The Centers for Medicare and Medicaid Services (CMS) have announced that Stryker’s SpineJack System has qualified for the Transitional pass-through (TPT) payment. The TPT payment will become effective from January 2021, and forms part of the 2021 Medicare hospital outpatient prospective payment system.
The SpineJack is an implantable fracture reduction system, and is now one of 11 devices which have qualified for the TPT status since 2016. According to Stryker, the CMS decision was made based on both public commentary as well as the findings from the SAKOS trial. The SAKOS trail, a prospective multicentre, randomised study designed to support a non-inferiority finding for us of the SpineJack System versus balloon kyphoplasty (BKP), with regards to the absence of adjacent level fractures and midline vertebral body height restoration at both six and 12 months after the procedure.
According to Stryker’s press release, the TPT payment provides additional payments for new medical devices that demonstrate a substantial clinical improvement over existing technologies. The TPT payment will provide outpatient facilities with incremental Medicare payment for the SpineJack System for up to three years.
This decision from the CMS comes two months after the SpineJack System was awarded the New Technology Add-on Payment (NTAP), which provides additional payment for an inpatient setting.
Greg Siller, vice president and general manager of Stryker’s interventional spine business, USA, commented, “The CMS Transitional Pass-Through payment determination is a monumental step in providing a superior device technology in the treatment of osteoporotic vertebral compression fractures.” He continued, “Due to the SpineJack System receiving both NTAP and TPT payment, physicians and administrators no longer have to make a decision between care and cost. We remain committed to offering innovative Interventional Spine solutions and working with our customers to improve patients’ lives.”