VA Health Care
Improvements Needed in Hepatitis C Disease Management Practices Gao ID: GAO-03-136 January 31, 2003In 1998, the Department of Veterans Affairs (VA) launched an initiative to screen and test veterans for hepatitis C--a chronic blood-borne virus that can cause potentially fatal liver-related conditions. Since 2001, GAO has been monitoring VA's hepatitis C program. This year GAO was asked to report on VA's hepatitis C disease management practices. GAO surveyed 141 VA medical facilities about their processes for notifying veterans concerning hepatitis C test results and evaluating veterans' medical conditions regarding potential treatment options. In addition, GAO reviewed medical records of 100 hepatitis C patients at 1 facility and visited 4 other facilities that used unique hepatitis C disease management processes.
There is considerable variation among VA facilities in the time it takes to notify veterans that they have hepatitis C. For example, 29 VA medical facilities estimated that veterans were typically notified within 7 days of testing while 16 estimated that notification times exceeded 60 days. At facilities with longer notification times, primary care providers generally notified veterans at their next regularly scheduled appointments--sometimes more than 4 months away. In contrast, facilities with shorter notification times generally scheduled special appointments focused on hepatitis C notification or notified veterans by telephone or mail. Longer notification times increase the risk that veterans may unknowingly infect others or continue to engage in behaviors, such as alcohol use, that could accelerate the damaging effects of hepatitis C on their livers. VA medical facilities also varied considerably in the time that veterans must wait before physician specialists evaluate their medical conditions concerning hepatitis C treatment recommendations. For example, 23 facilities estimated that veterans waited 30 days or less for appointments with physician specialists while 52 facilities estimated that veterans waited over 60 days. At facilities with longer waiting times, primary care providers frequently referred all veterans to physician specialists for evaluations. In contrast, facilities with shorter waiting times often relied on nonspecialists, such as primary care providers, to conduct initial hepatitis C evaluations, referring only those with certain conditions, such as liver injury, to specialists for additional evaluations.
RecommendationsOur recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
Director: Team: Phone:GAO-03-136, VA Health Care: Improvements Needed in Hepatitis C Disease Management Practices
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Report to the Chairman, Subcommittee on National Security, Veterans
Affairs, and International Relations, Committee on Government Reform,
House of Representatives:
United States General Accounting Office:
GAO:
January 2003:
VA Health Care:
Improvements Needed in Hepatitis C Disease Management Practices:
GAO-03-136:
GAO Highlights:
Highlights of GAO-03-136, a report to the Chairman, Subcommittee on
National Security, Veterans Affairs, and International Relations,
Committee on Government Reform, House of Representatives:
January 2003:
VA Health Care:
Improvements Needed in Hepatitis C Disease Management Practices:
Why GAO Did This Study:
In 1998, the Department of Veterans Affairs (VA) launched an
initiative to screen and test veterans for hepatitis C”a chronic
blood-borne virus that can cause potentially fatal liver-related
conditions. Since 2001, GAO has been monitoring VA‘s hepatitis C
program. This year GAO was asked to report on VA‘s hepatitis C
disease management practices. GAO surveyed 141 VA medical facilities
about their processes for notifying veterans concerning hepatitis C
test results and evaluating veterans‘ medical conditions regarding
potential treatment options. In addition, GAO reviewed medical
records of 100 hepatitis C patients at 1 facility and visited 4 other
facilities that used unique hepatitis C disease management processes.
What GAO Found:
There is considerable variation among VA facilities in the time it
takes to notify veterans that they have hepatitis C. For example,
29 VA medical facilities estimated that veterans were typically
notified within 7 days of testing while 16 estimated that notification
times exceeded 60 days. At facilities with longer notification times,
primary care providers generally notified veterans at their next
regularly
scheduled appointments”sometimes more than 4 months away. In contrast,
facilities with shorter notification times generally scheduled special
appointments focused on hepatitis C notification or notified veterans
by telephone or mail. Longer notification times increase the risk
that
veterans may unknowingly infect others or continue to engage in
behaviors,
such as alcohol use, that could accelerate the damaging effects of
hepatitis
C on their livers.
VA medical facilities also varied considerably in the time that
veterans must wait before physician specialists evaluate their medical
conditions concerning hepatitis C treatment recommendations. For
example, 23 facilities estimated that veterans waited 30 days or
less
for appointments with physician specialists while 52 facilities
estimated
that veterans waited over 60 days. At facilities with longer waiting
times,
primary care providers frequently referred all veterans to physician
specialists for evaluations. In contrast, facilities with shorter
waiting
times often relied on nonspecialists, such as primary care providers,
to
conduct initial hepatitis C evaluations, referring only those with
certain
conditions, such as liver injury, to specialists for additional
evaluations.
Figure:
[See PDF for image]
Source: GAO:
Note: This information from our survey of VA medical facilities.
Of the
141 surveyed facilities, 18 used providers other than physician
specialists
to perform evaluations.
What GAO Recommends:
GAO recommends that VA direct facilities to make special
arrangements
to notify veterans about hepatitis C test results when veterans‘
next
scheduled appointments are longer than 30 days away and to ensure
that
providers are promptly alerted about test results. In addition,
GAO
recommends that VA encourage facilities to increase reliance on
primary
care providers and other nonspecialists to initially evaluate the
medical
condition of hepatitis C-infected veterans while continuing to
consult
with specialists, when appropriate. VA concurred with these
recommendations.
www.gao.gov/cgi-bin/getrpt?GAO-03-136.
To view the full report, including the scope and methodology,
click
on the link above. For more information, contact Cynthia A.
Bascetta,
(202) 512-7101.
Contents:
Letter:
Results in Brief:
Background:
Hepatitis C Notification Time Frames Vary:
Evaluations of Medical Conditions of Veterans with Hepatitis C
Hampered
by Waits for Physician Specialist Appointments:
Conclusions:
Recommendations for Executive Action:
Agency Comments:
Appendix I: Scope and Methodology:
Appendix II: Comments from the Department of Veterans
Affairs:
Appendix III: GAO Contact and Staff Acknowledgments:
Figures:
Figure 1: 101 VA Facilities‘ Estimated Typical Time Frames for
Notifying Veterans That They Have Hepatitis C:
Figure 2: Reasonable Time Frames to Notify Veterans of Hepatitis C Test
Results Reported by VA Medical Facilities:
Figure 3: Time to Inform Veterans That They Had Hepatitis C at the
Washington, D.C., VA Medical Facility:
Figure 4: VA Facilities‘ Estimated Typical Waiting Times for
Appointments with Physician Specialists:
Figure 5: Waiting Times for Veterans to See Physician Specialists at
the Washington, D.C., VA Medical Facility:
Abbreviations:
ALT: alanine aminotransferase:
NIH: National Institutes of Health:
VA: Department of Veterans Affairs:
Letter:
January 31, 2003:
The Honorable Christopher Shays
Chairman
Subcommittee on National Security, Veterans Affairs,
and International Relations
Committee on Government Reform
House of Representatives:
Dear Mr. Chairman:
Hepatitis C is a chronic blood-borne virus that can cause potentially
fatal liver-related conditions. In 1998, the Department of Veterans
Affairs (VA) launched a major initiative to screen all veterans who
received care in its health care system for hepatitis C risk factors
and conduct diagnostic blood tests for those at risk of infection.
Since 1999, VA included a total of $700 million in budgets submitted to
the Congress to screen and test veterans, as well as treat those with
hepatitis C. In fiscal year 2002, VA expected about 4.7 million
veterans to use its health care system. VA reports that its initiative
had identified almost 160,000 veterans infected with hepatitis C as of
the end of fiscal year 2002.
Since 2001, we have been monitoring VA‘s efforts to screen, test, and
treat veterans with hepatitis C. Unless tested, veterans infected with
the virus could unknowingly spread it to others. Once diagnosed,
veterans face complex decisions about the best course of treatment they
should follow to protect their health. Last year, we testified before
your subcommittee that VA missed opportunities to screen and test many
veterans for hepatitis C when they visited VA‘s medical
facilities.[Footnote 1] In response to our work, VA has begun to
improve screening and testing procedures. Subsequent to the hearing,
you asked us to focus on VA‘s efforts to
(1) notify veterans concerning their hepatitis C test results and (2)
evaluate veterans‘ medical conditions regarding potential treatment
options.
To do our work, we surveyed 141 VA medical facilities (accounting for
the care provided at most of VA‘s 1,013 health care delivery locations)
about their hepatitis C notification and disease management processes.
We also conducted a case study at VA‘s Washington, D.C., medical
facility, including a review of 100 medical records of patients who
tested positive for hepatitis C during the first 6 months of fiscal
year 2001. We visited 4 other VA facilities that, in response to our
survey, reported unique processes for notifying veterans and evaluating
their medical conditions when making treatment decisions. In addition,
we interviewed representatives from veterans‘ advocacy groups and the
American Liver Foundation to gain their perspectives on the timeliness
and adequacy of VA‘s notification and disease management processes. For
a complete description of our scope and methodology, see appendix I.
Our review was conducted from July 2001 through January 2003 in
accordance with generally accepted government auditing standards.
Results in Brief:
There is considerable variation among VA facilities in the time it
takes to notify veterans that they have hepatitis C. For example, in
response to our survey, 29 facilities estimated that veterans are
typically notified within 7 days after test results are available,
while 16 estimated that notification times exceeded 60 days. At
facilities with longer notification times, primary care providers
generally notified veterans at their next regularly scheduled
appointments, which, in some cases, were more than 4 months away. In
contrast, at most facilities with shorter notification times, providers
generally scheduled special appointments focused on hepatitis C
notification, or notified veterans by telephone or mail. Longer
notification times increase the risk that veterans may unknowingly
infect others or continue to engage in behaviors, such as alcohol use,
that could accelerate the damaging effects of hepatitis C on their
livers.
There is also considerable variation among VA facilities in the time
that veterans must wait before physician specialists evaluate their
medical condition concerning hepatitis C treatment recommendations. For
example, in response to our survey, 23 facilities estimated that
veterans waited 30 days or less while 52 facilities estimated that
veterans waited over 60 days, including 26 that had waits exceeding 90
days. At facilities with longer waiting times, primary care providers
frequently referred all veterans to physician specialists for
evaluations. In contrast, facilities with shorter times (30 days or
less) usually relied on nonspecialists to evaluate patients. In these
cases, primary care physicians, nurses, or nurse practitioners
evaluated veterans and referred only selected veterans, such as those
with liver injury or those who were candidates for antiviral drug
therapy, to specialists.
We are recommending that VA direct facilities to use special
arrangements to notify veterans when veterans‘ next scheduled
appointments are longer than 30 days away and to ensure that providers
are promptly alerted about test results. In addition, we recommend that
VA develop referral guidelines to encourage the use of nonspecialists
to conduct initial evaluations of veterans diagnosed with hepatitis C,
while continuing to consult with specialists, when appropriate. VA
concurred with our recommendations.
Background:
Hepatitis C was first recognized as a unique disease in 1989. It is the
most common chronic blood-borne infection in the United
States.[Footnote 2] The virus causes a chronic infection in 85 percent
of cases. Undiagnosed hepatitis C can eventually lead to liver cancer;
cirrhosis (scarring of the liver); or end-stage liver disease, which is
the leading indication for liver transplantation.[Footnote 3] While
hepatitis C antibodies generally appear in the blood within 3 months of
infection, it can take 15 years or longer for the infection to develop
into cirrhosis. Blood tests to detect the antibody, which became
available in 1992, helped to virtually eliminate risk of infection
through blood transfusions and curb the spread of the virus. However,
many were already infected and, because they had no symptoms, were
unaware of their infection.
Early detection of hepatitis C is important for several reasons. First,
undiagnosed persons miss opportunities to safeguard their health. Those
who have hepatitis C infections could unknowingly behave in ways that
speed the progression of the disease. For example, alcohol use can
hasten the onset of cirrhosis and liver failure. Vaccinations prevent
those with hepatitis C from contracting hepatitis A and B, other
infections that could further damage the liver. Second, persons
carrying the virus pose a public health threat because they could
infect others. Specifically, as a blood-borne virus, hepatitis C can be
spread to family members through sharing of razors; to health care
workers through blood exposure, such as needlestick injuries; and to
others who come in contact with contaminated blood, such as intravenous
drug abusers.
In the last few years, considerable research has been done concerning
hepatitis C. The National Institutes of Health (NIH) held a consensus
development conference on hepatitis C in 1997 to assess the methods to
diagnose, treat, and manage hepatitis C. NIH convened a second
hepatitis C consensus development conference in June 2002[Footnote 4]
that reviewed the most recent developments in the management of the
disease and the treatment options available and identified directions
for future research. This panel concluded that there have been
substantial advances in the effectiveness of antiviral drug therapy for
chronic hepatitis C.
VA‘s Public Health Strategic Healthcare Group coordinates VA‘s
hepatitis C program, which calls for universal screening of veterans
when they visit VA facilities for routine medical services and
conducting blood tests for veterans identified by the screening as
being at risk[Footnote 5] or who want to be tested. VA has developed
guidelines intended to assist health care providers who screen, test,
and counsel patients for hepatitis C. Providers are to educate veterans
about their risk of acquiring hepatitis C, notify veterans of hepatitis
C test results, and provide education to those infected with the virus
to help facilitate behavior changes to reduce veterans‘ risk of
transmitting hepatitis C. In addition, providers are to evaluate the
medical condition of those diagnosed with hepatitis C. An evaluation
could include a medical history, blood tests to measure liver functions
and virus genotype or strain, and a liver biopsy. VA has also developed
guidance for providers to use when conducting such evaluations based on
recommendations of NIH and the Centers for Disease Control and
Prevention.
Through such evaluations, providers are to identify veterans who have
the greatest risk of progressive liver disease--abnormal alanine
aminotransferase (ALT) blood tests or liver biopsies showing
fibrosis[Footnote 6]--and who may benefit from an antiviral therapy
regimen consisting of injections of interferon plus ribavirin (an oral
antiviral agent) capsules. The effectiveness of this therapy to rid--
’clear“--a patient of the virus has been shown to vary from a 30 to 80
percent success rate depending on the genotype of the virus, the extent
of the infection, and the type of interferon used. Genotype 1, the most
common genotype found in VA patients, is the genotype least responsive
to antiviral therapy. The recommended duration of antiviral therapy for
patients with genotype 1 is 48 weeks compared to 24 weeks for patients
with other genotypes.
Also, providers‘ evaluations are expected to identify veterans with
hepatitis C who are not considered to be candidates for antiviral
therapy because they have co-morbid conditions that contraindicate
therapy. Veterans with coronary artery disease, uncontrolled diabetes,
or chronic obstructive pulmonary disease, for example, are often not
candidates for antiviral therapy because of the reduced life expectancy
from the underlying co-morbid condition in addition to the potential
for increased side effects from antiviral therapy. In addition,
veterans with active drug or alcohol abuse may not be candidates for
antiviral therapy because of potential toxic effects of the antiviral
therapy and compliance problems with the antiviral regimen, which
requires adherence to a regular schedule of interferon injections and
doses of ribavirin. Additionally, interferon-based therapies may worsen
the psychological problems of patients with uncontrolled, severe
psychiatric disorders--particularly depression and suicide risk.
However, the recent NIH consensus conference expanded the scope of
patients eligible for treatment to include some patients with substance
abuse problems.
Providers may also recommend watchful waiting--monitoring the disease
status without antiviral treatment--because the risks of drug therapy
outweigh the potential benefits. Antiviral drugs have severe side
effects, such as depression, flu-like symptoms, and intense itching,
which patients sometimes find unbearable. Providers may make such a
recommendation to older veterans with slowly advancing disease and
minimal liver injury and encourage those veterans to lead healthy
lifestyles and receive periodic liver evaluations to assess the
progression of their disease. In these cases, if the disease advances,
a more effective antiviral therapy may have become available or the
patient‘s health may be at a point where it may be worth the risk of
undergoing drug therapy.
Hepatitis C Notification Time Frames Vary:
There is considerable variation among VA facilities in the time it
takes to notify veterans that they have hepatitis C. Systemwide, 71
facilities, in response to our survey, estimated typical notification
time frames of 30 days or less, including 29 facilities with estimates
of 7 days or less. In contrast, 30 facilities estimated that
notification typically took longer than 30 days, including 7 facilities
that estimated time frames of 90 days or longer.[Footnote 7] (See fig.
1.):
Figure 1: 101 VA Facilities‘ Estimated Typical Time Frames for
Notifying Veterans That They Have Hepatitis C:
[See PDF for image]
Note: This information is from our survey of VA medical facilities.
[End of figure]
VA has delegated responsibility for establishing a hepatitis C
notification process to local facilities, including when veterans will
be notified. VA hepatitis C guidance suggests that providers schedule a
return date for veterans to meet with them to discuss hepatitis C test
results, but does not designate a time frame within which veterans
should be notified of their hepatitis C test results. Also, VA does not
specifically require facilities to monitor notification of veterans
concerning their hepatitis C test results.
In addition, most facilities do not provide guidance to their providers
regarding notification time frames, responding to our survey that
notification was left to provider discretion. However, when we asked
facilities what would be a reasonable time frame for notifying
veterans, 112 of 136 survey respondents (about 80 percent) reported
that veterans should be notified in 30 days or less from the day the
hepatitis C test results are available. [Footnote 8] (See fig. 2.):
Figure 2: Reasonable Time Frames to Notify Veterans of Hepatitis C Test
Results Reported by VA Medical Facilities:
[See PDF for image]
Note: This information is from our survey of VA medical facilities. Of
the 141 surveyed facilities, 136 responded to this question.
[End of figure]
Facilities estimating longer notification times (over 30 days)
generally relied on primary care providers to notify veterans at their
next regularly scheduled appointments, often more than 30 days away
and, in some cases, longer than 4 months away. At our case study
facility--Washington, D.C.--we analyzed medical records of veterans who
tested positive for hepatitis C from October 1, 2000, through March 31,
2001. Our analysis of 100 medical records showed that although many
veterans were notified in 30 days or less, it took longer than 30 days
to notify over half. Thirty-two of these veterans had to wait over 90
days to be notified. (See fig. 3.):
Figure 3: Time to Inform Veterans That They Had Hepatitis C at the
Washington, D.C., VA Medical Facility:
[See PDF for image]
Note: This information is from our analysis of medical records sampled
from the universe of veterans who tested positive for hepatitis C from
October 1, 2000, through March 31, 2001, at the Washington, D.C.,
facility. At the time of our review (fall 2001), the 32 veterans whose
notification took longer than 90 days included 19 veterans who had
waited 256 to 425 days without being notified. We provided the
Washington, D.C., facility with the names of these veterans so that
they could be notified.
[End of figure]
Headquarters officials told us that providers may wait to notify
veterans at their next regular appointments because hepatitis C is a
slowly advancing disease, and as such, waiting until the next
appointments should not significantly affect veterans‘ medical
conditions. In the meantime, however, veterans with hepatitis C could
unknowingly infect others or continue to engage in behaviors, such as
alcohol use, that could accelerate the damaging effects of hepatitis C
on their livers.
In contrast, most of the 29 facilities with the shortest estimated
notification times--7 days or less--generally established special
processes for notifying veterans, rather than waiting until the next
regularly scheduled appointments. For example, providers at 4
facilities scheduled special appointments to discuss hepatitis C test
results with veterans, and providers at 17 facilities notified veterans
by telephone or mail. To facilitate these special processes, these
facilities also made other adjustments. For example, 16 facilities used
a computerized ’alert“ system that reminds providers to notify veterans
as soon as the providers log onto VA‘s computerized patient record
system and before they access individual patient records. This system
proactively reminds primary care providers to notify veterans.
Previously, hepatitis C test results were placed in a patient‘s medical
record, and providers would only learn the results by accessing the
record, which was generally only done at the time of the veteran‘s next
regularly scheduled visit.[Footnote 9]
In addition, 6 of the 29 facilities with shorter time frames
established special systems whereby the laboratory notified a
designated person directly of the hepatitis C test results. For
example, the San Francisco facility has a full-time registered nurse
who each week receives a list of veterans--directly from the
laboratory--whose hepatitis C test results are available. She attempts
to notify these veterans by telephone. If unsuccessful, she tries to
notify the veterans in person at upcoming appointments in outpatient
clinics. If the nurse is unable to notify a veteran, she documents this
in the veteran‘s medical record and e-mails the veteran‘s primary care
provider to make him or her aware that the veteran has not yet been
notified. She told us that it could be difficult to notify veterans who
are homeless or who do not have telephones.
About one-third of the 141 surveyed facilities have established
oversight processes to monitor providers‘ notification performance. For
example, the hepatitis C coordinator at the Wilmington VA facility
receives all hepatitis C test results directly from the laboratory and
checks the medical records of veterans with hepatitis C, reminding
primary care providers to notify veterans if records indicate that
veterans were not notified. Since the start of our medical record
review, our Washington, D.C., case study site has modified its
notification processes and has hired a hepatitis C coordinator who
monitors primary care providers‘ notification of veterans to ensure
that all veterans found to be infected with hepatitis C are notified.
Evaluations of Medical Conditions of Veterans with Hepatitis C Hampered
by Waits for Physician Specialist Appointments:
Almost all VA medical facilities involved physician
specialists[Footnote 10] in evaluating veterans with hepatitis C to
determine a treatment recommendation, but waiting times for
appointments with physician specialists varied considerably. Twenty-
three facilities, in response to our survey, estimated that veterans
typically waited 30 days or less for appointments with physician
specialists. By contrast, 100 facilities estimated that veterans
typically waited more than VA‘s 30-day standard to see physician
specialists including 26 that had waits exceeding 90 days. (See fig.
4.):
Figure 4: VA Facilities‘ Estimated Typical Waiting Times for
Appointments with Physician Specialists:
[See PDF for image]
Note: This information is from our survey of VA medical facilities. Of
the 141 surveyed facilities, 18 used providers other than physician
specialists to perform evaluations.
[End of figure]
Moreover, the level of involvement of physician specialists in
evaluating veterans to determine treatment recommendations for veterans
diagnosed with hepatitis C varies by facility. For example, 62
facilities refer all veterans diagnosed with hepatitis C to physician
specialists to decide whether antiviral therapy should be started. By
contrast, it is the customary practice at most other facilities
surveyed to refer only certain veterans diagnosed with hepatitis C for
specialists to evaluate, such as those with evidence of liver injury or
those who were candidates for antiviral drug therapy.
Since 1999, VA‘s efforts to screen and test all veterans for hepatitis
C have significantly increased the volume of veterans who need
physician specialist appointments, therefore creating a bottleneck at
many specialty clinics. This is especially true for the 62 facilities
that refer all veterans with hepatitis C to physician specialists--80
percent of which estimated waiting times exceeding 30 days. For
example, at Washington, D.C., where it is the customary practice to
refer all veterans with hepatitis C to physician specialists, our
analysis of medical records of 69[Footnote 11] veterans who were
notified that they had hepatitis C and should have been referred to
physician specialists showed that only 2 veterans received appointments
with physician specialists within VA‘s 30-day standard for a specialty
appointment. Sixty-one veterans waited longer than 60 days, and we
could find no evidence that 13 of these veterans ever received
appointments with physician specialists to begin the evaluation
process. (See fig. 5.):
Figure 5: Waiting Times for Veterans to See Physician Specialists at
the Washington, D.C., VA Medical Facility:
[See PDF for image]
Note: This information is from our analysis of medical records sampled
from the universe of veterans who tested positive for hepatitis C from
October 1, 2000, through March 31, 2001, at the Washington, D.C.,
facility. At the time of our review (fall 2001), the 36 veterans who
waited over 90 days for appointments included 13 veterans for whom we
could find no evidence of appointments with physician specialists.
[End of figure]
However, some facilities with shorter waiting times have found that it
is not necessary for all veterans diagnosed with hepatitis C to see
physician specialists and have assigned responsibility for hepatitis C
evaluations to additional providers--not just physician specialists.
Sixteen of the 23 facilities estimating waiting times of 30 days or
less indicated that primary care providers or hepatitis C coordinators-
-often nurses or nurse practitioners--evaluate hepatitis C patients to
determine who should be referred to physician specialists. For example,
at the San Francisco facility, a nurse practitioner is responsible for
evaluating all veterans diagnosed with hepatitis C except those whose
disease is very complex, whom she refers to a physician
specialist.[Footnote 12] At the Boston VA facility, primary care
providers order diagnostic tests so that results are available when
veterans diagnosed with hepatitis C receive evaluations by the
hepatitis C coordinator--a physician assistant. She evaluates veterans
with guidance from the physician specialist. Likewise, the hepatitis C
coordinator at the Wilmington facility, a nurse practitioner, evaluates
all veterans with hepatitis C, referring only those with more complex
symptoms to the physician specialist.
Conclusions:
VA has invested considerably in its efforts to identify and treat
veterans with hepatitis C. However, there is wide variation across VA
in the time it takes to notify and recommend a course of action for
veterans with hepatitis C. When veterans are not promptly notified that
they have hepatitis C, they could unknowingly spread the disease to
others or engage in activities, such as alcohol use, that could worsen
the effect of hepatitis C on their livers. In addition, many veterans
must wait too long for their disease to be evaluated by physician
specialists.
VA can look to successes within its own system to improve processes and
timeliness outcomes systemwide. Promoting best practices for notifying
veterans about their hepatitis C test results would encourage providers
to think of alternate ways of notifying veterans--such as by telephone
or mail--when a veteran‘s next scheduled appointment is more than 30
days away. Other best practices such as the use of a computerized alert
reminding providers to notify veterans would further improve VA‘s
hepatitis C program. Likewise, using clinical guidelines to help
providers other than physician specialists evaluate certain veterans
with hepatitis C would shorten the time that veterans wait to learn
what may be the best course of treatment for their disease. In
addition, using providers other than physician specialists could help
better allocate the expertise of physician specialists across VA
locations. Systemwide use of such best practices that are already being
used successfully at some VA facilities would benefit all veterans.
Recommendations for Executive Action:
To continue to improve the management of hepatitis C, we recommend that
the Secretary of Veterans Affairs direct the Under Secretary for Health
to:
* direct facilities to use special arrangements, such as mail or
telephone when appropriate, to notify a veteran rather than waiting
until the next regularly scheduled visit if it is more than 30 days
away;
* direct facilities to modify their computerized patient record systems
so that providers are alerted to positive hepatitis C test results as
soon as possible; and:
* help facilities improve the timeliness of evaluations for veterans
diagnosed with hepatitis C by encouraging facilities to use
nonspecialists to conduct initial evaluations, and develop clinical
guidelines for when to refer veterans to physician specialists for
additional consultations.
Agency Comments:
In commenting on a draft of this report, VA agreed with our findings
and conclusions and concurred with our recommendations. VA‘s letter is
reprinted in appendix II.
Regarding timely notification of veterans, VA identified several
activities that are expected to improve performance in this area. These
include collecting data on notification times systemwide, investigating
notification issues, and piloting electronic reminder systems to
encourage providers to make prompt notifications. VA mentions that it
is considering a directive from the Under Secretary for Health to more
effectively target the specific settings and circumstances in which
notification is delayed.
Regarding notifications to providers, VA has informed facilities that a
system for calling a clinician‘s attention to diagnostic test results
is a high priority because hepatitis C testing is frequently done in
outpatient settings on patients who appear clinically well. Because of
the diversity of its facilities, VA suggested three possible methods
for ensuring prompt notifications: (1) laboratories generating phone
calls to providers,
(2) facilities modifying their computerized patient record systems so
that providers are alerted to positive hepatitis C test results as soon
as possible, or (3) laboratories reporting all test results to a single
designated individual, such as a hepatitis C coordinator, primary care
case manager, or another locally designated individual. The designated
individual has responsibility for ensuring that patients with positive
test results are notified and that proper clinical assessments take
place. VA noted that the optimal process will vary depending on local
workload, resources, and environment. VA describes these methods in the
Under Secretary for Health‘s Information Letter (mentioned in VA‘s
letter as enclosure 2), which is available on the Web at www.va.gov/
publ/direc/health/infolet/10200219.pdf.
Regarding the use of nonspecialists to conduct initial evaluations and
development of clinical guidelines for referral to physician
specialists, VA stated that it has developed an educational program for
primary care providers regarding the initial evaluation of hepatitis C
patients as well as a training program to improve the skill of
providers who work with liver specialists. In addition, VA is
developing templates to standardize and streamline referral to
specialists when appropriate. To measure the effect of these efforts,
VA has begun to collect data on the time between a positive test and
the point at which a disease management decision is made.
As agreed with your office, unless you publicly announce its contents
earlier, we will plan no further distribution of this report until 30
days after its date. At that time, we will send copies to interested
congressional committees and other parties. We also will make copies
available to others upon request. In addition, the report will be
available at no charge on the GAO Web site at http://www.gao.gov. If
you or your staff have any questions about this report, please call me
at (202) 512-7101. Another contact and key contributors are listed in
appendix III.
Sincerely yours,
Cynthia A. Bascetta
Director, Health Care--Veterans‘
Health and Benefits Issues:
Signed by Cynthia A. Bascetta:
[End of section]
Appendix I: Scope and Methodology:
To achieve our objectives, we reviewed and analyzed the Department of
Veterans Affairs‘ (VA) hepatitis C program documents and guidance,
including VA‘s Hepatitis C Testing and Prevention Counseling Guidelines
and Treatment Recommendations for Patients with Chronic Hepatitis C. We
interviewed officials from VA‘s Public Health Strategic Healthcare
Group. We also reviewed and analyzed the current literature pertaining
to hepatitis C.
We conducted an E-mail survey to obtain information on hepatitis C
notification and disease management processes and practices throughout
the VA system, including evaluating veterans‘ medical conditions
regarding potential treatment options. We asked each of VA‘s 22
regional clinical managers to identify the provider most knowledgeable
about the hepatitis C program at each medical facility in his or her
region. We received the names of hepatitis C providers located in 141
VA medical facilities (accounting for the care provided at most of the
1,013 health care delivery locations within the VA system). We e-mailed
a survey to each identified provider. Our survey response rate was 100
percent, although not every location responded to each question.
We conducted a case study at VA‘s Washington, D.C., facility in the
fall of 2001 to understand the complexity of managing a hepatitis C
program. We interviewed primary care providers, liver clinic physician
specialists and nurses, the chief of laboratory services, and hospital
administrators. As part of our case study, we reviewed the medical
records of a sample of veterans who tested positive for hepatitis C for
the first time during the first 6 months of fiscal year 2001. We
selected our sample from a facility-provided list of 346 veterans who
had a positive hepatitis C test during this period. To ensure that we
examined an adequate number of veterans who had evidence of liver
damage (as measured by high levels of alanine aminotransferase (ALT)),
we separated the names into two groups--veterans with tests showing
high ALT levels (n=149) and those with tests showing normal levels
(n=197)--and randomly selected names from each group resulting in a
sample of 100 veterans: 53 with high ALT levels and 47 with normal ALT
levels. In reviewing the medical records, we discovered that some of
the veterans sampled had tested positive prior to October 1, 2000.
These veterans were excluded from our sample and other veterans were
randomly selected. This discrepancy in the sampling list and the
oversampling of the high ALT group may limit the generalizability of
our findings.
To obtain information about unique hepatitis C notification and disease
management processes that could serve as best practices, we conducted
site visits to 4 other VA facilities: San Francisco, Wilmington,
Boston, and Minneapolis. We selected these facilities based on their
responses to our survey. At each site we interviewed hepatitis C
physician specialists and coordinators and reviewed their hepatitis C
notification and disease management processes.
To gain their perspectives on the timeliness and adequacy of VA‘s
hepatitis C notification and disease management processes, we conducted
interviews with representatives from four veterans‘ advocacy groups:
American Legion, Vietnam Veterans of America, Veterans Aimed Toward
Awareness, and Disabled American Veterans. We also interviewed a
representative from the American Liver Foundation. Our review was
conducted from July 2001 through January 2003 in accordance with
generally accepted government auditing standards.
[End of section]
Appendix II: Comments from the Department of Veterans Affairs:
THE SECRETARY OF VETERANS AFFAIRS WASHINGTON:
December 30, 2002:
Ms. Cynthia Bascetta:
Director, Health Care-Veterans‘ Health and Benefits Issues:
U. S. General Accounting Office 441 G Street, NW Washington, DC 20548:
Dear Ms. Bascetta:
The Department of Veterans Affairs (VA) has reviewed your draft report,
VA HEALTH CARE: Improvements Needed in Hepatitis C Disease Management
Practices (GAO-03-136) and agrees with your findings and conclusions
and concurs with your recommendations. The Veterans Health
Administration (VHA) will continue to give priority attention to assure
that more timely notification of test results to both providers and
patients is achieved.
As the General Accounting Office (GAO) observed, VA has many positive
accomplishments in the field of hepatitis C counseling, testing, and
clinical care. Recent medical record reviews indicate that performance
in screening and testing meet or exceed established targets. VHA
continues to work diligently to ensure that quality of care is
consistent by developing comprehensive treatment recommendations,
implementing the new Hepatitis C Registry, offering extensive
educational programs, and creating the Hepatitis C Resource Center
Program.
The National Hepatitis C Program Office, the Hepatitis C Resource
Center Program, and the Employee Education Service are actively
involved in developing educational programs for clinical providers,
particularly regarding the initial evaluation of patients with
hepatitis C.In addition, the computerized medical record is being
enhanced to expedite both the patient notification and referral
processes.
Enclosure (1) describes actions VHA has taken as well as its plans to
improve its hepatitis C disease management. VHA is already engaged in
several activities to meet its improved notification goals. These
efforts include focused review by the External Peer Review Program to
identify better the extent of notification delays and electronic
reminder systems to encourage prompt notification and documentation of
results. Also, recently, VHA distributed a national Information Letter,
Enclosure (2), that provides suggested algorithms for the diagnosis of
hepatitis C and notification of related test results.
Thank you for the opportunity to comment on your draft report.
Sincerely yours,
Anthony J. Principi:
Signed by Anthony J. Principi:
Enclosure:
Enclosure 1:
DEPARTMENT OF VETERANS AFFAIRS‘:
COMMENTS TO GAO DRAFT REPORT VA HEALTH CARE: Improvements Needed in
Hepatitis C Disease Management Practices (GAO-03-136):
To continue to improve the management of hepatitis C, GAO recommends
that the Secretary of Veterans Affairs direct the Under Secretary for
Health to:
Direct facilities to use special arrangements, such as mail or
telephone when appropriate, to notify veterans rather than waiting
until the next regularly scheduled visit to notify them if the next
regularly scheduled visit is greater than 30 days;
Concur-The Veterans Health Administration (VHA) is engaged in several
activities to define better the identified problems with notification.
Beginning in fiscal year 2003, the External Peer Review Program (EPRP)
will collect data during chart reviews pertaining to the time between
testing and documentation of notification. The National Hepatitis C
Program Office is also partnering with the Office of the Medical
Inspector to investigate issues related to patients not being informed
in a timely manner of positive test results. In addition, the Hepatitis
C Resource Center Program, in coordination with VA‘s Office of
Information, is developing and piloting electronic reminder systems to
encourage prompt notification and better documentation of the
notification process. VHA believes that these activities will lead to
improved performance in this area. A directive from the Under Secretary
for Health is one possible solution that VHA will consider along with
others that may more effectively target the specific settings and
circumstances in which notification is delayed.
Direct facilities to modify their computerized patient record system so
that providers are alerted to positive hepatitis C test results as soon
as possible;
Concur - VHA agrees with GAO that this recommendation is a high
priority to improve its hepatitis C program. On December 13, 2002, the
Under Secretary‘s office distributed to field facilities an Information
Letter (IL 10-2002-019) that outlines diagnostic testing algorithms and
systems to ensure that providers are notified of test results. It
provides information on how to configure laboratory test file entries
so that they can trigger ’view alerts.“ Three possible notification
algorithms are suggested, all of which will accomplish the goal of
notifying providers promptlyBecause of the diversity of VA‘s system,
the optimal process will vary depending on local workload, resources
and environment. Adoption of any of the three algorithms of the
Information Letter will accomplish the goal that GAO recommended. The
Office of Information will continue to work with the clinical business/
program users to ensure that the information technology systems support
the notification process.
Help facilities improve the timeliness of evaluations for veterans
diagnosed with hepatitis C by encouraging facilities to use non-
specialists to conduct initial evaluations; and develop clinical
guidelines for when to refer to physician specialists for additional
consultations.
Concur - Recently, the National Hepatitis C Program Office, the
Hepatitis C Resource Center Program, and the Employee Education Service
developed an educational program for primary care and other front line
providers regarding the initial evaluation of patients identified with
hepatitis C. Pocket guides, slide presentations, and training notes are
being developed and will be distributed through local hepatitis C lead
clinicians for training non-specialists who test, counsel, and evaluate
patients with hepatitis C. In addition, the Hepatitis C Resource Center
Program is developing templates for use in the electronic medical
record to streamline and standardize the process of referral to liver
specialists when appropriate. Training programs are also being set up
to improve the skill of mid-level providers who work with liver
specialists so that their time may be better devoted to truly
specialized services. VA expects that all of these efforts will improve
timeliness and quality of initial evaluations. To support and measure
the effect of these efforts, EPRP is collecting data beginning in
fiscal year 2003 on the time between a positive test and the point at
which a disease management decision is made.
[End of section]
Appendix III GAO Contact and Staff Acknowledgments:
GAO Contact:
Paul Reynolds, (202) 512-7109:
Acknowledgments:
In addition to the contact named above, Cheryl Brand, Irene J. Barnett,
Frederick Caison, Deborah L. Edwards, Martha A. Fisher, Susan Lawes,
Gay Hee Lee, and Clare Mamerow made key contributions to this report.
FOOTNOTES
[1] U.S. General Accounting Office, Veterans‘ Health Care: Standards
and Accountability Could Improve Hepatitis C Screening and Testing
Performance, GAO-01-807T (Washington, D.C.: June 14, 2001).
[2] W. Ray Kim, MD. M.Sc., M.B.A., ’The Burden of Hepatitis C in the
United States,“ NIH Consensus Development Conference: Management of
Hepatitis C: 2002 (Bethesda, Md.: National Institutes of Health, 2002),
23.
[3] R. Cheung, ’Epidemiology of Hepatitis C Virus Infection in American
Veterans,“ The American Journal of Gastroenterology, vol. 95, no. 3
(March 2000), 740.
[4] NIH Consensus Development Conference, Management of Hepatitis C:
2002, June 2002. The 12-member consensus panel is an independent,
nonadvocate and nonfederal panel including representatives from
internal medicine, gastroenterology, infectious diseases, family
practice, and the public. The panel heard presentations from 28
hepatitis C experts and reviewed an extensive body of medical
literature and a report prepared by the Johns Hopkins University School
of Medicine Evidence-based Practice Center.
[5] VA identifies veterans at risk for hepatitis C infection as those
who have one or more of the following 11 risk factors: Vietnam-era
veteran; blood transfusion before 1992; past or present intravenous
drug use; unequivocal blood exposure of skin or mucous membranes;
history of multiple sexual partners; history of hemodialysis; tattoo or
repeated body piercing; history of intranasal cocaine use; unexplained
liver disease; unexplained/abnormal alanine aminotransferase, which is
an enzyme that is present in high concentration in the liver and other
organs; and intemperate or immoderate use of alcohol.
[6] Fibrosis is an increase in fibrous tissue in the liver that can
progress to a more severe stage called cirrhosis.
[7] Forty facilities did not estimate typical notification time frames
when responding to our survey. Many of these facilities told us they
did not know how long it typically took to notify veterans.
[8] In addition, we asked a representative from the American Liver
Foundation what would be a reasonable notification time frame, and he
suggested that 2 to 4 weeks would be a reasonable time frame within
which to notify veterans that they have hepatitis C.
[9] In addition to these 16 facilities, another 47 report that they use
the alert system to notify providers that hepatitis C results are
available for veterans whose tests are completed. Of these, 40 reported
notification times ranging from 8 to 30 days.
[10] We have used the term physician specialists to mean
gastroenterologists, hepatologists, and infectious disease
specialists, all of whom provide care for hepatitis C patients in the
VA health care system.
[11] We reviewed 100 medical records of veterans with hepatitis C.
Thirty-one veterans were not candidates for referral to physician
specialists because 19 were not notified that they had hepatitis C, 9
received evaluations from primary care physicians, and 3 stopped using
this VA facility. If a veteran received an appointment with a physician
specialist and did not keep it, we kept that veteran in the analysis
using the original appointment date.
[12] The nurse practitioner operates under a protocol set up by the
hepatologist, and a physician specialist approves all treatment
decisions that she makes. In cases where the hepatitis C is advanced,
the evaluation is conducted by the hepatologist.
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