KALAMAZOO—Officials at the Kalamazoo medical device maker Stryker Corp. announced that the Centers for Medicare & Medicaid Services has approved its SpineJack implantable fracture reduction system for the Transitional Pass-Through (TPT) payment as part of the 2021 Medicare Hospital Outpatient Prospective Payment System.
The SpineJack System now becomes one of only 11 medical devices to receive TPT status since 2016.
The TPT payment provides additional payments for new medical devices that demonstrate a substantial clinical improvement over existing technologies. The TPT payment will be effective on Jan. 1. The TPT payment will provide outpatient facilities with incremental Medicare payment for the SpineJack System for up to three years.
This announcement comes just over two months after CMS awarded the SpineJack System the New Technology Add-on Payment (NTAP), which provides additional payment in the hospital inpatient setting.
“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,” said Greg Siller, vice president and general manager of Stryker’s interventional spine business. “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.”
According to a recent study, more than 700,000 patients in the United States suffer from osteoporotic compression fractures each year. Changing the course of treatment for vertebral compression fractures, the SpineJack System comprehensively addresses reduction, fixation and restoration of these fractures. Vertebral augmentation procedures—such as balloon kyphoplasty—have been shown to reduce mortality by up to 55 percent compared to non-surgical management.
Stryker officials said the CMS decision was based on both public commentary as well as findings of a prospective, multicenter, randomized study designed to support a non-inferiority finding for use of the SpineJack System vs. balloon kyphoplasty in the treatment of painful osteoporotic VCFs. The study provided compelling evidence to establish the superiority of the SpineJack System over BKP with regards to absence of adjacent level fractures and midline vertebral body height restoration at both 6 and 12 months after the procedure.
Stryker offers products and services in its orthopaedics, medical-surgical, and neurotechnology-spine business lines. More at www.stryker.com.