Medicare administrative contractor Novitas Solutions now covers SI-Bone's iFuse Implant System on a case-by-case basis, pushing the number of Medicare beneficiaries who have access to reimbursement for the product up to nearly 15 million, the company said.
Novitas joins Palmetto as the second Part A/B MAC (out of 8) to offer coverage of the implant for fusion of the sacroiliac joint, which connects the pelvis to the lowest part of the spine, SI-Bone said in a statement. The product is now covered in 15 states and Washington, DC.
"This decision by Novitas provides further validation that (minimally invasive surgical) SI joint fusion is supported by strong clinical evidence and confirms that the procedure is consistent with generally accepted standards of medical practice in the medical community and is safe and effective," SI-Bone Vice President Michael Mydra said in the statement. "We expect significant additional clinical publications over the next 12 months with long-term data."
Novitas' decision became effective May 8 and Palmetto's in February. In technical terms, the two MACs removed CPT code 0334T from their list of non-covered services, SI-Bone said.
The iFuse received FDA clearance in 2008 and a CE mark in 2010.
Last month, SI-Bone received $33 million in financing from VC giants Orbimed and Novo A/S along with previous investors Skyline Ventures and Montreux Equity Partners. The money followed a promising implant, for the number of spinal fusion therapies increased 70% between 2001 and 2011 to 488,300, according to the federal Agency for Healthcare Research and Quality.
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