Washington Highlights: May 5, 2006
Contents
Prior Issues
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HHS Secretary Leavitt Testifies on FY 2007 Budget
Secretary of Health and Human Services (HHS) Michael Leavitt May
3 testified
before the Senate Appropriations Subcommittee on Labor, Health and
Human Services, Education, and Related Agencies. Subcommittee members
expressed concern over the Administration's proposed cuts to the
Centers for Disease Control and Prevention (CDC) and the level funding
of the National Institutes of Health (NIH), especially in light
of an anticipated flu pandemic. Leavitt testified that he is committed
to maintaining momentum in research and "fought hard to keep
[NIH] funding flat" in this deficit reduction budget.
Other issues of concern to the subcommittee included the importance
of prevention initiatives, support for rural and aging populations,
and health professions training. Sen. Dick Durbin (D-Ill.) worried
that the country is not keeping up with the demand for health professionals,
and Sen. Larry Craig (R-Idaho) asked how the Administration reconciles
expanding Community Health Centers while reducing support for training
programs that help staff the centers.
Information:
Tannaz Rasouli, Senior Legislative Analyst
AAMC Government Relations
trasouli@aamc.org
(202) 828-0525
HHS OIG Sends Open Letter to Health Care Providers
Health and Human Services Inspector General Daniel R. Levinson
April 24 issued "An Open
Letter to Health Care Providers" that, as in the past,
touts the advantages to providers of using the OIG's Self Disclosure
Protocol (SDP)
to notify the government when certain conduct is discovered that
may subject the provider to liability.
In the letter, Mr. Levinson encourages hospitals that discover
improper arrangements under the physician self-referral ("Stark")
and anti-kickback laws to use the SDP, especially in situations
involving a financial benefit knowingly conferred by a hospital
upon one or more physicians; for example, when a physician pays
the hospital below fair market value for a good or service. While
no promises are made as to the possible financial penalties that
the government has the authority to impose, Mr. Levinson writes
that the "OIG will generally settle matters for an amount near
the lower end of this continuum" when the SDP is employed.
Information:
Ivy Baer, Director & Regulatory Counsel
AAMC Health Care Affairs
ibaer@aamc.org
(202) 828-0490
Senate Bills Outline Medical Liability Reform
Sens. John Ensign (R-Nev.) and Rick Santorum (R-Pa.) May 3 introduced
separate bills that would help preserve access to healthcare services
by reforming the medical liability system. Majority Leader Bill
Frist (R-Tenn.) stated that "hopefully we will be debating
these bills sometime in the next 3 to 4 days."
According to a draft of Sen. Ensign's bill, the "Medical Care
Access Protection Act of 2006" (S.22),
includes several of the AAMC-supported provisions contained in the
House-passed "Help Efficient, Accessible, Low-cost, Timely
Healthcare (HEALTH) Act of 2005 "(H.R.
5) [see Washington
Highlights, July 29,
2005]. However, S.22 follows Texas medical liability laws by
limiting awards for non-economic damages at $750,000, including
up to $250,000 from a physician, up to $250,000 from a single institution,
and up to $250,000 from a second institution.
According to draft language, Sen. Santorum's specialty-specific
bill, the "Healthy Mothers and Healthy Babies Access to Care
Act" (S.
23), would establish a cap similar to S. 22; however, it would
only apply to obstetricians and gynecologists.
Information:
Christiane Mitchell, Senior Legislative Analyst
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526
Senators Introduce Public Access Bill
Sens. John Cornyn (R-Texas) and Joseph Lieberman (D-Conn.) May
2 introduced the "Federal Research Public Access Act of 2006"
(S.
2695). The bill requires that federal agencies with annual extramural
research expenditures of more than $100 million make publicly available
manuscripts of journal articles that resulted from research funded
by that agency. The final manuscripts must be available on the Internet
for users to access without charge within six months after publication
in peer-reviewed journals.
The introduction of this legislation occurs one year after National
Institutes of Health Director Elias Zerhouni, M.D., initiated a
voluntary public access policy. Members of Congress, including Rep.
Ernest Istook (R-Okla.) at an April 6 House appropriations hearing,
have expressed their desire that publicly-funded research be made
widely available to the public, free of charge [see Washington
Highlights, April 14].
The legislation is expected to affect 11 agencies, including the
National Science Foundation and the departments of Agriculture,
Education, Health and Human Services, and Homeland Security.
Information:
Erica Froyd, Director, Public Health and Research Legislative Affairs
AAMC Government Relations
efroyd@aamc.org
(202) 828-0525
House Budget Impasse Shows Signs of Ending
House Appropriations Chair Jerry Lewis (R-Calif.) has proposed
moving $6 billion from defense and foreign aid to domestic programs
in an effort to secure House passage of the FY 2007 budget resolution
(H.Con.Res.
376). The House Republican leadership has been trying to negotiate
a budget plan that satisfies both conservatives, who want to cap
discretionary spending at the $873 billion proposed by the Administration,
and moderates, who are seeking more funding for health, education,
and job training programs.
Chairman Lewis May 4 released House Appropriations subcommittee
allocations (also known as 302(b) allocations). Under the proposed
allocations, which will be formally approved by the full Appropriations
Committee the week of May 8, the Defense subcommittee would get
$4 billion less than the Administration's planned $23 billion increase.
This difference would be made up in a forthcoming defense supplemental
spending bill. The Foreign Operations subcommittee would get $2.4
billion less than the Administration's request, but still receive
a 2.9 percent increase over FY 2006.
The Labor-HHS-Education subcommittee would get an allocation of
$141.9 billion, which is $843 million (0.6 percent) over the FY
2006 enacted level and $4.136 billion (3 percent) over the President's
budget. Republican moderates, led by Reps. Mike Castle (Del.) and
Nancy Johnson (Conn.), have been pushing for an increase of $7.2
billion over the Administration's budget for programs in the Labor-HHS
bill. While praising the leadership's efforts to seek a compromise,
Rep. Castle indicated he would still vote against the budget resolution
unless the final number for health and education programs is closer
to the $7.2 billion target sought by the moderates. It is unknown
how many moderates would vote for the resolution under Chairman
Lewis's proposed plan.
Earlier, GOP leaders gained support for the resolution when Chairman
Lewis and other appropriators dropped their opposition to the measure
after an agreement was reached to extend earmark reforms to authorizing
as well as appropriations bills. No date has been set for House
floor action on the budget resolution. House leaders face pressure
to pass the budget before the May 15 statutory deadline when appropriations
bills can be brought to the House floor without a budget resolution.
No date has been set for House floor action on the budget resolution.
House leaders face pressure to pass the budget before the May 15
statutory deadline when appropriations bills can be brought to the
House floor without a budget resolution.
The Senate passed its budget plan in March. Even if the House passes
its budget, it will have a difficult time reconciling its plan with
the Senate's, which would permit an additional $16 billion in discretionary
spending over the President's budget.
Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
President Bush, Senate Address Pandemic Flu Preparedness
The White House May 3 released its Implementation
Plan for the National Strategy for Pandemic Influenza,
a more detailed set of guidelines than the overview released in
November 2005. Though the report describes actions at all levels
of government, it emphasizes that "the center of gravity of
the pandemic response … will be in communities," and encourages
individuals, states and localities to plan accordingly.
Meanwhile, the Senate May 4 approved (77-21) its FY 2006 Emergency
Supplemental Appropriations bill (H.R.
4939), sending the bill to Conference with the House passed
version. The $108.9 billion price tag of the Senate bill, which
includes an amendment adding $2.3 billion for pandemic flu preparedness,
is well over the Administration's $92.2 billion proposal and the
House's $91.9 billion measure that passed March 16. The President
has threatened to veto any bill exceeding $94.5 billion, which represents
his original request and the additional flu funding. In a different
amendment, the Senate May 3 voted 53-46 to add $289 million to the
supplemental to fund the flu vaccine compensation fund, as proposed
by Sen. Edward Kennedy (D-Mass.).
Information:
Tannaz Rasouli, Senior Legislative Analyst
AAMC Government Relations
trasouli@aamc.org
(202) 828-0525
GAO Report Shows Major Teaching Hospitals Pay
Less For SCODs
The Government Accountability Office (GAO) April 28 released a
report on
the variation in acquisition costs among hospitals. The report is
part of a series of legislatively mandated reports that are intended
to provide the Centers for Medicare and Medicaid Services (CMS)
with information that could help the agency set future payment rates
for specified covered outpatient drugs (SCOD) and radiopharmaceuticals.
As mandated by Medicare Modernization Act of 2003, CMS is required
to set Medicare payment rates for SCODs equal to hospitals' average
acquisition costs, starting in fiscal year 2006.
The GAO report, drawing data from a survey of approximately 1,200
hospitals between July 1, 2003, and June 30, 2004, determined that
SCOD and radiopharmaceutical prices vary across hospitals. The study
examined the effects of three hospital characteristics on prices
(teaching status, location, and size of the outpatient department)
and factored in the cost differences of the multiple SCODs that
hospitals purchased. Major teaching hospitals paid on average 3.2
percent less for SCODs than non-teaching hospitals. Teaching status
did not affect the prices paid for nine radiopharmaceuticals that
are purchased in unit doses, the form purchased by most hospitals.
When all three factors were taken into consideration, the study
found that large major teaching hospitals in urban areas paid prices,
on average, that were an estimated 4 percent lower for SCODs and
3 percent lower for radiopharmaceuticals.
The report also notes GAO's concerns with regard to the accuracy
of the average sales price (ASP) methodology currently used by CMS
to set prices for SCODs. Specifically, it mentions the inconsistency
in calculating ASPs across manufacturers that has resulted from
a lack of detailed instructions from CMS.
The report recommends that CMS validate manufacturers' reported
drug ASPs either by using a survey of hospitals conducted once or
twice every 10 years, or by finding a similarly accurate and efficient
method. For radiopharmaceuticals, the GAO report recommends using
unit-dose prices paid by hospitals as the data source for setting
payment rates.
Information:
Karen Fisher, Sr. Director, Health Care Affairs
AAMC Health Care Affairs
kfisher@aamc.org
(202) 862-6140
Diana Mayes, Specialist
AAMC Health Care Affairs
dmayes@aamc.org
(202) 828-0498
NRC-IOM Panel Named to Revise Stem Cell Guidelines
The National Academies' National Research Council (NRC) and Institute
of Medicine (IOM) May 2 announced the appointment of a committee
to monitor and revise the Guidelines for Human Embryonic Stem Cell
Research, issued by an NRC-IOM panel in February 2005. This new
committee will provide updates to the voluntary guidelines based
on comments
from the community. These updates will be issued in periodic reports,
and workshops will be held to keep the committee informed of developments
in the field.
The Human Embryonic Stem Cell Research Advisory Committee will
be co-chaired by R. Alta Charo, J.D., Warren P. Knowles Professor
of Law and Bioethics, University of Wisconsin Law School and Medical
School, and Richard O. Hynes, Ph.D., HHMI Investigator, and Daniel
K. Ludwig Professor for Cancer Research, Center for Cancer Research
and Department of Biology Massachusetts Institute of Technology.
Dr. Hynes co-chaired - along with Dr. Jonathan Moreno (see below)
- the panel that developed the 2005 Guidelines.
Members of the 14-member panel from the medical school community
include:
- Eli Y. Adashi, M.D., M.S., Dean of Medicine and Biological
Sciences, Brown University;
- Brigid L.M. Hogan, Ph.D., Chair, Department of Cell Biology,
Duke University Medical Center;
- Terry Magnuson, Ph.D., Chair, Department of Genetics, University
of North Carolina;
- Jonathan D. Moreno, Ph.D., Director, Center for Biomedical
Ethics, University of Virginia;
- Stuart H. Orkin, M.D., HHMR Investigator and Chair, Department
of Pediatric Oncology, Dana-Farber Cancer Institute;
- E. Albert Reece, M.D., Ph.D., Vice Chancellor and Dean, University
of Arkansas for Medical Sciences;
- Joshua R. Sanes, Ph.D., Director, Center for Brain Science,
Harvard University; and
- John Wagner, M.D., Professor of Pediatrics and Director of
Pediatric Hematology/Oncology at the University of Minnesota Medical
School.
Adam P. Fagen, Ph.D., and Bruce Altevogt, Ph.D., will staff the
committee as Study Co-Directors.
Information:
Tony Mazzaschi, Interin Chief Scientific Officer, Senior Director
AAMC Scientific Affairs
tmazzaschi@aamc.org
(202) 828-0059
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