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ORA FAQs
For device studies, how is a qualifying determination made?

Coverage determinations must be made before any claims are submitted.  In order to bill routine care costs for Category A/B device trials you need to obtain Medicare contractor approval prior to billing.   Even when device is provided without charge, the Medicare contractor must still approve study for “routine costs” to be billable.

 

IDE Category A devices: Yes, with Medicare medical director approval if used in “immediately life threatening disease or condition”

IDE Category B devices: Yes, with Medicare medical director approval

HUD: Only if approved by Medicare medical director

Post-marketing approval FDA-required studies: Yes, with Medicare medical director approval

Off-label use of FDA-approved device: Generally, no; needs IDE categorization

 

When the Medicare medical director approves a device trial, the study qualifies for coverage but all Medicare rules still apply – many services, including the main procedure may not be covered by Medicare. See our website at http://www.indiana.edu/~ora/CRCO/CRBC/crbc_fda_ide.html for further information.


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