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FDA Workshop on Drug Development for CFS and ME

Ember

Senior Member
Messages
2,115
We're still operating under ICD-9-CM which doesn't have a code for myalgic encephalomyelitis.
Can't ME be diagnosed using ICD-9-CM? I've taken this explanation from the National Alliance for Myalgic Encephalomyelitis:
ICD-9-CM (U.S.)
At present, the U.S. still uses its modification of WHO's ICD 9th revision, the ICD-9-CM. Chronic fatigue syndrome is classified under "Symptoms, Signs and Ill-Defined Conditions," code 780.71, under the sub-heading of "General Symptoms." As the Definitions and Research pages of this website demonstrate, M.E. is a clearly defined clinical entity that was coded in the ICD-9 as 323.9 under "6. Diseases of the Nervous System and Sense Organs(320-389); Inflammatory Diseases of the Central Nervous System(320-326)." However, the U.S. modification of the ICD-9 (ICD-9-CM) tabular document revised 323.9 to "Unspecified cause of encephalitis, myelitis, and encephalomyelitis" but still lists in the ICD-9-CM Index: "Encephalomyelitis (chronic) (granulomatous) (hemorrhagic necrotizing, acute) (myalgic, benign) (see also Encephalitis) 323.9." This is the diagnostic code we recommend doctors use when a patient fits the distinct M.E. definitions, according the the Consensus Document, Ramsay, Dowsett et al definitions, and Hyde descripton. According to a CDC ICD coding representative (July 2006), "M.E. has always been indexed to code 323.9. That is the code number that patients should be assigned." Correctly diagnosing this disease benefits patients and health care providers by acknowledging the true prevalence of ME in the U.S.
 

Ember

Senior Member
Messages
2,115
Even in the ICD-10-CM ME is coded under Postviral Fatigue Syndrome (not neurological disorders as it is in the WHO-generated ICD documents) and is given as equivalent to CFS.
I had thought that the ICD-10-CM coding for ME and CFS was to be under “Diseases of the Nervous System:"
CFSAC continues to recommend that CFS should be classified in ICD‐10‐CM in Chapter 6 under Diseases of the Nervous System at G93.3 in line with ICD‐10, the World Health Organization, and ICD‐10‐CA, the Canadian Clinical Modification and in accordance with CFSAC’s recommendations of August 2005 and May 2011.
But I hadn't thought that equivalency had been decided:
CFSAC rejects CDC’s National Center for Health Statistics Option 2 and recommends that CFS remain in the same code and the same subcode as myalgic encephalomyelitis because CFS includes both viral and non‐viral triggers.
Here (in part) is the NCHS Option 2:

G93.3 Other disorders of the brain

G93.3 Postviral and other Chronic Fatigue Syndromes

G93.3.1 Postviral Fatigue Syndrome
Myalgic Encephalomyelitis

G93.3.2 Chronic Fatigue Syndrome
 

SOC

Senior Member
Messages
7,849
I had thought that the ICD-10-CM coding for ME and CFS was to be under “Diseases of the Nervous System:"
CFSAC continues to recommend that CFS should be classified in ICD‐10‐CM in Chapter 6 under Diseases of the Nervous System at G93.3 in line with ICD‐10, the World Health Organization, and ICD‐10‐CA, the Canadian Clinical Modification and in accordance with CFSAC’s recommendations of August 2005 and May 2011.

Since when is what the CFSAC recommends actually what happens? I was reading the ICD-10-CM itself.

I don't care to argue this point. I looked up the ICD-9-CM and the ICD-10-CM, but I'm happy to be wrong. If I am.
 

Ember

Senior Member
Messages
2,115
Thanks, SOC. As I read this version of ICD-10-CM, PVS is classified in Chapter 6 under "Diseases of the Nervous System" at G93.3. It subsumes CFS (also known as ME), and it's “applicable” to benign myalgic encephalomyelitis:
2013 ICD-10-CM Diagnosis Code G93.3
hierarchy2.png


Postviral fatigue syndrome
  • distinctive syndrome characterized by chronic fatigue, mild fever, lymphadenopathy, headache, myalgia, arthralgia, depression, and memory loss; candidate etiologic agents include Epstein-Barr and other herpesviruses.
  • Syndrome thought to be caused by a viral organism resulting in chronic fatigue, fever, pain, sore throat, and, in some cases, depression.
  • A syndrome of unknown etiology. Chronic fatigue syndrome (CFS) is a clinical diagnosis characterized by an unexplained persistent or relapsing chronic fatigue that is of at least six months' duration, is not the result of ongoing exertion, is not substantially alleviated by rest, and results in substantial reduction of previous levels of occupational, educational, social, or personal activities. Common concurrent symptoms of at least six months duration include impairment of memory or concentration, diffuse pain, sore throat, tender lymph nodes, headaches of a new type, pattern, or severity, and nonrestorative sleep. The etiology of CFS may be viral or immunologic. Neurasthenia and fibromyalgia may represent related disorders. Also known as myalgic encephalomyelitis.
  • G93.3 is a specific ICD-10-CM code that can be used to specify a diagnosis.
  • ICD-10-CM officially replaces ICD-9-CM on October 1, 2014, therefore, G93.3 and all ICD-10-CM diagnosis codes should only be used for training or planning purposes until then.
Applicable To
  • Benign myalgic encephalomyelitis
Type 1 Excludes
help.png

  • chronic fatigue syndrome NOS (R53.82
    note.png
    )

Meanwhile, the National Alliance for Myalgic Encephalomyelitis recommends that ME be diagnosed under ICD-9-CM: "According to a CDC ICD coding representative (July 2006), 'M.E. has always been indexed to code 323.9. That is the code number that patients should be assigned. Correctly diagnosing this disease benefits patients and health care providers by acknowledging the true prevalence of ME in the U.S.'"

2013 ICD-9-CM Diagnosis Codes > Diseases Of The Nervous System And Sense Organs 320-389 > Inflammatory Diseases Of The Central Nervous System 320-327 > Encephalitis myelitis and encephalomyelitis 323-
2013 ICD-9-CM Diagnosis Code 323.9

Unspecified causes of encephalitis, myelitis, and encephalomyelitis
  • ICD-9-CM 323.9 is a billable medical code that can be used to specify a diagnosis on a reimbursement claim.
ICD-9-CM 323.9 converts approximately to:

2013 ICD-10-CM Diagnosis Codes > Diseases of the nervous system G00-G99 > Inflammatory diseases of the central nervous system G00-G09 > Encephalitis, myelitis and encephalomyelitis G04-
ME would seem, then, to qualify as a smaller population of patients with an orphan condition, deserving the attention of the FDA "office of orphan products." With reference to the ICC, we'd "be able to articulate what the subpopulation is."
 

Ember

Senior Member
Messages
2,115
FDA Scientific Stakeholder Workshop Needs Your Input

By Bob Miller on March 6, 2013
Ampligen patients and I are asking you to email the FDA and Secretary of Health to urge them to invite the most experienced ME/CFS clinicians who use the most sophisticated treatments available and to host an Ampligen Roundtable in conjunction with the FDA scientific and stakeholder workshop. The lessons that are being learned from the Ampligen trials will benefit every ME/CFS patient....
 

JohnnyD

Senior Member
Messages
206
Here is bob's full post:

-----------------------
  • Dear Patients, Patient’s Loved ones and Friends,

    Since I ended my hunger strike, I have learned that the FDA has sent invitations for the ME/CFS stakeholder workshop scheduled for April 25-26th. The FDA hasn’t disclosed who it is inviting, and did not solicit input from patients. You, the patients, made this FDA stakeholder meeting happen, and we believe patients need to be involved in setting the agenda and ensuring that the most valuable clinical expertise is represented at the meeting.

    Therefore, Ampligen patients and I are asking you to email the FDA and Secretary of Health to urge them to invite the most experienced ME/CFS clinicians who use the most sophisticated treatments available and to host an Ampligen Roundtable in conjunction with the FDA scientific and stakeholder workshop. The lessons that are being learned from the Ampligen trials will benefit every ME/CFS patient.

    During my hunger strike, the FDA and Secretary Sebelius’s office were inundated with emails and phone calls, and congress people heard from their constituents. I humbly thank you for all your work during those days; our coming together raised the attention of our federal agencies on our health crisis. Once again we need to ACT together by emailing and phoning the FDA to have our voices heard. There is a template email/letter below. For those wishing to use it, just copy and paste for ease. The Cc is to me allowing me to calculate the number of emails sent.

    For the health of Our ME/CFS community,

    Kindly,
    Robert Miller &The Ampligen Team

    Email To:
    Secretary of Health Kathleen Sebelius, FDA Commisioner Dr. Margaret Hamburg, CDER Deputy Director Sandra Kweder, David Banks in FDA Office of Special Health Issues

    Phone contacts: Please call in to make a personal request if you can:

    •FDA Commisioner, Dr. Margaret Hamburg (301) 796-5000
    •Mr. David Banks, Office of Special Health Issues (301)-796-8459
    ---------------------------------------------------------------------------------
    See Email Template Below:

    Email To: kathleen.sebelius@hhs.gov; margaret.hamburg@fda.hhs.gov; Sandra.Kweder@fda.hhs.gov; david.banks@fda.hhs.gov

    ME-CFS-Meeting@fda.hhs.gov; ampligenteam@gmail.com;

    SUBJECT: ME/CFS FDA Scientific Stakeholder Workshop

    Dear Secretary Sebelius, FDA Commissioner Hamburg, Dr. Kweder and Mr. Banks,

    FDA states that the upcoming FDA scientific workshop and stakeholder meeting on ME/CFS is the right place to address the path forward for treatments, including but not limited to Ampligen. There is a serious unmet need in the patient community for medical treatment, and Ampligen is the only medicine that has been tested in clinical trials for ME/CFS in the last 20 years. However, we understand that the few clinicians with extensive experience using Ampligen have not been invited to the workshop to share their understanding of clinical endpoints related to this debilitating illness.

    As a patient with ME/CFS, I am strongly urging FDA to do three things regarding the ME/CFS science and stakeholder workshop:

    1.The FDA should invite Dr. Daniel Peterson, who has undeniably the most experience treating patients with Ampligen and has among the most sophisticated understandings of clinical endpoints, enabling him to identify likely responders by subgrouping patients for various treatments, not limited to Ampligen. In his role as Scientific Advisor to Simmaron Research Foundation, he is collaborating in scientific studies into the immunological abnormalities of ME/CFS, including the NIH and CFI multi-site studies. His clinic has the highest response rate to Ampligen. That, along with his 30-year clinical experience, necessitates his input into future treatment pathways

    2.FDA should hold an Ampligen roundtable with the most experienced Ampligen clinicians, patients, the sponsor and the FDA, CDC and NIH representatives, in conjunction with the FDA workshop. No other medication is, or is about to be, in advance studies for treating ME/CFS or has shown such promise. The experts need to collaborate on a path toward approval for Ampligen, so current Ampligen patients can continue to have access to the drug and many other patients and their doctors can decide if Ampligen might work for them. The benefit of clinical knowledge gained from identifying those who respond to Ampligen is imperative. After FDA denied the application for Ampligen’s approval in February, it posted a statement, saying “To assist companies with their development, FDA is sponsoring a workshop in spring 2013 focused specifically on ME/CFS drug development.” And Dr. Hamburg has stated, “We are committed to continuing our dialogue with companies, innovators, patients, and other stakeholders to identify barriers to progress and better define what steps need to be taken to overcome any obstacles to innovation.” This is the time to learn from Ampligen, as well as other experts.

    3.I also urge FDA to invite Robert Miller as a patient representative. Mr. Miller has taken the lead among patients in urging federal health agencies to pursue smart science and effective treatments for more than 10 years. He played a large part in getting the FDA stakeholder meeting scheduled. His longtime experience in the Ampligen clinical trial gives him a perspective that is necessary to represent patients who participate in the only clinical trial available, as distinct from any of the patients who have been invited thus far. He is a leader among ME/CFS patients generally.

    Our understanding is that this stakeholder meeting is designed to identify endpoints for measuring efficacy, so that more clinical trials can be set up and a path to approved treatments and drugs will be established and clarified.

    As an ME/CFS patient my voice should be represented at this critically important meeting.

    Your Name Here___________
    Years ill ______________
    City and State ______________

 

JohnnyD

Senior Member
Messages
206
I think everyone, as Stakeholders, should call Hamburg's office and ask for a list of Participants for the April 24th, 25th meeting.
 
Messages
5,238
Location
Sofa, UK
I think everyone, as Stakeholders, should call Hamburg's office and ask for a list of Participants for the April 24th, 25th meeting.
I like your thinking Johnny, and your take on what a 'stakeholder' is - that seems like a good step to me, because I would like more information about this. Perhaps a mass phone call isn't necessary though: if somebody is able to obtain this information they can post it here.
 

Ember

Senior Member
Messages
2,115
Apparently, “for purposes of this workshop, the terms 'CFS' and 'ME' have been used interchangeably in describing the conditions:”
These terms are used as a frame of reference only. The terms are intended to be inclusive and make no judgment on the cause of different symptom complexes. Drug development focuses on quantitative measures of benefit (e.g., symptom improvement) in either the entire population or in a defined subset, not on the name of the disease.
But ME, as defined by the ICC, isn't the name of the disease; it's a defined subset:
Remove patients who satisfy the ICC from the broader category of CFS. The purpose of diagnosis is to provide clarity. The criterial symptoms, such as the distinctive abnormal responses to exertion can differentiate ME patients from those who are depressed or have other fatiguing conditions. Not only is it common sense to extricate ME patients from the assortment of conditions assembled under the CFS umbrella, it is compliant with the WHO classification rule that a disease cannot be classified under more than one rubric. The panel is not dismissing the broad components of fatiguing illnesses, but rather the ICC are a refinement of patient stratification. As other identifiable patient sets are identified and supported by research, they would then be removed from the broad CFS/CF category (emphasis added).

 

Ember

Senior Member
Messages
2,115
Occupy CFS -- Jennie Spotila
March 19th, 2013
The upcoming FDA Drug Development Workshop for ME/CFS will be a showcase for our disease and our patient community. We must prepare now to bring our A game on April 25th-26th....

We have four hours on April 25th to describe how ME/CFS affects us, list the many treatments we’ve tried, and make the case for immediate investment in developing new treatments. We will have the microphone for half a day, and we will be watched by FDA, HHS, drug companies, and advocates for other diseases. What we say at the meeting will help us or hurt us. Showing drug developers and FDA that there is a market for new treatments, and telling them which symptoms to target and how to measure improvement, will help us....
 

Sasha

Fine, thank you
Messages
17,863
Location
UK
Does anyone know if the second survey is open to those outside the USA?

I'd really like to participate in this but the second survey asks for which US state you live in and won't save if you leave this field blank.
I left it blank and carried on with no problem. Unless my memory's gone (very possible).