Tina Jacobsen, CFA
Senior Manager of Investor Relations
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Surgical Societies Address BCBS of North Carolina Lumbar Fusion Policy Change
CMS' 2011 Final Addenda Includes XLIF in Existing Procedure Code
FY 2011 Final Addenda (PDF)
NASS comments on XLIF Reimbursement
January 2010 (PDF)
July 2006 (PDF)
AANS Comments on XLIF Reimbursement
Links to updated coverage decisions:
This document was last updated on January 18, 2011. Updates will be provided on a periodic basis, or as NuVasive® deems necessary.
NuVasive announced further reversal decisions by both CIGNA and Humana on January 18, 2011. At this time, all of the major commercial insurance providers that once had non-coverage policies for XLIF have reversed their position. This list includes Aetna, United Healthcare, Health Care Service Corporation, Humana and most recently CIGNA. Aetna and United Healthcare changed their spinal surgery policies to include coverage for the eXtreme Lateral Interbody Fusion, or XLIF® procedure, as of February 26, 2010, a reversal from their previous policies that labeled XLIF as experimental and investigational, or unproven. Both policies add XLIF coding clarification in line with the North American Spine Society (NASS) recommendation letter dated January 5, 2010.
As reported on the third quarter 2010 conference call, NuVasive began to experience a deceleration in procedure volumes due to heightened push back from some private insurance providers. The pushback is related to lumbar spine fusion procedures in general, not to the XLIF procedure specifically. Insurers have done two things. First, they have increased the criteria necessary to preauthorize lumbar spine fusion surgery, and second, they have increased the level of scrutiny of preauthorization forms. The increased criteria allow insurers to deny coverage for lumbar fusion surgery if patients present without meeting each condition in a list of stringent requirements including such things as instability, neural compression or stenosis, and radicular pain in the legs or arms.
NuVasive hopes to lead the charge to improve coverage of spinal fusion through data from our extensive pipeline of clinical trials as well as by marshalling the surgeon community to rally behind their patients and fight for coverage of spinal fusion and better patient care. It is NuVasive’s belief that the stringent list of requirements being demanded for fusion procedures is ill informed, so the Company is driving an advocacy effort that will better educate the payor and surgeon communities to the essential nature and improved outcomes made possible with fusion procedures, as well as to the proper preparation of documentation to obtain approval.
Some progress has been made. On December 15, 2010, the North American Spine Society (NASS) responded to a policy change instituted by Blue Cross Blue Shield of North Carolina, which effective January 1, 2011, will increase the qualifications necessary to obtain preauthorization for lumbar spine fusion procedures. The American Association of Neurological Surgeons (AANS), the American Association of Orthopaedic Surgeons (AAOS), the Congress of Neurological Surgeons (CNS), the AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves, the International Society for the Advancement of Spine Surgery (ISASS), the North American Spine Society (NASS), the North Carolina Neurosurgical Society (NCNS), the Pediatric Orthopaedic Society of North America (POSNA) and the Scoliosis Research Society (SRS) provided suggestions to Blue Cross Blue Shield of North Carolina for modifying its policy to ensure appropriate coverage for those patients who will benefit from spine fusion procedures. The letter can be viewed via the link at the top of this page.
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 minimally invasive procedures. The XLIF open exposure allows standard tools, instruments, and implants to be used, as opposed to endoscopic minimally invasive techniques which require specialized instrumentation and changes to surgeon technique.
NuVasive cannot offer definitive time frames for resolution of this issue, as the process is dictated by the private insurers. 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.
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. Open spine surgery from a lateral or anterolateral retroperitoneal approach is a longstanding technique that has been in practice for many years. 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.
For a better understanding of the NASS guidelines regarding XLIF coding, refer to the following anatomical diagram.
NuVasive does not encourage coding practices; instead, NuVasive refers physicians to guidance from surgical societies, like NASS.
Despite the coding guideline recommendation by NASS, the XLIF procedure has been deemed investigational or experimental by some private insurance providers. NuVasive actively tracks the top providers, which comprise the majority of the private pay market. Of these major providers, only Cigna currently has a nationwide XLIF non-coverage policy as of January 12, 2011. Some providers do not publicly disclose coverage policies and some providers make only regional coverage decisions. In these instances, NuVasive does not plan to publish updates as they are not readily available.
|1.||What is the NuVasive®, Inc. ticker symbol and on what exchange does it trade?|
|2.||When was the NuVasive initial public offering and what was the offering price?|
|3.||Where is NuVasive headquartered?|
|4.||Where is NuVasive incorporated?|
|5.||When does the NuVasive fiscal year end?|
|6.||Who is the independent auditor for NuVasive?|
|7.||Who is on the NuVasive Board of Directors?|
|8.||Who is the NuVasive transfer agent and how does one contact them regarding my stock certificates or change of address?|
|9.||Does NuVasive currently pay a dividend on its common stock?|
|10.||Does NuVasive offer a direct stock purchase plan?|
|11.||Who are the financial analysts that cover NuVasive and what are their expectations for future growth?|
|12.||Does NuVasive issue quarterly reports?|
|13.||What is the NuVasive CUSIP number?|
|14.||How can I get stock prices for NuVasive?|
|15.||How can I contact someone at NuVasive with a question or request?|
|16.||How can I be placed on the NuVasive e-mail news distribution list?|
|17.||How can I obtain additional financial or investor information on NuVasive?|
|18.||How can I obtain the latest quarterly earnings information?|
|What is the NuVasive®, Inc. ticker symbol and on what exchange does it trade?|
|NuVasive®, Inc. trades on the NASDAQ Global Select Market under the ticker symbol "NUVA."|
|When was the NuVasive initial public offering and what was the offering price?|
|NuVasive's initial public offering (IPO) was completed on May 13, 2004. After giving effect to the exercise of the over-allotment option, the Company sold a total of 6,882,991 shares in the underwritten offering at $11.00 per share, resulting in total net proceeds of approximately $70.4 million.|
|Where is NuVasive headquartered?|
NuVasive's principal executive offices are located at:|
7475 Lusk Blvd.
|Where is NuVasive incorporated?|
|NuVasive was incorporated in Delaware in 1997, and since that time has focused primarily on research and development, and seeking regulatory clearances to market products. The Company began commercial sales of products in 2001, launched the NVM5® Nerve Monitoring System in November 2002 and launched the MaXcess® Access System in November 2003.|
|When does the NuVasive fiscal year end?|
|NuVasive operates on a December 31 fiscal year end.|
|Who is the independent auditor for NuVasive?|
|The Company's independent auditor is Ernst & Young LLP.|
|Who is on the NuVasive Board of Directors?|
|To view a complete Board list with biographies, click on the Board of Directors link in the About Us section of the Company's website.|
|Who is the NuVasive transfer agent and how does one contact them regarding my stock certificates or change of address?|
The Company's transfer agent is Computershare Trust Company, N.A.. They can be contacted directly via email at the addresses below for address changes, stock transfers, proxy voting, or any other questions regarding NuVasive stock certificates. The customer service phone number for Computershare Trust Company, N.A.is (800) 962-4284.
For DWAC instructions provided to brokers
|Does NuVasive currently pay a dividend on its common stock?|
|NuVasive does not currently pay a dividend on its common stock.|
|Does NuVasive offer a direct stock purchase plan?|
|The Company does not currently offer a direct stock purchase plan.|
|Who are the financial analysts that cover NuVasive and what are their expectations for future growth?|
|A complete listing of covering analysts can be found by clicking on the Analyst Coverage link.|
|Does NuVasive issue quarterly reports?|
|The Company does complete a quarterly form 10Q with the Securities and Exchange Commission (SEC). To view this form, and other SEC filings of NuVasive, click on the SEC Filings link in the Investor Relations section of the Company website.|
|What is the NuVasive CUSIP number?|
|The Company's CUSIP number is 670704303.|
|How can I get stock prices for NuVasive?|
|Historical stock closing prices can be obtained by visiting the Stock Quote link on the Investor Relations section of the Company website. There is also the option to sign-up for end-of-day NuVasive stock quote email alerts.|
|How can I contact someone at NuVasive with a question or request?|
|Please view the IR Contact box for contact information in the Investor Relations section of the Company website.|
|How can I be placed on the NuVasive e-mail news distribution list?|
|To be placed on the Company's e-mail news distribution list, please type your email address in the IR Contact box in the Investor Relations section of the Company website.|
|How can I obtain additional financial or investor information on NuVasive?|
|Current or potential investors that wish to obtain more information about NuVasive should view the IR Contact box for contact information in the Investor Relations section of the Company's website.|
|How can I obtain the latest quarterly earnings information?|
|The most recent quarterly earnings information can be obtained from the Press Releases link on the Investor Relations section of the Company website.|