Washington Highlights: October 10,
2008
NIH Reduces Non-Competing Grant Awards under the
Current Continuing Resolution
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The National Institutes of Health (NIH) Oct. 2 announced
that until complete funding FY 2009 is enacted, NIH will issue non-competing
research grant awards at a level below that indicated on the most
recent Notice of Award (generally up to 90 percent of the previously
committed level). Currently, NIH is funded under a continuing resolution
that extends through March 6, 2009 [see Washington
Highlights,
Sept. 26]. NIH will consider upward adjustments to these levels
after the final FY 2009 appropriation is enacted.
Information:
Tony Mazzaschi, Senior Director
AAMC Scientific Affairs
tmazzaschi@aamc.org
(202) 828-0059
AAMC Submits Comments on Cesium-137 Irradiators
The AAMC joined with the Federation of American Societies for Experimental
Biology (FASEB) Oct. 10 in a letter
asking the Nuclear Regulatory Commission (NRC) to proceed slowly
in developing regulations that might lead to a ban the use of radioactive
cesium-137 chloride in research and clinical applications. On July
31, the NRC published a request for comments in the Federal
Register (73 Fed. Reg. 44780) on the extent to which the
medical and research communities rely on cesium irradiators and
the potential impact a ban on these sources might have.
The NRC has been assessing security concerns about the use of radionuclide
sources for several years. Moreover, in February 2008 a National
Academies panel commissioned by Congress recommended that use of
cesium-137 chloride be discontinued given that the compound is highly
dispersible and would be almost impossible to remediate if it were
intentionally released in the environment by terrorists. The cesium-137
isotope has a half-life of more than 30 years. The NRC also held
a well attended workshop on the cesium issue on Sept. 29-30.
The AAMC, FASEB, and other organizations noted that cesium source
irradiators are still widely and productively used in research and
clinical applications. For some types of research (including some
research projects relevant to homeland security), there currently
is no effective substitute. For other types of research, alternative
radiation sources-where they do exist-are often less reliable, more
difficult to use and more costly. In scientific investigation, switching
to alternative sources would also make comparisons with controls
and baseline data far more difficult. But the central argument of
the AAMC-FASEB letter against an immediate ban is the concern that
no system or plan currently exists for removing and storing existing
cesium sources in a secure national repository. Several institutions
reported extensive investment over recent years to improve security
of irradiation facilities, including background checks for all personnel,
24-hour surveillance, and provisions for armed response in the event
of unauthorized intrusion. The associations have therefore requested
increased support for improving security of these facilities and
support for development of alternative forms of cesium-137 that
are less dispersible in the environment. The AAMC and FASEB also
requested that any further proposal for disposition of these sources
go through regular rulemaking with sufficient time for public comment.
Information:
Stephen Heinig, Lead Science Policy Analyst
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488
MedPAC Considers Recommendations on Public Reporting
of Physician's Financial Interests
At its Oct. 2 meeting, the Medicare Payment Advisory Commission
(MedPAC) considered draft recommendations to Congress that would
require a broad array of manufacturers to publicly report information
on their financial relationships with physicians and other recipients
of payments from them, including teaching hospitals, medical schools,
professional organizations, and organizations that sponsor continuing
medical education. The draft also would require the Centers for
Medicare and Medicaid Services (CMS) to report on the prevalence
of financial relationships between hospitals and physicians or other
entities. The commission acknowledged that some of these relationships
can lead to important advances in science, technology, and patient
care and should be preserved. However, the commission also noted
that these relationships can create conflicts of interest for physicians,
undermine objectivity, and increase costs.
The commission actively debated the types of relationships that
should be reported publicly, whether there should be full or partial
preemption of state laws, and the extent of detail that should be
provided to the public. The commission's discussion gave special
attention to whether samples should be treated differently from
other pharmaceutical and device manufacturers transfers to physicians.
The threshold for reporting and whether or not physicians' financial
relationships with entities in addition to hospitals and ambulatory
surgery centers should be the subject of reports also received special
attention.
Commission staff will revise the draft recommendations based on
the Oct. 2 discussion and will resubmit recommendations to the commission
at a future meeting. If ultimately approved by MedPAC, the recommendations
will appear in the Commission's March 2009 Report to the Congress.
The transcript of the discussion, as well as the presentation slides
can be found on MedPAC's website.
Information:
Susan Ehringhaus, Sr. Director & Regulatory Counsel
AAMC Biomedical Health Sciences Research
sehringhaus@aamc.org
(202) 828-0543
MedPAC Panel Addresses Medical Education Training
At its Oct.2 meeting, the Medicare Payment Advisory Commission
(MedPAC) heard from a three-person panel on the topic "Is medical
education training our physicians for health care delivery in the
21st century?" Over the last several years, the commission
has expressed concern that while Medicare provides significant funding
to teaching hospitals for their teaching and clinical care missions,
there is little accountability for how those funds are used. MedPAC
also has raised the question whether future physicians are being
trained to be leaders in shaping and implementing needed changes
in the health care delivery system.
Panel members comprised:
- Thomas Nasca, M.D., CEO of the Accreditation Council for Graduate
Medical Education (ACGME), who discussed the role of the ACGME
and new approaches for residency accreditation, including the
need to focus more on outcomes of residency education and the
educational experiences and rotations that will produce those
outcomes;
- Michael Whitcomb, M.D., former Vice President of Medical Education
at the AAMC, who noted the importance of not only residency training,
but also the need to provide better systems to assist practicing
physicians in maintaining clinical competence; and
- Benjamin Chu, M.D., President of Kaiser Permanente Southern
California Region, who discussed the importance of information
technology (HIT) in creating highly functioning systems and then
asked the question "do you reform medical education to produce
drivers for systems change, or do you actually try to change systems
to pull the training programs to a point where you're requiring
them to train people to function in a high performance system?"
The commission plans to have further discussions on this topic
at upcoming meetings. The transcript of the panel discussion, as
well as the presentation slides can be found on MedPAC's website.
Information:
Karen Fisher, Sr. Director, Health Care Affairs
AAMC Health Care Affairs
kfisher@aamc.org
(202) 862-6140
Sunny Yoder, Director of Resident Affairs
AAMC Health Care Affairs
syoder@aamc.org
(202) 828-0497
NIH Announces New Policy on Amended Applications
The National Institutes of Health (NIH) Oct. 8 announced
a major change in its policy on the submission of amended grant
applications. Beginning with original new applications and competing
renewal applications submitted for the Jan. 25, 2009, due date and
beyond, the NIH will accept only a single amendment to the original
application. NIH says "It is expected that this policy will
lead to funding high quality applications earlier, with fewer resubmissions."
In the transition, original new and competing renewal applications
that were submitted prior to Jan. 25, 2009, will be permitted two
amendments (A1 and A2). For these "grandfathered" applications,
NIH will not accept A2 applications after Jan. 7, 2011.
This new policy applies to all grant applications, including applications
submitted under the NIH Small Business Innovation Research (SBIR)
and Small Business Technology Transfer (STTR) programs, Career Development
Awards, Individual Fellowships, Institutional Training Grants, Resource
Grants, Program Projects, and Centers.
Information:
Tony Mazzaschi, Senior Director
AAMC Scientific Affairs
tmazzaschi@aamc.org
(202) 828-0059
NIH Responds to Comments on Public Access Policy
and Implementation
The National Institutes of Health (NIH) Sept. 30 issued an analysis
of comments submitted in response to a March 31 Request for Information
on the Consolidated Appropriations Act of 2008 (P.L.
110-161) provision requiring "all investigators funded
by the NIH [to] submit or have submitted for them to the National
Library of Medicine's PubMed Central an electronic version of their
final, peer-reviewed manuscripts upon acceptance for publication,
to be made publicly available no later than 12 months after the
official date of publication…"
NIH reports that it received 613 unduplicated comments "from
a broad cross-section of the public, including NIH-funded investigators,
members of the general public, patient advocates, professional organizations,
and publishers." NIH also reports that "Most comments
offered broad support for the policy as written. Many comments requested
a reduction in the delay period before papers can be made publicly
available on PubMed Central. In some cases, commenters expressed
concern about the Policy, others asked for clarification, and still
others suggested alternatives to NIH's implementation."
NIH's response to the comments strongly defends its current policy.
However, NIH modified several "Frequently Asked Questions"
about the policy and changed the manuscript submission process as
well as other program materials. NIH pointedly rejected suggestions
that the implementation of the policy should have followed the Administrative
Procedures Act. NIH said it "believes the initiation of notice
and comment rulemaking to implement the new statute is unwarranted
and contrary to the interests of science and the public health."
Information:
Tony Mazzaschi, Senior Director
AAMC Scientific Affairs
tmazzaschi@aamc.org
(202) 828-0059
HHS OIG Releases 2009 Work Plan
The Department of Health and Human Services (HHS) Office of the
Inspector General (OIG) Oct. 1 issued its annual Work
Plan for Fiscal Year 2009. The Work Plan describes on-going
and new areas of OIG review. The OIG notes in the preamble that
"over the last several years, we have allocated about 80 percent
of our resources to reviews and investigations of the Medicare and
Medicaid programs and 20 percent to HHS's public health and human
services programs." Among the new projects this year will be
a review of the Center for Medicare and Medicaid Services' (CMS)
oversight of hospital compliance with the Emergency Medical Treatment
and Labor Act of 1986 (P.L. 99-272, EMTALA). There will also be
on-going and new reviews about the incidences of and payments for
serious medical errors, known as "never events," in the
Medicare population.
Information:
Ivy Baer, Director & Regulatory Counsel
AAMC Health Care Affairs
ibaer@aamc.org
(202) 828-0490
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