May is Lyme Disease Awareness Month
Lyme is the most prevalent vector-borne disease and one of the fastest spreading diseases throughout the United States, and the subjects of diagnosis and treatment of Lyme are politically-charged.
This series of diaries is designed to provide information to the Daily Kos community both for Lyme disease prevention and for those Kossacks living with Lyme. Because the disease is often missed by physicians, these diaries may assist an individual or two in pursuing testing which might otherwise have been missed.
The LymeDiseaseAwareness series will be eclectic including personal statements, informational pieces about the science of Lyme, and calls to action for community and political advocacy.
We hope you'll all join us in learning about this rampant disease and the medical/industrial/political morass in which Lyme patients find themselves.
The LymeDiseaseAwareness Team
Today's diary by: MsGrin
This is part of the story of why Lyme disease patients struggle to get diagnosed and cured: Insurance companies use the guidelines written by a major medical association to deny claims. This is a political issue as well as a medical one.
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.
-- Connecticut Attorney General Richard Blumenthal
Attorney General's Investigation Reveals Flawed Lyme Disease Guideline Process, IDSA Agrees To Reassess Guidelines, Install Independent Arbiter
A May 1, 2008 press release from the Connecticut Attorney General's office describes an unprecedented investigation of a major medical association's guidelines because of the impact those guidelines have on patient access to health care:
Attorney General Richard Blumenthal today announced that his antitrust investigation has uncovered serious flaws in the Infectious Diseases Society of America's (IDSA) process for writing its 2006 Lyme disease guidelines and the IDSA has agreed to reassess them with the assistance of an outside arbiter.
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.
(Full text of the agreement with IDSA)
If you've been following the LymeDiseaseAwareness series, you have seen that denial of treatment coverage is not a hypothetical issue for some Lyme patients, and one of our own is quite literally sick about it. UnaSpenser continues to be seropositive for Lyme after antibiotic treatment, but based upon the IDSA guidelines, her insurance company refuses to pay for treatment which her doctors say will give her a chance at recovery given her continued, deteriorating illness. Again, from the Atty Gen's press release:
In a step that the British Medical Journal deemed "unusual," 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." In fact, 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.
Make no mistake: Health insurance companies use the IDSA Lyme guidelines to exclude treatment they don't wish to pay for.
IDSA claims their rules do not dictate how physicians treat Lyme disease
On October 2, 2006, IDSA releases its Updated Guidelines on Diagnosis, Treatment of Lyme Disease. (Press release, IDSA Guidelines)
On Jauary 17, 2007, Henry Masur, MD, then President of IDSA wrote to all Senators and Congressmembers, "Our primary concern is for patients and the quality of their care":
We recognize that medicine, and the application of practice guidelines, must take into account individual patient needs and circumstances. As such, we make clear that guidelines are not mandates. They are recommendations and are not intended to supersede individual physician judgment. The IDSA guidelines make no recommendations regarding insurance coverage or reimbursement for treatment.
IDSA's 'No Recommendation regarding insurance coverage'
Just three months later on April 10, 2007, Masur wrote to the chair of the Pennsylvania Senate Committee on Banking and Insurance about pending legislation on Lyme disease. Part of that legislation was written to ensure that individual physician judgement for the treatment of Lyme disease was covered, i.e. the new law was intended to address insurance companies declining to pay for treatment beyond that specified in the IDSA guidelines. On behalf of the IDSA, Masur objects to the legislation in part because it would:
...force payment for treatment regimens that are not supported by professional standards
Presumably, by 'professional standards,' they mean their own guidelines because the guidelines is the only enclosure listed in the letter.
So, we seem to have a contradiction - first IDSA says that the guidelines should not be used as mandates, and then when a state responds to insurance companies using the guidelines as mandates with respect to coverage, they object to the legislation, indicating that the legislation does not comport with their guidelines. Does the "The IDSA guidelines make no recommendations regarding insurance coverage or reimbursement for treatment" statement still stand after only three months? Held in the best light, the subsequent position muddies the original statement.
Advocacy Efforts on the part of IDSA
There are eight letters and/or statements linked on the IDSA website where they have taken a position on potential legislation with regard to Lyme disease since January of 2007 in four states and at the Federal level. In the document dated November 15, 2007, IDSA asserts that their position is supported by the American Academy of Neurology.
Attorney General Blumenthal speaks to IDSA's assertion of corroboration of their Lyme guidelines:
IDSA sought to portray a second set of Lyme disease guidelines issued by the American Academy of Neurology (AAN) as independently corroborating its findings. In fact, IDSA knew that the two panels shared key members, including the respective panel chairmen and were working on both sets of guidelines a the same time -- a violation of IDSA's conflicts of interest policy.
The resulting IDSA and AAN guidelines not only reached the same conclusions regarding the non-existence of chronic Lyme disease, their reasoning at times used strikingly similar language. Both entities, for example, dubbed symptoms persisting after treatment "Post-Lyme Syndrome" and defined it the same way.
When IDSA learned of the improper links between its panel and the AAN's panel, instead of enforcing its conflict of interest policy, it aggressively sought the AAN's endorsement to "strengthen" its guidelines' impact. The AAN panel -- particularly members who also served on the IDSA panel -- worked equally hard to win AAN's backing of IDSA's conclusions.
The two entities sought to portray each other's guidelines as separate and independent when the facts call into question that contention.
Following is a summary of Attorney General Blumenthal's findings regarding IDSA's Lyme guidelines:
^The IDSA failed to conduct a conflicts of interest review for any of the panelists prior to their appointment to the 2006 Lyme disease guideline panel;
^Subsequent disclosures demonstrate that several of the 2006 Lyme disease panelists had conflicts of interest;
^The IDSA failed to follow its own procedures for appointing the 2006 panel chairman and members, enabling the chairman, who held a bias regarding the existence of chronic Lyme, to handpick a likeminded panel without scrutiny by or formal approval of the IDSA's oversight committee;
^The IDSA's 2000 and 2006 Lyme disease panels refused to accept or meaningfully consider information regarding the existence of chronic Lyme disease, once removing a panelist from the 2000 panel who dissented from the group's position on chronic Lyme disease to achieve "consensus";
^The IDSA blocked appointment of scientists and physicians with divergent views on chronic Lyme who sought to serve on the 2006 guidelines panel by informing them that the panel was fully staffed, even though it was later expanded;
^The IDSA portrayed another medical association's Lyme disease guidelines 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. In allowing its panelists to serve on both groups at the same time, IDSA violated its own conflicts of interest policy.
Here is a portion of IDSA's media statement about the agreement with the Attorney General:
"IDSA has agreed to this unique, singular review of our guidelines because the panel will consist solely of physicians and scientists," said IDSA President Donald Poretz, MD. "We are confident that our guidelines for the diagnosis and treatment of Lyme disease represent the best advice that medicine currently has to offer, as is the case with all of the medical guidelines issued by the Society, and we look forward to the opportunity to put to rest any questions about them."
~snip~
IDSA is voluntarily agreeing to this extra scrutiny in the hope that it will help put to rest assertions that have been made – all of them unfounded – that IDSA has ignored divergent opinions in developing its Lyme disease guidelines. This expanded review process is pertinent to this unique case only. IDSA has not agreed to use it as a model for other IDSA guidelines, nor is IDSA urging other medical organizations and societies to use it.
In future diaries we will discuss the current state of the agreement between Attorney General Blumenthal and the IDSA on their guidelines, the economic and legal ramifications for physicians who have gone beyond the scope of the IDSA guidelines to treat their patients, the 'compeling medical evidence' upon which IDSA relies to support its guidelines, and conflicts of interest on the panel which wrote the Lyme guidelines.
Request: We are awaiting the announcement of panels for NN09 and are hopeful that the panel we proposed Lyme Disease: Denial Politics of Epidemic Proportions will be part of the line up. Please nominate UnaSpenser today for one of the DFA scholarships to attend NN09. Thank you.