Transoral GERD Devices: Riding Out The Road To Reimbursement

Article preview from Medtech Insight - May 28, 2013

With health care becoming increasingly data driven, third-party payors are requiring a higher level of evidence before making a positive coverage determination for a new technology or procedure. This has made the road to reimbursement much longer and tougher for device companies in general, and manufacturers of transoral devices for GERD are a prime example.

Transoral GERD Devices: Riding Out The Road To Reimbursement

Article preview from Medtech Insight - May 28, 2013

For medical device start-ups, the hurdles to bringing a new device to market seem higher than ever given the current financial constraints, regulatory challenges, and increasing demand for data that demonstrate the value of new medical technologies in terms of cost effectiveness and patient outcomes. But even if companies can rise above these challenges, they still have to overcome what has arguably become the highest hurdle of all: obtaining reimbursement. Many start-ups are running into a wall when it comes to obtaining insurance coverage for a new technology or procedure, and companies can easily run out of time and financing before they can obtain the type of clinical data that third-party payors are requiring before they provide reimbursement. The path to reimbursement has always been long and arduous, but health care is becoming increasingly data driven and more and more payors are requiring higher level evidence before making a positive coverage determination for a new technology or medication. 

Lately, these challenges have been particularly acute for companies developing minimally invasive devices for the treatment of GERD (gastroesophageal reflux disease). In the early 2000s, physicians and payors were hopeful that minimally invasive GERD devices might provide a less invasive and less costly alternative to Nissen fundoplication, the established surgical treatment for medically refractory GERD.

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