Washington Highlights: April 13,
2007
Contents
Prior Issues
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Senate Passes Stem Cell Legislation
The Senate April 12 passed (63-34) the "Stem Cell Research
Enhancement Act of 2007" (S.
5), which would allow federal funding for research on new human
embryonic stem cell lines, overturning President Bush's 2001 ban.
Senators Christopher Dodd (D-Conn.), Tim Johnson (D-S.D.), and Mary
Landrieu (D-La.) were not present for the vote, but are expected
to support the measure. President Bush April 11 announced
his intention to veto S. 5 should Congress approve it. In the Senate,
67 votes are needed to overturn President Bush's veto. Since the
two Democrats who voted against the measure -Sens. Bob Casey (Pa.)
and Ben Nelson (Neb.)- are unlikely to change their votes, the Democratic
leadership and advocates of the bill will be seeking an additional
Republican supporter.
S. 5 also authorizes appropriations for research "to develop
techniques for the isolation, derivation, production, or testing"
of pluripotent stem cells that "are not derived from a human
embryo." This language was not included in the House version
of the "Stem Cell Research Enhancement Act of 2007" (H.R.
3), passed Jan. 11 [see
Washington Highlights, Jan. 12].
The Senate April 12 also passed (70-28) an alternative measure,
the "Hope Offered through Principled and Ethical Stem Cell
Research (HOPE) Act" (S.
30), that would fund human embryonic stem cell research that
does not involve "the destruction or discarding of, or risk
of injury to, a human embryo or embryos other than those that are
naturally dead."
AAMC President Darrell G. Kirch, M.D., April 9 sent a letter
to Senators in support of S. 5. The letter states, "The discovery
of human pluripotent stem cells is a significant research advance
and Federal support to American researchers is essential both to
translate this discovery into novel therapies for a range of serious
and intractable diseases, and to ensure that this research is conducted
under a rigorous and credible ethical regime."
The House is expected to clear S. 5 after it returns from recess,
but is unlikely to secure a veto-proof majority.
Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
Matthew Shick, Senior Legislative Analyst
AAMC Government Relations
mshick@aamc.org
(202) 862-6116
HHS Advisory Committee Releases Key Reports on
Genomic Research
The Department of Health and Human Services' (HHS) Secretary's
Advisory Committee on Genetics, Health and Society has released
two reports to help guide genomic research and its application to
public health. The first document, "Policy Issues Associated
with Undertaking a New Large U.S. Population Cohort Study of Genes,
Environment, and Disease," provides information that would
help the HHS Secretary make a decision whether to pursue large population
studies on gene-environment or gene-health interactions. The report,
which is final, reflects comments from industry, patient advocacy,
and academic organizations, including AAMC [see
Washington Highlights, Oct. 27, 2006].
The second document is a draft, "Realizing the Promise of
Pharmacogenomics: Opportunities and Challenges," that would
assess the potential for genomics to improve productivity of the
drug development pipeline, increase the safety and effectiveness
of drugs by reducing adverse reactions, and allow for more efficient
use of drugs in clinical and public health practice. The draft report
also outlines and makes recommendations on issues associated with
product development in pharmacogenomics and integration into clinical
practice and public health. Public comments
should be submitted to the HHS Advisory Committee by June 1.
Information:
Stephen Heinig, Lead Science Policy Analyst
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488
House Committee Requests Study of Resident Work
Hours
House Energy and Commerce Committee Chair John Dingell (D-Mich.),
Ranking Member Joe Barton (R-Texas), Oversight and Investigations
Subcommittee Chair Bart Stupak (D-Mich.) and Ranking Member Ed Whitfield
(R-Ky.) sent a March 29 letter
to the Agency for Health Research and Quality (AHRQ) requesting
"the continued study of medical errors associated with physician
and resident work schedules." The request, which was addressed
to AHRQ's Center for Quality Improvement and Patient Safety Acting
Director William Munier, M.D., is part of a committee investigation
into preventable medical errors.
The committee members ask AHRQ "to assist us in ascertaining
if the long work hours of physicians and residents...are among the
most serious threats to patient care." They suggest that AHRQ
fund an IOM study "similar in design" to the 2004 study
of nurse work hours.
According to the letter, interest in the topic "was recently
heightened" by an AHRQ-funded study published in the Public
Library of Science. The study found that "sleep deprived and
over-extended medical residents and interns" contributed to
medical errors ("including death"). The letter adds that
the "number of reported fatigue-related medical errors increased
as the number extended duration shifts per month increased."
Information:
Christiane Mitchell, Senior Legislative Analyst
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526
Grassley Requests GAO Study of Community Benefit
Reporting by Nonprofit Hospitals
Senate Finance Committee Ranking Member Charles Grassley (R-Iowa)
April 5 sent a letter
to Comptroller General David Walker requesting that the Government
Accountability Office (GAO) "conduct additional work on uncompensated
care and other community benefits provided by nonprofit hospitals."
Concerned that "the amount of uncompensated care provided by
nonprofit hospitals is an imprecise measure of ... charity care,"
Sen. Grassley asks the GAO to examine community benefit guidelines
used by the hospital community, as well as how hospitals "interpret
and report" community benefit, uncompensated care, charity
care, and bad debt.
Concerned by "alarming reports about the lavish lifestyle"
of some nonprofit hospital executives and board members, Sen. Grassley
also asks the GAO to review compensation levels. Additionally, he
requests a GAO examination of nonprofit hospital executive and board
member involvement in for-profit business ventures "that enrich
these individuals to the detriment of the nonprofit hospital."
According to an April 5 press release from Sen. Grassley, the request
is part of a "wide-ranging view of nonprofit practices to ensure
that tax-exempt status results in public benefits."
Information:
Christiane Mitchell, Senior Legislative Analyst
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526
NGA Adopts SCHIP Policy Position
The National Governors Association (NGA) April 9 adopted a policy
position on the reauthorization of State Children's Health Insurance
Program (SCHIP) that includes "adequate, predictable funding"
and "enhanced flexibilities for states."
The NGA calls upon Congress to "act quickly to fill the fiscal
2007 shortfalls...prior to reauthorization." The governors
also urge Congress to reauthorize the program "well before
the end of the year," and to increase federal funding levels
"to account for increased medical costs and population growth."
Additionally, the NGA believes that the SCHIP funding formula should
be "revisited" to "ensure that state programs have
access to adequate funds."
According to the policy position, SCHIP reauthorization should
provide greater program flexibility, and not "impose any new
mandates or restrictions." Also under the NGA policy position,
SCHIP enrollment outreach should be a state option, since such efforts
increase Medicaid enrollment, "and therefore increased costs
for states."
Authorization of SCHIP is scheduled to expire on Sept. 30.
Information:
Christiane Mitchell, Senior Legislative Analyst
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526
CMS Issues Proposed Revisions to Medicare National
Clinical Trial Policy
The Centers for Medicare and Medicaid Services (CMS) April 10 proposed
revisions to the Medicare National Clinical Trial Policy, to
be renamed the "Clinical Research Policy" (CRP). Since
the September 2000 issuance of a National Coverage Decision (NCD),
Medicare has paid for the routine costs of beneficiaries enrolled
in qualifying clinical trials. The revised policy would pay for
investigational treatments and services if they are covered by Medicare
outside the clinical trial or are required in order to manage the
patient's health within the study.
Among other revisions, the proposed CRP:
- Adds a definition of research;
- Requires the research study to be registered on the ClinicalTrials.gov
website prior to the enrollment of the first study subject;
- Renames "routine costs" to "routine clinical
services" and recommends that this term be defined "as
those items and services that are available to Medicare beneficiaries
outside the study, but are not explicitly the item or service
being evaluated for its effect on health outcomes (i.e., not the
investigational item or services), only when those items and services
are used for patient management within the study;" and
- Requires research studies to have written protocols that "specify
and fulfill" method and timing for public release of results,
have "explicitly discussed inclusion criteria and considered
relevant subpopulations (as defined by age, gender, race/ethnicity,
socioeconomic, or other factors)," and contain a discussion
of how the results will "generalize to the Medicare population."
CMS is requesting comments on the proposed revisions by May 10.
The AAMC plans to submit a comment letter to the agency.
Information:
Ivy Baer, Director & Regulatory Counsel
AAMC Health Care Affairs
ibaer@aamc.orc
(202) 828-0490
AAMC Submits Recommendations for HEA Reauthorization
AAMC President Darrell G. Kirch, M.D., April 12 sent a letter
to House Education and Labor Committee Chair George Miller (D-Calif.)
regarding reauthorization of the Higher Education Act (HEA). The
letter outlines the AAMC's priorities and proposes legislative language
to:
- Extend the Economic Hardship Deferment to the length of a medical
residency (currently the deferment is only available for 3 years);
and
- Increase federal subsidized Stafford loan limits from $8,500
to $12,000.
The AAMC also reiterates its concerns with language proposed last
Congress to revise accreditation policy and procedure [see
Washington Highlights, Nov. 18, 2005].
Current authority for HEA expired on Sept. 30, 2003; however, several
extensions have been enacted, making no policy changes but allowing
uninterrupted administration of the programs authorized under the
law. The Senate Committee on Health, Education, Labor, and Pensions
is expecting to markup a new reauthorization bill before the current
extension's June 30 expiration. The House Committee on Education
and Labor is planning a later mark-up that will require another
temporary extension of HEA.
Information:
Matthew Shick, Senior Legislative Analyst
AAMC Government Relations
mshick@aamc.org
(202) 862-6116
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