OIG Cardiac Implant Review Finds $1.5bn In Medicare Payments For Failed, Recalled Devices
Medicare was billed $1.5bn, and beneficiaries paid $140 million in copayments, for procedures associated with replacing seven models of defective or failed cardiac implants, according to preliminary results from an ongoing review by the US Department of Health and Human Services’ Office of Inspector General. The "early alert" from OIG’s investigation blamed a lack of device identifiers on claims forms for masking device performance data.
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Medicare lost $1.5bn in claims over a 10-year period to cover procedures to fix or replace seven faulty cardiac devices due to the lack of product-specific information on its claims form for malfunctioning defibrillators and pacemakers, says the US HHS Office of Inspector General. Recalls of Medtronic, Boston Scientific and Abbott/St. Jude Medical cardiac rhythm management devices are likely behind most of the cost.
The Health & Human Services’ watchdog branch plans to look at a spike in recall costs; Medicare’s progress in implementing lab-test payment reforms; and an ongoing review of FDA’s work on device cybersecurity issues.
The acting head of the Center for Medicare and Medicaid Services has signaled his agency's plan to support the effort to get UDIs incorporated as a standard element of insurance claims by signing a letter jointly with the FDA commissioner. Previously, CMS had worried about the move due to the significant system upgrades that hospitals and payers will need to make to support UDIs in claims.