American Pediatric Society & Society for Pediatric Research

Public Policy Council

 February 2004 Legislative Report 

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Congress adjourned for the year on December 9, bringing to a close the first session of the 108^th Congress. In a long-sought victory for children, Congress approved and the president signed into law the pediatric rule legislation, ensuring that drugs and biologic products are tested for use in children. Despite adjournment, Congress failed to wrapped up seven of the required 13 spending bills for FY 2004, including the bill that funds the Department Health and Human Services. The seven spending bills were combined into a “catchall” $820 billion omnibus spending measure to expedite the process. While the House approved the FY 2004 spending bill before leaving for the year, the Senate did not take up the measure until January 22, two days after returning to Washington for the second session of the 108^th Congress.

The health community worked very hard to see the FY 2004 budget/appropriations process brought to a close.  The belt-tightening that has been the hallmark of recent funding cycles was especially challenging in 2004, and all indications are that FY 2005 promises more of the same.  Nevertheless, the health community is gearing up and girding itself for what appears will be a tough fight for adequate funding for health discretionary programs.  With 2004 a Congressional and Presidential election year, the Congressional calendar will be punctuated with many district “work periods” (allowing time for campaigning), as well as much partisan posturing.

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 in the year ahead. We encourage you to share this report with your colleagues. 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 as the second session of the 108^th Congress begins in January 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

• FY 2005 Budget

• Health Insurance Coverage and Access to Healthcare

• Immunizations

• Join the Federal Advocacy Action Network

• How To Contact Congress/White House

• 2004 Congressional Calendar

PEDIATRIC RESEARCH   

National Institute of Health (NIH)/Appropriations: Through its coalition work with the Ad Hoc Group for Medical Research Funding, the PPC has supported an adequate increase above FY 2003 funding ($26.98 billion) for the NIH in FY 2004. In addition, the PPC advocated for an increase in funding for the National Institute of Child Health and Human Development. NICHD is currently funded at $1.2 billion.  Despite the multiple efforts by Congressional supporters and the advocacy community to increase the funding for the NIH in FY 2004 to reach closer to $30 billion - the NIH advocacy community's original target - the final funding for the NIH in FY 2004 will be $27.8 billion. To continue the progress and research investment of the past five years, the PPC is continuing its advocacy efforts with the Ad Hoc Group and is recommending a 10% increase above FY 2004 in the FY 2005 budget debate. President Bush’s FY 2005 recommendation released on February 2 is a very modest 2.6% increase - $28.6 billion.

NIH Peer-Review Controversy: During consideration of the FY 2004 L/HHS/Education appropriations bill on the House floor an 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, such as heart disease or cancer. In anticipation of possible Senate consideration of a similar amendment, the Academy joined with over 145 others in the research community - including ACOG, AAFP, AAMC - in a sign-on letter supporting the NIH's merit review process. Fortunately, the Senate did not take up this amendment during its floor deliberations. However, this issue is far from over.  Following an October joint House/Senate hearing, NIH Director, Dr. Elias Zerhouni, has been asked to provide a response to several questions submitted by Congress on almost 150 grants that were deemed questionable by some members of Congress.

The several congressional committees are considering holding hearings on NIH in general and possibly this issue in particular during the second session of the 108^th Congress.  The pediatric academic societies joined the AAP in sending its own letter supporting the peer review process to Congress in December.  At the AMA interim meeting in early December, the House of Delegates approved a resolution supporting the NIH peer review process and recommended its support be conveyed to Congress.

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 the fall. Concern was expressed during this meeting that if adequate funding is not provided and the hiring of more staff does not occur the initial enrollment of children may be slowed down by three to six months. The NCS Director indicated that "we will need an estimated $26 million" in FY 2004 to enroll the first subjects by the end of 2005. However, the President's FY 2004 budget request included $12 million from the various funding agencies; it is unclear at this time what the FY 2005 budget request will be. The National Children's Study Assembly meeting, “the primary vehicle for sharing information among stakeholders,” was held in Atlanta, Georgia in mid-December 2003. Further information and updates are available at - http://www.nationalchildrensstudy.gov. 

During the May 2004 Pediatric Academic Societies’ Annual Meeting in San Francisco, the Public Policy Council (PPC) (APS/SPR/AMSPDC) and the Public Policy and Advocacy Committee of the Ambulatory Pediatric Association (APA) will sponsor a public policy plenary session that will focus on the National Children's Study. The session entitled The National Children's Study: "Framingham" for Children - Can We Pull It Off? will be held on May 2, 2004. 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. AAP and SPR member Elena Fuentes-Afflick, MD, MPH, will moderate the panel discussion.

Pediatric Research Loan Repayment: The NIH loan repayment program, including pediatric and clinic research, (http://www.lrp.nih.gov) is doing very well. According to information released from NIH in November  - NIH has awarded almost 1200 student loan repayment contracts totaling $63.3 million in FY 2003 under the 5 loan repayment programs (clinical research, pediatric research, health disparities, clinical research LRP for individuals from disadvantaged backgrounds and contraception and infertility research). This is a 65.6% increase over FY 2002 - 63.3% of those who applied received awards. More then 1/2 went to MDs, over 1/3 to PhDs, 8% MD/PhDs and 5% to persons with other doctoral degrees. There were 298 awards in FY 2003 for pediatric loan repayments in contrast to 168 in 2002.  NIH expects its FY 2004 funding for the program to be comparable to that of FY 2003 so it will award about the same amount in FY 2004.  It is very important that this program, that allows eligible researchers and trainees supported by governmental (including AHRQ) and private, nonprofit grants to apply to the NIH for loan repayment, continues to be well publicized and utilized by pediatricians to ensure ongoing funding for this critical program.

“Therapeutic Cloning”- President’s Council on Bioethics: President Bush's Council on Bioethics continues to meet regularly to discuss issues pertaining to the ethics and policies of genetic and reproductive technologies and the patentability of human organisms, stem cell research and biotechnology related issues. The Council has recommended a ban on human cloning to produce humans and a four-year moratorium on human cloning for medical research.  The Council has also recently discussed pediatric psychopharmacology, biotechnology, and public policy.  In October, the Council released its second report, entitled “Beyond Therapy: Biotechnology and the Pursuit of Happiness,” which takes a look at present and future biotechnology interventions that are aimed at self-improvement and the enhancement of the “genetic inheritance” of future offspring, rather than on restoring health or curing disease. The report details, among other issues, the Council’s objections to sex selection through genetic screening; warns against future use of PGD to create “designer babies”; and expresses concerns about the use of psychotropic medications in children. Additional information about the President's Council, including meeting transcripts and reports, is available online at www.bioethics.gov.

IOM Committee on Clinical Research Involving Children: The IOM has convened a Committee on Clinical Research Involving Children to review and consider federal regulations, federally prepared or supported reports, federally supported evidence-based research, and other sources of available information related to research involving children. The Committee is chaired by Richard Behrman, MD, FAAP, Executive Chair of the Pediatric Education Steering Committee of the Federation of Pediatric Organizations and includes several pediatricians, Drs. Russ Chesney, Francis Sessions Cole, III, Robert “Skip” Nelson, David Poplack, Bonnie Ramsey and Stephen Spielberg. A public hearing and meeting was held in the summer. Christine Gleason, MD, FAAP, representing the APA and APS/SPR, David Schonfeld, MD, FAAP, representing the AAP, and George Dover, MD representing AMSPDC were among those participating in this hearing.  The statements of all of these and the participants from the meeting are available at www.iom.edu/subpage.asp?id=13665.  The Committee will finish its work and report to Congress in March 2004.

Secretary’s Advisory Committee on Human Research Protections: The inaugural meeting of the Secretary’s Advisory Committee on Human Research Protections (formerly known as the National Research Protections Advisory Committee) was held in July.   SACHRP was chartered in October 2002 to advise the Secretary of the Department of Health and Human Services (HHS) on issues concerning research involving human subjects, with particular emphasis on special populations such as neonates and children, prisoners, and pregnant women, embryos, and fetuses. At its most recent meeting in December, SACHRP heard a report from its Subcommittee for Research Involving Children.  This subgroup, which includes several notable pediatricians, was formed to take the lead on addressing the Committee’s charge of creating a national review process for section 407 protocols (research not otherwise approvable under CFR 46.404-406, and which examines a serious problem affecting the health of children).  The Subgroup is considering the merits of a federal advisory committee (FAC)-level review process, versus a non-FAC open panel.   The Subgroup will continue to confer this spring before the next SACHRP meeting to finalize its recommendations for a model for 407 review.  Additional information, including its charter and the children’s subcommittee roster, can be found on the Committee’s website, at http://ohrp.osophs.dhhs.gov/sachrp/sachrp.htm.

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, supported increased funding for AHRQ -  $390 million - in FY 2004. AHRQ's FY 2003 funding was  $303.7 million, which included $55 million for research on reducing medical errors. President Bush's FY 2004 budget proposal recommended $279 million - a decrease of almost $25 million.  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.  However, the final omnibus-spending bill contained level funding of $303.7 million.  

Two important AHRQ reports were released in late December. The first report is on quality of health care and the second report is on health disparities in health care delivery as it relates to racial and socioeconomic factors in priority populations. The reports can be found online at http://www.qualitytools.ahrq.gov/.  Congress mandated both reports; they will be 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. Just over one year after this blow to children’s health, Congress passed legislation, The Pediatric Research Equity Act, restoring those protections requiring pharmaceutical companies to conduct pediatric drug studies of certain drugs if they are used in pediatric populations.  President Bush signed the bill into law  (P.L. 108 - 155) on December 3, 2003. 

The passage and subsequent signing of the Pediatric Research Equity Act into law was the culmination of many, many months of intense activity on both the legal and legislative front. As a result of this successful advocacy effort, children will no longer be therapeutic afterthoughts by the pharmaceutical industry.  Pediatricians and parents can now be assured that the medications they use in infants, children and adolescents will have safety and efficacy information and appropriate formulations for the pediatric populations in which they are used. 

Legal Proceedings: The American Academy of Pediatrics (AAP) and the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) filed a motion in late 2002 that asked for and was granted the ability for the two organizations to appeal the lower court ruling that struck down the 1998 Pediatric Rule.  The legal appeal proceeded forward throughout the entire congressional debate and proved to be a catalyst in prompting Congress to act swiftly on legislation to fully restore the requirements and protections of the Pediatric Rule. Congressional staff stated that the continuation of the lawsuit was one of several motivating factors in moving strong and unambiguous legislation through Congress. 

Once the President signed the Pediatric Research Equity Act into law there was no need to continue the court appeal and the AAP and EGPAF has filed a motion to dismiss the case.
  

PEDIATRIC WORKFORCE

Children’s Hospitals Graduate Medical Education (CHGME): Throughout the year the PPC collaborated 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 for the Children's Hospital Graduate Medical Education program (CHGME). The President's FY 2004 budget proposal contained only $199 million for CHGME. This is less then the FY 2003 funding level of $292 million. The final appropriation for CHGME is $303 million (this reflects the across the board cut of .59% from $305 million).

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. Fiscal Year 2003 funding for Titles VII and VIII (nursing) is $421.2 million. It appears that ongoing efforts by the pediatric community with other health professions groups proved helpful in not eliminating funding for the Title VII program. Funding from health professions and nursing education training under both Titles VII and VIII will be slightly increased in FY 2004 to $436.1 million, with the majority of the additional funding for nursing education. However, the funding for the primary care medicine and dentistry provision under Title VII that includes pediatrics was reduced by 11.5 percent from FY 2003 funding, to $81.7 million.

Reauthorization: The Title VII program was due to be reauthorized in 2002 but was not; nor was it taken up during the first session of the 108^th Congress.  Therefore, it will likely be taken up sometime in 2004. 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

Congress began the FY 2004 budget and appropriations process in early spring, passing the FY 2004 budget in record time and proceeding to debate the 13 appropriations bills. The House completed 11of the 13 bills comprising the total federal government-spending package by the time they adjourned for its summer recess, although the Senate worked at a slightly slower pace. Throughout this period of time the PPC worked diligently to ensure that public health discretionary programs, such as children's hospital GME, health professions, health services and biomedical research, immunizations and EMSC to name a few, received at least modest inflationary increases or at a minimum were maintained at current level (FY 2003) funding. However, although the new Fiscal Year - 2004 - officially began on October 1, 2003, it essentially was postponed because Congress was not able to complete its work on seven of the 13 freestanding appropriations bills, resulting in the signing of a sixth short-term funding bill - Continuing Resolution (CR). The CR kept the federal government running and funded at FY 2003 levels through January 31, 2004.  The seven remaining bills, including Labor/Health and Human Services/Education, were bundled into an omnibus (“catch-all”) spending bill.  The omnibus spending bill includes a .59 percent across-the-board cut to provide funding for certain congressional and White House priorities including additional funding for veterans medical care. The House of Representatives voted to approve the $820 billion package before it adjourned for the year. The Senate approved the final measure on January 22 by a vote of 65-28. The president signed the bill, P.L. 108-199, the same day.
 

FY 2005 BUDGET

With record deficits in FY 2003 and an estimated $400+ billion in FY 2004, there appears to be difficult fiscal year ahead in FY 2005 – in fact, possibly until 2011, since there are no surpluses projected until that year. Meetings recently held with the staff of the White House Office of Management and Budget (OMB) to discuss key public health discretionary programs concluded with the simple message – “there's no extra money”, and key priorities remain defense/homeland security. The President released his FY 2005 budget proposal on February 2, 2004, thus starting the official budget and appropriations process for the coming fiscal year scheduled to begin on October 1, 2004.
 

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 107^th Congress. The pediatric community supports this legislation that 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. At the end of 2003, the MediKids legislation has 7 Senate cosponsors and 51 House cosponsors.

Genetic Information Nondiscrimination Act Of 2003: In May, Sen. Olympia Snowe (R-ME) introduced the “Genetic Information Nondiscrimination Act of 2003” (S.1053).  This legislation would prohibit health discrimination on the basis of genetic information or services.  The bill prevents employers and health insurers from discriminating against a person based on their predisposition to a disease.  Specifically, the bill would bar employers from using individuals’ genetic information when making a hiring, firing, job placement, or promotion decision, and it would bar health insurers from underwriting based on genetic information.  The bill would also establish privacy protections for genetic information.

Following a 10-year effort, in October, the Senate unanimously passed the bill, and urged the House to move quickly to get its version of the bill to the floor. This is the first genetic discrimination bill to pass. A House bill introduced in May by Reps. Louise Slaughter (D-NY) and Bob Ney (R-OH), the Genetic Nondiscrimination in Health Insurance and Employment Act (HR 1910), currently has 221 cosponsors. The legislation will need to be considered by both the House Education and Workforce and the Energy and Commerce Committees before it can be considered by the full House. At the moment, the future of the bill in the House remains uncertain. The Bush Administration has announced its support for enactment of the Senate bill.
 

IMMUNIZATIONS

Federal Legislation: Sen. Bill Frist (R-TN) introduced the Improved Vaccine Affordability and Availability Act, S.754, early in the 108^th Congress. Briefly summarized, under S.754 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. It would extend the statute of limitations from three to six years for families of children injured by required vaccines to file claims under VICP, and also would increase the amount of compensation that families can receive for children's pain and suffering from $250,000 to $350,000. In addition, the legislation would allow parents to receive compensation for their own pain and suffering.

Mark-up on this bill has been postponed numerous times.  Although at the time of this writing it remains unclear when it will be considered in the second session of the 108^th Congress, it is hoped that it will be early in the congressional session. 

Vaccine Programs/Appropriations: The PPC joined with other child and adolescent health care advocates in supporting at least $700 million in FY 2004 for section 317, CDC’s National Immunization Program (NIP). The FY 2003 appropriation was $650 million. The President’s original FY 2004 budget proposal provided $511 million, which reflects a reduction in funding pursuant to a proposed legislative recommendation that would transfer some funding for vaccine purchase and delivery to the Vaccines for Children (VFC) entitlement program. The initial FY 2004 House and Senate appropriations bills provided $650.5 million and $655.6 million, respectively. Initiated by Senators Jack Reed (D-RI), Richard Durbin (D-IL), Jim Jeffords (I-VT) and Gordon Smith (R - OR), the PPC joined the Academy in advocacy efforts to attempt to increase the funding for section 317 during the House/Senate conference process on the FY 2004 Labor/HHS/Education bill.  However, these efforts were not successful in the final appropriations agreement, where final funding was $643.6 million. This also reflects the transfer of $7.3 million to support the National Vaccine Program Office that moved from the CDC in Atlanta to Washington, DC.

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 Rosenkranz (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