Citing nearly $1 billion in potential savings associated with a single medical device, researchers at the University of Michigan say the FDA needs to make use of existing administrative data to improve medical device safety.
Furthermore, requiring all medical devices to have a unique identifier would allow regulators to connect valuable claims data with each device to spot potential problems sooner.
In a viewpoint published in JAMA, two researchers with the Center for Healthcare Outcomes and Policy at the University of Michigan highlighted data points associated with a gastric band device commonly known as Lap-Band, which was approved by the FDA in 2001.
After an initial spike in gastric band surgeries, the medical community has soured on the device after reports questioned its effectiveness and found a growing number of complications associated with the surgery.
But the authors argue that those problems could have been identified earlier by using claims data and ICD-9 codes to identify an increase in payments tied to reoperations beginning in 2009. That went unnoticed by regulators in 2011, who used clinical trial data that showed reoperation rates were at 4%. Meanwhile, claims data showed reoperations made up 50% of annual spending.
In the same year (2011) when the @US_FDA expanded indications for the LapBand, >50% of $ were for device reopeations #ARM17 #EvidenceMatters https://t.co/G2SvHfd6cy
— Andrew M. Ibrahim MD (@AndrewMIbrahim) June 25, 2017
All told, payers could have saved about $1 billion between 2010 and 2014 if those trends were spotted earlier.
"While efforts by the FDA to use administrative claims and create detailed registries have been slow to mature, the example of the gastric band reveals that even crude measures (ie, payments for device removal) can be a valuable signal within existing data,” the authors wrote.
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The FDA has said it plans to leverage big data for better decision-making and incorporate real-world data into the medical device approval process.
An updated user fee agreement that is currently making its way through Congress would fund a National Evaluation System for health Technology (NEST) that would leverage data buried in EHRs to support regulatory approvals.