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American Pediatric Society & Society for Pediatric Research Public Policy Council |
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November 2005 Legislative Report |
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Congress
returned from its Columbus Day recess to a very full plate.
Hurricane Katrina/Rita relief continues to impact the
timetable for many issues pending before Congress.
The calendar has been adjusted as hearings on the
government response to the disaster are continuing and the
annual spending process will be influenced and quite possibly
delayed as additional emergency funds are provided for victims
of Hurricane Katrina and spending is re-prioritized.
Finally, as partisan finger pointing continues, in
combination with already increased tensions that will accompany
the confirmation of the next Supreme Court Justice nominee
Harriet Miers, the scene is set for a fractious end to the first
session of the 109th Congress - one in which budgets are tight,
discretionary spending is limited, and mandatory programs such
as Medicaid remain extremely vulnerable. 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: National
Institute of Health (NIH)/Appropriations: During the FY 2006 budget
debate, an amendment to add $1.5 billion for the NIH was offered by Sen.
Arlen Specter (R-PA), but was not included in the final FY 2006 concurrent
budget resolution passed in April. The
House approved its FY 2006 spending bill, which included $28.507 billion
for NIH, an increase of $142.3 million (0.5 percent) in late June.
The Senate Appropriations Committee was able to provide a bit more
than the House—$29.415 billion—by using an accounting gimmick that may
or may not hold up when the House and Senate meet to work out their
differences in funding. Through
its work with the Ad Hoc Group for Medical Research Funding, the PPC will
continue to seek stability in funding for the NIH during the upcoming
senate floor debate. We will also continue to support an adequate funding
level for the NICHD of $1.35 billion including sufficient funding for the
National Children's Study. During
consideration of the FY 2006 appropriations bill in the House, several
amendments were offered and some accepted that would have targeted
specific grants within NIH for de-funding.
Offered by Representatives Ted Poe (R-TX) and Randy Neugebauer
(R-TX), the amendments would have cut funding for the NICHD "Milk
Matters" campaign and for two on-going grant projects funded through
NIMH respectively. The Academy is a partner in the "Milk
Matters" campaign. This is the third attempt in as many years that
some members of the House of Representatives have raised the prospect of
threatening to de-fund certain NIH grants they find
"objectionable"—an act that would seriously undermine the
peer-review process. The Poe
amendment was ultimately withdrawn. However, in a subsequent letter to the
director of the NIH, Rep. Poe requested that the director respond to
several questions including the program's effectiveness, as well as
"how many children could have been treated for a life threatening
disease with the money used to make the "Milk Matters" coloring
book?" and "how much money has NIH and/or the NICHD spent on the
campaign to date?" The House of Representatives adopted the
Neugebauer amendments by voice vote.
The PPC will work with others in the research community to
encourage the Senate to strip out the amendments when (and if) the House
and Senate go to conference on this appropriations bill. ACTION
NEEDED: Urge your Senators and Representatives to maintain and sustain
the investment in and adequate funding for NIH in the FY 2006 L/HHS/Education
bill by supporting the Senate Committee funding level of $29.415 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. Rep. Joe Barton (R-TX), the chair
of the committee of jurisdiction, the House Energy and Commerce Committee,
has indicated his interest in reauthorizing the NIH sometime this year and
to this end is currently circulating a draft reauthorization bill. In
general the draft legislation focuses on the organization and functions of
the Office of the Director of NIH and its relationship to the individual
NIH institutes and centers, provides enhanced authorities for strategic
planning and support of trans-institute initiatives and creates a detailed
series of reporting requirements covering research and other activities
supported by the NIH. The draft also eliminates several disease specific
authorizations for appropriations and reporting requirements. 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 complicated and contentious to
reach closure. National
Children's Study (NCS): The PPC continues to be very involved with and
participates in various aspects of this important national longitudinal
study. The PPC is working
with and taking a lead with other advocates, such as the March of Dimes,
to secure adequate and stable funding for the study.
While the President's budget proposal included $12 million in FY
2006 for the Study, the full cost for FY 2006 has been estimated to be at
least $70 million, assuming the initial sites have started to enroll
subjects. Sufficient funds
have been appropriated for the launch of at least three Vanguard Centers
and one Coordinating Center, but, beyond the final pilot work, the outlook
for funding of this important study is uncertain.
It is estimated that the total cost of the NCS over 25 years will
be between $2 - $3 billion. The membership of the reconfigured National
Children's Study Federal Advisory Committee includes several prominent
pediatricians including Myron Genel, MD, chair of the Public Policy
Council, former AAP president Antoinette P. Eaton, MD, Edward R.B. McCabe,
MD, PhD, David Schonfeld, MD, chair of the AAP's Committee on Pediatric
Research, and Alan Fleischman, MD, who chairs the Advisory Committee.
On September 29 a press briefing was held to announce that
contracts have been awarded to six Vanguard Centers to pilot and complete
the first phases of the Study:
The
federal agencies sponsoring the Study are still negotiating to establish ACTION
NEEDED: Urge your Senators to support at least $70 million for the NCS
in FY 2006. Contact all members of the House and Senate to convey the
importance of this comprehensive longitudinal study. 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 current extramural funding cycle began September 1, 2005.
Additional information is available at http://www.lrp.nih.gov. Publication
and Disclosure Issues in Clinical Trials:
The issue of publication and disclosure in clinical trials is one
that Congress still remains interested in.
Senator Chris Dodd (D-CT) reintroduced the Fair Access to Clinical
Trials Act of 2005 (FACT), 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 six 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."
At the end of June, Representatives Henry Waxman (D-CA) and Edward
Markey (D-MA) reintroduced H.R. 3196, a bill similar to the bill
introduced in the 108th Congress. The bill would expand on the National
Library of Medicine's www.clinicaltrials.gov
database. Sponsors would be required to register all privately and
publicly funded studies of drugs, biologics, or medical devices with
safety or effectiveness endpoints. The registry will not include drug or
biologic studies designed solely to detect major toxicity (phase 1
studies) and pharmacokinetic studies other than those in special
populations. Studies must be registered as a condition of obtaining
Institutional Review Board (IRB) approval.
H.R. 3196 has 35 co-sponsors.
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 proposed 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.
On June 24, the full House approved the House Appropriations
Committee's recommendation for level funding—$319 million—for AHRQ
again in FY 2006. The
Senate Appropriations Committee approved its bill in July, proving $323.6
million for AHRQ. Secretary's
Advisory Committee on Human Research Protections (SACHRP): The
Secretary's Advisory Committee on Human Research Protections (SACHRP) has
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 meeting in April, 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
under this section. 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. The next areas of consideration for the subcommittee,
as discussed at the most recent meeting in August, are issues of parental
permission and child assent, as well as further clarification of terms and
decision-making challenges found within section 46.405 such as placebo
controlled and vaccine trials involving children.
Additional information, including its charter and the pediatric
subcommittee roster, can be found on the SACHRP's website, at http://www.hhs.gov/ohrp/sachrp/index.html. Embryonic
Stem Cell Research: On
May 24, 2005, the House passed H.R. 810, the Stem Cell Enhancement Act of
2005, by a vote of 238 to 194. The
bill—introduced on February 16, 2005, by a Reps. Mike Castle (R-DE) and
Diane DeGette (D-CO)—seeks to modify the current stem cell policy,
established in August 2001, by expanding the number of stem cell lines
that are eligible for federally funded research.
A companion Senate bill, S. 471, introduced by Senators Arlen
Specter (R-PA) and Tom Harkin (D-IA), currently has 40 bipartisan
cosponsors. The pediatric
community, working as part of a broad coalition of patient and research
advocacy groups, is urging Senate action on this bill this year.
However, it was recently announced that due to other pressing
Senate business a vote is not expected until 2006.
Of course it is anticipated that even if both the House and the
Senate approve an embryonic stem cell bill, President Bush has indicated
his intent to veto the measure. In addition, while the debate continues in
Congress, several states have or are contemplating introducing stem cell
legislation following the success of the 2004 California stem cell ballot
initiative. In
the meantime, in April, 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:
The
PPC will continue to be involved in efforts with the pediatric research
societies and others 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. ACTION
NEEDED: Urge your Senators to cosponsor and support S. 471, the Stem
Cell Research Enhancement Act. NIH
Conflict of Interest Regulations: In a Senate hearing held in April,
key Senators indicated that some adjustments must be made in the conflict
of interest regulations that NIH Director Elias Zerhouni, MD announced in
February. 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 forbid
6,000 top NIH employees from holding stock in pharmaceutical or
biotechnology companies, and require current stockholders in the group to
sell their shares. Other agency employees must divest by the same date any
holdings that exceed $15,000 in value for a particular company. During the
hearing Senator Harkin told NIH Director Elias Zerhouni
"[t]hey are too onerous, and they must be redone, soon before
you lose more people. I think we've gone overboard." Senator Specter
added that the committee would recommend ways to loosen the rules. In
addition, Secretary of Health and Human Services Michael Leavitt also
indicated that these regulations might need to be reviewed, in light of
the numerous comments received on the interim final ethics regulations.
Accordingly, to allow time for this review and consideration, the
deadlines for filing supplemental financial disclosure reports was
extended to October 3, 2005, and the deadline for divesting financial
interests prohibited under the regulation announced in February has moved
to January 2, 2006. 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 as well as the Society for Adolescent Medicine 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 is now in effect, 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. IOM
Committee on Clinical Research Involving Children: In 2003 the IOM
convened a Committee on Clinical Research Involving Children to review and
consider federal regulations, federally prepared or supported reports,
federally supported evidence-based research, and other sources of
available information related to research involving children. The
pediatric societies presented testimony at the IOM's public forum.
The Committee, chaired by Richard Behrman, MD, finished its work,
and released its report - The Ethical Conduct of Clinical Research
Involving Children - to Congress at a briefing held in March 2004. A copy
is available on line http://books.nap.edu/catalog/10958.html. There
are several members of Congress who remain interested in crafting
legislation to implement some of the recommendations made in the IOM
report. These include the need for pediatric expertise on IRBs, the
collection and reporting of data, developing best practices when involving
children in clinical research and the education of researchers,
institutions, families and patients involved in clinical research. Pediatric
medical devices remains a very active issue both within Congress and the
Administration, as well as 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, the National Organization for Rare Disorders, the National
Association of Children's Hospitals, and the Advanced Medical Technology
Association hosted a series of four invitational meetings, which also
included representatives from the Food and Drug Administration, National
Institutes of Health, and Institute of Medicine, to discuss pediatric
device availability and needs during the summer and fall of 2004.
Jon Abramson, MD, represented the AAP and PPC at the meetings,
which focused on several specific areas:
data collection and information sharing; administrative and
regulatory issues; and market capacity and incentives.
Other issues such as reimbursement and liability were also touched
on. The AAP has convened a
Task Force on Pediatric Devices, chaired by Dr. Abramson, that will sunset
in two years. Congressional Activities: Senate staff remains interested, and PPC staff are optimistic, about the development of 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 any legislation is comprehensive and adequately addresses the needs of pediatricians and their patients. 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.
Spearheaded by the National Association of Children's Hospitals,
the PPC, AAP, and the entire pediatric community sought an increase in
funding for FY 2006 of $309 million.
In June the House of Representatives responded favorably, approving
the Appropriations Committee's recommendation to restore funding for CHGME
to $300 million (as did the Senate Committee in July), close to current
level funding. Plans are now
well underway for the FY 2007 funding recommendations. Reauthorization:
In July the Senate passed S.285 (originally introduced by 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 in the 108th Congress. 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 to children's hospitals for expenses
associated with operating approved graduate medical residency training
programs. The House bill, H.R.1246, introduced by Representatives Nancy
Johnson (R-CT) and Deborah Pryce (R-OH), currently has 152 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 Grants/Appropriations: As
in the previous four years, President's FY 2006 proposed budget removed
all funding for primary care, interdisciplinary community projects, 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. Unfortunately,
the House followed suit with major cuts to the Title VII program.
The House Appropriations Committee reported out and the House
passed its FY 2006 Labor-HHS bill, which provided only $47 million for all
of Title VII - in the form of diversity programs such Scholarships for
Disadvantaged Students. Training
in Primary Care and Dentistry was eliminated.
The full House approved the Committee's recommendations in late
June. In July, the Senate
Appropriations Committee approved its bill, which provided most Title VII
programs with level funding, with the notable exception of Primary Care
Training, which received a $1.2 million increases over FY 2005 - to $90
million, thanks in large part to the advocacy efforts of the pediatric and
child health community. Following
a tradition of many years, the pediatric community continues 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 is pushing for at least restoring the funding
to current levels. The PPC continues to advocate for adequate funding of
at least $40 million for the general internal medicine/general pediatrics
provision of Title VII. ACTION
NEEED: Urge your legislators to continue to maintain and support
adequate funding for health professions education and training programs,
in particular $40 million for general internal medicine/general
pediatrics. Describe specific
examples of its importance in faculty development and to
training/educating more pediatricians in a variety of ambulatory and
community-based settings. In addition, if you have information about the
impact on the health of children and your community if these funds were no
longer available, that would be very important to convey to Congress. 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 to have ongoing discussions
with colleagues in the internal medicine community in anticipation of
possible reauthorization in the 109th Congress. Additionally, the
Association of American Medical Colleges (AAMC) assembled a committee of
physicians to review the mission and effectiveness of the Title VII
program, and make legislative recommendations for reauthorization.
Tom DeWitt, MD, former chair of the AAP Committee on Pediatric
Education, represented the pediatric community at the committee's
inaugural meeting in January 2005, and presented several recommendations
for the program, including supporting primary care and interdisciplinary
training, and increasing the number of primary care professionals from
underrepresented minority groups. The group issued its six recommendations
in June, and has begun meeting with Congressional staff in the coming
weeks to see how best to proceed with releasing the report to Congress.
The AAMC is interested in outside organizations endorsing their
recommendations which includes proposing a new structure for Section 747,
in which grants are preferentially awarded to applicants who enter into a
formal relationship and submit a joint application with a Federally
Qualified Health Center (FQHC), an FQHC Look-Alike, Area Health Education
Center (AHEC), or a clinic located in a Health Professions Shortage Area (HPSA)
or Medically Underserved Area (MUA) or a clinical practice setting in
which at least 40 percent of its patients are either uninsured or
supported by Medicaid. In the months ahead the PPC will review this and
the other proposed recommendations. Resident
Hours: In March
2005, Rep. John Conyers (D-MI) reintroduced the "Patient and
Physician Safety and Protection Act of 2005" (H.R. 1228).
The bill establishes specific limits on work hours, allows
residents to file anonymous complaints regarding violations, and imposes
financial penalties for noncompliance. Specifically, the bill limits
postgraduate trainees to 80 hours of work per week and 24 hours of work
per shift. They must have at least 10 hours between scheduled shifts, at
least one of every 7 days off, and at least one full weekend off per
month. The bill also limits on-call responsibilities to no more than every
third night. H.R. 1228 offers
whistleblower protections to individuals who report violations to HHS,
ACGME or hospital management, and subjects hospitals to penalties of up to
$100,000 for violations in each resident training program in any 6-month
period. The bill—which has
no cosponsors—has been referred to the House Energy and Commerce
Committee's Health subcommittee. A Senate companion bill, S. 1297, was
introduced on June 23 by Senator Jon Corzine (D-NJ) and has three
cosponsors. FY 2006 BUDGET/APPROPRIATIONS FY
2006 Budget: The
vast differences in spending and tax cuts in the House and Senate budget
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 pursuant to
Hurricane Katrina have been granted additional time - October 26, 2005 -
to submit their plans for cutting mandatory spending and legislative
changes. Moreover, it is possible that Congress may not be able to
complete work on reconciliation at all this year. 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. FY
2006 Appropriations: At
the end of June, the House of Representatives approved the FY 2006 Labor/HHS/Education
spending bill (H.R.3010) adopting the funding levels recommended by the
House Appropriations Committee a week earlier. The number of programs that
were cut or received essentially level funding is a reflection of the
inadequate allocation the Labor/HHS/Education subcommittee received.
Among the "highlights" in the House bill are several
programs that received level funding (a relative good thing in this
current environment) or even slight increases:
EMSC, CHGME, NIH, and AHRQ.
On
July 14, the Senate Labor/HHS/Education Committee reported its FY 2006
bill, which contained - thanks to an accounting "gimmick" that
creates an additional, albeit temporary, pot of money from which to draw -
some increases above the House-passed bill. NIH, EMSC, MCH, and AHRQ all
saw some funding increases in the Senate bill.
One program of note was Title VII, which received level funding,
with the notable exception of Primary Care Training, which received a $1.2
million increase over FY 2005 - to $90 million.
With Congress preparing for the confirmation hearings of Supreme
Court nominee Harriet Miers this fall, the legislative calendar continues
to be in flux, leaving the outlook for action on appropriations somewhat
uncertain at this time. In
the meantime, the first of what could be several continuing resolutions (CRs),
which fund the federal government at FY 2005 levels, was passed to give
Members of Congress through mid-November to complete its work on the
remaining appropriations bills. ACTION
NEEDED: Contact your Member of Congress and urge them to support the
highest level of funding for child and public health programs important to
your community, including biomedical and health services research,
independent children's hospital GME, mental health, programs addressing
infectious diseases, and substance abuse prevention and treatment
programs. HEALTH
INSURANCE COVERAGE AND ACCESS TO CARE President's
FY06 Budget Proposal for Medicaid/ SCHIP: The President's FY 2006
budget proposal, included $60 billion in mandatory spending reductions
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. During the Senate budget debate in the spring there was some
success 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. In
April, Congress passed the FY 2006 concurrent budget resolution.
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
PPC working with the AAP must remain actively engaged in the process and
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 late October 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 pediatric community is deeply involved in advocacy to protect
Medicaid, and has activated federal and state advocacy networks through
the FAAN and Key Contact programs and through AAP chapters collaborating
with members of AMSPDC to strongly urge lawmakers to protect Medicaid for
children. Specifically, members of Congress are urged to preserve the
Early and Periodic Screening, Diagnosis and Treatment (EPSDT) program and
to not impose cost-sharing for children and pregnant women.
As of this writing the situation remains very fluid. The
President's FY 2006 budget outline also included a proposal to move up the
reauthorization of SCHIP. Currently,
SCHIP is scheduled to 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. Medicaid
Commission: On July 8, Secretary of Health and Human Services Mike
Leavitt, announced the members of his Medicaid Commission. It includes 13
voting members and 15 non-voting members with an additional two governors
to be added later. The advisory commission is charged with outlining
recommendations for Medicaid to achieve $10 billion in reductions in
spending growth during the next five years as well as ways to begin
meaningful long-term enhancements that can better serve beneficiaries. The
Commission, which held its first two meetings in late summer, is chaired
by former Tennessee Governor Don Sunquist, and former Maine Governor Angus
King serves as the vice chair. Among the non-voting members are AAP
immediate past president Carol Berkowitz, MD and James Anderson, president
and CEO of Cincinnati Children's Hospital Medical Center.
On September 1, the Commission released its first report to
Congress, suggesting ways to realize the $10 billion in savings.
While most of the recommendations did not impact children
negatively, there is concern that a proposal to add cost-sharing (co-pays)
for prescription drugs could pose a significant burden to pregnant women
and families with children. The
pediatric community is working aggressively with Congress to preserve
EPSDT and keep cost-sharing out of the equation. MediKids:
On June 23, 2005, The MediKids Health Insurance Act of 2005 was
reintroduced in the 109th Congress by Rep. Pete Stark (D-CA) in the House
(H.R. 3055), and Sen. John Rockefeller (D-WV) in the Senate (S. 1303). The
bill creates 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
House bill currently has 43 cosponsors; the Senate bill has five.
Kids
Come First Act of 2005: In late January, Senator John Kerry (D-MA)
introduced the Kids Come First Act of 2005 (S.114). The bill has nine
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
Immigrant Children's Health Insurance Act legislation).
Importantly, the legislation also provides for an increase in
pediatric provider payments under Medicaid.
Family
Opportunity Act (FOA): Senators Charles Grassley (R-IA) and Edward
Kennedy (D-MA) and Rep. Pete Sessions (R-TX) have reintroduced the
pediatric community supported Dylan Lee James Family Opportunity Act of
2005 (S. 183/H.R. 1443). This
program establishes a state option to allow families of children with
severe disabilities to purchase Medicaid coverage on a sliding premium
scale. The House bill has 54
cosponsors; the Senate bill has 55. Several legislative options have been
offered during this 109th Congress for FOA. Senator Grassley proposed
adding it in during the budget reconciliation process.
However, with slated cuts in Medicaid, FOA would once again be
competing with Medicaid for dollars.
Senator Kennedy has expressed his intention to find an alternative
legislative vehicle for FOA and find non-Medicaid funding offsets, but
with the clock ticking, the predicted solution is still very much up in
the air. Association
Health Plans (AHPs): The Small Business Health Fairness Act has been
reintroduced this Congress in the form of S.406/H.R.525. The House bill
passed in late July prior to the August congressional recess. 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 work with other groups 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: In February, the Senate by
a vote of 98 - 0, passed 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. 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, which has 153
cosponsors, 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 vigorously opposes the elimination and strongly supports at least $20
million in FY 2006, which is current year funding for this important
program. The House Appropriations Committee's Labor-HHS bill, which the
full House approved on June 24, included an allocation of
$19 million, while the Senate Appropriations Committee provided $20
million. Reauthorization: The Senate has introduced legislation to reauthorize the EMSC program for five years. S.760, the Wakefield Act, when reauthorized would allow the EMSC program to carry out its existing initiatives and address gaps in care through its survey and planning process. The APS, SPR, and AMSPDC were among 32 organizations that signed a letter to the Senate in early July supporting the Wakefield Act. 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. The House Labor-HHS bill and the Senate
Appropriations Committee bill included $531 million for immunization
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. The House passed and the Senate Appropriations Committee
approved FY 2006 funding level is $531 million and $510 million
respectively. Thimerosal
Legislation: In July, Sen. Chuck Hagel (R-NE) introduced a Senate
companion, S. 1422, to a bill introduced in the House by Representatives
Dave Weldon (R-FL) and Carolyn Maloney (D-NY), H.R. 881, to amend the
Federal Food, Drug, and Cosmetic Act to reduce human exposure to mercury
through vaccines. The Mercury Free Vaccines Act of 2005 is similar to
legislation introduced in the 108th Congress. Both H.R. 881 (with 70
cosponsors) and S. 1422 are awaiting committee and floor action.
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. In the past two years, over 20
states have introduced legislation banning thimerosal in vaccines and six
states have passed legislation. Based on the scientific data, including
several IOM reports, the pediatric community continues to oppose this
legislation. Vaccine
Supply: Senators Evan Bayh (D-IN), Larry Craig (R-WY) and Mary
Landrieu (D-LA) have reintroduced legislation (S.375) to address issues
surrounding the manufacture, distribution, and supply of influenza
vaccine, as has Sen. Hillary Rodham Clinton (D-NY), S. 1828.
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. The PPC will continue to monitor any such efforts. Plans
are now under way for the 2006 PAS meeting. The Public Policy Council and
the APA's jointly sponsored state of the art plenary session is entitled
New Resident Work Hours and Quality Care—Synergistic or Antagonistic?
Confirmed speakers include: David Leach, MD, Executive Director of ACGME;
Doug Jones, MD, representing the Residency Review Committee for
Pediatrics; and Ted Sectish, MD, pediatric program director at Stanford
University Medical School. Richard Behrman, MD Executive Chair, Pediatric
Education Steering Committee, Federation of Pediatric Organizations will
moderate this session. The
Monday, 7:00 a.m., Legislative Breakfast, sponsored by the Public Policy
Council for all members of the PAS meeting, is entitled, "Medicaid
"Reform:" Can We Preserve Our Children's Safety Net?" with
a presentation by Medicaid Commission member Carol Berkowitz, MD, former
APA president and the 2004–2005 AAP president. Also
on Monday, tentatively scheduled for 12 noon, there will be an update and
progress report on the National Children's Study provided by Alan
Fleischman, MD, Ethics Advisor, National Children's Study, NICHD/NIH and
others from NICHD. Elena Fuentes-Afflick, MD, MPH will chair this session. Please
note that the APS-SPR website (www.aps-spr.org)
has posted the PowerPoint presentations from the 2005 Public Policy
Council/APA State of the Art Public Policy Plenary session, "Clinical
Trial Registries: Challenges and Opportunities," as well as the
Legislative Breakfast on Stem Cell Research. 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 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: Call: 202-456-1414 2006 CONGRESSIONAL CALENDAR (to come)
Additional information and resource material on these and other pediatric and child health issues are available from:
Public Policy Council Members:
Report Submitted By:
October 22, 2005 |
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