I'm a member
You will be redirected to myBlue. Would you like to continue?
Please wait while you are redirected.
Please enter a username and password.
Printer Friendly Version
Percutaneous balloon kyphoplasty and mechanical vertebral augmentation with Kiva VCF Treatment System are interventional techniques involving the fluoroscopically guided injection of polymethylmethacrylate into a cavity created in the vertebral body with a balloon or mechanical device. These techniques have been investigated as options to provide mechanical support and symptomatic relief in patients with osteoporotic vertebral compression fracture, or in those with osteolytic lesions of the spine (i.e., multiple myeloma or metastatic malignancies).
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 polymethylmethacrylate (PMMA). Radiofrequency kyphoplasty is a modification of balloon kyphoplasty. In this procedure, an ultra-high 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.
It has been proposed that kyphoplasty 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, one of which is thermal damage to intraosseous nerve fibers given that PMMA undergoes a heat-releasing (exothermic) reaction during its hardening process.
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 Treatment System consists of a shaped memory coil and an implant, which is filled with bone cement. The coil is inserted into the vertebral body over a removable guidewire. 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, made from PEEK-OPTIMA, 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.
Osteoporotic Vertebral Compression Fracture
Osteoporotic compression fractures are a common problem. It is estimated that up 50% of women and approximately 25% of men will have a vertebral fracture at some point in their lives. However, only about one-third of vertebral fractures actually reach clinical diagnosis, and most symptomatic fractures will heal within a few weeks or one month. A minority of patients will exhibit chronic pain following osteoporotic compression fracture that presents challenges for medical management. Chronic symptoms do not tend to respond to the management strategies for acute pain such as bed rest, immobilization or bracing device, and analgesic medication, sometimes including narcotic analgesics. The source of chronic pain after vertebral compression fracture may not be from the vertebra itself but may be predominantly related to strain on muscles and ligaments secondary to kyphosis. This type of pain frequently is not improved with analgesics and may be better addressed through exercise.
Osteolytic Vertebral Body Lesions
Vertebral body fractures can also be pathologic, due to osteolytic lesions, most commonly from metastatic tumors. Metastatic malignant disease involving the spine generally involves the vertebral bodies, with pain being the most frequent complaint. While radiation and chemotherapy are frequently effective in reducing tumor burden and associated symptoms, pain relief may be delayed days to weeks, depending on tumor response. Further, these approaches rely on bone remodeling to regain vertebral body strength, which may necessitate supportive bracing to minimize the risk of vertebral body collapse during healing.
Kyphoplasty is a surgical procedure and, as such, is not subject to regulation by the U.S. Food and Drug Administration (FDA). Balloon kyphoplasty requires the use of an inflatable bone tamp. In July 1998, one such tamp, the KyphX® inflatable bone tamp, was cleared for marketing by FDA through the 510(k) process. Other devices with FDA 510(k) marketing clearance include AVAmax® Vertebral Balloon system (Carefusion), NeuroTherm Parallax® Balloon Inflatable Bone Tamp (NeuroTherm), Stryker iVAS® Balloon catheter, and Synthes Synflate™ Vertebral Balloon System (Synthes). (FDA product code NDN).
In 2014, the Kiva® VCF Treatment System (Benvenue Medical) was cleared for marketing by FDA through the 510(k) process. (FDA product code NDN).
PMMA bone cement was available as a drug product before enactment of the FDA’s device regulation and was at first considered what the FDA terms a “transitional device.” It was transitioned to a class III and then to a class II device, which required future 510(k) submissions to meet “special controls” instead of “general controls” to assure safety and effectiveness. In July 2004, KyphX® HV-RTM bone cement was cleared for marketing by FDA through the 510(k) process for the treatment of pathologic fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a balloon kyphoplasty procedure. Subsequently, other products such as Spine-Fix® Biomimetic Bone Cement, KYPHON® HV-R® Bone Cement, and Osteopal® V have been issued 510(k) marketing clearance for the fixation of pathologic fractures of the vertebral body using vertebroplasty or kyphoplasty procedures.
Related medical policy -
POLICYPercutaneous balloon kyphoplasty and Kiva® may be considered medically necessary for the treatment of symptomatic osteoporotic vertebral compression fractures that have failed to respond to conservative treatment (e.g., analgesics, physical therapy, and rest) for at least 6 weeks.
Percutaneous balloon kyphoplasty and Kiva® may be considered medically necessary for the treatment of severe pain due to osteolytic lesions of the spine related to multiple myeloma or metastatic malignancies.
Percutaneous balloon kyphoplasty and Kiva® are considered investigational for all other indications, including use in acute vertebral fractures due to osteoporosis or trauma.
Percutaneous mechanical vertebral augmentation using any other device is considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
POLICY HISTORY2/2000: Approved by Medical Policy Advisory Committee (MPAC)
5/2000: Reviewed by MPAC; policy exceptions will be considered on an individual case basis
6/5/00 NOTE: See POLICY EXCEPTIONS and POLICY HISTORY.
11/2000: Reviewed by MPAC; investigational status maintained
1/17/2001: Code Reference section updated.
2/8/2002: Appeal statement deleted from Policy Exception section, Investigational definition added
5/2/2002: Type of Service and Place of Service deleted
6/11/2002: CPT code 22899 deleted, HCPCS S2360 added
9/27/2002: Policy renamed "Percutaneous Vertebroplasty (PV) and Kyphoplasty", Description and Policy sections revised to be consistent with BCBSA policy, PMMA off-label use added, Sources and Code Reference sections updated
11/2002: Reviewed by MPAC; changed to medically necessary as treatment of vertebral compression fracture related to osteoporosis or as a treatment of osteolytic lesions of the spine relative to multiple myeloma or metastatic malignancies. Code Reference section updated
3/2003: Reviewed by MPAC, no changes, Sources updated
11/2003: Code Reference section updated, ICD-9 diagnosis code 238.9 deleted, ICD-9 diagnosis code range 733.00-733.09 listed separately
7/30/2004: Code Reference section updated, HCPCS S2361, S2362, S2363 added, Sources updated BCBSA policy # 6.01.38
7/21/2005: Reviewed by MPAC, no changes, Description section revised to be consistent with BCBSA policy # 6.01.25 & 6.01.38
9/21/2005: Code Reference section updated, ICD-9 procedure code 81.65, 81.66 added covered codes, “Note: This code is no longer used to report vertebroplasty and kyphoplasty effective 10-1-2004. For services on or after this date, see codes 81.65 and 81.66.” added ICD-9 procedure code 78.49
10/18/2005: Code Reference section updated, non-covered table deleted.
3/22/2006: Coding updated. CPT4/HCPCS 2006 revisions added to policy.
1/3/2007: Code reference section updated per the 2007 CPT/HCPCS revisions.
10/19/2007: Policy reviewed and investigational status given to all instances per BCBSA policy.
10/29/2007: Code reference section updated, non-covered table added. ICD-9 diagnosis codes 170.2, 198.5, 203.00, 203.01, 733.00, 733.01, 733.02, 733.03, 733.09 and 733.13 deleted. ICD-9 procedure code 78.49 deleted. Removed CPT codes 76012 and 76013 and HCPCS codes S2362 and S2363.
6/6/2008: Effective August 1, 2008, percutaneous vetebroplasty and kyphoplasty will be considered investigational for all indications.
9/22/2008: Annual ICD-9 updates effective 10-1-2008 applied
10/28/2008: Percutaneous vertebroplasty and kyphoplasty separated into two distinct policies. Percutaneous kyphoplasty changed from investigational for all indications to medical necessary if not responding to conservative treatment or for severe pain due to osteolytic lesions of the spine related to multiple myeloma or metastatic malignancies. CPT 22523, 22524, 22525, 72291, 72292 moved to covered. ICD-9 procedure code 81.66 moved to covered. Added ICD-9 diagnosis codes 170.2, 198.5, 203.00-203.02, 238.0, 239.2, 733.00-733.09, 733.13.
11/20/2008: Approved by Medical Policy Advisory Committee (MPAC)
10/5/2009: Code reference section updated. New ICD-9 diagnosis code 209.73 added to covered table.
4/15/2010: Policy description section revised to change vertebroplasty to cementoplasty and policy statement revised to add use in acute vertebral fractures due to osteoporosis or trauma is considered investigational. Code reference section updated. CPT codes 72291 and 72292 descriptions revised.
04/12/2012: Policy reviewed; policy statement unchanged. FEP verbiage added to the Policy Exceptions section.
11/15/2013. Policy description updated. Policy title changed from "Percutaneous Kyphoplasty" to "Percutaneous Balloon Kyphoplasty and Mechanical Vertebral Augmentation." Added the following investigational policy statement: Percutaneous mechanical vertebral augmentation using any other device, including but not limited to Kiva, is considered investigational.
07/11/2014: Policy description updated regarding devices and FDA status. Added "vertebral body stenting" to the investigational policy statement.
12/31/2014: Added the following new 2015 CPT codes to the Code Reference section: 22513, 22514, and 22515.
08/26/2015: Code Reference section updated for ICD-10.
11/12/2015: Policy description updated regarding Kiva® and vertebral body stenting. Policy statements updated to change "percutaneous kyphoplasty" to "percutaneous balloon kyphoplasty." Removed Kiva as investigational for percutaneous mechanical vertebral augmentation. Added Kiva to medically necessary policy statements and as investigational for all other indications, including use in acute vertebral fractures due to osteoporosis or trauma. Policy guidelines updated to state that based on currently available evidence, health outcomes for kyphoplasty, Kiva® and vertebroplasty appear to be equivalent, therefore the “least costly alternative” provision of the medically necessary definition may apply. Added medically necessary and investigative definitions.
12/03/2015: Policy guidelines updated to remove the following statement: Based on currently available evidence, health outcomes for kyphoplasty, Kiva® and vertebroplasty appear to be equivalent, therefore the “least costly alternative” provision of the medically necessary definition may apply.
05/31/2016: Policy number A.6.01.38 added.
01/04/2017: Policy description updated regarding products; removed information regarding vertebral body stenting and vertebral hemangiomas. First medically necessary policy statement updated to change "vertebral fractures" to "vertebral compression fractures." Investigational policy statement updated to remove "including but not limited to vertebral body stenting." It previously stated: Percutaneous mechanical vertebral augmentation using any other device, including but not limited to vertebral body stenting, is considered investigational. Code Reference section updated to remove deleted CPT codes 22523, 22524, 22525, 72291, and 72292.
SOURCE(S)Blue Cross & Blue Shield Association Policy # 6.01.38
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.
CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.