Transoral GERD Devices: Riding Out The Road To Reimbursement

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. (See [A#2013800067] and Also see "UnitedHealthcare Teams Up With Hospitals To Scrutinize Device Outcomes" - Medtech Insight, 15 April, 2013..)

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...