The 108th Congress was sworn in on January 7, 2003, and immediately faced numerous challenges.  In addition to the challenges of homeland security and an impending war in the Middle East, the 108th Congress had on its plate the remaining 11 of 13 appropriations bills for FY 2003 that the 107th Congress had failed to pass before it adjourned in November. Congress finally approved a $397.4 billion omnibus spending on February 13. In addition, on February 3, President Bush released his FY 2004 budget proposal that outlines his spending priorities for the coming fiscal year. Because of this confluence of events and the many children's health issues at stake, members of the American Pediatric Society, Society for Pediatric Research and the Association of Medical School Pediatric Department Chairs are urged to continue to make your views heard throughout the spring months of 2003.

The following is an update and summary of recent federal legislative and regulatory activities of interest to the pediatric academic community.  This report includes information on the following issues:

National Institute of Health (NIH)/Appropriations: Through its work with the Ad Hoc Group for Medical Research Funding, the PPC in FY 2003 supported the final year in the five-year doubling effort of the NIH budget. The Ad Hoc Group for Medical Research Funding is a coalition of more then 300 patient and voluntary health groups, medical and scientific societies, academic and research organizations, and industry. Its mission is to enhance the federal investment in biomedical, behavioral, and population-based research by increasing the finding for the NIH.

On February 13, 2003, both the House and Senate approved the FY 2003 omnibus appropriations package, which included $27.2 billion for the NIH, 16.2% increase over FY 2002 and $1.213 billion for the National Institutes of Child Health and Human Development. 

The President's FY 2004 budget proposal, released on February 3, contained a modest 2% increase - $27.7 billion - for NIH.  Through its work with the Ad Hoc Group for Medical Research Funding, the PPC will support a 10% increase—$30 million—in FY 2004 for the NIH.

National Children's Study: Created by the Children's Health Act of 2000, the National Children's Study is a national longitudinal study of environmental effects (including physical, chemical, biological and psychosocial) on child health and development. It is an interagency collaboration for biomedical research including most NIH Institutes and Centers, 11 HHS agencies and 9 cabinet departments. Currently in its planning phase, the lead federal agencies are the NICHD, the National Institute of Environmental Health Sciences and the Environmental Protection Agency. To carry out this research, approximately 30 - 40 National Children's Study Centers will be established across the U.S. Currently there are 22 Working Groups, including working groups on asthma, birth defects, ethics, health disparities, to name just a few.  The pediatric community is working closing with the NICHD on this important study. The Working Groups, Study Assembly, and Federal Advisory Committee met in December in Baltimore, Maryland.  Further information is available at - http://www.nationalchildrensstudy.gov. 

Pediatric Research Loan Repayment: The NIH has indicated that in FY 2003, it is estimated that approximately $56 million in funding will be available to double the pediatric loan repayment program.  In October 2002, NIH released its new loan repayment program for pediatric and clinical researchers' policy (http://www.lrp.nih.gov). The new policy allows for eligible researchers and trainees supported by governmental (including AHRQ) and private, nonprofit grants to apply to NIH for loan repayment. Previously, only NIH-supported researchers were eligible to apply for support. Applications were due at the end of January and decisions on loan repayment funding will be made in the late spring or early summer.

The pediatric academic community will work with the 108th Congress to ensure the continued need and support for these important loan repayment programs across a spectrum of pediatric research needs.

"Therapeutic Cloning"- President's Council on Bioethics: President Bush's Council on Bioethics met several times last year and again in January 2003, to discuss issues pertaining to the ethics and policies of genetic and reproductive technologies and the patentability of human organisms. The Council has recommended a ban on human cloning to produce humans and a four-year moratorium on human cloning for medical research. Additional information about the President's Council, including meeting transcripts, is available online at www.bioethics.gov.

Legislation: Throughout the 107th Congress, the PPC supported the advocacy efforts of over 200 prominent biomedical research scientists, patient groups and others to urge Congress to oppose legislation that would criminalize an important research pathway, somatic cell nuclear transfer (SCNT)—"therapeutic cloning."  Similar efforts are already underway in the 108th Congress.  In February, Senators Orrin Hatch (R-UT), Dianne Feinstein (D-CA), Arlen Specter (R-PA), Edward Kennedy (D-MA), Tom Harkin (D-IA), and Zell Miller (D-GA) introduced S.303, a bill that would ban human reproductive cloning but allow somatic cell nuclear transplantation (SCNT) to move ahead with federal oversight. The "Human Cloning Ban and Stem Cell Protection Act of 2003" makes it a crime to clone or attempt to clone a human being, but permits nuclear transplantation to be conducted on unfertilized eggs for up to 14 days, under strict ethical and federal regulation.  Also in February, in contrast, the House Judiciary Committee approved HR 534, a bill sponsored by Reps. Dave Weldon (R-FL) and Bart Stupak (D-MI) that would totally ban all human cloning, including SCNT.  The committee rejected by party-line votes a number of amendments offered by Democrats, including proposals to allow the use of SCNT for therapeutic and research uses and to permit the importation of medical treatments derived from human cloned embryos.

IOM Committee on Centers Of Excellence:  The Institute of Medicine Committee on Assessment of NIH Centers of Excellence Programs is seeking input from professional and scientific societies and other groups on the use of research center grants by the National Institutes of Health, focusing in particular on the criteria and procedures used in deciding to adopt the use of centers, how they are designed and administered, comparisons with other mechanisms of research support, their impacts and costs, and how they are evaluated.  The Public Policy Council submitted a comment letter to the IOM Committee providing examples from the PPRU, neonatal, and CHRC networks, and calling the centers "worthy examples of the best kind of investment the NIH can make." Additional information and a roster of the committee members can be found on the IOM web site: http://www.iom.edu/IOM/IOMHome.nsf/Pages/HSP+NIH+Excellence

Agency for Healthcare Research and Quality (AHRQ)/Appropriations: The PPC, as part of a broad coalition, the Friends of AHRQ, supported $390 million in funding for AHRQ in FY 2003. Congress agreed to a final appropriation in the omnibus bill of  $303.7 million and increase of 1% over last year's level. This includes $55 million for research on reducing medical errors.

QUALITY—PEDIATRIC DRUG STUDIES

Pediatric Studies Provision within the Food and Drug Administration Modernization Act (FDAMA): Last year President Bush signed into law the Best Pharmaceuticals for Children Act (BPCA). The measure, P.L. 107-109, reauthorizes the pediatric studies provision that provides a 6-month incentive to pharmaceutical companies that conduct pediatric studies that have been requested by the Food and Drug Administration.

The President's FY 2004 budget proposal includes $30 million for the BPCA - $5 million to go to the FDA, and $25 million to NIH. As it did in FY 2003, the pediatric community will request at least $200 million to support research of off-patent drugs as well as on-patent drugs that the patent holder has declined to study.

The Pediatric Rule: In October 2002, the U.S. Federal District Court in Washington, DC, struck down the Pediatric Rule, saying Congress never intended to give the FDA power to require drug companies to test adult medicines commonly given to children.  In December, the American Academy of Pediatrics (AAP) and the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) filed a motion in federal court asking for the right to intervene in the lawsuit over requiring drug companies to test medicines used in children because the FDA had not yet decided whether to appeal on its own.  The FDA decided not to appeal, stating that congressional action is the surest and swiftest way to ensure that the Pediatric Rule is restored.

The pediatric community has always maintained that if the BPCA is the "carrot" (incentive) to improve therapeutics for children, the Pediatric Rule is the "stick".  They must BOTH be in place - the requirement and the incentive - to ensure that therapies for children are not lost in a legal or political quagmire. The pediatric academic societies, AAP, and EGPAF supported legislation in the107th Congress that would have permanently codified the essential protections of the Rule and allowed the FDA to reinstate those protections immediately upon enactment, and similar legislation is being strongly urged in the 108th Congress.
 

PEDIATRIC WORKFORCE

Children's Hospitals Graduate Medical Education (CHGME): The pediatric academic community working with the National Association of Children's Hospitals (NACH), were successful in advocating for $292 million ($285 million plus an adjustment for inflation) for Children's Hospitals GME in FY 2003. It was funded at $285 million in FY 2002.  The President's FY 2004 budget contained only $199 million for CHGME; the PPC will continue its efforts to vigorously advocate for adequate and sustained funding in FY 2004 and beyond.

Titles VII and VIII-Health Professions Training Grants/Appropriations: The FY 2003 omnibus appropriations package has provided for $93 million for primary care medicine and dentistry (this includes general pediatrics), and a total of $423.9 million for the combined Title VII and VIII programs.  This represents an overall increase of 9.3% over FY 2002. Title VII funding is $310.5 million of the total amounts appropriated.

As in FY 2003, the President's FY 2004 budget removes all funding for primary care, interdisciplinary community projects, training for diversity, and public health. The president proposes only $11 million for the Title VII program although it does address the nursing shortage through a modest increase for Title VIII. The PPC has joined over 40 national organizations in the Health Professions and Nursing Education Coalition (HPNEC) to support $550 million for the Title VII and VIII programs in FY 2004.  In addition, the pediatric community continues to support innovative training for generalist pediatricians through appropriate funding for the General Internal Medicine/General Pediatrics program, that is part of Title VII, of at least $40 million.  This represents a step towards a multi-year effort to achieve a funding level of at least $69 million for the General Internal Medicine/General Pediatrics programs, as recommended by the Congressionally-established Advisory Committee on Training in Primary Care Medicine and Dentistry. Ongoing advocacy to maintain and support increased funding for the health professions training program is crucial in the 108th Congress.

Reauthorization: The Title VII program was due to be reauthorized last year but was not; therefore, it will be taken up in the 108th Congress. This process, if past years are any example, may well take quite some time. The pediatric community is gearing up for the reauthorization process now by beginning preliminary conversations with colleagues at the internal medicine societies this month.  We certainly appreciate the involvement of members of the pediatric academic societies as reauthorization moves forward.  If you or your colleagues have examples of how Title VII is working in your institution, or comments on changes or additions that might be needed in the reauthorized bill, please do let us know.  
 

FY 2003 APPROPRIATIONS

Although the new fiscal year began on October 1, 2002, the lack of an agreement on overall spending levels led Congress to pass a series of short-term funding bills -  "continuing resolutions" (CR)—that funded the government at FY 2002 levels until a final FY 2003 spending could be hammered out.  The House and Senate finally came to an agreement on a $397.4 billion omnibus spending package—the "Consolidated Appropriations Resolution, 2003,"—on February 12, 2003, and approved it the following day, by a vote of 338–83 in the House and 76–20 in the Senate. President Bush signed it on February 20.
 

FY 2004 BUDGET

Budget committees are beginning work on the FY 2004 budget, which the President began on February 3 with the release of his FY 2004 proposal.  The Committees' tentative timetable calls for completion of the budget resolution (which does not need to be signed by the President) by April 15.  While this date is seldom met, this year there is an indication by both the House budget committee chairman Jim Nussle ( R-IA) and the new Senate budget chairman (Senator Don Nickles (R-OK) that the House and Senate will meet that deadline.  Set forth by the President, the overall focus of the Administration's budget proposal for FY 2004 is on safety of Americans, homeland security, economic well-being, Medicare, and global AIDS programs, particularly in Africa and the Caribbean. 
 

HEALTH INSURANCE COVERAGE AND ACCESS TO CARE

SCHIP: On October 1, 2002, states lost $1.2 billion in SCHIP funds that had been appropriated for FY 1998 and FY 1999. As law currently exists, unspent SCHIP funds from these fiscal years expired September 30, 2002, and are to be returned to the Treasury. Unspent SCHIP funds from FY 2000 are to be recovered and redistributed to states that have spent all of their FY 2000 funds. Any remaining unspent funds will expire and revert to the Treasury on September 30, 2003. The pediatric community supported several federal proposals to keep retired funds in the SCHIP program. The 107th Congress did not complete action on these proposals, and legislation will certainly be introduced in the 108th Congress. A state-by-state updated listing of unspent SCHIP funds returned at the end of FY 2002 can be found in at: http://www.cbpp.org/7-15-02health.htm.

Medicaid Reform/SCHIP Proposal: The Bush Administration's 2004 budget includes a proposal to reform the Medicaid and State Children's Health Insurance Programs (SCHIP) by combining the two programs into one state block grant.

This Medicaid/SCHIP proposal would divide up an estimated $12.7 billion in additional funding over seven years that would be loaned to those states that agree to have their Federal funding for Medicaid and SCHIP capped for the next 10 years. Federal funding for Medicaid and SCHIP would be provided in two annual allotments, with one allotment for acute care and another for long-term care. These annual capped amounts would be given to states based on its level of spending in 2002 for Medicaid and SCHIP, and would be increased each year based on a formula.

States that do not choose the new proposal option would continue to administer their Medicaid and SCHIP programs under existing rules, but will not receive any additional federal funds for fiscal relief.

This proposal clearly poses a risk to the child health care safety net. Medicaid currently has open-ended Federal financing. If the costs of the state program grow, the Federal funding automatically grows - with no cap. Through capped allotments, this proposal limits federal funds states would receive in the future for coverage of low-income children regardless of increases in enrollment or needed services. The proposal provides states tremendous flexibility concerning the Medicaid "optional" population, which includes over 8 Million enrolled children. Such flexibility, combined with limited federal funds, poses a serious risk to all children's health benefits under Medicaid and SCHIP, including benefits for children with special needs. Pediatricians are urged to contact their governor, senators and representative to oppose the Administration's Medicaid proposal and to ask them to protect the Medicaid and SCHIP programs.
 

IMMUNIZATIONS

Federal Legislation: Several legislative proposals have been introduced to address the Vaccine Injury Compensation Program (VICP). In March 2002, Sen. Bill Frist (R-TN) introduced S. 2053, the Improved Vaccine Affordability and Availability Act. The bill currently has four cosponsors. The bill addresses increasing influenza rates as well as requires the HHS Secretary to provide for a program of research, demonstration projects, and education to ensure that public and private health care providers routinely offer immunizations to adults and adolescents. The VICP program would be required to collect data on adverse impacts associated with immunizations. The bill also revises provisions governing VICP, such as: equitable relief; third party petitions; jurisdiction to dismiss improperly brought claims; vaccine-unrelated injury; an increase in the award for pain and suffering in the case of a vaccine-related death. A companion bill was introduced in the House, HR 5282, by Representatives Jim Greenwood (R-PA) and Edolphus  Towns (D-NY).  While S. 2053 did not pass in the 107th Congress there are plans to reintroduce the Improved Vaccine Affordability and Availability Act in the 108th Congress.
 

2003 PEDIATRIC ACADEMIC SOCIETIES ANNUAL MEETING

Public Policy Plenary Session: The title for this year's PPC annual Public Policy plenary session, a popular feature of the PAS Annual Meeting jointly sponsored with the Ambulatory Pediatric Association, is "The Changing Spectrum of Pediatric Specialty Care: Implication for Pediatric Generalist and Specialist." The 2-hour session will be held on Sunday, May 4. It will focus on the generalist-specialist interface and the roles of these groups in the new century.  Our speakers are: James Perrin, MD, Director of General Pediatrics, MassGeneral Hospital for Children,  Julia McMillan, MD, Vice Chair for Education and Residency Program Director, Johns Hopkins University School of Medicine and Robert Haslam, MD, Emeritus Professor and Chairman of Pediatrics, University of Toronto and Emeritus Pediatrician-in Chief of the Hospital for Sick Children, Toronto. This session will be moderated by Russell Chesney, MD, Chair, Department of Pediatrics, University of Tennessee -Memphis and member of the PPC. We look forward to an exciting and informative exchange.

Legislative Breakfast: The PAS legislative breakfast will be at 7:00 a.m. the following morning, Monday, May 5.  David Rimoin, MD, PhD, will lead a presentation tentatively titled "The Clinical Research Enterprise (Report from the IOM's Clinical Research Roundtable)". We look forward to seeing you and your colleagues at both of these events.
 

CONSIDER JOINING THE AAP FEDERAL ADVOCACY ACTION NETWORK (FAAN)

The American Academy of Pediatrics invites you to become a member of the Federal Advocacy Action Network (FAAN).  Coordinated by the AAP Department of Federal Affairs, FAAN is a network of AAP members who help support federal legislative and regulatory activities from their position as constituents.  FAAN members play an important role in passing federal legislation that benefits children and pediatricians.

The AAP Department of Federal Affairs gives FAAN members the information and tools you need to persuade your legislators.  For example, each month via e-mail you will receive FAAN MAIL with updates on AAP legislative priorities in Washington, D.C.  We will keep you up to date with timely information with "THIS JUST IN."  You will also receive "SPECIAL ALERTS" when immediate action is needed by you on a key issue. 

To join FAAN go to the Members Only Channel of the AAP web site, www.aap.org/moc, and click on Federal Affairs, then click on Join FAAN and follow the easy directions.   The Members Only Channel has some great tools to make your advocacy work easy.  Find the names of Congressional representatives, contact legislators via e-mail, read about daily congressional activity, view actual bills and use the media contact list.

HOW TO CONTACT YOUR MEMBER OF CONGRESS:

Write: Be courteous, to the point, and include key information, using examples, if possible, to support your position. Address only one issue in each letter and, if possible, keep the length to one page.

Call: You can contact your Senators and Representative's office by calling the Capitol Hill Switchboard at 202-224-3121. If you do not know who your Representative is, the switchboard operator will be able to direct you to the proper office. Ask to speak to the staff member who works on health care issues. Be prepared to leave a very short message as well as your name and address. You can also call your legislators in their home districts: information about local offices is available on the Academy's Members Only website at www.aap.org/moc

Fax: Most offices have fax machines, so you can call and ask for the fax number if you would like to fax your letter. Some offices do not give out their fax numbers, however.

E-mail: All of members of Congress now have e-mail addresses, but there is no set format for them. We suggest calling the member's office to get an accurate e-mail address or visit www.aap.org/moc the Members Only website of the American Academy of Pediatrics. 

HOW TO CONTACT THE PRESIDENT: 

Write:
The Honorable George W. Bush
The White House
1600 Pennsylvania Avenue
Washington, DC 20500

Call: 202-456-1414

Fax: 202-456-2461

Email: president@whitehouse.gov 

Myron Genel, MD, Chairman
Karen M. Hendricks, JD, Washington Coordinator

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