CurrentCentenePolicy HNCA CP.MP.94

Clinical Trials — Routine Costs and Complication Care

Governs coverage and medical necessity guidelines for routine costs and treatment of complications arising from participation in qualifying clinical trials for Health Net of California / Centene plan members.

Policy Summary

PayerCentene

PolicyClinical Trials — Routine Costs and Complication Care

Policy CodePolicy HNCA CP.MP.94

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain and document prior authorization and required trial documentation, including a written IRB‑approved protocol that meets qualifying criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

CA refsstate law citations

Medicare NCDorigin

07/25last revision

Routine costscoverage focus

Coverage Criteria for Routine Costs and Complication Care

Covered Routine Costs and Complication Care

Covered when ALL of the following are met

Routine costs coverage: Item or service is generally medically necessary and a covered benefit for plan members and is provided in either the experimental or control arm of a qualifying clinical trial.

Includes items or services typically provided absent a clinical trial; includes items or services required solely for provision, monitoring, or prevention of complications of the investigational item or service.

Complication care: Items and services used to diagnose and treat complications arising from participation in a qualifying clinical trial are covered.

Qualifying clinical trial requirements: The trial evaluates an item or service within a covered benefit category; has a written protocol that describes a scientifically sound study and is approved by all relevant institutional review boards (IRBs); has therapeutic intent (not solely designed to test toxicity or disease pathophysiology); and is federally funded or approved by an acceptable entity.

Policy Summary

PayerCentene

PolicyClinical Trials — Routine Costs and Complication Care

Policy CodePolicy HNCA CP.MP.94

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain and document prior authorization and required trial documentation, including a written IRB‑approved protocol that meets qualifying criteria.

SourceLink

On This Page

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Provider Responsibilities and Utilization Management

Prior Authorization

Prior Authorization and Utilization Management

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

Applies to routine costs and services tied to the clinical trial
Prior authorization and standard UM requirements remain in effect

Billing Rule

Network and Management Applicability

Plan limitations for out-of-network coverage apply to routine costs associated with a clinical trial. Providers should follow the plan's standard network/utilization rules when arranging care for trial participants and verify network status and benefit limits prior to services.

Out-of-network coverage limitations still apply to routine clinical trial costs
Verify network status and apply standard cost-sharing and referral rules

Documentation Required

Required Trial Documentation

Clinical trials must have a written, IRB-approved protocol and meet qualifying criteria to be considered for coverage of routine costs. Qualifying criteria include that the trial evaluates an item or service within a covered benefit category and has therapeutic intent (not solely to test toxicity or pathophysiology).

Written protocol approved by relevant IRBs
Trial objective falls within a covered benefit (e.g., physician services, DME, diagnostic tests)
Trial has therapeutic intent

Denial Risk

Utilization Management and Coverage Risk

Failure to follow the plan's existing utilization management guidelines — including prior authorization and required notifications for routine care provided in the context of a clinical trial — may affect coverage determinations.

Noncompliance with prior authorization/notification requirements may lead to denial or altered coverage
Providers should submit required documentation and follow normal UM workflows

Key Definitions

inv-09: Routine costs — definition of routine costs for qualifying clinical trials

DefinitionRoutine costs are items and services generally considered medically necessary and covered benefits provided in either the experimental or control arms of a qualifying clinical trial.

Included examplesItems or services that are typically provided absent a clinical trial (standard-of-care services).

Monitoring and preventionItems or services required for clinically appropriate monitoring of the effects of the investigational item or service and the prevention of complications.

Complication careItems and services needed for reasonable and necessary care arising from the investigational item or service, including diagnosis and treatment of complications.

inv-10: Excluded costs — investigational items/services and data-collection-only services exclusion

Investigational item/serviceThe 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 not used in direct clinical management (e.g., monthly CT scans when only a single scan is clinically required) are excluded.

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

inv-11: Qualifying clinical trial — definition and qualifying criteria (IRB-approved protocol, therapeutic intent, etc.)

Covered benefit categoryThe trial must evaluate an item or service that falls within a covered benefit category (e.g., physician services, durable medical equipment, diagnostic tests).

IRB-approved protocolThe clinical trial must have a written protocol describing a scientifically sound study and be approved by all relevant institutional review boards (IRBs).

Therapeutic intentThe trial must have therapeutic intent and not be solely designed to test toxicity or disease pathophysiology.

Acceptable funding/approval sourcesTrials must be federally funded or approved by specified groups (examples include CMS, CDC, NIH, AHRQ, DoD, VA, DOE, qualified nongovernmental entities, or cooperative groups).

Enrollment for therapeutic interventionsTrials of therapeutic interventions must enroll patients with the diagnosed disease (diagnostic trials may enroll healthy patients for control groups).

OpenPayer

Clinical Trials — Routine Costs and Complication Care

Coverage Criteria for Routine Costs and Complication Care

Provider Responsibilities and Utilization Management

Key Definitions

Background