Hep C Screening: Life Insurance's Impact On Your Health

Hepatitis C is a liver disease caused by the Hep C virus, which spreads through infected blood. It is a serious condition that can lead to liver damage, liver cancer, and even death if left untreated. The good news is that Hep C is curable, and direct-acting antiviral (DAA) medications have been available since 2014, with a 95% cure rate. However, the high cost of treatment, which can be up to $95,000, has created barriers to accessing these medications, even for those with insurance.

In the United States, the Centers for Disease Control and Prevention (CDC) recommends Hep C screening for everyone over the age of 18 and during each pregnancy. Additionally, those with certain risk factors, such as injected drug use, specific health issues, organ transplants, or blood transfusions, are advised to get tested.

While Hep C screening is available to anyone who requests it, insurance coverage for treatment may vary. Some insurance providers only cover treatment for people with advanced stages of Hep C or those with specific complications. The high cost and potential insurance restrictions emphasize the importance of timely diagnosis and treatment to prevent the progression of the disease and improve patient outcomes.

Hep C treatment access barriers

Hepatitis C (Hep C) treatment access barriers exist at multiple levels, from diagnosis to specialist referral. At the patient level, lack of awareness, fear of side effects, poor adherence, and comorbid conditions may prevent treatment. For providers, limited knowledge, lack of availability, and communication difficulties may be problematic. At the government and payer level, a lack of promotion, surveillance, and funding may interfere.

Patient-level barriers

Patients may lack awareness of their Hep C infection, representing the single greatest barrier to treatment. Among infected or at-risk persons, knowledge about Hep C is often poor. Confusion regarding modes of transmission, disease complications, and interpretation of Hep C screening tests is common. These deficiencies may contribute to missed treatment opportunities, continued transmission, and poorer health outcomes.

Even when diagnosed, patients may fail to seek treatment due to a lack of perceived urgency to treat an asymptomatic disease, as well as significant economic and social pressures. Persons with Hep C are more likely to be uninsured, and uninsured persons are less likely to have contact with healthcare professionals, reducing the likelihood of diagnosis and treatment. The high cost of treatment, which can be up to $100,000 per course, is a significant barrier, especially for uninsured patients.

Psychiatric illness, including depression, is a further barrier, as clinicians frequently defer therapy for patients with underlying psychiatric conditions. Injection drug use, a frequent mode of Hep C acquisition, is also a common reason for treatment deferral due to concerns about poor patient adherence, increased risk of adverse effects, and post-treatment reinfection.

Provider-level barriers

Provider-level barriers include a lack of knowledge and awareness, limited specialist availability and/or lack of referral, and communication issues. Healthcare professionals have demonstrated knowledge deficits related to Hep C prevalence, risk factors, prevention, and management. Primary care physicians infrequently refer Hep C patients for subspecialty evaluation, and the availability of specialists is limited, resulting in long-distance travel, extended wait times, and a lack of scheduling flexibility for patients.

Negative interactions with Hep C treatment providers may also serve as a barrier, with patients reporting feeling rushed, misled, or not listened to. Such interactions may discourage patients from seeking treatment and adhering to physician recommendations.

Government and payer-level barriers

Governments and payers play a critical role in delivering Hep C services, implementing surveillance programs, disseminating information, and increasing public and provider awareness. Lack of treatment promotion, insufficient funding, lack of insurance coverage, high out-of-pocket expenses, and excessive paperwork are all barriers that can interfere with access to treatment.

Insurance denial reasons

People with Hepatitis C (Hep C) may be denied insurance coverage for several reasons, which can have life-threatening consequences. Here are some of the reasons for insurance denial and the challenges faced by those living with Hep C:

High Treatment Costs

The high cost of treating Hep C is a significant factor in insurance denial. Treatment typically involves an 8- to 12-week course of antiviral medication, which can cost up to $95,000. As a result, insurance providers often only cover treatment for people with advanced stages of the disease. Those with early-stage Hep C may be deemed "not sick enough" for treatment, even though delaying treatment increases the risk of the condition advancing and causing life-threatening complications.

Insurance Restrictions

Insurance providers often have restrictions in place that prevent people with Hep C from accessing treatment. For example, some insurers require individuals to have liver damage or liver cancer before approving treatment. Additionally, insurance companies may deny coverage if the patient consumes alcohol or uses other substances.

Lack of Insurance

About one-third of people diagnosed with Hep C in the United States do not have health insurance. This lack of insurance coverage can make it challenging for individuals to access the necessary treatment and increase their risk of developing serious liver diseases.

Insurance Type

The type of insurance also plays a role in access to treatment. People with Medicaid are less likely to receive timely treatment than those with private insurance. Racial disparities also exist, with Medicaid recipients of other races being up to 27% less likely to get timely treatment compared to White recipients.

Pre-existing Conditions

Insurance companies may deny coverage or increase premiums for individuals with pre-existing conditions, including Hep C. This can create a barrier for people living with Hep C to access the necessary treatment and improve their health outcomes.

Limited Provider Network

In some cases, insurance providers may cover Hep C treatment, but the number of in-network specialists may be limited. As a result, individuals may face challenges finding a liver specialist who accepts their insurance, further delaying their access to treatment.

Treatment cost and affordability

Hepatitis C treatments can be expensive, with drug prices ranging from $1,000 per pill to $23,600 per month. The total cost of treatment can be as high as $84,000 for a 12-week course. While health insurance can cover some of these costs, not all insurance plans cover direct-acting antivirals (DAAs), and co-pays can still be substantial.

The high cost of hepatitis C treatment is due in part to the market exclusivity of the drugs. Pharmaceutical companies that manufacture these drugs have the freedom to set high prices, as there are currently no generic versions available. This freedom to set prices is further enabled by the lack of transparency around negotiated pricing and cost structure for pharmaceutical products in the US.

Despite the high cost of treatment, there are ways to make hepatitis C treatment more affordable. Drug companies often offer patient assistance programs to help people afford medication, and some states and nonprofit groups also offer assistance programs. Additionally, doctors and pharmacists may be able to find lower-cost treatments or direct patients to less expensive places to purchase medication. Clinical trials for new drugs can also be an option for those who cannot afford treatment.

For those with insurance, it is important to check with the insurer to find out what is covered and what co-payments will be. Many insurance providers have restrictions in place that prevent people from accessing treatment, such as requiring patients to have liver damage or to be sober.

Even with insurance, only about one in three people with hepatitis C receive timely treatment. This number is even lower for people with Medicaid, who were 46% less likely to receive treatment than those with private insurance.

The affordability of hepatitis C treatment is a significant issue, and it is important for healthcare providers, insurers, policymakers, and public health professionals to work together to improve access to treatment.

Screening recommendations

United States Preventive Services Task Force (USPSTF)

The USPSTF recommends screening for Hepatitis C virus (HCV) infection in adults aged 18 to 79 years. This includes asymptomatic adults, including pregnant persons, without known liver disease. The USPSTF also suggests that clinicians consider screening persons younger or older than the recommended age range who are at high risk for infection, such as those with past or current injection drug use.

CDC Recommendations

The CDC recommends hepatitis C screening at least once in a lifetime for all adults aged 18 and older, except in settings where the prevalence of HCV infection is less than 0.1%. They also recommend hepatitis C screening for all pregnant women during each pregnancy, except in settings where the prevalence of HCV infection is less than 0.1%. Additionally, the CDC recommends routine periodic testing for persons with ongoing risk factors, such as injection drug use and sharing needles.

World Health Organization (WHO)

The WHO has issued the following general guidelines for screening:

• The condition should be an important health problem.
• There should be a treatment for the condition.
• Facilities for diagnosis and treatment should be available.
• There should be a latent stage of the disease.
• There should be a test or examination for the condition.
• The test should be acceptable to the population.
• The natural history of the disease should be adequately understood.
• There should be an agreed-upon policy on whom to treat.
• The total cost of finding a case should be economically balanced in relation to medical expenditure as a whole.
• Case-finding or selective screening should be a continuous process, not just a one-time project.

Other Organisations

Other organisations, such as the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), have their own recommendations for hepatitis C screening. These may differ from the CDC and USPSTF guidelines in certain aspects.

HCV test process and results

The HCV Ab test is used for initial screening for hepatitis C. The test is performed by enzyme immunoassays (EIAs), which detect the presence of hepatitis C antibodies in the serum. The result of the test is reported as positive or negative. Third-generation EIAs have a sensitivity/specificity of approximately 99%. However, the presence of HCV Ab does not indicate whether the infection is acute, chronic, or resolved. A positive antibody test result should be followed up with an HCV RNA test to confirm that viremia is present.

False-negative and false-positive HCV Ab results are possible. A false negative may occur if the test is performed during the window period after acute HCV infection but before seroconversion (when the HCV Ab converts from negative to positive). The average time from infection until seroconversion is 8 weeks and is referred to as the "serologic window." If acute infection is suspected to have taken place within the past 8 weeks, it is appropriate to order the HCV RNA test. If the HCV Ab test result is negative within the first 8 weeks after infection, it is appropriate to retest the antibody after 8 weeks to check for seroconversion.

A false-negative HCV Ab result may also occur in immunocompromised individuals such as those infected with HIV, recipients of organ transplants, and patients receiving chronic hemodialysis. If the HCV Ab result is negative in immunocompromised patients but there is a strong suspicion of HCV infection, it is appropriate to order the HCV RNA test.

A false-positive HCV Ab result may occur due to cross-reactivity with other viral antigens or the presence of immunologic disorders such as lupus or rheumatoid arthritis.

The turnaround time for third-generation EIAs is at least 1 day. Many labs do not perform the tests on-site and must send specimens to another lab for processing, which may further increase the turnaround time. A point-of-care test, the OraQuick® HCV Rapid Antibody Test, is also available. It is an FDA-approved test that can be performed with a fingerstick (or venous blood draw) and provides results within 20 minutes. Similar to the standard HCV Ab test, a positive OraQuick® test must be confirmed by an HCV RNA test.

The presence of HCV RNA is required to confirm chronic HCV infection. Therefore, a positive HCV Ab screening result must be followed by a test for HCV RNA. The HCV RNA tests can detect the virus within 1-2 weeks following exposure. There are four major reasons for using HCV RNA tests:

• To confirm a positive HCV Ab result and make the diagnosis of current HCV infection.
• To measure a patient's baseline viral load before starting HCV therapy.
• To monitor a patient's response to therapy.
• To determine whether a patient has achieved a sustained virologic response (SVR).

Additionally, HCV RNA testing is used when either very acute HCV infection is suspected or a false HCV Ab is suspected. It is not appropriate to repeatedly order HCV RNA viral load screening for a patient who is not on or was recently on HCV treatment, or to use the HCV viral load to determine the severity of the patient's infection or their risk of developing significant liver disease.

Interpreting the results of the HCV Ab and HCV RNA tests:

• HCV Ab nonreactive = negative
• HCV Ab reactive = positive

If the antibody result is negative (nonreactive), no further action is required. However, if acute HCV is suspected, testing for HCV RNA is necessary, as the HCV Ab result may not be positive yet.

A positive HCV Ab result indicates exposure to HCV. Testing for HCV RNA is then performed to determine if there is an active or resolved infection. Once the HCV Ab result is positive, the test does not need to be repeated, as the result will remain positive even after successful HCV treatment.

Interpreting the results of the HCV RNA test:

• HCV Ab positive, HCV RNA detected: Active HCV infection. If the infection occurred >6 months ago, this is chronic HCV infection.
• HCV Ab positive, HCV RNA not detected: No active HCV infection. The patient spontaneously cleared HCV and did not become chronically infected, or they were successfully treated and achieved SVR.

If there is concern about a false-positive antibody screen, a repeat HCV Ab test using a different assay may be considered.

The HCV RNA PCR test is another method used to determine the presence of HCV in the bloodstream and measure the viral load. A healthcare provider will take a blood sample, and the test can be conducted through a process called polymerase chain reaction (PCR) in qualitative or quantitative approaches. The qualitative test indicates whether HCV is present in the blood, while the quantitative test measures the exact amount of HCV in international units per milliliter (IU/mL).

Interpreting the qualitative and quantitative HCV RNA PCR test results:

• Qualitative results: "Detected" indicates the presence of HCV in the blood, while "Undetected" means no virus is present or it is present in tiny amounts that cannot be detected by the test.
• Quantitative results: The number of HCV RNA international units per milliliter of blood (viral load) is measured. A low viral load is detected at fewer than 800,000 IU/mL, while a high viral load is detected at more than 800,000 IU/mL.

The HCV test process involves initial screening with the HCV Ab test, followed by confirmatory HCV RNA testing to diagnose active infection. The HCV RNA PCR test is also used to determine the viral load and monitor the response to treatment. Interpreting the results of these tests helps in confirming the presence of HCV and guiding treatment decisions.

Frequently asked questions