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Mandatory Medicaid Coverage of Routine Patient Costs in Qualifying Clinical Trials (for Kansas Only)
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Defines UnitedHealthcare Community Plan's application of mandatory Medicaid coverage for routine patient costs associated with qualifying clinical trials in Kansas; affects providers submitting claims for Medicaid members participating in qualifying clinical trials in Kansas.
Medical Records Documentation Used for Reviews: added language specifying that benefit coverage is determined by federal, state, or contractual requirements and that medical records documentation may be required to assess whether the member meets clinical criteria but does not guarantee coverage.
Updated FDA and References sections to reflect the most current information.
Archived previous policy version CS018KS.02.
Coverage Criteria for Qualified Clinical Trials
Criteria for Qualified Clinical Trials and Covered Routine Patient Costs
Covered when ALL of the following are met:
Source lists required agencies and peer-review criteria (comparable to NIH and unbiased review).
Coverage limited to services that would otherwise be covered outside the trial.
Excluded from routine patient cost coverage are items and services that are the investigational item or service that is the subject of the qualifying clinical trial and not otherwise covered outside of the clinical trial. Also excluded are items and services provided solely to satisfy data collection and analysis needs for the qualifying clinical trial that are not used in the direct clinical management of the member (for example, laboratory tests and imaging studies performed at protocol-driven frequencies that are not consistent with signs and symptoms or standards of care). Services provided free of charge by research sponsors for any person enrolled in the trial are likewise not included as routine patient costs.
Note that FDA approval alone is not a basis for coverage. Coverage determinations are governed by the applicable federal, state, or contractual requirements for benefit plan coverage, which may differ from this policy; in the event of a conflict those federal, state, or contractual requirements govern. The FDA provides informational resources about clinical trials and requires certain trials to be registered on ClinicalTrials.gov, but FDA actions or registration do not automatically mandate benefit coverage under this policy.
Billing and Coding
| 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 |
| G0276 | Covered When Criteria Are Met |
| G0293 | Listed in document |
| G0294 | Listed in document |
| S9990 | Services provided as part of a Phase I clinical trial |
| S9991 | Services provided as part of a Phase II clinical trial |
| S9992 | Services provided as part of a Phase III clinical trial |
| S9994 | 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 |
| S9996 | Meals for clinical trial participant and one caregiver/companion |
| Z00.6 | Encounter for examination for normal comparison and control in clinical research program |
Provider Responsibilities, Documentation, and Billing
Provider and PI attestation required for trial coverage
Coverage determinations will be based on an attestation by the treating health care provider and the principal investigator using the Secretary’s streamlined uniform form; the form may include an option to reference publicly available trial information (for example, ClinicalTrials.gov). Clinical trial claim modifiers Q0/Q1 and diagnosis code Z00.6 are referenced for trial claims.
- Attestation must be made using the Secretary’s streamlined uniform form
- Form may reference publicly available ClinicalTrials.gov information
- Use clinical trial modifiers (Q0, Q1) and diagnosis code Z00.6 as referenced
Check governing federal/state/contract rules first
Before applying this policy, verify the applicable federal, state, or contractual benefit requirements because those govern in the event of a conflict; check these requirements prior to using the policy.
- Federal, state, or contractual requirements govern if they differ from this policy
- Confirm applicable benefit rules for the member before submitting claims
Document and code services as trial-related when submitting claims
Ensure all documentation and coding submitted with the claim clearly identify the service as related to a qualifying clinical trial and comply with the attestation and coding guidance in this policy.
- Include trial identifiers or references (e.g., ClinicalTrials.gov) on the attestation form when available
- Apply the appropriate modifiers and diagnosis code as referenced
Adhere to attestation, documentation, and coding requirements
Follow the policy’s attestation, documentation, and coding instructions when requesting coverage for routine patient costs associated with qualifying clinical trials.
- Use the Secretary’s uniform attestation form as described
- Maintain complete medical records to support medical necessity
Maintain history, exam, and diagnostic results in the medical record
The patient's medical record must contain relevant medical history, physical examination findings, and results of pertinent diagnostic tests or procedures to support medical necessity for requested services.
- Include history, exam, and pertinent diagnostic results in the record
- Ensure information directly supports the medical necessity of the service
Documentation must fully support medical necessity and be available on request
Documentation must fully support medical necessity, be legible, maintained in the patient’s medical record, and made available upon request; records may be required to assess whether the member meets clinical criteria but do not guarantee coverage.
- Documentation should be legible and kept in the patient’s record
- Records must be provided upon request for reviews
- Medical record review may be used to determine whether clinical criteria are met
Insufficient documentation may lead to denial
Lack of adequate medical record documentation that supports medical necessity may lead to adverse coverage determinations or denial of the requested services.
- Insufficient or missing documentation can result in claim denial
- Ensure records demonstrate why services were medically necessary for the member
Denial risk if records don’t meet governing benefit requirements
Coverage decisions are governed by federal, state, or contractual requirements; if medical records do not adequately document medical necessity in accordance with those requirements, the claim may be denied.
- Confirm the governing benefit rules for the member’s plan before claiming coverage
- Maintain documentation that meets federal/state/contractual standards to reduce denial risk
Background on Clinical Trials
Clinical trials are research studies involving human volunteers to evaluate interventions such as drugs, devices, procedures, or behavioral changes and to measure safety and efficacy. Trials may be randomized against standard care, placebo, or other interventions and are organized into phases that correspond to purpose and scale. Routine patient costs in connection with qualifying clinical trials are limited to items and services provided to the participant that are used to prevent, diagnose, monitor, or treat complications of participation or are required solely for the provision of the investigational item or service (for example, physician services, laboratory tests, and imaging) and do not include investigational products, protocol-only data-collection services, or sponsor-provided free items.
Definitions and Trial Phase Descriptions
Policy Revision History
Added medical records documentation language clarifying that benefit coverage is governed by federal, state, or contractual requirements, that documentation may be required to assess clinical criteria but does not guarantee coverage, and specifying required contents and availability of documentation for review.
Updated FDA and References sections to reflect current information.
Archived previous policy version CS018KS.02.
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