L28772-LCD

Automated World Health

Local Coverage Determination (LCD) for B-Type Natriuretic Peptide (BNP) (L28772)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number 09101

Contractor Type MAC - Part A

LCD Information

Document Information

LCD ID Number L28772

LCD Title

B-Type Natriuretic Peptide (BNP)

Contractor's Determination Number A83880

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 02/16/2009

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

Congestive Heart Failure (CHF) is characterized by a progressive activation of the neurohormonal systems that control vasoconstriction and sodium retention; the activation of these systems plays a role in its pathogenesis and progression. As the heart fails, B-Type Natriuretic Peptide (BNP), a cardiac neurohormone is secreted from the cardiac ventricles in response to ventricular volume expansion and pressure overload. Used in conjunction with other clinical information, rapid measurement of BNP is useful in establishing or excluding the diagnosis and assessment of severity of CHF in patients with acute dyspnea so that appropriate and timely treatment can be initiated. This test is also used to predict the long-term risk of cardiac events or death across the spectrum of acute coronary syndromes when measured in the first few days after an acute coronary event. For the purposes of this policy, the total and N terminal assays are both acceptable.

Medicare will consider B-Type Natriuretic Peptide (BNP) measurements medically reasonable and necessary to establish or exclude the diagnosis and assessment of severity of CHF in patients with acute dyspnea when used in combination with other medical data such as medical history, physical examination, laboratory studies, chest x- ray, and electrocardiography (ECG). Rapid measurement of BNP concentration in the blood appears to be a sensitive and specific test for differentiating patients with CHF from primary pulmonary causes of dyspnea in acute care settings.

• Plasma BNP levels are significantly increased in CHF patients with or without concurrent lung disease compared with patients with primary lung disease.

• Plasma BNP levels are significantly increased in CHF patients presenting with acute dyspnea compared with patients presenting with acute dyspnea due to other causes.

• BNP levels are also useful for risk stratification (to assess risk of death, myocardial infarction or congestive heart failure) among patients with acute coronary syndrome (myocardial infarction with or without T-wave elevation

and unstable angina).

BNP measurements must be analyzed in conjunction with standard diagnostic tests, the medical history, and clinical findings; its efficacy as a stand-alone test has not yet been established.

Additional investigation is required to further define the diagnostic value of plasma BNP in monitoring the efficiency of treatment for CHF and in tailoring the therapy for heart failure. Therefore, BNP measurements for monitoring and management of CHF are not a covered service.

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.

012x Hospital Inpatient (Medicare Part B only) 013x Hospital Outpatient

085x Critical Access Hospital

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.

0301 Laboratory - Chemistry

CPT/HCPCS Codes

83880 NATRIURETIC PEPTIDE

ICD-9 Codes that Support Medical Necessity

402.01 MALIGNANT HYPERTENSIVE HEART DISEASE WITH HEART FAILURE

402.11 BENIGN HYPERTENSIVE HEART DISEASE WITH HEART FAILURE

402.91 UNSPECIFIED HYPERTENSIVE HEART DISEASE WITH HEART FAILURE HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, MALIGNANT, WITH HEART

404.01

404.03

FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE I THROUGH STAGE IV, OR

UNSPECIFIED

HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, MALIGNANT, WITH HEART FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE

404.11 HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, BENIGN, WITH HEART FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE I THROUGH STAGE IV, OR UNSPECIFIED

404.13 HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, BENIGN, WITH HEART FAILURE AND CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE

HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, UNSPECIFIED, WITH HEART

404.91

FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE I THROUGH STAGE IV, OR UNSPECIFIED

404.93 HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, UNSPECIFIED, WITH HEART FAILURE AND CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE

410.00 - 410.92

ACUTE MYOCARDIAL INFARCTION OF ANTEROLATERAL WALL EPISODE OF CARE UNSPECIFIED - ACUTE MYOCARDIAL INFARCTION OF UNSPECIFIED SITE SUBSEQUENT EPISODE OF CARE

411.1 INTERMEDIATE CORONARY SYNDROME

428.1 CONGESTIVE HEART FAILURE UNSPECIFIED

428.2 LEFT HEART FAILURE

428.20 UNSPECIFIED SYSTOLIC HEART FAILURE

428.21 ACUTE SYSTOLIC HEART FAILURE

428.22 CHRONIC SYSTOLIC HEART FAILURE

428.23 ACUTE ON CHRONIC SYSTOLIC HEART FAILURE

428.30 UNSPECIFIED DIASTOLIC HEART FAILURE

428.31 ACUTE DIASTOLIC HEART FAILURE

428.32 CHRONIC DIASTOLIC HEART FAILURE

428.33 ACUTE ON CHRONIC DIASTOLIC HEART FAILURE

428.40 UNSPECIFIED COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE

428.41 ACUTE COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE

428.42 CHRONIC COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE

428.43 ACUTE ON CHRONIC COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE

428.9 HEART FAILURE UNSPECIFIED

786.00 RESPIRATORY ABNORMALITY UNSPECIFIED

786.02 ORTHOPNEA

786.5 SHORTNESS OF BREATH

786.6 TACHYPNEA

786.7 WHEEZING

786.09 RESPIRATORY ABNORMALITY OTHER

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 physician must clearly indicate the medical necessity of the services being billed. In addition, documentation that the service was performed must be included in the patient’s medical record. This information is normally found in the office/progress notes, hospital notes, and/or test results.

If the provider of the service is other than the ordering/referring physician, that provider must maintain hard copy documentation of test results and interpretation, along with copies of the ordering/referring physician’s order for the studies. The physician must state the clinical indication/medical necessity for the study in his order for the test.

Appendices

Utilization Guidelines Generally, it is not expected that this test would be performed more than four times in a given year.

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

Baker, D., Chin, M., Cinquegrani, M., Feldman, A., Francis, G., Ganiats, T., Goldstein, S., Gregoratos, G., Jessup, M., Noble, R., Packer, M., Silver, M., & Stevenson, L. (2001). ACC/AHA guidelines for the evaluation and management of chronic heart failure in the adult: Executive summary. Journal of the American College of Cardiology, 38(7), 2101-2113. This reference consulted for guidelines to establish indications and limitations.

Bettencourt, P., Ferreira, A., Dias, P., Castro, A., Martins, L., & Cerqueira-Gomes, M. (1999). Evaluation of brain natriuretic peptide in the diagnosis of heart failure. Cardiology, 93, 19-25. This reference consulted for evidence of the role BNP plays in the diagnosis of isolated diastolic HF.

Cheng, V., Kazanagra, R., Garcia, A., Lenert, L., Krishnaswamy, P., Gardetto, N., Clopton, P., Maisel, A. (2001). A rapid bedside test for B-type peptide predicts treatment outcomes in patients admitted for decompensated heart failure: A pilot study. Journal of the American College of Cardiology, 37(2), 386-391. This source consulted for clinical study results.

Collins, S., Ronan-Bentle, S., Storrow, A. (2003). Diagnostic and prognostic usefulness of natriuretic peptides in emergency department patients with dyspnea. Annals of Emergency Medicine. 41(4), 532-545. This source used for clinical study results.

Dao, Q., Krishnaswamy, P., Kazanegra, R., Harrison, A., Amirnovin, R., Lenert, L., Clopton, P., Alberto, J., Hlavin, P., & Maisel, A. (2001). Utility of B-type natriuretic peptide in the diagnosis of congestive heart failure in an urgent-care setting. Journal of the American College of Cardiology, 37(2), 379-385. This reference consulted for clinical study results.

DeLemos, J., Morrow, D., Bentley, J., Omland, B., Sabatine, M., McCabe, C., Hall, B., Cannon, C., Brauwald, E. (2001). The prognostic value of B-type natriurietic peptide in patients with acute coronary syndromes. New England Journal of Medicine, 345(14), 1014-1021.

Kazanegra, R., Cheng, V., Garcia, A., Krishnaswamy, P., Gardetto, N., Clopton, P., & Maisel, A. (2001) A rapid test for B-type natriuretic peptide correlates with falling wedge pressures in patients treated for decompensated heart failure: A pilot study. Journal of Cardiac Failure, 7(1), 21-29. This reference used for clinical study results.

Kuster, G., Tanner, H., Printzen, G., Suter, T., Mohacsi, P. & Hess, O. (2003). B-type natriuretic peptide for diagnosis and treatment of congestive heart failure. Swiss Medical Weekly, 133, 623-628. This reference was consulted for clinical study results.

Lubien, E., DeMaria, A., Krishnaswamy, P., Clopton, P., Koon, J., Kazanegra, R., Gardetto, N., Wanner, E., & Maisel, A. (2002). Utility of B-natriuretic peptide in detecting diastolic dysfunction: Comparison with doppler velocity recordings. Circulation, 105(5), 595-601. This source consulted for information on the role of BNP with echocardiography.

Mair, J., Hammerer-Lercher, A., & Puschendorf, B. (2001). The impact of cardiac natriuretic peptide determination of the diagnosis and management of heart failure. Clin. Lab., 39(7), 571-588. This reference used for information on natriuretic peptides and management of heart failure.

Maisel, A., Koon, J., Krishnaswamy, P., Kazenegra, R., Clopton, P., Gardetto, N., Morrisey, R., Garcia, A., Chiu,

A., & De Maria, A. (2001). Utility of B-natriuretic peptide as a rapid, point-of-care test for screening patients undergoing echocardiography to determine left ventricular dysfunction. American Heart Journal, 141(3), 367-374. This reference used for role of BNP in conjunction with echocardiography.

Maisel, A., Krishnaswamy, P., Nowak, R., McCord, J., Hollander, J., Duc, P., Omland, T., Storrow, A., Abraham, W., Wu, A., Clopton, P., Steg, P., Westheim, A., Knudsen, C., Perez, A., Kazanegra, R., Herrmann, H., & McCullough, P. (2002). Rapid measurement of B-type natriuretic peptide in the emergency diagnosis of heart failure. The New England Journal of Medicine, 347, 161-167. This source used for clinical study results.

McCullough, P., Nowak, R., McCord, J., Hollander, J., Herrmann, H., Steg, P., Duc, P., Westheim, A., Omland, T., Knudsen, W., Storrow, A., Abraham, W., Lamba, S., Wu, A., Perez, A., Clopton, P., Krishnaswamy, P., Kazanegra, R., Maisel, A. (2002). B-type natriuretic peptide and clinical judgment in emergency diagnosis of heart failure. Circulation, 106(4), 416-422. This reference used to determine indications and limitations.

McNairy, M., Gardetto, N., Clopton, P., Garcia, A., Krishnaswamy, P., Kazanegra, R., Ziegler, M., & Maisel, A. (2002). Stability of B-type natriuretic peptide levels during exercise in patients with congestive heart failure: Implications for outpatient monitoring with B-type natriuretic peptide. American Heart Journal, 143(3), 406-411. This reference used for information on evaluation of BNP levels with exercise.

Morrison, L., Harrison, A., Krishnaswamy, P., Kazanegra, R., Clopton, P., & Maisel, A. (2002). Utility of a rapid B- natriuretic peptide assay in differentiating congestive heart failure from lung disease in patients presenting with dyspnea. Journal of the American College of Cardiology, 39(2), 201-209. This source used to determine indications and limitations.

Peacock, F. (2002). The B-type natriuretic peptide assay: A rapid test for heart failure. Cleveland Clinic Journal of Medicine. 69(3), 243-251. This source used for additional clarification of the role of BNP with other assessment tools.

Remme, W., & Swedberg, K. (2001). Guidelines for the diagnosis and treatment of chronic heart failure: Task force for the diagnosis and treatment of chronic heart failure, European society of cardiology. European Heart Journal, 22(17), 1527-1560. This reference consulted for guidelines used in management of CHF to establish indications and limitations.

Vogeser, M., & Jacob, K. (2001). B-type natriuretic peptide (BNP)-Validation of an immediate response assay. Clin. Lab., 47, 29-33. This source used for information on laboratory parameters for BNP.

Wieczorek, S., Wu, A., Christenson, R., Krishnaswamy, P., Gottlieb, S., Rosano, T., Hager, D., Gardetto, N., Chiu, A., Bailly, K., & Maisel, A. (2002). A rapid B-type natriuretic peptide assay accurately diagnoses left ventricular dysfunction and heart failure: A multicenter evaluation. American Heart Journal, 144, 834-839. This reference used for clinical study to support the use of this test.

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 Original Effective Date:02/16/2009

LCR A2009-

December 2008 Bulletin

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

For Florida (00090) this LCD (L28772) replaces LCD L14340 as the policy in notice. This document (L28772) is effective on 02/16/2009.

8/1/2010 - The description for Bill Type Code 12 was changed 8/1/2010 - The description for Bill Type Code 13 was changed 8/1/2010 - The description for Bill Type Code 85 was changed

8/1/2010 - The description for Revenue code 0301 was changed

Reason for Change