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The American Journal of Managed Care May 2018
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Monitoring the Hepatitis C Care Cascade Using Administrative Claims Data
Cheryl Isenhour, DVM, MPH; Susan Hariri, PhD; and Claudia Vellozzi, MD, MPH
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Monitoring the Hepatitis C Care Cascade Using Administrative Claims Data

Cheryl Isenhour, DVM, MPH; Susan Hariri, PhD; and Claudia Vellozzi, MD, MPH
Development, validation, and application of hepatitis C case-finding algorithms to describe the care cascade among a commercially insured population in the United States.
ABSTRACT

Objectives: With the availability of curative therapies, it is important to ensure that individuals infected with hepatitis C virus (HCV) receive recommended testing, care, and treatment. We sought to evaluate insurance claims data as a source for monitoring progression along the HCV care cascade.

Study Design: Longitudinal evaluation of disease progression, from diagnosis to treatment, among commercially insured enrollees with chronic HCV.

Methods: We validated and used algorithms derived from standardized procedure and diagnosis codes to identify enrollees with chronic HCV in large insurance claims databases to describe the HCV care cascade, including the proportion engaged in HCV-specific care (13 possible definitions), the proportion prescribed HCV treatment, and the proportion who received an HCV RNA test 30 or more days after initiating treatment.

Results: Approximately 90% of individuals with an HCV RNA test procedure code followed by either 3 or more chronic HCV diagnosis codes on different service dates or 2 or more chronic HCV diagnosis codes separated by more than 60 days truly had chronic HCV. Using these algorithms, we identified 5791 HCV cases from January 1, 2013, to June 30, 2014. Among enrollees with HCV, 95% were engaged in HCV care, but only 49% initiated treatment and 43% received a follow-up HCV RNA test 30 or more days after initiating treatment.

Conclusions: With validated case-finding algorithms, insurance claims data can be used to describe and monitor portions of the HCV care cascade. Although nearly all enrollees with HCV were engaged in HCV care, only half received treatment, indicating that even commercially insured enrollees may find it challenging to access treatment.

Am J Manag Care. 2018;24(5):232-238
Takeaway Points

Just half of commercially insured enrollees identified by our validated hepatitis C virus (HCV) case-finding algorithms were prescribed HCV treatment, highlighting the need for improved treatment access.
  • With the use of validated case-finding algorithms, researchers can describe and monitor the HCV care cascade using administrative healthcare data and identify potential targets for public health intervention.
  • This is the first study to describe the cascade among commercially insured enrollees from a large nationally representative claims database.
  • Analyses are underway to identify factors impacting progression along the HCV care cascade, from diagnosis to treatment, among infected enrollees in this commercially insured population.
An estimated 3.5 million individuals are currently living with hepatitis C virus (HCV) infection in the United States,1 more than half of whom are unaware of their status.2,3 Although 81% of infected individuals were born between 1945 and 1965 (defined as the birth cohort),4 new HCV infections among younger individuals have increased in recent years.5 Approximately 75% to 85% of acutely infected individuals develop chronic HCV,6 which is associated with increased risk of chronic liver disease, hepatocellular carcinoma, and death.7-9 With the availability of highly effective direct-acting antiviral (DAA) medications, virologic cure can be achieved for more than 90% of treated patients with 8 to 12 weeks of therapy.10,11 It is critical to monitor how well patients proceed along the HCV care cascade, including appropriate testing, engagement in HCV-specific care (eg, liver disease staging), treatment, and confirmation of virologic cure. Such measures across the cascade could provide important baselines for comparison and highlight factors impacting progression along the cascade, thereby informing targets for improved clinical care and public health intervention.

Although a growing body of research describes the care cascade in a variety of populations and settings across the United States, the data are based on small studies and theoretical models.12-27 The various methods, settings, and populations under study make it challenging to directly compare findings. Additionally, investigators are limited by the information captured within each data source when determining which steps can be assessed and what metrics are appropriate. Therefore, it is necessary to utilize a variety of data sources to generate an accurate depiction of the HCV care cascade on a national scale to include different types of health insurance coverage (such as commercial, public, and uninsured) and those populations at high risk for HCV infection (such as individuals with a history of injection drug use).

Although not representative of all individuals infected with HCV in the United States, commercial insurance claims databases contain clinical and pharmacy data on millions of individuals. In particular, claims data can be used to monitor national trends in HCV testing.28 However, because laboratory test results are not included in claims data, they cannot be used to determine serostatus among those who had an HCV antibody test or identify individuals confirmed to be positive for HCV by HCV RNA detection. Claims data are limited to standard procedure and diagnosis codes for identifying enrollees with a particular disease condition, which may result in misclassification.29

Although algorithms for identifying chronic HCV infection among enrollees with diagnosed liver cirrhosis have been published,30,31 no algorithm is available to accurately identify enrollees with chronic HCV infection, irrespective of liver disease stage, using standard procedure and diagnosis codes derived from insurance claims data. Using a large commercial insurance claims database, we sought to both validate algorithms to identify enrollees living with chronic HCV and to describe the care cascade among the identified cases.

METHODS

Data Source

We obtained enrollment information and insurance claims from Truven Health Analytics MarketScan commercial and Medicare Supplemental Insurance claims databases from 2010 through 2014. These nationally representative data include more than 100 million covered lives, including both commercially insured enrollees younger than 65 years and Medicare-eligible enrollees 65 years or older with employer-sponsored supplemental insurance coverage.32 Laboratory test results were available in a separate data set for a subset of approximately 3 million enrollees included in the claims database, with linkage using unique identification numbers.

This secondary analysis of deidentified insurance claims data did not require institutional review board approval. All analyses were conducted using SAS software, version 9.3 (SAS; Cary, North Carolina).

Algorithm Validation

Study population. Using Logical Observation Identifiers Names and Codes,33 we identified all enrollees with at least 1 quantitative or qualitative HCV RNA result in the laboratory test results database from January 1, 2011, to December 31, 2014. Quantitative HCV RNA tests were considered positive if the viral load was 36.2 IU/mL or higher.34 As some enrollees had several HCV RNA test results available during the study period, the HCV RNA index date was defined by the first positive result among enrollees who were ever positive and the first negative result among enrollees who were always negative. We included enrollees 18 years or older who had prescription drug coverage and no claim for HCV treatment in the 6 months prior to the HCV RNA index date. We also required at least 6 months of continuous enrollment both before and after the HCV RNA index date, limiting the analysis to enrollees with an index date between January 1, 2011, and June 30, 2014 (Figure 1A).

Developing and testing algorithms. Using Current Procedural Terminology (CPT) codes for an HCV RNA test (87520, 87521, or 87522) and various combinations of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes for HCV infection (070.41, 070.44, 070.51, 070.54, 070.70, 070.71, and V02.62), we developed and tested the accuracy of 9 algorithms to identify chronic HCV cases using inpatient and outpatient claims data (Table 1). Using the HCV RNA index test results as the gold standard, we calculated the sensitivity, specificity, positive predictive value (PPV), and negative predictive value for each algorithm. Our goal was to describe the HCV care cascade among enrollees with chronic HCV; thus, we selected algorithms with the highest PPV for most accurate case identification.

HCV Care Cascade

Study population. To target the era of DAA treatment regimens, we identified claims for RNA testing from inpatient and outpatient files from January 1, 2013, to June 30, 2014. Claims were deduplicated by service date to identify each enrollee’s first test during the study period, defined as the RNA CPT index date. Enrollees 18 years or older with at least 6 months of continuous enrollment both before and after the RNA CPT index date, prescription drug coverage, and no treatment for HCV during the 6-month look-back period were included in the analysis (Figure 1B). We then applied the 2 algorithms with the highest PPV from the validation study and described enrollees living with chronic HCV by age group, birth cohort, sex, US Census division, and insurance plan type.

Defining and describing the cascade. To describe the care cascade, we examined inpatient, outpatient, and pharmacy claims between the RNA CPT index date and December 31, 2014, for each enrollee. Enrollees had between 6 and 24 months of claims data available for review, depending on when their RNA CPT index date and dates of continuous enrollment occurred.

Among enrollees with chronic HCV, we calculated the proportions who were engaged in HCV-specific care, were actually treated for HCV, and received an HCV RNA test 30 or more days after initiating treatment. Enrollees were considered to be engaged in HCV-specific care if they met at least 1 of 13 definitions of engagement (Table 2) or if they were prescribed HCV treatment but did not meet any of our 13 definitions of engagement. These definitions included different diagnostic tests or procedures used to stage or monitor the progression of liver disease. Enrollees were identified as having initiated treatment if at least 1 outpatient pharmacy claim included a National Drug Code for an FDA-approved drug to treat HCV.35 We also calculated the proportion of those treated who ever received a DAA as part of their treatment regimen and described the DAA types dispensed. Finally, we calculated the proportion of enrollees who received a follow-up HCV RNA test by CPT code 30 or more days after initiating HCV treatment, because an RNA test is currently recommended for monitoring individuals during antiviral therapy36 and serves as an indicator for continued engagement in care.


 
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