SI-Bone's spinal fusion implant gains near-total Medicare coverage on back of strong studies

iFuse Implant System--Courtesy of SI-Bone

SI-Bone's iFuse Implant System is one state away from nationwide Medicare coverage. Medicare Administrative Contractor National Government Services has agreed to reimburse the spinal implant used to treat sacroiliac joint disruption and degenerative sacroiliitis via minimally invasive spinal fusion.

NGS covers New England, as well as New York, Minnesota, Illinois and Wisconsin, leaving Florida as the only state where the device is not covered by the local MAC, First Coast Service Options.

The 8 MACs make coverage determinations for devices that are not covered on nationwide basis by the Centers for Medicare and Medicaid Services. San Jose's SI-Bone says the NGS decision makes the iFuse available to 9.5 million additional Medicare beneficiaries starting in April.

The positive decision comes a few months after SI-Bone announced a $39.2 million credit facility from Oxford Finance and Silicon Valley Bank to help market iFuse.

"The decision by NGS is a positive step forward for Medicare beneficiaries in the NGS service area who will soon have access to the iFuse procedure and it is gratifying to know that Medicare recipients in all but one state will soon have coverage. Some doctors have said iFuse can be a life-changing procedure for properly diagnosed patients and our studies demonstrate that many people treated with iFuse have shown meaningful improvements in their quality of life and have been able to return to their normal activities of daily living following the procedure," said SI-Bone's vice president of health outcomes & reimbursement, Michael Mydra, in a statement.

Separately, SI-Bone touted two recent studies of the device's health economics published in ClinicoEconomics and Outcomes, which may have contributed to the positive local coverage decision. One, found the minimally invasive sacroiliac joint fusion is cost-effective and produces cost savings in the long-run, while the other determined that the procedure should be considered in preoperative patients with chronic lower back pain.

"Shooting at the wrong target, i.e., performing surgery on the wrong body part, is clearly not in the patient's best interest," said Dr. David Polly, author of the second study, in a statement. "We were interested in understanding the financial impact of failing to consider the SI joint as a potential pain generator in patients with chronic lower back pain who are seeking surgical treatments. The results are edifying in terms of the amount of money, but perhaps not surprising given the high intensity and cost of surgical interventions."

Last year, the company gained an indication statement that says, "Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function and quality of life at 12 months post-implantation."

The positive studies are needed to reassure doctors and payers of the procedures' necessity. The government estimates that $200 million was spent on unnecessary spinal fusion procedures in 2011, leading to a crackdown on reimbursement. By one estimate the procedure is 14 times more likely to be carried out in a locality in Florida than one in Maine.

- read the release | here's another one about the studies
- read the study | read the other study