Subject:
B-Type Natriuretic Peptide in Heart Failure
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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B-type natriuretic peptide (BNP), initially called brain natriuretic peptide, is a 32-amino-acid neurohormone synthesized almost exclusively by the ventricular myocardium and released into the circulation in response to ventricular dilatation and pressure overload. This natriuretic peptide appears to improve the loading conditions of the failing heart by promoting sodium and water loss and dilating blood vessels.
When BNP is cleaved from its precursor (proBNP), N-terminal proBNP (NT-proBNP) is released. Both BNP and NT-proBNP have been used as useful markers that may aid in the diagnosis and assessment of severity of congestive heart failure. In general, plasma BNP and NT-proBNP levels correlate positively with the degree of left ventricular dysfunction. Based on the Breathing Not Properly study of 1586 patients presenting to the emergency department or urgent care setting with a major complaint of acute dyspnea, plasma BNP was markedly higher in patients with clinically diagnosed heart failure compared to those without heart failure. A plasma BNP >100 pg/mL diagnosed heart failure with a sensitivity, specificity, and predictive accuracy of 90, 76, and 83 percent, respectively. Choosing values >125 or 150 pg/mL decreased sensitivity, increased specificity, and did not change overall predictive accuracy. The predictive accuracy of plasma BNP for heart failure was equivalent to or better than other parameters such as cardiomegaly on chest x-ray, a history of heart failure, or rales on physical examination, and was better than the widely used NHANES and Framingham criteria for the diagnosis of heart failure (83 versus 67 and 73 percent, respectively).
According to UpToDate, a variety of clinical immunoassays are clinically available for plasma BNP. These include a rapid point-of-care assay as well as central lab assays that offer improved precision compared to the point-of-care test. These assays are harmonized at a value of 100 ng/mL, but above or below this level the correlations are not strong.
Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
1. Measurement of B-type natriuretic peptide (BNP) or N-terminal proBNP (NT-proBNP) is considered medically necessary for the following indications.
- to differentiate dyspnea due to heart failure from pulmonary disease, especially when the etiology of dyspnea is unclear;
- to determine prognosis or disease severity in chronic heart failure;
- measurement of baseline level on admission to the hospital to determine prognosis in acutely decompensated heart failure.
2. All other indications for measurement of BNP or NT-proBNP are considered investigational.
Medicare Coverage:
There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for this service. Therefore, Medicare Advantage will follow the Horizon BCBSNJ Medical Policy.
Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.
FIDE SNP:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.
[INFORMATIONAL NOTE: The following statements are excerpts from the 2017 ACC/AHA/HFSA Heart Failure Focused Update:
- Natriuretic peptide biomarker testing in the setting of chronic ambulatory heart failure provides incremental diagnostic value to clinical judgement, especially when the etiology of dyspnea is unclear. In emergency settings, natriuretic peptide biomarker levels usually have higher sensitivity than specificity and may be more useful for ruling out than ruling in heart failure. Although lower values of natriuretic peptide biomarkers exclude the presence of heart failure, and higher values have reasonably high positive predictive value to diagnose heart failure, clinicians should be aware that elevated plasma levels for both natriuretic peptides have been associated with a wide variety of cardiac and noncardiac causes.
- Studies have demonstrated incremental prognostic value of these biomarkers to standard approaches of cardiovascular disease risk assessment. However, there were differences in the risk prediction models, assay cutpoints, and length of follow-up. Furthermore, not all patients may need biomarker measurement for prognostication, especially if they already have advanced heart failure with established poor prognosis or persistently elevated levels of biomarkers in former settings. Therefore, assays of natriuretic peptide biomarkers for incremental prognostication should not preclude good clinical judgment; an individualized approach to each patient is paramount.
- Higher levels of natriuretic peptide biomarkers on admission are usually associated with greater risk for clinical outcomes, including all-cause and cardiovascular mortality, morbidity, and composite outcomes, across different time intervals in patients with decompensated heart failure. Similarly, abnormal levels of circulating cardiac troponin are commonly found in patients with acute decompensated heart failure, often without obvious myocardial ischemia or underlying coronary artery disease, and this is associated with worse clinical outcomes and higher risk of death.
The guideline further states the following:
- The role of natriuretic peptide biomarkers in population screening to detect incident heart failure is emerging.
- Developing a standardized strategy to screen and intervene in patients at risk of heart failure can be difficult because of different definitions of heart failure risk, heterogeneity of prevalence in different populations, variable duration until clinical heart failure or left ventricular dysfunction develops, and variable interventions for risk factor modification or treatment. Further studies are need to determine cost-effectiveness and risk of natriuretic peptide-based screening in patients at risk of heart failure, as well as its impact on quality of life and mortality rate.
- Although observational or retrospective studies have suggested that patients with natriuretic peptide biomarker reduction had better outcomes than those without any changes or with a biomarker rise, targeting a certain threshold, value, or relative change in these biomarker levels during hospitalization may not be practical or safe for every patient and has not been tested in a prospective large-scale trial. Clinical assessment and adherence to guideline-directed management and therapy should be the emphasis, and the prognostic value of a predischarge value or relative changes does not imply the necessity for serial and repeated biomarker measurements during hospitalization.
- Strategies that combine multiple biomarkers may ultimately prove beneficial in guiding heart failure therapy in the future, but multicenter studies with larger derivation and validation cohorts are needed.
- Because of the absence of clear and consistent evidence for improvement in mortality and cardiovascular outcomes, there are insufficient data to inform specific guideline recommendations related to natriuretic peptide-guided therapy or serial measurements of BNP or NT-proBNP levels for the purpose of reducing hospitalization or deaths in the present document.
- Strategies that combine multiple biomarkers may ultimately prove beneficial in guiding heart failure therapy in the future, but multicenter studies with larger derivation and validation cohorts are needed.]
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
B-Type Natriuretic Peptide in Heart Failure
B Type Natriuretic Peptide in Heart Failure
Brain Natriuretic Peptide in Heart Failure
BNP in Heart Failure
NT-proBNP
N-Terminal proBNP
N-BNP
Triage BNP Test
Elecsys proBNP Immunoassay
Natriuretic Peptide, B-Type
References:
1. Hunt SA, Baker DW, Chin MH, et al. ACC/AHA guidelines for the evaluation 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 (Committee to Revise the 1995 Guidelines for the Evaluation and Management of Heart Failure). 2001. American College of Cardiology Web site. http://www.acc.org/clinical/guidelines/failure/hf_index.htm
2. Remme WJ, Swedberg K; Task Force for the Diagnosis and Treatment of Chronic Heart Failure, European Society of Cardiology. Guidelines for the diagnosis and treatment of chronic heart failure. Eur Heart J. 2001 Sep;22(17):1527-60.
3. ECRI. Health Technology Trends: Rapid blood test may facilitate heart failure diagnosis in emergency department (ED). October 2002;14(10).
4. Maisel AS, Krishnaswamy P, Nowak RM, et al. Rapid measurement of B-type natriuretic peptide in the emergency diagnosis of heart failure. N Engl J Med. 2002 Jul18;347(3):161-7.
5. McCullough PA, Nowak RM, McCord J, et al. B-type natriuretic peptide and clinical judgement in emergency diagnosis of heart failure: analysis from Breathing Not Properly (BNP) Multinational Study. Circulation. 2002 Jul 23;106(4):416-22.
6. Baughman KL. B-type natriuretic peptide - a window to the heart. N Engl J Med. 2002 Jul 18;347(3):158-9.
7. Wieczorek SJ, Wu AH, 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 Nov;144(5):834-9.
8. Stein BC, Levin RI. Natriuretic peptides: physiology, therapeutic potential, and risk stratification in ischemic heart disease. Am Heart J. 1998 May;135(5):914-23.
9. Vasan RS, Benjamin EJ, Larson MG, et al. Plasma natriuretic peptides for community screening for left ventricular hypertrophy and systolic dysfunction: the Framingham heart study. JAMA. 2002 Sep11;288(10):1252-9.
10. de Lemos JA, Morrow DA, Bentley JH, et al. The prognostic value of B-type natriuretic peptide in patients with acute coronary syndromes. N Engl J Med. 2001 Oct 4;345(14):1014-21.
11. Troughton RW, Frampton CM, Yandle TG, et al. Treatment of heart failure guided by plasma aminoterminal brain natriuretic peptide (N-BNP) concentrations. Lancet. 2000 Apr 1;355(9210):1126-30.
12. Johnson W, Omland T, Hall C, et al. Neurohormonal activation rapidly decreases after intravenous therapy with diuretic and vasodilators for class IV heart failure. J Am Coll Cardiol. 2002 May 15;39(10):1623-9.
13. Murdoch DR, McDonagh TA, Byrne J, et al. Titration of vasodilator therapy in chronic heart failure according to plasma brain natriuretic peptide concentration: randomized comparison of the hemodynamic and neuroendocrine effects of tailored versus empirical therapy. Am Heart J. 1999 Dec;138(6 Pt 1):1005-6.
14. Cheng V, Kazanagra R, Garcia A, et al. A rapid bedside test for B-type natriuretic peptide predicts treatment outcomes in patients admitted for decompensated heart failure: a pilot study. J Am Coll Cardiol. 2001 Feb;37(2):386-91.
15. Troughton RW, Frampton CM, Yandle TG et al. Treatment of heart failure guided by plasma aminoterminal brain natriuretic peptide (N-BNP) concentrations. Lancet 2000 Apr 1;355(9210):1126-30.
16. Dries DL, Stevenson LW. Brain natriuretic peptide as a bridge to therapy for heart failure. Lancet. 2000 Apr 1;1112-3.
17. Omland T, Persson A, Ng L, Caidahl K, et al. N-terminal pro-B-type natriuretic peptide and long-term mortality in acute coronary syndromes. Circulation. 2002 Dec 3;106(23):2913-8.
18. U.S. FDA. Triage B-Type Natriuretic Peptide (BNP) Test. http://www.fda.gov/cdrh/pdf2/k021317.pdf
19. FDA Talk Paper: FDA clears new automated lab test for congestive heart failure (Elecsys proBNP Immunoassay). http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01173.html
20. Maisel A. B-type natriuretic peptide measurements in diagnosing congestive heart failure in the dyspneic emergency department patient. Rev Cardiovasc Med. 2002;3 Suppl 4:S10-7.
21. McCullough PA, Hollander JE, Nowak RM et al. Uncovering heart failure in patients with a history of pulmonary disease: Rationale for the early use of B-type natriuretic peptide in the emergency department. Acad Emerg Med. 2003 Mar;10(3):198-204.
22. Pesola GR. The use of B-type natriuretic peptide (BNP) to distinguish heart failure from lung disease in patients presenting with dyspnea to the emergency department. Acad Emerg Med. 2003 Mar;10(3):275-7.
23. ECRI. Hotline Response: Brain (B-Type) natriuretic peptide for diagnosis of congestive heart failure and ventricular dysfunction. Updated on 08/04.
24. Empire Medicare Services. Local Medical Review Policy #L-5A: B-Type Natriuretic Peptide (BNP). 10/01/2003. Available at:http://www.empiremedicare.com/combinedpolicies/policy/L5_LB010E_FINAL.htm
25. Mueller C, Scholer A, Laule-Kilian K et al. Use of B-type natriuretic peptide in the evaluation and management of acute dyspnea. N Eng J Med. 2004 Feb 12;350(7):647-54.
26. Wang TJ, Larson MG, Levy D et al. Plasma natriuretic peptide levels and the risk of cardiovascular events and death. N Engl J Med. 2004 Feb 12;350(7):655-63.
27. Mark DB, Felker GM. B-type natriuretic peptide - a biomarker for all seasons? N Engl J Med. 2004 Feb 12;350(7):718-20.
28. ECRI. Windows on Medical Technology: B-Type Natriuretic Peptide for Diagnosing Heart Failure. Issue No. 115, August 2004.
29. Nieminen MS, Bohm M, Cowie MR et al. Executive summary of the guidelines on the diagnosis and treatment of acute heart failure: the Task Force on Acute Heart Failure of the European Society of Cardiology. Eur Heart J. 2005 Feb;26(4):384-416. Epub 2005 Jan 28.
30. Cohen S, et al. Amino-terminal pro-brain-type natriuretic peptide: Heart or lung disease in pediatric respiratory distress? Pediatrics 2005 May;115:1347-50.
31. Institute for Clinical Systems Improvement (ICSI) Technology Assessment Report: B-Type Natriuretic Peptide (BNP) for the Diagnosis and Management of Congestive Heart Failure. Released 08/2005.
32. Figueroa MS, Peters JI. Congestive Heart Failure: Diagnosis, Pathophysiology, Therapy, and Implications for Respiratory Care. Respir Care 2006;51(4):403-412.
33. Strunk A, Bhalla V, Clopton P, et al. Impact of the history of congestive heart failure on the utility of B-type natriuretic peptide in the emergency diagnosis of heart failure: results from the Breathing Not Properly Multinational Study. Am J Med 2006 Jan;119(1):69.e1-11.
34. Hunt SA, 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. J Am Coll Cardiol 2005 Sep 20;46(6):e1-82.
35. Agency for Healthcare Research and Quality (AHRQ). Evidence Report/Technology Assessment Number 142. Testing for BNP and NT-proBNP in the Diagnosis and Prognosis of Heart Failure. September 2006.
36. Krum H, Jelinek MV, Stewart S, et al. Guidelines for the prevention, detection and management of people with chronic heart failure in Australia 2006. Med J Aust 2006 Nov 20;185(10):549-57.
37. Kapoor JR, Perazella MA. Diagnostic and therapeutic approach to acute decompensated heart failure. Am J Med 2007 Feb;120(2):121-7.
38. Anderson JL, Adams CT, Antman EM et al. ACC/AHA 2007 guidelines for the management of patients with unstable angina/non-ST-elevation myocardial infarction: a report of the American College of Cardiology/Amercian Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction): developed in collaboration with the American College of Emergency Physicians, American College of Physicians, Society for Academic Emergency Medicine, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol 2007;50:e1-157. Available at: http://content.onlinejacc.org/cgi/reprint/50/7/e1
39. Troughton RW, Richards AM. Outpatient monitoring and treatment of chronic heart failure guided by amino-terminal pro-B-type natriuretic peptide measurement. Am J Cardiol. 2008 Feb 4;101(3A):72-5.
40. Isaac DL. Biomarkers in heart failure management. Curr Opin Cardiol. 2008 Mar;23(2):127-33.
41. Gallegos PJ, Maclaughlin EJ, Haase KK. Serial monitoring of brain natriuretic peptide concentrations for drug therapy management in patients with chronic failure. Pharmacotherapy. 2008 Mar;28(3):343-55.
42. Baggish AL, van Kimmenade RR, Januzzi JL Jr. Amino-terminal pro-B-type natriuretic peptide testing and prognosis in patientw with acute dyspnea, including those with acute heart failure. Am J Cardiol. 2008 Feb 4;101(3A):49-55.
43. Zuber M, Cuculi F, Jost CA et al. Value of brain natriuretic peptides in primary care patients with the clinical diagnosis of chronic heart failure. Scan Cardiovasc J. 2009 Feb 26:1-6.[Epub ahead of print]
44. Coppola G, Corrado E, Augugliaro S et al. Short term prognostic role of NT-proBNP in patients after myocardial infarction. Minerva Cardioangiol. 2009 feb;57(1):13-21.
45. 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) Investigators. JAMA. 2009 Jan 28;301(4):383-92.
46. Troughton RW, Frampton CM, Brunner-La Rocca H, et al. Effect of B-type natriuretic peptide-guided treatment of chronic heart failure on total mortality and hospitalization: an individual patient meta-analysis. European Heart Journal 2014 Mar 6. [Epub ahead of print]
47. UpToDate. Natriuretic peptide measurement in non-heart failure settings. Literature review current through March 2016.
48. Moe GW, Ezekowitz JA, O"Meara E, et al. The 2014 Canadian Cardiovascular Society Heart Failure Management Guidelines Focus Update: anemia, biomarkers, and recent therapeutic trial implications. Can J Cadiol 2015 Jan: 31(1):3-16.
49. UpToDate. Natriuretic peptide measurement in heart failure. Literature review current through March 2016.
50. Chen HH, Colucci WS. Natriuretic peptide measurement in non-heart failure settings. In: UpToDate, Gottlieb SS, Jaffe AS (Eds), UpToDate, Waltham, MA. (Accessed August 8, 2017.)
51. Colucci WS, Chen HH. Natriuretic peptide measurement in heart failure settings. In: UpToDate, Gottlieb SS, Jaffe AS (Eds), UpToDate, Waltham, MA. (Accessed August 8, 2017.)
52. Yancy CW, Jessup M, Bozkurt B, et al. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. Circulation. 2017; Apr 28 [Epub ahead of print].
53. Chow SL, Maisel AS, Anand I, et al. Role of Biomarkers for the Prevention, Assessment, and Management of Heart Failure: A Scientific Statement From the American Heart Association. Circulation. 2017 May 30;135(22):e1054-e1091.
54. Chen HH, Colucci WS. Natriuretic peptide measurement in non-heart failure settings. In: UpToDate, Gottlieb SS, Jaffe AS (Eds), UpToDate, Waltham, MA. (Accessed July 3, 2018.)
55. Colucci WS, Chen HH. Natriuretic peptide measurement in heart failure settings. In: UpToDate, Gottlieb SS, Jaffe AS (Eds), UpToDate, Waltham, MA. (Accessed July 3, 2018.)
56. Chen HH, Colucci WS. Natriuretic peptide measurement in non-heart failure settings. In: UpToDate, Gottlieb SS, Jaffe AS, Yeon SB (Eds), UpToDate, Waltham, MA. (Accessed June 20, 2019.)
57. Colucci WS, Chen HH. Natriuretic peptide measurement in heart failure settings. In: UpToDate, Gottlieb SS, Jaffe AS, Yeon SB (Eds), UpToDate, Waltham, MA. (Accessed June 20, 2019.)
58. Chen HH, Colucci WS. Natriuretic peptide measurement in non-heart failure settings. In: UpToDate, Gottlieb SS, Jaffe AS, Yeon SB (Eds), UpToDate, Waltham, MA. (Accessed June 8, 2020.)
59. Colucci WS, Chen HH. Natriuretic peptide measurement in heart failure. In: UpToDate, Gottlieb SS, Jaffe AS, Yeon SB (Eds), UpToDate, Waltham, MA. (Accessed June 8, 2020.)
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