Washington Highlights: November
7, 2008
AAMC Issues Health Care Reform Principles
Contents
Prior Issues
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The AAMC Oct. 28 issued six principles to help guide reform of
the nation's health care system.
The document observes that the U.S. health care system faces a
crisis of access, cost, and quality, calling for U.S. medical schools
and major teaching hospitals to play "a pivotal role in improving
health and health care and in achieving positive changes in the
health care system," given their significant roles as health
care providers, educators of future physicians, and discoverers
of new scientific knowledge. The document also notes that such reform
should improve both health care delivery and financing, "while
preserving the greatest strengths of the current health care system."
In an Oct. 28 statement,
AAMC President and CEO Darrell G. Kirch, M.D. said, "Ensuring
access to safe, high-quality, appropriate, and affordable patient-centered
health care should be the focus of any national dialogue on reforming
the U.S. health care system." He also said, "With a concerted
effort from both the private and public sectors, we believe the
goal of affordable, quality health care for all is achievable and
sustainable within the next decade."
The AAMC's six principles
of health care reform affirm that:
- Health care coverage that is affordable, transportable, and
continuous, and that combines that best of public and private
systems, should be available to all.
- The health care delivery system must be restructured to facilitate
health promotion and disease prevention while providing high-quality,
cost-effective diagnosis and treatment of illness as well as palliative
care.
- Health care financing mechanisms should be sustainable, equitable,
explicit, accountable, and promote efficiency and quality.
- Existing programs that serve defined populations should be maintained
until superior alternatives can fully replace them.
- The supply of health care practitioners must be adequate and
reflect the population and its health care needs.
- Any reconfiguration of the health care system should recognize
and provide stable support for the costs inherent in health research,
technology development, and the provision of necessary specialized
services to the broader society.
Information:
Travis W. Crytzer, Legislative Analyst
AAMC Government Relations
tcrytzer@aamc.org
(202) 828-0418
CMS Posts 2009 Physician Fee Schedule Final Rule
on Web
The Centers for Medicare and Medicaid Services (CMS) Oct. 30 posted
the final rule for the 2009 physician fee schedule (PFS) on the
web. The rule updates the physician fee schedule by 1.1 percent
for 2009; however, due to a change in budget neutrality adjustment
methodology, the 2009 conversion factor (CF) ($36.0666) is lower
than the 2008 CF ($38.0870).
The rule finalizes a number of proposed changes, implements some
provisions in the recently enacted "Medicare Improvement for
Patients and Providers Act of 2008" (MIPAA, P.L.
110-275), and provides an additional comment period on several
proposals. Most provisions of the rule are effective Jan. 1, 2009.
Since 2007, physicians have been able to participate in the Physician
Quality Reporting Initiative (PQRI). Physicians who successfully
participate in the PQRI program will receive a 2 percent bonus incentive
for 2009 and 2010. MIPAA made several major changes in PQRI that
are incorporated into the final rule - most notably, establishing
a separate e-prescribing program with its own incentives and disincentives
for participation and failure to participate. Beginning in 2009
and extending through 2010, successful e-prescribers will be eligible
for a 2 percent bonus. For physicians who also successfully participate
in the PQRI program, the e-prescribing bonus will be in addition
to the PQRI bonus. The e-prescribing bonus dips to 1 percent for
2011 and 2012 and to 0.5 percent for 2013. Physicians who are not
successful e-prescribers will face a 1 percent reduction in payments
for 2012, 1.5 percent for 2013, and 2 percent for 2014 and subsequent
years. At a later time CMS will engage in rulemaking about how the
reductions will be implemented.
MIPPA requires public reporting of those who successfully e-prescribe
and those who successfully report in PQRI. In the rule, CMS indicated
that it would publish the 2009 results starting in 2010 on a Physician
Compare website.
CMS also sought comments about an approach for establishing an
effective date for Medicare billing for physician organizations
and others. The final rule allows physician practices to bill Medicare
for 30 days prior to the latter of: (1) the date of filing a Medicare
provider enrollment application that was subsequently able to be
processed by a Medicare contractor; or (2) the date a new provider
began furnishing services at a new practice location.
CMS proposed a new exception to the physician self-referral law
("Stark") for incentive payment and shared savings programs
that includes gainsharing and pay for performance. Acknowledging
that "we did not receive . . . . sufficient information or
agreement among commenters regarding possible modifications to the
proposal to allow us to finalize an exception," CMS decided
to reopen the public comment period for an additional 90 days.
The rule is expected to be published in the Federal Register
on Nov. 19. A display copy can be accessed online.
The AAMC continues to review the rule and will provide members
with additional information in the next several weeks.
Information:
Mary Patton, Senior Specialist
AAMC Health Care Affairs
mpatton@aamc.org
(202) 862-6297
Ivy Baer, Director & Regulatory Counsel
AAMC Health Care Affairs
ibaer@aamc.org
(202) 828-0490
MedPAC Recommends Manufacturers Report Financial
Relationships
At its Nov. 6 meeting, the Medicare Payment Advisory Commission
(MedPAC) approved a series of recommendations for manufacturers
to disclose relationships to physicians, and for hospitals and other
healthcare entities billing Medicare, to disclose physician ownership
shares. The recommendations will be published in the March Report
to Congress. MedPAC recommended that Congress require manufacturers
and distributors to report financial relationships with a broad
range of recipients including physicians, health plans, medical
schools, and organizations that fund continuing medical education.
The relationships should be posted in a searchable database. While
not explicitly stated in the recommendation, MedPAC staff indicated
that the manufacturers would report if the annual value to the recipient
exceeds $100.
MedPAC also recommended that Congress require manufacturers to
report information on drug samples. Due to the sensitive data collected,
the drug sample data would not be publicly posted, but accessed
through a data use agreement. The final two recommendations focus
on transparent financial relationships between physicians and health
care entities. Entities that bill Medicare and are not publicly-traded
corporations would report the ownership shares for each physician
that directly or indirectly owns an interest in the entity. MedPAC
also recommended that the Centers for Medicare and Medicaid Services
(CMS) submit a report on the types and prevalence of financial arrangements
between hospitals and physicians. A transcript will be posted on
the MedPAC website.
Information:
Susan Ehringhaus, Sr. Director & Regulatory Counsel
AAMC Biomedical Health Sciences Research
sehringhaus@aamc.org
(202) 828-0543
OHRP Posts Guidance Documents
The Department of Health and Human Services (HHS)'s Office for
Human Research Protections (OHRP) has posted its "Final
Guidance on Engagement of Institutions in Human Subjects Research"
and "Revised
Guidance on Research Involving Coded Private Information or
Biological Specimens."
OHRP announced in the Oct. 23 Federal
Register
the availability of the "Final Guidance on Engagement of
Institutions in Human Subjects Research." The new guidance
document replaces two prior OHRP guidance documents on the engagement
of institutions in human subjects research: (1) the Jan. 26, 1999,
document on "Engagement of Institutions in Research,"
and (2) the Dec. 23, 1999, document on "Engagement of Pharmaceutical
Companies in HHS Supported Research." The AAMC responded
in February 2007 to OHRP's request for comments on draft guidance
published December 2006.
The guidance document describes situations that would determine
whether an institution is engaged in a human subjects research project,
as well as considerations for IRB review of cooperative research
in which multiple institutions are engaged in the same non-exempt
human subjects research project.
The guidance also provides scenarios in which institutions are
not considered engaged in human subjects research. These include
institutions that are not selected as research sites whose employees
or agents administer clinical trial-related medical services or
administer study interventions on a one-time or short-term basis.
Institutions releasing identifiable private information or identifiable
biological specimens to another institution also are not considered
to be engaged in human subjects research.
OHRP also posted a revised version of the "Guidance on Research
Involving Coded Private Information or Biological Specimens,"
with two substantive changes. First, under the section heading,
"Guidance," OHRP clarifies its interpretation of "obtaining
identifiable private information or identifiable specimens."
Additionally, the guidance deletes the first example of when investigators
would not be able to readily ascertain the identity of the individual(s)
to whom the coded private information or specimens pertain; that
example addressed a circumstance in which the key to decipher the
code was destroyed before the research began.
Comments regarding the guidance documents may be submitted to OHRP
at any time via e-mail to ohrp@hhs.gov or via facsimile at 240-453-6909.
Information:
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Kington to Serve as NIH Acting Director
Raynard Kington, M.D., Ph.D., was named Acting Director of the
National Institutes of Health (NIH) upon the Oct. 31 departure of
NIH Director Elias Zerhouni, M.D. Dr. Kington was appointed Deputy
Director in February 2003; previously, he had served as Acting Director
of the National Institute on Alcohol Abuse and Alcoholism, as well
as Associate Director of NIH for behavioral and social sciences
research. In addition to his roles at NIH, Dr. Kington, board-certified
in Internal Medicine and Public Health and Preventive Medicine,
held positions at the Centers for Disease Control and Prevention
(CDC) and the RAND Corporation.
In addition to Dr. Kington's appointment, the NIH also announced
appointments to two new positions. Norka Ruiz Bravo, Ph.D., will
step down as NIH Deputy Director for Extramural Research and Director
of the Office of Extramural Research (OER) to transition to a new
role as Special Advisor to the Director. OER Deputy Director Sally
J. Rockey, Ph.D., will serve as Acting Deputy Director for Extramural
Research in the interim. Additionally, Director of the NIH Office
of Science Policy (OSP) Lana Skirboll, Ph.D., was named Acting Director
of the newly formed Division of Program Coordination, Planning,
and Strategic Initiatives (DPCPSI). DPCPSI, which was mandated in
the NIH Reform Act of 2006 (P.L.
109-482), will include the Office of Behavioral and Social Sciences
Research (OBSSR), Office of Research on Women's Health (ORWH), Office
of AIDS Research (OAR), and Office of Disease Prevention (ODP),
as well as functions under the former Office of Portfolio Analysis
and Strategic Initiatives (OPASI). Amy Patterson, M.D., will serve
as OSP Acting Director.
New Docs on Capitol Hill
At least three, and possibly four, additional physicians will join
the ranks of the House of Representatives when the 111th Congress
convenes in January, bringing the total number of physicians on
Capitol Hill to at least 13.
Parker Griffith, M.D., (D) defeated Wayne Parker (R) to succeed
Robert E. "Bud" Cramer (D) to represent Alabama's 5th
District. A retired radiation oncologist, Dr. Griffith received
his M.D. degree from Louisiana State University. He reportedly is
interested in seats on the Armed Services Committee and the Transportation
and Infrastructure Committee.
Bill Cassidy, M.D., (R) defeated incumbent Rep. Don Cazayoux (D)
for the Louisiana 6th District. Dr. Cassidy received his M.D. from
Louisiana State University (LSU). A gastroenterologist, he is an
Associate Professor of Medicine with LSU Health Sciences Center,
teaching at Earl K. Long Hospital. He hopes to continue to practice
medicine as a member of Congress.
Phil Roe, M.D., (R), defeated Rob Russell (D) for Tennessee's 1st
District after defeating Rep. David Davis (R) in the primary. A
graduate of the University of Tennessee College of Medicine, Dr.
Roe retired after practicing obstetrics and gynecology for 31 years.
At press time, the race for Maryland's 1st District was undecided.
Andy Harris, M.D., (R) is running against Frank M. Kratovil, Jr.
(D) to succeed Rep. Wayne T. Gilchrist (R), whom Dr. Harris defeated
in the primary. Dr. Harris is an obstetric anesthesiologist at The
Johns Hopkins Hospital, where he also is an Associate Professor
of Anesthesiology and Critical Care Medicine. He received his M.D.
from the Johns Hopkins University School of Medicine.
The 110th Congress had 11 physicians: two in the Senate and nine
in the House. All of the physicians in the House were re-elected
except for Rep. Dave Weldon, M.D., (R-Fla.), who retired. Sen. John
Barrasso, M.D., (R-Wyo.), an orthopedic surgeon elected to the Senate
in a special election to replace the late Sen. Craig Thomas (R),
was re-elected. Sen. Tom Coburn, M.D., (R-Okla.), a family physician,
will be up for re-election in 2010.
In addition, Kurt Schrader, D.V.M., (D) defeated Mike Erickson
(R) to succeed Rep. Darlene Hooley (D), who retired from Oregon's
5th District.
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