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V. RESPONSE TO THE DHHS DAB DECISION 21. Who are minority-opinion specialists? Who are classic patients who fall outside the usual spectrum of disease? DHHS DAB writes: “In addition to her professional interest, Dr. Calabrese explained her personal perspective based on her own medical difficulties and her tragic loss of her own two children.” Plaintiffs wish to comment: Who are majority-opinion allergist-immunologists? Who are minority-opinion allergist-immunologists? You learn medicine in lectures, labs, clinical pathological conferences and so forth in medical school. But you learn how to be a doctor from apprenticeship with attending physician and surgeons who are kind enough to share their art and science, the nuances, their vision, their passion and their compassion with you. I had many symptoms from severe allergies growing up, which I described to the NHIC staff on November 23, 2003. They admitted that they simply hadn’t heard of patients who presented the way I described. I appreciated their honesty. These were all honest people who throughout the two hours explained that they were simply doing what they were trained to do by NHIC. So we must ask: does the EDS - NHIC personnel training, their manuals and internal policies conform to the NHIC Medicare contract? Does that contract conform to federal law? Where I left off in telling my story to the NHIC staff was the obvious: that if gamma globulin, many broad-spectrum antimicrobials, custom dermatologic preparations, every pharmaceutical known for respiratory and gastrointestinal allergies, hives and skin allergies worked, I would now be a neonatologist. During my residency, I trained for an extended period under a top perinatologist - neonatologist who greatly admired me, as I did him. I would have stayed in neonatology and worked with him for the rest of my life in a heartbeat. It was a guaranteed position. But recurrent infection and this allergic-immune progressive illness made that impossible. I saw top docs at Columbia Presbyterian Medical Center, UCSF and Long Beach Memorial. I lived on buckets of pharmaceuticals that did little and frequently made me worse. The preservative in epinephrine almost landed me on a ventilator. I skin tested positive to nothing except sycamore tree. The Wednesday evening before Thanksgiving 1980, I saw my majority-opinion allergist-immunologist, Stanley Gallant, M.D. at Long Beach Memorial Medical Center again on an emergency basis. He’s a world-class doctor who trained at UCSF. My chronic symptoms were extremely debilitating and then there were these episodes of status asthmaticus. Dr. Gallant’s dad was in status-asthmaticus in the exam room next to mine. I never asked but guessed that Dr. Gallant may have chosen to train as a majority-opinion allergist-immunologist because of his dedication to an illness that directly impacted his family. For him, pharmaceuticals are a major arm of his therapeutic armamentarium. Dr. Gallant defines a majority-opinion allergist-immunologist. Dr. Gallant saved my life that night, but not with medical therapy. He had no more answers and he was ethical enough to say it. Firstly, I could see that his efforts with his own dad were no different than his efforts with me, but for his dad they worked. I knew Dr. Gallant was really trying. He told me that even with massive amounts of steroids I was going to die. When you’re 27 years old, when you’ve just finished your residency, when you’re a new mom and very sick . . . it’s really easy to be in denial. This was never the future picture I had for when I completed so many years in medical training. But I knew Dr. Gallant was right. He needed to tell me my life was all coming to an abrupt end. Many doctors would not have taken the time to lay it out so plainly. It was in that moment that he saved my life because he set the proverbial ticking-clock. I knew I’d better look for other answers and I’d better get on with it quickly. But in my heart, I had surely given up because it never dawned on me to look to the past. . .the older therapies that were used in the 1940’s and 1950’s. Our academic medical training is always biased toward new breakthroughs. So I approached this situation as an intellectual exercise to be complete so my son when he got older wouldn’t say:
It was a $1.95 Pocket Book, at Mc Donald’s, the local bookstore in San Juan Capistrano that turned my life around. The bookseller said that people who bought it had highly recommended it. I remember paying her and saying: “If it works I’ll let you know for sure.” I thought, if it doesn’t work, I’ll never see you again because I won’t be around anymore. Remember at this point everything I knew was majority-opinion allergy-immunology. The author was Marshall Mandell, M.D., a Board-certified allergist-immunologist trained at Mount Sinai Medical Center. The cover and title seemed ridiculous. I only found out later that authors have no control over such things, unless they’re Stephen King. Dr. Mandell described his training with Theron Randolph, M.D., a Board-certified allergist, and ACAAI and AAAI fellow. Ted was the first minority-opinion allergist-immunologist to define the clinical symptomatology he observed that represents chemical sensitivity. I immediately started reading Dr. Randolph’s publications in Annals of Allergy etc. and shared patients with him for many years. It allowed me to learn the limits of minority-opinion allergy-immunology. Even to this day, some patients who are in the prodrome of what will eventually be a malignancy are hard to distinguish clinically from our patient group. That is where allergy testing and therapeutic trials can help sort things out. Attachment 2 was written by minority-opinion otolaryngologist-allergist Bruce R. Gordon in the prestigious Clinics of North America. It clearly sets forth the basics of the minority-opinion allergist-immunologists approach. Each of us has a subspecialty interest within minority-opinion allergy-immunology as we are allergists, ENT surgeons, thoracic surgeons, pathologists and so forth. Minority-opinion allergy is our shared perspective. In short order, it became clear what I had. Firstly, I was severely allergic to many foods, molds, pollens, weeds, dust, and dust mite despite the negative testing. I was anergic because I had abnormal delayed cell-mediated immunity. It morphed my extensive allergies so they were more difficult to diagnose and responded differently than a patient with competent cellular immunity. And indeed transfer factor immunomodulatory therapy effected the right clinical result and did what all the gamma-globulin I received through the Columbia Presbyterian Medical Center, as a child, could not do. The irony is that if I had grown up near lower Manhattan instead of upper Manhattan, I would have been seen at New York University Medical Center, and H. Sherwood Lawrence, M.D., the father of transfer factor immunomodulatory therapy, would have successfully treated me. Dr. Lawrence was a graduate of New York University and NYU School of Medicine, and he completed his residency at Bellevue Hospital. He also was a decorated veteran of WWII, having served as a lieutenant in the Medical Corps of the U.S. Naval Reserve during the invasions of Normandy, Okinawa and Southern France. Dr. Lawrence was a pioneering figure in the field of cellular immunology and conducted some of the earliest research on mechanisms of tissue damage and homograft rejection in humans. He served as both the Associate Chair of the Department of Medicine and as Chief of the Division of Infectious Diseases & Immunology for more than 40 years. A member of the National Academy of Sciences, he was the recipient of many honors and awards for his contributions to medicine. Dr. Lawrence was also a superb clinician and an inspiring teacher to generations of students. He will be remembered for his great intellect, his warm sense of humor, and his kindness. But this is the curious way medicine has always been and always will be. . .it’s about doctors who are real people who leave their mark on other doctors who continue their legacy. If we ever allowed Medicare reimbursement to be used to nuke physicians who treat orphan classes of Medicare beneficiaries, it would be a public health catastrophe. I did not have a form of extensive allergies that responded well to medications, quite the contrary. I learned how to take avoidance and elimination of environmental triggers way beyond what most families are willing to do. For me, there was no choice. It was never a burden, only a freedom, as it is for my patients. I saw Bruce Sanderson M.D., a Board-certified minority-opinion otolaryngologist-allergist at UCSD Medical Center and received customized allergy-testing and immunotherapy. Over time, it became apparent that our families have very significant multi-variant genetic illnesses. My journey typifies that of a minority-opinion allergist-immunologist. We typically have come to this perspective based on family illness. We do best treating the most refractory allergy-immunology families who are willing to buckle down and do the hard work despite such serious illness. Those of us who restrict our practice to allergy-immunology, as I do, attend the ACAAI and/or AAAI continuing medical education conferences. We have the physician and surgeon license and skills to use steroids and the whole complement of pharmaceuticals available in the way majority-opinion allergists do. We simply choose to tie that arm behind our back and be challenged to get the most refractory patients better without relying much on pharmaceuticals. . .because that strategy hasn’t worked for these patients. It is harder on the patient and the physician. But ultimately, many patients respond when all hope was lost. And therein lies the ultimate reward, for it is common knowledge that majority-opinion allergist-immunologists earn far more money than minority-opinion allergist-immunologists. Both majority-opinion and minority-opinion allergist immunologists rely on custom biologicals to meet individual patient needs. These will never be replaced by pharmaceutical company biologicals. For any Medicare contractor to stop reimbursement for allergist-immunologist prepared custom biological, prepared for their own patients, as was done in this case is a threat to allergy-immunology patients everywhere. Custom biologicals are the final safety net for the refractory patient. When a patient in my office suddenly realizes they’re going to get well, it brings me back to that same day when I realized custom immunotherapy would save my life. That is why I am proud to be a minority-opinion allergist-immunologist. I am a classic patient who falls outside the usual spectrum. Every disease has patients who fall outside the usual spectrum. . .they lay outside the usual pattern of diagnosis and therapy. Many of these patients, like me and my family, have multi-variant genetics combined with significant environmental factors. At the time of this writing, there have been no scientific research genetic studies on the effect of one gene on another. I was a physician at Kaiser Permanente Medical Center at this time. I started a minority-opinion allergy-immunology protocol at Kaiser for adults and children there. The focus was on those who lay outside the usual spectrum. It was easy to recruit patients, primarily families of RN’s, in such a closed system. Doctors at Kaiser were happy to “dump” refractory patients on me, some of whom were perceived as annoying and psychiatric. In retrospect it seemed clear to everyone that these moms were getting desperate because there were no answers and their child was very sick from allergies and/or asthma. It fit my training at Columbia Presbyterian Medical Center, which prides itself on treating refractory patients from other major medical centers. To take the classic “patient that lies outside the spectrum” concept a little farther, there came my beloved son, Andy. As an infant he was hospitalized at UCSF Medical Center. After a ten day hospitalization, the Pediatric Gastrointestinal team said: “You need to do what is best for your baby. You need to go to the University of Miami and see Dr. Sandberg.” I will always remember that they didn’t have to tell me this because I had just bought the plane tickets that day. But they did, even though it was the most politically incorrect thing because Dr. Sandberg was a minority-opinion allergist-immunologist. It was one of those sentinel moments in your life that you never forget. We arrived at University of Miami and Dr. Sandberg put my son on 100% gut rest and total parenteral nutrition. This could have been done at any children’s hospital at the time. But he had an end game. He knew how to use custom immunotherapy to get Andy off parenteral nutrition without the projectile vomiting to every food. Without custom antigen immunotherapy and transfer factor, Andy would never have made it to age 17. He would have died as an infant. Douglas Sandberg was a sergeant in WWII who trained at UCSF-Stanford. He became Professor of Pediatrics at the University of Miami - Jackson Memorial Hospital, Chairman of Pediatric Gastroenterology, and ran the Allergy and Nutrition Unit for adults and children for 40 years. Dr. Sandberg became my mentor. He specialized in the most refractory allergy-immunology patients and used Dr. Randolph and Dr. Miller’s methodology. My practice is based on his practice. When he retired from the University of Miami, his West Coast patients came here. This is the normal way that physicians tend to choose their subspecialty. They have a brilliant and kind physician mentor who opens the doors to that certain kind of magic that gets you to the hospital at 5 AM, or has you forget normal people take vacations, or has you typing Federal lawsuits, when you never wanted to be a lawyer. From a public health standpoint, this is essential. There will always be patients who lay outside the usual disease spectrum. We need doctors to treat them. Stopping Medicare reimbursement for patients that lie outside the usual disease spectrums will guarantee that there will be no more of these physicians who are needed the most for patients that lay outside the usual disease spectrum. But that is reality, not a legal argument. Anti-competition protections are there for a reason for all industries, not just health care. Diversity and competition is essential for medicine and there is absolutely no way that the “widespread acceptance” clause should be twisted and misconstrued to annihilate practices like Dr. Sandberg’s or mine. . . particularly by civil servants who are charged with protecting our most vulnerable citizens. How do patients who fall outside the usual spectrum fit into the medical literature? They are found in single case reports in medical journals of every nation and every specialty. In 1990, at the San Francisco American College of Allergy and Immunology (ACAAI) meeting, Douglas Heiner, M.D. from the University of Utah at Provo spoke. Dr. Heiner is a world-class majority-opinion allergist-immunologist with a focus on food allergy. Heiner’s syndrome: Cow’s milk allergy syndrome was named after him. He spoke at our annual literature review. This is a marathon event where important cases from the medical literature are presented by 10 top academic allergist-immunologists. That year he presented a case of a baby from UCSF Medical Center that was an almost identical case to my Andy. It was now clear why UCSF had told me to take Andy to see Dr. Sandberg. The baby they had treated before Andy who was written up in the medical literature as a single case report and presented by Dr. Heiner, didn’t survive. In defining this rare clinical diathesis, Dr. Heiner laid out the final pieces which fit perfectly to complete the autopsy findings that Dr. Blanc, the pediatric pathologist at Columbia Presbyterian Medical Center, had found. He had done the autopsy on my first son. The UCSF paper presented a family with the exact same rare clinical diathesis my family had. I met with Dr. Heiner after his presentation and he told me in their experience at the University of Utah, this specific constellation of symptoms was consistently found in the most extreme allergic families. In November 2005, I asked Dr. Robert Wood, Director of Pediatric Allergy & Immunology at Johns Hopkins University Children’s Center, if he had ever seen a case like the one Dr. Heiner presented. He remembered the case report well. Dr. Wood said no. This clinical diathesis was so rare, there hadn’t been a single case at Johns Hopkins even fifteen years after it was reported at UCSF and discussed by Dr. Heiner at the ACAAI. Medicare reimbursement can never be predicated on patient statistics such that those with orphan illnesses may be excluded. Their care doesn’t have widespread acceptance. Their cases don’t have widespread understanding. This is well described in Robert Proctor’s brilliant book, Racial Hygiene: Medicine under the Nazis, Harvard University Press, Reprint 2006. The solutions lie in better social policies, such as raising the age of Medicare eligibility for healthy seniors to match actuarial improvements in life expectancy. We can never ration medical care. We must make fair and even changes across the beneficiary system. In conclusion, minority-opinion allergist-immunologists treat those who lay outside the usual disease spectrum. Each of us have completely different patient populations. Only a few allergist-immunologists have ever focused on patients with abnormal delayed cell-mediated immunity, extensive allergies and allergic hypersensitivity to chemicals. They are our experts in this case. The legislators in their collective wisdom wrote the LCD appeal such that it requires experts who have clinical experience with this same patient group and who preferably have also published in this specific area. That is definitely not the group of experts NHIC chose. In fact, Dr. Quinn refused to contact Alan Levin, M.D. J.D., a pioneer in transfer factor immunomodulatory therapy, who has extensively published and who has decades of experience with the small orphan class represented by the Medicare beneficiaries in the LCD appeal. Dr. Levin is a decorated Marine veteran, was on the staff at UCSF Medical Center and was on the California Medical Board. His only horse in this race is the truth. His updated CV is attached. [attachment 6]
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
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