Local Coverage Determination (LCD)

B-type Natriuretic Peptide (BNP) Testing

L33573

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Document Information

LCD ID
L33573
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 11/07/2019
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 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 an NCD. See Section 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):

Section 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.

Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Code of Federal Regulations:

42 CFR Section 410.32 indicates that diagnostic tests may only be ordered by treating physician (or other treating practitioner acting within the scope of his or her license and Medicare requirements) who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary's specific medical problem. Tests not ordered by the physician (or other qualified non-physician provider) who is treating the beneficiary are not reasonable and necessary (see Sec. 411.15(k)(1) of this chapter).

CMS Publications:

CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 9:

    100 General Billing Requirements

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, factors often found in congestive heart failure (CHF). Used in conjunction with other clinical information, rapid measurement of BNP is useful in establishing or excluding the diagnosis and assessing the 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.

Evidence has accumulated to support use of BNP measurements for prognostic purposes in individuals with heart failure and a low ejection fraction and to improve dosing in guideline-directed medical therapy (GDMT) (Yancy et al., 2013). Berger et al. (2002) studied use of BNP levels to predict sudden death in heart failure patients and suggested BNP levels could be used to determine which patients might benefit from an implantable cardioverter-defibrillator (ICD). Other authors have shown a relationship between BNP levels and CHF morbidity and mortality (Anand et al., 2003; Taub et al., 2009; Maeda et al., 2000; and Neuhold et al., 2008). Januzzi et al, 2011; Jourdain et al., 2007; Berger et al., 2010; and Lainchbury et al., 2010 studied the use of BNP to guide therapy in CHF. Porapakkam et al, 2010 and Felker et al, 2009 performed meta-analyses showing the benefit of using BNP levels in the management of CHF patients.

Palladini et al. (2003) studied 152 consecutive patients seen at the time of amyloidosis diagnosis and obtained NT-proBNP levels. Heart involvement was estimated using clnical signs, electrocardiography, and echocardiography. NT-proBNP was the most sensitive index of myocardial dysfunction and the best predicted prognosis in patients with light-chain amyloidosis. Dispenzieri et al. (2004) retrospectively studied 242 patients with newly-diagnosed primary systemic amyloidosis in whom echocardiograms and NT-pro levels were obtained and used to divide the patients into three stages to promote cross comparisons of therapeutic outcomes, The National Comprehensive Cancer Network (NCCN) clinical practice guidelines, “Systemic Light Chain Amyloidosis,” list recommend a BNP level be obtained in the initial diagnositic work-up. Palladini et al. (2010) again evaluated the use of BNP levels to predict prognosis. Levels of NT-proBNP, high-sensitivity (hs) cTnT, and tropronin were obtained at initial diagnosis and six months later were obtained in 171 consecutive patients. The high-sensitivity and NT-proBNP ertr independent prognostic determinants. The author recommended BNP levels be used to follow response to therapy. For the purposes of this policy, either total or N-terminal assays are acceptable.

This local coverage determination (LCD) documents National Government Services indications and limitations of coverage for BNP testing.

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, chest x-ray, and electrocardiography:

  • To distinguish cardiac cause of acute dyspnea from pulmonary or other non-cardiac causes. Plasma BNP levels are significantly increased in patients with CHF presenting with acute dyspnea compared with patients presenting with acute dyspnea due to other causes.
  • To distinguish decompensated CHF from exacerbated chronic obstructive pulmonary disease (COPD) in a symptomatic patient with combined chronic CHF and COPD. Plasma BNP levels are significantly increased in patients with CHF with or without concurrent lung disease compared with patients who have primary lung disease.
  • To establish prognosis or disease severity in chronic CHF when needed to guide therapy
  • To achieve optimal dosing of guideline-directed medical therapy (GDMT) in select clinically euvolemic patients followed in a well-structured heart failure (HF) disease management program
  • To guide therapeutic decision-making in individuals who have amyloidosis



Limitations:

BNP measurements must be analyzed in conjunction with standard diagnostic tests, medical history and clinical findings. The efficacy of BNP measurement as a stand-alone test has not yet been established. Clinicians should be aware that certain conditions such as ischemia, infarction and renal insufficiency, may cause elevation of circulating BNP concentration and require alterations of the interpretation of BNP results.


Summary of Evidence

N/A

Analysis of Evidence (Rationale for Determination)

N/A

General Information

Associated Information
N/A
Sources of Information

Food and Drug Administration (FDA) [Web site]. Center for Devices and Radiological Health (CDRH). 510(k) approvals page. K010266. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K010266. Accessed August 24, 2011.

Food and Drug Administration (FDA) [Web site]. Center for Devices and Radiological Health (CRDH). 510(k) approvals. Page. K093758. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K093758 Accessed September 2, 2011.

National Institutes of Health (NIH). Clinical Trials.Gov. http://www.clinicaltrials.gov/ct2/results?term=BNP+and+heart+failure&no_unk=Y&pg=2. Accessed September 3, 2011.

Other Medicare Contractor LCDs: Florida (L14340) and New York (L13097, L13522 and L13889)

Other Medicare Contractor LCDs (Noridian Administrative Services, LLC) L31193.



Bibliography


Anand IS, Fisher LD, Chiang YT, et al. Changes in brain natriuretic peptide and norepinephrine over time and mortality and morbidity in the Valsartan Heart Failure Trial (Val-HeFT). Circulation. 2003;107: 1278–83.

Berger R, Huelsman M, Strecker K, et al. B-type natriuretic peptide predicts sudden death in patients with chronic heart failure. Circulation. 2002;105: 2392–7.

Bibbin-Domingo K, Ansari M, Schiller N, Massie B, Whooley M. Is B-type natriuretic peptide a useful screening test for systolic dysfunction in patients with coronary disease? Data from the Heart and Soul Study. Am J Med. 2004;116(8):561-563.

Brenden CK, Hollander JE, Guss D, et al. Gray zone BNP levels in heart failure patients in the emergency department: results from the rapid emergency department heart failure outpatient trial (REDHOT) multicenter study. Am Heart J. 2006;151(5):1006-1011.

Cowie M, Jourdain P, Maisel A, et al. Clinical applications of B-type natriuretic peptide (BNP) testing. European Heart Journal. 2003;24:1710-1718. http://www.westershopsitals.nhs.uk/WHC/archive/evidence/05%20hf/BNP%20clinical%20applications-EHJ%202003.pdf. Accessed April 5, 2005.

Dao Q, Krishnaswamy P, Kazanegra R, et al. Utility of B-type natriuretic peptide in the diagnosis of congestive heart failure in an urgent-care setting. J AM Coll Cardiol. 2001;37(2):379-385.

deLemos J, Morrow D, Bentley J, et al. The prognostic value of B-type natriuretic peptide in patients with acute coronary syndromes. N Engl J Med. 2001;345(14):1014-1021.

Dispenzieri A. Gertz M, Kyle R, et al. Serum cardiac troponins and N-terminal pro-brain
natriuretic peptide: a staging system for primary systemic amyloidosis. Journal of Clinical Oncology. 2004;22(18):3751-3757.

Forfia PR, Watkins SP, Rame JE, et al. Relationship between B-type natriuretic peptides and pulmonary capillary wedge pressure in the intensive care unit. J Am Coll Cardiol. 2005;45:1667–71.

Hunt SA, Abraham WT, Chin MH, et al. ACC/AHA 2005 guideline update for the diagnosis and management of chronic heart failure in the adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure). http://www.acc.org/clinical/guidelines/failure/index.pdf. Accessed: October 7, 2005.

Januzzi JL Jr., Rehman SU, Mohammed AA, et al. Use of aminoterminal pro-B-type natriuretic peptide to guide outpatient therapy of patients with chronic left ventricular systolic dysfunction. J Am Coll Cardiol. 2011;58:1881–9.

Jessup M, Abraham WT, Casey DE, et al. 2009 focused update incorporated into the ACC/AHA 2005 guidelines for the diagnosis and management of heart failure in adults. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines.
http://www.guideline.gov/content.aspx?id=24035. Accessed March 4, 2013.

Jourdain P, Jondeau G, Funck F, et al. Plasma brain natriuretic peptide-guided therapy to improve outcome in heart failure: the STARS-BNP Multicenter Study. J Am Coll Cardiol. 2007; 49:1733–9.

Kuster G, Tanner H, Printzen G, Suter T, Mohacsi P, Hess O. B-type natriuretic peptide for diagnosis and treatment of congestive heart failure. Swiss Med Wkly. 2003;133:623-628. http://www.smw.ch/pdf200x/2002/43/smw-10081.pdf. Accessed April 5, 2005.

Lainchbury JG, Troughton RW, Strangman KM, et al. N-terminal pro-B-type natriuretic peptide-guided treatment for chronic heart failure: results from the BATTLESCARRED (NT-proBNP-Assisted Treatment To Lessen Serial Cardiac Readmissions and Death) trial. J Am Coll Cardiol. 2009;55:53–60.

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):70e24-70.

Logeart D, Thabut G, Jopurdain P, et al. Predischarge B-type Natriuretic peptide assay for identifying patients at high risk of re-admission after decompensated heart failure. J Am Coll Cardiol. 2004;43(4):635-641.

Lubien E, DeMaria A, Krishnaswamy P, et al. Utility of B-natriuretic peptide in detecting diastolic dysfunction: comparison with Doppler velocity recordings. Circulation. 2002;105(5):595-601.

Maeda K, Tsutamoto T, Wada A, et al. High levels of plasma brain natriuretic peptide and interleukin-6 after optimized treatment for heart failure are independent risk factors for morbidity and mortality in patients with congestive heart failure. J Am Coll Cardiol 2000;36: 1587–93.

Maisel A, Clopton P, Krishnaswamy P, et al. Impact of age, race, and sex on the ability of B-type natriuretic peptide to aid in the emergency diagnosis of heart failure: results from the Breathing Not Properly (BNP) multinational study. Am Heart J. 2004;147(6):1078-1084.

Maisel A, Hollander J, Guss D, et al. Primary results of the Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT). A multicenter study of B-type natriuretic peptide levels, emergency department decision making, and outcomes in patients presenting with shortness of breath. J Am Coll Cardiol. 2004;44(6):1328-1333.

Maisel A, Krishnaswamy P, Nowak R, et al. Rapid measurement of B-type natriuretic peptide in the emergency diagnosis of heart failure. N Engl J Med. 2002;347(3):161-167.

Mak G, DeMaria A, Clopton P, Maisel A. Utility of B-natriuretic peptide in the evaluation of left ventricular diastolic function: comparison with tissue Doppler imaging recordings. Am Heart J. 2004;148(5):895-902.

McCullough P, Nowak R, McCord J, et al. B-type natriuretic peptide and clinical judgment in emergency diagnosis of heart failure: analysis from Breathing Not Properly (BNP) Multinational Study. Circulation. 2002;106(4):416-422.

Morrison L, Harrison A, Krishnaswamy P, Kazanegra R, Clopton P, Maisel A. Utility of a rapid B-natriuretic peptide assay in differentiating congestive heart failure from lung disease in patients presenting with dyspnea. J Am Coll Cardiol. 2002;39(2):202-209.

Mueller C, Scholer A, Laul-Kilian K, et al. Use of B-type Natriuretic peptide in the evaluation and management of acute dyspnea. N Engl J Med. 2004 350(7)647-654.

Mueller C, Laule-Kilian K, Frana B, et al. Use of B-type natriuretic peptide in the management of acute dyspnea in patients with pulmonary disease. Am Heart J. 2006; 151(2):471-477.

Neuhold S, Huelsmann M, Strunk G, et al. Comparison of copeptin, Btype natriuretic peptide, and amino-terminal pro-B-type natriuretic peptide in patients with chronic heart failure: prediction of death at different stages of the disease. J Am Coll Cardiol. 2008; 52:266–72.

O’Connor CM, Gattis Strough W, Gallup DS, Hasselblad V, Gheorghaiade M. Demographic, clinical characteristics, and outcomes of patients hospitalized for decompensated heart failure: observations from the IMPACT-HF registry. J Card Fail.. 2005;11(3):200-2005.

Palladini G, Barassi A, Klersy C, et al.The combination of high-sensitivity cardiac troponin T (hs-cTnT) at presentation and changes in N-terminal natriuretic peptide type B (NT-proBNP) after chemotherapy best predicts survival inAL amyloidosis. Blood. 2010;116(18).

Palladini G, Campana C, Klersy C, et al. Serum N-terminal pro–brain natriuretic peptide is a sensitive marker of myocardial dysfunction in AL amyloidosis. Circulation. 2003;107:2440-2445.

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;301(4):383-392.

Philbin EF, Rocco TA, Lindenmuth NV, Ulrich K, Jenkins PL. Clinical outcomes in heart failure: report from a community hospital-based registry. Am J Med. 1999;107:549-555.

Porapakkham P, Porapakkham P, Zimmet H, et al. B-type natriuretic peptide-guided heart failure therapy: a meta-analysis. Arch Intern Med. 2010;170:507–14.

Taub PR, Daniels LB, Maisel AS. Usefulness of B-type natriuretic peptide levels in predicting hemodynamic and clinical decompensation. Heart Fail Clin. 2009;5:169-75.

Wieczorek S, Wu A, Christenson R, et al. A rapid B-type natriuretic peptide assay accurately diagnoses left ventricular dysfunction and heart failure: a multicenter evaluation. Am Heart J. 2002;144(5):834-839.

Wu A, Omland T, Duc P, et al. The effect of diabetes on B-type natriuretic peptide concentrations in patients with acute dyspnea: an analysis from the Breathing Not Properly (BNP) Multinational Study. http://care.diabetesjournals.org/cgi/content/full/27/10/2398. Accessed April 7, 2005.

Yancy CW, et al. ACCF/AHA guideline for the management of heart failure. JACC. 2013;62(16):e147–239.

Young J, Supplement Ed and Roundtable Moderator. Testing for B-type natriuretic peptide in the diagnosis and assessment of heart failure: what are the nuances? Cleve Clin J Med. 2004;71(Supplement 5):S1-S17. http://www.ccjm.org/toc/BNP.htm. Accessed April 5, 2005.

Revision History Information

Revision History DateRevision History NumberRevision History ExplanationReasons for Change
11/07/2019 R6

Consistent with Change Request 10901, all coding information, National coverage provisions, and Associated Information (Documentation Requirements, Utilization Guidelines) have been removed from the LCD and placed in the related Billing and Coding Article, A56826. There has been no change in coverage with this LCD revision.

  • Revisions Due To Code Removal
01/01/2018 R5

ICD-10 code I50.810 was added to the "ICD-10-CM Codes that Support Medical Necessity section" effective for dates of service on or after 10/01/2017.

DATE (12/28/2017): 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.

  • Request for Coverage by a Practitioner (Part B)
10/01/2017 R4

The following ICD-10 codes and code ranges were added to the ICD-10 Codes that Support Medical Necessity section: I50.811- I50814, I50.82- I50.84, I50.89 and R06.03.  ICD 10 Codes E85.81, E85.82, and E85.89 will replace the current range E85.0-E85.9, due to the annual ICD-10-CM update.

DATE (10/01/2017): 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.

 

  • Revisions Due To ICD-10-CM Code Changes
04/01/2017 R3 Based on a reconsideration request to update the LCD to allow coverage in concert with the ACC/AHA Heart Failure Guideline published in 2013 (Yancy et al.), updates were made to the indications: use of BNP to establish prognosis or disease severity in chronic CHF when needed to guide therapy (Class I, Level of Evidence A) and/or to achieve optimal dosing of guideline-directed medical therapy (GDMT) in select clinically euvolemic patients followed in a well-structured heart failure (HF) disease management program (Class IIa, Level of Evidence B). Referenced literature was secured and reviewed. Limitations supported by previous ANA/ACC heart failure guidelines (Hunt et al., 2005) were removed. References added include Anand et al. (2003); Berger et al. (2002); Berger et al. (2010); Forfia el al. (2005); Januzzi et al. (2011); Lainchbury et al. (2010); Maeda et al. (2000); Neuhold et al. (2008); and Porapakkaham al. (2010).
  • Reconsideration Request
07/01/2016 R2 Based on a reconsideration request, received on 11/16/2015, an indication of coverage has been added to allow BNP to guide therapeutic decision-making in individuals who have amyloidosis. Diagnosis code range E85.0-E85.9 has been added to the ICD-10-CM diagnosis codes that support medical necessity section, effective for services rendered on or after 07/01/2016.
  • Reconsideration Request
10/01/2015 R1 LCD updated to reflect administrative changes.
  • Provider Education/Guidance

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