The U.S. Food & Drug Administration has a difficult job – striking a balance between ensuring devices and drugs are safe and meeting patient needs. To augment pre-market studies, the agency requires post-market surveillance, which relies on clinical trials and published articles to further monitor safety and efficacy after a device is approved.
But now, in a study and a viewpoint piece published in JAMA Surgery and JAMA, general surgeon Andrew Ibrahim and professor of surgery Justin Dimick, of the Institute for Healthcare Policy & Innovation at the University of Michigan, propose that administrative data could be a more timely and accurate way to assess devices. To get there, they tracked payer data for the gastric band, a device used for bariatric surgery.
“We looked at complications through the Medicare claims data, and about one in five Medicare beneficiaries (who had gastric band surgery) were having the device removed,” said Ibrahim in a phone interview. “They often underwent multiple operations: had it removed, had it replaced, had it removed again and opted for a different procedure.”
The researchers chose the gastric band because it has a unique set of ICD-9-CM codes for placement, revision and removal —44.95, 44.96-98 — one of the few devices with this much granular data. Between 2006 and 2013, Medicare spent $470 million on gastric band procedures: $224 million for reoperations. Unfortunately, clinical studies did not tell the same story.
“In 2011, the FDA re-evaluated the device, looked at the research at the time and found that resurgery rates were as low as 4 percent,” said Ibrahim. “In administrative claims, we saw more than half the money spent on the device that year was to fix or remove it.”
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Other evidence hints the problem may go well beyond gastric bands. Denmark has a registry to track flexible meshes for hernia repairs. Data from the registry showed that a new mesh, which was rapidly gaining popularity, had a much higher than normal recurrence rate. The device was eventually taken off the market.
“It’s sobering to think about,” said Ibrahim. “What if this small European country didn’t have a registry? This mesh would have been widely disseminated throughout the world. How long would it have taken to figure it out?”
The problem is not lost on Congress and the FDA. The agency has been pushing for new unique device identifiers, but progress has been slow and the fix would require whole new sets of codes, forms, etc.
Ibrahim and Dimick believe the faster and easier solution is to simply expand the existing payer code structure to capture more information. The Medical Device Safety Monitoring Act was recently introduced in the U.S. Senate and could be the right legislation to advance these codes.
“You’re not going to capture every complication, but for something as obvious as the device going in and the device being replaced or removed, administrative claims are really good for that,” said Ibrahim. “The fact that we can’t reliably track many of our medical devices certainly makes it harder for patients.”
Photo: Simonkr, Getty Images
