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Response to recommendations from the Nov. 2011 CFSAC meeting

Discussion in 'General ME/CFS News' started by CJB, Aug 26, 2012.

  1. CJB

    CJB Senior Member



    REF: November 8-9, 2011 CFSAC Meeting

    Recommendation 1: This recommendation addresses the process by which CFSAC transmits
    recommendations to the Secretary and the Secretary communicates back to CFSAC whether or not
    a recommendation was acted upon. CFSAC recommends that this process be transparent and
    clearly articulated to include regular feedback on the status of the Committee's recommendations.
    This communication could originate directly from the Office of the Secretary or be transmitted via
    the relevant agency or agencies.

    Procedures are in place to ensure that recommendations made by federal advisory committees are
    properly handled. The CFSAC charter stipulates that the Committee provides advice and
    recommendations to the Secretary, through the Assistant Secretary for Health (ASH). Initially, the
    CFSAC recommendations are sent to the ASH for review. After reviewing the recommendations,
    the ASH forwards them to appropriate officials within the Office of the Secretary and the Operating
    and/or Staff Divisions that may be impacted by the Committee's recommendations. A letter is sent
    to acknowledge receipt of the recommendations. A response may be prepared to accompany the
    letter which describes any actions that the Department may take in response to the
    recommendations made by the Committee. All pertinent information about the recommendations is
    provided to the designated Federal officer (DFO). The DFO then provides the information to the
    Chair and the Committee.

    Recommendation 2: CFSAC recommends to the Secretary that the NIH or other appropriate
    agency issue a Request for Application (RFA) for clinical trials research on chronic fatigue
    syndrome/myalgic encephalomyelitis (ME/CFS).

    The National Institutes of Health (NIH) funds research on myalgic encephalomyelitis/chronic fatigue
    syndrome (ME/CFS); investigators are encouraged to submit proposals for ME/CFS research,
    including clinical trials, through two funding announcements that are currently open for submission
    of applications. The next deadline for receipt of applications is October 24, 2012. In fiscal year 2011,
    NIH funded two applications for clinical trials on ME/CFS. NIH has received few applications
    proposing ME/CFS research, and even fewer applications proposing ME/CFS clinical trials. It is
    unclear whether the paucity of ME/CFS clinical trial applications reflects the current status of the
    field or an acknowledgement that clinical trials are difficult to design for a complex and multifaceted illness. Clinical trials are challenging to design and conduct for all diseases, with basic
    requirements of a well-defined patient population, valid measurement instruments, appropriate
    safeguards for subjects, and generalizability of the clinical trial outcomes to the larger affected
    patient population. NIH is taking action to stimulate ME/CFS research across NIH through the
    regular monthly meetings of the Trans-NIH ME/CFS Working Group (WG). The WG discusses the
    current status of ongoing research on ME/CFS and proposes methods to increase the number and
    quality of research applications submitted to NIH ranging from preclinical research to clinical trials. In addition, the WG is focusing on the recommendations from the April 2011 State of the Knowledge Workshop on ME/CFS to develop priorities. The outcome from these planning sessions will suggest a range of activities and research.

    Recommendation 3: 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

    HHS leadership has identified the need for a Department-wide plan to address ME/CFS. The Department
    established the HHS Ad Hoc Workgroup on ME/CFS to develop a plan and to identify opportunities for
    interagency collaboration. The HHS ME/CFS plan will highlight recently initiated programs and future
    agency-specific and cross-agency activities. In developing the report, the Ad Hoc Workgroup will
    consider recommendations made by CFSAC. After completion, the ME/CFS plan will be posted on the
    CFSAC website. The DFO, Nancy C. Lee,
    M.D. is responsible for providing leadership and coordination for development of the HHS
    ME/CFS report.

    Recommendation 4: 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 MEICFS as a psychiatric condition in the U.S. disease classification systems.

    b) CFSAC rejects the current classification of MEICFS in Chapter 18 offCD-9-CM under
    R53.82, chronic fatigue unspecified, chronic fatigue syndrome, not otherwise

    c) CFSAC continues. to recommend that MEICFS should be classified in ICD-IO-CM in
    Chapter 6 under Diseases of the Nervous System at G93.3 in line with ICD-IO, the
    World Health Organization, and ICD-I-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 (NCHS) Option 2 and recommends
    that MEICFS remain in the same code and the same subcode as myalgic
    encephalomyelitis because CFS includes both viral and non-viral triggers.

    d) CFSAC recommends that an "excludes one" be added to G93.3 for chronic fatigue,
    2 R53.82, and neurasthenia, F48.8. CFSAC recommends that these changes be made in
    ICD-10-CM prior to its rollout in 2013.

    Development and implementation of the guidelines for the lCD-1O fall within HHS under the purview
    of the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid
    Services. Use of the revised codes will provide robust and specific data that will improve patient care
    and enable the international comparability of health care data. On February 16, 2012, the Department
    issued a press release announcing that HHS would initiate a process to postpone the date that certain
    health care entities must comply with the ICD-I O.

    A proposal to change the classification of ME/CFS in ICD-10-CM was presented at the September
    2011 Coordination and Maintenance (C&M) Committee/CDC/NCHS; a subsequent proposal was
    received on January 12, 2012 and will be presented at the September 19,2012 C&M meeting for
    additional discussion.
  2. Desdinova

    Desdinova Senior Member

    Anyone have any info on who comprises this work-group and what there credentials are?
  3. CJB

    CJB Senior Member

    I think this quote from Jenny's website is the most up-to-date info we have:


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