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Barbara Johnson, Chief, Molecular Biology Section Centers for Disease Control and Prevention Division of Vector-Borne Infectious Diseases Bacterial Zoonoses Branch PO Box 2087 Fort Collins, CO 80522
Re: HMO abuse of Lyme disease surveillance case definition
Dear Dr. Johnson,
Early last year, the U.S. Senate issued a directive that the Centers for Disease Control develop standards for Lyme disease in order to prevent the abuse of restrictive surveillance criteria for (non) diagnosis. I wish to bring your attention that Kaiser Permanente appears to have repeatedly abused surveillance criteria to deny diagnoses of Lyme disease. Previously, I had written David Lawrence, the former CEO of Kaiser Permanente to make him aware of the problem and offered to bring a number of patients to meet with him. Mr. Lawrence never responded to my offer.
I am relating my experience to provide an example to help the CDC in formulating new standards. My experience is only one of many with this HMO. If it would be helpful to you, I can provide many more detailed accounts of Lyme disease victims who were denied a diagnosis and care by Kaiser Permanente.
In my case, I believe the refusal to diagnose was deliberate and made possible by inappropriate use of CDC guidelines. To illustrate the lengths to which clinicians at this HMO will go to deny a diagnosis, I am enclosing documentation pertinent to my own case. It should be noted that when I told my former primary care physician that I suspected I had Lyme disease, he refused to give me an appointment despite many documented attempts over many weeks. The main facts are summarized below;
Kaiser’s refusal to correct my medical records continues to affect my health care. There are others who have been through far worse than my experience. Some having to spend considerable sums to get tests and treatment that should have been covered by Kaiser Permanente. This situation must be corrected and the CDC must do its part to prevent these abuses.
- A “Chronology of Symptoms” was constructed by me, primarily from information in my medical records, and was a listing of new and unusual symptoms following my tick bite. The vast majority of these symptoms were consistent with Lyme disease as stated in CDC/NIH criteria as well as other more comprehensive sources. My symptoms started after returning from a trip to Northern California in 1994, an area the CDC considers as one of three areas with the highest incidence of Lyme disease in the United States. My dog who came with me on this trip was also infected and had many of the same symptoms, with more severe arthritic complications, and eventually had to be euthanized.
- This information was provided to the infectious disease clinician who met with me in June, 2000. The medical report written by this clinician stated that these symptoms, in his opinion, were not consistent with Lyme disease. In particular, he dismissed the erythema migrans that the NIH considers to be the “hallmark” symptom of Lyme disease. He also told me that an erythema migrans could be caused by “many, many, many diseases.” Three times I asked him to name even one of these diseases. Three times he refused to provide an answer. He also refused any differential diagnosis. In brief, he refused to provide any help in any way. He supported his opinion by a negative ELISA test from Kaiser’s laboratory.
- To damage my credibility, he falsely wrote in his medical report that I stated I believed in Lyme “conspiracists,” his non-word. The inspiration for this lie came from the fact that I had provided him with a copy of Dr. Joseph Burrascano’s then newly released treatment guidelines. You may recall that Dr. Burrascano gave a speech before the U.S. House of Representatives titled “The Lyme Conspiracy.” There was no discussion of any kind concerning conspiracies or anything of any remote resemblance during my encounter with this clinician.
- In 2001, a neurologist at Kaiser tried to help me by ordering Western Blot IgG and IgM tests and bypassing ELISA. He understood that the ELISA was not an appropriate test for late-stage Lyme disease. I told him that I had questions on the reliability of Kaiser’s contracted laboratory, American Medical Laboratories in Chantilly, VA, and would prefer to have the test performed at a reference laboratory experienced in tick-borne infections. He agreed to order the Western Blot tests from both labs as long as I paid for my lab of choice. He also wanted to do a side-by-side comparison of the results from the two labs. At my request and expense, an IgG was ordered from the reference laboratory. A Western Blot IgG and IgM was ordered through Kaiser’s lab. His nurse read me the order that was entered and it was exactly as he stated, an ELISA was not ordered. When I went to have the blood drawn, this doctor’s orders were apparently blocked. I could have the Kaiser Western Blot tests only if the ELISA was positive. This is a surveillance criterion for cases of new infection. (The ELISA was, of course, once again negative).
- The Western Blot IgG showed the presence of 4 bands of positive intensity and one band of equivocal intensity. One of the bands was OspA according to CDC criteria. The CDC surveillance criteria require 5 bands of positive intensity to meet the case definition. You must certainly be familiar with the trials done for the vaccine study showing that only 22% of proven Lyme cases are able to meet the 5 band IgG criteria. The neurologist who challenged the non-specific negative ELISA result with the IgG results was forced to defer to the infectious disease clinicians. The same infectious disease clinician who denied my diagnosis, and a cohort, also dismissed the Western Blot IgG as significant stating that the results do not increase the probability that “he has active chronic Lyme disease in any organ system.” They supported this comment by the second negative ELISA test which was done by Kaiser’s contracted lab although the Western Blot is specific and more reliable. This denial was in contradiction to the recommendation by the NIH that the most appropriate serologic test for prior infection with Borrelia burgdorferi, the spirochete that causes Lyme disease, is the IgG western blot assay.
- In response to a request asking what other diseases could cause an erythema migrans, the Chief of Infectious Diseases for this Kaiser Permanente facility wrote me a letter stating that my symptoms were likely due to other health problems and the erythema migrans I had was a self-limiting episode of Lyme disease. I wrote a letter in response questioning how he have concluded that it was self-limiting, given my progression of symptoms and positive response to antibiotic treatment. Also, in the copies of the two complaints that were given to him, it was documented that I received a diagnosis of 6th cranial nerve palsy from a Kaiser opthalmologist, yet another symptom consistent with Lyme disease indicating the infection had spread to my central nervous system. I also attached a copy of a recent Western Blot IgM that, in fact, exceeded CDC criteria in terms of the number of bands and specific bands.
- Both of my complaints were dismissed with no explanation. I received no further response from Kaiser other than from the manager of the infectious diseases department essentially stating that my time to file additional complaints or grievances through Kaiser had expired. I am informed that one strategy employed by Kaiser is to delay and postpone until the member’s allowed time for complaints, grievances and arbitration have expired. Patients with late-stage Lyme disease are simply unable to file timely grievances because they are too sick to do so.
I would like to bring your attention to a study cited in CDC references. It was a study apparently performed by Kaiser showing that of 117 cases of suspected Lyme disease by both physicians and patients, only one ELISA test came back positive. The lab that was being used at the time of the study was American Medical Laboratories in Virginia. This is the same lab where my samples were sent. The study samples were from a California facility. This skewed result may have been due to flawed specimen handling and testing rather than the strong implication that Lyme disease is “rare” in California. The latter conclusion is highly misleading as evidenced by recent studies on rates of nymphal tick infection which rival areas of the East Coast in which Lyme disease is hyperendemic. Dr. Robert Lane of U.C. – Berkeley did these studies.
You might want to reconsider the use of this Kaiser study as a reference in CDC information. And you may want to investigate why this laboratory generated only one positive result out of 117 samples of suspected Lyme disease. These samples were sent across the country, a practice criticized by the Infectious Diseases Society of America because of the high risk of sample degradation. In fact, my samples were analyzed five or more days after being drawn compared to the laboratory specification of two days. There appears to be a strong bias against diagnosis for Lyme disease at this institution. To summarize;
Bias against diagnosing Lyme disease is putting patients at additional risk since it provides a basis for ignoring other tick-borne infections. The grievance procedures and binding arbitration requirements of this HMO have not been favorable to Lyme disease victims. You should know that patients enrolled in this HMO do not have the option of seeking help from an outside doctor unless they pay for it themselves or they are able to enroll in another health plan. It has been suggested that an indictment be prepared against Kaiser regarding Lyme disease and signed by currently known victims. The true numbers of patients with Lyme disease that have been undiagnosed or misdiagnosed by Kaiser are not known.
- My primary care physician absolutely refused to see me when I told him I suspected I had Lyme disease.
- In issuing his denial, the infectious disease clinician I saw lied to me and lied about me on my medical report. Differential diagnosis was refused.
- The neurologist who tried to help me was not allowed to bypass the CDC ELISA surveillance requirement and order the Western Blot through Kaiser’s contracted laboratory.
- The presence of five bands on Western Blot IgG (paid by me) was dismissed as evidence of Lyme disease. CDC/NIH diagnostic recommendations were ignored.
- After all of the ongoing clinical and serologic evidence and positive response to antibiotic treatment, the Chief of Infectious Diseases at this facility suggested that my episode of Lyme disease may have been self-limiting. He claimed he could not find my Western Blot IgG.
- My complaints were dismissed without explanation. CDC positive results on Western Blot IgM were ignored.
CDC criteria should not be used as a platform for deceit and denial of medical care. Kaiser Permanente claims to have 11,000 physicians, medical expertise in all specialties, has a clinician on a CDC Lyme disease committee, and has an ex-CDC Director on the Board of Directors. Ignorance cannot be claimed as an excuse.
Unless the CDC heeds the recommendation of the U.S. Senate and takes a more active stance in discouraging the use of the surveillance case definition for diagnosis, it is implicitly condoning the kind of behavior I have outlined in this letter. I cannot believe that this was the intention of the CDC.
Very Truly Yours,
Miguel A. Perez-Lizano
Cc; Julie Gerberding, Director – Centers for Disease Control and Prevention Phillip Baker, Lyme Disease Program Officer – National Institutes of Health George Halvorson, CEO, Kaiser Foundation Health Plan Denise Honzel, Kaiser Permanente Northwest Other interested parties
Enc; Excerpts from Public Law 107-116 Signed by President Bush 1/10/02 Chronology of Symptoms Kaiser Permanente medical report dated 6/05/2000 (but submitted much later) Western Blot IgG Comment of infectious disease clinicians regarding Western Blot IgG dated 4/16/2001 Letter from KPNW Chief of Infectious Diseases dated 12/13/2001 Letter to KPNW Chief of Infectious Diseases dated 7/17/2002
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