Washington Highlights: January 18,
2008
Contents
Prior Issues
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AAMC Responds to OHRP's Request for Information
and Comments
The AAMC submitted a Jan. 11 comment letter
in response to the Department of Health and Human Services Office
for Human Research Protections' request for information and comments
on research that involves adult individuals with impaired decision-making
capacity. AAMC expressed support for the position that "research
involving adults with impaired decision-making capacity is important
and necessary in order to improve the health and well-being of such
individuals."
AAMC's letter indicates that changes in existing regulations or
additions thereto are not needed to adequately protect adult individuals
with impaired decision-making capacity. The letter notes that additional
regulation could conflict with state or local provisions, could
impede research progress, and would unnecessarily increase administrative
costs and regulatory burdens.
AAMC proposed that OHRP issue guidance that further clarifies the
definition and role of a legally authorized representative that
may be (but would not have to be) considered by an IRB in making
its determinations. Such guidance could be used when, in the judgment
of the institution, the applicable law does not provide sufficient
guidance regarding the determination of a legally authorized representative.
In addition, AAMC suggested that OHRP consider providing additional
guidance in the form of "points to consider" when reviewing
research that involves decisionally impaired individuals (including
the issues of fluctuating competence, means of assessing competence,
and limitations on risks when there is no possibility of direct
benefit).
Information:
Irena Tartakovsky, M.D., Clinical Research Program Manager
AAMC Division of Biomedical and Health Sciences Research
itartakovsky@aamc.org
(202) 862-6134
Susan Ehringhaus, Sr. Director & Regulatory Counsel
AAMC Biomedical Health Sciences Research
sehringhaus@aamc.org
(202) 828-0543
HHS IG Issues Report on Management of Emergencies
at Specialty Hospitals
The Inspector General (IG) for the Department of Health and Human
Services released a January 2008 report
about the ability of physician-owned specialty hospitals to manage
medical emergencies. The report had been requested by Senate Finance
Committee Chair Max Baucus (D-Mont.) and Ranking Member Charles
Grassley (R-Iowa).
According to the IG report, two-thirds of physician-owned specialty
hospitals use "911" as part of their emergency response.
About one-third (34 percent) use "911" to obtain assistance
with stabilizing a patient, "a practice," the report states,
"that may violate Medicare requirements." Nearly one-half
(46 percent) use "911" to transfer patients.
Over one-half (55 percent) of the surveyed specialty hospitals
have an emergency department, yet more than one-half of those departments
have only one emergency bed. About 7 percent of the surveyed hospitals
failed to have nurses on duty and physicians on call (as required
under Medicare Conditions of Participation). Interviews with specialty
hospital administrators indicated that less than one-third of the
hospitals are staffed around-the-clock by physicians. However, 45
percent of the hospitals with emergency departments had an on-site
physician at all times. The IG also found that written policies
at about one-quarter of specialty hospitals fail to address the
appraisal and initial treatment of emergencies. Nor do they address
the referral and transfer of patients.
The IG recommends that the Centers for Medicare and Medicaid Services
(CMS) take the following actions to address these issues:
- develop a system to identify/track specialty hospitals;
- ensure that the hospitals adhere to the CMS Conditions of Participation
regarding nurse and physician staffing;
- ensure that the hospitals do not rely on "911" as
a substitute for the appraisal and treatment of medical emergencies;
and
- require that written policies include "necessary information"
for managing medical emergencies.
CMS concurs with all four recommendations.
In a Jan. 10 press
release, Sen. Baucus expressed concerns about specialty hospital
"shortcomings across the board" and stated that "Medicare
dollars for hospitalization should not be spent on facilities that
most people wouldn't even call a hospital." Sen. Grassley added
that he will continue to work for legislation "to strengthen
the community hospital system and protect patients."
Information:
Christiane Mitchell, Senior Legislative Analyst
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526
NIH Issues Revised Policy Statement on Public
Access
The National Institutes of Health (NIH) Jan. 11 issued a revised
policy statement reflecting that compliance with the agency's "public
access" rules is now required by statute, specifically the
recent "Consolidated Appropriations Act of 2008" (P.L.
110-161) [see Washington
Highlights, Jan. 4]. The
legislation requires that all investigators funded by NIH ensure
that an electronic version of their final, peer-reviewed manuscripts
accepted for publication is submitted to the National Library of
Medicine within 12 months of the official date of publication.
The NIH specified that:
- The NIH Public Access Policy applies to all peer-reviewed articles
that arise, in whole or in part, from direct costs funded by NIH,
or from NIH staff, that are accepted for publication on or after
April 7, 2008;
- Institutions and investigators are responsible for ensuring
that any publishing or copyright agreements concerning submitted
articles fully comply with this Policy;
- PubMed Central
is the NIH digital archive of full-text, peer-reviewed journal
articles. Its content is publicly accessible and integrated with
other databases;
- The final, peer-reviewed manuscript includes all graphics and
supplemental materials that are associated with the article;
- Beginning May 25, 2008, anyone submitting an application, proposal
or progress report to the NIH must include the PubMed or NIH Manuscript
Submission reference number when citing
- applicable articles that arise from their NIH funded research.
This policy includes applications submitted to the NIH for the
May 25, 2008, due date and subsequent due dates.
Further details are provided in the notice
and through the NIH public access website.
Information:
Stephen Heinig, Lead Science Policy Analyst
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488
Tony Mazzaschi, Senior Associate Vice President
AAMC Biomedical Health Sciences Research
tmazzaschi@aamc.org
(202) 828-0059
Latest "Science Indicators" Detect Declining Federal
Support for Academic R&D
The U.S. National Science Board on Jan. 15 released its Science
and Engineering Indicators 2008, the latest in a series of biennial
reports analyzing
funding and other trends in U.S. research and development (R&D).
The two volume compendium provides comprehensive data on all aspects
of national science policy, from K-12 math and science education
to U.S. global competitiveness. Press coverage largely focused on
the report's evidence for eroding dominance of U.S. science relative
to other nations, and on mixed findings relating to the public's
understanding of fundamental scientific concepts and facts. Regarding
university-based research, the report finds that the federal share
of funding for academic R&D, which had risen dramatically at
the turn of the century, began to decline from 2005 to 2006 (the
most recent year measured) and that "for the first time since
1982, federal funding did not keep pace with inflation." The
share of state and local support also "reached an all time
low in 2006." However, industry support for academic R&D
did increase in absolute dollars in 2005-2006, after declining in
the 3 previous years. Despite the real (i.e., inflation-adjusted)
decline in federal support, academic institutions continued to expand
research space, "particularly in the biological and medical
sciences."
The National Science Board is the oversight body for the National
Science Foundation (NSF), which staffs the indicators program. In
announcing the release, the NSF noted the Board's three major recommendations:
- The federal government should take action to enhance the level
of funding for, and the transformational nature of, basic research;
- Industry, government, the academic sector and professional
organizations should take action to encourage greater intellectual
interchange or synergy between industry and academia, with industry
researchers encouraged to also participate as authors and reviewers
for articles in open, peer-reviewed publications.
- New data are critically needed, and this need should be expeditiously
addressed by relevant federal agencies to track the implications
for the U.S. economy of the globalization of manufacturing and
services in high technology industry.
Information:
Stephen Heinig, Lead Science Policy Analyst
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488
IRS Working on Instructions for Schedule H
The Internal Revenue Service (IRS) Dec. 20 released draft
revisions to Form 990 and the accompanying schedules, including
Schedule H that is to be completed by hospitals [see Washington
Highlights,
Jan. 4]. The IRS has begun working with the AAMC and other hospital
associations on draft instructions for Schedule H. The Service is
pursing an aggressive time table and hopes to make the instructions
available for public comment in late February. Instructions for
Form 990 are being developed separately, with a goal of finalizing
them in the summer.
Schedule H is designed to collect information on charity care and
other community benefits and will be required of all hospitals that
complete a Form 990. However, for the 2008 tax filing year, only
Part V, Facility Information, of Schedule H will be required; other
parts are optional for 2008, but will be required for the 2009 tax
filing year.
Information:
Ivy Baer, Director & Regulatory Counsel
AAMC Health Care Affairs
ibaer@aamc.orc
(202) 828-0490
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