Washington Highlights: December
5, 2008
IOM Issues Residency Duty Hours Report
Contents
Prior Issues
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The Institute of Medicine (IOM) Dec. 2 released the report, "Resident
Duty Hours: Enhancing Sleep, Supervision, and Safety." A committee
chaired by Michael M.E. Johns, M.D., Emory University chancellor,
conducted the study as charged in 2007 by Carolyn Clancy, M.D.,
director of the Agency for Healthcare Research and Quality, which
funded the project. Recognizing that residents need to gain experience
to practice safely and competently, the report recommends steps
to create safer conditions within the existing limits established
by the Accreditation Council for Graduate Medical Education: 80
hours per week and 24 hours of continuous duty, plus 6 hours for
educational activities and handing over patient responsibilities.
The IOM report calls for:
- increased opportunities for sleep;
- improved resident supervision;
- limits on resident workloads;
- enhanced patient handovers, with more overlapping time as residents
go off and come on duty; and
- stronger enforcement by the ACGME.
The committee recommends a period of 5 hours of sleep at the end
of 16 hours on duty before continuing to a maximum of 30 hours,
and additional days off in each month. It also recommends longer
periods between shifts on duty. The report estimates that the national
costs of personnel to substitute for the residents' reduced work
would total $1.7 billion and calls upon health care payers to support
the recommended changes.
In a Dec. 2 press release, AAMC President and CEO Darrell G. Kirch,
M.D., responded to the report: "We agree with the IOM that we must
examine duty hours as one of many factors in patient safety and
quality of care. The AAMC and the nation's teaching hospitals have
always been committed to providing safe, high- quality patient care
while still ensuring that tomorrow's doctors receive the very best
clinical education ... Moving forward, we will continue to work
with the IOM and other stakeholders to make additional improvements
to the processes that govern the well being, supervision, and workload
of residents at every stage of their training."
Information:
Sunny Yoder, Director of Resident Affairs
AAMC Health Care Affairs
syoder@aamc.org
(202) 828-0497
CMS Releases Issues Paper for Physician Value
Based Purchasing Program
.The Centers for Medicare and Medicaid Services (CMS) released
an issues
paper in preparation for a Dec. 9 listening session on the development
of a Physician Value Based Purchasing Program (PVBP) as required
by the "Medicare Improvement for Patients and Providers Act
of 2008" (P.L.
110-275). The issues paper outlines the foundation of the PVBP
including plan goals/objectives, assumptions, and design principles.
As stated in the paper, the program will be designed to measure
key dimensions of quality, with attention to outcomes, cost of care,
patient experience, care coordination, prevention, and adoption
and use of HIT.
In addition to general information on the foundation of the program,
CMS is seeking input and feedback on how the program should be designed
and implemented. As such, CMS poses many questions throughout the
paper to which they are seeking answers in the broad topic areas
of measures, incentive structure, data strategy and infrastructure
and public reporting.
CMS will accept comments on the issue paper through Dec. 16. The
AAMC will submit comments and asks member institutions to share
their own comment letters with the AAMC.
Information:
Jennifer Faerberg, Director, Health Care Affairs
AAMC Health Care Affairs
jfaerberg@aamc.org
(202) 862-6221
CMS Issues Three Proposed National Coverage Determinations
The Centers for Medicare and Medicaid Services (CMS) Dec. 2 issued
three proposed national coverage determinations (NCDs) that, if
finalized, would halt Medicare hospital inpatient and physician
payments for preventable medical errors. The NCDs include: "Surgery
on the Wrong Patient" (CAG-00401N),
"Surgery on the Wrong Body Part" (CAG-00402N),
and "Wrong Surgery Performed on a Patient." (CAG-00403N).
CMS determined these events do not constitute a "reasonable and
necessary treatment" for Medicare beneficiaries. CMS will issue
a final coverage decision following a 30-day public comment period.
Comments must be submitted electronically and separately for each
proposed NCD.
Information:
Will Dardani, Constituent Services Specialist
AAMC Health Care Affairs
wdardani@aamc.org
(202) 828-0541
FDA Releases Guidance for Sponsors, Clinical Investigators,
and IRBs
The Food and Drug Administration (FDA) Dec. 1 released a guidance
entitled "Data Retention When Subjects Withdraw from FDA Regulated
Clinical Trials." This guidance clarifies FDA's position that data
must be retained from trial participants who decide to discontinue
participation in clinical studies of investigational products, who
are withdrawn by their legally authorized representative, or who
were discontinued from participation by the clinical investigator.
The document notes that clinical studies data is submitted to the
FDA in support of research applications for a new product approval,
and it is critical that FDA have a complete and accurate data set.
Incomplete study databases could compromise the scientific validity
of investigations and jeopardize agency's ability to analyze the
study and eventually, to safeguard the public health. Written or
electronic comments on this guidance may be submitted at any time.
Information:
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OHRP Requests Comments on Draft Guidance Regarding
When Participation of Human Subjects in Research Is Discontinued
The Department of Health and Human Services (HHS) Office for Human
Research Protections (OHRP) Dec. 1 requested public comment on a
Nov. 7 draft guidance document entitled "Guidance on Important Considerations
for When Participation of Human Subjects in Research is Discontinued."
The draft
guidance provides OHRP's interpretation of the terms "participation"
and "discontinuation of a subject's participation in research" used
in HHS regulations. According to the Dec. 1 Federal Register
notice,
the draft guidance offers a "distinction between a complete versus
a partial discontinuation of a subject's participation in research"
and allows investigators to "continue to analyze already collected
individually identifiable private information about a subject even
when the subject's participation has been completely discontinued."
The draft guidance also includes scenarios to provide direction
in situations when subject's participation is discontinued during
different stages of analysis of the individually identifiable data.
Written or electronic comments should be submitted by Jan. 30, 2009.
Information:
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NIH Council of Councils Discusses Transformative
Research
The NIH Council of Councils
met Nov. 20-21, one year after its inaugural "planning"
meeting and its second meeting since March 2008 [See Washington
Highlights,
April 4]. At the meeting, the council reviewed progress on transformative
research, standardization of NIH research categorization, and research
that cuts across established NIH institutes and centers.
The meeting started with an overview of the many changes that have
occurred within the office that staffs the council. The NIH's former
Office of Policy Analysis and Strategic Initiatives (OPASI) has
now been incorporated within the Division of Program Coordination,
Planning, and Strategic Initiative (DPCPSI). Lana Skirboll, Ph.D.,
longtime Director of NIH's Office of Science Policy, was named Acting-Director
of DPCPSI in September by the outgoing NIH Director, Elias Zerhouni,
M.D. As Acting Director, Dr. Skirboll now chairs the council. Dr.
Skirboll replaces Allan Krensky, M.D., who became Senior Advisor
to the NIH Deputy Director. Like OPASI, DPCPSI provides NIH with
analysis and coordination of initiatives that cut across institutes,
as well as for special initiatives that pursue potentially "high
risk, high payoff" scientific projects. These initiatives include
those supported by the NIH Common fund. In her opening remarks,
Dr. Skirboll credited Dr. Krensky for guiding the successful establishment
of this new structure within NIH.
While this structure and leadership have changed, the original
agenda
continues unchanged. Among some notable projects, Tim Hays, M.D.
presented on the status of the Research, Condition, and Disease
Categorization (RCDC) Project, which will provide standard nomenclature
and coding for classifying all NIH research according to specific
areas of disease or disability to which they contribute. The project
will post the first classifications (for projects in fiscal year
2008) in early 2009.
Betsy Wilder, Ph.D., Program Director, National Institute of Diabetes
and Digestive and Kidney Diseases, presented plans for the Transformative-R01
(T-R01), a program announced in September and scheduled to accept
applications this year. The T-R01 program is designed to address
groundbreaking, high risk proposals of the type that usually would
not be funded as more routine R01 applications. Up to $25 million
of the NIH Common Fund is available to fund the TR01s (60 awards
are anticipated this fiscal year). The T-R01 is not intended to
derogate from the traditional R01 research projects. In response
to a question from the council about this concern, Dr. Skirboll
compared the spectrum of award mechanisms to an investment portfolio,
and the importance of balancing "stocks" and securities
according to relative levels of risk.
The council also received presentations on examples of new health
and scientific research that cut across established NIH institutes
and centers, such as obesity research and intriguing research on
of the human microbiome, the intricate and diverse ecosystems of
microorganisms that inhabit human beings, and which vary across
individuals, families, and societies.
Information:
Stephen Heinig, Lead Science Policy Analyst
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488
SACGHS Reviews Findings on Gene-Based Diagnostic
Tests
The Department of Health and Human Services Secretary's Advisory
Committee on Genetics, Health, and Society (SACGHS) met Dec. 1 and
2 to review its task force's findings on the impact of gene patents
and licensing practices on gene-based diagnostic tests. SACGHS is
evaluating differing views as to whether licensing terms arising
from patents on human genes and gene sequences have restricted or
promoted the availability of many gene-based diagnostic tests. The
committee also is addressing questions as to whether licensing practices
have impeded or incentivized further refinement of such diagnostic
tests.
James P. Evans, M.D., Ph.D., Chair of the Task Force on Gene Patents
and Licensing Practices and Professor of Genetics and Medicine at
the University of North Carolina, reviewed the committee's findings,
including several case studies of the development of gene-based
diagnostic tests under a variety of licensing terms. Among findings,
Dr. Evans noted that the availability and pricing of many diagnostic
tests is similar whether based on patented or unpatented sequences.
Moreover, the ability to patent a sequence in itself does not appear
to have been decisive in whether a diagnostic test was developed.
SACGHS has developed policy options based on its findings, which
will be available for public comment, and plans to issue a report
with its final recommendations in February.
Information:
Stephen Heinig, Lead Science Policy Analyst
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488
DHS Selects Site for New Biodefense Lab
The Department of Homeland Security (DHS) has recommended Kansas
State University in Manhattan as the site for a new $450 million
National Bio and Agro-Defense Facility (NBAF).
DHS announced their choice in its Final
Environmental Impact Statement, released Dec. 5. A joint activity
with the departments of Agriculture and Health and Human Services,
the new federal laboratory will replace the current complex on Plum
Island, N.Y., and will conduct research on foot-and-mouth disease
and other livestock diseases and biohazards.
A total of 29 sites applied
in 2006 to host the Bio Safety Level 4 (BSL-4) facility, and DHS
narrowed
the field to five potential sites in July 2007. DHS issued a Draft
Environmental Impact Statement for review and comment in June, followed
by a series of public meetings. DHS is expected to issue a final
Record of Decision on Jan. 12, 2009.
Information:
Tannaz Rasouli, Senior Legislative Analyst
AAMC Government Relations
trasouli@aamc.org
(202) 828-0525
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