Medicare defines Qualifying Clinical Trials (QCTs) to determine coverage of “routine costs” for participants. To qualify, a clinical trial must meet specific regulatory requirements and be considered a “Deemed” trial under AHRQ guidance.
Qualifying Clinical Trial
A clinical trial must meet all three of the following:
- Medicare Benefit Category: The investigational item or service falls within a Medicare-covered benefit.
- Therapeutic Intent: The trial is designed to improve patient health outcomes.
- Patient Population:
- Therapeutic trials enroll patients with diagnosed disease.
- Diagnostic trials may enroll healthy volunteers only when necessary to provide an appropriate control group.
Meeting the Part I requirements alone is not sufficient. To be covered, a trial must also be “Deemed” by the AHRQ, meaning it meets Medicare’s seven desirable characteristics. A trial is considered “Deemed” if it meets any of the following:
- Funded by NIH, CDC, AHRQ, HCFA, DOD, or VA
- Supported by an NIH-, CDC-, AHRQ-, HCFA-, DOD-, or VA-funded center or cooperative group
- Conducted under an FDA-reviewed Investigational New Drug (IND) application
- A drug trial exempt from IND under 21 CFR 312.2(b)(1)
- The trial potentially improves patient health outcomes.
- The trial is supported by credible medical and scientific information.
- The trial does not unjustifiably duplicate existing studies.
- The trial is designed to answer a specific research question.
- The trial is sponsored by a credible organization.
- The trial complies with federal regulations.
- The trial is conducted according to scientific standards of integrity.
Routine Costs
Under NCD 310.1, Medicare covers the routine costs of qualifying clinical trials, as well as reasonable and necessary items and services to diagnose or treat complications arising from trial participation.
Routine costs include:
- Items/services typically provided to Medicare beneficiaries outside of clinical trials
- Items/services required solely for the investigational item/service, monitoring its effects, or preventing complications
- Care needed for diagnosis or treatment of complications arising from the investigational item/service
Investigational Item or Service
Medicare will cover an investigational item/service if it would be covered outside of the trial for the same purpose and patient population. For example, a drug or device being studied is considered a routine cost if it would otherwise be covered by Medicare when used in standard care.
References:
- Medicare NCD 310.1
- NCD qualifying criteria (flowchart)
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