Local Coverage Determination (LCD)

B-type Natriuretic Peptide (BNP) Testing

L35526

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Contractor Information

LCD Information

Document Information

LCD ID
L35526
LCD Title
B-type Natriuretic Peptide (BNP) Testing
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 10/01/2019
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

Language quoted from the Centers for Medicare and Medicaid Services (CMS) National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the Local Coverage Determination (LCD) Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review a 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:

Title XVIII of the Social Security Act (SSA):
Title XVIII of the Social Security Act, §1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Title XVIII of the Social Security Act, §1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Section 1862(a)(7) excludes routine physical examinations (screening).

Code of Federal Regulations:
42 CFR Sections 410.32(a) & 410.32(a)(3) require that clinical laboratory services be ordered and used promptly by the physician (or other treating practitioner acting within the scope of his or her license and Medicare requirements) who is treating the beneficiary.

42CFR411.15 excludes from coverage examinations performed for a purpose other than treatment or diagnosis of a specific illness, symptoms, complaint, or injury with specific legislative enactments as the only exceptions.

CMS Manual System, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 6, §§20.4.4 and 20.4.5.

CMS Manual System, Pub 100-04, Medicare Claims Processing Manual, Chapter 9, §100 General Billing Requirements

CMS Manual System, Pub 100-20, One Time Notification, Transmittal 477, dated April 24, 2009, Change Request 6338.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Abstract:
B-type natriuretic peptide (BNP) is a cardiac neurohormone produced mainly in the left ventricle. It is secreted in response to ventricular volume expansion and pressure overload, conditions often present in congestive heart failure (CHF). Used in conjunction with other clinical information, measurement of BNP levels (either total or N-terminal) is useful in rapidly establishing or excluding the diagnosis or worsening of CHF in patients with acute exacerbation of dyspnea. Also, BNP levels determined in the first few days after an acute coronary syndrome or event (ACS) may be useful in the prediction of longer-term cardiovascular risk but this risk assessment does not change the management of ACS and is non-covered by regulation.

Indications:
BNP measurements may be considered reasonable and necessary when used in combination with other medical data such as medical history, physical examination, laboratory studies, and chest x-ray.

    • to diagnose or to differentiate heart failure from other potential clinical conditions if the patient’s signs and/or symptoms are consistent with both heart failure and one or more other conditions, e.g., acute dyspnea in a patient with known or suspected pulmonary disease.
    • to diagnose or differentiate worsening heart failure if use of the test replaces other diagnostic tests, such as chest film; and/or to confirm the diagnosis when other diagnostic tests are equivocal.

Limitations:

    • BNP measurements must be assessed in conjunction with standard diagnostic tests, medical history and clinical findings. The efficacy of BNP measurement as a stand-alone test has not been established yet.
    • BNP measurements for monitoring and management of CHF are non-covered. Treatment guided by BNP has not been shown to be superior to symptom-guided treatment in either clinical or quality-of-life outcomes.
    • The efficacy but not the utility of BNP as a risk stratification tool (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) has been established. However, the assessment of BNP level has not been shown to alter patient management. The BNP is not sufficiently sensitive to either preclude or necessitate any other evaluation or treatment in this group of patients.
    • Screening examinations are statutorily non-covered.

 

Summary of Evidence

N/A

Analysis of Evidence (Rationale for Determination)

N/A

General Information

Associated Information

Documentation supporting medical necessity should be legible, maintained in the patient's record, and must be made available to the A/B MAC upon request.

The patient's medical record must contain documentation that fully supports the medical necessity for services included within this LCD. (See "Indications and Limitations of Coverage.") This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.


Sources of Information

1. Alehagen U, Dahlström U, Rehfeld JF, Goetze JP. Association of copeptin and N-terminal proBNP concentrations with risk of cardiovascular death in older patients with symptoms of heart failure. JAMA. May 25 2011;305(20):2088-95. [Medline].

2. Balion C, Don-Wauchope A, Hill S, Santaguida PL, et al. Use of natriuretic peptide measurement in the management of heart failure. Comparative Effectiveness Review No. 126 (Prepared by the McMaster University Evidence-based Practice Center under Contract No. 290-2007-1060-1.) AHRQ Publication no. 12(14)-EHC118-EF. Rockville, MD: Agency for Healthcare Research and Quality; November 2013. www.effectivehealthcare.ahrq.gov/reports/final.cfm

3. Bayes-Genis A, de Antonio M, Galan A, et al. Combined use of high-sensitivity ST2 and NTproBNP to improve the prediction of death in heart failure. Eur J Heart Fail. Jan 2012;14(1):32-8. [Medline].

4. Carpenter CR, Keim SM, Worster A, et al. Brain natriuretic peptide in the evaluation of emergency department dyspnea: is there a role? J Emerg Med. Nov 26 2011;[Medline].

5. Daniels LB, Maisel AS. Natriuretic peptides. J Am Coll Cardiol. Dec 18 2007;50(25):2357-68. [Medline].

6. DeVecchis R, Esposito C, DiBiase G, Ariano C, . et al. B-type natriuretic peptide-guided versus symptom-guided therapy in outpatients with chronic heart failure: a systematic review with meta-analysis. J Cardiovasc Med 2014; 15: 122-134.

7. Doust J, Lehman R, Glasziou P. The Role of BNP Testing in Heart Failure. Am Fam Physician. 2006;74(11):1893-1900.

8. Felker GM, Hasselbad V, Hernandez AF, O’Connor CM. Biomarker-guided therapy in chronic heart failure: A meta-analysis of randomized controlled trials. Am Heart J. 2009;158:422-430.

9. Januzzi JL, van Kimmenade R, Lainchbury J, et al. NT-proBNP testing for diagnosis and short-term prognosis in acute destabilized heart failure: an international pooled analysis of 1256 patients: the International Collaborative of NT-proBNP Study. Eur Heart J. 2006;27(3):330-7. [Medline].

10.Latini R, Masson S, Wong M, et al. Incremental prognostic value of changes in B-type natriuretic peptide in heart failure. American Journal of Medicine. 2006;119(1):70.e23-30.

11. Le Jemtel TH, Padeletti M, Jelic S. Diagnostic and therapeutic challenges in patients with coexistent chronic obstructive pulmonary disease and chronic heart failure. J AM Coll Cardiol. 2007; 49 (2): 171–180.

12. Li P, Luo Y, Chen Y-M. B-type Natriuretic peptide-guided chronic heart failure therapy: A meta-analysis of 11 randomized controlled trials. Heart Lung Circ. 2013;22:852-860.

13. Lindenfeld J, Albert NM, Boehmer JP, et al. HFSA 2010 Comprehensive Heart Failure Practice Guideline. J Card Fail.  Jun 2010;16(6):e1-194. [Medline].

14. Maisel AS, Mueller C, Adams K Jr, et al. State of the art: using natriuretic peptide levels in clinical practice. Eur J Heart Fail.  2008;10(9):824-39.  

15. MClavel, MaloufJ, MichelenaHI, et al. B-type Natriuretic Peptide Clinical Activation in Aortic Stenosis. J Am Coll Cardiol 2014;63:2016-25

16. McMurray JJV. Systolic heart failure. N Engl J Med. 2010;362(3):228-238.

17. Pfisterer M, Buser P, Rickli H, et al. BNP-guided vs. symptom-guided heart failure therapy: the Trial of Intensified vs Standard Medical Therapy in elderly patients with congestive heart failure (TIME-CHF) randomized trial. JAMA. 2009 Jan 28;301(4):383-92.

18. Porapapkkham P, Zimmet H, Billah B, et al. B-type Natriuretic peptide-guided heart failure therapy: A meta-analysis. Arch Intern Med.  2010;170:507-514.

19. Ray P, Le Manach Y, Riou B. Houle T. Statistical evaluation of a biomarker. Anesthesiology. 2010; 112:1023-1040. Issue 4

20. Saenger AK, Jaffe AS. The Use of Biomarkers for the Evaluation and Treatment of Patients with Acute Coronary Syndromes. Medical Clinics of North America.  2007;91(4):657-681.

21. Savarese G, Trimarco B, Dellegrottaglie S, Prastero M, et al. . Natriuretic peptide-guided therapy in chronic heart failure: A meta-analysis of 2,686 patients in 12 randomized controlled trials. PLoS One. 2013;8:e58287.

22. Silvers SM, Howell JM, Kosowsky JM, et al. Clinical Policy: Critical Issues in the Evaluation and Management of Adult Patients Presenting to the Emergency Department with Acute Heart Failure Syndromes. Ann Emerg Med. 2007;49(5):627-669.

23. Troughton RW, Frampton AM. Biomarker-Guided Treatment of Heart Failure. Journal of the American College of Cardiology 2010; 56 (25):2101-2103.

24. Steinhart B, Thorpe KE, Bayoumi AM, Moe G, Januzzi JL
Jr, Mazer CD. Improving the diagnosis of acute heart
failure using a validated prediction model. J Am Coll
Cardiol. Oct 13 2009;54(16):1515-21. [Medline].

25. Wu AH. Serial Testing of B-Type Natriuretic Peptide and NTpro-BNP for Monitoring Therapy of Heart Failure: The Role of Biologic Variation in the Interpretation of Results. American Heart Journal. 2006;152(5):828-834.

26. Yancey CW, Jessup M, Bozkurt B, Butler J, et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013;62(16):e147-e239.

27. Yardan T, Altintop L, Baydin A, et al. B-type natriuretic peptide as an indicator of right ventricular dysfunction in acute pulmonary embolism. Int J Clin Pract. Aug 2008;62(8):1177-82. [Medline].

Bibliography

N/A

Revision History Information

Revision History DateRevision History NumberRevision History ExplanationReasons for Change
10/01/2019 R11

10/01/2019: 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.

LCD was converted to the "no-codes" format.

  • Revisions Due To Code Removal
10/01/2019 R10

10/01/2019: 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.

The following codes were added to Group I coding:

I20.0;121.01;I21.02;I21.09;I21.11;I21.19;I21.21;I21.29;I21.3;I21.4;I21.A1;I21.A9;I22.0;I22.2

I22.8;I22.9;I25.110;I25.700;I25.710;I25.720;I25.730;I25.750;I25.760;

I25.790;R06.89;R60.1

 

  • Revisions Due To ICD-10-CM Code Changes
10/01/2017 R9

08/23/2017: 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.

Updated Sources of Information to be consistent in all LOB.

  • Creation of Uniform LCDs Within a MAC Jurisdiction
10/01/2017 R8

08/21/2017: 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.

LCD is revised to add the following diagnoses effective 10/01/2017:

I50.810: Right heart failure, unspecified.

I50.811: Acute right heart failure

I50.812: Chronic right heart failure

I50.813: Acute on chronic right hear failure

I50.814: Right heart failure due to left heart failure.

I50.82: Biventricular heart failure

I50.83: High output heart failure

I50.84: End state heart failure

I50.89: Other heart failure

R06.03: Acute Respiratory distress

  • Creation of Uniform LCDs With Other MAC Jurisdiction
10/01/2016 R7 This final LCD, effective 10/01/2016, combines JEA L34054 into the JEB LCD so that both JEA and JEB contract numbers will have the same final MCD LCD number.
  • Creation of Uniform LCDs Within a MAC Jurisdiction
10/01/2016 R6 Revision date change from 09/01/2016 to 10/01/2016
  • Typographical Error
09/01/2016 R5 2016-2017 ICD 10 Update to add: I16.0 and I16.1 To Group I codes.
  • Revisions Due To ICD-10-CM Code Changes
10/01/2015 R4 The LCD revised to add I50.9 to the ICD-10 Codes that Support Medical Necessity section effective 10/1/2015
  • Reconsideration Request
10/01/2015 R3 LCD was revised only to fix the "Sources of Information and Basis for Decision" field, #25 unended tag (italic).
  • Typographical Error
10/01/2015 R2 The LCD revised to remove ICD10 codes I21.01, I21.02, I21.09, I21.11, I21.19, I21.21, I21.29, I21.3, I21.4, I22.0, I22.1, I22.2, I22.8, I22.9, R06.83, R60.89. Asterisk for diagnosis codes also removed.
  • Revisions Due To ICD-10-CM Code Changes
10/01/2015 R1 The LCD was revised to add the correct contract numbers in the ÔÇťAssociated Contract Numbers
  • Creation of Uniform LCDs Within a MAC Jurisdiction

Associated Documents

Attachments
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Related National Coverage Documents
N/A
Public Versions
Updated On Effective Dates Status
09/12/2019 10/01/2019 - N/A Currently in Effect You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

  • BNP
  • B-type natriuretic peptide

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