Whistleblowers may report medical device fraud against the government, which typically involves misconduct with Medicare and Medicaid.
Medical device fraud can take many forms by both manufacturers of medical devices and providers who bill for the use of medical devices, including:
- Kickbacks: Medical device manufacturers are generally prohibited from paying kickbacks to service providers for the use of a medical device, and service providers are prohibited from accepting kickbacks from medical device manufacturers.
- Misrepresentations to the FDA: Medical device manufacturers may be liable if they fraudulently obtain FDA approval for a device by lying to the FDA or omitting significant information.
- Billing for medical devices in violation of coverage policies, such as national coverage determinations (NCDs) and local coverage determinations (LCDs).
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