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Impact of Hepatitis C Virus and Insurance Coverage on Mortality
Haley Bush, MSPH; James Paik, PhD; Pegah Golabi, MD; Leyla de Avila, BA; Carey Escheik, BS; and Zobair M. Younossi, MD, MPH
The Drug Price Iceberg: More Than Meets the Eye
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Impact of Hepatitis C Virus and Insurance Coverage on Mortality

Haley Bush, MSPH; James Paik, PhD; Pegah Golabi, MD; Leyla de Avila, BA; Carey Escheik, BS; and Zobair M. Younossi, MD, MPH
The Medicaid population has significantly higher hepatitis C virus (HCV) prevalence and mortality rates than patients with private insurance. These data must be considered when policy makers assess providing additional support to Medicaid programs for HCV elimination.
DISCUSSION

Our study reveals that among the NHANES population, the prevalence of HCV is quite high among individuals who are covered by Medicare and Medicaid and among the uninsured population.

Additionally, our analysis showed that presence of HCV infection is an independent risk factor for mortality (eAppendix Table 2) and that the risk further increases in the subgroup of HCV-infected individuals who are covered by Medicare or Medicaid—specifically, those covered by Medicaid (Table 4). To our knowledge, this is the first study to document an association between mortality and Medicaid coverage in HCV-infected subjects using a population-based database.

When assessing the mortality of patients enrolled in this NHANES-based analysis, we also confirmed some of the other well-known risk factors for mortality. Those factors include HCV status, age, smoking status, comorbidities, and some sociodemographic components, such as income level (eAppendix Table 2). These findings have also been reported in previous studies and are reflected in our results supporting the validity of our analyses.28-32 Specifically, our data analysis shows that HCV infection is an independent risk factor for mortality, as HCV-infected individuals are nearly twice as likely to experience mortality as HCV-negative individuals. Numerous studies have examined and confirmed this increased risk of mortality in HCV-positive subjects.33-35 A CDC report highlights that the HCV deaths in the United States have now surpassed deaths from 60 other infectious conditions combined.35 Furthermore, El-Kamary et al demonstrated that HCV all-cause mortality is more than twice that of HCV-negative individuals, indicating that HCV-positive individuals are at a higher risk of death even after accounting for liver-related morbidity.33 Also, Sayiner et al concluded that among Medicare recipients, a diagnosis of HCV is independently associated with higher mortality.34

Additionally, our study found that among the entire study population, those with Medicaid had an increased risk of all-cause mortality. This was confirmed after adjustment for confounders. Several other studies have reported an association between insurance type and negative health outcomes.36-41 Saunders et al examined a nationally representative sample of individuals with albuminuria and concluded that lack of insurance and having public insurance such as Medicaid were both associated with increased mortality compared with private insurance, even after controlling for numerous variables.36 Furthermore, a nationally representative study of Americans hospitalized for myocardial infarction, stroke, or pneumonia found significantly lower in-hospital mortality for privately insured patients relative to the uninsured or to Medicaid recipients.38 Similarly, multiple studies assessing cancer survival and insurance status concluded that the uninsured and those with Medicaid experienced shorter survival relative to those with all other types of insurance.39-45

The exact reasons for this increased mortality in HCV-positive patients with Medicaid are not known but could potentially be related to other confounders that are not captured by these databases. These factors could include health literacy about HCV, access to preventive services, access to specialized care for HCV, number of HCV treatment providers who accept Medicaid patients, and other barriers to screening for HCV and linkage to appropriate care.

Regardless of the reasons for the adverse outcomes, our analysis provides evidence to support the conundrum faced by many Medicaid recipients and Medicaid programs in the United States. These programs cover populations that not only have high prevalence of HCV but also are at increased risk for mortality. In fact, our data show that HCV-infected individuals with Medicaid were nearly 10 times more likely to experience mortality compared with HCV-infected individuals who are covered by private insurance, and this risk was independent of a large number of confounders. The fiscal and ethical challenges of facing the combination of high prevalence and high mortality of HCV are a double-edged sword for Medicaid programs. In this context, it is important that Medicaid programs are funded appropriately to deal with this ongoing major challenge.

It is important to note that our study examined data only up to 2010, the same year the ACA was signed into law. This major reform changed the healthcare landscape in the United States, in particular by increasing the number of Americans covered by Medicaid.46 This is especially important because our data show the highest prevalence of HCV in the uninsured. As these individuals are increasingly being covered through Medicaid expansion, the burden of HCV to Medicaid will certainly increase. Also, after 2011, treatment for HCV improved dramatically with the development of DAAs.47,48 Consequently, a record number of people could become candidates for these highly effective HCV treatment options with minimal adverse events.14 Despite this high efficacy, there is evidence that Medicaid programs are not able to cope with anti-HCV treatment coverage and some programs have created substantial barriers to treatment.17,23,49 Given the time frame of our study, we are not able to assess the impact of Medicaid expansion or new antiviral regimens on the mortality of patients with HCV covered by Medicaid. Nevertheless, the increasing number of HCV-infected individuals covered through Medicaid expansion and restrictions in providing treatment regimens could have exacerbated the problem. In this context, it is important that future studies assess outcomes in the Medicaid population after these recent changes.

Limitations

Our study has several limitations. NHANES collects insurance type at the time of interview without any validation. If types of insurance were misclassified, it might dilute the true effect on mortality in our sample. This is important because the reported prevalence of Medicaid and Medicare recipients in our study is smaller than in the general population for the study period.50 After the interview, the gain or loss of coverage was not measurable. Furthermore, NHANES does not have data regarding the duration of insurance coverage or the amount of cost sharing (out-of-pocket expenses) experienced by the participants. Also, this analysis included a time period that predates ACA legislation in the United States. The impact of the insurance expansion through ACA must be analyzed in the future. Lastly, we excluded dually eligible individuals from our study because they were classified as having 2 types of insurance. We believe this exclusion had a minimal effect because this cohort included fewer than 1% of NHANES participants from 2000 to 2010. Nevertheless, our analysis still produced a number of results that are supported by the literature, indicating the validity of our analytic approach.

CONCLUSIONS

Our data show that HCV-infected individuals are at twice the risk for mortality. Additionally, patients with Medicaid had higher mortality than privately insured patients with HCV. In fact, having Medicaid coverage in HCV-infected patients independently contributed to the mortality outcomes. Given the high prevalence of HCV in the Medicaid population and their increased risk of mortality (both related to HCV and Medicaid coverage), these patients require special attention. Now that the availability of highly effective treatment regimens is wider, access to these regimens for the Medicaid population with HCV is urgently needed. In this context, it is critical that policy makers provide adequate resources to Medicaid programs to deal with this urgent need. Further research is warranted to assess the impact of the ACA, new antiviral regimens, and recent changes in the payer coverage restrictions for HCV treatment on the coverage and completion of treatment among these HCV-infected patients.

Author Affiliations: Betty and Guy Beatty Center for Integrated Research, Inova Health System (HB, JP, PG, LdA, CE, ZMY), Falls Church, VA; Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital (ZMY), Falls Church, VA.

Source of Funding: None.

Author Disclosures: Dr Younossi reports consultancies or paid advisory boards for Gilead, Intercept, and Bristol-Myers Squibb. The remaining authors report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.

Authorship Information: Concept and design (HB, JP, PG, CE, ZMY); acquisition of data (JP, ZMY); analysis and interpretation of data (HB, JP, PG, CE, ZMY); drafting of the manuscript (HB, JP, PG, LdA, CE, ZMY); critical revision of the manuscript for important intellectual content (HB, PG, LdA, CE, ZMY); statistical analysis (JP); obtaining funding (ZMY); administrative, technical, or logistic support (LdA); and supervision (ZMY).

Address Correspondence to: Zobair M. Younossi, MD, MPH, Betty and Guy Beatty Center for Integrated Research, Inova Health System, Claude Moore Health Education and Research Building, 3300 Gallows Rd, Falls Church, VA 22042. Email: Zobair.Younossi@inova.org.
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