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OIG Work Plan highlights device issues

Device Regulation Alert: Safety, Compliance and Reimbursement News, October 8, 2007

The Office of Inspector General (OIG) highlighted some medical device-related issues in its recently-released 2008 Work Plan.

The OIG plans to study FDA adverse event reporting for medical devices. The OIG notes adverse event reporting is a "key part of the FDA's oversight of new medical devices." Therefore the OIG said it will review how the FDA enforces adverse event reporting requirements and what it does with the information it gets from such reporting.

Other device related concerns the OIG included in its plan are:

• Inpatient payments to hospitals for new technologies and devices
• Disclosure of clinical investigators' financial interest in drug, device, and biologic applications
• Payments for durable medical equipment in nursing homes and home health situations
• Medicaid payments for DME and medical equipment
• Medicare payment for power wheelchairs
• Use of modifiers on claims for DME

Click here to view the OIG's 2008 Work Plan.

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