Washington Highlights: October 9,
2009
Contents
Prior Issues
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Reps. Schwartz and Tiberi Establish Congressional
Academic Medicine Caucus
Reps. Allyson Schwartz (D-Pa.) and Patrick Tiberi (R-Ohio) Oct.
6 formally registered the new Congressional Academic Medicine Caucus
(CAMC) in the House of Representatives. Reps. Schwartz and Tiberi
will serve as co-chairs of the new bipartisan caucus which will
focus on maintaining and strengthening the nation's medical schools
and teaching hospitals. When establishing the new caucus, Reps.
Schwartz and Tiberi wrote, "The new caucus will also strive
to educate other members on the unique health care, research, and
training missions of teaching hospitals and medical schools."
In an Oct. 6 press
release, AAMC President and CEO Darrell G. Kirch, M.D., thanked
Reps. Schwartz and Tiberi for "ensuring that academic medicine
continues to have a strong voice and the support to continue to
provide the best that American medicine has to offer." Dr.
Kirch also stressed the importance of academic medicine saying "academic
medicine is where patients, their families and other health care
providers turn for hope. With the establishment of this caucus,
the nation's medical schools and teaching hospitals will have a
strong voice in Congress and the support they need to continue to
provide the high-quality care that all Americans deserve, and pioneer
the innovations that transform medicine and improve health. We look
forward to working with Reps. Schwartz and Tiberi and all the members
of this important new caucus."
Information:
Len Marquez, Director
AAMC Government Relations
lmarquez@aamc.org
(202) 862-6281
Finance Committee Moves Closer to Final Vote on
Health Care Reform
The Senate Finance Committee has scheduled an Oct. 13 vote on
its health care reform package, the "America's Healthy Future
Act of 2009" (see Washington
Highlights, Oct. 2).
In preparation for the vote, Committee Chair Max Baucus (D-Mont.)
Oct. 7 released a preliminary Congressional Budget Office (CBO)
analysis of the legislation that incorporates amendments adopted
during the committee's two-week mark-up.
According to the CBO, the $829 billion cost of the Finance package
is fully offset and reduces the federal deficit by $81 billion over
ten years. Its coverage provisions will insure an estimated 94 percent
of all legal residents (91 percent of all residents) over the same
period. Approximately 25 million people will remain uninsured.
Upon release of the CBO analysis,
Chairman Baucus stated that "Our balanced approach to health
reform has paid off yet again." He added that the "legislation
is a smart investment on the federal balance sheet" and "an
even smarter investment for American families, businesses, and our
economy."
Information:
Christiane Mitchell, Director, Federal Affairs
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526
Len Marquez, Director
AAMC Government Relations
lmarquez@aamc.org
(202) 862-6281
Senate Panel Questions NIH on Recovery Act Funds
for SBIR
The Senate Committee on Small Business and Entrepreneurship Oct.
5 held a hearing
on the impact of the American Recovery and Reinvestment Act (ARRA,
P.L.
111-5) on the small business community. One of the issues the
hearing addressed was the Recovery Act's exemption of the National
Institutes of Health (NIH) from the statutory requirements for funding
the Small Business Innovation Research (SBIR) and Small Business
Technology Transfer (STTR) programs.
Federal agencies with extramural research and development (R&D)
budgets over $100 million are required to administer SBIR programs
using an annual set-aside of 2.5 percent for small companies to
conduct innovative research or R&D that has potential for commercialization
and public benefit. Federal agencies with extramural R&D budgets
over $1 billion are required to administer STTR programs using an
annual set-aside of 0.30 percent. The Recovery Act exempted the
$10.4 billion it provided to NIH from being included in the SBIR
and STTR set-asides.
In her opening statement,
Committee Chair Mary Landrieu (D-La.) noted this exemption "should
not have made it in and needs to be changed." She said, "This
provision cheated small businesses out of as much as $230 million
in work, and it directly counters the goals of the Recovery Act
to create high-paying jobs, spur innovation and boost America's
competitiveness. The SBIR and STTR programs have a proven track
record in these areas."
While Chairwoman Landrieu acknowledged, "NIH has made some
efforts to include small businesses in their Recovery Act spending
since we started raising the issue last spring," she added,
"However, their efforts are small and have fallen well short
of restoring the full amount of spending to the SBIR and STTR programs."
She also noted, "The anger from the small business community
over this exemption has not waned, and I am very interested to hear
today about realistic ways to help NIH make up the $230 million
that should have gone to SBIR and STTR."
Sally Rockey, Ph.D., NIH Acting Deputy Director for Extramural
Research, told the committee that NIH has "developed a multifaceted
strategy in implementing the ARRA program and small businesses were
participants throughout the range of Recovery Act funding approaches."
She added, "By including qualified small businesses in almost
every ARRA funding opportunity offered by NIH, we were able to assure
that small businesses had opportunities where they traditionally
may not have participated in the past."
Dr. Rockey testified
that, as of September 30, NIH has dedicated almost $150 million
of ARRA funds to small businesses; approximately $97 million of
stimulus dollars to meritorious small business concerns for FY 2009
and about $50 million in additional stimulus funds for second-year
commitments of the FY 2009 awards. She added that additional Recovery
Act funds will be expended in FY 2010 for new programs that target
the small business community, along with potentially additional
supplement and competing revision awards.
Dr. Rockey also described two new NIH programs specifically targeted
at small business. The Biomedical Research, Development, and Growth
to Spur the Acceleration of New Technologies (BRDG-SPAN) pilot program
is intended to address the funding gap and provide a critical bridge
across the so-called "Valley of Death" between discovery
and commercialization for U.S. commercial enterprises. NIH received
742 applications for this program and anticipates completing the
review process and making funding decisions in early FY 2010. NIH
has designated at least $30 million for this program.
The Small Business Catalyst Awards for Accelerating Innovative
Research (Catalyst) program is designed to encourage high-risk,
high-reward ideas with high commercial potential to lead to products
that will improve public health and generate significant value and
economic stimulus. Applications from small business concerns and
entrepreneurs of exceptional creativity without a history of prior
NIH funding are especially encouraged for the Catalyst program,
which utilizes the SBIR Phase I funding mechanism. This program
received 689 applications, and funding decisions are expected in
early FY 2010. NIH has designated at least $5 million for this program.
In response to a question from Chairwoman Landrieu about declining
numbers of SBIR applications, Dr. Rockey said that Phase I applications
have fallen from a peak of 6,141 in 2003 to 3,312 in 2008. Dr. Rockey
expressed concern about the declining applications and said NIH
is committed to increasing outreach to the small business community.
Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
House Chairs Object to Harm Standard in Breach
Notification Rule
Leaders of the House Committees on Energy and Commerce and Ways
and Means sent an Oct. 1 letter
urging the Department of Health and Human Services (HHS) to revise
its interim final
rule on notification requirements for breaches of unsecured
protected health information [see Washington
Highlights, Aug. 21].
The letter objects to HHS's proposal that covered entities and
business associates must perform a risk assessment to determine
if an impermissible use or disclosure of protected health information
triggers breach notification requirements added to the HIPAA Privacy
Rule through the American Recovery and Reinvestment Act (ARRA, P.L.
111-5). According to the legislators, the HHS approach "is
not consistent with Congressional intent" because when the
legislation was crafted, "Members considered the comments they
received, the practices of States, and ultimately decided against
inclusion of a harm standard."
Signed by House Energy and Commerce Committee Chair Henry Waxman
(D-Calif.), Ranking Member Joe Barton (R-Texas), Chairman Emeritus
John Dingell (D-Mich.), Health Subcommittee Chair Frank Pallone
(D-N.J.), Ways and Means Committee Chair Charles Rangel (D-N.Y.)
and Ways and Means Health Subcommittee Chair Pete Stark (D-Calif.),
the letter urges HHS "to revise or repeal the harm standard
provision included in its interim final rule at the soonest appropriate
opportunity."
In a Sept. 24 comment letter
on the rule, the AAMC praised HHS for its efforts to implement the
"breach notification requirement in a way that fulfills the
goals of the legislation while recognizing the burden that covered
entities face in complying with it." The AAMC letter also described
the risk assessment as a "reasonable approach" that allows
covered entities to gauge the harm that may result from a breach
before fulfilling the notification requirements.
Comments
on the interim final rule are due Oct. 23 and should be labeled
with reference number RIN 0991-AB56.
Information:
Ivy Baer, Director & Regulatory Counsel
AAMC Health Care Affairs
ibaer@aamc.org
(202) 828-0490
Tannaz Rasouli, Senior Legislative Analyst
AAMC Government Relations
trasouli@aamc.org
(202) 828-0525
HHS; Labor; Treasury Release Interim Final Rule
to Implement GINA
The departments of Health and Human Services (HHS), Labor, and
the Treasury Oct. 7 published in the Federal Register an interim
final rule "Prohibiting Discrimination Based on Genetic Information
in Health Insurance Coverage and Group Health Plans." The HHS
Office for Civil Rights (OCR) also issued an Oct. 7 proposed
rule modifying the HIPAA privacy rule to prohibit insurers from
using or disclosing genetic information for underwriting purposes.
The interim final rule and the notice of proposed rulemaking implement
Title I (Sections 101 through 103) of the Genetic Information Nondiscrimination
Act of 2008 (GINA, P.L.
110-233). Under GINA, health plans and insurers in both group
and individual health insurance markets are prohibited from:
- Increasing premiums for the group or individual based on the
results of individual genetic information;
- Denying coverage based on genetic information;
- Imposing pre-existing condition exclusions based on genetic
information;
- Requesting, requiring or buying genetic information for underwriting
purposes or prior to and in connection with enrollment; and
- Asking individuals or family members to undergo a genetic test.
The interim final rule will take effect on Dec. 7, 2009, and comments
are due by Jan. 5, 2010. Comments on the OCR proposed rule must
be submitted no later than Dec. 7.
Information:
Irena Tartakovsky, Senior Science Policy Analyst
AAMC Biomedical and Health Sciences Research
itartakovsky@aamc.org
(202) 862-6134
AAMC Mourns Passing of Dr. Kirschstein
Former Acting National Institutes of Health (NIH) Director Ruth
L. Kirschstein, M.D., passed away late Oct. 6 at 82 after battling
a long illness. In 1974, Dr. Kirschstein was the first woman to
serve as director of an NIH institute ? the National Institute of
General Medical Sciences (NIGMS) ? and served as acting NIH director
on several occasions.
In an Oct. 7 statement,
AAMC President and CEO Darrel G. Kirch noted "Dr. Ruth Kirschstein's
death is a tremendous loss to patients, researchers, and all Americans
who value medical research and the [NIH] … From her work on
the Sabin vaccine to her many leadership positions at the NIH, she
maintained a singular focus on scientific excellence, while demonstrating
a steadfast devotion to public service. Dr. Kirschstein leaves a
legacy that will continue to enrich the scientific enterprise and
the health of the American people for generations to come."
Senate HELP Committee Approves President Obama's
Surgeon General Nominee
The Senate Health Education Labor and Pensions (HELP) Committee
Oct. 7 unanimously approved
Regina Benjamin, M.D., M.B.A., as U.S. Surgeon General, clearing
her nomination for the full Senate's consideration. President Barack
Obama announced Dr. Benjamin as the Surgeon General-nominee on July
13 [see Washington Highlights,
July 17].
In a July 14 statement,
AAMC President and CEO Darrell G. Kirch, M.D., praised Dr. Benjamin
as "a gifted physician with a strong commitment to caring for
the underserved and community health." Dr. Kirch noted that
"this nomination also appears to mark the first time that a
former participant in the National Health Service Corps (NHSC) could
serve as our chief public health official," observing that
the program is "critically important to America's future health
care needs."
Dr. Benjamin is founder and CEO of the Bayou Le Batre Rural Health
Clinic in Alabama, a primary care facility that treats all patients
regardless of their ability to pay. Her service within the medical
community includes her work as the Associate Dean for Rural Health
at the University of South Alabama College of Medicine and as Chair
of the Federation of State Medical Boards of the United States.
The Senate has not scheduled a vote for Dr. Benjamin's confirmation.
On the Agenda in Washington
Oct. 13: Senate Finance Committee Markup of Health Care Revision
10 a.m.; 216 Senate Hart Building.
The full Senate Finance Committee is scheduled for a final vote
to markup
draft comprehensive health care revision legislation.
Oct. 14: HIT Standards Committee Meeting
9 a.m. - 3 p.m. ; The Omni Shoreham Hotel, 2500 Calvert Street,
NW, Washington, DC.
The HIT Standards Committee will meet
to discuss reports from its Clinical Operations, Clinical Quality,
and Privacy and Security Workgroups and will take testimony from
invited experts in the field of health information technology security.
Oct. 14: House VA Committee Oversight Hearing
10 a.m.; 334 Cannon House Office Building.
The full House Committee on Veterans Affairs is scheduled to hold
an oversight hearing
on the "State of the Department of Veterans Affairs."
Oct. 14: House Education and Labor Subcommittee on Higher
Education, Lifelong Learning, and Competitiveness Hearing
10 a.m., 2175 Rayburn House Office Building.
Higher Education, Lifelong Learning, and Competitiveness Subcommittee
of House Education and Labor Committee will hold a hearing
on efforts to ensure student eligibility requirements for federal
aid.
Oct. 20: HIT Policy Committee Information Exchange Workgroup
Meeting
9 a.m. -3 p.m.; The Omni Shoreham Hotel, 2500 Calvert Street,
NW, Washington, DC.
HIT Policy Committee Meeting's Information Exchange Workgroup will
meet
to hear testimony from invited experts and stakeholders in the area
of electronic exchange of laboratory information.
Oct. 27-28: HIT Policy Committee
10 a.m.; The Omni Shoreham Hotel, 2500 Calvert Street, NW, Washington,
DC.
The full HIT Policy Committee will meet
to hear presentations from the Meaningful Use, Certification/Adoption,
and Information Exchange Workgroups and will hear testimony from
experts on the mapping of core Meaningful Use objectives and existing
measures to medical specialties, small practices, and small hospitals.
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