Special guidance for device studies How does the Investigator ensure there is appropriate approval from CMS to bill Medicare for the items/services on the device study protocol?For Investigator-initiated IDE and non-significant risk device studies, the Investigator will need to work with the Director of Reimbursement for UCLA Medical Financial Services to submit the device study information to local MAC for approval to bill Medicare. For industry-sponsored device studies initiated after January 1, 2015 the sponsor has the obligation to submit centrally to CMS for approval to bill Medicare. The Investigator should initiate this communication early as the approval or denial letter may be needed to complete contract negotiations and coverage analysis certification with the Clinical Trial Administration Office.5 | |
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