The Medicare Coverage Analysis (MCA) is required for all clinical research studies anticipating to enroll Medicare beneficiaries and billing of costs associated with items and services related to routine care. In order to bill Medicare and/or Medicaid for routine care costs of items and services, a clinical trial must meet certain criteria to qualify for reimbursement.
For non-device studies, a qualifying clinical trial determination consists of two parts:
Part 1 – Is the study “deemed” to have the 7 desirable characteristics?
The study must be one of the following:
- Studies funded by NIH, CDC, AHRQ, CMS, DOD, or VA;
- Studies supported by centers or cooperative groups funded by NIH, CDC, AHRQ, CMS, DOD, or VA; (Medicaid also includes-FDA,NHLBI, National Human Genome Research Institute, NCI, NIDDK, NIMH and other sources)
- Studies being conducted under an IND application; or
- IND exempt studies
Part 2 – Does the study have all three necessary requirements?
All three of the following must be met:
- The study must investigate an item or service already paid for by Medicare and is not statutorily excluded from coverage.
- Trials of therapeutic interventions may only enroll patients with diagnosed disease rather than healthy volunteers. Trials of diagnostic interventions may enroll healthy patients in a control group if a control group is scientifically necessary.
- The study must have therapeutic intent. It must not be designed exclusively to test toxicity or disease pathophysiology.
The summary determination at the end of the MCA must be printed and maintained with the study budget files for research billing purposes. See our website at http://www.indiana.edu/~ora/CRCO/CRBC/crbc_mca.html to access the MCA online tool and obtain more information.
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