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.
Portions of this article originally appeared in ORTHOKNOW®.
The NASS coverage recommendations eBook is available from spine.org.
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?