Alert detail

FDA Approval: ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) — Type 5 - New Formulation or New Manufacturer

Policy ID: FDA-NDA204242Specialty: Multi-specialtyAdded: 8/19/2026Effective: 2013-07-03federal register

Low

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: Multi-specialty billing teams · Effective: 2013-07-03

Primary source: View the official CMS/MAC document ↗

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