CurrentUnitedHealthcarePolicy MMP393.05

Experimental Procedures and Items, Investigational Devices, and Clinical Trials

Defines UnitedHealthcare Medicare Advantage policy on coverage of experimental/investigational procedures, Investigational Device Exemption (IDE) studies (Category A and B), Coverage with Evidence Development (CED) clinical studies, payment responsibilities for routine costs and devices, and MAO obligations for member cost-sharing related to clinical trials.

Policy Summary

PayerUnitedHealthcare

PolicyExperimental Procedures and Items, Investigational Devices, and Clinical Trials

Policy CodePolicy MMP393.05

Change TypeRevised (clarifications & additions)

Effective DateApr 1, 2026

Next Review Date

Key ActionIf a bill includes clinical trial codes for routine services associated with a qualified clinical trial, UnitedHealthcare will return the bill and instruct the provider to submit 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.

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

Replaced wording to specify MACs will directly pay providers for routine services associated with a qualified clinical trial (rather than clinical trial services generally).

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 & Scope

Policy MMP393.05 (Status: CURRENT) defines UnitedHealthcare Medicare Advantage coverage for experimental and investigational procedures, investigational devices, and clinical trials. Experimental/investigational items are not Reasonable and Necessary except when coverage requirements for qualifying Medicare-approved clinical trials or Investigational Device Exemption (IDE) studies are met. The policy applies to Medicare Advantage (MA) plans and aligns with CMS manuals, NCD/LCD guidance, and Medicare claims rules.

UnitedHealthcare (MAO) responsibility: MAOs are responsible for payment of claims related to members' participation in both Category A (Experimental) and Category B (Nonexperimental/Investigational) IDE studies that are covered by the Medicare Administrative Contractor (MAC) with jurisdiction over the MA plan's service area, including payment of Routine Care Items and Services furnished in CMS‑approved Category A and Category B IDE studies. MAOs are also responsible for payment of CMS‑approved Category B devices. CMS will not approve Category A devices because they are statutorily excluded from coverage.

Coverage with Evidence Development (CED) and NCDs: In NCDs requiring CED, Medicare covers items and services in CMS‑approved CED studies; the MAO is responsible for payment of items and services in CMS‑approved CED studies unless CMS determines the significant cost threshold for an item or service is exceeded (see 42 CFR 422.109).

Routine clinical trial costs and member liabilities: Medicare (via MACs) typically pays routine costs associated with qualifying clinical trials on a fee‑for‑service basis for MA members; MAOs must reimburse members for the difference between original Medicare cost‑sharing and the MA plan's in‑network cost‑sharing when applicable. Members remain liable for coinsurance amounts under traditional Medicare rules for services paid under those rules.

Policy dates and quick facts

EffectiveApril 1, 2026

Last reviewMarch 11, 2026

Next review

Policy numberMMP393.05

Plan scopeApplies to Medicare Advantage

Policy typeInformational

Coverage Criteria and Operational Conditions

General Coverage Rationale

Covered when ALL of the following are met:

ALL of the following

Items, procedures, and medications that are experimental and investigational are considered not Reasonable and Necessary
Routine costs associated with Medicare-approved clinical trials are the financial responsibility of Medicare (MACs)
IDE study categories
- Category A (Experimental) IDE studies: 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 (statutorily excluded)

Actions Providers Must Take

Billing Rule

Submit clinical trial routine costs to MACs

If a bill includes clinical trial codes for routine services associated with a qualified clinical trial, UnitedHealthcare will return the bill and instruct the provider to submit to the appropriate Medicare Administrative Contractor (MAC); MACs will directly pay providers for these routine services.

Documentation Required

Notification and documentation for member reimbursement

Members or providers must notify the plan that qualified clinical trial services were received and provide documentation (e.g., provider bill) to be eligible for reimbursement of the difference in cost-sharing; MAOs may request original Medicare cost-sharing info from trial providers.

Coding and Billing Groupings

Clinical trial billing handling (operational)mixed

No codes listed

Operational note: Per Medicare instructions, Medicare Administrative Contractors (MACs) will directly pay providers for routine services associated with qualified clinical trials furnished to UnitedHealthcare Medicare members. If UnitedHealthcare receives a bill that includes clinical trial codes for routine services associated with a qualified clinical trial, UnitedHealthcare will return the bill to the provider and instruct the provider to submit the claim to the appropriate MAC.

Providers should follow the provider actions: submit clinical trial routine costs to MACs and, for member reimbursement of cost‑sharing differences, ensure members or providers notify the plan and provide documentation (for example, the provider bill). UnitedHealthcare may seek original Medicare cost‑sharing information from trial providers as needed.

Background & Definitions

Background: This Medicare Advantage policy is aligned with CMS source materials, including the Medicare Benefit Policy Manual (Chapter 14 §20), the Medicare Managed Care Manual, Medicare Claims Processing Manual (Chapter 32), and NCD/LCD guidance. It reflects Medicare rules that routine costs of qualifying clinical trials are Medicare's financial responsibility and clarifies exceptions and payment pathways for IDE studies and CED—specifically the MAO payment responsibilities for routine care and certain IDE devices and the CMS fee‑for‑service processing of routine trial services for MA members.

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; initial questions of safety/effectiveness of the device type have been resolved or similar devices have FDA approval/clearance (42 CFR §405 Subpart B).
Coverage with Evidence Development (CED)
A pathway whereby Medicare covers items and services on the condition they are furnished in the context of approved clinical studies or with the collection of additional clinical data (established based on section 1862(a)(1)(E) of the Act).
Investigational Device Exemption (IDE)
An FDA-approved IDE application permitting a device to be shipped for clinical study purposes pursuant to 21 U.S.C. 360j(g) and 21 CFR part 812 (42 CFR §405 Subpart B).
Routine Care Items and Service
Items/services generally available to Medicare beneficiaries that would be furnished even if not enrolled in a clinical study (Medicare Benefit Policy Manual, Chapter 14 §20).
Reasonable and Necessary
An item/service considered safe and effective, not experimental/investigational (exceptions for qualifying clinical trials), appropriate in duration/frequency, furnished per accepted standards, in an appropriate setting, ordered/furnished by qualified personnel, meets but does not exceed medical need, and at least as beneficial as alternatives.

Medicare Coverage Determinations

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

Revision History

04/01/2026materialLatest

Added MAO responsibility for payment of claims related to members' participation in both Category A and B IDE studies and for Routine Care Items and Services in CMS‑approved Category A and B IDE studies; MAO is also responsible for CMS‑approved Category B devices; CMS will not approve Category A devices (statutory exclusion).

04/01/2026materialLatest

Added reference to 42 CFR 422.109 and clarified billing instructions per Medicare Claims Processing Manual Chapter 32 §69.9 regarding Coverage with Evidence Development (CED): in NCDs requiring CED, Medicare covers items/services in CMS‑approved CED studies and the MAO is responsible for payment unless CMS determines the significant cost threshold is exceeded.

Cost Sharing and Billing Rules for Qualified Clinical Trials

Operational requirements and payer responsibilities:

ALL of the following

MAOs pay the member the difference between original Medicare cost-sharing incurred for qualified clinical trial items/services and the MA plan's in-network cost-sharing for the same category of items/services; this applies to all qualifying clinical trials
MAO owes the difference even if the member has not yet paid the clinical trial provider
Member's in-network cost-sharing portion must be included in plan's out-of-pocket maximum calculation
To be eligible for reimbursement, members (or providers acting on their behalf) must notify their plan that they have received qualified clinical trial services and provide documentation of the cost-sharing incurred (e.g., provider bill); MAOs may seek original Medicare cost-sharing information directly from clinical trial providers
Medicare 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 provider and inform provider to send bill to appropriate MAC
Member is not responsible for meeting Part A or Part B deductibles for routine services obtained through qualified clinical trials
Member is liable for coinsurance amounts applicable to services paid under traditional Medicare rules when participating in a qualified clinical trial

ref': 'b1_1

title': 'Cost Sharing and Billing Rules for Qualified Clinical Trials

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