Medical Device Utilization

Medical Device Efficacy

Challenge:

Over several years, a large workers' compensation carrier was seeing a marked increase in billing for treatment of non-surgical back injuries, attributable to the use of a new medical device. We were asked to evaluate this device for efficacy.

Solution:

Evaluation of the device began with review of the 510K USFDA application, the FDA's criticisms of the device and supportive research studies submitted with the application, the limitations they placed on the treatment claims and its clinical applications. We conducted an independent analysis of all research studies involving this device and outcome results. We also reviewed the device manufacturer's website, marketing material, and advertisements. In addition, we reviewed current studies and evaluations of the device in evidence-based practice guidelines for non-surgical back injuries, and a literature review of regarding treatment modalities for non-surgical back injuries performed by the Cochran Collaboration. Finally, we reviewed Medicare coding and reimbursement decisions for the device, as well as multiple medical and workers' compensation insurers' reimbursement policies and adjudicated decisions across the country. We issued an efficacy report that provided an objective basis for the workers' compensation carrier's decision to deny reimbursement for use of this device on injured workers.

Reflection:

Medically-based evaluation of device efficacy was determined through an objective appraisal of a variety of sources of information concerning the device. Our thorough and complete determination provided strong support for our client's claims decisions.

Other Case Studies