CurrentUCarePolicy N/A

Coverage for Routine Costs For Members Participating in Clinical Trials

Defines coverage of routine patient costs for UCare members who qualify and participate in approved clinical trials for cancer or other life‑threatening conditions; applies to specified UCare products and affects providers billing for trial‑related services.

Policy Summary

PayerUCare

PolicyCoverage for Routine Costs For Members Participating in Clinical Trials

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2021

Next Review DateJan 1, 2026

Key ActionSubmit accurate claims and, when appropriate, use modifiers Q0/Q1 or diagnosis code Z00.6 for clinical research encounters.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Applies to IFPUCare product applicability

Routine costs coveredCoverage stance

Prior auth: Not requiredAuthorization

Investigational itemsExclusions

Coverage Criteria for Routine Patient Costs

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Member eligibility: Member is a UCare member and is a qualified individual (has cancer or a life-threatening condition)

Qualified individual defined in policy (see definitions)

Appropriate participation: The individual's participation in the trial would be appropriate based upon the trial conditions

Clinical appropriateness per trial eligibility

Trial approval status: The clinical trial is an approved clinical trial (Phase I–IV) related to prevention, detection, or treatment of cancer or other life‑threatening disease and is not designed exclusively to test toxicity or disease pathophysiology; the trial must be conducted under an FDA investigational new drug (IND) application or be IND‑exempt, or be a federally funded or peer‑reviewed study as specified

See policy for list of qualifying federal agencies and peer‑review criteria

Covered services: Items and services are routine patient costs consistent with coverage provided for a qualified individual who is not enrolled in a clinical trial

Routine patient costs exclude investigational items and services provided solely for data collection or not used in direct clinical management (see exclusions)

This policy excludes as routine patient costs any investigational item, device, or service that is part of the trial. Additionally, items and services that are provided solely to satisfy data collection and analysis needs and are not used in direct clinical management of the patient are not covered. Services that are clearly inconsistent with widely accepted and established standards of care for a particular diagnosis are also excluded.

Coding and Modifier Guidance

Informational CPT/HCPCS/ICD-10 modifiers and codemixed

Q0	Investigational clinical service provided in a clinical research study that is in an approved clinical research study.
Q1	Routine clinical service provided in a clinical research study that is in an approved clinical research study.
Z00.6	Encounter for examination for normal comparison and control in clinical research program

Provider Actions, Billing & Documentation

Prior Authorization

Prior authorization is not required for routine patient costs for members participating in an approved clinical research study.

Note

Documentation Required

Claims Documentation & Coding

Providers must submit accurate and compliant claims. Use applicable modifiers and diagnosis codes when billing clinical research encounters to support correct processing.

Modifier Q0 — Investigational clinical service provided in a clinical research study that is in an approved clinical research study.
Modifier Q1 — Routine clinical service provided in a clinical research study that is in an approved clinical research study.
ICD-10 Z00.6 — Encounter for examination for normal comparison and control in clinical research program

Denial Risk

Exclusions That May Trigger Denial

Investigational items, devices, or services that are part of the trial are excluded and may be denied. Items and services provided solely to satisfy data collection/analysis needs (not used in direct clinical management) or services clearly inconsistent with accepted standards of care may also be denied.

Key Definitions

inv-09: Qualified individual — definition of a qualified UCare member for trial participation

Who qualifiesA UCare member who has cancer OR a life‑threatening condition (any disease or condition from which the likelihood of death is probable unless the course of the disease or condition is interrupted)

Membership requirementMember must be enrolled in a UCare plan

Appropriate participationParticipation in the clinical trial must be appropriate based on the trial conditions and eligibility criteria

Covered services contextRoutine patient costs are covered for qualified individuals when provided in approved clinical trials for treatment of cancer or other life‑threatening conditions

inv-10: Approved clinical trial — definition covering Phase I–IV trials not designed exclusively for toxicity or dose-finding

Phases includedPhase I, Phase II, Phase III, or Phase IV clinical trials or drug trials

Scope of trialTrials conducted in relation to the prevention, detection, or treatment of cancer or other life‑threatening disease or condition

Exclusion — toxicity/pathophysiology onlyTrials designed exclusively to test toxicity or disease pathophysiology are not included

Regulatory statusMust be conducted under an FDA investigational new drug (IND) application or be IND‑exempt

inv-11: Federally funded or peer‑reviewed study — definition of qualifying studies (federal agencies, peer-review comparable to NIH, etc.)

Federal agencies qualifying studiesStudies approved or funded by NIH, CDC, AHRQ, CMS, Department of Defense, Department of Veterans Affairs or Department of Energy

Cooperative groupsCooperative group or center of any of the listed federal entities qualifies

Peer‑review requirementStudies reviewed and approved through a peer‑review system determined by the HHS Secretary to be comparable to NIH review and ensuring unbiased review by qualified individuals with no interest in the outcome

Qualified non‑governmental entitiesQualified non‑governmental research entities identified in NIH guidelines for center support grants also qualify

Background

This policy supports coverage of routine patient costs for UCare members who are qualified individuals and participate in approved clinical trials for cancer or other life‑threatening conditions. Coverage applies when the member meets eligibility criteria, participation is clinically appropriate, and the trial is an approved clinical trial (Phase I–IV) conducted under an FDA IND or IND‑exempt, or is federally funded/peer‑reviewed as specified. Prior authorization is not required for routine patient costs associated with participation in approved clinical trials, and providers should follow standard claims documentation and coding guidance when submitting charges.