Washington Highlights: Date
House Panel Gives
NIH $782 Million Increase, Cuts Title VII Health Professions Funding
Contents
Prior Issues
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The House Labor, Health and Human Services, Education and Related
Agencies Appropriations Subcommittee July 8 marked
up its FY 2005 spending bill, including a 2.8 percent increase
for the National Institutes of Health (NIH) and an 8.4 percent cut
to the Title VII health professions education programs. The subcommittee
passed the bill by a vote of 18 to 0 after defeating an amendment
by Rep. David Obey (D-Wis.), the ranking member on the full committee,
to provide additional funding for health, education, and labor programs,
offset by a reduction in the tax cuts passed in 2001 and 2003 for
individuals with annual incomes above $1 million.
In the Senate, Appropriations Committee Chairman Ted Stevens (R-Alaska)
cancelled planned subcommittee markups of nine FY 2005 spending
bills, including the Labor-HHS-Education bill, after Senate Democrats
rejected the chairman's demand that they agree to time limits on
floor debate on the bills before the subcommittees or full committee
could consider them.
For the NIH, the subcommittee provides $28.4 billion, an increase
of $782 million (2.8 percent) over FY 2004, and the same level proposed
by the Administration. All institutes and centers are funded at
the Administration-proposed levels. The bill allots $1.09 billion
to the National Center for Research Resources (NCRR) a 7.2 percent
cut caused, in part, by the elimination of funding for extramural
facilities construction.
While restoring much of the funding eliminated in the president's
proposed budget, the bill contains an 8.4 percent cut below the
FY 2004 level for the Title VII health professions education programs.
The Title VII budget provides level funding to all programs other
than a 21.9 percent cut to primary care medicine and dentistry,
a 63 percent cut to rural training, elimination of workforce information
and analysis (funded at $722,000 last year), and a 24 percent cut
to public health, preventive medicine and dental public health programs.
Title VIII nursing programs receive a 3.5 percent increase. Advanced
nursing education receives a 8.5 percent cut below FY 2004, while
nurse education, practice and retention program, and the loan repayment
and scholarship program see increases of 15.8 and 18.7 percent,
respectively.
The Agency for Healthcare Research and Quality (AHRQ) is allotted
$303.7 million, the same level as last year and proposed in the
President's budget. All money is derived from transfers from other
Public Health Service programs.
The bioterrorism hospital preparedness program administered by
the Health Resources and Services Administration (HRSA) received
level funding with FY 2004 in the House subcommittee bill at $542.6
million, while the funding for the Centers for Disease Control and
Prevention (CDC) state bioterrorism program is boosted $130.5 million
to $1.637 billion, an 8.6 percent increase. The House bill adopts
the Administration's proposal for an additional $47 million for
NIH to support research on nuclear and radiological medical countermeasures.
The subcommittee proposed level funding of $169.9 million for the
National Health Service Corps, $35 million less than the Administration
proposed. The bill also cuts the overall CDC budget by 2.2 percent
to $4.48 billion. The Children's Hospital Graduate Medical Education
is allocated $303.3 million in the House bill, the same level recommended
in the Administration's budget and an $88,000 increase over FY 2004.
The full Appropriations Committee reportedly will consider the
bill the week of July 12 and on the House floor the week of July
19.
Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
Jonathan Fishburn, Director, Research, Education and Veterans' Legislative Affairs
AAMC Government Relations
jfishburn@aamc.org
(202) 828-0525
Erica Froyd, Director, Public Health and Research Legislative Affairs
AAMC Government Relations
efroyd@aamc.org
(202) 828-0525
HHS Publishes Proposed Rule for IRB Registration
The Office for Human Research Protections (OHRP), Office of Public
Health and Science, Department of Health and Human Services (HHS),
issued a notice of proposed rulemaking (NPRM) in the July 6 Federal
Register [69
FR 40584] proposing to require registration of institutional
review boards (IRBs) that review human subjects research conducted
or supported by HHS and that are designated under an assurance of
compliance approved for federal wide use by OHRP. Comments on the
proposed rule are due by October 4, 2004.
The proposal grows out of the 1998 Office of the Inspector General
reports and recommendations on IRBs. One of the recommendations
was that IRBs should register with the federal government on a regular
basis as part of an effort to develop a more coordinated means of
assessing IRB performance and enhancing the government's ability
to identify emerging problems. The new proposal is an expansion
of the registration process put in place in December 2000, which
required certain information to be included in an assurance of compliance
filed with OHRP and requested other information on a voluntary basis.
The proposal seeks to require submission of most of the information
listed on the current IRB registration form. The Food and Drug Administration
(FDA) is simultaneously proposing substantially similar requirements,
and OHRP and FDA intend to operate a single registration system
for HHS in which all IRBs that review human subjects research conducted
or supported by HHS or clinical investigators regulated by the FDA
can be registered. Though only the name and location of registered
IRBs and registration numbers would be posted on the registration
Web site, other information collected during the registration process
would be subject to the Freedom of Information Act (FOIA), and unless
protected under that act, would be available to the public upon
request.
Information proposed to be required includes name, earned degree,
title, specialty, affiliation, gender, telephone, fax, email, and
mailing address of the senior or head official who is responsible
for overseeing the IRBs, similar information on the IRB chair, and
IRB roster that includes similar information about IRB members (except
contact information), the approximate number of active protocols
undergoing initial and continuing review, the approximate number
of active protocols supported by HHS (by broad ranges), the approximate
number of full time positions devoted to the IRBs administrative
activities, an indication of whether or not the institution is accredited
by a human subjects accrediting organization and the name of the
organization (to help OHRP evaluate the extent and value or IRB
accreditation). OHRP is not proposing to collect information about
IRB review of research supported by agencies other than HHS.
Information:
Susan Ehringhaus, Sr. Director & Regulatory Counsel
AAMC Biomedical Health Sciences Research
sehringhaus@aamc.org
(202) 828-0543
House Members Circulate Letter Seeking CMS Solution
on Volunteer Physicians
Representatives Kenny Hulshof (R-Mo.), Earl Pomeroy (D-N.D.), Greg
Walden (R-Ore.), and John Tanner (D-Tenn.) are circulating for Congressional
signatures a letter to Centers for Medicare
and Medicaid Services (CMS) Administrator Mark McClellan, M.D.,
Ph.D., on the importance of volunteer physicians. The letter urges
CMS to adopt a regulatory solution in the upcoming final FY 2005
hospital inpatient PPS rule to ensure that Medicare Direct Graduate
Medical Education and Indirect Medical Education payments are not
disqualified when teaching hospitals count residents training in
non-hospital sites where supervising physicians are volunteering
their time.
The letter acknowledges recent CMS rule-making and agency interpretations
that are negatively impacting residency training programs in non-hospital
settings. States the letter, "In fact, in direct response to
CMS's policy regarding volunteer faculty, the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003 (MMA) called for
a temporary moratorium on these payment denials for family practice
programs."
The letter also requests "that any clarification of the rule
cover all specialty areas-not just family practice-that utilize
training in non-hospital sites. Many specialties have resident rotations
in rural communities and, upon residency completion, a portion of
these physicians chooses to remain in rural areas and provide much-needed
care to underserved populations. Finally, we urge CMS to ensure
that both Congress and CMS have the opportunity to review, evaluate,
and act upon the Inspector General report [on volunteer physicians]
released later this year prior to any permanent changes to reimbursement
policy."
Information:
Lynne Davis Boyle, Assistant Vice President
AAMC Government Relations
ldavisboyle@aamc.org
(202) 828-0526
Final SEVIS Fee Collection Rule Published
The Bureau of Immigration and Customs Enforcement of the Department
of Homeland Security July 1 published in the Federal Register
[69
FR 39814] a final rule, effective Sept. 1, regarding
collection of the $100 fee imposed on foreign students and scholars
subject to the Student and Exchange Visitor Information System (SEVIS).
SEVIS is the Department's database to track foreign students (F
and M visas) and exchange visitors (J visas) that enter the United
States. The fee is used to cover the cost of the continued operation
of the Student and Exchange Visitor Program (SEVP), including administration
and maintenance of SEVIS, compliance activities, and the deployment
of liaison officers.
Under the rule, students and exchange visitors will be required
to present proof of payment of the fee during their visa application
process; however, schools or exchange visitor sponsors may choose
"to pay for some or all of their participants, as they choose."
DHS will also continue to explore alternative fee payment methodologies.
Information:
Jonathan Fishburn, Director, Research, Education and Veterans' Legislative Affairs
AAMC Government Relations
jfishburn@aamc.org
(202) 828-0525
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