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CMS Restricts Coverage For Devices More Than Drugs, Study Finds

Discrepancies between FDA-approved labeling and national Medicare coverage decisions are frequent, particularly for medical devices, where CMS tends to be more restrictive than FDA, researchers reported in Health Affairs. The findings have implications for the parallel review program.

The US Centers for Medicare and Medicaid Services (CMS) has been more restrictive in its national coverage policies affecting medical devices compared to those targeting drugs and biologics, according to a study that researchers say offers insight into the nascent FDA-CMS parallel review program.

Three researchers at Tufts University’s Center for the Evaluation of Value and Risk in Health analyzed data from the...

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