CMS NCD 311: Nesiritide (Natrecor®) Coverage Policy for Heart Failure — What Billing Teams Need to Know in 2026

The Centers for Medicare & Medicaid Services has issued a modification to National Coverage Determination (NCD) 311, which governs Medicare coverage of nesiritide (Natrecor®) for the treatment of congestive heart failure (CHF). This update reaffirms CMS's longstanding non-coverage determination for nesiritide in the CHF setting—a position that has been in effect since March 2, 2006. If your facility bills for inpatient cardiology services or incident-to infusions, this policy directly affects how you should handle claims involving this drug.

What CMS NCD 311 Says About Nesiritide and CHF Coverage

Nesiritide is a recombinant B-type natriuretic peptide administered intravenously for patients with acutely decompensated congestive heart failure—specifically those experiencing dyspnea at rest or with minimal exertion. The FDA approved it for this indication, and it is not a self-administered drug, meaning it falls squarely within the administered infusion billing framework.

Despite that FDA approval, CMS has determined that nesiritide is not reasonable and necessary for Medicare beneficiaries when used to treat CHF in any care setting. That determination took effect for dates of service on or after March 2, 2006, and NCD 311 codifies that position as a nationally non-covered indication.

This is a critical distinction for billing teams: FDA approval does not equal Medicare coverage. The two operate on separate tracks, and CMS's medical necessity standard has consistently excluded nesiritide for CHF regardless of the FDA label.

Nationally Covered vs. Non-Covered Indications Under NCD 311

The structure of NCD 311 is straightforward, and billing managers should understand both sides of it.

Nationally covered indications: None. Section B of the NCD explicitly lists "N/A" for nationally covered indications. There is no Medicare-covered CHF use case for nesiritide under this NCD.

Nationally non-covered indications: Effective March 2, 2006, CMS concluded there is sufficient clinical evidence to determine that nesiritide for CHF treatment is not reasonable and necessary for Medicare beneficiaries—regardless of the care setting (inpatient, outpatient, or incident-to).

This blanket non-coverage applies across both benefit categories identified in the NCD: inpatient hospital services and services incident to a physician's professional service.

The Off-Label Exception: Where MAC Discretion Still Applies

Here's where the policy gets nuanced—and where claims errors are most likely to occur.

NCD 311 is explicit that the non-coverage determination applies only to CHF treatment. It does not restrict Medicare Administrative Contractor (MAC) discretion to cover:

• Other off-label uses of nesiritide not related to CHF
• Use consistent with the current FDA indication—that is, intravenous treatment of patients with acutely decompensated CHF who have dyspnea at rest or with minimal activity

Wait—that second point sounds contradictory. It isn't, but it requires careful reading. The FDA-consistent use language in Section D preserves MAC-level flexibility for circumstances where a MAC might independently evaluate coverage under its local coverage determination (LCD) authority. In practice, this means your MAC has the discretion to cover nesiritide if the clinical presentation strictly aligns with the FDA-approved indication and the MAC has issued guidance permitting it. You cannot assume national coverage exists—you must verify your MAC's current LCD or coverage article.

If your facility is billing nesiritide for any indication other than CHF—or is relying on MAC-level discretion for an FDA-consistent use—robust medical necessity documentation is non-negotiable.

Benefit Categories Affected by This NCD

NCD 311 applies to two Medicare benefit categories:

1. Incident to a physician's professional service — This covers situations where nesiritide is administered in an outpatient or office setting as part of a physician's care plan.
2. Inpatient hospital services — This covers administration during a Medicare Part A inpatient stay.

Billing teams should flag both claim types in their charge capture workflows. A non-covered drug claim submitted without an Advance Beneficiary Notice (ABN) for the appropriate situations, or without a non-covered service modifier, can create compliance exposure.

Affected Codes

The policy does not list specific CPT or HCPCS codes. Per the actual NCD 311 policy document, no billing codes are enumerated in this determination. Billing teams should work directly with their MAC and internal coding resources to identify the applicable HCPCS J-code for nesiritide (historically J2325) and confirm current MAC-level guidance, since the NCD itself does not specify codes.

What Your Billing Team Should Do