The following report, covering programmatic activities of the Public Policy Council from April 27, 2001 to May 3, 2002 is modified from a report provided to the joint APS/SPR councils on May 3 during the meeting of the Pediatric Academic Societies and affiliated organizations in Baltimore. 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 Council chairman, myron.genel@yale.edu.

The Public Policy Council, formed almost eighteen 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 sixteenth, was held on the morning of May 6, and featured Jennifer Kulynych, J.D., Ph.D., director of the AAMC's Division of Biomedical and Health Sciences Research, who discussed the impact of new privacy and confidentiality regulations on medical research and academic medicine. The privacy regulations, mandated by the Health Insurance Portability and Accountability Act (HIPAA) are scheduled to go into effect next April. The ninth annual Public Policy Plenary Symposium, conducted by the Public Policy Council in collaboration with the Public Policy Committee of the Ambulatory Pediatric Association, was held on Sunday, May 5, and was devoted to a topical issue of great importance to our membership and the public at large—"Children as Research Subjects: Ethical and Regulatory Issues." Panelists included Alan Fleischman, senior vice president of the New York Academy of Medicine and a member of the National Human Research Protections Advisory Committee (NHRPAC); Eric Meslin, former executive director of the National Bioethics Advisory Commission and presently director of the Indiana University Center for Bioethics; Pearl O'Rourke, director of Human Research Affairs for the Partners Health Care System; and Brian Kamoie, George Washington University's School of Public Health and Health Sciences.

Membership on the Public Policy Council continued to be stable with one change in the past year—Elena Fuentes-Afflick from UCSF replacing Ora Pescovitz for the Society for Pediatric Research, Ora's term having expired after an active four-year tenure. Continuing members of the Public Policy Council include Russ Chesney and Jon Abramson for AMSPDC, Jimmy Simon and myself for the American Pediatric Society and Christine Gleason for SPR. Karen Hendricks continues to serve most effectively as the Public Policy Council's Washington Coordinator, until recently assisted by Molly Hicks, who has assumed other duties within the Academy's Washington office. 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. On our most recent April conference call, we were joined by Richard Behrman, executive chair of the Pediatric Education Steering Committee for the Federation of Pediatric Organizations, for discussion of recruitment and training of pediatric subspecialists. 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.

Members of the Public Policy Council have been engaged in a variety of issues during the past year, much of this reflected in the legislative report prepared by our Washington staff. The Public Policy Council continued to support efforts to complete the doubling of the NIH budget by 2003 and to increase funding for pediatric research through implementation of the Pediatric Research Initiative (PRI). While oral testimony was not presented this year, the Public Policy Council joined in a statement submitted by the American Academy of Pediatrics. The Public Policy Council, principally through the efforts of member Russ Chesney, actively promoted implementation of the Pediatric Research Initiative, authorized by the Children's Health Act of 2000 with funding up to $50 million allocated to the office of the NIH director. Together with representatives from the National Association of Children's Hospitals, Dr. Chesney met with acting NIH director, Ruth Kirschstein, on February 25. A report on implementation of the Pediatric Research Initiative was due to Congress by April 1. Implementation of the loan repayment program for health professionals committed to careers in pediatric research was initiated by NIH for initial funding during the FY 2002 budget. The Public Policy Council actively supported passage of the Best Pharmaceuticals for Children Act which re-authorized the incentive program for pediatric studies conducted by pharmaceutical companies through a six-month patent extension incentive and created an Office for Pediatric Therapeutics within the FDA. More recently, the Public Policy Council worked together with the Academy and other pediatric organizations to successfully oppose a proposal to temporarily suspend the FDA's Pediatric Rule. Ethical and regulatory issues relating to protection of human subjects research continued to be a high-profile issue during the 2001–2002 year, noteworthy for two highly publicized cases in Baltimore, one involving the death of a normal volunteer in a study at Johns Hopkins Bayside facility and the other a ruling by the Maryland Appeals Court in a suit brought against the Kennedy-Krieger Institute by parents of children who participated in a study comparing various forms of abatement for lead poisoning. In the latter case, the Maryland court ruled that children should not be permitted to participate in research that did not offer them direct benefit. While this was tempered somewhat in a subsequent opinion, the court's ruling has served to highlight the importance of current efforts to examine the Common Rule and procedures for safeguarding children in research. Members of the Public Policy Council have been very active in this effort with three members of the Public Policy Council—myself, Jon Abramson and Christine Gleason—serving on the Children's Workgroup established by the National Human Research Protections Advisory Committee. In addition, a statement was submitted for a hearing conducted April 23, 2002 by the Senate HELP Committee, a hearing for which I was originally scheduled to provide oral testimony, indeed on four separate occasions dating to last spring, all postponed for a variety of reasons. On other matters, the Public Policy Council has continued to work within various coalitions on a variety of issues relating to funding for research, support for embryonic stem cell research and nuclear transfer technology or "therapeutic cloning", increased funding for the Agency for Healthcare Research and Quality (AHRQ), generally and specifically for children, and for full funding for health professional training programs, Titles VII and VIII of the Public Health Act. Finally, the Public Policy Council has been actively involved in a variety of post-September 11 events, in particular related to omnibus legislation, the Bioterrorism Preparedness Act, and a variety of immunization-related issues on which PPC member Jon Abramson, who chairs the AAP Committee on Infectious Diseases, had been especially prominent.

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 that 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. John Lewy, a member of all of the Public Policy Council societies, now heads the Academy's Task Force on Access to Health Care previously headed by Dr. Bucciarelli.

Other than for a brief meeting at the Academy's annual meeting in San Francisco, COFGA met on only one occasion during the past year, February 10–11, 2002. COFGA continued to work actively on provision of universal health insurance and improving access to health care for children, principally through legislation—the MediKids Health Insurance Act—introduced last May by Sen. John Rockefeller and Rep. Pete Stark. The bill incorporates principles developed by the Academy's Task Force on Access to Health Care, principally by providing that all children are covered by either private or government insurance with Medicaid serving as a "wrap-around" benefit for children with special needs. With Congress' attention diverted to a number of other issues following the September 11 terrorist attacks and the Enron debacle, there has been limited activity. Currently the bill has 57 sponsors in the House and three in the Senate, all from the Democratic Party. Even before September 11, there were clear indications from a meeting with Rep. Nancy Johnson, chair of the House Ways and Means Subcommittee, that the MediKids Act, as introduced, would not attract strong bi-partisan support. At the February COFGA meeting, the MediKids bill was looked upon more as a vehicle for ongoing advocacy with key Congressional members. Current COFGA and Academy activities have been directed at ensuring adequate reimbursement for pediatricians. Last year, the Academy initiated legal action to ensure adequate reimbursement for Medicaid services under the "equal access provision," which requires Medicaid beneficiaries to have access to care and services, at least to the same extent as the general population in the area. This action was filed in the latter stages of the Clinton administration and discussions have continued with the now not so new Bush administration via CMS administrator Tom Scully and Medcaid director Dennis Smith. COFGA and the Academy have mounted a major effort to reverse a CMS decision to ignore recommendations of the CPT Code Advisory Committee that physician payment for immunization should be increased to appropriately reflect physician work efforts. As a result of Academy advocacy, a number of Congressional offices have sent letters to CMS in support of the Academy position. COFGA and the Academy's Washington office were extensively involved during the year in passage of the Best Pharmaceuticals for Children Act and retention of the Pediatric Rule, referred to earlier in this report. The Academy continues to be in the leadership or active among various coalitions devoted to preventing youth violence, gun control and in limiting tobacco use among children. A grass roots Federal Advocacy Action Network (FAAN) has been implemented and is being upgraded by the Academy's Washington office to facilitate Academy advocacy.

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 98 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. For the first time in fifteen years, the Administrative Board of the Council of Academic Societies is absent a pediatrician. Paul McCarthy, an APS/SPR member representing APA, retired from the CAS Administrative Board at the 2001 annual meeting. Dr. McCarthy was chair of the CAS in the 1999–2000 year, while I was chairman during the1990–1991 year, both of us serving on the CAS Administrative Board for six-year terms. I currently serve as a member of the AAMC's Advisory Panel on Research.

The Council of Academic Societies met on two occasions during the academic year: November 3–7, 2001 in Washington as part of the annual general meetings of the AAMC and March 14–17, 2002 in Santa Fe, New Mexico. A number of unique CAS activities continued during the year. The CAS Professionalism Task Force has drafted a statement on "Attributes of Professionalism in Medicine," in essence a synthesis from a very lively Professionalism Roundtable held during the 2001 CAS spring meeting in San Antonio and outlined in my 2001 activities report. The Task Force has focused on efforts to enhance professionalism in medical schools and teaching hospitals, to sensitize faculty and students to the nature of professionalism and to study how it can be evaluated and has been led by Terry Cooper, immediate past chair of the CAS. The efforts to enhance services provided to department chairs, begun a few years ago, has resulted in formation of the CAS Chairs Objectives Project Panel which held an extensive meeting late in November in Dallas. The Task Force includes Public Policy Council member and AMS/PDC president Russ Chesney. A report from the Project Panel has been drafted and was presented at the spring CAS meeting in Santa Fe by Lloyd Michener, chair of Duke's Department of Family Medicine. The AAMC is developing a manual entitled "Good Practice in the Development of the Successful Department Chair," which will include materials prepared by the CAS Chairs Objectives Project Panel. The first module of the "practice" manual deals with good practices in the search selection and appointment process of new chairs and leadership transition between permanent chairs. A second module will describe department chair responsibilities and expectations and identify good practices for development of skills necessary to carry out these responsibilities effectively. This module will include the product of the CAS Chairs Objectives Project. A final section will address the good practice and evaluation of performance review of department chairs, rewards, career transition and issues related to conclusion of service. During the year, the AAMC overall was very active in a variety of issue affecting academic medicine in addition to its customary advocacy for support of research and training across the entire spectrum of the biologic sciences and medicine. Following September 11, the AAMC, upon the request of Congressional leaders, embarked upon a new bioterrorism initiative entitled "First Contact, First Response" and has convened an expert panel to provide guidance on curriculum content related to biological agents and radiation and chemical exposure. The AAMC continues to work collaboratively with the CDC to improve partnerships between public health and medicine, especially in the context of bioterrorism. The initial report of the AAMC's Task Force on Financial Conflicts of Interest was issued early in 2002. This report deals with COI among individual investigators; a subsequent report will deal with the delicate issue of institutional conflicts of interest. Under the leadership of the AAMC, an accreditation agency for protection of human subjects - the Association for the Accreditation of Human Research Protection Programs (AAHRPP) has been launched with a full-time executive director, Marjorie Speers, Ph.D., formerly deputy director of the National Bioethics Advisory Commission. The AAMC has formed an Advisory Committee on the Definition of Under-represented Minorities which is reviewing the Association's current definition of the term. The AAMC has also released a new statement on graduate medical education which calls for a number of reforms in resident duty hours and intensity of patient care responsibilities. It is hoped that tangible evidence of reform will prevent passage of legislation explicitly regulating GME.

As usual, the CAS programs at these meetings covered the spectrum of issues that are topical within academic medicine. The November meeting included the joint session with the Councils of Deans and Council of Teaching Hospitals on the cost of compliance with regulatory requirement for research and patient billing, and another joint session on information technology. The spring meeting included major sessions on "Genetics and the Evolving Art and Science of Medicine" featuring Frances Collins, NIGR director, and a session on "Preserving the Social Contract and Our Academic Values" which highlighted a presentation by David Hunter, president of the Hunter Group, which has consulted at virtually every academic health center with financial woes.

Once again, I call for increased involvement of academic pediatrics and constituent societies within the AAMC, and specifically the Council of Academic Societies. Without any presence on the CAS Administrative Board, and minimal participation in the activities of the CAS, we are not utilizing a unique opportunity to have influence within the leadership of academic medicine. This fall's annual meeting of the AAMC will be in San Francisco, November 8–13 and the 2003 CAS spring meeting will be in Tampa, March 13–16.