Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Percutaneous Image-Guided Lumbar Decompression (PILD) for Spinal Stenosis

Policy #:11.15.22d

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.

Percutaneous image-guided lumbar decompression (PILD) for spinal stenosis is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

BILLING REQUIREMENTS

There is a specific procedure code that represents PILD for spinal stenosis. Current Procedural Terminology (CPT) code 0275T is used to report this procedure. Other procedure codes (e.g., CPT codes 63020, 63030 and/or 63035) do not appropriately represent PILD for spinal stenosis. These services are subject to post-payment review and audit procedures.

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

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, PILD 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. Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The MILD® tool kit (Vertos Medical Inc., San Jose, CA) initially received 510(k) marketing clearance as the X-Sten MILD Tool Kit (X-Sten Corp.) from the US Food and Drug Administration (FDA) on December 19, 2006, as a class II device with intended use as a set of specialized surgical instruments to be used to perform percutaneous lumbar decompressive procedures for the treatment of various spinal conditions. A subsequent approval for the Vertos Medical MILD® Device Kit (Vertos Medical Inc.) was given by the FDA on February 4, 2010.

Description

Lumbar spinal stenosis (LSS) is a condition in which the space around the spinal cord narrows and causes compression of the spinal cord and nerves. This compression may cause symptoms such as pain, numbness, and weakness of the lower extremities that often worsen with standing or walking and are alleviated by sitting or leaning forward. Back pain may or may not be present. LSS is often associated with age-related changes in disc height and arthritis of the facet joints. It is often seen in individuals over the age of 65. For individuals with severe symptoms that have not been alleviated by rest and conservative therapy (e.g., non-steroidal anti-inflammatory drugs [NSAIDs], epidural steroid injections), surgery to decompress the spinal cord and/or nerves may be considered.

Percutaneous image-guided lumbar decompression (PILD) is a minimally invasive technique using the MILD® system, which consists of a specialized cannula and surgical tools. This novel technique has been proposed as an alternative, less invasive treatment for LSS. In contrast to the traditional spinal surgery treatment for LSS such as lumbar laminectomy, PILD with the MILD® system uses fluoroscopic guidance to achieve minimally invasive lumbar decompression for the treatment of LSS. After filling the epidural space with contrast medium under fluoroscopic guidance, a specialized cannula and surgical tools provide access for bone and tissue to be sculpted near the spinal canal. However, the devices are not intended to be used near the lateral neural elements and are contraindicated for disc procedures. In addition, PILD is indicated for central stenosis only, without the capability of addressing nerve root compression or disc herniation that may also be present.

PEER-REVIEWED LITERATURE

In an industry-sponsored, prospective study (MiDAS I), Chopko and Caraway (2010) evaluated the safety and effectiveness of PILD using the MILD® system in 78 individuals with neurogenic claudication (i.e., pain or weakness in the legs) due to LSS. Six-week follow-up data was available for 75 of the study participants. Outcome measurements included visual analog scale (VAS) pain scores, the Oswestry Disability Index (ODI), and Zurich Claudication Questionnaire (ZCQ) patient satisfaction. At 6-week follow-up, the authors reported statistically significant reductions in pain and improvements in physical function and mobility. They concluded that PILD demonstrated safety and effectiveness for improving mobility and reducing pain associated with LSS. The study is limited in its short-term follow-up and lack of appropriate comparative control groups. In a follow-up study, Chopko (2013) reported on 2-year results from this study, though the longer-term results are uncertain due to the high loss to follow-up.

In a randomized controlled trial, Brown (2011) evaluated the safety and effectiveness of PILD using the MILD® system compared with epidural steroid injections (ESI) for the treatment of low back pain, including LSS. Thirty-eight individuals were randomized into PILD (n=21) and ESI treatment groups (n=17). Outcome measurements included VAS pain scores, ODI, and ZCQ patient satisfaction at 12-week follow-up. Individuals in the PILD treatment group reported significantly greater pain reduction (p < 0.0001) and functional mobility improvement (p < 0.01) when compared to individuals in the ESI group. Individuals in the PILD group reported similar improvements in patient satisfaction. However, at 12-week follow-up, individuals treated with PILD had no significant change in mean VAS from their 6-week follow-up. No major procedure-related complications were reported. The authors concluded that PILD using the MILD® system provided better pain reduction and improved functional mobility when compared with ESI. The study is limited in its lack of long-term follow-up, heterogeneous study population, and lack of comparisons with gold standard surgical treatments (e.g., lumbar laminectomy). Additionally, after only 6 weeks of assessment, 82% of study participants crossed over to PILD (n=14). This cross-over design may confound the validity of the author's conclusions.

In a systematic review from the International Spine Intervention Society, Kreiner et al. (2014) evaluated the available peer-reviewed literature to determine the safety and effectiveness of PILD using the MILD® system in individuals with symptomatic, degenerative LSS. One randomized controlled trial and 12 cohort studies were included in the review. Primary outcome measurements included VAS pain scores and ODI, with short (i.e., 4-6 weeks), mid-term (3-6 months), and long-term (> 1 year) endpoints. Secondary outcomes included patient satisfaction, adverse events, and complications. VAS pain scores had a mean improvement of 41% in the short-term, 46% at 3 months, and 49% at 1 year. However, mean VAS remained greater than 3 at all times after treatment. Ten of the studies assessed function using ODI, which improved by a weighted mean of 16.5 at 6 weeks, 16.2 at 12 weeks, 15.4 at 6 months, and 14.0 at 1 year. However, the mean final ODI was greater than 30 in most of the studies, which did not meet the definition of a minimally acceptable outcome according to one of the included study authors. While no direct procedure-related complications were identified, the possibility of nerve and dural damage during this minimally invasive procedure were noted. The authors concluded that the available body of evidence was of low quality and that longer-term data was needed to determine the overall utility of the procedure. Higher quality studies were needed to clarify which individuals may benefit from PILD and the degree to which the individuals may benefit.

Benjaymin et al (2016) published 6-month and 1-year results for 302 participants from a CMS coverage with evidence development protocol study, MiDAS ENCORE (Evidence-based Neurogenic Claudication Outcomes Research). Their trial concluded a nonblinded, randomized study at 26 interventional pain management centers in the United States, in a 1:1 ratio to IG-MLD or epidural steroid injections (ESIs). This trial included Medicare beneficiaries 65 years of older who had neurogenic claudication symptoms for at least 3 months and had failed standard therapies, including physical therapy, home exercise programs, and oral analgesics.

Individuals in the ESI group were allowed up to 4 ESI treatments and received a mean of 2 injections over 1 year. The primary outcome was the proportion of responders achieving the minimal improvement difference (MID) of at least a 10 points on the Oswestry Disability Index (ODI) score being significantly higher in the IG-MLD group than in the ESI group at both 6 months and 1 year. Adverse events were low and similar between groups. Researchers report it may be difficult to separate out the effect of comorbidities because over 80% of patients had 1 or more spinal stenosis comorbidities.

The primary study outcomes were numeric rating scale for pain (NRS), Oswestry Disability Index (ODI), and Zurich Claudication Questionnaire (ZCQ). This unequal dropout rate raises the possibility of bias due to nonblinding of patients and assessors and patient expectations.

SUMMARY

For individuals with severe symptoms that have not been alleviated by rest or conservative therapy, lumbar laminectomy is often considered the gold standard surgical treatment for LSS. While PILD represents a novel, minimally invasive surgical approach for the treatment of central LSS, there is a lack of adequately designed peer-reviewed literature or guidance from relevant medical societies to establish its safety and effectiveness. There is a need for additional research with sufficient follow-up, sample size, and relevant comparative control groups to establish the appropriateness of PILD for the treatment of central LSS.
References


Benyamin, RM, Staats, PS. MILD® Is an Effective Treatment for Lumbar Spinal Stenosis with Neurogenic Claudication: MiDAS ENCORE Randomized Controlled Trial. Pain Physican. 2016; 19(4):229-42.

ClinicalTrials.gov. MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study 03/07/2017. Assessed February 6, 2018.

Brown LL. A double-blind, randomized, prospective study of epidural steroid injection vs. the mild procedure in patients with symptomatic lumbar spinal stenosis. Pain Pract. 2012;12(5):333-341.

Castro-Menendez M, Bravo-Ricoy JA, Casal-Moro R, et al. Midterm outcome after microendoscopic decompressive laminotomy for lumbar spinal stenosis: 4-year prospective study. Neurosurgery. 2009;65(1):100-10.

Chopko BW. A novel method for treatment of lumbar spinal stenosis in high-risk surgical candidates: pilot study experience with percutaneous remodeling of ligamentum flavum and lamina. J Neurosurg Spine. 2011;14(1):46-50.

Chopko BW. Long-term results of percutaneous lumbar decompression for LSS: two-year outcomes. Clin J Pain. 2013;29(11):939-943.

Chopko B, Caraway DL. MiDAS I (mild Decompression Alternative to Open Surgery): A preliminary report of a prospective, multi-center clinical study. Pain Physician. 2010;13(4):369-78.

Chou R, Baisden J, Carragee EJ, et al. Surgery for low back pain: a review of the evidence for an American Pain Society Clinical Practice Guideline. Spine. 2009;34(10):1094-109.

Chou R, Loeser JD, Owens DK, et al. Interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain: an evidence-based clinical practice guideline from the American Pain Society. Spine. 2009;34(10):1066-77.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Percutaneous Image-Guided Lumbar Decompression for Lumbar Spinal Stenosis. (150.13) [CMS Web site]. 01/09/2014. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=358&ncdver=1&bc=AgAAQAAAAAAAAA%3d%3d&
Accessed February 6, 2018.

Centers for Medicare & Medicaid Services (CMS). Coverage with Evidence Development approved clinical trials for Percutaneous Image-guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS) . [CMS Web site] 03/19/2015. Available at: http://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/PILD.htmlAccessed February 6, 2018.

Centers for Medicare & Medicaid Services (CMS). Decision Memo for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis (CAG-00433N). [CMS Web site]. 01/09/2014. Available at:
http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=269 Accessed February 6, 2018.

Centers for Medicare & Medicaid Services (CMS) MLN Matters.News Flash. MM8757. Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis. 01/09/2014. [CMS Web site]
http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM8757.pdf Accessed February 6, 2018.

Deer TR, Kapural L. New image-guided ultra-minimally invasive lumbar decompression method: the mild® procedure. Pain Physician. 2010;13(1):35-41.

Deer TR, Kim CK, Bowman RG, 2nd, et al. Study of percutaneous lumbar decompression and treatment algorithm for patients suffering from neurogenic claudication. Pain Physician. 2012;15(6):451-460.

Fu YS, Zeng BF, Xu JG. Long-term outcomes of two different decompressive techniques for lumbar spinal stenosis. Spine. 2008;33(5):514-8.

Kreiner DS, Macvicar J, Duszynski B et al. The mild® Procedure: A Systematic Review of the Current Literature. Pain Med. 2014;15(2):196-205.

Levy RM, Deer TR. Systematic safety review and meta-analysis of procedural experience using percutaneous access to treat symptomatic lumbar spinal stenosis. Pain Med. 2012;13(12):1554-1561.

Lingreen R, Grider JS. Retrospective review of patient self-reported improvement and post-procedure findings for mild® (minimally invasive lumbar decompression). Pain Physician. 2010;13(6):555-60.

Mayo Clinic. Spinal stenosis. [Mayo Clinic Web site]. Available at: http://www.mayoclinic.org/diseases-conditions/spinal-stenosis/basics/definition/con-20036105 Accessed February 6, 2018.

Mekhail N, Costandi S, Abraham B, et al. Functional and patient-reported outcomes in symptomatic lumbar spinal stenosis following percutaneous decompression. Pain Pract. 2012;12(6):417-425.

Mekhail N, Vallejo R, Coleman MH, et al. Long-term results of percutaneous lumbar decompression mild (®) for spinal stenosis. Pain Pract. 2012;12(3):184-93.

Thome C, Zevgaridis D, Leheta O, et al. Outcome after less-invasive decompression of lumbar spinal stenosis: a randomized comparison of unilateral laminotomy, bilateral laminotomy, and laminectomy. J Neurosurg Spine. 2005;3(2):129-41.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Vertos Medical mild® Device Kit. 510(k) summary. [FDA Web site]. 02/04/10. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf9/K093062.pdf. Accessed February 6, 2018.

Weinstein JN, Lurie JD, Tosteson TD, et al. Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. N Engl J Med. 2007;356(22):2257-70.

Weinstein JN, Tosteson TD, Lurie JD, et al. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med. 2008;358(8):794-810.

Wilkinson JS, Fourney DR. Failure of percutaneous remodeling of the ligamentum flavum and lamina for neurogenic claudication. Neurosurgery. 2012;71(1):86-92.





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)

0275T


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)

N/A


HCPCS Level II Code Number(s)

G0276 Blinded procedure for lumbar stenosis, percutaneous image-guided lumbar decompression (pild) or placebo-control, performed in an approved coverage with evidence development (ced) clinical trial


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

Revisions from 11.15.22d:
03/27/2019This policy has been reissued in accordance with the Company's annual review process.
04/11/2018The 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: 03/28/2019

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