[DOCID: f:sr247.110]
From the Senate Reports Online via GPO Access
[wais.access.gpo.gov]
Calendar No. 540
110th Congress Report
SENATE
1st Session 110-247
======================================================================
ESTABLISHING EPILEPSY CENTERS OF EXCELLENCE IN THE VETERANS HEALTH
ADMINISTRATION
_______
December 12, 2007.--Ordered to be printed
_______
Mr. Akaka, from the Committee on Veterans' Affairs,
submitted the following
R E P O R T
[To accompany S. 2004]
The Committee on Veterans' Affairs (hereinafter, ``the
Committee''), to which was referred the bill (S. 2004) to amend
title 38, United States Code, to establish epilepsy centers of
excellence in the Veterans Health Administration of the
Department of Veterans Affairs, and for other purposes, having
considered the same, reports favorably thereon and recommends
that the bill do pass.
Introduction
On August 3, 2007, Senator Murray, for herself and Senator
Craig, introduced S. 2004. S. 2004 would designate six health
care facilities of the Department of Veterans Affairs as
centers of excellence for research, education, and clinical
care of epilepsy. S. 2004 is also cosponsored by Senators
Lincoln and Obama.
On October 24, 2007, the Committee held a hearing on
pending veterans' health legislation at which testimony was
offered by: the Honorable Michael J. Kussman, M.D., M.S.,
M.A.C.P., Under Secretary for Health, Department of Veterans
Affairs, accompanied by Walter Hall, Assistant General Counsel,
Department of Veterans Affairs; Carl Blake, National
Legislative Director, Paralyzed Veterans of America; Joy J.
Ilem, Assistant National Legislative Director, Disabled
Veterans of America; Brenda Murdough, M.S.N., RN-C, Military/
Veterans Initiative Coordinator, American Pain Foundation;
Brien J. Smith, M.D., Director, Epilepsy Monitoring Unit, Henry
Ford Hospital; and Capt. Constance Walker, USN (Ret.),
President, Southern Maryland Chapter of the National Alliance
on Mental Illness.
Earlier, on May 23, 2007, the Committee held a hearing on
pending veterans' health legislation. The testimony of John
Booss, M.D., American Academy of Neurology included a
discussion about epilepsy care and research within VA and the
veteran population.
Committee Meeting
After carefully reviewing the testimony from the foregoing
hearings, the Committee met in open session on November 14,
2007, to consider, among other legislation, S. 2004. The
Committee voted unanimously to report favorably S. 2004.
Summary of S. 2004 As Reported
S. 2004, as reported, (hereinafter, ``the Committee bill'')
would establish within the Veterans Health Administration
epilepsy centers of excellence.
Section (a) of the Committee bill would amend chapter 73 of
title 38, United States Code, by adding a new section 7330A,
consisting of six subsections (a) through (f) as follows:
New subsection (a) would require the Secretary to designate
not less than six Department health care facilities as
locations for epilepsy centers of excellence, and, subject to
the availability of appropriations, establish and operate such
centers.
New subsection (b) would stipulate that the Secretary may
not designate a Department health care facility as a location
for an epilepsy center of excellence without the approval of
the peer review panel established under new subsection (c).
New subsection (c) would establish a peer review panel to
assess the scientific and clinical merit of proposals submitted
to the Secretary for the designation of epilepsy centers of
excellence. This subsection would also set forth requirements
concerning the composition and operation of the peer review
panel.
New subsection (d) would define ``epilepsy center of
excellence'' as a facility that has, or can develop, the
necessary capacity to function as a center of excellence in
research, education, and clinical care activities in the
diagnosis and treatment of epilepsy.
New subsection (e) would require the Secretary to designate
an individual in the VHA to act as a national coordinator for
epilepsy programs of the VHA, and would specify the duties of
that coordinator.
New subsection (f) would authorize $6,000,000 to be
appropriated for the operation of the centers under this
section for each fiscal year 2008 through 2012. In addition,
such sums as may be necessary would be authorized to be
appropriated to fund the national coordinator designated under
subsection (e).
Section (b) of the Committee bill would make a clerical
amendment to the table of contents of chapter 73 of title 38.
Background and Discussion
The Committee bill would add a new section 7330A to title
38, United States Code, which would require the Secretary to
designate not less than six Department facilities as locations
for epilepsy centers of excellence. For a wide range of
diseases and disabilities, VA Centers of Excellence are the
model of innovation in the delivery of specialized health care
and research. As discussed below, the centers would fill gaps
in research, care, and education for epilepsy.
The need for these centers has been demonstrated by both
past experience and current research. Following the return of
veterans from Vietnam, VA became a leader in research and
treatment of epilepsy. VA's efforts were, however, reactive,
and the opportunity to intervene early to prevent epilepsy was
missed.
Dr. John Booss, of the American Academy of Neurology, and
formerly the national director of neurology for the VA, said in
testimony before the Committee on May 23, 2007, that
At one point, the VA was a national leader in care and
research for patients with epilepsy. As early as 1972
the VA recognized the need for VA health centers that
specialized in epilepsy. But starting in the 1990's
these epilepsy centers have languished due to lack of
funds.
This sentiment was echoed by Dr. Brien J. Smith, Medical
Director of the Comprehensive Epilepsy Program at the Henry
Ford Hospital in Detroit, in testimony before the Committee on
October 24, 2007.
The VA established Epilepsy Centers as early as 1972,
but these Centers have languished over the years with
few staff and no national budget. The net result of
allowing these Centers to fall by the wayside is that
veterans with post traumatic brain injury epilepsy are
at the variable mercy of a system with markedly uneven
distribution of epilepsy services. This often results
in denial of services in locations without the
necessary epilepsy facilities and in which
administrators are hard pressed to meet their budget.
Sadly, the potential of these Centers to be the
backbone of a national epilepsy program never
materialized.
The centers of excellence that would be created by this
bill would provide VA with the wherewithal to research the
connection between epilepsy and Traumatic Brain Injury (TBI),
and to provide timely care to veterans who develop epilepsy.
Although we do not yet have data on post-traumatic epilepsy
for current conflicts, past experience suggests the rate may be
high. Statistics from the Vietnam era indicate that soldiers
with an open TBI faced at least a fifty percent chance of
experiencing epilepsy. VA-funded research conducted in
collaboration with the Department of Defense found that 53
percent of veterans who suffered a penetrating TBI in Vietnam
developed epilepsy within 15 years. The risk of epilepsy
associated with closed TBI, a wound common among veterans of
Operations Enduring Freedom and Iraqi Freedom, has not been
clearly established. Dr. Booss testified that ``As
neurologists, we believe that the rate of epilepsy from blast
TBI will also be high.''
The creation of national epilepsy centers of excellence is
supported by the American Academy of Neurology, the Epilepsy
Foundation, the Brain Injury Association of America, Disabled
American Veterans, Paralyzed Veterans of America, Blinded
Veterans Association, the Marine Corp League, Vietnam Veterans
of America, Military Order of the Purple Heart and Iraq and
Afghanistan Veterans of America.
Subsections (b) and (c) of new section 7330A would
establish and define a peer review panel to assess the
scientific and clinical merit of proposals submitted to the
Secretary for the designation of epilepsy centers of
excellence. A similar process is used by VA to create and award
other centers of excellence to ensure the awards are based on
objective criteria. Similar panels have been used in the
creation of centers of excellence for Parkinson's disease and
multiple sclerosis. Other government agencies, such as the
National Institutes of Health (NIH), use this mechanism to
award clinical center contracts.
Subsection (d) of new section 7330A would define ``epilepsy
center of excellence'', and describes the purpose of the
centers. In designating the centers, facilities would have to
demonstrate a number of qualifications, or the ability to meet
such requirements, including those described below.
Facilities would be required to have or develop an
affiliation with an accredited medical school that provides
education and training in neurology. In testimony before the
Committee on May 23, 2007, Dr. John Booss said that
A VA health care facility affiliated with a medical
school that trains residents in the diagnosis and
treatment of epilepsy, including epilepsy surgery,
would be able to attract the participation of
clinicians and scientists capable of driving innovation
in the prevention and treatment of post-traumatic
epilepsy.
Affiliations with research universities greatly expand the
strength, range, and diversity of research capacities of
affiliated VA research units.
Facilities would also be required to have an advisory
committee to advise the facility on policy matters pertaining
to the activities of the center. Further, the facility would
have to have the capability to conduct appropriate evaluations
of the activities of the
center.
In the Committee's view, the proposed new epilepsy centers
of excellence would serve a number of essential purposes. Most
importantly, the centers would improve quality of care for
veterans around the country. In addition, the centers would
prepare VA to meet the growing demand for specialized treatment
of epilepsy and seizure disorders, a demand that is likely to
grow, given the high incidence of TBI among veterans of
Operations Enduring Freedom and Iraqi Freedom.
The Committee is concerned that VA lacks clear evidence-
based guidelines for the referral of veterans for epilepsy
screening and treatment. To address this issue, facilities
would be required to participate in research, education, and
dissemination of clinical best-practices coordinated at a
national level. These measures are essential to the effective
promotion of quality care and treatment of epilepsy beyond the
six centers to meet the needs of the entire veteran population.
Coordination and collaboration with other Department facilities
and centers, especially those focused on TBI, would also be
required.
The incidence of epilepsy among the veteran population is
not precisely known, and the creation of these centers would
improve VA's ability to study this population. In the general
population, the incidence of epilepsy is approximately one
percent. To study the veteran population more closely, VA
officials appointed the Epilepsy Advisory Committee in 1999.
This committee estimated that 50,000 veterans were seeking care
at VA facilities for epilepsy or seizure disorders at the time
of the study. That number may have grown to 79,000, based on
the national rate, and on the number of veterans enrolled in VA
health care today.
Subsection (e) of new section 7330A would require the
Secretary to designate an individual in the VHA to act as a
national coordinator for epilepsy programs of the VHA. The
national coordinator would supervise the operation of the
centers established by this Act, and would coordinate and
support the promotion of research, education and care for
epilepsy throughout the Department. The national coordinator
would also be responsible for regularly evaluating the centers.
Subsection (f) of new section 7330A would authorize the
appropriation of $6,000,000 for the operation of the centers
under this section for each fiscal year 2008 through 2012, and
would authorize for each fiscal year after 2012 such sums as
may be necessary for the operation of the centers. Centers
established with sufficient funding would lay the foundation
for enduring programs in epilepsy care, research, and
education. Once established, the Centers would be equipped to
compete for funding from NIH, and funds from other sources, to
further advance care for veterans with
epilepsy.
In addition, the Committee bill would authorize the
appropriation of such sums as may be necessary to fund the
national coordinator position that would be established by
subsection (e).
Committee Bill Cost Estimate
In compliance with paragraph 11(a) of rule XXVI of the
Standing Rules of the Senate, the Committee, based on
information supplied by the CBO, estimates that enactment of
the Committee bill would, relative to current law, increase
discretionary spending by $3,000,000 in 2008 and by $31,000,000
over the 2008-2012 period, assuming appropriation of the
necessary amounts. The Committee bill would not increase direct
spending, based on information supplied by the CBO. Enactment
of the Committee bill would not affect receipts, and would not
affect the budget of state, local or tribal governments.
The cost estimate provided by CBO, setting forth a detailed
breakdown of costs, follows:
U.S. Congress,
Congressional Budget Office,
Washington, DC, November 30, 2007.
Hon. Daniel K. Akaka,
Chairman,
Committee on Veterans' Affairs,
U.S. Senate, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for S. 2004, a bill to
amend title 38, United States Code, to establish epilepsy
centers of excellence in the Veterans Health Administration of
the Department of Veterans Affairs, and for other purposes.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Sunita
D'Monte, who can be reached at 226-2840.
Sincerely,
Peter R. Orszag,
Director.
Enclosure.
cc: Honorable Richard Burr, Ranking Member.
S. 2004--A bill to amend title 38, United States Code, to establish
epilepsy centers of excellence in the Veterans Health
Administration of the Department of Veterans Affairs, and for
other purposes
S. 2004 would require the Secretary of the Department of
Veterans Affairs (VA) to establish at least six centers of
excellence for epilepsy research, education, and clinical care
at VA health care facilities, and to appoint a national
coordinator for those centers and for other epilepsy programs
at the Veterans Health Administration. The bill would authorize
the appropriation of $6 million each year over the 2008-2012
period and such sums as may be necessary for the national
coordinator. CBO estimates that in addition to the specified
authorizations, VA would require less than $500,000 annually
for the national coordinator.
In total, CBO estimates that implementing S. 2004 would
cost $3 million in 2008 and $31 million over the 2008-2012
period, assuming that the specified and estimated amounts are
appropriated and that outlays follow historical spending
patterns for similar programs. Enacting the bill would have no
effect on direct spending or revenues.
S. 2004 contains no intergovernmental or private-sector
mandates as defined in the Unfunded Mandates Reform Act and
would impose no costs on state, local, or tribal governments.
The CBO staff contact for this estimate is Sunita D'Monte,
who can be reached at 226-2840. This estimate was approved by
Peter H. Fontaine, Assistant Director for Budget Analysis.
Regulatory Impact Statement
In compliance with paragraph 11(b) of rule XXVI of the
Standing Rules of the Senate, the Committee on Veterans'
Affairs has made an evaluation of the regulatory impact that
would be incurred in carrying out the Committee bill. The
Committee finds that the Committee bill would not entail any
regulation of individuals or businesses or result in any impact
on the personal privacy of any individuals and that the
paperwork resulting from enactment would be minimal.
Tabulation of Votes Cast in Committee
In compliance with paragraph 7 of rule XXVI of the Standing
Rules of the Senate, the following is a tabulation of votes
cast in person or by proxy by members of the Committee on
Veterans' Affairs at its November 14, 2007 meeting. On that
date, the Committee ordered S. 2004 reported favorably to the
Senate, by voice vote.
Agency Report
On October 24, 2007, the Honorable Michael J. Kussman,
Under Secretary for Health, Department of Veterans Affairs,
appeared before the Committee and submitted testimony on, among
other things, S. 2004. Excerpts from this statement are
reprinted below:
STATEMENT OF HON. MICHAEL J. KUSSMAN, UNDER
SECRETARY FOR HEALTH, DEPARTMENT OF VETERANS
AFFAIRS
Good morning Mr. Chairman and Members of the Committee:
Thank you for inviting me here today to present the
Administration's views on several bills that would affect
Department of Veterans Affairs (VA) programs that provide
veterans benefits and services. With me today is Walter A.
Hall, Assistant General Counsel. I will address the five bills
on today's agenda and then I would be happy to answer any
questions you and the Committee members may have.
S. 2004 would require the Secretary, not later than 120
days after enactment of this provision, to designate at least
six Department health-care facilities as epilepsy centers of
excellence based on the recommendation of the Under Secretary
for Health (USH). The mandate to establish and operate these
centers, however, would be subject to the availability of
appropriations for this purpose.
The bill defines an ``epilepsy center of excellence'' as a
Department health-care facility that has (or in the foreseeable
future can develop) the necessary capacity to function as a
center of excellence in research, education, and clinical care
activities in the diagnosis and treatment of epilepsy. To
qualify as a center, the facility would need:
<bullet> An affiliation with an accredited medical school
that provides education and training in neurology (or may
reasonably be anticipated to develop such an affiliation).
<bullet> The ability to attract scientists of ingenuity and
creativity.
<bullet> An advisory committee composed of veterans and
appropriate health-care and research representatives of the
facility and of the affiliate.
<bullet> The capability to effectively evaluate the
activities of the
centers.
<bullet> The capability to coordinate the centers'
education, clinical care, and research activities.
<bullet> The capability to develop a national consortium of
providers with interest in treating epilepsy at VA medical
centers; the consortium would have to include a designated
epilepsy referral clinical in each Veterans Integrated Service
Network.
<bullet> The capability to assist in the expansion of VA's
use of information systems and databases to improve the quality
and delivery of care.
<bullet> The capability to assist in the expansion of VA's
tele-health program to develop, transmit, monitor, and review
neurological diagnostic tests.
<bullet> The ability to perform epilepsy research,
education, and clinical care activities in collaboration with
VA's Poly-Trauma Centers.
A number of specific requirements governing the competitive
selection of the six facilities are set forth in the bill,
including a requirement that the Secretary consider appropriate
geographic distribution when making the selections.
S. 2004 would further mandate the designation of an
individual in VHA to act as a national coordinator for VHA's
epilepsy programs. The bill includes a list of duties for that
position, including that such individual report to the VHA
official responsible for neurology.
The bill would authorize $6 million for each of fiscal
years 2008 through 2012 to establish and operate the centers;
such sums as may be necessary for operating the centers for
each fiscal year after fiscal year 2012 would also be
authorized. For the first three years of the centers operation,
the bill would require that the centers be designated as a
special purpose program in order to avoid funds for the centers
being allocated through the Veterans Equitable Resource
Allocation system. In addition to those amounts, the USH would
be required to allocate such amounts as he deems appropriate
from other funds made available to VHA. The bill includes a
separate authorization of appropriations to fund the national
coordinator position.
VA does not support S. 2004. As I have discussed in the
past, I am concerned that statutory mandates for ``disease
specific'' centers have the potential to fragment care in what
is otherwise a well-designed, world-class integrated health
care system. I am increasingly concerned about the
proliferation of this disease-specific model and its impact on
patient care and VA's integrated health care model. As it
relates to a particular disease, I believe that it is much more
important for VA to disseminate the best in evidence-based
practices across its health care system than to establish
centers that provide care for a particular disease.
Treating epilepsy, like every other serious condition,
requires an interdisciplinary approach. By mandating new
``education, research, and clinical centers'' that are disease-
specific, flexibility to respond to changing combinations of
related conditions is reduced. The centers' mandated
collaboration with VA's Poly-trauma Centers would not cure this
short-coming.
It is also important to note that the ``models'' on which
these Epilepsy Centers are based, the successful Geriatric
Research, Education and Clinical Center (GRECC) and Mental
Illness Research, Education and Clinical Center (MIRECC)
programs, are not narrowly-focused on a disease process but
address a wide gamut of issues facing a significant portion of
the veteran population.
* * * * * * *
Changes in Existing Law
In compliance with rule XXVI paragraph 12 of the Standing
Rules of the Senate, changes in existing law made by the bill,
as reported, are shown as follows (existing law proposed to be
omitted is enclosed in black brackets, new matter is printed in
italic, existing law in which no change is proposed is shown in
roman).
TITLE 38--VETERANS BENEFITS
PART V--BOARDS, ADMINISTRATIONS, AND SERVICES
CHAPTER 73--VETERANS HEALTH ADMINISTRATION--ORGANIZATION AND FUNCTIONS
* * * * * * *
SEC. 7330A. EPILEPSY CENTERS OF EXCELLENCE.
* * * * * * *
Subchapter II--General Authority and Administration
* * * * * * *
SEC. 7330A. EPILEPSY CENTERS OF EXCELLENCE
(a) Establishment of Centers.--(1) Not later than 120 days
after the date of the enactment of this section, the Secretary
shall, upon the recommendation of the Under Secretary for
Health, designate not less than six Department health-care
facilities as the locations for epilepsy centers of excellence.
(2) Subject to the availability of appropriations for such
purpose, the Secretary shall establish and operate epilepsy
centers of excellence at the locations designated pursuant to
paragraph (1).
(b) Designation of Facilities.--(1) The Secretary may not
designate a Department health-care facility as a location for
an epilepsy center of excellence under subsection (a)(1) unless
the peer review panel established under subsection (c) has
determined under that subsection that the proposal submitted by
such facility seeking designation as a location for an epilepsy
center of excellence is among those proposals that meet the
highest competitive standards of scientific and clinical merit.
(2) In choosing from among the facilities meeting the
requirements of paragraph (1), the Secretary shall also
consider appropriate geographic distribution when designating
the epilepsy centers of excellence under subsection (a)(1).
(c) Peer Review Panel.--(1) The Under Secretary for Health
shall establish a peer review panel to assess the scientific
and clinical merit of proposals that are submitted to the
Secretary for the designation of epilepsy centers of excellence
under this section.
(2)(A) The membership of the peer review panel shall
consist of experts on epilepsy, including post-traumatic
epilepsy.
(B) Members of the peer review panel shall serve for a
period of no longer than two years, except as specified in
subparagraph (C).
(C) Of the members first appointed to the panel, one half
shall be appointed for a period of three years and one half
shall be appointed for a period of two years, as designated by
the Under Secretary at the time of appointment.
(3) The peer review panel shall review each proposal
submitted to the panel by the Under Secretary for Health and
shall submit its views on the relative scientific and clinical
merit of each such proposal to the Under Secretary.
(4) The peer review panel shall not be subject to the
Federal Advisory Committee Act.
(d) Epilepsy Center of Excellence Defined.--In this
section, the term ``epilepsy center of excellence'' means a
Department health-care facility that has (or in the foreseeable
future can develop) the necessary capacity to function as a
center of excellence in research, education, and clinical care
activities in the diagnosis and treatment of epilepsy and has
(or may reasonably be anticipated to develop) each of the
following:
(1) An affiliation with an accredited medical school
that provides education and training in neurology,
including an arrangement with such school under which
medical residents receive education and training in the
diagnosis and treatment of epilepsy (including
neurosurgery).
(2) The ability to attract the participation of
scientists who are capable of ingenuity and creativity
in health-care research efforts.
(3) An advisory committee composed of veterans and
appropriate health-care and research representatives of
the facility and of the affiliated school or schools to
advise the directors of such facility and such center
on policy matters pertaining to the activities of the
center during the period of the operation of such
center.
(4) The capability to conduct effectively evaluations
of the activities of such center.
(5) The capability to coordinate (as part of an
integrated national system) education, clinical care,
and research activities within all facilities with such
centers.
(6) The capability to develop jointly a national
consortium of providers with interest in treating
epilepsy at Department health-care facilities lacking
such centers in order to ensure better access to state-
of-the-art diagnosis, research, clinical care, and
education for traumatic brain injury and epilepsy
throughout the health-care system of the Department.
Such consortium should include a designated epilepsy
referral clinic in each Veterans Integrated Service
Network.
(7) The capability to assist in the expansion of the
Department's use of information systems and databases
to improve the quality and delivery of care for
veterans enrolled within the Department's health care
system.
(8) The capability to assist in the expansion of the
Department telehealth program to develop, transmit,
monitor, and review neurological diagnostic tests.
(9) The ability to perform epilepsy research,
education, and clinical care activities in
collaboration with Department medical facilities that
have centers for research, education, and clinical care
activities on complex multi-trauma associated with
combat injuries established under section 7327 of this
title.
(e) National Coordinator for Epilepsy Programs.--(1) To
assist the Secretary and the Under Secretary for Health in
carrying out this section, the Secretary shall designate an
individual in the Veterans Health Administration to act as a
national coordinator for epilepsy programs of the Veterans
Health Administration.
(2) The duties of the national coordinator for epilepsy
programs shall include the following:
(A) To supervise the operation of the centers
established pursuant to this section.
(B) To coordinate and support the national consortium
of providers with interest in treating epilepsy at
Department health-care facilities lacking such centers
in order to ensure better access to state-of-the-art
diagnosis, research, clinical care, and education for
traumatic brain injury and epilepsy throughout the
health-care system of the Department.
(C) To conduct regular evaluations of the epilepsy
centers of excellence to ensure compliance with the
requirements of this section.
(3) In carrying out duties under this subsection, the
national coordinator for epilepsy programs shall report to the
official of the Veterans Health Administration responsible for
neurology.
(f) Authorization of Appropriations.--(1) There are
authorized to be appropriated $6,000,000 for each of fiscal
years 2008 through 2012 for the support of the clinical care,
research, and education activities of the epilepsy centers of
excellence established and operated pursuant to subsection
(a)(2).
(2) There are authorized to be appropriated for each fiscal
year after fiscal year 2012 such sums as may be necessary for
the support of the clinical care, research, and education
activities of the epilepsy centers of excellence established
and operated pursuant to subsection (a)(2).
(3) The Secretary shall ensure that funds for such centers
are designated for the first three years of operation as a
special purpose program for which funds are not allocated
through the Veterans Equitable Resource Allocation system.
(4) In addition to amounts authorized to be appropriated
under paragraphs (1) and (2) for a fiscal year, the Under
Secretary for Health shall allocate to such centers from other
funds appropriated generally for the Department medical
services account and medical and prosthetics research account,
as appropriate, such amounts as the Under Secretary for Health
determines appropriate.
(5) In addition to amounts authorized to be appropriated
under paragraphs (1) and (2) for a fiscal year, there are
authorized to be appropriated such sums as may be necessary to
fund the national coordinator established by subsection (e).
<all>