IDE Coverage Decisions
When conducting a device study, submission to the state contracted
Medicare Intermediary is required if the FDA Approval letter of the IDE is dated prior to January
1, 2015, in order to ensure patient routine charges incurred during the
studies are covered. For all IDE studies with an FDA Approval letter dated
on or after January 1, 2015, submission to the state contracted local
Medicare Intermediary is not required.
CORA facilitates Medicare Intermediary submissions on behalf of Investigators for
facility reimbursement (Part A), once supporting documentation is provided to CORA. Requirements differ
by state. Please refer to the provider information for your state.
As a courtesy, CORA will submit Investigators'
provider reimbursement (Part B) Cover Letter and any additional documents that may be required. Requirements
differ by state; please refer to the provider information for your state.