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Clinical Policy Title: Interspinous dynamic stabilization devices

Clinical Policy Number: CCP.1213

Effective Date: April 1, 2016

Initial Review Date: November 18, 2015

Most Recent Review Date: January 8, 2019

Next Review Date: January 2020

Related policies:

CCP.1003 Spine pain — epidural steroid injections

CCP.1030 Spine pain — facet joint injections

CCP.1063 Spinal surgeries

CCP.1072 Spine pain — trigger point injections

CCP.1101 Hierarchy of chronic pain management

ABOUT THIS POLICY: AmeriHealth Caritas has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas’ clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of “medically necessary,” and the specific facts of the particular situation are considered by AmeriHealth Caritas when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas’ clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas’ clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas will update its clinical policies as necessary. AmeriHealth Caritas’ clinical policies are not guarantees of payment.

Coverage policy

AmeriHealth Caritas considers the use of the coflex® Interlaminar Stabilization® device (Paradigm Spine LLC,

New York, NY) to be clinically proven and, therefore, medically necessary when all of the following criteria

are met (Guyer, 2016; Li, 2017; Musacchio, 2016; Schmidt, 2018; Schmier, 2014):

Diagnosis of at least moderate lumbar spinal stenosis between L1 and L5 of one or two contiguous

vertebrae, confirmed by radiography, with or without spondylolisthesis, which requires surgical

decompression.

Absence of gross angular or translatory instability of the spine at index or adjacent levels confirmed

by radiology.

Member must experience relief in flexion from their symptoms of leg, buttock, or groin pain, with

or without back pain, and must have undergone a regimen of at least six months of unsuccessful

Policy contains:

Interspinous or interlaminar spacer.

Neurogenic intermittent

claudication.

Spinal decompression.

Lumbar spinal stenosis.

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non-operative treatment consisting of non-steroidal anti-inflammatory drugs and at least one of

the following: rest, restriction of activities of daily living, physical therapy, or steroid injections.

Member is skeletally mature.

AmeriHealth Caritas considers the use of all other interspinous dynamic stabilization devices to be

investigational and, therefore, not medically necessary. Medical necessity of requests for this device,

therefore, will be considered on a case-by-case basis.

Limitations:

All other uses of interspinous dynamic stabilization devices are not medically necessary.

Stabilization with the coflex device is not medically necessary for members with the following conditions

(Donnally, 2018; Guyer, 2016; Jackson, 2016):

More than two vertebral levels requiring surgical decompression.

Conditions resulting in gross instability of the lumbar spine, including:

o Prior surgical procedure that resulted in gross translatory instability of the lumbar spine.

o Prior fusion, implantation of a total disc replacement, or complete laminectomy at index

level.

o Radiographically compromised vertebral bodies at any lumbar level(s) caused by current or

past trauma, tumor, or infection.

o Severe facet hypertrophy requiring extensive bone removal that would cause gross

instability.

o Radiographic confirmation of gross angular or translatory instability of the spine at index or

adjacent levels with sagittal plane translation > 4.0 mm as spondylolisthesis or retrolithesis.

o Osteopenia and osteoporosis.

o Degenerative lumbar scoliosis (Cobb angle > 25° lumbar segmental).

Isthmic spondylolisthesis or spondylolysis (pars fracture).

Back or leg pain of unknown etiology.

Axial back pain only, with no leg, buttock, or groin pain.

Obesity defined as a body mass index ≥ 35.

Active or chronic infection at a systemic or localized level, including infection with human

immunodeficiency virus. Clinicians should exercise caution in referring patients who are prone to

infection for elective spinal stabilization surgery.

History of Paget disease, osteomalacia, or any other metabolic bone disease (excluding osteopenia,

which is addressed above).

Rheumatoid arthritis or other autoimmune disease requiring chronic steroid use.

Active malignancy: a member with a history of any invasive malignancy (except nonmelanoma skin

cancer), unless they have been treated with curative intent and there has been no clinical signs or

symptoms of the malignancy for at least five years. Patients with a primary bony tumor are

excluded as well.

Known allergy to titanium alloys or magnetic resonance contrast agents.

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Cauda equina syndrome defined as neural compression causing neurogenic bowel or bladder

dysfunction.

Active tobacco use. Members who use tobacco should cease tobacco use for at least four weeks

before surgery and at least six months after surgery.

Uncertain commitment to rehabilitation. Members must express commitment to adhere to

recommendations for post-surgery limitations, activity, and exercise.

For Medicare members only:

AmeriHealth Caritas considers the use of interspinous dynamic stabilization devices to be clinically proven

and, therefore, medically necessary when using the X STOP® Interspinous Process Decompression System

(Medtronic Sofamor Danek Inc., Memphis, Tennessee) for persons who meet all of the following criteria

(Medicare coverage article A52693; Local Coverage Decisions L34006 and L35094):

Age 50 or older and suffering from intermittent neurogenic claudication secondary to a confirmed

diagnosis of lumbar spinal stenosis.

Experiencing moderately impaired physical function and relief in flexion from their symptoms of

leg, buttock, or groin pain, with or without back pain.

Have undergone at least six months of non-operative treatment.

The X STOP is not medically necessary for persons with any of the following conditions:

Allergy 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 levels, or acute fracture of the spinous process or pars interarticularis.

Significant scoliosis (Cobb angle greater than 25 degrees).

Cauda equina syndrome defined as neural compression causing neurogenic bowel or bladder

dysfunction.

Diagnosis of severe osteoporosis, defined as bone mineral density (from dual-energy X-ray

absorptiometry scan or some comparable study) in the spine or hip that is more than 2.5 standard

deviations below the mean of adult normals in the presence of one or more fragility fractures.

Active systemic infection or infection localized at the site of implantation.

Body mass index > 40 kg/m².

Alternative covered services:

Conservative nonsurgical treatments for lumbar spinal stenosis, including nonsteroidal anti-

inflammatory drugs, analgesics, muscle relaxants, epidural steroids, physical therapy, and bracing.

Surgical options including decompressive procedures such as laminotomy, hemilaminotomy,

laminectomy, hemilaminectomy, laminoplasty, foraminotomy, and facetectomy. Patients may

undergo surgical spinal fusion.

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Background

Spinal stenosis generally affects the cervical and lumbar spinal regions (National Institute of Arthritis and

Musculoskeletal and Skin Diseases, 2016). Neurogenic intermittent claudication is a common symptom of

lumbar spinal stenosis and a leading preoperative diagnosis in Americans, particularly those age 60 years or

older. The effectiveness of nonsurgical treatments, the extent of pain, and patient preferences may all

factor into the decision to have surgery (National Institute of Arthritis and Musculoskeletal and Skin

Diseases, 2016). For persons with moderate-to-severe symptoms, surgical decompression, with or without

spinal fusion and discectomy, may be indicated. However, they are associated with serious complications

and high operative risk, particularly for elderly patients.

Several patient-level factors, some of them not modifiable, have been associated with adverse spinal

surgery outcomes. These include: diabetes mellitus (Meng, 2015; Pull ter Gunne, 2012); well-controlled

infection with human immunodeficiency virus (Donnally, 2018); obesity (Epstein, 2017; Meng, 2015; Pull ter

Gunne, 2012); and smoking (Jackson, 2016). Ceasing smoking at least four weeks before elective spinal

surgery and refraining from smoking for at least six months after surgery are both associated with

numerous benefits, including reduced pain, improved fusion, higher postoperative patient satisfaction, and

higher rates of returning to work (Jackson, 2016).

Interspinous dynamic stabilization is a minimally invasive technique that implants a titanium spacer or plate

between the spinous processes or attaches to the spinous processes affected by stenosis (North American

Spine Society, 2011). Interspinous dynamic stabilization achieves sagittal balance and segment stability by

widening the spinal canal and decompressing the nerve, thereby reducing pain. Its theoretical advantages

are using minimally invasive surgical techniques rather than direct decompression (e.g., laminotomy,

laminectomy, or foraminotomy) at the time of insertion, reducing the risk of epidural scarring, and

cerebrospinal fluid leakage. Unlike conventional fusion that prevents spinal segment movement,

interspinous dynamic stabilization restricts spinal movement in the direction that causes pain, while

permitting mobility in the other directions, and it may be performed alone or with surgical decompression.

Regulation:

While the U.S. Food and Drug Administration (2018) does not regulate surgical procedures, it does regulate

the spacer implants as class III devices requiring pre-market approval. They have approved three

interspinous spacers or plates for treating neurogenic intermittent claudication caused by radiologically-

confirmed lumbar spinal stenosis:

X STOP interspinous dynamic stabilization system.

Superion® InterSpinous Spacer (ISS) (Vertiflex® Inc., San Clemente, California).

Coflex.

These devices are intended for patients with at least moderately impaired physical function who experience

relief in flexion from their symptoms of leg, buttock, or groin pain, with or without back pain, and have

undergone a regimen of at least six months of unsuccessful non-operative treatment. X STOP and Superion

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are stand-alone devices that may be implanted at one or two lumbar levels in patients in whom operative

treatment is indicated. Coflex is intended to be implanted midline between adjacent lamina of one or two

contiguous lumbar motion segments after surgical decompression of stenosis at the affected levels.

Continued approval of these class III devices is contingent upon the submission of periodic reports and the

results of post-market studies assessing long-term safety and effectiveness.

Searches

AmeriHealth Caritas searched PubMed and the databases of:

UK National Health Services Centre for Reviews and Dissemination.

Agency for Healthcare Research and Quality.

The Centers for Medicare & Medicaid Services.

We conducted searches on October 9, 2018. Search terms were: “back” (MeSH), “back pain” (MeSH), and

“prostheses and implants” (MeSH), along with free text terms “coflex,” “XSTOP,” “X STOP,” “Superion,”

“interspinous process spacer” and “interspinous” combined with “device” and “space.”

We included:

Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and

greater precision of effect estimation than in smaller primary studies. Systematic reviews use

predetermined transparent methods to minimize bias, effectively treating the review as a scientific

endeavor, and are thus rated highest in evidence-grading hierarchies.

Guidelines based on systematic reviews.

Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost

studies), reporting both costs and outcomes — sometimes referred to as efficiency studies — which

also rank near the top of evidence hierarchies.

Findings

We identified one systematic review (Lee, 2015), three evidence-based guidelines (American Academy of

Orthopaedic Surgeons, 2015; North American Spine Society, 2014 and 2011), three cost-effectiveness

analyses (Parker, 2015; Skidmore, 2011; Burnett, 2010), and one additional randomized controlled trial

(Patel, 2015) for this policy. Overall, the quality of the evidence is low to moderate. The evidence consists of

largely non-comparative, observational studies. The systematic review identified several randomized

controlled trials comparing patient outcomes of an interspinous dynamic stabilization device to surgical

decompression with or without fusion in persons with lumbar spinal stenosis.

The implant procedure using any of the three devices is relatively safe. X STOP and Superion spacers can be

inserted using local anesthesia, whereas the Coflex is usually performed after surgical decompression. The

most common implant-related adverse events were device migration, spinous process fracture, and

malpositioned implant. Other adverse events were sensitivity or allergy to the implant material, pain and

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discomfort associated with the operative site or presence of implants, formation of scar tissue at the

implant site, and degradation of the implant, all of which may require revision surgery.

Contraindications to interspinous dynamic stabilization devices include anatomy that prevents implantation

due to significant lumbar instability, ankylosis, acute fracture of the spinous process or pars interarticularis,

allergy to titanium or titanium alloy, significant scoliosis, fixed motor deficit, cauda equina syndrome,

neural compression causing neurogenic bowel or bladder dysfunction, previous lumbar surgery, significant

peripheral neuropathy, degenerative spondylolisthesis at the affected level, sustained pathological

fractures, severe osteoporosis of the vertebrae or hips, severe foraminal stenosis, obesity, active infection

or systemic disease, Paget's disease or metastasis to the vertebrae, and steroid use for more than one

month within 12 months preceding surgery. A relative contraindication is adjacent-level disease.

Results of the systematic reviews suggest interspinous dynamic stabilization offers greater short-term

improvement in symptoms and functional status than nonsurgical therapy. Symptomatic outcomes for

interspinous dynamic stabilization and surgical decompression were similar, but interspinous dynamic

stabilization was associated with a higher reoperation rate and higher cost. One randomized controlled trial

comparing Superion to X STOP found greater durable clinical improvement with Superion after three years

in the treatment of patients with moderate degenerative lumbar spinal stenosis (Patel, 2015). Long-term

(i.e., more than two years) outcome data on durability of symptom relief, the need for repeat procedures,

and implant survival compared to other surgical options are inadequate. Longer-term studies are in

progress as part of FDA post-approval requirements (ClinicalTrials.gov identifiers NCT00534235 and

NCT02555280).

Results of cost effectiveness analyses vary depending on several factors, including the spacer used, number

of levels involved, and time horizons. Laminectomy was more cost-effective than either X-STOP or

conservative treatment (Burnett, 2010; Skidmore, 2011), whereas either Superion or decompression

surgery was more cost-effective than conservative treatment (Parker, 2015).

The American Academy of Orthopaedic Surgeons makes no specific recommendation for or against

interspinous dynamic stabilization devices but acknowledges them as a minimally invasive option for

appropriately selected patients who experience relief of buttock and leg pain when sitting or bending

forward but return of pain when standing (American Academy of Orthopaedic Surgeons, 2015). The North

American Spine Society (2011) found insufficient evidence to recommend for or against interspinous

dynamic stabilization devices for treatment of lumbar spinal stenosis or degenerative lumbar

spondylolisthesis.

Policy updates:

We identified one update of a previously included systematic review comparing interspinous dynamic

stabilization versus decompression surgery (Machado, 2016) and one new Cochrane review comparing

interspinous dynamic stabilization to non-surgical treatment (Zaina, 2016) for lumbar spinal stenosis. The

new evidence confers no clear outcome advantage of adding interspinous dynamic stabilization to

decompression surgery compared to either decompression surgery alone (with or without fusion) or

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conservative treatment. These results do not change previous findings. Therefore, no policy changes are

warranted.

In 2018, we added five-year outcomes from the Superion treatment arm of a U.S. Food and Drug

Administration noninferiority randomized controlled trial comparing two interspinous dynamic stabilization

devices (Nunley, 2017; ClinicalTrials.gov identifier: NCT00692276). Forty-eight of 88 patients underwent

revision surgery, and 38 of the 48 patients required revision within the initial two postoperative years.

These results suggest that patients who demonstrate early clinical improvement with spacer implantation

will maintain that benefit over time, but direct comparison to laminectomy is lacking. Forty-one adverse

events related to interspinous dynamic stabilization devices have been reported to the U.S. Food and Drug

Administration (2017) Manufacturer and User Facility Device Experience database since October 1, 2016.

The new information confirms previous findings on the Superion device. Additionally, we reviewed recently

published data on the coflex device.

Early studies of the coflex interlaminar stabilization device were based on small samples with relatively

short follow-up periods, limiting the ability to derive conclusions regarding the device’s benefits. A recent

systematic review and meta-analysis comparing decompression with either fusion or coflex for lumbar

spinal stenosis (Li, 2017) included eight studies in a qualitative synthesis and eight in a meta-analysis,

providing results with a likelihood of greater validity. Two of these, the only randomized controlled trials,

are based on work with the same cohort, resulting in seven samples of heterogeneous, low-quality

evidence in all. Final follow-up ranged between one and five years after baseline measures. Compared with

decompression plus fusion, combined decompression plus coflex was safe and effective based on the

Oswestry Disability Index. The improvement was discernible at 6, 12, and 24 months, but not at 60 months.

Five studies reported a significant reduction in length of hospital stay (five studies) and blood loss (six

studies), but no significant difference in visual analogue scale scores for back pain or in major device-

related complications.

The randomized controlled trial included in Li (2017) with the largest sample and a five-year follow-up

period compared the outcomes using the coflex device (n = 215 participants) to decompression combined

with fusion (n = 107 participants) for treatment of moderate to severe lumbar stenosis at one or two

contiguous levels and up to Grade I spondylolisthesis (Musacchio, 2016). At five years, the two arms had

roughly equivalent findings on four-point success criteria (survivorship, Oswestry Disability Index scores,

and absence of neurological deterioration, or device- or procedure-related severe adverse events) and on

rates of reoperation and revision (16.3 percent in the coflex group versus 17.8 percent in the

decompression with fusion group, P = .09).

A sub-analysis within the two-level cohort showed that a higher proportion of the coflex arm achieved

greater success (55.1 percent versus 35.3 percent; borderline statistical significance at .05 < P < .065). Both

groups maintained a statistically significant improvement through 60 months (> 15 points) in the Oswestry

Disability Index score, but the between-group difference was not statistically significant. The visual analog

scale, Short Form-12, and Zürich Claudication Questionnaire scores followed a similar pattern. In the coflex

group, the Short Form-12 and Zürich Claudication Questionnaire scores were statistically and significantly

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higher during early follow up, and foraminal height, disc space height, and range of motion at the index

level were maintained through five years. There were no significant differences favoring the fusion arm at

any point.

Two randomized controlled trials not included in the Li analysis (2017) were Bae (2016) and Schmidt (2018).

Bae (2016) examined three-year follow-up data from a prospective investigational device exemption study

conducted at 21 U.S. clinical sites, comparing the coflex device after decompression to fusion after

decompression. The primary endpoint was a composite measure of clinical success in each of five

components: (1) Oswestry Disability Index scores; (2) absence of corrective surgeries; (3) absence of major

device-related complications; (4) absence of lumbar epidural steroid injections at any lumbar level; and (5)

absence of persistent new or worsening sensory or motor deficit. In the coflex arm (n = 196), 62.2 percent

achieved composite clinical success compared with 48.9 percent in the fusion arm (n = 94) (difference =

13.3 percent, 95 percent confidence interval 1.1 to 25.5, P = .03). The authors concluded that coflex is

“proven effective and durable at improving overall composite clinical success without altering normal spinal

kinematic motion at the index level of decompression or adjacent levels,” while decompression alone and

decompression combined with fusion have potential limitations.

Schmidt (2018) concluded that compared to decompression alone (n = 110), decompression combined with

coflex (n = 115) resulted in a statistically significant improvement on a four-point validated composite score

(survivorship, Oswestry Disability Index scores, and absence of neurological deterioration, or device- or

procedure-related severe adverse events) at two years (P = .017), increased walking tolerance, decreased

compensatory pain management, and maintained radiographic foraminal height, thereby extending the

durability and sustainability of decompression. There were no statistically significant differences in 1- or 2-

year survival rates without secondary surgical intervention (P = .72). Those in the decompression alone

group were 228.0 percent more likely to have lumbar injections (4.5 percent for the coflex arm versus 14.8

percent for decompression alone; P = .0065); and more likely to have narcotic use at every follow-up point

(at final 24-month follow-up, narcotic use was 16.7 percent for coflex versus 23 percent for decompression

alone; difference not statistically significant). At 24 months, the investigators analyzed the compensatory

effect of the narcotics through examining leg pain. Narcotic use was associated with no statistically

significant difference in leg pain in the coflex arm between participants taking narcotics and those not

taking narcotics, while there was a statistically significant difference in leg pain in the decompression-alone

group between participants taking narcotics compared with those not taking narcotics.

One cost effectiveness study comparing coflex to fusion (Schmier, 2014) found that over five years, costs

were lower for care associated with coflex implantation compared with those undergoing the fusion

procedure. Average Medicare payments were estimated at $15,182 for coflex compared with $26,863 for

the fusion procedure, a difference of $11,681 over five years. The mean quality-adjusted life years were

higher for patients implanted with coflex compared with controls (3.02 versus 2.97). These results suggest

that the coflex device results in more benefit at lower costs than fusion. The cost advantage was greater in

an evaluation of commercial insurance payments. In subgroup analyses, the cost advantage for coflex was

greater for two-level procedures compared to one-level procedures.

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A recommendation from the International Society for the Advancement of Spinal Surgery recommended

that, specific to coflex, in patients with stenosis where a direct surgical decompression has been deemed

medically necessary and there is no gross instability (greater than grade 1), non-fusion interlaminar

stabilization can provide controlled reliable motion (Guyer, 2016). The International Society for the

Advancement of Spine Surgery argues for insurance coverage and provides suggestions for coverage

indications and limitations. These suggested coverage indications and limitations, along with other

reviewed literature, provide the basis for revising this policy to include coflex as a medically necessary

device.

In 2019, we included one systematic review and meta-analysis (Mo, 2018), one low-quality study (Nunley,

2018) and one cost effectiveness analysis (Tapp, 2018) to the policy. A systematic review and network

meta-analysis that compared posterior lumbar interbody fusion with three devices (coflex, Wallis, and X-

Stop) among a total sample of 2,241 found that the devices were comparable to fusion in terms of pain

relief, improved quality of life, recovery of disc space height and lumbar function, and that the devices may

lower the incidence of adjacent segment degeneration (Mo, 2018). The results of the Nunley (2018)

analysis of noninferiority trial data on 88 participants suggest sustained improvement in quality of life over

five years for those who tolerated the Superion device, however, significant loss to follow up limited the

validity of the findings. Tapp’s (2018) cost-effectiveness analysis of interspinous dynamic stabilization

devices from 2005 to 2009 concluded that costs will depend largely on reoperation rates over an extended

time period, as well as initial procedure costs. These results are consistent with previous findings and no

policy changes are warranted.

The policy ID was changed from CP# 14.02.07 to CCP.1213. The policy CCP.1387 Coflex interlaminar

stabilization device was combined with this policy and updated to address all interspinous dynamic

stabilization devices in one policy.

Summary of clinical evidence:

Citation Content, Methods, Recommendations

Nunley (2018)

Interspinous process

decompression improves

quality of life in patients with

lumbar spinal stenosis

ClinicalTrials.gov identifier

NCT00692276

Key points:

Study assessed health-related quality of life outcomes (SF-12) through five years in 189

patients age 45 years or older with moderate symptoms of intermittent neurogenic

claudication, secondary to moderate degenerative lumbar spinal stenosis at one or two

contiguous levels, who were initially randomized to Superion treatment.

SF-12 questionnaire responses were captured in 144, 128, 96, 55, and 68 study

subjects at 1, 2, 3, 4, and 5 years, respectively.

Overall quality: low with high risk of bias. Loss to follow up not accounted for.

Physical component summary mean scores improved from 29.4 ± 8.1 preoperatively to

41.2 ± 12.4 at 2 years (40%) and to 43.8 ± 11.6 at 5 years (49%) (P < .001 for both

comparisons); at 2 years, 81% (103/128) of subjects maintained or improved scores.

Mental component mean scores improved from 50.0 ± 12.7 preoperatively to 54.4 ±

10.6 and 54.7 ± 8.6 at 2 and 5 years, respectively (P > .10 for both comparisons).

Schmidt (2018)

Key points:

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Citation Content, Methods, Recommendations

Prospective, randomized,

multicenter study with 2-year

follow-up to compare the

performance of

decompression with and

without interlaminar

stabilization

In this seven-site German randomized controlled trial, 110 participants received

decompression alone, and 115 received decompression along with the coflex device.

Participants had diagnoses of moderate-to-severe lumbar spinal stenosis at one or two

adjacent segments in sites from L-3 to L-5. Overall, there was 91 percent retention at 24

months of follow-up.

The composite score of four items (survivorship, Oswestry Disability Index scores, and

absence of neurological deterioration or device- or procedure-related severe adverse

events) was statistically superior for the compression-plus coflex arm (P = .017).

There was increased walking distance, decreased compensatory pain management,

and maintenance of radiographic foraminal height in the coflex arm compared with the

decompression-only arm, extending the durability and sustainability of a decompression

procedure.

Those in the decompression-alone arm were more likely to have a secondary procedure

(borderline statistically significant at P = .055); 228% more likely to have lumbar

injections (4.5% for the coflex arm versus 14.8%for decompression alone; P = .0065);

and more likely to have narcotic use at every follow-up point (16.7% for coflex versus

23% for decompression alone at 24 months).

In the coflex arm, foraminal height and disc height were mainly maintained, whereas in

the decompression-alone arm, there was a significant decrease at 24 months

postoperatively (P < .001).

There was no difference between groups in individual patient-reported outcomes on the

Oswestry Disability Index, the visual analog scale, or the Zürich Claudication

Questionnaire when they were analyzed individually.

Nunley (2017)

Five-year durability of stand-

alone interspinous process

decompression for lumbar

spinal stenosis using

Superion

ClinicalTrials.gov identifier:

NCT00692276

Key points:

Noninferiority trial of 88 patients with moderate lumbar spinal stenosis treated with the

Superion device. Reporting results at five years.

Clinical success = 84% of patients on ≥ two of three Zurich Claudication Questionnaire

domains.

Leg and back pain success rates = 80% and 65%, respectively.

Oswestry Disability Index success rate = 65%.

Percentage improvements over baseline were significant for all outcome measures (all

P < .001).

Free from reoperation, revision, or supplemental fixation = 75%.

Revision required in 48 patients; 38 of them underwent revision within the initial two

years of the procedure. Of the remaining 10 reoperations, one occurred during the fifth

year of observation, suggesting a decreasing risk of revision surgery with time.

Machado (2016)

Comparative effectiveness

of different surgical

techniques for lumbar spinal

stenosis

Key points:

Systematic review and meta-analysis of three randomized controlled trials of

interspinous dynamic stabilization vs. conventional bony decompression.

Overall quality: low (two randomized controlled trials), high (one randomized controlled

trial).

Compared to decompression, interspinous dynamic stabilization was associated with:

- Similar reductions in pain (mean difference [MD] -0.55, 95% confidence

interval [CI] -8.08 to 6.99) and disability (MD 1.25, 95% CI -4.48 to 6.98).

- Longer operation time (MD 39.11 min., 95% CI 19.43 min. to 58.78 min.) and

higher risk of reoperation (relative risk [RR] 3.95, 95% CI 2.12 to 7.37).

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Citation Content, Methods, Recommendations

- Comparable perioperative blood loss (MD 144.00 mL, 95% CI -209.74 mL to

497.74 mL).

Compared to decompression plus fusion, interspinous dynamic stabilization was

associated with:

- No difference in pain relief (MD 5.35, 95% CI -1.18 to 11.88).

- A small but significant reduction in disability (MD 5.72, 95% CI 1.28 to 10.15).

- Superior operation time (MD 78.91 minutes, 95% CI 30.16 minutes to 127.65

minutes) and perioperative blood loss (MD 238.90 mL, 95% CI 182.66 mL to

295.14 mL).

- Similar rate of reoperation (RR 0.70, 95% CI 0.32 to 1.51).

Decompression plus fusion plus interspinous dynamic stabilization were not superior to

decompression alone.

Zaina (2016)

Cochrane review

Surgical versus non-surgical

treatment for lumbar spinal

stenosis

Key points:

Systematic review of one randomized controlled trial of interspinous dynamic

stabilization vs. usual conservative treatment (191 total participants).

Overall quality: low.

Side effects: conservative care 0% vs. interspinous dynamic stabilization 11% (spinous

process fracture, coronary ischemia, respiratory distress, hematoma, and death due to

pulmonary edema).

Significant treatment effect favored surgery on the SF-36 scale for bodily pain, with an

MD in change from baseline of 7.8 (95% CI, 1.5 to 14.1).

No significant difference in scores on physical function or disability.

Significant advantage for surgery at three months for all primary outcomes that

remained significant at two years.

Lee (2015)

Safety and efficacy of

interspinous dynamic

stabilization

Key points:

Systematic review of 20 studies of the DIAM® (Medtronic, Tolochenaz, Switzerland), X

STOP (two randomized controlled trials), Wallis, and Coflex devices (two randomized

controlled trials).

Overall quality: low to moderate with three- to 41-month follow-up.

Complication rate: X STOP alone was 0% to 11%. Spinous process fracture, implant

displacement, and foreign body reaction to polyethylene were noted, but no permanent

disability.

Long-term results are lacking.

Parker (2015)

Cost-effectiveness analysis

of conservative care,

laminectomy, and Superion

spacer for lumbar spinal

stenosis

Key points:

Markov model using three strategies of care for lumbar spinal stenosis.

Conservative care had the lowest cost at $10,540, while spacers and laminectomy were

nearly identical at about $13,950.

Quality-adjusted life years: conservative care had the lowest increase (0.06), while

spacers and traditional decompressive surgery were nearly identical (.28).

The incremental cost-effectiveness ratios versus conservative care: spacers $16,300

and traditional decompressive surgery $15,200.

Results suggest surgical alternatives provide superior value versus sustained

conservative care.

Patel (2015)

Key points:

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Citation Content, Methods, Recommendations

Superion spacer vs. X

STOP

ClinicalTrials.gov identifier:

NCT00692276

Multisite randomized controlled trial of Superion (n = 190 patients) versus X STOP (n =

201 patients) with three-year follow-up.

Overall quality: moderate. Blinding not reported.

Primary composite endpoint: Improvement in two of three domains of the Zurich

Claudication Questionnaire, no reoperations at the index level, no major implant- or

procedure-related complications, and no clinically significant confounding treatments.

At three years, Superion (63/120, 52.5%) versus X STOP (49/129, 38.0%) (P = .023)

achieved the desired endpoint and maintained improvements in back and leg pain.

Success rates > 80% for each component of the primary endpoint in the Superion group

(range: 81% – 91%).

References

Professional society guidelines/other:

Evidence-based clinical guidelines for multidisciplinary spine care. Revised 2011. North American Spine

Society website.

https://www.spine.org/Portals/0/Documents/ResearchClinicalCare/Guidelines/LumbarStenosis.pdf.

Accessed October 9, 2018.

FDA Manufacturer and User Facility Device Experience database searched from October 1, 2016 to the

present using product code NQO. U.S. Food and Drug Administration website.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm. Accessed October 9, 2018.

FDA Premarket approval database searched using product code NQO. U.S. Food and Drug Administration

website. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm. Accessed October 9, 2018.

Guyer R, Musacchio M, Cammisa FP, Jr., Lorio MP. ISASS recommendations/coverage criteria for

decompression with Interlaminar Stabilization - coverage indications, limitations, and/or medical necessity.

Int J Spine Surg. 2016;10:41. Doi: 10.14444/3041.

InterQual 2018.1 CP: Procedures. Neurosurgery. Interspinous process decompression. Change Healthcare

LLC. Philadelphia, Pennsylvania.

Lumbar spinal stenosis. American Academy of Orthopaedic Surgeons website.

http://orthoinfo.aaos.org/topic.cfm?topic=A00329. Accessed October 9, 2018.

Spinal stenosis. Questions and answers about spinal stenosis. National Institute of Arthritis and

Musculoskeletal and Skin Diseases website. http://www.niams.nih.gov/Health_Info/Spinal_Stenosis/.

Accessed October 9, 2018.

Peer-reviewed references:

13

Bae HW, Davis RJ, Lauryssen C, Leary S, Maislin G, Musacchio MJ, Jr. Three-year follow-up of the

prospective, randomized, controlled trial of Coflex interlaminar stabilization vs instrumented fusion in

patients with lumbar stenosis. Neurosurgery. 2016;79(2):169-181. Doi: 10.1227/NEU.0000000000001237.

Burnett MG, Stein SC, Bartels RH. Cost-effectiveness of current treatment strategies for lumbar spinal

stenosis: nonsurgical care, laminectomy, and X-STOP. J Neurosurg Spine. 2010; 13(1): 39 – 46. Doi:

10.3171/2010.3.spine09552.

Donnally CJ, 3rd, Kalakoti P, Buskard ANL, et al. Inpatient outcomes after elective lumbar spinal fusion for

patients with human immunodeficiency virus in the absence of acquired immunodeficiency syndrome.

World Neurosurg. 2018. Doi: 10.1016/j.wneu.2018.05.128.

Epstein NE. More risks and complications for elective spine surgery in morbidly obese patients. Surg Neurol

Int. 2017;8:66. Doi: 10.4103/sni.sni_49_17.

Jackson KL, 2nd, Devine JG. The effects of smoking and smoking cessation on spine surgery: a systematic

review of the literature. Global Spine J. 2016;6(7):695-701. Doi: 10.1055/s-0036-1571285.

Lee SH, Seol A, Cho TY, et al. A systematic review of interspinous dynamic stabilization. Clin Orthop Surg.

2015; 7(3): 323 – 329. Doi: 10.4055/cios.2015.7.3.323.

Li AM, Li X, Yang Z. Decompression and coflex interlaminar stabilisation compared with conventional

surgical procedures for lumbar spinal stenosis: a systematic review and meta-analysis. Int J Surg.

2017;40:60-67. Doi: 10.1016/j.ijsu.2017.02.056.

Machado GC, Ferreira PH, Yoo RI, et al. Surgical options for lumbar spinal stenosis. Cochrane Database Syst

Rev. 2016; 11: CD012421. Doi: 10.1371/journal.pone.0122800.

Meng F, Cao J, Meng X. Risk factors for surgical site infections following spinal surgery. J Clin Neurosci.

2015;22(12):1862-1866. Doi: 10.1016/j.jocn.2015.03.065.

Mo Z, Li D, Zhang R, Chang M, Yang B, Tang S. Comparative effectiveness and safety of posterior lumbar

interbody fusion, Coflex, Wallis, and X-stop for lumbar degenerative diseases: a systematic review and

network meta-analysis. Clinical neurology and neurosurgery. 2018;172:74-81. Doi:

10.1016/j.clineuro.2018.06.030

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. Doi: 10.14444/3006.

Nunley PD, Patel VV, Orndorff DG, et al. Five-year durability of stand-alone interspinous process

decompression for lumbar spinal stenosis. Clin Interv Aging. 2017; 12: 1409 – 1417. Doi:

10.2147/cia.s143503.

14

Nunley PD, Patel VV, Orndorff DG, et al. Interspinous process decompression improves quality of life in

patients with lumbar spinal stenosis. Minim Invasive Surg. 2018; 2018: 1035954. Doi:

10.1155/2018/1035954.

Parker SL, Anderson LH, Nelson T, Patel VV. Cost-effectiveness of three treatment strategies for lumbar

spinal stenosis: conservative care, laminectomy, and the Superion interspinous spacer. Int J Spine Surg.

2015; 9. Doi: 10.14444/2028.

Patel VV, Nunley PD, Whang PG, et al. Superion® 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. Doi: 10.2147/jpr.s92633.

Pull ter Gunne AF, Hosman AJ, Cohen DB, et al. A methodological systematic review on surgical site

infections following spinal surgery: part 1: risk factors. Spine. 2012;37(24):2017-2033. Doi:

10.1097/BRS.0b013e31825bfca8.

Schmidt S, Franke J, Rauschmann M, Adelt D, Bonsanto MM, Sola S. Prospective, randomized, multicenter

study with 2-year follow-up to compare the performance of decompression with and without interlaminar

stabilization. J Neurosurg Spine. 2018;28(4):406-415. Doi: 10.3171/2017.11.spine17643.

Schmier JK, Halevi M, Maislin G, Ong K. Comparative cost effectiveness of Coflex® interlaminar stabilization

versus instrumented posterolateral lumbar fusion for the treatment of lumbar spinal stenosis and

spondylolisthesis. Clinicoecon Outcomes Res. 2014;6:125-131. Doi:10.2147/CEOR.S59194.

Skidmore G, Ackerman SJ, Bergin C, et al. Cost-effectiveness of the X-STOP® interspinous spacer for lumbar

spinal stenosis. Spine. 2011; 36(5): E345 – 356. Doi: 10.1097/BRS.0b013e3181f2ed2f.

Tapp SJ, Martin BI, Tosteson TD, et al. Understanding the value of minimally invasive procedures for the

treatment of lumbar spinal stenosis: the case of interspinous spacer devices. Spine J. 2018; 18(4): 584 –

592. Doi: 10.1016/j.spinee.2017.08.246.

Zaina F, Tomkins-Lane C, Carragee E, Negrini S. Surgical versus non-surgical treatment for lumbar spinal

stenosis. Cochrane Database Syst Rev. 2016; (1): Cd010264. Doi: 10.1002/14651858.CD010264.pub2.

Centers for Medicare & Medicaid Services National Coverage Determinations:

NCD 150.13. Percutaneous Image-Guided Lumbar Decompression for Lumbar Spinal Stenosis.

A55413 2017 HCPCS Part A and Part B local coverage determination changes.

A55741 2018 ICD-10-CM Coding Changes (Part A/B, Part A and Part B).

15

Local Coverage Determinations:

L34006 Interspinous Process Decompression.

L35094 Services That Are Not Reasonable and Necessary.

Commonly submitted codes

Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not

an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill

accordingly.

CPT Code Description Comment

22867 Insertion of interlaminar/interspinous process stabilization/distraction device, without fusion, including image guidance when performed, with open decompression, lumbar; single level

22868

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

22870

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)

ICD-10 Code Description Comments

G95.89 Disease of the spinal cord, other specified

M48.061 Spinal stenosis, lumbar region without neurogenic claudication

M43.06 Spondylolisthesis, lumbar region

HCPCS

Level II Code Description Comments

C1821 Interspinous process distraction device (implantable)