CurrentCentenePolicy CP MP.94

Clinical Trials (Routine Costs)

Defines medical necessity, coverage, exclusions, and administrative requirements for routine costs incurred by plan members/enrollees participating in qualifying clinical trials for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyClinical Trials (Routine Costs)

Policy CodePolicy CP MP.94

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain and document a written trial protocol approved by the applicable IRB and follow all applicable prior-authorization and utilization management requirements for routine care.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1policy number

Included/Excludedcoverage stance summary

Annualdocument maintenance

CMS/PPACAregulatory basis

Coverage Criteria for Routine Clinical Trial Costs

Covered when qualifying trial requirements are met

Routine costs are medically necessary and covered when ALL of the following are met:

Qualifying trial criteria: The clinical trial has a written protocol that describes a scientifically sound study and is approved by all relevant institutional review boards (IRBs).

From policy: written protocol and IRB approval.

Covered benefit scope: The subject or purpose of the trial evaluates an item or service that falls within a covered benefit category (for example: physician services, durable medical equipment, diagnostic tests).

Ensures the trial evaluates services that are within plan benefits.

Therapeutic intent and population: For therapeutic intervention trials, the trial enrolls patients with the diagnosed disease (diagnostic trials may enroll healthy controls); the trial has therapeutic intent and is not solely designed to test toxicity or disease pathophysiology.

Policy Summary

PayerCentene

PolicyClinical Trials (Routine Costs)

Policy CodePolicy CP MP.94

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain and document a written trial protocol approved by the applicable IRB and follow all applicable prior-authorization and utilization management requirements for routine care.

SourceLink

On This Page

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Provider Responsibilities and Administrative Requirements

Prior Authorization

Prior authorization and utilization management

All applicable utilization management requirements apply to routine care for members/enrollees participating in clinical trials. Providers must follow prior-authorization and notification requirements in place for the member's plan.

Prior authorization and notification requirements remain applicable to routine costs in a clinical trial

Documentation Required

Clinical trial documentation required

The clinical trial must have a written protocol describing a scientifically sound study and must be approved by all relevant Institutional Review Boards (IRBs). Providers should ensure documentation of the written protocol and IRB approval is available in the member’s record when seeking coverage for routine costs.

Written study protocol on file
IRB approval documented

Denial Risk

Investigational and research-only services excluded

Services that are investigational, the investigational item or service itself, and services provided solely for data collection (not used in direct clinical management) are excluded from coverage. Also excluded are items or services required solely to provide the investigational item or service (for example, administration of a non‑covered investigational drug) and services customarily provided free of charge by the research sponsor.

Investigational item or service itself is not covered
Services provided solely to satisfy research data collection and analysis needs are excluded
Items/services required solely for provision or monitoring of the investigational item/service are excluded
Items/services customarily provided free by research sponsors are excluded

Definitions — Routine and Excluded Costs

Routine costs — definition and scope

DefinitionRoutine costs in a clinical trial are items and services generally considered medically necessary and a covered benefit that are provided in either the experimental or control arms, including items/services used to diagnose and treat complications arising from trial participation.

Typical examplesItems or services that are typically provided absent a clinical trial (i.e., standard-of-care services).

Complication careServices needed for reasonable and necessary care arising from the provision of an investigational item or service, including diagnosis or treatment of complications from trial participation.

Monitoring vs routineRoutine costs exclude services required solely for provision of the investigational item or for clinically appropriate monitoring of the investigational intervention (these are not covered as routine).

Administrative noteAll applicable plan utilization management (including prior-authorization and notification) and out-of-network coverage limitations apply to routine costs for members/enrollees in clinical trials.

Excluded costs/services

DefinitionExcluded costs/services include the investigational item or service itself, items and services provided solely to satisfy data collection and analysis needs not used in direct clinical management, and items and services customarily provided free of charge by research sponsors.

Investigational itemThe investigational item or service itself is excluded from routine cost coverage.

Data-collection only servicesItems and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient (e.g., monthly CT scans when normally only a single scan is required) are excluded.

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

Background

Routine costs in a qualifying clinical trial are defined as items and services that are generally considered medically necessary and a covered benefit when provided in either the experimental or control arms, including care to diagnose and treat complications arising from trial participation. The policy requires that qualifying trials be scientifically sound with a written protocol approved by relevant institutional review boards, and it also clarifies that all existing utilization management guidelines (including prior‑authorization and notification requirements) continue to apply to routine care for members/enrollees in clinical trials.