Clinical Policy: Clinical Trials
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Defines medical necessity and coverage for routine costs and management of complications for members/enrollees participating in qualifying clinical trials for Arizona Complete Health (Centene-affiliated plans). Applies to providers submitting claims or prior authorizations for trial-related routine care.
No material clinical or coverage changes in this revision.
Coverage Criteria for Routine Clinical Trial Costs
Covered routine clinical trial costs
Covered when ALL of the following are met:
Based on policy section I.A (chunk 2).
Based on policy sections I.D.1 and CLINICAL POLICY criteria (chunks 2 and 3).
Based on policy section I.C (chunk 2).
This policy excludes coverage for investigational items or services and certain research-only costs. Specifically, the following are not covered: (1) the investigational item or service itself; (2) items and services provided solely to satisfy data collection and analysis needs that are not used in the direct clinical management of the patient (for example, repeated imaging performed only for study data when clinically a single scan would suffice); and (3) items and services customarily provided by the research sponsor at no charge to trial enrollees. Claims for these excluded costs may be denied under the Plan’s coverage rules.
Definitions
Provider Actions, Documentation, and Billing Requirements
Prior authorization and notification required per plan
All existing utilization management guidelines apply to routine care for members/enrollees in clinical trials, including prior-authorization and notification requirements.
Utilization and network limitations apply
Plan limitations for out-of-network care and existing utilization management (including prior authorization and notification) apply to routine clinical trial care and claims.
Document qualifying trial and approvals
Providers must have documentation that the clinical trial meets qualifying trial requirements, including a written protocol approved by relevant institutional review boards and that the trial evaluates an item/service within a covered benefit category with appropriate funding or approvals.
- Written study protocol approved by all relevant IRBs (chunk 2).
- Trial subject evaluates an item/service within a covered benefit category (chunk 3).
- Evidence of federal funding or approval by listed entities (AHRQ, CDC, CMS, NIH, cooperative groups, VA/DoD/DoE peer review, FDA IND, or exempt drug trials) (chunk 3).
Excluded costs may trigger denial
Claims for the investigational item/service itself, services provided solely for data collection not used in direct clinical management, or items customarily provided free by research sponsors are excluded and may be denied.
- The investigational item or service itself (chunk 2).
- Items/services provided solely to satisfy data collection and analysis needs not used in direct clinical management (chunk 2).
- Items/services customarily provided by research sponsors free of charge for any enrollee (chunk 2).
Background
This policy defines routine costs in a clinical trial as items and services that are generally considered medically necessary and are a covered benefit when provided in either the experimental or control arms. Routine costs include: (1) services that would typically be provided absent a clinical trial; (2) services required solely for the provision or clinically appropriate monitoring of the investigational item or service (for example, administration of a non-covered chemotherapy agent or monitoring of its effects) or for prevention of complications; and (3) services needed for the reasonable and necessary diagnosis or treatment of complications arising from the investigational item or service. All applicable plan limitations and utilization management rules (including prior authorization and network restrictions) continue to apply to these routine costs, and providers must document that the trial meets qualifying trial requirements described in the policy.
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