AGENCIES NOT USING ENOUGH DATA TO MAKE APPROVAL, COVERAGE DECISIONS
The FDA and the Centers for Medicare & Medicaid Services (CMS) need to base their product approvals and reimbursement decisions on more complete evidence when dealing with costly new technologies such as heart imaging devices, an expert says.
"Technology is a major driver of total healthcare spending," but the current process for evaluating medical technology often results in "high spending for unproven procedures," according to Rita Redberg, a professor of medicine in the division of cardiology at the University of California, San Francisco.
The data used for FDA approval and CMS coverage decisions are "insufficient and lack independence," Redberg said in an article published in the January-February issue of Health Affairs.
Clinical trials conducted to obtain FDA device approval "are designed to prove safety and efficacy but often do not show specific patient benefits in the clinical setting," she said. On the coverage side, no statutory definition exists for the standard of "reasonable and necessary" used by the CMS.