Summary Of Evidence

N/A

Analysis of Evidence

N/A

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.