ModifiedUnitedHealthcarePolicy MMP393.05

Experimental Procedures and Items, Investigational Devices, and Clinical Trials

Defines UnitedHealthcare Medicare Advantage coverage stance for experimental/investigational procedures, IDE studies (Category A and B), Coverage with Evidence Development (CED) and routine costs for Medicare-approved clinical trials; affects MA plan members and provider billing for clinical trial services.

Policy Summary

PayerUnitedHealthcare

PolicyExperimental Procedures and Items, Investigational Devices, and Clinical Trials

Policy CodePolicy MMP393.05

Change TypeDefinitions addedpayment/terminology clarificationspolicy archived

Effective DateApr 1, 2026

Next Review Date

Key ActionDo not submit clinical-trial-coded bills to UnitedHealthcare; bill routine clinical trial services to the appropriate MAC and retain supporting documentation.

SourceLink

POLICY UPDATE CHANGES

The Medicare Advantage Organization (MAO) is responsible for payment of claims related to members' participation in both Category A and B IDE studies that are covered by the Medicare Administrative Contractor (MAC) with jurisdiction over the MA plan's service area.

MACs will directly pay providers for routine services associated with a qualified clinical trial furnished to a UnitedHealthcare Medicare member; UnitedHealthcare will return bills with clinical trial codes to providers and instruct them to bill the appropriate MAC.

Definitions for Category A device, Category B device, Coverage with Evidence Development (CED), and Investigational Device Exemption (IDE) were added.

Replaced references to payment for 'clinical trial services' with payment for 'routine services associated with a qualified clinical trial' in multiple policy statements.

Replaced references to 'Medicare fee-for-service rules' wording with 'traditional Medicare rules' in language about member coinsurance liability when participating in a qualified clinical trial.

Added definitions for Category A (Experimental) Device, Category B (Nonexperimental/Investigational) Device, and Coverage with Evidence Development (CED).

Added definition for Investigational Device Exemption (IDE).

Archived previous policy version MMP393.04.

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CMS-approved IDEsCMS-approved IDEs listed online

MAO pays routine careMAO pays routine care in IDE/CED

MAC direct payMAC direct pay

>=1new definitions added

1previous policy archived

Coverage Criteria and Scope

Coverage conditions and exceptions

Covered when ALL of the following conditions are met or as noted in exceptions below:

General stance: Experimental and investigational procedures, items, and medications are considered not Reasonable and Necessary.

Exceptions for Medicare-approved IDE, CED, and qualifying clinical trials are described below.

IDE Category A (Experimental): MAO is responsible for payment of Routine Care Items and Services in CMS-approved Category A IDE studies that are covered by the MAC with jurisdiction over the MA plan's service area.

CMS will not approve Category A devices for coverage (Category A device itself is statutorily excluded); approval of a Category A IDE study allows coverage only of routine care, not the device.

IDE Category B (Nonexperimental/Investigational): MAO is responsible for payment of claims related to members' participation in CMS-approved Category B IDE studies, including payment of CMS-approved Category B devices and Routine Care Items and Services furnished in the trial.

Approval of a Category B IDE study allows coverage of the Category B device and routine care items and services.

Coverage with Evidence Development (CED): In NCDs requiring CED, Medicare covers items and services in CMS-approved CED studies; MAOs are responsible for payment of items and services in CMS-approved CED studies unless CMS determines the significant cost threshold is exceeded (42 CFR 422.109).

Approved CED studies are posted on the CMS Coverage with Evidence Development webpage.

Routine costs for qualifying clinical trials: Medicare covers routine costs of qualifying clinical trials and reasonable and necessary services to diagnose and treat complications from participation; MACs will directly pay providers for routine services associated with a qualified clinical trial furnished to a UnitedHealthcare Medicare member.

If UnitedHealthcare receives a bill with clinical-trial codes it will be returned to the provider and the provider will be instructed to bill the appropriate MAC; members are not responsible for Part A or B deductibles for routine services, but remain liable for coinsurance per traditional Medicare rules.

Category A (Experimental) devices are statutorily excluded from Medicare coverage and therefore CMS will not approve Category A devices for coverage. While a CMS approval of a Category A IDE study allows coverage of routine care items and services furnished in the study, the Category A device itself remains excluded and is not covered.

Benefit coverage is determined by the member-specific benefit plan document and applicable law. If there is a conflict between this policy and the member's benefit plan document, the member-specific benefit plan document supersedes this policy. For questions about a specific member's coverage, providers should use the customer service number on the member ID card or consult the Administrative Guide.

Procedures, items, and medications that are determined to be experimental or investigational are considered not Reasonable and Necessary and are not covered, except as explicitly described for Medicare-approved IDE studies, Coverage with Evidence Development (CED), or qualifying clinical trials where Medicare requirements are met and routine costs may be payable.

Provider Billing, Documentation, and Prior Authorization

Prior Authorization

Prior Authorization Not Required for Medicare-Approved Clinical Trials

No prior authorization by UnitedHealthcare MA Plan is required for Medicare-approved clinical trials. Providers and members should be directed to 1-800-MEDICARE to confirm whether a trial is Medicare-approved.

Prior Authorization

Follow Delegate Prior Authorization When Applicable

When a delegate (e.g., contracted network or delegated entity) manages utilization management or prior authorization for a UnitedHealthcare Medicare Advantage member, providers must follow the delegate's prior authorization and UM processes. Verify delegate requirements before submitting requests to avoid denials or delays.

Denial Risk

Coverage Stance for Experimental/Investigational Items

Background and Context

Clinical trials involving devices are categorized to reflect differing levels of evidence and coverage implications. A Category A (Experimental) IDE device is one for which the absolute risk and initial questions of safety and effectiveness remain unresolved; CMS will not approve Category A devices themselves, though approval of a Category A IDE study permits coverage of the study's routine care items and services. A Category B (Nonexperimental/Investigational) IDE device is one where device-type safety/effectiveness questions have been largely resolved and incremental risk is the primary issue; CMS-approved Category B IDE studies can permit coverage of both the Category B device and routine care. Coverage with Evidence Development (CED) is a Medicare pathway that conditions coverage on furnishing the item/service in CMS-approved CED studies or collecting additional data. Medicare covers routine costs of qualifying clinical trials and reasonable and necessary services to diagnose or treat complications arising from participation; payment mechanics for routine costs follow Medicare rules referenced in this policy.

Supporting Information / Definitions

Category A (Experimental) Device — definition

DefinitionA device for which 'absolute risk' of the device type has not been established (initial questions of safety and effectiveness have not been resolved).

Regulatory reference42 CFR § 405 Subpart B (as referenced in definitions).

Coverage implicationCategory A devices are statutorily excluded from Medicare coverage; approval of a Category A IDE study allows coverage of routine care items/services but not the device itself.

Category B (Nonexperimental/Investigational) Device — definition

DefinitionA device where incremental risk is the primary question and initial questions of device-type safety and effectiveness have been resolved, or the device type is known to be safe and effective (for example, other manufacturers have FDA clearance/approval).

Regulatory reference

Policy Summary

PayerUnitedHealthcare

PolicyExperimental Procedures and Items, Investigational Devices, and Clinical Trials

Policy CodePolicy MMP393.05

Change TypeDefinitions addedpayment/terminology clarificationspolicy archived

Effective DateApr 1, 2026

Next Review Date

Key ActionDo not submit clinical-trial-coded bills to UnitedHealthcare; bill routine clinical trial services to the appropriate MAC and retain supporting documentation.

SourceLink

On This Page

Experimental, investigational, and unproven items or procedures are not considered Reasonable and Necessary and are not covered unless explicitly allowed under Medicare-approved clinical trial rules or an applicable NCD/LCD.

Documentation Required

Documentation Retention Expectation

Providers are expected to retain and make available documentation supporting medical necessity, trial participation, and billing upon request. Failure to produce required documentation may result in claim denial or recoupment.

Billing Rule

Cost-Sharing Documentation for Member Reimbursement

To support member reimbursement for cost-sharing differences related to qualified clinical trials, members or providers acting on their behalf must notify the plan and provide documentation of the original Medicare cost-sharing incurred (for example, the provider bill). UnitedHealthcare may also request original Medicare cost-sharing information directly from clinical trial providers.

Member or provider must notify the plan of qualified clinical trial services and submit documentation (e.g., provider bill).
MAO will pay the difference between original Medicare cost-sharing and the MA in-network cost-sharing; member in-network cost share counts toward OOP maximum.

Billing Rule

Billing Returned if Clinical Trial Codes Submitted to UnitedHealthcare

If UnitedHealthcare receives a bill that contains clinical trial billing codes, the bill will be returned to the provider and the provider will be instructed to submit the claim to the appropriate Medicare Administrative Contractor (MAC) for payment.

Documentation Required

Documentation and Claims Accuracy

Providers are responsible for submission of accurate claims and should ensure coding reflects whether services are associated with a qualified clinical trial. Retain or have access to supporting documentation to substantiate claims and respond to requests; inaccurate or unsupported claims may be denied.

Note

Provider Action / Billing Note

For questions about whether a trial is Medicare-approved or for additional information on clinical trials and routine cost categories, providers and members should refer to Medicare resources (NCD 310.1, CMS Clinical Trial Policies) and the Medicare Approved Facilities/Trials/Registries listings.

42 CFR § 405 Subpart B (as referenced in definitions).

Coverage implicationApproval of a Category B IDE study allows coverage of the Category B device and routine care items and services; MAOs are responsible for payment of CMS-approved Category B devices and routine care in CMS-approved Category B IDE studies.

Coverage with Evidence Development (CED) — definition

DefinitionCoverage with Evidence Development (CED) is a Medicare pathway that conditions coverage on furnishing the item/service in the context of CMS/AHRQ-reviewed and approved clinical studies or on collection of additional clinical data.

EstablishmentCED was established based on section 1862(a)(1)(E) of the Act and uses the NCD process for public notice and input.

Coverage implicationIn NCDs requiring CED, Medicare covers items/services only when furnished in CMS-approved CED studies; approved CED studies are posted on the CMS website.

Investigational Device Exemption (IDE) — definition

DefinitionInvestigational Device Exemption (IDE) is an FDA‑approved application that permits a device that would otherwise require marketing approval or clearance to be shipped lawfully for the purpose of conducting a clinical study in accordance with 21 U.S.C. 360j(g) and 21 CFR part 812.

Regulatory referenceDescribed in 42 CFR § 405 Subpart B (IDE provisions referenced in policy).

Coverage implicationCMS approval of IDE studies (Category A or B) determines whether routine care and/or the device itself may be covered as described in IDE rules.

Category A (Experimental) Device — new definition added (policy update)

New definition addedCategory A (Experimental) Device — added to Definitions section of the policy. It denotes device types where 'absolute risk' has not been established and initial safety/effectiveness questions remain unresolved.

Policy impactSpecifies that Category A devices remain statutorily excluded from Medicare coverage; approval of a Category A IDE study allows coverage only for routine care items/services, not the device itself.

ReferenceSee CMS-approved IDE study listings on the CMS Coverage website for applicable studies and approvals.

Category B (Nonexperimental/Investigational) Device — new definition added (policy update)

New definition addedCategory B (Nonexperimental/Investigational) Device — added to Definitions section of the policy. It denotes devices where incremental risk is the primary question and device-type safety/effectiveness has been resolved or demonstrated by prior FDA approvals/clearances.

Policy impactMAOs are responsible for payment of CMS-approved Category B devices and routine care items/services in CMS-approved Category B IDE studies.

Operational noteCMS posts lists of approved Category B IDE studies on the CMS Coverage website; MAOs follow CMS determinations for payment responsibility.

Coverage with Evidence Development (CED) — new definition added (policy update)

New definition addedCoverage with Evidence Development (CED) — added to Definitions section. It conditions Medicare coverage on furnishing items/services within CMS‑approved studies or collecting additional clinical data following CMS/AHRQ review.

Policy implicationIn NCDs requiring CED, Medicare covers items/services only in CMS‑approved CED studies; MAOs are responsible for payment unless CMS determines a significant cost threshold is exceeded per regulation (42 CFR 422.109).

Public noticeCED determinations use the NCD process to provide public notice and obtain input; approved CED studies are posted on CMS resources.

Investigational Device Exemption (IDE) — new definition added to Supporting Information/Definitions (policy update)

New definition added to Supporting Information/DefinitionsInvestigational Device Exemption (IDE) — added to Supporting Information/Definitions as the FDA‑approved application permitting a device to be used lawfully in a clinical study that would otherwise require marketing approval/clearance.

Regulatory citationReferenced statutory/regulatory authority: 21 U.S.C. 360j(g) and 21 CFR part 812; policy cites 42 CFR § 405 Subpart B for IDE context.

Implementation noteCMS approval of IDE studies (Category A or B) determines coverage of routine care and/or the device itself per IDE rules; MAOs follow CMS determinations for payment responsibility.