If your insurer is using the
IDSA Lyme Disease Guidelines
To deny you benefits...
The response below should be
Submitted with your documents.
Conflicts of Interest and Bias
After a lengthy investigation, Attorney General Richard Blumenthal (currently US Senator), stated the medical guidelines used as a basis for the opinions in your denials have “sweeping and significant impacts on Lyme disease medical care.” He further stated the guidelines “are commonly applied by insurance companies in restricting coverage for long-term antibiotic treatment or other medical care and also strongly influence physician treatment decisions.”
Blumenthal added, "The IDSA's 2006 Lyme disease guideline panel undercut its credibility by allowing individuals with financial interests -- in drug companies, Lyme disease diagnostic tests, patents and consulting arrangements with insurance companies-- to exclude divergent medical evidence and opinion. In today's healthcare system, clinical practice guidelines have tremendous influence on the marketing of medical services and products, insurance reimbursements and treatment decisions. As a result, medical societies that publish such guidelines have a legal and moral duty to use exacting safeguards and scientific standards.”
He found the “IDSA included in its Lyme guidelines a statement calling them "voluntary" with "the ultimate determination of their application to be made by the physician in light of each patient's individual circumstances." However, he followed up by stating, “United Healthcare, Health Net, Blue Cross of California, Kaiser Foundation Health Plan and other insurers have used the guidelines as justification to deny reimbursement for long-term antibiotic treatment.”
Not only is the foundation of your report flawed by using the infectious disease organization’s guidelines, the neurology guidelines are equally tainted. AG Blumenthal determined:
“The IDSA portrayed another medical association's Lyme disease guidelines [American Academy of Neurology–AAN] as corroborating its own when it knew that the two panels shared several authors, including the chairmen of both groups, and were working on guidelines at the same time.”
He further stated, "My office uncovered undisclosed financial interests held by several of the most powerful IDSA [and AAN] panelists. The IDSA's guideline panel improperlyignored or minimized consideration of alternative medical opinion and evidence regarding chronic Lyme disease, potentially raising serious questions about whether the recommendations reflected all relevant science.”
It is obvious by your denial that these same tactics were utilized by your reviewers, as there was no science to support the opinions expressed, and the comments made were the basic cookie-cutter lines used by the IDSA/AAN and their members as a self-serving approach to the diagnosis and treatment of Lyme disease.
Blumenthal stated, “The two entities [Infectious Diseases Society of American and American Academy of Neurology] sought to portray each other's guidelines as separate and independent when the facts call into question that contention. The IDSA subsequently cited AAN's supposed independent corroboration of its findings as part of its attempts to defeat federal legislation to create a Lyme disease advisory committee and state legislation supporting antibiotic therapy for chronic Lyme disease.”
Organizations and its members that go to the extent these two have to thwart federal (and state) legislative efforts designed to improve the health and lives of citizens across the country can not be trusted to be impartial or honest in their day-by-day activities. Therefore, utilizing either or both the AAN and IDSA flimsy, seriously flawed and unsubstantiated guidelines to justify and uphold the denial of my benefits is a serious breech of our contract.
Additionally, opinions expressed by Infectious Diseases Society of America and the American Academy of Neurology members defied official recommendations set forth by federal (NIH, CDC, FDA), state (NY Health Department) and other organizations and medical institutions in regards to Lyme disease diagnosis and treatment. See attached scientific documentation.
The opinions stated in your denial are totally without merit. Your clinical experience with successfully treating chronic Lyme and tick borne disease patients is non-existent.
Therefore, without a doubt or second thought, your denial should be totally dismissed, in part for the bias and conflicts of interest, unsubstantiated and unprofessional opinions, the omissions of facts, inaccurate and misleading statements, and lack of science to support their claims. In light of this situation, all of my benefits should be reinstated, retroactively, immediately.
If you have been denied benefits by your insurer, the reason was probably and unjustly based on the seriously flawed IDSA and/or AAN Lyme Disease Guidelines.
The information below may help support your claim.
Flawed Guidelines- AAN & IDSA
LB [The American Academy of Neurology (AAN) Nervous System Lyme Disease Guidelines and its authors were investigated by Connecticut Attorney General Richard Blumenthal (currently Senator Blumenthal) and were determined to be, along with the Infectious Diseases Society of America (IDSA), in violation of the conflicts of interest policy. The IDSA subsequently cited AAN’s supposed independent corroboration of its findings as part of its attempts to defeat federal legislation. Please refer to the Attorney General’s Report attached to this document.]
Guidelines & Process Discredited Due to Bias and Conflicts of Interest
Infectious Diseases Society of America (IDSA) & American Academy of Neurology (AAN) Lyme Disease Guideline development processes were investigated by Attorney General Richard Blumenthal. In May 2008 the AG determined, in part:
"The IDSA's 2006 Lyme disease guideline panel undercut its credibility by allowingindividuals with financial interests -- in drug companies, Lyme disease diagnostic tests, patents and consulting arrangements with insurance companies -- to exclude divergent medical evidence and opinion.”
“The IDSA guidelines have sweeping and significant impacts on Lyme disease medical care. They are commonly applied by insurance companies in restricting coverage for long-term antibiotic treatment or other medical care and also strongly influence physician treatment decisions. Insurance companies have denied coverage for long-term antibiotic treatment relying on these guidelines as justification. The guidelines are also widely cited for conclusions that chronic Lyme disease is nonexistent.”
He continued:
“The IDSA's guideline panel improperly ignored or minimized consideration of alternative medical opinion and evidence regarding chronic Lyme disease,potentially raising serious questions about whether the recommendations reflected all relevant science. … The IDSA's 2000 and 2006 Lyme disease panels refused to accept or meaningfully consider information regarding the existence of chronic Lyme disease…”
“The IDSA portrayed another medical association's Lyme disease guidelines [American Academy of Neurology- AAN] as corroborating its own when it knew that the two panels shared several authors, including the chairmen of both groups, and were working on guidelines at the same time.”
Source: Attorney General's Investigation Reveals Flawed Lyme Disease Guideline Process, May 1 2008. http://www.ct.gov/ag/cwp/view.asp?a=2795&q=414284&pp=12&n=1
LB [The supposed independent panel that reviewed the 2006 IDSA guidelines (which included IDSA members and its own past president), recommended over twenty changes be made to the IDSA’s current recommendations when the updated guidelines were next published. The IDSA will claim their guidelines were “approved” by their own new Panel in an effort to save face, however, the fact remains the past and current guideline development process was found to be “riddled with conflicts of interest”, “extremely biased” and it was determined the authors excluded “divergent medical evidence and opinion”. Therefore, the IDSA, and its sister AAN guidelines, should never be used as a basis for making solid scientific or medical determinations.]
American Academy of Neurology Nervous System Lyme Disease Guidelines* Practice parameter: treatment of nervous system Lyme disease (an evidence-based review). Report of the Quality Standards Subcommittee of the American Academy of Neurology. 2007 Jul. NGC:005671 American Academy of Neurology – Medical Specialty Society
*See Attorney General’s Anti-trust Violations Report on IDSA and AAN Lyme Guidelines- The AG found the Panels/Guidelines were extremely biased and riddled with conflicts of interest.
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American Academy of Neurology Guidelines
“Published guidelines are available to assist in the diagnosis of nervous system Lyme disease,1 and for treatment of Lyme disease in general.2 However, there continues to be considerable controversy and uncertainty about the best approach to treatment of neuroborreliosis.”
“Finally, there is a lack of clarity as to which syndromes associated with Lyme disease reflect nervous system infection, which are consequences of infection outside the nervous system, and which are postinfectious.”
“A separate entity, defined differently by different authors, often referred to as “post-Lyme syndrome,” occurs in patients who have had Lyme disease, but, after treatment that would normally be expected to be effective, have continued to have residual chronic symptoms, including one or more of the following: musculoskeletal pain (without frank arthritis; fibromyalgia-like), fatigue, and “neuro-psychiatric” symptoms. The latter typically consist of perceived memory or cognitive difficulty, irritability, sleep disturbance, depression, headache, limb or other paresthesias—all in the absence of clinical or laboratory evidence of focal or inflammatory central or peripheral nervous system involvement.5-7 Thus, this entity is often included in discussions of neuroborreliosis, even though there is no evidence of CNS infection in such individuals.”
“Six months following treatment [for neurological Lyme], 17 (63%) had improved, 6 (22%) improved but relapsed, and 4 (15%) were unchanged. Since symptoms had been prolonged and unremitting prior to treatment, this was believed to be due to the effect of treatment, even though no control group was included for direct comparison.”
“While most studies demonstrated excellent responses to a wide range of antimicrobial regimens, several have raised the possibility that a significant number of patients may have residual difficulties. In one25 (Class IV), 50 patients were identified who had intrathecal production of anti-B burgdorferi antibody. Of the 44 who were studied, 31 had cranial neuropathies, 12 radicular weakness, 12 other forms of weakness, 29 had pain, 11 had headache (multiple findings in most). At post-treatment follow-up, half the patients reported headache and concentration problems, although their neurologic deficits were better. The authors believed this represented an increase in subjective symptoms, despite improvement in objectively demonstrable abnormalities, similar to findings reported earlier.26”
“In another study27 (Class IV) 25% of the patients assessed 5 years following treatment reported persistent “neurologic” difficulties. However, in this study, sequelae appeared to reflect neurologic damage at the time of infection, not ongoing infection or antibiotic treatment failure. Similarly, in a study of 36 patients28 (Class IV) treated for Lyme meningitis, many described continued problems at 1 year follow-up.”
“However, given the absence of evidence of late CNS complications following oral antibiotic treatment of Lyme meningitis in all trials performed to date, coupled with the potential for greater morbidity associated with parenteral regimens, initial treatment with oral doxycycline, without a lumbar puncture, also appears to be a safe and valid approach to treatment—at least of facial nerve palsy.42”
“A wide range of Lyme disease-associated neurologic disorders has been described in children, including cranial neuropathies, headache, seizures, meningitis, meningoencephalitis, encephalopathy, focal neurologic signs, ataxia, vertigo, chorea, and transverse myelitis.Information comes from case reports, small series of patients, and from studies mainly focused on rheumatologic aspects of the disease, conducted shortly after Lyme disease was recognized as a distinct clinical entity.51-53”
Post-Lyme Disease Syndrome- “As discussed above, patients who have received accepted antibiotic regimens for various forms of Lyme disease sometimes have residual chronic symptoms, referred to variably as post-Lyme syndrome (PLS), post-Lyme disease syndrome, post- treatment chronic Lyme disease (PTCLD), or even chronic Lyme disease. There has been controversy as to whether PLS is a form of active infection in which the organism is difficult or impossible to eradicate from various “privileged” sites vs a postinfectious or noninfectious type of chronic fatigue syndrome, in which there is no ongoing infection. Arguments offered to support the possibility of persistent active infection derive from the apparent similarity between these symptoms and patients’ perceptions of the cognitive difficulty and fatigue noted with untreated or partially treated Lyme disease…”
“Fourth, anti-B burgdorferi antibody concentrations often decline, even to undetectable levels, despite persistent symptoms.5,63,65 Such a decline in antibody in the face of persistent infection appears to be without precedent in other bacterial infections. Entrance criteria were symptoms of classic Lyme disease, physician-documented recommended treatment of Lyme disease, and typical musculoskeletal or cognitive PLS symptoms often accompanied by fatigue that had begun within 6 months of the initial infection, and that had been present for at least 6 months (but less than 12 years). Patients could be either seropositive or seronegative, but were excluded if they had previously received IV antibiotics for 60 or more days, had known hypersensitivity to study medications, had active synovitis or positive PCR for B burgdorferi gene segments in CSF or blood.”
“At 6 months, there was a significant improvement in the FSS-11 fatigue score in patients treated with ceftriaxone compared to placebo, with no improvement in mental speed (or any of the other secondary neuropsychological tests) or in clearance of CSF antigen (although antigen was detected in CSF of only 16% of the patients at baseline) in the antibiotic vs placebo group.”
Source: American Academy of Neurology Report of the Quality Standards Subcommittee of the Practice Parameter: Treatment of nervous system Lyme disease (an evidence-based review).* J. J. Halperin, E. D. Shapiro, E. Logigian, et al. Neurology DOI 10.1212/01.wnl.0000265517.66976.28; Prepublished online May 23, 2007. http://www.neurology.org/content/early/2007/05/23/01.wnl.0000265517.66976.28.full.pdf
*See Attorney General’s Anti-trust Violations Report on IDSA and AAN Lyme Guidelines- The AG found the Panels/Guidelines were extremely biased and riddled with conflicts of interest.