Federal CFSAC Meeting Report

Advocacy Alert: 11/30/2007

Federal CFSAC Meeting Report

Click here to read a PDF version of this report: November CFSAC report

--------------------------------------------------------------------------------

Report on the November 28-29, 2007 Meeting of the DHHS CFS Advisory Committee

The CFS Advisory Committee (CFSAC) to the Department of Health and Human Services (DHHS) met on Wednesday, November 28, and Thursday, November 29, in Washington, D.C. This was the Committee's second meeting with its current membership and its 13th overall since being chartered under the Federal Advisory Committee Act in 2002. Committee chairman Dr. James Oleske opened the meeting and executive secretary Dr. Anand Parekh, representing the Department's Office of Public Health and Science, reviewed the agenda. Ten of 11 Committee members were in attendance, with Dr. Arthur Hartz unable to attend. The meeting was sparsely attended by members of the public. Participating on behalf of the CFIDS Association of America were Kim McCleary, president & CEO, Dr. Suzanne Vernon, scientific director, and Chris Revere of the Sheridan Group.

Federal agencies officials from CDC and NIH provided progress reports on the morning of the first day. Dr. William Reeves of the Centers for Disease Control and Prevention (CDC) gave an update on research studies led by his group, including a community-based study in Georgia, a three-day clinical study beginning soon at the general clinical research center at Emory University, and a pilot registry planned for summer 2008 in Bibb County, Georgia. Dr. Fred Fridlinger, the project officer for the CDC's public awareness campaign, being conducted in collaboration with the CFIDS Association of America, delivered an update on the campaign and statistics related to TV/radio PSAs, print ads, earned media, web site traffic and the traveling photo exhibit. He also presented some preliminary data from two broad health public opinion surveys that contained questions about CFS, indicating that while 57 percent of the public and 96 percent of doctors surveyed had heard of CFS, and 45 percent and 90 percent (respectively) believed it was debilitating, more education was warranted.

Dr. Eleanor Hanna of the National Institutes of Health reported on a September 17, 2007 grantsmanship workshop sponsored by the Office of Research on Women's Health and the Trans-NIH CFS Working Group. She stated that four new grants had been funded for CFS and there were 17 other CFS grants receiving support. The program announcement for CFS used to outline current research priorities is being revised and will be reissued in early 2008. Questions from Committee members of all three speakers led to extended discussions on a number of important topics, including funding levels for both agencies, provider education activities, the Committee's recommendation from the May meeting for NIH to support five center grants and future research directions.

After the lunch break, Dr. Marc Cavaille-Coll from the Food and Drug Administration (FDA) gave a brief report on the FDA Amendments Act, which became law on September 27, 2007 and will fund FDA efforts to facilitate more efficient development of safe and effective new medications. In response to a question about the status of Ampligen, which manufacturer Hemispherx reported having submitted an application for marketing approval, Dr. Cavaille-Coll was unable to comment. Dr. Deborah Willis-Fillinger provided a short update from the Health Resources and Services Administration, noting the agency's 25th anniversary. Social Security Administration (SSA) representative Dr. Laurence Desi was unable to attend.

Reports from each of three subcommittees followed agency updates. Committee member Kristine Healy described an effort by the Education Subcommittee that followed a formal recommendation from the May meeting, to engage the Surgeon General to send a letter about available CFS resources to a broad range of health care professional organizations and public health institutions. A September briefing with the acting Surgeon General, Rear Admiral Steven Galson, yielded interest from him and his senior staff, but no firm commitment to send the letter at present. Dr. Parekh outlined concerns, ranging from Dr. Galson's recent appointment to ensuring that the letter will have measurable outcomes. Dr. Parekh encouraged the Committee to refine the letter, considering it an "intervention" and to reapproach the Surgeon General in the spring when he was more settled in his role. Questions about other provider education activities followed, with Dr. Morris Papernik inquiring about the Association's year-end withdrawal from a renewal of its contractual relationship with CDC on provider education as reported by Dr. Reeves. Kim McCleary responded that concerns about the direction of the program, specifically the lack of clinical information being communicated by CDC speakers, and increasingly unfavorable contractual requirements being imposed by CDC led to this decision. She reiterated that the Association remains strongly committed to continuing provider activities independent of CDC funding, and that the public awareness campaign will continue uninterrupted. Dr. Reeves stated that his research staff would manage the provider education program internally. This topic generated discussion throughout the two-day meeting.

The Research Subcommittee report was delivered by Dr. Leonard Jason, listing numerous topics addressed by the subcommittee over the course of three conference calls. From funding to NIH review panels, to the extent and quality of information about CFS included in medical school texts, the subcommittee had requested a great deal of information and was sorting through it with plans to make a more thorough report at the next meeting. Dr. Ronald Glaser reported that his review of the membership of the NIH's review group for CFS grants found that just 15% of those serving as reviewers had any active interest or past publications in CFS. In response to a question about the number of extramural studies being supported by CDC, Dr. Reeves reported that there were no outside collaborators (other than the Emory study using the clinical research facility).

Rebecca Artman gave an update from the Quality of Life Subcommittee, indicating that in response to discussion at the May meeting, they had attempted to contact numerous third-party payers to learn more about medical and disability reimbursement issues affecting CFS patients and clinicians. Only one agreed to address the Committee, the federal Centers for Medicaid & Medicare Services (CMS); another, Florida BlueCross/BlueShield submitted written responses to a set of questions circulated. Ms. Artman expressed the subcommittee's frustration with the poor response, indicating this to be a reflection of their overall interest in dealing with CFS. Members of the Committee offered their experiences with reimbursement issues with Dr. Nancy Klimas stating the importance of teaching clinicians how to use appropriate symptom codes to maximize payment.

Dr. Cheryl Kitt, deputy director of the NIH's Center for Scientific Review, gave a presentation on current initiatives to update and improve the agency's peer review process for the 57,000 grant applications reviewed each year. She addressed questions from the Committee about problems specific to CFS grants, including the inadequate number of experienced reviewers on the CFS Special Emphasis Panel, and those of a more general nature. She invited participants to listen to a webcast of the December 7, 2007 meeting of the Advisory Committee to the NIH Director, at which time recommendations will be delivered regarding further changes to the peer review process.

The final agency presentation of the day was made by David Atkins, chief medical officer of the Center for Outcomes and Evidence at the Agency for Healthcare Research and Quality (AHRQ). Dr. Atkins described AHRQ's mission as being one dedicated to health services research that seeks to improve the quality and effectiveness of health care. He outlined current priorities and summarized by saying that the agency is best suited to help bridge the gap between known best practices and full implementation of those practices. Like other federal representatives, he responded to the Committee's questions about how AHRQ might help advance care and quality in the management of CFS.

The final session of the day was dedicated to public testimony. In response to the Committee's past request to make meetings more accessible to those unable to travel to Washington, D.C., two individuals gave their five-minute testimonies by speakerphone, Annette Bacola and Cort Johnson. Three others, Mary Schweitzer, Nancy McGregor and Marla Silverman, were present to make remarks. The Committee then adjourned for the day.

Day two began with a presentation from Dr. Jyme Schafer of the Centers for Medicare & Medicaid Services. She described these federal entitlement programs and coverage, payment and quality for services is determined. She was careful to point out differences in how Medicare and Medicaid are funded and administered, and what types of coverage each program provides. She did not have much information specific to CFS and questions from the Committee did not illuminate much about how coverage for CFS diagnosis and management might be better handled under each program. Dr. Lucinda Bateman offered her experience as a clinician whose practice is limited to the care of patients with fatiguing illnesses that Medicare coverage is an important safety net for many of her patients who qualify for Social Security disability and are covered after the two-year waiting period. Her experience was that the payment was at least as good as other third-party payers, if not better.

Next, Prudence Goforth, director of the DHHS Web Communications and New Media division reviewed departmental policy about the websites for the department and its agencies. In preparing for the presentation to the Committee, she identified some needed enhancements to the CFSAC website and the CFS sections of the CDC and NIH websites. She informed the Committee of policies that restrict links to commercial organizations or interest groups. In response to questions about using the web to enhance accessibility to the meetings, she cited cost and compliance issues as barriers to "on demand" webcasting and webinar formats. However, she promised to explore these possibilities with guidance from Dr. Parekh.

Jason Newfield suggested that possible recommendations to the Secretary be discussed, as two Committee members would be leaving to catch early flights. A motion was passed to recommend to the Secretary that a representative from AHRQ be added to the CFSAC as an ex-officio member in advance of the next meeting. Mr. Newfield then expressed frustration that the recommendation made at the last Committee, to support five centers for CFS clinical care, research, training and outreach, appeared unlikely to be enacted by Secretary Leavitt. Discussion centered on barriers to implementing these types of centers, from available funding to a move at NIH away from disease-specific centers. The Committee also discussed other agencies' roles in fostering improved care, such as through community health centers funded by HRSA and clinical care guidelines developed by AHRQ. There was general agreement that repeating this recommendation would not increase the likelihood of securing support. Dr. Christopher Snell urged other organizations, including the patient advocacy community, to seek other means of enacting this recommendation, possibly through Congress. Mr. Newfield also asked that Secretary Leavitt be invited to attend a portion of the next meeting in person; Dr. Parekh agreed to make this request of the Secretary. (Dr. Parekh had reported earlier in the meeting that Assistant Secretary for Health Dr. John Agwunobi, who had attended the Committee's meetings on past occasions, had resigned on September 4 to take a Senior Vice President position with Wal-Mart to oversee the company's plans to open and operate hundreds of health care clinics in its stores.)

Dr. Snell then acknowledged the important work being done at the CDC and the need to expand the resources being brought to bear on CFS by that agency. He proposed the following recommendation: "The Committee recommends that CDC efforts on CFS be restructured to reflect a broader expertise on the multifaceted capabilities required to execute a comprehensive program that incorporates the following elements:

1. Extramural effort directed by the Office of the CDC Director;
2. Sufficient funds to support a program for which the authority and accountability is based at the level of a Coordinating Center;
3. Lab-based component that maintains current the search for biomarkers and pathophysiology
4. Fulfills the recommendations of the external CDC Blue Ribbon Panel including developing, analyzing and evaluating new interventions and continuing support for longitudinal studies; and,
5. Expanded patient, healthcare provider and family caregiver education efforts that are managed by staff with appropriate expertise in clinical and patient education strategies."

After discussion, including input from Dr. Reeves and other ex-officio representatives, some revisions were made to the original wording and the motion to approve the recommendation passed unanimously.

After a break for lunch, the subcommittees met in tandem. When the full Committee reconvened, each subcommittee chairman presented a short list of next steps. Dr. Klimas then brought a proposal from the Education Subcommittee that sought to identify a mechanism for accelerating the translation of research-based information to meaningful improvements in patients' lives. The proposal generated considerable discussion and all were supportive of its aims; however, the specific strategies warranted more contemplation and the subcommittee agreed to continue working to refine the proposal. Dr. Klimas requested that Dr. Reeves prepare an analysis of the data from the Georgia study on health care access and utilization by CFS patients, as well as public survey data from the omnibus surveys reported briefly by Dr. Fridlinger. He agreed to do so.

The Committee then heard public testimony from Kim McCleary and Marian Lemley.

At 3:00 p.m. a majority of Committee members were no longer present; Dr. Oleske and Dr. Parekh thanked the members of the Committee, the ex-officio representatives and members of the public for the time and attention and the meeting was adjourned.