ModifiedEmblemHealthPolicy N/A

Coverage of routine costs in clinical trials

Defines EmblemHealth coverage position on routine costs associated with qualified clinical trials, aligning with the CMS Medicare NCD for Routine Costs in Clinical Trials, including what routine costs are covered, qualifications for eligible trials, and explicit exclusions/limitations.

Policy Summary

PayerEmblemHealth

PolicyCoverage of routine costs in clinical trials

Policy CodePolicy N/A

Change TypeMaterial revision

Effective Date

Next Review Date

Key ActionSubmit clinical evidence that the member meets criteria to enable EmblemHealth review for preauthorization or post-payment review and confirm the trial meets Medicare NCD criteria or is a CMS‑approved Category B IDE when seeking coverage.

SourceLink

POLICY UPDATE CHANGES

Added language clarifying that Category B devices integral to CMS-approved Category B Investigational Device Exemption (IDE) trials are covered.

1Primary Coverage Position (routine costs covered when trial qualifies)

7Automatically Qualified Trial Funding Sources Listed

7Explicit Routine Cost Exclusions Listed

Coverage Summary

This policy aligns EmblemHealth coverage with the CMS Medicare National Coverage Determination (NCD) for Routine Costs in Clinical Trials to encourage Medicare beneficiary participation by covering routine costs of qualified clinical trials. It adopts the NCD's intent to assure beneficiaries that routine medical costs associated with qualifying trials will be covered, which is expected to increase trial participation and accelerate development of new treatment options.

Quick Facts

Primary Coverage PositionRoutine costs covered when trial qualifies (per Medicare NCD)

Automatically Qualified Trial Funding Sources ListedNIH, CDC, AHRQ, CMS, DOD, VA, centers/cooperative groups funded by the above (7 listed)

Explicit Routine Cost Exclusions Listed7 exclusions (investigational item unless integral to CMS Category B IDE; items with no Medicare benefit category; statutorily excluded items; national non-coverage; data-collection-only services; sponsor-provided items; experimental/investigational procedures/equipment/medications)

Last Review2026-05-12

Has Material Changetrue (Revision May 9, 2025 added Category B IDE device coverage language)

Medical-Necessity / Qualification Criteria

General Coverage Position

EmblemHealth covers routine costs of a qualified clinical trial when ALL of the following are met:

ALL of the following

The clinical trial is a Qualified Clinical Trial as defined by the Medicare NCD (falls into a deemed category or otherwise meets qualifying criteria).
The subject or purpose of the trial evaluates an item or service that falls within a Medicare benefit category and is not statutorily excluded (e.g., not cosmetic).
The trial has therapeutic intent and is not designed solely to test toxicity or pathophysiology.
Trials of therapeutic interventions enroll patients with diagnosed disease (diagnostic trials may enroll healthy volunteers as appropriate).
The trial has desirable characteristics (appropriate design, scientifically/medically supported, non-duplicative, credible sponsor, compliance with federal human subjects protections, and conducted with scientific integrity).

Automatically Qualified Trial Categories

Trials in the following categories are considered automatically qualified (ANY of):

ANY of the following

Trials funded by the National Institutes of Health (NIH).
Trials funded by the Centers for Disease Control and Prevention (CDC).
Trials funded by the Agency for Healthcare Research and Quality (AHRQ).
Trials funded by the Centers for Medicare & Medicaid Services (CMS).
Trials funded by the Department of Defense (DOD).

Covered Routine Costs

EmblemHealth covers the following routine costs when trial qualifies:

ANY of the following

Items or services that would typically be provided absent a clinical trial (medically necessary conventional care).
Items and services required for provision of the investigational item or service (e.g., administration of a non-covered chemotherapeutic agent).
Items and services required for clinically appropriate monitoring of the effects of the investigational item/service or prevention of complications.
Items and services medically necessary for diagnosis or treatment of complications arising from the investigational item or service.
Category B IDE devices integral to CMS-approved Category B IDE trials (added language in revision).

Routine Costs NOT Covered (Exclusions/Limitations)

Routine costs do NOT include the following (ANY of):

ANY of the following

Experimental or investigational procedures, equipment and medications not covered by Fee-for-Service Medicare or covered under clinical trials.
The investigational item or service itself, unless integral to a CMS-approved Category B IDE trial or covered outside the trial.
Items and services for which there is no Medicare benefit category.
Items and services which are statutorily excluded.
Items and services that fall under a national non-coverage policy.

Provider Actions & Documentation

Documentation Required

Submit clinical evidence for preauthorization / review

The treating physician or primary care provider must submit clinical evidence that the member meets the criteria for the treatment or surgical procedure to enable EmblemHealth review for preauthorization or post-payment review. Without this documentation and information, EmblemHealth will not be able to properly review the request for preauthorization or post-payment review.

Provide clinical documentation showing the member meets treatment criteria
Include indication, relevant diagnostic tests, and prior/concurrent therapies
Attach trial enrollment documentation if applicable
Include investigator protocol pages relevant to routine care vs. investigational items

Documentation Required

Confirm trial qualification and CMS status

Providers must confirm that the trial meets Medicare NCD qualified trial criteria or is a CMS-approved IDE (Category B) when seeking coverage of routine costs. If relying on a CMS-approved Category B IDE, reference the CMS-approved IDE Studies list for confirmation; ensure the trial otherwise meets NCD requirements (funding/IND status, therapeutic intent, appropriate design).

Reference CMS-approved IDE Studies list (CMS website)
Confirm trial falls within an NCD-qualified category (e.g., NIH, CDC, AHRQ, CMS, DOD, VA or IND-reviewed drug trials)
Confirm IND status or exemption and therapeutic intent and trial design meet NCD criteria
Document CMS IDE Category B status when device is integral to the trial

Definitions & Background

Background: The CMS Medicare NCD for Routine Costs in Clinical Trials is intended to encourage greater use of clinical trials by Medicare beneficiaries by assuring coverage for routine medical costs associated with qualifying trials. EmblemHealth adopts this alignment and outlines the categories of qualified trials, the trial characteristics required for coverage, the routine costs that will be paid (including items typically provided absent a trial, those required to provide or monitor the investigational item or service, and services needed to diagnose or treat complications), and specific exclusions where routine costs are not covered.

The policy includes the May 9, 2025 revision clarifying that Category B devices integral to CMS-approved Category B Investigational Device Exemption (IDE) trials are covered, consistent with CMS IDE study guidance and the NCD framework.

Definitions

Scope Notes / Thresholds

Revision History

2024-05policy_adoption

EmblemHealth aligned with the CMS National Coverage Determination (NCD) for Routine Costs in Clinical Trials to cover routine costs of qualified trials; describes qualified trial categories, required trial characteristics, covered routine costs, and exclusions. (Source: CMS NCD referenced)

2025-05-09material_revisionLatest

Revision added language clarifying that Category B devices integral to CMS-approved Category B Investigational Device Exemption (IDE) trials are covered.

2026-05-12last_review

Policy last reviewed; source references to CMS NCD and Approved IDE Studies accessed on this date.

OpenPayer

Coverage of routine costs in clinical trials

Coverage Summary

Medical-Necessity / Qualification Criteria

Provider Actions & Documentation

Coding / External References

Definitions & Background

Revision History