VI  BIAS OF THE NHIC LOCAL COVERAGE DETERMINATION

FE3-24-20E5 00:44 FROM:  CA Article for Transfer Factor - Update (A24677)  Article for Transfer Factor (A24677/A24754)
Original Article Effective Date04/01/2004
Article Revision Effective Datel 2/23/2004
Article TextNHIC published a non-coverage notification on transfer factor In April 2004. This article updates and expands upon information furnished at that time.

1) NHIC writes: “The use of parenteral Transfer Factor" to treat any illness is not a recognized treatment modality accepted by the scientific and medical community, and may be dangerous.”

This is entirely false. We have extensive documentation: 788 pages of scientific and medical literature specific to delayed cell mediated immunity in the LCD docket. Transfer factor is inert. Almost any medical or surgical intervention can be "dangerous" when physicians don't select the right patient population or don't use the correct risk benefit ratio. That is why we all do so many years of medical training before we are licensed to practice medicine. But transfer factor immunomodulatory therapy use in this patient population has been entirely safe without any adverse consequences in our practice in over two decades. This is corroborated by the literature.

NHIC refuses to correlate any source for anything in the LCD. The reviewer makes incomplete lists but never makes any associations whatsoever. Meanwhile, they totally ignore the scientific evidence that was presented to them in this case. Can there ever be any excuse for such bias?

NHIC is not only obstructing justice by making such false statements, it is unfairly prejudicing patients who need this therapy, who will now not consider it because of these entirely false statements made by EDS - NHIC.

2) NHIC writes: “NHIC solicited commentary from several external clinical consultants In allergy and immunology. None of the additional experts recommended coverage of transfer factor for allergic and immunodeficiency conditions.”

NHIC refused to consult the transfer factor immunomodulatory therapy experts who have worked with this patient population and also published. This contradicts the intent of the legislature when they require that an LCD consider experts with clinical experience and preferably who have also published in this group. The experts they consulted are unnamed, their credentials are uncited, their experience with this patient group is not mentioned. Were they told that their decision was going to stop ongoing successful medical therapy in this class of patient? What exactly were they told? Were they paid? Was the information impartial?

Was it recorded? No. NHIC has already said they have absolutely no documentation for anything written in this LCD.

3) NHIC writes: “Via MEDLINE, NHIC reviewed 5 major clinical Immunology Journals for articles dealing with "transfer factor" as a current clinical treatment regimen for any allergy or Immunology condition. The five Journals were Journal of Clinical immunology, Allergy, Clinical and Experiments) Allergy, Journal of Allergy and Clinical Immunology; Journal of Clinical and Laboratory Immunology.  Of 22,375 articles in this MEDLINE data set. only 5 (Including case reports) dealt with transfer factor, none published in the last 15 years. In a broader search of all Journals, rare anomalous results were found. For example, a 1985 article reported 70% response to transfer factor in a cohort of 50 patients (1). However, no follow-up reports were found. We carefully reviewed two review articles (refs. 2, 3) published 15 years ago. Only anecdotal positive findings or findings not later replicated were found. We noted a report of serious adverse effects of transfer factor (raf.4). Books. NHIC reviewed a book chapter (5) provided by a provider requesting coverage of transfer factor. We noted this author had 11 Medline citations on transfer factor thirty years ago, from 1973 to 1976, a brief period of transfer factor Investigations shortly predating Medicare's noncoverage decision on transfer factor. NHIC also reviewed 32 textbooks in allergy and immunology published In the USA or U.K. between 1979 and 2004. 27 did not cite transfer factor (ref. 6; 1979-2003). One cited transfer factor only negatively (7). Four cited transfer factor en passant, by definition, or mildly positively (8). Interestingly, that en passant citations In tha 4th edition (1988, in ref. 8) of Samter's textbook disappear in the much expanded 5th edition (1995, In ref. 6). Lachmann (1993, ref. 8) cites "several serious side effects" and states "in general results have been disappointing and the interpretation of benefit controversial."

• Who analyzed the transfer factor immunomodulatory therapy literature in this way? What are the reviewer’s credentials? 

• Do our patients lose their transfer factor immunomodulatory therapy when this reviewer doesn’t even list a single complete reference in contrast to the 788 pages of complete scientific articles that we presented to NHIC? 

• Why are the transfer factor immunomodulatory therapy citations that were given to NHIC on January 25, 2003 and November 23, 2003 excluded?  Why are the transfer factor immunomodulatory therapy citations that were given to NHIC on January 25, 2003, November 23, 2003 and many subsequent dates excluded? Who excluded them? The reviewer? His supervisor? Dr. Quinn? Why were they excluded? It had to be intentional. Everyone at EDS and NHIC received our 3" stack of documents through our US Department of Justice ATR attorney, by certified mail return receipt requested, Fedex, and by personal service. Then EDS and NHIC received our LCD appeal filing which exceeded 1200 pages. We have all the receipts.

• It is a total breach of fiduciary duty to exclude the many citations that NHIC was given before reimbursement was stopped for successful ongoing medical care. When no one is accountable and sovereign immunity is used as a reason why there is no fiduciary duty, we have a recipe for disaster.

• The reviewer negligently and/or intentionally has excluded a top reference that was given to NHIC from CRC press that shows enormous response in a patient group exactly like ours to transfer factor immunomodulatory therapy.  That body of work weighed heavily in ALJ Stanley Sadur’s decision that transfer factor immunomodulatory therapy was medically necessary and covered by Medicare in this group.  Yet this reviewer mentions other CRC Press books that have no significant relationship to our patients.

• He mentions Alan Levin, M.D., J.D. All we have to do is look at Dr. Levin's current CV [attachment 6] to see how this NHIC employee inaccurately diminishes one of the greatest medical pioneers in our lifetime by taking his incredible body of clinical, laboratory, academic and legal work and diminishing it down to: "We noted this author had 11 Medline citations on transfer factor thirty years ago, from 1973 to 1976, a brief period of transfer factor." Meanwhile, NHIC had Dr. Levin's CV. So they knew this is entirely false and yet they still published it on a public website for a very extended period of time. And the real question is why has Dr. Quinn refused for the entire time he has been NHIC medical director (March 2004 to the present) to consult with Alan Levin M.D.? Somehow, Dr. Levin was good enough to be an expert allergist-immunologist on a California Medical Board panel but he's not good enough for NHIC. How is that possible?

• Has any physician ever heard of counting the number of books the reviewer thinks is available (with no criteria for how they were selected) and then conducting a poll (for which there is no standardization or precedent) to see the frequency of times transfer factor immunomodulatory therapy is mentioned (without any criteria for context)? Nielsen does more scientific polling to see if a sit-com will stay on the air.

• The reviewer mentions that the major textbook of immunology Samter drops the chapter on transfer factor from one edition to another. Does that mean the superb body of work on transfer factor immunomodulatory therapy done by majority-opinion allergist-immunologist, Charles Kirkpatrick, M.D. (who wrote the chapter that included transfer factor) means nothing because the following edition that chapter was changed to a different topic? Does he not realize that physician expert availability, publication space and deadline issues have nothing to do with the fact that Dr. Kirkpatrick's excellent work on transfer factor didn't just disappear? Can this reviewer take his CV and match it to Charles Kirkpatrick, M.D. who is a clinical professor of allergy and clinical immunology at the University of Colorado Health Sciences Center? Has this reviewer no respect for this pioneer and medical legend? Or Dr. Levin? Or Dr. Lawrence?

• What are these serious adverse side effects that the reviewer keeps mentioning but never gives the sources or shows that they occurred in our Medicare patient population? We certainly haven't seen it. Our 788 pages of full articles includes centers that have used transfer factor immunomodulatory therapy being given IV safely over long periods. Is this reviewer talking about the same patient group?

• And then there is this reviewer's obsession with "old." Transfer factor immunomodulatory therapy which was developed by H. Sherwood Lawrence, M.D. at NYU in the 1940's before even a white blood cell was identified. Lots of things in medicine are "old:" oxygen and blood transfusions and so forth. Old means there's a long record to evaluate safety and efficacy. And if you don't do well with newer therapeutic strategies, why would anyone deny you care because it's "old?" It is disrespectful of all the pioneers in medicine from the forties and fifties to treat their work like an old toaster. If it was your life that was on the line: old, safe, and effective, would sound really good.

• Will it take a patient death? That could have happened in this case and would have happened except I vowed that we would not ever play this EDS - NHIC game on that playing field. Every Medicare beneficiary completed their care and those who require ongoing care still receive it despite the illegal actions of EDS - NHIC stopping their reimbursement. We are not interested in catastrophes and headlines. A large part of our lives has already been stolen by EDS - NHIC during the past four years. That can never be returned. There is no giant eraser. For me these actions by EDS - NHIC came right on the heels of the death of my son, Andy. Instead of grieving and putting our family's life back together, we have worked 60-70 hour weeks without interruption for years. Now the best we can hope for is that our lives will return to the sanity that existed with the previous Medicare carrier, Transamerica Occidental. Perhaps it will take a new contractor. We certainly pray for that. Our reimbursement should never have been stopped. The illegal retroactive liability needs to be relieved, the past due beneficiary reimbursements need to be repaid despite any statutory deadline EDS - NHIC forced us to pass, and current reimbursement needs to be reestablished. This EDS - NHIC nightmare needs to end. And only a Federal court order will really end this, because EDS - NHIC is entrenched. As California Medical Association outgoing CEO, Jack Lewin said to me about our case: "Who knew you were right and NHIC was wrong?" These Medicare contracts are worth too much money. The stakes are too high. Solo Medicare physician providers and Medicare beneficiaries are ordinary people with simple lives because of serious illness. We can't compete in this high stakes arena with EDS - NHIC. We never should have been forced to.

4) NHIC writes: Acceptance by individual health care providers, or even a limited group of health care providers, normally does not indicate general acceptance by the medical community. Testimonials indicating such limited acceptance, and limited case studies distributed by sponsors with financial interest in the outcome, are not sufficient evidence of general acceptance by the medical community.

• Daubert is quite clear that general acceptance means that the scientific methodology used in the transfer factor immunomodulatory therapy literature must meet accepted scientific standards. We have presented 788 pages of scientific literature that shows that standard is met.

• We have a limited group of health care providers because we have a limited group of beneficiaries who really need this care and want it. There are only thirty-two patients over three years: an orphan class. Medicare beneficiaries aren't reimbursed for treatment based on whether the incidence of their disease is significant enough or sponsored by a celebrity telethon etc.

• There will always be diversity and Socratic differences in medicine. It is our lifeblood. But never, never, never can Medicare be used to allow majority-opinion specialists to silence minority-opinion specialists. Medicare was never intended by the legislature to do that. That is not why American make regular payroll tax deductions to pay for their Medicare.

• There are NO testimonials from our Medicare beneficiaries. A testimonial is:
  
  In promotion and advertising, a testimonial or endorsement consists of a written or spoken statement, sometimes from a public figure, sometimes from a private citizen, extolling the virtue of some product. The term "testimonial" most commonly applies to the sales-pitches attributed to ordinary citizens.
  
  [Wikipedia]
  
  How dare this reviewer say our patients wrote testimonials? What are our patients advertising? What are our patients promoting? If the reviewer stood back a minute he would see that this outrageous act of EDS - NHIC forcing beneficiaries to beg for their Medicare benefits is an anti-testimonial for Medicare and a testimonial for privatization. None of our Medicare beneficiaries has been fighting for privatization. They are fighting for Medicare as we know it.
  
  Our patients were forced by EDS - NHIC to write to Dr. Lurvey and their elected representatives, knowing that no majority-opinion allergy-immunology patient is ever forced to write and beg for their Medicare reimbursement.
  
  The Medicare Act and related Federal laws demand that the contractor consider beneficiary input. Here EDS - NHIC doesn't pay any attention to our beneficiary input. Instead they casually demean these honest patients written words as "testimonials."
  
  EDS - NHIC is not given an extremely lucrative contract to "protect" Medicare patients from the care they need and deserve. We have seen this before when government agencies and contractors were inappropriately unresponsive to the real needs of real Americans. We look no farther than the superb work: And the Band Played On: Politics, People, and the AIDS Epidemic by Randy Shilts.

The reviewer clearly has no respect for anti-competition protections afforded these patients through federal law. Did NHIC even tell this reviewer or any of their other experts that we had US Department of Justice ATR oversight in this case? Did the reviewer know that there is a long history of the majority-opinion allergist-immunologists trying to block appropriate reimbursement to minority-opinion allergist-immunologists? Would a competent reviewer think that a majority can suppress a minority? Surely we see bad manners from prestigious institutions, even including the New York Times, who slammed Columbia Presbyterian Medical Center as not having the best cardiac surgery statistics, when President Clinton chose CPMC for his bypass surgery. I am personal witness to the fact that no one, even the most "unlikely to survive" candidate for cardiac surgery, will be denied at CPMC, because they have never put statistical outcomes first. They put patients first. President Clinton had a right to choose a center that favors bypass surgery and his outcome was excellent. But many "stent" specialists criticized President Clinton's choice. We can never have one group of specialists dictate what everyone does. This is anathema to the ultimate goal of our American Health care system.

Who are these sponsors with a financial interest in the outcome of transfer factor immunomodulatory therapy? Majority-opinion and minority-opinion allergists make biologicals. Are all allergists now suspect as having a "financial interest" in biologicals because they practice their specialty? Is there something wrong with allergists providing their patients with an orphan custom-made biological, that is not patentable because it has been in the scientific literature for six decades, and has very limited availability? Who are the sponsors with a big financial interest in parenteral immune globulin? Bayer et al. Who are the sponsors with a big financial interest in anti-IgE monoclonal antibody? Genentech. Is transfer factor supposed to compete at the same level with Bayer and Genentech, two of the greatest and most powerful pharmaceutical giants in modern history.

Don't we want Medicare to pay for immune globulin, as it does? Don't we want Medicare to pay for anti-IgE monoclonal antibody as it does? And what if you have abnormal delayed cell mediated immunity? Immune globulin and Anti-IgE monoclonal antibody won't do anything for you at all and both are extremely expensive and have a much higher risk of very serious side effects. Because a biological has been in the medical literature too long to patent so there is no biotech incentive or money for NCD's and the like, do we simply throw out the baby with the bath water?

5) NHIC writes: The broad range of available evidence must be considered and its quality shall be evaluated before a conclusion is reached. It is not covered as a treatment for multiple sclerosis because its use for the purpose is still experimental.” NHIC has reviewed literature on the use of transfer factor in multiple sclerosis. The preponderance of evidence has been negative, including controlled trials. However, NHIC notes that the literature on the use of transfer factor in the treatment of multiple sclerosis was not universally negative; there were occasional positive individual case reports or less unfavorable trial reports. Therefore, Medicare's transfer factor NCO demonstrates comprehensive standards of evidence as used by Medicare for coverage decisions.

This is entirely wrong. There is an elegant study from the New England Journal of Medicine proving that transfer factor does not work in multiple sclerosis, which is not a disease of abnormal cell mediated immunity. The NCD that states transfer factor is not reimbursed for patients with multiple sclerosis shows good judgment. It was not unduly restrictive and was based on sound scientific evidence. The fact that the reviewer is totally oblivious to the existence of the NEJM article speaks volumes. He says "it (transfer factor) was not universally negative (for multiple sclerosis)" and this demonstrates the comprehensive standards of evidence as used by Medicare for coverage decisions. His conclusion is totally correct. His methodology and logic for reaching that conclusion are entirely wrong, because he doesn't have the background to be writing this LCD and ultimately be making decisions on what medical care is or is not reimbursed by Medicare.

And NHIC has stated to CMS FOIA that their experts must remain anonymous because otherwise they might be harassed. The right of the Medicare beneficiary to know who is making decisions that will cause them morbidity and mortality greatly outweighs the need for NHIC expert anonymity.

Our California Medical Board, the finest in the nation, has very high standards for their full-time physicians as well as their expert physician panelists. Their identity is not a secret, because that is definitely not in the best interests of Californians. The CMB physicians are protected from harassment. Transparency only increases the qualifications and due diligence of the expert.

This Medicare website published non-coverage of transfer factor immunomodulatory therapy LCD is the height of medical and scientific mediocrity. The Medicare beneficiaries have a right to know who the physician experts are who are advising Dr. Quinn and writing LCD's and making other very important decisions that directly impact morbidity and mortality.

Sovereign immunity does not mean secret policies and secret experts that breach all sensibility of contractor fiduciary duty and Federal law protections.

ALL FILINGS IN THIS CASE:

Medicare Patients File Second Amended Complaint Against EDS & NHIC 07-09-07

Medicare Patients File Federal Lawsuit Against EDS & NHIC 01-03-07

Interrogatories for Bruce Quinn, MD NHIC Medicare Medical Director 04-09-07

Interrogatories for Charity Horton NHIC Hearing Officer 04-09-07

Complaint against NHIC National Heritage Insurance Company Medicare Hearing Office 04-02-07

Production of documents from Medicare, Bruce Quinn MD and Michael H Jordan 03-28-07

2nd Ex parte filing 03-28-07

1st Ex parte filing 02-02-07