Clinical Trials

Published 10/01/2025

Clinical trials are interventional studies that assess treatments or diagnostics compromising experimental and control groups. As of January 2014, it has become mandatory to report a clinical trial number on claims for items and services provided in clinical trials, studies, registries, or under Coverage with Evidence Development (CED). This is the number assigned by the National Library of Medicine (NLM) website when a new study appears in the NLM Clinical Trials database. This number is listed prominently on each specific study’s page and is always preceded by the letters “NCT.” Contractors verify the validity of a trial/study/registry by consulting the Centers for Medicare & Medicaid Services's (CMS’s) clinical trials/registry website.

Medicare Coverage

Medicare Part B coverage for clinical trials includes routine services such as doctor visits, lab tests, surgeries and treatments that are usually covered by Medicare when provided outside a trial. It also covers FDA–approved Investigational Device Exemption (IDE) studies for Category B devices. This includes services needed to provide or administer the investigational item, as well as patient monitoring and lab tests.

Medicare Non-Coverage

Medicare Part B will not cover the investigational item or service, itself, items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient (e.g., monthly CT scans for a condition usually requiring only a single scan); and items and services customarily provided by the research sponsors free of charge for any enrollee in the trial.

Category A and B IDE Studies

Category A (experimental) device refers to a device for which “absolute risk” of the device type has not been established (that is, initial questions of safety and effectiveness have not been resolved) and the FDA is unsure whether the device type can be safe and effective.

Category B (non-experimental/investigational) device refers to a device for which the incremental risk is the primary risk in question (that is, initial questions of safety and effectiveness of that device type have been resolved), or it is known that the device type can be safe and effective because, for example, other manufacturers have obtained FDA premarket approval or clearance for that device type.

Claim Submission

Medicare-enrolled providers submit claims for routine services provided under an approved clinical trial and/or IDE study to the Part B Medicare Administrative Contractor (MAC). Payment is based on the payment methodology applicable for the service that was furnished (e.g., physician fee schedule, lab fee schedule, durable medical equipment fee schedule, reasonable charge, etc.). With the exception of managed care enrollees, applicable deductibles and coinsurance rules apply to clinical trial items and services. The Part A and Part B deductibles are assumed to be met for covered clinical trial services billed on a fee service basis for managed care enrollees.

Clinical Trial Modifiers

  • Modifier Q0 is used for investigational items/services in a clinical research study. It is appended to the Category B IDE codes in conjunction with the IDE number on claims
  • Modifier Q1 applies to routine clinical services performed within a clinical trial context. It indicates services performed as part of clinical management related to the study and requires the trial name, sponsor and sponsor-assigned protocol number on the beneficiary’s medical record.
    • For claims with modifier Q1 or Q0 appended to the Healthcare Common Procedure Coding System (HCPCS) or Current Procedural Terminology (CPT®) code, ICD-10 code Z00.6 must be present (in either primary/secondary positions), and, if routine services involve a Category A or B IDE device, the IDE number must also be on the claim

Medical Records Documentation Requirements

The billing provider must report the clinical trial and IDE numbers. Claims lacking these identifiers will be rejected, requiring resubmission with the necessary information.

Table 1. Medical Records Documentation Requirements.
1500 Claim Field Loop and Segment Information Required
19 2300 REF02 and qualifier REF01 = P4

Key the Clinical Trial Number, preceded by “CT”

Example: CT XXXXXXXX
23 2300, REF02 and qualifier REF01 = P4 IDE number

References


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