CurrentUnitedHealthcarePolicy MP.006.25

Coverage of Routine Patient Costs for Qualifying Clinical Trials

UnitedHealthcare policy MP.006.25 defines coverage for routine patient costs incurred by qualified individuals participating in Approved Clinical Trials (cancer or life‑threatening disease) and describes additional optional coverage for certain other clinical trials, applicable exclusions, documentation and network considerations. It applies to UnitedHealthcare standard benefit plans and references member-specific plan documents and federal/state mandates.

Policy Summary

PayerUnitedHealthcare

PolicyCoverage of Routine Patient Costs for Qualifying Clinical Trials

Policy CodePolicy MP.006.25

Change TypeNon-material revisions and archival

Effective DateAug 1, 2025

Next Review Date

Key ActionProvide trial documentation (protocol, IRB approval, funding/approval source) to UnitedHealthcare on request to establish that the trial meets Approved Clinical Trial criteria.

POLICY UPDATE CHANGES

Added reference link to the Medicare Advantage policy titled 'Experimental Procedures and Items, Investigational Devices, and Clinical Trials'.

Updated definition of 'Covered Health Care Service(s)'.

Updated FDA section to reflect the most current information.

Archived previous policy version MP.006.24.

Phase I-IVTrial Phases Addressed

Routine costs coveredCoverage Summary

Travel/lodging/mealsCommon Exclusions

Category B devicesDevice Exception

Coverage Summary

UnitedHealthcare policy MP.006.25 defines coverage for Routine Patient Costs incurred by Qualified Individuals participating in Approved Clinical Trials (Phase I–IV) related to cancer or other life‑threatening diseases and conditions, when all criteria for an Approved Clinical Trial are met. The policy also describes UnitedHealthcare's optional coverage for certain non-life‑threatening trials (for example, selected cardiovascular and musculoskeletal surgical trials) under the standard Clinical Trial benefit when specified conditions are satisfied.

The policy clarifies documentation and operational requirements (written protocol, IRB approval, evidence of trial funding/approval, and that the trial evaluates an item/service that meets the definition of a Covered Health Care Service), notes network and out‑of‑state considerations, and lists key exclusions — notably that the experimental or investigational item itself is not covered except for certain Category B devices and limited promising interventions for terminal illness, and that travel, transportation, lodging, and meals are excluded. UnitedHealthcare may request trial documentation and the member's specific benefit plan governs coverage determinations.

Key Policy Facts

Effective Date2025-08-01

Policy StatusCURRENT

Trial Phases AddressedPhase I-IV

Coverage SummaryRoutine patient costs covered when criteria met for qualifying Approved Clinical Trials (cancer or life‑threatening)

Common ExclusionsTravel, transportation, lodging, and meals excluded

Device ExceptionCertain FDA Category B devices may be covered only when all specified conditions are met (FDA‑approved trial context, protocol use, benefit category, medical necessity, appropriate setting)

Medical-Necessity Criteria

Indications for Coverage / Approved Clinical Trial

Benefits for routine patient costs are covered when ALL of the following are met:

ALL of the following

ALL of the following
- Member is a 'Qualified Individual' (covered under the health plan and eligible to participate in the Approved Clinical Trial according to the trial protocol).
- Trial approval/funding sources
  - Study is approved or funded by NIH (includes NCI)
  - Study is approved or funded by CDC

Coding

Clinical trial claim modifiers (considered clinical trials claim when present)Modifier

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

Covered When Criteria Are Met / Clinical trial specific HCPCS/CPTCPT|HCPCSCovered

G0276	Blinded procedure for lumbar stenosis, percutaneous image-guided lumbar decompression (PILD) or placebo-control, performed in an approved coverage with evidence development (CED) clinical trial.
G2000	Blinded administration of convulsive therapy procedure, either ECT or MST, performed in an approved IDE-based clinical trial, per treatment session.
S9988	Services provided as part of a Phase I clinical trial.
S9990	Services provided as part of a Phase II clinical trial.
S9991	Services provided as part of a Phase III clinical trial.

Noncovered / Not Covered (examples)CPT|HCPCSNot Covered

G0293	Noncovered surgical procedure(s) using conscious sedation, regional, general, or spinal anesthesia in a Medicare qualifying clinical trial, per day.
G0294	Noncovered procedure(s) using either no anesthesia or local anesthesia only, in a Medicare qualifying clinical trial, per day.
S9992	Transportation costs to and from trial location and local transportation costs for clinical trial participant and one caregiver/companion.
S9994	Lodging costs for clinical trial participant and one caregiver/companion.
S9996	Meals for clinical trial participant and one caregiver/companion.

Diagnosis example listedICD-10

Z00.6

Encounter for examination for normal comparison and control in clinical research program (document referenced generically as diagnosis listing for clinical trials claims).

Provider Actions & Billing Guidance

Documentation Required

Provide trial documentation on request

UnitedHealthcare may request documentation about the Clinical Trial to assess whether it meets the policy's Approved Clinical Trial criteria. Requested documentation can include the study protocol, institutional review board (IRB) approval, and the trial's funding or approval source.

protocol
IRB approval
funding source

Prior Authorization

Verify member plan coverage & applicability

Providers must reference the member-specific benefit plan document and any applicable federal or state mandates when seeking coverage for routine patient costs in a clinical trial. Benefit coverage and determinations are governed by the member-specific benefit plan terms.

Definitions & Background

PPACA requirement: Effective for plan years starting on or after January 1, 2014, the Patient Protection and Affordable Care Act requires non-grandfathered health plans to cover Routine Patient Costs for a qualifying individual who is participating in an approved clinical trial; benefits include reasonable and necessary items and services to prevent, diagnose, and treat complications arising from participation when the person is clinically eligible for the trial.

Relation to UnitedHealthcare Clinical Trial benefit: UnitedHealthcare implements this PPACA mandate through its Clinical Trial benefit (MP.006.25) for Approved Clinical Trials (cancer or life‑threatening disease) and extends optional coverage under the standard Clinical Trial benefit for certain non-life‑threatening trials (e.g., specified cardiovascular and musculoskeletal trials) when the policy criteria are met.

Documentation and operational requirements: Coverage requires that the clinical trial have a written protocol describing a scientifically sound study approved by relevant IRBs before enrollment; UnitedHealthcare may request documentation about the trial (protocol, IRB approval, and funding/approval source). The trial’s subject must evaluate an item/service that meets the definition of a Covered Health Care Service and is not otherwise excluded under the policy.

Exclusions: The experimental or investigational service/item is not covered except for limited exceptions (certain FDA-designated Category B devices that meet all listed criteria, certain promising interventions for terminal illness, or other items UnitedHealthcare determines meet policy criteria). Items and services provided solely for data collection, services inconsistent with accepted standards of care, items provided free by research sponsors, and travel, transportation, lodging, and meals are excluded. Routine patient costs obtained out-of-network may be excluded when non-network benefits do not exist under the member's plan.

Approved Clinical Trial: A Phase I–IV trial related to cancer or other life‑threatening disease or condition that meets the policy's listed funding/approval criteria (for example, NIH/NCI, CDC, AHRQ, CMS, cooperative groups, DOD/VA, qualified non‑governmental entities, FDA IND-reviewed trials, or IND‑exempt drug trials) and the Criteria for Approved Clinical Trials.

Revision History

08/01/2025revised

Added reference link to the Medicare Advantage policy titled 'Experimental Procedures and Items, Investigational Devices, and Clinical Trials'.

08/01/2025revised

Updated definition of 'Covered Health Care Service(s)'.

08/01/2025revised

Updated FDA section to reflect the most current information.

Policy Summary

PayerUnitedHealthcare

PolicyCoverage of Routine Patient Costs for Qualifying Clinical Trials

Policy CodePolicy MP.006.25

Change TypeNon-material revisions and archival

Effective DateAug 1, 2025

Next Review Date

Key ActionProvide trial documentation (protocol, IRB approval, funding/approval source) to UnitedHealthcare on request to establish that the trial meets Approved Clinical Trial criteria.

On This Page

Study is approved or funded by AHRQ

Study is approved or funded by CMS

Study is approved or funded by a cooperative group/center of entities above or DOD or VA

Study is approved or funded by a qualified non-governmental research entity as identified by NIH guidelines

Study is approved or funded by Dept. of Veterans Affairs, Dept. of Defense, or Dept. of Energy with peer review comparable to NIH and unbiased review

Study is conducted under an investigational new drug (IND) application reviewed by the FDA

Study is a drug trial exempt from having an IND

The trial is Phase I-IV (or Early Phase 1 described in definitions) and is conducted in relation to prevention, detection, or treatment of cancer or other life‑threatening disease or condition.

The trial meets the Requirements under Criteria for Approved Clinical Trials (written protocol, IRB approval, scientifically sound).

The subject/purpose of the trial evaluates an item/service that meets definition of a Covered Health Care Service and is not otherwise excluded under the policy.

Routine Patient Costs - What is Included

Routine patient costs covered when criteria are met include items/services that are:

ANY of the following

Typically provided absent a clinical trial
Required solely for provision of the experimental/investigational service or item (e.g., infusion administration to deliver an investigational drug)
Clinically appropriate monitoring of effects of the service/item (e.g., lab tests and imaging done consistent with signs/symptoms and standards of care)
Prevention of complications
Needed for reasonable and necessary care arising from provision of an experimental or investigational service/item

Exclusions / Not Covered

The following are NOT covered for Clinical Trials:

ANY of the following

ANY of the following
- ALL of the following
  - Device used within context of an FDA-Approved Clinical Trial
  - Device used according to the Clinical Trial's approved protocols
  - Device falls under a covered benefit category and is not excluded by law/regulation/current Medicare coverage guidelines
  - Device is medically necessary for the member and amount/duration/frequency is medically appropriate
  - Device furnished in setting appropriate to member's medical needs and condition
Items/services provided solely to satisfy data collection/analysis needs and not used in direct clinical management (e.g., lab tests/imaging at frequency dictated solely by protocol and inconsistent with standards of care).
A service clearly inconsistent with widely accepted/established standards of care for that diagnosis.
Items/services provided by research sponsors free of charge for the enrolled person.
Travel and transportation expenses (transportation fees, rental car, mileage reimbursement, lodging, meals).
Routine patient costs obtained out-of-network where non-network benefits do not exist under the plan.
Clinical trials that do not meet the Indications for Coverage requirements.

Qualified Individual referral/eligibility

To be a qualified individual, ONE of the following must be met:

ANY of the following

Referred to the Clinical Trial by an in-network health care professional who concluded the individual's participation is appropriate and eligible per the trial protocol.
Member provides the plan with medical and scientific information establishing that participation is appropriate and eligible per the trial protocol.

Additional Requirements (documentation and protocol)

Coverage requires ALL of the following operational conditions:

ALL of the following

Clinical Trial must have a written protocol describing a scientifically sound study approved by relevant IRBs before enrollment; UnitedHealthcare may request documentation about the trial.
Subject/purpose must evaluate an item/service that meets the definition of a Covered Health Care Service and is not otherwise excluded under the policy.

Benefit determination governed by member-specific plan terms

Billing Rule

Use clinical trial modifiers when applicable

When a claim includes Q0 or Q1 modifiers it is considered a Clinical Trials claim. Providers should also report appropriate trial-specific HCPCS/CPT codes (for example, S9988, S9990, S9991) when applicable.

Q0
Q1
S9988
S9990
S9991

Denial Risk

Out-of-network routine costs may be denied

Routine patient costs obtained out-of-network may be excluded when non-network benefits do not exist under the member's plan. Claims for routine costs may also be denied if the Clinical Trial does not meet the policy's Indications for Coverage.

Qualified Individual: A member covered under the health plan who is eligible to participate in an Approved Clinical Trial according to the trial protocol and who either is referred by an in‑network health care professional who concluded participation is appropriate or provides the plan with medical and scientific information establishing eligibility.

Routine Patient Costs: Covered health care services typically provided absent a clinical trial that are required solely to provide the experimental/investigational item or service (for example, infusion administration), for clinically appropriate monitoring of effects (labs/imaging consistent with standards of care), to prevent complications, or are otherwise needed for reasonable and necessary care arising from provision of the experimental service/item.

Category B Devices: FDA‑determined non‑experimental and/or investigational devices where the incremental risk is the primary question (initial safety/effectiveness questions resolved or similar device types have FDA PMA/clearance); certain Category B devices are covered only when all policy criteria are met (used within an FDA‑approved clinical trial, used according to the trial protocol, fall under a covered benefit category and are not excluded by law/regulation/Medicare guidance, are medically necessary and appropriate in amount/duration/frequency, and furnished in an appropriate setting).

08/01/2025removed

Archived previous policy version MP.006.24.