Bridging the gap between new spine technology & patients — The role of the Medical Science Liaison

Megan Wood -  

Originally a pharmaceutical model, the medical science liaison is now entering the medical device industry to bridge the gap between various healthcare stakeholders.

A clinically focused educator, a MSL assists all stakeholders during a patient's care continuum:


• Physician offices, ambulatory surgery centers and hospitals
• Allied healthcare providers
• Hospital executives
• Academic institutions and thought leaders
• Patients and patient advocacy groups


During a Paradigm Spine-sponsored webinar on March 29, 2017, Hallett Mathews, MD, MBA, New York City-based Paradigm Spine's chief medical officer, and Devon Billeter, Paradigm Spine's Midwest/Central US Medical Science Liaison, highlighted how Paradigm Spine leverages medical science liaisons to connect patients with the coflex® Interlaminar Stabilization® device.


Role of a medical science liaison
The MSL collaborates with healthcare providers to teach, train and advocate for the best path for the patient. MSLs use clinical research, peer-reviewed articles and medical society publications to bring expertise to any setting of care.


"The MSL role is fairly new to the device world, but we are an important resource in helping bridge the gap to new technology," said Ms. Billeter. "We operate on a proof platform of evidence-based medicine."


Paradigm Spine unveiled its MSL role with the intention of supporting the front, middle and back office in any care setting, ultimately boosting patient access to new technology. The five-pronged role of Paradigm Spine's MSLs, who specifically work to link the right patient to coflex:


Research: MSLs understand treatment guidelines and identify unmet needs for treatments. "The MSL team is able to understand the true evolution of spine treatment, sharing the story via key publications that might be from the past, present, even the future," said Ms. Billeter.


Learning: MSLs learn past and evolving technologies in order to teach providers. By participating in team journal clubs; MRI webinars; and society conferences, MSLs boast well-rounded professional backgrounds.


"We have a common desire to be the most well-informed resources in our respective fields, thus, we do continually challenge ourselves to stay current," Ms. Billeter says.


Teaching: MSLs provide medical information on products to managed care customers and healthcare professionals. They also offer customers payer education, helping with initial dictation and the appeals process.


"We help all settings of care educating patients on treatment choices and real-world expectations of true timelines to accessing new technology," says Ms. Billeter.


Service: MSLs provide facilities a new resource that serves as the link between the academic thought leaders and other stakeholders.


Networking: MSLs offer needs-based, value-added services to boost patient and physician advocacy.


"The MSL wears all hats for the company, so we act as conduits for our stakeholders, so they can access information, people and resources to make informed healthcare decisions for their patients," explains Ms. Billeter.


Coflex® Interlaminar Stabilization
The MSL process begins with an ASC or hospital staff's initial introduction to coflex.


MSLs start off by educating their partners on spinal stenosis disease state management. Prevalent in society, lumbar spinal stenosis narrows the spinal canal and causes neurogenic compression. Patients suffering from this disease experience pain or numbness in their legs and lower back. As the disease progresses, it may cause facet disease and early instability.


LSS patients may undergo indirect decompression; decompression alone; decompression and fusion; or decompression and coflex Interlaminar Stabilization.


"Introduce Interlaminar Stabilization as the middle of the bell-shaped curve that is not for the early patients…and it's not for the later patients. But the majority of patients who present with spinal stenosis actually present with the disease of marked spinal compression and no gross instability," explains Dr. Mathews.


A load-bearing device, coflex is intended to treat lumbar spinal stenosis patients who require more than a decompression alone but less than a fusion. Coflex is designed to preserve motion; reduce leg and back pain; maintain foraminal height; and preserve normal kinematics.


Surgeons insert the device following a microsurgical visualized open surgical decompression. Coflex loads the laminar bone and helps to unload the facet, creating a stabilizing effect.


More than 70 publications include data on coflex. A 2016 study published in the International Journal of Spine Surgery compared coflex Interlaminar Stabilization with decompression and fusion for lumbar spinal stenosis patients.


The five-year follow-up study found 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. Researchers also found coflex maintained foraminal height, disc space height and range of motion at the index level.

New 2017 CMS codes
Effective Jan. 1, 2017, CMS created a new Category 1 CPT code for interlaminar stabilization following a decompression surgery. "This coding clarity brings with it published CMS reimbursement pathways for both inpatient and now outpatient facilities," Ms. Billeter said.


The new bundled code for coflex 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 the code CPT 22868. It is listed in addition to the primary code and covers a second coflex procedure performed at an additional level.


The published Medicare average payment for CPT 22867 is $1,025 and CPT 22868 garners an additional $256.


A Milliman third-party actuarial analysis found coflex saves 14 percent to more than 27 percent in per-member per-month costs.


"In addition to MSL support, Paradigm does partner with a dedicated team of coverage and access specialists that can assist you with private payers," says Ms. Billeter.


MSLs provide facilities with a variety of resources to help with gaining coverage, including a prior-authorization laminated guide; an appeals consideration laminated guide; patient and physician advocacy guides; and a physician advocacy letter template modules booklet.


To partner with a Paradigm MSL, contact:


• Erin Crawford in the Western U.S. —
• Devon Billeter in the Central U.S. —
• Gaye Zingler in the Eastern U.S. —


Listen to the webinar recording here and view the webinar slides here.


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