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DESCRIPTIONPercutaneous balloon kyphoplasty and mechanical vertebral augmentation with Kiva® are interventional techniques involving the fluoroscopically guided injection of polymethylmethacrylate (PMMA) into a cavity created in the vertebral body with a balloon or mechanical device. These techniques have been investigated as an option 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 the 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 ultrahigh 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 implant is made from PEEK-OPTIMA®, a biocompatible polymer, and is inserted into the vertebral body over a guide wire. The implant can be customized by changing the coil stack height, with a maximum height of 12 mm. PMMA is injected through the lumen 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, and it is estimated that up to one half of women and approximately one quarter 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 1 month. However, 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/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.
Vertebral Body Metastasis
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.
Vertebral hemangiomas are relatively common lesions noted in up to 12% of the population based on autopsy series; however, only rarely do these lesions display aggressive features and produce neurologic compromise and/or pain. Treatment of aggressive vertebral hemangiomas has evolved from radiation therapy to surgical approaches using anterior spinal surgery for resection and decompression. There is the potential for large blood loss during surgical resection, and vascular embolization techniques have been used as adjuncts to treatment to reduce blood loss. Percutaneous cementoplasty has been proposed as a way to treat and stabilize some hemangioma to limit the extent of surgical resection and as an adjunct to reduce associated blood loss from the surgery.
Kyphoplasty is a surgical procedure and, as such, is not subject to U.S. Food and Drug Administration (FDA) approval. Balloon kyphoplasty requires the use of an inflatable bone tamp. One such tamp, the KyphX® inflatable bone tamp, received 510(k) marketing clearance from the FDA in July 1998. Other devices with FDA 510(k) marketing clearance include AVAmax® Vertebral Balloon system (Carefusion), NeuroTherm Parallax® Balloon Inflatable Bone Tamp (NeuroTherm Inc.), Stryker iVAS® Balloon catheter, and Synthes Synflate™ Vertebral Balloon System, Synthes (USA) LLC (FDA product code NDN).
The Kiva® VCF Treatment System (Benvenue Medical) received FDA 510(k) marketing clearance in January 2014 (FDA product code NDN).Vertebral body stenting (VBS™; Synthes, Switzerland) is available in Europe at this time.
PMMA bone cement was available as a drug product prior to 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 device requiring premarketing applications. Several orthopedic companies have received approval of their bone cement products since 1976. In October 1999, PMMA was reclassified from class III to class II, which requires future 510(k) submissions to meet “special controls” instead of “general controls” to assure safety and effectiveness.
Thus, use of PMMA in kyphoplasty represented an off-label use of an FDA-regulated product prior to July 2004. In July 2004, KyphX® HV-RTM bone cement was given 510(k) marketing clearance by the FDA 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 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.
The FDA also issued a “Public Health Web Notification: Complications related to the use of bone cement in vertebroplasty and kyphoplasty procedures.” This notification is intended to inform the public about reports on safety and to encourage hospitals and other user facilities to report adverse events related to bone cement malfunctions either directly to manufacturers or to MedWatch, the FDA’s voluntary reporting program.
Related medical policy -
POLICYPercutaneous kyphoplasty may be considered medically necessary for the treatment of symptomatic osteoporotic vertebral fractures that have failed to respond to conservative treatment (e.g., analgesics, physical therapy, and rest) for at least 6 weeks.
Percutaneous kyphoplasty 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 kyphoplasty is 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, including but not limited to Kiva and vertebral body stenting, 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.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
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.
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.