VA Health Care: Improvements Needed in Hepatitis C Disease
Management Practices (31-JAN-03, GAO-03-136).
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.
-------------------------Indexing Terms-------------------------
REPORTNUM: GAO-03-136
ACCNO: A05909
TITLE: VA Health Care: Improvements Needed in Hepatitis C
Disease Management Practices
DATE: 01/31/2003
SUBJECT: Health care facilities
Infectious diseases
Veterans
Disease detection or diagnosis
******************************************************************
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GAO-03-136
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
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. Estimated
Waiting Times for Appointments with VA Physician Specialists for Hepatitis
C
Evaluations 010 20 30 40 50 0 - 30 days
31 - 60 days 61 - 90 days
> 90 days Estimated typical waiting time
Number of facilities estimating these times
26 23
48 26
Source: GAO. 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. VA HEALTH CARE
Improvements Needed in Hepatitis C Disease Management Practices
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. 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
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.
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.
Page i GAO- 03- 136 VA Hepatitis C Management Letter 1 Results in Brief 2
Background 3 Hepatitis C Notification Time Frames Vary 6 Evaluations of
Medical Conditions of Veterans with Hepatitis C Hampered by Waits for
Physician Specialist Appointments 10 Conclusions 13 Recommendations for
Executive Action 13 Agency Comments 14 Appendix I Scope and Methodology 16
Appendix II Comments from the Department of Veterans Affairs 18
Appendix III GAO Contact and Staff Acknowledgments 22
Figures
Figure 1: 101 VA Facilities* Estimated Typical Time Frames for Notifying
Veterans That They Have Hepatitis C 6 Figure 2: Reasonable Time Frames to
Notify Veterans of Hepatitis
C Test Results Reported by VA Medical Facilities 7 Figure 3: Time to
Inform Veterans That They Had Hepatitis C at the Washington, D. C., VA
Medical Facility 8 Figure 4: VA Facilities* Estimated Typical Waiting
Times for Appointments with Physician Specialists 10 Figure 5: Waiting
Times for Veterans to See Physician Specialists at the Washington, D. C.,
VA Medical Facility 12 Abbreviations
ALT alanine aminotransferase NIH National Institutes of Health VA
Department of Veterans Affairs Contents
Page 1 GAO- 03- 136 VA Hepatitis C Management 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. 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.
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).
United States General Accounting Office Washington, DC 20548
Page 2 GAO- 03- 136 VA Hepatitis C Management 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.
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
Results in Brief
Page 3 GAO- 03- 136 VA Hepatitis C Management 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.
Hepatitis C was first recognized as a unique disease in 1989. It is the
most common chronic blood- borne infection in the United States. 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 endstage
liver disease, which is the leading indication for liver transplantation.
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
bloodborne
virus, hepatitis C can be spread to family members through sharing of
razors; to health care workers through blood exposure, such as
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. Background
Page 4 GAO- 03- 136 VA Hepatitis C Management 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 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 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.
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.
Page 5 GAO- 03- 136 VA Hepatitis C Management 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 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,
interferonbased 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 6
Fibrosis is an increase in fibrous tissue in the liver that can progress
to a more severe stage called cirrhosis.
Page 6 GAO- 03- 136 VA Hepatitis C Management 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.
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. 7 (See fig. 1.)
Figure 1: 101 VA Facilities* Estimated Typical Time Frames for Notifying
Veterans That They Have Hepatitis C Note: This information is from our
survey of VA medical facilities. VA has delegated responsibility for
establishing a hepatitis C notification
process to local facilities, including when veterans will be notified. VA
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. Hepatitis C
Notification Time Frames Vary
Page 7 GAO- 03- 136 VA Hepatitis C Management 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. 8 (See fig. 2.)
Figure 2: Reasonable Time Frames to Notify Veterans of Hepatitis C Test
Results Reported by VA Medical Facilities
Note: This information is from our survey of VA medical facilities. Of the
141 surveyed facilities, 136 responded to this question.
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
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.
Page 8 GAO- 03- 136 VA Hepatitis C Management 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
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.
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
Page 9 GAO- 03- 136 VA Hepatitis C Management 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. 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.
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.
Page 10 GAO- 03- 136 VA Hepatitis C Management Almost all VA medical
facilities involved physician specialists 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
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.
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
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. Evaluations of
Medical Conditions of Veterans with Hepatitis C Hampered by Waits for
Physician Specialist Appointments
Page 11 GAO- 03- 136 VA Hepatitis C Management 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 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.) 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.
Page 12 GAO- 03- 136 VA Hepatitis C Management Figure 5: Waiting Times for
Veterans to See Physician Specialists at the Washington, D. C., VA Medical
Facility
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.
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. 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
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.
Page 13 GAO- 03- 136 VA Hepatitis C Management 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. 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.
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 Conclusions
Recommendations for Executive Action
Page 14 GAO- 03- 136 VA Hepatitis C Management 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. 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 Agency Comments
Page 15 GAO- 03- 136 VA Hepatitis C Management 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
Appendix I: Scope and Methodology Page 16 GAO- 03- 136 VA Hepatitis C
Management 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
facilityprovided 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
Appendix I: Scope and Methodology
Appendix I: Scope and Methodology Page 17 GAO- 03- 136 VA Hepatitis C
Management 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.
Appendix II: Comments from the Department of Veterans Affairs
Page 18 GAO- 03- 136 VA Hepatitis C Management Appendix II: Comments from
the Department of Veterans Affairs
Appendix II: Comments from the Department of Veterans Affairs Page 19 GAO-
03- 136 VA Hepatitis C Management
Appendix II: Comments from the Department of Veterans Affairs Page 20 GAO-
03- 136 VA Hepatitis C Management
Appendix II: Comments from the Department of Veterans Affairs Page 21 GAO-
03- 136 VA Hepatitis C Management
Appendix III: GAO Contact and Staff Acknowledgments
Page 22 GAO- 03- 136 VA Hepatitis C Management Paul Reynolds, (202) 512-
7109 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. Appendix
III: GAO Contact and Staff
Acknowledgments GAO Contact Acknowledgments
(290077)
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