The Centers for Medicare & Medicaid Services granted Stryker’s SpineJack implantable fracture reduction system Transitional Pass-Through payment status as part of the 2021 Medicare Hospital Outpatient Prospective Payment System, ensuring increased patient access to a cutting-edge device for the treatment of osteoporotic vertebral compression fractures.
The Centers for Medicare & Medicaid Services (CMS) made the announcement last week, and the Transitional Pass-Through (TPT) payment will be effective Jan. 1.
The TPT payment program — which provides supplemental reimbursements to Medicare on top of the base capitalization rate — was established by Congress in 2000 to facilitate “beneficiary access to innovative medical devices, drugs and biologicals” that “demonstrate a substantial clinical improvement over existing technologies” to prevent inadequate payment when the technologies are used in an appropriate outpatient setting. In other words, CMS provides the TPT payment so as not to prevent use of new technologies due to cost concerns.
The TPT payment will provide outpatient facilities with incremental Medicare payment for the SpineJack System for up to three years. SpineJack is now one of only 11 medical devices to receive TPT status since 2016.
Stryker being awarded TPT status for SpineJack 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. We remain committed to offering innovative interventional spine solutions and working with our customers to improve patients’ lives.”
Over 700,000 patients in the U.S. suffer from osteoporotic compression fractures each year. Changing the course of treatment for vertebral compression fractures (VCF), the SpineJack System comprehensively addresses reduction, fixation and restoration of these fractures. Vertebral augmentation procedures — such as balloon kyphoplasty (BKP) — have been shown to reduce mortality by up to 55% compared to nonsurgical management.
The CMS TPT decision was based on public commentary as well as findings from the SAKOS trial — a prospective, multicenter, randomized study designed to support a noninferiority finding for use of the SpineJack System versus BKP in the treatment of painful osteoporotic VCFs.
SAKOS 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 six and 12 months after the procedure.