NuVasive Inc. 08.04.16
NuVasive Inc. said 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 U.S. Food and Drug Administration for pediatric spinal deformity, helping surgeons reduce the number of surgeries required to treat patients with early onset Scoliosis (EOS).
"CMS's decision will significantly improve patient access to MAGEC, which is quickly becoming the standard of care for pediatric patients with EOS," said Gregory T. Lucier, chairman and CEO of NuVasive. "The 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 technology."
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 Oct. 1, 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 of the Scoliosis Research Society. "This is not only good for the children, but for their families as well."
NuVasive develops minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, 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 worldwide.
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 U.S. Food and Drug Administration for pediatric spinal deformity, helping surgeons reduce the number of surgeries required to treat patients with early onset Scoliosis (EOS).
"CMS's decision will significantly improve patient access to MAGEC, which is quickly becoming the standard of care for pediatric patients with EOS," said Gregory T. Lucier, chairman and CEO of NuVasive. "The 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 technology."
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 Oct. 1, 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 of the Scoliosis Research Society. "This is not only good for the children, but for their families as well."
NuVasive develops minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, 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 worldwide.