National Institute of Health (NIH)/Appropriations: Congress approved the FY 2002 Labor, Health and Human Services, and Education (L/HHS) appropriations bill on December 20^th, clearing the way for the President’s signature.  The bill provided $23.285 billion for NIH, a $2.9 billion increase over FY 2001. Of that amount, $1.113 billion is provided for the National Institute of Child Health and Human Development (NICHD).

Pediatric Research Initiative: The conference report for the FY 2002 L/HHS appropriations bill concurs with Senate-passed language in support of the Pediatric Research Initiative, authorized by the Children’s Health Act of 2000, P.L. 106-310 (H.R. 4365).  This legislation, signed into law last year, authorizes the NIH Director to establish a Pediatric Research Initiative to “conduct and support research that is directly related to diseases, disorders, and other conditions in children.”  It also provides for increased training grants for pediatric training, additional career development awards for health professionals intending to build careers in pediatric basic and clinical research, and a pediatric research loan repayment program of up to $35,000 per year for qualified health professionals who “agree to conduct pediatric research.”

The Senate-passed language includes specific language supporting funding for the pediatric research loan repayment program in FY 2002, “particularly in the areas of Duchenne muscular dystrophy and fragile X.”  The language also instructs NIH to provide a status report on the Initiative by April 2002.

Agency for Healthcare Research and Quality (AHRQ)/Appropriations: Congress provided $299 million for AHRQ in FY 2002, a $29 million increase over FY 2001.  However, early reports on the President’s FY 2003 budget proposal indicate that AHRQ may face both A significant decrease in funding and possible reorganization in the coming year. Staff will continue to monitor the issue closely in the weeks ahead.

Reauthorization of the Pediatric Studies Provision in the Food and Drug Administration Modernization Act (FDAMA)

Congress approved the Best Pharmaceuticals for Children Act in mid-December, after several procedural delays had slowed the bill’s progress in the Senate. The president is expected to the sign the bill into law. As passed, the bill would, among other things: extend the FDA pediatric studies provision through October 1, 2007; establish an Office of Pediatric Therapeutics within the FDA; designate pediatric drugs as "priority supplements" which triggers a goal of 6 months for the FDA to review pediatric labeling supplements submitted by the company; and establish a timeline for achieving labeling changes within 11 months for those drugs that may not be labeled within 6 months.  It also would require the FDA to make public a summary of the medical and clinical pharmacology reviews of the pediatric studies within 6 months after a drug, and require an IOM study of federal regulations involving children in research.  This legislation was approved only after intensive advocacy by the pediatric community, including the PPC, the National Association of Children’s Hospitals, Academy and the Pediatric AIDS Foundation.

Health Insurance Portability and Accountability Act

Congress passed legislation in mid-December that would extend the deadline for compliance with the electronically transmittal requirements of the Health Insurance Portability and Accountability Act (HIPAA).  Specifically, the legislation would give health care providers, payers and clearinghouses until October 16,2003, to comply with the regulation if they submit a plan to the Department of Health and Human Services that details how their organization will come into compliance. The legislation also would appropriate $44 million to the Department of Health and Human Services to provide technical assistance, education and outreach and enforcement activities related to the regulation. Covered entities must reconfigure computer systems to accept the standard transactions, which set uniform formats for exchanging data to perform administrative transactions, including eligibility requests, enrollment in a health plan, and health care payment and remittance.

Pediatric Workforce

GME Financing in Children’s Hospitals/Appropriations: Congress provided $285 million for Children’s Hospitals GME in FY 2002, the fully authorized amount and a $50 million increase over FY 2001.  This funding increase followed significant advocacy work by the PPC with the National Association of Children’s Hospitals and the American Academy of Pediatrics.  Continued vigilance will be needed to ensure that children’s hospitals GME is maintained in FY 2003 and beyond.

Titles VII and VIII-Health Professions Training Grants/Appropriations: While the President requested only $140 million for the Titles VII and VIII health professions training and education programs in FY 2002 – a 60 percent decrease from FY 2001 – Congress rejected this cut and provided $378 million for the programs as part of the FY 2002 L/HHS appropriations bill.  This amount includes $93 million for primary care programs such as pediatrics and internal medicine.  It is expected that the FY 2003 Bush budget proposal will again propose significant cuts for the Titles VII and VIII program in FY 2003.

FY 2002 Budget/Appropriations

Appropriations:  The FY 2002 L/HHS appropriations bill was approved in late December, more than two months after the new fiscal year began.  Despite the delay, the final bill included funding increases for some programs of interest to the pediatric community, including:

• $23.3 billion for the National Institutes of Health, including $1.113 billion for the National Institute for Child Health and Human Development;

• $299 million for the Agency for Healthcare Quality and Research;

• $285 million for Children’s Hospitals Graduate Medical Education, the fully authorized amount;

• $378 million for the Titles VII and VIII health professions training and education , including $93 million for primary care programs such as pediatrics and dentistry; $1.190 billion for the Ryan White program, including $71 million for Ryan White pediatric demonstrations; and

• $732 million for Title V, the Maternal and Child Health Block Grant.

Funding for these and other programs may be tenuous in FY 2003 if as expected the recession continues and additional funds diverted to bioterrorism and defense. Emergency and supplemental appropriations related to the terrorist attacks of September 11^th have significantly drained federal coffers, and less-robust economic forecasts will likely limit congressional spending.  President Bush is expected to release his FY 2003 budget in early February. Staff will continue efforts to ensure that all pediatric programs receive adequate funds in the new year.

Terrorism

The PPC-supported Bioterrorism Preparedness Act of 2001 (S. 1765) was passed by the Senate on December 20, 2001.  The bill, introduced by Senators Bill Frist (R-TN) and Edward Kennedy (D-MA), would, among other things: establish a National Task Force on Children and Terrorism; ensure that the National Pharmaceutical Stockpile meets the needs of children; provide funding for pediatric education and training of providers; require state preparedness plans address the needs of children; allow children’s hospitals to be designated as bioterrorism response medical centers; and ensure that all countermeasures research and develop consider children’s needs.  While the House-passed bioterrorism bill, H.R. 3488, does contain several children-specific provisions, it is less comprehensive than S. 1765.  House-Senate conferees are expected to meet early in the new-year to reconcile their bills before final passage.

In a related matter, the American Academy of Pediatrics has established a Task Force on Terrorism to serve as an advisory body to the Academy’s board of directors on issues related to terrorism and other disasters.  The Task Force’s mission includes: (1) assuring that the Academy is providing timely medical information to its members and the public; (2) defining gaps in knowledge and services in order to advocate for appropriate research; (3) serving in a leadership/advisory role on child-specific needs to the AAP and various governmental bodies; (4) assisting AAP Chapters in playing appropriately similar roles at the state and community levels; and (5) facilitating the organization of a broad coalition of interested groups to make sure children’s needs are adequately addressed in national, state and local disaster/public health plans.  The Task Force is comprised of: Joseph Hagan, Jr., MD, Chairperson; Marion J. Balsam, MD; Richard Gorman, MD; Julia Lynch, MD; Julia McMillan, MD; Karen Olness, MD; Gary Peck, MD; Irwin Redlener, MD; David Schonfeld, MD; and Michael Shannon, MD.  Academy President Louis Z. Cooper, MD, and Academy President-elect Stephen Edwards, MD, also serve on the Task Force as ex officio Members. 

Immunizations

Vaccine Programs/Appropriations: The FY 2002 L/HHS appropriations bill included $628 million for CDC’s childhood immunizations programs (section 317 program).  This represents a $76 million increase over FY 2001, and $53 million more than the President’s budget request. Staff has already begun efforts to ensure that childhood immunizations programs receive adequate funds in FY 2003.

Vaccine Safety/Congressional Hearing: House Government Reform Committee Chairman Dan Burton (R-IN) held additional hearings on vaccine safety in November and December, entitled “The National Vaccine Injury Compensation Program: Is It Working As Congress Intended?”  Hearing witnesses included three parents who claim their children were injured by childhood vaccines, as well as Thomas Balbier, Director, Vaccine Injury Compensation Program, Department of Health and Human Services, and Paul Harris, Deputy Assistant Attorney General, Civil Division, Department of Justice.  Chairman Burton is expected to hold additional hearings on vaccine safety and vaccine injury compensation next year. 

2002 PAS Annual Meeting

Sunday, May 5^th - Public Policy Plenary Session: Planning is well underway for the 2002 PAS Annual Meeting, to be held in Baltimore, Maryland on May 3-6, 2002. The session, jointly sponsored with the Ambulatory Pediatric Association, is tentatively entitled Children as Research Subjects: Ethical and Regulatory Issues. This session will include an interactive panel presentation by Alan Fleischman, MD, Senior Vice President of the New York Academy of Medicine and member of the National Human Research Protections Advisory Committee, Eric Meslin, Ph.D., Director of the Indiana University Center for Bioethics, P.Pearl O’Rourke, MD, Director, Human Research Affairs, Partners HealthCare Systems, Inc. and Sara Rosenbaum, JD, George Washington University . Public Policy Council Chairman Myron Genel, MD, Professor of Pediatrics and Associate Dean of Governmental and Community Affairs at the Yale University School of Medicine will moderate this informative and certain to be lively session.  During the two-hour event, audience members will be encouraged to participate in an expanded question-and-answer session.

Monday, May 6^th  - Breakfast Legislative Symposium at 7:00 a.m.: David Korn, MD, Senior Vice President for Biomedical and Health Sciences Research at the Association of American Medical Colleges, will be the featured guest at the 2002 Legislative Breakfast.  Dr. Korn will discuss the impact of U.S. Department of Health and Human Services’ new privacy regulations on medical research and research institutions.

How To Contact Your Member of Congress:

The winter adjournment provides a good opportunity for members of the American Pediatric Society, Society for Pediatric Research and the Association of Medical School Pediatric Department Chairs to contact their legislators in their home districts. Because 2002 is an election year – all 435 members of the House of Representatives and 1/3 of the Senate are up for re-election -  the second session of the 107^th Congress will be fairly compact with regular recess/district work periods.

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 

Additional information and resource material on these and other pediatric and child
health issues are available from:

Myron Genel, MD, Chairman
Karen M. Hendricks, JD, Washington Coordinator
Molly A. Hicks, MPA, Legislative Assistant

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