Ask the experts — Why coflex® is right for your ASC

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Paradigm Spine's coflex® Interlaminar Stabilization® device is meeting an unmet need in surgical treatment at spinefocused ASCs.

This article is sponsored by Paradigm Spine.

The coflex® device provides pain relief with clinical outcomes similar to spinal fusion. However, unlike spinal fusion, coflex® preserves lumbar motion. As CMS continues to approve additional spinal procedures for the ASC setting, coflex® is a clinically appropriate and economical option for ASC administrators everywhere.

Becker's ASC Review spoke with several experts about the coflex® Interlaminar Stabilization® device to gain insight into how spine is trending in the ASC setting and how coflex® is revolutionizing spine care. Conversation participants included:

  • Erich Wolf, MD, PhD a neurosurgeon at Surgicare of Lake Charles (La.)
  • Paul Jeffords, MD, an orthopedic surgeon at Atlanta-based Resurgens Orthopaedics
  • Anuj Prasher, MD, a spine surgeon at Stuart-based South Florida Orthopaedics & Sports Medicine
  • Michael Judge, administrator of Norwood, Ohio-based Mayfield Spine Surgery Center

Note: Response have been lightly edited for length and clarity.

Question: How is spine trending in the ASC setting, and what impact has it had on you, your facility and your patients?

Dr. Erich Wolf: Spine surgery is definitely a growing trend in the ASC setting. With the trend toward minimally invasive surgery we are able to perform increasingly complex spinal surgery in an outpatient setting. This allows our patients to enjoy the benefits of the ASC, that is, convenience, personalized care and lower cost. As a surgeon and shareholder in the ASC, we are the architect of our own environment, allowing us to tailor our daily experience to our personal preference.

Dr. Paul Jeffords: The trend over the years has been a greater number of spine cases moving out of the hospital and into the surgery center. I think that's a byproduct of more minimally invasive surgeries, better technologies in terms of spinal implants, better anesthesia techniques and better regimens for postoperative pain control. What that resulted in is a better experience for the patient. When a patient is able to have a surgery at a dedicated outpatient orthopedic and spine center, it's more of a tailored experience for the patient. They're getting more of a boutique experience and are taken care of at a specialty center that's dedicated to that aspect of medicine. Patients have a more efficient experience in terms of check-in and check-out. It's just better overall for the patient, plus they don't have to spend the night in a hospital, which reduces the risk of infection. It's better for the surgeon and better for the patient and as time goes on we're going to see that happening more and more and you'll see a greater number of cases move to the outpatient setting.

Michael Judge: For us, patient and surgeon interest in spine surgery continues to grow. We've seen that growth over the 11 years we've been operating as the Mayfield Spine Surgery Center. Patients can be amazed when they hear they can have this type of surgery in the ASC setting.

They appreciate the reduction in complexity the day of the surgery. From parking, navigating the building, staying in the same room with the same staff, to even leaving the same day, patients and families appreciate the ASC experience. The surgeons also appreciate the efficiencies we bring operationally along with the specialized experience our staff and the anesthesia team we work with bring, given we've been doing what we've been doing for over a decade.

[Focusing on spine was] really a push by the Mayfield practice neurosurgeons. They wanted to make a move that ultimately was what turned into the spine surgery center.

Q: In your opinion, why is spine in an ASC so valuable to the healthcare system?

Dr. Anuj Prasher: [Spine in an ASC is] definitely more cost effective and cost conscious. Everyone involved in the center is aware of how much all the materials and disposable items we use [cost], so there is very little that goes to waste in the ASC setting.

That's why I think [spine-based ASC procedures are] really valuable. We're able to provide the same or better care at a much lower cost in a much more convenient and efficient fashion.

EW: Spine surgery in an ASC setting is economically competitive compared with a hospital setting, providing value to payers. A clinical advantage is enjoyed by the ASC since the staff become very familiar with a niche of spinal surgical procedures.

Q: How does the coflex® Interlaminar Stabilization® device help improve quality outcomes?

EW: The coflex® interlaminar implants have really improved the patient experience following lumbar decompression surgery. The additional segmental stabilization afforded by the implant seems to provide improved patient satisfaction, particularly in cases where adequate decompression may cause decreased stability.

AP: [I use] coflex® in my practice mainly for people without significant instability that still have severe spinal stenosis. It's a stabilization device that has been shown to be used safely in patients who have very minimal instability in the setting of severe spinal stenosis. Research has shown it's a very good option to use in those patients because it still provides stability after decompression.

PJ: The way I see coflex® is it's a procedure for patients that need more than just a laminectomy but may not necessarily need a fusion. It's that in between option that we've never had in the past. It can be done minimally invasively and as an outpatient. Coflex® 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.

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