Ch 12 Managing Medical Devices witin a Regulatory Framework

What is it about?

Reimbursement for innovative technology is fundamental to sustainability of physician practices, health care organizations, payers, regulators, the network of industry dedicated to the development of novel medical devices, and the general public with unmet medical needs. This manuscript will discuss the cycle of inspiration, innovation, and integration of medical device development; the central role of regulation—in particular, medical device classification and the influence of billable fees associated with procedural and disease coding; key aspects of reimbursement evaluation; and the three types of user payments in the United States health system. Overall, we present information on the regulations guiding decision-making and obtaining the correct information to ensure reimbursement viewed through the symbiotic relationship among and between these stakeholders towards the development of new medical technology that ultimately impacts the national healthcare system.

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