How to Conduct a Medicare Coverage Analysis Overview Device Studies
Device Regulation Alert: Safety, Compliance and Reimbursement News, February 25, 2008
CMS' updates to its Clinical Trials Research Policy mean big changes to which services Medicare will cover as part of clinical trials.
Medicare may reimburse for some devices and associated items and services used in research, such as:
- Post-marketing approved (PMA) devices
- 510-K approved devices
- Hospital IRB approved devices
- IDE Category B devices
- IDE Category A devices used in a life-threatening situation
Medicare contractors must approve billing for devices and associated items and services used in research prior to the initiation of the study.
Learn more about potential pitfalls and top risk-areas by ordering the audio archive, 2008 Clinical Trials Billing Update: Comply with CMS' Coverage Changes.
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