The following is an update and summary of recent federal legislative and regulatory activities of interest to the pediatric academic community. Congress still has much work to do on the annual appropriations bills, as well as several measures related to the terrorist attacks of September 11^th.   Therefore, it remains a good time for members of the American Pediatric Society, Society for Pediatric Research and the Association of Medical School Pediatric Department Chairs to make your views heard on Capitol Hill.

This report includes information on the following issues: 

• Pediatric Research

• Reauthorization of the Pediatric Studies Provision

• Pediatric Workforce

• FY 2002 Appropriations

• MCH Block Grant

• Bioterrorism

• Immunizations

• Managed Care

• How to Contact Congress/White House

National Institute of Health (NIH)/Appropriations: The House-passed version of the FY 2002 Labor, Health and Human Services, and Education (L/HHS) appropriations bill includes $22.874 billion for NIH.  While the full Senate has not yet taken up the bill, the Senate Appropriations Committee has approved $23.695 billion for NIH in FY 2002. The Senate amount reflects the next step in doubling the NIH budget by FY 2003. The Public Policy Council (PPC) will continue to work with the other biomedical research advocates including Research!America and the Association of American Medical Colleges in support of the highest possible funding level for NIH in FY 2002.

The PPC also will continue to advocate for adequate funding the National Institute of Child Health and Human Development (NICHD).  The House-passed and Senate Appropriations Committee L/HHS appropriations bill included $1.08 billion and $1.12 billion, respectively, for NICHD in FY 2002.

NIH/Legislation: In July, the House Energy and Commerce Subcommittee on Health approved legislation introduced by Subcommittee Chairman Rep. Michael Bilirakis (R-FL) to allow taxpayers to designate part or all of their federal income tax refunds for use in biomedical research conducted through the NIH.  The Biomedical Research Assistance Voluntary Option Act, H.R. 1340, currently awaits action by the full Energy and Commerce Committee, as well as the Committee on Ways and Means.  To date, no companion legislation has been introduced in the Senate.

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

The Senate Committee report includes specific language supporting funding for the pediatric research loan repayment program in FY 2002 but does note “particularly in the areas of Duchenne muscular dystrophy and fragile X.” Although the House Committee report does not include any language on the loan repayment program, the PPC is working with congressional staff to ensure that funding is available for all pediatric researchers.

In addition, both reports asked NIH to provide a status report on the Initiative by April 2002 (in the Senate) and at the FY 2003 appropriations hearing (in the House).  The House Report also requested data on the number of applications for NIH’s Clinical Research Loan Repayment Program by May 2002, as well as the number and size of awards made by September 2002. 

The PPC will continue to work to ensure that strong language in support of the Pediatric Research Initiative is included in the final FY 2002 L/HHS appropriations bill.

Stem Cell Research/Legislation: The House-passed and Senate Appropriations Committee FY 2002 L/HHS appropriations bills include significant – and significantly different – language regarding stem cell research.  Where the Senate Appropriations Committee “urges the NIH to move quickly to support all types of stem cell research, including embryonic, adult, and cord blood, and to keep the Committee informed of the research progress,” the House urges NIH to “move ahead expeditiously to implement the President’s policy concerning support of scientifically meritorious research involving both adult and human embryonic stem cells.”  The Senate Committee Report also includes language that would provide federal funding for the adoption of human embryos.  As noted, the full Senate has not yet taken up the measure.  A final decision on the stem cell language is expected to be hammered out in Conference.

Beyond the appropriations debate, Representatives Carolyn Maloney (D-NY) and Connie Morella (R-MD) reintroduced a resolution, H. Con. Res. 17, supporting federal funding of pluripotent stem cell research. The bipartisan resolution currently has 84 co-sponsors.  The PPC,  along with many others in the biomedical research community, endorsed a similar measure that was not acted upon in the 106^th Congress.

Senators Arlen Specter (R-PA) and Tom Harkin (D-IA) also have reintroduced legislation to authorize federal funding for research using embryonic stem cells. The bill, S. 723, would permit federally funded scientists to extract stem cells from embryos that have been donated from in-vitro fertilization clinics, a practice not permitted under current law.  The bill calls for the expansion of the existing NIH guidelines governing human embryonic stem cell research to include rules that govern the derivation of stem cells from donated embryos.

And, Representatives Diana DeGette (D-CO) and Jim Ramstad (R-MN) introduced legislation in August that would permit NIH to fund research using human pluripotent stem cells from embryos and fetal tissue. H.R. 2747, the Stem Cell Research for Patient Benefit Act of 2001, if passed, would give NIH the authority to conduct or support the research in accordance with the guidelines finalized by NIH in November 2000.

Agency for Healthcare Research and Quality (AHRQ)/Appropriations: The House approved $306 million for AHRQ in FY 2002 – a $36 million increase over FY 2001 – while the Senate Appropriations Committee provided $291 million.  Unlike the House, however, the Senate’s funding comes through the appropriations process and not by “tapping” other funding within the Public Health Service.  As noted, the full Senate has not yet taken up the L/HHS appropriations bill.  Once that action occurs, all remaining funding difference will be addressed by House and Senate conferees.  The PPC will continue to support the highest possible funding level for AHRQ in FY 2002.

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

The Senate passed the S. 838, the Best Pharmaceuticals for Children Act, on October 18, 2001.  As passed, the bill would:

• Extend the FDA pediatric studies provision through October 1, 2007;

• Establish an Office of Pediatric Therapeutics within the FDA;

• Establish both a public (funded by the federal government) and a private (funded through charitable contributions via the pharmaceutical industry, associations, etc.) research fund for the study of off-patent drugs and on-patent drugs that have received a written request to do pediatric studies but have not acted on those written requests;

• Require that Prescription Drug User Fees (PDUFA) are paid by industry for both on and off-patent pediatric studies (this is not the case in current law);

• Designate pediatric drugs as "priority supplements" which triggers a goal of 6 months for the FDA to review pediatric labeling supplements submitted by the company;

• Establish a timeline for achieving labeling changes within 11 months for those drugs that may not be labeled within 6 months.  If the company does not agree the labeling change request by the FDA and Advisory Pediatric Committee, then the Commissioner may deem the drug misbranded;  

• Clarify that pediatric age groups in which pediatric studies are to be performed in response to written requests should include neonates when their inclusion is appropriate;

• Require the FDA to make public a summary of the medical and clinical pharmacology reviews of the pediatric studies within 6 months after a drug manufacturer has submitted pediatric labeling change proposals to the FDA;

• Clarify that the 6-month exclusivity available via the pediatric studies provision does not overlap with the exclusivity a generic drug company receives under the Hatch-Waxman law;

• Clarify that a generic drug may come onto the market without pediatric use information.  However, the FDA may require that the generic drug include in the label a statement of any appropriate pediatric contraindications, warnings or precautions the FDA considers necessary.  (This addresses Bristol Myers efforts to extend the length of exclusivity beyond 6 months);

• Require an IOM study of federal regulations involving children in research; and

• Require the FDA to report to Congress by January 31, 2007 on the pediatric exclusivity program;

The House is expected to take up its version of the bill in late October or early November.  The PPC will continue its strong advocacy with the AAP on passage of this important legislation this year.

Pediatric Workforce

GME Financing in Children’s Hospitals/Appropriations:  Although the House approved and passed $285 million for Children’s Hospitals GME in FY 2002 – the fully authorized amount – the Senate Appropriations Committee provided less – $243 million  – for the program in FY 2002.  As noted, the full Senate has not yet taken up the L/HHS appropriations bill.  Once that action occurs, all remaining funding difference will be addressed by House and Senate conferees.  The PPC will continue to advocate for full funding – $285 million – for this program in FY 2002.

GME/Legislation: During this session of Congress several bills have been introduced to improve payments for direct graduate medical education. Early in the year Sen. Dianne Feinstein (D-CA) introduced, the Direct Graduate Medical Education Improvement Act of 2001, S. 135. It would increase the payment of the floor for the locality adjusted national average per resident amount of direct graduate medical education (DGME) payments.  This floor would be phased in over five years - starting at the current 70% of average in FY 2001 and reaching 100% in FY 2006.  No action has occurred on the bill since its introduction, and no companion measure has yet been introduced in the House. The bill currently has 11 cosponsors.

In April, Senator Jack Reed (D-RI) along with Senators Hillary Rodham Clinton (D-NY) and Charles Schumer (D-NY) introduced S. 743, legislation to establish a Medical Education Trust fund to support medical schools and teaching hospitals.  The bill is modeled after legislation introduced by Sen. Daniel Patrick Moynihan (D-NY) in 1999. Recognizing that all sectors of the health care system should share the responsibility to fund graduate medical education, the bill requires Medicare, Medicaid, and private payers - through a 1.5 percent assessment of all health insurance premiums - to pay into the fund.  Within the trust fund, five accounts would be created: the Medical School Account; the Medicare Teaching Hospital Direct Account; the Medicare Teaching Hospital Indirect Account; the Non-Medicare Teaching Hospital Indirect Account; and the Non-Medicare Teaching Hospital Direct Account. Teaching hospitals would apply to the Secretary of Health and Human Services for funds related to direct and indirect costs of graduate medical education. Payments to teaching hospitals from the Medicare accounts would be based on Medicare's current formula for direct and indirect graduate medical education payments. Payments to teaching hospitals from the Non-Medicare accounts would use Medicare's same formula for determining direct and indirect graduate medical education payments, but would substitute the hospitals' Medicare volume with the hospital's non-Medicare volume.

During the summer, Rep. Ben Cardin (D-MD), along with 16 cosponsors, introduced H.R. 2178, the All Payer Graduate Medical Education Act.  This legislation establishes a trust fund to finance private payers contributions to GME while continuing the Medicare, Medicaid and veterans health care programs’ commitments to physician training through their current GME financing mechanisms.

Titles VII and VIII-Health Professions Training Grants/Appropriations: While the President requested only $140 million for the Titles VII and VIII programs in FY 2002 –a 60 percent decrease from FY 2001 – both the House and Senate Appropriations Committee provided modest funding increases in their respective appropriations bills.  Specifically, the House provided $385 million and the Senate Appropriations Committee provided $353 million for Titles VII and VIII in FY 2002.  The programs received $353 million in FY 2001.  The PPC will continue to work with others in the medical community to ensure adequate funding for these programs in FY 2002.

FY 2002 Budget/Appropriations

Appropriations: While the House approved its version of the FY 2002 L/HHS appropriations bill on October 9^th, the full Senate has not yet taken up the measure, which was approved by the Senate Appropriations Committee on October 11^th.  Although the numbers are not yet final, the House-passed and Senate Appropriations Committee figures represent increases for several programs of interest to the pediatric community, including:

• NIH – The House provides $22.874 billion for NIH in FY 2002, while the Senate Appropriations Committee provides $23.695 billion.  NIH received $20.361 billion in FY 2001;
• AHRQ – The House provides $306 million for AHRQ in FY 2002, while the Senate Appropriations Committee provides $291 million.  AHRQ received $270 million in FY 2001;
• CDC – The Senate Appropriations Committee provides $4.419 billion for CDC in FY 2002, while the House provides $4.077 billion.  CDC received $4.121 billion in FY 2001;
• HRSA – The House provides $5.691 billion for HRSA in FY 2002, while the Senate Appropriations Committee provides $5.519 billion.  HRSA received $5.576 billion in FY 2001; and
• SAMHSA – The House provides $3.132 billion for SAMHSA in FY 2002, while the Senate Appropriations Committee provides $3.074 billion.  SAMHSA received $2.957 billion in FY 2001.

The full Senate is expected to take up the bill in late October.  Once that occurs, House and Senate conferees will work out the remaining funding differences in Conference prior to final passage and Presidential approval.  

Maternal and Child Health Block Grant

President Bush requested only $709 million for the MCH Block Grant program in FY 2002, $5 million less than the program received in FY 2001.  While both the House and Senate Appropriations Committee rejected the proposed cut, they disagreed on how much of an increase the program should receive in FY 2002.  Specifically, the House provided $740 million (a $36 million increase), while the Senate provided $719 million (a $5 million increase).  The PPC, working with other Title V supporters, will continue to advocate for the highest possible funding level for the MCH Block Grant Program in FY 2002.

Bioterrorism

Vaccine Programs/Appropriations:  The Senate Appropriations Committee provided $637 million for childhood immunization programs in FY 2002, while the House approved $600 million.  As noted, the full Senate has yet to take up the FY 2002 L/HHS Appropriations bill. The two chambers will meet in conference to resolve this and other funding differences once the Senate passes the bill.

Vaccine Coverage/Legislation: Two bills have been introduced this session to increase vaccination rates among children and adolescents.  First, Senators Dick Durbin (D-IL) and Jack Reed (D-RI) have introduced the Comprehensive Insurance Coverage of Childhood Immunization Act of 2001, S. 1297, to ensure that all health plans cover the recommended childhood and adolescent immunizations.  Second, Senator Diane Feinstein (D-CA) and Representative Jane Harman (D-CA) have introduced a bill S. 573/H.R. 2701 to allow children enrolled in the State children's health insurance program to be eligible for benefits under the pediatric vaccine distribution program.  To date, neither measure has received any action since being introduced.

New IOM Report on Vaccine Safety:  In an October 2001 report entitled Thimerosal-Containing Vaccines and Neurodevelopmental Disorders, the IOM concluded that no evidence currently exists that proves a link between thimerosal-containing vaccines and autism, attention deficit-hyperactivity disorder (ADHD), and speech and language delay.  The report emphasized both the remarkable value of vaccines in disease prevention and the importance of public trust in vaccine safety.  The report also made strong recommendations for expanded public health and biomedical research to assure that public trust is based on sound science.  Copies of the report are available online at www.nap.edu.

Managed Care

Medicaid Managed Care: When President Bush took office on January 20, 2001, he delayed the effective dates all federal regulations that had not yet gone into effect so that his staff could complete thorough policy reviews.  One of the regulations that was delayed was a January 19, 2001, final rule on Medicaid managed care.  During its review of the rule, the Bush Administration identified several key changes it felt had to be made to increase state flexibility and improve implementation.  The Center for Medicare & Medicaid Services (CMS) subsequently incorporated these changes and re-released the material on August 21, 2001, as a new Notice of Proposed Rulemaking.

The PPC joined the Academy and others in the pediatric community in submitting comments to CMS about this new proposal on October 19, 2001. Among other things, these comments raised concerns about proposed language to: eliminate federal guidance and timelines regarding the assessment and care of special needs populations; weaken appeals and grievance options available to participants; remove many of the information disclosure requirements placed on plans; and minimize cultural competency obligations.  The comments also raised concerns about the proposal to split Prepaid Health Plans into Prepaid Inpatient and Prepaid Ambulatory Health Plans.  CMS is expected to review all public comments on the proposed regulations before taking further action next year.  A copy of the comments are available on the Academy’s Members’ Only Channel at www.aap.org/moc.

How To Contact Your Member of Congress:

Recent anthrax threats on Capitol Hill have led Congress to halt delivery of all mail to congressional offices until the risk of future threats can be sufficiently minimized.  As a result, contact with Members of Congress currently is limited to phone calls, emails and faxes.   The remainder of the congressional schedule will be a busy time; legislators must still complete work on many of the 13 annual appropriations bills, as well as several other pieces of legislation.  As such, members of the PPC are still encouraged to contact their Members of Congress by phone, email or fax. At this time, it is anticipated that Congress will remain in session until Thanksgiving.

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 switch board 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.

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 web site of the American Academy of Pediatrics. 

How To Contact the President:

Write:
The Honorable George W. Bush
The White House
1600 Pennsylvania Avenue
Washington, DC 20500

Call: 202-456-1414

Fax: 202-456-2461

Email: president@whitehouse.gov 

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

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

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