Washington Highlights: June
22, 2007
Senate Panel
Approves HHS Funding Bill
Contents
Prior
Issues
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The Senate Appropriations Committee June 21 approved
the FY 2008 Labor-HHS-Education appropriations bill. The bill, which had been
approved by the Labor-HHS-Education Appropriations Subcommittee on June 19, includes
$29.9 billion for NIH, an amount that is described as an increase of $1 billion
(3.5 percent) over the FY 2007 level, and $250 million over the level in the House
Subcommittee bill approved June 7.
However, it is believed that the Senate
subcommittee took the same approach as the House subcommittee to increase the
amount of the transfer from NIH to the Global HIV/AIDS fund from $99 million in
FY 2007 to $300 million for FY 2008. As a result, the increase over FY 2007 in
the NIH program level in the Senate bill is $799 million (2.8 percent), compared
to $549 million (1.9 percent) in the House bill. Both the House and Senate bills
fall short of the projected 3.7 percent increase in the Biomedical Research and
Development Price Index (BRDPI) for FY 2008.
The bill provides $329.6 million for the Agency for Healthcare
Research and Quality (AHRQ), which is a $10.6 million (3.3 percent)
increase over last year. The bill cuts the Children's Hospitals
Graduate Medical Education program by $97 million (33 percent) to
$200 million. The Title VII health professions programs are level
funding at the FY 2007 level of $184.7 million, and the Title VIII
nursing programs are increased by $20 million to $169.7 million.
The schedule
for Senate floor consideration of the bill is uncertain. The House Appropriations
Committee is tentatively scheduled to consider its bill the week of July 9.
Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
Bush Vetoes Stem Cell Legislation; Override Effort Expected
to Fail
President Bush June 20 vetoed the "Stem Cell Research Enhancement Act of 2007" (S.
5). The House had cleared the bill on June 7 by a vote of 247-176.
The Senate passed the bill by a vote of 63-34 in April. A Senate
vote to override the veto is expected to fail. This is the third
veto by President Bush in his 5 plus years in office, and the second
time he has vetoed stem cell legislation.
The
bill would require the Secretary of Health and Human Services to conduct and support
research that utilizes human embryonic stem cells, regardless of the date on which
the stem cells were derived from a human embryo. Federal funding for research
would be limited to stem cells that meet the following requirements:
- The
stem cells were derived from human embryos donated from in vitro fertilization
clinics for the purpose of fertility treatment and were in excess of the needs
of the individuals seeking such treatment;
- The embryos would never
be implanted in a woman and would otherwise be discarded; and
- Such
individuals donate the embryos with written informed consent and receive no financial
or other inducements.
Senate Democrats included a stem cell provision in the FY 2008
Labor, Health and Human Services, and Education Appropriations bill,
which funds the National Institutes of Health (NIH) and was approved
by the Senate Appropriations Committee on June 21 (see related story).
The provision allows federal funding for research on stem cell lines
derived before June 15, 2007.
In a White
House event announcing the veto, President Bush issued an executive
order directing the HHS and NIH "to ensure that any human pluripotent
stem cell lines produced in ways that do not create, destroy, or harm human embryos
will be eligible for federal funding." The White House acknowledged that
this research is already eligible for funding. The President also ordered NIH
to expand the Embryonic Stem Cell registry to include all types of human pluripotent
stem cells.
Information:
Tony Mazzaschi, Senior Director
AAMC Scientific Affairs
tmazzaschi@aamc.org
(202) 828-0059
Circuit Court Upholds
Ruling on Control of Biological Samples
The 8th U.S. Circuit Court of Appeals
unanimously upheld a lower court ruling that tissue and blood samples donated
by patients to Washington University School of Medicine in St. Louis for prostate
cancer research belong to the institution and cannot be reclaimed by the donors.
The AAMC joined several major research universities in an amicus
brief in support of upholding the decision of the District Court in favor
of Washington University.
In the first ruling to date by a federal appeals
court on research participants' ownership rights in their tissue samples, the
three-judge panel said the donors voluntarily made an irrevocable gift to Washington
University when they donated their biological samples and, therefore, the specimens
belong to the school. The original case, Washington University v. William J.
Catalona, centered on whether tissue donors can reclaim or redirect the use
of samples donated to a research institution to another institution or specific
researcher.
Information:
Stephen Heinig, Lead Science Policy Analyst
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488
Senate Committee Approves HEA
Reauthorization Package
The Senate Committee on Health, Education, Labor,
and Pensions June 20 approved a pair of Higher Education Act (HEA) reauthorization
bills: the "Higher Education Amendments of 2007" (S.1642) and the "Higher
Education Access Act." The bills include several changes to federal student
loans, financial aid administration oversight, and accreditation. According to
a press release from Chairman Edward Kennedy (D-Mass.), the bills would increase student aid by
more than $17 billion.
The "Higher Education Access Act" increases
the cap on the economic hardship deferment from 3 years to 6 years, allowing qualifying
resident physicians to postpone federal loan repayments. The "College Cost
Reduction Act of 2007" (H.R.
2669), approved by the House Education Committee June 13, eliminates this
limit completely [see Washington Highlights,
June 15]. The Senate bill also decreases the debt-to-income ratio necessary
to qualify for the economic hardship deferment and create an income-based repayment
system for federal educational loans. This system would cap repayment at 15 percent
of the amount by which a borrower's adjusted gross income exceeds 150 percent
of the poverty line.
Of particular importance to financial aid administration,
the student loan oversight language in S. 1642 differs from the "Student
Loan Sunshine Act" (H.R.
890), passed by the House May 9 [see Washington
Highlights, May 11], as follows:
- Allows financial aid administrators
to participate on lender advisory boards with reimbursement for travel and related
activities;
- Exempts travel for training sessions sponsored by lenders
from prohibited gifts;
- Does not require lenders to notify institutions
before issuing private educational loans.
S. 1642 would require the public
disclosure of accrediting agencies' findings and official "comments of the
affected institution." The bill also would require consideration of an institution's
"mission" as part of the standards for accrediting agencies. In an April
12 letter, the AAMC stated its opposition to the inclusion of these provisions
in HEA reauthorization.
Information:
Matthew Shick, Senior Legislative Analyst
AAMC Government Relations
mshick@aamc.org
(202) 862-6116
Senate Finance Leaders,
Member of Congress Express Concern with Inpatient Proposed Rule
Senate
Finance Committee Chairman Max Baucus (D-Mont.) and Ranking Member Charles Grassley
(R-Iowa) urged Centers for Medicare and Medicaid Services (CMS) Acting Administrator
Leslie Norwalk in a June 19 letter to base any planned cuts to prospective Medicare hospital reimbursement rates
on actual, not "speculative," changes in coding practices by hospitals.
The potential cuts are included in the May 3 FY 2008 Medicare Inpatient Prospective
Payment System (IPPS) proposed rule's new "Medicare Severity" diagnosis-related
groups [see Washington Highlights, May 11].
The letter states, "These prospective payment reductions are based
on speculative conclusions about how these changes will be implemented and they
may have a negative financial impact, particularly on rural hospitals." The
letter praises CMS for proposing to improve the current payment system's ability
to recognize patient severity of illness, but suggest that the proposal be implemented
before determining whether adjustments for inappropriate coding are necessary.
In a statement accompanying the release of the letter, Chairman Baucus
said, "The financial stability of rural hospitals should not be gambled on
guesses about how this new system will operate…. We can't get ahead of ourselves
and put our hospitals-especially our vital rural hospitals-in jeopardy."
The letter follows a June 12 letter to Norwalk signed by 269 Representatives expressing opposition to
a portion of the FY 2008 IPPS proposed rule that cuts $25 billion
in hospital inpatient operating and capital payments. The letter
was spearheaded by Reps. John Lewis (D-Ga.) and Jerry Weller (R-Ill.).
Information:
AAMC Government Relations
Grassley Urges CMS to Improve Uncompensated Care Data
Collection
Senate Finance Committee Ranking Member Charles Grassley (R-Iowa)
June 20 sent a letter urging Centers for Medicare and Medicaid Services (CMS) Acting Administrator Leslie
Norwalk to expedite efforts to improve data collection methods related to uncompensated
care provided by hospitals.
According to the letter, CMS is considering
recommendations made by the Medicare Payment Advisory Commission (MedPAC) to improve
worksheet S-10 on the hospital Medicare cost report. Hospitals use worksheet S-10
to report costs incurred for providing uncompensated care, as required under the
Balanced Budget Refinement Act of 1999. The letter notes that the MedPAC recommendations
included a revised worksheet with definitions and detailed guidance on what should
and should not be included when reporting data on uncompensated care. Grassley
asks CMS when the suggested changes will be implemented and when the data reported
in the revised worksheet will be available.
According to his letter, Grassley
intends to use the data "to guide important decisions in numerous policy
areas." In a statement accompanying the letter, Grassley said, "Congress
and CMS need accurate data to set Medicare policy. This information has implications
on tax-exempt policy, too." Grassley also indicated that he intends to review
how improvements to uncompensated care filings by Medicare-participating hospitals
will complement a separate Internal Revenue Service effort to improve and standardize
the reporting of community benefit by non-profit hospitals.
Information:
AAMC Government Relations
House Panel Approves Drug Safety Package
The House
Committee on Energy and Commerce June 21 combined and approved nine draft
bills seeking to renew Food and Drug Administration (FDA) user fees and to
improve drug safety regulations. The Health Subcommittee approved the measures
June 19.
Four of the bills reauthorize existing laws, including the Prescription
Drug User Fee Act (PDUFA) and the Medical Device User Fee Modernization
Act (MDUFMA), which authorize FDA to collect fees from drug companies
and device manufacturers for product review, approval and subsequent
safety monitoring. The measure extends FDA's authority to collect
the fees through FY 2012, and includes an "appropriations trigger,"
which reduces drug company user fees by a corresponding increase
in appropriations. The Committee also approved renewals of the Pediatric
Research Equity Act (P.L.
108-155) and the Best Pharmaceuticals for Children Act (P.L.
107-109), which allow FDA to require pediatric testing of new
drugs.
The remaining measures propose a series of initiatives addressing
drug safety, including a contentious bill imposing penalties for
noncompliance with Risk Evaluation and Mitigation Strategy (REMS)
requirements, and a bill limiting financial conflicts of interest
of FDA advisory panel members.
Also included in the package is a bill establishing a new drug
and device clinical trials registry and a separate results database,
to be publicly available online. The measure incorporates registry
provisions from H.R. 1561, a drug safety bill introduced March 19
by Reps. Henry Waxman (D-Calif.) and Edward Markey (D-Mass.). The
committee draft does not require a "non-promotional" summary
of results, as mandated in H.R. 1561, and delays applicability of
device trials until after FDA approval.
The Senate passed its own omnibus bill (S. 1082) on
May 9 [see Washington Highlights, May 11].
Information:
Tannaz Rasouli, Senior Legislative Analyst
AAMC Government Relations
trasouli@aamc.org
(202) 828-0525
Senators Urge Title VII Restoration
A total of 54 Senators signed a letter urging appropriators to restore funding for the Title VII health
professions programs to the FY 2005 level of $300 million. The letter,
sent June 18 to Labor, Health and Human Services, and Education
Appropriations Subcommittee Chair Tom Harkin (D-Iowa) and Ranking
Member Arlen Specter (R-Pa.), was originally submitted May 4 with
39 signatures [see Washington
Highlights, May 11]. The leads on the letter, Senators Jack
Reed (D-R.I.) and Pat Roberts (R-Kan.) reopened the letter May 15
to accommodate additional signatures. The final list included Majority
Leader Harry Reid (D-Nev.), 10 members of the Appropriations Committee,
and 13 Republicans.
Information:
Tannaz Rasouli, Senior Legislative Analyst
AAMC Government Relations
trasouli@aamc.org
(202) 828-0525
Nussle Nominated to Head OMB
President
Bush June 19 announced that he is nominating former Iowa Congressman and House
Budget Committee Chair Jim Nussle to replace Rob Portman as director of the Office
of Management and Budget (OMB). Nussle ran for governor of Iowa last year and
was defeated.
In his announcement of the nomination, President Bush described
Nussle as a "strong advocate for fiscal discipline." White House Chief
of Staff Joshua B. Bolten, a former OMB director, said in a Washington Post interview that Nussle's appointment is a sign that the administration intends
to "hew closely to the low-tax, low-spending routes that are part of Republican
orthodoxy."
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