CurrentUnitedHealthcarePolicy MMP393.04

Experimental Procedures and Items, Investigational Devices, and Clinical Trials

This policy governs coverage determinations for experimental/investigational procedures, items, and devices and UnitedHealthcare Medicare Advantage responsibilities for Medicare-approved clinical trials and IDE/CED studies affecting Medicare Advantage members.

Policy Summary

PayerUnitedHealthcare

PolicyExperimental Procedures and Items, Investigational Devices, and Clinical Trials

Policy CodePolicy MMP393.04

Change TypeRegulatory update and additions

Effective DateMay 1, 2025

Next Review Date

Key ActionSubmit clinical trial claims to the appropriate Medicare Administrative Contractor (MAC); no UnitedHealthcare prior authorization is required for Medicare‑approved clinical trials.

SourceLink

POLICY UPDATE CHANGES

Added reference link to the Medicare Claims Processing Manual, Chapter 32, §68 - Investigational Device Exemption (IDE) Studies.

Revised notation pertaining to jurisdiction for coverage of IDE studies to reflect CMS regulatory changes (42 CFR § 405 Subpart B) and centralized review/approval of IDE studies.

Added instruction to refer to the National Coverage Determination (NCD) for Routine Costs in Clinical Trials (NCD 310.1) for Medicare coverage information on clinical trials.

Category ACategory A

Category BCategory B

CMS centralized IDE reviewRegulatory change

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Routine costs paid by MACs

Coverage Determinations and Study Categories

Coverage Rules and Study Categories

Covered when the following conditions and study-specific rules are met:

General coverage rule: Experimental and investigational procedures, items, and medications are considered not Reasonable and Necessary and are not covered.

IDE study coverage by category

Category A (Experimental): MAOs are 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; the Category A device itself remains statutorily excluded from coverage.
Category B (Nonexperimental/Investigational): MAOs are responsible for payment of Routine Care Items and Services in CMS-approved Category B IDE studies and are also responsible for payment of CMS-approved Category B devices.

Coverage with Evidence Development (CED): In NCDs requiring Coverage with Evidence Development (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.

Clinical trials — routine costs and complications: Medicare covers routine costs of qualifying clinical trials for all Medicare members, including MA enrollees, and covers Reasonable and Necessary items and services to diagnose and treat complications arising from participation in qualifying clinical trials.

Billing/payment for MA members in clinical trials: Medicare Administrative Contractors (MACs) will directly pay providers for covered clinical trial services furnished to UnitedHealthcare Medicare members; Medicare payments for covered clinical trial services for MA members are handled per Medicare guidance.

Category A devices are statutorily excluded from coverage. Although Medicare may approve a Category A IDE study such that the Medicare Advantage Organization (MAO) is responsible for payment of Routine Care Items and Services furnished in that CMS‑approved Category A study, the Category A device itself remains excluded from coverage and will not be approved for payment.

Items, procedures, and medications determined to be experimental or investigational are considered not Reasonable and Necessary and therefore are not covered. When a service is characterized as experimental or investigational, the appropriate denial rationale is that the item or service is not Reasonable and Necessary due to its experimental or investigational status.

Clinical Trial and IDE Coding / Regulatory Dates

Clinical Trial Billing Guidancemixed

N/A	Clinical trial billing handled by MACs; bills with clinical trial codes sent to MACs rather than UnitedHealthcare Medicare.

Regulatory effective date

Regulation and citation42 CFR §405 Subpart B

Effective dateJanuary 1, 2015

Operational changeChanged IDE review from local MACs to centralized CMS review and approval

Coverage implication notedCMS added criteria for coverage of IDE studies; approvals permit coverage of Routine Care Items and Services (Category A) and permit coverage of Category B device and Routine Care Items and Services (Category B)

Provider Billing, Authorization, and Documentation Requirements

Prior Authorization

Clinical Trial Billing and Prior Authorization

Medicare-approved clinical trials: No UnitedHealthcare Medicare Advantage prior authorization is required. Medicare Administrative Contractors (MACs) pay providers directly for routine costs associated with qualified clinical trials. If UnitedHealthcare receives a clinical trial bill, it will be returned and the provider will be directed to bill the appropriate MAC.

Member not responsible for Part A/B deductibles for routine clinical trial services
Member remains responsible for applicable coinsurance under Medicare FFS when participating in a qualified trial
Providers should bill the Medicare MAC — UnitedHealthcare MA will not pay clinical trial codes

Documentation Required

Documentation Retention

Providers should retain and be prepared to produce documentation that supports medical necessity, coverage determinations, and claim accuracy when requested by UnitedHealthcare or auditors. This includes medical records, trial enrollment documentation, informed consent forms, and billing records showing the services rendered.

Policy Background and Medicare IDE Categories

Medicare classifies IDE studies into categories that determine coverage. A Category A (experimental) IDE device is one for which absolute risk and safety/effectiveness have not been established; CMS will not approve Category A devices for coverage. If CMS approves a Category A IDE study, Medicare (and the MAO for MA members) is responsible for payment of the study's Routine Care Items and Services, but the Category A device itself remains statutorily excluded from coverage. By contrast, CMS approval of a Category B (nonexperimental/investigational) IDE study allows coverage of both the Category B device and the Routine Care Items and Services in the trial. In all cases, investigational or experimental items and services that do not meet Medicare coverage requirements are considered not Reasonable and Necessary and are not covered.

Key Definitions

Routine Care Items and Service

DefinitionItems and services otherwise generally available to Medicare beneficiaries that are furnished during a clinical study and that would be furnished even if the beneficiary were not enrolled in the study (i.e., a benefit category exists and it is not statutorily excluded).

ScopeIncludes services that would be provided absent trial participation; excludes items that are statutorily excluded or subject to a national noncoverage decision.

Reference manualMedicare Benefit Policy Manual, Chapter 14, §20 (FDA‑Approved IDE Studies)

ApplicationRoutine care costs in qualifying clinical trials are covered by Medicare when requirements of the Clinical Trials NCD are met and per CMS guidance.

Reasonable and Necessary

Core definition

Policy Summary

PayerUnitedHealthcare

PolicyExperimental Procedures and Items, Investigational Devices, and Clinical Trials

Policy CodePolicy MMP393.04

Change TypeRegulatory update and additions

Effective DateMay 1, 2025

Next Review Date

Key ActionSubmit clinical trial claims to the appropriate Medicare Administrative Contractor (MAC); no UnitedHealthcare prior authorization is required for Medicare‑approved clinical trials.

SourceLink

On This Page

Keep documentation for the duration required by state and federal law and UnitedHealthcare contractual requirements
Provide supporting records promptly upon request to avoid claim denials or recoupments

Denial Risk

Denial Risk for Experimental/Investigational Services

Items, procedures, or medications considered Experimental or Investigational are not Reasonable and Necessary and are subject to denial. Providers should verify coverage status and submit supporting clinical evidence when services may be considered experimental.

Denials may occur if an item/procedure is classified as experimental/investigational
IDE studies covered only when Medicare coverage requirements are met
When uncertain, providers should document rationale and clinical evidence demonstrating accepted medical practice

Note

Provider Guidance / Next Steps

Provider next steps: verify member-specific benefits and plan documents, confirm whether a clinical trial is Medicare-approved (call 1-800-MEDICARE), bill the appropriate Medicare MAC for qualified clinical trial routine costs, and maintain complete documentation to support any coverage determinations.

Confirm Medicare approval of the trial via 1-800-MEDICARE or CMS resources
If billed to UnitedHealthcare in error, expect the bill to be returned with instructions to resubmit to the MAC
Retain enrollment, consent, and clinical documentation to support claims

An item or service is Reasonable and Necessary when it is safe and effective, not experimental or investigational (with specified clinical trial exceptions), and appropriate in duration, frequency, setting, provider qualifications, and at least as beneficial as alternatives.

Clinical trial exceptionRoutine costs of qualifying clinical trial services with dates of service on or after September 19, 2000 that meet the Clinical Trials NCD requirements are considered Reasonable and Necessary.

Appropriateness criteriaIncludes furnished in accordance with accepted standards of medical practice, appropriate setting, ordered and furnished by qualified personnel, meets but does not exceed medical need.

Source guidanceMedicare Program Integrity Manual, Chapter 13, §13.5.4 and Medicare Benefit Policy Manual references