Code intelligence

FDA-NDA215014 reimbursement alerts

Policy changes, MAC LCD updates, and CMS guidance matched to code FDA-NDA215014.

Elevated code risk

Signal breakdown

1 shown · 1 total in platform

Risk: Elevated
0

Critical

0%

1

High

100%

0

Routine

0%

0

Low

0%

New this month

+1

alerts added in last 30 days

Effective soon

no upcoming deadlines

FDA Approval: EMPAVELI (PEGCETACOPLAN) — Type 1 - New Molecular Entity

Policy FDA-NDA215014 · Hematology

High

Empaveli (pegcetacoplan) was approved May 14, 2021 as a subcutaneous solution for a rare condition under orphan drug designation, billing under Medicare Part B. As a subcutaneous injectable administer

Audit documentation

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