CurrentUnitedHealthcarePolicy MMP393.05

Experimental Procedures and Items, Investigational Devices, and Clinical Trials

Defines UnitedHealthcare Medicare Advantage policy for coverage of experimental/investigational items and participation in clinical trials, including IDE Category A and B, Coverage with Evidence Development (CED), payment responsibility for Routine Care Items and Services, and related Medicare-aligned billing rules for MA members.

Policy Summary

PayerUnitedHealthcare

PolicyExperimental Procedures and Items, Investigational Devices, and Clinical Trials

Policy CodePolicy MMP393.05

Change TypeClarifications & Additions

Effective DateApr 1, 2026

Next Review Date

Key ActionIf providers submit bills with clinical trial codes to UnitedHealthcare, UnitedHealthcare will return the bill and instruct the provider to send the bill to the appropriate Medicare Administrative Contractor (MAC).

POLICY UPDATE CHANGES

Added language indicating MAO is responsible for payment of claims related to members' participation in both Category A and B IDE studies covered by the MAC with jurisdiction over the MA plan's service area.

Clarified that MAO is responsible for payment of Routine Care Items and Services in CMS-approved Category A and B IDE studies and MAO is responsible for CMS-approved Category B devices.

Added language that in NCDs requiring CED, Medicare covers items and services in CMS-approved CED studies and MAO is responsible for payment unless the significant cost threshold is exceeded.

Replaced prior phrasing to consistently state that MACs will directly pay providers for routine services associated with a qualified clinical trial furnished to a UnitedHealthcare Medicare member.

Added definitions for Category A Device, Category B Device, Coverage with Evidence Development (CED), and Investigational Device Exemption (IDE).

Archived previous policy version MMP393.04.

Coverage Summary

This policy (Policy Number MMP393.05, effective April 1, 2026; last review/committee approval March 11, 2026) defines UnitedHealthcare Medicare Advantage (MA) coverage and payment responsibilities for investigational devices and clinical trials. It aligns MA payment and coverage rules with Medicare guidance for Investigational Device Exemption (IDE) studies (Category A and B), Coverage with Evidence Development (CED), routine care costs for Medicare‑approved clinical trials, and billing rules consistent with Medicare Claims Processing instructions. The policy clarifies MA Organization (MAO) responsibilities for payment of routine care items and services and for CMS‑approved Category B devices, and explains provider billing procedures (including use of MACs for covered clinical trial services).

Key Policy Facts

Effective DateApril 1, 2026

Last ReviewMarch 11, 2026

Policy NumberMMP393.05

Coverage Stancemixed

Scope SummaryDefines UnitedHealthcare Medicare Advantage policy for coverage of experimental/investigational items and participation in clinical trials, including IDE Category A and B, Coverage with Evidence Development (CED), payment responsibility for Routine Care Items and Services, and related Medicare-aligned billing rules for MA members.

Significant Cost ThresholdRefer to 42 CFR 422.109

Coverage / Medical Necessity Criteria

General Coverage Rationale

Covered or not covered when the following conditions apply:

Experimental and investigational procedures, items, and medications are considered not Reasonable and Necessary.
Investigational Device Exemption (IDE) studies are only covered when the Medicare coverage requirements are met.
Routine costs associated with Medicare approved clinical trials are Medicare's financial responsibility.

refIdForCriteriaGroupActuallyShouldBeRefButNameIsRefInSchemaPleaseEchoRefExactlyRefShouldMatchInputRef_but_field_name_is_ref_b1_0_which_must_be_exact_here_because_instructions_say_echo_the_block_s_ref_EXACTLY_ref_b1_0_is_the_requested_ref_but_output_field_required_is_ref_so_using_ref_b1_0_as_key_name_is_invalid_but_per_instructions_provide_ref_field_below_is_missing_ref_field_due_to_schema_limitation_relaxing_this_note_to_meet_instructions":"b1_0

Codes and Referenced Regulations

Referenced Manuals and Regulations (informational)mixed

42 CFR § 405 Subpart B	IDE regulations referenced for Category A/B device definitions and CMS IDE review process
42 CFR 422.109	Regulation referenced regarding significant cost threshold for MAO payment responsibility
NCD 310.1	NCD for Routine Costs in Clinical Trials (referenced)

Supporting references include Medicare source materials: Medicare Benefit Policy Manual, Chapter 14 §20 (FDA‑Approved IDE Studies); Medicare Claims Processing Manual, Chapter 32 (IDE studies and billing for covered clinical trial services, including §68 and §69.9); Medicare Managed Care Manual, Chapter 4 §10.7.x (payment for IDE studies and CED); and Medicare Program Integrity Manual, Chapter 13 §13.5.4, along with National Coverage Determination NCD 310.1 for routine costs in clinical trials.

Provider Actions & Billing Rules

Billing Rule

Submit clinical trial routine service claims to MAC

If a provider submits bills with clinical trial codes to UnitedHealthcare, UnitedHealthcare will return the bill and instruct the provider to send the bill to the appropriate Medicare Administrative Contractor (MAC). MACs will directly pay providers for routine services associated with a qualified clinical trial in accordance with applicable Medicare fee-for-service rules; see Medicare Claims Processing Manual, Chapter 32, §69.9 for billing/processing fee-for-service claims for covered clinical trial services furnished to managed care enrollees.

UnitedHealthcare will return bills with clinical trial codes and direct providers to the appropriate MAC.
MACs directly pay providers for routine services associated with qualified clinical trials per Medicare rules.

Documentation Required

Member/provider notification for cost-sharing reimbursement

Definitions & Background

Background: This policy aligns UnitedHealthcare MA rules with Medicare guidance. It restates that experimental and investigational items are generally not Reasonable and Necessary and that IDE studies are covered only when Medicare coverage requirements are met. The policy defines Category A (experimental) and Category B (nonexperimental/investigational) devices per 42 CFR §405 Subpart B and explains that CMS will not approve Category A devices for coverage, though CMS‑approved Category A IDE studies allow coverage of routine care items and services (but not the device). For Category B IDE studies, CMS approval permits coverage of the device and routine care items and services; the MAO is responsible for payment of claims for member participation and for CMS‑approved Category B devices when the MAC with jurisdiction covers the study. The policy also covers CED: in NCDs requiring CED, Medicare covers items and services in CMS‑approved CED studies and MAOs are responsible for payment unless the significant cost threshold in 42 CFR 422.109 is exceeded. Routine costs and billing rules mirror Medicare practice: MACs directly pay providers for routine services associated with qualified clinical trials, UnitedHealthcare returns bills with clinical trial codes to providers and directs them to the appropriate MAC, and Medicare covers routine costs and Reasonable and Necessary services to diagnose/treat complications from qualifying clinical trials.

Term	Definition
Category A (Experimental) Device	A device for which 'absolute risk' of the device type has not been established and the FDA is unsure whether the device type can be safe and effective. (42 CFR §405 Subpart B).
Category B (Nonexperimental/Investigational) Device	A device for which the incremental risk is the primary risk in question or device type is known to be safe/effective (e.g., other manufacturers have obtained FDA clearance/approval). (42 CFR §405 Subpart B).
Coverage with Evidence Development (CED)	A pathway whereby Medicare covers items and services on condition they are furnished in approved clinical studies or with collection of additional clinical data; used in NCDs requiring CED. (Medicare Coverage with Evidence Development).
Investigational Device Exemption (IDE)	An FDA-approved IDE application permitting a device to be shipped lawfully for clinical study purposes per 21 U.S.C. 360j(g) and 21 CFR part 812; see 42 CFR §405 Subpart B.
Routine Care Items and Service	Items and services generally available to Medicare beneficiaries that are furnished during a clinical study and would be furnished even if the beneficiary were not enrolled in the study. (Medicare Benefit Policy Manual, Chapter 14 §20).
Reasonable and Necessary	Item/service considered Reasonable and Necessary if safe and effective, not experimental/investigational (with specific exception for routine costs of qualifying clinical trials), appropriate in duration/frequency, furnished per accepted standards, in appropriate setting, ordered/furnished by qualified personnel, meets but does not exceed medical need, and at least as beneficial as existing alternatives. (Medicare Program Integrity Manual, Chapter 13 §13.5.4).

Medicare Determinations / NCDs

Name	Number	Type	Effective Date
Routine Costs in Clinical Trials	310.1	NCD

Revision History

2026-04-01addedLatest

Added language indicating the MAO is responsible for payment of claims related to members' participation in both Category A and B IDE studies covered by the MAC with jurisdiction over the MA plan's service area.

2026-04-01revised

Clarified that the MAO is responsible for payment of Routine Care Items and Services in CMS-approved Category A and Category B IDE studies and that the MAO is responsible for CMS-approved Category B devices; added instruction to refer to Medicare Claims Processing Manual, Chapter 32, §69.9 for billing and processing fee-for-service claims for covered clinical trial services furnished to managed care enrollees.

2026-04-01

Policy Summary

PayerUnitedHealthcare

PolicyExperimental Procedures and Items, Investigational Devices, and Clinical Trials

Policy CodePolicy MMP393.05

Change TypeClarifications & Additions

Effective DateApr 1, 2026

Next Review Date

On This Page

Investigational Device Exemption (IDE) Studies - Category A (Experimental)

Coverage and payment responsibilities for Category A IDE studies:

Investigational Device Exemption (IDE) - Category A (Experimental)

Category A definition: Category A device: Device type where absolute risk not established; FDA unsure whether device type can be safe and effective.
(42 CFR §405 Subpart B)
CMS approval and coverage: CMS will not approve Category A devices because they are statutorily excluded from coverage.
An approval for a Category A IDE study allows coverage of Routine Care Items and Services furnished in the study, but not of the Category A device.
MAO payment responsibility: 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.

Investigational Device Exemption (IDE) Studies - Category B (Nonexperimental/Investigational)

Coverage and payment responsibilities for Category B IDE studies:

Investigational Device Exemption (IDE) - Category B (Nonexperimental/Investigational)

Category B definition: Category B device: Device type for which incremental risk is the primary risk question or device type is known to be safe/effective (e.g., other manufacturers obtained FDA clearance/approval).
(42 CFR §405 Subpart B)
Coverage upon approval: Approval for a Category B IDE study allows coverage of the Category B device and the Routine Care Items and Services in the trial.
MAO payment responsibility: MAOs are responsible for payment of claims related to members' participation in Category B IDE studies that are covered by the MAC with jurisdiction over the MA plan's service area; MAO is responsible for Routine Care Items and Services and for CMS-approved Category B devices.

Coverage with Evidence Development (CED) / Clinical Trials

Coverage in NCDs requiring CED and related MAO responsibilities:

CED coverage: In NCDs requiring CED, Medicare covers items and services in CMS-approved CED studies.
MAO payment responsibility and significant cost threshold: MAOs are responsible for payment of items and services in CMS-approved CED studies unless CMS determines that the significant cost threshold is exceeded for that item or service (refer to 42 CFR 422.109).42 CFR 422.109
Administrative details: Approved CED studies are posted on the CMS Coverage with Evidence Development webpage; billing instructions are issued for each NCD.

Routine Costs and Billing for Medicare-Approved Clinical Trials

Rules governing payments and member cost-sharing for qualified clinical trials:

MAC payment to providers: MACs will directly pay providers for routine services associated with a qualified clinical trial furnished to a UnitedHealthcare Medicare member, in accordance with applicable Medicare fee-for-service rules.
Medicare MACs make payments on behalf of MA organizations directly to providers of covered routine services associated with a qualified clinical trial.
Billing to MACs: If UnitedHealthcare receives a bill with clinical trial codes, these bills will not be paid but will be returned to the provider with instruction to send the bill to the appropriate MAC.
Refer to Medicare Claims Processing Manual, Chapter 32, §69.9 for billing and processing fee-for-service claims for covered clinical trial services furnished to managed care enrollees.
Member deductibles and coinsurance: The member is not responsible for meeting either Part A or Part B deductibles for routine services obtained through qualified clinical trials; the member is liable for coinsurance amounts applicable under traditional Medicare rules.

Complications Arising From Participating in Qualifying Clinical Trials

Coverage for complications from trial participation:

Coverage of routine costs and complications: Medicare covers routine costs of qualifying clinical trials for all Medicare members including MA enrollees, and Reasonable and Necessary items and services used to diagnose and treat complications arising from participating in qualifying clinical trials.
The Clinical Trial NCD defines routine costs and clarifies when items and services are Reasonable and Necessary; all other Medicare rules apply.

Cost Sharing Reconciliation for Clinical Trials

MAO obligations regarding cost-sharing differences:

MAO payment of difference: MAOs pay the member the difference between original Medicare cost-sharing incurred for qualified clinical trial items and services and the MA plan's in-network cost-sharing for the same category of items and services; applies to all qualifying clinical trials.
Scope and timing of obligation: MAOs may not choose which clinical trials/items this applies to and owe the difference even if the member has not yet paid the clinical trial provider.
OOP maximum inclusion: The member's in-network cost-sharing portion must be included in the plan's out-of-pocket maximum calculation.
Member notification and documentation: To be eligible for reimbursement, members (or providers on their behalf) must notify their plan that they have received qualified clinical trial services and provide documentation of the cost-sharing incurred, such as a provider bill. MAOs may seek original Medicare cost-sharing information directly from clinical trial providers.

Prior Authorization

No UnitedHealthcare prior authorization required for Medicare-approved trials

UnitedHealthcare MA Plans do not require prior authorization to determine if a clinical trial is Medicare‑approved. Members should be directed to call 1‑800‑MEDICARE to determine Medicare approval and for additional clinical trial information.

No UnitedHealthcare prior authorization required to determine Medicare approval of clinical trials.
Members should call 1-800-MEDICARE for approval status and information.

Documentation Required

Follow member-specific benefit plan

Providers must consult the member-specific benefit plan document to determine covered services, exclusions, and limitations. In the event of a conflict, the member-specific plan document supersedes this policy; contact the customer service number on the member ID card or refer to the Administrative Guide for plan details.

Check the member-specific benefit plan for coverage, exclusions, and limitations.
Member-specific plan governs if there is a conflict with this policy.

Prior Authorization

Follow delegate prior authorization requirements when applicable

For UnitedHealthcare MA plans where a delegate manages utilization management and prior authorization, providers must follow the delegate's prior authorization and utilization management requirements.

Follow delegate prior authorization requirements when the delegate manages UM/PA for the member's plan.

Documentation Required

Submit accurate claims using CPT/CMS coding guidelines

Providers are responsible for submission of accurate claims and should use CPT, CMS, or other coding guidelines referenced by UnitedHealthcare. References to coding sources are for definitional purposes only and do not guarantee payment.

Use CPT, CMS, or other coding guidelines when submitting claims.
Accurate submission does not guarantee payment; references are definitional.