C-Reactive Protein High Sensitivity Testing (hsCRP)

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for hsCRP testing. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for hsCRP testing and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:

IOM Citations:

• CMS IOM Publication 100-02, Medicare Benefit Policy Manual  
  • Chapter 6, Section 20.4 Outpatient Diagnostic Services
  • Chapter 15, Section 80.1 Clinical Laboratory Services
• CMS IOM Publication 100-04, Medicare Claims Processing Manual 
  • Chapter 16, Laboratory Services
  • Chapter 23, Section 40 Clinical Diagnostic Laboratory Fee Schedule

Social Security Act (Title XVIII) Standard References:

• Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.
• Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.
• Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.
  
  

Federal Register References:

• 42 CFR, Section 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.

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.

N/A

N/A

Refer to the Local Coverage Article: Billing and Coding: C-Reactive Protein High Sensitivity Testing (hsCRP), A56643, for all coding information.

Documentation Requirements

1. All documentation must be maintained in the patient’s medical record and made available to the contractor upon request.
2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
3. The medical record documentation must support the medical necessity of the services as stated in this policy.
4. The ordering physician should retain in the patient’s medical record, history and physical examination notes documenting evaluation and management of one of the Medicare covered conditions/diagnoses, with relevant clinical signs/symptoms or abnormal laboratory test results, appropriate to clinical signs/symptoms or abnormal laboratory test results, appropriate to one of the covered indications.
5. The patient’s clinical record should further indicate changes/alterations in medications or management prescribed for the treatment of the patient.
6. There must be an attending/treating physician’s order for each test documented in the patient’s medical/clinical record.

Utilization Guidelines

In accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice.

Generally, the measurement of hsCRP markers is performed twice (averaging results), optimally two weeks apart and fasting or nonfasting, with the average expressed in mg/L, in metabolically stable patients.

It is considered reasonable and necessary to perform no more than 3 hsCRP services per patient lifetime.

Notice: This LCD imposes utilization guideline limitations. Despite Medicare's allowing up to these maximums, each patient's condition and response to treatment must medically warrant the number of services reported for payment. Medicare requires the medical necessity for each service reported to be clearly demonstrated in the patient's medical record. Medicare expects that patients will not routinely require the maximum allowable number of services.

Contractor is not responsible for the continued viability of websites listed.

Other Contractor(s)' Policies

Contractor Medical Directors

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34. Spatz ES, Canavan ME, Desai MM. From Here to JUPITER: Identifying New Patients for Statin Therapy Using Data From the 1999 2004 National Health and Nutrition Examination Survey. Circ Cardiovasc Qual Outcomes. 2009;2:41-48.
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36. Tanne D, Benderly M, Goldbourt U, et al. C-reactive protein as a predictor of incident ischemic stroke among patients with preexisting cardiovascular disease. Stroke. 2006; 37:1720-1724.
37. Tchernof A, Nolan A, Sites CK, et al. Weight loss reduces C-reactive protein levels in obese postmenopausal women. Circulation. 2002; 105:564-569.
38. Vainas T, Lubbers T, Stassen FRM, et al. Serum C-reactive protein level is associated with abdominal aortic aneurysm size and may be produced by aneurysmal tissue. Circulation. 2003; 107:1103-1105.
39. Ventetuolo C E, Levy M M. Biomarkers: Diagnosis and Risk Assessment in Sepsis. Clin Chest Med. 2008; 29:591-603.
40. Walston J, McBurnie MA, Newman A, et al. Frailty and Activation of the Inflammation and Coagulation Systems With and Without Clinical Comorbidities; Results From the Cardiovascular Health Study. Arch Intern Med. 2002; 162:2333-2341.
41. Wilson P, Pencina M, Jacques P, et al. C-Reactive Protein and Reclassification of Cardiovascular Risk in the Framingham Heart Study. Circ Cardiovasc Qual Outcomes. 2008; 1:92-97.
42. Yin WH, Chen JW, Jen HL, et al. Independent prognostic value of elevated high-sensitivity C-reactive protein in chronic heart failure. Am Heart J. 2004; 147:931-938.
43. Zebrack JS, Muhlestein JB, Horne BD, et al. C-reactive protein and angiographic coronary artery disease: independent and additive predictors of risk in subjects with angina. J Am Coll Cardiol. 2002; 39:632-637.