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Date Printed: June 23, 2017: 11:32 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-20000-18

Original Effective Date: 02/15/01

Reviewed: 02/25/16

Revised: 03/15/16

Subject: Percutaneous Vertebroplasty, Kyphoplasty, and Sacroplasty

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

Percutaneous Vertebroplasty

Percutaneous vertebroplasty is an interventional radiology technique involving the fluoroscopically guided injection of polymethylmethacrylate (PMMA) through a needle inserted into a weakened vertebral body. It has been proposed that vertebroplasty may provide an analgesic effect through mechanical stabilization of a fractured or otherwise weakened vertebral body. However, other possible mechanisms of effect have been postulated, including thermal damage to intraosseous nerve fibers.The technique has been used in all levels of the vertebrae (cervical, thoracic, and lumbar).

Kyphoplasty

Balloon kyphoplasty is a variant of vertebroplasty and uses a specialized bone tamp with an inflatable balloon to expand a collapsed vertebral body, as close as possible to its natural height before injection of PMMA. Radiofrequency kyphoplasty is a modification of balloon kyphoplasty. In this procedure, an ultrahigh viscosity cement is injected into the fractured vertebral body and radiofrequency is used to achieve the desired consistency of the cement. The ultra-high viscosity cement is designed to restore height and alignment to the fractured vertebra, along with stabilizing the fracture.

Kiva® is another mechanical vertebral augmentation technique that uses an implant for structural support of the vertebral body and to provide a reservoir for bone cement. The Kiva® VCF system consists of a shaped memory coil and a Kiva® implant, which is filled with bone cement. The coil is inserted into the vertebral body over a removable guide wire. The coil reconfigures itself into a stack of loops within the vertebral body and can be customized by changing the number of loops of the coil. The implant, a biocompatible polymer, is deployed over the coil. The coil is then retracted and PMMA is injected through the lumen of the implant. The PMMA cement flows through small slots in the center of the implant, which fixes the implant to the vertebral body and contains the PMMA in a cylindrical column. The proposed advantage of the Kiva® system is a reduction in cement leakage.

Sacroplasty

Sacroplasty evolved from the treatment of insufficiency fractures in the thoracic and lumbar vertebrae with vertebroplasty. The procedure, essentially identical, entails guided injection of PMMA through a needle inserted into the fracture zone. While first described in 2000 as a treatment for symptomatic sacral metastatic lesions, it is most often described as a minimally invasive procedure employed as an alternative to conservative management for sacral insufficiency fractures (SIFs). SIFs are the consequence of stress on weakened bone and are often the cause of low back pain in the elderly population. Osteoporosis is the most common risk factor for SIF.

POSITION STATEMENT:

Percutaneous vertebroplasty

Percutaneous vertebroplasty meets the definition of medical necessity for the following indications:

Percutaneous vertebroplasty is considered experimental or investigational for all other indications, including acute vertebral fractures due to osteoporosis or trauma.

Kyphoplasty and Kiva®

Percutaneous balloon kyphoplasty and Kiva® meets the definition of medical necessity for the following indications:

Percutaneous balloon kyphoplasty and Kiva® are considered experimental or investigational for all other indications, including acute vertebral fractures due to osteoporosis or trauma.

Sacroplasty

Percutaneous sacroplasty is considered experimental or investigational for all indications, including sacral insufficiency fractures due to osteoporosis, spinal lesions due to metastatic malignancies, and multiple myeloma. The available published clinical literature does not support clinical value.

BILLING/CODING INFORMATION:

CPT Coding:

0200T

Percutaneous sacral augmentation (sacroplasty), unilateral injection(s), including the use of a balloon or mechanical device, when used, one or more needles, includes imaging guidance and bone biopsy, when performed (investigational)

0201T

Percutaneous sacral augmentation (sacroplasty), bilateral injections, including the use of a balloon or mechanical device, when used, two or more needles, includes imaging guidance and bone biopsy, when performed (investigational)

22510

Percutaneous vertebroplasty (bone biopsy included when performed) 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance, cervicothoracic

22511

Percutaneous vertebroplasty (bone biopsy included when performed) 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance, lumbosacral

22512

Percutaneous vertebroplasty (bone biopsy included when performed) 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance, each additional cervicothroacic or lumbosacral, vertebral body (List separately in addition to code for primary procedure)

22513

Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (e.g., kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; thoracic

22514

Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (e.g., kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; lumbar

22515

Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (e.g., kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; each additional thoracic or lumbar vertebral body (List separately in addition to code for primary procedure)

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

C41.2

Malignant neoplasm of vertebral column

C79.51 – C79.52

Secondary malignant neoplasm of bone and bone marrow

C90.00

Multiple myeloma not having achieved remission

C90.01

Multiple myeloma in remission

D18.00

Hemangioma, unspecified site

D19.0

Benign neoplasm of mesothelial tissue of pleura

D47.9

Neoplasm of uncertain behavior of lymphoid , hematopoietic and related tissue, unspecified

D47.z9

Other unspecified neoplasms of uncertain behavior of lymphoid, hematopoietic and related tissue

M48.50xA – M48.58xS

Collapsed vertebra, not elsewhere classified

M80.08XA – M80.08XS

Age-related osteoporosis with current pathological fracture, vertebra(e)

S12.000A – S12.691S

Fracture of cervical vertebra

S12.9xxA – S12.9xxS

Fracture of neck, unspecified

S22.000A – S22.089S

Fracture of thoracic vertebra

S32.000A – S32.059S

Fracture of lumbar vertebra

REIMBURSEMENT INFORMATION:

None applicable.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

The following Local Coverage Determinations (LCD) was reviewed on the last guideline revised date: Vertebroplasty, Vertebral Augmentation; Percutaneous (L34976) located at fcso.com.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

None applicable.

OTHER:

None applicable.

REFERENCES:

  1. ACR-ASNR-ASSR-SIR-SNIS. Practice guideline for the performance of vertebral augmentation (2012). Accessed at http://www.acr.org/~/media/ACR/Documents/PGTS/guidelines/Vertebral_Augmentation.pdf.
  2. American College of Radiology (ACR). Practice guideline for the performance of percutaneous vertebroplasty. 2005.
  3. American Medical Association CPT (current edition).
  4. Baerlocher MO, Saad WE, Dariushnia S, et al. Quality improvement guidelines for percutaneous vertebroplasty. J Vasc Interv Radiol. Feb 2014;25(2):165-17.
  5. Barr JD, Jensen ME, Hirsch JA, et al. Position statement on percutaneous vertebral augmentation: a consensus statement developed by the Society of Interventional Radiology (SIR), American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS), American College of Radiology (ACR), American Society of Neuroradiology (ASNR), American Society of Spine Radiology (ASSR), Canadian Interventional Radiology Association (CIRA), and the Society of NeuroInterventional Surgery (SNIS). J Vasc Interv Radiol. Feb 2014;25(2):171-181.
  6. Blue Cross and Blue Shield Association Medical Policy Reference Manual. 6.01.25 – Percutaneous Vertebroplasty and Sacroplasty, April 2015.
  7. Blue Cross and Blue Shield Association Medical Policy Reference Manual. 6.01.38 – Percutaneous Balloon Kyphoplasty and Mechanical Vertebral Augmentation, April 2015.
  8. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). – Percutaneous Vertebroplasty, TEC Assessments 2001 Vol. 15, No. 21.
  9. Blue Cross and Blue Shield Association. Technology Evaluation Center (TEC). Percutaneous Kyphoplasty for Vertebral Fractures Caused by Osteoporosis or Malignancy. TEC Assessments 2005, Vol. 20, No. 7.
  10. Blue Cross and Blue Shield Association. Technology Evaluation Center (TEC). Percutaneous Vertebroplasty for Vertebral Fractures Caused by Osteoporosis or Malignancy. TEC Assessments 2008, Vol. 25, No. 5.
  11. Blue Cross and Blue Shield Association. Technology Evaluation Center (TEC). Percutaneous Vertebroplasty for Vertebral Fractures Caused by Osteoporosis or Malignancy. TEC Assessments 2005, Vol. 20, No. 6.
  12. Boswell, Mark V., MD, PhD, Trescot, Andrea M, MD, Sukdeb Datta, MD, et al. Interventional Techniques:Evidence-based Practice Guidelines in the Management of Chronic Spinal Pain. Pain Physician 2007; 10:7-111, ISSN 1533-3159.
  13. Butler, Carina L., Given, Curtis A., Michel, Steven J., Tibbs, Phillip A. Percutaneous Sacroplasty for the Treatment of Sacral Insufficiency Fractures. AJR 2005; 184:1956-1959.
  14. ECRI. Percutaneous kyphoplasty for the treatment of vertebral fractures. Plymouth Meeting, PA: ECRI. 2006:75. ECRI.
  15. ECRI. Percutaneous vertebroplasty for the treatment of vertebral fractures. Plymouth Meeting, PA: ECRI. Dec. 2008:123. ECRI.
  16. ECRI. Percutaneous vertebroplasty for the treatment of vertebral fractures. Plymouth Meeting, PA: ECRI. 2005:123. ECRI.
  17. Elnoamany H. Percutaneous Vertebroplasty: A New Serial Injection Technique to Minimize Cement Leak. Asian Spine J. 2015 Dec;9(6):855-62.
  18. First Coast Service Options, Inc. Local Coverage Determination (LCD) for Percutaneous Vertebroplasty (L29257), 01/10.
  19. First Coast Service Options, Inc. Local Coverage Determination (LCD) for Percutaneous Vertebral Augmentation (Vertebral Augmentation) (formerly Kyphoplasty) (L29209), 03/10.
  20. First Coast Service Options, Inc. Local Coverage Determination (LCD) for Vertebroplasty, Vertebral Augmentation; Percutaneous (L34976) (10/01/15).
  21. Frey ME, DePalma MJ, Cifu DX, et al. Efficacy and safety of percutaneous sacroplasty for painful osteoporotic sacral insufficiency fractures a prospective, multicenter trial. Spine. July 2007; 32(15): 1635-1640.
  22. Gupta AC, et al. Safety and effectiveness of sacroplasty: a large single-center experience. AJNR Am J Neuroradiol. 2014 Nov-Dec;35(11):2202-6.
  23. Hayes, Inc. HAYES Medical Technology Directory – Percutaneous Vertebroplasty and Kyphoplasty Lansdale, PA: Hayes, Inc.; May 2004. Update performed 05/11/07.
  24. Jensen ME, McGraw JK, et al, Position Statement on Percutaneous Vertebral Augmentation: A Consensus Statement Developed by the American Society of Interventional and Therapeutic Neuroradiology, Society of Interventional Radiology, American Association of Neurological Surgeons/Congress of Neurological Surgeons, and American Society of Spine Radiology, The American Journal of Neuroradiology (2007) Volume 28, 1439-1443.
  25. Jurczyszyn A, et al. Percutaneous Vertebroplasty for Pathological Vertebral Compression Fractures Secondary to Multiple Myeloma--Medium-Term and Long-Term Assessment of Pain Relief and Quality of Life. Adv Clin Exp Med. 2015 Jul-Aug;24(4):651-6.
  26. McGraw JK, Cardella J, Barr JD, Mathis JM, Sanchez O, Schwartzberg MS, Swan TL, Sacks D; Society of Interventional Radiology Standards of Practice Committee. Society of Interventional Radiology quality improvement guidelines for percutaneous vertebroplasty. J Vasc Interv Radiol. 2003 Sep; 14(9 Pt 2): S311-5.
  27. National Institute for Health and Clinical Excellence. Balloon kyphoplasty for vertebral compression fractures. London: National Institute for Health and Clinical Excellence (NICE). 2006:2. National Institute for Health and Clinical Excellence (NICE).
  28. Ontario Ministry of Health and Long-Term Care. Medical Advisory Secretariat. Balloon kyphoplasty. 2004:42. Toronto, ON, Canada: Ministry of Health and Long-Term Care.
  29. Otten LA, et al. Comparison of balloon kyphoplasty with the new Kiva® VCF system for the treatment of vertebral compression fractures. Pain Physician. 2013 Sep-Oct;16(5):E505-12
  30. Richards, A.M., Mears S.C., Knight, T.A., Dinah A.F., Belkoff, S.M. Biomechanical Analysis of Sacroplasty: Does Volume or Location of Cement Matter? American Journal of Neuroradiology 30:315-317, February 2009.
  31. Shi-Ming G, et al. Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for osteoporotic vertebral compression fracture: A metaanalysis. Indian J Orthop. 2015 Jul-Aug;49(4):377-87.
  32. Smith, Douglas k., Dix, James E. Percutaneous Sacroplasty: Long-Axis Injection Technique. AJR 2006; 186:1252-1255.
  33. Strub, W.M., Hoffmann, H., Ernst, R.J., Bulas, R.V. Sacroplasty by CT and Fluoroscopic Guidance: Is the Procedure Right for Your Patient? American Journal of Neuroradiology 28:38-41, January 2007.
  34. Whitlow, C.T., Mussat-Whitlow, B.J., Mattern, C.W.T., Baker, M.D., Morris, P.P. Sacroplasty versus Vertebroplasty: Comparable Clinical Outcomes for the Treatment of Fracture-Related Pain. American Journal of Neuroradiology 28:1266-1270, August 2007.
  35. Zhang GQ, et al. Comparison of percutaneous vertebroplasty and percutaneous kyphoplasty for the management of Kümmell's disease: A retrospective study. Indian J Orthop. 2015 Nov-Dec;49(6):577-82.
  36. Zhang J, Wu CG, Gu YF, Li MH. Percutaneous sacroplasty for sacral metastatic tumors under fluoroscopic guidance only. Korean J Radiol. 2008 Nov-Dec;9(6):572-6.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 02/25/16.

GUIDELINE UPDATE INFORMATION:

01/25/01

Medical Coverage Guideline developed.

07/15/02

Revised coverage criteria for vertebroplasty and added investigational statement for kyphoplasty.

07/15/03

Reviewed; added coverage criteria for kyphoplasty.

01/01/04

HCPCS coding update.

06/15/04

Review and revision of guideline; consisting of updated references.

04/15/05

Review and revision of guideline; consisting of updated references.

01/01/06

Annual HCPCS coding update consisting of the addition of 22523 – 22525.

04/01/06

2nd qtr HCPCS coding update consisting of the deletion of S2362 – S2363.

01/01/07

Annual HCPCS coding update consisting of the deletion of 76012 – 76013 and the addition of 72291 – 72292.

09/15/07

Review and revision of guideline consisting of updated references and reformatted guideline.

04/15/09

Scheduled review; no change in position statement. Update references.

07/15/09

HCPCS coding revision; add 0200T & 0201T. Add investigational statement for sacroplasty. Update description section. Update guideline title. Update references.

01/01/10

Annual HCPCS coding update: revised descriptors for CPT codes 22520, 22521, 22523, 72291, and 72292.

10/15/10

Revision; related ICD-10 codes added.

01/01/11

Annual HCPCS coding update. Revised descriptors for codes 0200T, and 0201T.

06/15/11

Scheduled review; position statements maintained and references updated.

01/01/12

Annual HCPCS coding update. Revised 22520, 22521 and 22522 descriptors.

05/11/14

Revision: Program Exceptions section updated.

01/01/15

Annual CPT/HCPCS update. Added 22510, 22511, 22512, 22513, 22514, 22515. Revised 0200T, 0201T descriptors. Deleted 22520, 22521, 22522, 22523, 22524, 22525, 72291, 72292.

11/01/15

Revision: ICD-9 Codes deleted.

01/01/16

Annual CPT/HCPCS coding update. Deleted codes S2360, S2361. Revised Program Exceptions section.

03/15/16

Scheduled review. Revised description section and position statement. Updated references.

Date Printed: June 23, 2017: 11:32 AM