DESCRIPTION
It is estimated that nearly 4 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.
Genotypic analysis of hepatitis C is used for the determination of disease probability, preventive intervention, selection of pharmacotherapy, and individual design of medical care based on genotype. Genotypes are genetically distinct groups of hepatitis C virus isolates that develop during the evolution of the virus. Genotype is determined by analysis of protein, RNA or DNA. The prevalence of genotypes vary geographically with types one, two and three found most commonly in the United States. Genotypes do not change during the course of infections therefore retyping is unnecessary.
Hepatitis C virus exists as a heterogeneous group of viruses that have been classified into six major genotypes (1-6) and several subtypes based on analysis of nucleotide sequences. For those who meet criteria for pharmaceutical treatment, the drug(s) used and the duration may depend on the genotype. For example, individuals with non-one genotype (2-6), a 24-week course of combination treatment with alpha interferon and ribavirin is generally adequate. For individuals with genotype 1, which is associated with a higher frequency of cirrhosis and abnormal serum aminotransferases than other genotypes, a 48-week course is recommended
POLICY
Genotyping for chronic hepatitis C as a technique for determining the duration of drug therapy is considered medically necessary.
IMPORTANT REMINDER
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, 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.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2005). Identification of microorganisms using nucleic acid probes (2.04.10). Retrieved March 20, 2009 from BlueWeb.
BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2005). Treatment of hepatitis C with interferon and/or ribavirin (5.01.11). Retrieved from March 20, 2009 BlueWeb.
Centers for Disease Control and Prevention. (2003, February). Morbidity and Mortality Weekly Report. Guidelines for laboratory testing and result reporting of antibody to hepatitis c virus. Retrieved February 3, 2006 from http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5203a1.htm.
Institute for Clinical Systems Improvement. (2005, December). Antiviral treatment for chronic hepatitis C. Retrieved April 20, 2009 from. http://www.icsi.org/guidelines_and_more/technology_assessment_reports/technology_assessment_reports_-_active/antiviral_treatment_for_chronic_hepatitis_c.html.
National Institute of Diabetes and Digestive and Kidney Disease. (2003, March). Chronic hepatitis C: Current disease management. Retrieved May 22, 2003 from http://www.niddk.nih.gov/health/digest/pubs/chrnhepc/chrnhepc.htm.
Nguyen, M. H., & Keeffe, E. B. (2005). Chronic hepatitis C: Genotypes 4 to 9. Clinics in Liver Disease, 9 (3), 411-426.
Ross, R. S., Viazov, S. O., Holtzer, C. D., Beyou, A., Monnet, A., Mazure, C., et al. (2000). Genotyping of hepatitis C virus isolates using CLIP sequencing. Journal of Clinical Microbiology, 38 (10), 3581-3584.
Strader, D. B., Wright, T., Thomas, D. L., & Seeff, L. B. (2004). AASLD Practice Guideline. Diagnosis, management, and treatment of hepatitis C. Hepatology, 39 (4), 1147-1171.
U. S. Food and Drug Administration. (2001, September). Center for Biologics Evaluation and Research. Substantially Equivalent 510(k) Device information. Retrieved December 28, 2005 from http://www.fda.gov/cber/510k/k000038.htm.
ORIGINAL EFFECTIVE DATE: 1/1/2002
MOST RECENT REVIEW DATE: 7/9/2009
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.
This document has been classified as public information.