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CommercialCoverageMedium impact

Clinical Trials 11.01.10

Excellus BlueCross BlueShield·Oncology·Miscellaneous
Effective date
Sep 18, 2025
We identified it
Jun 20, 2026
Days to comply

Summary

Excellus BlueCross BlueShield has updated their clinical trials policy (11.01.10) effective September 18, 2025, establishing specific criteria for coverage approval and clarifying which routine costs are covered versus non-routine costs that are excluded. The policy requires institutional review board approval and specifies that for Medicare Advantage members, original Medicare is primary for routine clinical trial services.

Action Required

Action needed
By September 18, 2025: Billing team must update clinical trial billing procedures to ensure all claims include required documentation (clinical trial protocol and IRB approval) and use appropriate HCPCS codes S9988-S9991 for different trial phases with Q0/Q1 modifiers. For Medicare Advantage members, route routine clinical trial services to original Medicare as primary payer. Update billing system to distinguish between covered routine costs and non-covered investigational items.

Affected Billing Codes

S9988
S9990
S9991
S9992
S9994
S9996
FB
Z00.6