On Sept. 18, 2014, Paradigm Spine sponsored a webinar titled "Growing your ASC spine practice: A discussion on contemporary MIS technology for Spinal Stenosis." The webinar featured John Peloza, MD, FACS, founder and CEO of Center for Spine Care in Dallas; James Chappuis, MD, FACS, founder and CEO of SpineCenterAtlanta; and Vincent Zeringue, a practice development consultant in New York. The webinar covered:
• Lumbar spinal stenosis treatment options
• The coflex device, including clinical evidence and outcomes studies
• Patient selection
• Reimbursement and payer issues
Spinal stenosis is expected to be diagnosed in 2.4 million people per year by 2020. Currently, 600,000 of the 1.2 million patients diagnosed with spinal stenosis choose surgical intervention. Until recently, the treatment options for surgical intervention were decompression alone and decompression with fusion. But now there is a new technology that can address a large population of patients with spinal stenosis: interlaminar stabilization with the coflex® device from Paradigm Spine.
"Most patients don't want a fusion and they'll put off surgery as long as possible. Where coflex comes in is we can offer them a surgery that isn't a fusion, maintains motion and we don't get the adjacent level disease to the extent that fusions do. Most patients are choosing to have surgery much earlier in the disease process now whereas in the past the only other option had been fusion," says Dr. Peloza.
The coflex® device is different from the X-STOP spinous process fixation. The coflex® Interlaminar Stabilization® device maintains foraminal height and volume as well as offloads the facet joints. It also preserves motion and coflex® patients maintain motion at two-year follow-ups with no adjacent level disease. In the company's investigational device exemption study, fusion patients at the same two-year follow-up already showed some adjacent segment disease.
The coflex® device and procedure is also better from a cost-effectiveness perspective. An article published in the March 2014 edition of the Journal of Clinicoeconomics and Outcomes Research found a $11,700 savings over five years for coflex®. The average Medicare payments over five years for coflex® were $15,182, compared with $26,863 for fusion patients.
In a separate research article on clinical results, three key findings were:
• 94 percent of coflex® patients were satisfied with their procedure, compared with 87 percent of spinal fusion patients
• 90 percent of coflex® patients had early relief compared with 77 percent of fusion patients
• 88 percent of coflex® patients had lasting relief compared with 78 percent of fusion patients.
Dr. Chappius went through case studies for patients who underwent non-fusion Interlaminar Stabilization® with the coflex® device. The cases included middle age and older patients who failed conservative treatment and chose the coflex® device.
"I wasn't sure how well this device would address back pain, but I've been really impressed by the relief of leg pain and back pain as it relates to the release of the radiculopathy," says Dr. Chappuis. "One of the fun things about this procedure is the rehab and recovery. They come back quicker and the patients are really happy with the outcomes of the procedure."
Finally, Mr. Zeringue discussed reimbursement. New innovation can be challenging to achieve reimbursement, but integrating coflex® in spine practices can work with a mix of payers: government, private and workers compensation. Diversification in the practice and patient population is also important.
"There's a period of time that must pass between the introduction of an innovation and innovation evidence to really move payers to coverage of payment. Like all innovations in the spine space, sometimes there is a need for alternatives. One of the alternatives that Paradigm Spine has appreciated is lending organizations," says Mr. Zeringue. Paradigm Spine also suggests engaging MCRA to obtain prior authorization and pre-determination approvals.
"We also advocate as more payers are becoming aware of the evidence for coflex®, if there are cases where preauthorizations are denied, it's worth it to pursue a second authorization for the patient as the evidence becomes more clearly in favor of the procedure," says Mr. Zeringue.
Download the webinar presentation here.
View the webinar by clicking here. We suggest you download the video to your computer before viewing to ensure better quality. If you have problems viewing the video, which is in Windows Media Video format, you can use a program like VLC media player, free for download here.
Note: View archived webinars by clicking here.
• Lumbar spinal stenosis treatment options
• The coflex device, including clinical evidence and outcomes studies
• Patient selection
• Reimbursement and payer issues
Spinal stenosis is expected to be diagnosed in 2.4 million people per year by 2020. Currently, 600,000 of the 1.2 million patients diagnosed with spinal stenosis choose surgical intervention. Until recently, the treatment options for surgical intervention were decompression alone and decompression with fusion. But now there is a new technology that can address a large population of patients with spinal stenosis: interlaminar stabilization with the coflex® device from Paradigm Spine.
"Most patients don't want a fusion and they'll put off surgery as long as possible. Where coflex comes in is we can offer them a surgery that isn't a fusion, maintains motion and we don't get the adjacent level disease to the extent that fusions do. Most patients are choosing to have surgery much earlier in the disease process now whereas in the past the only other option had been fusion," says Dr. Peloza.
The coflex® device is different from the X-STOP spinous process fixation. The coflex® Interlaminar Stabilization® device maintains foraminal height and volume as well as offloads the facet joints. It also preserves motion and coflex® patients maintain motion at two-year follow-ups with no adjacent level disease. In the company's investigational device exemption study, fusion patients at the same two-year follow-up already showed some adjacent segment disease.
The coflex® device and procedure is also better from a cost-effectiveness perspective. An article published in the March 2014 edition of the Journal of Clinicoeconomics and Outcomes Research found a $11,700 savings over five years for coflex®. The average Medicare payments over five years for coflex® were $15,182, compared with $26,863 for fusion patients.
In a separate research article on clinical results, three key findings were:
• 94 percent of coflex® patients were satisfied with their procedure, compared with 87 percent of spinal fusion patients
• 90 percent of coflex® patients had early relief compared with 77 percent of fusion patients
• 88 percent of coflex® patients had lasting relief compared with 78 percent of fusion patients.
Dr. Chappius went through case studies for patients who underwent non-fusion Interlaminar Stabilization® with the coflex® device. The cases included middle age and older patients who failed conservative treatment and chose the coflex® device.
"I wasn't sure how well this device would address back pain, but I've been really impressed by the relief of leg pain and back pain as it relates to the release of the radiculopathy," says Dr. Chappuis. "One of the fun things about this procedure is the rehab and recovery. They come back quicker and the patients are really happy with the outcomes of the procedure."
Finally, Mr. Zeringue discussed reimbursement. New innovation can be challenging to achieve reimbursement, but integrating coflex® in spine practices can work with a mix of payers: government, private and workers compensation. Diversification in the practice and patient population is also important.
"There's a period of time that must pass between the introduction of an innovation and innovation evidence to really move payers to coverage of payment. Like all innovations in the spine space, sometimes there is a need for alternatives. One of the alternatives that Paradigm Spine has appreciated is lending organizations," says Mr. Zeringue. Paradigm Spine also suggests engaging MCRA to obtain prior authorization and pre-determination approvals.
"We also advocate as more payers are becoming aware of the evidence for coflex®, if there are cases where preauthorizations are denied, it's worth it to pursue a second authorization for the patient as the evidence becomes more clearly in favor of the procedure," says Mr. Zeringue.
Download the webinar presentation here.
View the webinar by clicking here. We suggest you download the video to your computer before viewing to ensure better quality. If you have problems viewing the video, which is in Windows Media Video format, you can use a program like VLC media player, free for download here.
Note: View archived webinars by clicking here.