VA Health Care: Improvements Needed in Hepatitis C Disease Management Practices
Published: 2003-01-31T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.

section_title: Letter
paragraphs: 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. In response to our  work, VA has begun to improve screening and testing procedures.  Subsequent to the hearing, you asked us to focus on VA’s efforts to   (1) notify veterans concerning their hepatitis C test results and (2)  evaluate veterans’ medical conditions regarding potential treatment  options.
To do our work, we surveyed 141 VA medical facilities (accounting for the  care provided at most of VA’s 1,013 health care delivery locations) about  their hepatitis C notification and disease management processes. We also  conducted a case study at VA’s Washington, D.C., medical facility,  including a review of 100 medical records of patients who tested positive  for hepatitis C during the first 6 months of fiscal year 2001. We visited 4  other VA facilities that, in response to our survey, reported unique  processes for notifying veterans and evaluating their medical conditions  when making treatment decisions. In addition, we interviewed  representatives from veterans’ advocacy groups and the American Liver  Foundation to gain their perspectives on the timeliness and adequacy of  VA’s notification and disease management processes. For a complete  description of our scope and methodology, see appendix I. Our review was  conducted from July 2001 through January 2003 in accordance with  generally accepted government auditing standards.
subsections: section_title: Background
paragraphs: 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.
section_title: Hepatitis C Notification Time Frames Vary
paragraphs: 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.
section_title: Evaluations of Medical Conditions of Veterans with Hepatitis C Hampered by Waits for Physician Specialist Appointments
paragraphs: 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.
section_title: Conclusions
paragraphs: 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.
section_title: Recommendations for Executive Action
paragraphs: 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.
section_title: Agency Comments
paragraphs: 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.
section_title: Appendix I: Scope and Methodology
paragraphs: 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.
section_title: Appendix II: Comments from the Department of Veterans Affairs
section_title: Appendix III: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Acknowledgments
paragraphs: 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.