Medicare Clinical Trial Policy (NCD 310.1)

The Medicare Clinical Trial Policy is the national coverage framework, codified as National Coverage Determination (NCD) 310.1 ("Routine Costs in Clinical Trials"), under which Medicare pays the routine patient-care costs of a beneficiary enrolled in a qualifying clinical trial, plus reasonable and necessary costs of treating complications from participation. A trial only qualifies if it meets three threshold criteria (the studied intervention falls within a Medicare benefit category, the trial has therapeutic intent, and trials of a therapeutic intervention enroll patients with a diagnosed disease) and satisfies at least one deeming criterion: funding or endorsement by NIH, CDC, AHRQ, CMS, DOD, or VA (or by a cooperative group/center they support); conduct under an FDA Investigational New Drug (IND) application; or exemption from IND requirements as a drug trial under 21 CFR 312.2(b)(1). A trial that meets none of these is not automatically excluded, but its sponsor must instead complete CMS's qualifying-trial checklist demonstrating the trial's scientific validity and integrity. Separately, since Change Request 5790 (Transmittal 310, effective 2008), Medicare claims for routine costs under a qualifying trial must report the trial's ClinicalTrials.gov identifier (the NCT number) alongside condition code 30 -- so registration in the National Library of Medicine's public registry functions, in practice, as a billing prerequisite: a claim without a valid NCT number is at risk of denial even if the trial itself otherwise qualifies.

ByCASRAI Editorial Board

· Last updated 23 Jul 2026

Worked examples

Is an instance

A Phase III oncology trial testing a new drug under an active FDA IND, registered on ClinicalTrials.gov with an NCT number: it is deemed qualifying automatically because it runs under an IND, and its routine costs (the standard-of-care office visits, scans, and labs a patient would receive regardless of trial participation) are billable to Medicare using condition code 30 and the trial's NCT number.

Is an instance

An investigator-initiated behavioral-intervention trial funded by an NIH cooperative group grant: it satisfies the deeming criterion for NIH-supported research, so the site's research billing office can bill Medicare for the beneficiary's routine visits under NCD 310.1 without needing to submit the separate qualifying-trial checklist.

Looks similar, but isn't

Not an instance

A registry-only observational study with no investigational intervention and no therapeutic intent does not meet NCD 310.1's threshold criteria at all -- there is no 'routine cost' category to bill under this policy because the study is not an interventional clinical trial in the sense the NCD defines, regardless of whether it is listed on ClinicalTrials.gov.

Not an instance

A small, industry-funded device feasibility study not conducted under an IND/IDE, not NIH/CDC/AHRQ/CMS/DOD/VA-funded, and not accompanied by a completed qualifying-trial checklist does not automatically qualify -- Medicare may deny routine-cost claims until the sponsor or site documents that the trial meets the qualifying criteria.

The Medicare Clinical Trial Policy is a coverage-eligibility framework, not a trial registry. It answers a narrow but consequential question for research billing offices: when a Medicare beneficiary enrolls in a clinical trial, which of that patient’s care costs can be billed to Medicare, and under what conditions?

What NCD 310.1 Actually Covers

Issued by the Centers for Medicare & Medicaid Services (CMS) as National Coverage Determination 310.1, “Routine Costs in Clinical Trials,” the policy took effect July 9, 2007, formalizing coverage that CMS had extended under a 2000 policy. It allows Medicare to pay for the routine patient-care costs a beneficiary incurs while enrolled in a qualifying clinical trial — the office visits, imaging, and laboratory work that would occur even outside the trial — plus the reasonable and necessary costs of treating complications that arise from participation. It does not cover the investigational item or service itself, or costs the sponsor is separately responsible for funding.

For the full mechanics of how a coverage analysis distinguishes routine costs from sponsor-funded research costs, and how that maps onto CMS’s broader National Coverage Determination (NCD) and Local Coverage Determination (LCD) system, see Medicare Coverage Determinations: NCD vs LCD Explained.

How a Trial Qualifies

A trial must satisfy three threshold criteria under NCD 310.1: the intervention under study falls within a Medicare benefit category (e.g., physician service, diagnostic test), the trial has a therapeutic intent, and if the trial studies a therapeutic intervention, it enrolls patients with a diagnosed disease rather than only healthy volunteers. Beyond that, a trial must satisfy at least one deeming criterion:

Funding or support from NIH, the CDC, AHRQ, CMS itself, the Department of Defense, or the Department of Veterans Affairs — including trials conducted by a cooperative group or center these agencies fund;
Conduct under an active FDA Investigational New Drug (IND) application; or
Exemption from IND requirements as a drug trial under 21 CFR 312.2(b)(1).

Trials that meet none of these deeming criteria are not automatically disqualified — CMS allows the trial’s sponsor to instead complete a qualifying-trial checklist demonstrating the study meets equivalent standards of scientific validity and integrity.

The Registration Requirement: NCT Numbers on Claims

NCD 310.1 is a coverage policy, not a registry — the actual public registry of trials is ClinicalTrials.gov, operated by the National Library of Medicine. The two connect at the claims-processing level: since CMS Change Request 5790 (Transmittal 310, effective 2008), Medicare claims for routine costs under a qualifying trial must carry the trial’s ClinicalTrials.gov identifier (its NCT number) together with condition code 30. In practice, this means a trial’s public registration functions as a billing prerequisite: without a valid, correctly reported NCT number, a claim for otherwise-qualifying routine costs is at risk of denial. This billing mechanic, and how it intersects with False Claims Act exposure when it is handled incorrectly, is covered in False Claims Act Liability in Clinical Trial Billing.

Why the Distinction from ClinicalTrials.gov Matters

Research administrators sometimes conflate “is this trial registered” with “does this trial qualify for Medicare coverage.” They are separate questions answered by separate systems: ClinicalTrials.gov registration (and, for applicable trials, results reporting under FDAAA 2007) is a public-transparency and, for many trials, an FDA/NIH legal obligation in its own right — see ClinicalTrials.gov and What Is a Clinical Trial? The NIH Definition for how that determination is made. NCD 310.1 qualification is a distinct Medicare coverage-eligibility test layered on top: a trial can be properly registered on ClinicalTrials.gov and still fail to qualify for Medicare routine-cost coverage if it meets none of the deeming criteria and no qualifying-trial checklist has been completed, and conversely a qualifying trial’s claims can still be denied if its NCT number is missing or incorrectly reported.

Related Terms

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