Medicare defines Qualifying Clinical Trials for coverage of "routine costs." Qualifying Clinical Trials must meet all three requirements in Part I and be a "Deemed" trial.

Medicare NCD 310.1

NCD qualifying criteria (flowchart)

Part I
A Qualifying Clinical Trial must meet these three requirements:

• The investigational item or service falls within a Medicare benefit category.
• The trial must have therapeutic intent.
• Trials of therapeutic interventions must enroll patients with diagnosed disease rather than healthy volunteers; trials of diagnostic interventions may enroll healthy patients to have a proper control group.

Part II

The above three requirements are not enough to qualify a trial for coverage of "routine costs." A qualifying trial also is a trial that is "Deemed" by the AHRQ to meet Medicare’s seven desirable characteristics of a clinical trial. To be considered "Deemed," the trial must meet one of the following:

• Trial is funded by NIH, CDC, AHRQ, HCFA, DOD, VA.
• Trial is supported by centers or cooperative group that is funded by NIH, CDC, AHRQ, HCFA, DOD, VA.
• Trial is conducted under an investigational new drug application (IND) reviewed by the FDA.
• Drug trial is exempt from an IND under 21 CFR 312.2(b)(1).

Part III

Medicare’s seven desirable characteristics of a clinical trial are:

• Trial potentially improves patent health outcome.
• Trial is supported by medical and clinical info.
• Trial does not unjustifiably duplicate existing studies.
• Trial is designed to answer the research question.
• Trial is sponsored by credible organization.
• Trial is compliant with federal regulations.
• Trial is conducted according to scientific standards of integrity.

Routine Costs

Under NCD 310.1, the Medicare program covers "routine costs of qualifying clinical trials … as well as reasonable and necessary times and services used to diagnose and treat complications arising from participation in all clinical trials." The term “routine costs” is a defined term under the Clinical Trial Policy.

Routine costs, as defined by Medicare, include:

• Items or services that are typically provided to Medicare beneficiaries absent a clinical trial.
• Items or services required solely for the provision of the investigational item/service, clinically appropriate monitoring of the effects of the item or service, or the prevention of complications.
• Items or services needed for the reasonable and necessary care arising from the provision of an investigational item or service — e.g., for the diagnosis or treatment of complications.

Investigational Item or Service

NCD 310.1 clarifies that Medicare considers the investigational item or service to be a “routine cost” if the investigational item or service is covered by Medicare outside of clinical trial.

Consequently, the item or service that is being studied (e.g., the drug or device) can be covered by Medicare during the research study if the exact same item or service would be covered by Medicare if it were used the same way and for the same purpose to treat or diagnose a patient who is not enrolled in a clinical research study.