Washington Highlights: June 12,
2009
AAMC, AAU Comment on NIH Conflicts of Interest
Measures
Contents
Prior Issues
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The AAMC and the Association of American Universities (AAU) June
10 jointly submitted comments
to the National Institutes of Health (NIH) on how to strengthen
the regulatory framework governing conflicts of interest in federally
funded research. The letter responds to a May 8 Advance Notice of
Proposed Rule Making (ANPRM)
issued by the NIH [see Washington
Highlights, May 8].
The AAMC-AAU letter is consistent with earlier
recommendations from the associations, and it supports enhancing
transparency and strengthening regulations in key respects. The
comments support requiring covered investigators to report to institutions
all of their external financial interests directly or indirectly
related to their research responsibilities, regardless of amount.
They also support NIH lowering to $5,000 the threshold for requiring
institutions to disclose to the awarding agency related external
financial interests of investigators that have been determined to
represent conflicts of interest. The letter indicates that the associations
would not be opposed to a zero disclosure threshold, except for
the enormous amount of "noise" generated by such a requirement.
The associations also note that receiving and reviewing such a huge
volume of information would have a trivial impact, if any, on research
integrity.
The letter supports requiring institutions to submit information
on managed conflicts of interest that goes beyond current regulatory
requirements, and, as is currently the case, to submit full management
plans when requested by the awarding component. The comments oppose
mandatory accreditation of conflicts of interest programs but support
the Association for the Accreditation of Human Research Protection
Programs (AAHRPP)'s current efforts to enhance its standards relating
to conflicts of interest with respect to existing regulatory requirements
governing research on human subjects.
Senator Charles Grassley (R-Iowa) praised AAMC and AAU as "real
leaders for their professional communities in trying to establish
transparency and, in turn, build public confidence" and urged
NIH to consider the recommendations outlined in the comment letter.
He noted, "The research community could have avoided a lot
of the problems we see today with great discrepancies and disregard
for policies, if it had listened to the AAU and the AAMC in 2001,
when they made recommendations along the same lines."
The comment deadline on the NIH notice is July 7.
Information:
Susan Ehringhaus, Sr. Director & Regulatory Counsel
AAMC Biomedical Health Sciences Research
sehringhaus@aamc.org
(202) 828-0543
HELP Democrats File Health Care Reform Bill
Democrats on the Senate Health, Education, Labor, and Pensions
(HELP) Committee June 9 unveiled the Affordable Health Choices Act,
a comprehensive bill
that addresses health care reform issues under the committee's jurisdiction.
Meanwhile, the House Committees on Energy and Commerce, Ways and
Means, and Education and Labor, June 9 issued a document outlining
their joint principles for health care reform.
The HELP bill strives to expand health insurance coverage and
improve its affordability by reorganizing private insurance markets,
creating new government agencies, subsidizing premiums, and expanding
Medicaid. The bill also includes individual and employer mandates.
Additionally, the legislation includes several provisions aimed
at improving the health care workforce. The HELP Committee is scheduled
to consider the legislation on June 16.
Of particular interest to academic medicine, the bill:
- Establishes a program for publicly reporting Readmission rates;
- Authorizes grant funding for the development of Community Health
Teams to support the medical home model;
- Creates a demonstration program through grant funding to develop
and implement patient safety and quality improvement curriculum
into health professionals' clinical education;
- Requires the Secretary of Health and Human Services (HHS) to
publish a notice of proposed rulemaking to establish in consultation
with relevant stakeholders a methodology for designating medically
underserved populations and health professions shortage areas;
- Directs the Secretary to establish a Center for Health Outcomes
Research and Evaluation to conduct and support research that compares
the "outcomes, effectiveness, and appropriateness" of
health care services;
- Incrementally increases the authorization for the National
Health Service Corps (NHSC) to $1.15 billion in FY 2015, and establishes
a formula for increased authorizations in future years;
- Establishes a primary care extension program offering grants
through states to assist primary care providers in educating health
care professionals on preventive medicine, health promotion, chronic
disease management, mental health, and other areas;
- Promotes efforts to prevent, detect, and address health care
fraud and abuse;
- Establishes a National Health Care Workforce Commission to collect,
review, and report information on projected health workforce needs
and capacity; and,
- Reauthorizes the Health Resources and Services Administration's
Title VII health professions and Title VIII nursing education
programs (see related story).
Information:
Tannaz Rasouli, Senior Legislative Analyst
AAMC Government Relations
trasouli@aamc.org
(202) 828-0525
Matthew Shick, Senior Legislative Analyst
AAMC Government Relations
mshick@aamc.org
(202) 862-6116
Christiane Mitchell, Director, Federal Affairs
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526
HELP Bill Reauthorizes Title VII Health Professions
Programs
The health care reform bill released June 9 by Democrats on the
Senate Health, Education, Labor, and Pensions (HELP) Committee includes
provisions to reauthorize the Health Resources and Services Administration
(HRSA)'s Title VII health professions and Title VIII nursing education
programs.
For example, the bill:
- Updates the Title VII student loan programs, including the Primary
Care Loan;
- Establishes a National Center for Health Care Workforce Analysis
to coordinate with State and Regional Centers for Health Workforce
Analysis, and authorizes grants to establish and maintain a longitudinal
database of Title VII outcomes measures;
- Establishes a pediatric specialty loan repayment program and
a public health workforce loan repayment program with obligated
service requirements;
- Authorizes funding and activities for the Title VII primary
care medicine programs distinctly from the Title VII primary care
dentistry programs;
- Allows Title VII primary care medicine grantees to train physicians
teaching in community-based settings, develop joint degree programs
in interdisciplinary training in public health and other areas,
and develop demonstration programs providing training in new competencies
as recommended by the HRSA Advisory Committee on Training in Primary
Care Medicine and Dentistry;
- Prioritizes Title VII primary care applicants that, among other
priorities, establish formal relationships and submit joint applications
with community health centers, Area Health Education Centers (AHEC),
rural health clinics, or clinics in underserved areas;
- Expands the Title VII geriatric education training program
to develop CME-satisfying fellowships on geriatrics, chronic care
management, and long-term care for health professions faculty
and to offer family caregiver training or to incorporate mental
health best practices in training courses;
- Directs the HHS Secretary to support the development, evaluation,
and dissemination of model health professions curricula for cultural
competency, prevention, and public health proficiency, and aptitude
for working with individuals with disabilities;
- Reauthorizes at higher funding levels the Title VII diversity
programs, including the Centers of Excellence, Health Careers
Opportunity Program, Scholarships for Disadvantaged Students,
and Faculty Loan Repayment; Reauthorizes AHECs with a "Point
of Service Maintenance and Enhancement Award" to maintain
and improve existing AHECs, requires that each AHEC program include
at least one area health education center that is not a school
of medicine or the parent institution, and includes a "Sense
of Congress" that each state should have an AHEC program;
- Establishes a grant program to support distance learning, continuing
education, collaborative conferences, and electronic and telelearning
activities, with priority for primary care.
Information:
Tannaz Rasouli, Senior Legislative Analyst
AAMC Government Relations
trasouli@aamc.org
(202) 828-0525
Abigail Schopick, Legislative Analyst
AAMC Government Relations
aschopick@aamc.org
(202) 828-0525
AAMC, FASEB Recommend Ways to Strengthen Security
of Select Agents
The AAMC and Federation of American Societies for Experimental
Biology (FASEB) May 29 jointly made recommendations
on ways to strengthen the security of research with select agents.
In a letter to the Working Group on Strengthening the Biosecurity
of the United States, AAMC and FASEB endorsed the preliminary assessment
of a separate federal body (the National Science Advisory Board
on Biosecurity) that current federal select agent provisions are
sufficiently strict. The organizations also noted that no incident
of theft or attempted theft of a select agent from an academic facility
has been reported.
The interagency working group was established by the Bush Administration
in the wake of allegations connecting a federal scientist with the
2001 anthrax attacks. A central question for the working group is
how best to ensure that personnel working with select agents will
not endanger others, as well as protecting their own safety. The
group's report is expected this summer.
Information:
Stephen Heinig, Lead Science Policy Analyst
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488
Science and Education Community Opposes Visa Delays
The AAMC joined 29 higher education and scientific associations
on a June 10 statement
asking federal agencies to clear delays that impede travel by foreign
scientists and scholars to the United States. The statement, sent
to the Departments of State and Homeland Security and to the White
House Office of Science and Technology Policy, includes recommendations
for addressing increasing delays in the current visa system. The
statement does not cite the number or extent of problems in the
visa backlog for visiting scientists, and acknowledges that federal
agencies recently have made commitments to solving problems of delay.
Among the associations' recommendations is to clear the current
applications backlog expeditiously, to streamline the requirements
for visa applications and approval, to make processes for visa applicants
more consistent and transparent, and specifically to convene a "high
level interagency panel" to review the policies and procedures
put into place after Sept. 11, 2001, with attention to the rules'
costs and effectiveness.
Information:
Stephen Heinig, Lead Science Policy Analyst
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488
Senate Subcommittee Holds Hearing on HHS FY 2010
Budget
The Senate Appropriations Subcommittee on Labor, Health and Human
Services, and Education June 9 held
a hearing to discuss the FY 2010 budget for the Department of Health
and Human Services (HHS). Subcommittee members questioned HHS Secretary
Kathleen Sebelius about health care reform, the National Institutes
of Health (NIH), and the health care workforce, among other issues.
Secretary Sebelius spoke about the need to provide high quality,
cost effective health care for all Americans and stressed that prevention
and wellness measures would be essential to lower future health
care costs. When questioned about whether pay-as-you-go measures
would apply to health care reform, Secretary Sebelius stressed that
they would as much as possible. However, she pointed out that it
is difficult to estimate the costs and savings of such reform, as
cost saving measures like prevention and wellness will not be scored.
She also described significant savings from curbing waste, fraud
and abuse in Medicare and Medicaid.
Senator Arlen Specter (D-Pa.) urged the Secretary to take another
look at the NIH budget. Both Sen. Specter and Subcommittee Chair
Tom Harkin (D-Iowa) stressed that although the American Recovery
and Reinvestment Act (ARRA, P.L.
111-5) provides NIH with additional funds, the NIH's base budget
needs to be looked at without the ARRA funds. Sen. Specter stated
that ARRA funding was intended as a one time infusion of funding
to create jobs and stimulate the economy, and was not intended to
be looked at as part of NIH's FY 2010 funding. Chairman Harkin stated
that he is worried about NIH's base, as purchasing power has decreased
in the past few years. Secretary Sebelius echoed their concern about
the need to invest in science and research, and testified that it
is important to try to prevent a funding cliff after the ARRA funding
ends.
Both Chairman Harkin and Sen. Specter also expressed concern about
the administration's designation for over half of the proposed increase
for NIH to go specifically toward cancer and autism research, with
Sen. Specter stating that this designation politicizes science.
They both spoke about the need for researchers to designate where
the money needs to go, not Congress or the administration.
Senator Mark Pryor (D-Ark.) questioned the Secretary about the
challenge of ensuring adequate providers for all Americans, especially
in rural areas. He pointed out that while many focus on access to
insurance as a barrier to providing health care for all, access
to providers needs to be looked at as well. Secretary Sebelius expressed
a shared concern about problems with provider distribution. She
acknowledged that part of the problem is the disparity in Medicare
reimbursement rates, and stated that HHS is looking into this problem.
She mentioned that health information technology (HIT) is making
rural medicine more appealing, especially with advances in telemedicine
allowing easier access to other providers, especially specialists.
Additionally, she mentioned that programs such as the National Health
Service Corps encourage providers to practice in rural and underserved
areas, and many of those providers end up staying in such areas.
Information:
Abigail Schopick, Legislative Analyst
AAMC Government Relations
aschopick@aamc.org
(202) 828-0525
House Appropriators Approve Allocations
The House Appropriations Committee June 9 approved its FY 2010
allocations. The allocations, also known as 302(b)s, determine
how $1.086 trillion in non-emergency spending in FY 2010 will be
divided among the 12 annual spending bills.
The allocations provide the first details on how Democrats intend
to implement a spending plan that is estimated to be $8.9 billion
less than President Obama's request. Previous estimates released
when Congress finalized its FY 2010 budget resolution (S.
Con. Res. 13) had put the difference at $10 billion [see Washington
Highlights, May 1].
The Labor-HHS-Education Appropriations Subcommittee received an
allocation of $160.7 billion - an increase of nearly $8.9 billion
(5.8 percent) over the subcommittee's funding level in the FY 2009
omnibus (P.L.
111-8) and approximately $50 million short of the President's
request.
The committee also announced the Labor-HHS-Education subcommittee
tentatively is scheduled
to mark up its bill July 8, followed by full Appropriations Committee
action July 14, and House floor consideration July 22 through July
24.
Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
Tannaz Rasouli, Senior Legislative Analyst
AAMC Government Relations
trasouli@aamc.org
(202) 828-0525
Baucus, Conrad Introduce Comparative Effectiveness
Legislation
Senate Finance Committee Chair Max Baucus (D-Mont.) and Senate
Budget Committee Chair Kent Conrad (D-N.D.) June 9 introduced legislation
to establish a private entity responsible for advancing comparative
effectiveness research (CER). The "Patient-Centered Outcomes
Research Act of 2009" (S.
1213) creates the Patient-Centered Outcomes Research Institute,
which would be responsible for identifying national priorities for
"comparative clinical effectiveness research." Such research
would account for a variety of factors, including disease prevalence
and "burden," practice variations, and the potential for
"an effect on health expenditures" and "patient needs,
outcomes, and preferences, including quality of life."
The bill establishes a Patient-Centered Outcomes Research Trust
Fund (PCORTF) to support the institute's activities. The PCORTF
is funded by transfers from the Medicare Trust Funds and fees on
private health plans.
The bill directs the Institute to establish a research agenda and
"provide for" CER (both in-house and on a contract basis).
Additionally, the institute would appoint expert advisory panels
that include practicing and research clinicians to "ensure
that ... such research is clinically relevant to ... clinicians
and patients at the point of care."
The institute may not issue practice guidelines or recommendations
on coverage or other policy issues. Unlike previous iterations of
CER legislation, S. 1213 specifies that the Secretary of Health
and Human Services (HHS) can use the institute's CER findings to
make Medicare coverage determinations only if "such use is
through an iterative and transparent process." The legislation
also requires the Government Accountability Office to submit a report
to Congress determining whether HHS complies with such requirements
when using CER to make such coverage determinations.
Information:
Christiane Mitchell, Director, Federal Affairs
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526
House, Senate Differ on President's Call for Pay-As-You-Go
Law
President Obama's June 9 call
for Congress to promptly pass legislation to help control the
federal budget deficit is receiving mixed reviews on Capitol Hill.
The Statutory Pay-As-You-Go Act of 2009 would require Congress to
offset non-emergency increases in entitlement spending or taxes
cuts by raising taxes or reducing other entitlement programs. If
the Office of Management and Budget determines at the end of the
fiscal year that the new initiatives have not been paid for, the
President would be required to make across-the-board cuts in entitlement
spending.
The proposal is similar to statutory requirements, also known as
PAYGO, in place during the Clinton Administration. Republicans allowed
the law to lapse in 2002. In a statement announcing the proposal,
the President said, "I am committed to returning our Government
to a path of fiscal discipline, and PAYGO represents a key step
back to the path of shared responsibility."
House leaders reportedly want to move quickly to pass the legislation,
but the proposal is running into solid opposition in the Senate.
The President released his proposal at a June 9 White House event
attended by House leaders and a number of members of the House Blue
Dog Coalition. The Blue Dogs are fiscally conservative Democrats
who have made reinstituting PAYGO into law a top priority.
Senate leaders, including Senate Budget Committee Chair Kent Conrad
(D-N.D.), who has not been supportive of statutory PAYGO rules,
were conspicuously absent from the White House unveiling. Conrad
has supported the creation of a bipartisan task force to develop
policy recommendations on long-term budget issues that would be
voted on by Congress.
When the Democrats regained control of Congress in 2007, they implemented
PAYGO rules that frequently have been waived. The President, Blue
Dogs, and House leaders maintain the rule would be strengthened
by putting it into statute.
However, the Obama proposal would exempt a number of high-price
programs already in place. Congress could extend the Bush tax cuts
past their scheduled 2010 expiration, restrain the growth of the
alternative minimum tax, and continue to delay scheduled payments
cuts for Medicare physician fees without off-sets. In a statement
reacting to the proposal, the Committee for a Responsible Federal
Budget (CRFB) said "Although [the Committee] is a proponent
of PAYGO and stands by the President's efforts to pass it into law,
we believe that exempting these items largely undermines the purpose."
CRFB, a bipartisan group of former budget officials, estimates the
exemptions would increase the deficit by more than $2.5 trillion
over the next decade.
The Blue Dogs have agreed to the exemptions in return for restoring
statutory PAYGO requirements. House Democratic leaders have pledged
not to consider conference reports on legislation extending the
exempted policies unless pay-as-you go legislation is enacted, the
conference agreement includes langue to implement PAYGO, or they
are fully offset. This may complicate House-Senate negotiations
when Medicare legislation is considered later this year.
Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
On the Agenda in Washington . . .
June 16: HIT Policy Committee to Meet
10 a.m. to 1 p.m., Hubert H. Humphrey Building (200 Independence
Ave., SW) or via Web
cast and teleconference
The Health Information Technology Policy Committee established by
the American Recovery and Reinvestment Act (ARRA, P.L.
111-5) is scheduled
to hold its second meeting. The meeting will be open to the public
and will include presentations by the committee's work groups.
June 16: Senate HELP Committee to Mark Up Health Care Reform
Legislation
2:30 p.m., 325 Russell Senate Office Building
The Senate Health, Education, Labor, and Pensions (HELP) Committee
is scheduled to consider the "Affordable Health Choices Act."
June 18: House Energy and Commerce Committee to Hold Briefing
on Medical Devices
9:30 a.m., 2322 Rayburn House Office Building
The Health Subcommittee of the House Energy and Commerce Committee
is scheduled to hold a hearing titled, "Medical Devices: Are
Current Regulations Doing Enough for Patients?"
June 23: HIT Standards Committee to Meet
9 a.m. to 12 p.m., Omni Shoreham Hotel (2500 Calvert Street NW)
or via Web
cast and teleconference
The Health Information Technology Standards Committee established
by the American Recovery and Reinvestment Act (ARRA, P.L.
111-5) is scheduled
to hold its second meeting. The meeting will be open to the
public and will include presentations by the committee's workgroups.
July 8: House Labor-HHS-Education Appropriations Subcommittee
to Mark Up FY 2010 Bill
Time TBD, Location TBD
The House Labor-HHS-Education Appropriations Subcommittee is scheduled
to consider its FY 2010 appropriations bill.
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