Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Spinal Decompression with Interspinous and Interlaminar Devices

Policy #:11.14.22d

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

Although the US Food and Drug Administration (FDA) has approved interspinous and interlaminar devices for spinal decompression, the Company has determined that the safety and/or effectiveness of this procedure cannot be established by review of the available published peer-reviewed literature. Therefore, spinal decompression with interspinous and interlaminar devices is considered experimental/investigational by the Company and not covered.

REQUIRED DOCUMENTATION

The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must reflect the medical necessity of the care and services provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

An order for each item billed must be signed and dated by the professional provider who is treating the member and kept on file by the supplier. Medical record documentation must include a shipment confirmation or member's receipt of supplies and equipment. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, spinal decompression with interspinous and interlaminar devices is not eligible for payment under the medical benefits of the Company’s products because the service is considered experimental/investigational and, therefore, not covered.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are numerous interspinous and interlaminar devices approved by the FDA for spinal decompression.

Description

Spinal decompression with interspinous and interlaminar devices (i.e., spacers) is a surgical procedure that has been proposed as a minimally invasive alternative to fusion or conventional surgical decompression (e.g., laminectomy) for individuals with lumbar spinal stenosis. Spinal stenosis is the narrowing of the vertebral canal, which is a passage for the spinal cord and nerves. It is generally associated with intervertebral disc degeneration and the loss of disc height. Symptoms include neurogenic intermittent claudication (i.e., pain and numbness in the legs, back, and hips), loss of balance, and loss of bowel and bladder function. Conservative treatments for spinal stenosis typically include rest, physical therapy, bracing, anti-inflammatory medications, analgesics, local anesthetic blocks, and epidural steroid injections. Additionally, surgical decompression with or without fusion is considered the standard surgical treatment for moderate-to-severe spinal stenosis.

Interspinous implants are small devices implanted between the vertebral spinous processes. After implantation, the device is opened or expanded to distract (i.e., open) the neural foramen and decompress the nerves. Interlaminar implants are implanted midline between adjacent lamina and spinous processes to provide stabilization following decompressive surgery. Both implants are intended to stabilize or distract the adjacent lamina and/or spinous processes, while restricting extension to reduce pain in individuals with spinal stenosis and neurogenic claudication.

INTERSPINOUS DEVICES

An example of an interspinous device used during spinal decompression is the X-STOP® Interspinous Process Decompression System (Kyphon, now part of Medtronic Spine). This device was approved by the US Food and Drug Administration (FDA) in November 2005 for the treatment of individuals aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-STOP® is indicated for individuals with moderately impaired physical function who experience relief in flexion from leg, buttock, or groin pain, with or without back pain, and who have undergone a regimen of at least six months of non-operative treatment. The device is approved by the FDA for implantation at one or two lumbar levels in individuals whose conditions warrant surgery at no more than two levels. The X-STOP® PEEK (polyethereterketone) received approval from the FDA in 2006 and is a modified version of the X-STOP® that has been designed to be more elliptical than the first generation X-STOP® device. It is believed that this shape increases the contact area with the bone, thereby increasing the load-bearing surface. This distributes the loads to the spinous processes, resulting in a decrease in contact pressures. The indications are the same as for the X-STOP®.

Another example of an interspinous device is the Superion Interspinous Spacer (ISS VertiFlex). This device was approved by the FDA in May 2015 for the treatment of skeletally mature individuals suffering from pain, numbness, and/or cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of moderate degenerative lumbar spinal stenosis, with or without Grade 1 spondylolisthesis, confirmed by X-ray, MRI and/or CT evidence of thickened ligamentum flavum, narrowed lateral recess, and/or central canal or foraminal narrowing. The Superion® ISS is indicated for those individuals with impaired physical function who experience relief in flexion from symptoms of leg/buttock/groin pain, numbness, and/or cramping, with or without back pain, and who have undergone at least 6 months of non-operative treatment. The device may be implanted at one or two adjacent lumbar levels in individuals in whom treatment is indicated at no more than two levels, from L1 to L5.

The Wallis® System (originally from Abbott Spine; currently from Zimmer Spine) was developed in 1986. The original Wallis® implant consisted of a titanium block inserted between adjacent processes held in place with a flat Dacron cord or ribbon. The second-generation of the Wallis® implant uses an interspinous block composed of polyetheretherketone (PEEK), a strong plastic-like polymer that has more elasticity and is therefore less rigid that the previously used titanium. The current generation of the Wallis® device is being evaluated in a multi-center FDA-regulated clinical trial in the United States. It is hypothesized that the Wallis® device might be a treatment option for low back pain associated with degenerative disc disease as well as lateral recess and central spinal stenosis. A clinical trial evaluating the efficacy and safety of the Wallis® device for treatment of symptomatic degenerative disc disease has recently been started. This trial for degenerative disc disease will compare the Wallis® to a total disc replacement. A second clinical trial of the Wallis® to treat spinal stenosis is being contemplated.

Also in an FDA-regulated clinical trial is the DIAM™ Spinal Stabilization System (Medtronic Sofamor Danek, Memphis, TN), which is a non-rigid interspinous spacer with a silicone core. The DIAM™ system is an "H" shaped polyester-covered, silicone bumper that is placed between the spinous processes with a mesh band and suture to hold it in place. The clinical trial, which was started in late 2006, evaluates the DIAM™ system in individuals with lumbar stenosis. In 2006, the FDA granted an IDE to Medtronic to study the DIAM™ system in individuals with low back pain caused by degenerative disc disease.

Other clinical trials underway at centers in the United States are studying the In-Space (Synthes) and FLEXUS™ (Globus Medical) devices. The comparator in these trials is the X-STOP® Interspinous Process Decompression System.

PEER-REVIEWED LITERATURE
In a prospective, randomized controlled trial, Zucherman et al. (2005) evaluated the X-STOP® device for the treatment of neurogenic intermittent claudication. One hundred and ninety one patients were randomized to X-STOP® (n=100) or a non-operative medically managed control group (n=91). Primary outcome measurements included Zurich Claudication Questionnaire (ZCQ) scores, a patient-completed validated instrument for assessing neurogenic intermittent claudication. At two-year follow-up, patients in the X-STOP® group improved by 45.4% over the mean baseline symptom severity score, compared with 7.4% of patients in the control group. The mean improvement in physical function domain was 44.3% in the X-STOP® group and -0.4% in the control group. In the X-STOP® group, 73.1% of patients were satisfied with their treatment compared with 35.9% of patients in the control group. The authors concluded that the X-STOP® device provided an effective treatment for patients with lumbar spinal stenosis and is an alternative to both conservative care and decompressive surgery. However, the study did not compare outcomes with established surgical treatments (e.g., bony decompression). The study is limited in its small sample size, short-term follow-up period, and lack of blinding, which may introduce bias.

In a separate analysis of the Zucherman et al. (2005) study population, Hsu et al. (2006) evaluated the quality of life (QOL) of patients treated with the X-STOP® device for lumbar stenosis. Using a 36-item Short Form questionnaire (SF-36, used to measure an individual's overall subjective health status), the authors compared the results of patients who underwent treatment with X-STOP® with those obtained in patients who underwent medical management. Patients were followed for 2 years. Mean domain scores for patients in the X-STOP® group were statistically significantly greater than those in the control group, with the exception of mean general health, role emotional, and mental component summary scores. Mean postoperative domain scores in the X-STOP® group were not statistically significantly greater than mean preoperative domain scores at 6, 12, and 24 months. The authors concluded that the X-STOP® device was effective in improving QOL in patients with lumbar spinal stenosis. The study is limited in its small sample size, short-term follow-up period, lack of blinding, and high loss to follow-up (42%), which may hinder the internal validity of the study.

In a four-year follow-up study, Kondrashov et al. (2006) evaluated 18 patients from the Zucherman et al. (2005) study. The average follow-up was 51 months. Twelve patients had the X-STOP® device implanted at both the L3-4 and L4-5 levels. Six patients had grade I spondylolisthesis (i.e., anterior or posterior displacement of vertebra). The mean preoperative Oswestry Disability Index (ODI) was 45. The mean postoperative ODI was 15. The authors utilized a 15-point improvement threshold and determined that 78% of patients (n=14) had successful outcomes. The authors concluded that the intermediate outcomes of lumbar interspinous process decompression (IPD) with X-STOP® device were stable. The study is limited in its small sample size, mid-term follow-up period, and lack of a comparative control group.

In a prospective study, Siddiqui et al. (2007) evaluated the effectiveness of the X-STOP® device for the treatment of lumbar spinal stenosis. Forty consecutive patients underwent lumbar IPD with the X-STOP® device at either 1 or 2 levels. Patients were followed for 12 months. Outcome measurements included ZCQ, ODI, and SF-36 and were measured preoperatively and at 3 months, 6 months, and 12 months. Ultimately, 16 patients were lost to follow-up. Of the 24 remaining patients, 54% of the patients reported clinically significant improvements in their symptoms, 33% reported clinically significant improvement in physical function, and 71% were satisfied with the procedure. Twenty-nine percent of these patients required a caudal epidural for symptom recurrence at 12 months after lumbar IPD. The authors concluded that X-STOP® may offer short-term improvement, however the results were less favorable than Zucherman et al. (2005)’s initial study. The study is limited in its small sample size, short-term follow-up period, high loss to follow-up (40%), and lack of a comparative control group. A potential concern is the relatively high prevalence of symptom recurrence despite X-STOP® implantation after 12 months.

In a retrospective study, Verhoof et al. (2008) evaluated the effectiveness of lumbar IPD with the X-STOP® device for the treatment of lumbar spinal stenosis caused by degenerative spondylolisthesis. Twelve consecutive patients with symptomatic lumbar spinal stenosis underwent lumbar IPD. All patients had low back pain, neurogenic claudication, and radiculopathy. The mean follow-up was 30.3 months. Four patients experienced no relief of symptoms and pain recurrence, neurogenic claudication, and neurological deterioration was observed in 3 patients within 24 months. Secondary surgical treatment by standard decompression with posterolateral fusion was performed in 58% of the patients (n=7) within 24 months. The authors concluded that after short-term follow-up, lumbar IPD with the X-STOP® device has a high failure rate, defined by surgical re-intervention. X-STOP® for the treatment of spinal stenosis was not recommended. The study is limited in its small sample size, retrospective study design, and lack of a comparative control group.

In a retrospective study, Tuschel et al. (2011) evaluated the survivorship of the X-STOP® device when treating patients with neurogenic claudication. Forty-six patients were followed for a mean of 40 months. Outcome measurements included pain levels, SF-36, ODI, and the rates of revision surgery. At final follow-up, the revision rate was 30.4%. Lack of improvement at 6-week follow-up correlated well with subsequent revision surgery, which predominantly took place within 12 months after the index procedure with the X-STOP® device. Kaplan-Meier analysis predicted that X-STOP® survivability at 48 months after the index procedure was 68%. The authors concluded that the clinical outcomes after X-STOP® implantation may be less favorable than previously published and that better patient selection criteria may be needed for future longer-term studies. The study is limited in its small sample size, retrospective study design, and lack of a comparative group.

In a systematic review, Chou et al. (2011) evaluated the effectiveness of lumbar IPD compared with surgical decompression for the treatment of lumbar spinal stenosis. The authors noted that traditionally, the most effective treatment for degenerative lumbar spinal stenosis is surgical decompression. Ultimately, five studies were included in this systematic analysis. No randomized controlled studies or cohort studies were identified that made direct comparisons of lumbar IPD with conventional surgical decompression. Three randomized controlled trials made comparisons between surgical decompression and conservative management and 2 randomized controlled trials compared lumbar IPD with conservative management for disability and pain at 12 month follow-up. The authors concluded that there was low evidence demonstrating little to no difference in treatment effects between interspinous and surgical decompression. The study is limited in its indirect comparisons. Additionally, the included studies were limited by their small sample sizes and short-term follow-up periods.

In a prospective observational study, Kim et al. (2011) determined the rate of acute spinous process fractures associated with IPD. Fifty implants were placed in 38 individuals who completed follow-up for up to 1 year. Postoperative computed tomography revealed 11 non-displaced spinous process fractures in 11 participants (28.9% of participants; 22% of levels). Five fractures were associated with mild to moderate lumbar back pain and six fractures were asymptomatic. No individuals reported traumatic incidents. Three individuals underwent interspinous device removal and laminectomy. Overall, individuals with fractures had poorer outcomes as defined by ZCQ and had lower satisfaction rates. The authors concluded that IPD appeared to be associated with higher rates of early postoperative spinous process fracture than previously reported in the literature. The study is limited in its lack of a comparative control group and relatively small sample size.

In a multi-center prospective study, Hartjen et al. (2012) evaluated the effectiveness of lumbar IPD with the X-STOP® device for the treatment of neurogenic intermittent claudication due to lumbar spinal stenosis. New patients meeting inclusion criteria were enrolled along with cross-over patients from the Zucherman et al. (2005) study who were randomized to the conservative medical management arm and refractory to treatment. Fifty-five patients from these two separate cohorts were enrolled and followed for 2 years (42 new patients; 13 cross-over patients). Outcome measurements included ZCQ and SF-36 scores. Twenty percent of patients were lost to follow-up. At 2 year-follow-up, clinically significant improvements were found in 60.5% of patients for symptom severity, 58.1% of patients for physical function, and 70.5% for patient satisfaction. Statistically significant improvements were obtained for all physical domains of the SF-36, with the exception of general health. Mean improvement in ZCQ and SF-36 was not as pronounced in the new patient cohort compared with the cross-over patient cohort. The authors concluded that overall success rates do not improve as greatly in patients with long-standing lumbar spinal stenosis symptoms. The study is limited in its small sample size, heterogeneous patient population, short-term follow-up period, and lack of a comparative control group.

In a prospective study, Nandakumar et al. (2013) evaluated the effectiveness of lumbar IPD with the X-STOP® device for the treatment of lumbar spinal stenosis. Fifty-seven consecutive patients with radiologically confirmed lumbar spinal stenosis underwent lumbar IPD, with implantation of the X-STOP® device at a maximum of two levels. Outcome measurements included ZCQ, ODI, and SF-36 preoperatively and at 6, 12, and 24 months postoperatively. Of the 57 patients initially enrolled, 15% were lost to follow-up (n=8). Clinically significant improvements were attained for 57% of the patients at 2 years and 70% of patients indicated they were satisfied with their outcomes. Single and double level insertions did not have a statistically significant difference in outcome. The authors concluded that after X-STOP® implantation, clinical outcomes were maintained after 2 years. The study is limited in its small sample size, short-term follow-up period, loss to follow-up, and lack of a comparative control group.

In a prospective, randomized controlled trial, Stromqvist et al. (2013) compared the outcomes of indirect decompression by means of X-STOP® implant with conventional decompression in individuals with neurogenic intermittent claudication due to lumbar spinal stenosis. A total of 100 individuals with 1- or 2-level lumbar spinal stenosis and neurogenic claudication were included in this study, with 50 participants in each group. The primary outcome measurement was ZCQ and secondary outcome measurements included visual analogue scale (VAS) pain scores, complication and reoperation rates. At 24-month follow-up, primary and secondary outcome measurements had a statistically significant improvement in both groups. Six percent of individuals (n=3) in the conventional treatment group and 26% of individuals (n=13) in the X-STOP® group underwent revision surgery, representing at a statistically significant difference. The authors concluded that both conventional treatment and decompression by means of X-STOP® implant were appropriate procedures. However, there was a higher number of reoperations with the X-STOP® implant. The study is limited in its relatively mid-term follow-up period and lack of comparisons with nonsurgical conservative treatment.

In a meta-analysis, Wu et al. (2014) conducted a meta-analysis of two randomized controlled trials (RCTs) and three non-randomized prospective comparative studies. There were 204 patients in the interspinous spacer group and 217 patients in the decompressive surgery group. The spacers studied were the X-STOP, Aperius, coflex, DIAM, and distraXion. The meta-analysis revealed no significant difference between the two groups for back/leg pain, Oswestry Disability Index (ODI) score, Roland-Morris Disability Questionnaire (RMDQ) score, or complications. However, the reoperation rate was significantly higher in the interspinous spacer group (37/161; 23.0%) compared to the decompressive surgery group (11/160, 6.9%). A limitation of this meta-analysis was that only five studies were included. The authors noted that "[t]here is a lack of studies comparing interspinous spacer use and traditional decompressive surgery in the published literature".

In a meta-analysis, Hong et al. (2015) evaluated the safety and effectiveness of IPD compared with open decompression in treating lumbar spinal stenosis. The peer-reviewed literature was evaluated with the Grading of Recommendations Assessment Development and Evaluation (GRADE) guidelines. A total of 21 publications were included, representing 20 different clinical trials and 54,138 individuals. The results indicated that there was no statistically significant difference in improvement rate, ODI, or VAS score of back pain or leg pain between the IPD or open decompression groups. Postoperation complication rates, perioperative blood loss, hospitalization time, and operation time were lower and shorter in the IPD group when compared to the open decompression group. However, the reoperation rate in the IPD group was higher. The authors concluded that due to the higher reoperation rate of IPD when compared with open decompression, they were unable to conclude that IPD could replace open decompression as the gold standard for treating spinal stenosis.

In a prospective randomized controlled trial, Lonne et al. (2015) compared the effectiveness of IPD with the X-STOP® implant with minimally invasive decompression in individuals with neurogenic intermittent claudication due to lumbar spinal stenosis. Ninety-six individuals with one or two-level lumbar spinal stenosis were randomized to both groups. The primary outcome measurement was ZCQ in this intent-to-treat analysis. Secondary outcome measurements included ODI and a numerical rating system for lower back pain and leg pain. There were no statistically significant differences found in ZCQ at any follow-up. Both groups did have a statistically and clinically significant improvement at 6 -weeks and throughout the 2-year follow-up period. The number of individuals having secondary surgery due to persistent or recurrent symptoms was statistically significantly higher in the IPD group, with an odds ratio of 6.5. The authors concluded that there were no significant clinical differences between IPD and minimally invasive decompression, however IPD with the X-STOP® implant was associated with a significantly higher risk of secondary surgery.

In 2015, Patel VV, Whang PG, et al. reported the 2-year results from an FDA-regulated, industry-sponsored, multicenter randomized, investigational device exemption (IDE), noninferiority trial comparing the Superion ISS with the X-STOP. A total of 391 patients with intermittent neurogenic claudication despite 6 months of nonsurgical management were enrolled, randomized, and implanted with the Superion ISS or X-STOP spacers, and followed for 2 years. The primary end point was a composite of clinically significant improvement in at least 2 of 3 ZCQ domain scores compared with baseline; freedom from reoperation, revision, removal, or supplemental fixation at the index level; freedom from epidural steroid injection or nerve block within 12 weeks of the 2-year visit; freedom from rhizotomy or spinal cord stimulator at any level; and freedom from major implant or procedure-related complications. The primary noninferiority end point was met, with a Bayesian posterior probability of 0.993. However, 111 (28%) patients (54 Superion ISS, 57 X-STOP) were withdrawn from the study during follow-up due to a protocol-defined secondary intervention. Modified intention-to-treat analysis showed clinical success (improvement, ≥20 mm; on 100-point scale) for leg pain in 76% to 77% of patients and for back pain in 67% to 68% of patients, with no significant differences between groups. At 2 years, ODI success was achieved by 63% of Superion ISS patients and by 67% of X-STOP patients (p=0.061). Rates of complications and reoperations (44 [23.2%] Superion, 38 [18.9%] X-STOP) were similar between groups. Spinous process fractures, reportedly asymptomatic, occurred in 16.4% of Superion ISS patients and 8.5% of X-STOP patients.

Also in 2015, Patel VV, Nunley PD, et al. reported the 3-year follow-up results from the noninferiority trial comparing the Superion ISS with the X-STOP. Of the original 391 patients enrolled in the study, 249 (64%) remained (120 patients in the Superion ISS group and 129 in the X-STOP group). Of these, composite clinical success was obtained in 52.5% of patients in the Superion ISS group and 38.0% of the X-STOP group (p=0.023). The 36-month clinical outcomes were reported for 82 patients in the Superion ISS group and 76 patients in the X-STOP group (40% [158/391]). It is not clear from the report whether the remaining patients were lost to follow-up or were considered treatment failures and censured from the results. In addition, study interpretation is limited by questions about the efficacy of the comparator and lack of a control group treated with surgical decompression.

INTERLAMINAR DEVICES

An example of an interlaminar device used during spinal decompression is the coflex® Interlaminar Technology implant (Paradigm Spine; New York, NY). This device was approved by the FDA in 2012 and is a single-piece dynamic stabilization device with pairs of wings that surround the superior and inferior spinous processes. The coflex® is indicated for use in skeletally mature individuals with lumbar stenosis at one or two levels from L1 to L5, with at least moderate impairment in function refractory to at least 6 months of non-operative treatment. The coflex® device is intended to be implanted midline between adjacent lamina of one or two contiguous lumbar motion segments. Interlaminar stabilization is performed after decompression of stenosis at the affected levels. Continued FDA approval of the coflex® device is contingent on annual reports of two post-approval studies to provide longer-term safety and effectiveness data. One study will provide 5-year follow-up of the cohort in the pivotal investigational device exemption trial. The second will be a multicenter trial with 230 patients with follow-up at 5 years that compares decompression alone versus decompression plus coflex®.

PEER-REVIEWED LITERATURE
In a retrospective case-control study, Kong et al. (2007) evaluated interlaminar implant decompression with the coflex® device for the treatment of degenerative spinal stenosis with segmental instability. Forty-two adult patients with degenerative spinal stenosis and mild segmental instability underwent interlaminar implant decompression (n=18) or posterior lumbar interbody fusion (n=24). Patients were followed for 12 months. Outcome measurements included VAS pain and ODI scores for both lower extremity pain and low back pain. At final follow-up, both groups showed a statistically significant improvement in VAS and ODI scores. However, there was a statistically significant increase in range of motion (ROM) in L3-4 for patients in the fusion group, while patients in the interlaminar implant decompression group observed no increase in ROM. The authors concluded that interlaminar implant decompression may be an alternative treatment for spinal stenosis in select conditions which pose less stress on the superior adjacent level. The study is limited in its small sample size, short-term follow-up period, retrospective design, and lack of prospective randomization.

In a prospective case-control study, Richter et al. (2010) evaluated the outcomes of 60 individuals with one or two-level symptomatic lumbar spinal stenosis who either underwent interlaminar implant decompression with the coflex® device (n=30) or conventional decompressive surgery (n=30). Outcome measurements included ODI and VAS. Study participants were followed for 12 months. Both groups had a statistically significant improvement in clinical outcomes. However, at 1-year follow-up, there were no statistically significant differences between both groups, including subjective outcomes such as participant satisfaction. The authors concluded that there was a need for further data from randomized controlled studies to define the indications for these procedures. The study is limited in its study design and relatively mid-term follow-up period.

In a retrospective study, Sun et al. (2011) evaluated the effectiveness of interlaminar implant decompression for the treatment of degenerative lumbar diseases. Fifty-two cases of interlaminar implant decompression with the coflex® (n=27) or Wallis® devices (n=25) were identified. Outcome measurements included lumbar and lower limb VAS pain scores and radiological results. Patients were followed for an average of 30.4 months. At final follow-up, lumbar and lower limb VAS pain scores were improved in both groups. In the coflex® group, four cases of lumbar disc herniation relapsed and three cases required revision surgery. The authors concluded that lumbar spinal decompression with interlaminar implants may be effective in treating degenerative lumbar disease. They admitted that it was important to determine the appropriate indications for the procedure and that the potential use in lumbar disc herniation should be cautiously considered. The study is limited in its small sample size, relatively short-term follow-up period, heterogeneous treatment, retrospective design, and lack of an appropriate comparative control group.

In a retrospective study, Liu et al. (2011) compared the effectiveness of interlaminar implant decompression with the coflex® device and lumbar fusion for the treatment of single-level degenerative spinal disorders in L4-5. Sixty patients underwent posterior decompression with the coflex device (n=29) or posterior decompression combined with lumbar fusion. Patients were followed for at least 12 months. Outcome measurements included VAS pain and ODI scores. ROM and intervertebral height of the index and adjacent segments were measured preoperatively and at final follow-up. At final follow-up, VAS pain and ODI scores in both groups were statistically significantly improved (p < 0.05). The VAS pain score of the coflex® group was statistically significantly higher than that of the fusion group, indicating a lower pain level among the patients who underwent fusion (p < 0.05). There was no statistically significant difference in the intervertebral height between the two groups. ROM in L4-5 was statistically significantly reduced in the coflex® group, whereas the ROM was statistically significantly increased in the fusion group. The authors concluded that interlaminar compression with the coflex® device was as effective as lumbar fusion in treating degenerative lumbar spinal disorder at L4-5. The study is limited in its small sample size, short-term follow-up period, and retrospective study design. Statistically significant differences in favor of spinal fusion are also a concern when considered spinal decompression with the coflex® as an alternative surgical treatment option for a select patient population.

In a prospective controlled study, Richter et al. (2012) evaluated the effectiveness of interlaminar implant decompression with the coflex® device for lumbar spinal stenosis. Sixty-two patients with symptomatic lumbar spinal stenosis were treated with traditional decompression surgery. Of these patients, 31 were implanted with the coflex® device. Patients were followed for 24 months. Outcome measurements included VAS pain and ODI scores. A statistically significant improvement in VAS pain and ODI scores for both groups, though there were no statistically significant differences between the two groups. The authors concluded that the additional placement of a coflex® device does not improve the already successful clinical outcomes in traditional surgical decompression for lumbar spinal stenosis. The study is limited in its small sample size, short-term follow-up period, and lack of randomization.

In a prospective, randomized multi-center FDA investigational device exemption (IDE) trial, Davis et al. (2013) compared coflex® with laminectomy and posterolateral spinal fusion (PSF). A total of 322 individuals with spinal stenosis or grade 1 spondylolisthesis were enrolled and randomized to receive decompression and interlaminar coflex® stabilization (n=215) or PSF (n=107). In a separate analysis, 150 individuals with grade 1 spondylolisthesis from the original cohort were also evaluated. Outcome measurements included perioperative assessment, ODI scores, VAS pain scores, and radiographic outcomes at a minimum of 2 years. The FDA criteria for overall device success required a 15-point reduction in ODI, no reoperations, no major device-related complications, and no postoperative epidural injections. Individuals undergoing surgery with coflex® had significantly shorter operative times, less estimated blood loss, and shorter lengths of stay in both studies. Both the coflex® and PSF cohorts experienced significant improvements from baseline in ODI and VAS pain score measurements, though there were no statistically significant differences. Among the entire cohort of individuals with spinal stenosis or low-grade spondylolisthesis, overall device success was achieved in 66.2% of coflex® individuals and 57.7% of PSF controls. Among the low grade spondylolisthesis cohort, overall device success was achieved in 62.8% of coflex® individuals and 62.5% of PSF controls. Neither represented a statistically significant difference. Additionally, the reoperation rate was higher in the coflex® cohort (n=14) compared with the fusion cohort (n=3). The authors concluded that while reoperation rates were higher with the coflex® device, it was a less-invasive, safe, and effective option for individuals with spinal stenosis or low-grade spondylolisthesis. The studies are limited in their relatively mid-term follow-up and lack of comparisons with nonsurgical conservative treatment.

In a multi-center, randomized controlled trial, Moojen et al. (2013) evaluated whether interlaminar implant decompression was more effective than conventional surgical decompression for individuals with intermittent neurogenic claudication due to lumbar spinal stenosis. A total of 159 individuals with spinal stenosis at one or two levels received either an interlaminar implant (n=80) or underwent spinal bony decompression (n=79). The primary outcome measurement was the ZCQ. At 8-week follow-up, there were no statistically significant differences between the two groups, though the conventional surgical group had a higher success rate according to the ZCQ (p=0.44). Additionally, the revision surgery rate in the interlaminar implant group was statistically significantly higher than in the conventional group (29% vs. 8%; p < 0.001). The authors concluded that there was no short-term advantage for interlaminar implant decompression when compared to conventional surgery and that interlaminar implant decompression had a fairly high reoperation rate. The study is limited in its short-term follow-up period and lack of comparisons with nonsurgical conservative treatment.

In a prospective cohort study, Kumar et al. (2014) evaluated the effectiveness of interlaminar implant decompression with coflex® (n=22) when compared to decompression alone (n=24) for individuals with symptomatic lumbar spinal stenosis. Outcome measurements including the ODI, VAS back and leg pain, and the SF-36. Individuals were followed for 2 years postoperatively. Both groups showed statistically significant improvement in all clinical outcome indicators compared to baseline (p < 0.001). Additionally, individuals undergoing coflex® implantation had a statistically significantly greater improvement (p < 0.001). The authors concluded that interlaminar implant decompression with coflex® provided better clinical outcomes than decompression alone in the short-term. The study is limited in its lack of randomization, study design, relatively small sample size, and short-term follow-up period.

In a double-blind randomized controlled trial, Moojen et al. (2015) compared the effect of IPD and bony decompression in individuals with lumbar spinal stenosis. Ultimately, 159 participants with intermittent neurogenic claudication were randomized to both groups, with 80 participants receiving IPD and 79 receiving bony decompression. The primary outcome measurement at 2-year follow-up was the ZCQ. There was no statistically significant difference between the two groups in ZCQ (p = 0.2). Reoperations were indicated and performed in 33% of IPD cases (n=23) compared with 8% of bony decompression cases (n=6), representing a statistically significant difference (p < 0.01). Furthermore, long-term VAS back pain was statistically significantly higher in the IPD group when compared to the bony decompression group (p = 0.04). The authors concluded that the proposed advantages of IPD could not be confirmed at 2 years after surgery. Furthermore, the reoperation rate was higher and back pain was more intense for individuals after IPD.

In a retrospective study of the prospective, randomized controlled trial by Davis et al. (2013), Bae et al. (2015) evaluated the 4-year follow-up data on the therapeutic sustainability and durability of interlaminar stabilization with coflex® after decompression. Of the 322 included individuals from the Davis et al. (2013) study, ultimately 274 individuals were followed for up to 4 years, with 184 individuals having undergoing interlaminar implant decompression and 90 undergoing PSF. Success was defined as outcomes that did not require second intervention and an ODI improvement of at least 15 points. The success rates were 57.6% for the interlaminar stabilization group and 46.7% of the PSF group, though there was no statistically significant difference between the two interventions. The authors concluded that interlaminar stabilization was a sustainable treatment after decompression for individuals with lumbar spinal stenosis. The study is limited in its retrospective study design, potential for publication bias, and lack of generalizability in comparative control groups beyond PSF.

In a retrospective study of the prospective, randomized controlled trial by Davis et al. (2013), Musacchio et al. (2016) evaluated the 5-year follow-up data on the therapeutic sustainability and durability of interlaminar stabilization using coflex® after decompression (D+ILS) compared to decompression and fusion with pedicle screws (D+PS). The reported follow-up rates at 5 years ranged from 40% to 100%, depending on the outcome measured. For example, improvement of 15 points or more in ODI at 5 years compared to baseline were reported in 56% of patients, whereas no reoperations, revisions, removals, or supplemental fixation were reported in 100% of patients. At 5 years, 50.3% of D+ILS vs. 44% of D+PS patients (p>0.35) met the composite success criteria. Reoperation/revision rates were similar in the two groups (16.3% vs. 17.8%; p >0.90). Both groups had statistically significant improvement through 60 months in ODI scores with 80.6% of D+ILS patients and 73.2% of D+PS patients demonstrating >15 point improvement (p>0.30). VAS, SF-12, and ZCQ scores followed a similar pattern of maintained significant improvement throughout follow-up. On the SF-12 and ZCQ, D+ILS group scores were statistically significantly better during early follow-up compared to D+PS. In the D+ILS group, foraminal height, disc space height, and range of motion at the index level were maintained through 5 years. The authors concluded that "decompression and interlaminar stabilization with coflex is a viable alternative to traditional decompression and fusion in the treatment of patients with moderate to severe stenosis at one or two lumbar levels". The study is limited by the variable loss to follow-up in outcomes, and lack of blinding during follow-up, which may have introduced a bias.

In a multicenter, randomized controlled trial, Schmidt et al (2018) compared 230 participants with moderate to severe LSS who were treated with either decompression and interlaminar stabilization (D+ILS) using the coflex device (n=115) or decompression alone (DA) (n=115). The primary outcomes of interest included ODI, VAS scores, and a quality of life questionnaire. All analyses will measure between individuals without secondary interventions. ODI failed to report a statistical difference amongst the two treatment groups (D+ILS: 24.8 ± 16.5; DA: 28.0 ± 19.8; p = 0.22). At 24 months, there was no difference between those with interlaminar stabilization (22.8 ± 15.9) compared with decompression alone ([24.6 ± 18.8]; p = 0.51). Treatment success defined as improvement in ODI > 15 only slightly improved and was not statistically significant between the two groups (70 % for decompression alone compared to 75.6% in the device arm, p = 0.47). VAS scores were compared between treatment arms, researchers reported 69.5% in the stabilization group and 74.6% in the DA group reported at least a 20mm improvement from baseline to month 24 in back pain VAS (p = 0.48). Regardless of treatment, VAS scores showed statistically significant differences from baseline at all follow-ups; however there was no difference between treatments at any of the follow-up visits.

Researchers assessed functional walking distance time for participants preoperatively and again at 3, 12, and 24 months post surgery. No statistical difference was reported for walking time in the baseline median scores (1.55 minutes versus 1.75 minutes for decompression alone; p = 0.45). Compared to baseline median scores, statistically significant improvements in walking time were observed for at 3 months (p= 0.004), and 12 months (p = 0.008) but failing to reach significant improvements at 24 months (p= 0.06). Study participants reported at least a 20-mm improvement in leg pain, individuals who underwent D+ILS reported 85.4% and 76.1% for those who received DA (p = 0.14). The study reported that the addition of interlaminar devices to spinal decompression was an effective treatment but provided no without pain reduction benefits when compared to of decompression alone.

SUMMARY

There are several studies that report short-term improvements in symptom and functional status after spinal decompression with interspinous and interlaminar devices when compared to non-operative medical management. However, there are very few randomized controlled trials with sufficient follow-up that appropriately evaluate the effectiveness of spinal decompression with interspinous and interlaminar devices with conventional surgical approaches (e.g., surgical decompression) for the treatment of neurogenic intermittent claudication due to a confirmed diagnosis of lumbar spinal stenosis. Based on clinical guidance and the available peer-reviewed literature, comparisons should be made with gold standard surgical treatments, including bony decompression.

Additionally, there exist studies that do not recommend the use of interspinous and interlaminar implants (e.g., X-STOP®, coflex®) during spinal decompression due to poorly established clinically relevant outcomes and high failure rates defined by surgical re-intervention. Additionally, there are studies that indicate that better ROM and pain outcomes may be associated with conventional spinal fusion than with spinal decompression with interspinous and interlaminar devices. The available short-term follow-up studies indicate that there may be a high failure rate with interspinous and interlaminar devices and a surgical revision rate that may be as high as 58%. Mid-term results (e.g., 4 years) are primarily derived from retrospective case series with small sample sizes. Adverse events may include device dislocation, spinous process fracture, and newly onset radiculopathy.

There is no national coverage determination regarding spinal decompression with interspinous and interlaminar devices from the Centers for Medicare and Medicare Services (CMS). In 2007, CMS approved a special add-on payment for hospitals that offer surgery for the X-Stop® Interspinous Process Decompression device.

In both a 2007 and revised 2011 guidelines, the North American Spine Society (NASS) published recommendations on the diagnosis and treatment of degenerative lumbar stenosis. They concluded that there was insufficient evidence to make recommendations for the use of the X-Stop® device during spinal decompression.

In a 2009 guideline, the American Pain Society indicated that interspinous spacer devices constituted a B-level recommendation, indicating that clinicians may consider offering the intervention. The net benefit was considered to be moderate through 2 years, with insufficient evidence to permit conclusions on the long-term outcomes. It was noted that there were no trials that compared the use of interspinous spacer devices to standard decompressive surgery.

In a 2010 guideline, the National Institute for Health and Clinical Excellence (NICE) published recommendations on interspinous distraction procedures for lumbar spinal stenosis causing neurogenic claudication. NICE determined that in the short- and mid-term, interspinous distraction procedures may be effective, although failure and revision surgery may be needed. Noted adverse events included implant migration, device fracture, and infection.

In a 2014 guideline, the NASS published recommendations on interspinous fixation without fusion specific to X-Stop®. They noted that there are a number of interspinous distraction devices available on the market today, including static (i.e., non-flexible or compressible) devices such as the X-Stop® implant, and dynamic implants such as coflex®. Static devices are typically used to provide indirect decompression of neural elements, while dynamic devices are intended to be used in conjunction with laminectomy according to their FDA labeling. Specific to static devices (e.g., X-Stop®), NASS noted that they may be indicated without fusion for individuals greater than 50 years of age refractory to conservative nonsurgical treatment who have degenerative lumbar stenosis with associated neurogenic claudication that is relieved by lumbar flexion, no more than 25 degrees of degenerative scoliosis, no more than a grade 1 degenerative spondylolisthesis, and for whom open surgery (e.g., laminectomy) is not a medically safe option due to comorbidities.

Based on the available published peer-reviewed literature, clinical input, and guidelines from relevant medical societies, the current scientific evidence is insufficient to permit conclusions regarding the safety and effectiveness of spinal decompression with interspinous and interlaminar devices. The majority of the available literature consists of case series and randomized controlled trials that do not appropriately compare spinal decompression with interspinous and interlaminar devices to conventional surgical treatments, including surgical decompression or spinal fusion. Additionally, the potentially high rates of revision surgery and adverse events associated with interspinous and interlaminar devices are concerns as well, especially when considering there are several studies that conclude that there are no statistically significant differences between gold standard conventional surgical treatments and spinal decompression with interspinous and interlaminar devices. Larger randomized controlled trials with appropriate follow-up and valid comparative control groups are necessary to help determine the safety, effectiveness, and long-term outcomes of spinal decompression with interspinous and interlaminar devices.
References


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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

22867, 22868, 22869, 22870


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

This service is E/I for all diagnoses.


HCPCS Level II Code Number(s)

C1821 Interspinous process distraction device (implantable)


Revenue Code Number(s)

N/A

Coding and Billing Requirements



Policy History

Revisions from 11.14.22d:
04/11/2018This policy has undergone a routine review, and no revisions have been made.

Effective 10/05/2017 this policy has been updated to the new policy template format.

Version Effective Date: 01/01/2017
Version Issued Date: 12/30/2016
Version Reissued Date: 04/11/2018

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