Wednesday, May 25, 2016

Update: S.483 Ensuring Patient Access and National Pain Strategy

It’s hard to believe that it has been a year since I first made a call to action on S.483

A lot has happened since then. The act was signed into law by President Obama on April 19, 2016. That’s right, just last month. In March, the CDC opioid Guidelines went through despite outrage regarding the lack of transparency and biased, non-evidence based reports on opioids that led to the development of the guidelines. The National Pain Strategy (NPS), which was drafted to the Federal Registry last year, was also released in March after a long and concerted effort by many engaged individuals and stakeholders, but not without incident. A comment was added on the NIH Interagency Coordinating Committee website, the HHS committee that drafted the guidelines, suggesting the CDC Opioid Guidelines would help implement the strategy, despite no such reference in the original NPS draft.

The National Pain Strategy

The Pain Action Alliance to Implement a National Strategy is an initiative formed by the Center for Practical Bioethics. My friend, Myra Christopher, contributed to the development of the Institute of Medicine Report on Relieving Pain in America. She and many others knew as a result of that report a strategy was needed to address the problems identified having to do with access to medications and treatments, discrimination in pain care, and the stigma associated with chronic pain. Along  with other stakeholders Myra participated in helping draft the National Pain Strategy (NPS).  Myra and PAINS are now calling on President Obama to see that actions are taken to make the necessary funds available to carry out the plan. The letter is riveting and I hope you will read it. Here is an excerpt.

1.       Immediately direct the Office of the Assistant Secretary for Health at the U.S. Department of Health and Human Services to develop and, before the end of 2016, initiate a plan across all federal agencies to restore balance between federal efforts to reduce drug abuse and efforts to reduce the burden of pain in order to establish parity between these two critical public health issues…
2.      Designate a specific agency to be responsible for implementation of the National Pain Strategy Report and establish an independent work group, including people living with both chronic pain and opioid abuse disorder and/or family members, primary care providers and specialists who treat chronic pain, behavioral health experts, complementary care providers, third party payers, patient advocacy groups, and bioethicists to…
3.      Direct CMS to establish chronic pain care as an essential health benefit as quickly as possible and to adequately fund:
a.      Comprehensive chronic pain care provided in primary care medical homes and inter-disciplinary, comprehensive pain clinics,
b.      Evidence-based complementary therapies, including yoga, massage therapy, acupuncture, chiropractic and osteopathic manipulation (those therapies specifically listed in the DOD pain report), and
c.      Abuse deterrent opioid formulations.

Can S.483 Work to Support Patients Who Have Been Abandoned?

As a result of the CDC guidelines and reports that the DEA is charging full force, I have received many emails and messages regarding patients being forced to taper off their opioids or stop them completely. Of particular interest is what is happening to patients in Buffalo, New York, but it is only one example of what is happening across the nation. Because I have been overwhelmed and I donate my time to advocacy, I felt the need to provide patients with some guidelines that will hopefully help them make a case to take to their attorney general. Ensuring Patient Access and Effective Drug Enforcement Act of 2015,  S.483, also protects patients and gives you the right to make sure it is enforced for everyone, including those of us who live with chronic pain. 

 “There's a difference between interest and commitment. 
When you're interested in doing something, you do it only when it's convenient. 
When you're committed to something, you accept no excuses; only results.”
~Kenneth Blanchard

Additional Reading:
Gosy and Associates to reopen under new supervision. Bridge the gap solution within 75 days, really?

(Signature line appended, March 2018)

In healing,
Celeste Cooper, RN / Author, Freelancer, Advocate

Think adversity?-See opportunity!

Wednesday, May 11, 2016

A Year of Fibro: Musings, Writings, and Opinions

A Gift from Shari-In My EVFM Support Group
Being a published author five times,  I know great joy and diversion from my own pain. I truly enjoy what I do. 

Writing for ProHealth and Health Central  is a great opportunity to learn  from the enlightening comments you take the time to share.

We make great strides learning to cope with the effects of body-wide pain, non-refreshing sleep, problems putting thoughts and concepts together, and exhausted body systems. (If you are struggling to find balance, please pick up one of our books). 

As I count my spoons, I remember my fellow warriors who also live with invisible illness and pain. As my dear colleague, Dr. Robert Bennett and his team say,  “A careful clinical evaluation is always required in order to identify any condition that could fully account for the patient’s symptoms and/or contribute to the severity of the symptoms.”  It would be overwhelming to include all my articles, but you can find them on my website now. Following are articles through last May on fibromyalgia and common overlapping conditions.  Please take your time, favorite this link and revisit it when you have a particular question and please share what you learn with others in the comments where the articles are posted, that’s how we all learn.

In healing and hope, Celeste

Some of you may know I am having cataract surgery on the 12th. It’s important to me to have better vision so I can continue what I love to do. This blog was prepared in advance to raise awareness for FIBROMYALGIA AWARENESS DAY. I hope you will help me spread the word by sharing this list of fibro related articles.

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In healing,
Celeste Cooper, RN / Author, Freelancer, Advocate

Think adversity?-See opportunity!

Friday, May 6, 2016

Dear Legislators-Stop S.2758 - PROP Act of 2016

An article written by Pat Anson, editor at Pain Network News, PROP Leads New Effort to Silence Pain Patients, prompted me to respond in my comments, and take it a step further by letting my legislators know how I feel. Once posted on my blog, this letter will also be tweeted out to various individuals and shared on my various social media accounts. I hope you will do the same.

You can find contact information, including how to contact your senator, representative, and others on my website at the bottom of the "Advocacy Template Letter".

April, 2016

S.2758 - PROP Act of 2016
A bill to amend title XVIII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing  program, and for other purposes; to the Committee on Finance.

As an RN who worked her entire career in the hospital setting, writing policies and procedures for staff development and working closely with hospital standards, the Joint Commission, and the American Society of Hospital and Education and Training (ASHET), this Act is deplorable. Surgical pain is clearly not the only pain that needs to be addressed in the hospital setting, though controlling pain improves healing and patient outcome in surgical patients, gets them moving, and prevents things like pneumonia. Pancreatitis, the affects of systemic rheumatologic events, kidney stones, broken bones, burns, and even heart attack are among the hospital patient population requiring pain care.

How would you feel if you were given morphine during a heart attack, which we know improves cardiac output, and you were not reassessed? What if your daughter develops post partum pancreatitis and suffers needlessly? What if you have a kidney stone and you are left to pace the ER with no relief? What happens if a patient’s pain creates an ugly primal instinct that puts hospital staff at risk? You MUST pay attention, because that is exactly what will happen. Hospital policies and procedures are based on what their governing bodies (i.e. CMS and JCAHO) suggest and find important. When outcome is the goal, patients are less likely to be readmitted. There is a very good reason that hospital pain care should be assessed by the patient. Patient suffering to boost PROP, Phoenix House, profit margins is inhumane.

Please support the efforts of Lemeneh Tefera, MD, Centers for Medicare & Medicaid Services and stop the lunacy created by the PROP Act of 2016, S.2758.

Sincerely, Celeste Cooper

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Resources of interest:

S.2758 - PROP Act of 2016
04/07/2016   Read twice and referred to the Committee on Finance.
Type of Action: Introduction and Referral
Action By: Senate

H.R.4499 - PROP Act of 2016
Sponsor: Rep. Mooney, Alexander X.  [R-WV-2] (Introduced 02/09/2016)
Committees:  House - Ways and Means
Latest Action: 02/11/2016 Referred to the Subcommittee on Health.  (All Actions)

Measurement of the Patient Experience Clarifying Facts, Myths, and Approaches ONLINE FIRST
Lemeneh Tefera, MD, MSc1; William G. Lehrman, PhD2; Patrick Conway, MD, MSc3

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"Adversity is only an obstacle if we fail to see opportunity."  
Celeste Cooper, RN
Author—Patient—Health Central Chronic Pain Pro Advocate

Celeste’s Website:

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.  

Tuesday, May 3, 2016

Blood Test for Fibromyalgia: FM/a Test ® Is Real, Q&A

A blood test for fibromyalgia is available that you, or your doctor, may not know about. It is the FM/a® test.                                                       
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. 

1.       Go to 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.

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?”

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.

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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.

In healing,
Celeste Cooper, RN / Author, Freelancer, Advocate

Think adversity?-See opportunity!

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Learn more about Celeste’s books here. Subscribe to posts by using the information in the upper right hand corner or use the share buttons to share with others. 

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