New devices in a new era: Reimbursement and legality

The development of new technology is often anticipated with great enthusiasm by physicians involved in the evaluation of new therapies. There is a countervailing view that rapid diffusion of new technology into practice is a significant contributing factor to the rapid rate of rise of health care spending in the United States. The central argument is not that technology should not be developed; rather, that technology should be developed and evaluated according to carefully derived scientific criteria and that payment policy should not create an unintended discrimination in access to new therapies. It is essential that physicians who are involved in the development of new technologies understand the reasons for concern about technology, the requirements for evaluation of new devices, and the payment policies related to the use of new technology.