Hepatitis C was first recognized as a unique disease in 1989. It is the most common chronic blood-borne infection in the United States. 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. 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 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 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— and who may benefit from an antiviral therapy regimen consisting of injections of interferon plus ribavirin (an oral antiviral agent) capsules. The effectiveness of this therapy to rid—“clear”—a patient of the virus has been shown to vary from a 30 to 80 percent success rate depending on the genotype of the virus, the extent of the infection, and the type of interferon used. Genotype 1, the most common genotype found in VA patients, is the genotype least responsive to antiviral therapy. The recommended duration of antiviral therapy for patients with genotype 1 is 48 weeks compared to 24 weeks for patients with other genotypes. Also, providers’ evaluations are expected to identify veterans with hepatitis C who are not considered to be candidates for antiviral therapy because they have co-morbid conditions that contraindicate therapy. Veterans with coronary artery disease, uncontrolled diabetes, or chronic obstructive pulmonary disease, for example, are often not candidates for antiviral therapy because of the reduced life expectancy from the underlying co-morbid condition in addition to the potential for increased side effects from antiviral therapy. In addition, veterans with active drug or alcohol abuse may not be candidates for antiviral therapy because of potential toxic effects of the antiviral therapy and compliance problems with the antiviral regimen, which requires adherence to a regular schedule of interferon injections and doses of ribavirin. Additionally, interferon- based therapies may worsen the psychological problems of patients with uncontrolled, severe psychiatric disorders—particularly depression and suicide risk. However, the recent NIH consensus conference expanded the scope of patients eligible for treatment to include some patients with substance abuse problems. Providers may also recommend watchful waiting—monitoring the disease status without antiviral treatment—because the risks of drug therapy outweigh the potential benefits. Antiviral drugs have severe side effects, such as depression, flu-like symptoms, and intense itching, which patients sometimes find unbearable. Providers may make such a recommendation to older veterans with slowly advancing disease and minimal liver injury and encourage those veterans to lead healthy lifestyles and receive periodic liver evaluations to assess the progression of their disease. In these cases, if the disease advances, a more effective antiviral therapy may have become available or the patient’s health may be at a point where it may be worth the risk of undergoing drug therapy. 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. (See fig. 1.) 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. (See fig. 2.) 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.) Headquarters officials told us that providers may wait to notify veterans at their next regular appointments because hepatitis C is a slowly advancing disease, and as such, waiting until the next appointments should not significantly affect veterans’ medical conditions. In the meantime, however, veterans with hepatitis C could unknowingly infect others or continue to engage in behaviors, such as alcohol use, that could accelerate the damaging effects of hepatitis C on their livers. In contrast, most of the 29 facilities with the shortest estimated notification times—7 days or less—generally established special processes for notifying veterans, rather than waiting until the next regularly scheduled appointments. For example, providers at 4 facilities scheduled special appointments to discuss hepatitis C test results with veterans, and providers at 17 facilities notified veterans by telephone or mail. To facilitate these special processes, these facilities also made other adjustments. For example, 16 facilities used a computerized “alert” system that reminds providers to notify veterans as soon as the providers log onto VA’s computerized patient record system and before they access individual patient records. This system proactively reminds primary care providers to notify veterans. Previously, hepatitis C test results were placed in a patient’s medical record, and providers would only learn the results by accessing the record, which was generally only done at the time of the veteran’s next regularly scheduled visit. 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. Almost all VA medical facilities involved physician specialists 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.) Moreover, the level of involvement of physician specialists in evaluating veterans to determine treatment recommendations for veterans diagnosed with hepatitis C varies by facility. For example, 62 facilities refer all veterans diagnosed with hepatitis C to physician specialists to decide whether antiviral therapy should be started. By contrast, it is the customary practice at most other facilities surveyed to refer only certain veterans diagnosed with hepatitis C for specialists to evaluate, such as those with evidence of liver injury or those who were candidates for antiviral drug therapy. Since 1999, VA’s efforts to screen and test all veterans for hepatitis C have significantly increased the volume of veterans who need physician specialist appointments, therefore creating a bottleneck at many specialty clinics. This is especially true for the 62 facilities that refer all veterans with hepatitis C to physician specialists—80 percent of which estimated waiting times exceeding 30 days. For example, at Washington, D.C., where it is the customary practice to refer all veterans with hepatitis C to physician specialists, our analysis of medical records of 69 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.) 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. 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. 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 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 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. To achieve our objectives, we reviewed and analyzed the Department of Veterans Affairs’ (VA) hepatitis C program documents and guidance, including VA’s Hepatitis C Testing and Prevention Counseling Guidelines and Treatment Recommendations for Patients with Chronic Hepatitis C. We interviewed officials from VA’s Public Health Strategic Healthcare Group. We also reviewed and analyzed the current literature pertaining to hepatitis C. We conducted an E-mail survey to obtain information on hepatitis C notification and disease management processes and practices throughout the VA system, including evaluating veterans’ medical conditions regarding potential treatment options. We asked each of VA’s 22 regional clinical managers to identify the provider most knowledgeable about the hepatitis C program at each medical facility in his or her region. We received the names of hepatitis C providers located in 141 VA medical facilities (accounting for the care provided at most of the 1,013 health care delivery locations within the VA system). We e-mailed a survey to each identified provider. Our survey response rate was 100 percent, although not every location responded to each question. We conducted a case study at VA’s Washington, D.C., facility in the fall of 2001 to understand the complexity of managing a hepatitis C program. We interviewed primary care providers, liver clinic physician specialists and nurses, the chief of laboratory services, and hospital administrators. As part of our case study, we reviewed the medical records of a sample of veterans who tested positive for hepatitis C for the first time during the first 6 months of fiscal year 2001. We selected our sample from a facility- provided list of 346 veterans who had a positive hepatitis C test during this period. To ensure that we examined an adequate number of veterans who had evidence of liver damage (as measured by high levels of alanine aminotransferase (ALT)), we separated the names into two groups— veterans with tests showing high ALT levels (n=149) and those with tests showing normal levels (n=197)—and randomly selected names from each group resulting in a sample of 100 veterans: 53 with high ALT levels and 47 with normal ALT levels. In reviewing the medical records, we discovered that some of the veterans sampled had tested positive prior to October 1, 2000. These veterans were excluded from our sample and other veterans were randomly selected. This discrepancy in the sampling list and the oversampling of the high ALT group may limit the generalizability of our findings. To obtain information about unique hepatitis C notification and disease management processes that could serve as best practices, we conducted site visits to 4 other VA facilities: San Francisco, Wilmington, Boston, and Minneapolis. We selected these facilities based on their responses to our survey. At each site we interviewed hepatitis C physician specialists and coordinators and reviewed their hepatitis C notification and disease management processes. To gain their perspectives on the timeliness and adequacy of VA’s hepatitis C notification and disease management processes, we conducted interviews with representatives from four veterans’ advocacy groups: American Legion, Vietnam Veterans of America, Veterans Aimed Toward Awareness, and Disabled American Veterans. We also interviewed a representative from the American Liver Foundation. Our review was conducted from July 2001 through January 2003 in accordance with generally accepted government auditing standards. 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.

Summary: 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. 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.