Local Coverage Determination (LCD)

B-type Natriuretic Peptide (BNP) Testing

L34410

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L34410
Original ICD-9 LCD ID
Not Applicable
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 06/10/2021
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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Issue

Issue Description
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

Title XVIII of the Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be 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, §1862(a)(1)(D) addresses items related to research and experimentation.

42 CFR §410.32(a) indicates that diagnostic tests may only be ordered by the treating physician (or other treating practitioner acting within the scope of his or her license and Medicare requirements).

CMS Internet-Only Manual, Pub 100-02, Medicare Benefit Policy Manual, Chapter 6, §20.4.1 Diagnostic Services Defined

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, 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. For the purposes of this policy, either total or N-terminal assays are acceptable.

Indications:

The measurement of BNP as part of cardiovascular risk assessment panels, consisting of various combinations of biochemical, immunologic, hematologic, and molecular tests, is considered screening when performed on an asymptomatic patient, and, as such, is not a Medicare benefit. Refer to MolDX: Biomarkers in Cardiovascular Risk Assessment L36129 Local Coverage Determination (LCD).

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.
  • As a risk stratification tool (to assess risk of death, myocardial infarction or CHF) among patients with acute coronary syndrome (myocardial infarction with or without T-wave elevation and unstable angina). Obtained in the first few days after the onset of ischemic symptoms, results of BNP measurement can provide useful information.

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.

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 (HF). Therefore, BNP measurements for monitoring and management of CHF are not a covered service.

Although a correlation between serum BNP levels and the clinical severity of HF has been shown in broad populations, “it cannot be assumed that BNP levels can be used effectively as targets for adjustment of therapy in individual patients. The BNP measurement has not been clearly shown to supplement careful clinical assessment” (Hunt, et al, 2005).

Summary of Evidence

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Analysis of Evidence (Rationale for Determination)

N/A

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
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Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
View Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description

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N/A

Revenue Codes

Code Description

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CPT/HCPCS Codes

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N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

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

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information

Documentation Requirements

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

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

Utilization Guidelines

As a diagnostic test, BNP testing is not expected to be performed more than 4 times in a given year.

The use of BNP for monitoring CHF is not covered.

Sources of Information
N/A
Bibliography

Doust J, Lehman R, Glasziou P. The role of BNP testing in heart failure. Am Fam Physician. 2006;74(11):1893-1898.

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. J Am Coll Cardiol. 2005;46(6):e1-82.

Maisel AS, 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 Jour. 2004;147(6):1078-1084.

Maisel A, Hollander JE, 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. JACC. 2004;44(6):1328-1333.

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

Morrison LK, 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.

Saenger AK, Jaffe AS. The use of biomarkers for the evaluation and treatment of patients with acute coronary syndromes. Med Clin N Am. 2007;91(4):657-681.

Shapiro BP, Chen HH, Burnett JC, Redfield MM. Use of plasma brain natriuretic peptide concentration to aid in the diagnosis of heart failure. Mayo Clinic Proceedings. 2003;78(4):481-486.

Silvers SM, Howell JM, Kosowsky JM, Rokos IC, Jagoda AS. Clinical policy: Critical issues in the evaluation and management of adult patients presenting to the emergency department with acute heart failure syndromes. Ann of Emerg Med. 2007;49(5):627-669.

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 Jour. 2002;144(5):834-839.

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. Am Heart Jour. 2006;152(5):828-834.

Young JB, Correia NG, Francis GS, Maisel A, Michota F. Testing for B-Type natriuretic peptide in the diagnosis and assessment of heart failure: What are the nuances? Cleve Clin J Med. 2004;71(5):S1-S17.

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
06/10/2021 R16

Under CMS National Coverage Policy updated descriptions. Under Bibliography changes were made to citations to reflect AMA citation guidelines. Acronyms were inserted where appropriate throughout the LCD.

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.

  • Provider Education/Guidance
01/14/2021 R15

Under CMS National Coverage Policy updated description for regulation Title XVIII of the Social Security Act, §1862(a)(1)(D) to read “items related to research and experimentation”. Under Bibliography changes were made to citations to reflect AMA citation guidelines. Formatting, punctuation and typographical errors were corrected throughout the LCD. Acronyms were inserted where appropriate throughout the LCD.

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.

  • Provider Education/Guidance
10/10/2019 R14

This LCD is being revised in order to adhere to CMS requirements per chapter 13, section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs. There has been no change in coverage with this LCD revision. Title XVIII of the Social Security Act, §1833(e) was removed from the CMS National Coverage Policy section of this LCD and placed in the related Billing and Coding: B-type Natriuretic Peptide (BNP) Testing A56605 article.

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.

 

  • Provider Education/Guidance
05/30/2019 R13

All coding located in the Coding Information section has been moved into the related Billing and Coding: B-type Natriuretic Peptide (BNP) Testing A56605 article and removed from the LCD.

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.

 

  • Provider Education/Guidance
04/11/2019 R12

Under Coverage Indications, Limitations and/or Medical Necessity and Bibliography changes were made to citations to reflect AMA citation guidelines. Acronyms were inserted where appropriate throughout the LCD. Formatting, punctuation and typographical errors were corrected throughout the LCD.

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.

 

  • Provider Education/Guidance
10/01/2018 R11

Under ICD-10 Codes that Support Medical Necessity Group 1: Codes the code description was revised for ICD-10 codes I63.333 and I63.343. This revision is due to the 2018 Annual ICD-10 Update and is effective on October 1, 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
02/08/2018 R10

Revisions were made to the B-type Natriuretic Peptide (BNP) Testing Local Coverage Determination (LCD) L34410. Under CMS National Coverage Policy added (a) to the following: 42 CFR §410.32. Under Coverage Indications, Limitations and/or Medical Necessity-Indications revised “are” to now read “is” in the first paragraph. Under Bibliography corrected punctuation and capitalization throughout. This revision becomes effective. 

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.

 

  • Provider Education/Guidance
  • Typographical Error
01/29/2018 R9 The Jurisdiction "J" Part A Contracts for Alabama (10111), Georgia (10211) and Tennessee (10311) are now being serviced by Palmetto GBA. The notice period for this LCD begins on 12/14/17 and ends on 01/28/18. Effective 01/29/18, these three contract numbers are being added to this LCD. No coverage, coding or other substantive changes (beyond the addition of the 3 Part A contract numbers) have been completed in this revision.
  • Change in Affiliated Contract Numbers
10/01/2017 R8

Under ICD-10 Codes that Support Medical Necessity added ICD-10 codes I21.9, I21.A1, I21.A9, I50.810, I50.811, I50.812, I50.813, I50.814, I50.82, I50.83, I50.84, I50.89 and R06.03. The code description was revised for ICD-10 codes I50.1, I63.323, I63.333, I63.513, I63.523 and I63.533. These revisions are due to the 2017 Annual ICD-10 Updates.

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. 

 

  • Provider Education/Guidance
  • Revisions Due To ICD-10-CM Code Changes
03/16/2017 R7 Under CMS National Coverage Policy removed CMS Internet Only Manual Pub 100-04 Chapter 9 Section 100. Under Sources of Information and Basis for Decision revisions were made to add missing reference addressed in texts; 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. J Am Coll Cardiol. 2005; 46(6): e1-82. Grammatical correction to reference to change “Recording” to “Recordings”: Utility of B-Natriuretic Peptide in the Evaluation of Left Ventricular Diastolic Function: Comparison with Tissue Doppler Imaging Recordings. Am Heart Jour. 2004;148(5):895-902.
  • Provider Education/Guidance
  • Typographical Error
11/03/2016 R6 Under ICD-10 Codes That Support Medical Necessity Group 1: Codes added R60.0 and R60.1 to maintain consistency with the Part B B-type Natriuretic Peptide (BNP) Testing LCD L33422.
  • Provider Education/Guidance
  • Creation of Uniform LCDs Within a MAC Jurisdiction
  • Other
10/01/2016 R5 Under ICD-10 Codes That Support Medical Necessity-Group 1 added I16.0, I16.1, I16.9, I60.2, I63.013, I63.033, I63.113, I63.133, I63.213, I63.233, I63.313, I63.323, I63.333, I63.343, I63.413, I63.423, I63.433, I63.443, I63.513, I63.523, I63.533, and I63.543. This revision is due to the Annual ICD-10 Code Update
  • Provider Education/Guidance
  • Revisions Due To ICD-10-CM Code Changes
02/11/2016 R4 Under Coverage Indications, Limitations and/or Medical Necessity-Limitations corrected the page numbers cited in the last sentence of the last paragraph to now read”…page 15 from pages 1-82.” Under Associated Information-Documentation Requirements in the last paragraph revised J11 to now read A/B. Under Sources of Information and Basis for Decision author initials were corrected X2 for AH Wu. The complete journal title was corrected for the following: Maisel A, Hollander JE, Guss D, et al. Primary Results of the Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT). A Multi-Center Study of B-Type Natriuretic Peptide Levels, Emergency Department Decision Making, and Outcomes in Patients Presenting With Shortness of Breath. JACC. 2004;44(6):1328-1333. The page number was corrected for the following: Doust J, Lehman R, Glasziou P. The Role of BNP Testing in Heart Failure. Am Fam Physician. 2006;74(11):1893-1898. Author names were added and “et al” was deleted for the following: Morrison LK, 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.
  • Provider Education/Guidance
  • Typographical Error
10/16/2015 R3 Under Coverage Indications, Limitations and/or Medical Necessity-Indications added the first paragraph indicating BNP included as a component of a CV risk assessment panel is considered screening when performed on an asymptomatic patient.
  • Provider Education/Guidance
  • Other (Consistency of LCDs)
10/01/2015 R2 Per CMS Internet-Only Manual, Pub 100-08, Medicare Program Integrity Manual, Chapter 13, §13.1.3 LCDs consist of only “reasonable and necessary” information. All bill type and revenue codes have been removed.
  • Other (Bill type and/or revenue code removal)
10/01/2015 R1 Under CMS National Coverage Policy added “the” to 42 CFR §410.32 and added Change Request 6338. Under Bill Type Codes deleted bill type 073X. During a quality review of this LCD it was identified that revenue codes 0522, 0527, 0528, 096X, 0971-0979, and 0981-0989 were inadvertently included among the billing revenue codes listed under Revenue Codes . These revenue codes were deleted without substantive change to the LCD. Under Associated Information-Utilization Guidelines the second sentence in the first paragraph was deleted referring to stated frequency parameters for BNP testing found in the Coverage Indications, Limitations, and/or Medical Necessity section of the LCD. Under Sources of Information and Basis for Decision all journal titles were italicized, several journal titles were corrected, the spelling of several author names was corrected, “et al” was deleted and replaced with the appropriate author names and supplement numbers were added. The following reference was deleted as it was redundant: 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 of Emerg Med. 2007;49(5):627-669.
  • Provider Education/Guidance
  • Typographical Error
  • Other
N/A

Associated Documents

Attachments
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Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
06/04/2021 06/10/2021 - 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
  • Brain Natriuretic Peptide

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