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Reimbursement / Regulatory

NuVasive Secures CMS Add-On Payment for MAGEC System -

The U.S. Centers for Medicare and Medicaid Services (CMS) granted a new technology add-on payment (NTAP) for magnetically-controlled growth rods. NuVasive's MAGEC® system is the only magnetically-controlled growth modulation system cleared by FDA for the treatment of pediatric spinal deformity.

Effective as of 4Q16, the NTAP will provide added reimbursement to U.S. hospitals/health systems for using MAGEC to treat Medicare patients with early onset scoliosis, in addition to the DRG reimbursement of up to 50% of the cost of MAGEC.

For a technology to qualify for an NTAP in the inpatient setting, the solution must demonstrate a substantial clinical improvement relative to available alternatives.

MAGEC comprises a sterile, single-use surgically-implanted spinal rod to brace the spine during growth. The system includes an internal magnet that is controlled by an external remote controller. Periodic rod lengthening is performed externally, in an office setting, to distract the spine. This non-invasive treatment can reduce planned distraction surgeries from up to 15 down to one, minimizing risks and reducing the total cost of care.

Ellipse Technologies announced the world’s first dynamic adjustment of its MAGnetic Expansion Control system in late 2009. The system received initial FDA 510(k) clearance in 1Q14, followed soon after by its first U.S. implantation. NuVasive acquired MAGEC technology with its purchase of Ellipse Technologies.

Sources: NuVasive, Inc.; ORTHOWORLD Inc.

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