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.
Insurance
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.
1. Go
to https://fmtest.com/
and click the “Getting the Test” button.
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.
https://fmtest.com/ |
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.
Questions
“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?”
My Opinion
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.
Particularly
Interesting
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.
~ • ~ • ~ • ~ • ~ •
~
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.
In healing,
Celeste Cooper, RN / Author, Freelancer, Advocate
Think adversity?-See opportunity!
~ • ~ • ~ • ~ • ~ • ~
Learn more about
Celeste’s books here. Subscribe
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