**Notice:** It is not appropriate to bill Medicare for services that are not
covered (as described by this entire LCD) as if they are covered. When billing
for non-covered services, use the appropriate modifier.  
  
Compliance with the provisions in this policy may be monitored and addressed
through post payment data analysis and subsequent medical review audits.

**History/Background and/or General Information**

C-reactive protein (CRP), is a nonspecific, acute-phase reactant produced in
response to tissue injury, inflammation or infection. As an acute phase
reactant, concentrations rise rapidly and half-life is short. Studies have
shown that chronic, low-grade inflammation contributes to atherogenesis and
the development of coronary artery disease (CAD). Inflammatory changes lead to
progressive disease, which culminates in plaque instability, rupture,
thrombosis, and myocardial infarction (MI).  
  
CRP testing is eligible for coverage as a diagnostic test for the detection
and evaluation of infection, tissue injury, and inflammatory disease. High
sensitivity C-reactive protein (hsCRP) testing is the subject of this policy.  
  
A high sensitivity C-reactive protein (hsCRP) assay measures low levels of
CRP, which allows for measurement of conditions indicative of chronic, low-
grade inflammation. The stimulus for the rise in serum CRP in CAD remains
undetermined, although it may result from local inflammation within
atheromatous plaques, from a systemic or local inflammation or infection
elsewhere in the body that contributes to atherogenesis, or to unrelated
conditions. Increased CRP may reflect plaque instability and an increased risk
for a CAD event. Published literature presents strong evidence to refute the
hypothesis that CRP itself has a causative effect on coronary heart disease.  
  
High-sensitivity assays can measure levels as low as 0.175 mg/L, which may be
associated with CAD. HsCRP assays are based on nephelometric analysis of
antigen-antibody complexes using monoclonal antibodies with sufficient
sensitivity to detect low levels of CRP.

**Covered Indications**  
  
This contractor will consider high-sensitivity C-reactive protein (hsCRP)
testing reasonable and necessary when **ALL** of the following criteria are
met:

  1. When the hsCRP would add substantial incremental information in the decision making process to optimize/maximize lipid lowering pharmacologic therapy, (e.g., use of statins), in a patient who has been identified as being at intermediate risk for CAD (10-year risk of coronary heart disease between 10-20% per the ATPIII Guidelines). This is to be used for a one time decision point and is not intended to monitor therapy.  
  

  2. The test is performed in patients considered to be metabolically stable and without obvious inflammatory or infectious conditions.

The American Heart Association (AHA) recommends the following cutpoints for
hsCRP corresponding to three levels of risk:

  * Low risk less than 1.0 mg/L  


  * Average risk greater than 1.0 to less than 3.0 mg/L  


  * High risk greater than 3.0 mg/L

**Limitations**

  1. Medicare does not provide coverage for routine screening performed without a relationship to the evaluation or treatment of a symptom, sign, illness or injury. If high sensitivity C-reactive protein (hsCRP) testing is performed for cardiovascular risk assessment, in the absence of signs or symptoms of illness or injury, then the service will be denied as not reasonable and necessary.  
  

  2. Medicare does not cover hsCRP testing as a screening test for the general population or for monitoring response to therapy.  
  

  3. Although hsCRP is commonly elevated in inflammatory conditions (e.g., rheumatic fever, rheumatoid arthritis, systemic vasculitis, myocardial infarction, acute pancreatitis), measurements in these illnesses is not appropriate and is considered not reasonable and necessary.

This LCD imposes frequency limitations. For frequency limitations, please
refer to the Utilization Guidelines section below.  
  
 **Notice:** Services performed for any given diagnosis must meet all of the
indications and limitations stated in this policy, the general requirements
for medical necessity as stated in CMS payment policy manuals, any and all
existing CMS national coverage determinations, and all Medicare payment rules.
Refer to Billing and Coding: C-Reactive Protein High Sensitivity Testing
(hsCRP), A56643, for applicable CPT codes and diagnosis codes.

The redetermination process may be utilized for consideration of services
performed outside of the reasonable and necessary requirements in this LCD.