Currentblue cross blue shield - tennesseePolicy N/A

Hepatitis C (HCV) screening, diagnosis, and monitoring

Defines coverage criteria for Hepatitis C (HCV) screening, diagnostic testing (including genotype and RNA/NAT), and monitoring of viral load for initiation and follow-up of therapy for Blue Cross Blue Shield - Tennessee members.

Policy Summary

Payerblue cross blue shield - tennessee

PolicyHepatitis C (HCV) screening, diagnosis, and monitoring

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 1, 2023

Next Review DateN/A

Key ActionPerform HCV-antibody testing with reflex HCV RNA PCR to confirm active infection and document results for referral and treatment decisions.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18-79USPSTF screening age range

one-timeOne-time lifetime testing

pre/4wk/EOT/12/24RNA testing schedule

18+Guideline citations

Coverage Criteria for HCV Testing and Monitoring

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Covered Indications and Monitoring

Covered when any of the following indications are present (policy uses a combination of one-time and ongoing risk criteria):

One-time adult screening: One-time HCV testing for all individuals over 18 years of age meets coverage criteria.

One-time/post-exposure testing indications: One-time, post-exposure testing meets coverage for individuals with illicit intranasal or injectable drug use; receipt of clotting factor concentrates produced before 1987; history of hemodialysis; evidence of liver disease based on clinical presentation or persistently abnormal ALT or abnormal liver function studies; presence of HIV infection; receipt of an organ transplant before July 1992; receipt of a blood transfusion or blood component before July 1992; individuals notified that they received blood from a donor who later tested positive for HCV; history of incarceration; receipt of a tattoo in an unregulated setting; healthcare/public safety workers after needle stick, sharps, or mucosal exposure to HCV-positive blood; children born to an HCV-positive individual; current sexual partners of HCV-infected persons.

Routine periodic testing for ongoing risk: Routine periodic HCV testing meets coverage for individuals with ongoing risk factors while risks persist, including current persons who inject drugs and share equipment; individuals receiving ongoing hemodialysis; and individuals engaging in high-risk sexual behavior.

Genotype testing prior to therapy: One-time testing for HCV genotype meets coverage criteria prior to initiation of treatment to guide selection of the most appropriate antiviral regimen.

HCV RNA quantitative testing schedule: Testing for HCV viral load using a quantitative nucleic acid test meets coverage prior to initiation of HCV therapy; after 4 weeks of therapy; at the end of treatment; and at 12 weeks and 24 weeks after completion of treatment.

Monitoring acute infection: For acute HCV infection, monitoring HCV RNA meets coverage to determine spontaneous clearance versus persistence: testing every 4–8 weeks for 6–12 months.

Populations recommended for HCV testing

Covered testing populations per cited guidelines (examples consolidated by source):

USPSTF general adult screening: Screen adults aged 18-79 years (anti-HCV antibody testing followed by confirmatory PCR)age 18-79

USPSTF B recommendation

CDC one-time testing and routine testing: One-time testing regardless of age for persons with HIV; persons who ever injected drugs; people with selected medical conditions (eg, maintenance hemodialysis, persistently abnormal ALT); prior recipients of transfusions or organ transplants before specified dates; healthcare, emergency medical, and public safety personnel after exposure; children born to HCV-infected mothers; and routine testing for those with ongoing risks such as current injection drug use.

CDC: antibody testing followed by NAT for positives

AASLD-IDSA testing recommendations: One-time opt-out testing for all individuals ≥18 years; prenatal testing with each pregnancy; periodic repeat testing for persons with ongoing exposures; annual testing for people who inject drugs and selected HIV-infected MSM groups.age >=18

AASLD-IDSA recommendations

WHO focused testing: Offer serological anti-HCV testing to populations most affected and consider general population testing in settings with ≥2% prevalence; use RDTs where laboratory access is limited and follow positive serology with NAT per recommendations.general population prevalence >=2%

WHO guidance

Initial and acute diagnostic testing

Diagnostic testing sequence per AASLD-IDSA:

Initial testing: HCV-antibody testing with reflex HCV RNA PCR is recommended for initial testing.

Class I, Level A

Acute infection suspected: When acute HCV infection is suspected due to recent exposure, clinical presentation, or elevated aminotransferases, perform both HCV antibody and HCV RNA testing.

Class I, Level C

Monitoring for patients undergoing or after DAA therapy

Laboratory monitoring recommendations from AASLD-IDSA and AGA:

Pre-DAA therapy workup: Within 6 months prior to starting DAA therapy obtain CBC, INR, hepatic function panel (albumin, total and direct bilirubin, ALT, AST, alkaline phosphatase) and eGFR; obtain quantitative HCV RNA prior to initiation; obtain genotype/subtype testing if a non-pangenotypic regimen will be prescribed.within 6 months

Class I, Level C/A

Post-treatment SVR testing: Quantitative HCV RNA testing is recommended 12 or more weeks after completion of therapy to document sustained virologic response (SVR); AGA also recommends routine confirmation of SVR at 48 weeks may be considered and testing at 24 weeks individualized.>=12 weeks post-treatment

SVR12 confirms cure

Monitoring failed treatment or not retreated: If treatment failed or the patient is not retreated, assess disease progression every 6–12 months with hepatic function panel, CBC, INR; patients with cirrhosis require HCC surveillance every 6 months with ultrasound ± AFP.6-12 months

AGA/AASLD guidance

HCV in pregnancy

Testing and monitoring in pregnancy per AASLD-IDSA:

Prenatal testing: Test all pregnant individuals for HCV infection as part of routine prenatal care, ideally at the initial visit; for antibody-positive pregnant individuals obtain HCV RNA and routine liver function tests at initiation of prenatal care to assess risk of mother-to-child transmission and disease severity.initial prenatal visit

AASLD-IDSA Rating IIb/I

Pregnancy with cirrhosis: Counsel HCV-infected pregnant individuals with cirrhosis about increased maternal and perinatal risks and coordinate care with maternal–fetal medicine specialists.presence of cirrhosis

Rating I, B

Liver disease severity assessment

Recommended methods to assess fibrosis/cirrhosis:

Noninvasive assessment: Estimate liver disease severity using liver-directed physical exam, routine labs (ALT, AST, albumin, bilirubin, INR, platelet count), serum fibrosis marker panels, transient elastography, and liver imaging (eg, ultrasound or CT); liver biopsy is rarely required.

AASLD-IDSA/EASL guidance

Screening, Diagnosis, and Referral Criteria

Covered when following guideline-recommended screening and diagnostic steps:

Screening

Populations: Includes adults ≥18 at least once (IHS) and all pregnant persons during each pregnancy (IHS); some organizations recommend targeted rather than universal screening in low-risk adults—follow applicable local/government guidance.

Diagnostic confirmation: For individuals with a positive HCV antibody screening test, perform a laboratory-based HCV RNA PCR to confirm active infection.

Confirmed HCV RNA indicates active infection and warrants referral for DAA therapy

Treatment referral: Refer patients with confirmed HCV RNA for direct-acting antiviral (DAA) treatment per clinical guidelines; assess liver disease severity prior to therapy and consider genotype determination where it may alter treatment, recognizing that pre-treatment resistance testing is not routinely recommended.

EASL: genotype useful; resistance testing not recommended

Coverage for hepatitis C testing and related services is dependent on the member's specific benefit plan at the time of the request. Providers should verify the member's plan benefits and applicable Medicare/Medicaid specifications before ordering tests. Requests for testing that fall outside the covered indications described in this policy (for example, tests not meeting the one-time testing criteria for adults >18 years or not aligned with listed risk/exposure groups) may be denied.

The AASLD advises not to repeat hepatitis C viral load testing outside of antiviral therapy, noting that repeat virologic testing when patients are not receiving antiviral treatment generally does not change clinical management. For monitoring related to therapy, quantitative HCV RNA testing is recommended prior to initiating direct-acting antiviral (DAA) therapy and at defined intervals during and after treatment to document response and sustained virologic response (SVR). Providers should follow guideline-recommended timing for RNA testing when initiating or assessing antiviral therapy rather than ordering serial viral load tests in untreated individuals.

Not all guideline bodies recommend universal screening for low-risk adults. The Canadian Task Force on Preventive Health Care (CTFPHC) recommends against screening adults who are not at elevated risk for HCV. Similarly, the Society of Obstetricians and Gynecologists of Canada (SOGC) does not recommend universal screening for individuals capable of becoming pregnant; instead, SOGC recommends targeted testing for those who fall into defined at‑risk categories after counselling and informed consent.

Provider Actions, Documentation, and Testing Requirements

Prior Authorization

Genotype and HCV RNA testing (coverage & timing)

Genotype and quantitative HCV RNA (viral load) testing are required to guide treatment selection, document baseline viremia, and monitor response to direct-acting antiviral (DAA) therapy. A single HCV genotype test (one-time) should be performed prior to initiating therapy when results may alter regimen, dosing, or duration. Quantitative HCV RNA testing is required prior to starting therapy to document baseline viral load, during therapy (per guideline timing), at end of treatment, and post-treatment to document sustained virologic response (SVR).

One-time HCV genotype testing prior to initiation of DAA therapy when clinically relevant.
Quantitative HCV RNA (NAT/NAAT) prior to therapy, at week 4 on therapy, at end of treatment, and at 12 weeks post-treatment (SVR12); consider 24-week testing when indicated.
For acute infection, perform quantitative HCV RNA every 4–8 weeks for 6–12 months to evaluate spontaneous clearance versus persistence.

Denial Risk

Coverage dependent on benefit

Coverage and payment for testing are subject to the member's specific benefit plan. Requests for testing that fall outside of the member's covered benefits, or that are inconsistent with the indications and timing described in this policy and cited guidance, may be denied.

Verify member benefits prior to ordering tests.
Testing inconsistent with benefits or outside specified indications may be denied.

Note

Government policy precedence

When federal or state government coverage determinations (for example, Medicare Local Coverage Determinations or National Coverage Determinations) conflict with this policy, the applicable government policy takes precedence and will be applied for members covered by those programs.

Check LCDs, NCDs, and state Medicaid rules for members covered under those programs.
Government coverage policy supersedes internal policy where conflicts exist.

Documentation Required

Genotype directs regimen

HCV genotype and subtype influence selection of antiviral regimen, dosing, and duration. Document genotype results in the medical record prior to prescribing non-pangenotypic DAAs and use genotype information to select the most appropriate therapy.

Perform genotype/subtype testing when results may alter treatment choice, especially if prescribing a non-pangenotypic DAA.
Document genotype in records used for treatment authorization and dispensing.

Documentation Required

Monitoring viral load

Use quantitative HCV RNA testing to document baseline viral load and to monitor on-treatment response and post-treatment cure (SVR). Adhere to guideline-recommended timepoints to assess virologic response and to support medical necessity for ongoing or additional testing.

Obtain a quantitative HCV RNA prior to initiation of antiviral therapy (baseline).
Repeat quantitative HCV RNA at ~4 weeks on therapy (on-treatment monitoring), at end of treatment, and at 12 weeks after completion to document SVR (SVR12). Consider 24-week post-treatment testing in select cases per clinician judgment or guideline suggestions.
For patients with ongoing risk factors, consider periodic HCV RNA testing after SVR to detect reinfection.

Note

Genotype and resistance testing guidance

EASL advises that genotype/subtype testing is useful where available and does not limit access to care, but routine pre-treatment resistance testing is not recommended. Clinicians should follow current guideline statements (EASL, AASLD-IDSA, WHO) regarding when genotype or resistance testing may be appropriate.

Determine genotype/subtype when it may influence regimen selection and when testing availability does not impede access to treatment.
Do not routinely perform pre-treatment HCV resistance testing unless indicated by specific clinical circumstances or as recommended by current guidance (eg, prior DAA failure or when resistance data would change management).
Follow specialty society guidance and local lab capabilities when considering testing for resistance-associated substitutions.

Definitions and Key Terms

inv-24: DAA — definition of direct acting antiviral

DefinitionDirect-acting antiviral (DAA): antiviral agents used to treat hepatitis C virus (HCV).

PurposeUsed to cure HCV infection by targeting viral proteins to achieve sustained virologic response (SVR).

Clinical rolePatients with confirmed active HCV RNA should be referred for DAA treatment per guideline-based care.

inv-25: NAT / NAAT — definition and purpose

DefinitionNucleic acid test (NAT) / Nucleic acid amplification test (NAAT): molecular assays that detect HCV RNA (including PCR-based methods).

PurposeUsed to determine active HCV infection and to quantify baseline viral load prior to therapy and for treatment monitoring.

TimingNAT/NAAT becomes positive ~1–2 weeks after infection and is the gold standard to confirm active infection after a positive antibody test.

inv-26: HCV antibody and HCV RNA — what each indicates (exposure vs active infection)

HCV antibody (anti-HCV)Indicates past or current exposure to HCV but cannot distinguish active from resolved infection.

HCV RNA (NAT/PCR)Detects viral RNA and confirms active HCV infection; used to differentiate active versus resolved infection and to document baseline viremia prior to therapy.

InterpretationAnti-HCV positive + HCV RNA positive = active infection; Anti-HCV positive + HCV RNA negative = no evidence of current infection but susceptible to reinfection.

inv-27: Noninvasive liver disease assessment — examples of methods (serum markers, elastography, labs, imaging)

Examples of methodsSerum fibrosis marker panels, transient elastography (e.g., FibroScan), liver imaging (ultrasound or CT), and routine labs (ALT, AST, albumin, bilirubin, INR, platelet count).

PurposeEstimate fibrosis/cirrhosis noninvasively to guide treatment decisions and follow-up; liver biopsy rarely required.

Clinical useIncorporated into pretreatment workup and to determine need for HCC surveillance in patients with cirrhosis.

inv-28: Active HCV infection — detectable HCV RNA by PCR following positive antibody test

DefinitionActive HCV infection: presence of detectable HCV RNA by laboratory-based PCR following a positive HCV antibody screening test.

ActionIndividuals with confirmed HCV RNA indicating active infection should be referred for DAA treatment per guidelines.

Note on testingFor recent exposure (<6 months) a negative antibody with suspected exposure should prompt HCV RNA testing or repeat antibody testing ≥6 months after exposure.

inv-29: Laboratory-developed test (LDT) — definition and regulatory context (CLIA/high-complexity)

DefinitionLaboratory-developed test (LDT): a test developed and validated by a laboratory for in‑house use and not approved/cleared by the FDA.

Regulatory contextLDTs are regulated by CMS as high-complexity tests under CLIA '88; FDA clearance/approval is not required for clinical use but labs must validate the assays per CLIA.

Clinical requirementLaboratories using LDTs for HCV RNA must follow CLIA high-complexity validation processes to support diagnostic use and confirmatory testing.

Background and Context

Hepatitis C virus (HCV) is a blood-borne, positive-stranded RNA virus that can establish chronic infection and lead to progressive liver disease, including cirrhosis and hepatocellular carcinoma. Many infected individuals are asymptomatic, which contributes to underdiagnosis. HCV exists as multiple genotypes (commonly numbered 1–6), and genotype influences regimen selection because antiviral efficacy, dosing, and duration can vary by genotype. Diagnostic evaluation typically begins with serologic anti-HCV screening followed by nucleic acid testing (quantitative HCV RNA by PCR) to confirm active infection and to establish baseline viremia for treatment planning and monitoring.

Policy Revision History

2023-07-01policy_effectiveLatest

Policy adopted (Avalon policy recommendation) and became effective on 2023-07-01.