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Excellus BlueCross BlueShieldCommercial · Coverage · Miscellaneous · NYMedium impact

Clinical Trials 11.01.10

Effective date
Sep 17, 2026
Identified
Jun 20, 2026

Summary

Clinical trial participation coverage requires that the member is eligible under the trial's protocol, that a copy of the protocol including institutional review board approval is provided to the Health Plan, and that the trial is an approved Phase I, II, III, or IV trial conducted for the prevention, detection, or treatment of cancer or another life-threatening disease or condition and approved or funded by a listed body such as the NIH, CDC, AHRQ, or CMS. Routine costs of approved trials are eligible for coverage, while the investigated item or service, services used only to collect trial data, non-health care services such as transportation, lodging and meals, and items provided free by the sponsor are not. The current effective date is September 17, 2026, and the annual review kept the policy intent unchanged.

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What to do

Action · 5 steps
01Already effective September 17, 2026: Billing team: Before requesting coverage for clinical trial participation, confirm the member is eligible under the trial's protocol, and provide the Health Plan a copy of the clinical trial protocol including IRB approval.
02For Medicare Advantage members, original Medicare is primary for routine services rendered as part of a clinical trial.
03Do not expect coverage for the item or service being investigated, for services provided only to collect and analyze trial data that are not used in direct clinical management, for non-health care services such as transportation, lodging and meal expenses, for items or services inconsistent with the established standard of care, for items provided free of charge by the research sponsors, or for duplicative items or services.
04The code section lists Q0 for an investigational clinical service in an approved research study and Q1 for a routine clinical service in an approved research study, and lists S9988, S9990 and S9991 for Phase I, II and III trial services.
05Services are contract dependent: if a product does not cover a service, these medical policy criteria do not apply, and for Medicare products with no national or local Medicare coverage decision, the criteria do apply.

Codes mentioned

S9988S9990S9991S9992S9994S9996FBZ00.6

Original notice

Clinical Trials 11.01.10
excellusbcbs.com · Always check the source before changing claims.
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Related policy hubs

Excellus BlueCross BlueShield policiesNY policy changesCode S9988Code S9990Code S9991Code S9992Code S9994Code S9996Code FBCode Z00.6

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