CurrentUnitedHealthcarePolicy CS018KY.06

Mandatory Medicaid Coverage of Routine Patient Costs in Qualifying Clinical Trials (for Kentucky Only)

Defines UnitedHealthcare's application of mandatory Medicaid coverage for routine patient costs when a Medicaid member in Kentucky participates in a qualified clinical trial; establishes which trials qualify, what routine costs are covered/excluded, required attestation, and applicable billing codes/modifiers for claims.

Policy Summary

PayerUnitedHealthcare

PolicyMandatory Medicaid Coverage of Routine Patient Costs in Qualifying Clinical Trials (for Kentucky Only)

Policy CodePolicy CS018KY.06

Change TypeRevised (supporting information updated, prior version archived)

Effective DateSep 1, 2025

Next Review Date

Key ActionProviders must complete a streamlined uniform attestation form confirming the appropriateness of the clinical trial; the form may reference public trial information such as clinicaltrials.gov.

SourceLink

POLICY UPDATE CHANGES

Updated FDA section to reflect the most current information and archived previous policy version CS018KY.05.

Kentucky-onlyState scope

Phase I–IVTrial phases defined as qualified

Z00.6, Q0, Q1, G0276, G0293, G0294, G2000, S9988–S9996Example codes referenced

Qualified clinical trials and routine patient cost coverage

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Qualified Clinical Trial definition and qualifying criteria

A clinical trial qualifies when ALL of the following are met:

ALL of the following

Trial is Phase I, Phase II, Phase III, or Phase IV
Trial is conducted in relation to prevention, detection, or treatment of a serious or life‑threatening disease or condition
Trial meets the Criteria for Qualified Clinical Trials per federal/state requirements (see list of qualifying sponsors/approvals)
Study is described in one of the following sponsor/approval categories
- Study approved, conducted, or supported (including in-kind funding) by NIH (including NCI)
- Study approved, conducted, or supported by CDC
- Study approved, conducted, or supported by AHRQ
- Study approved, conducted, or supported by CMS
- Study approved, conducted, or supported by a cooperative group or center of the entities above, or DOD or VA
- Study approved, conducted, or supported by a qualified non-governmental research entity identified in NIH center support grant guidelines
- Study conducted by VA, DOD, or DOE and reviewed/approved via a peer-review system comparable to NIH and ensuring unbiased high-standard review
- OR, study conducted under an investigational new drug (IND) exemption under section 505(i) of the Federal Food, Drug and Cosmetic Act, or an exemption for a biological product under section 351(a)(3) of the Public Health Service Act
- OR, drug trial that is exempt from the IND/biologic exemption described above (per policy instructions)

Coverage of routine patient costs during qualified clinical trials

Routine patient costs are covered when ALL of the following conditions are met:

ALL of the following

Item or service is provided to the individual under the qualifying clinical trial
Item or service would otherwise be covered outside the course of participation in the qualifying clinical trial
Includes items or services to prevent, diagnose, monitor, or treat complications resulting from participation in the qualifying clinical trial
Examples of covered service types
- Physician services

Coverage exclusions (routine patient costs do not include)

Routine patient costs exclude any of the following:

ANY of the following

The investigational item or service that is the subject of the qualifying clinical trial when it is not otherwise covered outside the clinical trial
Items and services provided solely to satisfy data collection and analysis needs for the qualifying clinical trial and not used in direct clinical management of the member (examples: lab tests and imaging performed at protocol‑dictated frequency inconsistent with signs/symptoms or standard of care)
Items and services provided by the research sponsor free of charge for any person enrolled in the trial

Attestation and documentation requirement

Coverage determinations will be based on the following provider attestation/documentation:

ALL of the following

An attestation by the health care provider and principal investigator regarding appropriateness of the clinical trial is required
Attestation must use the streamlined, uniform form developed for use by the Secretary and may reference public trial information (e.g., clinicaltrials.gov)

Relevant billing codes and modifiers

Modifiers identifying clinical trial claimsModifier

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

HCPCS/CPT codes referenced (examples)CPT|HCPCS

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
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
G2000	Blinded administration of convulsive therapy procedure, either electroconvulsive therapy (ECT, current covered gold standard) or magnetic seizure therapy (MST, noncovered experimental therapy), 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
S9992	Transportation costs to and from trial location and local transportation costs (e.g., fares for taxicab or bus) for clinical trial participant and one caregiver/companion (listed as Not Covered)
S9994	Lodging costs (e.g., hotel charges) for clinical trial participant and one caregiver/companion (listed as Not Covered)
S9996	Meals for clinical trial participant and one caregiver/companion (listed as Not Covered)

Diagnosis codes referenced (examples)ICD-10

Z00.6

Encounter for examination for normal comparison and control in clinical research program

Documentation and claim-denial considerations

Documentation Required

Provider and principal investigator attestation required

Providers and the principal investigator must complete the streamlined, uniform attestation form developed for use by the Secretary confirming the appropriateness of the clinical trial; the attestation may reference publicly available trial information (for example, clinicaltrials.gov).

Denial Risk

Claims may be denied if service is investigational or sponsor‑provided

Claims for items or services that are the investigational item or service not otherwise covered, items/services provided solely for data collection and analysis (and not used in direct clinical management), or items/services provided free of charge by the research sponsor may be denied as excluded routine patient costs.

Exclusions include: the investigational item/service that is the subject of the trial when not otherwise covered
Items/services provided solely to satisfy data collection and analysis needs and not used in direct clinical management (e.g., protocol‑dictated lab tests or imaging inconsistent with signs/symptoms or standard of care)
Items/services provided by the research sponsor free of charge for any person enrolled in the trial

Policy purpose and legal basis

This policy implements mandatory Medicaid coverage in Kentucky for routine patient costs associated with participation in qualifying clinical trials, in accordance with federal law (42 USC 1396d) and related federal guidance. It applies only to the state of Kentucky and becomes effective September 1, 2025. The policy aligns UnitedHealthcare's coverage approach with the federal framework and applicable state/contractual requirements.

The policy clarifies which clinical trials qualify and which costs are considered routine and therefore eligible for coverage. A Qualified Clinical Trial is defined as a Phase I–IV trial conducted in relation to prevention, detection, or treatment of a serious or life‑threatening condition that meets the specified federal/state criteria for qualifying trials (for example, studies approved, conducted, or supported by NIH/NCI, CDC, AHRQ, CMS; cooperative groups; DOD/VA; peer‑reviewed VA/DOD/DOE studies; or trials conducted under an IND exemption or specified exemptions under federal law).

The policy explains that routine patient costs include items and services provided to the participant that would otherwise be covered outside the trial, including services to prevent, diagnose, monitor, or treat complications of trial participation, and items required solely to provide the investigational item (for example, administration). Examples of covered routine services include physician services, laboratory services, and medical imaging services.

The policy also lists explicit exclusions: the investigational item or service that is the subject of the trial when it is not otherwise covered outside the trial; services provided solely to satisfy data collection or analysis needs that are not used in direct clinical management (for example, protocol‑dictated lab tests or imaging inconsistent with standard care); and items or services provided free of charge by the research sponsor. Coverage determinations require a provider and principal investigator attestation using the streamlined, uniform form developed for use by the Secretary and may reference public trial information such as ClinicalTrials.gov.

Applicable billing modifiers and example procedure/diagnosis codes are referenced for claims processing (for example, modifiers Q0 and Q1, HCPCS/CPT and S‑series codes for trial phases, and ICD‑10 code Z00.6), but listing a code does not guarantee coverage or payment; federal, state, and contractual requirements govern final benefit determinations.

Policy history notes a revision effective 09/01/2025 updating the FDA informational section and archiving the prior policy version CS018KY.05.

Terms defined in this policy

Key Definitions

Qualified Clinical TrialA Phase I–IV clinical trial related to prevention, detection, or treatment of a serious or life‑threatening disease or condition that meets the specified federal/state criteria for qualifying trials (including approval/conduct/support by NIH, CDC, AHRQ, CMS, cooperative groups, DOD/VA/DOE peer‑reviewed studies, IND exemptions, or specific drug exemptions).

Routine patient costsAny item or service provided to the individual under the qualifying clinical trial that would otherwise be covered outside trial participation, including services to prevent, diagnose, monitor, or treat complications and services required solely to deliver the investigational item (for example, physician services, laboratory services, medical imaging services).

Excluded costsInvestigational items or services that are the subject of the trial and not otherwise covered outside the trial; items/services provided solely for data collection and analysis not used in direct clinical management (e.g., protocol‑dictated extra labs or imaging); and items/services provided free of charge by the research sponsor to trial participants.

OpenPayer

Mandatory Medicaid Coverage of Routine Patient Costs in Qualifying Clinical Trials (for Kentucky Only)

Qualified clinical trials and routine patient cost coverage

Relevant billing codes and modifiers

Documentation and claim-denial considerations

Policy purpose and legal basis

Terms defined in this policy

Policy changes and history

Quick reference