The impact of regulation and payment innovations on acquisition of new imaging technologies.

Increasing concerns about the cost of health care in this country and uncertainties about the marginal benefits of the growing number of diagnostic imaging techniques available to clinicians have resulted in a number of changes in regulatory and payment policies that could have a major impact on the rate at which technologic innovations are adopted in the future. Three of these policies--FDA premarket approval, Medicare's prospective payment system, and state-run capital expenditure review programs--have been examined in this article. Experience with the FDA premarket approval process has been limited. The diffusion of MR imagers, the first imaging devices to have required premarket approval, does not appear to have been constrained by the premarket approval process. In contrast, the existence of certificate-of-need regulations and the institution of prospective payment are likely to restrain the rate at which hospitals acquire new technologies in the future. This impact is likely to be most marked in the case of technologies that increase the cost of patient care. The challenge to manufacturers will be to develop new techniques that improve patient care at an affordable price or that maintain the current quality of care at less cost. Researchers and clinicians, in turn, will need to identify those innovations that are likely to be most beneficial and to develop the data necessary to help utilize limited health care dollars in a fiscally and socially responsible way.