oversight

VA Health Care: Improvements Needed in Hepatitis C Disease Management Practices

Published by the Government Accountability Office on 2003-01-31.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

               United States General Accounting Office

GAO            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




GAO-03-136
                                               January 2003


                                               VA HEALTH CARE

                                               Improvements Needed in Hepatitis C
Highlights of GAO-03-136, a report to the      Disease Management Practices
Chairman, Subcommittee on National
Security, Veterans Affairs, and
International Relations, Committee on
Government Reform, House of
Representatives




In 1998, the Department of                     There is considerable variation among VA facilities in the time it takes to
Veterans Affairs (VA) launched an              notify veterans that they have hepatitis C. For example, 29 VA medical
initiative to screen and test                  facilities estimated that veterans were typically notified within 7 days of
veterans for hepatitis C—a chronic             testing while 16 estimated that notification times exceeded 60 days. At
blood-borne virus that can cause               facilities with longer notification times, primary care providers generally
potentially fatal liver-related
conditions. Since 2001, GAO has
                                               notified veterans at their next regularly scheduled appointments—
been monitoring VA’s hepatitis C               sometimes more than 4 months away. In contrast, facilities with shorter
program. This year GAO was asked               notification times generally scheduled special appointments focused on
to report on VA’s hepatitis C                  hepatitis C notification or notified veterans by telephone or mail. Longer
disease management practices.                  notification times increase the risk that veterans may unknowingly infect
GAO surveyed 141 VA medical                    others or continue to engage in behaviors, such as alcohol use, that could
facilities about their processes for           accelerate the damaging effects of hepatitis C on their livers.
notifying veterans concerning
hepatitis C test results and                   VA medical facilities also varied considerably in the time that veterans must
evaluating veterans’ medical                   wait before physician specialists evaluate their medical conditions
conditions regarding potential                 concerning hepatitis C treatment recommendations. For example, 23
treatment options. In addition,
GAO reviewed medical records of
                                               facilities estimated that veterans waited 30 days or less for appointments
100 hepatitis C patients at 1 facility         with physician specialists while 52 facilities estimated that veterans waited
and visited 4 other facilities that            over 60 days. At facilities with longer waiting times, primary care providers
used unique hepatitis C disease                frequently referred all veterans to physician specialists for evaluations. In
management processes.                          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.
GAO recommends that VA direct
facilities to make special
                                               Estimated Waiting Times for Appointments with VA Physician Specialists for Hepatitis C
arrangements to notify veterans                Evaluations
about hepatitis C test results when             Estimated typical waiting time
veterans’ next scheduled
appointments are longer than 30                  0 - 30 days
                                                                                                             23
days away and to ensure that
providers are promptly alerted
about test results. In addition,                31 - 60 days
                                                                                                                                               48
GAO recommends that VA
encourage facilities to increase
reliance on primary care providers              61 - 90 days
                                                                                                                  26
and other nonspecialists to initially
evaluate the medical condition of
hepatitis C-infected veterans while               > 90 days
                                                                                                                  26
continuing to consult with
specialists, when appropriate. VA                              0                 10                20                  30      40                50
concurred with these                                           Number of facilities estimating these times
recommendations.                               Source: GAO.

www.gao.gov/cgi-bin/getrpt?GAO-03-136.
                                               Note: This information is from our survey of VA medical facilities. Of the 141 surveyed facilities, 18
To view the full report, including the scope
                                               used providers other than physician specialists to perform evaluations.
and methodology, click on the link above.
For more information, contact Cynthia A.
Bascetta, (202) 512-7101.
Contents


Letter                                                                                      1
               Results in Brief                                                             2
               Background                                                                   3
               Hepatitis C Notification Time Frames Vary                                    6
               Evaluations of Medical Conditions of Veterans with Hepatitis C
                 Hampered by Waits for Physician Specialist Appointments                  10
               Conclusions                                                                13
               Recommendations for Executive Action                                       13
               Agency Comments                                                            14

Appendix I     Scope and Methodology                                                      16



Appendix II    Comments from the Department of Veterans
               Affairs                                                                    18



Appendix III   GAO Contact and Staff Acknowledgments                                      22



Figures
               Figure 1: 101 VA Facilities’ Estimated Typical Time Frames for
                        Notifying Veterans That They Have Hepatitis C                       6
               Figure 2: Reasonable Time Frames to Notify Veterans of Hepatitis
                        C Test Results Reported by VA Medical Facilities                    7
               Figure 3: Time to Inform Veterans That They Had Hepatitis C at the
                        Washington, D.C., VA Medical Facility                               8
               Figure 4: VA Facilities’ Estimated Typical Waiting Times for
                        Appointments with Physician Specialists                           10
               Figure 5: Waiting Times for Veterans to See Physician Specialists at
                        the Washington, D.C., VA Medical Facility                          12



               Abbreviations

               ALT      alanine aminotransferase
               NIH      National Institutes of Health
               VA       Department of Veterans Affairs



               Page i                                    GAO-03-136 VA Hepatitis C Management
United States General Accounting Office
Washington, DC 20548




                                   January 31, 2003

                                   The Honorable Christopher Shays
                                   Chairman
                                   Subcommittee on National Security, Veterans Affairs,
                                    and International Relations
                                   Committee on Government Reform
                                   House of Representatives

                                   Dear Mr. Chairman:

                                   Hepatitis C is a chronic blood-borne virus that can cause potentially fatal
                                   liver-related conditions. In 1998, the Department of Veterans Affairs (VA)
                                   launched a major initiative to screen all veterans who received care in its
                                   health care system for hepatitis C risk factors and conduct diagnostic
                                   blood tests for those at risk of infection. Since 1999, VA included a total of
                                   $700 million in budgets submitted to the Congress to screen and test
                                   veterans, as well as treat those with hepatitis C. In fiscal year 2002, VA
                                   expected about 4.7 million veterans to use its health care system. VA
                                   reports that its initiative had identified almost 160,000 veterans infected
                                   with hepatitis C as of the end of fiscal year 2002.

                                   Since 2001, we have been monitoring VA’s efforts to screen, test, and treat
                                   veterans with hepatitis C. Unless tested, veterans infected with the virus
                                   could unknowingly spread it to others. Once diagnosed, veterans face
                                   complex decisions about the best course of treatment they should follow
                                   to protect their health. Last year, we testified before your subcommittee
                                   that VA missed opportunities to screen and test many veterans for
                                   hepatitis C when they visited VA’s medical facilities.1 In response to our
                                   work, VA has begun to improve screening and testing procedures.
                                   Subsequent to the hearing, you asked us to focus on VA’s efforts to
                                   (1) notify veterans concerning their hepatitis C test results and (2)
                                   evaluate veterans’ medical conditions regarding potential treatment
                                   options.




                                   1
                                    U.S. General Accounting Office, Veterans’ Health Care: Standards and Accountability
                                   Could Improve Hepatitis C Screening and Testing Performance, GAO-01-807T
                                   (Washington, D.C.: June 14, 2001).



                                   Page 1                                         GAO-03-136 VA Hepatitis C Management
                   To do our work, we surveyed 141 VA medical facilities (accounting for the
                   care provided at most of VA’s 1,013 health care delivery locations) about
                   their hepatitis C notification and disease management processes. We also
                   conducted a case study at VA’s Washington, D.C., medical facility,
                   including a review of 100 medical records of patients who tested positive
                   for hepatitis C during the first 6 months of fiscal year 2001. We visited 4
                   other VA facilities that, in response to our survey, reported unique
                   processes for notifying veterans and evaluating their medical conditions
                   when making treatment decisions. In addition, we interviewed
                   representatives from veterans’ advocacy groups and the American Liver
                   Foundation to gain their perspectives on the timeliness and adequacy of
                   VA’s notification and disease management processes. For a complete
                   description of our scope and methodology, see appendix I. Our review was
                   conducted from July 2001 through January 2003 in accordance with
                   generally accepted government auditing standards.


                   There is considerable variation among VA facilities in the time it takes to
Results in Brief   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



                   Page 2                                     GAO-03-136 VA Hepatitis C Management
             as those with liver injury or those who were candidates for antiviral drug
             therapy, to specialists.

             We are recommending that VA direct facilities to use special arrangements
             to notify veterans when veterans’ next scheduled appointments are longer
             than 30 days away and to ensure that providers are promptly alerted about
             test results. In addition, we recommend that VA develop referral guidelines
             to encourage the use of nonspecialists to conduct initial evaluations of
             veterans diagnosed with hepatitis C, while continuing to consult with
             specialists, when appropriate. VA concurred with our recommendations.


             Hepatitis C was first recognized as a unique disease in 1989. It is the most
Background   common chronic blood-borne infection in the United States.2 The virus
             causes a chronic infection in 85 percent of cases. Undiagnosed hepatitis C
             can eventually lead to liver cancer; cirrhosis (scarring of the liver); or end-
             stage liver disease, which is the leading indication for liver
             transplantation.3 While hepatitis C antibodies generally appear in the blood
             within 3 months of infection, it can take 15 years or longer for the
             infection to develop into cirrhosis. Blood tests to detect the antibody,
             which became available in 1992, helped to virtually eliminate risk of
             infection through blood transfusions and curb the spread of the virus.
             However, many were already infected and, because they had no
             symptoms, were unaware of their infection.

             Early detection of hepatitis C is important for several reasons. First,
             undiagnosed persons miss opportunities to safeguard their health. Those
             who have hepatitis C infections could unknowingly behave in ways that
             speed the progression of the disease. For example, alcohol use can hasten
             the onset of cirrhosis and liver failure. Vaccinations prevent those with
             hepatitis C from contracting hepatitis A and B, other infections that could
             further damage the liver. Second, persons carrying the virus pose a public
             health threat because they could infect others. Specifically, as a blood-
             borne virus, hepatitis C can be spread to family members through sharing
             of razors; to health care workers through blood exposure, such as



             2
              W. Ray Kim, MD. M.Sc., M.B.A., “The Burden of Hepatitis C in the United States,” NIH
             Consensus Development Conference: Management of Hepatitis C: 2002 (Bethesda, Md.:
             National Institutes of Health, 2002), 23.
             3
             R. Cheung, “Epidemiology of Hepatitis C Virus Infection in American Veterans,” The
             American Journal of Gastroenterology, vol. 95, no. 3 (March 2000), 740.




             Page 3                                          GAO-03-136 VA Hepatitis C Management
needlestick injuries; and to others who come in contact with contaminated
blood, such as intravenous drug abusers.

In the last few years, considerable research has been done concerning
hepatitis C. The National Institutes of Health (NIH) held a consensus
development conference on hepatitis C in 1997 to assess the methods to
diagnose, treat, and manage hepatitis C. NIH convened a second hepatitis
C consensus development conference in June 20024 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 risk5 or who want to be
tested. VA has developed guidelines intended to assist health care
providers who screen, test, and counsel patients for hepatitis C. Providers
are to educate veterans about their risk of acquiring hepatitis C, notify
veterans of hepatitis C test results, and provide education to those infected
with the virus to help facilitate behavior changes to reduce veterans’ risk
of transmitting hepatitis C. In addition, providers are to evaluate the
medical condition of those diagnosed with hepatitis C. An evaluation could
include a medical history, blood tests to measure liver functions and virus
genotype or strain, and a liver biopsy. VA has also developed guidance for
providers to use when conducting such evaluations based on
recommendations of NIH and the Centers for Disease Control and
Prevention.



4
 NIH Consensus Development Conference, Management of Hepatitis C: 2002, June 2002.
The 12-member consensus panel is an independent, nonadvocate and nonfederal panel
including representatives from internal medicine, gastroenterology, infectious diseases,
family practice, and the public. The panel heard presentations from 28 hepatitis C experts
and reviewed an extensive body of medical literature and a report prepared by the Johns
Hopkins University School of Medicine Evidence-based Practice Center.
5
 VA identifies veterans at risk for hepatitis C infection as those who have one or more of
the following 11 risk factors: Vietnam-era veteran; blood transfusion before 1992; past or
present intravenous drug use; unequivocal blood exposure of skin or mucous membranes;
history of multiple sexual partners; history of hemodialysis; tattoo or repeated body
piercing; history of intranasal cocaine use; unexplained liver disease;
unexplained/abnormal alanine aminotransferase, which is an enzyme that is present in high
concentration in the liver and other organs; and intemperate or immoderate use of alcohol.



Page 4                                           GAO-03-136 VA Hepatitis C Management
Through such evaluations, providers are to identify veterans who have the
greatest risk of progressive liver disease—abnormal alanine
aminotransferase (ALT) blood tests or liver biopsies showing fibrosis6—
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



6
 Fibrosis is an increase in fibrous tissue in the liver that can progress to a more severe
stage called cirrhosis.




Page 5                                              GAO-03-136 VA Hepatitis C Management
                    periodic liver evaluations to assess the progression of their disease. In
                    these cases, if the disease advances, a more effective antiviral therapy may
                    have become available or the patient’s health may be at a point where it
                    may be worth the risk of undergoing drug therapy.


                    There is considerable variation among VA facilities in the time it takes to
Hepatitis C         notify veterans that they have hepatitis C. Systemwide, 71 facilities, in
Notification Time   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
Frames Vary         contrast, 30 facilities estimated that notification typically took longer than
                    30 days, including 7 facilities that estimated time frames of 90 days or
                    longer.7 (See fig. 1.)

                    Figure 1: 101 VA Facilities’ Estimated Typical Time Frames for Notifying Veterans
                    That They Have Hepatitis C




                    Note: This information is from our survey of VA medical facilities.


                    VA has delegated responsibility for establishing a hepatitis C notification
                    process to local facilities, including when veterans will be notified. VA


                    7
                     Forty facilities did not estimate typical notification time frames when responding to our
                    survey. Many of these facilities told us they did not know how long it typically took to
                    notify veterans.




                    Page 6                                                   GAO-03-136 VA Hepatitis C Management
hepatitis C guidance suggests that providers schedule a return date for
veterans to meet with them to discuss hepatitis C test results, but does not
designate a time frame within which veterans should be notified of their
hepatitis C test results. Also, VA does not specifically require facilities to
monitor notification of veterans concerning their hepatitis C test results.

In addition, most facilities do not provide guidance to their providers
regarding notification time frames, responding to our survey that
notification was left to provider discretion. However, when we asked
facilities what would be a reasonable time frame for notifying veterans,
112 of 136 survey respondents (about 80 percent) reported that veterans
should be notified in 30 days or less from the day the hepatitis C test
results are available. 8 (See fig. 2.)

Figure 2: Reasonable Time Frames to Notify Veterans of Hepatitis C Test Results
Reported by VA Medical Facilities




Note: This information is from our survey of VA medical facilities. Of the 141 surveyed facilities, 136
responded to this question.


Facilities estimating longer notification times (over 30 days) generally
relied on primary care providers to notify veterans at their next regularly
scheduled appointments, often more than 30 days away and, in some



8
 In addition, we asked a representative from the American Liver Foundation what would be
a reasonable notification time frame, and he suggested that 2 to 4 weeks would be a
reasonable time frame within which to notify veterans that they have hepatitis C.




Page 7                                                   GAO-03-136 VA Hepatitis C Management
cases, longer than 4 months away. At our case study facility—Washington,
D.C.—we analyzed medical records of veterans who tested positive for
hepatitis C from October 1, 2000, through March 31, 2001. Our analysis of
100 medical records showed that although many veterans were notified in
30 days or less, it took longer than 30 days to notify over half. Thirty-two
of these veterans had to wait over 90 days to be notified. (See fig. 3.)

Figure 3: Time to Inform Veterans That They Had Hepatitis C at the Washington,
D.C., VA Medical Facility




Note: This information is from our analysis of medical records sampled from the universe of veterans
who tested positive for hepatitis C from October 1, 2000, through March 31, 2001, at the Washington,
D.C., facility. At the time of our review (fall 2001), the 32 veterans whose notification took longer than
90 days included 19 veterans who had waited 256 to 425 days without being notified. We provided
the Washington, D.C., facility with the names of these veterans so that they could be notified.


Headquarters officials told us that providers may wait to notify veterans at
their next regular appointments because hepatitis C is a slowly advancing
disease, and as such, waiting until the next appointments should not
significantly affect veterans’ medical conditions. In the meantime,
however, veterans with hepatitis C could unknowingly infect others or
continue to engage in behaviors, such as alcohol use, that could accelerate
the damaging effects of hepatitis C on their livers.

In contrast, most of the 29 facilities with the shortest estimated
notification times—7 days or less—generally established special processes
for notifying veterans, rather than waiting until the next regularly
scheduled appointments. For example, providers at 4 facilities scheduled
special appointments to discuss hepatitis C test results with veterans, and


Page 8                                                   GAO-03-136 VA Hepatitis C Management
providers at 17 facilities notified veterans by telephone or mail. To
facilitate these special processes, these facilities also made other
adjustments. For example, 16 facilities used a computerized “alert” system
that reminds providers to notify veterans as soon as the providers log onto
VA’s computerized patient record system and before they access
individual patient records. This system proactively reminds primary care
providers to notify veterans. Previously, hepatitis C test results were
placed in a patient’s medical record, and providers would only learn the
results by accessing the record, which was generally only done at the time
of the veteran’s next regularly scheduled visit.9

In addition, 6 of the 29 facilities with shorter time frames established
special systems whereby the laboratory notified a designated person
directly of the hepatitis C test results. For example, the San Francisco
facility has a full-time registered nurse who each week receives a list of
veterans—directly from the laboratory—whose hepatitis C test results are
available. She attempts to notify these veterans by telephone. If
unsuccessful, she tries to notify the veterans in person at upcoming
appointments in outpatient clinics. If the nurse is unable to notify a
veteran, she documents this in the veteran’s medical record and e-mails
the veteran’s primary care provider to make him or her aware that the
veteran has not yet been notified. She told us that it could be difficult to
notify veterans who are homeless or who do not have telephones.

About one-third of the 141 surveyed facilities have established oversight
processes to monitor providers’ notification performance. For example,
the hepatitis C coordinator at the Wilmington VA facility receives all
hepatitis C test results directly from the laboratory and checks the medical
records of veterans with hepatitis C, reminding primary care providers to
notify veterans if records indicate that veterans were not notified. Since
the start of our medical record review, our Washington, D.C., case study
site has modified its notification processes and has hired a hepatitis C
coordinator who monitors primary care providers’ notification of veterans
to ensure that all veterans found to be infected with hepatitis C are
notified.




9
 In addition to these 16 facilities, another 47 report that they use the alert system to notify
providers that hepatitis C results are available for veterans whose tests are completed. Of
these, 40 reported notification times ranging from 8 to 30 days.




Page 9                                              GAO-03-136 VA Hepatitis C Management
                         Almost all VA medical facilities involved physician specialists10 in
Evaluations of           evaluating veterans with hepatitis C to determine a treatment
Medical Conditions of    recommendation, but waiting times for appointments with physician
                         specialists varied considerably. Twenty-three facilities, in response to our
Veterans with            survey, estimated that veterans typically waited 30 days or less for
Hepatitis C Hampered     appointments with physician specialists. By contrast, 100 facilities
                         estimated that veterans typically waited more than VA’s 30-day standard to
by Waits for Physician   see physician specialists including 26 that had waits exceeding 90 days.
Specialist               (See fig. 4.)
Appointments
                         Figure 4: VA Facilities’ Estimated Typical Waiting Times for Appointments with
                         Physician Specialists




                         Note: This information is from our survey of VA medical facilities. Of the 141 surveyed facilities, 18
                         used providers other than physician specialists to perform evaluations.


                         Moreover, the level of involvement of physician specialists in evaluating
                         veterans to determine treatment recommendations for veterans diagnosed
                         with hepatitis C varies by facility. For example, 62 facilities refer all
                         veterans diagnosed with hepatitis C to physician specialists to decide
                         whether antiviral therapy should be started. By contrast, it is the
                         customary practice at most other facilities surveyed to refer only certain



                         10
                          We have used the term physician specialists to mean gastroenterologists, hepatologists,
                         and infectious disease specialists, all of whom provide care for hepatitis C patients in the
                         VA health care system.




                         Page 10                                                  GAO-03-136 VA Hepatitis C Management
veterans diagnosed with hepatitis C for specialists to evaluate, such as
those with evidence of liver injury or those who were candidates for
antiviral drug therapy.

Since 1999, VA’s efforts to screen and test all veterans for hepatitis C have
significantly increased the volume of veterans who need physician
specialist appointments, therefore creating a bottleneck at many specialty
clinics. This is especially true for the 62 facilities that refer all veterans
with hepatitis C to physician specialists—80 percent of which estimated
waiting times exceeding 30 days. For example, at Washington, D.C., where
it is the customary practice to refer all veterans with hepatitis C to
physician specialists, our analysis of medical records of 6911 veterans who
were notified that they had hepatitis C and should have been referred to
physician specialists showed that only 2 veterans received appointments
with physician specialists within VA’s 30-day standard for a specialty
appointment. Sixty-one veterans waited longer than 60 days, and we could
find no evidence that 13 of these veterans ever received appointments with
physician specialists to begin the evaluation process. (See fig. 5.)




11
  We reviewed 100 medical records of veterans with hepatitis C. Thirty-one veterans were
not candidates for referral to physician specialists because 19 were not notified that they
had hepatitis C, 9 received evaluations from primary care physicians, and 3 stopped using
this VA facility. If a veteran received an appointment with a physician specialist and did not
keep it, we kept that veteran in the analysis using the original appointment date.




Page 11                                            GAO-03-136 VA Hepatitis C Management
Figure 5: Waiting Times for Veterans to See Physician Specialists at the
Washington, D.C., VA Medical Facility




Note: This information is from our analysis of medical records sampled from the universe of veterans
who tested positive for hepatitis C from October 1, 2000, through March 31, 2001, at the Washington,
D.C., facility. At the time of our review (fall 2001), the 36 veterans who waited over 90 days for
appointments included 13 veterans for whom we could find no evidence of appointments with
physician specialists.


However, some facilities with shorter waiting times have found that it is
not necessary for all veterans diagnosed with hepatitis C to see physician
specialists and have assigned responsibility for hepatitis C evaluations to
additional providers—not just physician specialists. Sixteen of the 23
facilities estimating waiting times of 30 days or less indicated that primary
care providers or hepatitis C coordinators—often nurses or nurse
practitioners—evaluate hepatitis C patients to determine who should be
referred to physician specialists. For example, at the San Francisco
facility, a nurse practitioner is responsible for evaluating all veterans
diagnosed with hepatitis C except those whose disease is very complex,
whom she refers to a physician specialist.12 At the Boston VA facility,
primary care providers order diagnostic tests so that results are available
when veterans diagnosed with hepatitis C receive evaluations by the



12
 The nurse practitioner operates under a protocol set up by the hepatologist, and a
physician specialist approves all treatment decisions that she makes. In cases where the
hepatitis C is advanced, the evaluation is conducted by the hepatologist.




Page 12                                               GAO-03-136 VA Hepatitis C Management
                      hepatitis C coordinator—a physician assistant. She evaluates veterans
                      with guidance from the physician specialist. Likewise, the hepatitis C
                      coordinator at the Wilmington facility, a nurse practitioner, evaluates all
                      veterans with hepatitis C, referring only those with more complex
                      symptoms to the physician specialist.


                      VA has invested considerably in its efforts to identify and treat veterans
Conclusions           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
Recommendations for   that the Secretary of Veterans Affairs direct the Under Secretary for Health
Executive Action      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



                      Page 13                                   GAO-03-136 VA Hepatitis C Management
                  •   help facilities improve the timeliness of evaluations for veterans diagnosed
                      with hepatitis C by encouraging facilities to use nonspecialists to conduct
                      initial evaluations, and develop clinical guidelines for when to refer
                      veterans to physician specialists for additional consultations.


                      In commenting on a draft of this report, VA agreed with our findings and
Agency Comments       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


                      Page 14                                    GAO-03-136 VA Hepatitis C Management
streamline referral to specialists when appropriate. To measure the effect
of these efforts, VA has begun to collect data on the time between a
positive test and the point at which a disease management decision is
made.


As agreed with your office, unless you publicly announce its contents
earlier, we will plan no further distribution of this report until 30 days after
its date. At that time, we will send copies to interested congressional
committees and other parties. We also will make copies available to others
upon request. In addition, the report will be available at no charge on the
GAO Web site at http://www.gao.gov. If you or your staff have any
questions about this report, please call me at (202) 512-7101. Another
contact and key contributors are listed in appendix III.

Sincerely yours,




Cynthia A. Bascetta
Director, Health Care—Veterans’
 Health and Benefits Issues




Page 15                                    GAO-03-136 VA Hepatitis C Management
             Appendix I: Scope and Methodology
Appendix I: Scope and Methodology


             To achieve our objectives, we reviewed and analyzed the Department of
             Veterans Affairs’ (VA) hepatitis C program documents and guidance,
             including VA’s Hepatitis C Testing and Prevention Counseling
             Guidelines and Treatment Recommendations for Patients with Chronic
             Hepatitis C. We interviewed officials from VA’s Public Health Strategic
             Healthcare Group. We also reviewed and analyzed the current literature
             pertaining to hepatitis C.

             We conducted an E-mail survey to obtain information on hepatitis C
             notification and disease management processes and practices throughout
             the VA system, including evaluating veterans’ medical conditions regarding
             potential treatment options. We asked each of VA’s 22 regional clinical
             managers to identify the provider most knowledgeable about the hepatitis
             C program at each medical facility in his or her region. We received the
             names of hepatitis C providers located in 141 VA medical facilities
             (accounting for the care provided at most of the 1,013 health care delivery
             locations within the VA system). We e-mailed a survey to each identified
             provider. Our survey response rate was 100 percent, although not every
             location responded to each question.

             We conducted a case study at VA’s Washington, D.C., facility in the fall of
             2001 to understand the complexity of managing a hepatitis C program. We
             interviewed primary care providers, liver clinic physician specialists and
             nurses, the chief of laboratory services, and hospital administrators. As
             part of our case study, we reviewed the medical records of a sample of
             veterans who tested positive for hepatitis C for the first time during the
             first 6 months of fiscal year 2001. We selected our sample from a facility-
             provided list of 346 veterans who had a positive hepatitis C test during this
             period. To ensure that we examined an adequate number of veterans who
             had evidence of liver damage (as measured by high levels of alanine
             aminotransferase (ALT)), we separated the names into two groups—
             veterans with tests showing high ALT levels (n=149) and those with tests
             showing normal levels (n=197)—and randomly selected names from each
             group resulting in a sample of 100 veterans: 53 with high ALT levels and 47
             with normal ALT levels. In reviewing the medical records, we discovered
             that some of the veterans sampled had tested positive prior to October 1,
             2000. These veterans were excluded from our sample and other veterans
             were randomly selected. This discrepancy in the sampling list and the
             oversampling of the high ALT group may limit the generalizability of our
             findings.

             To obtain information about unique hepatitis C notification and disease
             management processes that could serve as best practices, we conducted


             Page 16                                   GAO-03-136 VA Hepatitis C Management
Appendix I: Scope and Methodology




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.




Page 17                                   GAO-03-136 VA Hepatitis C Management
             Appendix II: Comments from the Department
Appendix II: Comments from the Department
             of Veterans Affairs



of Veterans Affairs




             Page 18                                     GAO-03-136 VA Hepatitis C Management
Appendix II: Comments from the Department
of Veterans Affairs




Page 19                                     GAO-03-136 VA Hepatitis C Management
Appendix II: Comments from the Department
of Veterans Affairs




Page 20                                     GAO-03-136 VA Hepatitis C Management
Appendix II: Comments from the Department
of Veterans Affairs




Page 21                                     GAO-03-136 VA Hepatitis C Management
                  Appendix III: GAO Contact and Staff
Appendix III: GAO Contact and Staff
                  Acknowledgments



Acknowledgments

                  Paul Reynolds, (202) 512-7109
GAO Contact
                  In addition to the contact named above, Cheryl Brand, Irene J. Barnett,
Acknowledgments   Frederick Caison, Deborah L. Edwards, Martha A. Fisher, Susan Lawes,
                  Gay Hee Lee, and Clare Mamerow made key contributions to this report.




(290077)
                  Page 22                                GAO-03-136 VA Hepatitis C Management
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