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DESCRIPTIONC-reactive protein (CRP) is an acute phase reactant produced by the liver that has long been used to monitor inflammatory processes, such as infection and autoimmune diseases. Recent studies have suggested that low level chronic inflammation may play a role in atherogenesis, and thus measurement of CRP has been investigated in various settings of cardiovascular disease, i.e., in patients with known cardiovascular disease, in patients with risk factors for cardiovascular disease, and as a general risk assessment tool for cardiovascular disease. Conventional methodologies for measuring CRP in acute inflammatory diseases have a detection limit of 3-5 mg/L. However, in the setting of the low levels of chronic inflammation in otherwise healthy individuals, this level of detection is not adequate. To be used as a risk assessment tool, a greater precision at lower levels of CRP is needed such that the range of values collected in epidemiologic studies can be subdivided into quartiles and quintiles; in this way, the data from large epidemologic studies can be applied to individual patients. Such new technologies, collectively known as high-sensitivity C-reactive protein (hs-CRP) include enzyme linked immunoabsorbent assays (ELISA), and various other techniques based on monoclonal antibodies. While the ELISA test is still primarily used as a research tool, various immunoassays have been automated and are commercially available. Several of the high-sensitivity C-reactive protein tests have received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA).
Measurements of high sensitivity C-reactive protein are considered investigational, including, but "not" limited to, its use as a risk factor for cardiovascular disease.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
POLICY HISTORY8/2001: Approved by Medical Policy Advisory Committee (MPAC)
2/12/2002: Investigational definition added
2/19/2002: New 2002 CPT code added
5/1/2002: Type of Service and Place of Service deleted
8/8/2002: Code Reference section revised
3/2003: Reviewed by MPAC - no changes, Sources updated
12/19/2003: Code Reference section reviewed
3/8/2006: Policy reviewed, no changes
3/29/2007: Policy reviewed, description updated, no changes to policy statement
4/29/2008: Policy reviewed, no changes
1/8/2009: Policy reviewed, no changes
12/30/2010: Policy statement and description unchanged. FEP verbiage added to the Policy Exceptions section.
10/30/2013: Policy reviewed; no changes.
07/30/2015: Code Reference section updated for ICD-10.
06/07/2016: Policy number L.2.04.410 added. Investigative definition updated in Policy Guidelines section.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.04.22
Hayes Medical Technology Directory
Roberts WL, Sedrick R, Moulton L, et al. Evaluation of four automated high-sensitivity C-reactive protein methods: Implications for clinical and epidemiologic applications. Clin Chem 2000; 46:461-68.
Rifai N, Tracy RP, Ridker PM. Clinical efficacy of an automated high-sensitivity C-reactive protein assay. Clin Chem 1999; 45:2136-41.
Ockene IS, Matthews CE, Rifai N, et al. Variability and classification accuracy of high-sensitivity c-reactive protein measurements in healthy adults. Clin Chem 2001; 47(3):444-50.
Kuller LH, Tracy RP, Shaten J for the MRFIT Research Group. Relationship of C-reactive protein and coronary heart disease in the MRFIT nested case control study. Am J Epidemiol 1996; 144:537-47.
Ridker PM, Glynn Rj, Hennekens CH. C-reactive protein adds to the predictive value of total and HDL cholesterol in determining risk of first myocardial infarction. Circulation 1998; 97:2007-11. Circulation 2001; 103:1191-3.
Ridker PM, Cushman M, Stampfer MJ, et al. Inflammation, aspirin and the risk of cardiovascular disease in apparently healthy men. N Eng J Med 1997; 336:973-9.
Ridker PM, Hennekens CH, Buring JE, Rifai N. C-reactive protein and other markers of inflammation in the prediction of cardiovascular disease in women. N Engl J Med 2000; 342:836-42.
Garcia-Moll X, Zouridakis E, Cole D, Kaski JC. C-reactive protein in patients with chronic stable angina; differences in baseline serum concentration between men and women. Eur H J 2000; 21;1598-06.
Versaci F, Gaspardone A, Tomai F, et al. Predictive value of c-reactive protein in patients with unstable angina pectoris undergoing coronary artery stent implantation. Am J Cardiol 2000; 85:92-94.
Ridker PM, Rifai N, Lowenthal SP. Rapid reduction in c-reactive protein with cervistatin among 785 patients with primary hypercholesterolemia.
Rifai N, Ridker PM. Proposed cardiovascular risk assessment algorithm using high sensitivity C-reactive protein and lipid screening. Clin Chem 2001; 47:28-30.
Ridker PM, Danielson E, Fonseca FA et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med 2008: 359(21):2195-207.
Hayes Alert, Volume V, Number 12, December 2002
American Heart Association and the Centers for Disease Control and Prevention Panel Recommendations on CRP Testing, Journal Report 01/28/2003
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.