Case Study 2 – Third Party Payer Risk Analysis

Identifying the Issue
Medical devices can usually be FDA approved through a streamlined 510K process (indicating similarity to another device), priced at a premium, and marketed. However, our client identified that their current marketed spinal device was considered investigational by most payers, and therefore, not a covered service.
 
The Role of DK Pierce & Associates
Our staff conducted discussions with several payers to identify what issues were present related to the device in question and similar devices.  We determined that a 510K approval does not support payer uptake and coverage without consistent clinical outcome data.  Additionally, trial endpoints currently targeted by device manufacturers do not clearly demonstrate an outcome for insurance beneficiaries.

Demonstrated Outcomes
DK Pierce recommended, and subsequently facilitated, a board of payer advisors (under our Payer and Stakeholder Services Group) to provide feedback on necessary clinical endpoints to target for more comprehensive studies. We helped develop a case-by-case approval consideration process to propose to payers. This process included providing available published data and surgeons’ local outcome data to payers.