Washington Highlights: March 27,
2009
House, Senate Begin Work on FY 2010 Budget
Contents
Prior Issues
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The House and Senate Budget committees each March 26 approved their
respective versions of a budget blueprint for FY 2010.
The House Budget Committee passed (24-15) an FY 2010 budget resolution
that allows $533 billion in non-emergency, non-defense spending.
This level represents an 8.8 percent increase over FY 2009 (not
including funds provided in the economic recovery package), but
is $7 billion below the President's budget request. According
to committee Chair John Spratt (D-S.C.), the committee's budget
will support President Obama's goals of halving the deficit by 2013
and funding "critical initiatives" in energy, education,
and health care.
Such initiatives include a reserve fund to support Medicare physician
payment system reforms that "change incentives" to promote
efficiency and quality, "improve payment accuracy" (including
"appropriate compensation" for primary care), improve
care coordination, and make providers "accountable" for
quality and utilization. The reserve fund cannot exceed $87.3 billion
over 5 years/$285 billion over 10 years. The budget resolution also
includes a reserve fund for health care reforms that "may include"
quality improvement, cost reduction, and public/private coverage
expansions.
The legislation contains budget reconciliation language instructing
the House Ways and Means Committee (which oversees the Medicare
program) to identify by Sept. 29, $1 billion in savings over 5 years.
The House Energy and Commerce Committee (which oversees Medicaid
and Medicare Part B) must identify a similar level of savings.
Additionally, the budget resolution includes a "Sense of the
House on Promoting American Innovation and Economic Competitiveness."
The provision states that the "resolution builds on significant
funding provided in the American Recovery and Reinvestment Act for
scientific research," through funds provided under the "Health"
function and other functions of the budget resolution.
The Senate Budget Committee similarly passed (13-10) an FY 2010
budget resolution that "preserves the major priorities in President
Obama's budget." The Senate version permits $525 billion in
non-emergency, non-defense spending, a 7.0 percent increase over
FY 2009 non-recovery spending, but $15 billion below the President's
proposed level.
A committee-prepared overview
of the "Chairman's Mark" includes reserve funds for health
care reform and changes in Medicare physician reimbursements (levels
not specified), but does not contain reconciliation instructions.
However, in his opening remarks,
committee Chair Kent Conrad (D-N.D.) urged his colleagues to "insist"
that any changes to Medicare physician reimbursement "be paid
for."
The overview also acknowledges funding provided for the National
Institutes of Health (NIH) in the American Recovery and Reinvestment
Act (P.L.
111-5). According to the document, the "Chairman's Mark
continues to support funding for NIH in 2010 including support for
cancer research." The summary further pledges "funding
for the Health Professions program and the National Health Service
Corps to increase the number of health professionals practicing
in medically underserved areas."
Chairman Conrad anticipated a Senate floor vote during the week
of March 30.
Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
Christiane Mitchell, Director, Federal Affairs
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526
AAMC, Health Professions Groups Outline Joint
Health Care Reform Principles
The AAMC March 27 joined 14 other health professions groups on
a statement
on health professions education in health reform. The statement,
coordinated by the Federation of Associations of Schools of the
Health Professions (FASHP), outlines the group's recommendations
for six principles that should be included in Congress's and the
Obama administration's efforts on health care reform.
Acknowledging that the group's members "will implement innovative
approaches to educate the next generation of providers who will
offer this team-based, patient-centered care," the statement
recommends:
- Increased access to high-quality, cost-effective, and patient-centered
care through existing or new public and private health insurance options.
- An emphasis on prevention and wellness.
- A stable funding source to maintain and expand the educational infrastructure
for a well-educated and trained health professions workforce.
- A stable investment to promote faculty development and address health
professions faculty shortages.
- Incentives to increase participation of underrepresented minorities
and the financially disadvantaged in health professions education,
as well as incentives to encourage all health professionals to practice
in rural and underserved areas.
- A mechanism to collect and analyze data on programs developed to strengthen
the health professions workforce.
Information:
Tannaz Rasouli, Senior Legislative Analyst
AAMC Government Relations
trasouli@aamc.org
(202) 828-0525
House Panel Investigates For-Profit IRBs
The House Energy and Commerce Subcommittee on Oversight and Investigations
March 26 held a hearing
on for-profit institutional review boards (IRBs). The focus of the
hearing was a General Accounting Office (GAO) "sting"
investigation, instigated at the behest of the committee, which
included creating a research protocol for a fictitious medical device
to approach IRBs for review and approval.
Subcommittee Chair Bart Stupak (D-Mich.) opened the hearing by
noting the committee "wanted to know whether IRBs are rubber
stamping research studies, whether clinical researchers are 'IRB
shopping' or choosing IRBs based on how quickly and inexpensively
they approve studies, and whether governmental oversight of IRBs
is adequate."
Gregory Kutz, Managing Director, GAO's Forensic Audits and Special
Investigations, provided a summary of GAO's investigation, which
also included creating a fake IRB, which it registered with the
Department of Health and Human Services (HHS), and then using this
registration to apply for and receive an HHS-approved assurance
for GAO's fictitious medical device company.
Daniel Dueber, Chief Executive Officer, Coast IRB, LLC, in Colorado,
accused GAO of fraud in investigating his company without probable
cause of the commission of a crime and of violation of federal and
state criminal laws. Coast IRB approved the bogus protocol for human
subjects testing after only minor edits of the falsified submission
materials.
Jerry Menikoff, M.D., J.D., Director, HHS Office for Human Research
Protections, and Joanne Less, Ph.D., Director, FDA's Good Clinical
Practice Program, testified on the procedures followed by their
respective offices.
Committee members criticized HHS and FDA for lax or non-existent
oversight. In his opening statement, Subcommittee Ranking Member
Greg Walden (R-Ore.) challenged the HHS officials, saying "[W]hat
in the devil is going on in your agency that allows you to think
you can ignore the law and regulations governing the adequacy of
IRBs and simply enter whatever is emailed your way and put the U.S.
Government stamp of approval on an IRB?" Rep. Joe Barton (R-Texas),
the ranking Republican on the full committee, asked Drs. Menikoff
and Less what their agencies "are prepared to do today to shut
down Coast IRB."
While the investigation and hearing focused on for-profit IRBs,
committee members, including Reps. Stupak, Walden, and Diana DeGette
(D-Colo.) spoke forcefully about the need to review the entire system
for approving experimental testing for humans and called for additional
legislation and regulation. Rep. DeGette noted that she reintroduced
her "Protection for Participants in Research Act" (H.R.
1715) on March 25. In a press release, Rep. DeGette said her
bill would:
- Make federal regulations applicable to all research that is in or
affects interstate commerce;
- Strengthen the education and monitoring of IRBs;
- Harmonize FDA regulations and the Common Rule, the two major sets
of federal regulations governing research participant protection;
- Strengthen protections against conflicts of interest by investigators
or IRB members; and
- Improve monitoring of research risks and reporting of adverse events
and unanticipated problems.
Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
NIH Director Testifies on Use of Recovery Funding
Raynard Kington, M.D., Ph.D., Acting Director of the National Institutes
of Health (NIH), March 26 told
the House Labor-HHS-Education Appropriations Subcommittee that the
agency is employing "a number of innovative strategies to quickly
and wisely invest" funds made available by the American Recovery
and Reinvestment Act (ARRA, P.L.
111-5). Emphasizing the essential role that medical research
plays in the economy, he expressed appreciation to the Congress
for "the continued trust that you place in NIH to make the
discoveries that will lead to better health for everyone."
He told the subcommittee that NIH is already hearing from principal
investigators about jobs that will be saved by supplemental funding.
Dr. Kington said NIH intends to use the ARRA funds to expand their
understanding of various diseases and to expand their efforts in
community based research. He described the Challenge Grants, which
have the largest RFA in NIH history. He also mentioned the Grand
Opportunity (GO) grants, which would be 2-year grants for large,
specific research topics (see related story). He
talked about various initiatives that would cross the NIH, and a
summer program for high school and undergraduate students, as well
as K-12 and community college teachers. He also mentioned a program
aimed at newly trained faculty, to help young investigators get
their first opportunities.
Dr. Kington explained the extramural construction funds would not
only create but also help ease the backlog of necessary construction
projects at research centers across the country. He did not provide
an estimate of how many jobs will be created by the construction
projects or by the research programs, except to say that each grant
leads to 6-7 jobs. He said that the increased reporting required
by ARRA will assist NIH in determining how many and what types of
jobs are created by NIH grants.
Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
NIH Announces "Grand Opportunity" Program, Other
ARRA Opportunities
The National Institutes of Health (NIH) March 23 announced a new
program entitled Research and Research Infrastructure "Grand
Opportunities," or the "GO" grant program (RFA-OD-09-004)
for projects with budgets greater than $500,000 a year. This program,
funded through the American Recovery and Reinvestment Act (ARRA,
P.L.
111-5), will support projects that address large, specific biomedical
and bio-behavioral research endeavors that will benefit from significant
2-year funds without the expectation of continued NIH funding beyond
2 years. Supported research should have high short-term impact,
and a high likelihood of enabling growth and investment in biomedical
research and development, public health, and health care delivery.
The total annual cost for individual awards is expected to vary,
depending on the nature and scope of the project and the number
of participating institutions. At least $200 million will be designated
by participating NIH Institutes and Centers in FYs 2009 - 2010 to
fund 200 or more grants.
A separate ARRA-related Funding Opportunity Announcement (FOA)
solicits
applications for proposals relevant to research on the heterogeneity
of Autism Spectrum Disorders (ASD). These FOAs will be supported
by ARRA funds, but will utilize RO1, R21, and R34 award mechanisms.
Additionally, NIH March 24 announced
that $21 million of ARRA funding for administrative supplements
to existing NIH grants over 2 years has been allocated for educational
opportunities in NIH-funded laboratories for students and science
educators. Investigators and institutions with existing NIH funding
will be able to apply for separate administrative supplements to
support meaningful research experiences for summer students and
science educators.
Information:
Irena Tartakovsky, Senior Science Policy Analyst
AAMC Biomedical and Health Sciences Research
itartakovsky@aamc.org
(202) 862-6134
NCRR Competitive Revision Application Information
Now Available
The National Center for Research Resources (NCRR) March 24 announced
a competitive revision application (formerly termed competitive
supplements) funding opportunity for NIH funded investigator-initiated
awards (R01, R33, R37, R21, U01) originally reviewed by the Center
for Scientific Review (CSR). These revision applications will support
new research objectives that are outside the scope of the approved
parent grant to include innovative research, training, outreach,
and networking through a partnership with NCRR Centers and Center-like
Programs in active research and resource/infrastructure projects.
NCRR intends to commit $20 million to this supplement program, with
up to $300,000 direct cost per individual award. To be considered,
all applications must contain the following title: "Enabling
RPGs to Leverage NCRR Center and Center-like Programs." Application
deadlines are April 21 and July 10.
Information:
Irena Tartakovsky, Senior Science Policy Analyst
AAMC Biomedical and Health Sciences Research
itartakovsky@aamc.org
(202) 862-6134
House Panel Continues Hearings on Health Reform
The House Energy and Commerce Health Subcommittee March 24 held
a hearing
entitled, "Making Health Care Work for American Families: Improving
Access to Care." This was the third in a series of five overview
hearings on health reform. The hearing explored racial, ethnic,
and geographic disparities in access to health care, and the role
of the health care workforce in addressing these disparities, with
particular emphasis on primary care. The hearing also examined the
role of Medicare, Medicaid, and medical liability reform in addressing
access and workforce issues.
In his opening statement,
Subcommittee Chair Frank Pallone (D-N.J.) stated, "Titles VII
and VIII of the Public Health Service Act are crucial programs to
increase the primary care workforce, and the National Health Service
Corps is a very successful program to entice young medical professionals
to practice in underserved neighborhoods." Full Committee Chair
Emeritus John Dingell (D-Mich.) indicated that loan forgiveness
and scholarship opportunities were important to ensuring access
to primary care practitioners.
Rep. Michael Burgess (R-Texas) noted that "the Association
of American Medical Colleges reports that the physician shortage
is expected to exceed 124,000 doctors by [2025]." Rep. Lois
Capps (D-Calif.) stated that "one of the barriers to access
today is a lack of health professionals" and stressed, "as
we talk about ways to improve access to everyone, let's talk about
what else we can be doing to educate more health professionals and
get them into the areas where they are needed most." Rep. Kathy
Castor (D-Fla.) highlighted the "arbitrary and out-dated [GME]
caps on physician resident slots."
Witnesses included:
- Brian D. Smedley, Ph.D., Vice President and Director, Health Policy
Institute, Joint Center for Political and Economic Studies;
- Michael John Kitchell, M.D., President-Elect of Iowa Medical Society,
McFarland Clinic PC;
- Michael A. Sitorius, M.D., Professor and Chairman, Department of Family
Medicine, University of Nebraska Medical Center;
- Risa Lavizzo-Mourey, M.D., M.B.A., President and CEO, Robert Wood
Johnson Foundation;
- Fitzhugh Mullan, M.D., Murdock Head Professor of Medicine and Health
Policy, Professor of Pediatrics, The George Washington University;
- Jeffrey P. Harris, M.D., F.A.C.P., President, American College of
Physicians;
- James R. Bean, M.D., President, American Association of Neurological
Surgeons; and
- Diane Rowland, Sc.D., Executive Director, The Kaiser Commission on
Medicaid and the Uninsured.
Witnesses and committee members agreed that reimbursement rates
play a key part in increasing access. There was a lack of consensus
among hearing participants on how to address Medical liability reform.
Witnesses' written statements and audio of the hearing are available
on the Energy and Commerce Committee website. The AAMC will submit
a statement for the record.
Information:
Matthew Shick, Senior Legislative Analyst
AAMC Government Relations
mshick@aamc.org
(202) 862-6116
President Names HHS Assistant Secretary for Health
President Obama March 25 announced
his intent to nominate Howard Koh, M.D., M.P.H. as Assistant Secretary
for Health at the Department of Health and Human Services (HHS).
Dr. Koh is the Harvey V. Fineberg Professor of the Practice at the
Harvard School of Public Health (HSPH), where he also is director
of the Center for Public Health Preparedness. Additionally, he served
as the principal investigator on research grants related to community-based
participatory research, cancer prevention, health disparities, tobacco
control, and emergency preparedness. Previously, Dr. Koh served
as Commissioner of Public Health for the Commonwealth of Massachusetts.
An elected member of the Institute of Medicine and Chair of the
Board of Scientific Counselors for the CDC's Coordinating Office
for Terrorism Preparedness and Emergency Response, Dr. Koh also
was appointed by President Clinton to the National Cancer Advisory
Board from 2000 to 2002. Dr. Koh graduated from Yale University
School of Medicine and completed his postgraduate training and chief
residencies at Boston City Hospital and Massachusetts General Hospital.
He has earned board certification in internal medicine, hematology,
medical oncology, and dermatology.
Senate Confirms Holdren as OSTP Director
The Senate March 19 voted unanimously to confirm Harvard physicist
John P. Holdren, Ph.D., as director of the White House Office of
Science and Technology Policy (OSTP). Dr. Holdren also serves as
Assistant to the President for Science and Technology and Co-Chair
of the President's Council of Advisors on Science and Technology
(PCAST).
Prior to the appointment, Dr. Holdren was the Teresa and John Heinz
Professor of Environmental Policy and director of the Program on
Science, Technology, and Public Policy at Harvard University's Kennedy
School of Government. He served concurrently as Professor of Environmental
Science and Policy in Harvard's Department of Earth and Planetary
Sciences and as director of the independent, nonprofit Woods Hole
Research Center. He also served previously as president of the American
Association for the Advancement of Science and was a PCAST member
through both terms of the Clinton administration.
The President nominated the MacArthur Foundation awardee and subsequent
board member for the post in December. Dr. Holdren testified at
his Feb. 12 confirmation hearing before the Senate Committee on
Commerce, Transportation, and Science that scientific and technological
advances have directly contributed to economic growth, noting "In
today's time of economic crisis, we must resist the temptation to
reduce our investments in these foundations of our prosperity."
President Names New FDA Commissioner
President Obama March 14 announced
the appointment of Margaret Hamburg, M.D., as Commissioner of the
Food and Drug Administration (FDA). Most recently, Dr. Hamburg worked
at the Nuclear Threat Initiative as the founding Vice President
for the Biological Program. Prior to that, she was the Assistant
Secretary for Planning and Evaluation at the U.S. Department of
Health and Human Services, and served for six years as the Commissioner
of Health for the City of New York. She also was the Assistant Director
of the National Institute of Allergy and Infectious Diseases at
the National Institutes of Health.
President Obama described Dr. Hamburg as "a nationally and
internationally recognized leader in public health and medicine,
and an authority on global health, public health systems, infectious
disease, bioterrorism and emergency preparedness." In announcing
her appointment, he also stated, "Dr. Hamburg brings to this
vital position not only a reputation of integrity but a record of
achievement in making Americans safer and more secure."
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