Washington Highlights: March 13,
2009
President Signs FY 2009 Spending Bill
Contents
Prior Issues
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The President March 11 signed into law the FY 2009 Omnibus Appropriations
Act (H.R.
1105, P.L. 111-8), after the Senate voted, 62-35, to limit debate
on the bill and approved it by voice vote. The $410 billion spending
package combines the nine FY 2009 appropriations bills remaining
from the previous Congress. The measure provides $151.8 billion
for programs in the Labor-Health and Human Services-Education spending
bill, including increases for the National Institutes of Health,
Agency for Healthcare Research and Quality, the Title VII health
professions programs, and the National Health Service Corps [see
Washington Highlights,
March 6]. Programs in the bill had been operating at FY 2008
funding levels under a continuing resolution (P.L.
110-329) that was set to expire March 11.
Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
President Obama Lifts Restrictions on Stem Cell
Research, Issues Memo on Scientific Integrity
President Obama March 9 issued an executive
order lifting restrictions on the federal funding of human embryonic
stem cell research. The executive order directs the National Institutes
of Health (NIH) to issue guidelines to permit such funding within
120 days. President Obama's action is the first significant change
in federal stem cell research policy since Aug. 9, 2001, when President
Bush announced a policy that federal funds could only be used to
support research using human embryonic stem cells lines that were
derived before that date.
AAMC President and CEO Darrell G. Kirch, M.D., issued a March 9
statement
applauding the policy reversal: "This executive order recognizes
the need to expand federal support of stem cell research so that
millions of patients can benefit from the scientific and medical
breakthroughs that may result from this extremely promising research.
We look forward to working with the [NIH] as it develops the strict
ethical guidelines called for by President Obama, and moves forward
with research to improve the health of the nation."
Reps. Diana DeGette (D-Colo.) and Mike Castle (R-Del.) March 9
announced
their intention to pass legislation designed to prevent future restrictions
on stem cell research [see Washington
Highlights, Feb. 20].
Legislative efforts passed in the 110th Congress to lift the policy
restrictions were vetoed by President Bush.
Coinciding with the executive order, President Obama issued a memorandum
to help "inform and guide decisions of [the] Administration"
to ensure "the highest level of integrity in all aspects of
the executive branch's involvement with scientific and technological
processes." The memorandum requires the Director of the Office
of Science and Technology Policy to develop recommendations within
120 days regarding executive appointments, transparency, oversight,
whistleblower protections, and agency rules and procedures. The
memorandum notes, "Political officials should not suppress
or alter scientific or technological findings and conclusions."
Information:
Tony Mazzaschi, Senior Director
AAMC Scientific Affairs
tmazzaschi@aamc.org
(202) 828-0059
Matthew Shick, Senior Legislative Analyst
AAMC Government Relations
mshick@aamc.org
(202) 862-6116
Finance Committee Hearing Focuses on Workforce
Supply
A March 12 Senate Finance Committee hearing
focused on health care workforce issues within the context of broad
health care reform. In his opening remarks, Committee Chair Max
Baucus (D-Mont.) identified a need to "step back and ask whether
we have a solid, national strategy to strengthen our workforce."
He added that "Volumes of research have been published on the
problems facing our national health workforce," but no clear
strategy has emerged. Chairman Baucus consistently has raised concerns
about the supply of physicians, nurses, and other health professionals
as part of his ongoing work to draft health care reform legislation.
Testifying at the hearing were Fitzhugh Mullan, M.D., Professor
of Medicine and Health Policy at George Washington University; David
Goodman, M.D., Director of the Center for Health Policy Research
at Dartmouth; Allan Goroll, M.D., Professor of Medicine at Harvard
Medical School; and Steven Wartman, M.D., Ph.D., President of the
Association of Academic Health Centers. In addition to urging payment
reform for primary care services (particularly as an incentive for
attracting more medical students to primary care careers), the panelists
praised and encouraged additional support for the Title VII health
professions programs and the National Health Service Corps.
All four witnesses also expressed strong support for the establishment
of a new health workforce commission to develop and oversee policy
related to the broad health workforce. According to Dr. Goodman,
effective workforce policy "requires a dedicated staff that
is independent of professional societies and trade associations."
He criticized the charter of the Council on Graduate Medial Education
for having "impaired its effectiveness" in assuring an
adequate supply of physicians. Dr. Wartman recommended the immediate
appointment of "a national health workforce coordinator,"
along with the creation of "a permanent, multi-professional,
multi-disciplinary national health workforce planning body to bring
together all stakeholders to address the challenges we face in a
comprehensive, coordinated, and strategic manner."
Additionally, Dr. Goodman encouraged the committee to distribute
federal support for graduate medical education (GME) on a competitive
basis. He suggested that "applicants for GME funding could
be scored for factors such as training in evidence-based medicine,
in chronic illness management, and in shared patient decision-making."
Applicant scores would be weighted to reflect "societal needs."
To accomplish this, Dr. Goodman suggested implementing the competitive
peer review model used by the National Institutes of Health (NIH).
Dr. Goodman advised the committee that, "just as the NIH targets
certain money for cancer research, we could prospectively allocate
certain sums to primary care, in particular adult primary care or
other high priority specialties."
During the hearing, Sen. Bill Nelson (D-Fla.) raised concerns about
the current cap on Medicare-funding residency training slots. He
worried that the cap is a serious obstacle to assuring a sufficient
physician supply in rapidly growing areas of the nation, as well
as areas that already face primary care and specialty physician
shortages. While Dr. Mullan hesitated to support a wide-scale increase
in resident caps, he indicated some support for "nuanced"
increases that reflect regional workforce needs, and Dr. Goroll
agreed.
The AAMC submitted a statement
for the hearing record that reiterated the Association's workforce
policies, including its long-standing support for additional funding
for Title VII programs and the National Health Services Corps, greater
workforce diversity, and the implementation of a "medical home"
delivery model. Additionally, the AAMC's statement cautioned, "Medicare's
GME funding should not be used as an instrument to alter workforce
specialty composition. Further, programs should be allowed greater
flexibility in order to encourage training in non-hospital settings."
Information:
Christiane Mitchell, Director, Federal Affairs
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526
HHS, NIH Launch Recovery Act Activities
The Department of Health and Human Services (HHS) March 11 announced
the creation of the Office
of Recovery Act Coordination within the Office of the Secretary
to oversee successful distribution of an estimated $137 billion
in HHS-managed funds under the recently enacted "American Recovery
and Reinvestment Act of 2009" (ARRA, P.L.
111-5). The new office will ensure that ARRA requirements and
guidelines
issued by the Office of Management and Budget (OMB) on timely and
transparent reporting are followed. Former Deputy Administrator
of the Health Resources and Services Administration (HRSA) Dennis
Williams, Ph.D., will lead the office as a new Deputy Assistant
Secretary for Recovery Act Coordination.
As part of the effort, the National Institutes of Health (NIH)
has posted online
the first series of funding opportunity announcements for ARRA-supported
projects. The website
includes a broad outline of types of projects that NIH expects to
fund, as well as links to limited competition Requests for Applications
(RFA) and Notices on Shared Instrumentation; Facilities Construction;
Renovations, Repair and Improvements; and the newly created Challenge
Grants.
At least $200 million of the ARRA funding in FYs 2009 and 2010
has been designated for 200 or more Challenge Grants, and NIH anticipates
that Recovery Act funding allocated to NIH for comparative effectiveness
research may be available to fund the Challenge Grants as well.
These grants will support research that has an immediate, high impact
on "challenge topics" specified by NIH institutes and
centers, within 15 broad, NIH-wide "challenge areas."
Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
Irena Tartakovsky, Senior Science Policy Analyst
AAMC Biomedical and Health Sciences Research
itartakovsky@aamc.org
(202) 862-6134
HHS Proposes to Rescind "Provider Conscience
Rule"
The Department of Health and Human Services (HHS) March 10 published
a proposed rule
to rescind a final rule published by the Bush Administration on
Dec. 19, 2008, "Ensuring That Department of Health and Human
Services Funds Do Not Support Coercive or Discriminatory Policies
or Practices in Violation of Federal Law," dubbed "The
Provider Conscience Rule" [see Washington
Highlights, Dec.
19, 2008]. Any worker who has objections to performing certain
services or activities because of religious beliefs or moral convictions
already is protected by federal statutes, including Sec. 245 of
the Public Health Service Act. Noting that "comments on the
August 2008 proposed rule raised a number of questions that warrant
further careful consideration," HHS has provided a 30 day comment
period "to aid our consideration of the many complex questions
surrounding the issue and the need for regulation in this area."
Comments must be received by April 9, 2009.
The AAMC strongly opposed the original rule and submitted a Sept.
23 comment letter noting that there must be a "careful balance
between the rights of the health care professional to avoid behavior
that violates his/her moral code, and the right of the patient to
receive legal health care services that are medically appropriate."
[see Washington Highlights,
Sept. 26, 2008]
Information:
Ivy Baer, Director & Regulatory Counsel
AAMC Health Care Affairs
ibaer@aamc.org
(202) 828-0490
Finance Committee Hearing Focuses on President's
FY 2010 Health Care Proposals
The Senate Finance Committee March 10 held a hearing
on President Obama's FY 2010 budget
health care proposals. While the President's budget proposes a $634
billion investment to reform the health care system, Director of
the Office of Management and Budget (OMB) Peter Orszag suggested
that "the Administration recognizes that the reserve is not
sufficient to fully fund comprehensive reform, and we are committed
to working with Congress to find additional resources to devote
to health care reform." Orszag outlined the administration's
guiding principles for health reform, which include: affordable,
quality health care coverage for all Americans, portability of coverage,
choice of doctors, prevention and wellness, safety and quality of
care, strengthening Medicare through competitive payments, reducing
drug prices, improving payment accuracy, reducing readmission rates,
and expanding the hospital quality improvement program.
Finance Committee Chair Max Baucus (D-Mont.) expressed the need
for "fundamental reform in cost, quality, and coverage. We
need to address all three objectives at the same time. They are
interconnected." Baucus also stated, "Senator Grassley
and I have laid out a schedule … [that] calls for this committee
to mark up a comprehensive health care reform bill in June. We should
put a health care bill on the President's desk by July 4."
Information:
Travis W. Crytzer, Legislative Analyst
AAMC Government Relations
tcrytzer@aamc.org
(202) 828-0418
AHRQ Releases Updated List of Patient Safety Organizations
The Agency for Healthcare Research and Quality (AHRQ) March 9 released
an updated list
of certified Patient Safety Organizations (PSO). The list includes
more than 50 entities across the country. The PSOs are designed
to establish a framework by which hospitals, physicians, and other
health care providers may voluntarily provide information on a privileged
and confidential basis, for the aggregation and analysis of patient
safety events.
Information:
Jennifer Faerberg, Director, Health Care Affairs
AAMC Health Care Affairs
jfaerberg@aamc.org
(202) 862-6221
House Introduces Generic Drugs Legislation
Reps. Henry Waxman (D-Calif.), Frank Pallone (D-N.J.), Nathan Deal
(R-Ga.) and Jo Ann Emerson (R-Mo.) March 11 introduced legislation
that would allow the Food and Drug Administration (FDA) to approve
generic versions of biotech drugs.
The "Promoting Innovation and Access to Life-Saving Medicine
Act" (H.R.
1427) allows makers of an original biologic drug a 5-year period
of exclusivity in marketing, and a 3-year exclusivity period for
a modification to an already FDA-approved drug. The legislation
grants six months of exclusive generic marketing to the first company
that proves to the FDA that its generic is safe and interchangeable
with the original branded drug. Exclusivity periods for brand name
biologics can be extended up to one year if the drug can be used
for a new disease indication, or if the applicant conducts pediatric
studies.
The sponsors of this bill believe that this legislation will allow
greater access to biologic drugs. The bill sponsors released letters
of support from a broad array of groups including, AARP, National
Organization of Rare Disorders, and General Motors. The Biotechnology
Industry Organization (BIO) issued a statement
objecting to the bill, saying it would jeopardize the development
of new biologics.
H.R. 1427 has been referred to the House Committees on Energy and
Commerce and the Judiciary. Rep. Waxman chairs the Committe on Energy
and Commerce while Reps. Pallone and Deal are the chair and ranking
member, respectively, of the panel's health subcommittee.
There is currently no companion legislation in the Senate, but
Senators Charles Schumer (D-N.Y.), Susan Collins (R-Maine), Sherrod
Brown (D-Ohio) and David Vitter (R-La.) are expected to introduce
legislation soon.
Information:
Abigail Schopick, Legislative Analyst
AAMC Government Relations
aschopick@aamc.org
(202) 828-0525
Senate Panel, HHS Advisory Committee Consider
Patent Policy and Reform
The Senate Judiciary Committee March 10 held its first hearing
of the new session on the "Patent Reform Act of 2009,"
(S.
515). The legislation was introduced March 3 by Senate Judiciary
Chair Patrick Leahey (D-Vt.) and Sen. Orrin Hatch (R-Utah), a senior
member of the committee. House Judiciary Committee Chair John Conyers
(D-Mich.) and Ranking Member Lamar Smith (R-Texas) introduced companion
legislation (H.R.
1260) the same day.
The hearing focused primarily on industry perspectives, but Sen.
Dianne Feinstein (D-Calif.) noted the need to reconcile views of
all parties, including the universities. The AAMC continues to work
with the Association of American Universities and other academic
associations to present a consensus position on patent reform.
Members of the committee expressed hope of reaching compromise
on certain provisions that have prevented enactment of similar legislation
in previous Congresses. In 2007, the House passed a patent reform
bill but the Senate was unable to do so. The legislation stalled
primarily over provisions for the allocation infringement damages
and a proposed "second window," in which outside parties
could contest the award of a patent by the U.S. Patent and Trademark
Office.
In a separate development, the Department of Health and Human Services
(HHS) Secretary's Advisory Committee on Genetics, Health, and Society
(SACGHS) has requested public comments regarding its draft report,
"Public Consultation Draft Report on Gene Patents and Licensing
Practices and Their Impact on Patient Access to Genetic Tests."
Public comments on the draft are due May 15.
Information:
Stephen Heinig, Lead Science Policy Analyst
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488
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