CMS Restricts Coverage For Devices More Than Drugs, Study Finds

Article preview from Medtech Insight - July 2013

 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.

CMS Restricts Coverage For Devices More Than Drugs, Study Finds

Article preview from Medtech Insight - July 2013

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 Tufts’ Medical National Coverage Determinations (NCD) database for FDA-approved or cleared products and published their findings June 3 in Health Affairs.

The database includes information on 152 national coverage determinations from 1999 to 2011, but the Tufts researchers ultimately analyzed 69 NCDs after excluding decisions targeting procedures or services that don’t require FDA approval and some other categories. They found that the Medicare agency agreed to cover products in 80% of the NCDs, including all of the drugs and biologics (covered by Medicare Part B) and 75% of the devices.

The researchers found that in a majority of the positive coverage decisions, there was a discrepancy between the labeling FDA approved and the population CMS agreed to cover, in particular for medical devices, where CMS tended to be more restrictive than FDA.

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