Client received Category B status for an IDE, and Quorum points them to best practices for coverage.
Business Challenge
A medical device company gearing up for their pivotal clinical trial with centers across the US obtained Category B status for their device under an Investigational Device Exemption (IDE) from the Food and Drug Administration (FDA). Due to its Category B IDE status, the device was eligible for coverage under the Medicare program. The medical device company sought expertise in how to initiate this effort with their clinical trial sites and secure coverage for their device under Medicare prior to full FDA approval.
Our Approach
We knew that gathering all the appropriate parties who would be needed in this effort early on was important to success. That meant identifying the proper individuals from the manufacturer and the clinical trial sites, as well as defining roles and responsibilities from the beginning. They were to idenitfy each party’s stake in the overall process, to have contingency plans in case changes occur, and to ensure responsive, critical support for the providers as they engage payers through this process.
Our Solution
With our extensive experience in this arena, we developed comprehensive materials for: (1) the client, in order to engage principal investigators on the IDE reimbursement effort, (2) the clinical trial site coordinators, to integrate reimbursement initiatives into their ongoing efforts, and (3) the billing and financial people, to ensure proper coding and follow-through with payers.
In addition to preparing the necessary materials, Quorum led teleconferences with all interested parties to launch the effort, conducted clinical trial site visits throughout the trial, and was available for any ad hoc support inquiries along the way.
Results Delivered
We tracked all payer communications diligently, and therefore, we were able to follow up with all payers on a regular basis to help achieve an 80 percent approval rate with Medicare contractor medical directors.
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