From medical invention to clinical practice: the reimbursement challenge facing new device procedures and technology--part 1: issues in medical device assessment.

Although reimbursement shapes medical practice, it is hard to get a handle on this issue because reimbursement requirements seem to change and evolve over time, and different insurers approach it in different ways for different technologies. This paper and the 2 that follow attempt to explain the reimbursement challenges facing new medical device technology. This first paper addresses the particular characteristics of medical device innovation and explains how they complicate the technology assessment process. It also notes the importance of codes as a means to identify new technologies and procedures, citing some issues that affect technology adoption. The subsequent papers delve into specific coverage and payment matters affecting medical devices. The perspective presented in these papers is that of a medical device manufacturer, and the focus tends to be on Medicare, given the size of this insurance program and its impact on the US health care system, but the issues that are raised affecting medical innovation can be extended to all payers.