September - October
1999 Newsletter
AST Attends White
House Organ Donation Ceremony
On Friday, September 24, 1999, AST
Public Policy Chair, Dr. John Neylan, and the Society's Washington
Representative, Bill Applegate, joined Vice President Al Gore
in a ceremony to announce $13 million dollars in new grant
funding to support increased organ donation initiatives. In
addition, the Vice President also announced support for a series
of new public service announcements to further educate the
public on the importance of organ donation. Last year, AST
testified twice before Congress to urge the Appropriations
Committees to provide stronger support for such donation activities.
AST Continues
Fight to Expand Federal Coverage of Immunosuppressive Drugs
During the month of September, AST
has continued to educate and mobilize Members of Congress to
support legislation that would expand coverage of immunosuppressive
drugs beyond the current 36-month limit. In addition to the
Society's grassroots efforts (e.g., letters to Congress, telephone
calls, meetings, etc.), AST's new Washington Representative
has been working closely with the Immunosuppressive Drugs Coalition
to target and meet with key Congressional leaders on this important
legislation. At present, these efforts have resulted in 193
bipartisan cosponsors of the House bill, H.R. 1115, and 19
cosponsors of the Senate bill, S. 631. AST and other members
of the Immunosuppressive Drugs Coalition are currently implementing
a variety of strategies to secure final passage of this important
legislation.
Organ Donor Leave
Act Becomes Law
In early 1998, Congressman
Elijah Cummings (D-MD) asked the AST to assist him in crafting
legislation
that would encourage and provide incentives for federal employees
to become living organ donors. Following the introduction of
this important legislation, AST led a variety of grassroots
initiatives to garner Congressional support and secure a "companion
bill" (similar legislation) for introduction in the Senate.
During this year long process, AST's efforts were applauded
several times by Congressman Cummings and others on the floor
of the U.S. House of Representatives. On Friday, September
24, 1999, President Bill Clinton signed this important bill
into law. During a ceremony at the White House, Congressman
Elijah Cummings and Deputy Surgeon General Kenneth Moritsugu
thanked Dr. John Neylan for the Society's support and commitment
to ensuring the passage of this important legislation.
House Subcommittee
Approves OPTN Amendment Legislation
On Thursday, September
30, 1999, AST attended the House Commerce Subcommittee on Health's
mark-up
(consideration) and approval of H.R. 2418, the "Organ
Procurement and Transplantation Network Amendments of 1999." This
legislation, introduced by Subcommittee Chairman Michael Bilirakis
(R-FL) and supported strongly by Full Commerce Committee Chairman
Tom Bliley (R-VA), seeks to: 1) redefine the current roles
and relationships between the Department of Health and Human
Services, the Organ Procurement and Transplantation Network,
the contractor managing the network; and 2) addresses various
aspects of the nation's current organ allocation system. AST
has testified several times during the last two years before
Congress, the Administration, and the IOM on these critical
issues.
During the mark-up
of H.R. 2418, Chairman Bilirakis amended the bill to include
several new
provisions seeking technical changes to the legislation. On
the Democratic side of the aisle, Representative Diana DeGette
(D-CO) successfully added an amendment requiring the OPTN to
focus more attention on gathering and examining information
related to pediatric transplantation. Overall, the markup proceedings
centered largely on the issue of the HHS Secretary's oversight
of the OPTN. Several Democratic members of the Health Subcommittee,
including ranking minority member Congressmen Sherrod Brown
(D-OH) and Henry Waxman (D-CA), argued that H.R. 2418 significantly
reduced the current authority of the Secretary of HHS to oversee
the OPTN contractor and protect public safety. Chairman Bilirakis
defended his legislation and reiterated his concern that the
Secretary should not have a role in the medical decisions related
to the OPTN. The next step for this legislation is a consideration
by the House Full Commerce Committee. At present, no companion
bill (similar legislation) has been introduced in the Senate.
As a result, some Congressional sponsors of this legislation
may attempt to "attach" (include) H.R. 2418 as an
amendment to a larger legislative vehicle that is more likely
to reach final passage.
Appropriations
Bill Seeks Additional One-Year Delay of HHS Rule
The House and Senate Appropriations
Committees, during the week of September 20, 1999, considered
and approved their versions of legislation to fund the FY 2000
operations of the Department of Health and Human Services.
The final omnibus (all inclusive) appropriations package approved
in FY 1999, the House funding bill for FY 2000 contains language
which seeks to delay the HHS organ allocation rule by an additional
one-year. At this point, it is unclear whether or not such
a provision has the Congressional support necessary to clear
a conference committee (House and Senate meeting to reconcile
differences between both bills) and reach final passage. AST
continues to monitor this situation closely.
The AST Washington office remains
active on a variety of other key public policy issues as well.
If you have any questions or require additional information,
please do not hesitate to contact AST's Washington Representative,
Bill Applegate, at (202) 828-3460 or applegaw@arentfox.com.
HHS Releases Report
on Access to Liver Transplantation
In August, the Office
of the Inspector General (OIG) of the Department of Health
and Human Services
released a report entitled, “Fostering Equity in Patient Access
to Transplantation: Local Access to Liver Transplantation.” The
purpose of this report is to examine the validity of the perception
that widespread local access to a transplant center exists.
Information is provided on the geographic configuration of
the nation’s liver transplant centers and the factors that
contribute to that configuration.
The report found that liver transplant
centers are concentrated geographically around major metropolitan
areas. This pattern leaves large portions of the United States
population at considerable distance from a transplant center.
Liver transplants were also found to be concentrated among
few transplant centers. The report stated that the following
factors limit broader geographic distribution of liver transplant
centers:
- Limited number of organs for
transplant.
- Relationship between volume and
quality.
- Costs of a transplant center.
- Role of academic medical centers.
The OIG Report concluded
that national policies on organ allocation are not likely to
affect the overall
distribution of transplant centers one way or the other. OIG
agreed with the recently released Institute of Medicine Report
in noting that it “did not find credible evidence that broader
sharing or the Final Rule (on allocation) would result in the
closure of smaller transplant centers.”
NIH to Change
its Scientific Review Process
The peer-review system at National
Institutes of Health is itself undergoing peer-review. . Approximately
three-quarters of the 40,000 applications NIH receives each
year are evaluated by the Center for Scientific Review (CSR),
including individual pre- and post-doc fellowships (F32s) and
investigator initiated proposals (R01s). The proposed re-organization
of CSR could benefit clinical researchers, bioengineers and
innovative newcomers.
The current system,
established over 50 years ago, receives a fair amount of criticism.
While
the concerns are “based on subjective impressions that are
hard to document, they are worthy issues and sufficiently common
to suggest consideration for new ways to organize the review
process,” the advisory panel wrote in a draft proposal. The
current structure does not sufficiently accommodate emerging
fields: proposals using innovative techniques and high-impact
studies are assigned to too few study sections. At the same
time, other sections receive only low-impact proposals, thus
creating “entitlements” for certain fields, the advisory panel
noted. And some segments of the research community—including
clinical researchers, behavioral scientists, bioengineers,
and developers of technology and instrumentation—believe they
are inadequately served by the existing system.
The advisory panel,
chaired by National Academy of Sciences president Bruce Alberts,
recommends a major
reorganization that replaces the 20 existing review sections
with 21. Sixteen of the proposed review groups are based around
specific diseases, organs or physiological systems, and general
health problems. The review section for cardiovascular sciences,
for example, would review a range of applications that includes
basic studies of vessel development and clinical studies pertaining
to heart disease and treatment. The remaining 5 review groups
would be clustered around “fundamental science that underlies
and transcends all physiological and disease systems,” for
example, “bioengineering and technology development.” These
5 clusters would review proposals that are not expected to
have an immediate application to human health.
The first phase of the project,
due to conclude in November, will finalize the set of review
groups. The second phase, expected to run through 2001, would
populate the study sections within the review groups. The 27-page
report is open for comment until October 15 and is available http://www.csr.nih.gov/bioopp/intro.htm
Government Analysis
Estimates One-third Cut in NIH Programs and Possible Elimination
of All New Grants. Contact Congress Now!
The House and Senate
Appropriations Subcommittees on Labor, Health and Human Services
(HHS), Education
and Related Agencies both failed to consider or “mark-up” legislation
that funds health related programs for FY 2000 before leaving
for the August recess. Both the House and Senate will begin
their respective “mark-up sessions” in September. As the new
fiscal year approaches, Congress must now face difficult budget
choices brought on by 1997 Balanced Budget Agreement (BBA).
The BBA placed “caps” or limits on overall government spending.
In an effort to hold spending under these caps, the pool of
money available for the House and Senate Appropriations Subcommittees
is presently quite small. Specifically, under the present “allocation” for
FY 2000, spending for health programs would be cut by approximately
$18 billion compared to FY 1999 levels. Therefore, transplant
research programs would be subject to huge cuts. In particular,
one government analysis estimated that NIH would have to cut
all grants and Institutes by one-third or simply eliminate
all new grants! These include funding for the National Institute
of Allergy and Infectious Disease (NIAID), the National Heart,
Lung, and Blood Institute (NHLBI), and the National Institute
of Diabetes, Digestive and Kidney Diseases (NIDDK). As a result,
AST members must communicate with their Members of Congress
regarding the need for adequate federal support for transplant
research programs.
