Washington Highlights: September
12, 2008
AAMC Submits Amicus Brief on IME Count
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The AAMC Aug. 22 submitted an amicus curiae brief to the
U.S. Court of Appeals for the First Circuit in a case that involves
the question of whether time spent in research and other scholarly
activity by medical residents should be included in the Medicare
Indirect Medical Education (IME) count of full-time equivalent (FTE)
residents. In Aug. 2007, Rhode Island Hospital received a favorable
District Court decision that involved the IME resident count for
1996. The government appealed the court's decision.
The AAMC's brief
argues that "excluding time spent in research and other
scholarly activities because they do not occur within 'areas' (defined
by the nature of the resident's services, and not the geographical
location of his/her assignment) of the hospital subject to the prospective
payment system simply ignores the indisputable fact that research
and scholarly activities are part of 'teaching activities' in an
approved program."
A favorable Appeals Court decision may be helpful to other hospitals
that are appealing IME exclusions related to research prior to the
implementation of a 2001 regulation. In 2001, the Centers for Medicare
and Medicaid Services (CMS) issued a regulation that excludes time
residents spend in research from the IME, so even if the Circuit
Court issues a favorable opinion, it will not have an effect on
resident counts for reporting periods after the rule became final.
Information:
Ivy Baer, Director & Regulatory Counsel
AAMC Health Care Affairs
ibaer@aamc.org
(202) 828-0490
Senate Approves ADA
The Senate Sept. 12 approved by voice vote its version of the "ADA
Amendments Act of 2008" (S.
3406), a bill that clarifies and broadens the definition of
disability and expands eligibility for protections under the Americans
with Disabilities Act (ADA). The House reportedly will consider
the Senate bill on Sept. 17.
The legislation eliminates the idea set forth by the Supreme Court
that mitigating measures should play a part in determining whether
an individual has a disability, and clarifies the definition of
"substantially limits" with regard to the effect a disability
has on major activities in a person's life.
In his floor statement, Senator Orrin Hatch (R-Utah) noted an attempt
to "minimize the impact this bill would have in the educational
arena." At the request of the higher education community, the
measure includes a provision affirming the underlying ADA provision
that accommodations or modifications in policies, including "academic
requirements in postsecondary education," are not required
if making such modifications would demonstrably "fundamentally
alter" educational standards.
The AAMC joined with 7 other educational testing groups to send
July 14 letters to both the Senate
and the House,
expressing concerns about the "unintended and negative consequences
the proposed legislation would have on individuals and institutions
involved in higher education, on entities that administer and rely
upon standardized tests, and on the public that is served by the
physicians, lawyers, engineers, and other professionals whose certification
and licensing depends, in part, on the results achieved on such
examinations" [see Washington
Highlights, July 18].
Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
House Panel Explores Implementation of NIH Reauthorization
Legislation
The House Energy and Commerce Health Subcommittee Sept. 9 held
a hearing on the impact of the NIH Reform Act of 2006 [P.L.
109-482] on the operations of the National Institutes of Health
(NIH). NIH Director Elias Zerhouni, M.D. noted the agency is using new authorities to enable and expedite trans-NIH
research, funded through the Common Fund, an appropriations line
item authorized by the NIH Reform Act. NIH recently issued a new
Biennial Report, required by the Act, which explains NIH programs
to Congress in one consolidated and transparent publication. He
also described the progress being made on "an open and electronic
disease funding report" also required by the legislation.
Dr. Zerhouni also announced the membership of the Scientific Management
Review Board (SMRB), which was mandated by the NIH Reform Act to
conduct periodic organizational reviews, issue reports on organizational
issues, and advise the NIH on the use of its management authorities.
The SMRB was chartered in August 2007.
Several Democrats on the subcommittee criticized the Administration
for not providing increased funding for the agency. Subcommittee
Chair Frank Pallone (D-N.J.) noted that the flat funding of the
NIH budget had resulted in a 14 percent decrease in real dollars.
Responding to a question from Rep. Diana DeGette (D-Colo.) about
the impact of the flat budget, Dr. Zerhouni identified three top
priorities: maintaining an adequate workforce; sustaining the investment
in a predictable, long-term manner; and maintaining the success
rate for scientists receiving NIH grants. Saying that a success
rate of 25 percent is the bare minimum, he noted that the enterprise
has done well with a success rate of 30 percent.
Rep. Tammy Baldwin (D-Wis.) asked about the strategy of funding
more but smaller Clinical Translational Science Awards (CTSAs).
Dr. Zerhouni replied that the CTSA awards were intended to be a
"leveraging investment" rather than a "resource grant"
and the recipient institutions could seek funding from other institutes
and centers. He also stated the decision on the total number of
awards has not been finalized.
Energy and Commerce Ranking Member Joe Barton (R-Texas), who authored
the NIH Reform Act when he chaired the committee, asked about the
potential impact of legislative proposals to create disease specific
structures and programs. Dr. Zerhouni said the issue is implementing
programs that do not become entitlements and encouraged flexibility
regarding congressional mandates. He expanded this point in his
written testimony, cautioning the panel "it would be a grave
mistake to go backwards in mandating disease-specific research at
a time when barriers need to be torn down, not rebuilt."
Dr. Zerhouni ended the hearing by saying the nation needs a mechanism
to make long-term capital investments in science.
Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
NIH Announces Scientific Management Review Board
Members
The National Institutes of Health (NIH) Sept. 9 announced
the nomination of 21 individuals to serve on the newly chartered
Scientific Management Review Board (SMRB). The NIH Reform Act of
2006 [P.L.
109-482] mandated the creation of the board, which will conduct
periodic organizational reviews, issue reports on organizational
issues, and advise the NIH on the use of its management authorities.
Norman R. Augustine, the former chairman of the executive committee
of Lockhead Martin Corporation, has been nominated to serve as the
board's first chairman. Several members of the SMRB are leaders
from academic medicine, including: William R. Brody, M.D., Ph.D.,
President, Johns Hopkins University; Deborah Powell, M.D., Dean
and Assistant Vice President for Clinical Science, University of
Minnesota Medical School; William Roper, M.D., Dean, University
of North Carolina School of Medicine, and CEO on UNC Healthcare;
Arthur Rubenstein, M.D., Executive Vice President, University of
Pennsylvania Health System and dean, University of Pennsylvania
School of Medicine; Harold Varmus, M.D., President, Memorial Sloan-Kettering
Cancer Center; Eugene Washington, M.D., Executive Vice Chancellor,
and Chair, Obstetrics, Gynecology, and Reproductive Sciences, University
of California, San Francisco; and Huda Zoghbi, M.D., professor,
Baylor College of Medicine.
At a Sept. 9 House Energy and Commerce Committee hearing (see
related story), NIH Director Elias Zerhouni, M.D., stated that
the panel will be independent and that "the scope and breadth
of their work will be determined by their own independent judgments."
Informaton:
Tony Mazzaschi, Senior Director
AAMC Scientific Affairs
tmazzaschi@aamc.org
(202) 828-0059
HHS Publishes "Provider Conscience Regulation"
Proposed Rule
The Department of Health and Human Services (HHS) Aug. 26 issued
a proposed
rule, "Ensuring that Department of Health and Human Services
Funds Do Not Support Coercive or Discriminatory Policies or Practices
in Violation of Federal Law," that would withhold federal funding
to health care entities that fail to accommodate employees that
object to participation in any medical service or procedure that
conflicts with their personal, moral or religious convictions. It
also requires a written certification by recipients and sub-recipients
of HHS funds that they operate in compliance with the Church Amendments,
section 245 of the Public Health Service Act, and the Weldon Amendment
to the FY 2008 Consolidated Appropriations Act [P.L.110-161];
these three provisions prohibit recipients of federal funds from
discriminating against individuals in the health care field on the
basis of their religious or moral beliefs.
An HHS impact analysis concluded over 584,000 health care entities,
including medical schools, hospitals, nursing homes, and physician
offices, will be affected by the proposed regulation at a total
expected cost of $44.5 million per year.
Comments must be submitted by Sept. 25. The AAMC will be submitting
comments.
Information:
Ivy Baer, Director & Regulatory Counsel
AAMC Health Care Affairs
ibaer@aamc.org
(202) 828-0490
Will Dardani, Constituent Services Specialist
AAMC Health Care Affairs
wdardani@aamc.org
(202) 828-0541
Grassley, Welch Hold Roundtable on University
Endowments
Senate Finance Committee Ranking Member Charles Grassley (R-Iowa)
and Rep. Peter Welch (D-Vt.) Sept. 8 held a roundtable on "Maximizing
the Use of Endowment Funds and Making Higher Education More Affordable."
The roundtable was divided into three panel topic areas: 1) college
costs and rising tuition; 2) charitable contributions and university
endowments; and 3) a proposed mandatory annual endowment payout
for student financial aid. Panelists
included representatives from the Congressional Research Service
(CRS), higher education associations, academic institutions, finance
industry and other groups.
Questioning university endowment spending, Sen. Grassley stated
"If the endowment per student includes graduate students, shouldn't
endowment spending include assistance for graduate students so that
future teachers, social workers and health care professionals can
work in underserved areas without worrying about their debt load?"
He added that "Congress would be remiss if it didn't question
what benefits tax-exempt colleges and universities provide in return
for all of the federal benefits they receive."
Sen. Grassley concluded his opening remarks
by asking the Internal Revenue Service (IRS) to develop a separate
Form 990 Schedule for colleges and universities similar to the new
Schedule H for hospitals. The new Schedule would focus on endowment
spending, the student population, and education costs.
Most of the panelists agreed that increased transparency in endowment
spending and educational costs would be beneficial, but that a mandated
annual endowment payout would be problematic. Their testimony reflected
that a primary difficulty in analyzing education costs is the complexity
of and variance in funding sources, academic needs, and individual
institutions' spending:
- Anthony Marx, Ph.D., President, Amherst College, noted that while
tuition has increased across the board, it had generally decreased
as a percentage of total funding contributions at education institutions
nationwide. He added that this lost funding is made up by endowment
spending and charitable contributions.
- David Shulenburger, Vice-President, Academic Affairs, National Association
of State Universities and Land Grant Colleges, noted that decreased
state education appropriations and federal research funding required
flexible use of endowments.
- Daniel Fogel, Ph.D., President, University of Vermont, pointed out
that generally 35 to 40 percent of annual endowment spending at institutions
with medical schools was directed to medical education expenditures.
- Shirley Tilghman, Ph.D., President, Princeton University, and Vice-Chair,
Association of American Universities, noted that expansions in academic
fields, such as genomics, will continue to increase institutional
costs. She also echoed Dr. Shulenburger's remarks that decreasing
research funds greatly increases individual university contributions
for research infrastructure.
- Blake Naughton, Ph.D., Analyst in Education Policy, CRS, added that
while state appropriations for higher education have increased, their
contributions have decreased as a percentage of the total share of
educational revenues.
A full webcast
of the roundtable is available on the Senate Finance Committee website.
Information:
Matthew Shick, Senior Legislative Analyst
AAMC Government Relations
mshick@aamc.org
(202) 862-6116
House Panel Examines NIH Public Access Policy
The House Judiciary Subcommittee on Courts, the Internet, and Intellectual
Property Sept. 12 held a hearing on the "Fair Copyright in
Research Works Act" (H.R.
6845), which seeks to reverse the National Institutes of Health
(NIH)'s recently implemented public access policy [see Washington
Highlights, Jan. 18].
The policy, included in the FY 2008 Consolidated Appropriations
Act [P.L.
110-161], requires all NIH-funded investigators to ensure that
their final, peer-reviewed manuscripts are submitted to the National
Library of Medicine (NLM) within 12 months of publication, "in
a manner consistent with copyright law." Critics of the policy
argue that requiring free public access to the copyrighted material
will have a negative impact on scientific journal subscriptions
and will remove the incentive for the journals to invest in peer
review processes.
Witnesses included George Washington University law professor Ralph
Oman, J.D., and Executive Director of the American Physiological
Society, Martin Frank, Ph.D., who argued that the public access
policy is not consistent with copyright law, and NIH Director Elias
Zerhouni, M.D., and Executive Director of the Scholarly Publishing
and Academic Resources Coalition Heather Dalterio Joseph, who defended
the NIH policy. Dr. Zerhouni noted that many publishers already
provide free access to journal articles after 12 months and that
providing uniform access to the results of publicly funded research
through NLM's PubMed Central website will allow digital and conceptual
linkages to the full range of NIH scientific databases.
At the hearing, Judiciary Committee Chair John Conyers (D-Mich.),
who introduced H.R. 6845, expressed concern that the committee had
not had the opportunity to examine the provision before it was added
to the spending bill. Subcommittee Chair Howard Berman (D-Calif.)
inquired whether the approach included in the America COMPETES Act
[P.L.
110-69] - which requires publicly accessible summaries of journal
articles resulting from National Science Foundation-funded research
- could serve as a "middle ground" solution.
Information:
Tannaz Rasouli, Senior Legislative Analyst
AAMC Government Relations
trasouli@aamc.org
(202) 828-0525
National Academies Panel Revises Guidelines for
Human Embryonic Stem Cell Research
The National Academies' Human Embryonic Stem Cell Research Advisory
Committee Sept. 5 released
amendments
to the National Academies' Guidelines for Human Embryonic Stem Cell
Research. The Guidelines were first issued in 2005 and updated in
2007. The changes approved by the panel in the latest revision include:
- Clarifying that "direct expenses" for reimbursement to women
donating their eggs for use in stem cell research may include costs
associated with travel, housing, child care, medical care, health
insurance, and actual lost wages.
- Recommending that the public be informed about the types of stem cell
research under way at an institution and how the research conforms
to the institution's established procedures. Moreover, the committee
strongly suggested as a good management practice that institutions
conducting human embryonic stem cell research carry out periodic audits
of their embryonic stem cell research oversight (ESCRO) committees
to ensure proper performance and make the findings of the audits publicly
available.
- Clarifying that an institutional ESCRO committee may conduct expedited
review for research done exclusively in a laboratory dish or test
tube that does not create new lines of stem cells but uses previously
derived human embryonic stem cell lines.
The panel also modified its guidance on the derivation and use
of stem cells in light of the development of "induced pluripotent
cells." The panel noted that although induced pluripotent stem
cells can be derived without using embryos, the ethical and policy
concerns related to their potential uses are similar to those pertaining
to human embryonic stem cells. The panel said that derivation of
induced pluripotent stem cells does not require special stem cell
expertise and is adequately covered by current Institutional Review
Board regulations.
Information:
Tony Mazzaschi, Senior Director
AAMC Scientific Affairs
tmazzaschi@aamc.org
(202) 828-0059
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