How do I know if a clinical trial qualifies for Medicare coverage?

Under NCD 310.1, also known as CMS Clinical Trials Policy, a trial must meet three core requirements to qualify for Medicare coverage of routine costs:

• the subject of the trial must evaluate an item or service that falls within a Medicare benefit category and is not statutorily excluded;
• the trial must have therapeutic intent and not be designed solely to test toxicity or disease pathophysiology; and
• trials of therapeutic interventions must enroll patients with diagnosed disease rather than healthy volunteers.

In addition to the above core requirements, the clinical trial must meet one of the following:

• Trials funded by NIH, CDC, AHRQ, CMS, DOD, and VA;
• Trials supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, CMS, DOD and VA;
• Trials conducted under an IND reviewed by the FDA; and
• Drug trials that are exempt from having an IND.

Confirming qualifying status is the first step of the Medicare coverage analysis. BRANY provides qualifying clinical trial screening as part of its service.