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American Pediatric Society & Society for Pediatric Research Public Policy Council |
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April–May 2006 Legislative Report |
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The
calendar may read April, but it is growing increasingly clear
that time may be the biggest impediment to Congressional action
on items of interest and importance to the pediatric community
this year. As it does every two years, the November mid-term elections
are quickly eating away at valuable Congressional business days,
as Members of Congress are increasingly anxious to return to the
district to campaign. President
Bush's poor approval ratings and the continued dissatisfaction
among the public on the War in Iraq, the price of gasoline and
immigration reform are weighing heavily on the minds of
Republicans, especially in the House, where Democrats are
showing uncharacteristic unity of message as they hope to regain
majority control. Of
course, the other challenge—and a perennial one at that— is
money. While not
legislatively binding, the President's annual budget proposal,
released every year on the first Monday in February, sets the
tone for the fiscal agenda and environment for child and
adolescent health advocates.
This year the tone is grave, at best.
In his FY 2007 budget proposal, released on February 6,
the President proposed $13.6 billion in cuts from Medicaid and
the State Children's Health Insurance Program over five years.
The President's budget also proposes to eliminate or decrease
funding for many other child and adolescent health discretionary
programs, including Children's Hospitals Graduate Medical
Education (CHGME) program, Title VII health professions training
grants, Emergency Medical Services for Children (EMSC) program,
and the National Children's Study (NCS). These devastating cuts
come on the heels of a child and adolescent health safety net
already compromised by the passage in February of deep spending
cuts to the Medicaid program by the House of Representatives. The pediatric community will be urging Congress in the
strongest possible voice that funding for health programs must
be sustained and increased in the FY 2007 budget and
appropriations process. 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)/FY 2006 and FY 2007 Appropriations:
Through its coalition work with the Ad Hoc Group for Medical
Research, the Public Policy Council (PPC) and the entire
pediatric community engaged heavily in the fight to encourage an adequate
increase for the NIH in FY 2006.
Unfortunately, after months of hard work and advocacy,
the House and Senate in the final days of an extended session of
Congress approved an FY 2006 Labor/HHS spending bill that
contained $28.6 billion for NIH - an increase of just $153
million over FY 2005, the lowest increase to the NIH (less than
1%), in more than thirty years. That small increase, however,
was essentially wiped out by a provision in the FY 2006 Defense
Appropriations bill - also approved in the final hours of the
Congressional session - that made a 1% across-the-board cut to
all non-defense discretionary spending.
Therefore, the FY 2006, current year funding for the NIH
is $28.4 billion reflecting a cut of $66 million. FY
2007: The President's FY 2007 budget proposal for NIH is
level funded at $28.4 billion. Through
its work with the Ad Hoc Group the PPC will continue to seek
adequate and appropriate increases in funding for the NIH. The
advocacy community request for FY 2007 is a 5 percent increase
above the FY 2006 funding level - $29.75 billion. We will also
continue to support an adequate funding level for the NICHD of
$1.35 billion including sufficient funding for and stability of
the National Children's Study. NIH
Reauthorization: There has been a good deal of discussion
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 strong interest
in reauthorizing the NIH and to this end is 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 or when
Congress will seriously address these concerns in the second
session of the 109th Congress. 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
further complicate the process as this moves forward in the
coming year. However,
at a congressional hearing earlier this year Chairman Barton
reiterated his commitment that the reauthorization of the NIH is
a top priority this year. National
Children's Study (NCS): The NCS continues to move forward,
however, the implementation of the study could be over before it
even begins if the president's proposed zero funding for the NCS
in FY 2007 is approved by Congress. Sufficient
funds previously 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 at best.
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 people, 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 NCS Advisory
Committee. There
are now seven Vanguard Centers that will pilot and complete the
first phases of the Study:
The
pediatric and adolescent medicine community will need to work
very hard to insure that the NCS is allowed to go forward and
that funding is available for the implementation of the study in
the fiscal year ahead. In this regard two recent Congressional
briefings - one on the Senate side sponsored by Senators Tim
Johnson (D -SD) and John Thune (R-SD) and the other sponsored by
Representatives Doris Matsui (D-CA), Jim Gerlach (R-PA) and
Stephanie Herseth (D-SD) were held. The pediatric community is
working in collaboration with the March of Dimes to support an
FY 2007 appropriation of $69 million. Further
information and updates are available at http://www.nationalchildrensstudy.gov. Pediatric
Research Loan Repayment: The NIH loan repayment program,
including pediatric and clinical research, continues to be a
successful and important option for early and mid-career
pediatric researchers. According to the NIH, over 500 new and
100 renewal applications were submitted to the Pediatric
Research LRP in FY 2004. Nearly 50 percent of the new
applications and more than 80 percent of the renewal
applications were funded. In FY 2004, more than 50 percent of
awards went to applicants with M.D. or M.D. /Ph.D. degrees. Also, half of the awardees were within 5 years of the receipt
of their doctoral degree. There
were 228 awards in FY 2004 for pediatric loan repayments in
contrast to 298 in FY 2003 and 168 in 2002.
It is very important that this program - which allows
eligible researchers and trainees supported by governmental
(including AHRQ) and private, nonprofit grants to apply to the
NIH for loan repayment - continue to be well publicized and
utilized by pediatricians to ensure ongoing funding for this
critical initiative. The
current extramural funding cycle is now closed.
Funding decisions will be announced in August 2006.
The next application will open in September 2006.
Additional information is available at http://www.lrp.nih.gov.
Publication
and Disclosure Issues in Clinical Trials: This topic
continues to be a high profile issue, due in part to the
problems with Vioxx and other drugs.
Senator Chris Dodd (D-CT) has reintroduced from the 108th
Congress the Fair Access to Clinical Trials (FACT) Act of 2005,
S. 470. 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 currently has six bipartisan co-sponsors.
On the House side, Reps. Henry Waxman (D-CA) and Edward
Markey (D-MA) reintroduced in June 2005, H.R. 3196, a bill that
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 as a condition of
obtaining Institutional Review Board (IRB) approval.
H.R. 3196 has 41 co-sponsors.
The PPC will monitor and work with the primary authors of
the legislation to make sure that the voice of the adolescent
research community is heard as this legislation moves forward in
the second session of 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 2007.
The President proposed level funding at $319 million for
AHRQ in FY 2006 and again for FY 2007, with all funds allocated
via transfers from other public health service agencies. The
funding is designated for health information technology and
patient safety ($84 million), $15 million for clinical
effectiveness research and $17.1 million available for new
non-patient safety research grants. There is also interest by
the Senate to reauthorize AHRQ before the end of this session.
AHRQ should have been reauthorized in 2005. Secretary's
Advisory Committee on Human Research Protections: 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. In
April 2005, 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 has submitted the recommendations in a letter to
HHS Secretary Leavitt. The next areas of consideration for the
subcommittee 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: In April 2005, the Committee on
Guidelines for Human Embryonic Stem Cell Research of the
National Research Council and the Institute of Medicine issued a
report that provides guidelines for the responsible practice of
human embryonic stem cell research. Some of the key
recommendations of the report include:
In
May 2005, the House
passed H.R. 810, the Stem Cell Enhancement Act of 2005, by a
vote of 238 to 194. The
bill—introduced in February 2005 by Reps. Mike Castle (R-DE)
and Diane DeGette (D-CO)—modifies 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 41
bipartisan cosponsors. On
December 16, the Senate unanimously passed the Stem Cell
Therapeutic and Research Act of 2005, which provides for the
collection and maintenance of cord blood units for the treatment
of patients and research, and to authorize the Bone Marrow and
Cord Blood Cell Transplantation Program to increase the number
of transplants for recipients suitable matched to donors of bone
marrow and cord blood. A number of Senators, including Sen. Tom
Harkin (D-Iowa), sought to amend the bill to include language
from the Castle/DeGette Stem Cell Research Enhancement Act (HR
810). Ultimately, the amendment was retracted, though the bill's
House sponsors and the Coalition for the Advancement of Medical
Research urged Senate Leadership to schedule a On
February 16, 2006, the National Academies' National Research
Council and Institute of Medicine announced that they were
convening a new committee to provide updated guidelines on the
conduct of human embryonic stem cell research. According to the
press release, the "committee will periodically update the
guidelines issued last year by the Academies to reflect advances
in stem cell science. The guidelines are voluntary and intended
to enhance the integrity of human embryonic stem cell research
by encouraging responsible practices." The Committee will
be funded by private sources, including the Ellison Medical
Foundation, the Greenwall Foundation, and the Howard Hughes
Medical Institute. 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. NIH
Conflict of Interest Regulations: In a Senate hearing held
last year, 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 pediatric
academic societies, along with the Society for Adolescent
Medicine, continue 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 some of these same
challenges will occur as the FY 2007 appropriations process
moves forward. NIH
Public Access: Last year, 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. There has been some interest among some Senators on
Capitol Hill in introducing legislation to make deposit of
manuscripts in PubMed Central mandatory (not elective) and
mandate a free access window of 6 months (instead of the current
12 months). Following
the series of stakeholder meetings hosted by the AAP, the
Elizabeth Glaser Pediatric AIDS Foundation, the National
Organization for Rare Disorders (NORD), the National Association
of Children's Hospitals, and the Advanced Medical Technology
Association last year, the pediatric community has continued
legislative efforts to increase the access and availability of
pediatric medical devices for neonates, infants, children, and
adolescents. On
November 1, 2005, AAP along with Elizabeth Glaser Pediatric AIDS
Foundation, the American Thoracic Society and NORD hosted a
briefing for Senate Health, Education, Labor and Pensions (HELP)
Committee staff on the need for pediatric medical devices.
The briefing was well attended and FDA regulatory
pathways for medical devices were discussed fully. Chaired
by PPC member Dr. Jon Abramson, the AAP has convened a Task
Force on Pediatric Devices,.
The two-year Task Force, which has six members, will
provide leadership and direction on issues surrounding the
safety and effectiveness of existing devices and promote the
development of new medical devices that address the needs of
children. Congressional
Activities: Senate
staff remains interested, and staff is optimistic, about the
development of legislation in the second session of the 109th
Congress to increase access to pediatric devices.
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: As in the past, the PPC
continues to work closely with the National Association of
Children's Hospitals (NACH) to advocate for the CHGME program.
The FY 2006 Labor-HHS-Education conference agreement
provided $297 million for the CHGME program (inclusive of the 1%
across the board cut). The
2007 proposed budget from the president would reduce funding for
this program by two-thirds, to $99 million.
The President also asks Congress to "reform"
CHGME by targeting the remaining CHGME funding to only
children's hospitals that have the greatest financial need,
serve the largest number of uninsured patients, and train the
most residents. With
this proposed change in mind, PPC will work closely with NACH to
ensure adequate funding, as well as protect the original
statutory functioning of the CHGME program. The pediatric
community is supporting funding for the CHGME in FY 2007 of
$330 million. Reauthorization:
Last July the Senate passed S.285, reauthorizing the CHGME
through FY 2010.
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.
Independent children's teaching hospitals represent less than
one percent of all hospitals but they train nearly 30 percent of
all pediatricians, half of all pediatric sub-specialists, and
the majority of the nation's pediatric research scientists.
They are also the safety net for the poorest children and
adolescents, the centers of excellence for the nation's sickest
children and adolescents, and the centers of research for
improving health care for all children and adolescents. The
House bill, H.R.1246, introduced by Representatives Nancy
Johnson (R-CT) and Deborah Pryce (R-OH), currently has 166
cosponsors. The members of the PPC will continue to work closely in
collaboration with NACH to secure final passage in the second
session of the 109th Congress. It is imperative that action is
taken swiftly on reauthorization in the House of Representatives
in light of the changes proposed by the Administration to the
CHGME. These changes include reducing funding dramatically and
targeting the remaining dollars to only children's hospitals
that have the greatest financial need, it is absolutely critical
that reauthorizing legislation be enacted as soon as possible. Title
VII - Appropriations: Once again, the Title VII program has
been a target for near-elimination by the Administration and
Congress. As in the previous four years, President's FY 2007
proposed budget removed all funding for primary care,
interdisciplinary community projects, and public health. The
President proposed only $10 million for the Title VII program.
As in previous years, Title VII also faces major funding
threats in Congress. Following
a tradition of the past several years, PPC is joining with the
health professions and nursing education community to continue
to 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 Academy supports the full
restoration of funding of the Title VII health professions
programs, which received $300 million in FY 2005. The PPC also
continues to advocate for adequate funding of at least $40
million for the general internal medicine/general pediatrics
provision of Title VII. 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 leadership efforts with the Health
Professions and Nursing Education Coalition, the PPC will push
for the restoration of funds for this small but vitally
important program. In
addition, staff is compiling examples of the real impact that
these severe cuts to Title VII will have on programs, providers,
patients, and communities. Title
VII - Reauthorization: The Title VII program was due to be
reauthorized in the 107th Congress (2002) but four years later
Congress still has not taken it up.
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 APA president and former chair of
the AAP's 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 2005. AAMC staff has
begun meeting with Congressional staff 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. The PPC can review the AAMC
proposal and recommendations at
http://www.aamc.org/advocacy/library/laborhhs/t7reauth.pdf. 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, 2005,
by Senator (now Governor) Jon Corzine (D-NJ) and has three
cosponsors. FY 2006/2007 BUDGET/APPROPRIATIONS FY
2006 - The Current Fiscal Year
On
November 17, the House of Representatives—somewhat
surprisingly—defeated FY 2006 Labor/HHS appropriations
conference report 224 to 209. The following day, the Senate
voted to send the bill back to a House-Senate conference
committee to reach an acceptable compromise.
While a number of factors contributed to the defeat of
the bill in the House, certainly one of the main reasons was the
bill's failure to fund critical health and education programs
adequately. For example the Maternal and Child Health Block
Grant was funded at $700 million a decrease of $24 million from
FY 2005. So, the
House and Senate resumed discussion, and on Tuesday, December
13, the House narrowly passed a slightly revised conference
agreement, with additional funding for rural health programs and
health professions (Title VII) to satisfy some of the 22 House
Republicans who voted with all of the Democrats against the
initial version. Because
the revised legislation still cut or froze many health and
education programs and provided the lowest increase to the NIH,
less than 1%, in more than thirty years, Senate passage proved
difficult. Finally,
a threat from Senator Arlen Specter (R-PA) to attach the
conference report to the FY 2006 Defense Appropriations bill—a
must-pass bill—the Senate on December 21 approved the FY 2006
Labor/HHS-Education Appropriations bill by voice vote, clearing
it for the President's signature on December 30, 2005—almost
three months after the new fiscal year began. FY
2007 - The Upcoming Fiscal Year President
Bush released his 2007 budget February 6 with a proposed $13.6
billion in cuts from Medicaid and the State Children's Health
Insurance Program over five years. The 2007 budget proposal came
just days after the 2006 budget reconciliation bill passed
Congress, which significantly cut Medicaid. The president's
budget also proposes to eliminate or cut funding for many other
child health programs, including Children's Hospitals Graduate
Medical Education (GME) program, Title VII health professions
training grants, Emergency Medical Services for Children (EMSC)
program, and the National Children's Study (NCS). The
president's budget is the first step in a months-long process
and is used as a blueprint for Congress to decide how to fund
programs. The Senate passed its version of the FY 2007 budget on
March 16, by a vote of 51–49.
Prior to the final passage, the senate approved an amendment, by
a vote of 73–27,
offered by Senators Arlen Specter (R-PA) and Tom Harkin (D-IA)
to provide an additional $7 billion in discretionary spending
over the budget resolution.
The Specter-Harkin amendment would provide an additional
$7 billion in funding for priority health programs, including
NIH, CDC, HRSA, SAMHSA and education and training programs. On a
straight party-line vote of 22–17, the House Budget Committee
approved its version of the FY 2007 version of the Budget
Resolution on March 29. However, it rejected an amendment
offered by Rep. Rosa DeLauro (D-CT) that was similar to the
Specter-Harkin amendment to increase by $7 billion health and
education programs. Despite passage at the committee level, the
House was unable to garner sufficient votes to bring the bill to
the House floor prior to the April recess (April 7 - 25). The
House leadership has indicated that they will try again when
they return to the Capitol at the end of April. The PPC will
continue to lobby Congress aggressively to sustain and increase
funding for child and adolescent health programs until the
process is (hopefully) finished in October. In this election
year, there is some hope that Congressional members will choose
to help children and adolescents. HEALTH
INSURANCE COVERAGE AND ACCESS TO CARE FY
2006 Budget Reconciliation - Medicaid/ SCHIP: The House and
Senate passed very different versions of a spending-cuts bill
(reconciliation) late last year.
The Senate bill did not hurt children on Medicaid, but
the House bill did. Just
before Christmas, the House-Senate conference agreement
(reconciling the two versions of the bill) came to a vote.
The House passed it by a vote of 212-206.
The Senate passed it 50-51, with Vice-President Cheney
casting the tie-breaking vote.
BUT, for technical reasons, the Senate deleted several
provisions, which meant the bill had to go back to the House for
an up-or-down vote. On February 1, 2006, the House of
Representatives passed the bill, known as the Deficit Reduction
Act of 2005 (DRA) (P.L. 109-171), by a vote of 216-214, and the
President signed it shortly thereafter.
The
legislation will change federal Medicaid law and allow states to
offer scaled-back benefit packages for children.
It will also let states charge children in poor families
premiums for Medicaid coverage, and fees for prescription drugs
and some medical services.
However, the legislation did add as an amendment the
Dylan Lee James Family Opportunity Act of 2005, introduced by
Senators Charles Grassley (R-IA) and Edward Kennedy (D-MA) and
Rep. Pete Sessions (R-TX) and supported by the full pediatric
and adolescent health community. This program establishes a
state option to allow families of children with severe
disabilities to purchase Medicaid coverage on a sliding premium
scale. However, with cuts to Medicaid, FOA will once again be
competing with Medicaid dollars. While
the pediatric community's work at the federal level will
continue on this issue, state governments will need to decide if
they want to adopt any of these Medicaid options.
The pediatric community will need to persuade their
governors and state legislators to reject the options, and
protect child health care coverage and services. A summary
document on the impact of the Deficit Reduction Act is available
from the American Academy of Pediatrics Division of State
Government Affairs: http://www.aap.org/moc/displaytemp/15042006141513.pdf.
Currently,
SCHIP is scheduled to be reauthorized in 2007.
The pediatric and adolescent medicine community will
monitor this issue closely and will work to protect this program
for near poor children, adolescents and their families. Medicaid
Commission: In July 2005, 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 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. The
Commission released its first report to Congress in September
2005, 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 limit the impact of cost-sharing
as included in the Deficit Reduction Act. The Medicaid
Commission most recently met on March 13 -15, 2006, and a second
report is expected on December 31 containing longer-term
recommendations on the future of the Medicaid program. MediKids:
In June 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 January 2005, Senator John Kerry
(D-MA) introduced the Kids Come First Act of 2005 (S.114). The
bill has ten cosponsors. This legislation is an effort to
provide affordable health insurance to all children and
adolescents up to 300 percent of the federal poverty level
(FPL), with an emphasis on reforms to Medicaid and SCHIP.
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.
The bill also includes outreach and enrollment efforts
that have long Association
Health Plans: In early 2005, Representative Sam Johnson
(R-TX) and Sen. Olympia Snowe (R-ME) introduced (S.406/H.R. 525)
the Small Business Health Fairness Act of 2005.
This legislation would allow AHPs, groups of small
employers that band together and purchase health coverage, to be
exempt from state regulation, oversight, mandates and would be
federally regulated by the Department of Labor. H.R. 525 passed
the House in July 2005. Although,
the Senate Committee on Health, Education, Labor, and Pensions
(HELP) has held a hearing regarding AHPs, S.406 faces stronger
opposition. On
November 2, 2005, HELP chairman Michael Enzi (R-WY) introduced
S. 1955, the Health Insurance Marketplace Modernization and
Affordability Act (HIMMA) of 2005, legislation that provides for
"Small Business Health Plans" that are very similar to
AHPs. S.1955 is opposed by the PPC and the pediatric community
on similar grounds as the AHP legislation - this legislation
would threaten the progress that has been made in ensuring that
insured children have appropriate access to preventive and
well-child care. The HELP Committee began mark-up of S. 1955 on March 8, and
approved the bill on a party-line vote on March 15. The pediatric and adolescent medicine community has been
activated in opposition to this harmful legislation, and urge
instead that Congress consider legislative solutions for small
business that will provide affordable quality health insurance
to these families such as that offered by Senators Dick Durbin
(D-IL) and Blanche Lincoln (D-AR) on April 6, 2006, S. 2510, the
Small Employers Health Benefits Program Act. Genetic
Information Nondiscrimination Act Of 2005: In February 2005,
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. Reps. Judy Biggert (R-IL), Louise Slaughter (D-NY),
Bob Ney (R-OH) and Anna Eshoo (D-CA) introduced the
Senate-passed bill in March 2005 in the House, and it currently
has 182 co-sponsors. This
strong bipartisan leadership is being leveraged to pressure the
House leadership to finally take up the legislation.
The pediatric societies have joined the Coalition for
Genetic Fairness, which was formed to push Congress to pass a
strong genetic nondiscrimination law, and is actively
participating in strategy and advocacy.
EMERGENCY
MEDICAL SERVICES FOR CHILDREN (EMSC): The
President's FY 2007 budget once again proposed completely
eliminating funding for the EMSC program.
The PPC vigorously and successfully opposed the
elimination of the program in FY 2006 and will do the same in FY
2007. The FY 2007 funding
request for the EMSC program is $25 million, and increase of $5
million above current level funding. 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
pediatric societies were among 32 organizations that signed a
letter to the Senate in early July supporting the Wakefield Act. The bill currently has 15 bipartisan cosponsors. Vaccine
Programs/Appropriations: The final House and Senate
conference agreement included $461.4 million for immunization
assistance to states and localities under the section 317
program, $4.9 million for vaccine tracking and $58.5 million for
prevention activities (including $1.49 million for expanded
vaccine safety research) for a total of $524.9 million. In
addition the Vaccines for Children (VFC) program, which is
funded through Medicaid, includes $1.5 billion in vaccine
purchase and distribution support for FY 2006. The
President's FY 2007 budget included $324.9 million for the
section 317 immunization programs, $4.8 million for vaccine
tracking, and $77.5 million for prevention activities, for a
total of $407.3 million for all immunization programs.
This reflects a proposed transfer of $100 million from
Section 317 to the Vaccines for Children program. This proposal
offered for the fourth time by the Administration continues to
be problematic for the Academy because it could leave the VFC
program vulnerable to modifications and mischief that will not
help children and adolescents. The Administration's budget
proposed legislative change to the VFC that would allow
underinsured children to receive VFC vaccines at public health
clinics. The VFC
mandatory program, at $2.1 billion, received increased funding
over FY 2006 to cover the newly recommended meningococcal
conjugate and hepatitis A vaccines. The Academy does not support this proposal for fear that
significant modifications could be made that would endanger the
entitlement that VFC provides similar to efforts that occurred
during the authorization of the VFC program in 1993. Thimerosal
Legislation: In July 2005, 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 73 cosponsors) and S. 1422 (no cosponsors) 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 joined by other organizations such as the Sabin
Vaccine Institute, Every Child By Two, and others continues to
oppose this legislation. Several states are also introducing
anti-thimerosal legislation. Local pediatricians are working
extremely hard to oppose passage of these state-based proposals. 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. The
activities on pandemic influenza continue to increase both in
Congress and for the Administration. The Administration's
pandemic plan (http://www.pandemicflu.gov/)
has been reviewed by many and at a recent meeting convened by
the Senate Minority Leader Harry Reid (D-NV),
and Senators Clinton, Obama, Dayton, Dorgan, and Harkin,
AAP president Eileen Ouellete, MD, JD attended and as is often
the case was the only participant to raise some of the important
issues related to children and avian flu. These issues included
the fact that first and foremost consideration should be given
to the needs of children right upfront (using the analogy of
the poor care children received during Hurricane
Katrina); what happens to sick parents who are not able to care
for their children; what if schools are closed but may need to
be open as an infirmary; hospitals will need additional staffing
if parents are ill and must bring their children with them or if
kids are sick what will parents need to do Also Dr. Ouellete
emphasized the need that pediatricians must be involved in the
early planning at the local level. Other participants at this
meeting included the AMA, IDSA, APHA, several vaccine
manufacturers, ASTHO and NACCHO. In addition, the Trust for
America's Health (TFAH) has convened a working group on the
pandemic that staff is participating in its meetings not as a
member but to ensure that the Academy remains connected to the
advocacy that is needed and necessary to ensure appropriate
funding for pandemic flu. TFAH has produced several brochures
entitled—"It's Not Flu as Usual"—with an emphasis
on health care providers, faith and community based
organizations and one that focuses on what businesses need to
know. STATE
OF THE ART PLENARY SESSION: Sunday, April 30, 2006, the
Public Policy Council and the Ambulatory Pediatric Association's
Public Policy Advocacy Committee will jointly sponsor a session
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. LEGISLATIVE
BREAKFAST: Monday, May 1, 2006, 7:00am, sponsored by the
Public Policy Council for all attendees 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, the 2004-05 AAP president
and former APA president. SPECIAL
SYMPOSIUM: Monday, May 1, from 12:15pm–1:15pm, The National
Children's Study: Status and Future Plans. The panel
presenters will discuss the current budgetary outlook, status of
the study, options to implement the study and respond to
questions from the audience. The panelists include: Duane
Alexander, Director, NICHD/NIH, Peter C. Scheidt, Director,
National Children's Study, NICHD/NIH, Alan R. Fleischman, Chair,
National Children's Study Federal Advisory Committee, New York
Academy of Medicine and NIH, and David Schonfeld, Chair, AAP
Committee on Research and Member, National Children's Study
Federal Advisory Committee. Elena Fuentes-Afflick, University of
California, San Francisco, a member of the Public Policy Council
will chair this session. 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 Priscilla Ring (pring@aap.org)
in the AAP Department of Federal Affairs at 800/336-5475.
Together we can make a real difference for children and
pediatricians! HOW TO CONTACT YOUR MEMBER OF CONGRESS: Write: The letter remains the most popular choice of communication with a congressional office. If you decide to write a letter, remember to be courteous, to the point, and include key information and examples to support your position. Address only one issue in each letter and, if possible, keep the length to one page.
Fax: Currently it is best to fax your letter to Congress. Fax numbers are available through the Capitol Hill Switchboard (202) 224-3121, or you can look up your members of Congress on "Thomas" the official website for Congress, available at http://thomas.loc.gov/, by going to "House Directory" or "Senate Directory" from the front page. Call: You can contact your Senator's and Representative's offices by calling the U.S. Capitol Hill Switchboard at (202) 224-3121. If you do not know who your Representative is, the switchboard operator will be able to direct you to the proper office. Ask to speak to the staff member who works on health care issues. Be prepared to leave a very short message as well as your name and address. You can also call your legislators in their home districts; information about local offices is available on the American Academy of Pediatrics' Members Only website, www.aap.org/moc. E-mail: All of members of Congress now have e-mail addresses, but there is no set format for them. On some members web sites there is a mechanism to directly email most notably if you are a constituent. We suggest calling the congressional office to get an accurate e-mail address or visit www.aap.org/moc the Members Only website of the AAP. HOW TO CONTACT THE PRESIDENT: Write: Call: 202-456-1414
Additional information and resource material on these and other pediatric and child health issues are available from:
Public Policy Council Members:
Report Submitted By:
April 17, 2006 |
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