Medicare paid $1.5 billion over defective cardiac devices

The U.S. Health and Human Services Inspector General reported Monday that Medicare spent $1.5 billion over the decade ending in 2014 on health services related to failed or recalled cardiac devices.

The report did not name the device makers, but firms with Minnesota operations are among the leading sources of cardiac devices.

In addition to the $1.5 billion, Medicare recipients spent $140 million satisfying co-payments and deductibles related to failed heart devices over the study's 10-year period.

The report says recalls of medical devices nearly doubled from 2003 through 2012, but the government lacks good data to track costs and problem devices. Lack of information impedes the Food and Drug Administration's and the Centers for Medicare and Medicaid Services' ability "to identify poorly performing devices as early as possible."

Medical Alley CEO Shaye Mandle questioned the value of the report. The head of a medical technology trade group said he's not sure how the federal government came up with the dollar cost. He said things are done a lot differently now compared to 2004, the study's first year.

"This is a lot of old data and a lot of data that it just isn't clear how certain costs are connected and I think the number would be very different today," Mandle said.

The Inspector General's office is recommending Centers for Medicare and Medicaid Services require that a device identifier is included on the next version of claim forms and require hospitals to report if a device replacement procedure resulted from a device recall or premature failure.

The centers say the recognizes the value of stepped up reporting in cases where costs increase and is studying whether additional reporting would place an unnecessary burden on doctors.