Washington Highlights: April 17,
2009
Draft Stem Cell Funding Guidelines Issued by NIH
for Public Comment
Contents
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The National Institutes of Health (NIH) April 17 published draft
guidelines
for federal funding of stem cell research by the NIH. President
Obama's March 9 Executive
Order lifting the Bush Administration's restrictions on human
embryonic stem cell research ordered NIH to finalize such guidance
within 120 days (July 7). This draft guidance is open for public
comment for 30 days after its publication in the Federal Register,
which is expected the week of April 20. Such a schedule should allow
NIH to meet its July 7 mandate.
The guidelines limit federal funding to human embryonic stem cell
lines derived from embryos created by in vitro fertilization (IVF)
for reproductive purposes and that are in excess of clinical need.
Stem cell lines derived from somatic cell nuclear transfer (SCNT),
parthanogenisis, or via the IVF process if the embryo was created
for research purposes will not be eligible for federal funding.
Acting NIH Director Raynard Kington, M.D., Ph.D., said that NIH
was unaware of any existing stem cell lines created by SCNT or from
embryos expressly created for research. He said that NIH has "heard
reports" of 700 or more human embryonic stem cell lines in
circulation and that many of the lines will meet the requirements
of the new federal guidelines. Federal funding of derivation activities
remain prohibited by legislative fiat.
In addition, NIH will not fund research using otherwise eligible
stem cell lines if the cells are introduced into non-human primate
blastocysts or if the cells may have contributed to the germ line.
Institutions receiving funding for stem cell research would be
required to provide an assurance that such research meets various
procedural and donor informed consent requirements, as stated in
the guidance. NIH reports it has not made a decision whether an
NIH stem cell registry or the NIH-funded stem cell bank will be
maintained. The question of whether the stem cell lines that were
eligible for funding under the Bush policy will qualify under the
new proposed NIH guidance is not clear. Such lines will need to
be assessed following the issue of the final guidelines.
NIH also issued a notice providing interim guidance
on the funding of on-going NIH funded stem cell research, as well
as proposed stem cell research, before the NIH guidance is finalized
on or before July 7.
Information:
Tony Mazzaschi, Senior Director
AAMC Scientific Affairs
tmazzaschi@aamc.org
(202) 828-0059
Congress to Return from Spring District Work Period
The Senate will return from a two-week district work period April
20 and resume consideration the "Fraud Enforcement and Recovery
Act of 2009" (S.386)
[see Washington
Highlights,
March 6]. Majority Leader Harry Reid (D-Nev.) April 2 filed
cloture on the motion to proceed to S.386, which if passed will
end debate and require a vote on the bill. The House will return
from the recess April 21, but a schedule has not been announced.
Additionally, budget conferees are expected to meet to finish work
on a final conference agreement for the House- and Senate-passed
budget resolutions (H.Con.Res.85
and S.Con.Res.13)
[see Washington
Highlights,
April 3].
Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
AAMC Testifies Before CER Coordinating Council
The AAMC April 14 testified
before the Federal Coordinating Council for Comparative Effectiveness
Research, the new advisory body established by the American Recovery
and Reinvestment Act (P.L.
111-5) [see Washington
Highlights,
March 20]. AAMC Scholar-in-Residence Eugene Rich, M.D., presented
the statement to the panel during a public listening session
designed to receive stakeholder input on comparative effectiveness
research (CER) priorities and the council's activities.
Praising Congress for the $1.1 billion included for CER in the
Recovery Act, Dr. Rich identified five AAMC priorities for investments
in such research, including:
- Investments to strengthen research methods to support CER, given
promising new sources of data - such as electronic health records
and expanded clinical registries - beyond randomized controlled
clinical trials;
- Sustained investment in clinical and translational research
training and CER workforce development;
- Investments to develop and maintain the national CER infrastructure,
including support for expanded networks for evidence review, new
clinical research databases, interdisciplinary research teams
and academic-community partnerships;
- Further investments in research to inform clinical care and
delivery system reforms; and
- Developing and using CER "through means that are synergistic
with continued discovery of clinical innovations through biomedical
science."
The council is charged with advising federal agencies and others
on coordinating comparative effectiveness and related health services
research. The council also will issue recommendations regarding
priorities for spending $400 million provided through ARRA for CER
to be allocated at the discretion of the Secretary of Health and
Human Services.
Information:
Tannaz Rasouli, Senior Legislative Analyst
AAMC Government Relations
trasouli@aamc.org
(202) 828-0525
AAMC, Other Groups Urge Investment in Pandemic
Preparedness, Advanced Research and Development
The AAMC joined 24 other organizations of the Working Group on
Pandemic Influenza Preparedness on an April 8 letter
urging House and Senate appropriators to support increased investment
in pandemic preparedness and advanced research and development activities.
Addressed to the chairs and ranking members of the House and Senate
Labor-HHS-Education Appropriations Subcommittees, the letter recommends
that Congress complete the previous administration's request for
$870 million in "no-year" funding for medical countermeasures,
as well as provide ongoing funding for preparedness activities at
the Centers for Disease Control and Prevention, National Institutes
of Health, Food and Drug Administration, and Office of the Secretary
of Health and Human Services. Additionally, the letter supports
$350 million for states and localities to develop and implement
pandemic response plans and to build medical surge capacity.
The groups also recommend that the committees provide at least
$500 million for the Biomedical Advanced Research and Development
Authority (BARDA) in FY 2010. Noting that "BARDA's budget must
be substantial to allow for flexible decision-making and risk-taking
and its portfolio diverse to encompass a range of conventional 'one
bug, one drug' approaches to more novel, high-risk projects,"
the letter requests the funds be made avilable for two fiscal years.
Information:
Tannaz Rasouli, Senior Legislative Analyst
AAMC Government Relations
trasouli@aamc.org
(202) 828-0525
MedPAC Continues Medical Education Discussion
The Medicare Payment Advisory Commission (MedPAC) April 8 continued
the discussion it began at its March meeting on the role of medical
education in supporting long-term delivery system reforms [see Washington
Highlights,
March 20]. The outcome of these discussions will be a chapter
in the commission's June report.
MedPAC's June report will provide an overview of the educational
process for physicians, including a discussion of the accreditation
processes for both undergraduate and graduate medical education.
The chapter also will include a summary of semi-structured interviews
with 26 internal medicine program directors that were conducted
by the RAND Corporation on MedPAC's behalf. The interviews focused
on whether internal medicine program curricula address topics that
MedPAC believes are important to support overall delivery system
reform, such as systems-based practice that focuses on care coordination,
cost awareness, and patient safety. There will be no recommendations
in the chapter.
At the meeting, commissioners also discussed potential future work
that MedPAC staff could pursue. Suggestions included examining how
to increase residency training in nonhospital sites and how to improve
resident's knowledge and skills for delivery system reforms. A key
issue was how Medicare might use its leverage, through graduate
medical education and indirect medical education payments, to improve
education that supports more effective delivery of care in the future.
For example, should Medicare "reward" institutions that
are leaders in innovative care delivery which would translate into
a better clinical educational environment for both medical residents
and students? Commissioners agreed that the issue of Medicare's
role in supporting medical education will be a focus of future meetings.
Other topics discussed at the April meeting included:
- Accountable care organizations;
- A mandated report on Medicare Advantage payments;
- A mandated report on quality comparisons between Medicare fee-for-service
and managed care; and
- The impact of physician self-referral on use of imaging services
within an episode.
The next public meeting of MedPAC is September 17-18.
The presentation slides for all of the sessions, as well as a transcript
of the meeting is available on the MedPAC website.
Information:
Karen Fisher, Sr. Director, Health Care Affairs
AAMC Health Care Affairs
kfisher@aamc.org
(202) 862-6140
HHS Secretary-designate Sebelius Responds to Senate
Panel Inquiries
The Senate Finance Committee has posted the responses
of President Obama's nominee for Secretary of Health and Human Services
(HHS), Gov. Kathleen Sebelius (D-Kan.), to questions from committee
members that followed an April 2 confirmation hearing.
The questions and responses for the record addressed issues of interest
to medical schools and teaching hospitals including Medicare, Medicaid,
health care reform, the National Institutes of Health (NIH), conflicts
of interest, and health professions training.
In response to a question from Senator Stabenow (D-Mich.) regarding
the Medicare disproportionate share hospital (DSH) program and its
impact on acute care, Secretary-designate Sebelius recognized the
concern and said, "We must ensure that the Medicare DSH program
fulfills its goal of supporting true safety-net providers. If confirmed,
I pledge to carefully review this issue and keep you informed of
my findings." In response to a question regarding the scheduled
physician payment cuts, Gov. Sebelius stated, "We [the Administration]
believe that Medicare's payment system should support more primary
care and a 21 percent cut in physician payments is simply unsustainable.
I look forward to working with you to improve the Medicare payment
system to promote broader reform goals."
Senate Finance Committee Chair Max Baucus (D-Mont.) asked Secretary-designate
Sebelius if she supported the creation of a Federal Health Board
and how she would ensure accountability of such an entity if confirmed
as the HHS Secretary. She acknowledged that better alignment of
the health system will improve quality of care and lower costs and
she "looks forward to working with Members of Congress on developing
this [Federal Health Board] and other ideas about how to make the
health system more effective and better for patients."
Responding to a question from Senate Finance Committee Ranking
Member Charles Grassley (R-Iowa) regarding conflicts of interest,
Secretary-designate Sebelius described an Advanced Notice of Proposed
Rulemaking (ANPRM) that will seek public comment in the following
areas:
- Expanding the scope of the regulation and disclosure of interests
(including questions addressing a new requirement for grantees
to provide details regarding the nature of financial conflicts
of interest and how they are managed, reduced, or eliminated)
- Definition of ?significant financial interest
- Identification and Management of Conflicts by Institutions
- Assuring Institutional Compliance
- Requiring Institution to provide additional information to the
PHS
- Institutional Conflict of Interest (institutional conflict of
interest is an area of increasing concerning that currently is
not addressed by the Federal regulations)
Gov. Sebelius also stressed the importance of NIH research and
increased funding in response to numerous questions, noting "After
a five year doubling initiated in the Clinton Administration, NIH
has been essentially flat-funded since 2003. This has produced a
17 percent loss of buying power since 2003, and an acute fall in
the success rates for grant applicants, now as low as 10 percent
for many NIH Institutes." She continued in another response,
"If confirmed, I will work to strengthen NIH, with leadership
that focuses on the dual objectives of addressing the health care
challenges of our people and maintaining America's economic edge
through innovation."
In response to another question from Ranking Member Grassley regarding
health care provider shortages, Secretary-designate Sebelius acknowledged
the need for a multi-faceted approach. In particular, she emphasized
the role of health professions programs at the Health Resources
and Services Administration, noting "First, we need to expand
support for workforce training programs, including Title VII, Title
VIII, and National Health Service Corps programs, which incentivize
students to pursue careers in the primary care health professions."
Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
Tannaz Rasouli, Senior Legislative Analyst
AAMC Government Relations
trasouli@aamc.org
(202) 828-0525
Travis W. Crytzer, Legislative Analyst
AAMC Government Relations
tcrytzer@aamc.org
(202) 828-0418
Nuclear Regulatory Commission Decides on Cesium
Chloride Irradiators
The Nuclear Regulatory Commission (NRC) April 15 directed the agency's
staff to continue enhancing the security of cesium chloride radiation
sources, while encouraging research and further technological developments
for alternative chemical forms of cesium-137 chloride. The isotope
is used widely in research and clinical applications. Proponents
of banning the use of cesium chloride are concerned that an intentional
release into the environment would be effectively impossible to
remediate. However, the commission agreed with staff's analysis
that near-term replacement of cesium chloride sources in existing
blood, research, and calibration irradiators is not practicable
and would be harmful to the delivery of medical care, research,
and emergency response capabilities. That evaluation was based on
broad public input from many research and health care organizations,
including the AAMC [see Washington
Highlights,
Oct. 10, 2008].
According to an April 15 NRC press release,
NRC Chairman Dale E. Klein stated that "Banning or phasing-out
cesium chloride radiation sources at this time - before a replacement
form or other technology is available - would be counterproductive,
because society would lose the many benefits these sources provide
in medicine, industry and research." The commission noted that
security controls already implemented over the past several years
have significantly improved the security of these sources. However,
it directed the staff to continue exploring new ways to improve
their security further. Those efforts are to include working with
federal and state agencies to define criteria for a "dispersible
source of concern" that could then be used to guide research
efforts to develop an alternative form of cesium. The staff also
was directed to develop a commission policy statement detailing
the commission's emphasis on security of cesium chloride sources.
Information:
Stephen Heinig, Lead Science Policy Analyst
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488
FTC Proposes Rule on Personal Health Records
The Federal Trade Commission (FTC) April 16 released
a proposed Health Breach Notification rule that applies to vendors
of personal health records (PHRs), PHR-related entities, and third
party service providers. The FTC is expected to publish the proposed
rule in the Federal Register. The rule would require notification
of U.S. citizens and residents when a vendor of PHRs discovers a
breach of security of unsecured identifiable information that is
in a personal health record maintained or offered by the vendor.
Notification of the FTC also would be required in the case of a
breach. The rule will not apply to HIPAA-covered entities or to
an entity's activities as a business associate of a HIPAA-covered
entity. Promulgation of this rule was required by the "American
Recovery and Reinvestment Act" (P.L.
111-5).
Information:
Ivy Baer, Director & Regulatory Counsel
AAMC Health Care Affairs
ibaer@aamc.org
(202) 828-0490
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