Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Lumbar Interspinous Process Decompression System
Policy #:MA11.048c

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.

The use of a lumbar interspinous process decompression system (e.g., X STOP®) to insert a stabilization implant is considered medically necessary and, therefore, covered when all of the following criteria are met:
  • The individual is a candidate for operative treatment at no more than two lumbar levels.
  • The individual has neurogenic intermittent claudication (i.e., pain or weakness radiating from the lumbar region into the legs) due to a confirmed diagnosis of lumbar spinal stenosis.
  • The individual has moderately impaired function (as defined by outcomes instruments specific to lumbar spinal stenosis, such as the Zurich Claudication Questionnaire) and experiences relief in flexion from leg, buttock, or groin pain, with or without back pain.
  • The individual has undergone a regimen of at least six months of non-operative treatment (e.g., physical therapy, non-steroidal anti-inflammatory medication).

All other uses for the lumbar interspinous process decompression system are considered not medically necessary and, therefore, not covered.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Policy Guidelines

This policy is consistent with Medicare’s coverage determination. The Company’s payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, the lumber interspinous process decompression system is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

Description

The X STOP® Interspinous Process Decompression System (“X STOP”) is used to relieve symptoms of lumbar spinal stenosis, a narrowing of the passages for the spinal cord and nerves. The X STOP® is a titanium implant that fits between the spinous processes of the lower (lumbar) spine. It is made from titanium alloy and consists of two components: a spacer assembly and a wing assembly.

The X STOP® implant is placed between the spinous processes of the symptomatic lumbar levels. Spinous processes are the thin projections from the back of the spinal bones to which muscle and ligaments are attached. The X STOP® is designed to limit extension of the spine in the affected area, which may relieve the symptoms of lumbar spinal stenosis.

The X STOP® implant is indicated for treatment of individuals aged 50 or older suffering from pain or cramping in the legs (neurogenic intermittent claudication) secondary to a confirmed diagnosis of lumbar spinal stenosis. The X STOP® is indicated for those patients with moderately impaired physical function who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of nonoperative treatment. The X STOP® may be implanted at one or two lumbar levels.
References

Centers for Medicare & Medicaid Services (CMS). MLN Matters (MM5276). Updated 11/06/2012. Available at: http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/mm5276.pdf. Accessed February 6, 2018.

Centers for Medicare & Medicaid Services (CMS). Press release: CMS announces payment reforms for inpatient hospital services in 2007. [CMS Web site]. 08/01/2006. Available at:
http://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2006-Press-releases-items/2006-08-01.html. Accessed February 6, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. X STOP® Interspinous Process Decompression System. Premarket approval letter. [FDA Web site]. 11/21/2005. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf4/P040001A.pdf. Accessed February 6, 2018.



Coding

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

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

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

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

CPT Procedure Code Number(s)

22867, 22868, 22869, 22870


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

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


ICD - 10 Procedure Code Number(s)

N/A


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

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


ICD -10 Diagnosis Code Number(s)

M48.062 Spinal stenosis, lumbar region with neurogenic claudication

M48.07 Spinal stenosis, lumbosacral region



HCPCS Level II Code Number(s)

C1821 Interspinous process distraction device (implantable)


Revenue Code Number(s)

N/A

Coding and Billing Requirements






Policy History

Revisions from MA11.048c:
09/25/2019This policy has been reissued in accordance with the Company's annual review process.
05/21/2018This policy has undergone a routine review, and the following diagnosis code have been added to the policy: M48.062.

The following ICD-10 code have been removed from this policy: M48.06.

The policy statement was updated to more closely align with the language in the coding table.

Revisions from MA11.048b:
06/21/2017This policy has been reissued in accordance with the Company's annual review process.
01/01/2017Policy MA11.048b was updated with CPT coding.

The following CPT codes have been added to this policy: 22867, 22868, 22869, 22870

The following CPT codes have been removed from this policy: 0171T, 0172T


Revisions from MA11.048a:
09/23/2015Policy MA11.048a was updated with ICD-10 coding. This policy will become effective 09/23/2015.


Revisions from MA11.048:
01/01/2015This is a new policy




Version Effective Date: 05/21/2018
Version Issued Date: 05/21/2018
Version Reissued Date: 09/26/2019