June 7, 2001
Christopher Shays to Hold June 14 Oversight Hearing
C: Screening in the VA Health Care System”
(Washington, DC) -- Congressman Christopher Shays (R-CT),
Chairman of the Subcommittee on National Security, Veterans
Affairs, and International Relations, will hold an oversight
hearing June 14 to assess efforts by the Department of
Veterans Affairs (VA) to screen and test veterans for
Hepatitis C (Hepatitis C Virus) infection. The hearing was announced
today by Congressman Dan Burton (R-IN), Chairman of the
Committee on Government Reform.
C is a serious national health crisis with an estimated four
million Americans infected, many of whom are veterans and many
of whom are not even aware they are at-risk," said
Chairman Shays. "But after two years, the laudable
promise of the VA initiative to screen and treat Hepatitis C Virus-infected
veterans remains unfulfilled.
The decentralized VA health system seems incapable of
carrying out the Hepatitis C Virus program aggressively or
The Thursday, June 14, 2001
hearing will convene at 10:00 a.m. in Room 2247, Rayburn
Building in Washington, D.C. Witnesses will include
representatives from the General Accounting Office (GAO), and
With an estimated four million
Americans infected, and 30,000 new infections occurring
annually, veterans are five to six times more likely to carry
the Hepatitis C virus than the general U.S. population.
Termed the "silent epidemic," the blood-borne
disease of the liver was not officially recognized until 1989,
and reliable tests to detect the Hepatitis C virus were not
available until 1992. It is believed many veterans of
the Vietnam War, for example, may have received blood
transfusions contaminated by Hepatitis C Virus.
Hepatitis C can lead to serious
and permanent liver damage. It is the leading cause of
cirrhosis and liver cancer and accounts for 40% of all chronic
liver disease, about 20% to 30% of all liver transplants, and
more than 8,000 deaths annually. In 1998, the number of
persons needing liver transplants was twice the available
number of organs. According to the Congressional
Research Service, annual deaths from chronic liver disease
caused by Hepatitis C could triple in the next 20 to 30 years
if effective therapies are not found.
Surveys were conducted in 1998
among patients at two VA Medical Centers (VAMCs) to determine
how many were infected with Hepatitis C. At the
Washington DC VAMC, 20% of the veterans seeking care in the
facility tested positive for HVC; and at the San Francisco
VAMC, 18% were infected.
In January 1999, the VA announced
a new policy on Hepatitis C, a "major initiative to
respond to the Hepatitis C epidemic in a comprehensive and
consistent manner across its nationwide health care system.”
VA's goal is to screen all veterans who have not been
screened during routine clinic visits to VAMCs, and provide
treatment when appropriate. In FY2001, VA received $340
million to reach this goal; however, VA believes it will spend
only $151 million of that amount on Hepatitis C Virus related care.
The VA has requested $171 million in FY2002 for the Hepatitis C Virus
"In each of
the two hearings we’ve held since 1999 on this
subject," Shays said,
“VA officials said the program was improving, and
that every facility would soon be screening every veteran.
In fact, barely twenty percent of veterans using VA
health care have been reached by the Hepatitis C Virus initiative.
Hepatitis C Virus-infected veterans are walking out of VA clinics and
hospitals every day, unaware they may be ill, unaware of
options available to prolong their lives, unaware they may be
infecting friends and family."
The Subcommittee requested that
the General Accounting Office (GAO) assess the reach and
consistency of the Hepatitis C program by visiting a number of
VA health care facilities.
GAO testimony at the hearing is expected to state
several reasons why screening has been limited and
inconsistent. According to GAO, local VA managers have
adopted restrictive Hepatitis C Virus program efforts because they were not
aware funding was available to screen and test patients.
GAO found instances in which screening for Hepatitis C Virus risk factors
was limited to certain clinics on certain days of the week. In
some cases, the decision to test for Hepatitis C Virus infection was not
clearly stated as a matter of VA policy, but left to the
judgment of each physician.
“This is not a matter of
dollars, but of determination,” Shays said.
“The VA has not been able to spend the money Congress
provided for Hepatitis C Virus screening and treatment because the message
got lost somewhere between headquarters and the local clinics
that this was a priority.
This important public health initiative has to be
implemented more aggressively and more consistently.”
The Subcommittee on National
Security, Veterans Affairs, and International Relations has
oversight of those departments and agencies of government
managing programs and activities related to national security,
including the VA.
Care - Veterans' Health and Benefits Issues
Mr. Paul Reynolds
Director - Veterans' Health Care Issues
General Accounting Office
Under Secretary for Health
of Veterans Affairs
Dr. Lawrence Deyton
Chief Consultant for Public Health
Department of Veterans Affairs
Dr. Robert Lynch
Veterans Integrated Service Network 16
Department of Veterans Affairs
Ms. Mary Dowling
VA Medical Center, Northport, New York
Department of Veterans Affairs
Mr. James Cody
VA Medical Center, Syracuse New York
Department of Veterans Affairs
from the American Legion
ON NATIONAL SECURITY, VETERANS AFFAIRS,
AND INTERNATIONAL RELATIONS
Christopher Shays, Connecticut
Room B-372 Rayburn Building
Washington, D.C. 20515
Tel: 202 225-2548
Fax: 202 225-2382
June 8, 2001
Members of the Subcommittee on National Security,
Veterans Affairs, and
Kristine K. McElroy, Professional Staff Member
Briefing memorandum for the hearing Hepatitis
C: Screening in the VA Health
Care System, scheduled for Thursday, June 14,
2001,at10:00a.m. in room 2247
Rayburn House Office Building in Washington D.C.
PURPOSE OF THE HEARING:
The purpose of the hearing is to assess
the Department of Veterans Affairs’ efforts to screen and
test veterans for the Hepatitis C Virus (Hepatitis C Virus).
Why has screening and testing for the Hepatitis C Virus
(Hepatitis C Virus) been limited and inconsistent?
Why weren’t VA personnel made aware of the funding
available for screening and testing veterans for the Hepatitis
Hepatitis C Virus (Hepatitis C Virus) represents a serious national health
crisis with an estimated 4 million Americans infected, and
30,000 new infection occurring annually.
The disease is of great concern because of the possible
long-term health consequences and the current lack of vaccine
or curative therapy. It
is a blood-borne infectious disease of the liver. Some persons exposed to the virus never develop identifiable
symptoms, although a large percentage eventually experience
liver disease. The
latency period between exposure and manifestation of symptoms
can be as much as 30 years. It is a disease that is seen in increasing numbers
among high-risk groups and effects veterans at a rate five
times higher than the general U.S. population.
disease can lead to serious and permanent liver damage.
It is a leading cause of cirrhosis and liver cancer and
accounts for 40% of all chronic liver disease, 20% to 30% of
all liver transplants and more than 8,000 deaths annually.
However, a major barrier to transplant surgery is liver
transplants are both costly and unavailable to many due to the
insufficient supply of organs.
In 1998, the number of persons needing liver
transplants was twice the number of available organs.
The cost of a liver transplant is at least $200,000 and
approximately $25,000 annually thereafter for required
to the Congressional Research Service (CRS), annual deaths
from chronic liver disease caused by Hepatitis C could triple
in the next 10 to 20 years if effective therapies are not
virus was first recognized in the 1970s when the majority of
transfusion-associated infections were found to be unrelated
to Hepatitis A and B, the two Hepatitis viruses known at the
time. Research resulted in sequencing of the genome in 1989, and
the term Hepatitis C was subsequently applied to this
1992, reliable and accurate tests to detect the Hepatitis C Virus antibody
became available and have been used to screen donated blood.
Hepatitis C Virus blood screening technology has continued to
improve, contributing to a decline in new Hepatitis C Virus cases.
is no effective vaccine to prevent, or immune globulin to
treat Hepatitis C infection.
Hepatitis C is spread primarily by contact with blood
and blood products. Prior to 1990, and the advent of any Hepatitis C Virus testing, many
individuals contracted Hepatitis C through tainted blood or
blood-derived products. Contraction
of the disease through the blood supply has been reduced due
to both a change in the donor population, and the use of
screening tests for donated blood products.
factors for Hepatitis C Virus include receipt of blood or blood products
prior to 1992, injection drug use, nasal cocaine, needle-stick
accidents, and possibly tattooing.
Persons with multiple sexual partners are at higher
risk of becoming infected. The source of some Hepatitis C Virus infection is unknown.
for Hepatitis C is expensive and limited.
It consists primarily of administration of interferon
alpha, with or without the addition of ribavirin over the
course of six to 12 months.
Interferon alfa was approved by the Food and Drug
Administration (FDA) for treatment of chronic Hepatitis C and
the National Institutes of Health (NIH) Consensus Conference
recommended initial therapy for 12 months.
The treatment benefits some patients and appears to
interfere with the natural progression of the disease,
although “evidence is lacking that it will translate into
improvements in the quality of life or reduction in the risk
of hepatic failure.”
(Web Resources 1)
VA and Hepatitis C
C is of particular interest to the Department of Veterans
Affairs (VA) because of the high incidence of the disease
among veterans. Studies of Hepatitis C Virus prevalence among veterans/patients within the
VA health care system have “confirmed seropositive rates of
8%-10%, or nearly five times higher than that (1.8%) of the
general U. S. population,” according to the American Liver
1991, the VA began tracking the number of persons examined in
VA facilities who tested positive for Hepatitis C Virus.
While the availability of an antibody test was limited
in 1991, about 6,600 persons in the VA system were identified
with Hepatitis C Virus. This
number increased to 18,800 in 1994, to about 21,400 in 1996.
The VA states it is not clear whether the initial
increase was due to an increase in the number of persons with
Hepatitis C Virus or the trend was a reflection of improved testing
to the VA, a 1998 six-week survey at the VA Medical Center in
Washington, D.C. found a prevalence of 20% positive antibody
in veterans seeking care in the facility.
A similar survey in the San Francisco VA Medical Center
found 18% of their patients to be infected. In
addition, the VA's transplant program data reveals that 52% of
all liver transplants in VA facilities showed Hepatitis C
1998, the VA reported that a 10-month electronic survey of 125
VA Medical Centers identified 14,958 patients who tested
positive for Hepatitis C.
During 1999 and 2000, VA screened 20%
of all system users for Hepatitis C Virus.
In the first half of FY 1999, VA reported 198,000
patients were tested for Hepatitis C Virus. Of that number, close to 40,000 VA patients tested positive.
The VA reported 478,000 veterans were screened and
77,886 veterans were treated for Hepatitis C- related
conditions in fiscal year 2000 at a cost of $100 million.
In FY 2000, there were 39,426 unique hepatitis C
positive patients. According to VA, 333,782 blood tests for
hepatitis C were given, and 107,509 tests were Hepatitis C Virus positive.
It is important to note tests may be given more than
once to the same patient in order to verify results.
January 27, 1999 the VA, “announced major initiatives to
respond to the Hepatitis C virus (Hepatitis C Virus) epidemic in a
comprehensive and consistent manner across its (VA’s)
nationwide health-care system.” The VA’s 5-point strategic initiative to respond to Hepatitis C Virus
included: patient education; health care provider education;
epidemiologic assessment; treatment; and research.
The plan in part called for “Two new ‘Hepatitis C
centers of excellence,’ to be located at VA medical centers
in Miami and San Francisco to coordinate treatment and
research efforts, as well as develop education for patients
and their families, health-care providers, and counselors who
will advise patients prior to and following testing.”
(Attachment 3, p. 1)
follow up on its initiative, the Veterans Health
Administration (VHA) issued directive 2000-019 on July 19,
2000, mandating the installation and use of software on
clinical reminders to support the Hepatitis C reporting
(Attachment 4, p. 1)
February 27, 2001, the VHA issued directive 2001-009 entitled
“National Hepatitis C Program.”
The purpose of the directive was to compile all VHA
policies and programs on Hepatitis C and to outline specific
requirements for implementing the program.
The directive also states “each VA medical center
Director must designate a Hepatitis C Lead Clinician to be the
point of contact for all clinical Hepatitis C communication
and reporting between the facility, the Hepatitis C Program
office and other program offices.”
VA’s Emerging Pathogens Index (EPI) registry is used to
track the incidence of Hepatitis C Virus in the VA system. VA claims it is
now able to track veterans who tested positive for Hepatitis C Virus in each
of the 22 Veterans Integrated Service Networks (VISNs) on a
quarterly and annual basis.
(Attachment 2, p. 7) However,
VA admits, “the true prevalence of Hepatitis C Virus in veterans who
utilize medical care services is unknown.”
p. 12) VA
attributes this to “deficiencies in data (due to both gaps
in our [VA] knowledge about the epidemiology of hepatitis C in
the VA population as well as limitation in available data
collection systems).” (Attachment 2, p. 11)
Screening and Testing
has posted on the Internet guidelines for both public and
private health care providers to follow in handling patients,
including guidelines for counseling, risk assessment,
screening, and treatment.
for risk factors involves asking a variety of questions.
Current VHA policy enables veterans to be tested for
Hepatitis C Virus infection if they desire to be tested, or if they have one
or more of the following risk factors: 1.Vietnam-era veterans
(as defined by dates of service or in the age range of 40-55
years), 2. received a blood transfusion before 1992, 3. past
or present intravenous drug use, 4. unequivocal blood exposure
of skin or mucous membrane, 5. history of multiple sexual
partners (defined as more than 10 lifetime partners), 6.
history of hemodialysis, 7. tattoo or repeated body piercing,
8. history of intranasal cocaine use, 9. unexplained liver
disease, 10. unexplained/abnormal ALT, 11. intemperate or
immoderate use of alcohol (defined as more than 50 g of
alcohol per day for ten or more years.
(Attachment 6, p. 1)
Should a patient have one or more risk
factors, VA recommends providers test the patient for the Hepatitis C Virus
antibody. This initial test is called the Enzyme immunoassays (EIA).
Since this test has a high rate of false positives, VA
guidelines recommend all patients who test positive initially
be given a confirmatory test called a recombinant immunoblot
assay (RIBA). This
test confirms a patient is antibody positive.
If no risk factors are present in the initial
screening, testing is not recommended unless at a patient’s
request. (Attachment 7)
Funding for Hepatitis C
received $195 million for screening and treating patients with
Hepatitis C Virus for FY 2000. On
June 28, 2000, Dr. Thomas Garthwaite, the Under Secretary for
Health, granted an additional $20 million to be distributed to
the 22 Veterans Integrated Service Networks (VISNs) in order
to “ recognize the geographic differences in the prevalence
of hepatitis C and to provide incentive to VA health care
facilities to aggressively outreach, screen, diagnose and
treat hepatitis C.” The letter stated:
order to recognize the geographic differences in the
prevalence of Hepatitis C and to provide incentive to VA
health care facilities to aggressively outreach, screen,
diagnose, and treat Hepatitis C, I have made the decision to
provide $20 million from the National Reserve Fund to the
Veterans Integrated Service Networks (VISNs) based on each
network’s Hepatitis C costs during the first two quarters of
FY 2000. It is
important to note that funds allocated under the Veterans
Equitable Resource Allocation (VERA) will continue to be
expended by each VISN to support the costs of veterans with
Hepatitis C. This $ 20 million simply supplements those
funds.” (Attachment 8)
In recognition of the high cost of
treating Hepatitis C Virus infection, VA decided Hepatitis C patients on
drug therapy would be funded at the complex care level,
starting in FY 2001. This
new classification will help medical centers offset the costs
of treating Hepatitis C patients on drug therapy.
goal is to screen all veterans who have not been screened
during routine clinic visits to VA medical centers, and
provide treatment when it is appropriate.
In fiscal year 2001, VA received $340 million to
accomplish this goal, however VA does not believe it will
spend the full $340 million, but instead will spend closer to
$151 million. Since
VA does not expect to spend $189 million of its FY 2001 budget
allocations on Hepatitis C Virus costs, it has lowered the request for
fiscal year 2002 budget to $171 million to treat veterans who
have Hepatitis C Virus. (Attachment
9 p. 1)
Based on testimony at previous
Subcommittee hearings, and persistent reports the VA Hepatitis C Virus
initiative was not being aggressively or consistently
implemented across the regional VISN structure, the
Subcommittee requested that the General Accounting Office
assess program implementation at several VA health facilities.
DISCUSSION OF HEARING
Why has screening and testing for Hepatitis C been
limited and inconsistent?
Many are concerned that over two full
years VA has only managed to screen and test 20% of all health
system users, despite setting far higher goals and
veterans tend to have a higher rate of infection than the
general public, the wide availability of screening and testing
is seen as the central element of the VA initiative.
Until Hepatitis C Virus-positive veterans are diagnosed, they may
continue to engage in behaviors which can speed the
progression of the disease or spread it to others.
Undiagnosed veterans are not being provided access to
vaccinations (against other forms of hepatitis) and viral drug
therapies which can be vital to sustaining their health.
GAO found several reasons why screening
has been limited and inconsistent.
According to GAO, local managers have adopted
restrictive Hepatitis C screening policies because they were
not aware specific funding was available to screen and test
found instances where Hepatitis C Virus screenings for risk factors were
limited to a few clinics, on certain days of the week.
In other instances, GAO found patient access to
screening and testing was viewed as solely a matter of the
individual physician’s judgment, not a matter of VA policy.
In some cases
providers were concerned about the costs of laboratory tests.
As a result, they screened in primary care clinics on a
rotating basis, one clinic per day.
visiting the Northport VA Medical Center (VAMC), in Long
Island, NY, GAO found the director was concerned about
pharmacy costs relating to Hepatitis C Virus treatment and the increased
patient load the facility might incur because of the closure
of the Health Maintenance Organizations (HMO) in the area.
The Northport VAMC had limited Hepatitis C Virus screening in one
clinic, and no screening in specialty care clinics prior to FY
2001, but has since expanded Hepatitis C Virus screening.
visit to the Syracuse, New York VAMC found similar concerns
about expenses. Syracuse
providers expressed concerns about the cost of lab tests for
Hepatitis C Virus. As a result
of these concerns, Syracuse patients were screened for Hepatitis C Virus in
primary clinics on a rotating basis, one clinic per day.
A second reason for the low rate of
screening and testing veterans for Hepatitis C Virus is attributed to
weaknesses in facilities’ risk assessment procedures.
GAO is concerned the screening process may discourage
veterans from being candid about risky behaviors.
Veterans are asked a series of questions relating to
their sexual practices and drug and alcohol history which some
may find invasive and embarrassing.
If a patient admits to a risk factor, the provider will
order testing. However,
if a patient is not forthcoming about risk factors, providers
will not test the patient unless the patient requests to be
tested. GAO also
found instances of screening for risk factors being conducted
near public areas where a veteran’s answers might be
routine administration of the Hepatitis C Virus questionnaire amidst other
screening procedures may also result in veterans not
understanding the risk factors.
A third factor why many veterans remain
undiagnosed, according to GAO, is weakness in
GAO found instances of blood tests never ordered, or
never completed, for veterans with risk factors.
In order to improve screening
performance, GAO is expected to recommend VA set performance
targets to convince providers Hepatitis C Virus screening and testing is a
high priority, and that VA provide definitive implementation
guidelines regarding who should be screened and how screenings
should be conducted.
Hearing witnesses from the VA will be
asked what incentives are in place to encourage providers to
increase the number of patients screened for Hepatitis C Virus risk factors.
VA is anticipated to testify the installation of the
clinical reminder software will encourage providers to screen
patients for Hepatitis C Virus risk factors.
However, while VA mandated clinical reminder software
be installed by July 30, 2000, GAO found many instances where
facilities were slow to turn on the software.
Why weren’t VA personnel made aware of the funding
available for screening and testing veterans for Hepatitis C?
cost of testing and treating patients for Hepatitis C Virus is high.
Post (1/27/99) quoted Dr. Kenneth Kizer, then the VA’s
top doctor, as saying the new testing and treatment program
will be a controversial “big ticket item” costing $12,000
to $15,000 per year per patient, or $250 million to $300
million in FY 1999 alone, and as much as $500 million in
is a huge cost that is involved,” Kizer was quoted as
acknowledge it, but I don’t know what choice we have.”
3, p. 3)
believe providers are reluctant to test patients for fear the
resources and funding for treatment will not be available.
These concerns were raised by Mr. James J. Farsetta,
Director of Veterans Integrated Service Network (VISN) Region
III in a Subcommittee hearing on June 9, 1999 entitled,
“VA Outreach to Veterans at Risk for Hepatitis C
Farsetta stated his treating clinicians for Hepatitis C were
“troubled not by today, but by the uncertainty about
tomorrow, that when you engage in screening and make a
diagnosis and treatment, then you are really ethically
committed to provide that treatment.
And do we want to engage a population that we are not
quite certain that we are going to have the wherewithal to
treat 6 months from today when we know the treatment is 48
weeks. So it is
(Web Resource 3)
The Congress responded to concerns
about the cost of testing and treating VA patients for Hepatitis C Virus by
appropriating $195 million in FY 2000 and $340 million for Hepatitis C Virus
expenses in FY 2001. For
FY 2000, the Veterans Health Administration (VHA) included
Hepatitis C funds in the general medical care resource
distributions process, without distinguishing how much was
specifically allocated for screening and treatment for Hepatitis C Virus.
As a result of this, GAO found network budget officers,
medical managers and clinical staff were not aware VA had
allocated $21 million in funding for Hepatitis C Virus screening and testing
for FY 2000. Those
VA employees who thought funds were available did not know how
much funding was available.
It was not until June 2000
when VA released $20 million from the National Reserve Fund to
the Veterans Integrated Service Networks (VISNs) based on each
network’s Hepatitis C costs during the first two quarters of
FY 2000, that managers and providers became aware of funding
for Hepatitis C Virus costs. It
is for this reason some believe funding for Hepatitis C Virus expenses
should be earmarked and separate from the general medical care
resource distribution process.
VA spent $14 million of the
$21 million budgeted for Hepatitis C Virus screening and testing in FY 2000. VA believes the shortfall may be attributable to the use of
“untested assumptions” in budget estimates regarding the
number of veterans who would need to be screened for Hepatitis
C. Or, the number
screened may be underreported due to inadequate data systems.
(Attachment 9 p. 3)
reasons do not explain why VA has still not been able to test
more than 20% of patients using VA health facilities.
There are also concerns as to why VA
did not make it a point to notify networks of the funds
available to screen and test patients for Hepatitis C Virus, since VA was
aware network directors and providers were concerned about
costs. VA has
acknowledged concerns for Hepatitis C Virus costs may effect the screening
of patients. This was noted in VA’s White Paper to Inform Congress on
Decisions for Hepatitis C Funding in which VA stated, “we
cannot be certain that local choices regarding allocation of
available resources amongst a number of critical patient care
areas have not created potential disincentives to the
diagnosis and treatment of hepatitis C infection.” (Attachment 2, p. 3)
VA Information Letter, “Hepatitis C: Standards for Provider
Evaluation & Testing
Department of Veterans Affairs, “White Paper to Inform
Congress on Decision for Hepatitis C Funding” 2001.
VA Press Release, “VA launches Broad Attack on Hepatitis C
Epidemic,” and Washington Post article, “VA Offers New Hepatitis C Drugs”
VHA Directive 2000-019, “Installation of Clinical Reminders
1.5 Software” (7/19/00).
VHA Directive 2001-009, “National Hepatitis C Program”
“Screening Veterans for Hepatitis C Virus Infection” and “Hepatitis C Virus Risk
Factor Assessment (Sample).”
“Hepatitis C Virus Antibody Screening Flow Chart for the
Letter to Chairman Shays from Dr. Garthwaite on additional
funding for selected VISNs to supplement approved budgets for
the Hepatitis C testing and treatment programs (6/28/00).
GAO testimony before the Subcommittee on VA, HUD, and
Independent Agencies, Committee on Appropriations.
“Veterans’ Health Care: Observations on VA’s
Assessment of Hepatitis C Budgeting and Funding” GAO-01-661T
“Hepatitis C: A Challenge To Public Health.”
VA’s Centers of Excellence in
Hepatitis C Research and Development website .
Subcommittee on National Security, Veterans Affairs and
International Relations hearing transcript. “VA Outreach to
Veterans At Risk For Hepatitis C Infection” June 9, 1999.
Serial No. 106-30.