Medical Devices Approved Using Low-Quality Data Affect Medicare Costs


High-risk medical devices are sometimes approved using low-quality clinical data and this increases Medicare costs, a member of a Medicare congressional advisory panel said Sept. 8.

The Medicare Payment Advisory Commission's (MedPAC) session reflected its first major examination of the medical device industry. The session may portend a deeper examination of the device industry's practices, which could cause Congress and/or the Department of Health and Human Services to change payment rates for devices and related services, as the commission's recommendations are fairly influential among policy makers.

Commissioner Rita Redberg, a cardiologist at the University of California San Francisco Medical Center, called for further MedPAC examination of how to push the Centers for Medicare & Medicaid Services to more broadly consider quality over an entire episode of care when deciding whether to cover a device. Devices with a high risk to patients are sometimes approved by the Food and Drug Administration using poor quality data, Redberg said. This can result in low-quality devices being implanted into patients. These low-quality devices then need to be deactivated or removed, which drives up Medicare costs.

Reacting to Redberg's comments, Don May, executive vice president, payment and health-care delivery policy at the Advanced Medical Technology Association, a device trade group, told me in a Sept. 8 e-mail that patient safety “is the number one priority of the medical technology industry, and our industry has—on balance—an extraordinary safety record.” Moreover, with some hospitals participating in Medicare bundling programs now responsible for the costs and quality of care over a full 90-day episode, providers already have an incentive to use high-quality products that improve care and lower costs, he explained to me.

Commissioners didn’t vote on recommendations. However, they debated how MedPAC staff should further research device company practices and their role in driving Medicare costs. Results of that research could prompt the commission to draft recommendations in the future.

Read my full story for more details about the meeting.

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