L29204-LCD

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Local Coverage Determination (LCD) for Interspinous Process Decompression (L29204)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L29204

LCD Title

Interspinous Process Decompression

Contractor's Determination Number 0171T

Primary Geographic Jurisdiction Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

CPT only copyright 2002-2011 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 02/02/2009

Original Determination Ending Date

Revision Effective Date

For services performed on or after 10/01/2010

Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determination (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represent quotation from one or more of the following CMS sources:

N/A

Indications and Limitations of Coverage and/or Medical Necessity

Interspinous Process Decompression (IPD®) is a less invasive surgical procedure in which a titanium metal implant is placed between the spinous processes of the symptomatic lumbar disc levels. The implant may be placed at two levels if necessary. It is performed as an alternative to laminectomy for patients diagnosed with lumbar spinal stenosis who exhibit symptoms of intermittent neurogenic claudication and are able to relieve their symptoms when bending forward or when the spine is in a flexed position such as when sitting. The implant is designed to limit pathologic extension of the spinal segments and maintain them in a neutral or slightly flexed position which may allow patients to resume their normal posture rather than flex the entire spine to gain symptom relief. IPD® is performed in the operating room under local, spinal or general anesthesia. It is done as either an inpatient or outpatient procedure depending upon the number of levels performed and the associated co

-morbidities.

IPD® is an emerging technology. The development of this LCD will provide access to care for Medicare beneficiaries. The extent of future coverage and/or limitations will be considered as additional data regarding IPD® becomes available.

Indications

Medicare will consider IPD® medically reasonable and necessary for patients who meet ALL of the following criteria:

• Aged 50 or older suffering from (intermittent neurogenic claudication) secondary to a confirmed diagnosis of lumbar spinal stenosis.

• with moderately impaired physical function who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain; and

• Patients who have undergone at least 6 months of non operative treatment

Limitations

IPD® will not be considered medically reasonable and necessary with ANY of the following conditions:

• 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

• 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 DEXA scan or some comparable study) in the spine or hip that is more than 2.5 SD 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 (BMI) > 40kg/m²

Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

999x Not Applicable

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

99999 Not Applicable

CPT/HCPCS Codes

0171T INSERTION OF POSTERIOR SPINOUS PROCESS DISTRACTION DEVICE (INCLUDING NECESSARY REMOVAL OF BONE OR LIGAMENT FOR INSERTION AND IMAGING GUIDANCE), LUMBAR; SINGLE LEVEL

INSERTION OF POSTERIOR SPINOUS PROCESS DISTRACTION DEVICE (INCLUDING NECESSARY REMOVAL 0172T OF BONE OR LIGAMENT FOR INSERTION AND IMAGING GUIDANCE), LUMBAR; EACH ADDITIONAL LEVEL

(LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)

ICD-9 Codes that Support Medical Necessity

724.03 SPINAL STENOSIS, LUMBAR REGION, WITH NEUROGENIC CLAUDICATION

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity XX000 Not Applicable

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

The medical record must contain documentation that fully supports the medical necessity of the procedure performed. This documentation includes, but is not limited to relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.

Documentation must include evidence of six months of non operative treatment. Examples of non operative treatment include medications, corticosteroid injection therapy, rest or restricted activity, devices designed to help stabilize the spine such as back braces/corsets, and physical therapy/exercises to help stabilize the spine, that help to build endurance and increase flexibility.

The diagnosis of lumbar stenosis must be confirmed by radiological evidence i.e. a report resulting from a CT scan, MRI, or a myelogram.

Appendices

Utilization Guidelines It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. This procedure may be performed at one or two spinal levels. When services are performed in excess of established parameters, they may be subject to review for medical necessity.

It is expected that the patient has not previously received a laminotomy or laminectomy at the same level of the spine as the IPD®.

Services performed on patients who have received another spinal procedure such as any spinal instrumentation (CPT codes 22840-22849) and laminectomy or laminotomy (CPT codes 63001-63048) may be subject to denial.

Sources of Information and Basis for Decision

California Technology Assessment Forum (2006) An interspinous process distractor (X STOP) for the treatment of spinal stenosis of the lumbar spine -A technology assessment retrieved from http://www.ctaf.org/ on February 9, 2007.

Department of Health and Human Services (2005) X STOP® Interspinous Process Decompression System

–P040001 retrieved from http://www.fda.gov/cdrh/pdf4/p040001.html. Retrieved February 9, 2007.

Kondrashov DG, Hannibal M, Hsu KY, Zucherman, JF. (2006) Interspinous process decompression with the X- STOP device for lumbar spinal stenosis. Journal of Spinal Disorders & Techniques 2006; 19 (5):323-327.

Murphy DR, Hurwitz EL, Gregory AA, Clary R.(2006) A non-surgical approach to the management of lumbar spinal stenosis; a prospective observational cohort study. BMC Musculoskelet Disord. 2006; 7:16.

Richards JC, Majumdar S, Lindsey DP, Beaupre GS, Yerby SA. (2005) The treatment mechanism of an interspinous process implant for lumbar neurogenic intermittent claudication. Spine. Apr 1 2005; 30(7): 744-749.

Sagun K, Scott A, Yerby SA, Katz JN. (2006) Methodological approaches to developing criteria for improvement in lumbar spinal stenosis surgery. Spine 2006; 31: 1276-1280.

Siddiqui M, Karadimas E, Nicol M, Smith FW, Wardlaw D. (2006) Influence of X Stop on neural foramina and spinal canal area in spinal stenosis. Spine 2006; 31(25): 2958-2962.

Wiseman CM, Lindsey DP, Fredrick AD, Yerby, SA. (2005) The effect of an interspinous process implant on facet loading during extension. Spine 2005; 30 (8): 903-907.

Zucherman JF, Simons P, Timothy J. (2005) X STOP Interspinous implant for lumbar spinal decompression. Brussels International Spine Symposium November 18-19, 2005.

Zucherman JF, Hsu KY, Hartjen CA, et al.(2006) A multicenter, prospective, randomized trial evaluating the X STOP interspinous process decompression system for the treatment of neurogenic intermittent claudication. Spine 2006; 30(12): 1351-1358.

Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was

developed in cooperation with advisory groups, which includes representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 10/01/2010

Revision History Number 1

Revision History Explanation Revision Number:1 Start Date of Comment Period:N/A

Start Date of Notice Period:10/01/2010 Revised Effective Date: 10/01/2010

LCR B2010-071

September 2010 Update

Explanation of Revisions: Annual 2011 ICD-9-CM Update. Added diagnosis code 724.03. Removed diagnosis code

724.02. The effective date of this revision is based on date of service.

Revision Number:Original

Start Date of Comment Period:N/A Start Date of Notice Period:12/04/2008 Revised Effective Date:02/02/2009

LCR B2009-044FL

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the carrier predecessors of First Coast Service Options, Inc. (Triple S and FCSO).

For Florida (00590) this LCD (L29204) replaces LCD L25281 as the policy in notice. This document (L29204) is effective on 02/02/2009.

09/06/2010 - This policy was updated by the ICD-9 2010-2011 Annual Update.

Reason for Change