Growing your ASC & offering a better treatment for lumbar spinal stenosis patients

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Paradigm Spine's coflex® Interlaminar Stabilization® device is helping ASCs and spine-based practices stand out in a crowded healthcare field.

During a Sept. 28 webinar sponsored by Paradigm Spine and hosted by Becker's ASC Review, Jeff Hayes, Paradigm Spine's Director of Field Training and Support; Kevin Ammar, MD, a neurosurgeon at the Neurological Institute of Savannah (Ga.) and Center for Spine; and Saul Epstein, Administratoionfor Coconut Creek, (Fla.)-based Park Creek Surgery Center and Delray (Fla.) Beach Surgery Center, discussed Paradigm Spine's coflex® Interlaminar Stabilization® device for lumbar spinal stenosis treatment and why it is a smart fit for any setting of care. S. Raymond Golish, MD, PhD, MBA, an orthopedic surgeon in Palm Beach, Fla.,moderated.

Lumbar spinal stenosis is one of the most common diagnoses spine surgeons see. While most minor cases can be handled non-surgically, major cases require surgical intervention. Historically, that intervention folloed one of two pathways: spinal decompression for less severe cases and spinal decompression with fusion for the more severe. Until recently, there was no option for the patient with both leg and back pain caused by lumbar spinal stenosis, which includes a large part of the patient population.

"Surgeons were left with the possibility of undertreatment with decompression and overtreatment with fusion, " Dr. Golish said.

This dilemma was resolved when the FDA approved the coflex® Interlaminar Stabilization® device in 2012. coflex® is the first and only non-fusion stabilization device for lumbar spinal stenosis inserted post direct surgical decompression, Mr. Hayes said. The device received FDA approval in 2012 to fit at one or two contiguous levels in the L1-L5 interlaminar space.

The ease and minimally invasive nature of the procedure made it a natural fit for the ASC and outpatient setting. CMS followed suit updating C-APC codes in 2017 to properly reimburse for the procedure. In the hospital outpatient setting, this level 6 musculoskeletal procedure (C-APC 5116) is $14,698 as of January 2017 on average, while in the ASC setting, the procedure is $10,542 on average, Dr. Golish said. The payments are contained within a bundled code. The procedure can also be reimbursed through a commercial carrier, though requires a prior authorization process, Mr. Epstein said.

Dr. Golish said the level of evidence supporting coflex® Interlaminar Stabilization® is "second to none."

Paradigm Spine conducted a study of 215 patients undergoing decompression and interlaminar stabilization using coflex® and of 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."

Concerning both leg and back pain, coflex® relieved pain scores by 70% immediately and through  to 60 months postoperatively which demonstrated the sustained effectiveness of the device while preserving motion, according to Mr. Hayes

He said, "coflex® is a durable and sustainable treatment option for lumbar spinal stenosis patients. In addition, as a primary indicator to measure operative success, ODI pain and functional outcome scores are often used. At the three month postoperative point out to five years, coflex® patients demonstrated greater sustained improvement in overall ODI, indicating that stabilizing with the coflex® device is a safe, effective, and durable treatment for your lumbar spinal stenosis patients."

In practice

Dr. Ammar shared his clinical expertise using coflex®.

Dr. Ammar first heard about it two years ago while attending a local seminar introducing the technology. He thought the procedure was a "modest technical extrapolation from Medtronic's X-Stop," but after researching it more, his thoughts changed. Dr. Ammar now sees coflex® as a "durable solution for one- or two-level lumbar stenosis and also a simple but efficacious option that warrants consideration for certain cases of Grade 1 spondylolisthesis."

Dr. Ammar provided a breakdown of which patients should be in either hospital inpatient or outpatient, as well as ASC site of service, based on his experience. He recommends performing a coflex® case in an inpatient setting if the patient has:

  • Medical comorbidities that may necessitate overnight observation
  • A poor social network at home
  • Two-level cases with anticipated needs for overnight drainage

He recommends the hospital outpatient setting for patients who prefer a hospital setting of care and he recommends the ASC setting for "everyone else."

"I think about coflex® patients the same way I think about patients I treat for laminectomy alone," Dr. Ammar said.

Dr. Ammar incorporated coflex® Interlaminar Stabilization® into his ASC first with a simple single-level case, and after completing his first case with "great success," his ASC started offering the procedure. "It did really bring a new population of patients that previously weren't considered for the surgery center setting; specifically, those that were considered for a fusion."  

He had some suggestions for those interested in bringing coflex® to their ASC: start simple, build appropriate expectations with patients preoperatively; consider paraspinal musculature local anesthetic used for other outpatient procedures; and stay cognizant of a possible hematoma while considering polymerized gelfoam or even placing a temporary drain.

ASC Administration Mr. Epstein has also seen success since integrating coflex® into his practice. He was first introduced to coflex® in 2015 at the request of one of his center's surgeons. After evaluating the economics of the procedure, he decided to adopt it and begin offering it.  

Mr. Epstein said his surgery center was one of the first in Florida to do "real spine surgery." coflex® fit right into the culture at his surgery center, while also not requiring additional postoperative services. In 2017, CMS assigned the aforementioned CPT code to this procedure, which correlated with an increase in the center's case volume. An unintended benefit of that increase was an increase in both case and surgeon recruitment.

"In the past they had not been coming, and the existing medical staff members doing coflex® at the hospital began bringing surgeons over to the ASC because of the economics," Mr. Epstein said.

Mr. Epstein reiterated that coflex® provides the opportunity to differentiate his center from other centers. "Our doctors say that patients are very happy from the procedure," Mr. Epstein said.

Both Dr. Ammar and Mr. Epstein recommend coflex® to boost case volume at an ASC or outpatient facility.

"As a surgeon you want to do what's safest for your patient. A lot of surgeons have concerns over outpatient procedures… My experience is the more I've done, the more I've seen that it's something that's really just a win-win," Dr. Ammar said. "The patients have been very comfortable and as a result it has built up the cases that I'll do there. Anyone who is a safe medical candidate is someone who warrants medical consideration."

To view the webinar's slides, click here. To view the webinar's recording, click here.


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