High Sensitivity C-Reactive Protein (hs-CRP) Testing for Cardiovascular Disease (CVD)
DESCRIPTION
C-reactive protein (CRP) is produced by the liver. CRP is a classic acute-phase reactant protein. Under normal conditions CRP is found in low levels in the blood. Levels of CRP can increase in response to inflammatory conditions, infections and other disease states where tissue necrosis occurs. CRP is a nonspecific marker of inflammation. Levels of CRP can fluctuate substantially from day to day. Blood specimens are collected by venipuncture.
Conventional methodologies for measuring CRP in acute inflammatory diseases have a detection limit of 3-5 mg/L. The average CRP reading in this country is 1.5 mg/L, with lower levels being a possible indication of chronic inflammation. High sensitivity CRP (hs-CRP) immunoassays can measure levels of CRP as low as 0.175 mg/L. The results of these hs-CRP assays are being investigated in various settings for a possible association with cardiovascular disease (e.g., screening, diagnosis and management).
POLICY
High sensitivity C-reactive protein testing for the screening, diagnosis and management of cardiovascular disease is considered investigational.
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.
ADDITIONAL INFORMATION
Well-designed, randomized, controlled trials with long-term follow-up are not available to determine long-term benefits of the use of high sensitivity C-reactive protein testing for the screening, diagnosis, and management of cardiovascular disease.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2009). High sensitivity C-reactive protein (2.04.22). Retrieved May 4, 2010 from BlueWeb. (37 articles and/or guidelines reviewed)
Cao, J. J., Arnold, A. M., Manolio, T. A., Polak, J. F., Psaty, B. M., Hirsch, C. H., et al. (2007). Association of carotid artery intima-media thickness, plaques, and C-reactive protein with future cardiovascular disease and all-cause mortality: The Cardiovascular Health Study. Circulation, 116 (11), 32-38
Hanefeld, M., Marx, N., Pfützner, A., Baurecht, W., Lübben, G., Karagiannis, E., et al. (2007). Anti-inflammatory effects of pioglitazone and/or simvastatin in high cardiovascular risk patients with elevated high sensitivity C-reactive protein: The PIOSTAT Study. Journal of the American College of Cardiology, 49 (3), 290-297. (Level 1 Evidence - Industry sponsored)
Junnila, J. L., & Runkle, G. P. (2006, December). Coronary artery disease screening, treatment, and follow-up. Primary Care: Clinics in Office Practice, 33 (4), 863-885.
National Guideline Clearinghouse. (2007). National Academy of Clinical Biochemistry laboratory medicine practice guidelines: Clinical characteristics and utilization of biochemical markers in acute coronary syndromes. Retrieved September 5, 2008 form http://www.guidelines.gov.
Oliveira, A. C., Oliveria, A. M., Almeida, M. S., Silva, A. M., Adan, L., & Ladeia, A. M. (2008). Alanine aminotransferase and high sensitivity C-reactive protein: Correlates of cardiovascular risk factors in youth. Journal of Pediatrics, 152 (3), 337-342.
Schnell-Inderst, P., Schwarzer, R., Gohler, A., Grandi, N., Grabein, K., Stollenwerk, B., et al. Prognostic value, clinical effectiveness, and cost-effectiveness of high-sensitivity C-reactive protein as a marker for major cardiac events in asymptomatic individuals: A health technology .assessment report. International Journal of Technology Assessment in Health Care, 26 (1), 30-39.
Wilson, P. W., Nam, B. H., Pencina, M., D'Agostino, R.B. Sr., Benjamin, E. J., & O'Donnell C. J. (2005, November). C-reactive protein and risk of cardiovascular disease in men and women from the Framingham Heart Study. Archives of Internal Medicine, 165 (25), 2473-2478.
Windram, J. D., Loh, P. H., Rigby, A. S., Hanning, I., Clark, A. L., & Cleland, J. G. F. (2007). Relationship of high-sensitivity C-reactive protein to prognosis and other prognostic markers in outpatients with heart failure. American Heart Journal, 153 (6), 1048-1055.
ORIGINAL EFFECTIVE DATE: 9/1/2003
MOST RECENT REVIEW DATE: 6/10/2010
ID_BA
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