NASS Defends XLIF

The North American Spine Society (NASS) flexed its surgeon and patient advocacy muscles when it notified five major insurance carriers on January 5 that XLIF and DLIF procedures are not “investigational” and “experimental” and should be covered by the carriers.

Major carriers, such as CIGNA have characterized the procedures as investigational and said they would not pay for them.

NASS: THE Authoritative Spine Voice

The Society’s entry into an issue that has reeled the financial markets for the companies manufacturing lateral interbody fusion (LIF) devices sends a powerful message that the Society intends to be the authoritative voice for defining what constitutes high quality, evidence-based, and ethical spine care.

In letters to Aetna, BlueCross BlueShield, WellPoint, CIGNA and United Healthcare, NASS President Ray Baker, M.D., stated that NASS recently became aware that the carriers had proposed or are considering noncoverage/nonpayment of, “a technique of lumbar interbody fusion that utilizes a lateral approach with the use of specialized retractors.”

“While the concept of this technique…is not proprietary, there are two commonly used proprietary retractor systems; XLIF, manufactured by NuVasive and DLIF manufactured by Medtronic.”

NASS’ letter said the investigational and experimental terms, “do not seem to be justified.” While the retractor systems are new in recent years, the letter said “the approach is not novel.”

NuVasive Cheers

NuVasive was happy with the NASS letter.

Pat Miles, NuVasive’s President of the Americas, told OTW,

“The letter by NASS provides a clear position from the definitive authority in spine surgery that lateral interbody fusion is a longstanding technique and recent technology additions to the lateral technique are not sufficiently distinct to merit an investigational label or a new code. CMS (Centers for Medicare and Medicaid Services) has also recently included the newer trade names for lateral surgery within the description for anterior interbody fusion and those additions go into effect later this year. This provides clarity that there is not now, nor will there be in the future, a coding concern for lateral spine surgery.”

In a not too subtle manner, the NASS letter reminded the carriers that “in order to provide comment, it is necessary to fully comprehend the technical aspects of LIF.” In a recent conference call with Wall Street analysts, NuVasive CEO Alex Lukianov made the point that insurance carriers do not fully comprehend the procedure.

NASS Conclusions

After laying out arguments why XLIF and DLIF were not investigational and experimental, NASS offered the following conclusions regarding coverage for the procedures:

• Lateral interbody fusion (LIF), in the form of XLIF, DLIF, would be inappropriately characterized as “experimental” or “investigational”
• While additional clinical outcomes data would be helpful for any surgical procedure including LIF, these data are not needed to endorse continued use and coverage of these forms of interbody fusion
• XLIF and DLIF should be coded and reimbursed as an ALIF. The technical execution and surgical principles of LIF are sufficiently analogous to if not a variation of ALIF. It should not be coded as a percutaneous procedure (unlisted CPT code)
• XLIF and DLIF, which are anterior procedures, should not be confused with posterior procedures that have similar sounding names, such as TLIF, PLIF, and GLIF (Trademark, Alphatec)

Coverage and Patient Access

Baker told OTW that NASS entered this debate because the Society felt it was appropriate to defend its previous coding recommendations and to advocate for spine care that allows spine surgeons to offer their patients the best spine procedures and devices available.

Ray Baker, M.D.
NASS PresidentIt’s not the first time the Society has entered a coverage and payment fray. It made payment recommendations regarding vertebroplasty and kyphoplasty procedures in 2007.

Baker also told OTW that numerous NASS members had contacted the Society and asked it to get involved. “We’re looking out for our members here too, ” said Baker.

NASS formed a task force of members without ties to the companies involved in the issue to draft the response to the insurance carriers. He praised Christopher Bono, M.D., Chair of the Society’s Professional Economic and Regulatory Committee for taking a leading role in the drafting of the response.

Standard Method

NuVasive’s XLIFXLIF procedures, according to the NASS letter, “utilize a portal made in the lateral flank through which serial dilators and retractors are placed through the psoas muscle to be seated on the lateral aspects of the disc space and vertebral bodies. By utilizing a smaller incision than other open surgical techniques that often utilize a posterior or anterior approach, it is appropriately described as an open, minimally invasive operation that is performed under direct visualization (in contrast to a percutaneous procedures which are billed using unlisted CPT codes).”

The letter noted, “Open lateral approaches to the upper lumbar spine and thoracic spine are considered a standard method of accessing the discs and vertebral bodies in appropriately indicated cases. Such approaches have been used for the treatment of lumbar degenerative disorders, tumors, fractures, and infections of the spine. The major anatomical distinction between open anterior and lateral approaches is, notwithstanding the size of the incision, dissection being performed anterior or through the psoas muscle. As the psoas muscle is only present in the lumbar spine (L1 to S1), this discussion is most relevant to the lumbar spine.

Variations in how exposure to the lumbar is executed are dictated by surgeon preference and are based on the location of pathology, the patient’s body habitus and the presence or absence of spinal deformity.

“The LIF procedures in question have standardized the approach to direct lateral access that utilizes dissection through the psoas muscle instead of anterior to the muscle, ” noted the letter.

No New Code Needed

“Prior to the introduction of XLIF and DLIF, a spinal surgeon could have chosen to perform an open procedure using a direct lateral corridor, as is performed in LIF, as part of standard customary practice, including transpsoas approaches. Anterior interbody arthrodesis (thoracic, lumbar, additional level) accurately describes these procedures and as such CPT codes 22556, 22558, and 22585 have been recommended. Regardless of the exact direction of accessing the lumbar spine from L1 to L5, the appropriate code has been that for ALIF, 22558. The technical aspects of XLIF and DLIF are not sufficiently distinct from an ALIF to justify another code. NASS has consistently held this position.”

No Randomized Trials Needed

In contrast to LIF procedures, NASS noted that the terms “investigational” or “experimental” used at the time of the introduction of lumbar artificial disc replacement (LADR) was to “the betterment of patient care.”In the case of LADR, the risks, complications, and efficacy were unknown with no analogous procedure from which one could extrapolate results. Thus, randomized trials were needed.

However, NASS’ letter states that a “major distinction must be made between a new procedure such as LADR and a modified approach for a standard, accepted procedure, such as LIF…which is a method of performing an operation that has long been considered standard practice. It is novel only in its use of a smaller incision and a different retractor system. If one were to consider LIF as experimental or investigational, then one would need to conclude that there is only one correct method of performing an anterior lumbar interbody fusion, that all surgeons access the spine through the exact same tissue planes, and that the disc and vertebral bodies are all accessed in the exact same orientation. Not only is this technically impossible, it is not verifiable.”

Neuro Monitoring and Safety

“While accessing the lumbar spine by dissection of the psoas muscle has attendant risk, other types of open anterior lumbar surgery also have risk.

“Because the psoas muscle and associated structures are not widely dissected, a neurological monitor is employed… If [the dilators or retractors] are too close, they are repositioned. This is analogous to neurological monitoring that is performed for any other type of spinal surgery. Cadaver studies have shown that there is a safe corridor through which the lumbar spine can be accessed by a direct lateral approach.

“The approach-related nerve complications for LIF are comparable to posterior lumbar fusion procedures.”

Literature Results

“Perhaps these two parameters are most pertinent, as there are a multitude of studies regarding the outcomes of lumbar interbody fusion, whether via an anterior or posterior technique. Anand et al. (J Spinal Disord Tech. 2008; 21:459-467) published results from a prospective evaluation of 12 patients who underwent XLIF, in addition to other minimally invasive fusion techniques, for the treatment of degenerative scoliosis. At a mean follow-up of 75.5 days, the VAS pain score improved an average of 2.3 points. Knight et al. (J Spinal Disord Tech. 2009; 22:34-37) retrospectively reviewed results of 58 patients who underwent DLIF or XLIF. Though clinical outcomes were not measured, the group found that blood loss, complication rates, and operative times were comparable between the DLIF and XLIF groups.”

“These parameters were comparable to those in a historical cohort of patients who underwent posterior fusion at the same institution.”

Whether or not insurance carriers will review their coverage decisions for LIF procedures and accept NASS’ position that the procedures are common, safe and effective will be determined over the coming months. What is not in doubt is that NASS will continue to defend its position of remaining the final authoritative medical society advocating for quality spine care.   

To read the entire letter from NASS, please click here:

http://www.spine.org/Documents/XLIF_010510.pdf