Oncology Alert: Glofitamab Approval — Prepare for Part B Billing Changes
FDA approves Glofitamab; oncology practices should prepare for upcoming billing updates.
Action required by
June 15, 2023
Review the Action Required section below and ensure your team has completed all compliance steps before this date.
The FDA has recently approved COLUMVI (Glofitamab) as a new molecular entity for oncology, with an effective date of June 15, 2023.
What Changed Glofitamab, an injectable treatment, has been approved for oncology care and is expected to impact Medicare Part B billing. The approval introduces a new molecular entity with specific requirements for handling and billing, awaiting a J-code assignment.
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Quick answers
What steps should oncology practices take following Glofitamab's approval?
Oncology practices should monitor for the J-code assignment and update billing workflows to reflect Glofitamab's inclusion in Part B claims.
When is Glofitamab scheduled to take effect for billing purposes?
The effective date for Glofitamab as an approved entity is June 15, 2023.
Content summarized from publicly available federal publications including CMS, MAC contractors, and the Federal Register. CLV Intelligence is not affiliated with or endorsed by any government agency. This is not legal or medical advice.