CurrentAmbetter NevadaPolicy MO.IFP.MP.01

Clinical Trial Coverage

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This policy governs medical-necessity coverage for routine patient care costs incurred by members enrolled in qualifying phase II, III, or IV clinical trials for cancer prevention, early detection, or treatment. It defines covered routine services, excluded trial costs, and eligibility requirements for the trial, member, and treating facility.

Policy Summary

PayerAmbetter Nevada

PolicyClinical Trial Coverage

Policy CodePolicy MO.IFP.MP.01

Change TypeAnnual review and criteria update

Effective DateN/A

Last ReviewJun 1, 2026

Next Review DateN/A

Key ActionObtain informed consent for trial participation and make the consent documents available to the health plan upon request.

SourceLink

POLICY UPDATE CHANGES

The June 2026 annual review updated the clinical trial coverage criteria to align with Missouri Statute 376.429 for certain cancer clinical trials.

Phase II-IVClinical trial phases addressed

3Explicitly excluded routine-cost categories

6Eligible trial approval or funding pathways listed for phase III/IV trials

Enrollment required

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CurrentAmbetter NevadaPolicy MO.IFP.MP.01

Clinical Trial Coverage

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Sign up for Ambetter Nevada Policy MO.IFP.MP.01 alerts

Get alerted when Policy MO.IFP.MP.01 changes without checking for updates manually.

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Policy Summary

PayerAmbetter Nevada

PolicyClinical Trial Coverage

Policy CodePolicy MO.IFP.MP.01

Change TypeAnnual review and criteria update

Effective DateN/A

Last ReviewJun 1, 2026

Next Review DateN/A

Key ActionObtain informed consent for trial participation and make the consent documents available to the health plan upon request.

SourceLink

POLICY UPDATE CHANGES

The June 2026 annual review updated the clinical trial coverage criteria to align with Missouri Statute 376.429 for certain cancer clinical trials.

Phase II-IVClinical trial phases addressed

3Explicitly excluded routine-cost categories

6Eligible trial approval or funding pathways listed for phase III/IV trials

Enrollment required

Member eligibility condition

Qualifying Clinical Trial Coverage

General qualifying clinical trial criteria

Routine patient care costs are medically necessary when all applicable requirements are met.

General qualifying trial criteria

ALL of the following
- The costs are routine patient care costs that are otherwise generally considered medically necessary and covered for plan members or enrollees.
- The clinical trial is for the prevention, early detection, or treatment of cancer.
- Documentation shows that equal or superior non-investigational treatment alternatives exist and that available clinical or pre-clinical data provide a reasonable expectation that the trial treatment will be superior to the non-investigational alternatives.
- The member or enrollee is enrolled in the clinical trial.
  Following a phase II clinical trial protocol without actually being enrolled does not satisfy this requirement.

Phase III or IV clinical trial

For phase III or IV trials, all of the following must be met.

Phase III or IV eligibility

The clinical trial is phase III or IV for the prevention, early detection, or treatment of cancer.Phase III or IV
The trial is approved or funded by ONE of the following
- The National Institutes of Health (NIH).
- An NIH cooperative group or center.
- The Food and Drug Administration (FDA) through an investigational new drug application.

Phase II clinical trial

For phase II trials, all of the following must be met.

Phase II eligibility

The clinical trial is phase II and is sanctioned by the National Institutes of Health (NIH) or National Cancer Institute (NCI).Phase II
The trial is conducted at an academic center or National Cancer Institute Center.
The individual is enrolled in the clinical trial.
Following a phase II clinical trial protocol without actually being enrolled does not satisfy this requirement.

Covered routine patient care costs

Covered routine patient care costs include the following services when they are otherwise medically necessary and covered.

Covered routine patient care services

Drugs and devices approved for sale by the Food and Drug Administration (FDA), regardless of whether the FDA approved them for use in treating the member's particular condition.
Reasonable and medically necessary services needed to administer the trial drug or use the device under evaluation in the clinical trial.
Other items and services that are otherwise generally available and provided in the clinical trial.

The investigational item or service itself is excluded from coverage. Routine patient care coverage does not extend to the drug, device, procedure, or other service being evaluated in the clinical trial.

Items and services provided solely to meet data collection or analysis requirements are excluded when they are not used in the direct clinical management of the member or patient.

Items and services that the research sponsor customarily provides free of charge to any member or enrollee participating in the trial are excluded from coverage.

Documentation and Coverage Conditions

Documentation Required

Alternative Treatment and Supporting Data

Document that equal or superior non-investigational treatment alternatives exist and that available clinical or pre-clinical data provide a reasonable expectation that the investigational treatment will be superior to those alternatives.

Include the supporting clinical or pre-clinical data in the trial coverage documentation.

Documentation Required

Informed Consent Required

Obtain the member’s informed consent for participation in the clinical trial in a manner consistent with current legal and ethical standards. Make the consent documentation available to the health plan upon request.

Retain documentation of informed consent.
Provide the documentation to Ambetter Nevada upon request.

Documentation Required

Policy Scope

This policy addresses coverage of routine patient care costs for members enrolled in qualifying phase II, III, or IV clinical trials for cancer prevention, early detection, or treatment. Covered costs generally include medically necessary services otherwise available to plan members, including FDA-approved drugs or devices and services needed to administer or use the trial drug or device. The investigational item or service itself, research-only data collection or analysis, and sponsor-provided free services are excluded.

Key Terms

Cooperative Group

DefinitionA formal network of facilities that collaborate on research projects and have an established NIH-approved Peer Review Program operating within the group.

Included programsThe NCI Clinical Cooperative Group and the NCI Community Clinical Oncology Program are included.

Multiple Project Assurance Contract

DefinitionA contract between an institution and the federal Department of Health and Human Services (DHHS).

PurposeDefines the institution's relationship with the DHHS and sets out the institution's responsibilities and procedures for protecting human subjects.

Routine Patient Care Costs

Policy Summary

PayerAmbetter Nevada

PolicyClinical Trial Coverage

Policy CodePolicy MO.IFP.MP.01

Change TypeAnnual review and criteria update

Effective DateN/A

Last ReviewJun 1, 2026

Next Review DateN/A

Key ActionObtain informed consent for trial participation and make the consent documents available to the health plan upon request.

SourceLink

On This Page

The federal Department of Veterans' Affairs or Department of Defense.

An institutional review board in the state with an appropriate assurance approved by the Department of Health and Human Services for compliance with and implementation of regulations protecting human subjects under 45 CFR 46.

A qualified research entity that meets the criteria for NIH Center support grant eligibility.

Institutional Review Board Trial Listing

For a clinical trial approved by an institutional review board under this policy, the entity seeking coverage must maintain and electronically post a list of qualifying clinical trials. If electronic posting is not practical, periodically provide payers and providers in Nevada with a written list.

List the phase for which the trial is approved.
Identify the entity approving the trial.
Identify the particular disease.
State the number of trial participants.

Denial Risk

Excluded Trial Costs

Routine patient care costs may be covered when otherwise medically necessary and covered under the plan, but the following trial-related costs are excluded and may be denied.

The investigational item or service itself.
Items and services provided solely to satisfy data-collection or analysis needs and not used in the direct clinical management of the member.
Items and services customarily provided free of charge by the research sponsor to any member in the trial.
For phase II trials, coverage may be limited to treatment facilities within the plan’s provider network, subject to applicable network-sufficiency requirements.

Denial Risk

Actual Trial Enrollment Required

Coverage of routine patient care costs requires actual enrollment in the clinical trial. A member who only follows the protocol of a phase II trial without being enrolled does not qualify under this provision.

Verify and document the member’s enrollment in the trial before requesting coverage.
Do not assume protocol participation alone establishes eligibility.

Documentation Required

Clinical Trial Qualification Requirements

Confirm and document that the clinical trial satisfies the applicable qualification pathway before seeking coverage of routine patient care costs.

For cancer prevention, early detection, or treatment, the trial must be Phase III or IV and approved or funded by the NIH; an NIH cooperative group or center; the FDA through an investigational new drug application; the federal Department of Veterans Affairs or Department of Defense; an institutional review board in Nevada with an appropriate Department of Health and Human Services assurance for compliance with 45 CFR 46; or a qualified research entity meeting NIH Center support grant eligibility criteria.
A Phase II trial must be sanctioned by the NIH or National Cancer Institute and conducted at an academic center or National Cancer Institute Center.
Document the applicable approval or funding source and the trial phase.

DefinitionReasonable and medically necessary services needed to administer the drug or device under evaluation in the clinical trial.

Included servicesAll items and services otherwise generally available and provided in the clinical trial.

Excluded costThe investigational item or service itself.

Excluded costItems and services provided solely to satisfy data collection and analysis needs that are not used in the direct clinical management of the patient.

Excluded costItems and services customarily provided by the research sponsors free of charge for any member or enrollee in the trial.