American Pediatric Society & Society for Pediatric Research

Public Policy Council

 May 2005 Legislative Report 

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The first session of the 109th Congress is well underway, and partisan battles seem to be dominating the tenor of legislative business.  From ethics troubles to parliamentary challenges and beyond, the magnitude of political wrangling and partisan bickering has reached a fever pitch.  Among the biggest issues Members of Congress have gone toe-to-toe on is the annual budget process, as legislators reached closure on the spending blueprint for FY 2006.  The outlook for funding of public health discretionary programs is especially bleak for this year and mandatory programs such as Medicaid are extremely vulnerable. 

Because of the atmosphere on Capitol Hill and the many children's health issues at stake, everyone is urged to continue to make your views heard throughout the upcoming months. In particular, if you are planning to be in town for the PAS annual meeting in May, please take the time to make appointments with your legislators to communicate your views on protecting critical programs such as human embryonic stem cell research, Medicaid, NIH funding, children's hospital GME, Title VII Health Professions, and others. 

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 weeks and months ahead. We encourage you to share this information 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 to advocate for key health and pediatric-specific issues. 

This report includes information on the following issues:

• Pediatric Research

• Pediatric Medical Devices

• Pediatric Workforce

• FY 2006 Budget

• Health Insurance Coverage and Access to Healthcare

• Emergency Medical Services for Children

• Immunizations

• 2005 PAS Annual Meeting

• Join the Federal Advocacy Action Network

• How To Contact Congress/White House

• Congressional Calendar

PEDIATRIC RESEARCH   

National Institute of Health (NIH)/Appropriations: Through its advocacy with and leadership in the Ad Hoc Group for Medical Research Funding, the PPC has supported a sustained and an adequate increase in funding for the NIH. The Ad Hoc Group has one mission: to enhance the federal investment in biomedical, behavioral, and population-based research by increasing the funding for the NIH. The President's FY 2006 budget proposal, released on February 7, contains a very small increase for the NIH of $196 million (0.7%) - $2.8.845 billion. During the FY 2006 budget debate an amendment offered by Senator Arlen Specter (R-PA) to add $1.5 billion to function 550 (Health) for the NIH and added $500 million for function 500 for education was adopted. However, in the final version of the FY 2006 concurrent budget resolution, passed on April 28, this amendment was not included. Through its work with the Ad Hoc Group for Medical Research Funding, the PPC will seek a FY 2006 NIH budget of at least $30 billion, a 6 percent increase over FY 2005. We will also support an adequate funding level for the NICHD of $1.35 billion.

NIH Reauthorization: There has been a good deal of discussion in the last year about the reauthorization of the NIH in this 109th Congress. The last time the NIH was reauthorized was 1993. The new chair of the House Energy and Commerce Committee, Rep. Joe Barton (R-TX) has indicated his interest in reauthorizing the NIH sometime this year. With allegations that the NIH has significantly grown over the years (both in size and in funding) and with that growth perhaps it's structure may need to be reformed or streamlined. At this time it is unclear if Congress will seriously address these concerns this year. However, there are also several areas of concern - such as stem cell research, fetal tissue research, and conflict of interest issues, as well as some of the allegedly "controversial" behavioral research grants that may make this process too contentious to reach closure.

National Children's Study (NCS): The pediatric community continues to be involved with and participate in various aspects of this important national longitudinal study.  The professional judgment of those involved with the study has indicated that the study needed $27 million in FY 2005 to begin collecting data and enrolling participants in 2006. However, the final FY 2005 budget did not include this amount for the NCS. The PPC is working with other advocates, such as the March of Dimes, to secure adequate funding for the study, which has been estimated as needing at least $70 million in FY 2006, assuming the initial sites have started to enroll subjects. It is estimated that the total cost of the NCS over 25 years will be between $2 - $3 billion. The FY 2005 omnibus appropriations bill included language that commended NICHD for its leadership on the National Children's Study and requested that the NICHD provide Congress by March 2005 a projection of total and annual costs of the study. Further information and updates are available at - http://www.nationalchildrensstudy.gov.

Pediatric Research Loan Repayment: The NIH loan repayment program, including pediatric and clinical research, continues to be successful. 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.  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.  The 2005 application cycle loan repayment ended on December 15, 2004 (http://www.lrp.nih.gov). 

IRB Registration:  In the summer of 2004, the HHS Office for Human Research Protections (OHRP) issued for comment a proposal to require and standardize registration of IRBs that review research involving human subjects. The PPC joined with the AAP in submitting comments to HHS, reinforcing the recommendation made to the Institute of Medicine's Committee on Clinical Research Involving Children that IRBs have adequate pediatric expertise. The letter urged that the new registration requirements be modified to require an indication of whether each IRB member has child health care and research expertise, and expanded to include an estimate of the number of protocols an IRB reviewed during the preceding calendar year that involved children.

Publication and Disclosure Issues in Clinical Trials:  The issue of publication and disclosure in clinical trials is one in which Congress still remains interested.  On February 28, Sen. Chris Dodd (D-CT) reintroduced the Fair Access to Clinical Trials Act of 2005, S. 470, a bill that is very similar to the one he introduced in the 108th Congress.  The legislation calls for a clinical trial registry, accessible to patients and health care practitioners, for ongoing clinical trials for serious or life-threatening diseases and conditions, and a clinical trials database of all publicly and privately funded clinical trial results regardless of outcome, accessible to the scientific community, health care practitioners, and members of the public.  The bill also calls for registration of all FDA reviews of a new drug application. This is a topic that currently has great momentum, due in part to the high-profile problems with Vioxx and other drugs.  The bill currently has three bipartisan co-sponsors, and in their introductory language, Senators Dodd and Grassley (R-IA) indicated that the language is "consistent with recommendations from the AMA and International Committee of Medical Journal Editors." The PPC will work closely with the primary authors of the legislation to make sure that the voice of the pediatric research community is heard as this legislation moves forward in the 109th Congress.

Agency for Healthcare Research and Quality (AHRQ)/Appropriations: The PPC, as part of a broad-based coalition, the Friends of AHRQ, supports a $440 million funding request for AHRQ in FY 2006. The President proposes level funding at $319 million for AHRQ in FY 2006, with all funds allocated via transfers from other public health service agencies. The budget designates $50 million for health information technology, $34 million for patient safety, and $15 million for comparative effectiveness research.  Congress and the administration continue to request that AHRQ undertake new and important responsibilities but additional dollars for the agency to complete these new tasks is rarely forthcoming. The final FY 2005 omnibus appropriations bill funded AHRQ at $319 million for an additional $15 million (5%) over last year. However, the $15 million, according to conference committee report language, is to be used for clinical effectiveness research as authorized in the Medicare Modernization Act.

Secretary's Advisory Committee on Human Research Protections (SACHRP): The Secretary's Advisory Committee on Human Research Protections (SACHRP) has created a Subcommittee for Research Involving Children, which includes several notable pediatricians. The subcommittee was formed to provide recommendations for consideration by SACHRP on interpretations of the requirements of HHS regulations 45 CFR 46.404-407 ("Subpart D") in order to help ensure that children who participate in research are appropriately and adequately protected.  At its most recent meeting on April 18, the pediatric subcommittee finalized, after more than a year, its recommendations for defining a number of terms in Subpart D.  These recommendations are designed to increase the clarity and consistency in research approvable these sections.  Among the concepts defined by the subcommittee are uniform standard, minimal risk, condition, commensurate, and vital importance.  The Subcommittee will submit the recommendations in a letter to HHS Secretary Leavitt.  Staff will forward the letter to the PPC when it becomes available, and will keep members apprised of future activities of the Subcommittee.  Additional information, including its charter and the pediatric subcommittee roster, can be found on the Committee's website, at http://ohrp.osophs.dhhs.gov/sachrp/sachrp.htm.

Embryonic Stem Cell Research:  On February 16, 2005, a bipartisan group of House and Senate members led by Representatives Mike Castle (R-DE) and Diane DeGette (D-CO) and Senators Arlen Specter and Tom Harkin reintroduced legislation - Stem Cell Enhancement Act of 2005 (S. 471/H.R. 810) - to modify the current stem cell policy. The Senate bill currently has 23 cosponsors and the House bill has 197 cosponsors. Working with the House leadership, Rep. Castle has apparently reached an agreement to bring this bill to the House floor some time this year. Of course it is anticipated that even if the House and the Senate approve an embryonic stem cell bill, President Bush will veto the measure. In addition while the debate continues in Congress, several states are contemplating introducing stem cell legislation following the success of the 2004 California stem cell ballot initiative.

In the meantime, on April 26, 2005, the Committee on Guidelines for Human Embryonic Stem Cell Research of the National Research Council and the Institute of Medicine issued a report that provides guidelines for the responsible practice of human embryonic stem cell research. The Committee had been asked to provide guidelines to encourage responsible best practices in stem cell research regardless of the source of funding including the use and derivation of new stem cell lines. Some of the key recommendations of the report as summarized include:

• Establishing an embryonic stem cell oversight committee to provide local oversight of all issues related to derivation and research using stem cells

• Institutional Review Boards cannot waive the requirement for obtaining informed consent.

• No cash or in-kind payments may be provided for donating blastocysts in excess of clinical need for research purposes

• A national body should be established to assess periodically the adequacy of the guidelines proposed by this NRC/IOM report and to provide a forum for continuing discussions of issues involved in human embryonic stem cell research.

Background: In the 108th Congress, a bipartisan group of Members, led by Representatives Castle and DeGette, introduced a bill that would have expanded the current policy on federal funding of embryonic stem cell research.  The legislation attempted to address some of the challenges with the current embryonic stem cell policy that was established in August 2001. These challenges include the fact that the embryonic stem cell lines available to researchers were originally thought to be more than 60 in number may now only be 19 according to the NIH registry. In addition there are also issues including whether of not all of the available stem cell lines are contaminated with mouse feeder cells, making their therapeutic use for humans uncertain; and scientists are reporting that it is increasingly difficult to attract new scientists to this area of research because of concerns that funding restrictions will keep this research from being successful. The Senate also embarked on a similar but failed effort in 2004, with more than a majority of the Senate supporting expansion of the stem cell policy. Senators Orrin Hatch (R-UT), Diane Feinstein (D-CA), Arlen Specter (R-PA), Tom Harkin (D-IA), and Ted Kennedy (D-MA) led the Senate effort.

The PPC will continue to monitor efforts throughout the 109th Congress to urge the Administration to modify its current stem cell policy, which limits federal funding for research on embryonic stem cells to those cells derived prior to the August 9, 2001, date when the policy was announced.

NIH Conflict of Interest Regulations: On February 1, 2005, NIH Director Elias Zerhouni, MD, announced sweeping new ethics regulations, to mixed reviews.  While several key Members of Congress were very pleased, and it could cause them to back off (at least on the House side) from going forward with hearings on conflicts of interest at the NIH, there was no small amount of unhappiness expressed among NIH staff.  Under the rules, NIH employees will be barred from entering outside consulting agreements with pharmaceutical companies, hospitals, health insurers and health care providers. The guidelines also will mandate that about 6,000 top NIH employees cannot hold stock in pharmaceutical or biotechnology companies and require current stockholders in the group to sell their shares by October 3, 2005. Other agency employees must divest by the same date any holdings that exceed $15,000 in value for a particular company.  To date, at least four upper-level researchers and one institute director have announced their resignation since the new rules were announced. In a senate hearing held on April 6, key senators indicated that some adjustments must be made in the conflict of interest regulations. "They are too onerous, and they must be redone, soon before you lose more people," Senator Harkin told NIH Director Elias Zerhouni. "I think we've gone overboard." Specter added that the committee would recommend ways to loosen the rules. In addition, Secretary of Health and Human Services Michael Leavitt recently also indicated that these regulations might need to be reviewed.

Coalition to Protect Research: The Coalition to Protect Research is a coalition of organizations committed to promoting public health through research. Sexual health and behavior research is essential to providing a scientific foundation for sound public health prevention and intervention programs. The PPC continues to closely monitor the challenges to the peer review process and certain NIH grants that have arisen during the appropriations process from some members of Congress over the past three years. It is anticipated that there could be further challenges this year during the FY 2006 appropriations process in addition to a possible reauthorization of the NIH.

NIH Public Access: On February 3rd, NIH director Elias Zerhouni, MD released the agency's revised policy on public access. The policy requests - but does not require - NIH grantees to send to NIH research manuscripts that have been accepted for publication in peer reviewed journals. NIH's National Library of Medicine will compile an archive of these manuscripts and will post them on PubMed Central within the period of time specified by the author.

The policy, which will become effective on May 2, 2005, is similar to the proposed version published in the Federal Register on September 17, 2004, although the final policy allows authors themselves to specify when their manuscripts should be made publicly available (up to 12 months) after publication. Under the original proposal, all author manuscripts were to be posted six months after publication.

The American Academy of Pediatrics submitted written comments to the Federal Register notice both commending the efforts that were being made by the NIH to increase the accessibility of federally funded medical and scientific research but also expressing concerns about some aspects of the proposal that could have unintended negative consequences for the health and well-being of children due to the proposal's impact on pediatric research. A copy of the Academy's comments to the Federal Register notice is on the AAP's web site at www.aap.org

"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 2004, the Council released a fifth report, entitled "Reproduction and Responsibility: The Regulation of New Biotechnologies" which critically assess the various oversight and regulatory measures that now govern the biotechnologies and practices of assisted reproduction, human genetics, and human embryo research.  The report's recommendations fall into three broad categories: studies and data collection, oversight and self-regulation by professional societies, and targeted legislative measures to "institute a moratorium on certain particularly questionable practices", including prohibitions on the transfer, for any purpose, of any human embryo into the body of any member of a non-human species. The Council met again in March 2005 to discuss aging and care-giving including assisted suicide, end of life and long-term care. Additional information about the President's Council, including meeting transcripts and reports, is available online at www.bioethics.gov.

On April 21, 2005, Senators Orrin Hatch (R-UT), Dianne Feinstein (D-CA), Specter (R-PA), Edward Kennedy (D-MA) and Harkin (D-IA) re-introduced S.876, the Human Cloning Ban and Stem Cell Protection Act of 2005, legislation to ban human reproductive cloning but to allow somatic cell nuclear transplantation (SCNT) - "therapeutic cloning." The legislation would make it a crime, punishable by up to 10 years in prison and fines of $1 million or three times any profits made, whichever is greater, on any person who clones or attempts to clone a human being. It permits nuclear transplantation to be conducted on unfertilized eggs for up to 14 days, under strict ethical and federal regulation. The bill would restrict any financial inducements for egg donations and requires informed consent by egg donors. The bill currently has 11 cosponsors.

Earlier this year "The Human Cloning Prohibition Act of 2005," was introduced as S.658 by Senators Sam Brownback (R-KS) and Mary Landrieu (D-LA) and in the House as H.R. 1357 by Representatives Dave Weldon (R-FL) and Bart Stupak (D-MI). In contrast it would prohibit any person or entity, public or private, from performing or attempting to perform human cloning; participating in an attempt to perform human cloning; or shipping or receiving for any purpose an embryo produced by human cloning or any product derived from such embryo. The bills also make it unlawful to import for any purpose an embryo produced by human cloning. Under this legislation therapeutic cloning would be banned. S.658 currently has 30 cosponsors. 

PEDIATRIC MEDICAL DEVICES

Pediatric medical devices has become a very active issue both within Congress and the Administration and among pediatric health advocates, to examine the unmet needs of and possible solutions to improving the availability of medical devices for neonates, infants, children and adolescents. In an ongoing effort to improve therapeutics and diagnostics for pediatric populations, the AAP, the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), the National Organization for Rare Disorders (NORD), the National Association of Children's Hospitals (NACH) and the Advanced Medical Technology Association (AdvaMed) hosted a series of four invitational meetings to discuss pediatric device availability and needs during the summer and fall of 2004. PPC member and chair of pediatrics at Wake Forest, Jon Abramson, MD, represented the AAP and PPC at the meetings.

An initial meeting was held in June 2004, which served, as the starting point to identify unmet pediatric device needs, barriers to addressing those needs, and possible mechanisms for increasing the availability of pediatric appropriate products. A series of three follow-up meetings (October and November) were then held that focused discussions on several specific areas: data collection/information sharing; administrative and regulatory issues; and market capacity and incentives. Other issues such as reimbursement and liability were also touched on. Participants at the meetings also included representatives from the Food and Drug Administration, National Institutes of Health, Institute of Medicine, in addition to members of the device industry, pediatric organizations and biomedical engineers.

Perhaps the most significant outcome of these meetings was the clear recognition by the group that children have medical devices needs that can differ considerably from adults across a broad range of illnesses, conditions, and subspecialties. Other key outcomes were the identification of examples of pediatric needs across the specialties represented, the listing of current barriers to pediatric device development, and the identification of potential legislative, regulatory and other solutions to improving the availability of pediatric devices. Additional meetings may be convened this year, if necessary, to fully examine these and other important issues.

Congressional Activities: Senate staff remains interested in developing legislation in the 109th Congress that will address the unmet pediatric needs for the pediatric population. The pediatric community will continue to meet regularly with congressional staff to ensure that legislation is comprehensive and adequately addresses the needs of pediatricians and their patients.

Regulatory Activities: In the summer of 2004 the Food and Drug Administration issued a Federal Register notice requesting comments concerning the possible barriers to the availability of medical devices intended to treat or diagnose diseases and conditions that affect children. The FDA sought comments on:

• The unmet medical device needs for the pediatric population;

• The possible barriers to the development of pediatric devices;

• Things the FDA could do to facilitate device development.

This information will assist the FDA in preparing a report to Congress. The PPC and AAP submitted a comment letter to the FDA that made several recommendations, including that: 1) Congress should consider establishing the presumption that devices manufactured for adults should also be required to be designed for and tested for pediatric populations if the indication occurs in those populations; 2) Congress should consider the creation of financial incentives, including grants or guaranteed loans for R&D to small companies, modifying the existing Humanitarian Device Exemption provision to allow for profit, and financial support for prototype development and the conduct of clinical trials; and 3) A mechanism should be developed for sharing information that may be useful in helping a manufacturer identify a potential market for a new or modified product, and for identifying opportunities for collaboration between manufacturers with pediatricians or institutions.

Institute of Medicine Activities: The Institute of Medicine (IOM) has been charged by Congress to study the postmarket surveillance of pediatric medical devices and report back to Congress by October 2006. Jon Abramson, MD, FAAP testified before an IOM committee hearing in August, 2004, presenting a statement reviewed and endorsed by the pediatric academic societies which concluded that postmarketing surveillance, monitoring and reporting for pediatric devices is gravely inadequate, and that fixing the problems will take the commitment by a wide number of stakeholders in order to improve the availability of appropriately studied pediatric devices for infants, children and adolescents. 

PEDIATRIC WORKFORCE

GME Financing in Children's Hospitals: Somewhat surprisingly, the President's FY 2006 budget proposed a $100 million decrease in funding for the CHGME program, providing only $200 million. The PPC and the entire pediatric community are working with NACH requesting funding of $309 million in FY 2006. During the past several weeks over 200 members of the House of Representatives - 72 Republicans and 136 Democrats - co-signed either the House Republican letter or the House Democratic letter in support of "full funding" for CHGME in the FY 2006 Labor-HHS Appropriations Bill. Forty-seven Senators - 16 Republicans, 30 Democrats, and 1 Independent - did the same in the Senate, when they co-signed a bipartisan letter.

Reauthorization: On February 9, 2005, the Senate Committee on Health, Education, Labor and Pensions (HELP) marked up and passed S.285 (Sen. Kit Bond R-MO), reauthorizing the CHGME for FY 2006 through FY 2010. S. 285 contains the same language as the bill the Senate passed last November by unanimous consent. S. 285 now goes to the full Senate for action. The legislation, the Children's Hospitals Educational Equity and Research (CHEER) Act, authorizes $330 million for FY 2006 and "such sums as necessary" for subsequent years. The House bill, H.R.1246, introduced in March by Representatives Nancy Johnson (R-CT) and Deborah Pryce (R-OH), currently has 43 cosponsors. The PPC will continue to work closely in collaboration with NACH to secure final passage in the 109th Congress.

Titles VII and VIII - Health Professions Training and Nursing Education Grants/Appropriations: As in the previous four years, President's FY 2006 proposed 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 once again it does address the nursing shortage through a modest increase for Title VIII.

Following a tradition of many years, the pediatric community will continue to vigorously fight to restore funding for health professions and nursing education training under both Titles VII and VIII. Through its efforts with the Health Professions and Nursing Education Coalition, the PPC will push for $550 million in FY 2006. The PPC will also advocate for adequate funding of at least $40 million for the general internal medicine/general pediatrics provision of Title VII.

Reauthorization: The Title VII program was due to be reauthorized in the 107th Congress (2002) but was not; nor was it taken up during the 108th Congress. The pediatric community is continuing its conversations with colleagues in the internal medicine community in anticipation of reauthorization in the 109th Congress. Additionally, the Association of American Medical Colleges (AAMC) has put together a committee of physicians to review the mission and effectiveness of the Title VII program, and make legislative recommendations for reauthorization. The Committee met for the first time in January 2005. Tom DeWitt, MD, past president of the Ambulatory Pediatric Association and chair of the AAP Committee on Pediatric Education, represented the pediatric community at the committee meeting, and presented several recommendations for the program, as outlined in a letter submitted to the AAMC on December 1. Two of the recommendations were: supporting primary care and interdisciplinary training and increasing the number of primary care professionals who are from underrepresented minority groups. The letter is available on the AAP member center.

FY 2006 BUDGET/APPROPRIATIONS

On February 7, 2005, President Bush unveiled the details of his FY 2006 budget proposal to Congress. The $2.568 trillion spending plan calls for a 0.5 percent decrease in non-defense, non-homeland security discretionary spending and caps discretionary funding by $843.4 billion. The Administration's proposal includes a 0.7 percent increase for the National Institutes of Health (NIH), elimination of the Title VII health professions programs and the emergency medical services for children program, level funding for both the Agency for Healthcare Research and Quality (AHRQ) and the Title X, family planning program and a $100 million decrease in funding for the Children's Hospitals Graduate Medical Education program (CHGME).

On March 17, after many long hours of partisan debate, the Senate passed its FY 2006 concurrent budget resolution by a 51-49 vote. In doing so, through the adoption of an amendment offered by Senator Ted Kennedy (D-MA) for education, the Senate increased discretionary spending by $5.4 billion, to a total of $848.8 billion. In a rebuke of the White House and a victory for child and adolescent health advocates, the Senate earlier in the day approved by a vote of 52-48 an amendment offered by Senators Gordon Smith (R-OR) and Jeff Bingaman (D-NM) that would eliminate nearly $15 billion in cuts to Medicaid and instead create a reserve fund for a Bipartisan Medicaid Commission to review the program and make recommendations to improve service delivery, quality of care, and cost-efficiencies. Joining all Democrats and in the vote to preserve Medicaid were seven Republicans: lead amendment cosponsor Senators Gordon Smith (OR), Susan Collins (ME), Arlen Specter (PA), Lincoln Chafee (RI), Mike DeWine (OH), Olympia Snowe (ME), and Norm Coleman (MN). In the debate prior to the vote, Smith exhorted colleagues to "vote your conscience". The Senate also adopted an amendment offered by Senator Arlen Specter (R-PA) to add $1.5 billion to function 550 (Health) for the NIH and added $500 million for function 500 for education.

The House also approved its budget resolution on March 17, by a vote of 218-214. However, the House bill is much more aggressive than the Senate bill, calling for proposed cuts in mandatory spending of $69 billion.

FY 2006 Concurrent Budget Resolution: The vast differences in spending and tax cuts in the two chambers' bills made for a contentious process that was finally resolved on April 28. The House by a close vote of 214 to 211 and the Senate by a vote of 52 to 47 passed the $2.6 trillion FY 2006 concurrent budget conference agreement - H.Con. Res 95. The reconciliation instructions included in the final budget agreement directs the committees of jurisdiction to identify $34.7 billion in savings over the next five years through reductions to mandatory spending, such as Medicaid (up to $10 billion but not in effect until 2007) and food stamps (up to $3 billion). The committees must submit their plans for cutting mandatory spending by September 16, 2005.

HEALTH INSURANCE COVERAGE AND ACCESS TO CARE

President's FY 2006 Budget Proposal for Medicaid/ SCHIP: The President's FY 2006 budget proposal, released on February 7, 2005, included $60 billion in mandatory spending including $20 million cuts to the Medicaid program over 10 years. The House of Representatives accepted this provision in its version of the budget resolution. The entire child and adolescent health community rallied together with a broad coalition of child health, elderly and low income advocates opposing these incredible cuts to an important safety net program. There was some success on the Senate floor when it approved an amendment to reject these reductions to the Medicaid program. Senators Gordon Smith (R-OR) and Jeff Bingaman (D-NM) offered this bipartisan amendment.

On April 28, Congress passed the FY 2006 concurrent budget resolution - reminder that this does not need to be signed by the president - it is a nonbonding document that provides the blueprint that will be followed for spending (appropriations), taxes and entitlements - Medicaid- in a process known as reconciliation. However, the agreement that was reached allowing the budget resolution to go to the floor of the House and Senate included at least $10 billion in cuts to the Medicaid program beginning in 2007. While the proposed $20 billion in cuts to the Medicaid program that were passed by the House were successfully brought down to $10 billion, these cuts to the program are of grave concern.

The next steps will be for the pediatric community to remain actively engaged in the process and to be closely involved in how these cuts to the Medicaid program are put forward. The reconciliation instructions to the committees of jurisdiction - the House Energy and Commerce Committee and the Senate Finance Committee have until September to develop reform legislation that will result in cost-savings or cuts to the Medicaid program. This timeframe coincides with the recommendations from the bipartisan Medicaid commission that also was created under the concurrent budget resolution.

The President's FY 2006 budget outline also included a proposal to move up the reauthorization of SCHIP. Currently, SCHIP is should be reauthorized in 2007. Details on the President's proposals related to an early reauthorization have yet to be revealed; however, the pediatric community will monitor this issue closely and will work to protect this program for near poor children and families.

MediKids: The MediKids legislation will be reintroduced in the 109th Congress by Rep. Pete Stark (D-CA) in the House, and Sen. John Rockefeller (D-WV) in the Senate. The bill would create a unified health care system that would achieve the pediatric community's goal of health insurance for all children and adolescents regardless of family income. MediKids would make coverage automatic and promote equity, family responsibility, choice, and uniform benefits. The bill is scheduled to be introduced later in the spring.

Kids Come First Act of 2005: On January 24, 2005, Sen. John Kerry (D-MA) introduced the Kids Come First Act of 2005 (S.114). The bill has eight cosponsors. This legislation is an effort to provide affordable health insurance to all children, with an emphasis on reforms to Medicaid and SCHIP to enroll all children up to 300 percent of the federal poverty level (FPL). Included in the proposal is a "swap" for the states that would provide a 100 percent federal match for all children in the Medicaid mandatory population, in exchange for their expansion of their SCHIP program up to 300 % FPL. Through this "swap", states will get much needed fiscal relief and nearly all uninsured children will be enrolled through either Medicaid or SCHIP. For those uninsured children who are above 300% FPL, there will now be an option for these families to buy affordable coverage through the SCHIP program. In order to enroll all eligible children in either Medicaid or SCHIP, the legislation includes outreach and enrollment efforts that have long been supported by the pediatric community such as: presumptive eligibility; 12-month continuous eligibility; acceptance of self-declaration of income; adoption of express lane eligibility; elimination of face-to-face interview for redetermination; no waiting lists for children under SCHIP; no assets tests for children; and no 5-year waiting period for legal immigrant children (previously supported ICHIA legislation). Importantly, the legislation also provides for an increase in pediatric provider payments under Medicaid.

Association Health Plans: The Small Business Health Fairness Act has been reintroduced this Congress in the form of S.406/H.R.525. This legislation allows association health plans - groups of small employers that band together and purchase health coverage - to be exempt from state regulation, oversight and mandates. Many child and adolescent health organizations opposed legislation in the 108th Congress, as it threatened the progress that has been made in ensuring that insured children and adolescents have appropriate access to preventive and well-child and adolescent care because families who purchase health coverage from these plans would no longer be protected by state laws. The PPC will continue to collaborate with the Academy to urge Congress to consider legislative solutions for small businesses that will provide affordable quality health insurance to families.

Genetic Information Nondiscrimination Act of 2005: On February 7, 2005, Sen. Olympia Snowe (R-ME) introduced the "Genetic Information Nondiscrimination Act of 2005" (S. 306/H.R. 1227). 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. The bill would bar health insurers from underwriting based on genetic information. The bill would also establish privacy protections for genetic information. The Senate Health Education Labor and Pensions (HELP) Committee reported the legislation favorably with an amendment in the nature of a substitute, and just ten days after it was introduced, the Senate passed the measure unanimously (98-0) on February 17. In the House, three committees have jurisdiction over the issue, the Education and Workforce, Energy and Commerce, and Ways and Means Committees. This shared jurisdiction will make House passage of the bill a bit more challenging.

EMERGENCY MEDICAL SERVICES FOR CHILDREN (EMSC):

Emergency Medical Services for Children (EMSC)/Appropriations: The President's budget proposed eliminating funding for the EMSC program for FY 2006. The PPC joins the Academy and supports at least $20 million in FY 2006, which is current year funding for this important program.

Trauma Care Systems Planning and Development Act of 2005: Legislation was introduced during the 108th Congress in the House of Representatives that eliminated the Emergency Medical Services for Children (EMSC) program by combining it with HRSA's trauma care program. The PPC worked in partnership with the AAP to protect and preserve the national EMSC program in 2004, but remains concerned about a repeat attempt in 2005. Since September, the PPC and AAP have been working with the trauma community to come to a mutually satisfactory strategy that would improve the trauma care program without damaging EMSC in the process. In February, the Senate Committee on Health, Education, Labor and Pensions reported S. 265, a bill that reauthorized the trauma program without harming EMSC. 

AAP/PPC staff has also met with the Institute of Medicine (IOM) to discuss the work of the IOM's pediatric subcommittee on emergency medicine, which will be issuing a report in late 2005/early 2006 as part of a larger assessment of the emergency medical services in the United States.

IMMUNIZATIONS

Federal Legislation: As the 108th Congress came to a close, no action had been taken on the bill Sen. Bill Frist (R-TN) introduced making modifications to the Vaccine Injury Compensation Program (VICP). The Improved Vaccine Affordability and Availability Act of 2003 (S.754) - a bill similar to one he introduced in the 107th Congress, with additional changes offered by the AAP and the Advisory Commission on Childhood Vaccines (ACCV) makes several changes to the VICP including data collection on adverse impacts associated with immunizations, extending the statute of limitations from three to six years for families of children injured by required vaccines to file claims under VICP, and increasing the amount of compensation that families can receive for children's pain and suffering from $250,000 to $350,000. The PPC will work in conjunction with the Academy for the introduction of similar legislation in the 109th Congress.

Additional advocacy "action" information and materials are available AAP Member Center - www.aap.org/moc, click on Federal Affairs.

Vaccine Programs/Appropriations: Current year funding for the section 317 immunizations program is $479 million for discretionary immunization activities. There is also $138.3 million appropriated for global immunization including polio eradication. [NOTE: The difference in funding levels is pursuant to the reorganization of the CDC with certain administrative funds related to the CDC national immunization program in other funding lines.]

The FY 2006 President's budget request includes $529 million for immunization activities. This reflects a $50 million increase - $20 million for purchase of influenza vaccine for use by states during the 2005 - 2006 influenza season and $30 million for production guarantees contracts with influenza vaccine manufacturers. Additional funds are needed for operations and infrastructure, to purchase vaccines for children and adolescents, including the recently recommended meningococcal vaccine and for funding to implement the new routine influenza recommendations, the flu vaccine stockpile and for additional surveillance, communication and public education activities. Childhood and adult immunization advocates are supporting a FY 2006 appropriation for that includes $431 million for the state grants for vaccine purchase for children and adults, $258 million for state grants for operations and infrastructure for children and adult immunizations, and $72 million for the National Immunization Program prevention, safety and administrative activities.

Congressman Weldon's Thimerosal Legislation: On February 17, 2005, Representatives Dave Weldon (R-FL) and Carolyn Maloney (D-NY) reintroduced a bill to amend the Federal Food, Drug, and Cosmetic Act to reduce human exposure to mercury through vaccines. The bill H.R. 881, Mercury Free Vaccines Act of 2005, is similar to legislation introduced in the 108th Congress and to the amendment Dr. Weldon had planned to offer to the FY 2005 appropriations bill. The bill, which currently has 35 cosponsors, was recently referred to the House Subcommittee on Health of the Energy and Commerce Committee in anticipation of action shortly. As proposed in the bill, "a vaccine is a banned mercury-containing vaccine under this section if 1 dose of the vaccine contains 1 or more micrograms of mercury in any form." There is an exception if the Secretary of HHS makes a declaration of a public health emergency. In addition, the legislation also includes a restriction on administration of mercury-containing vaccines to children and pregnant women manufactured for use in the 2006 - 2007 influenza season. There are several effective dates including: July 1, 2006, the vaccine shall not be administered to any child under the age of 3 years old; and if the vaccine contains thimerosal, the vaccine shall not be administered to any pregnant woman; and effective July 1, 2007, the vaccine shall not be administered to any child under the age of 6 years old. There is also a public health emergency exception in this provision.

Background: Last summer, during the House Appropriations Committee's markup of the FY 2005 funding bill, Rep. Weldon offered a troubling amendment. As originally crafted the amendment would have prohibited the CDC from purchasing and funding influenza vaccines containing thimerosal or trace thimerosal (subsequently eliminated in offered amendment) given to children under age 6 (subsequently this, too, was changed to 3 years of age and under) during the 2005-2006 flu season. In letters to the House Appropriations Committee, the pediatric community, the Association of State and Territorial Health Officials and others expressed strong opposition to the amendment. Rep. Weldon ultimately withdrew the modified amendment on the condition that a hearing on this issue be held. The AAP and PPC staff worked very closely with the staff of the House Labor/HHS/Education Appropriation Subcommittee Chairman Ralph Regula (R-OH) and other congressional offices to insure that accurate information on the flu vaccine and thimerosal was provided for the hearing.

Vaccine Supply: It was at the October hearing on the flu vaccine and thimerosal that the CDC announced a severe shortage in the nation's supply of flu vaccine pursuant to one of the company's inability to complete its order of almost 50 million doses. In the weeks following the announcement, several bills were introduced to address issues surrounding the manufacture, distribution, and supply of influenza vaccine. None of these bills were approved before Congress adjourned in December. Senators Evan Bayh (D-IN), Larry Craig (R-WY) and Mary Landrieu (D-LA) (S.375) in the 109th Congress have reintroduced similar legislation. Also Senators Mike DeWine (R-OH) and Hillary Rodham Clinton (D-NY) reintroduced their bill (S.226) from last year that requires the Secretary of HHS to develop a plan for the purchase, storage, and rotation of a six-month supply of vaccines routinely recommended for children and adults. Finally, the National Vaccine Advisory Committee (NVAC) held a second workshop in late January 2005 on the next steps in addressing the overall vaccine supply issue. The PPC will continue to monitor any such efforts.

National Vaccine Advisory Committee Public Participation Working Group: Last fall, the NVAC Public Participation Working Group convened a meeting to examine models for enhancing public involvement in vaccine decision-making. The Working Group heard from representatives of various public and private groups, mostly outside the public health sector, which engage citizen involvement in information gathering, policy development, and decision-making. The Working Group will consider which models might be appropriate for vaccine issues, and will present a report to NVAC at an upcoming meeting. 

PAS ANNUAL MEETING

2005 PAS: The 2005 PAS Public Policy Plenary Symposium will address the topic of clinical trial registries/databases. Entitled "Clinical Trial Registries: Challenges and Opportunities", the session will be held on Sunday, May 15, from 4:15 - 6:15 p.m. (Convention Center Room 145B) and will be moderated by Myron Genel, MD, Chair, Public Policy Council and Professor Emeritus of Pediatrics, Yale University School of Medicine. The 2-hour plenary session will include the following presentations:  

• Why We Need a Uniform, Comprehensive Registry of Clinical Trials. 
  Kay Dickersin, Director, U.S. Cochrane Center and Professor of Community Health, Brown University, Providence, RI.

• Registering Clinical Trials - The Response from Medical Journals. 
  Christine Laine, Deputy Editor, Annals of Internal Medicine and Executive Secretary, International Committee of Medical Journal Editors.

• ClinicalTrials.gov - For All and Open to All. 
  Donald Lindberg, Director, National Library of Medicine, NIH, Bethesda, MD

• Implications for Pediatric Research. 
  David Schonfeld, Chair, American Academy of Pediatrics Committee on Pediatric Research, New Haven, CT.

At 7:00 a.m. on Monday, May 16 (Convention Center Room 203) the Public Policy 19th Annual Legislative Breakfast Symposium will feature the session: "Politics of Stem Cell Research." The speaker will be Anthony J. Mazzaschi, Director of CAS Affairs and Senior Associate Vice President for Biomedical and Health Sciences Research, Association of American Medical Colleges, Washington, DC. The focus of the session would be the implications for pediatric research and practice.

Also on Monday, May 16, at 12:00 noon (Convention Center 204AB) Drs. Duane Alexander and Peter Scheidt will provide an update on the Status of the National Children's Study since the 2004 PAS Meeting.

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 (trosenkranz@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: The letter remains the most popular choice of communication with a congressional office.  If you decide to write a letter, remember to be courteous, to the point, and include key information and examples to support your position.  Address only one issue in each letter and, if possible, keep the length to one page.

Fax: Currently it is best to fax your letter to Congress.  Fax numbers are available through the Capitol Hill Switchboard (202) 224-3121, or you can look up your members of Congress on "Thomas" the official website for Congress, available at http://thomas.loc.gov/, by going to "House Directory" or "Senate Directory" from the front page. 

Call: You can contact your Senator's and Representative's offices by calling the U.S. 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 American Academy of Pediatrics' Members Only website, www.aap.org/moc.

E-mail: All of members of Congress now have e-mail addresses, but there is no set format for them. On some members web sites there is a mechanism to directly email most notably if you are a constituent.  We suggest calling the congressional office to get an accurate e-mail address or visit www.aap.org/moc the Members Only website of the AAP.

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