CurrentFidelis CarePolicy CP MP.94

Clinical Trials — Routine Costs Coverage Criteria

Defines medical necessity guidelines for coverage of routine costs and complication care related to qualifying clinical trials for plan members/enrollees, aligned with CMS and PPACA requirements.

Policy Summary

PayerFidelis Care

PolicyClinical Trials — Routine Costs Coverage Criteria

Policy CodePolicy CP MP.94

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain and document prior authorization and required trial documentation (including IRB‑approved protocol) for routine care related to qualifying clinical trials.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Includedroutine costs included

Excludedinvestigational item excluded

Prior authutilization management applies

Qualifying trialsfederal/NIH/FDA criteria

Coverage criteria for routine costs in qualifying clinical trials

Covered when ALL of the following are met:

Items/services covered as routine costs: Items and services generally considered medically necessary and a covered benefit to Plan members/enrollees that are provided in either the experimental or control arms, including items and services needed for reasonable and necessary care arising from the provision of an investigational item or service (for example, diagnosis or treatment of complications).

Supported by policy definition of routine costs

Trial requirements: The clinical trial has a written protocol describing a scientifically sound study approved by all relevant institutional review boards (IRBs); the subject or purpose of the trial evaluates an item or service that falls within a covered benefit category; trials of therapeutic interventions enroll patients with the diagnosed disease (diagnostic trials may enroll healthy patients for controls); the trial must have therapeutic intent (not solely to test toxicity or pathophysiology).

Listed qualifying clinical trial criteria

Policy Summary

PayerFidelis Care

PolicyClinical Trials — Routine Costs Coverage Criteria

Policy CodePolicy CP MP.94

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain and document prior authorization and required trial documentation (including IRB‑approved protocol) for routine care related to qualifying clinical trials.

SourceLink

On This Page

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Provider requirements, prior authorization, and denials

Prior Authorization

Prior authorization requirement

All existing utilization management guidelines apply to routine care for members/enrollees participating in qualifying clinical trials. This includes prior-authorization and notification requirements that would otherwise apply to the same services when provided outside of a trial.

Prior authorization requirements remain in effect for routine services delivered in clinical trials.
Providers should follow standard UM processes (prior auth, referrals, network rules) when billing for routine care related to trial participation.

Note

Provider action required

Important: Providers must submit required documentation (trial protocol, IRB approval, evidence of trial qualification) with prior authorization requests and claims to avoid administrative delays or denials.

Include the trial name, sponsor, ClinicalTrials.gov identifier (if available), and the treating physician's relationship to the trial on authorization requests and claims.
Notify the plan when routine services are rendered in the context of a qualifying clinical trial per plan notification rules.

Documentation Required

Required trial documentation

A qualifying clinical trial must have a written protocol approved by the relevant institutional review board(s) and describe a scientifically sound study. The trial must evaluate an item or service that falls within a covered benefit category and have therapeutic intent (not solely to test toxicity or pathophysiology).

Protocol must be IRB-approved and identify inclusion/exclusion criteria and study objectives.
Trials of therapeutic interventions must enroll patients with the diagnosed disease; diagnostic trials may enroll healthy controls when appropriate.
Trials should be federally funded or approved by recognized entities (e.g., NIH, CDC, AHRQ, CMS, VA, DoD) or conducted under an FDA investigational new drug/application when applicable.

Denial Risk

Excluded costs that trigger denial

Claims for routine costs associated with a clinical trial may be denied when the billed items or services are excluded from coverage. Common denial triggers include the investigational item/service itself and items/services provided solely for data collection rather than direct clinical management.

The investigational item or service under study is not a routine covered cost and is excluded from payment.
Items and services provided solely to satisfy data collection and analysis (e.g., additional protocol-specified imaging or tests not used for clinical management) are not covered.
Items and services customarily provided by the research sponsor at no charge are excluded from coverage.
Services required solely for the provision or administration of the investigational item (for example, administration of a non-covered investigational drug) may be denied.

Key definitions

inv-08: Routine costs — definition of routine costs in a clinical trial

DefinitionRoutine costs include items and services generally considered medically necessary and a covered benefit to plan members/enrollees that are provided in either the experimental or control arms of a qualifying clinical trial.

Included examplesItems or services typically provided absent a clinical trial (routine care), and items/services needed for reasonable and necessary care arising from provision of an investigational item or service, including diagnosis or treatment of complications.

ScopeAlso covers services used to diagnose and treat complications arising from participation in a qualifying clinical trial.

Administrative noteAll applicable plan limitations for out-of-network coverage apply to routine costs in a clinical trial.

Utilization managementAll existing utilization management guidelines apply to routine care for members/enrollees in clinical trials, including prior-authorization and notification requirements.

inv-09: Excluded costs — investigational item/service; data-collection-only items; sponsor-provided items

Investigational item/serviceThe investigational item or service itself is excluded from routine costs.

Data-collection-only itemsItems and services provided solely to satisfy data collection and analysis needs that are not used in the direct clinical management of the patient (e.g., protocol-mandated imaging for research data only) are excluded.

Sponsor-provided itemsItems and services customarily provided by research sponsors free of charge for any enrollee in the trial are excluded.

Denial riskClaims may be denied when services fall into these excluded categories (investigational intervention, data-collection-only items, sponsor-provided items).

Background

Routine costs of clinical trials are those items and services that are generally considered medically necessary and a covered benefit for plan members/enrollees when provided in either the experimental or control arms. Routine costs also include items and services needed for reasonable and necessary care arising from the provision of an investigational item or service, including diagnosis or treatment of complications. To qualify for coverage, the clinical trial must have a written protocol describing a scientifically sound study and approved by relevant institutional review boards (IRBs). All applicable plan administrative limitations apply, and all existing utilization management guidelines (including prior-authorization and notification requirements) continue to apply to routine care provided in clinical trials.