Reimbursement in Spine: A NASS Priority

I’m reminded of a BONEZONE® article we published about five years ago, in which author Kelli Hallas asserted,

Bottom line is this…no matter how unique or innovative a product, no matter how fine-tuned your internal processes, no matter how great the initial demand, in order to be successful in today’s marketplace, everybody needs to be paid.”

Ms. Hallas’ statement, by way of its use of the word “everybody,” alludes to the reality that you should take an interest in helping those downstream from you get paid. In other words, don’t send your products to market without confidence that everyone involved in the process will be compensated.

The North American Spne Society (NASS) is taking action. Specifically, proactive reimbursement measures are a prime initiative for the society. For instance, its coverage policy recommendations are seen by the society as a powerful tool for surgeons as well as device companies.

“Members and industry benefit greatly from this [living document],” says Eric Muehlbauer, Executive Director and CEO of NASS. “In this hierarchy of developing evidenced-based comments there are clinical guidelines, which are the highest form of evidence; then there are things like appropriate use criteria documents. The coverage recommendation documents are evidence-informed. We know that insurance companies will use whatever they can to formulate a policy, so we try to do all of that homework for them.”

To date, NASS has produced 25 coverage recommendations addressing treatments and procedures such as cervical and lumbar disc replacement, cervical and lumbar fusion, percutaneous sacroiliac joint fusion and certain discectomies and injections. More than 30 recommendations remain in the works, including one for facet joints, which is under final review by the initiative’s multi-specialty committee.

A measure of the initiative’s success is the fact that insurance companies often cite these recommendations in policy revisions, and sometimes adopt them verbatim, Muehlbauer says.

Still, work needs to be done. For all of the years that reimbursement has been a pain point, Muehlbauer says that industry mindsets have not sufficiently shifted from reactive to proactive.

“Focus on proving value,” Muehlbauer urges.

All too often, from Muehlbauer’s perspective, companies neglect to develop a reimbursement strategy alongside their device approval strategy. FDA might want you to prove safety and effectiveness, but insurance companies work by the standard of reasonable and necessary.

Device companies must play a role in evidence generation to positively impact reimbursement, not only for themselves, but for their customers. One way to do that is to be published in the literature and presented at meetings.

Take for instance two of the coverage recommendations mentioned above: cervical artificial disc replacement and percutaneous sacroiliac joint fusion. LDR (recently acquired by Zimmer Biomet) and SI-BONE have invested heavily in clinical and economic data, surgeon reimbursement resources and marketing of information to expand reimbursement of their devices and position them for surgeon adoption.

Similar examples from 2016 alone include:

  • Efficacy data on the first patient in a pilot Phase IIA study of Bone Therapeutics’ ALLOB®, presented at the Clinical Applications of Stem Cells Conference
  • Results from a study of K2M’s MESA Rail™ in the treatment of adolescent idiopathic scoliosis, published in Spine
  • 7-year follow-up data on clinical outcomes and patient satisfaction for Medtronic’s 2-level Prestige LP™ Cervical Disc vs. 2-level anterior cervical discectomy and fusion, presented at the annual meeting of the American Association of Neurological Surgeons
  • Results of cellular study on the effects of Orthofix’s Physio-Stim® pulsed electromagnetic field therapy, published in The Spine Journal
  • 12-month study of 1-level anterior cervical discectomy and fusion patients treated with Orthofix’s Trinity Evolution® + a PEEK interbody spacer and supplemental anterior fixation, published in the European Spine Journal
  • 5-year follow-up on Level 1 data for Paradigm Spine’s coflex Interlaminar Stabilization® device vs. fusion, published in the International Journal for Spine Surgery
  • 2-year clinical results for Spineart’s BAGUERA® C cervical disc in 1- or 2-level arthroplasty, published in the Journal of Spine

There are other companies whose proactive approach to reimbursement is making news, as well:

  • The Center for New Health Technology in Korea granted Innovative Technology status to the EOS imaging platform, recognizing EOS as a unique modality worthy of a new reimbursement code with higher coverage than conventional X-rays
  • The German reimbursement authority released new reimbursement payment coding for Medovex's DenerveX™ system technology for the treatment of facet joint syndrome
  • NuVasive secured a CMS Add-On Payment for the MAGEC magnetically-controlled growth modulation system for the treatment of pediatric spinal deformity
  • Titan Spine secured a CMS ICD-10 Code for nanoLOCK™ nanotextured surface technology for Endoskeleton® interbody fusion devices

Remember: in order to succeed, everyone needs to be paid. Be proactive for you and your customers by making reimbursement a part of your development timeline and by investing in the collection of data.

Julie Vetalice is Editorial Assistant for ORTHOWORLD. Reach her by This email address is being protected from spambots. You need JavaScript enabled to view it..

Portions of this article originally appeared in ORTHOKNOW®.

The NASS coverage recommendations eBook is available from

Interested in learning more about planning for reimbursement? Try these other BONEZONE articles:
Integrating Internal Strategies to Impact a Successful Product Launch
The CMS/FDA Proposed Parallel Review Process: Can One Clinical Trial Really Satisfy Two Agencies?