Coverage Policy Manual
Policy #: 2013023
Category: PPACA Preventive
Initiated: July 2013
Last Review: August 2023
  PREVENTIVE SERVICES FOR NON-GRANDFATHERED (PPACA) PLANS: HEPATITIS C VIRUS SCREENING
Description:
The Federal Patient Protection and Preventive Care Act was passed by Congress and signed into law by the President in March 2010.  The preventive services component of the law became effective 23 September 2010. A component of the law was a requirement that all “non-grandfathered” health insurance plans are required to cover those preventive medicine services given an “A” or “B” recommendation by the U.S. Preventive Services Task Force.  
 
Plans are not required to provide coverage for the preventive services if they are delivered by out-of-network providers.
 
Task Force recommendations are graded on a five-point scale (A-E), reflecting the strength of evidence in support of the intervention.  Grade A: There is good evidence to support the recommendation that the condition be specifically considered in a periodic health examination.  Grade B: There is fair evidence to support the recommendation that the condition be specifically considered in a periodic health examination.  Grade C: There is insufficient evidence to recommend for or against the inclusion of the condition in a periodic health examination, but recommendations may be made on other grounds.  Grade D: There is fair evidence to support the recommendation that the condition be excluded from consideration in a periodic health examination.  Grade E: There is good evidence to support the recommendation that the condition be excluded from consideration in a periodic health examination.
 
Those preventive medicine services listed as Grade A & B recommendations are covered without cost sharing (i.e., deductible, co-insurance, or co-pay) by Health Plans for appropriate preventive care services provided by an in-network provider.  If the primary purpose for the office visit is for other than Grade A or B USPSTF preventive care services, deductible, co-insurance, or copay may be applied.
 
 
Policy/
Coverage:
In accordance with Act 598 [Hepatitis C Virus Screening] of the Arkansas legislature for all contracts subject to this law, coverage of Hepatitis C Virus screening during pregnancy is provided at no cost-share.
 
Effective October 2021
 
Screening for Hepatitis C Virus Infection in Adults is covered one time for members of “non-grandfathered” plans without cost-sharing (i.e., deductible, co-insurance, or co-pay) for adults between the ages of 18 to 79.
 
For all fully-insured health insurance policies issued in the state of Arkansas and for all self-insured government plans subject to Act 598, testing for hepatitis C during pregnancy is covered at no cost share.
  
The appropriate ICD-10 codes to report these services are: Z00.00-Z00.01, Z11.59, Z20.5, Z57.8, Z72.89, Z72.9, Z73.9
 
Codes that may be used to report the screening for Hepatitis C Virus are HCPCS G0472 and CPT 86803 and 87521.  When the primary purpose of the service is the delivery of an evidence-based service in accordance with a US Preventive Services Task Force A or B rating in effect and other preventive services identified in preventive services mandates (legislative or regulatory), the service may be billed with Modifier ‘-33’.  The correct coding as listed for both ICD-10 and CPT or HCPCS codes are also required.
 
Effective January 1, 2021 through September 2021
 
Screening for Hepatitis C Virus Infection in Adults is covered one time for members of “non-grandfathered” plans without cost-sharing (i.e., deductible, co-insurance, or co-pay) for adults between the ages of 18 to 79.
 
Screening for Hepatitis C Virus Infection in persons at high risk for infections is covered 3 times per year for members of “non-grandfathered” plans without cost-sharing (i.e., deductible, co-insurance, or co-pay). Persons at high risk for infection include the following:
 
        • Persons with past or current drug use
        • Persons in receipt of a blood transfusion before 1992  
        • Persons on long-term hemodialysis   
        • Persons born to an HCV-infected mother   
        • Persons incarcerated
        • Persons taking illicit drugs intranasally
        • Persons who have received an unregulated tattoo  
        • Persons who have received other percutaneous exposures (i.e., health care workers or surgery before the implementation of universal precautions).   
 
The appropriate ICD-9 codes to report these services are: V01.79, V15.85, V69.8, V69.9, V70.0, V73.89 or V73.99.
 
The appropriate ICD-10 codes to report these services are: Z00.00-Z00.01, Z11.59, Z20.5, Z57.8, Z72.89, Z72.9, Z73.9
 
Codes that may be used to report the screening for Hepatitis C Virus are HCPCS G0472 and CPT 86803 and 87521.  When the primary purpose of the service is the delivery of an evidence-based service in accordance with a US Preventive Services Task Force A or B rating in effect and other preventive services identified in preventive services mandates (legislative or regulatory), the service may be billed with Modifier ‘-33’.  The correct coding as listed for both ICD-9 and CPT or HCPCS codes are also required.
 
Effective Prior to January 1, 2021
 
Screening for Hepatitis C Virus Infection in Adults is covered one time for members of “non-grandfathered” plans without cost-sharing (i.e., deductible, co-insurance, or co-pay) born between 1945 and 1965.
 
Screening for Hepatitis C Virus Infection in persons at high risk for infections is covered 3 times per year for members of “non-grandfathered” plans without cost-sharing (i.e., deductible, co-insurance, or co-pay). Persons at high risk for infection include the following:
    • Persons with past or current drug use
    • Persons in receipt of a blood transfusion before 1992  
    • Persons on long-term hemodialysis   
    • Persons born to an HCV-infected mother   
    • Persons incarcerated
    • Persons taking illicit drugs intranasally
    • Persons who have received an unregulated tattoo  
    • Persons who have received other percutaneous exposures (i.e., health care workers or surgery before the implementation of universal precautions).   
 
The appropriate ICD-9 codes to report these services are: V01.79, V15.85, V69.8, V69.9, V70.0, V73.89 or V73.99.
 
The appropriate ICD-10 codes to report these services are: Z00.00-Z00.01, Z11.59, Z20.5, Z57.8, Z72.89, Z72.9, Z73.9
 
Codes that may be used to report the screening for Hepatitis C Virus are HCPCS G0472 and CPT 86803 and 87521.  When the primary purpose of the service is the delivery of an evidence-based service in accordance with a US Preventive Services Task Force A or B rating in effect and other preventive services identified in preventive services mandates (legislative or regulatory), the service may be billed with Modifier ‘-33’.  The correct coding as listed for both ICD-9 and CPT or HCPCS codes are also required.  
 
Rationale:
 
The USPSTF recommendations (Moyer, 2013) include the following information:
 
    • “Hepatitis C virus is the most common chronic bloodborne pathogen in the United States and a leading cause of complications from chronic liver disease”.
    • “The USPSTF found adequate evidence that anti–HCV antibody testing followed by confirmatory polymerase chain reaction testing accurately detects chronic HCV infection”.
    • “According to data from 1999 to 2008, about three fourths of patients in the United States living with HCV infection were born between 1945 and 1965, with a peak prevalence of 4.3% in persons aged 40 to 49 years from 1999 to 2002” (Chou, 2012; Smith, 2011).
    • “The most important risk factor for HCV infection is past or current injection drug use, with most studies reporting a prevalence of 50% or more”.
    • The recommendation applies to asymptomatic adults at high risk for HCV virus infection without known liver disease or functional abnormalities.
    • Risk factors for HCV infection include the following:
        • Past or current injection drug use;
        • Receipt of a blood transfusion before 1992;
        • Long-term hemodialysis;
        • Being born to an HCV-infected mother;
        • Incarceration;
        • Intranasal drug use;
        • Getting an unregulated tattoo; or
        • Other percutaneous exposures such as healthcare workers or from having surgery before the implementation of universal precautions.
      • Adequate evidence was found that “anti-HCV antibody testing followed by confirmatory PCR testing accurately detects chronic HCV infection”.
      • “Persons with continued risk for HCV infection (injection drug users) should be screened periodically. The USPSTF found no evidence about how often screening should occur in persons who continue to be at risk for new HCV infection”.
      • There have been no randomized trials comparing clinical outcomes between persons screened versus not screened for HCV infection. However, the USPSTF concludes, “there is a linkage between SVR [sustained virologic response] and clinical outcomes and that the overall net benefit of screening is moderate”.
 
2020 Update
 
The USPSTF commissioned a systematic evidence review to update its prior review (from 2013) on screening for HCV infection (Moyer, 2013; Chou, 2020). The scope of this review is similar to that of the prior systematic review, except in the current review, the USPSTF also examined the evidence on adolescents (Chou, 2020). For treatment, the USPSTF focused on currently recommended DAA regimens.
 
The USPSTF previously found HCV screening to be highly accurate (Moyer, 2013). The USPSTF found no new evidence on the yield of repeat vs 1-time screening or alternative screening strategies (eg, different risk- or prevalence-based methods).
 
The USPSTF found no direct evidence on the benefits of HCV screening vs no screening on health outcomes or the effects of prenatal HCV screening on the risk of vertical transmission (Chou, 2020). Treatment studies focused on populations without cirrhosis who are more likely to be asymptomatic and identified by screening. Of the trials of DAA regimens (n = 7167; 26% to 69% female; mean age, 45 to 62 years), 14 were multinational; 11 were conducted in the US or Canada; and the remainder were conducted in New Zealand, Egypt, France, or Asia. In 29 trials, 60% to 100% of patients were white (Chou, 2020). The trials evaluated a variety of DAA regimens recommended in current guidelines. Treatment duration was 12 weeks in all but 2 trials, which allocated patients to either 8 or 12 weeks of treatment. Eleven trials were of good quality and 22 were of fair quality. Forty-nine trials found DAA regimens to be associated with pooled SVR rates ranging from 95.5% to 98.9% across genotypes. Evidence was greatest for genotype 1 infection (32 trials), the most frequent genotype in the US (Chou, 2020). Sustained virologic response rates were similar in trials that stratified patients according to age, sex, race/ethnicity, or treatment experience with non-DAA regimens (Chou, 2020).
 
Direct evidence on the effects of current DAA regimens on health outcomes is limited (Chou, 2020). Pooled analysis from 10 trials found small, short-term improvements in quality of life scale scores after treatment with a DAA regimen compared with baseline scores (Chou, 2020). Trials reporting short-term mortality (<1 year) found few events and were not designed to detect differences in mortality rates. Twenty-one trials reported no deaths; in the other 10 trials, there were 17 deaths (0.4% [17/3848] overall) (Chou, 2020).
 
The USPSTF review evaluated the linkage between achieving SVR after antiviral therapy vs no SVR and health outcomes. Sustained virologic response after antiviral therapy was consistently associated with decreased risk of all-cause mortality (13 studies; pooled hazard ratio [HR], 0.40 [95% CI, 0.28-0.56]), liver mortality (4 studies; pooled HR, 0.11 [95% CI, 0.04-0.27]), cirrhosis (4 cohorts in 3 studies; pooled HR, 0.36 [95% CI, 0.33-0.40]), and hepatocellular carcinoma (20 studies; pooled HR, 0.29 [95% CI, 0.23-0.38]) vs no SVR, after adjustment for potential confounders (Chou, 2020).
 
The USPSTF found limited new evidence on the risk of vertical transmission. Five observational studies found no clear association between risk of vertical transmission of HCV infection and the mode of delivery (Chou, 2020). One good-quality US study showed that prolonged rupture of membranes (>6 hours) was associated with increased risk of HCV transmission in 189 mother-infant pairs compared with membrane rupture lasting less than 6 hours (adjusted odds ratio, 9.3 [95% CI, 1.5-180]) (Chou, 2020; Mast, 2005). One observational study in 188 mother-infant pairs found that internal fetal monitoring was associated with an increased risk of vertical transmission of HCV infection compared with external monitoring (adjusted odds ratio, 6.7 [95% CI, 1.1-35.9]) (Chou, 2020; Mast, 2005). Three observational studies did not find a clear association between breastfeeding and an increased risk of vertical transmission of HCV infection (Chou, 2020).
 
The evidence is also limited in adolescents. Seven trials (n = 300) reported SVR rates in adolescents taking DAA regimens similar to those taken by adults (97%-100%) (Chou, 2020). However, some of the trials evaluated regimens that are not approved by the US Food and Drug Administration for use in adolescents (Chou, 2020). Direct-acting antiviral regimens recommended and approved by the US Food and Drug Administration for use in adolescents are ledipasvir/sofosbuvir, sofosbuvir/ribavirin, and glecaprevir/pibrentasvir (Chou, 2020). The evidence on antiviral treatment and health outcomes in adolescents is very limited. One post hoc before-and-after analysis found that scores based on the Pediatric Quality of Life Inventory (ie, school and social functioning) improved from baseline to 24 weeks after treatment with a DAA regimen (Chou, 2020).
 
Modeling studies that compared screening in all persons 18 years and older with birth cohort screening suggested that expanded screening strategies would be beneficial, despite different assumptions regarding chronic HCV infection progression and rates of linkage to care (Chou, 2020). One analysis of a hypothetical cohort of the US population used more conservative assumptions and found that screening everyone 18 years and older would identify an estimated 256,000 additional HCV cases and lead to an estimated 280,000 additional individuals who achieve SVR and an estimated 4400 fewer cases of hepatocellular carcinoma over a lifetime (Chou, 2020; Barocas, 2018).
 
The USPSTF did not identify any new studies providing direct evidence on screening harms. Poor-quality evidence from the prior review suggested potential negative psychological and social effects from HCV screening (Chou, 2020; Chou 2012).
 
Direct-acting antiviral regimens are associated with fewer harms than older interferon-containing therapies. Treatment duration has shortened from 24 to 48 weeks with older interferon-containing regimens to 8 to 12 weeks (Chou, 2020). In DAA trials (33 trials; n = 7167) with adverse event data, the pooled rate of any adverse event was 73.3% (Chou, 2020). Rates of serious adverse events (1.9%) and withdrawal due to adverse events (0.4%) were low compared with rates reported for interferon-containing regimens (Chou, 2020). Pooled rates of specific adverse events ranged from 2.4% for anemia to 18.4% for headache and were also lower when compared with rates reported for older interferon-containing therapies (Chou, 2020). The most common adverse events were fatigue, headache, nausea, and diarrhea (Chou, 2020).
 
Seven nonrandomized, open-label trials (n = 300) in adolescents examined treatment harms. Five trials reported no withdrawals due to adverse events; 1 trial reported a serious adverse event (grade 3 joint injury). The rate of any adverse event was 27% in 1 trial and 71% to 84% in 4 trials. Specific adverse event rates across trials ranged from 3% to 48% for headache (7 trials), 5% to 53% for fatigue (7 trials), and 3% to 28% for gastrointestinal adverse events (nausea, vomiting, or diarrhea) (5 trials) (Chou, 2020). Three trials reported no deaths in adolescents (n = 182) treated with DAA regimens (Chou, 2020). These trials were not designed to evaluate long-term harms associated with DAA treatment during adolescence (Chou, 2020).
CPT/HCPCS:
86803Hepatitis C antibody;
87521Infectious agent detection by nucleic acid (DNA or RNA); hepatitis C, amplified probe technique, includes reverse transcription when performed
G0472Hepatitis c antibody screening, for individual at high risk and other covered indication(s)
References: Barocas JA, Tasillo A, Eftekhari Yazdi G, et al.(2018) Population-level outcomes and cost-effectiveness of expanding the recommendation for age-based hepatitis C testing in the United States. Clin Infect Dis. 2018;67(4):549-556.

Chou R, Cottrell EB, Wasson N et al.(2012) Screening for Hepatitis C Virus Infection in Adults. Comparative Effectiveness Review no. 69.AHRQ publication no. 12-EHC090-EF. Rockville, MD: Agency for Healthcare Research and Quality; 2012. Accessed at www.ncbi.nlm.nih.gov/books /NBK115423 on 24 May 2013.

Chou R, Dana T, Fu R, et al.(2020) Screening for Hepatitis C Virus Infection in Adolescents and Adults: A Systematic Review Update for the U.S. Preventive Services Task Force. Evidence Synthesis No. 188. Agency for Healthcare Research and Quality; 2020. AHRQ Publication No. 19-05256-EF-1.

Chou R, Dana T, Fu R, et al.(2020) Screening for hepatitis C virus infection in adolescents and adults: updated evidence report and systematic review for the US Preventive Services Task Force. JAMA. Published online March 2, 2020.

Mast EE, Hwang LY, Seto DS, et al.(2005) Risk factors for perinatal transmission of hepatitis C virus (HCV) and the natural history of HCV infection acquired in infancy. J Infect Dis. 2005;192(11):1880-1889.

Moyer VA.(2013) Screening for hepatitis c virus infection in adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 25 June 2013. epub ahead of print. Available at www.annals.org.

PPACA & HECRA: Pubic Laws 111-148 & 111-152. The Patient Protection and Affordable Care Act

Smith BD, Patel N, Beckett GA et al.(2011) Hepatitis C virus antibody prevalence, correlates and predictors among persons born from 1945 through 1965, United States, 1999-2008 [Abstract]. Hepatology. 2011;54(Suppl 1):554A-5A.
Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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