Reimbursement in treating morbid obesity will be focus of public, two-day workshop

With obese patients increasingly avoiding bariatric surgery, federal regulators and gastroenterologists will hold a two-day public workshop in Washington starting Thursday to re-evaluate how new minimally invasive obesity treatment devices should be regulated and reimbursed.

The Food and Drug Administration and the American Gastroenterological Association will sponsor the workshop at the Grand Hyatt Hotel on procedures and devices that treat morbid obesity and other metabolic diseases.

Physicians say that many obese patients choose not to have surgery because currently available bariatric procedures reducing stomach capacity or food intake are invasive, expensive, sometimes permanent and have significant health risks in both the short- and long-term.

“The major trend is the move away from conventional surgery to endoscopic or oral approaches,” said Dr. Pankaj Jay Pasricha, director of the center for neurogastroenterology at Johns Hopkins Medicine in Baltimore. “There is a push toward device procedures that do not require incisions.”

The FDA already has recognized some of the challenges in bringing obesity devices to market. Agency officials last year proposed a benefit-risk assessment that they say would provide a more consistent pathway to approval. “We are moving away from our 'one-size-fits-all' approach to clinical trial outcomes for these devices,” FDA officials wrote in an article published in Surgical Endoscopy in December 2012.

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