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November 21, 1998

Linda Farina
Senior Director, Benefits & Compensation
6500 International Parkway
Plano, Texas 75093



Ms. Farina,

I have attached copies of the two letters received from First Health's Director & Associate Counsel
[Attachment 1] , and their Manager, Support Services [Attachment 2] . Since you were not a cc: on either document, I'm not sure you are privy to the details. Unfortunately, I have not received any communications from the First Health Medical Director, as was promised at least twice.

I categorically deny any "appeal" status could or should be applied to my letter of response to "JC". It was addressed to "JC" because that was the only identifying information supplied. It was a response intended to clarify some factual errors in the letter, and to once again reiterate that First Health has not responded in the form required or requested.

I have made multiple Customer Service calls, and multiple written requests to both First Health and MRG that the denial reasons be provided to me in the form required by The Plan. The Synopsis clearly states (as have my requests) that on review of a denial, I will receive a written notification explaining:

Reason for the denial;
The Plan provisions on which it is based;
Any additional material or information needed to make the claim acceptable and the reason it is necessary;
The procedure for requesting a review.

A PWBA consumer information brochure states "Your plan must give you the reason for denial in writing and in a manner you can understand." I have asked for no more than what The Plan and the law requires. Until that is complied with, any actions to date by First Health must be considered inadequate and unresponsive.

The spreadsheet attached to Ms. Jones' letter gives more information than we have ever been able to shake out of First Health before. However, since the spreadsheet is the result of a review by their unnamed physician consultant, it does not address my multiple requests for amplification (in the form required and requested) of the original denials. I'd really like to know the who/what/when/where/why, and qualifications of the decision maker, surrounding the original denials.

I find it quite difficult to believe that requesting First Health to support their denials in the form required/requested is an appeal. I further believe that their "election" to treat it as such is premature and improper. While I appreciate their conducting a voluntary performance review and the subsequent adjustments, it has not responded adequately to my request. Why were the claims originally denied, and what new information did the nameless physician consultant bring to the table to show that First Health's original denials were erroneous, and in need of adjustment?

To Ms. Thompson, I must apologize for the expressed (and warranted) confusion to my qualified references to The Plan. I reviewed my handwritten draft against the final letter, and they were not even close. Further, when I checked my draft references, they also were not even close. I apologize for this brain blip, which is indicative of the deteriorating condition that we are trying to resolve and receive treatment for. At the simplest level, I was trying to lay out that we could not find any basis for denial based upon The Plan enumeration of medical necessity requirements, nor could we find by any stretch of the imagination a basis for casting the services rendered to be non-covered benefits.

There are a few points in the associate counsel's missive that I must take personal exception to:

The repeated use of the word "accuse." Statements of fact are not accusations. In this letter I have apologized for my own factual errors, which were in response to the "JC" factual errors. The only accusation that could be construed, and which I continue to uphold, is that the First Health denial EOBs do not comply with the requirements of The Plan, or my own requests. This, and only this, has been the underlying theme of all my communications. Bluntly, First Health's administration of The Plan does not follow the language of The Plan. Until the First Health denials are in a language we can understand, and in the proper form, we do not possess the requisite information to establish a basis for an appeal. If First Health's administration of The Plan had complied with The Plan in the first instance, it is quite possible that there would be no issues before us. Further, in reviewing the contents of my letter and the associate counsel's missive, I quite properly used "perhaps"; presenting possible explanations as to why a layman would know more about a progressively debilitating disease than the First Health medical staff. We all know that making literature and publications "available" does not guarantee that they are read, used, understood, or followed. Specialists exist because the body of knowledge is too great for a general internist to have experience with, or be conversant with.

Page 6, last paragraph: ..."you identify a number of diagnosis you
claim (emphasis mine) to have been afflicted with"... Perhaps the enclosures to the September 13, 1998 letter to "JC" were not forwarded to the associate counsel. The list of afflictions comes from Dr. 's letter of August 19, 1998. Further, they are listed on each of my Short Term Disability request forms. These were investigated and approved by MedEval. Since then, you may now add cerebral cortical atrophy and bilateral maxillary and ethmoid sinusitis. Withholding or limiting access to approved treatment methods leads to further disabilities, as has been evidenced in my own case.

Her contention that somehow we are responsible for First Health's delay in determining whether pre-existing conditions did/did not apply:

(1) We immediately provided our pharmacy records for the two-year period prior to our joining The Plan.
(2) We also provided in a timely manner the list of treating physicians covering the same period.
(3) Letters were sent to us by First Health that were copies of the letters sent to the physicians, and the information they required. They were clearly labeled that no action was needed on our part; we were merely receiving a courtesy copy of information requested.
(4) In 1996, when questioning First Health's delay in pre-existing condition certification, Lenora Balthrop of the MRG HR department communicated with First Health. The response was "waiting for information". Lenora was told the physicians status at that time. (None were currently in practice. One left the country, one was dead, and another was in jail, one required a fee).
(5) For 1996, 1997, and early 1998, we received no requests that made us responsible for providing the information. It was late in January, 1998 that we were made aware of the reasons for the delays. At that time, we did supply copies of the attending physician's statement, which listed the treatment and diagnosis information that we received at payment time, for submission to insurance. This information was considered insufficient by the plan administrator. Months were spent contacting every conceivable agency to determine if our records had been preserved by some other entity.
(6) The request to Dr. Ream for information was answered in a timely manner by Dr. Ream's office; a fee was involved to satisfy the request (bill the person/entity incurring the charge). First Health did not reply to his reply, and there the issue lay. We ultimately obtained a copy of the medical record (all one-and-a-half pages) at our expense, and provided it to you and First Health.
(7) It seems quite coincidental that the log jam was only broken when I pointed out a possible lack of due diligence in not exploring all avenues available to them. The claim that First Health couldn't do it without specific authorization is disingenuous at best. All the authorization forms specify "... from any person, insurance company," etc. She expresses confusion at my contention that First Health had an information-sharing relationship with NHL/LabCorp. It is called Coordination of Benefits, and has been exercised aggressively. As I stated, I was covered under that plan, and the EOB, diagnosis and treatment information was, and is, available. I don't know if First Health and LabCorp are subscribers to the MIB data services, but ...

Her question concerning "arbitrary and capricious" being used in conjunction with the cited plan paragraph. (The paragraph contained a typo. "are" should read "area"). The plan paragraph cited provides that all members of The Plan are to be treated equally. Other beneficiaries of The Plan have received the same treatments, the same diagnosis, by the same physician. Those same procedures were paid in all cases but mine. Whether you view this fact under the de novo , deferential, or less deferential standard of review, this fact alone supports an arbitrary, capricious or abuse of discretion charge.

Her instructive response to the request for CPT codes, ICD-9 codes, medical policy, etc. reinforces my thought that perhaps the attachments to my reply to "JC" were not forwarded to her. I provided an example of exactly what I was talking about. It is from a discovery motion involving litigation against another third-party administrator (TPA). While the TPA may maintain that the information is proprietary, it is usually found to be generic in nature, and in many cases, contradicts the language of The Plan.

Ms. Jones contends ..."you are incorrect in your assertion that the Texas Administrative Code is also governing." Bill Scott, senior trial attorney with the Office of the Solicitor at the US Department of Labor states:

"There is absolutely no evidence that Congress intended to preempt the state law of medical malpractice or extinguish malpractice remedies against health care providers when it enacted ERISA." The Department of Labor has been actively opposing managed care organizations' use of the ERISA defense, and has filed friend-of-the-court briefs in several cases to make its point."

In a brief filed with a Nevada district court: "As the federal agency with primary enforcement authority for numerous ERISA provisions, the Department of Labor has a strong interest in ensuring that preemption principles are applied appropriately to ensure that participants of ERISA-covered employee benefit plans are not stripped of rights and remedies under state law."

Now, to Ms. Thompson's letter. Again, I categorically deny that my September 13, 1998 letter was an "appeal". I attempted to respond to factual inaccuracies in the letter, and once again to request that First Health document their denials in the form required by The Plan. As stated earlier, the spreadsheet provided more information than we've been able to obtain in the past, but is incomplete in form and substance, and is considered unresponsive. Until the required information is received, and understood by us, we do not possess the information we are entitled to on which to base an appeal.

However, there is an amplifying footnote on the attached spreadsheet that is extremely troublesome; it brings the qualifications and ethics of the unnamed reviewing physician consultant in doubt. The footnote states "Medical literature indicates that it is not possible to deliver an effective treatment dose for eradication of Lyme disease with this antibiotic using the intramuscular route, as 2 mg. daily intravenously are required to accomplish this. Documentation includes 'Lyme Borreliosis and Related Disorders,' by Kenneth Liegner, MD and Conn's Current Therapies."

Surely the nameless physician consultant has heard of
Jarisch-Herxheimer (Herx) reactions. The first IM Rocephin injection (paid for by First Health) was 2G IM. However, the Herx reaction was so severe, and the pain so excruciating that I couldn't get out of bed, much less drive to work. Using this "patient tolerance" indicator, it was decided that 1G twice a week was more tolerable. These are the charges First Health declared "not medically necessary," and did not pay for. If First Health isn't going to pay for the cheaper IM treatment, it is logical to assume that First Health is going to find a way to deny the more expensive treatment cited in their footnote. Dr. has been cost conscious throughout, and "enjoys" a PPO status with First Health, at quite substantial discounts.

It is also quite apparent that the nameless physician consultant did not take into account complicating factors contained in my medical record, and cited as warnings in the literature. The IM route was chosen because IV treatment could not be undertaken while the patient is on high-dosage Coumadine. The depressed state of the auto immune system has a high probability of infection at the central line or PICC catheter insertion point. The surgery required to install a central line catheter has the danger of blood clot resulting in pulmonary embolism, especially in light of the protein-C clotting disorder.

By the way, in the texts cited by the spreadsheet footnote, there are no specific regimens for treatment -- they are only guidelines, modified by the treating physician using many factors. Perhaps the 2mg listed in the footnote is a typo; 2mg is totally inadequate.

We found two articles by Liegner with similar titles:

(1) Lyme Borreliosis and Related Disorders, Internal and Critical Care Medicine. Their are no specific treatment guidelines cited in this article. It is, however, replete with examples of a need to adjust treatment based upon patient response, presenting symptoms, etc. It also states that ..."individuals who have demonstrated relapses following aggressive treatment may require an open-ended antibiotic approach...".

It is quite ludicrous and obviously unethical for a remote physician that has not examined the patient to declare that treatment protocols should override the treating physician. The treating physician is the one that is intimately dealing with patient response, presenting symptoms, etc. Then to cite as a footnote dosage levels that are inadequate, and use "eradicate" in the same sentence as Lyme disease is ludicrous. Lyme cannot be eradicated; it is the presenting symptoms and the current "active infection cycle" that is the focus of the treatment. There is no wonder First Health didn't name their physician consultant. Antibiotics cannot kill the Lyme spirochete when it is in a dormant or encysted state.

(2) Lyme Borreliosis and Related Disorders , presented Sunday, April 26, 1998 at the 11th Scientific Conference on Lyme Disease and other Spirochetal & Tick-Borne Disorders (Dr. Xxxxx was an attendee).

The Disseminated Lyme Disease: Laboratory Diagnosis, Useful laboratory tests, Other useful adjunctive diagnostic studies, Disseminated Lyme Disease: Approach to Treatment , and Role of Empiric Diagnostic and Therapeutic Trial paragraphs show that denial reasons of "duplicate charges" and "not medically necessary" were arbitrarily applied. Specifically noted is the need for submitting specimens to multiple, qualified laboratories, and the need for various serial tests on a two-week or monthly basis while undergoing antibiotic therapy. This is because antibiotic therapy can have adverse effects on the system.

The Conn's Current Therapies section on Lyme Disease, written by Joseph J. Burrascano, Jr. MD is THE BIBLE on Lyme Disease (LD) since at least 1989. Conn's is a standard reference text for treating physicians.

"There is no universally effective antibiotic for treating Lyme Disease. The choice of medication used and the dosage prescribed will vary for different people based on multiple factors."

"Drug levels are done until the most acceptable dose is achieved and then at any time major changes in the treatment regimen occur."

"All patients respond differently and therapy must be individualized. It is not uncommon for a patient who has been ill for many years to require open ended treatment regimens; indeed, some patients will require ongoing maintenance therapy to remain well."

A few observations:

Penny wise, pound foolish? To me, it looks like the effort and cost to sustain the denials instead of paying for services rendered needs a thorough cost-benefit analysis.

First Health's "election" to consider a request for the information to which I am entitled as my "final" appeal is rapidly bringing us to a meeting in New Orleans. In light of the almost 18 pounds of documentation supplied to the administrative record (medical documentation, repeated requests for compliance with the plan, etc.), we are quite confident that the
de novo standard of review will apply. Considering that First Health employed a nameless physician consultant only during this latest round of incomplete review is telling, especially since adjustments to previously denied claims occurred. Did the original denials stem from a medically qualified position?

I have a high degree of bitterness and a firm conviction that my current, needless disability is a direct result of withholding or limiting my access to necessary health care. This has resulted in increasing physical, neurological, and economic harm.

The usage of the 60, 90, and 120 day allowances to reply has effectively used up my short term disability benefit. This time should have been used to undergo a treatment protocol that could lead to returning to a productive state of health and employment. To go forward with expensive treatment when an $ plus non-payment of previous treatment exists is an economic burden that neither Dr. or I can support. It is loathsome to expect us to do so when the previous denials have no basis in medical science. It now appears that job termination is inevitable due to these delays.

We do not want to appear pushy or threatening, but you should know that we have taken the following actions because of this on-going circus:

We have posted a chronological listing of our travails on our web page.
We've written to our Senators and Congressional Representatives, asking for support of the Lyme Disease Initiative Act of 1998 (H.R. 3795 in the House and S. 2034 in the Senate) , and H.R. 2960, 'Responsibility in Managed Care Act of 1997' . We have provided them the URL to our information.
We've connected to other LD "insurance horror story" web sites, keeping each other abreast of each action or inaction in the areas of treatment withholding or limiting, employment discrimination, and ADA violations.
We are currently interviewing legal representation.
We are currently correlating and cataloging our documentation for submission to the PWBA.
We are cooperating with interested print and broadcast media outlets.

Once you exercise your discretionary final review, we are cleared to contact PWBA. Their resolution of the case mis-management and treatment withholding or limiting may be too late to help us, but it will surely help others.

Additional supporting materials, "Selected legal and treatment notes," are contained in
Attachment 3 .

CONCLUSION

Based upon the foregoing, it is quite clear the "standard" texts are only a preliminary starting point for developing treatment regimens; reliance on guidelines in these texts as the only authorized or effective treatment is erroneous in the real world. That there are patients requiring modifications and departures from "standard" treatment is not anecdotal.

From a scientific standpoint, there is no basis for a remote reviewer to arbitrarily impose a standard of care in which only the guidelines determine "medical necessity". The assertion that there is only one way to treat Lyme Disease is simply not supported by the data in peer reviewed scientific literature or other reference material. To disregard this data and impose an arbitrary standard of care is not good medicine and does a great injustice to patients who need treatment for chronic Lyme Disease.

Only a qualified treating physician, evaluating all presenting symptoms, patient tolerance to current regimens, complicating factors such as multi-systemic disorders, and the active state of the infection can ultimately determine "medical necessity" at any particular point in time.

At this time, my diagnosis and manifestations include:

Anxiety
Bilateral Maxillary and Ethmoid Sinusitis
Cerebral Cortical Atrophy
Chronic DVT
Cognitive Dysfunction
Depression secondary to a major disease
Facial Palsy
Hypertension
Immunodeficiency, with lukopekia
Lyme Arthritis
Lyme Disease
Lyme Meningoencephalitis
Memory Loss
Optic Neuritis
Panic Disorder
Protein-C Clotting Disorder
Spasticity

All must receive treatment of some sort, crossing medical specialty boundaries. As each manifestation gains prominence, modifications of treatment must take place. These modifications must maintain some balancing of risk versus reward, so as to not lose ground in the "cure" process.

With First Health determining that the middle treatment road of IM antibiotics (oral, then IM, then IV antibiotics) is not "medically necessary", resulting in over $11,000.00 of prior treatment to not be paid for, precludes going to the more aggressive (and more appropriate) IV antibiotic approach.

Should First Health authorize and guarantee payment of IV antibiotic treatment, I am still left with $1,680.00 to $2,520.00 of financial exposure, based upon my 20% co-pay. With my current reduced income (55% short-term disability "benefit"), which is a direct result of First Health's intrangigence in paying for previously provided necessary care, there is no way the physician or I can absorb the $8.400.00 to $12,600.00 additional economic burden on top of the current non-payments.

To continue withholding or limiting treatment due to non-payment is inevitably leading to a needless permanent disability; possibly death. This is untenable on ethical, legal, or moral grounds.


R. James Martin


cc: Todd Watson, General Counsel


Attachments:
1. Copy of First Health Director & Associate Counsel letter of November 5, 1998.
2. Copy of First Health Manager, Support Services letter of November 5, 1998.
3. Selected legal and treatment notes.