Automated World Health
Local Coverage Determination (LCD) for Nesiritide (Natrecor®) Intravenous
Infusion Therapy (L28935)
Contractor Information
Contractor Name First Coast Service Options, Inc.
Contractor Number 09101
Contractor Type MAC - Part A
LCD Information
Document Information
LCD ID Number L28935
LCD Title Nesiritide (Natrecor®) Intravenous Infusion Therapy
Contractor's Determination Number AJ2325
Primary Geographic Jurisdiction Florida
Oversight Region Region IV
AMA CPT/ADA CDT Copyright Statement
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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: CMS Manual System, Pub 100-2, Medicare Benefit Policy Manual, Chapter 6, Section 20.4
CMS Manual System, Pub. 100-2, Medicare Benefit Policy Manual, Chapter 15, Section 50.1-50.4.3
CMS Manual System, Pub. 100-3, Medicare National Coverage Determinations, Transmittal 51, CR 4312, dated April 7, 2006
CMS Manual System, Pub 100-4, Medicare Claims Processing Manual, Chapter 17, Sections 10 and 40 CMS Manual System, Pub. 100-8, Medicare Program Integrity Manual, Chapter 13, Section 13.1.3
Indications and Limitations of Coverage and/or Medical Necessity
Nesiritide (Natrecor®) is a recombinant form of human B-type natriuretic peptide (hBNP), a naturally occurring hormone produced in the ventricles when a person is in heart failure that acts to help the body rid itself of sodium. Nesiritide is manufactured from E coli using recombinant DNA technology.
Nesiritide (Natrecor®) is Food and Drug Administration (FDA) approved for the short-term intravenous treatment of patients with acutely decompensated congestive heart failure (CHF) who have dyspnea (shortness of breath) at rest or with minimal activity. Nesiritide is not self-administered. CHF may develop suddenly, particularly as a complication of acute myocardial infarction or as an acute exacerbation in patients with previously compensated chronic heart failure.
The medical literature supports the use of Nesiritide as a first line option for the treatment of patients diagnosed with Class III or IV, acutely decompensated congestive heart failure in the emergency department or those in the hospital setting. Since these patients need to be closely monitored for response to and side effects of treatment, the medical literature currently does not support the administration of nesiritide in an office setting.
Medicare reimbursement for the administration of nesiritide, for the treatment of patients diagnosed with acutely decompensated congested heart failure, is covered only when administered in the hospital setting (inpatient admission, emergency department, or hospital outpatient observation) as evidenced by all of the following circumstances:
• Documented New York Heart Association Classification Class III or IV Heart Failure (see “Other Comments” under the Coding Guidelines section);
• Current medication regimen that includes maximal tolerable doses of beta blockers, diuretics, ACE inhibitors or angiotensin receptor blockers (ARBs) if ACE inhibitor is contraindicated, aldosterone inhibitors, and digitalis (if appropriate). For the purpose of this coverage, “maximum dosages” are defined as those doses beyond which are likely to impair the patient’s blood pressure, heart rate, or electrolyte balance); and
• An endogenous B type natriuretic peptide (BNP) determination of at least 300 pg/ml.
Dosage and Frequency
Drugs or biologicals approved for marketing by the FDA are considered safe and effective when used for indications specified on the labeling. The labeling lists the safe and effective, i.e. medically reasonable and necessary dosage and frequency. Therefore, doses and frequencies that exceed the accepted standard of recommended dosage and/or frequency, as described in the package insert, are considered non-medically reasonable and necessary and, therefore, not reimbursable.
Nesiritide (Natrecor) is provided as a sterile lyophilized powder in 1.5mg, single-use vials. The recommended dosing regimen of nesiritide is a 2 mcg/kg IV bolus followed by an intravenous infusion dose of 0.01 mcg/kg/min. The Natrecor bolus must be drawn from the prepared infusion bag. (See the drug label for specific instructions).
Limitations:
Nesiritide is not recommended for the following:
• For patients for whom vasodilating agents are not appropriate, such as patients with significant valvular stenosis, restrictive or obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade, or other conditions in which cardiac output is dependent upon venous return, or for patients suspected to have low cardiac filling pressures.
Nesiritide should not be used for the following:
• To replace diuretics;
• For chronic or maintenance therapy;
• For scheduled repetitive use;
• To improve renal function;
• To enhance diuresis;
• As primary therapy for patients with cardiogenic shock; and
• In patients with a systolic blood pressure <90 mm Hg.
The use of nesiritide should be strictly limited to patients presenting to the hospital with acutely decompensated congestive heart failure who have dyspnea at rest. Based on currently available evidence, the only acceptable settings for nesiritide therapy are inpatient admission, emergency department, or hospital outpatient observation. Intravenous injection of this drug will not be covered in the office or outpatient clinical setting.
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.
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.
0636 Pharmacy - Drugs Requiring Detailed Coding
CPT/HCPCS Codes
J2325 INJECTION, NESIRITIDE, 0.1 MG
ICD-9 Codes that Support Medical Necessity
It is the responsibility of the provider to code to the highest level specified in the ICD-9-CM (e.g., to the fourth or fifth digit). The correct use of the ICD-9-CM code listed below does not assure coverage of a service. The service must be reasonable and necessary in the specific case and must meet the criteria specified in this determination.
428.21 ACUTE SYSTOLIC HEART FAILURE
428.23 ACUTE ON CHRONIC SYSTOLIC HEART FAILURE
428.31 ACUTE DIASTOLIC HEART FAILURE
428.33 ACUTE ON CHRONIC DIASTOLIC HEART FAILURE
428.41 ACUTE COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE
428.43 ACUTE ON CHRONIC COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE
Diagnoses that Support Medical Necessity
See ICD-9 Codes that Support Medical Necessity
ICD-9 Codes that DO NOT Support Medical Necessity
All other diagnosis codes not listed as covered in the “ICD-9 Codes that Support Medical Necessity” section of this LCD.
XX000 Not Applicable
ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation
Diagnoses that DO NOT Support Medical Necessity
All other diagnoses not listed as covered in the “ICD-9 Codes that Support Medical Necessity” section of this LCD.
General Information
Documentations Requirements
The patient’s medical record must contain documentation that fully supports the medical necessity, frequency and duration of intravenous nesiritide therapy as it is covered by Medicare (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. This information must be available to Medicare upon request.
Appendices
Utilization Guidelines 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.
Natrecor® comes in 1.5 mg vials. More than one 1.5 mg vial (15 units of Natrecor® 0.01 mg) would not be expected to be billed per treatment based on the recommended dose.
Sources of Information and Basis for Decision
Berkowitz, R. (2004). B-Type Natriuretic Peptide and the Diagnosis of Acute Heart Failure. Reviews in Cardiovascular Medicine, 5(4) 3-16.
Elkayam,U., & et al. (2004). Comparisons of Effects on Left Ventricular Filling Pressure of Intravenous Nesiritide and High-Dose Nitroglycerin in Patients with Decompensated Heart Failure, The American Journal of Cardiology, 93, 237-240.
Scios News Press Release. (2006, January 3). Scios Submits Interim Report To FDA on Natrecor® (nesiritide).
Scios Inc. Press Release. (2005, July 13). Panel of Cardiology Experts with recommendations to Scios Regarding Natrecor® (nesiritide).
The United States Pharmacopeia Drug Information (USP DI). (March 2006). Oncology Online for Health Care Professionals. Micromedex, Inc. Available: http://www.thomsonhc.com/home/dispatch.
Advisory Committee Meeting Notes
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 Revised 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 (L28935) replaces LCD L23123 as the policy in notice. This document (L28935) is effective on 02/16/2009.
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 0636 was changed
Reason for Change
Related Documents
This LCD has no Related Documents.
LCD Attachments
Coding Guidelines
All Versions
Updated on 08/01/2010 with effective dates 02/16/2009 - N/A Updated on 08/01/2010 with effective dates 02/16/2009 - N/A Updated on 11/30/2008 with effective dates 02/16/2009 - N/A