Your opportunity to submit questions to an IOM committee member

[ClarkEllis]

A member of the IOM committee has agreed to do an interview that will be posted on the Phoenix Rising blog. They have graciously agreed to answer questions put forward by members of the community.

This is an opportunity for members to ask questions related to the IOM report.
BEFORE YOU POST A REPLY ON THIS THREAD, PLEASE READ THE RULES FIRST!

RULES AND GUIDANCE:

• Questions must be respectful. Any question that is rude or inappropriate will be removed and the poster will be banned from the thread.
• It may not be possible to answer every question, but all questions will be considered, and the aim is for a broad range of viewpoints to be represented. It is not first come, first served. This thread will be live for 4 days. All questions should be submitted by the end of Wednesday the 25th February, at 00:00 GMT.
• Please take your time to consider your question carefully, and write it as clearly and as concisely as possible.
• You may ask more than one question.
• Before you post a question, please check someone else has not asked it already.
• If you are able, please check the answer to your question can not already be found in the IOM report.
• Do not quote or reply to another members question, as this is not a discussion thread.
• Please note that this thread is not meant for general discussion; it exists solely to allow people to post their questions. I hope the process is clear but if you have any questions about it, send me a private message.
• Ensure that your post contains a question. If it does not, then it belongs on a different thread. Please also avoid making statements of opinion that have no bearing on your question. Focus on your question.

Thanks!

 

[Aurator]

The IOM's report contained much that was encouraging to the patient community.
What positive practical changes to the treatment patients receive does the committee hope will come out of it in both the short and long term?

 

[taniaaust1]

Thank you for giving us this opportunity.

My question is based on the fact that thou I matched/fit very well into the International ME criteria and the Canadian Consensus criteria and actually do have at least 3 of the the ME testable abnormalities in the CCC. Im a severe ME patient (use wheelchair) but actually I dont fit well into your new criteria. The new IOM one states my diagnoses with your criteria should be questioned by doctors.

So Im wanting to know the part in the IOM diagnostic definition which states we should have unrefreshing sleep at least 50% of the time, Im wanting to know what study that info came from? Im assuming the defination got made by evidence based info from studies???

or isnt that part of the definition not even based on any study done at all???? Assumption?

How did IOM come to the conclusion that those with ME usually have unrefreshing sleep at least 50% of time? What study? and was it one which used a good ME/CFS definition on its patient group or was it done on chronic "fatigue" people rather then ME/CFS people?

Thanks. I'd much appreciate this question being answered as this having my diagnoses being questioned every time I see a new doctor thou I are clearly a ME patient will affect me.

 

[Dx Revision Watch]

My questions relate to ICD-10-CM coding.

The report states:

‘A new code should be assigned to this disorder in the International Classification of Diseases, Tenth Edition (ICD-10), that is not linked to “chronic fatigue” or “neurasthenia.”’

and

“In the World Health Organization’s International Classification of Diseases, Tenth Revision, which will be implemented in October 2015, the clinical descriptions of ME and CFS are identical..."


The U.S. is scheduled to implement a U.S. specific "clinical modification" of the WHO's ICD-10, in October 2015, which is known as ICD-10-CM. Responsibility for the development, field testing and consultation for ICD-10-CM and its update and revision cycle is the purview of NCHS and CMS, not the WHO.

So my first question is:

1] (a) Could the references within the report to WHO ICD, Tenth Revision please be amended to reflect the fact that the U.S. will be implementing an adaptation of ICD-10 which is known as ICD-10-CM, which is the responsibility of NCHS?

(b) Could the link given in the report (on page 27) to a commercial data scraping website please be amended to the official current release of ICD-10-CM (FY 2015 release) that is available for download from the CDC's website at: http://www.cdc.gov/nchs/icd/icd10cm.htm


Secondly, the report states:

"In the World Health Organization’s International Classification of Diseases, Tenth Revision (...) the clinical descriptions of ME and CFS are identical..."

2] There are no clinical descriptions or definitions of ME, CFS or PVFS within either the WHO's ICD-10 or within the U.S. ICD-10-CM (FY 2015 release). Could this be amended please?


Thirdly, in order for clinicians to use any new term for diagnosis, clinical records and reimbursement purposes, a unique new code would be required to be created for ICD-10-CM or a new term would need to be added as an inclusion term to an existing ICD-10-CM code.

(Consideration for addition to the U.S. extension of SNOMED CT and the SNOMED CT to ICD-10-CM cross-walk may also be appropriate.)

Both the ICD-9-CM and the ICD-10-CM are currently subject to a partial code freeze [1] on modifications to the code sets in preparation for the implementation of ICD-10-CM. Until October 1, 2016, there will be only limited code updates to the ICD-10-CM code sets to capture new technologies and diagnoses.

If any new term projected to be adopted at some point in the future by IOM contract stakeholder agencies is not considered to fall under the criteria for changes that are permissable during a partial code freeze, then the earliest date for which a new, NCHS approved code could be inserted within ICD-10-CM is October 1, 2016.

So my third question is:

3] (a) Which agency would be taking the lead in drawing up and submitting a request for consideration of a new code (or new inclusion term) to the ICD-10-CM Coordination and Maintenance Committee that oversees the revision and update process? [2]

(b) Has any projected timeframe for preparation and submission of a request for consideration for addition of a new code (or new inclusion term) to ICD-10-CM been discussed with the IOM panel or within the wider context of a timeframe for rolling out a potential new term and criteria?


1 http://www.cdc.gov/nchs/icd/icd9cm_maintenance.htm#partial

2 Coordination and Maintenance Committee
http://www.cdc.gov/nchs/icd/icd9cm_maintenance.htm


Thank you for your consideration.

Suzy Chapman for Dx Revision Watch

 

[Sasha]

I'm extremely grateful to all members of the committee for their hard work and clear commitment to helping patients with this report.

Some questions:

(1) How do you think that patients and supporters can now best leverage the report to get progress on research funding, diagnosis, treatment and respect?

(2) The name is proving contentious. Patients don't appear to agree among themselves on the issue. A poll on Health Rising (of approx. 770 patients) found that 83% thought that the SEID name captured the core features of our disease; but 75% thought it had a high or moderate 'cringe factor'. Those favouring 'SEID' replacing the 'ME/CFS' name were not in a large majority (42% pro, 29% con, 29% undecided).

Given this:

(i) The name 'CFS' has been a terrible burden upon patients. We are the ones who must carry the consequences of any new name. Did the IOM committee have the option of conducting a wide consultation exercise with patients? Is there any place for consultation with a large, representative group of patients even at this stage of the process?

(ii) You'll be aware of Lenny Jason's points. What way do you see for patients to move forward together on this issue, and avoid derailing the progress that the report otherwise might bring?

(iii) One large concern that patients are focused on is how the name will play among the general public ('I can't tolerate exertion either!'), but how will clinicians interpret the name?

(iv) Are there things that you think that patients don't understand about the name selection process or the reasons for the name?

(v) I gather that committee members had trouble agreeing on the underlying basis of this heterogeneous condition, but would it not have been possible, given the key symptoms and some of the research findings, to have had 'neuroimmune' as part of the disease name, to help flag up to the public that this is indeed an organic disease with neurological and immune features? Or even just 'immune'?

 

[Nielk]

If implemented, how will the new IOM criteria effect Social Security Disability Insurance (SSDI) disability for ME/CFS patients. Will patients currently collecting SSDI have to be re-evaluated? What will be the procedure for new patients being evaluated ? Currently patients are assessed based on symptoms of the Fukuda criteria such as palpably swollen lymph nodes, sore throat, muscle tenderness and others. These symptoms are not mandatory for a SEID diagnosis. Did the IOM panel discuss how this new criteria will affect patients seeking disability?

In addition, some medical tests such as abnormal sleep studies and elevated EBV antigen titers are encouraged to support disability for Social security, yet the IOM report does not recommend any testing for SEID. Will health insurance companies cover the costs of these tests?

 

[Nielk]

When HHS contracted the IOM to redefine ME/CFS, it was met with great opposition from the ME/CFS community. Experts, advocates and patients alike wrote letters and voiced their complete opposition for Government to create another criteria when we have a good, proven criteria in the Canadian consensus Criteria (CCC). Some of the members of the IOM panel signed the 50 expert letters in opposition of the IOM process. Why did you decide to accept the invitation to serve on the IOM panel when you knew that the community was trying to put a stop to it?

 

[Wally]

1) Will the Committee Member who will be answering these questions be identified by name?

2) Will the Committee Member who will be answering these questions be doing so as spokesperson for the whole Committee or will the answers/opinions be those of the individual Committee Member?

3) Is there another platform available for the Public to ask questions of the Committee regarding this Report? For example, it is my understanding that the contract between the I.O.M. and the HHS runs through March 22, 2015 and comments from the Public will be accepted through this date via the I.O.M. ME/CFS e-mail address at mecfs@nas.edu . See, http://www.iom.edu/activities/disea...elitischronicfatiguesyndrome/2014-jan-27.aspx
"Public Comments:

Written comments may be submitted to the committee at any time during our study process. There is no deadline or character limit to submit comments. As with any information sent to inform the committee, all written comments will be placed in a Public Access File in compliance with Section 15 of the Federal Advisory Committee Act.

If you would like to submit written comments for the first meeting, please use the email (mecfsopensession@nas.edu). Please focus your comments on the following question: "What is the most important aspect or information that this committee should consider throughout the course of the study?" Written comments received by January 22, 2014 will be distributed to the committee before the meeting on January 27. After January 27, written comments should be sent to the project email address (mecfs@nas.edu). . . ."

4) Has the I.O.M. ME/CFS Committee considered soliciting questions about its Report via the official I.O.M. ME/CFS website link and posting answers to some or all of the questions that are received from the Public on that site?

 

[Wally]

1) Did the I.O.M. ME/CFS Committee receive instructions or recommendations from the HHS, or one of its affiliated agencies, that if a recommendation was to made by the Committee that the name of this illness be changed that the Committee should also recommend what that new name should be? Was this instruction/recommendation given in writing? Was the instruction/recommendation given orally? If this instruction/recommendation was given, who specifically gave the Committee this instruction/recommendation?

2) Did the I.O.M. ME/CFS Committee receive instructions or recommendations from the HHS, or one of its affiliated agencies, to address/consider whether the ICD Code for this illness be changed? If yes, was this instruction/recommendation applicable only if a name change to the illness was recommended or was it also given regardless or whether there was a name change recommendation? Was this instruction/recommendation given in writing? Was the instruction/recommendation given orally? If this instruction/recommendation was given, who specifically gave the Committee this instruction/recommendation? If no instruction/recommendation was given by the HHS, or one of its affiliated agencies, what was the reason the Committee made the recommendation that the Code(s) be changed?

 

[Nielk]

Dr. Derek Enlander of the M.E. and CFS Center of Mt. Sinai commented to M.E. Global chronicle re. the IOM criteria:

"The naivete of the IOM criteria are the lack of exclusions which are contained in previous criteria. It is peculiar that Lucinda Bateman did not see this problem in her specialist opinion. The IOM criteria as they now stand can include psychiatric induced fatigue or simple fatigue conditions, there are virtually no exclusions."

Unlike the Fukuda, CCC and ICC the new IOM criteria do not include any exclusions. Can you explain why the panel decided on this move with the risk of including psychiatric conditions?

 

[Nielk]

Dr. Bateman in her comment on the IOM for the M.E. Global Chronicle stated:

I don't recall anything in the IOM report that states the term Myalgic Encephalomyelitis, or ME, can not be used to describe someone who meets published ME criteria. The recommendation is stop using ME/CFS.

Can you explain what she meant by that statement?

 

[Scarecrow]

The committee were unable to distinguish between subgroups within ME/CFS yet by excluding Fukuda CFS patients without PEM from the new diagnostic criteria for ME/CFS, an element of subgrouping was done. My question is in two parts:

1. Did the committee conclude that Fukuda CFS patients without PEM had been misdiagnosed with CFS and was any consideration given to what will happen to these patients?
2. In stating that they were unable to distinguish between subgroups and calling for more research, did the committee have a sense that there are subgroups within ME/CFS but that there was insufficient evidence [edit: to identify them] at this time?

 

[Nielk]

There are people who were diagnosed with Fukuda who do not experience PEM who will be left out of SEID diagnosis.
They will be left without a diagnosis. Should we then amend the IOM criteria making PEM a choice so that everyone can be included?

Can you see how this train of thought will end up including people who don't have the same disease? At some level there needs to be exclusions to properly define a disease.

 

[taniaaust1]

So this thread doesnt go off topic as I want to respond to Nielk.. Ive started a new thread at http://forums.phoenixrising.me/inde...ined-which-dont-fit-with-iom-defintion.35778/ to continue this discussion topic of the ones who now dont have a diagnoses.

 

[Kati]

Here are my questions:

Will the IOM fight and defend their report to physicians who discredit them (often publicly) as an organization because they are issuing this SEID report? What support can we expect?

Second question: What is the next step? Does the new definition needs to be validated/ operationalized?

 

[LaurelW]

1. How confident are you that the sensitivity and specificity of the new criteria are better than any of the other case definitions?
2. Since it says in the report that the new definition is a clinical one, what will be the preferred research criteria in the future?

 

[Dr.Patient]

Hi,

I am a 45 yr old family physician, presently homebound for the last 3 years with this illness.

SEID sounds better than CFS or ME. But as somebody noted above, people can still say "I too cannot tolerate exertion". Also, "exertion intolerance" can also apply to normal people. It is missing the key component, which is the intolerance following the exertion is prolonged. If the intolerance disappears in a day, and they are back to normal the next day, they do not have this illness.

While exertion can cause intolerance in people, it is the prolonged recovery (prolonged by days, weeks, months, even years) that characterizes our illness.

While in some patients, the "intolerance" might happen soon after exertion, in a significant number, the intolerance appears after a delay, like 24 to 72 hours, even more, after the exertion. This is why initially, patients cannot connect the two, due to this delay. However, in some patients, it may also happen soon after exertion, so we cannot use this criterion to define this illness.

Everybody with this illness has asthenia. (Asthenia: Weakness. Lack of energy and strength. Loss of strength. Asthenia is from the Greek asthenes, from a- (without) + sthenos (strength).) There is not one patient that can say they do not have asthenia. (They may say that is not their most bothering symptom, but they will not deny it.). This may be subtyped into mild, moderate, severe, profound, based on how much strength they have.

My proposal is to name this illness PRAG Prolonged Recovery Asthenia Gravis. When you say to somebody I have PRAG, and then tell them what is stands for, they don't go like " I too have prolonged recovery asthenia gravis". The name sounds serious!

PRAG also captures the two essential components of this illness, one - Asthenia (which is not fatigue), and two- Prolonged Recovery, which will not let us lead our pre-illness, normal lives.

Objection to this PRAG will come from patients who have other symptoms predominantly, like cognitive, or orthostatic or viral-type. Unfortunately, patients presenting with these symptoms will be evaluated differently initially, for cognitive, orthostatic or viral-type illnesses. Eventually, they may end up with the PRAG diagnosis.

Some illnesses may also have asthenia and prolonged recovery, like MS or cancer. In those cases, obviously, the diagnosis is MS or cancer. Our illness PRAG stands alone by itself.

Thank you for your time!

 

[Sushi]

@Dr.Patient
Can you distill a concise question from what you have written above? This thread is not meant to be for comments or discussion, rather just questions for the IOM member.

Thanks,
Sushi

 

[Valentijn]

@Dr.Patient - Was there a question in there somewhere? I don't think commentary was intended to be the focus of the invitation, though perhaps someone can correct me if I'm wrong.

 

[Sushi]

I don't think commentary was intended to be the focus of the invitation, though perhaps someone can correct me if I'm wrong.

Commentary is not only "not the focus" of this thread, but should be posted elsewhere--on another thread. This thread is only for questions for the IOM member who has offered to respond.