Zyga Technology announced the first patient enrollment in its study to evaluate fusion and pain reduction following use of the SImmetry Sacroiliac Joint Fusion System.
Here are five things to know:
1. The SImmetry Sacroiliac Joint Fusion System is a minimally invasive procedure intended for conditions such as sacroiliac joint disruptions and degenerative sacroiliitis. It was granted 510(k) clearance by the U.S. Food and Drug Administration in March 2013.
2. The prospective, single-arm, post-market study, called the Sacroiliac Fusion Study or SAIF, will be performed at a single center and will include up to 15 patients. "Clinical studies such as SAIF are critical to demonstrate the empirical value of sacroiliac joint fusion," said Noel D. Goldthwaite, MD, who performed the surgery for the study.
3. Reimbursement for SI fusion has undergone some changes recently. In March 2014, the American Medical Association's CPT Editorial Panel announced it would establish a Category I CPT code for minimally invasive SI joint fusion, which previously had a Category III code. The change will go into effect Jan. 1, 2015.
Also, the Medicare Administrative Contractor Novitas Solutions removed minimally invasive sacroiliac joint fusion from non-coverage. It removed CPT code 0334T, which was previously used to report the iFuse procedures, from the "Services That Are Not Reasonable and Necessary." There are more than 11 million Medicare beneficiaries covered by Novitas that will now have access to MIS SI Joint fusion.
Finally, Medicare Administrative Contractor Palmetto GBA announced it will cover minimally invasive sacroiliac joint fusion procedures on a case-by-case basis.
4. SI-BONE, a major player in the SI fusion market released an economic analysis last year that compared costs between non-operative care and minimally invasive surgery for both sacroiliac joint disruption and degenerative sacroiliitis in a U.S. Medicare population. The researchers found MIS SI joint fusion could save between $660 million and $4 billion over a lifetime of non-operative care. The model showed a per patient lifetime cost savings of $8,692.
5. GlobalData recently reduced its predicted compound annual growth rate for the spinal fusion market from 10 percent to 5 percent through 2020. Spinal fusions remain an expensive procedure and as a result payers are demanding more documentation before approving these procedures. Their reimbursement policies are changing and surgeons across the country are reporting more denials.
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