American Pediatric Society & Society for Pediatric Research

Public Policy Council

 October/November 2003 Legislative Report 

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Congress is nearing the end of the first session of the 108th Congress, and despite a full and ambitious agenda this year, much remains to be done.  Congress was set to adjourn for the year on October 3, a deadline that they clearly missed.  Both the House and Senate continue to be consumed by issues surrounding homeland security and the economy.  The ongoing struggles in Iraq and the Middle East, bioterrorism preparedness, a record deficit, and all the bipartisan rancor that comes with the approaching Presidential primaries and party caucuses: these are only some of the factors contributing to the air of tension and urgency on the Hill this fall.

Most pressing, as is usually the case in recent years, is an appropriations process that remains unfinished after the 2003 fiscal year came to a close on September 30.  (The government is currently being funded until October 31 at FY 2003 levels by the first of possibly several Continuing Resolutions.)  The House and Senate have both passed their respective FY 2004 Labor/HHS/Education appropriations bills, and are now looking towards a conference to reconcile differences.  However, at the time of this writing, only three (Defense, Homeland Security, and Legislative Branch) of the 13 required spending bills have been signed the President, and the pressure is building to complete the others as soon as possible or package all of the remaining spending bills into a mega omnibus spending bill.   As mentioned in previous Legislative Reports, funding for health programs remains extremely tight.  Nevertheless, the health community continues to work hard for - at the least - comparable funding levels to FY 2003 for some programs significantly cut.  Additionally, the pediatric community continues to work with key House members to see that a hard-fought victory is realized for the Pediatric Rule legislation in this Congress. 

The following is an update and summary of recent federal legislative and regulatory activities of interest to the pediatric academic community that will assist you in your advocacy. Members of the American Pediatric Society, Society for Pediatric Research and the Association of Medical School Pediatric Department Chairs are urged to reach out to their Members of Congress during the remaining weeks of this session of Congress to advocate for key health and pediatric-specific issues.  This report includes information on the following issues:

• Pediatric Research

• Pediatric Rule

• Pediatric Workforce

• FY 2004 Appropriations

• Health Insurance Coverage and Access to Healthcare

• Immunizations

• Join the Federal Advocacy Action Network

• How To Contact Congress/White House

• 2003 Congressional Calendar

PEDIATRIC RESEARCH   

National Institute of Health (NIH)/Appropriations: Through its work with the Ad Hoc Group for Medical Research Funding, the PPC continues to support an adequate increase above current year funding for the NIH in FY 2004. 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. In addition, the PPC continues to advocate for an increase in funding for the National Institute of Child Health and Human Development (NICHD) to $1.3 billion in FY 2004. NICHD is currently funded at $1.2 billion.

After essentially completing the five-year doubling of the NIH budget, the President's FY 2004 budget proposal contained a very modest 2% increase—$27.7 billion—for NIH. The House of Representatives passed bill provided $27.6 billion in its FY 2004 L/HHS/Education bill; the Senate provided $27.9 billion.  Members of the House and Senate Labor/HHS/Education Appropriations subcommittees are trying to reconcile the differences between the two bills. There are several efforts underway both by congressional supporters and the NIH advocacy community to increase the funding for the NIH this year to closer to $30 billion.

ACTION NEEDED: Urge your Senators and Representatives, especially those on the Labor/HHS Appropriations subcommittees, to support efforts to increase funding for NIH in the FY 2004 L/HHS/Education bill to sustain the Institutes' crucial research. 

National Children's Study: The National Children's Study (NCS)—a national longitudinal study of environmental effects (including physical, chemical, biological and psychosocial) on the health and development of more than 100,000 children across the United States—is currently still in the planning phase. The pediatric community continues to be very involved in this important study. The Study's Advisory Committee, which includes several pediatricians, met again in September. Concern was expressed during this meeting that if adequate funding is not provided and hiring of staff does not occur the initial enrollment of children may be slowed down by three to six months.  NCS Director Peter Scheidt, MD said that "we will need an estimated $26 million" in FY 2004 to enroll the first subjects by the end of 2005, but the President's budget request includes only $12 million from the various funding agencies. The National Children's Study Assembly meeting, "the primary vehicle for sharing information among stakeholders," will take place in Atlanta, Georgia on December 17. Further information and updates are available at http://www.nationalchildrensstudy.gov. 

The Public Policy Council (APS/SPR/AMSPDC) and the Public Policy and Advocacy Committee of the APA's 2004 PAS public policy plenary session will focus on the National Children's Study. Duane Alexander, MD, Director of the NICHD at the National Institutes of Health, Peter Scheidt, MD, Director of the Study, and Michael Weitzman, MD, Executive Director of the Center for Child Health Research, have agreed to participate in the panel discussion. Elena Fuentes-Afflick, MD, MPH, the SPR representative of the PPC, will moderate the panel discussion.

Pediatric Research Loan Repayment: Last year the NIH released its new loan repayment program for pediatric and clinical researchers (http://www.lrp.nih.gov), which allows for eligible researchers and trainees supported by governmental (including AHRQ) and private, nonprofit grants to apply to NIH for loan repayment. Applications for extramural NIH loan repayment for FY 2004 opened September 1, 2003, and will close December 31, 2003.  Eligibility criteria and other program information are listed on the NIH website at www.LRP.nih.gov.

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

FY 2002 Pediatric Research Initiative Report to Congress: In late July, the NIH released its annual report to Congress and the public on the FY 2002 Pediatric Research Initiative.  This report, mandated by the Children's Health Act (PL 106-310), outlines the total funds the NIH has obligated to pediatric research and shows the new NIH funding opportunities in FY 2002 that increased support for pediatric biomedical research and training. On September 4, the Senate approved a non-binding sense of the Senate resolution offered by Senator Mike DeWine (R-OH) during floor debate on the FY 2004 L/HHS/Education bill to continue to support and encourage ongoing pediatric research at the NIH.  The resolution is virtually identical to a bill Sen. DeWine introduced the previous day, S. 1579, directing the NIH director to continue the Pediatric Research Initiative and emphasize the importance of pediatric research, particularly translational research. 

Agency for Healthcare Research and Quality (AHRQ)/Appropriations: Throughout the appropriations process the PPC, as part of a broad-based coalition, the Friends of AHRQ, has supported increased funding for AHRQ—$390 million—in FY 2004. AHRQ's current funding is  $303.7 million including $55 million for research on reducing medical errors. President Bush's FY 2004 budget proposal recommended $279 million—a decrease of almost $25 million.  Both the House and Senate bills contain level funding—$303.7 million—for FY 2004. In September, the PPC joined 50 other national organizations in a letter to the House-Senate conferees of the FY 2004 Labor/HHS/Education bill to request an additional $10 million in funding for AHRQ ongoing health services research to offset some of the proposed funding earmarks for the agency.

Two important AHRQ reports are pending release—a report on quality of health care and a report on health disparities in health care delivery as it relates to racial factors and socioeconomic factors in priority populations. Both reports were mandated by Congress and are to be available in this fiscal year and the updated in subsequent years.
 

PEDIATRIC RULE

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 2002, 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 decided not to appeal, stating that congressional action is the surest and swiftest way to ensure that the Pediatric Rule is restored.

On September 26th the U.S. Department of Justice filed an amicus brief on behalf of the U.S. Government to the appeals case of the Pediatric Rule.  Unfortunately, for reasons that supercede the pediatric rule case, the government stated that they believe the appeal brought by the AAP/EGPAF should be dismissed.  While this is not a welcome event and complicates the AAP/EGPAF arguments, it does not damage the AAP/EGPAF appeal.

The lawyer representing AAP/EGPAF in its appeal indicated that at times, the Justice Department/U.S. Government has challenged a private party's efforts to continue litigation that the government had decided not to appeal.  The circumstance of this amicus brief is more a broader government-wide interest in contrast to one directly related to the continuation of the pediatric rule regulation. The Government stated in its brief:

"The standing question posed here is of substantial concern to the United States. When, after consulting closely with the government agencies involved, the Solicitor General exercises the power of the Executive to end litigation over a discretionary regulatory policy and instead pursue legislative means as the proper way to achieve the Government's goals, a private party does not have standing to use the courts to override that policy determination."

The AAP and EGPAF are preparing appellate briefs due in October, with follow-up response briefs due in the fall and oral arguments before the U.S. Court of Appeals scheduled for January 22, 2004. 

Legislation to Codify the Pediatric Rule: In the 108th Congress reinstating the Pediatric Rule remains a top priority for the pediatric academic societies working under the leadership of and in partnership with the AAP. 

In March, Senators Judd Gregg (Chair of the Senate Health, Education, Labor and Pensions Committee (HELP)), Edward Kennedy (D-MA), Mike DeWine (R-OH), Christopher Dodd (D-CT), and Hillary Clinton (D-NY) introduced and reported out S. 650, the Pediatric Research Equity Act of 2003. The pediatric community, including APS, SPR, AMSPDC, endorsed the legislation.

On July 23, 2003, in a win for children's therapeutics, the Senate passed S. 650 by unanimous consent, as amended.  In a manager's amendment offered on the floor by Senator Gregg, the two outstanding issues—enforcement and effective date—were appropriately fixed, although a sunset provision remains.

On July 25, Representatives Jim Greenwood (R-PA), Anna Eshoo (D-CA) and Deborah Pryce (R-OH) introduced H.R. 2857, the Pediatric Research Equity Act of 2003, the House bill identical to the Senate-passed bill.  The pediatric community is working aggressively to see that the House Energy and Commerce Committee consider this legislation and then bring the bill to the House floor before Congress adjourns for the year later this fall.

ACTION NEEDED: Urge your Representative to support H.R. 2857, the Pediatric Research Equity Act. This legislation is identical to the Senate-passed bill, S. 650. While the pediatric community, including the PPC, does not support the provision in the bill that time-limits the authority of the FDA to require pediatric testing, we join with the AAP in believing that the Pediatric Research Equity Act is strong legislation that at long last establishes in law the right of children to the same kind of drug safety and efficacy information that was previously available only to adults.
 

PEDIATRIC WORKFORCE

Children's Hospitals Graduate Medical Education (CHGME): The President's FY 2004 budget contained only $199 million for CHGME. The pediatric academic community is continuing its efforts with the National Association of Children's Hospitals (NACH) to vigorously advocate for adequate and sustained funding—$305 million ($292 million plus an adjustment for inflation)—in FY 2004. The House-passed L/HHS/Ed bill contained $305 million for CHGME in FY 04; the Senate spending bill provides less, at $290 million. During the Senate floor debate, Senator Arlen Specter (R-PA), chairman of the L/HHS appropriations subcommittee, pledged in a colloquy with Senator Tom Harkin (D-IA) to "do all that I can to see to it that the GME program is funded at the highest level possible in conference." 

Titles VII and VIII-Health Professions Training Grants/Appropriations: As in FY 2003, the President's FY 2004 budget removed all funding for primary care, interdisciplinary community projects, training for diversity, and public health. The president proposed only $11 million for the Title VII program, although it does address the nursing shortage through a modest increase for Title VIII. Current funding for Titles VII and VIII is $421.2 million. The House of Representatives-approved FY 2004 Labor/HHS/Education bill provides $391 million for the program—a 7.1 percent cut below last year. The Senate-approved bill provides only $133 million for both Title VII and VIII in FY 2004. Of this, $113 million is designated for the Title VIII nursing programs (level with the FY 2003 level), leaving just $20 million for all of the Title VII health professions programs. Of this $20 million, $9.9 million is specified for the Scholarships for Disadvantaged Students and $5.5 million to expand the pediatric dentistry program, leaving only $5 million for ALL of Title VII health professions programs. For all intents and purposes, the majority of Title VII programs, including the General Internal Medicine/General Pediatrics cluster, have been essentially eliminated by the Senate, a devastating cut. 

However, during the debate on the Senate floor, Majority Leader Bill Frist (R-TN) engaged in a colloquy (conversation on the Senate floor) with Senators Specter (R-PA), Harkin (D-IA) and Jack Reed (D-RI), pledging to "fully restore funds for the four diversity programs and, at a minimum, bring funding for the other programs to the House level" in Conference.  Efforts are currently underway to urge the House and Senate Labor/HHS/Education appropriations conferees to fully restore funding to the Title VII health professions programs to at least last year's level of $308 million.

ACTION NEEED: Urge your Senators/Representative to restore and support adequate funding for health professions training programs of at least the House-passed funding level of $391 million, and $40 million for general internal medicine/general pediatrics.  Describe specific examples of its importance in faculty development and to training/educating more pediatricians in a variety of ambulatory/community based settings.

Reauthorization: The Title VII program was due to be reauthorized in 2002 but was not; therefore, it will likely be taken up in the second session of the 108th Congress. This process, if past years are any example, may well take quite some time. The pediatric community is continuing its conversations with colleagues in the internal medicine community. 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. (Contact kbutterfield@aap.org) 
 

FY 2004 APPROPRIATIONS

Meeting a timeline that hasn't been met in several years, Congress began the FY 2004 appropriations process in earnest in late spring. The House completing 11of the 13 bills comprising the total federal government spending package by July's end although the Senate worked at a slightly slower pace.

In late June, the House and Senate Appropriations Committees adopted the Labor–HHS–Education bill. The House and Senate versions of the spending package are not dissimilar. For example, the Centers for Disease Control and Prevention would receive $4.55 billion in the House bill and $4.4 billion in the Senate. Ryan White AIDS funding would be set at $2 billion under both bills. The National Institutes of Health is slated to receive $27.6 billion in the House measure and $27.9 billion in the Senate's measure. Children's Hospital GME is set at $305 million in the House, $290 million in the Senate. On a party line vote on the floor, the House approved the measure in late July.

The Senate, by a vote of 94 - 0, passed its version of the FY 2004 appropriations bill following seven days of often contentious debate in mid-September. Most amendments offered to boost funding for programs the PPC cares about were rejected. At the time of this writing, the House and Senate must reconcile their two different versions of the bill and bring it back to the floor for final passage before sending it to the president for his signature. President Bush has already indicated his possible veto of the measure due to a labor provision on overtime pay that the administration has objections. The new fiscal year—2004— was to begin on October 1, 2003, but essentially has been postponed with the signing of the first of what could be several short-term funding bills - Continuing Resolutions (CRs). This will keep the government running and funded at FY 2003 levels through October 31.

During consideration of the FY 2004 L/HHS/Education appropriations bill on the House floor, a troubling amendment offered by Rep. Pat Toomey (R-PA) to prohibit the NIH from funding five specific research grants was narrowly defeated, 210-212.  The amendment challenged the peer review process at the NIH and required that funding for these grants, including three of the five that were sexual health-related research grants, be redirected toward other research. In anticipation, of possible Senate consideration of a similar amendment the PPC joined with over 145 others in the research community in joining a sign-on letter supporting the NIH's merit review process. The Senate did not take up this amendment during its floor deliberations. However, this issue does not seem to be over; at an October congressional hearing, Dr. Elias Zerhoni, the Director of the NIH was asked repeatedly about these particular grants.

ACTION NEEDED: Urge your Senators and Representatives to support the highest level of funding for maternal and child health programs important to your community, including biomedical and health services research, independent children's hospital, mental health, health professions training, programs addressing infectious diseases, e.g., West Nile, SARs, TB, HIV/AIDS, and substance abuse prevention and treatment programs.  
 

HEALTH INSURANCE COVERAGE AND ACCESS TO CARE

MediKids: In March, Representative Pete Stark (D-CA) and Senator John Rockefeller (D-WV) reintroduced the MediKids legislation (H.R. 1205/S. 588), legislation first introduced in the 107th Congress. The pediatric community supports this legislation, which would create a unified health care system that would achieve the goal of health insurance for all children regardless of family income. MediKids would make coverage automatic and promote equity, family responsibility, choice, and uniform benefits. The MediKids legislation currently has 7 Senate cosponsors and 47 House cosponsors.
 

IMMUNIZATIONS

Federal Legislation: Several legislative proposals have been introduced to address the Vaccine Injury Compensation Program (VICP). In April, Sen. Bill Frist (R-TN) introduced the Improved Vaccine Affordability and Availability Act  (S.754)—similar to a bill introduced last year by Sen. Frist with additional modifications recommended by the Academy and the Advisory Commission on Childhood Vaccines (ACCV).  Mark-up on this important legislation has been postponed numerous times, and it remains unclear when it will be considered. 

Also, this year, Senators DeWine (R-OH), Clinton (D-NY), and Reed (D-RI) introduced S. 371, the Childhood Vaccine Supply Act. Echoing the recommendations of the General Accounting Office's September 2002 report, S. 371, requires a national six-month stockpile for routine childhood vaccines, and requires manufacturers to give one-year's advance notice when they intend to stop producing a vaccine, enabling the CDC and FDA to better monitor the supply stream of vaccines coming into the market, and allows them more time to prepare for potential shortfalls.

ACTION NEEDED: Urge your senators to support and pass S.754 to strengthen the vitally important Vaccine Injury Compensation Program and S. 371 to ensure an adequate supply of childhood vaccines.

IOM Vaccine Financing Report: In August, the Institute of Medicine released a report Financing Vaccines in the 21st Century: Assuring Access and Availability.  The report proposes a new vaccine-financing program involving a federal vaccine insurance mandate, subsidy, and voucher plan. The mandate would require all insurance plans to include vaccine benefits, and the federal government would subsidize health plans and providers for the purchase costs and administration fees created by the vaccine mandate.

The report is available on the IOM website, at http://www.iom.edu/report.asp?id=14451.
 

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.

If you are already a member of FAAN, thank you!  If you are interested in joining FAAN and have questions, please contact Taryn Houghton (thoughton@aap.org) in the AAP Department of Federal Affairs at 800/336-5475.  Together we can make a real difference for children and pediatricians!  
 

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