Minimally invasive sacroiliac joint fusion surgery obtained a Category I CPT code beginning January 1, 2015.
The new payment code could encourage more payers to reimburse for the procedure. This past year, two Medicare contractors approved coverage, including Palmetto and Novitas, where the procedure is covered. Just recently, Noridian confirmed allowed coverage of the new Category I code for MIS SI joint fusion starting January 1, 2015.
"For many patients today, surgeons have to file appeals for iFuse procedures because many insurance companies still consider the procedure experimental," says Jeff Dunn, President and CEO of SI-BONE. "However, now there is a Category I code. That doesn't mean all insurance companies will immediately provide coverage, but we believe we've done a spectacular job presenting clinical evidence that shows very positive efficacy, safety, durability and economic value of the iFuse procedure, and that will therefore support coverage decisions."
A recent outcome study published in The Open Orthopaedics Journal on SI-BONE's iFuse technology examined 21 patients at five years following surgery. Of these, 17 provided clinical information and 15 underwent x-ray and CT imaging.
The study found:
• Patient satisfaction of 82 percent at one and five years after surgery
• Visual analogue scores improved from 8.3 at baseline to 3.4 one year after surgery and 2.4 at five years after surgery
• Oswestry Disability Index score was 21.5 at five years
• None of the patients showed device migration
• There were no intraoperative or long-term complications
• Osseous bridging across the SI joint was observed in 13 out of 15 (87 percent) of patients
"This five-year paper shows very impressive results," says Mr. Dunn. "In addition, a new paper was published this past week in Europe that shows even better results on 24 patients treated with iFuse at an average 23 month follow up, including results out to 4.5 years for some patients."
SI-BONE is also sponsoring a large prospective, randomized controlled trial with 148 patients enrolled at 19 sites. The study will be submitted for publication this month and will be available early next year. In addition, there is a new study that evaluates the revision rate after iFuse surgery in an 11,000 patient database.
"Our expectation is that the RCT (randomized control study) publication will show similarly excellent results," says Mr. Dunn. "As a result, in the first quarter of 2015, we are optimistic that we will see some uptick in insurance companies covering minimally invasive SI joint surgery. I think in the second quarter, the procedure coverage will increase dramatically and in the third and fourth quarter it will hopefully be common to cover this type of procedure."
Insurance companies aren't the only barrier to these procedures; physician education also creates an access problem. Many surgeons don't learn minimally invasive SI joint surgeries during training and sometimes don't have a grasp of the indications or how to diagnose. SI-BONE is training surgeons and SIJ diagnostic techniques are being added to back pain differential diagnosis and interest is growing.
"There are more people willing to be trained now," says Mr. Dunn. "We've trained more than 1,000 surgeons in the United States so far. Some surgeons learned the procedure when it was a Category III code, and they'll continue to do the procedure while others waited for the Category I code. But I'm quite sure we'll see robust activity with the new code."
In preparation for increased demand, SI-BONE has ramped up its sales force in the face of the reimbursement headwind. The company now has 60 sales people in the United States with another 85 to 90 people who support its field organization, as well as patients and surgeons. The company is also expanding worldwide, but most revenue still comes from the United States.
"We are doing surgeries in 16 countries in Europe," says Mr. Dunn. "We are also expanding in Asia and have approvals in Australia, New Zealand, Hong Kong and Singapore. We're thoughtfully making investments in Asia and Europe, as well as significant investments in the United States, with our field team as well as in medical affairs to support surgeon education and expand our training programs."
The company is also working on more clinical studies and new innovative products. "We are keenly aware that SIJ fusions with the iFuse procedure are only appropriate when patients fail conservative care and when they are properly diagnosed with certain FDA cleared indications," says Mr. Dunn. "When we first started the company, we were confident that the product was good. Now we have the clinical evidence to back up what we always knew."