L29191-LCD

Automated World Health

Local Coverage Determination (LCD) for High Sensitivity C-Reactive Protein (hsCRP) (L29191)

Contractor Information

Contractor Name First Coast Service Options, Inc. opens in new window

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L29191

LCD Title High Sensitivity C-Reactive Protein (hsCRP)

Contractor's Determination Number 86141

Primary Geographic Jurisdiction opens in new window Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

CPT only copyright 2002-2011 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 02/02/2009

Original Determination Ending Date

Revision Effective Date

Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources: N/A

Indications and Limitations of Coverage and/or Medical Necessity

Recent 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). Increasing recognition of the inflammatory component of atherogenesis provides the biological plausibility for the use of inflammatory markers as prognostic indicators of atherosclerotic complications.

Increased serum levels of C-reactive protein (CRP), an inflammatory biomarker, have been linked to an increased risk of myocardial infarction, stroke, peripheral arterial disease, and sudden cardiac death even in the absence of hyperlipidemia. CRP is a nonspecific, acute-phase reactant produced in response to tissue injury, inflammation or infection. CRP is secreted by hepatocytes, where its synthesis is regulated by cytokines. 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.

The standard CRP assays have limits of measuring acute-phase detection of 3.0-5.0 mg/L and lack the sensitivity required to detect slight elevations that occur in CAD. 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.

The hsCRP results, along with The Framingham Heart Study Risk Assessment (a tool which considers gender, age, total cholesterol, HDL cholesterol, systolic blood pressure, antihypertensive medications, family history and smoking risks) provides cardiac prognostic information. However, hsCRP and LDL cholesterol levels are minimally correlated.

Currently, First Coast Service Options (FCSO) will consider high-sensitivity C-reactive protein (hsCRP) testing medically reasonable and necessary for the assessment of CAD risk when ALL of the following criteria are met:

• When the hsCRP would add substantial incremental information in the decision making process to optimize/maximize current lipid lowering pharmacologic therapy 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.

• 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 < 1.0 mg/L

• Average risk > 1.0 to < 3.0 mg/L

• High risk > 3.0 mg/L Limitations

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 or medically necessary.

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

Commonly, hsCRP is elevated in inflammatory conditions (e.g., rheumatic fever, rheumatoid arthritis, systemic vasculitis, myocardial infarction, acute pancreatitis) and are not considered medically reasonable and necessary for purposes of this policy.

Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

999x Not Applicable

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

99999 Not Applicable

CPT/HCPCS Codes

86141 C-REACTIVE PROTEIN HIGH SENSITIVITY (HSCRP)

ICD-9 Codes that Support Medical Necessity

272.1 PURE HYPERCHOLESTEROLEMIA

272.2 PURE HYPERGLYCERIDEMIA

272.3 MIXED HYPERLIPIDEMIA

272.4 HYPERCHYLOMICRONEMIA

272.5 OTHER AND UNSPECIFIED HYPERLIPIDEMIA

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity XX000 Not Applicable

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

Medical record documentation maintained by the ordering/referring physician/qualified nonphysician practitioner must indicate the medical necessity for performing the test and the test results. In addition, if the service exceeds the frequency parameter listed in this policy, documentation of medical necessity must be submitted upon request. This information is usually found in the history and physical, office/progress notes, or test results.

If the provider of the service is other than the ordering/referring physician/nonphysician practitioner, that provider must maintain a copy of test results, along with copies of the ordering/referring physician/nonphysician practitioner’s order for the test. The clinical indication/medical necessity for the test must be indicated in the order for the test.

Documentation should support the criteria for coverage as set forth in the “Indications and Limitations of Coverage and/or Medical Necessity” section of this policy and should reflect how the results of this test will be used in the patient’s plan of care.

Appendices

Utilization Guidelines Generally, the measurement of hsCRP markers may be performed twice (averaging results), optimally two weeks apart and fasting or nonfasting, with the average expressed in mg/L, in metabolically stable patients. If an average CRP level of >10.0 mg/L is found on two tests performed 2 weeks apart, a third test may be performed after ruling out possible infectious or inflammatory causes for the increase (AHA/CDC Recommendation).

It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they may be subject to review for medical necessity.

Sources of Information and Basis for Decision

Agmon, Y., Khandheria, B., Meissner, I., Petterson, T., O’Fallon, W., Wiebers, D., Christianson, T., McConnell, J., Whisnant, J., Seward, J., Tajik, J. (2004). C-reactive protein and atherosclerosis of the thoracic aorta. Arch Intern Med, 164, 1781-1787.

HAYES Medical Technology Directory. (2004). High-sensitivity C-reactive protein testing for coronary artery disease screening of asymptomatic individuals. Lansdale, PA: HAYES, March 2004.

HAYES Medical Technology Directory. (2004). High-sensitivity C-reactive protein testing for diagnosis and management of coronary artery disease. Lansdale, PA: HAYES, March 2004.

National Institutes of Health (NIH). National Heart, Lung, and Blood Institute (NHLBI) [Web site]. (2002). The National Cholesterol Education Program (NCEP). Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). NIH Publication. No. 02-5215. September 2002. Available at http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3full.pdf. Retrieved August 31, 2005.

National Institutes of Health (NIH). National Heart, Lung, and Blood Institute (NHLBI) [Web site]. (2002). The National Cholesterol Education Program (NCEP). Risk Assessment Tool for Estimating 10-year Risk of Developing Hard CHD (Myocardial Infarction and Coronary Death). 2002b. Available at: http://hin.nhlbi.nih.gov/atpiii/calculator.asp?usertype=prof. Retrieved August 31, 2005.

Nissen, S., Tuzcu, E., Schoenhagen, P., Crowe, T., Sasiela, W., Tsai, J., Orazem, J., Magorien, R., O’Shaughnessy, C., Ganz, P. (2005). Statin therapy, LDL cholesterol, C-reactive protein, and coronary artery disease. N Engl J Med, 352(1), 29-38.

Pai, J.K. (2004). Inflammatory markers and the risk of coronary heart disease in men and women. New England Journal of Medicine. 351(25): 2599-2610.

Pearson, T., Mensah, G., Alexander, R., Anderson, J., Cannon, R., Criqui, M., Fadl, Y., Fortmann, S., Hong, Y., Myers, G., Rifai, N., Smith, S., Taubert, K., Tracy, R., & Vinicor, F. (2003). Markers of inflammation and cardiovascular disease: application to clinical and public health practice: A statement for healthcare professionals from the centers for disease control and prevention and the American heart association. Circulation, 107(3), 499- 511.

Ridker, P., Cannon, C., Morrow, D., Rifai, N., Rose, L., McCabe, C., Pfeffer, M., Braunwald, E. (2005). C-reactive protein levels and outcomes after statin therapy. N Engl J Med, 352(1), 20-28.

Ridker, P. (2003). Rosuvastatin in the primary prevention of cardiovascular disease among patients with low levels of low-density lipoprotein cholesterol and elevated high-sensitivity c-reactive protein: Rationale and design of the Jupiter trial. Circulation, 108, 2292-2297.

Verma, S., Szmitko, P., & Ridker, P. (2005). C-reactive protein comes of age. Nature Clinical Practice Cardiovascular Medicine, 2(1), 29-36.

Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was

developed in cooperation with advisory groups, which includes representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 12/04/2008

Revision History Number Original

Revision History Explanation Revision Number:Original Start Date of Comment Period:N/A

Start Date of Notice Period:12/04/2008 Revised Effective Date:02/02/2009

LCR B2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the carrier predecessors of First Coast Service Options, Inc. (Triple S and FCSO).

For Florida (00590) this LCD (L29191) replaces LCD L22473 as the policy in notice. This document (L29191) is effective on 02/02/2009.

11/21/2010 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:

86141 descriptor was changed in Group 1

11/21/2011 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:

86141 descriptor was changed in Group 1

Reason for Change