Tuesday, May 3, 2016
Following is information on insurance, criticism, realities, and research. Dr. Bruce Gillis, MD, MPH, founder and CEO of EpicGenetics and I consulted, so you can have the best information.
Many insurance carriers, including Blue Shield of California and Medicare are now reimbursing for the FM/a® blood test. The following explanation is for you and your provider.
2. This takes you to the "I’d Like to Order FM/a®” page. Here you will find, "Can you answer YES to experiencing or having recently experienced several common fibromyalgia symptoms, including: chronic fatigue, many painful or tender areas, mental/brain fogginess, poor sleep, trouble concentrating, frequent headaches, joint aches, leg cramps, restless legs when you sleep, anxiety/nervousness, feeling depressed, numbness or tingling?"
*You must be able to answer YES to at least four of the symptoms to be eligible.
3. Next is the online form that asks for relevant data, including contact and insurance information; information needed for the authorization and order processing.
4. After completing the first three steps, you will receive an email confirmation. This begins the insurance review and statement of coverage.
5. A link to a “Physician Authorization Form”, and instructions for your doctor on how to fax paperwork will also be sent to your email.
6. The FM/a® test kit is sent to your doctor for a simple blood draw. The kit includes an overnight shipping package and instructions for returning blood samples to the CLIA-certified and CAP Accredited laboratory in Los Angeles.
7. Results take 7 to 10 days.
*If you don’t have insurance, EpicGenetics offers a zero percent interest, six-month payment plan.
Dr Gillis Is Dedicated
Dr. Gillis has personally spoken with many people who have questions about the diagnosis, available treatments, how to work with doctors, spouses, family members, etc. He says he feels a personal obligation to be available because he and his co-researchers at the University of Illinois, College of Medicine were the first to legitimize fibromyalgia with a confirmable diagnostic test.
He appreciates advocates and patients willing to help build a database that will lead researchers to explore immune system pathways, potential DNA/RNA gene markers, and the development of medications and other treatments that target the cause rather than mask symptoms.
Why Are More Physicians Ordering the FM/a® Test?
Dr. Gillis says there has been a significant increase in tests ordered. He believes this is because there is greater acceptance by physicians. They are moving away from “rule-out” tests because the FM/a® test gives a direct, “rule-in”, rapid, accurate and cost-effective diagnosis. Because more people are aware and more insurance companies are paying for the test, we (people living with fibromyalgia) are asking our doctors to order it too. It is affirming to know there is a biomarker— a biological test—that confirms our symptoms.
My rheumatologist is willing to order it for me. And, now I have the information I need to get the ball rolling in time for my next appointment. I hope you can do the same.
Questions, Answers, and Opinions
A recent article in Fibromyalgia News Today came to me via Google Health News, Proprietary FM/a Fibromyalgia Blood Test Claims Quick, High Accuracy Results. When I shared it, I received some valid questions. Following I address the questions, and share my thoughts.
“What if you've got all the symptoms of fibro, you've had all the testing to rule out everything else, you've been treated for fibro for years, you have the test, and it says you do not have the markers? Will you be told it's all in your head and be taken off all of your meds? Can the test truly be trusted?”
I have asked myself these questions and reasonable deduction tells me that if my test is negative, it is possible that other chronic pain has become centralized, causing changes in my brain that leads to body-wide tenderness. (There is ongoing research on this.) However, no test is 100% accurate. In fact, if someone says it is, question the validity.
The FM/a® test research, Unique ImmunologicPatterns in Fibromyalgia, found the biomarker in 93% of study participants. So, if there is reason to suspect a false negative, one might consider testing for loss of heart rate variability (HRV), which has also been suggested as a potential biomarker. Kenny, MJ and Ganta, CK (2014) state, “Further understanding of regulatory mechanisms linking the sympathetic nervous, parasympathetic nervous, and immune systems is critical for understanding relationships between chronic disease development and immune-associated changes in autonomic nervous system function.” Another reason the FM/a® test is so important.
It is possible to be misdiagnosed. Knowing what it isn’t could lead to the right tests and treatments for a disease that has been mistakenly attributed to fibromyalgia.
Dr. Gillis tells me that in the first four years since the FM/a® test has become available, “the only suspected false negative test results occurred in patients who failed to stop taking their immune system blocking drugs”.
Can the Test Be Trusted?
In late 2012, The FM/a® test was awarded for “Outstanding Research in Clinical and Diagnostic Immunology” by the American Association for Clinical Chemistry. And both the initial and follow up studies were conducted at the University of Illinois at Chicago, College of Medicine, which ranks #11 for 2016 | Best Medical Schools: Research Rankings Methodology. Both studies have been published in peer-reviewed journals.
The different results on cytokines (inflammatory immune protein molecules) compared to other studies could be due to the methods used (i.e. ELISA vs. the multi-biomarker based FM/a® test, which assesses cytokines and chemokines from blood mononuclear cells). The American College of Rheumatology suggests that FM occurs more frequently in immune rheumatic disorders and we know ME/CFS, interstitial cystitis and other disorders with suspected immune dysfunction overlap. So, differences in other studies could be due to subjects who are misdiagnosed with FM, something the FM/a® test will guard against.
The follow up study for specificity to FM, Cytokine and Chemokine Profiles in Fibromyalgia,Rheumatoid Arthritis and Systemic Lupus Erythematosus, compared other rheumatic conditions and found it to be specific to fibromyalgia, further solidifying the validity of the blood test.
Some, whose research is funded by pharmaceutical companies, criticize Dr. Gillis’ because he is the founder and CEO of the lab that does the FM/a® test. But, I have this to say. The FM/a® blood test is performed using a unique multiplex immunoassay. Because of the complexity, just like certain skin biopsies or DNA, it must be analyzed by a specific lab that is specially equipped. Remember, specialized labs were once used to detect HIV and now we are now looking at a vaccination, and the potential to wipe AIDS off the map. Specialized laboratories, such as EpicGenetics, are necessary to accommodate developing science.
It is also apparent that insurance companies and Medicare believe the test is valid. As more tests are ordered, it will maximize the lab’s resources and drive cost down, and just like the HIV test, we can expect the FM/a® test to receive the recognition it deserves.
Why Is Research Important?
I hope every study participant from here on has this test, because it will change the landscape of fibromyalgia. Overlapping symptoms with other disorders can be exclusively ruled out. This is important because the approved FM drugs (antidepressants and anticonvulsants) do not treat immune disease directly. After extensive literature review over the past two decades, I have seen a recurring trend, a disruption in the systems that affect immune response. Sure, there are many who do not have time to keep up with ALL the research. And, there are those who tell us fibromyalgia is psychosomatic (in my opinion due to 2010-2011 ill-conceived, unapproved diagnostic criteria), but remember multiple sclerosis was once known as hysterical paralysis until technology caught up to the patient.
In 2015, a second study on the cerebral spinal fluid of ME/CFS patients found significant reductions in the concentration of cytokine IL-10, which is in contrast to a previous study. Peterson D, et al., state the difference “may be due to the heterogeneity of the disease, different analytical methods, and the presence of divergent patient subgroups”. This further corroborates my personal opinions expressed here.
Because of the FM/a® test, Dr. Gillis can collect information that is just as important as empirical studies. The data will spirit life into important research, resurrect research previously conducted, and lead to more funding for replicated studies. Some research of recent years has gone off course, wasting precious financial resources for a disorder that was first documented by British surgeon William Balfour in 1816 (discussed in the history of fibromyalgia in our book).
Helping collect data through the FM/a® test is one way we can participate as change agents for the future of fibromyalgia. The only way is forward.
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I am not affiliated with EpicGenetics, nor have I received any pay for this article.
You might also be interested in reading Cort Johnson’s article regarding the FM/a®test at Health Rising.
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"Adversity is only an obstacle if we fail to see opportunity."
Celeste Cooper, RN
Celeste’s Website: http://CelesteCooper.com
Learn more about what you can do to help your body function to its potential in the books you can find here on Celeste's blog. Subscribe to posts by using the information in the upper right hand corner or use the share buttons to share with others.
All answers and blogs are based on the author's opinions and writing and are not meant to replace medical advice.