CAM 701107

Interspinous and Interlaminar Stabilization/Distraction Devices (Spacers)

Category:Durable Medical Equipment   Last Reviewed:August 2018
Department(s):Medical Affairs   Next Review:June 2019
Original Date:January 2007    

Description: 
Interspinous spacers are devices implanted between vertebral spinous processes. Interlaminar spacers are implanted between adjacent lamina and have two sets of wings that are placed around the inferior and superior spinous processes. These implants aim to restrict painful motion while otherwise enabling normal motion. The devices (spacers) distract the laminar space and/or spinous processes and restrict extension. This procedure theoretically enlarges the neural foramen and decompresses the cauda equina in patients with spinal stenosis and neurogenic claudication. Other types of dynamic posterior stabilization devices are pedicle screw/rod-based devices and total facet replacement systems; these are not covered in this policy.

One type of interspinous implant is inserted between the spinous processes through a small (4-8 cm) incision and acts as a spacer between the spinous processes, maintaining the flexion of that spinal interspace. The supraspinous ligament is maintained and assists in holding the implant in place. The surgery does not include any laminotomy, laminectomy, or foraminotomy at the time of insertion, thus reducing the risk of epidural scarring and cerebrospinal fluid leakage. Other interspinous spacers require removal of the interspinous ligament and are secured around the upper and lower spinous processes. Interlaminar implants are inserted between the adjacent lamina and spinous processes following decompressive surgery. These may be referred to as interlaminar implants or an interspinous U.

Regulatory Status 
In November 2005, the X-STOP® Interspinous Process Decompression (IPD®) System (Kyphon-now part of Medtronic Spine LLC) was approved by the U.S. Food and Drug Administration (FDA) for "treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis." It is  approved for patients with moderately impaired physical function who have had a regimen of at least 6 months of non-operative treatment and who have relief of their pain when in flexion. In 2015, Medtronic discontinued sales and distribution of the implant.

In 2015, the Superion® Interspinous Spacer (ISS VertiFlex) was approved by FDA through the premarket approval process. The Superion® ISS, as stated in the premarket approval, is to treat skeletally mature patients suffering from pain, numbness, and/or cramping in the legs secondary to a diagnosis of moderate degenerative lumbar spinal stenosis, with or without grade 1 spondylolisthesis, confirmed by x-ray, magnetic resonance imaging, and/or central canal or foraminal narrowing. The Superion® ISS is indicated for those patients 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 six months of nonoperative treatment. The Superion® ISS may be implanted at one or two adjacent lumbar levels in patients in whom treatment is indicated and at no more than two levels, from L1 to L5.

The coflex® Interlaminar Technology implant (Paradigm Spine) was approved by the FDA in 2012 (P110008). It is a single-piece U-shaped titanium alloy dynamic stabilization device with pairs of wings that surround the superior and inferior spinous processes. This device was previously called the Interspinous U.

The coflex® is indicated for use in 1- or 2-level lumbar stenosis from L1-L5 in skeletally mature patients with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/buttocks/groin pain, with or without back pain, and who have undergone at least 6 months of non-operative treatment. The coflex® is intended to be implanted midline between adjacent lamina of 1 or 2 contiguous lumbar motion segments. Interlaminar stabilization is performed after decompression of stenosis at the affected level(s).

The FDA lists the following contraindications to use of the coflex®:

  • •Prior fusion or decompressive laminectomy at any index lumbar level.
  • •Radiographically compromised vertebral bodies at any lumbar level(s) caused by current or past trauma or tumor (e.g., compression fracture).
  • •Severe facet hypertrophy that requires extensive bone removal, which would cause instability.
  • •Grade II or greater spondylolisthesis.
  • •Isthmic spondylolisthesis or spondylolysis (pars fracture).
  • •Degenerative lumbar scoliosis (Cobb angle of greater than 25 degrees).
  • •Osteoporosis.
  • •Back or leg pain of unknown etiology.
  • •Axial back pain only, with no leg, buttock, or groin pain.
  • •Morbid obesity defined as a body mass index >40.
  • •Active or chronic infection - systemic or local.
  • •Known allergy to titanium alloys or magnetic resonance imaging (MRI) contrast agents.
  • •Cauda equina syndrome defined as neural compression causing neurogenic bowel or bladder dysfunction.

Continued FDA approval of the coflex® is contingent on annual reports of 2 post-approval studies to provide longer-term device performance and device performance under general conditions of use. One study will provide 5-year follow-up of the cohort in the pivotal investigational device exemption (IDE) trial. The second will be a multi-center trial with 230 patients with follow-up at 5 years that compares decompression alone versus decompression plus coflex®. FDA product code: NQO.

Related Policies
701120 Facet Arthroplasty
701138 Interspinous Fixation (Fusion) Devices

Policy:
The Coflex device is considered MEDICALLY NECESSARY as a treatment of neurogenic intermittent claudication and/or spinal stenosis resulting in leg/buttock/groin pain, with or without back pain, or when used as a stabilization device following decompressive surgery. They may be considered useful therapeutic options for patients meeting specified patient selection criteria.

All other interspinous/interlaminar distraction devices are considered INVESTIGATIONAL. 

NOTE: Vertebral body replacement spacers (e.g., AVS AL PEEK Spacer) are considered MEDICALLY NECESSARY for vertebral body replacement used in spine surgery for persons with a collapsed, damaged or unstable vertebral body resected or excised during total and partial vertbrectomy procedures due to tumor or traums. Vertebral  body replacement with PEEK cages should NOT be confused with interspinous distraction devices (spacers) (e.g., X-stop).

Policy Guidelines
Inclusions (must meet all):

  • Patients age 40+ suffering from (intermittent neurogenic claudication) secondary to a confirmed diagnosis of lumbar spinal stenosis.
  • The patient must have a history of moderately impaired physical function with demonstrated relief when in flexion from their symptoms of leg/buttock/groin pain, with or without back pain; and
  • Patients must have undergone 6 months of non-operative conservative treatment including non-steroidal therapy, comprehensive physical therapy, and epidural injection series prior to be considered for surgery.

Exclusions:

  • Allergic to titanium or titanium alloy;
  • Spinal anatomy or disease that would prevent implant of the device or cause the device to be unstable in situ, such as significant instability of the lumbar spine, e.g., isthmic spondylolisthesis or degenerative spondylolisthesis greater than grade 1.0 (on a scale of 1 to 4); an ankylosed segment at the affected level(s); acute fracture of the spinous process or pars interarticularis;
  • Prior fusion or decompressive laminectomy at any index lumbar level;
  • Radiographically compromised vertebral bodies at any lumbar level(s) caused by current or past trauma or tumor (e.g., compression fracture);
  • Severe facet hypertrophy that requires extensive bone removal which would cause instability;
  • Significant scoliosis (Cobb angle greater than 25 degrees);
  • Grade II or greater spondylolisthesis;
  • Isthmic spondylolisthesis or spondylolysis (pars fracture);
  • Cauda equina syndrome defined as neural compression causing neurogenic bowel or bladder dysfunction;
  • Diagnosis of severe osteoporosis (T score of <-1.0 [WHO definition of osteopenia]).
  • Active systemic infection or infection localized at the site of implantation;
  • Body mass index (BMI) > 40kg/m2;
  • Back or leg pain of unknown etiology;
  • Axial back pain only, with no leg, buttock, or groin pain;
  • Active or chronic infection—systemic or local; 

Benefit Application:
BlueCard®/National Account Issues
State or federal mandates (e.g., FEP) may dictate that all FDA-approved devices may not be considered investigational, and thus, these devices may be assessed only on the basis of their medical necessity.
 

Rationale 
Superion® Device
In a prospective, multicenter, randomized, controlled trial, Patel at al (2015) reviewed two year outcomes in patients with intermittent neurogenic claudication secondary to moderate lumbar spinal stenosis who were treated with the Superion interspinous process spacer.1 A total of 391 randomized patients were implanted with Superion (n = 190) or control (n = 201) spacers at 29 sites in the United States between August 2008 and December 2011. Implants were successfully implanted in 99.5% of patients with Superion and 99.0% of control patients. The primary composite endpoint of this study was met, which demonstrated that the Superion spacer was noninferior to the X-Stop spacer. Leg pain, the predominant patient complaint, decreased in severity by 70% during 2 years in each group. Most (77%) patients achieved leg pain clinical success (improvement ≥20 mm) at 2 years. Back pain clinical success (improvement ≥20 mm) was 68%, with no differences between groups. Oswestry Disability Index clinical success (≥15% point improvement) was achieved in 65% of patients. The rates of complications and reoperations were similar between groups. The authors concluded that the Superion interspinous process spacer relieves symptoms of intermittent neurogenic claudication secondary to moderate LSS in the majority of patients through 2 years.

Patel et al (2015) reports on 3-year clinical outcomes from the randomized, controlled US Food and Drug Administration Investigational Device Exemption trial of the Superion(®) for the treatment of moderate degenerative lumbar spinal stenosis.2 The Superion(®) was evaluated in the treatment of subjects aged 45 years or older suffering from symptoms of intermittent neurogenic claudication, secondary to a confirmed diagnosis of moderate degenerative lumbar spinal stenosis at one or two contiguous levels from L1 to L5. Patients were treated between June 2008 and December 2011 at 31 investigational sites. Three hundred ninety-one subjects were included in the randomized study group consisting of 190 Superion(®) and 201 X-STOP(®) control subjects. The primary composite endpoint was individual patient success based on four components: improvement in two of three domains of the Zurich Claudication Questionnaire, no reoperations at the index level, no major implant/procedure-related complications, and no clinically significant confounding treatments. At 3 years, the proportion of subjects achieving the primary composite endpoint was greater for Superion(®) (63/120, 52.5%) than for X-STOP(®) (49/129, 38.0%) (P=0.023) and the corresponding success rates exceeded 80% for each of the individual components of the primary endpoint in the Superion(®) group (range: 81%-91%). Improvements in back and leg pain severity as well as back- and disease-specific functional outcomes were also maintained through 36 months. According to the authors, this randomized controlled trial demonstrated durable clinical improvement consistently across all clinical outcomes for the Superion(®) in the treatment of patients with moderate degenerative lumbar spinal stenosis.

Coflex® Device
Li et al (2017) conducted a meta-analysis to investigate whether decompression and coflex results in better performance for lumbar spinal stenosis patients when compared with decompression and fusion surgery.3 Ten studies that compared coflex with fusion surgery were included in our meta-analysis. The PRISMA guidelines and Cochrane Handbook were applied to assess the quality of the results published in all included studies to ensure that the results of our meta-analysis were reliable and veritable. The results showed that decompression and coflex was more effective than the control procedure in terms of the Oswestry Disability Index (ODI), length of hospital stay (LOS) and blood loss. However, no significant difference was found in visual analogue scale (VAS) and major device-related complications. The authors concluded that compared with conventional decompression plus fusion surgery, coflex was not inferior in terms of functional clinical outcomes, including ODI and VAS pain score. Moreover, coflex showed less blood loss, shorter LOS and similar device-related complications compared to decompression plus fusion surgery. Therefore, the coflex interlaminar stabilisation device was found to be safe and effective compared to decompression plus fusion for the treatment of LSS.

In a pivotal IDE trial for coflex® Interlaminar Technology, Davis et al (2013) reported on a nonblinded, randomized, multicenter trial of decompression plus coflex® compared to decompression plus posterolateral fusion and pedicle screw fixation in patients with low-grade spondylolisthesis.4 Four-year follow-up was reported in 2015 and 5 year follow-up in 2016.6  A total of 344 patients were randomized in a 2:1 ratio (215 coflex®, 107 fusion controls, with 22 protocol violators). This trial was conducted in a restricted population with numerous exclusion criteria. Compared with fusion, implantation of the coflex® device required less operative time (98.0 minutes vs. 153.2 minutes), resulted in less blood loss (109.7 mL vs. 348.6 mL), and required a shorter hospital stay (1.9 days vs. 3.2 days).

Composite clinical success (a combination of a minimum 15-point improvement in ODI score, no reoperations, no device-related complications, and no epidural steroid injections in the lumbar spine) at 24 months showed coflex® (66.2%) was noninferior to posterolateral fusion (57.7%). Secondary effectiveness criteria, which included ZCQ score, VAS scores for leg and back pain, SF-12 score, time to recovery, patient satisfaction, and several radiographic end points, tended to favor the coflex® group using Bayesian analysis. (In this analysis, nonoverlapping confidence intervals imply statistically reliable group differences). For example, ZCQ composite success was achieved in 78.3% of coflex® patients (95% confidence interval [CI], 71.9% to 84.7%) compared with 67.4% of control patients (95% CI, 57.5% to 77.3%). The percentage of device-related adverse events was the same for the two groups (5.6% coflex®, 5.6% control), and similar percentages of asymptomatic spinous process fractures were observed. In the subset of patients with grade I spondylolisthesis, the coflex® and fusion groups had similar outcomes in ODI, VAS, and ZCQ scores, but the reoperation rate trended higher in the coflex® cohort (14.1% vs. 5.9%, p=0.18). (28) FDA considered the data in this nonblinded trial to support reasonable assurance of safety and effectiveness for device approval, but approval was conditioned on two additional studies that will provide longer term follow-up (in the IDE cohort) and evaluate device performance under actual conditions of use. 

Bae et al (2016) reported a 36-month follow-up analysis of the coflex interlaminar stabilization after decompression, examined under a FDA investigational device exemption trial.7 Composite clinical success at 36 months was achieved by 62.2% among 196 coflex Interlaminar Stabilization patients and 48.9% among 94 fusion patients (difference = 13.3%, 95% confidence interval, 1.1%-25.5%, P = .03). Bayesian posterior probabilities for noninferiority (margin = -10%) and superiority of coflex Interlaminar Stabilization vs fusion were >0.999 and 0.984, respectively. Substantial and comparable improvements were observed in both groups for patient-reported outcomes, although the percentage with a clinically significant improvement (≥15) in the Oswestry Disability Index seemed larger for the coflex Interlaminar Stabilization group relative to the fusion group (P = .008). Radiographic measurements maintained index level and adjacent level range of motion in coflex Interlaminar Stabilization patients, although range of motion at the level superior to fusion was significantly increased (P = .005). The authors concluded that Coflex Interlaminar Stabilization for stenosis is proven to be effective and durable at improving overall composite clinical success without altering normal spinal kinematic motion at the index level of decompression or adjacent levels.

Musacchio et al (2016) investigated 5-year outcomes associated with an interlaminar device. This prospective, randomized, controlled trial was conducted at 21 centers.6 Patients with moderate to severe lumbar stenosis at one or two contiguous levels and up to Grade I spondylolisthesis were randomized (2:1 ratio) to decompression and interlaminar stabilization (D+ILS; n=215) using the coflex(®) Interlaminar Stabilization(®) device (Paradigm Spine, LLC) or decompression and fusion with pedicle screws (D+PS; n=107). Clinical evaluations were made preoperatively and at 6 weeks and 3, 6, 12, 18, 24, 36, 48, and 60 months postoperatively. Overall Food and Drug Administration success criteria required that a patient meet 4 criteria: 1) >15 point improvement in Oswestry Disability Index (ODI) score; 2) no reoperation, revision, removal, or supplemental fixation; 3) no major device-related complication; and 4) no epidural steroid injection after surgery. 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 both treatment groups achieved and maintained statistically significant improvements on multiple outcome assessments throughout 5-year follow-up. On some clinical measures, there were statistically significant differences during early follow-up favoring D+ILS. At no point were there significant differences favoring D+PS. Results of this 5-year follow-up study demonstrate 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.

In another study, Xu et al (2016) evaluated the feasibility and validity of the Coflex interlaminar stabilization in the treatment of degenerative lumbar diseases on L5/S1 level.8 A retrospective study was conducted for a consecutive series of 33 patients with degenerative lumbar spinal stenosis or lumbar disc herniation located in L5/S1 between November 2007 and September 2010. Subjects were all received decompressive laminectomy with implantation of Coflex device. Clinical effects were evaluated by visual analog scale and Oswestry Disability Index. Radiographs were done preoperatively, postoperatively, and at final follow-up. The Coflex devices were successfully implanted in all subjects. Fourteen cases completed the operations by inverting the prosthesis on account of too short S1 spinous processes. During the minimum 4-year follow-up period, all patients had obvious improvement in clinical effects (P < 0.05). Radiological evaluation revealed that dorsal intervertebral space height and intervertebral foramen height of target level increased significantly in all cases postoperatively and maintained well to final follow-up. In addition, the sagittal range of motion of operated level was restricted (P < 0.05), and the range of motion of adjacent segment did not change much (P > 0.05). The authors concluded that coflex is an efficacious dynamic interspinous process device for the treatment of degenerative lumbar diseases that can apply to L5/S1.

In 2015, Roder et al reported a cross registry study that compared lumbar decompression plus coflex® (SWISS spine registry) to lumbar decompression alone (Spine Tango registry) in 50 pairs matched by a multifactorial propensity score.9 SWISS spine is a governmentally mandated registry from Switzerland for coverage with evidence development. Spine Tango is a voluntary registry from the Spine Society of Europe. Both registries use the numeric rating scale (NRS) for back and leg pain and the Core Outcome Measures Index (COMI) as the patient-based outcome instrument. The COMI consists of seven questions to evaluate pain, function, well-being, quality of life, and disability. At 7- to 9-month follow-up, the coflex® group had greater reductions in NRS back pain score (3.8 vs. 2.5, p=0.014), NRS leg pain score (4.3 vs. 2.5, p<0.001), NRS maximum pain score (4.1 vs. 2.3, p=0.002), and greater improvement in COMI score (3.7 vs. 2.5; p=0.029). The authors concluded that in the short-term, lumbar decompression with coflex compared with decompression alone in patients with LSS and pronounced low back pain at baseline is safe and effective treatment option that appears beneficial regarding clinical and functional outcomes.  

Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1.

Table 1. Summary of Key Active Trials

NCT No.

Trial Name

Planned Enrollment

Completion Date

Ongoing

NCT02555280a

 

A 2 and 5 year comparative evaluation of clinical outcomes in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with and without additional stabilization using the Coflex® Interlaminar Technology for FDA real conditions of use study (post-approval ‘real conditions of use’ study)

245

 

June 2022

 

NCT00517751a

Treatment of lumbar spinal stenosis with X-Stop® PEEK spacer in moderately symptomatic patients—Condition of Approval Study (COAST)

240

 

July 2022

 

NCT02457468

 

The Coflex® Community Study: an observational study of Coflex® Interlaminar Technology

500

 

June 2023

 

Unpublished

NCT01316211a

 

Comparative evaluation of clinical outcome in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with and without additional stabilization using the Coflex® Interlaminar Technology

245

 

March 2016

 

NCT: national clinical trial.
a Denotes industry-sponsored or cosponsored trial.  

Summary of Evidence
Lumbar spinal stenosis has historically been treated with open decompressive surgery which is associated with significant morbidity and may give rise to various complications. Interspinous spacers (ISS) have been developed as a less invasive strategy which may serve to avoid many of these risks. The two current spacers that are FDA approved and commercially available are the Coflex and Superion devices.

The Coflex device has been shown to be analogous to decompression and fusion when treating moderate spinal stenosis. It provides dynamic stability after a decompression is performed, without the rigidity of pedicle-screw instrumentation. Recent results show improved outcomes in Coflex patients at 3 years of follow-up, as compared to decompression and fusion. The Superion implant is placed percutaneously in the interspinous space with minimal disruption of spinal anatomy. When compared to the X-Stop device (which is no longer available), the Superion implant shows improved outcomes at 3 years of follow-up. ISS are lesser invasive options as compared to formal decompression and fusion for the treatment of lumbar spinal stenosis.

Clinical Input Received through Physician Specialty Societies and Academic Medical Centers
While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.

2009
In response to requests from BCBSA, input was received from 1 physician specialty society and 3 academic medical centers while this policy was under review in 2009. Differing input was received; several reviewers felt data were sufficient to demonstrate improved outcomes.

2011
In response to requests, input was received from 2 physician specialty societies and 2 academic medical centers while this policy was under review in March 2011. Two of those providing input agreed this technology is investigational due to the limited high-quality data on long-term outcomes including durability. Two reviewers did not consider this investigational but felt the technology had a role in the treatment of selected patients with neurogenic intermittent claudication.

PRACTICE GUIDELINES AND POSITION STATEMENTS
National Institute for Health and Clinical Excellence
The United Kingdom’s National Institute for Health and Clinical Excellence (NICE) published guidance in November 2010 stating that "Current evidence on interspinous distraction procedures for lumbar spinal stenosis causing neurogenic claudication shows that these procedures are efficacious for carefully selected patients in the short and medium term, although failure may occur and further surgery may be needed. The evidence reviewed consisted mainly of reports on X-STOP®.35

American Pain Society
The 2009 guidelines from the American Pain Society indicate that interspinous spacer devices, based on fair evidence, have a B recommendation (panel recommends that clinicians consider offering the intervention).33, 34 The net benefit was considered moderate through 2 years, with insufficient evidence to estimate the net benefit for long-term outcomes.

North American Spine Society
In 2014, NASS published specific coverage policy recommendations on lumbar interspinous device without fusion. NASS recommended that interspinous distraction devices may be indicated for degenerative lumbar stenosis with the following criteria: a) associated with neurogenic claudication that is relieved by lumbar flexion, b) patients older than 50 years old, c) failure of nonoperative treatment, d) no more than 25 degrees of degenerative scoliosis, e) no more than a grade I degenerative spondylolistheses, and f) open surgery (e.g., laminectomy) is not a medically safe treatment option because of comorbidities. NASS states that interspinous distraction devices are not indicated in cases that do not fall within these parameters.33

U.S. Preventive Services Task Force Recommendations
Not applicable.

References: 

  1. Patel VV, Whang PG, Haley TR, et al. Superion Interspinous Process Spacer for intermittent neurogenic claudication secondary to moderate lumbar spinal stenosis: two-year results from a randomized controlled FDA-IDE pivotal trial. Spine (Phila Pa 1976). Dec 9 2015;40(5):275-282. PMID 25494323
  2. Patel VV, Nunley PD, Whang PG, et al. Superion((R)) InterSpinous Spacer for treatment of moderate degenerative lumbar spinal stenosis: durable three-year results of a randomized controlled trial. J Pain Res. 2015;8:657-662. PMID 26491369
  3. Li AM, Li X, Yang, Z. Decompression and coflex interlaminar stabilization compared with conventional surgical procedures for lumbar spinal stenosis: a systematic review and meta-analysis. Int J Surg. April 2017;40:60-67
  4. Davis RJ, Errico TJ, Bae H et al. Decompression and coflex interlaminar stabilization compared with decompression and instrumented spinal fusion for spinal stenosis and low-grade degenerative spondylolisthesis: two year results from the prospective, randomized, multicenter, FDA trial. Spine. Aug 2013;38(18):1529-1539.
  5. Bae HW, Lauryssen C, Maislin G, et al. Therapeutic sustainability and durability of coflex interlaminar stabilization after decompression for lumbar spinal stenosis: a four year assessment. Int J Spine Surg. 2015;9:15. PMID 26056630
  6. Musacchio MJ, Lauryssen C, Davis RJ, et al. Evaluation of decompression and interlaminar stabilization compared with decompression and fusion for the treatment of lumbar spinal stenosis: 5-year follow-up of a prospective, randomized, controlled trial. Int J Spine Surg. 2016;10:6. PMID 26913226
  7. Bae HW, Davis RJ, et al. Three year follow-up of the prospective, randomized, controlled trial of coflex interlaminar stabilization vs. instrumented fusion in patients with lumbar stenosis. Neurosurgery. Aug 2016;79(2):169-81
  8. Xu C, Mao F, Wang X, et al. Application of the coflex interlaminar stabilization in patients with L5/S1 degenerative diseases: minimum 4 year follow-up. Am J Ther. Nov 2016;23(6):e1813-e1818.
  9. Roder C, Baumgartner B, Berlemann U, et al. Superior outcomes of decompression with an interlaminar dynamic device versus decompression alone in patients with lumbar spinal stenosis and back pain: a cross registry study. Eur Spine J. Oct 2015;24(10):2228-2235. PMID 26187621
  10. North American Spine Society. Interspinous device without fusion. 2014; https://www.spine.org/Documents/PolicyPractice/CoverageRecommendations/Interspinous DevicesWithoutFusion.pdf. Accessed December 2016.
  11. National Institute for Health and Clinical Excellence. Interspinous distraction procedures for lumbar spinal stenosis causing neurogenic claudication [IPG365]. 2010; http://guidance.nice.org.uk/IPG365. Accessed December 2016.

Coding Section

Codes Number Description
CPT  22853 (effective 1/1/2017)

Insertion of interbody biomechanical device(s) (eg, synthetic cage, mesh) with integral anterior instrumentation for device anchoring (eg, screws, flanges), when performed, to intervertebral disc space in conjunction with interbody arthrodesis, each interspace (List separately in addition to code for primary procedure) 

  22854 (effective 1/1/2017)

Insertion of intervertebral biomechanical device(s) (eg, synthetic cage, mesh) with integral anterior instrumentation for device anchoring (eg, screws, flanges), when performed, to vertebral corpectomy(ies) (vertebral body resection, partial or complete) defect, in conjunction with interbody arthrodesis, each contiguous defect (List separately in addition to code for primary procedure) 

  22859 (effective 1/1/2017)

Insertion of intervertebral biomechanical device(s) (eg, synthetic cage, mesh, methylmethacrylate) to intervertebral disc space or vertebral body defect without interbody arthrodesis, each contiguous defect (List separately in addition to code for primary procedure) 

  22867 (effective 1/1/2017)

Insertion of interlaminar/interspinous process stabilization/distraction device, without fusion, including image guidance when performed, with open decompression, lumbar; single level 

  22868 (effective 1/1/2017)

Insertion of interlaminar/interspinous process stabilization/distraction device, without fusion, including image guidance when performed, with open decompression, lumbar; second level (List separately in addition to code for primary procedure)

  22869 (effective 1/1/2017)

Insertion of interlaminar/interspinous process stabilization/distraction device, without open decompression or fusion, including image guidance when performed, lumbar; single level 

  22870 (effective 1/1/2017)

Insertion of interlaminar/interspinous process stabilization/distraction device, without open decompression or fusion, including image guidance when performed, lumbar; second level (List separately in addition to code for primary procedure) 

  22899

Unlisted procedure, spine

ICD-9 Procedure 84.80

Insertion or replacement of interspinous process device(s)

ICD-9 Diagnosis  

Investigational for all codes

HCPCS C1821

Interspinous process distraction device (implantable)

ICD-10-CM (effective 10/01/15)  

Investigational for all codes

  M48.00-M48.08

Spinal stenosis code range

ICD-9-PCS (effective 10/01/15)  

ICD-10-PCS codes are only used for inpatient services.

 

0RH008Z, 0RH038Z, 0RH048Z, 0RH108Z, 0RH138Z, 0RH148Z, 0RH408Z, 0RH438Z, 0RH448Z, 0RH608Z, 0RH638Z, 0RH648Z, 0RHA08Z, 0RHA38Z, 0RHA48Z

Surgical, upper joints, insertion, spacer, interspinous process, code by body part and approach (open, percutaneous, percutaneous endoscopic)

 

0SH008Z, 0SH038Z, 0SH048Z, 0SH308Z, 0SH338Z, 0SH348Z

Surgical, lower joints, insertion, spacer, interspinous process, code by body part and approach (open, percutaneous, percutaneous endoscopic)

 

0RP008Z, 0RP038Z, 0RP048Z, 0RP108Z, 0RP138Z, 0RP148Z, 0RP408Z, 0RP438Z, 0RP448Z, 0RP608Z, 0RP638Z, 0RP648Z, 0RPA08Z, 0RPA38Z, 0RPA48Z

Surgical, upper joints, removal, spacer, interspinous process, code by body part and approach (open, percutaneous, percutaneous endoscopic)

 

0SP008Z, 0SP038Z, 0SP048Z, 0SP308Z, 0SP338Z, 0SP348Z

Surgical, lower joints, removal, spacer, interspinous process, code by body part and approach (open, percutaneous, percutaneous endoscopic)

Type of Service    
Place of Service    

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.  

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology© American Medical Association.  All Rights Reserved" 

History From 2014 Forward     

10/19/2018 

Interim review to specify that Coflex can be considered medically necessary, but, ALL other distraction devices are investigational. No other changes. 

08/06/2018 

Interim review, expanding coverage to include medical necessity criteria for previously investigational devices. Policy reformatted to reflect this update. 

06/28/2018 

Annual review, no change to policy intent. Updating rationale and references.  

06/15/2017 

Annual review. Updating background, description, regulatory status, policy statement, policy guidelines, rationale and references. 

11/21/2016 

Updated coding in the coding section. No other changes. 

06/13/2016 

Annual review, no change to policy intent. Updating background, description, regulatory status, rationale and references. 

06/15/2015 

Annual review, added language to allow PEEK cages as medically necessary. Updated regulatory status, rationale and references. Added guidelines and coding. 

06/16/2014

Annual review. Added related policies. No change to policy intent.


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