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HCV Elimination: Universal Routine Screening Should be Mandated
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HCV Elimination the USA: in light of the White House announcement that viral hepatitis would be eliminated by 2030 Our Nation has set a goal to eliminate viral hepatitis by 2030.", Pres. Biden - (05/19/21) - plus this recent CDC announcement New CDC Update - Acute HCV Increased 14% from 2018 to 2019 - (05/19/21) - therefore, nationwide universal routine screening should be implemented & mandated for all conducted by our labs who provide our routine blood labs testing (Labcorp, Quest, others)....
CDC: These findings highlight the need for immediate implementation of the new CDC universal hepatitis C screening recommendations for all adults and pregnant women (11). Following a decade of sharp increases in acute hepatitis C infections, particularly among young adults, the rates of newly reported chronic infections among baby boomers and millennials are now equal, demonstrating that even younger generations are at risk. Diagnosing HCV infection is a necessary first step to link-ing persons to cure to prevent life-threatening consequences of long-term chronic infections and transmission to others. https://www.natap.org/2020/HCV/mm6914a2-H2.pdf
Failure to Test and Identify Perinatally Infected Children Born to Hepatitis C-Positive Women: Of the births to mothers known to be HCV-positive, 20.3% (n=109) had received an HCV test during their pregnancy, though testing in pregnancy had no effect on the likelihood of their child being tested for HCV (data not shown)....Using the 5% vertical transmission rate, an estimated 27 children of the 537 births to HCV-positive mothers are expected to be chronically infected with HCV (Figure 1). Given that four (15%) are Confirmed Perinatal children, 23 (85%) children remain unidentified and may be living with chronic HCV infection (Figure 1).....These findings illustrate that a significant number of women giving birth in Philadelphia are HCV-positive and that most of their at-risk children remain untested. To successfully identify all HCV-infected children and integrate them into HCV-specific care, practices for HCV screening of pregnant women and their children should be improved. https://www.natap.org/2016/HCV/012716_04.htm
NEWBORN TESTING REVEALS HIGH HCV SEROPREVALENCE IN PREGNANT WOMEN FROM NEW YORK STATE....https://www.natap.org/2020/CROI/croi_47.htm
NEEDED - Routine Universal HCV Screening - followed by treatment with support services: homeless, recently incarcerated, incarcerated, methadone maintenance & substance abuse facilities...Telehealth treatment can be utilized to treat at substance abuse facilities where adequate professional care is provided....all IDUs should be screened and treated.
Just announced: HCV Screening During Pregnancy Recommended by ACOG: Am Coll. of Obstetricians & Gynecologists - (05/19/21)
Testing during pregnancy allows for simultaneous identification of infected mothers and infants who should receive testing at a pediatric visit. Testing of infants consists of HCV RNA testing at or after age 2 months or anti-HCV testing at or after age 18 months (39). Although DAA treatment is not approved for children aged <3 years, infected children aged <3 years should be monitored.
CDC Testing Recommendations: https://www.cdc.gov/hepatitis/hcv/guidelinesc.htm...which include -
• Hepatitis C screening at least once in a lifetime for all adults aged 18 years and older, except in settings where the prevalence of HCV infection (HCV RNA positivity) is less than 0.1%;
• Hepatitis C screening for all pregnant women during each pregnancy, except in settings where the prevalence of HCV infection (HCV RNA positivity)
• Children born to mothers with HCV infection
• People with HIV
• People who ever injected drugs and shared needles, syringes, or other drug preparation equipment, including those who injected once or a few times many years ago
• people with persistently abnormal ALT levels
• Routine periodic testing for people with ongoing risk factors
enhanced screening strategies, such as specific inquiry about risk factors by health care and social workers, focused on high-risk individuals, could lead to improved case finding. Risk factor assessment remains important to prioritize resources and to promote screening even in the situation in which universal HCV screening is the norm.
the HepC Testing and Linkage to Care program at MedStar Health Research Institute sought to leverage the Electronic Health Record (EHR) to identify and monitor HCV screening rates and institutional linkage to care proficiency within a large integrated healthcare system through the creation of a BC HCV clinical decision support (CDS) prompt. The aim of this study was to evaluate a large healthcare system’s HCV screening rates, linkage to care efficiency, and provider testing preferences.
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Leveraging the electronic health record to eliminate hepatitis C: Screening in a large integrated healthcare system
Alexander G. GeboyID1*, Whitney L. Nichols1, Stephen J. FernandezID1, Sameer Desale1, Peter Basch1,2,3, Dawn A. Fishbein1,4
1 MedStar Health Research Institute, Hyattsville, MD, United States of America, 2 MedStar Institute for Innovation, Washington, DC, United States of America, 3 MedStar Quality and Safety Institute, Washington, DC, United States of America, 4 MedStar Washington Hospital Center, Washington, DC, United States of America
Abstract
Highly efficacious and tolerable treatments that cure hepatitis C viral (HCV) infection exist today, increasing the feasibility of disease elimination. However, large healthcare systems may not be fully prepared for supporting recommended actions due to knowledge gaps, inadequate infrastructure and uninformed policy direction. Additionally, the HCV cascade of care is complex, with many embedded barriers, and a significant number of patients do not progress through the cascade and are thus not cured. The aim of this retrospective cohort study was to evaluate a large healthcare system’s HCV screening rates, linkage to care efficiency, and provider testing preferences. Patients born during 1945-1965, not previously HCV positive or tested from within the Electronic Health Record (EHR), were identified given that three-quarters of HCV-infected persons in the United States are from this Birth Cohort (BC). In building this HCV testing EHR prompt, non-Birth Cohort patients were excluded as HCV-specific risk factors identifying this population were not usually captured in searchable, structured data fields. Once completed, the BC prompt was released to primary care locations. From July 2015 through December 2016, 11.5% of eligible patients (n = 9,304/80,556) were HCV antibody tested (anti-HCV), 3.8% (353/9,304) anti-HCV positive, 98.1% (n = 311/317) HCV RNA tested, 59.8% (n = 186/311) HCV RNA positive, 86.6% (161/186) referred and 76.4% (n = 123/161) seen by a specialist, and 34.1% (n = 42/123) cured of their HCV. Results from the middle stages of the cascade in this large healthcare system are encouraging; however, entry into the cascade-HCV testing-was performed for only 11% of the birth cohort, and the endpoint-HCV cure-accounted for only 22% of all infected. Action is needed to align current practice with recommendations for HCV testing and treatment given that these are significant barriers toward elimination.
Discussion
The 11.5% MSH-wide BC screening rate of eligible patients (n = 9,304/80,556), was higher than one recently reported study describing national trends in HCV BC antibody testing of 3.3% [25], but lower than similar studies conducted after the 2012 CDC guidelines were released, of 18.6% and 21.3% respectively [20,21]. Nonetheless, this rate is suboptimal considering BC screening recommendations are now well-established (since 2012) and Medicare reimburses a single HCV Ab test for this population. This rate likely reveals universal gaps in testing methodology, provider knowledge and behavior, and suggests provider-initiated testing, regardless of prompts, fall short of expectations.
Overall, anti-HCV positive cases (3.8%) across the MSH network were congruent with the CDC BC prevalence rate of 3.25%, which is likely reflective of MSH being representative of the US population [8]. However, within individual sites, reactivity ranged from a high of 19% to less than 1% for sites that identified at least one reactive test. Sites with high reactivity need to be investigated further to determine whether the overall clinic populations contained fewer eligible patients, or whether providers were testing only those patients they anticipated to be infected. Similarly, sites with lower reactivity should also be investigated to determine whether providers were perhaps screening healthier patients and those more compliant with general medical care. It also needs to be considered whether these sites have appropriate resources for navigating their patients through the HCV cascade of care toward a cure. Other significant overall trends were also consistent with the BC literature from urban settings (i.e., patients were more likely to be anti-HCV positive if they were male and b/AA).
The MSH HCV RNA infection rate of 59.8%(n = 186/311) is notably lower than the often-reported rates of approximately 75%-85% [8], however there does appear to be variability within the literature. In 2012-2014, the CDC sponsored a nation-wide hepatitis C testing and linkage to care initiative [26]. Individual grantees testing similar populations to the one described in this study (i.e., previously undiagnosed BC patients) saw results ranging from 62.2% [27] and 64.7% to 72.3% [28,29] and 73.9% [30]. Interestingly, a comprehensive review of the 14 grantees supporting BC testing noted that chronic infection was identified in 75.6% (n = 822/1088) of patients who received same-day RNA testing as compared to 66.2% (n = 675/1020) who did not [31]. While this is evidence for the necessity of same-day HCV RNA reflex testing, it also points to the difficulty in obtaining a true rate of chronicity. Though the literature does generally support greater clearance rates in the BC, perhaps in those with active underlying risk factors and thus continued risk of reinfection there is less clearance. Lastly, the higher than expected RNA negative rate could be a consequence of either a false-positive anti-HCV results, or evidence of past resolved HCV infection. In both cases, persons testing anti-HCV positive and HCV RNA negative and without identified recent or active risk factors are considered negative for current infection and would not need further HCV testing.
The MSH HCV RNA testing rate of 88.1% (n = 311/353) was comparable to other recent studies [21,27,29,32-35], though fell short of 100% threshold [36], which was anticipated as the imbedded active decision support CDS prompt was for a HCV Ab with reflex to NAA test. There were two primary reasons for not reaching 100%: a) reflex processing errors with the need for a frozen specimen and/or an additional tube of blood; and b) incomplete use of the CDS prompt. To the latter reason, it is possible providers utilized the CDS prompt only as a guide or reminder to review a patient’s chart, but ordered a different lab test which did not include the reflex test. Nonetheless, as this study was observing provider practices across the entire system and without study intervention, the 76.4% linkage to care rate (n = 123/161) was lower than two recently reported linkage to care rates of 85.0% [2] and 92.2% [27], and higher than others ranging between 38.7% - 69.9% [21,29,32,33,35,37].
MSH did appreciably better at maintaining patients through the cascade of care (Fig 3) than other studies utilizing more targeted interventions [35,38], with 53.7% (n = 66/123) of patients receiving a prescription for HCV therapy, and 87.5% (n = 42/48) of those treated completed treatment achieving sustained virologic response (SVR) equating to cure. At the time of database close, six remaining patients had not yet returned for their end of treatment visit, though all 42 patients who completed treatment and had a 12-week post-treatment follow-up visit did achieve SVR. Regarding access to treatment, new oral DAAs were still being FDA approved during the study period. Starting in 2013, all new treatments required prior authorization. However, payers did not have a well-organized prior authorization approval process, and clinicians did not have adequate administrative support for the process. Once payer processes were established, there were fibrosis, sobriety and prescribing clinician specialty restrictions.
Additional work is underway to (a) identify factors that may be facilitators or barriers to successful HCV care, (b) intervene within the new EHR (MedConnect) by providing embedded reminders and resources to improve testing and linkage, and (c) educate primary care providers on HCV recommendations and best practices through quality improvement initiatives such as educational interventions (e.g., surveys evaluating clinician knowledge, barriers and attitudes, audit/feedback cycles, webinar sessions with HCV experts). Site comparisons will also need to be evaluated more closely considering multiple factors (i.e., white men in MD were more likely to test anti-HCV positive than white men in DC). To this point, there was variability between MD and DC sites regarding the association between highest testing and highest HCV Ab reactivity. In MD, sites that accounted for the highest overall testing rates had the lowest reactivity, while other sites with the highest reactivity accounted for the lowest testing. Within DC, however, two sites accounted for both the highest overall testing rate as well as the highest reactivity (Fig 4). Understanding these trends could provide valuable direction for the creation and implementation of targeted interventions to both increase testing and provide appropriate HCV services.
This study has several limitations. Providers did not need to utilize the CDS prompt, in part or in full, to test patients for HCV. As indicated in Fig 2, for 61.5% of patients seen by a provider, the VAP button was never clicked. Identifying the subsequent actions taken from this group was beyond the scope of this study, although ordering an HCV test could not be ruled out as a possible action. Once a provider entered the available VAP prompts, it appears they were more likely to not only access the HCV CDS prompt (73%), but to take an action within it (95%) (Fig 2). However, as there was not a one-to-one concordance between prompt testing orders and overall tests, it is possible the HCV Ab screening rate for this study was underestimated. Additionally, the affiliated test, HCV Ab with Reflex to Qualitative NAA, was not unique to the prompt and could be ordered outside the prompt.
Second, testing outcomes were dependent on provider action and proper documentation. Though the CDS prompt was programmed specifically for HCV testing, methods for extracting data from the EHR and tracking its utilization within the EHR is imperfect. Though all structured health information is stored as searchable observation terms, it is sometimes the case that searchable information pertaining to providers and provider locations, hospital locations, documents and associated signing provider, ordered tests and test codes, and patient information is all stored or coded differently (and sometimes incorrectly) between each site, therefore complicating and limiting the data extraction process. Furthermore, information that is contained as unstructured data, either as free text in provider notes or HCV lab values that do not populate to searchable fields such as flowsheets, are unsearchable and information is “lost” (at least with the current technology) to external quantification.
Third, it is unclear whether this CDS prompt led to increased testing, as there was no comparator group. Currently, these testing data are representative of MSH’s baseline, at least within the BC. Near the conclusion of 2016, MSH transitioned from the GE Centricity to Cerner MedConnect EHR; however, an HCV prompt has not yet been created and prior testing data has not yet migrated though it is currently underway.
One of the greatest challenges to eliminating HCV is the barrier to initial testing and identification of previously untested persons at risk for HCV. Though this EHR prompt approximated the magnitude and distribution of HCV within the BC across a large healthcare system, it highlighted several critical system-wide gaps in provider knowledge and behavior, including subsequent care needs, and EHR utility. It is unclear the degree to which primary care providers’ disease-specific knowledge, or the underlying framework and utility of the CDS prompt and EHR itself were limiting factors as these were not explicitly measured. A more knowledgeable provider base is certainly a benefit to any health system, and in this case would have likely been more aware of identification, screening, and linkage to care recommendations; however, it cannot alone be a solution to CDS non-adherence. Additionally, while this active decision support prompt at least followed certain structural recommendations for workflow integration (i.e., it was delivered at the point of care, patient specific, clinically relevant, as automated as possible, and not a hard-stop prompt), it was underutilized.
The success of any CDS prompt is measured by positive changes in provider behavior and/or clinical outcome [39]. Given a useful, useable, and effective prompt, coupled with appropriate educational interventions such as provider in-services, HCV-infected persons could be identified and likely treated faster and in earlier stages of fibrosis, thus reducing morbidity and mortality from complications related to cirrhosis and hepatocellular carcinoma. While this CDS prompt saw incomplete usage, there was enough activity to identify a MSH-wide anti-HCV prevalence rate of 3.8% within the BC, and individual site rates as high as 20%. In terms of outcome, this is evidence enough to suggest that HCV has, and will continue to have, a significant negative impact on the health of the MSH community of patients. These results therefore demonstrate the need for a more dynamic approach to constructing a CDS prompt focused on both optimal workflow integration and provider education. Additionally, buy-in from hospital and health-system committees appears requisite to fully impact this epidemic. The MSH health systems-and health systems in general-ought to consider complete testing automation with built in same-day reflex HCV RNA testing. This would not only comply with CDC/USPSTF/CMS recommendations, but would support recommended actions by the National Academies of Science, Engineering, and Mathematics [22] in support of the ultimate goal of HCV elimination by 2030.
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