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CommercialCoverageMedium impact

08.02.35, Drugs, Biologics, or Gene Therapies with an Accelerated Approval

Independence Blue Cross·Oncology, Pharmacy, Internal Medicine +1 more·Pharmacy
Effective date
Jan 1, 2025
We identified it
Jun 19, 2026
Days to comply

Summary

This is a new policy (Policy 08.02.35) effective January 1, 2025, establishing coverage and billing guidelines for drugs, biologics, or gene therapies that have received FDA accelerated approval status. The billing team must understand how this new policy affects claim submission, prior authorization requirements, and coverage determinations for accelerated approval medications.

Action Required

Action needed
By January 15, 2025: Billing team must review the full policy text at the provided URL to identify specific coverage requirements, prior authorization mandates, and billing procedures for drugs, biologics, or gene therapies with accelerated approval status. Update billing system rules and prior authorization workflows accordingly. Communicate any new requirements to providers and front desk staff. Beginning January 1, 2025, apply this policy to all claims involving accelerated approval medications. Claims submitted without compliance to new requirements may be denied.