BlueCross BlueShield of Tennessee Medical Policy Manual

High Sensitivity C-Reactive Protein (hs-CRP) Testing for Cardiovascular Disease (CVD)

DESCRIPTION

C-reactive protein (CRP) is produced by the liver. CRP is an 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 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 screening, diagnosis and management.

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

No evidence was found of direct testing of the hypothesis that measuring C-Reactive Protein to assess cardiovascular risk results in improved patient outcomes. Therefore this application of the technology remains investigational.

SOURCES 

American Academy of Family Physicians (AAFP). (2011, August). Summary of recommendations for clinical preventive services. Retrieved February 9, 2012 from http://www.aafp.org.

American College of Cardiology / American Heart Association (2014, July) 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Retrieved March 9, 2017 from the National Guideline Clearinghouse (NCG:010480).

American College of Preventive Medicine. (March, 2011) Atherosclerotic cardiovascular disease screening in adults: American College of Preventive Medicine position statement on preventive practice. Retrieved May 20, 2015 from the National Guideline Clearinghouse (NGC: 8738).

Arruda-Olson, A. M., Enriquez-Sarano, M., Bursi, F., Weston, S. A., Jaffee, A. S., Killian, J. M., et al. (2010). Left ventricular function and C-reactive protein levels in acute myocardial infarction. The American Journal of Cardiology, 105 (7), 917-921. (Level 4 evidence)

BlueCross BlueShield Association. Medical Policy Reference Manual. (11:2015). Cardiovascular Risk Panels (2.04.100). Retrieved March 9, 2017 from BlueWeb. (19 articles and/or guidelines reviewed)

Cahaba Government Benefit Administrators, LLC (2015, October) Local Coverage Determination LCD for pathology and laboratory: C-reactive protein; high sensitivity (hsCRP) (L34272). Retrieved April 26, 2016 from https://www.cms.gov.

Dorresteijn, J. A., Visseren, F. L., Ridker, P. M., Wassink, A. M., Paynter, N. P., Steverberg, E. W., et al. (2011). Estimating treatment effects for individual patients based on the results of randomised clinical trials. British Medical Journal, 343, 1-13. (Level 2 evidence)

Ferket, B. Van Kempen, B., Hunink, M., Agarwa, I., Kavous, M., Franco, O., et. al., (February 2014) Predictive Value of Updating Framingham Risk Scores with Novel Risk Markers in the U.S. General Population. PLoS One, 9 (2), e88312. (Level 3 evidence)

Hou, J., Li, J., Wang, J., Lu, D., Wang, R., Huang, J., et al. (2015). The prediction of high-sensitivity C reactive protein for peripheral arterial sclerosis in middle-aged population. Zhonghua Yu Fang Yi Xue Za Zhi, 49 (10), 883-887. Abstract retrieved April 26, 2016 from PubMed database.

Karadeniz, M., Akyel, A., Celik, I., Cankurt, T., and Bans, V. (2010, December) Relationship of high-sensitive C-reactive protein with cardiovascular risk factors, clinical presentation and angiographic profile in patients with acute coronary syndrome: An Indian perspective.Indian Heart Journal; 65, 357-367. (Level 3 evidence)

Oliveira, A. C., Oliveira, 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. (Level 2 evidence - Independent study)

Padayachee, L., Rodseth, R. N., & Biccard, B. M. (2009). A meta-analysis of the utility of C-reactive protein in predicting early, intermediate term and long term mortality and major adverse cardiac events in vascular surgical patients. Anaesthesia, 64 (4), 416-424. (Level 1 evidence - Independent study)

Schnell-Inderst, P., Schwarzer, R., Gohler, A., Grandi, N., Grabein, K., Stollenwerk, B., et al. (2010). 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. (Level 2 evidence)

U. S. Food and Drug Administration (September 2005) Review criteria for assessment of C-reactive protein (CRP), high sensitivity C-reactive protein (hsCRP) and cardiac C-reactive protein (cCRP) assays. Retrieved May 20, 2015 from: http://www.fda.gov.

U. S. Food and Drug Administration. (2007, May). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K071017. Retrieved February 9, 2010 from http://www.accessdata.fda.gov. 

U. S. Food and Drug Administration. (2008, July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K081294. Retrieved February 9, 2010 from http://www.accessdata.fda.gov. 

U. S. Preventative Services Task Force. (October 2009) Using nontraditional risk factors in coronary heart disease risk assessment: U.S. Preventive Services Task Force recommendation statement. Annals of Internal Medicine, 2009; 151:474-482.

ORIGINAL EFFECTIVE DATE:  9/1/2003

MOST RECENT REVIEW DATE:  4/13/2017   

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