ACADEMIC PEDIATRIC ASSOCIATION
LEGISLATIVE REPORT
APRIL 2008

OVERVIEW

The first session of the 110th Congress was marked by both grand action and great inaction on issues related to children and adolescents. On the one hand, the five-year reauthorization of the Best Pharmaceuticals for Children Act (BPCA), the Pediatric Research Equity Act (PREA) and the a new pediatric device legislation, the Pediatric Medical Device Safety and Improvement Act, was passed by Congress and signed by the president last September. On the other hand, despite several bipartisan proposals and strong advocacy from the pediatric community, Congress’ failed to override two vetoes to reauthorize the State Child Health Insurance Program (SCHIP). In the final hours of the first session, the 110th Congress settled for an extension of SCHIP with $1.6 billion in funding through March 2009. In the remaining months of this second session, Congress must still pass the FY 2009 budget resolution, 12 appropriations bills to fund the federal government in FY 2009, including funding the Children’s Hospital GME program and the National Children’s Study and countless other bills such as the Pediatric Research Consortia Establishment Act, a tobacco regulation bill, mental health parity to name a few.

The following is a summary of federal legislative and regulatory activities of interest to the Academic Pediatric Association. We encourage you to share this information with your colleagues and urged you to reach out to your members of Congress to advocate for key child health and pediatric-specific issues.

This report includes information on the following issues:

• Pediatric Workforce
• Access to Health Care
• Maternal and Child Health Block Grant
• Pediatric Research
• Pediatric Drugs and Devices
• Immunizations
• Pandemic Influenza
• Emergency Medical Services for Children
• Congressional Calendar
• How to Contact Congress and the President
• AAP FAAN and Key Contact Programs

PEDIATRIC WORKFORCE

Title VII Health Professions Program and Title VIII Nursing Professions Program – Appropriations: The president’s FY 2009 budget proposal eliminates funding for Title VII and calls for a significant cut in funding for nursing education. The APA will continue to work with the Health Professions and Nursing Education Coalition (HPNEC), led by the AAMC, to urge Congress to add back as well as increase funding for Titles VII and VIII. The coalition’s request is $550 million for both Titles VII and VIII in FY 2009.

In February two pediatric fellows from APA president-elect Tina Cheng’s program at Johns Hopkins participated in HPNEC’s “Health Professions Open House.” The focus of the day was to educate and help Capitol Hill staff understand what is and how Titles VII and VIII programs operate in various community settings. In addition to participating in a briefing that included former Surgeon General David Satcher, MD, PhD, several Capitol Hill offices were also visited.
Title VII Health Professions Program—Reauthorization: It remains to be seen what action, if any, will take place during the second session of the 110th Congress on reauthorizing Title VII. However, there has been some interest in the Senate. The pediatric community has already begun a dialogue with congressional staff to discuss how the Title VII program should look in the future. A letter, outlining specific issues for consideration, was submitted to the Senate HELP Committee hearing record by the Federation of Pediatric Organizations, which includes the APA, APS, SPR, AMSPDC as well as the AAP, ABP and AAPD. The letter, initially crafted by APA president-elect Tina Cheng, MD, included the following recommendations:

• Enhancing pediatrics in Title VII;
• Training primary care physicians in the workforce, especially those serving disadvantaged/underserved populations;
• Training all physicians in the workforce about primary care, care of underserved populations, and emerging health care needs;
• Training minority physicians and minority faculty; training primary care researchers and leaders to address: Healthy People 2010 objectives, disparities in health and health care, and primary care practice and health outcomes; and,
• Research and innovations in primary care training and health care delivery with demonstrated impact on health care quality.

GME Financing for Children’s Hospitals (CHGME)–Appropriations: Current funding (FY 2008) for the CHGME program is $301.65 million a modest – 3% - increase above FY 2007. However, heavy lifting from the pediatric community will be needed again this year because the president’s FY 2009 budget proposal calls for completely eliminating funding for CHGME. The APA will continue its collaboration with the National Association of Children’s Hospitals (NACH) in conjunction with the Academy, AMSPDC and others to urge the House and Senate Appropriations Committees to include funding for the CHGME at the authorized level of $330 million in FY 2009.

APA members please urge your Representative and Senators to support full funding - $330 million - of the CHGME program in FY 2009.

Higher Education Act: Late last September, President Bush signed the "College Cost Reduction and Access Act" (P.L. 110 - 84), the budgetary provisions of the current HEA reauthorization. Among the most notable changes, the measure includes a change to the definition of economic hardship deferment. The law also creates a new income-based repayment and "public service" loan forgiveness program. Shortly thereafter, the Secretary of Education Margaret Spellings retained this pathway in regulation and assured Congress and the medical education community that the Department would continue to offer the debt-to-income ratio. However, on March 4, 2008, the Department of Education abruptly reversed this decision and indicated that it plans to eliminate the 20/220 pathway in the November 1, 2008, regulations currently being drafted. Legislation has been introduced H.R. 4344/S.2303 to remedy this serious problem and reinstate the 20/220 pathway in the ongoing HEA reauthorization conference. The legislation would define borrowers as suffering economic hardship if they are working full-time, have a federal educational debt burden equal to at least 20% of their adjusted gross income, and the difference between their adjusted gross income minus such debt burden is less than 220% of the greater of: (1) the annual earnings of an minimum wage earner; or (2) 150% of the poverty line applicable to their family size.

APA members are encouraged to contact House and Senate members to urge them to support the freestanding legislation – H.R. 4344/S.2303 - to reinstate the 20/220 pathway regarding the definition of economic hardship.

ACCESS TO HEALTH CARE

State Children’s Health Insurance Program - First Session: Last fall, the Children’s Health Insurance Program Reauthorization Act (“CHIPRA) – HR 976 - passed the House of Representatives by a vote of 265–159, short of the veto proof two-thirds majority. The Senate did pass the same bill by a two-thirds majority. The bill included close to $35 billion in new funds for Medicaid and the State Children’s Health Insurance Program. Among other significant improvements to the program, the bill included a $225 million federal investment spread over five years to improve pediatric quality measurement. President Bush vetoed the bill on October 3, and thus began a long journey back and forth between the two branches of government.

The House passed the Medicare, Medicaid, and SCHIP Extension Act (S. 2499) on December 19 by a vote of 411-3. The bill was passed by Unanimous Consent in the Senate and provides states with enough funding to continue to operate their SCHIP programs at current enrollment levels through March 2009. As a flat extension of current law, the legislation does not include any of the policy improvements, like the quality package, included in the CHIPRA and CHIPRA II legislation. It does, however, include a six month moratorium on regulations that would limit federal payments for Medicaid-covered transportation and school-based rehabilitation services. The APA joined the Academy and other pediatric and child health groups in supporting the extension on SCHIP and the moratorium on the on the Medicaid regulations. The president signed the extension bill, P.L. 110-173, on December 29.

Second Session 110th Congress: Shortly after the House returned from recess on January 23, 2008, the House voted 260-152, to override President Bush's veto of the SCHIP expansion legislation (HR 3963). It fell 15 votes short of the two-third majority required. The legislation would have expanded the program to cover 10 million children and increased spending on the program by $35 billion over five years, funded by a 61-cent-per-pack increase of the federal cigarette tax. It also would have limited coverage to children and adolescents in families with annual incomes below 300% of the federal poverty level. The APA supported the veto override attempt. In the third override attempt, 42 Republicans voted to override the veto, two fewer than in the first override vote and one Democrat, Rep. Jim Marshall (D-GA) voted to sustain the veto.

Following the vote, House Democrats -the majority leadership - said they expect to revisit SCHIP later this year and have kept to their word. Rep. Frank Pallone (D-NJ), Chairman of the Energy and Commerce Health Subcommittee, convened two hearings to discuss the importance of SCHIP and covering the nation’s uninsured children. At the second hearing on February 26, several of the nation's Democratic governors asked Congress to rescind the Centers for Medicare & Medicaid Services (CMS) policy focusing enrollment in the State Children's Health Insurance Program and Medicaid on children from low-income families, saying it would derail state efforts to provide health insurance to thousands of children. Governors from both parties also urged Congress to stop several Medicaid regulations from being implemented, predicting that they would shift $13 billion in Medicaid spending over five years to the states at a time when states are facing an uncertain economy.

Additionally, House Democrats have considered several alternatives, including legislation that would combine a temporary boost to the federal medical assistance percentage for Medicaid, a moratorium on new regulations that limit Medicaid eligibility and an expansion of SCHIP. The strategy is intended to secure enough support from GOP colleagues and Republican governors in Democrats' push to enact legislation this year to increase funding for SCHIP.

CMS Threatens SCHIP: On August 17, 2007, the CMS issued an advisory that removed flexibility given to states under SCHIP. In this letter to state Medicaid directors, CMS set new criteria for states that wish to raise eligibility for SCHIP above 250 percent of the federal poverty level (FPL), and instituted year-long waiting periods and other requirements to assure that children are not leaving private health plans for public coverage. There is broad agreement that these requirements will be virtually impossible to meet.
Left intact, these CMS restrictions would cause tens of thousands of children across the country to lose SCHIP coverage. Further, states would be prohibited from building on the program’s success by expanding children’s access to coverage in the future.

The APA vigorously opposed the CMS guidelines and expressed that in a press statement issued shortly after the guidelines were released urging “the White House to reverse the new guidelines and focus on working collaboratively with a bipartisan U.S. Congress to reauthorize and fund a strengthened SCHIP bill.” The press statement highlighted the important research of the APA membership that has shown that SCHIP has:

• Improved child health insurance coverage, covering millions of US children
• Improved preventive care, immunization rates, and primary care among children who enroll
• Enhanced the quality of care and quality of life of children who enroll and their families
• Improved quality of care for the most vulnerable children with chronic diseases such as asthma
• Reduced racial/ethnic disparities in access, unmet need, and continuity of care

Even though the SCHIP extension law, P.L. 110-173, provides states with enough funding to maintain current enrollment, including the 21 states that would otherwise be in shortfall, the extension does not address the August 17, 2007, CMS letter to state Medicaid directors. As an extension of current law, the legislation does not include any language to address the damaging provisions promulgated by CMS. This year, House and Senate lawmakers are likely to respond to the letter and address the administration’s latest attempts to halt states from expanding SCHIP and Medicaid eligibility.
Several states, including NY, NJ, WA, IL, and MD, have filed lawsuits against the Department of Health and Human Services to block the implementation of the CMS letter. The outcome is pending.

On February 26, three Democratic governors called on Congress to block the directive. At the House Energy and Commerce Health Subcommittee hearing, Massachusetts Gov. Deval Patrick (D) emphasized that if left intact, the directive could have devastating effects on states’ progress, particularly in their effort to cover families who have no affordable options in the private marketplace. The directive would leave children between 250% and 300% of the federal poverty level uninsured. Washington State Gov. Chris Gregoire (D) said the directive will prevent the state from expanding its SCHIP eligibility limit from 250% of the poverty level to 300% next year. She said that no state will be able to meet the 95% standard. Ohio Gov. Ted Strickland (D) also criticized the directive and said it prevents states from enrolling uninsured children in the program. Two Republican governors -- Mississippi Gov. Haley Barbour (R) and Georgia Gov. Sonny Perdue (R) -- said that expanding SCHIP coverage to middle-income families would reduce funding for poorer states. At a time when at least 25 states are facing budget crises, states can not afford to comply with the stringent proposals promulgated in the directive.

On April 9, by voice vote, the House Energy and Commerce Subcommittee passed an amendment in the nature of a substitute to the pediatric community’s -supported "Protecting the Medicaid Safety Net Act of 2008" (H.R. 5613). The substitute was offered by Committee Chair John Dingell (D-MI) and preserves language that would prohibit, until April 1, 2009, any actions by CMS related to the Medicaid GME proposed rule, the Medicaid Cost Limit/Unit of Government final rule, and five other recently issued Medicaid rules. The full House Energy and Commerce Committee are scheduled to mark up the bill on April 16 and get it to the House floor as soon as possible.

FY 2009 Bush Budget and SCHIP: On February 4, 2008, President Bush released a $3 trillion fiscal year 2009 budget request that would significantly reduce or eliminate spending for dozens of health and other programs but would increase spending for SCHIP. The budget request includes a $19.7 billion increase in federal funds for states for SCHIP over the next five years. Under the President’s budget request, spending for SCHIP would increase to $45.1 billion in FY 2013. The increase would split the difference between the $5 billion increase that Bush requested last year and the $35 billion increase that Congress sought. Even though the President’s budget proposal provides a significant increase in SCHIP funding, it does so by cutting the growth of Medicaid spending by $18.1 billion over the next five years through program cuts and other regulatory action. The HHS budget proposal also includes $450 million in grants to states, localities, schools, and community groups to increase outreach efforts to enroll eligible children in Medicaid and SCHIP.
Both the House and the Senate rejected this proposal in their respective versions of the FY 2009 budget resolution that is currently being reconciled. The House and the Senate budget resolution included funding for expanding SCHIP to cover more children and adolescents.

FY 2009 BUDGET

President’s FY 2009 Budget Proposal: The president’s FY 2009 budget proposal was released on February 4, 2008. This is the final budget proposal for the Bush Administration. The budget proposal includes some interesting surprises such as an increase in funding for the State Child Health Insurance Program (SCHIP)—though it still falls short of the $35 billion needed to cover additional eligible low-income children and some serious disappointments slashing more than $2 billion from discretionary health and human services programs, including many for children and adolescents In addition, Bush has proposed trimming costs in Medicaid, the health safety net for the nation’s poorest children, by $18 billion over the next five years. The budget proposal maintains current level funding for several key programs aimed at children and adolescents, including child welfare and abuse prevention programs, child care and development grants, and crucial biomedical and health services research at the National Institutes of Health and the Agency for Healthcare Research and Quality. The president’s budget proposal also goes further and eliminates funding for the National Children’s Study at the NIH, Emergency Medical Services for Children, Title VII, health professions training including primary care medicine and dentistry, the Children’s Hospitals GME program, and universal newborn hearing screening.

The APA, the pediatric and adolescent medicine communities joined with over 440 organizations to ask Congress to increase funding for all aspects of public health in FY 2009 that will 1) restore funding to public health programs cut in FY 2006; 2) restore lost purchasing power that flat-funding for at least five years has eroded; and, 3) provide investments that begin to meet the health challenges currently facing the nation. The estimate to meet this goal is an additional $5.3 billion.

Congressional Budget Resolution: On March 13, the House and Senate approved similar $3 trillion fiscal year 2009 budget resolutions (H. Con. Res. 312 and S. Con. Res. 70). Both proposals would increase spending for health care and other domestic programs above the President’s budget proposal and balances the budget by 2012. For overall discretionary funding the House includes $25.4 billion above the president’s proposal and the senate would provide $21.8 billion. The House and Senate will now reconcile their two versions of the budget resolution and then vote again in April although to date there has been no action.
The budget resolution is essentially an internal congressional document, non-binding on other committees and does not need to be signed by the President. The budget resolution however, does offer an important spending blueprint and sets in motion the process in which decisions on spending and taxes must be made – appropriations and reconciliation.

MATERNAL AND CHILD HEALTH BLOCK GRANT

Appropriations: The President’s FY 2009 budget requested $666 million for the Title V, Maternal and Child Health Block Grant program, the same amount as in the current fiscal year. This is the lowest funding for this important program since 1993. In FY 2008, $20 million was transferred out of Title V to the Autism and Other Developmental Disorders program. As part of the Friends of Title V, the APA is supporting $850 million for this program, the same amount as currently authorized. In FY 2003, funding for the MCH Block Grant was $731 million and has remained flat or has decreased ever since. During the senate debate on the FY 2009 budget, Senator Chris Dodd (D-CT) along with Senators Orrin Hatch (R-UT), Charles Schumer (D-NY) and Richard Durbin (D-NY) introduced an amendment to increase funding for the Title V program by $184 million. The amendment passed by unanimous consent. The targeted number of children to be served by the Title V block grant in FY 2009 is 29 million.

PEDIATRIC RESEARCH

Agency for Healthcare Research and Quality (AHRQ): The president’s FY 2009 budget proposal includes $325.7 million, a decrease from the current fiscal year level of $335 million. This would mean that if funded at the president’s level there would be no new grants in the coming year. Working with the Friends of AHRQ, the pediatric academic research community is requesting $360 million for FY 2009, with a goal of increasing funding for AHRQ to $500 million in five years. At this time there is some interest that has been expressed by the Senate Health, Education, Labor and Pensions Committee (HELP) on the reauthorization of AHRQ that is now long overdue.
Pediatric Research Consortia Establishment Act (S.2773): On March 13, 2008, Senators Sherrod Brown (D-OH) and Kit Bond (R-MO) introduced S.2773, to amend Title IV of the Public Health Service Act to establish the National Pediatric Research Consortia. The APA as well as the other members of the Federation of Pediatric Organizations (APS, AAP, APPD, ABP, SPR, and AMSPDC) have all provided their collective support to this legislation. To date there are no additional senate cosponsors of the bill and there is not a House companion as yet.

The Pediatric Research Consortia Establishment Act authorizes up to 20 National Pediatric Research Consortiums at institutions throughout the country. The consortiums will conduct both basic and translational research. Each consortium will partner with satellite facilities. The peer reviewed awards will be made for five years with each consortium receiving initially no more than $2.5 million per year and renewable for another five years contingent on evaluations by a peer review panel and Director.

APA members are encouraged to contact your senators to urge them to support S.2773 – the Pediatric Research Consortia Establishment Act.
National Institutes of Heath (NIH)—Appropriations: The president’s FY 2009 budget proposal, released on February 4, 2008, includes level funding (FY 2008) - $29.23 billion - for the NIH. The pediatric community, including the APA, will continue its advocacy efforts led by the Ad Hoc Group for Medical Research in requesting an increase of $1.9 billion, for a total of $31.1 billion. The current FY 2008 allocation for the National Institute of Child Health and Human Development (NICHD) is $1.256 billion. As a member of the Friends of the NICHD, the APA is supporting an increase of approximately 6.5 percent for the NICHD - $1.34 billion in FY 2009.

National Children’s Study (NCS) – Appropriations: Once again the president’s FY budget proposal for FY 2009 has eliminated funding for the NCS. The APA is working in collaboration with the American Academy of Pediatrics and the March of Dimes with the support of members of Congress such as Representatives Doris Matsui (D-CA) and Chris Smith (R-NJ) who co-chair the congressional NCS caucus to support increased funding for FY 2009. Almost 40 organizations signed onto a letter supporting $192 million the next step in funding the NCS for FY 2009.
National Children’s Study— Research Plan: The NCS Research plan was made available for public review and comment in July 2007. The Research Plan describes the Study's background, design, measures, and the rationale for those selections in sufficient detail so that readers can understand the basis of the Study and how it will be carried out. In addition, the NCS Program Office sought review of its research plan by the National Academy of Sciences (NAS). Members of the NAS review panel include pediatricians Ellen Wright Clayton, MD, JD and Marie McCormick, MD, ScD. The NAS has commenced their review of the plan that is anticipated to take approximately 6-9 months.

New NCS Centers: In a statement released on March 20, 2008, the National Children's Study announced the issuing of a new Request for Proposals (RFP) for additional Study Centers. The Study plans to establish another wave of new Study locations and Centers across the country. Fifty-eight previously identified Study locations that have not been included in past awards are included in this solicitation. The RFP can be viewed at http://www.fbo.gov/spg/HHS/NIH/NICHD/Reference-Number-NIH-NICHD-NCS-08-21/listing.html
Further information and updates on the overall NCS may be found at: http://www.nationalchildrensstudy.gov.

On May 5, at 12:15 p.m., please join an update on and status of the NCS in the Hawaii Convention Center.

NICHD – name change: Prior to adjournment of the first session of the 110th Congress, it approved and the president signed a bill to rename the National Institute of Child Health and Human Development (NICHD) of the NIH the "Eunice Kennedy Shriver National Institute of Child Health and Human Development" in recognition of Mrs. Shriver's role in the creation of NICHD.

Stem Cells: For the second time in two years, President Bush vetoed the Stem Cell Research Enhancement Act of 2007, S. 5, on June 20, 2007. This legislation would expand the number of stem cell lines that are eligible for federal funding and allow federal funding for research using stem cells derived from embryos originally created for fertility treatments and willingly donated by patients. Currently, federal funding for embryonic stem cell research is allowed only for research using embryonic stem cell lines created on or before Aug. 9, 2001, under a policy announced by President Bush on that date.
Although an effort was made to add a stem cell expansion provision to the FY 2008 L-HHS-E Appropriations it was not included in the final FY 2008 Omnibus appropriations bill. The next steps at this time are uncertain.
Genetic Information Nondiscrimination Act (GINA): The Genetic Information Nondiscrimination Act (GINA) H.R. 493/ S.358, was reintroduced in the House of Representatives and the Senate last year. The House bill passed the bill by a vote of 420-3. The Senate bill still awaits a vote on the Senate floor. A vote had been scheduled to occur last August however; Senator Tom Coburn (R-OK) placed a hold on the legislation delaying such a vote from moving forward; at the time of this writing this hold on the bill continues. The Senate bill has 38 co-sponsors. At the time of this writing the Senate may bring its bill to the floor either the week of April 14 or April 21.

The House attached their bill (H.R. 493) to a Mental Health Parity bill on March 5, which also passed.
GINA prohibits discrimination on the basis of genetic information with respect to health insurance and employment. Its purpose is to establish basic legal protections that will enable and encourage individuals to take advantage of genetic screening, counseling, testing, and new therapies that will result from the scientific advances in the field of genetics. The legislation also prevents health insurers from denying coverage or adjusting premiums based on an individual's predisposition to a genetic condition, and prohibits employers from discriminating on the basis of predictive genetic information. Additionally, GINA would stop both employers and insurers from requiring applicants to submit to genetic tests, maintain strict use and disclosure requirements of genetic test information, and impose penalties against employers and insurers who violate these provisions. The APA continues to support genetic nondiscrimination legislation.

PEDIATRIC DRUGS AND MEDICAL DEVICES

The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA): was reauthorized by Congress in 2007. The president signed the Food and Drug Revitalization Act of 2007 (P.L. 110-85) legislation into law on September 27. PREA gives FDA the authority to require pediatric studies of drugs for the on-label indication only, i.e., when the pediatric use for the product would be the same as the designated adult use. When PREA was codified in 2003, it for the first time, established the presumption that certain new drugs and biologics must be tested for children and be produced in formulations (e.g., liquids or chewable tablets) appropriate for children. BPCA provides an incentive to drug manufacturers of an additional six months of marketing exclusivity for conducting pediatric studies of drugs that the FDA determines may be useful to children.
Pediatric Medical Device Safety and Improvement Act of 2007: As part of the Food and Drug Revitalization Act of 2007 the Pediatric Medical Device Safety and Improvement Act of 2007 was included and as such was signed into law on September 27. The legislation provides incentives to the medical device industry to produce new pediatric devices by lifting restrictions on profit from the Humanitarian Device Exemption (HDE) and creating new consortia to stimulate device development from idea to marketplace. The law gives FDA additional regulatory mechanisms to track pediatric device needs as well as provide increased post-market surveillance for adverse events in children as recommended by IOM.