Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Percutaneous Image-Guided Lumbar Decompression (PILD) for Spinal Stenosis
Policy #:MA11.097d

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


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. 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. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

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 Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

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

In accordance with Medicare, percutaneous image-guided lumbar decompression (PILD) for lumbar spinal stenosis is considered experimental/investigational and, therefore, not covered, with the exception of Coverage with Evidence Development.

COVERAGE WITH EVIDENCE DEVELOPMENT (CED)

Percutaneous image-guided lumbar decompression (PILD) for lumbar spinal stenosis is eligible for coverage consideration for individuals who meet all the requirements of Original Medicare's Coverage with Evidence Development (CED) provisions for PILD, including but not limited to CED approved devices (i.e., Vertos Medical, VertiFlex®, Inc.) and are enrolled in a Medicare-approved clinical study.

Claims for percutaneous image-guided lumbar decompression (PILD) for lumbar spinal stenosis for individuals enrolled in a CED clinical trial should be submitted to the Medicare Advantage plan.
Policy Guidelines

This policy is consistent with Medicare’s coverage determination for percutaneous image-guided lumbar decompression (PILD) for lumbar spinal stenosis. The Company’s payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, percutaneous image-guided lumbar decompression (PILD) for lumbar spinal stenosis is covered under the applicable medical benefits of the Company's Medicare Advantage products when the requirements for Coverage with Evidence Development listed in this medical policy are met.

PILD procedures performed when the requirements for Coverage with Evidence Development listed in this medical policy are met should be billed with G0276 for clinical trials that are blinded, randomized, controlled, and contain a placebo procedure control arm. CPT code 0275T should be billed for other clinical trials when the requirements of Original Medicare's Coverage of Evidence Development are met.

Services that are experimental/investigational are excluded for the Company’s Medicare Advantage products. Therefore, they are not eligible for reimbursement consideration.

Description

Percutaneous image-guided lumbar decompression (PILD) for lumbar spinal stenosis (LSS) is a procedure that has been proposed as a treatment for symptomatic LSS unresponsive to conservative therapy. PILD involves a posterior decompression of the lumbar spine performed under indirect image guidance without any direct visualization of the surgical area. It is generally described as a noninvasive procedure using specially designed instruments to percutaneously remove a portion of the lamina and debulk the ligamentum flavum. The procedure is performed under x-ray guidance (e.g., fluoroscopic, CT) with the assistance of contrast media to identify and monitor the compressed area via epiduragram.

Lumbar spinal stenosis is defined as the reduction of the cross sectional area, or narrowing, of the lumbar spinal canal. It is usually caused by spinal degenerative conditions and is commonly found to be asymptomatic. Lumbar spinal stenosis is subclassified into three broad categories, specifically central stenosis, lateral stenosis, and spondylolisthesis. Central stenosis refers to a narrowing of the spinal canal across the anteroposterior diameter, the transverse diameter, or both. Symptomatic individuals typically present with symptoms of radicular leg pain or with neurogenic claudication (i.e., pain in the buttocks or legs on walking or standing that resolves with sitting down or lumbar flexion).

While lumbar laminectomy is often considered the gold standard surgical treatment for LSS, PILD has been proposed as an alternative surgical treatment. However, 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 clinical studies with sufficient follow-up, sample size, and relevant comparative control groups to establish the appropriateness of PILD for the treatment of central LSS.

Two devices (Vertos Medical and VertiFlex® , Inc) have been approved by the Centers for Medicare and Medicaid Services (CMS) for Coverage with Evidence Development (CED). Additionally, as part of a Medicare Claims study, the Vertos Medical device is being investigated in a prospective, longitudinal analysis to evaluate individuals with lumber spinal stenosis who are treated with a minimally invasive lumber decompression (MILD) procedure compared to individuals who receive an alternative interspinous process decompression (IPD) procedure.
References

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]. Available at: http://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/PILD.htmlAccessed January 21, 2020.

Centers for Medicare & Medicaid Services (CMS). Decision Memo for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis (CAG-00433N). [CMS Web site]. 02/16/2017. Available at: https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=284. Accessed January 21,2020.

Centers for Medicare & Medicaid Services (CMS). Decision Memo for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis (CAG-00433R). [CMS Web site]. 12/07/2016. Available at: https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=284. Accessed January 21, 2020.

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 January 21, 2020.

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]. 12/07/2016. Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=358&ncdver=2&bc=AAAAgAAAAAAA&. Accessed January 21, 2020.

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 January 21, 2020.

US National Library of Medicine. MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study. 03/07/2017. Available at: https://clinicaltrials.gov/ct2/show/NCT03072927 . Accessed on January 21, 2020.


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)

THE FOLLOWING CODE REPRESENTS PERCUTANEOUS IMAGE-GUIDED MINIMALLY INVASIVE LUMBAR DECOMPRESSION FOR SPINAL STENOSIS WHEN PERFORMED IN A COVERAGE WITH EVIDENCE DEVELOPMENT CLINICAL TRIAL:

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)



THE FOLLOWING CODE REPRESENTS PERCUTANEOUS IMAGE-GUIDED MINIMALLY INVASIVE LUMBAR DECOMPRESSION FOR SPINAL STENOSIS WHEN PERFORMED IN A COVERAGE WITH EVIDENCE DEVELOPMENT CLINICAL TRIAL WITH BLINDING, AND RANDOMIZATION, CONTAINING A PLACEBO PROCEDURE CONTROL ARM:

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


Misc Code

:

N/A


Coding and Billing Requirements

There is a specific procedure code that represents image-guided minimally invasive lumbar decompression for spinal stenosis. Current Procedural Terminology (CPT) code 0275T is used to report this procedure. Other procedure codes (eg, CPT codes 63020, 63030 and/or 63035) do not appropriately represent image-guided minimally invasive lumbar decompression for spinal stenosis.

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

Cross References




Policy History

Revisions from MA11.097d:


MA11.097d
03/11/2020The policy has been reviewed and reissued to communicate the Company's continuing position on Percutaneous Image-Guided Lumbar Decompression (PILD) for Spinal Stenosis.


12/16/2019This version of the policy will become effective 12/16/2019.

The policy has been updated to include language identifying the applicable CMS approved devices part of Coverage with Evidence Development. The policy intent remains unchanged.

Revisions from MA11.097c:
04/15/2019This version of the policy will become effective 04/15/2019.

The policy has been updated to be consistent with Medicare and allow prospective longitudinal studies to be eligible for Coverage with Evidence Development. The policy intent remains unchanged.

Revisions from MA11.097b:
04/11/2018This policy has undergone a routine review, no revisions have been made.
06/21/2017This policy has been reissued in accordance with the Company's annual review process.
01/01/2017This version of the policy will become effective 01/01/2017.

The CPT narrative has been revised in this policy for the following code: 0275T

Revisions from MA11.097a:
04/13/2016The policy has been reviewed and reissued to communicate the Company’s continuing position on percutaneous image-guided lumbar decompression (PILD) for spinal stenosis
02/18/2015This policy was reviewed and updated to add HCPCS code G0276. Medicare notes that this code should be billed for PILD procedures performed when the requirements for Coverage with Evidence Development are met and the clinical trial is blinded, randomized, and controlled, and contains a placebo procedure control arm.

Revisions from MA11.097:
01/01/2015This is a new policy.






Version Effective Date: 12/16/2019
Version Issued Date: 12/16/2019
Version Reissued Date: 03/11/2020