may develop chronic arthritis, defined as one year or more of continuous joint inflammation.
**********************************************
outstanding, informative article! hope you enjoyed the statistics in this one as much as i did! betty :)_
posted
Thank you BettyG for all you do!!
Posts: 261 | From Piedmont | Registered: May 2008
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shazdancer
Frequent Contributor (1K+ posts)
Member # 1436
posted
Getting an insurance company to reconsider its ruling is serious business. You will not get an insurance company to change its mind simply by saying, "It's a clinical diagnosis." You will need to be able to quote high-level articles from government sources, major medical institutions, or peer-reviewed medical journals.
Every time you hear a statistic or an unusual claim, you should be asking yourself, "Says who?" I can guarantee the insurance company will be asking the same thing.
-- Shaz
Posts: 1558 | From the Berkshires | Registered: Jul 2001
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hshbmom
Frequent Contributor (1K+ posts)
Member # 9478
posted
The only think I can think of to improve this is to add references and links for documentation of your statements.
Great job BettyG!
Posts: 1672 | From AL/WV/OH | Registered: Jun 2006
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bettyg
Unregistered
posted
quote:Originally posted by shazdancer:
You will NOT get an insurance company to change its mind simply by saying, "It's a clinical diagnosis."
[QB] You will need to be able to quote high-level articles from government sources, major medical institutions, or peer-reviewed medical journals.[\qb]
Every time you hear a statistic or an unusual claim, you should be asking yourself, "Says who?" I can guarantee the insurance company will be asking the same thing. Shaz
shaz, i couldn't agree more with you!! and that's also what hshbmom is saying too.
nessa, tickedoffinnc, hshb....glad you got some benefits from this one too!
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