SAN DIEGO, CA --(Marketwired - August 04, 2016) - NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced that the U.S. Centers for Medicare and Medicaid Services (CMS) has granted a new technology add-on payment (NTAP) for magnetically controlled growth rods. For a technology to qualify for an NTAP in the inpatient setting, the solution must demonstrate a substantial clinical improvement relative to available alternatives. The Company's MAGEC® system is the only magnetically controlled growth modulation system cleared by the FDA for pediatric spinal deformity, helping surgeons reduce the number of surgeries required to treat patients with Early Onset Scoliosis (EOS).
Gregory T. Lucier, chairman and chief executive officer of NuVasive, commented, "CMS's decision will significantly improve patient access to MAGEC, which is quickly becoming the standard of care for pediatric patients with EOS. The innovative MAGEC rod can be extended non-invasively with a magnet, reducing the number of planned distraction surgeries from up to 15, to only a single one. By transforming the experience for these patients, NuVasive is able to help minimize the risks associated with multiple surgeries, while also reducing the total cost of care. Thank you to our surgeon partners for supporting NuVasive through this rigorous process, and we will continue to work alongside providers and payors to improve access to innovative technology."
CMS NTAP Policy
The CMS NTAP policy was implemented in 2001 to support access to innovative solutions for Medicare beneficiaries in the inpatient hospital setting that are not adequately paid for under the Medicare Severity Diagnosis-Related Groups (DRGs). Effective October 1, 2016, the NTAP will provide added reimbursement to U.S. hospitals and health systems for using MAGEC for treating Medicare patients with EOS, in addition to the DRG reimbursement of up to 50 percent of the cost of MAGEC.
MAGEC is comprised of a sterile, single use spinal rod that is surgically implanted to brace the spine during growth and includes a small internal magnet that is controlled by an external remote controller. Periodic lengthening of the rod is performed externally to distract the spine in an office setting, eliminating distraction surgeries and helping to simplify care.
"We are excited that CMS sees the value in new technology that lessens the number of surgeries to treat this condition in young children," said David M. Polly*, M.D., Professor and Chief of Spine Surgery, Department of Orthopedic Surgery at University of Minnesota and President, Scoliosis Research Society. "This is not only good for the children, but for their families as well."
NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive's highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $811 million in revenues (2015), NuVasive has an approximate 1,900 person workforce in more than 40 countries around the world. For more information, please visit www.nuvasive.com.
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive's results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with future changes in CMS reimbursement policies, acceptance of the Company's surgical products and procedures by spine surgeons, clinical and statistical verification of the benefits achieved via the use of NuVasive's products (including the iGA™ platform), the Company's ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive's news releases and periodic filings with the Securities and Exchange Commission. NuVasive's public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.
* Dr. David Polly has no financial conflicts or relations with NuVasive.