By Christina Frangou
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Houston—Since 2006, nearly half of the $470 million spent by Medicare for procedures related to the laparoscopic gastric band were for reoperations, reflecting complications related to gastric band placement or weight loss failure, surgeons reported at the 2017 annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.
The high cost of reoperations was evident as early as 2006, before many long-term studies of the gastric band were published while its popularity was still on the rise. But the cost grew tremendously over the next eight years; the proportion of Medicare payments for reoperations increased from 16.4% to 77.3% of its annual spending on the gastric band device.
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“These findings indicate that the gastric band is associated with high reoperation rates and considerable costs to payors, which raises concerns about its safety, effectiveness and value,” said lead author Andrew M. Ibrahim, MD, clinical lecturer in surgery at the University of Michigan and a Robert Wood Johnson Clinical Scholar at the Institute for Healthcare Policy & Innovation, in Ann Arbor.
The study, which was published in the May edition of JAMA Surgery, examined device-related reoperation rates and costs nationally between 2006 and 2013.
During those years, reports—mostly from single institutions or from outside the United States—revealed reoperations frequently occurred after gastric banding, for example, more than 50% in one study (Obes Surg 2010;20:1078-1085). However, the gastric band remained a prominent primary bariatric procedure until about 2011, when the annual numbers dropped substantially. By then, Medicare spending on reoperations related to the band surpassed the spending for gastric banding as the index procedure.
In 2011, the FDA expanded the eligibility criteria for the gastric band in a wider range of patients, lowering the threshold to a body mass index of 30 kg/m2 and at least one obesity-related comorbidity. The decision was made based on the FDA review of one- and two-year data from a prospective, single-arm, multicenter study with five years of follow-up. As a result, an estimated 19 million Americans eligible for the gastric band were not candidates for other bariatric procedures.
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“Clearly, if [the FDA] were looking at administrative claims data, they would have realized that we’re at the tipping point for reoperations for the device being more common than actually placing it,” said Dr. Ibrahim, during his presentation.
“We’re hoping some of this work will shed light that data from administrative claims may be a crude signal that can help us identify a device that isn’t working as well as we thought it was.”
The study’s most important consequence is that it shows how cost data could be used to change clinical practice, noted Jonah J. Stulberg, MD, PhD, MPH, assistant professor of surgery at Northwestern University Feinberg School of Medicine, in Chicago.
“The value is that the administrative records are able to show that this troubling trend towards reoperation was noted in the data well before any action was taken or most clinicians were aware. That means that we may be able to use data from administrative records to help change practice more expeditiously,” Dr. Stulberg said.
“It may serve as an early-warning signal that early success of a treatment may be overshadowed by late-onset complications.”
During the study period, Medicare paid $470 million for laparoscopic gastric band procedures, of which $224 million (47.6%) of the payments was for reoperations.
At its peak, as many as 96,000 gastric bands were implanted annually in North America, the vast majority in the United States. As late as 2015, the American Society for Metabolic and Bariatric Surgery estimated that more than 11,000 devices were placed per year.
Dr. Ibrahim and his colleagues studied data from the Medicare Provider Analysis and Review file from the Centers for Medicare & Medicaid Services for the years 2006 to 2013. By this time, the second- and third-generation gastric band devices that are currently used were already available.
Over the eight-year study period, 18.5% of all patients who received a gastric band as an index operation underwent reoperations, often multiple operations. There were 4,636 patients who underwent 17,539 reoperations, averaging 3.8 procedures per patient in addition to their index operation.
The most common reoperation was band removal, followed by band replacement. Of the patients who had a reoperation, 19.1% underwent a different bariatric operation, including gastric bypass or sleeve gastrectomy.
The mean payment was $12,345 for the index operation and $19,657 for each reoperation. Hospital referral regions demonstrated a 2.9-fold variation in risk- and reliability-adjusted rates of reoperation: at 13.3% in the lowest quartile and 39.1% in the highest.
Dr. Ibrahim and his colleagues repeated the study using data from the National Inpatient Sample, which includes Medicare patients and private insurers. The results paralleled the original study: In private insurers, $700 million of the $1.5 billion spent on procedures related to the gastric band were for reoperations.