Citing the data from a quartet of randomized, controlled trials, the AGA said transoral incisionless fundiplication with Esophyx ought to be reimbursed for the 20% to 40% of GERD patients who don’t respond to medication.
“[T]he 3‐year-plus evidence is sufficient to demonstrate sustainable improvement in health outcomes, symptom relief, decrease in [proton pump inhibitor] utilization and improvement in esophageal pH with transoral fundoplication,” according to the society’s new guidelines, which hadn’t been updated since 2008. “This option should be considered in patients not responding to PPI therapy (symptoms of regurgitation) who have documented objective evidence of GERD (pathologic acid exposure on pH testing (both off and on medication)) or esophagitis. Transoral fundoplication should be covered and reimbursed for appropriate patients who meet the selection criteria as described.”
“This demonstrates key society support for the TIF procedure as an anti-reflux procedure option for chronic GERD suffers,” EndoGastric Solutions president & CEO Skip Baldino said in prepared remarks. “We are grateful to the AGA and its panel of experts to issue such a review in advance of updates to existing society guidelines.”
“This statement by the AGA is important for advocacy work with payers,” added vice president of healthcare economics, policy & reimbursement Philip Macdonald. “Publishing new guidelines can be time consuming and cost prohibitive. The evolution of data-proven technologies to treat chronic diseases is accelerating, so the technology coverage statement by the AGA can help fill the gap during the society’s guideline review cycle. This ensures society membership is able to provide safe and effective treatments for chronic disease sufferers sooner.”
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.