There has been mounting pressure in recent years from third-party payers—and consumers—for evidence that a device or procedure actually performs as claimed before considering payment for services. In fact, Section 6301 of the Patient Protection and Affordable Care Act authorized the establishment of the Patient-Centered Outcomes Research Institute for the express purpose of examining the comparative clinical effectiveness of medical treatments, procedures, drugs, and medical devices, which may impact both government and private insurer’s coverage determinations.
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