The following report, covering programmatic activities of the Public Policy Council from May 12, 2000 to April 27, 2001, is modified from a report provided to the joint APS/SPR councils on May 27 during the joint meeting of the Pediatric Academic Societies and the American Academy of Pediatrics in Baltimore. A condensed version was provided at the business meetings of the American Pediatric Society on April 29 and the Society for Pediatric Research on April 30 respectively. This activities report supplements the legislative report prepared by the Public Policy Council’s Washington-based staff. Queries or comments should be directed to the Public Policy chairman, myron.genel@yale.edu.

The Public Policy Council, formed almost seventeen years ago, includes two representatives from each of the three constituent societies, the American Pediatric Society (APS), the Association of Medical School Pediatric Department Chairs (AMSPDC) and the Society for Pediatric Research (SPR). Members serve simultaneously as representatives to the AAMC Council of Academic Societies and as liaison and alternative representatives to the AAP Committee on Federal Government Affairs (COFGA).

The Public Policy Forum is a loosely knit assembly of designated representatives at each major academic institution represented in AMSPDC; it serves as a communication network with the membership of the three societies and with academic pediatrics in general. Materials are distributed regularly to the Forum, including periodic legislative updates as well as relevant items on time-specific issues. These are supplemented by the Public Policy Council’s home page on the APS/SPR web site which also provides E-mail access to our Washington coordinator and to myself. The Forum also serves as a vehicle for the annual legislative briefing at the annual meeting. The legislative breakfast at this year’s PAS meeting, the Forum’s fifteenth, was held on April 30, and devoted to funding for vaccine development and distribution, featuring American Academy of Pediatrics vice president (and APS/SPR member) Lou Cooper. PPC member Jon Abramson moderated the session. The eighth annual Public Policy Plenary Symposium, conducted by the Public Policy Council in conjunction with the Public Policy Committee of the Ambulatory Pediatric Association, was devoted to a very significant and topical issue of importance to academic medicine and clinical research in particular “Entrepreneurism and Conflicts of Interest in Academic Medicine”. Panelists included Marcia Angell, emeritus editor of the New England Journal of Medicine, Greg Koski, director of the HHS Office for Human Research Protections, Robert Kelch, dean of the University of Iowa College of Medicine, and Stephen Spielberg, a pediatric pharmacologist with Johnson and Johnson’s subsidiary, Janssen Research Fdn. Ora Pescovitz, PPC member and SPR president, moderated the session.

Membership on the Public Policy Council has been stable during the past year with Christine Gleason and Ora Pescovitz representing the Society for Pediatric Research, Russ Chesney and Jon Abramson for AMSPDC and Jimmy Simon and myself for the American Pediatric Society. Karen Hendricks continues to serve most effectively, and critically, as the Public Policy Council’s Washington Coordinator, ably assisted by Molly Hicks. Ms. Hendricks is a well-regarded, “inside” player within the health-research advocacy community and Washington policy circles. Ms. Hendricks is the immediate past president of the Coalition of Health Funding, a broad consortium of voluntary health organizations, professional societies and advocacy groups and remains on the Coalition’s board. She has served on the Steering Committee of the Ad Hoc Group for Medical Research Funding the past several years, is the past chairperson of Research!America’s Public Affairs Committee and is a central figure in a number of issue-specific coalitions. The effectiveness of the Public Policy Council and our continued visibility in Washington remains a reflection of Ms. Hendricks’ standing and efforts on our behalf.

The council's activities continue to be conducted primarily through a monthly conference call supplemented by frequent mailings and e-mail communications from the Academy’s Washington office as well as from the AAMC Council of Academic Societies. Conference calls have frequently included Jim Perrin, past president of the Ambulatory Pediatric Association, and Charles Oberg, chairmen of the APA’s Public Policy Committee, in part to coordinate plans for the PAS annual meeting but also to coordinate policy initiatives. Materials, including minutes of conference calls, are shared routinely with the leadership of the three societies and thus provide opportunity for input on specific issues. The semiannual legislative reports prepared for the councils and AMSPDC executive committee and testimony by Public Policy Council members are routinely placed on the Public Policy Council web site. Programs of the Public Policy Council continue to be conducted from both the Academy's Department of Federal Affairs and my Office of Government and Community Affairs at Yale. A comprehensive legislative report, prepared in March, appeared in the program booklet for the annual meeting.

Members of the Public Policy Council have been active on a variety of issues during the past year, much of this reflected in the legislative report prepared by our Washington staff. Formal testimony regarding the FY 2002 budget was not presented this year although a statement was submitted for inclusion in the record of the House Appropriations Subcommittee on Labor/HHS/Education. The Public Policy Council did endorse testimony provided by the American Academy of Pediatrics and in particular concerns raised regarding funding cuts for a variety of programs which impact children’s health, including reduced funding for graduate medical education at freestanding children’s hospitals. The Public Policy Council has been actively involved in the oversight of research involving children through advocacy for inclusion of children in clinical trials by implementation of provisions of the FDA Modernization Act which provides incentives for pharmaceutical firms testing drugs in children and through implementation of the FDA’s “Pediatric Rule”. In addition, the Public Policy Council has actively monitored development of more rigorous oversight mechanisms for the conduct of research in human subjects, particularly as they affect children. The Public Policy Council joined with the Academy in raising concerns regarding the initial exclusion of a pediatric representative to the newly established National Human Research Protections Advisory Committee (NHRPAC). This action resulted in the eventual addition of APS/SPR member Alan Fleischman to the panel. Dr. Fleischman is heading a NHRPAC workgroup on children which includes PPC members, Christine Gleason, Jon Abramson and myself. The Public Policy Council has also actively monitored development of regulations on privacy and confidentiality, required by the HIPPA legislation, in particular those aspects of the privacy regulations which impact on medical education and research. In a March 28, 2001 letter to HHS, the Public Policy Council raised concerns regarding potential adverse impact on medical teaching by the limitation of information made available to medical students, residents and fellows who are not included as “health care providers” deemed to have full access. The Public Policy Council also raised concerns regarding the impact of the regulations on the use of archival materials for retrospective, observational and health services research, supporting more extensive comments submitted by the AAMC. The Public Policy Council has continued to actively support federal funding for embryonic stem cell research as part of a coalition led by the American Society for Cell Biology and has actively worked with the Ad Hoc Group for Medical Research Funding, Research!America and other organizations in advocacy to double the NIH budget by FY 2003. A major accomplishment in the 106^th Congress was passage of the Children’s Health Act (PL106-310) which, among other provisions, provides authority for a loan forgiveness program for health professionals pursuing pediatric research and formally authorizes the Pediatric Research Initiative within the director’s office. The Public Policy Council also supported legislation, incorporated in the Public Health Improvement Act of 2000, which provides loan forgiveness for individuals committed to clinical research. The Public Policy Council continues to work with other agency specific coalitions to support funding for health services research, especially in children, within the Agency for Healthcare Research and Quality (AHRQ) and for restoration of full funding for the health professional training programs encompassed in titles VII and VIII of the Public Health Act.

AAP Committee on Federal Government Affairs: COFGA, formerly the AAP’s Council on Government Affairs, includes eight members appointed by the Academy plus liaison representation from the three societies which form the Public Policy Council, the Ambulatory Pediatric Association, Society for Adolescent Medicine, the Academy’s Committee on State Government Affairs, and the Academy’s senior and resident sections. Rick Bucciarelli, assistant vice-chancellor at the University of Florida, has been chairman since the committee was reorganized a few years ago, and also heads the Academy’s Task Force on Health Insurance Coverage and Access to Care. A number of APS/SPR members serve as either Academy or liaison members of COFGA.

COFGA met, per custom, on two occasions during the past year, November 19-20, 2000 and March 18-19, 2001, both in the Washington area, and briefly in October during the Academy’s annual meeting in Chicago. COFGA’s major activity continued to be devoted to development of an Academy proposal to provide universal health insurance and health coverage for all children. An Academy task force was formed two years ago, headed by COFGA , members Rick Bucciarelli and John Lewy. The workgroup has developed the following set of principles: (1) provide every child with health insurance; (2) right available to ALL children and pregnant women without means testing; (3) administrative simplicity; (4) choice of clinician(s); (5) AAP age-appropriate benefit package; (6) fully portable and continuous coverage; (7) access to pediatric medical subspecialists and pediatric surgical specialists; (8) appropriate levels of reimbursement and (9) coordinate and complement existing maternal and child health programs to help ensure maximum health benefits to families. As further refined, the Academy’s proposal calls for development of a National Child Health Plan which would be provided as a federal program as an alternative to private insurance, Medicaid or S-CHIP while maintaining Medicaid as a “wraparound” benefit for children with special needs. At its most recent meeting, held in conjunction with COFGA, the Academy task force met with representatives from the office of Sen. John Rockefeller and Rep. Pete Stark, co-sponsors of the Medikids Health Insurance Act of 2000 which was introduced late in the 106^th Congress. With modifications to provide a five-year phase in, the Academy has endorsed a revised Medikids Health Insurance Act that was introduced in mid May. Republican co-sponsors have yet to be identified. The academy has initiated legal action to ensure adequate reimbursement for Medicaid services under the “equal access” provision of Medicaid, requiring Medicaid beneficiaries to have access to care and services at least to the same extent of the general population in their area. The Academy has noted that access to these services has been restricted by problems in enrollment, provider participation, and reimbursement, especially under managed care contracts. As a result, HCFA has compiled a list of indicators of state compliance with Medicaid law which has been distributed to regional and state administrators. The Academy continues to be active in support for provisions of the FDA Modernization Act which provide market incentives for testing in children and in support of the “Pediatric Rule” promulgated separately by the FDA which requires pediatric testing in new drugs that will be used in a significant number of pediatric patients. Additional Academy efforts have been devoted to continued advocacy for childhood immunizations and rebuttal of purported linkages with a number of chronic illnesses in children, among these autism and childhood diabetes. The Academy has continued to be active in various coalitions devoted to prevention of youth violence and gun control and in efforts to limit tobacco among children.

AAMC Council of Academic Societies: The CAS is one of the three principal components of the Association of American Medical Colleges (AAMC) together with the Council of Deans and the Council of Teaching Hospitals. The CAS now includes 95 member societies of which four are pediatric, the three parents of the Public Policy Council as well as the Ambulatory Pediatric Association. The CAS provides an unparalleled opportunity for interaction of pediatric specialists with leaders of other professional societies as well as significant input into development of AAMC policies and activities. Paul McCarthy, an APS/SPR member representing APA, served as CAS Chair in the 1999-2000 year and remains on the CAS administrative board. I served in a similar capacity a decade earlier and currently serve on the AAMC’s Advisory Panel on Research.

The Council of Academic Societies met on two occasions during the academic year — October 28-30, 2000 in Chicago, as part of the annual general meetings of the AAMC, and March 22-25, 2001 in San Antonio. A major accomplishment of the CAS was publication of a monograph on scholarship as a supplement to the September, 2000 issue of Academic Medicine. The CAS has also developed a Professionalism Task Force which organized a roundtable prior to the CAS spring meeting with the goal of developing a CAS statement on the roles and responsibilities of faculty regarding professionalism. A statement on lifelong professional development and maintenance of competence, developed by the CAS administrative board, was approved by the AAMC Executive Council in June. In addition, the CAS and AAMC have further enhanced services provided to departmental chairmen, including creation of a CAS Task Force of Chairs which will begin work on a Chairs Objectives Project. At the AAMC Annual Meeting, AAMC President Jordan Cohen devoted his annual meeting address to “Ensuring Public Confidence in the Integrity of Clinical Research”, focusing in particular on conflict of interest issues. A 28 member AAMC Task Force on Conflicts of Interest in Clinical Research, chaired by Dr. William Danforth, emeritus chancellor of Washington University in St. Louis has been formed and will shortly begin a two-year effort. A summary of the CAS spring meeting in San Antonio is appended to this report.

As I have outlined in previous reports, the AAMC and the Council of Academic Societies provide a unique opportunity for academic pediatrics to have influence and assert leadership within academic medicine. The annual meeting of the AAMC will be held in Washington, November 2-7, 2001 and the spring meeting of the CAS will take place in Santa Fe, New Mexico, March 14-17, 2002.