Hepatitis C is a liver disease caused by the hepatitis C virus (HCV). Hepatitis C genotyping (e.g. Versant® HCV genotype 2.0 assays, 6 HCV genotyping 9G test) is helpful in selecting appropriate treatment regimens. There are at least six distinctive HCV genotypes (genotypes 1 – 6), and more than 50 subtypes have been identified. Genotype is determined by analysis of protein, RNA or DNA. For those who meet criteria for pharmaceutical treatment, the drug(s) used and the duration will depend on the genotype. For individuals with genotypes 2-6, a 24-week course of combination treatment with alpha interferon and ribavirin is usually adequate. For individuals with genotype 1, which is associated with a higher frequency of cirrhosis and abnormal serum aminotransferases than the other genotypes, a 48-week course is recommended.
It is estimated that nearly four million Americans have hepatitis C. Of these, 70% have chronic hepatitis and 15% to 20% will develop cirrhosis. Cirrhosis related to hepatitis C is now the most common indication for liver transplantation. The prevalence of genotypes varies geographically with types one, two and three found most commonly in the United States. Genotype 1 is the most common HCV genotype in the United States, accounting for 74% of prevalent cases. Genotypes do not change during the course of infections, and therefore retyping is unnecessary.
Genotyping for chronic hepatitis C as a technique for determining the duration of drug therapy is considered medically necessary.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, an explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
American Association for the Study of Liver Diseases. (2015). Hepatitis C guidance: AASLD-IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus. Retrieved July 1, 2018 from http://www.aasld.org.
Centers for Disease Control and Prevention. (2017). Hepatitis C FAQs for health professionals. Retrieved August 3, 2017 from https://www.cdc.gov/hepatitis/hcv/hcvfaq.htm#d5.
National Institute of Diabetes and Digestive and Kidney Diseases. (2017). Hepatitis C. Retrieved August 3, 2017 from https://www.niddk.nih.gov/health-information/liver-disease/viral-hepatitis/hepatitis-c.
U.S. Food and Drug Administration. (2017, March). Center for Devices and Radiological Health. Pre-market approval decisions for March 2017. P160016. Retrieved August 3, 2017 from https://www.fda.gov.
ORIGINAL EFFECTIVE DATE: 1/1/2002
MOST RECENT REVIEW DATE: 8/9/2018
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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