Washington Highlights: May 27, 2005
House Expands Eligibility
For Stem Cell Research Funding
Contents
Prior Issues
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After three hours of emotional debate, the House of Representatives
May 24 passed a proposal to expand the number of human embryonic
stem cell lines eligible for federal research funding by a vote
of 238 to 194. Despite a Statement of Administration Policy that
President Bush would veto the bill, 50 Republicans joined 187 Democrats
and 1 Independent to support the measure. Fourteen Democrats and
180 Republicans voted against the bill.
Following the House vote, AAMC President Jordan Cohen, M.D., issued
a statement thanking the principal cosponsors of the Stem Cell Research
Enhancement Act (H.R.
810) - Michael Castle (R-Del.) and Diana DeGette (D-Colo.) -
"for their hard work and leadership on this vital issue. Patients
and researchers alike are indebted to them for the perseverance,
passion, and political skill they exhibited in shepherding this
legislation through the House."
The principal cosponsors of the Senate companion bill (S.
471) - Senators Arlen Specter (R-Pa.), Tom Harkin (D-Iowa),
Orrin Hatch (R-Utah), Dianne Feinstein (D-Calif.), Gordon Smith
(R-Ore.) and Edward Kennedy (D-Mass.) - held a press conference
on May 25 to urge the Senate leadership to take up the bill immediately
without amendment. Senator Harkin said supporters of S. 471 have
"over 60 votes," enough to block a filibuster but short
of the 67 needed to override a veto. Majority Leader Bill Frist
(R-Tenn.) has not indicated how he intends to proceed on this proposal.
Senator Specter, who chairs the Labor-HHS-Education Appropriations
Subcommittee, has vowed to use the FY 2006 appropriations bill to
move the embryonic stem bill if necessary.
The House also passed under suspension of the rules 431 to 1 the
"Stem Cell Therapeutic and Research Act of 2005" (H.R.
2520) to support research using human cord blood stem cells
for research and the treatment of patients. Opponents of embryonic
stem cell research unsuccessfully tried to portray the cord blood
bill as an alternative to H.R. 810.
Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
CMS Establishes Medicaid Commission
The Centers for Medicare and Medicaid Services (CMS) May 24 issued
a Federal Register notice [70
FR 29765] regarding the establishment, purpose, and charter
of a Medicaid Commission. The creation of such a commission was
initially proposed during debate over the FY 2006 congressional
budget resolution.
According to the notice, the Commission will "advise the [Health
and Human Services] Secretary on ways to modernize the Medicaid
program so that it can provide high-quality health care to its beneficiaries
in a financially sustainable way." By Sept. 1, 2005, the Commission
must submit an initial set of "options to achieve $10 billion
in scorable Medicaid savings over five years." It is likely
that these recommendations will help guide the House Energy and
Commerce Committee in identifying the $14.7 billion in savings required
under the FY 2006 budget resolution. A second set of recommendations
to ensure "the long-term sustainability of the program"
is due by Dec. 31, 2006.
The notice establishes a June 3, 2005, deadline for nominating
individuals for Commission membership. The Commission will include
voting members (maximum of 15), non-voting advisor members (maximum
of 15), and non-voting congressional advisor members (maximum of
8). The voting members may include governors; policy experts; State
Medicaid Directors; "individuals with expertise in health,
finance, or administration;" federal Medicaid administrators;
the HHS Secretary; other members specified by the HHS Secretary;
and "Ex Officio Members." The non-voting advisor members
"will support the Commission's deliberations" and can
include state/local government officials, providers, and consumers
"who have an inherent interest in the Medicaid program."
Information:
Christiane Mitchell, Senior Legislative Analyst
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526
AAMC Testifies at PPAC on Physician-Pay-for-Performance
Albert Bothe Jr., M.D., associate dean and executive director,
University of Chicago Practice Plan, and past-chair of AAMC's Group
on Faculty Practice Steering Committee and chair of its Subcommittee
on Legislative and Regulatory Issues, May 23 testified
on behalf of the AAMC regarding physician quality and pay-for-performance
(P4P) initiatives at the quarterly meeting of the Practicing Physician's
Advisory Council (PPAC).
PPAC is a mandated advisory body to the Department of Health and
Human Services (HHS) that provides input on regulatory and carrier
manual issues relevant to physicians. The meeting covered a variety
of topics, including the new National Provider Identifier (NPI)
application process; the three-year recovery audit contract demonstration
for California, Florida and New York; an overview of the Part-D
prescription drug benefit and the expected physician and patient
support materials; the competitive acquisition program (an alternative
program for physicians who are having difficulty acquiring physician-administered
medications at average sales price plus 6 percent), and CMS quality
and P4P initiatives.
The AAMC's testimony expressed its support of Centers for Medicare
and Medicaid Services (CMS) initiatives to improve quality, but
also stated that any pay-for-performance initiatives must adhere
to specific design principles to ensure accurate and fair measurement
and reporting. The statement also noted that, although implementation
of quality initiatives may result in long tern savings, such initiatives
could increase utilization and thus spending on physicians and other
services covered by Part B. Increased expenditures would have a
negative financial impact under the current Part B Sustainable Growth
Rate (SGR) system.
Information:
Mary Patton, Senior Policy Analyst
AAMC Division of Health Care Affairs
mpatton@aamc.org
(202) 862-6297
Denise Dodero, Sr. Director, Health Care Affairs
AAMC Health Care Affairs
ddodero@aamc.org
(202) 828-0493
CMS Proposes Teaching Status Adjustment for Medicare
Rehab PPS
The Centers for Medicare and Medicaid Services (CMS) May 25 published
in the Federal Register [70
FR 30188] an FY 2006 proposed rule that proposes that a teaching
adjustment be added to the Medicare inpatient rehabilitation facility
(IRF) prospective payment system (PPS). The IRF PPS is the payment
system for Medicare-qualifying rehabilitation hospitals and distinct
part units of general acute care hospitals.
Similar to the indirect medical adjustment in the acute care PPS,
the IRF teaching adjustment would compensate teaching rehab facilities
for the higher costs they incur in providing rehabilitation care.
Analysis of 2003 data conducted by the RAND Corporation, CMS's research
contractor, indicated a statistically significant relationship between
teaching status and costs. While the inpatient IME adjustment uses
residents-to-beds as its teaching variable, the proposed IRF teaching
variable would be the ratio of residents to average daily census
(RADC). Under the proposal, a teaching IRF with an RADC of 0.10
would receive a 10.9 percent increase in their PPS payment. To constrain
the teaching payments, CMS proposes to impose a cap on the count
of residents that could be included in the RADC; this is similar
to the inpatient and psychiatric teaching adjustments.
While CMS is proposing a teaching adjustment, the accompanying
discussion in the proposed rule reflects some reluctance in doing
so. CMS states that it has "some concerns" about implementing
an adjustment at this time, due largely to perceived volatility
in the 2003 data on which the adjustment was determined. The agency
states that newer data may be examined that may "lead us to
conclude that a teaching status adjustment is not needed."
Comments on the proposed rule are due July 18, 2005.
Information:
Karen Fisher, Sr. Director, Health Care Affairs
AAMC Health Care Affairs
kfisher@aamc.org
(202) 862-6140
NIH Meeting Calls for Enhancing the Discipline
of Clinical and Translational Sciences
The National Institutes of Health (NIH) held a May 23 meeting
to introduce to the biomedical research community a new initiative
in which the National Center for Research Resources (NCRR) "will
lead a new effort on behalf of the NIH Roadmap Re-engineering the
Clinical Research Enterprise initiative to catalyze the development
of a new discipline of clinical and translational sciences".
NCRR sought "the advice of the clinical and translational sciences
community on ways that the NIH can:
- foster the clinical and translational sciences into a new
academic discipline;
- promote the training and career pathways of clinical and translational
investigators;
- allow for the more comprehensive integration and expansion
of resources for clinical and translational research; and
- improve inter-institutional collaborations."
NIH Director Elias Zerhouni, M.D., gave the lead talk, which was
followed by breakout sessions to solicit answers to a number of
questions posed by the NIH. He reviewed a number of factors that
have led to a decline in the number of physician-scientists conducting
clinical and translational research, noting that NIH Directors since
James Wyngaarden in 1979 had made attempts to address this problem
largely without success, and that fully half of his Roadmap was
focused on re-engineering the clinical research enterprise so as
not to fail again. Dr. Zerhouni shared his belief that the steps
implemented under the Roadmap to date were insufficient and would
not produce the transformational event that was needed. This led
him to the painful and unusual decision to cancel a Request for
Applications for "Regional Translational Research Center Planning
Grants," an action that provoked much criticism, in order to
preserve Roadmap resources for the initiative that he was now introducing.
Dr. Zerhouni's stated goal is: "Provide the academic home
and integrated resources needed to advance the new intellectual
discipline of clinical and translational sciences, create and nurture
a cadre of well-trained investigators, and advance the health of
the nation by transforming patient observations and basic discovery
research into clinical practice." He envisions this area as
a new discipline because of the advances that have occurred both
in knowledge and technology that require multidisciplinary teams
with appropriate skills and sufficient resources to tackle the highly
complex task of translating new knowledge into new ways of diagnosing,
treating and preventing human illnesses. In 6-8 years he would like
to see entities within Academic Medical Centers (AMCs) (flexibility
on whether a department, center, or institute) that will have as
components:
- Research design, statistics, and regulatory affairs;
- Biomedical informatics;
- Career Development program (Curriculum; slots);
- In-patient, outpatient, and community subject accrual sites;
- Core Labs;
- Pilot project program; and
- Governance core.
Dr. Zerhouni stated that the NIH Institute Directors and he were
committed to this initiative for the long term, and that funds would
be transferred from the individual institutes to support this Roadmap
initiative. He wants the NIH and the AMCs to work together to build
a strong foundation for clinical and translational sciences.
Information:
Howard B. Dickler, M.D.
AAMC Division of Biomedical and Health Science Research
hdickler@aamc.org
(202) 828-0567
AAMC Comments on Human Research Protections at
Non-U.S. Institutions
AAMC President Jordan J. Cohen, M.D., May 24 sent a letter
to the Office of Human Research Protections (OHRP) regarding criteria
recommended for making determinations of whether procedures prescribed
by institutions outside the U.S. afford protections that are at
least equivalent to those provided in the federal policy for the
protection of human subjects. While endorsing the identification
of seven specific protections afforded by the federal policy, Dr.
Cohen urged that the recommended focus shift from a technical, U.S.-centric
definition of what constitutes responsible measures for addressing
the specific protections to the protections themselves and alternative
ways to achieve them. The Department of Health and Human Services,
where OHRP is located, originally solicited comments in a March
25 Federal Register notice [70
FR 15322].
Information:
Susan Ehringhaus, Sr. Director & Regulatory Counsel
AAMC Biomedical Health Sciences Research
sehringhaus@aamc.org
(202) 828-0543
Kupersmith Announced as New VA CRADO
Department of Veterans Affairs (VA) Under Secretary for Health Jonathan
Perlin, M.D., May 25 announced that Joel Kupersmith, M.D., will be
the next VA Chief Research and Development Officer (CRADO). Dr. Kupersmith
is the former Dean of the School of Medicine and Graduate School of
Biomedical Sciences, and Vice President for Clinical Affairs at Texas
Tech University, where he also served as CEO of the Faculty Practice.
Prior to joining Texas Tech, Dr. Kupersmith served as Professor and
Director of the Clinical Pharmacology Section at the Mt. Sinai School
of Medicine, Chief of Cardiology and V.V. Cooke Professor of Medicine
at the University of Louisville, and Professor and Chairman of the
Department of Medicine at the College of Human Medicine at Michigan
State University. He is a graduate of New York Medical College where
he completed his clinical training in internal medicine. Subsequently,
he completed additional training in cardiology at Beth Israel Medical
Center/Harvard Medical Center, and research training in the Department
of Pharmacology at the Columbia College of Physicians and Surgeons.
Currently, Dr. Kupersmith is a Scholar-in-Residence at both the AAMC
and the Institute of Medicine. His appointment will be effective on
May 31.
House Panel Provides 3 Percent Increase for NSF
The House Science, State, Commerce and Justice Appropriations Subcommittee
May 24 marked up and approved an FY 2006 appropriations bill that
includes $5.64 billion for the National Science Foundation (NSF).
This represents an increase of $171 million (3.1 percent) over last
year and $38 million above the budget request. Within the total,
the subcommittee provided $4.38 billion for NSF research, $157 million
(3.7 percent) over FY 2005.
Information:
Jonathan Fishburn, Director, Research, Education and Veterans' Legislative Affairs
AAMC Government Relations
jfishburn@aamc.org
(202) 828-0525
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