Highlights from Day 1 of CFSAC May 2011 meeting
Agency updates and progress reports
NIH workshop meant to serve only as "snapshot"
Patients could be orphaned by ICD codes assigned to their illness
U.S. stands alone in its classification and coding of CFS
Highlights from the CFSAC Meeting held on May 10 - 11, 2011
The Chronic Fatigue Syndrome Advisory Committee (CFSAC), which is an official advisory committee within the Department of Health and Human Services (DHHS) held its spring two day conference on May 10 -11, 2011. The committee has been meeting twice a year to review multiple issues related to ME/CFS (i.e., research updates, educational issues, healthcare, diagnosis, treatment, progress and setbacks) and make recommendations accordingly. This particular meeting also included presentations on the recent National Institutes of Health (NIH) State of Knowledge Workshop for ME/CFS; classification of ME/CFS in the International Classification of Diseases - Clinical Modification; review of the 5-step process used for Social Security Disability evaluation; and discussion of ERISA and insurance issues. The committee scheduled, heard and recorded public testimonies by numerous advocates, patients, and families on both days of the meeting. Dr. Christopher Snell, scientific director of the Pacific Fatigue Laboratory at the University of the Pacific in California, served as Chair and Dr. Wanda Jones, as the Designated Federal Officer for the CFSAC.
Due to the amount of material covered over the course of this two-day meeting, a separate report was prepared for each day. This article reviews highlights from Day 1.
Updates and progress reports from federal health agencies
After opening remarks, roll call and housekeeping functions, representatives from various federal health agencies submitted updates on topics of interest and areas needing more attention, such as the need for appropriate assessment of ME/CFS by primary care providers, better training and uniform guidelines, and looking at models currently used for other chronic illnesses which could be beneficial if applied to ME/CFS. A representative from the Food and Drug Administration (FDA) reported that effective early 2011, all CFS drug applications are now assigned to a single division of the Office of New Drugs (OND). Prior to this change, these had been scattered over six different divisions. The new arrangement should promote more effective review of these drugs and create a single point of contact for CFS-related applications.
[Editor's note: These updates and work-in-progress reports seemed to skim over many topics, without much detail, other than the change reported by the FDA. Therefore, the coverage we give of these reports is minimal.]
NIH workshop meant to serve only as "snapshot" - overview by Dr. Mangan
Dr. Dennis Mangan, who holds the position of Health Scientist Administrator at the Office of Research on Women's Health (ORWH) at the NIH, delivered a synopsis of the recent NIH State of Knowledge workshop. First and foremost, Dr. Mangan wanted to clarify that the NIH workshop was meant to serve as a "snapshot" of where things stood in 2011.
The goal of the NIH workshop was to identify gaps and opportunities in knowledge and research about ME/CFS since the previous workshop, which was held in 2003. Dr. Mangan further reported that the workshop was not meant to meet any research-generating agenda, nor was it intended to target any specific aspect of ME/CFS. Lastly, he explained how it was deliberately designed to have an overlap of topics, without any break-outs (by panelists), which would consequently encourage networking amongst researchers from different fields. It may also help to create more effective partnering between various health departments, something which does not happen very often, according to Dr. Mangan. A final report of the NIH workshop has been drafted and is currently under review.
Discussion of International Classification of Diseases - patients could be orphaned by codes assigned to their illness
Discussion of the International Classification of Diseases - Clinical Modification (ICD-CM) concerns was another very important agenda topic. Initially, someone was supposed to come from the National Center for Health Statistics (NCHS) and speak about the changes with upgrade to ICD-10-CM codes (which are used for insurance and other purposes). However, in the absence of this presenter, the data provided by Dr. Wanda Jones and Dr. Leonard Jason was still quite valuable. Dr. Jones pointed out there has been a process in place by which codes are reviewed as well as a process providing opportunities for public comment during public meetings held by NCHS. To submit comments or recommendations, patients or organizations would have to register (much like for CFSAC meeting participation). She said that she was informed that there has been no reported presence by the ME/CFS community at those meetings.
Dr. Leonard Jason helped to explain the importance and the impact of codes used to categorize an illness, especially those like ME and CFS. Even though all through this meeting and elsewhere, the term ME/CFS is being used synonymously, CFS is not the same as ME, especially when it comes to ICD codes. CFS and ME are regarded as two distinct entities in their classification and in how they are coded. There are many other differences and repercussions, but here is what patients and physicians need to understand about CFS compared to ME, in this particular function:
• ICD-9-CM (referring to the 9th edition of the World Health Organization (WHO) international classification of diseases and the clinical modification currently used in the U.S.) classifies CFS under "Symptoms, Signs and Ill-Defined Conditions", with the code 780.71 ("General Symptoms"). In a subsequent revision, ME was moved to a completely different classification (a type of encephalomyelitis) and given the code 323.9.
• Use of ICD-9-CM is coming to an end. ICD-10 was released by the WHO in 1992 and everyone around the world has been using the 10th edition of classification and codes for illnesses, except the U.S.
• ICD-10-CM takes effect in the U.S. on Oct. 1, 2011, with a partial freeze on these codes while electronic records and systems are updated. Revisions will still be possible later on, but it is always more difficult to do so after adoption. This changeover was not sudden nor unexpected, especially when the rest of the world is now preparing for ICD-11 updated classifications. This will further complicate how these illnesses are grouped and coded in the U.S.
• Post-viral Fatigue Syndrome (PVFS) and ME - under ICD-10-CM, both will be classified with diseases of the nervous system, under the G93 group ("Other disorders of the brain"), and more specifically, coded as G93.3. Canada has already been using ICD-10-CA (the Canadian modification) and has placed all three terms (CFS, PVFS and ME) under G93.3.
• CFS - under ICD-10-CM, CFS will be classified in a group described as "Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified (R00-R99)". CFS will fall into the "R codes", under R53 (referring to malaise and fatigue) and more specifically, the new code for CFS will be R53.82.
U.S. stands alone in its classification and coding of CFS
The U.S. will be the only country in the world to classify and code CFS in this way. This was a remark echoed by Dr. Leonard Jason, Dr. Christopher Snell and other panelists during this presentation, which could cause increasingly more problems for patients as these codes continue to be upgraded but are not used in a consistent manner.
The implications of CFS being placed into this group of "R code" conditions could be very serious because it will become disconnected from the rest of the world, it might not be accepted in certain types of reporting or decision making. The assignment of ICD codes greatly relies on a clinician's judgment-if a doctor does not understand, or fails to pick up on, the viral component in a given patient's illness, then that patient will fall into this vague, "orphaned" category and will have a vague, orphaned illness. Worse yet, are the potential risks of having CFS be placed under the proposed category of "Complex Somatic Symptom Disorder" (CSSD), in the forthcoming Diagnostic and Statistical Manual of Mental Disorders (DSM-5), effective May 2013. One of the attorneys on the CFSAC panel warned this could have disastrous results, particularly for patients seeing doctors who are not well educated about CFS. They could be erroneously lumped in with this somatic disorder group and affect disability benefits as there are two year limits for certain mental disorders.
Public Comments shared many mutual concerns, suggestions, requests and demands
Public Comments and Testimonies were scheduled for several one hour segments on both days of the CFSAC meeting. Testimonies were presented either in person or by telephone and were limited to 5 minutes. These came from patients at many different levels-well known advocates, individuals who had lost their careers, individuals who had lost loved ones to this illness, parents but also entire families, older patients as well as students and teens. They shared many concerns, suggestions, requests and/or demands. A summary of the most commonly and urgently stated items for action to the CFSAC, are as follows:
- funding, funding, funding
- the need for research that is better coordinated, shared, and goes across multiple fields
- the CDC website must be rewritten or the entire site be taken down because it does not show current, biomedical information, and it does not acknowledge commonly used and proven methods of diagnosis and treatment
- the need for effective treatments and the need to fast track Ampligen (which could help a considerable percentage of ME/CFS patients)
- the need to use existing treatments and diagnostic methods which could provide improvement for some patients (i.e., tests and interventions that are not acknowledged by CDC or not on the CDC website and not known by many doctors)
- the need to adopt the Canadian Case Definition and disseminate it to clinicians
- the need to pay attention to reports of continued problems due to lack of knowledgeable doctors, with many patients experiencing humiliation and disregard by doctors
- the need to focus research on post-exertional malaise and cognitive difficulties
- the need to make a distinction between ME and CFS and to abolish the name of CFS
- the need to compare ME/CFS to a national disaster with the concomitant need for relief efforts
- questions raised about NIH: no sense of urgency or seriousness, continued delays in research; NIH spends less than 1% on ME/CFS compared to MS; neglect of patients (when compared to other illnesses); high rate of undiagnosed patients; situation remains unchanged for several decades
- patients want assurance that recommendations by CFSAC will be carried out and followed up by the other federal agencies
- patients, young and old, stressed that they did not want to spend the rest of their lives being sick nor to be missing out on so much
- patients, young and old, are deeply concerned about consequences of untreated and undiagnosed ME/CFS, cancer and death
- patients question the genetic and infectious components in ME/CFS because many families have several members who are ill with same illness
many patients feel not much has changed over past two decades
- the first May 12th International Awareness poster was brought in and displayed and blue ribbons were worn by patients - both to remind and signify the many years that patients have spent on advocacy
- patients conveyed anger, despair, pain, frustration and fear (about their health or future health of family member and their finances)
- patients expressed their appreciation to Dr. Wanda Jones, Dr. Dennis Mangan and other clinicians/researchers who have dedicated themselves to the ME/CFS community
Watch the video in its entirety for Day 1 of the CFSAC Meeting, May 10, 2011. A screen will open up and the lecture will start promptly. Below this screen is a display of the items scheduled for Day 1 discussion. Scroll down and click on the title for desired topic and the video will reposition itself (after a brief buffering). It is likely that more information, including documents of pubic testimonies and other material, will be posted in the near future on the CFSAC website. The Massachusetts CFIDS/ME & FM Association will be posting this information as it becomes available. Stay tuned for highlights of Day 2, held on May 11, to be released in the near future.