Policy Updates

Oncology Alert: Darzalex J-Code Expected — Prepare for Billing Update

By CLV IntelligenceSource published November 16, 2015

New J-code anticipated for Darzalex; actions needed include formulary updates and reimbursement model adjustments.

Action required by

November 16, 2015

Review the Action Required section below and ensure your team has completed all compliance steps before this date.

The FDA has approved DARZALEX (Daratumumab), an important update for the oncology specialty. Effective November 16, 2015, this approval impacts billing for oncologists and healthcare providers.

What Changed DARZALEX, used for certain cancer treatments, is anticipated to receive a new J-code in upcoming updates. Providers should expect changes in how this drug is billed under Medicare and other insurance plans. This change ensures the drug's reimbursement will reflect its established rate at ASP+6%.

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Quick answers

What is the anticipated reimbursement model for DARZALEX?

The reimbursement model for DARZALEX is expected to follow ASP+6%.

When was DARZALEX initially approved by the FDA?

DARZALEX was approved by the FDA effective November 16, 2015.

What action should providers take regarding the new J-code?

Providers should monitor for the specific J-code assignment and update their formularies and reimbursement models accordingly.

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.

Oncology Alert: Darzalex J-Code Expected — Prepare for Billing Update