Issue link: https://beckershealthcare.uberflip.com/i/1043345
15 Executive Briefing adds that stability to the segment. I feel the percentage of patients that will need subsequent surgery for progressive foraminal collapse and foraminal stenosis is going to go down as a result of coflex®. Q: What impact has the coflex® procedure had economically on the patient, the surgeon and the facility? EW: Having the coflex® procedure in the ASC can lead to an overall decrease in cost which is of benefit to the patient and insurer; the surgeon and facility benefit from the net balance. AP: [coflex®] is 1/10th the cost [of spinal fusion] in some cases, depending on the number of levels fused. I'd say it's a significant reduction in the overall cost. The advantage is ASC reimbursement went up in 2018 for interlaminar stabilization in the ASC setting. MJ: From the surgeon perspective, coflex® adds that stability after that laminectomy which can [prevent] problems down the road, as we in the industry prepare for and adapt to the bundled payment system. Patients appreciate the fact they can have a less-invasive surgery. For us as a facility, we work to ensure the procedure is economical for all parties. We are the ones ultimately trying to pull together all the different stakeholders, so we can get to a point and say, 'Yeah, this is economical for everybody.' PJ: For the center, the patient population that I'm using coflex® with is mostly a Medicare-age population. It's a patient that would've had a laminectomy, either inpatient or outpatient — or they would've had a fusion. In the Medicare population, those fusions are typically done at the hospital. If it's a patient and you can take into your surgery center, to do a laminectomy and implant a coflex® device, the economics for those cases is good. Financially it makes total sense to do those cases in your surgery center and the patient is getting a better surgery than fusion. Everybody wins. The patients win, the surgery centers win, the surgeon wins. Everybody is getting a better result by being able to do those coflex® cases. Q: What advice do you have for an ASC looking to add coflex®? AP: It's a very safe, reliable and reproducible procedure. There are good clinical outcomes documented in the literature. The coflex® device is safe and has good clinical quality. The most important thing [to keep in mind] is to find the right patient for it. There are certain patients that absolutely need a fusion. This is not a substitute for a lumbar fusion when indicated. This is more for bridging the gap for patients that generally don't need a fusion but just having a decompression alone could result in more instability. MJ: I would first say, you need to make sure you're working with your surgeons to identify these types of new procedures as early as you can. You always want to be as ahead of the curve as possible, [and] as part of that process you'll identify physician champions who will be willing to bring these cases if you can create an environment where it's economical to do them in. The final piece is to then work with the payers to make sure you have a fee schedule for these new procedures or surgeries, so once the payers allow it you can start bringing those cases to the surgery center. PJ: Don't do coflex® cases in your surgery center just because it's cost effective; Make sure you've done cases because you're a believer in the philosophy of why you're doing it and that you've done cases and seen positive outcomes from them. I did 15 cases in the hospital before I ever did one in a surgery center. I wanted to make sure I was happy with the technique and the patients were getting good outcomes. Once I saw the outcomes and was happy with the technique and the efficiency of the procedure I said, 'This is something I'd be happy to do in an outpatient setting.' Get comfortable with the procedure and the technique, make sure you're seeing reproducible, good outcomes and then move it into your surgery center. Why coflex® is right for your center Complimenting the anecdotal data, Paradigm Spine published several studies documenting the clinical effectiveness of coflex®. There are over 90 peer-reviewed publications on the coflex® device, making it one of the most studied lumbar spinal devices on the market. coflex® is the first and only lumbar spinal device with level 1 evidence in two separate clinical studies, against the two standard treatments (decompression alone and fusion), across two different countries. Paradigm Spine conducted a study in the U.S. as well as in Europe. The U.S. FDA study consisted of 322 patients; 215 patients undergoing decompression with coflex® interlaminar stabilization and 107 undergoing decompression and fusion with pedicle screws. Researchers captured five years of postoperative data. The researchers determined: "Results of this 5-year follow-up study demonstrate that decompression and interlaminar stabilization with coflex® is a viable alternative to traditional decompression and fusion in the treatment of patients with moderate to severe stenosis at one or two lumbar levels." The ESCADA (European Study of coflex® and Decompression Alone) trial consisted of 230 patients; 115 patients undergoing decompression with coflex® interlaminar stabilization and 115 undergoing decompression alone. Researchers captured two years of postoperative data. The coflex® device proved to be statistically superior compared to decompression alone for Composite Clinical Success, increases walking distance, decreases compensatory pain management, and maintains foraminal height; thereby extending the durability and sustainability of a decompression procedure. Last year a new Category 1 CPT code was created for interlaminar stabilization following a decompression surgery, effective Jan. 1, 2017. In addition, CMS added the code to the list of spine approved procedures for the ASC setting. Various commercial payers have begun to follow suit. The code is CPT 22867: Insertion of interlaminar / interspinous process stabilization / distraction device, without fusion, including image guidance when performed, with open decompression, lumbar; single level.n Paradigm Spine, LLC is the manufacturer of the non-fusion coflex® Interlaminar Stabilization® device, a smart option for lumbar spinal stenosis patients. As a single piece non-fusion device that's implanted after a microsurgical decompression, patients experience immediate and lasting pain relief from their stenosis symptoms, making coflex® a smart treatment option to offer at your ambu- latory surgical center.