Dr. Bateman answers IOM questions from the community: Part 1

ClarkEllis submitted a new blog post:

Dr. Bateman answers IOM questions from the community: Part 1

Clark Ellis brings us Part 1 of an interview with Dr. Lucinda Bateman, where she answered questions posed by the patient community ...


The Institute of Medicine recently published its report into myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). One of the committee members, Dr. Lucinda Bateman, graciously agreed to answer questions submitted by members of the patient community.

Questions were submitted on the Phoenix Rising forum and they can all be viewed here.

Questions have been arranged roughly by topic and will be published in two parts.

This part, the first, covers questions on the committee and IOM process, and the IOM's diagnostic definition.

Part 2 will cover the clinicians' guide, the new disease name systemic exertion intolerance disease (SEID) that the IOM has proposed, international classification of diseases (ICD) coding, and miscellaneous topics.

The Committee and the IOM

Q:

When the Department of Health and Human Services 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 against the government creating 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?

Dr. Bateman:

It's pretty simple. I read the statement of task and changed my mind. For 20 years I have been dreaming about putting together a "think tank" of experts who could critically review what we know and use combined expertise to recommend a path forward. While the IOM contract wasn't exactly what I had envisioned, it had many of the ingredients necessary for success that we haven't had access to — outside experts, staff support and funding. I also felt that the IOM would be able to provide the most "neutral" opinion of the evidence base.

Q:

Has the IOM committee considered soliciting questions about its report via the official IOM ME/CFS website link and posting answers to some or all of the questions that are received from the public on that site?

Dr. Bateman:

I don't think so. The IOM is a non-profit organization that accepts a discreet project or contract, plans and implements the project, creates and publishes a peer review report, and then moves on to a new project. They accepted a massive amount of public input that was considered in the ME/CFS report, a document that now recommends new diagnostic criteria based on the high quality published evidence.

It isn't the responsibility of the IOM to re-evaluate or defend the report based on public comment. The report was a specific task commissioned by DHHS. Now it is peer reviewed published scientific literature that DHHS can utilize to make policy and funding decisions. Most of all, it will serve as an immediate resource for physicians.

Q:

Will the IOM fight and defend their report to physicians who discredit it (often publicly)? What support can we expect? [original wording and context]

Dr. Bateman:

No. The IOM doesn't need to defend the report. It is a summary of the literature based on a standard plan for reviewing the evidence. The recommendations arise directly from the summary of the cited literature, clearly outlined section by section.

The IOM report does challenge physicians and scientists to use what is presented in the report to pursue additional answers about almost all aspects of the illness. The IOM report states clearly that more research and funding are needed, that the report has limitations because the existing evidence base has limitations, and that another funded literature review to revise the diagnostic should be done in no more than 5 years.

There is an expectation that a significant amount of meaningful scientific evidence will be published in the next 3-5 years. I don't know what more we could expect from any academic body.

The Diagnostic Definition

Q:

How confident are you that the sensitivity and specificity of the new criteria are better than any of the other case definitions?

Dr. Bateman:

Sensitivity and specificity must be determined by studies that apply the case definition to patient populations. Obviously, that hasn't been done yet. In my opinion, however, sensitivity and specificity are not well-established for any of the existing case definitions, and the subjective nature of case definition criteria make concrete comparisons a challenge.

Indeed, sensitivity and specificity may be an impossible task when we have subjectively defined and overlapping case definitions. Case definitions are a substitute for diagnosis based on objective diagnostic tests, so the ideal is to move beyond case definitions and toward biomarker discovery that helps us understand pathophysiology and better identify illness subgroups.

The report doesn't make any claims about sensitivity or specificity. The committee's goal was to put the major, persistent, measurable, uniquely combined and previously overlooked symptoms in a simple diagnostic formula that practicing physicians can use to recognize and treat the illness — based on the symptoms reported by patients in multisite studies, backed by research demonstrating the biological basis of the presenting symptoms.

If the diagnostic criteria succeed, and these are indeed a core combination of symptoms, the criteria will have decent sensitivity that is eventually supported by objective markers. If not, the criteria should be revised.

I've heard many complain that the diagnostic criteria don't list exclusionary criteria, and that this will diminish the specificity of the report.

My opinion is the opposite. If physicians are responsible for a differential diagnosis to determine the presence of other conditions, they can't simply order a panel of labs and say they've eliminated other diagnoses. As a clinician who has evaluated and followed hundreds of patients for decades, I can say that the process of differential diagnosis never ends.

It is impossible to list every possible exclusion in diagnostic criteria. Doing so just allows physicians to stop thinking critically about the patient. The IOM report encourages clinicians to make the diagnosis, continue investigations and provide care.

Q:

The IOM diagnostic definition requires that patients have unrefreshing sleep, and that if the symptom is not present at least 50 percent of the time, then the diagnosis of ME/CFS should be questioned. The IOM committee was charged to “develop evidence-based diagnostic criteria for use by clinicians.“ Can you say which study/studies this requirement was derived from? [original wording and context]

Dr. Bateman:

Figure 4-2 in the report (ref: Jason et al., 2013b) shows that 92% of patients in one high-quality study endorsed the symptom "unrefreshing sleep," along with high but sequentially decreasing percentages endorsing "problems falling asleep," "need to nap daily, " problems staying asleep," "waking up early," or sleeping all day/awake all night." When a high frequency (at least 50% of the time) and severity (moderate to severe) were employed, these questions clearly distinguished cases from controls.

In my clinical practice, problems with sleep maintenance plague patients and are often one of the most challenging aspects of treatment. It is amazing to me, that in spite of many sleep studies, whatever the problem with sleep in ME/CFS, it isn't diagnosable by currently used sleep evaluations (polysomnography), based on the published evidence. We need to understand it better.

Q:

Some patients who have ME according to the International Consensus Criteria (ICC) and/or CCC are concerned that they don't fit the criteria for SEID. Is there, or should there be, room for an 'atypical SEID' diagnosis, just as the
ICC allowed for an 'atypical ME' diagnosis? [original wording and context]

Dr. Bateman:

Certainly, but I'm not sure that the concern is warranted. All of the SEID criteria are also CCC criteria in one form or another. It is the Fukuda criteria that will prove to be broader than the SEID criteria, leaving many without the diagnosis of CFS, but those are arguably people who don't have ME/CFS anyway. For example, in my clinic that would be people with depression, mild or moderate fibromyalgia, undiagnosed other medical problems, etc.

Q:

Given that a sore throat and tender lymph nodes are often the earliest to appear, why were these symptoms not in the diagnostic criteria? Won't the omission create the risk of patients waiting till other symptoms appear to get a diagnosis, or doctors refusing to diagnose the illness at its earliest stages? [
original wording and context]

Dr. Bateman:

The sore throat and tender lymph node criteria aren't present in everyone with ME/CFS, even at onset, and the prevalence of these symptoms diminishes with time. People present to physicians at all stages of illness, not just at onset. Making these symptoms required for diagnosis doesn't make sense. Also, the report states that if these symptoms are present, it supports the diagnosis.

Q:

Currently, patients applying for Social Security Disability Insurance (SSDI) 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 might affect patients seeking disability? [
original wording and context]

Dr. Bateman:

Symptoms that are not mandatory are still symptoms that can support the illness. As for the pain symptoms, which can be significant in many patients, especially the severely ill, the diagnosis of comorbid fibromyalgia (widespread hyperalgesia and central sensitization) is often very descriptive and objectively defined.

Q:

Given that muscle weakness/asthenia is a key feature in this illness, why was it not in the diagnostic criteria?

Dr. Bateman:

Actually, while patients feel weak and can have dramatically reduced function, the problem is not exactly muscle weakness by the usual medical definition (hence the “normal” strength exam in most patients). The complaint of weakness or asthenia might be related to abnormal function of the central nervous system, pain, orthostatic intolerance, deconditioning, and PEM, for example. Actual muscle weakness might suggest another diagnosis.

Q:

Unlike the Fukuda, CCC and ICC, the new IOM criteria do not include any exclusions. Dr. Derek Enlander commented to the M.E. Global Chronicle:

"The naiveté 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."

Can you explain why the panel decided on this move with the risk of including psychiatric conditions? [original wording and context]

Dr. Bateman:

As I discussed above, it is a misconception that the IOM criteria do not require “exclusions” or a differential diagnosis. Physicians are expected to evaluate for other disorders that might completely explain the symptoms, and not make a diagnosis of ME/CFS or SEID if such an illness is identified. The committee decided not to attempt a list of every possible illness that could present with similar symptoms.

It is my own medical opinion that, after routine medical workup has been done (physical exam, ECG, labs, MRIs, mental health screen, etc.), there are very few illnesses, with “normal” tests, that present with such reduced functional capacity, PEM, pervasively disordered sleep, cognitive impairment and orthostatic intolerance. Not depression, for sure.

It would be hard to miss a diagnosis of depression so severe that it caused symptoms resembling ME/CFS. The key is that the combination of core symptoms are mandatory. They must all be present with no other apparent cause after an appropriate medical and mental health workup — a diagnostic process expected of providers.

I’ll also add that people with ME/CFS can and do develop other conditions that contribute to the symptom burden, including depression, menopause, primary sleep disorders and thyroid disorders, for example. Excluding them from an ME/CFS diagnosis would be wrong.

I have many patients that presented with straightforward ME/CFS and went on over the years to develop comorbid conditions which were diagnosed and treated. Don’t they still have ME/CFS?

Q:

The IOM criteria require substantially reduced functional capacity and fatigue, PEM, non-restorative sleep, neurocognitive impairment and/or orthostatic intolerance/ autonomic dysfunction. Does requiring only four criterial symptoms not increase the risk of “including groups of patients that do not suffer from the same disease?"[original wording and context]

Dr. Bateman:

Already answered above.

Q:

Did the IOM panel evaluate whether these diagnostic criteria would be reliable in the diagnosis of the most severe patients who may be bedbound and dependent on caretakers? Put another way, would doctors recognize a severely ill patient as an SEID patient based on the disease description and the criteria provided? [original wording and context]

Dr. Bateman:

The answer is no, the diagnostic criteria were not evaluated for reliability in the most severe patients, because these patients are largely overlooked and not included in the published literature, and the IOM report was generated from this literature. This limitation is recognized and stated in the report, with a call for additional research.

Severely ill patients do have reduced function, activity intolerance, sleep dysregulation, cognitive impairment and orthostatic intolerance. The fact that they have even more symptoms — such as widespread pain and severe central sensitivity — does not preclude a diagnosis using SEID criteria.

Q:

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 three parts:

a) 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?

Dr. Bateman:

It was recognized that a subgroup, previously diagnosed by Fukuda criteria but without PEM, might be created with the new criteria. In reviewing the existing case definitions, the committee responded to CFS clinicians and patients who communicated strongly that PEM should be a distinguishing feature of ME/CFS, and that it should be a required symptom.

This was supported in the evidence base. As a clinician, I have some ideas about alternate diagnoses for this no-PEM subgroup, but until comparative studies, are done it is only speculation on my part.

Q:

b) 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 to identify them at this time?

Dr. Bateman:

Yes.

Q:

c) Did the committee discuss what they felt should happen to Fukuda and Empirical? Did they expect these criteria to be disbanded?

Dr. Bateman:

The IOM committee did not directly address that question or make a recommendation regarding these criteria.

Q:

Was there any discussion of how to evaluate the validity and reliability of these new criteria for this disease prior to roll-out? Same question for the diagnostic tools being recommended if they have not already been evaluated specifically for this disease. If not, shouldn’t that be done before these criteria are rolled out, especially given the lack of recommended biomarkers?

Dr. Bateman:

It was not in the statement of task to do any of those things. The task was to review the literature, and based on the strongest evidence, make recommendations for new diagnostic criteria, on a fairly stringent time schedule. Those tasks are for future research.

Q:

Is SEID intended to cover patients with an existing diagnosis of myalgic encepheomyelits (as described by Dr. Melvin Ramsay and others) and which occurred in outbreaks through the 20th century? Please note, this is not a reference to the CCC or other ME/CFS criteria.

Dr. Bateman:

SEID criteria are intended for current use, for doctors to do better at making the diagnosis in a clinical setting. There was no discussion of anything but using them for this purpose.

Q:

I have had doctors claim in response to the new criteria that all of the symptoms listed there could be psychosomatic or psychological. How would you respond to clinicians who take that view?

Dr. Bateman:

I disagree. The criteria were chosen because they are not only common aspects of illness, but measurable by clinicians and supported by scientific research. Functional decline, disordered sleep, cognitive impairment and orthostatic intolerance are all objective and measurable findings.

We need to improve the tools we use to measure them, but these findings, combined with a typical history and other characteristic symptoms, are how the diagnosis can be made.

Naysayers have always claimed that people with ME/CFS are just experiencing psychological symptoms. That’s nothing new.

Q:

Since it says in the report that the new definition is a clinical one, where does that leave us regarding research criteria? [
original wording and context]

Dr. Bateman:

That was and is not the responsibility of the IOM committee to answer.

Q:

The suggested new name indicates that SEID is a systemic illness. But the diagnostic criteria don't include a systemic range of symptoms. Doesn't that contradiction send a confusing message about this disease, to doctors in particular?

Dr. Bateman:

I disagree. Fatigue, reduced function and orthostatic intolerance in particular are each “systemic.” The symptoms in combination create a multisystem illness as well.

***************************************************************************************************​

A big thank you to Dr. Lucinda Bateman for her answers and willingness to engage with patients.

Thank you also to members of the patient community for taking part and submitting questions. Please note that it was not possible to include every question in the interview, but we included as many as we could.

Some of the questions were shortened or reworded to improve readability of the article and to ensure that we could cover as many questions as possible. In doing so, I tried to maintain the spirit of each question. In such cases, a link to the specific original question has also been provided for full context.

Please also note that if your question did not appear in the interview then that may have been because Dr. Bateman has already provided an answer in her earlier response to an article by Dr. Leonard Jason, or the answer to the question may be evident from the IOM report itself.

Part 2 will be published shortly and will cover the clinicians' guide, the proposed new name: systemic exertion intolerance disease (SEID), international classification of diseases (ICD) coding, and miscellaneous topics.


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Comments

SEID gets a code, which is not fatigue or neurasthenia
Although the IOM panel recommended in the text of the prepublication version that a new code should be assigned that

'is not linked to “chronic fatigue” or “neurasthenia”'

the panel made no suggestions about which chapter a new code should potentially be located under and no suggestions (as far as I am aware) of what, if any, modifications should be made to the existing ICD-10-CM G93.3 and R53.82 hierarchies.

My understanding is that making recommendations for potential new codes or modifications to the existing code set did not fall within the panel's remit.

Although the panel did go as far as saying 'not linked to "chronic fatigue"' it did not specifically recommend against locating a new term elsewhere within the Symptoms and signs (R code) chapter.

It is NCHS that makes decisions about additions and modifications to the ICD-10-CM code set, via formal proposals submitted through the public C & M Committee process.

If NCHS or CDC were to prefer not to locate a new term under the Diseases of the nervous system chapter (the Neurology chapter) they would be faced with proposing an alternative chapter location.

If no other body system chapter is considered appropriate and given that there is no Multisystem Disorder chapter in ICD-10-CM, NCHS and CDC may consider that the most appropriate course, for the time being, would be to locate a new code within the R code chapter, but under a different parent class than R53 Malaise and fatigue.

NCHS and CDC might try to justify such a decision on the grounds that the new term needs a code for billing and health records but until WHO's ICD Revision has resolved how it intends to classify the G93.3 legacy terms for ICD-11, ICD-10-CM should use the R code chapter as a holding pen for the new term.

Note that it is very unlikely that NCHS could insert a new code until the partial code freeze has lifted in October 2016.

So I would not rule out the possibility of a new term being located as an interim measure, post October 2016, under a different parent class within the R codes, if NCHS/CDC is reluctant to locate under Diseases of the nervous system.


Here is the introductory text for ICD-10-CM Chapter 18:

Chapter 18

Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified (R00-R99)


Note:
This chapter includes symptoms, signs, abnormal results of clinical or other investigative procedures, and ill-defined conditions regarding which no diagnosis classifiable elsewhere is recorded.

Signs and symptoms that point rather definitely to a given diagnosis have been assigned to a category in other chapters of the classification. In general, categories in this chapter include the less well-defined conditions and symptoms that, without the necessary study of the case to establish a final diagnosis, point perhaps equally to two or more diseases or to two or more systems of the body. Practically all categories in the chapter could be designated' not otherwise specified', 'unknown etiology' or 'transient'. The Alphabetical Index should be consulted to determine which symptoms and signs are to be allocated here and which to other chapters. The residual subcategories, numbered .8, are generally provided for other relevant symptoms that cannot be allocated elsewhere in the classification.

The conditions and signs or symptoms included in categories R00-R94 consist of:

(a) cases for which no more specific diagnosis can be made even after all the facts bearing on the case have been investigated;
(b) signs or symptoms existing at the time of initial encounter that proved to be transient and whose causes could not be determined;
(c) provisional diagnosis in a patient who failed to return for further investigation or care;
(d) cases referred elsewhere for investigation or treatment before the diagnosis was made;
(e) cases in which a more precise diagnosis was not available for any other reason;
(f) certain symptoms, for which supplementary information is provided, that represent important problems in medicalcare in their own right.

Excludes2:
abnormal findings on antenatal screening of mother (O28.-)
certain conditions originating in the perinatal period (P04-P96)
signs and symptoms classified in the body system chapters
 
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To me it's not logical at all unless you can prove that SEID is a third distinct disease from both ME and CFS. As I understand it, the same disease is not supposed to appear in the ICD under mutliple rubrics.
There are a small number of diseases that will be associated with two chapters for ICD-10-CM, including the dementia related disorders, which straddle the Neurology and the Mental and behavioural chapters. This applies to WHO's ICD-10, too, where some dementia terms are listed under Chapter V but cross linked to a G code with the dagger symbol.
 
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Well, this is speculation, but I can see where the chairman, Dr. Clayton, would have reigned in any discussion or debate on topics outside the scope. It's hard enough to get a 15-person consensus on the particular questions out to them. Getting the group to stay on task is very common to get to the goal in the time allowed. Also, remember, the P2P was supposed to be handling the research definition aspect.
The P2P were not tasked to create research criteria. They originally were, and then it was left off. HHS left this gap which is creating a lot of confusion. If the Fukuda are the research criteria that HHS accepts and no new research criteria were created, does that mean that the Fukuda remains as the research criteria?
 
By the way, if the SEID recommendations are followed, it would not be in the R53 code under "Fatigue." But, considering it's multisystem nature, sure would be nice to have had some science-based guidance on where it should go.
R53 is fatigue and malaise so it could potentially fit there as described, since fatigue and post exertional malaise are the hallmarks of the SEID criteria. Regardless, with the way SEID is described, I still think it would have to be in R (symptoms, signs and abnormal clinical laboratory findings).
 
In an earlier post in this thread, I referenced the respective hierarchies for PVFS; BME; CFS, postviral and CFS NOS for ICD-10-CM for the 2003 draft compared with the 2007 Release.

For the history of PVFS, BME and CFS in ICD (ICD-9, ICD-9-CM, ICD-10, ICD-10-CM) to March 2001, see this archive CDC document:

https://dxrevisionwatch.files.wordpress.com/2009/12/icd_code-cdc-march-2001.pdf

A Summary of Chronic Fatigue Syndrome and Its Classification in the International Classification of Diseases
Prepared by the Centers for Disease Control and Prevention, National Center for Health Statistics, Office of the Center Director, Data Policy and Standards, March 2001


In March 2001, the intention had been to locate all three terms under G93.3 (as the Canadian ICD-10-CA has since done and as the German ICD-10-GM has since done). From the March 2001 document:

"In keeping with the placement in the ICD-10, chronic fatigue syndrome (and its synonymous terms) will remain at G93.3 in ICD-10-CM."



When the draft of ICD-10-CM was posted in 2003, this had been the proposal:





Around 2004, the G93.3 "Chronic fatigue syndrome, postviral" inclusion term was deleted, leaving "Chronic fatigue syndrome NOS" in the R code chapter as the only CFS term within the ICD-10-CM Tabular List.

This decision had been effected outside the public NCHS/CMS ICD-9-CM C & M Committee meeting process. Proposals for modifications to the ICD-10-CM code set did not become part of the public ICD-9-CM C & M Committee meeting process until 2010. So it was done behind closed doors.

(If you want the background to this deletion, Mary Schweitzer was at the meeting where this change first came to light during a slide presentation by the late William Reeves)


So when the 2007 ICD-10-CM Release was posted it had this arrangement, which is how it has stood for subsequent annual releases:

Chapter 6



Chapter 18


 
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So is the criteria and name for SEID meant to be a replacement or an addition to other names and criteria? I understand it is meant to be a replacement of based on looking at the report because it says SEID is a new name for "the disorder" and says that disorder has the current labels of "ME," "CFS," and "ME/CFS."
I have been equally confused about whether the panel envisages the new term replacing CFS, or replacing both CFS and (B)ME, or whether it intends that it should exist in tandem with the existing terms, and I can see this creating difficulties for NCHS/CDC's assigning of an ICD code and specifying its relationship to the existing ICD terms.
 
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Dr. Bateman:

The report doesn't make any claims about sensitivity or specificity. The committee's goal was to put the major, persistent, measurable, uniquely combined and previously overlooked symptoms in a simple diagnostic formula that practicing physicians can use to recognize and treat the illness — based on the symptoms reported by patients in multisite studies, backed by research demonstrating the biological basis of the presenting symptoms.
Dr. Bateman:

Figure 4-2 in the report (ref: Jason et al., 2013b) shows that 92% of patients in one high-quality study endorsed the symptom "unrefreshing sleep," along with high but sequentially decreasing percentages endorsing "problems falling asleep," "need to nap daily, " problems staying asleep," "waking up early," or sleeping all day/awake all night." When a high frequency (at least 50% of the time) and severity (moderate to severe) were employed, these questions clearly distinguished cases from controls.
Was the Jason et al. (2013b) study considered to be of such high quality as to provide the basis for making unrefreshing sleep, but not "additional" symptoms, a core SEID requirement? Or were decisions also based on unpublished CDC data? Dr. Bateman suggests that the SEID criteria were “based on the symptoms reported by patients in multisite studies, backed by research demonstrating the biological basis of the presenting symptoms.”

The Jason et al. (2013b) study tests a combined CFS (Fukuda) and ME/CFS (CCC) patient population using the DePaul Symptom Questionnaire (DSQ), a questionnaire that lacks independent validation. The study filters its findings using a frequency/severity standard that requires symptoms to be moderately severe at least half of the time. Although the presence of immune markers discriminates well between patients and healthy controls, these are found to be present in half the population or less when the frequency/severity filter is applied. Lymph node tenderness and pain are nevertheless found to track best with a high/low severity split (3:13:45) in a CFI cohort. Pain is reported by Jason et al. in more than half the population after the frequency/severity filter is applied, and as the authors acknowledge, “Pain is the major contributor to incapacity and self-reported symptoms; thus, some might challenge its relegation to a secondary role.” Commenting on the limitations of their study, Jason et al. point out, “Symptoms were not asked about in relation to activity; as some patients may only experience certain symptoms in response to activity, the prevalence of these symptoms may be underrepresented in this study’s results.”

The Report Guide for Clinicians uses figures from Jason et al. (2013b) to validate its core symptoms.
 
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Dr. Clayton stated that they did receive and consider information from the ongoing unpublished CDC multi-site study. Even though, dr. Clayton stated at the start of the IOM that once the IOM process starts, they will not get any input from any of the HHS sponsoring agencies-CDC being one of them.

I don't know how this was legal to include information from an ongoing study that has not completed yet and emanating from an agency that is sponsoring the work.
 
Dr. Clayton stated that they did receive and consider information from the ongoing unpublished CDC multi-site study.
When the ICC was introduced at the IACFS/ME Conference in September 2011, it was opposed by two researchers, Dr. Jason and Dr. Unger. Their work seems to have had a significant impact on these IOM criteria.
 
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My general take is that SEID is SEID. It's pretty similar to ICC and CCC, but not quite the same.... I don't think we have to have a war to decide whether SEID or CCC or ICC is the "one true criteria for our disease"..... CCC and ICC require slightly different things....
ME (ICC) differs from ME/CFS (CCC) enough to have warranted the development of distinct criteria, a new primer and a change of name. The Snell et al. (2005) test-retest exercise study was key to the development of PENE; genetic, neuorological, immune, mitochondria and ion transport studies brought greater clarity:
It was the accumulation of research and clinical knowledge that influenced the decision to develop new criteria, however, a few studies come to mind….The 2005 Snell et al study, the first test-retest exercise study, reported that some patients had a dramatic drop in their ability to produce energy following the second test. More exciting post- exertional studies followed – the Pacific Fatigue Lab, Drs. Light, White, Van Oosterwijck, de Meirleir, etc. The test-retest studies not only confirmed that ME patients had pathological responses to exertion, but the abnormalities were greater than expected in many cases. Genetic, neurological, immune, mitochondria and ion transport studies brought greater clarity. (Kerr, Broderick, Klimas, Myhill, etc.)
The differences between ME (ICC) and ME/CFS (CCC) matter more than you suggest.

As for ME/CFS (SEID), not even its authors seem able to tell what manner of hybrid that they conceived. In Part 2, Dr. Bateman will be asked to address International Classification of Diseases (ICD) coding for SEID.
 
And just to confirm, there were no proposals for additions or modifications to the ICD-10-CM code set of relevance to us presented at the March 18-19 NCHS/CMS ICD-10-CM C & M meeting.

The next meeting is scheduled for September 22-23, 2015, then March 2016, September 2016, March 2017 and so on.

Although the partial code freeze does not lift until October 1, 2016 (ie 12 months after ICD-10-CM's implementation date), it would be possible for proposals for additions/modifications to be submitted during 2015 and 2016 for consideration for deferred incorporation, once the partial code freeze has ended.

So in theory, proposals could be submitted by one of the stakeholder agencies at this year's September meeting or in March 2016 or September 2016, for consideration for incorporation on or after October 1, 2016.

As the 2003 draft and the 2007 Release are now difficult to find and as the FY 2015 Release is part of a very large zip file downloadable from the CDC site, I have posted PDFs of the Tabular Lists for all three iterations on my site. The FY 2016 Release is expected to be posted on the CDC site in June.


ICD-10-CM 2003 draft Tabular List
[9.4MB]

https://dxrevisionwatch.files.wordpress.com/2015/03/icd-10-cm-draft-2003.pdf


ICD-10-CM 2007 Release Tabular List
[5.4 MB]

https://dxrevisionwatch.files.wordpress.com/2015/03/2007-tabular-list-release.pdf


ICD-10-CM FY 2015 Release Tabular List
[8.0MB]

https://dxrevisionwatch.files.wordpress.com/2015/03/fy15_tabular.pdf
 
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Starting October 2015 we will have an ICD code in the U.S. for ME; ICD-10-CM G93.3
One really has to wonder if the IOM thing got done when it did due to knowing that was happening, otherwise ME may of become accepted there esp since we all not long ago (when considering how fast or I rather should say, not fast medicine stuff moves) got the International ME criteria.

There was a strong possibility that more and more people may of started using that code.
....

Thanks Dr Bateman for answering peoples questions.
 
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Despite the CCC being shared in thousands of dr's offices (at least in Canada) and the MEICC being published in a prominent journL, these 2 never caught up in the larger medicine field. )
Ive read something like it takes medicine around 15 years (it may of been 17 years) to catch up on what is going on in science etc. So maybe the CCC was about to just come into its own when the IOM happened (as we know we did get experts finally universally agree on it and sign that letter calling for it).

Anyway, in things to do with medicine and change, there is usually a big time delay. This field moves slowly with change.
 
Nielk said:

"Starting October 2015 we will have an ICD code in the U.S. for ME; ICD-10-CM G93.3"


One really has to wonder if the IOM thing got done when it did due to knowing that was happening,

But this was hardly a recent decision on the part of NCHS!

CMS commissioned a draft adaptation of WHO's ICD-10 in 1995. The entire draft of the Tabular List of ICD-10-CM and the preliminary crosswalk between ICD-9-CM and ICD-10-CM were made available on the NCHS website for public comment between December 1997 through February 1998.

The intention to retain BME under G93.3 was discussed in the March 2001 CDC document.

Field tests for ICD-10-CM were held in the summer of 2003.

A draft of ICD-10-CM was posted in 2003:

https://dxrevisionwatch.files.wordpress.com/2015/03/icd-10-cm-draft-2003.pdf

The issue of the coding of PVFS, BME and CFS NOS has been discussed at two ICD-9-CM C & M meetings (2010/11), when alternative proposals for the coding of CFS were presented by a patient advocacy group and by CDC, themselves.

Since 2010, annual releases of ICD-10-CM have been posted on the CDC website.

It's been apparent since 1997 that NCHS had chosen to retain the G93.3 codes inherited from ICD-10.

There has been a code freeze in effect since 2011 which severely limits modifications to the code set.

If HHS or CDC or any other agency were looking to rid ICD-10-CM of G93.3 BME, why wait until a code freeze is in effect to commission a potential code changing report?

They could have gotten rid of G93.3 BME at any time between 1997 and the enforcement of the code freeze, in 2011.

(The partial code freeze is intended to facilitate provider and payer preparations for transition from ICD-9-CM to ICD-10-CM by providing a more stable code set.)


BTW, the original implementation date for ICD-10-CM was proposed for October 1, 2011.

This was subsequently delayed until October 1, 2013 (to allow more time for provider and payer preparations). It was then delayed a further year, to October 1, 2014, then a further year, to October 1, 2015 (due to the signing into law of a piggyback clause in the HR 4302 PAM Act 2014).

Had it not been for these delays, the U.S. would already be using a code set that includes BME as the codeable inclusion term under G93.3 PVFS.
 
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As I understand it, we have a code today in ICD-9-CM for ME (listed as benign myalgic encephalomyelitis) but doctors rarely use it.

The index file of the 2011 ICD-9-CM on the NCHS website contains the following term, indexed to code 323.9
Encephalomyelitis (chronic) (granulomatous) (myalgic, benign) (see also Encephalitis)

the code 323.9 is indexed to this code in the tabular list of the ICD-9-CM
323.9 Unspecified cause of encephalitis, myelitis, and encephalomyelitis
which falls under the section
Inflammatory diseases of the central nervous system (320-326)"

The index file is Dindex12.zip and the tabular listing is Dtab12.zip - both are at this link
ftp://ftp.cdc.gov/pub/Health_Statistics/NCHS/Publications/ICD9-CM/2011/
 
Dr. Bateman:

It is my own medical opinion that, after routine medical workup has been done (physical exam, ECG, labs, MRIs, mental health screen, etc.), there are very few illnesses, with “normal” tests, that present with such reduced functional capacity, PEM, pervasively disordered sleep, cognitive impairment and (sic) orthostatic intolerance.
Are these tests considered to be part of a routine medical work-up? ECG, MRIs and a mental health screen aren't mentioned in the Report Guide for Clinicians. Neither are lab tests.
 
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Dr. Bateman:

No. The IOM doesn't need to defend the report. It is a summary of the literature based on a standard plan for reviewing the evidence. The recommendations arise directly from the summary of the cited literature, clearly outlined section by section.
Reading section by section, I can't find that the summary of the cited literature supports the Committee's conclusions and recommendations. A critical analysis of the report doesn't seem to yield consistent criteria by which core symptoms are differentiated from symptoms not considered core.
 
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The IOM criteria are billed to be a set of criteria with a diagnosis to be made; not an diagnosis by exclusion like the other criteria.... Is the only difference that the CCC actually lists a table of possible diagnosis and the IOM leaves it up to the individual clinicians to figure it out?
The Report Guide for Clinicians doesn't explicitly suggest that clinicians use the CCC list of exclusions, but the IOM report offers this advice with respect to comorbidies:
The committee decided against developing a comprehensive list of potential comorbid conditions, but points to conditions that clinicians may wish to consider that have been identified by the ME-International Consensus Criteria (ME-ICC) and the CCC, including fibromyalgia, myofascial pain syndrome, temporomandibular joint syndrome, irritable bowel syndrome, interstitial cystitis, irritable bladder syndrome, Raynaud’s phenomenon, prolapsed mitral valve, depression, migraine, allergies, multiple chemical sensitivities, Sicca syndrome, obstructive or central sleep apnea, and reactive depression or anxiety.
The Report Guide fails to provide such guidance.
 
Dr. Bateman:

As I discussed above, it is a misconception that the IOM criteria do not require “exclusions” or a differential diagnosis. Physicians are expected to evaluate for other disorders that might completely explain the symptoms, and not make a diagnosis of ME/CFS or SEID if such an illness is identified. The committee decided not to attempt a list of every possible illness that could present with similar symptoms.

It is my own medical opinion that, after routine medical workup has been done (physical exam, ECG, labs, MRIs, mental health screen, etc.), there are very few illnesses, with “normal” tests, that present with such reduced functional capacity, PEM, pervasively disordered sleep, cognitive impairment and (sic) orthostatic intolerance. Not depression, for sure.
As the more restrictive of the two definitions, the ICC lists fewer exclusions than does the CCC:
Exclusions [ICC]: As in all diagnoses, exclusion of alternate explanatory diagnoses is achieved by the patient's history, physical examination, and laboratory/biomarker testing as indicated. It is possible to have more than one disease but it is important that each one is identified and treated. Primary psychiatric disorders, somatoform disorder and substance abuse are excluded. Paediatric: 'primary' school phobia.
Differential Diagnosis [ICC]: When indicated on an individual basis, rule out other diseases that could plausibly simulate the widespread, complex, symptom pathophysiology defining ME. E.g.: Infectious disorders: TB, AIDS, Lyme, chronic hepatitis, endocrine gland infections; Neurological: MS, myasthenia gravis, B12; Autoimmune disorders: polymyostitis & polymyalgia rheumatica, rheumatoid arthritis; Endocrine: Addison's hypo & hyper thyroidism, Cushing's Syndrome; cancers; anemias: iron deficieny, B12 [megaloblastic]; diabetes mellitus; poisons.
Exclusions [CCC]: Exclude active disease processes that explain most of the major symptoms of fatigue, sleep disturbance, pain and cognitive dysfunction. It is essential to exclude certain diseases, which would be tragic to miss: Addison's disease, Cushing's Syndrome, hypothyroidism, iron deficiency, other treatable forms of anemia, iron overload syndrome, diabetes melitus, and cancer. It is also essential to exclude treatable sleep disorders such as upper airway resistance syndrome and obstructive or central sleep apnea; rheumatological disorders such as multiple sclerosis (MS), Parkinsonism, myasthenia gravis and B12 deficiency; infectious diseases such as tuberculosis, chronic hepatitis, Lyme disease, etc.; primary psychiatric disorders and substance abuse. Exclusion of other diagnoses, which cannot be reasonably excluded by the patient's history and physical examination, is achieved by laboratory testing and imaging. If a potential confounding medical condition is under control, then the diagnosis of ME/CFS can be entertained if patients meet the criteria otherwise.
In her “New Clinical Definitions for ME/CFS” presentation, Dr. Bateman comments on the IOM Committee's decision not to list exclusions for SEID:
There are no exclusionary criteria in this case definition. A differential diagnosis, appropriate work-up of symptoms, and treatment including referral to specialists is expected of health care providers. There is no way to list in case definition everything that can look like this. And as soon as you try to do it, guess what, you miss things. That's the rest of medicine that can present with abnormal symptoms, with fatigue, or cognitive function, or exercise intolerance, or pain syndromes or reasons for not sleeping. So doctors will be expected, like every other disease, when patients present with a symptom to assess them, and they will continue to assess them, and if the symptoms fall into place in this way, if early on it looks like this diagnosis, this can be a working diagnosis.... All other identifiable illness should be diagnosed and treated, and risk factors should be corrected within the 6 months; thus there's no need for this exhaustive list of exclusion criteria.
 
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So why do they distinguish the IOM criteria by stating that this is not an exclusionary criteria. It is a diagnosis to be made?
The only difference being that they don't list the specific exclusions?