Local Coverage Determination (LCD)

High Sensitivity C-Reactive Protein (hsCRP)

L33908

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
First Coast Service Options, Inc.	A and B MAC	09102 - MAC B	J - N	Florida
First Coast Service Options, Inc.	A and B MAC	09202 - MAC B	J - N	Puerto Rico
First Coast Service Options, Inc.	A and B MAC	09302 - MAC B	J - N	Virgin Islands

LCD Information

Document Information

LCD ID
L33908

LCD Title
High Sensitivity C-Reactive Protein (hsCRP)

Proposed LCD in Comment Period
N/A

Source Proposed LCD
N/A

Original Effective Date
For services performed on or after 10/01/2015

Revision Effective Date
For services performed on or after 01/08/2019

Revision Ending Date
N/A

Retirement Date
N/A

Notice Period Start Date
N/A

Notice Period End Date
N/A

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CMS National Coverage Policy

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for High Sensitivity C-Reactive Protein (hsCRP). 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 High Sensitivity C-Reactive Protein (hsCRP) 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 manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site.

Internet Only Manual (IOM) Citations:

CMS IOM Publication 100-02, Medicare Benefit Policy Manual,

Chapter 15, Section 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests

CMS IOM Publication 100-04, Medicare Claims Processing Manual,

Chapter 16 Laboratory Services
Chapter 23, Section 40 Clinical Diagnostic Laboratory Fee Schedule

CMS IOM Publication 100-08, Medicare Program Integrity Manual,
- Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD

Social Security Act (Title XVIII) Standard References:

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.
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.

Federal Register References:

Code of Federal Regulations (CFR), Title 42, Volume 2, Chapter IV, Part 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

History/Background and/or General Information

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.

Covered Indications

High-sensitivity C-reactive protein (hsCRP) testing will be considered 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

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).

Limitations

Routine screening performed without a relationship to the evaluation or treatment of a symptom, sign, illness or injury is not covered. 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.

Testing for hsCRP as a screening test for the general population or for monitoring response to therapy is not covered.

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 LCD.

As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary.

Summary of Evidence

N/A

Analysis of Evidence (Rationale for Determination)

N/A

Proposed Process Information

Synopsis of Changes

Changes	Fields Changed
	N/A

Associated Information

Sources of Information

Bibliography

Open Meetings

Contractor Advisory Committee (CAC) Meetings

MAC Meeting Information URLs

Proposed LCD Posting Date

Comment Period Start Date

Comment Period End Date

Reason for Proposed LCD

Requestor Name	Requestor Letter
	View Letter

Requestor Information

Contact for Comments on Proposed LCD

Coding Information

ICD-10-CM Codes that Support Medical Necessity

ICD-10-CM Codes that DO NOT Support Medical Necessity

Additional ICD-10 Information

General Information

Associated Information

Documentation Requirements

Please refer to the Local Coverage Article: Billing and Coding: High Sensitivity C-Reactive Protein (hsCRP) (A57803) for documentation requirements that apply to the reasonable and necessary provisions outlined in this LCD.

Utilization Guidelines

Please refer to the Local Coverage Article: Billing and Coding: High Sensitivity C-Reactive Protein (hsCRP) (A57803) for utilization guidelines that apply to the reasonable and necessary provisions outlined in this LCD.

Sources of Information

First Coast Service Options, Inc. reference LCD number – L29437

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.

Jellinger PS, Handelsman Y, Rosenblit PD, et al. American Association of Clinical Endocrinologists and American College of Endocrinology Guidelines for Management of Dyslipidemia and Prevention of Cardiovascular Disease. Endocr Practice 2017; 23; (Suppl 2), S1-S87.

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.

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.

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.

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;2195-2207.

Stone NJ, Robinson JG, Lichtenstein AH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation 2014; 129(25 Suppl 2), S1-S45.

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

Bibliography

N/A

Revision History Information

Revision History Date	Revision History Number	Revision History Explanation	Reasons for Change
01/08/2019	R4	Revision Number : 4 Publication: November 2019 Connection LCR B2019-031 Explanation of Revision: Based on Change Request (CR) 10901, the LCD was revised to remove all billing and coding and all language not related to reasonable and necessary provisions (“Bill Type Codes,” “Revenue Codes,” “CPT/HCPCS Codes,” “ICD-10 Codes that Support Medical Necessity,” “Documentation Requirements” and “Utilization Guidelines” sections of the LCD) and place them into a newly created billing and coding article. Also, the Social Security Act, Code of Federal Regulations, and IOM reference sections were updated. The effective date of this revision is for claims processed on or after January 8, 2019, for dates of service on or after October 3, 2018. At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination and therefore not all the fields included on the LCD are applicable as noted in this LCD.	Other (Revision based on CR 10901)
10/01/2018	R3	Revision Number: 3 Publication: September 2018 Connection LCR B2018-017 Explanation of Revision: Based on CR 10847 (Annual 2019 ICD-10-CM Update) the LCD was revised. Added ICD-10-CM diagnosis code E78.49. Deleted ICD-10-CM diagnosis code E78.4. In addition, the asterisked statement under the “ICD-10 Codes that Support Medical Necessity” section of the LCD was revised to include ICD-10-CM diagnosis code E78.49. The effective date of this revision is based on date of service. 10/01/2018: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination and therefore not all the fields included on the LCD are applicable as noted in this policy.	Revisions Due To ICD-10-CM Code Changes
07/10/2018	R2	Revision Number: 2 Publication: July 2018 Connection LCR B2018-013 Explanation of Revision: Based on a LCD reconsideration request, the LCD was revised to add, ICD-10-CM diagnosis codes Z74.09, Z78.9 and I25.10 and the asterisked explanation language “*Use ICD-10-CM code Z74.09 and Z78.9 for patients at intermediate risk for CAD who do not have elevated lipids (i.e., do not meet criteria to use ICD-10-CM codes E78.00-E78.4)” to the “ICD-10 Codes that Support Medical Necessity” section of the LCD for CPT code 86141. Also, the “Sources of Information and Basis for Decision” section of the LCD was updated. The effective date of this revision is based on date of service. 07/10/2018: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination and therefore not all the fields included on the LCD are applicable as noted in this policy.	Reconsideration Request
10/01/2016	R1	Revision Number: 1 Publication: October 2016 Connection LCR A/B2016-097 Explanation of Revision: Based on CR 9677 (Annual 2017 ICD-10-CM Update) the LCD was revised. Deleted ICD-10-CM diagnosis code E78.0. Added ICD-10-CM diagnosis codes E78.00 and E78.01. The effective date of this revision is based on date of service.	Revisions Due To ICD-10-CM Code Changes

Associated Documents

Attachments
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Related Local Coverage Documents
Articles
A57803 - Billing and Coding: High Sensitivity C-Reactive Protein (hsCRP)

Updated On	Effective Dates	Status
11/22/2019	01/08/2019 - N/A	Currently in Effect	You are here
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High Sensitivity C-Reactive Protein (hsCRP)

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Coding Information

Bill Type Codes

Revenue Codes

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Group 1

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Group 1

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