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CFSAC Meeting Scheduled for January 13, 2015

Messages
42
@halcyon -- what happened: During the December CFSAC meeting, a Working Group was set up to compile comments to the P2P panel report. It appears that this Working Group's draft was edited and influenced by at least one HHS staff member, the DFO (Designated Federal Official) for the CFSAC, Barbara James, before it was distributed and discussed by the full CFSAC in January. Jeannette has written more about this in a blog which deservedly has its own thread on this forum. See http://forums.phoenixrising.me/inde...d-hhs-orchestrate-cfsac’s-p2p-comments.35014/
 
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Ember

Senior Member
Messages
2,115
Gabby says:
January 18, 2015 at 12:01 am
“This HHS web is getting curiouser and curiouser.”
CFSAC voting members are non government people.
The suppression of dissent should be considered objectionable whether it's perpetrated by government or not. This web is getting curiouser and curiouser indeed! In Wonderland, Alice asks: “I wonder if I've been changed in the night? Let me think. Was I the same when I got up this morning? I almost think I can remember feeling a little different. But if I'm not the same, the next question is 'Who in the world am I?' Ah, that's the great puzzle!” Faced with criticism, citizens too may become in their tactics “totally transformed — indistinguishable from the...group,” vast or small, that they oppose.

This extended passage from the January 13 CFSAC meeting seems to show evidence of an attempt to censor the free expression of CFSAC voting members in order to suppress dissent. Donna and Dr. Fletcher disagree over a motion by Dr. Kaplan, and Barbara James tries to cut off, for lack of time, discussion of Dr. Kaplan's final motion (though she later allows 15 more minutes for discussion):
Donna Pierson: No, I think we agree with you, and that - maybe someone else could chime in on the change that was made there. Who could? Anybody. I think - I'll just say what I believe. I think we quoted the CCC, and ultimately it was suggested that the panel doesn't have the information to adopt that, and that the IOM is working on something right now, and that saying the failure to adopt it is almost a dig at the CDC and or the NIH, and might result in the report being rejected. I don't know that that's the case. And maybe (Barbara), you could help me out here.

(Barbara): Donna, I don't know if that's the case because we have mentioned the CCC in other sections.

Donna Pierson: Yes.

(Barbara): So what was the - (Gary), what were - you suggested, it can certainly be considered by the panel.

(Gary): Yes. I didn't come up with a specific wording on it. My concern with it-so the methods are quantitative and qualitatively characterize and the severity of the disease remain subjective in nature at this time." "The lack of universally accepted parameters", I disagree that we have a lack of universally accepted parameters. I think that to say or to adopt the Canadian Consensus Conference diagnostic parameters (unintelligible) stifle progress.

Donna Pierson: So there - and I also remember there were some that believed the ICC is more accurate, and there were some that believed the CCC is more accurate. And I think that was another reason why we didn't-we weren't specific. Although this commitment does endorse CCC.

Mary Ann Fletcher: This commitment has endorsed CCC over and over.

Donna Pierson: Correct. So I want to object...

Mary Ann Fletcher: I agree with what (Gary) is saying fully. I think it should be in there. And if this is one of the places where the NIH didn't want us to be inflammatory, negative, or derogatory to HHS or other agencies, etcetera, etcetera, I disagree with that too. (emphasis added)
..........

Donna Pierson: All right. We're down to lines 365 through 368. Currently it says, "Thus, for need of progress to occur, we recommend that the Oxford definition be retired, that the ME/CFS community agree on a single case definition even if it's not perfect, and that patients, clinicians and researchers agree on a definition for meaningful recovery."

Revision requested --"Thus, for need of progress to occur, we recommend (1), that the Oxford definition be retired, (2) that the ME/CFS community review the recommendation produced by the Institute of Medicine and then agree on a single case definition even if it's not perfect, (3) that the single case definition be followed by all conduct" - see, something's is wrong with this.

"...that the single case definition be followed by all conducting research on ME/CFS" - there's a problem, and I apologize. There was a suggested revision there, and it's not on my copy. But you all received it by email I think individually. And what it was, was - here it is. This is the revision. I don't know if I have an old copy here.

"Thus, for need of progress to occur, we recommend (1), that the Oxford definition be retired, (2) that the ME/CFS community review the clinical diagnostic criteria recommendation produced by the Institute of Medicine and then agree on a single clinical diagnostic case definition -- even if it's not perfect -- for use by all healthcare providers caring for patients with ME/CFS, (3) that the single clinical diagnostic case definition be followed development of a research case definition for use by all conducting research on ME/CFS, and (4), that patients, clinicians, and researchers agree on a definition for meaningful recovery.

Donna Pierson: Do you all have that in your copy?

(Gary): I don't have that, but I would remind us that we at one point made a statement that the CCC definition should be adopted until such time as data proved appropriate for modification of it. We made a very clear statement of that. And so we're ignoring that statement that we're all ready on record for having made.

Donna Pierson: Yes.

Mary Ann Fletcher: I would think that if we're going to do anything with the Institute of Medicine, it's produce a suggested (unintelligible) that we should compare it with the CCC. And then we could possibly agree on a single diagnostic case definition.

(Gary): We had wording to that effect that allowed us to revise the CCC in accordance to updated data. It was part of something (Dane) was doing. Do you remember, (Dane), that we had adopted the CCC's part of the proposal that you had put forward.

Dane Cook: Oh, boy. I'm not sure.

Donna Pierson: It was a few years ago, right, when you asked...

(Gary): One year ago

Donna Pierson: One, okay?

(Gary): It was about a year ago.

Donna Pierson: There was the request in I think October of 2012 to convene a stakeholders meeting, and create a definition starting with the CCC.

(Adrian): That's correct.

Donna Pierson: That I remember. I don't know. Maybe there was a working group discussion after that?

Mary Ann Fletcher: I don't think so, because we never got to have the...

(Barbara): Excuse me, Donna, this is (Barbara). We have four minutes.

Donna Pierson: And we're at the end. This is our last thing. So other than closing remarks let's make a decision on this.

(Barbara): ...closing remarks because...

Donna Pierson: All right.

(Barbara): I think we need to go back and focus on the language that we're suggesting that the panel substitute --which was discussed when it was read--and kind of decide whether we go with that.

Mary Ann Fletcher: I think that's what we're trying to do.

Donna Pierson: Yes. Right.

(Barbara): Okay.

Woman: We've approved everything so far. And I'm going to ask for a vote to approve the document as revised today. And this is our last comment I think.

Woman: Donna, can I I have one more comment if I convey it.

Woman: Okay. So wait a minute. Let's finish this one. Are we okay?

Woman: ;Okay.

Donna Pierson: Donna. So do you want to insert something about the CCC, (Gary)?

Woman: Yes, I do.

(Gary): Yes, I'm not - I can't wordsmith it this second though. But basically that the CCCB adopt it until such time as -and modified in accordance to new data as it emerges. But that's our base. That's where we start from.

Woman: Okay, I second that.

(Gary): And not pretend that we don't have anything to start with.

Mary Ann Fletcher: I'll second that.

Woman: And you guys, I also forwarded to Donna some added things for the bibliography for the-so if you guys could approve that or review it anyway.

Donna Pierson: So this is what I have for the revision then: " Thus, for need of progress to occur, we recommend (1), that the Oxford definition be retired, (2) that the CCC be universally adopted until such time that an adapted criteria is accepted, (3) that the ME/CFS community review the clinical diagnostic criteria recommendation produced by the IOM and then agree on a single clinical diagnostic case definition." And the rest of it is the same. So I've inserted "that the CCC be universally adopted until such time that an updated criteria is accepted." Here's the thing. I don't think that this panel has the right to tell us what definition-I mean we're saying that this is what we want. But I'm not sure that they can say it anyway. I mean they have one day, or two days worth of knowledge and we're trying to get them to adopt something that no one else has adopted with years of knowledge. Do you know what I'm saying?

Dane Cook: It's not going to read that way, because it's not going to say, and the (unintelligible) told us to put this in it.

(Gary): No, I would agree. So it won't modify, but we'll at least be on record as consistent with who we are and what we're saying.

Dane Cook: Okay. I can be down with we're on record, but...

Donna Pierson: Yes. I mean I don't know - what I'm saying is I don't know that this panel will do this. I don't know that they have the authority or the knowledge to do it. (unintelligible) think that we're just the smartest people ever, you know?

(Gary): And they may not adopt anything we've recommended. It's important that we're clear on the record about what our position is in our statements.

Donna Pierson: So what do you advise? (unintelligible).

Woman: I have one more question.

Donna Pierson: ...CCC be universally adopted until such time that an updated criteria is
accepted. Should we call a vote on that?

(Jose): Yes.

Donna Pierson: Does someone object? So the motion was made by who?

Mary Ann? I don't remember who made the motion on this.

Dane Cook: It was you, (Gary).

Donna Pierson: (Gary) did. (emphasis added)
..........

Donna Pierson: Everybody was involved. Excellent. Thanks. And (Barbara), do we have time for an audition, or what's happening?

(Barbara): We're past our time, but we can stay on. I've asked the operator to give us some additional time. So we can stay on for at least another 15 minutes (unintelligible) (emphasis added)
 
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Ember

Senior Member
Messages
2,115
The final CFSAC document includes the following preface and closing remarks:
Preface

Advancing the Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Since 2002, the Chronic Fatigue Syndrome Advisory Committee (CFSAC) has provided advice and recommendations to the Secretary of the Department of Health and Human Services on issues that affect access and care for persons with myalgic encephalomyelitis and chronic fatigue syndrome (ME/CFS); the science and definition of ME/CFS; and broader public health, clinical, research and educational issues related to ME/CFS.

This document contains the comments of the CFSAC on the 389 line version of the Draft Executive Summary for the December 2014 Pathways to Prevention (P2P) Workshop: Advancing the Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.

The CFSAC recognizes the challenge faced by the Pathway to Prevention Panel and wholly appreciates the astute observations that have informed the draft executive summary. It is clear that the Panel thoroughly digested the literature provided, absorbed the thoughtful comments made by the public, and listened carefully to each informative presentation. The Panel’s enthusiasm and dedication were evident during the Workshop, and its commitment to professionalism is evident in the draft summary generated in such a short period of time.

Many of the observations highlighted in the draft executive summary support recommendations made to the Secretary by this Committee. (See Appendix A). These observations have also been made by stakeholders and ME/CFS experts who recommend use of the 2003 Canadian Consensus Criteria to define the disease until further research warrants modification.

The CFSAC is extremely pleased to have the opportunity to offer its experience and expertise to the Panel as you finalize this important document. We sincerely hope our comments will be of value.

During our review, the Committee identified several important areas that should be addressed. Those areas are reflected in the “Comments” section of this document.

Additionally, if the Panel did not review The Voice of the Patient1 series of reports published in September 2013 following the U.S. Food and Drug Administration’s Patient-Focused Drug Development Initiative for Chronic Fatigue Syndrome and Myalgic Encephalomyelitis, we encourage you to do so.

Post-exertional malaise is a signature symptom of ME/CFS.”

We also ask that you review the Report from the National Institutes of Health (NIH) State of Knowledge Workshop during which researchers and stakeholders reached consensus on a number of key issues. Some of these issues may be of importance to the P2P Panel during the revision process:

• “Post-exertional malaise is a signature symptom of ME/CFS.”
• “If the rules for identifying who is a patient and who is not differ, then problems will occur, not only for a patient seeking an accurate diagnosis, but for the entire scientific enterprise.”

• “There is a lack of longitudinal, natural history, early detection, pediatric-versus adult-onset, and animal model studies. In addition, few studies look at comorbid conditions, biomarkers, or genetics. Moreover, study designs needed for clinical trials require further refinement. Improved and more extensive data from patient-derived and reported outcomes will better define the successes or failures of treatment interventions. To capture the extensive information from such studies, a centralized interactive database, using common data elements and accessible to everyone, is sorely needed to collect, aggregate, store, and analyze results.
• “While some major questions are currently being raised in the biomedical field as to what makes a biomarker and how to identify one, for ME/CFS, there is movement toward this research, with suggestions from Workshop participants to stratify biomarkers into four broad categories:
(1) diagnostics,
(2) predictive and preventive,
(3) metabolism biomarkers to determine how a patient metabolizes a particular medication and to help with dosing and schedule,
(4) outcome biomarkers to forecast the disease response itself.

“Keeping in mind that these are lean budgetary times, the panel called for more coordination and leadership by NIH and commended the Office of Research on Women’s Health as a driving force behind the transparency used in planning and execution of the Workshop and providing a home for ME/CFS research. The Trans-NIH ME/CFS Research Working Group will use the information from the Workshop to help NIH understand the complexity of this illness, and look for ways to further research on this devastating illness to conduct epidemiologic and clinical studies.”2

These reports contain important information that will help inform your deliberations. We ask that you review these important resources and consider them prior to finalizing the executive summary.

We also ask that you take note of the fact that among the 234 disease categories supported by NIH in 2014, chronic fatigue syndrome ranked 228th with an estimated $5 million in funding.

In order to move forward, it is vital that this issue be addressed.

We ask that the Panel explicitly address the urgent need for government funding in order to advance the research for ME/CFS.

Regarding the areas of review, the CFSAC agrees with many of the Panel’s observations.

We therefore ask the Panel to address the need for increase funding to accomplish those goals and advance the research for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Without a substantial change in funding at the national level, CFSAC believes it will be virtually impossible to address the comprehensive list of recommendations outlined in the Panel’s Draft Executive Summary.
Closing Remarks

The CFSAC appreciates the opportunity to provide expert advice and guidance regarding the executive draft summary. Our goal in preparing these comments is to assist you in developing a final Executive Summary that accurately reflects the concerns the Committee has heard from the ME/CFS community and ME/CFS experts caring for patients and conducting research in this area.

The P2P Panel is in a unique position to help advance research and care for individuals with ME/CFS. We appeal to you to leverage this opportunity to make comprehensive, concise targeted recommendations to the National Institutes of Health that will result in major efforts to “Advance the Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.”

We commend you for undertaking the effort to address clarify and make recommendations to resolve key issues relating to this challenging disease. It is hoped that the final P2P report will possess the power to move federal agencies forward with funding and action.
 
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Sing

Senior Member
Messages
1,782
Location
New England
Thank you, Ember! It is important to read the full text at the link Ember initially provided, as they have done considerable work on their recommendations since the call we listened to.
 

Denise

Senior Member
Messages
1,095
Thank you, Ember! It is important to read the full text at the link Ember initially provided, as they have done considerable work on their recommendations since the call we listened to.


In reading the transcript of the webinar (which is for some reason no longer available on the CFSAC website) Donna Pearson said that only the key points of the preface would be read aloud.
The CFSAC members had the entire document available to them - we were going only on what was said/read during the webinar. So it is likely that the full document was more extensive than what we heard.
 

Denise

Senior Member
Messages
1,095
The comments from CFSAC submitted in response to the P2P Draft Report are dated January 2015. It seems a bit odd to me that the date of the document is limited to a month and year and does not include a month, day and year. See, http://www.hhs.gov/advcomcfs/recommendations/cfsac-pathways-to-prevention-january-2015-updated.pdf


I agree that the date ought to have been included.
Amusingly on the CFSAC recommendations page it is listed as January 13, 2013(!). http://www.hhs.gov/advcomcfs/recommendations/index.html
 

Dx Revision Watch

Suzy Chapman Owner of Dx Revision Watch
Messages
3,061
Location
UK
The ICD-10 CM codes are online. ftp://ftp.cdc.gov/pub/Health_Statistics/NCHS/Publications/ICD10CM/2015/
Download the pdf and look under the Tabular Listing.


The link above is no longer the most recent release of ICD-10-CM (which is updated annually).

The most recent release is this one:

https://www.cdc.gov/nchs/icd/icd10cm.htm#FY 2018 release of ICD-10-CM

2018 release of ICD-10-CM

The 2018 ICD-10-CM codes are to be used from October 1, 2017 through September 30, 2018.
Note: This replaces the FY 2017 release.



The PDF for the FY 2018 Release can be downloaded from this page from Zip files:
ftp://ftp.cdc.gov/pub/Health_Statistics/NCHS/Publications/ICD10CM/2018/

But for ease of access, the 2018 Tabular List and Index can be downloaded as a PDFs from my Dx Revision Watch site:

Tabular List FY 2018:
https://dxrevisionwatch.files.wordpress.com/2017/09/icd10cm_tabular_2018.pdf

Index FY 2018:
https://dxrevisionwatch.files.wordpress.com/2017/09/icd10cm_index_2018.pdf


It is correct that no definitions, descriptions or guidance for coders and other end users is included for any of the three terms within the WHO's unmodified ICD-10, the US specific ICD-10-CM or other country modifications, for example, Canada's ICD-10-CA, Australia's ICD-10-AM and Germany's ICD-10-GM.

You might see on blogs and websites reference to the "WHO's definition of ME" with a textual description. This is a misconception - there is no "WHO definition" of ME or CFS and the text that often accompanies this misconception is an extract from the Canadian Guidelines - not from any WHO statement or document.

WHO, Geneva has never set out in a public statement or document what it understands by the terms "PVFS", "(Benign) ME" and "CFS" or how it views the relationship between these three terms.

For the WHO's ICD-10, the three terms continue to be coded (and in the case of CFS, indexed) at G93.3, in the Diseases of the nervous system chapter.

For ICD-11 Beta draft, all three terms are currently listed under the parent class: Other disorders of the nervous system. BME and CFS are both included in the ICD-11 equivalent of the Tabular List and are specified as inclusion terms under Title concept, PVFS.

For ICD-11 Beta draft, exclusions have been added for BME and CFS under "Fatigue" ("Malaise and fatigue" in ICD-10) in the ICD-11 Symptoms, signs chapter.


For a history of the evolving coding of PVFS, ME and CFS in ICD-9, ICD-9-CM, ICD-10 and ICD-10-CM to March 2001, see the CDC archived document:

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, CDC archive document, March 2001.


The development of an ICD-10-CM/PCS based on the WHO's ICD-10, was a very long time in preparation.

The draft of the Tabular List of ICD-10-CM was made available on the NCHS website for public comment from December 1997 through February 1998. There were several iterations before a draft was finally implemented in October 2015 - 23 years after the WHO had finalized and disseminated ICD-10.

By 2001, the point at which the document above was published, the proposal for the three terms had been to locate all three terms under G93.3:

Extract:

"ICD-10-CM
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.

"While it appears most appropriate to classify chronic fatigue syndrome in ICD-10 CM in the same way that it is classified in ICD-10, this placement is not without problems. The primary concern with the current WHO placement in ICD-10 has been that the abnormalities of the brain in chronic fatigue syndrome patients most often cited in the literature are not found in all chronic fatigue syndrome patients. While chronic fatigue syndrome may be a heterogeneous group of disorders, some but not all are neurological in nature. Likewise, not all patients have experienced a viral infection prior to being diagnosed with chronic fatigue syndrome, nor are immune system anomalies universally found. Also of potential concern is the similarity between the type of neurological findings in chronic fatigue syndrome and in depression, which is a psychiatric disorder. Involvement of multiple systems has complicated the classification of chronic fatigue syndrome."

This is how the draft ICD-10-CM had stood in the draft Tabular List, as released in 2003.

There had been a "Chronic fatigue syndrome, postviral" included under G93.3 and a "Chronic fatigue syndrome NOS (Not Otherwise Specified)" as an inclusion under R52.82 Chronic fatigue, unspecified, in the Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified (R00-R99) chapter.

The R code chapter "includes symptoms, signs, abnormal results of clinical or other investigative procedures, and ill defined conditions regarding which no diagnosis classifiable elsewhere is recorded."

2003.png


By 2004, it became apparent (via a presentation given by William Reeves at a CFSAC meeting attended by Mary Schweitzer) that a change of structure from the 2003 proposals had been effected.

"Chronic fatigue syndrome, postviral" had been removed from G93.3.

There was no revised draft released between 2003 and 2006 but when a 2007 draft Tabular List was posted, this is how the revised structure now stood and how it currently stands:

2007.png

So between the 2003 draft iteration and the 2007 draft iteration, the inclusion term, "Chronic fatigue syndrome, postviral" under G93.3 had been deleted.

Which left the only listing for "Chronic fatigue syndrome" the listing under the R codes, as: "Chronic fatigue syndrome NOS" (Not Otherwise Specified).


CDC's Donna Pickett has stated (at a CFSAC presentation and at an NCHS/CDC ICD-10-CM Coordination and Maintenance Committee meeting presentation) that where there is evidence of viral onset, the clinician/coder can use the G93.3 code. Where there is insufficient evidence of viral onset, the R53.82 code can be used.

According to a background document Dr Wanda Jones presented to a May 2011 CFSAC Committee meeting:

"As it relates to CFS the use of two codes is consistent with the classification as there would be a code to capture CFS when the physician has determined the cause as being due to a past viral infection (G93.3) or if the physician has not established a link with a past viral infection (R53.82).

"If code R53.82 were eliminated it would not be possible to disaggregate cases that are now distinguishable through the use of two codes.

"There is a general equivalence map between ICD-9-CM and ICD-10-CM codes, however, if a concept is not carried over from the earlier version to the newer version data will be lost going forward."


Source: Extract: ICD-related questions from CFSAC for May 2011 meeting


Dr. Jones clarified for the Committee that if, in the clinician's judgment, it was considered there is enough evidence to attribute the patient's illness to a viral illness onset then the clinician could code to G93.3 (Postviral fatigue syndrome). If "however they could not identify where the trajectory developed toward CFS, then it would wind up in the R codes."

It has been further confirmed that testing for a viral illness is not required to assign a code – that coding is based on the clinician's judgment.

And from the NCHS September 14, 2011 Coordination and Maintenance Committee meeting Proposals document:

"In ICD-10-CM chronic fatigue syndrome NOS (that is not specified as being due to a past viral infection) was added to ICD-10-CM in Chapter 18 at R53.82, Chronic fatigue, unspecified. ICD-10-CM retained code G93.3 to allow the differentiation of cases of fatigue syndrome where the physician has determined the cause as being due to a past viral infection from cases where the physician has not established a post viral link. It should be noted that including chronic fatigue syndrome NOS at code G93.3 would make it difficult to disaggregate cases that are now distinguishable through the use of two separate codes."

Hope this historical material may be of interest.
 
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