XLIF® Reimbursement Information This document was last updated on January 8, 2010. Updates will be provided on a periodic basis, or as NuVasive deems necessary. Background on the XLIF Procedure One of NuVasive’s signature offerings is a suite of products that enable spine surgeons to perform a procedure that NuVasive branded and marketed as the eXtreme Lateral Interbody Fusion, or XLIF® procedure. The XLIF procedure is an open surgical technique for spinal decompression and stabilization using existing methods, and does not require a steep learning curve. The exposure is customized to operative requirements and patient anatomy in order to enable clear and direct visualization, avoiding the need for cameras and monitors, while minimizing collateral damage to tissues. The surgeon’s access is not compromised with cannulas, tubes or scopes as it typically is with dissimilar percutaneous procedures. The XLIF open exposure allows standard tools, instruments and implants to be used, as opposed to endoscopic techniques which require specialized instrumentation and changes to surgeon technique. Physician Coding for the XLIF Procedure For spine procedures, reimbursement coding is established by the American Medical Association (AMA) with guidance from a specialty society called the North American Spine Society (NASS). NASS stated in July 2006 that the XLIF technique is an anterior or anterolateral interbody fusion and reiterated its view in a January 2010 letter to insurance companies. Open spine surgery from a lateral or anterolateral retroperitoneal approach is a longstanding technique that has been in practice for many years.1 Customized exposures for direct visualization in the anterolateral approach, such as XLIF, have been deemed by the NASS Operative Coding Committee to be described by existing CPT codes. Therefore, while a surgeon can anteriorly approach the spine from a ventral or lateral approach, both are described in CPT as an anterior/anterolateral procedure… In summary, XLIF should be reported as 22558 for arthrodesis, 22585 for additional level arthrodesis, 22845 for anterior instrumentation, 2‐3 segments.2 1
‐ Fraser RD: A wide muscle‐splitting approach to the lumbosacral spine. J Bone Joint Surg Br 64(1):44‐6, 1982. ‐ Wolfla CE, Maiman DJ, Coufal FJ, Wallace JR: Retroperitoneal lateral lumbar interbody fusion with titanium threaded cages. J Neurosurg 96(Spine 1):50‐55, 2002. ‐ Fraser RD, Gogan WJ: A modified muscle‐splitting approach to the lumbosacral spine. Spine 17(8):943‐8, 1992. ‐ Rechtine DG, McAllister EW: Flank retroperitoneal approach to the lumbar spine. In: Anterior Approaches to the Spine. Zdeblick TA ed., Quality Medical Publishing, St. Louis, MO, 1999, pp193‐201. 2
NASS SpineLine, July/August 2006 For a better understanding of the NASS guidelines regarding XLIF coding, refer to the following anatomical diagram. •
CPT code 22630 describes both PLIF (posterior) and TLIF (transforaminal) interbody fusion •
CPT code 22558 describes both ALIF (anterior) and XLIF (lateral) retroperitoneal interbody fusion NuVasive does not encourage coding practices; instead, NuVasive refers physicians to guidance from the societies, like NASS. Private Insurance Coverage of XLIF Despite the coding guideline recommendation by NASS, the XLIF procedure has been deemed investigational or experimental by some of the major private insurers. NuVasive actively tracks the top private insurers, which comprise the majority of the private pay market. Of these major insurers, four currently have nationwide XLIF non‐coverage policies, including Cigna, United Healthcare, Aetna, and as of December 2009, Humana. Some do not publicly disclose coverage policies and some make only regional coverage decisions. In these instances, NuVasive does not plan to publish updates as they are not readily available. NuVasive believes that among some insurers there is a misconception that the XLIF procedure requires a steep learning curve due to specialized instruments, a constrained exposure, and lack of direct visualization. The misconception is evidenced by the wording of some non‐coverage policies, which mischaracterize the XLIF procedure as percutaneous or one that requires something other than standard and customary techniques. Through education of the provider community by physicians, NuVasive believes insurers will gain clarity on the nature of the XLIF procedure and its similarity to other long‐standing anterior and anterolateral approaches. We believe that the educational process will ultimately result in the reversal of some or all of the non‐coverage decisions. NuVasive cannot offer definitive time frames nor final outcomes regarding reversal of the non‐coverage policies, as the process is dictated by the private insurers. NuVasive intends to update this document as facts change. NuVasive will continue to provide the appropriate resources to patients, physicians, hospitals, and insurers in order to ensure the best in patient care and clarity regarding XLIF reimbursement. Links to non‐coverage decisions: •
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Cigna: http://www.cigna.com/customer_care/healthcare_professional/coverage_positions/medical/mm_0303_covera
gepositioncriteria_lumbar_fusion_degenerative_conditions.pdf United Health: https://www.unitedhealthcareonline.com/b2c/CmaAction.do?channelId=016228193392b010VgnVCM100000c5
20720a____ Aetna: http://www.aetna.com/cpb/medical/data/1_99/0016.html Humana: http://apps.humana.com/tad/tad_new/home.aspx NuVasive cautions you that statements included above that are not a description of historical facts are forward-looking
statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct,
could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forwardlooking statements. The potential risks and uncertainties that could cause actual growth and results to differ materially
include, but are not limited to: the risk that additional private or government payers may deny reimbursement to surgeons or
hospitals for use of the Company’s products; the risk that NuVasive may be unsuccessful in its efforts to convince government
or private payers to provide adequate reimbursement for its products; and the risk that the Company’s revenue or earnings
prospects may be adversely impacted due to decreasing procedure volume associated with real or perceived lack of available
reimbursement to surgeons or hospitals; and other risks and uncertainties more fully described in NuVasive’s press releases
and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and
Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking
statement to reflect events or circumstances arising after the date on which it was made.