The Potential Impact of the Kennedy v. Braidwood Supreme Court Decision on Hepatitis C Diagnosis and Treatment in the United States

Kennedy v. Braidwood (formerly, Braidwood v. Becerra), is a US Supreme Court case challenging the Affordable Care Act (ACA) requirement that insurance plans cover preventive services receiving an A or B rating by the United States Preventive Services Task Force at no cost (ie, copays, coinsurance, or deductibles) to patients. Since screening for hepatitis C virus (HCV) is among these services, a ruling overturning the ACA coverage mandate has the potential to dramatically change the landscape for early detection and treatment of hepatitis C in the U.S.

The Clinical and Economic Impact of Hepatitis C

HCV is a major public health concern and a leading cause of cirrhosis and hepatocellular carcinoma (HCC). According to the Centers for Disease Control and Prevention, more than 2 million Americans are currently living with hepatitis C, despite the availability of a highly accurate screening tests and curative treatments. Alarmingly, HCV prevalence has more than doubled over the past decade and is projected to continue rising.¹

The clinical and economic impact of this detectable and treatable disease is widespread and devastating. Following acute infection, 55%–85% of individuals develop chronic hepatitis C. Of those with chronic disease, 20%–25% will go on to develop cirrhosis within 25–30 years. Once cirrhosis develops, the annual risk of liver failure, HCC, and liver-related mortality rises to 1%–4%.² Overall, HCV infection is associated with a 15- to 20-fold increased risk of HCC and is responsible for over 350,000 deaths each year. In countries with high HCV burden (including the United States) 30%–60% of liver cancers are attributable to HCV.^3,4

Hepatitis C Treatment is Effective

Treatment with direct-acting antivirals (DAAs) leads to a cure in virtually all cases. Treatment significantly reduces the risks of liver failure and HCC, and evidence shows that overall mortality among treated patients is about 43% lower compared to those untreated.⁵ Despite previous widespread attention to DAA acquisition costs, a 2022 American Journal of Managed Care study reported that since curative DAA medications for hepatitis C were approved in 2013 Medicaid has saved an estimated $15 billion in avoided health-care costs (even after factoring in the cost of treatment) and nearly 285,000 Medicaid enrollees have been cured.⁶

Hepatitis C can be Eliminated

To address these sobering statistics, a national hepatitis C elimination plan has been proposed, offering promising population health and economic benefits. If fully implemented, it could save more than 90,000 lives and nearly $60 billion in health-care costs by 2050.⁷ Modeling studies suggest that within 5 years, 92.5% of HCV-infected individuals could be diagnosed and 89.6% cured. Over a 10-year period, this initiative could prevent 20,000 cases of HCC, avert 24,000 deaths, and add 220,000 life years, while also saving an estimated $18.1 billion in direct health-care expenditures.⁸

Need to Increase Uptake of Hepatitis C Screening and Treatment

Despite the availability of highly effective, safe, and well-tolerated medications that lower total medical expenditures, screening and treatment rates remain unacceptably low in the US Hepatitis C can be identified through a simple blood test that is currently available without patient cost-sharing for almost all insured adult Americans. Current intervention strategies are insufficient to achieve HCV elimination targets.⁹ Approximately 12% of US adults born between 1945 and 1965 were screened for HCV in 2017. Further, there are disparities in who received HCV screening; individuals with lower incomes are screened less often even though they are 5 times more likely to have HCV and account for over one-third of current infections.¹⁰

To improve detection rates, the Centers for Disease Control and Prevention updated and expanded its screening guidelines in April 2020 to recommend a one-time HCV screening for all adults aged ≥18 year old.¹ That same year, the United States Preventive Services Task Force endorsed this recommendation with a grade B rating—that under the current ACA preventive services provision requires almost all insurers to cover HCV screening without consumer cost-sharing. The elimination of patient out of pocket costs has led to an increase in HCV screening rates. For example, following the guidance change, HCV screening rates rose from 141 to 253 per 1000 person-years among pregnant women and from 29 to 37 per 1000 person-years among nonpregnant women.¹¹ As a result of higher detection, in 2022 the rate of reported acute HCV infections decreased for the first time in more than a decade.¹ Despite this progress, screening rates remain low and continued efforts to increase screening uptake are warranted.

It is worth noting that the benefits that result from increased screening rates can be achieved only if those diagnosed with HCV receive curative treatment. Between 2014 and 2020, 1.2 million individuals were treated (approximately 170,000 annually), a fraction of the estimate of those infected.¹² One study demonstrated that after initially screening positive, 88% of patients received confirmatory RNA testing, 62% tested positive on this confirmatory testing, and 53% initiated treatment.¹³ Among those receiving a HCV diagnosis with continuous insurance coverage, fewer than 35% received treatment within 1 year.¹⁴ These treatment rates are even lower for Medicaid beneficiaries in states with restrictive coverage policies (eg, step-therapy, prior authorization).

Thus, efforts to reduce the immense clinical and economic burden of HCV must span the continuum from diagnosis through cure. Given that critical role of diagnosis in achieving this ambitious goal, the Kennedy v Braidwood case—regardless of the Supreme Court’s decision—reminds us that access to, and increased uptake of available, noninvasive, no/low cost, and highly accurate HCV screening tests are foundational to a national HCV elimination plan. If the plaintiffs prevail and insurance providers are no longer required to cover essential preventive services, such as hepatitis C screening, without cost-sharing, utilization of these services will likely decline. The voluntary reimposition of cost sharing—which we must oppose—will lead to more undiagnosed and untreated cases, resulting in worsening health outcomes and escalating financial strain on the health-care system. Alternatively, if the Supreme Court were to preserve the preventive services mandate, it offers a ‘second chance’ for key constituents, including those who diagnose and treat this condition, to better educate eligible patients about no-cost HCV screening. Increased diagnosis and treatment use would improve patient outcomes, reduce medical expenditures, and create a rare ‘win-win-win’ scenario for patients, clinicians and payers alike.