This is the accessible text file for GAO report number GAO-03-136 
entitled 'VA Health Care: Improvements Needed in Hepatitis C Disease 
Management Practices' which was released on March 04, 2003.

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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 Ca chronic 

blood-borne virus that can cause potentially fatal liver-related 

conditions. Since 2001, GAO has been monitoring VAs hepatitis C 

program. This year GAO was asked to report on VAs 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 appointmentssometimes 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 VAs 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 VAs 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 VAs 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 VAs 1,013 health care delivery locations) 

about their hepatitis C notification and disease management processes. 

We also conducted a case study at VAs 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 VAs 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.

VAs Public Health Strategic Healthcare Group coordinates VAs 

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 

patients 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 VAs 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 patients medical 

record, and providers would only learn the results by accessing the 

record, which was generally only done at the time of the veterans 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 veterans medical record and e-mails the veterans 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 VAs 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, VAs 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 VAs 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 veterans 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 VAs 

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. VAs 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 clinicians 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 Healths Information Letter (mentioned in VAs 

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 VAs Hepatitis C Testing and Prevention Counseling Guidelines 

and Treatment Recommendations for Patients with Chronic Hepatitis C. We 

interviewed officials from VAs 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 VAs 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 VAs 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 VAs 

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 VAs 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 Secretarys 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 VAs 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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