Pediatric
Research
National Institute of Health (NIH)/Appropriations: The Public Policy Council (PPC) continues to work with the other biomedical research advocates including Research!America and the Association of American Medical Colleges (AAMC) to support the Ad Hoc Group for Medical Research Funding’s recommendation of a 16.5% increase for NIH in FY 2002 as the fourth installment in doubling the NIH by 2003. The PPC also supports and continues to advocate for adequate funding - $1.7 billion in FY 2002 - for the National Institute of Child Health and Human Development (NICHD). The President’s budget proposes $23.1 billion a 13.4 percent increase ($2.75 billion) over current year funding of $20.3 billion for FY 2002, bringing the NIH budget to $23.1 billion.
NIH/Legislation: Early in this first session of the 107th Congress, Senators Arlen Specter (R-PA) and Tom Harkin (D-IA) introduced the Biomedical Revitalization Resolution of 2001, S. Res. 19. Rep. George Gekas (R-PA) introduced a companion bill in the House as H.Res. 72. The resolution expresses the Sense of the Senate and the Sense of the House that the funding for the NIH should be increased by $3.4 billion in FY 2002 with the goal of doubling NIH funding by fiscal year 2003. The Senate bill currently has 15 bipartisan cosponsors and the House bill has 27 cosponsors. The PPC supports both resolutions.
In July, the House Energy and Commerce Committee approved the Biomedical Research Assistance Voluntary Option Act, H.R 1340, a bill introduced by Health 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.
Pediatric
Research Initiative: The Children’s Health Act of 2000, P.L. 106-310 (H.R. 4365), signed into law by former President Clinton on October 17, 2000, 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.” The Act specifies that the NIH Director in consultation with the Director of the NICHD and the Administrator of the Health Resources and Services Administration will head the initiative. 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.” According to the FY 2002 Bush budget proposal, the NIH “plans to spend $28 million to award 261 contracts for loan repayments to extramural scientists engaged in pediatric and clinical research.” This amount is contingent on congressional appropriations and the PPC is working to ensure that funding is available for the coming fiscal year. Additional information on the loan repayment program is available on the NIH web site at www.lrp.nih.gov.
In FY 2002, the Pediatric Academic Societies and the Academy have joined the National Association of Children’s Hospitals in supporting the recommendation of $50 million for the Pediatric Research Initiative and sufficient funding for the pediatric training grant and pediatric research loan repayment programs.
National Human Research Protections Advisory Committee: The children’s workgroup on Subpart D (45 CFR Part 46) held a meeting in March convened by the Office of Human Research Protections Greg Koski, MD and children’s workgroup chair, Alan Fleischman, MD, FAAP through the National Human Research Protections Advisory Committee. This workgroup, which includes three members of the PPC, Drs. Myron Genel, Christine Gleason and Jon Abramson, concluded that existing regulations could be significantly improved by providing additional guidance on the issue of “minimal risk.” The workgroup felt additional commentary, as well as specific examples, could be provided to better illustrate what constitutes “minimal risk” for both healthy and non-healthy children. In addition, the workgroup raised serious concerns about the National Bioethics Advisory Commission (NBAC) position on “minimal risk,” noting that if instituted, the NBAC’s policy would jeopardize research options and participant-peer recruitment. In the summer following another meeting, the NHRPA children’s workgroup report was released to Congress. In addition to its above conclusions the children’s workgroup made three recommendations citing the need for further guidance to: “clarify certain terms in Subpart D such as “minimal risk, provide instructions to IRBs regarding the interpretation and application of the definition of minimal risk and directions regarding payments that may be provided to children.” Additional information on the Office of Human Research Protections can be found at
http://ohrp.osophs.dhhs.gov.
Stem Cell Research/Federal Regulations: On July 12 the NIH issued a “Clarification on the Use of NIH Funds Relevant to Human Embryonic Stem Cell Derivation.” It emphasizes that investigators “may derive human pluripotent stem cells from embryos in a university laboratory only if no NIH funds are used in support of the laboratory, its equipment, personnel working on the project, and/or building infrastructure costs usually charged to indirect cost.” Also in July, at the request of the White House, the NIH prepared a comprehensive stem cell report entitled “Stem Cells: Scientific Progress and Future Research Directions.” The report provides a review and an analysis of the scientific literature on stem cell research. The president considered the findings of this report in his deliberations and eventual decision. It is available at
http://www.nih.gov/news/stemcell/index.htm.
On August 9, 2001, after many months of public debate President Bush addressed a national television audience to announce his decision regarding federal funding for stem cell research. Under Bush’s new policy, federal funds can be used to support research of existing stem cell lines only, not for the creation of new lines. According to the NIH there are approximately 60 existing stem lines at this time. In this way, Bush reasoned that the federal government could support promising research without supporting the destruction of new embryos. The NIH Office of Science Policy indicated that the initial guidelines governing embryonic stem cell research would be replaced by the four conditions specified by President Bush in his August 9th speech. These conditions are that: “the cells were derived before that date, that donors gave informed consent, the cells must come from excess embryos created solely for reproductive purposes and donors were not offered financial inducement.” Bush also called for the creation of a new President’s Council on Bioethics to oversee embryonic stem cell research and its bioethical implications. Bush named Dr. Leon Kass, a professor at the University of Chicago and a member of the university’s Committee on Social Thought, as chair of the Council. Kass, a trained physician and biochemist, testified at a July 2001 House Judiciary Subcommittee on Crime hearing on cloning that it may be possible to “avoid the morally and legally vexing issues in embryo research” by “pouring our resources into adult stem cell research.” The White House fact sheet on stem cells can be found at
http://www.whitehouse.gov/news/releases/2001/08/20010810.html.
While Bush’s new position is not a complete ban on federally funded stem cell research, it falls short of the desire of many in the biomedical research community including the Public Policy Council and the American Academy of Pediatrics (AAP) who recently issued policy statement on stem cell research. The AAP policy, issued in July 2001, supports federal funding for human embryo research on stem cells derived from frozen embryos created during the process of in vitro fertilization. The policy statement does not support the creation of embryos for research purposes. The PPC similarly supports federal funding for stem cell research. A copy of the AAP policy statement can be found on the Academy’s web site at www.aap.org.
Stem Cell Research/Legislation: 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 83 co-sponsors. The PPC, along with many others in the biomedical research community, endorsed a similar measure that was not acted upon in the 106th Congress.
In April, Senators Arlen Specter (R-PA) and Tom Harkin ( D-IA) reintroduced legislation to authorize federal funding for research using embryonic stem cells. The bill has 18 cosponsors. 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.
In August, Representatives Diana DeGette (D-CO) and Jim Ramstad (R-MN) introduced legislation 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.
Following President Bush’s decision on stem cell research, the Senate Health, Education, Labor and Pensions Committee announced that it may hold a hearing to discuss both the Specter-Harkin legislation and the proposed recommendations offered by Sen. Bill Frist (R-TN) who has indicated his support for federal funding for stem cell research. The hearing could take place as early as September 5, 2001. It is anticipated that this will continue to be a hotly debated issue in Congress for the remainder of this session of Congress possibly through next year.
Agency for Healthcare Research and Quality (AHRQ)/Appropriations: Congress provided $270 million in funding for AHRQ in FY 2001 - $51 million more than that agency received in FY 2000 and $20 million more than President Clinton had requested in his budget proposal. The $270 million figure included an earmark for programs designed to reduce medical errors. The President’s budget includes $306 million for AHRQ in FY 2002. However, these funds are derived solely from transfers of evaluation funds. The PPC as a member of the Friends of AHRQ is requesting $400 million for AHRQ in FY 2002. This proposed funding request will support additional investigator initiated grants as well as additional funding for patient safety.
Reauthorization of the Pediatric Studies Provision Within the Food and Drug
Administration Modernization Act (FDAMA):
The Senate Committee on Health, Education, Labor and Pensions reported out
S. 838, the Best Pharmaceuticals
for Children Act on August 1. This marks an important step forward in getting Congress to
reauthorize an extraordinarily successful law that is achieving more
and better therapeutics for children. The bipartisan S. 838 was introduced by Senators Christopher
Dodd (D-CT) and Mike DeWine (R-OH) and reauthorizes the pediatric studies provision that provides a 6 month incentive to pharmaceuticals
who conduct pediatric studies that have been requested by the Food and Drug Administration. The pediatric studies provision will expire on January 1,
2002 unless Congress reauthorizes it.
The bill, endorsed by the Public Policy Council, was
reported out of Committee with only a technical modification. The next step is for consideration by the entire Senate. Several Senators indicated they would like to offer amendments
to the legislation when it moves to the Senate floor for debate. The pediatric community has
interest in some of the proposed changes and concerns over others, but
plans to work with Senators to ensure that the progress made by the pediatric drug studies provision is not sacrificed.
The House of Representatives has not yet introduced legislation to reauthorize the pediatric studies provision. Members of the House have indicated they are interested is
seeing how the Senate bill develops before moving forward on their own legislation.
GME Financing in Children’s Hospitals/Appropriations:
The Public Policy Council joined the Ambulatory Pediatric Association, the American Academy of Pediatrics and the National Association of
Children’s Hospitals (NACH), continues to support graduate medical
education funding for independent children’s hospitals at the fully
authorized and equitable amount of $285 million in FY 2002. Pediatric department chairs have been working very closely with
NACH in communicating to key members of the House and Senate
appropriations committee the importance of funding for independent
children’s hospitals.
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 10 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 HR 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: The PPC, APA and the Academy have joined the Health Professional and
Nursing Education Coalition (HPNEC) in requesting at least $440 million for Titles VII and VIII in FY 2002. This figure represents the first step in a two-year effort to increase funding to $550 million, which HPNEC members have determined
to be necessary for the programs to improve the quality, geographic distribution and racial/ethnic diversity of the public health care
workforce, particularly in underserved communities. Of this $440 million, the pediatric and internal medicine
communities support $35 million for the General Pediatrics and General Internal Medicine programs. Titles VII and VIII received $353 million in FY 2001.
President Bush’s FY 2002 budget provides only $140 million for the Titles VII and VIII programs – a proposed 60 percent decrease. Supporting documentation justifies the cut by arguing that the programs "were created almost forty years ago when a
physician shortage was looming. Today a physician shortage no longer exists." >Instead, the Administration proposes "focusing resources
on the Health Professions' grants that address current health workforce supply challenges, such as the impending nursing shortage
and improving diversity in the health professions." Intensive advocacy is underway to ensure that the President’s cut does not stand and adequate federal funding for the programs is restored.
Carol Carraccio, MD, FAAP (President of the Association of Pediatric Program Directors) and Bob Englender, MD, FAAP represented the pediatric community at a congressional advocacy day in support of the Title VII and VIII
programs on May 16, 2001. Drs. Carraccio and Englender receive Title VII funds for pediatric training and education programs at the University of
Maryland, School of Medicine. PPC staff and two 3rd year pediatric residents from Howard University
School of Medicine also represented the pediatric community at a July briefing for congressional staff on Titles VII and VIII. Staff will continue efforts to ensure adequate funding for
these programs in FY 2002.
Appropriations: Prior to its month long summer recess and district work period the House passed nine out of 13 appropriations bills and the Senate passed only five. Most notably the Labor/HHS/Education FY 2002 appropriations
bill has not moved through committee in either the House or the Senate. This is the bill that includes key federal funding issues that
effect the pediatric academic community such as NIH, AHRQ, MCH Block Grant, GME etc. Congress is scheduled to do so in September. However,
it is anticipated that once again Congress will miss the beginning of the new fiscal year – October 1 - deadline for passage of this bill.
Throughout this process, the PPC will continue to urge members of Congress to provide adequate funding for a range of child health
programs that improve the lives of children and adolescent such as, biomedical and health services research including funds for NIH loan repayment programs, graduate medical education for independent children’s hospitals and health professions education and training programs.
The Maternal and Child Health (MCH) Block Grant program received $714 million in FY 2001, a very modest $4 million increase over FY 2000. The PPC, APA, Academy, and several other MCH Block Grant
advocates are recommending that Congress appropriate the fully authorized amount of $850 million for the MCH Block Grant program in
FY 2002. The President’s budget proposal includes $709 million for FY 2002.
Vaccine Safety/Congressional Hearings To date Representative Dan Burton (R-IN), Chairman of the House Government Reform Committee,
has held one hearing in this Congress entitled “Autism – Why the Increased Rates? A One Year Update.” However, it is rumored although it is unclear what form it
might take that a hearing by Rep. Burton’s Committee could be held on the pneumococcal vaccine as well as a hearing on thimerosal in vaccines, the latter possibly following the release of the IOM report on vaccines and thimerosal. This report is scheduled to be released in the early fall.
Vaccine Programs/Appropriations: Despite modest increases in funding in FY 2001, the CDC’s Section 317 immunization program continues to face significant challenges, including critical infrastructure needs and the high cost of new
vaccines. It received $553 million in funding for childhood immunization programs in FY 2001. The PPC working with the Academy
continue its strong support for the childhood immunization program by requesting at least $752.5 million for CDC’s Section 317 immunization program in FY 2002. This includes an additional $69
million above the Administration’s request for CDC’s global immunization initiatives that, if appropriated, would provide funding for polio eradication and the elimination of measles and rubella in FY
2002. It also includes $6 million above the Administration’s request for vaccine safety and $32.5 million for state operations/infrastructure as recommended by the Institute for
Medicine’s 2000 report Calling the Shots. The FY 2002 Bush budget proposal includes $575 million for section 317 and $796 million for the Vaccines for Children Program.
Institute of Medicine Immunization Safety Review Committee: The IOM established an independent expert committee to review
hypotheses about existing and emerging immunization safety concerns. Marie McCormick, MD, ScD, FAAP, chairs the IOM Immunization Safety Review Committee. The Committee issued its first report on MMR and
Autism on April 23, just days before the congressional hearing chaired by Rep. Dan Burton (R-IN). A hearing in July in Boston was held on the
topic of the hypothesized link between thimerosal-containing vaccines and select neurodevelopmental disorders. The IOM report on that
hearing is scheduled for the early fall. A future meeting is scheduled for November. The topic for that hearing has yet to be determined.
Legislation: In August Senators Dick Durbin (D-IL) and Jack Reed (D-RI) introduced S. 1297, the "Comprehensive Insurance Coverage of Childhood Immunization Act of 2001."
If passed, S. 1297, would ensure that all health plans cover the recommended childhood and adolescent immunizations.
On the House side Congresswoman Jane Harman (D-CA) along with 32 cosponsors introduced HR 2701 a companion bill to Senator Diane Feinstein’s (D-CA) S. 573, a bill to amend title XIX of the Social Security Act to allow children enrolled in the State children's health insurance program to be eligible for benefits under the pediatric vaccine distribution program.
MediKids: On Thursday, May 3, AAP President Steve Berman, MD, joined Senator John Rockefeller (D-WV) and Representative Pete Stark (D-CA) in Washington,
DC to introduce the “MediKids Health Insurance Act of 2001” (H.R. 1733/S 827) which will insure all children, adolescents and young adults. Currently, MediKids has 45 cosponsors in the House and three
cosponsors in the Senate.
This legislation would automatically enroll all newborns into one national health care plan called MediKids regardless of family income. Parents can decline MediKids and choose private insurance or
public insurance (Medicaid or State Children’ Health Insurance Program) if they qualify. The legislation offers a comprehensive, age appropriate benefit package, and a physician payment schedule that is comparable to Medicare. If enacted, all children and young adults through age 22 would
be insured within 5 years.
Managed Care
Bipartisan Patient Protection Act: The House and Senate have passed separate versions of the Bipartisan Patient Protection Act, comprehensive managed care legislation endorsed by the PPC and the Academy. The bills, H.R. 2563 and S. 1052 respectively, contain
identical protections for children, including the right of parents to select pediatricians as primary care providers, guaranteed access to
pediatric specialists, equal access to emergency care for all children, and the inclusion of pediatric expertise on review panels. However, the two versions vary significantly on the issue of
liability. Consequently, a House and Senate conference is required before final action on the
bill can occur.
The Senate passed S. 1052 by a vote of 59-36 on July 29, 2001, following two weeks of intense debate. While the House took up a similar version as H.R. 2563 on August 2, 2001, it approved the measure 226-203 only after adopting an amendment offered
by Rep. Charlie Norwood (R-GA) that dramatically limited the bill’s liability provisions. Most notably, the amendment - which many in the medical community,
including the American Academy of Pediatrics, opposed - places a higher burden on patients than plans during the appeals process and
establishes new constraints for external and independent reviews. House Republicans faced tremendous pressure from the White House and party leaders to vote for the amendment, which was offered as a compromise to avoid a presidential veto. At the final count, the amendment was narrowly approved
218-213.
The pediatric community was extremely active in ensuring that the pediatric provisions of S. 1052/H.R. 2563 passed both the House and Senate intact. These efforts
will continue as House and Senate conferees work to reconcile the bills and move these important patient protections into law.
Medicaid Managed Care Regulations: The Center for Medicare & Medicaid Services (CMS) (formerly HCFA – Health Care Financing Administration) announced on August 17, 2001,
that it was delaying for the third time the effective date of its new regulations for Medicaid Managed Care. Originally issued on January 19, 2001, these regulations would
establish new access standards, new protections to ensure the coverage of emergency services, new rights to grieve denials of care, and new administrative oversight procedures for Medicaid managed care plans.
How
To Contact Your Member of Congress:
The remainder of the August recess and early fall provides an excellent opportunity to contact your members of Congress, both in your District and in Washington, DC. The following provides you the necessary information to make these contacts. Also
consider using the district work periods (Congressional recess) to invite your member of congress (and/or their staff) to your facility, office or community-based pediatric program. The congressional recess schedule is listed below.
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.
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To a Senator:
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To a Representative: |
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The Honorable (name)
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The Honorable (name) |
|
United States Senate
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United States House of
Representatives |
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Washington, DC 20515
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Washington, DC 20515 |
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Dear Senator:
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Dear Representative: |
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. This may not be the quickest or most effective mechanism to contact members offices because of the incredible volume of e-mails Congressional
offices receive and each office's response to e-mails varies greatly. However, there are some members of Congress and a great number
of congressional staff who appear to prefer e-mails and once you have an established a relationship with the office and staff this may prove to be an expeditious and efficient means of communication.
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
2001
Congressional Calendar (District Work Period)
| Aug 6-Sep 5 |
Congress not in session
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| Oct 5 |
Target adjournment
No target adjournment for Senate |
Additional information and resource material on these and other pediatric and child
health issues are available from:
|
Karen M. Hendricks, JD
Washington Coordinator
KHendricks@aap.org |
Molly A. Hicks, MPA
Legislative Assistant
MHicks@aap.org |
601 13th Street, NW
Suite 400 North
Washington, DC 20005
ph: 800/336-5475
fax: 202/393-6137 |
Public Policy Council Members:
|
APS |
Myron Genel, MD
Jimmy Simon, MD |
| SPR |
Ora Pescovitz, MD
Christine Gleason, MD |
AMSPDC
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Russell Chesney, MD
Jon Abramson, MD |
Report Submitted By:
Myron Genel, MD, Chairman
Karen M. Hendricks, JD, Washington Coordinator
Molly A. Hicks, MPA, Legislative Assistant
August 2001
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APS/SPR Home Page |