CJB
Senior Member
- Messages
- 877
http://www.hhs.gov/advcomcfs/asst-sect-letter2012.pdf
RESPONSES TO RECOMMENDATIONS FROM THE CHRONIC FATIGUE
SYNDROME ADVISORY COMMITTEE (CFSAC)
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
effort.
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
specified.
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.
RESPONSES TO RECOMMENDATIONS FROM THE CHRONIC FATIGUE
SYNDROME ADVISORY COMMITTEE (CFSAC)
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
effort.
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
specified.
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.
