Within the lumbar degenerative market, lumbar spinal stenosis (LSS) often progresses in patients over time. While conservative care is the desired treatment, sometimes surgical intervention is necessary.
LSS surgical intervention options include indirect decompression; decompression alone; decompression plus fusion stabilization; and decompression plus coflex Interlaminar Stabilization.
During a Paradigm Spine-sponsored workshop, Hallett Mathews, MD, Paradigm Spine chief medical officer, provided an overview of the coflex Interlaminar Stabilization device, and how it is implanted after a direct surgical decompression procedure. He delivered the presentation, titled "Introducing a Non-Fusion Alternative for Lumbar Spinal Stenosis in the ASC," at Becker's 15th Annual Spine, Orthopedic and Pain Management-Driven ASC Conference + The Future of Spine on June 24 in Chicago.
A motion-preserving, neutral stabilization device, the coflex device loads on interlaminar bone as opposed to spinous process bone. By leveraging this procedure, surgeons are able to see the nerve pathology through the laminotomy; complete the desired decompression; and add a non-fusion stabilization device.
coflex is designed to preserve motion; reduce leg and back pain; maintain foraminal height; and preserve normal kinematics at the operative and adjacent levels. "Surgeons now have the opportunity to stabilize a degenerative segment after direct surgical decompression for lumbar spinal stenosis that does not involve a fusion procedure,” explained Dr. Mathews.
Prime candidates for the coflex device are those with leg and back pain caused by spinal stenosis who may benefit from a more extensive decompression, but may not have gross instability or require a fusion procedure. The device's indications are for one or two levels of the lumbar spine, L1 through L5.
A class 3 device, the coflex device received premarket approval in October 2012. A five-year clinical trial compared coflex Interlaminar Stabilization to pedicle screw fusion surgery for treating moderate to severe LSS. The 2016 study, published in International Journal of Spine Surgery, analyzed coflex safety, efficacy and durability. coflex patients maintained significant improvement in visual analog scale leg and back pain. Decompression and interlaminar stabilization patients experienced significantly better SF-12 and Zurich Claudication Questionnaire scores during early follow-up, compared to decompression and fusion with pedicle screws patients.
"This [study] not only addresses the stenosis component, but it also helps both VAS back pain and leg pain that's sustained at five years," added Dr. Mathews. "So this treatment option is clinically durable and not a transition to a bigger and more invasive fusion procedure."
The device's ability to maintain foraminal height, retain index level motion while protecting the adjacent level kinematics creates a trifecta of care for spinal stenosis treatment.
"You see some very substantial evidence to prove that this is a sustainable, durable, stabilization procedure that is not a fusion technique, that involves motion-preserving stabilization after a surgeon's decompression and it's certainly fit for the ASC setting, as well as multiple sites of service depending on medical necessity," concluded Dr. Mathews.
coflex in the outpatient setting
During the workshop, Thomas Scully, MD, a neurosurgeon at Tucson, Arizona-based Northwest NeuroSpecialists, shared tips from his years of experience using the coflex device.
- Dr. Scully emphasized the procedure is mainly a decompression, and surgeons must complete adequate decompressions in order for the device to properly work.
- He recommended surgeons not be too aggressive with facet joint removal, as maintaining stability is critical.
- Place the device as close to the dura as possible, within 1 to 2 mm since it is an interlaminar device, not a spinous process device.
- When first using the coflex, Dr. Scully said many surgeons will undersize the device and with experience, surgeons will likely oversize it. Ideally, surgeons should shoot for 1 to 2 mm of facet separation.
- Dr. Scully recommended using intraoperative X-ray to directly visualize the distraction.
- Do not place the patient in kyphosis, but in neutral position.
- Using the coflex requires more "carpentry work" with the spinous processes than other procedures, said Dr. Scully. If surgeons don't properly align the spinous processes, they will face laminar "moguls" that impair proper placement of the device in an anterior position.
Dr. Scully shared three case studies of a 64-year-old male, 71-year-old male and 46-year-old female with varying symptoms. He performed a coflex Interlaminar Stabilization procedure on each patient, all of which experienced positive outcomes.
"This is a happy cohort of patients," said Dr. Scully.
CMS created a new Category 1 CPT code for interlaminar stabilization following a decompression surgery, effective Jan. 1, 2017. 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.
coflex is also indicated for two contiguous levels with using CPT 22868. It is listed in addition to the primary code and covers a second coflex procedure performed at an additional level.
"The exciting thing about this code is that it is a bundled, Category 1 code, which denotes the highest level of clinical evidence," said Devon Billeter, Medical Science Liaison for Midwest/Central U.S. at Paradigm Spine.
Medical Science Liaisons work with healthcare providers to teach, train and advocate for the best path for the patient by leveraging clinical research, peer-reviewed articles and medical society publications to bring expertise to any setting of care.
Ms. Billeter explained CMS also established clear reimbursement pathways for inpatient and outpatient facilities. "That really means that today, your surgeons and your facilities can choose the right site for the patient based on their unique medical necessity," she said.
A Milliman analysis found coflex saves 14 percent to 27 percent in per-member per-month costs compared to fusion. Ms. Billeter noted Medical Science Liaisons can help ASCs with their contracts by presenting this cost-saving information to payers.
"We feel very confident that the insurance companies, i.e. the commercial payers, are going to give us coverage policies, as soon as maybe even this year," Ms. Billeter said.
Medicare national average payment for coflex is as follows:
- Hospital inpatient — $17,253
- Hospital outpatient — $14,698
- ASC — $10,542
"Some of the things that are helpful in getting payer coverage are the spine societies writing policies," said Ms. Billeter. "That has begun to happen already." In December 2016, the International Society for the Advancement of Spine Surgery published a coverage recommendation for decompression with interlaminar stabilization. Ms. Billeter said they hope to see the North American Spine Society follow suit with coverage recommendation soon.
To partner with a Paradigm MSL, contact:
- Erin Crawford in the Western U.S. — firstname.lastname@example.org
- Devon Billeter in the Central U.S. — email@example.com
- Gaye Zingler in the Eastern U.S. — firstname.lastname@example.org
To view the full presentation slides, click here.