L29233-LCD

Automated World Health

Local Coverage Determination (LCD) for Nesiritide (Natrecor®) Intravenous Infusion Therapy (L29233)

Contractor Information

Contractor Name

First Coast Service Options, Inc.

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L29233

LCD Title

Nesiritide (Natrecor®) Intravenous Infusion Therapy

Contractor's Determination Number J2325

Primary Geographic Jurisdiction Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

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 02/02/2009 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. 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.1-50.4.3

CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Chapter 17, Section 40

CMS Manual System, Pub. 100-03, Medicare National Coverage Determinations, Transmittal 51, CR 4312, dated April 7, 2006

CMS Manual System, Pub. 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.1.3

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.

999x Not Applicable

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.

99999 Not Applicable

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 This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was

developed in cooperation with advisory groups, which includes representatives from numerous societies.

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:02/02/2009

LCR B2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the carrier predecessors of First Coast Service Options, Inc. (Triple S and FCSO).

For Florida (00590) this LCD (L29233) replaces LCD L23205 as the policy in notice. This document (L29233) is effective on 02/02/2009.

Reason for Change