SPECIAL SECTION
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(click images to enlarge) Source: Data from CMS Office of the Actuary, January 2007. |
It’s not an exaggeration to say that reimbursement is one of the greatest challenges device makers face—it can make or break a device. With that in mind, there are several ways to address reimbursement.
First, it takes research. Strong clinical research is the backbone of a coverage decision. And although getting coverage is the ultimate goal, the decision by a payer not to cover a device is not necessarily the end of the process.
Second, it takes knowledge. Guidance documents offer a wealth of information to those who take the time to understand and to act on them. It’s critical to be aware of Medicare projects such as gainsharing demonstrations and rules such as the proposed fee schedule for physicians. Such factors can help device makers understand the circumstances under which payers make their decisions. This is especially important considering that third-party expenditures for durable medical equipment are expected to rise over the next 10 years (see figures at left).
Device makers are beginning to think about reimbursement at the very beginning of a device life cycle—and they should. The following pages provide advice on how to conduct research, even if a payer has already said no, and discuss the significant developments that will inform the future of reimbursement.
What to Do if Your Device Doesn’t Get Reimbursement
Top Reimbursement Developments of 2006
