HEPATITIS B TESTING (SURFACE ANTIGEN AND ANTIBODY)

MEDICAL POLICY For use with the UnitedHealthcare Laboratory Benefit Management Program, administered by BeaconLBS HEPATITIS B TESTING (SURFACE ANTIGE...
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MEDICAL POLICY For use with the UnitedHealthcare Laboratory Benefit Management Program, administered by BeaconLBS

HEPATITIS B TESTING (SURFACE ANTIGEN AND ANTIBODY) Policy Number: CMP - 036 Effective Date: October 1, 2014 Table of Contents

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INSTRUCTIONS FOR USE BACKGROUND POLICY REFERENCES POLICY HISTORY/REVISION HISTORY

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INSTRUCTIONS FOR USE This Medical Policy provides assistance in interpreting UnitedHealthcare benefit plans. When deciding coverage, the enrollee specific document must be referenced. The terms of an enrollee's document (e.g., Certificate of Coverage (COC) or Summary Plan Description (SPD)) may differ greatly. In the event of a conflict, the enrollee's specific benefit document supersedes this Medical Policy. All reviewers must first identify enrollee eligibility, any federal or state regulatory requirements and the plan benefit coverage prior to use of this Medical Policy. Other Policies and Coverage Determination Guidelines may apply. UnitedHealthcare reserves the right, in its sole discretion, to modify its Policies and Guidelines as necessary. This Medical Policy is provided for informational purposes. It does not constitute medical advice. UnitedHealthcare may also use tools developed by third parties, such as the MCG™ Care Guidelines, to assist us in administering health benefits. The MCG™ Care Guidelines are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice. BACKGROUND Hepatitis B virus (HBV) is transmitted by exposure to infectious blood or body fluids. Infection with hepatitis B can run an asymptomatic or otherwise deceptively mild course, with symptoms including fatigue and nausea arising 60-150 days after exposure. HBV has been called the silent epidemic because infected individuals can spread the virus without even knowing they are infected. Infection can be self-limiting or can progress to chronic HBV. While 95% of infected adults will recover completely without progressing to chronic HBV, 90% of infants and up to 50% of children ages 1-5 will develop chronic HBV.1 Chronic HBV causes hepatic fibrosis that can ultimately lead to cirrhosis and hepatocellular carcinoma. Kidney disease and hepatic encephalopathy can also occur. Chronic HBV is the most common cause of hepatocellular carcinoma around the globe. Viral hepatitis accounts for the highest number of liver transplants in the United States.2 The expense of HBV grew from $357 million in 1990 to $1.3 billion in 2006.2 These health care costs can be Proprietary Information of UnitedHealthcare. Copyright 2014 United HealthCare Services, Inc. Page 1

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reduced by disease detection and therapy, estimated to cost $33,900 per quality-adjusted life year gained.2 Hepatitis B Surface antigen (HBsAg) and antibody to hepatitis B surface antigen (anti-HBsAg) are serologic tests that are important for HBV detection. Early detection and treatment can stop disease progression in the host. Factors that come to bear on disease progression include HBV viral load, age at onset, gender, comorbidities and genetic factors. Viral load is an independent risk factor for developing hepatocellular carcinoma; this association was proven in two large prospective studies in Taiwan known as REVEAL-HBV (Risk Evaluation of Viral Load Elevation and Associated Liver Disease/Cancer-Hepatitis B Virus).3 Infants have the highest rates of progression to serious disease, and one in four infants infected will ultimately die from disease complications.2 Males have a higher rate of progression to hepatocellular carcinoma. In terms of comorbidities, alcohol intake > 60g/day and aflatoxin (carcinogenic mycotoxin) exposure have a synergistic effect on the risk of hepatocellular carcinoma in HBV patients.4 Also, HBV patients with hepatitis C or HIV coinfection have higher rates of mortality due to liver disease.5 Hepatitis D virus, which is dependent on HBV for replication, also increases the risk of hepatocellular carcinoma. Genotype C HBV is associated with an increased risk of hepatocellular carcinoma.6 The Centers for Disease Control and Prevention (CDC) estimates there are 2.7-3.9 million persons living with hepatitis B (HBV) and that there were 16,000 new infections in 2009.1 It is estimated that 10% of Asian and Pacific Islander adults living in the United States are infected with HBV,7 but as many as 50% of people with chronic HBV in the United States are Asian American.8 It is believed that roughly two-thirds of people with HBV do not carry a diagnosis. These individuals with HBV are particularly at risk for complications of chronic HBV. When infected individuals are identified through serologic testing, this knowledge benefits their close contacts because they can be vaccinated. Children are particularly vulnerable to chronic infection, and in 1991, the routine vaccination of infants was instituted in the United States. Despite a decrease of HBV in birth cohorts due to infant vaccinations, the incidence of hepatocellular carcinoma is expected to increase for another twenty years due to the slow development of carcinoma after infection.4 Clinical intervention is key for those individuals who were not vaccinated at birth who may not be aware they are already infected with HBV. Transaminases are not elevated at every stage of infection and cannot be used to identify infected persons. HBV infection has four discrete stages based on the immune response to the pathogen although not all persons will progress through all four phases.9 First, viral replication takes place during an immune-tolerant phase. Next, the immune system clears the disease in 80-90% of patients, and during this phase, there can be transient increases in transaminases. Next, for those patients who progress to chronic infection, there is a chronic carrier stage when serum alanine aminotransferase is normal. The fourth phase, reactivation, can occur when the immune system is weakened. Because transaminase elevation cannot reliably identify every case of HBV infection at each phase of infection, viral detection must rely instead on laboratory testing specifically developed to identify HBV infection. There are numerous serologic and molecular laboratory assays for HBV. HBsAg and anti-HBsAg are serologies that are the basis for HBV detection. Originally called the Australia antigen, HBsAg is used to detect current HBV infection. The antigen is the envelope protein of the virus. It is the earliest indicator of infection, and positivity occurs 2-8 weeks before elevations of transaminases or the onset of jaundice. HBsAg does not persist after recovery; it is cleared in cases of self-limited HBV. Chronic HBV infection is defined by 6 months or more of HBsAg positivity.8 Anti-HBsAg levels increase during recovery and indicate previous infection; therefore, it is important to know the anti-HBsAg status of a person to determine if vaccination is appropriate. Individuals are tested for HBV Proprietary Information of UnitedHealthcare. Copyright 2014 United HealthCare Services, Inc. Page 2

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before vaccination, if testing can be carried out. Absence of antibodies to HBsAg indicates a person is susceptible to infection with HBV. Persons with occult HBV have detectable HBV DNA in liver and serum in the absence of detectable HBsAg. The prevalence and clinical significance of occult HBV remains unclear. Early HBV detection is the key to public health efforts to identify infected individuals so that close contacts can be vaccinated to prevent spread of the virus. The CDC recommends serologic testing with HBsAg and anti-HBsAg for the following individuals10:        

Pregnant women Infants born to HBsAg-positive mothers Persons born in geographic areas with a HBsAg prevalence of ≥2% Persons born in the United States but not vaccinated as infants whose parents were born in regions where the virus is endemic (≥8%) Men who have sex with men Persons with multiple sex partners or history of a sexually transmitted disease Past or current intravenous drug users Household, needle-sharing and sex contacts of HBV-infected persons

     

Persons who are the source of blood or body fluid exposure Patients who will be treated with cytotoxic or immunosuppressive therapy Persons with persistently elevated transaminase levels without a known etiology Hemodialysis patients Persons with HIV Donors of blood, plasma, organs, tissues, or semen

In addition to testing these individuals, health care providers often test patients with symptoms known to occur with HBV. These symptoms include nonspecific complaints such as fever, fatigue, loss of appetite and nausea and vomiting. Jaundice, joint pain, abdominal pain, dark urine and pale stools also suggest infection. Testing is important for patients presenting with symptoms of polyarteritis nodosa; HBV seropositivity is one of the clinical criteria for the diagnosis.11 HBsAg is measured during therapy for HBV to monitor treatment response; serologic loss of HBsAg is one of the endpoints for HBV therapy.10 National efforts are underway to increase awareness for the need for testing, and the CDC is the lead organization in the first annual “Hepatitis Testing Day” on May 19, 2012.2 Even in patients who have received HBV vaccination, HBsAg testing is recommended by the CDC for the following groups10:  Persons born in geographic regions where the prevalence exceeds 2%  Persons born the US who were not vaccinated as infants if their parents were born in regions with HBV endemicity ≥ 8%  Persons who were vaccinated after exposure to behaviors associated with viral transmission For patients who are at high risk of continued exposure, such as hemodialysis patients, annual testing is recommended following vaccination.5

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POLICY

It is recommended that for the following CPT code(s) in Table 1, the patient should have a diagnosis (ICD- 9-CM) code(s) listed in Table 2. Table 1. HCPCS Codes (Alphanumeric, CPT AMA) HCPCS Code 86706 87340

Description Hepatitis B Surface Antibody (HBSAB) Infectious agent antigen detection by enzyme immunoassay technique, qualitative or semiquantitative, multiple

Table 2. ICD-9-CM Codes Covered ICD-9 Code

Description

42 70.20-70.23 70.30-70.33 70.41-70.49 70.51-70.59 70.6 70.70 70.9 99.9 273.2 304

Human immunodeficiency virus [HIV] disease Viral hepatitis b with hepatic coma Viral hepatitis b without hepatic coma Other specified viral hepatitis with hepatic coma Other specified viral hepatitis without mention of hepatic coma Unspecified viral hepatitis with hepatic coma Unspecified viral hepatitis c without hepatic coma Unspecified viral hepatitis without hepatic coma Venereal disease, unspecified Other paraproteinemias Opiod type dependence, unspecified

304.7

Combinations of opiod type drug with any other drug dependence, unspecified

403.01

Hypertensive chronic kidney disease, malignant, with chronic kidney disease stage v or end stage renal disease

403.11

Hypertensive chronic kidney disease, benign, with chronic kidney disease stage v or end stage renal disease

403.9

Hypertensive chronic kidney disease, unspecified, with chronic kidney disease stage i through stage iv, or unspecified

403.91

Hypertensive chronic kidney disease, unspecified, with chronic kidney disease stage v or end stage renal disease

404.02

Hypertensive heart and chronic kidney disease, malignant, without heart failure and with chronic kidney disease stage v or end stage renal disease

404.03

Hypertensive heart and chronic kidney disease, malignant, with heart failure and with chronic kidney disease stage v or end stage renal disease

404.12

Hypertensive heart and chronic kidney disease, benign, without heart failure and with chronic kidney disease stage v or end stage renal disease Proprietary Information of UnitedHealthcare. Copyright 2014 United HealthCare Services, Inc. Page 4

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ICD-9 Code 404.13 446 570 571.2, 571.4, 571.5, 571.8 572.3 573.1 573.2 573.3 584.9 585.3 585.4 585.5 585.6 585.9 588 588.81 684.33 710 714 714.9 716.59 729.1 774.4 782.4 789 789.01 789.07 789.1 789.59 790.4 794.8 996.81 V01.6 V01.79 V02.61 V02.62 V05.3 V08 V15.85

Description Hypertensive heart and chronic kidney disease, benign, with heart failure and chronic kidney disease stage v or end stage renal disease Polyarteritis nodosa Acute and subacute necrosis of liver Chronic liver disease and cirrhosis Portal hypertension Hepatitis in viral diseases classified elsewhere Hepatitis in other infectious diseases classified elsewhere Hepatitis unspecified Acute kidney failure, unspecified Chronic kidney disease, stage iii (moderate) Chronic kidney disease, stage iv (severe) Chronic kidney disease, stage v End stage renal disease Chronic kidney disease, unspecified Renal osteodystrophy Secondary hyperparathyroidism (of renal origin) Drug dependence of mother, antepartum condition or complication Systemic lupus erythematosus Rheumatoid arthritis Unspecified inflammatory polyarthropathy Unspecified polyarthropathy or polyarthritis, multiple sites Myalgia and myositis unspecified Perinatal jaundice due to hepatocellular damage Jaundice unspecified not of newborn Abdominal pain, unspecified site Abdominal pain, right upper quadrant Abdominal pain, generalized Hepatomegaly Other ascites Nonspecific elevation of levels of transaminase or lactic acid dehydrogenase (ldh) Nonspecific abnormal results of function study of liver Complications of transplanted kidney Contact with or exposure to venereal diseases Contact or exposure to other viral diseases Carrier or suspected carrier of hepatitis b Hepatitis c carrier Need for prophylactic vaccination and inoculation against viralhepatitis Asymptomatic human immunodeficiency virus [hiv] infection status Personal history of contact with and (suspected) exposure to potentially hazardous body fluids Proprietary Information of UnitedHealthcare. Copyright 2014 United HealthCare Services, Inc. Page 5

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ICD-9 Code V20.2 V22.0-V22.2 V23.7 V23.89 V26.21 V42.7 V45.11 V49.83 V56.0 V56.1 V58.44 V65.45 V69.2 V70.0 V72.42 V74.5

Description Routine infant or child health check Supervision of normal first pregnancy Supervision of high-risk pregnancy with insufficient prenatal care Supervision of other high-risk pregnancy Fertility testing Liver replaced by transplant Renal dialysis status Awaiting organ transplant status Encounter for extracorporeal dialysis Fitting and adjustment of extracorporeal dialysis catheter Aftercare following organ transplant Counseling on other sexually transmitted diseases High-risk sexual behavior Routine general medical examination at a health care facility Pregnancy examination or test, positive result Screening examination for venereal disease

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REFERENCES 1. Hepatitis B information for health professionals. Centers for Disease Control and Prevention Web site. http://www.cdc.gov/hepatitis/HBV/StatisticsHBV.htm. Updated September 13, 2011. (Accessed: April 25, 2012). 2. United States Department of Health & Human Resources. Combating the silent epidemic of viral hepatitis. Action plan for the prevention, care & treatment of viral hepatitis. http://www.hhs.gov/ash/initiatives/hepatitis/actionplan_viralhepatitis2011.pdf. May 12, 2011. (Accessed: April 26, 2012). 3. Harkisoen S, Arends JE, van Erpecum KJ, et al. Hepatitis B viral load and risk of HBV-related liver disease: from East to West? Ann Hepatol. 2012;11(2):164-171. 4. Nguyen VTT, Law MG, Dore GJ. Hepatitis B-related hepatocellular carcinoma: epidemiological characteristics and disease burden. J Viral Hepat. 2009;16(7):453-463. 5. Lok AS, McMahon BJ. Chronic hepatitis B: update 2009. Hepatology. 2009;50(3):661-662. 6. Chan HL, Hui AY, Wong ML, et al. Genotype C hepatitis B virus infection is associated with an increased risk of hepatocellular carcinoma. Gut. 2004;53(10):1494-1498. 7. Hutton DW, Tan D, So SK, et al. Cost-effectiveness of screening and vaccinating Asian and Pacific Islander adults for hepatitis B. Ann Intern Med. 2007; 147(7):460-469. 8. Carey WD. The prevalence and natural history of hepatitis B in the 21st century. Cleve Clin J Med. 2009;76(suppl 3):s2-5. 9. Senadhi V. A paradigm shift in the outpatient approach to liver function tests. South Med J. 2011;104(7):521525. 10. Centers for Disease Control and Prevention. Recommendations for identification and public health management of persons with chronic hepatitis B virus infection. MMWR Morb Mortal Wkly Rep. 2008;57:120. 11. Henegar C, Pagnoux C, Puéchal X, et al. A paradigm of diagnostic criteria for polyarteritis nodosa: analysis of a series of 949 patients with vasculitides. Arthritis Rheum. 2008;58(5):1528-1538. POLICY HISTORY/REVISION HISTORY

Policy Effective Date

Action/Description

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