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Full Text CFSAC Recommendations

May 7th, 2013

As I’ve reviewed elsewhere in great detail, the CFS Advisory Committee will be discussing which recommendations should be designated “high priority” at their meeting on May 22-23rd. We now have the opportunity to voice our own views about which recommendations are most important. I’ve saved you the trouble of reviewing all 77 recommendations yourself, and have selected the recommendations that are incomplete and still relevant. The full text of those 17 recommendations are listed below for your convenience. I’ve listed them in chronological order, and have added a summary sentence in bold at the beginning of each recommendation. If you want to dive into the full list in greater detail, I review all the recommendations by category starting here.

  1. Establish Five Regional Centers for ME/CFS research, clinical care and education. The magnitude of CFS warrants a strong call to action to address the unmet needs of this underserved population. CFS affects at least one million Americans, 85% of whom have not been diagnosed. The degree of functional impairment experienced by CFS patients is equivalent to patients with end-stage renal failure, COPD, and late-state HIV/AIDS.
    The CFSAC has listened to public testimony at each of its meetings, and meeting after meeting patients and family members bring heart rending stories of limited access, physicians with no knowledge of diagnosis or treatment, and lives set aside waiting for effective treatment. These lives set on hold translate into an enormous economic impact, with families effected losing half of the household income, costs the U.S. economy $9.1 billion per year in lost productivity alone and up to $25 billion annually when medical costs are added to that estimate.
    The lack of diagnostic markers and effective treatments, or even treatment guidelines, represents a crisis for evaluation and management of this large population. These factors in combination mandate the creation of innovative measures to focus resources on identifying solutions to these critical problems.
    There have been basic science advances which should be leading to new treatment strategies, yet progress in translating these advances into effective treatments has been slow. This is in large part due to a complete lack of clinical care centers and research centers. Investigators are frustrated by a lack of access to representative patient populations, and patients are frustrated by a lack of accessible expert clinical treatment centers. Funding mechanisms to develop new centers for either clinical care or centers for research are shrinking, but the needs of this underserved very ill patient population are unmet and growing.
    Therefore, the CFSAC recommends that the Secretary use the resources and talent of the agencies that make up the HHS to find ways to meet these needs. One starting point is our request that the HHS establish 5 regional clinical care, research, and education centers, centers which will provide care to this critically underserved population, educate providers, outreach to the community, and provide effective basic science, translational and clinical research on CFS. The advisory committee understands that fiscal exigencies have to date prevented the formation of these previously recommended centers, but it is our hope the Secretary will use the full weight of his office to effectively fund this program through existing funding mechanisms that might be available or new programs. (5/07)
  2. Establish interagency/interdepartmental effort to coordinate support for children and young adults with ME/CFS. CFSAC recognizes that much can be done to ensure that every child with CFS has the best possible access to support and treatment and asks that the Secretary facilitate a taskforce or working group to establish an ongoing interagency and interdepartmental effort to coordinate school, family, financial, and health care support for children and young adults with CFS. (10/08) This was included in the High Priority List
  3. Fund CDC research into biomarkers and viral etiology. Provide adequate funding to CDC to effectively carry out a detailed 5-year plan. This should include, but not be limited to, immediate progress in these priority areas (Resubmitted from May 2009 with minor modification to [a]): a.     Identification of biomarkers, with increasing efforts in viral etiology of CFS: (10/09) This was included in the High Priority List in heavily modified form.
  4. Use regional hubs to create a national research and clinical network for ME/CFS. Develop a national research and clinical network for ME/CFS (myalgic encephalomyelitis/CFS) using regional hubs to link multidisciplinary resources in expert patient care, disability assessment, educational initiatives, research and clinical trials. The network would be a resource for experts for health care policy related to ME/CFS. (10/10)
  5. Adopt the term “ME/CFS” across HHS programs. (10/10) This was included in the High Priority List.
  6. Organize a disability workshop. CFSAC asks that HHS organize a workshop to engage experts in disability assessment, the outcome being a document useful to patients and adjudicators which could contribute to more efficient and fair disability process. (5/11)
  7. NIH should fund ME/CFS research commensurate with the magnitude of the problem, and issue an RFA specifically for ME/CFS. ME/CFS is an illness with enormous economic and human costs. The April 2011 NIH State of Knowledge Workshop identified a number of gaps in what is known about the illness. To address these gaps warrants an interagency effort comprising, but not limited to, NIH,CDC, and AHRQ. Further, the focus should be on interdisciplinary discovery and translational research involving interacting networks of clinical and basic science researchers. Areas to be examined would include the following: identification of patient subsets for detailed phenotyping and targeted therapeutic interventions, biomarker discovery, systems biology approaches and disability assessment. To facilitate the above goal, CFSAC recommends that ME/CFS research receive funding commensurate with the magnitude of the problem and that the NIH (and/or other appropriate agencies) issue an RFA specifically for ME/CFS. (5/11) This was included in the High Priority List in modified form.
  8. Pool resources to create Centers of Excellence, using physical or virtual locations. CFSAC would like to encourage and support the creation of the DHHS Interagency Working Group on Chronic Fatigue Syndrome and ask this group to work together to pool resources that would put into place the “Centers of Excellence” concept that has been recommended repeatedly by this advisory committee. Specifically, CFSAC encourages utilizing HHS agency programs and demonstration projects, available through the various agencies, to develop and coordinate an effort supporting innovative platforms that facilitate evaluation and treatment, research, and public and provider education. These could take the form of appropriately staffed physical locations, or be virtual networks comprising groups of qualified individuals who interact through a variety of electronic media. Outreach and availability to underserved populations, including people who do not have access to expert care, should be a priority in this effort. (11/11) This was included in the High Priority List.
  9. Classify ME/CFS at G93.3 in the ICD-10-CM. This multi-part recommendation pertains to classification of CFS in ICD classification systems: (a) CFSAC considers CFS to be a multi-system disease and rejects any proposal to classify CFS as a psychiatric condition in the U.S. disease classification systems.(b) CFSAC rejects the current classification of CFS in Chapter 18 of ICD-9-CM under R53.82, chronic fatigue unspecified, chronic fatigue syndrome, not otherwise specified. (c) CFSAC continues to recommend that CFS should be classified in ICD-10-CM in Chapter 6 under Diseases of the Nervous System at G93.3 in line with ICD-10, the World Health Organization, and ICD-10-CA, the Canadian Clinical Modification and in accordance with CFSAC’s recommendations of August 2005 and May 2011. CFSAC rejects CDC’s National Center for Health Statistics Option 2 and recommends that CFS remain in the same code and the same subcode as myalgic encephalomyelitis becauseCFS includes both viral and non-viral triggers. (d) CFSAC recommends that an “excludes one” be added to G93.3 for chronic fatigue, R53.82, and neurasthenia, F48.8. CFSAC recommends that these changes be made in ICD-10-CM prior to its rollout in 2013. (11/11) This was included in the High Priority List.
  10. RFA for clinical trials research. CFSAC recommends to the Secretary that the NIH or other appropriate agency issue a Request for Applications (RFA) for clinical trials research on chronic fatigue syndrome/myalgic encephalomyelitis. (11/11) This was included in the High Priority List.
  11. Remove the CDC Toolkit. CFSAC asks that the Centers for Disease Control and Prevention (CDC) remove the CFS Toolkit (both English and Spanish versions) from the CDC website. (6/12)
  12. Educate educators and school nurses about ME/CFS. CFSAC asks that HHS partner with Committee members and the Department of Education to educate educators and school nurses on ME/CFS affecting children and adolescents. (6/12)
  13. NIH should issue a $7-10 million RFA for outcomes measures, and biomarker discovery and validation. CFSAC recommends that you instruct the NIH to issue an RFA (funded at the $7-10 million range) for projects to establish outcomes measures for ME/CFS diagnosis, prognosis and treatment which would include but not be limited to biomarker discovery and validation in patients with ME/CFS. (10/12)
  14. CFSAC recommends that you allocate specific funds to study patients with ME/CFS from past cluster outbreaks. (10/12)
  15. CFSAC recommends that you allocate funds to study the epidemiology of patients with severe ME/CFS. (10/12)
  16. CFSAC recommends that you endorse the Coalition4ME/CFS Option 1 proposal for the ICD-10-CM that was recommended at the September 19, 2012 NCHS public meeting. (10/12)
  17. Hold a stakeholders’ workshop to reach a consensus on case definition. CFSAC recommends that you will promptly convene (by 12/31/12 or as soon as possible thereafter) at least one stakeholders’ (ME/CFS experts, patients, advocates) workshop in consultation with CFSAC members to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus Definition for discussion purposes. (10/12)

 

  1. Sasha
    May 7th, 2013 at 13:21 | #1

    Thanks, Jennie – this looks like a lot of work!

    What should people do (US people, presumably) if they have an opinion on which should be the priorities?

    Sorry if you’ve covered this somewhere else – hard to keep track!

    • Jennie Spotila
      May 7th, 2013 at 13:53 | #2

      Hi Sasha,

      I’m working on an article for Phoenix Rising that will have all the relevant information. But the best way to express your opinion about the priorities is to submit comment to the upcoming CFSAC meeting, in person or by telephone. You can sign up for public comment before May 15th: http://www.blsmeetings.net/CFSACPublicCommentMay2013 Slots will be confirmed by May 17th. You also have to register to attend if you want to deliver your comments in person.

      Or you can submit written comments to be part of the public record of the meeting. The deadline for that is also May 15th, and they should be sent to this address: CFSACMay2013@seamoncorporation.com

  2. Sasha
    May 7th, 2013 at 14:37 | #3

    Thanks – good to know!

  3. floydguy
    May 9th, 2013 at 08:23 | #4

    I think the list should be shortened to 17, 15, 14, 13. We’ve found that medical professionals and the government can’t walk and chew gum at the same time. Allowing too many priorities is a recipe for less action not more. The only priority should be for a better definition – one that allows for objective testing so that any MD can confidently diagnose properly. Treatment centers without this just opens treatment to CBT, GET and other wasted nonsensical treatment protocols that could do more harm than good. Focus, focus, focus!

  4. Jennie Spotila
    May 9th, 2013 at 09:08 | #5

    I 100% agree that we have to FOCUS. I suggest people choose no more than five recommendations as priorities, and choosing three would be better.

  5. May 9th, 2013 at 11:23 | #6

    Can you name one CFSAC recommendation that has actually been implemented?

    • Jennie Spotila
      May 9th, 2013 at 11:45 | #7

      I can name more than one:
      A 2007 recommendation to add an ex officio from AHRQ.
      A 2008 recommendation that CFS be included in the transition report to the new Secretary.
      A 2011 recommendation that the committee receive clarification on the process by which recommendations are considered, and this was answered by Dr. Koh in August 2012.
      A 2010 recommendation that CFS patients be indefinitely deferred from donating blood.
      A 2012 recommendation that the IACFS/ME Primer be be made widely available through guidelines.gov.
      A 2008 recommendation that HRSA communicate info about CFS to its networks.
      A 2012 recommendation that the CFSAC website link to the Dept of Education’s parent assistance network.

      But to your point, Patricia, the most important and urgently needed recommendations on research funding, etc have not been approved. That’s why people need to speak up. Let’s require the CFSAC to designate those most important recommendations!

  6. John
    May 9th, 2013 at 14:59 | #8

    I’d say the 5 Centers of Excellence, the various RFA’s from the NIH and the case definition workshop would be my top picks.

    @Patricia Carter

    There were 2 important recommendations to ‘establish new progressive leadership at the CDC’ that got implemented. While it may be debated whether Elizabeth Unger truly fulfills this category, Bill Reeves did end up getting the boot which was great.

    Re: setting up 5 Centers of Excellence, that recommendation has been repeated like half a dozen times, hasn’t it, and not just on 05-07?

    I’m not sure how important it is to fund the CDC’s search for biomarkers and viral etiology because everyone knows that CDC stands for Can’t Diagnose Cases.

    • Jennie Spotila
      May 9th, 2013 at 15:25 | #9

      John, you are absolutely right that Centers of Excellence (and other funding recommendations) have been recommended more than once – 6 times for the CoE I think. I tried to select the best wording for the often repeated ones.

  7. John
    May 9th, 2013 at 23:58 | #10

    @Jennie Spotila

    Ok, just making sure you knew. It might be worth selecting the best wording but also tacking on the number of times/dates that a given recommendation has been made, it seems like it could only help emphasize its importance and might also draw attention to the amount of time an issue has been neglected.

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