In addition to the money
The three companies that manufactured the seven devices have yet to be identified by investigators. Their examination, which has been underway for about a year, resonates in
"While the costs to government of these failed devices appears to be massive, the actual cost to taxpayers is going to be much higher, [because of] ancillary costs like future adverse health events, the need for continued medical monitoring, and lost wages and productivity,"
Data from the
While the increase was attributed to a variety of causes, the rise has led to questions about how to track flawed devices and their cost to the public.
Investigators discovered it was impossible to use insurance claims to make even a cost estimate because the forms are too vague.
To arrive at its estimate, the HHS watchdog office subpoenaed the manufacturers for lists of
"There's a physical cost and a financial cost to patients when medical devices fail, and a big expense to taxpayers as well. It makes sense to track medical devices on claims forms so flawed devices can be taken out of use and patients and taxpayers can be better protected," Grassley said in a statement Tuesday.
Levinson's report says the tracking code "could assist in identifying the costs to
In a letter last September, Levinson told Grassley and Warren it wasn't possible to tally
But he noted that just one situation --
"We believe that
The ongoing audit is examining seven specific cardiac devices that were implanted in 376,000
More than 72,000 of those patients eventually had their devices replaced, resulting in more than
But those figures include necessary device upgrades. Auditors had to pore over individual medical records obtained via subpoena to narrow their estimate to the
"Government needs a better handle on what is happening here, not only to make sure we are getting better health care outcomes, but also to see if we can claw back some of the public and private money being spent on defective devices," Burns said Tuesday.
The final audit report is scheduled for release later this year. Levinson issued Tuesday's memo in part to tell the
Last July top officials with the CMS and the
But they noted it wouldn't be as easy as it might sound -- they may need new computer systems to get it done.
"Collecting the DI is complex and involves providers changing their workflow and billing systems as well as requiring public and private payers ... and other entities to change their claims processing systems," the officials said in a
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