LCD/NCD Portal

NCD200.1

 

NESIRITIDE FOR TREATMENT OF HEART FAILURE PATIENTS

 

 

Effective Date of this Version

5/22/2006

 

 

Benefit Category

 

• Incident to a physician's professional Service.

• Inpatient Hospital Services.

• Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

 

 

Item/Service Description

 

General

 

• Nesiritide (Natrecor®) is Food and Drug Administration (FDA) approved for the 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.

 

 

Indications and Limitations of Coverage

 

 

Nationally Covered Indications

N/A

 

 

Nationally Non-covered Indications

 

• Effective for dates of service on or after March 2, 2006, the Centers for Medicare & Medicaid Services (CMS) has determined that there is sufficient evidence to conclude that the use of Nesiritide for the treatment of chronic heart failure is not reasonable and necessary for Medicare beneficiaries in any setting.

Other

• Effective for dates of service on or after March 2, 2006, this determination applies only to the treatment of chronic heart failure and does not change contractor discretion to cover other off-label uses of Nesiritide or use consistent with the current FDA indication for intravenous treatment of patients with acutely decompensated congestive heart failure who have dyspnea at rest or with minimal activity.

• (This NCD last reviewed March 2006.)

 

 

Claims Processing Instructions

 

• TN 218 (One-Time Notification)

 

 

Coverage Transmittal Link

 

• http://www.cms.gov/transmittals/downloads/R51NCD.pdf

 

 

National Coverage Analyses (NCAs)

 

• This NCD has been or is currently being reviewed under the National Coverage Determination process.

• The following are existing associations with NCAs, from the National Coverage Analyses database.

• Original consideration for Nesiritide for Treatment of Heart Failure Patients (CAG-00289N) opens in new window

 

 

Medicare NCD Link