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LCD for PERCUTANEOUS VERTEBROPLASTY/BALLOON-ASSISTED VERTEBROPLASTY (L11417)


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Contractor Information
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Contractor Name back to top
NHIC, Corp. 
Contractor Number back to top
31142 
Contractor Type back to top
Carrier 


LCD Information
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LCD ID Number back to top
L11417 
 
LCD Title back to top
PERCUTANEOUS VERTEBROPLASTY/BALLOON-ASSISTED VERTEBROPLASTY 
 
Contractor's Determination Number back to top
00-11.R4 
 
AMA CPT / ADA CDT Copyright Statement back to top
CPT codes, descriptions and other data only are copyright 2009 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.  
 
CMS National Coverage Policy back to top
. Title XVIII of the Social Security Act, Section 1862(a)(7) excludes routine physical examination and screening tests performed in the absence of signs or symptoms from coverage.

· Title XVIII of the Social Security Act, Section 1862(a)(1)(A) allows coverage and payment for services considered medically reasonable and necessary.

· Title XVIII of the Social Security Act, Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.
 
 
Primary Geographic Jurisdiction back to top
Massachusetts
Maine
New Hampshire
Vermont
 
 
Oversight Region back to top
Region I
 
 
Original Determination Effective Date back to top
For services performed on or after 11/01/2000  
 
Original Determination Ending Date back to top
 
 
Revision Effective Date back to top
For services performed on or after 10/01/2008  
 
Revision Ending Date back to top
04/30/2009 
 
Indications and Limitations of Coverage and/or Medical Necessity back to top
Percutaneous Vertebroplasty is a minimally invasive, interventional radiological procedure which consists of the injection of a biomaterial into a cervical, thoracic or lumbar vertebral body lesion for the relief of pain and the strengthening of bone.

Balloon-Assisted Vertebroplasty is a minimally invasive procedure for the treatment of compression fractures of the vertebral body. Under local or general anesthesia with X-ray or fluoroscopy guidance, one or two hollow needle guides are placed into the collapsed vertebra. Next, the vertebral body is drilled and the two inflatable bone tamps are placed. The bone tamps are inflated, expanding the compressed vertebral body to create a cavity. Some vertebral height may be restored, reducing kyphosis. Next, the cavity is filled with bone cement under low pressure, usually polymethylmethacrylate (PMMA). The cement stabilizes the fracture.




INDICATIONS OF COVERAGE:

Percutaneous Vertebroplasty and Balloon-Assisted Vertebroplasty are considered reasonable and necessary:

When all of the following exist:

- There is a high degree of certainty through targeted, documented physical exam and ancillary studies (e.g., x-ray, MRI, CT, fluoroscopy, bone scan), that the pain is being caused by a non-healing fracture, and

- An ancillary study indicates non-healing osteoporotic or pathologic fracture, and

- The procedure is not being performed on a prophylactic basis, either for osteoporosis of the spine or chronic back pain, even if associated with old, healed compression fracture(s), and

- The risks of open surgical vertebroplasty are greater than the risks associated with the percutaneous approach, and

Who have one of the following conditions:

- Osteoporotic vertebral collapse with persistent debilitating pain which has not responded to accepted standard medical treatment (physical therapy, bed rest, bracing, and analgesics) for at least six weeks

- Osteoporotic vertebral collapse requiring hospitalization due to incapacitating pain

- Osteoporotic vertebral collapse which has not required hospitalization, but has required narcotics for at least 2 weeks due to incapacitating pain

- Osteolytic vertebral metastasis or myeloma with severe back pain related to the destruction of a vertebral body that does not involve the major part of the cortical bone

- Vertebral hemangioma with aggressive clinical signs

LIMITATIONS OF COVERAGE:

Percutaneous Vertebroplasty and Balloon Assisted-Vertebroplasty are not considered reasonable and necessary:

When any of the following exists:

- There is a high degree of certainty through targeted, documented physical exam and ancillary studies (e.g., x-ray, MRI, CT, fluoroscopy, bone scan), that the pain is not being caused by a non-healing fracture

- An ancillary study does not indicate a non-healing osteoporotic or pathologic fracture

- The procedure is being performed on a prophylactic basis, either for osteoporosis of the spine or chronic back pain, even if associated with old, healed compression fracture(s)

- The risks of open surgical vertebroplasty are less than the risks associated with the percutaneous approach,

- An uncorrected coagulation disorder exists,

- Neurological symptoms, related to compression, exist, or

When the patient does not have one of the following conditions:

- Osteoporotic vertebral collapse with persistent debilitating pain which has not responded to accepted standard medical treatment (physical therapy, bed rest, bracing, and analgesics) for at least six weeks

- Osteoporotic vertebral collapse requiring hospitalization due to incapacitating pain

- Osteoporotic vertebral collapse which has not required hospitalization, but has required narcotics for at least 2 weeks due to incapacitating pain

- Osteolytic vertebral metastasis or myeloma with severe back pain related to the destruction of a vertebral body that does not involve the major part of the cortical bone

- Vertebral hemangioma with aggressive clinical signs

Note:

· No more than 2 vertebral levels at a time should be treated via percutaneous or the balloon-assisted approach.

· The decision for treatment should be multidisciplinary, taking into consideration the local and general extent of the disease, the spinal level involved, the severity of pain experienced by the patient as well as his or her neurologic condition, previous treatments and their outcomes, and the general state of health and life expectancy.

· It is expected by Medicare that entities that allow the performance of percutaneous vertebroplasty and/or balloon-assisted vertebroplasty in their facilities will credential physicians who perform this procedure. Recommended criteria for such credentialing include:

Completion of an adequate course of training in this technique, either in an approved residency program or a post-residency training program that meets at least the standards of the American College of Radiology or similar training program that has been established for percutaneous vertebroplasty and/or balloon assisted vertebroplasty; and,

Performance of an established number of percutaneous vertebroplasty and/or balloon-assisted vertebroplasty procedures under the direction of a physician already credentialed in the procedure. The number of procedures, performed under the direction of another credentialed physician, should be established by the credentialing committee, and should be adequate to ensure proficiency in the technique. 
 


Coding Information
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Bill Type Codes: back to top

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.

 
 
Revenue Codes: back to top

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 back to top

22520 PERCUTANEOUS VERTEBROPLASTY, ONE VERTEBRAL BODY, UNILATERAL OR BILATERAL INJECTION; THORACIC
22521 PERCUTANEOUS VERTEBROPLASTY, ONE VERTEBRAL BODY, UNILATERAL OR BILATERAL INJECTION; LUMBAR
22522 PERCUTANEOUS VERTEBROPLASTY, ONE VERTEBRAL BODY, UNILATERAL OR BILATERAL INJECTION; EACH ADDITIONAL THORACIC OR LUMBAR VERTEBRAL BODY (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
22523 - 22525 PERCUTANEOUS VERTEBRAL AUGMENTATION, INCLUDING CAVITY CREATION (FRACTURE REDUCTION AND BONE BIOPSY INCLUDED WHEN PERFORMED) USING MECHANICAL DEVICE, ONE VERTEBRAL BODY, UNILATERAL OR BILATERAL CANNULATION (EG, KYPHOPLASTY); THORACIC - PERCUTANEOUS VERTEBRAL AUGMENTATION, INCLUDING CAVITY CREATION (FRACTURE REDUCTION AND BONE BIOPSY INCLUDED WHEN PERFORMED) USING MECHANICAL DEVICE, ONE VERTEBRAL BODY, UNILATERAL OR BILATERAL CANNULATION (EG, KYPHOPLASTY); EACH ADDITIONAL THORACIC OR LUMBAR VERTEBRAL BODY (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
 
 
ICD-9 Codes that Support Medical Necessity back to top

170.2 MALIGNANT NEOPLASM OF VERTEBRAL COLUMN EXCLUDING SACRUM AND COCCYX
198.5 SECONDARY MALIGNANT NEOPLASM OF BONE AND BONE MARROW
203.00 MULTIPLE MYELOMA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION
203.01 MULTIPLE MYELOMA IN REMISSION
203.02 MULTIPLE MYELOMA, IN RELAPSE
228.09 HEMANGIOMA OF OTHER SITES
238.0 NEOPLASM OF UNCERTAIN BEHAVIOR OF BONE AND ARTICULAR CARTILAGE
238.6 NEOPLASM OF UNCERTAIN BEHAVIOR OF PLASMA CELLS
239.2 NEOPLASM OF UNSPECIFIED NATURE OF BONE SOFT TISSUE AND SKIN
277.7 DYSMETABOLIC SYNDROME X
277.81 PRIMARY CARNITINE DEFICIENCY
277.82 CARNITINE DEFICIENCY DUE TO INBORN ERRORS OF METABOLISM
277.83 IATROGENIC CARNITINE DEFICIENCY
277.84 OTHER SECONDARY CARNITINE DEFICIENCY
277.89 OTHER SPECIFIED DISORDERS OF METABOLISM
733.01 SENILE OSTEOPOROSIS
733.02 IDIOPATHIC OSTEOPOROSIS
733.09 OTHER OSTEOPOROSIS
733.13 PATHOLOGICAL FRACTURE OF VERTEBRAE
733.82 NONUNION OF FRACTURE
805.2 CLOSED FRACTURE OF DORSAL (THORACIC) VERTEBRA WITHOUT SPINAL CORD INJURY
805.4 CLOSED FRACTURE OF LUMBAR VERTEBRA WITHOUT SPINAL CORD INJURY
805.8 CLOSED FRACTURE OF UNSPECIFIED PART OF VERTEBRAL COLUMN WITHOUT SPINAL CORD INJURY
 
 
Diagnoses that Support Medical Necessity back to top
Any diagnosis consistent with the ICD-9-CM codes listed in the "ICD-9-CM Codes that Support Medical Necessity" section. 
 
ICD-9 Codes that DO NOT Support Medical Necessity back to top
All ICD-9 Codes not listed under the “ICD-9 Codes That Support Medical Necessity” section of this policy will be denied.
 
 
ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation back to top
 
 
Diagnoses that DO NOT Support Medical Necessity back to top
 


General Information
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Documentation Requirements back to top
· The medical record should support the medical necessity of this treatment by containing clear and legible documentation that the indications of coverage have been met.

· The medical record should contain evidence of a history and physical examination and reports of ancillary studies confirming that a non-healing fracture is causing the pain/clinical syndrome.

· The medical record must be made available to the carrier upon request.

 
 
Appendices back to top
 
 
Utilization Guidelines back to top
 
 
Sources of Information and Basis for Decision back to top
For Percutaneous Vertebroplasty:

Barr, J.D., Barr, M.D., Lemley, T.J., et al. Percuatneous Vertebroplasty for Pain Relief and Spinal Stabilization. SPINE. Vol. 25. No. 8, April 15, 2000.

Cotten, A., et al. 1998. "Percutaneous Vertebroplasty: State of the Art." RadioGraphics Vol. 18 (March-April):311-323.

Wong, DO, Wade et al., "Vertebroplasty/Kyphoplasty," Journal of Women's Imaging, August 2000, Vol. 2. No. 3, pg. 117.

Jenson, M., et al. 1997. "Percutaneous Polymethylmethacrylate Vertebroplasty in the Treatment of Osteoporotic Vertebral Body Compression Fractures: Technical Aspects." American Journal of Neuroradiology Vol. 18 (November):1897-1904.

Other Carriers Local Medical Review Policies.

www.SCVIR.org

Carrier Advisory Committee Orthopedic, Neurosurgery, Radiology Physician Workgroup members.

For Balloon-Assisted Vertebroplasty:

Garfin, SR; Reiley, MA; Yuan, HA; "Minimally Invasive Treatment Options for Painful Osteoporotic Vertebral Body Compression Fractures," to be published in Spine, July, 2001.

Lane, JM; Johnson, BA; Khan, SN; Girardi, FP; Cammisa, FP; "Minimally Invasive Options for the Treatment of Osteoporotic Vertebral Compression Fractures," to be published in Orthopedic Clinics of North America, January, 2002.

Nationwide Medicare-Ohio LMRP 2000-36-L

"Vertebroplasty/Kyphoplasty"; Wong DO, W., Reiley MD, M., Garfin MD, S.; Article written and accepted for publication in The Journal of Women's Imaging; designated JWI 11-00.

"The Clinical Consequences of Vertebral Compression Fracture"; S.L. Silverman, Bone Vol. 13, S27-31 (1992)

"Challenges of Spine Fixation in the Adult"; Garfin, S. , Mermelstein, L, Mirkovic, S, Sandhu, H., Vaccaro, A., North American Spine Society; Oct. 31, 1998,

"The Worldwide Problem of Osteoporosis: Insights Afforded by Epidemiology; Riggs, B.L., Melton, L.J.III, Bone, Vol. 17, no. 5, Supplement; November 1995; 505s-511s.

Carrier Medical Directors

CPT 2002 Standard Edition, copyrights © 2002 by the American Medical Association, Medicode

ICD-9-CM codes , 6th edition, are copyright © 2002 by Ingenix Publishing Group, Medicode

Jenson, M., et al. 1997. "Percutaneous Polymethylmethacrylate Vertebroplasty in the Treatment of Osteoporotic Vertebral Body Compression Fractures: Technical Aspects." American Journal of Neuroradiology Vol.18 (November): 1897-1904.

Other carriers LMRPs

Proceedings of Blue Shield of California Medical Policy Committee on Quality and Technology, February 14, 2001, San Francisco.

Final Rule, Federal Regulations, Ambulance, January 25, 1999; pages 3637-3650 define bed-confined status. 
 
Advisory Committee Meeting Notes back to top
Advisory Committee Meeting Date: 05/08/2000

Orthopedic, Radiology and Neurosurgery Carrier Advisory Committee members 
 
Start Date of Comment Period back to top
05/08/2000 
 
End Date of Comment Period back to top
06/22/2000 
 
Start Date of Notice Period back to top
12/01/2000 
 
Revision History Number back to top
R10 
 
Revision History Explanation back to top
R10
10/01/2008
Added 203.2 as a result of 2009 ICD9CM update.

R9
10/26/2006
This LCD Database Number was converted to LCD Database Number L11417

R8
12/14/2005
Deleted CPT Code 22899. Added CPT codes 22523-22525 due to the Annual 2006 HCPCS update. Removed documentation requirement for NOC code requirement under "Documentation Requirements".

R7
02/02/2004
National Coverage Policy crosswalked to CMS Manual System (Internet Only Manual)

R6
01/23/2004
This LCD was converted from an LMRP on 01/23/2004
The LMRP description was added to the Indications and Limitations Section of the LCD

R5
10/01/2003
Added the following diagnosis codes:
277.81
277.82
277.83
277.84
277.89

R-4
09/01/2002
Added: Balloon-Assisted Percutaneous Vertebroplasty to LMRP as a covered procedure; Added: CPT code 22899; Added: Sources of Information; Reformatted to CMS format; Deleted bullets #3 and #4 under Indications for Coverage and bullets #3 and #4 under Limitations of Coverage

R-3
11/01/2001
Added: ICD-9-code, 277.7

R-2
03/16/2001
Added: CPT codes 22520, 22521 and 22522

R-1
12/01/2000
Corrected: under Limitations of Coverage and Reasons for Denial, Open surgical vertebroplasty is “less” of a risk, not “greater than”.



08/10/2008 - This policy was updated by the ICD-9 2008-2009 Annual Update. 
 
Reason for Change back to top
 
Last Reviewed On Date back to top
09/09/2008 
 
Related Documents back to top
This LCD has no Related Documents.
 
LCD Attachments back to top
There are no attachments for this LCD.


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Updated on 04/03/2009 with effective dates 06/01/2009 - N/A
Updated on 03/19/2009 with effective dates 05/01/2009 - 05/31/2009
Updated on 02/12/2009 with effective dates 05/01/2009 - N/A
Updated on 09/10/2008 with effective dates 10/01/2008 - 04/30/2009
Updated on 08/10/2008 with effective dates 01/01/2006 - 09/30/2008
Updated on 05/13/2008 with effective dates 01/01/2006 - N/A
Updated on 05/02/2007 with effective dates 01/01/2006 - N/A
Updated on 10/29/2006 with effective dates 01/01/2006 - N/A
Updated on 10/27/2006 with effective dates 01/01/2006 - N/A
Updated on 10/23/2006 with effective dates 01/01/2006 - N/A
Updated on 12/14/2005 with effective dates 01/01/2006 - N/A
Updated on 12/14/2005 with effective dates 01/01/2006 - N/A
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