Alert detail

FDA Approval: KRYSTEXXA (PEGLOTICASE) — Type 1 - New Molecular Entity

Policy ID: FDA-BLA125293Specialty: RheumatologyAdded: 8/13/2026Effective: 2010-09-14billing update

Critical

What changed

New FDA drug approval. Coverage and billing pathway depend on the FDA label and applicable Medicare LCDs/NCDs — for very recent approvals the label may not be posted yet. Verify against the FDA label and current coverage policy before billing.

Who’s affected: Rheumatology billing teams · Effective: 2010-09-14

Affected codes

CodesJ2507

Primary source: View the official CMS/MAC document ↗

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This change affects 1 billing code.

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