Minimally Invasive Approaches to Vertebral Fractures and Osteolytic Lesions of the Spine

POLICY NUMBER

A.6.01.25

DESCRIPTION

Percutaneous vertebroplasty, percutaneous balloon kyphoplasty, radiofrequency kyphoplasty, and mechanical vertebral augmentation are interventional techniques involving the fluoroscopically guided injection of polymethyl methacrylate into a weakened vertebral body or a cavity created in the vertebral body with a balloon or mechanical device. The techniques have been investigated to provide mechanical support and symptomatic relief in patients with osteoporotic vertebral compression fractures or those with osteolytic lesions of the spine (i.e., multiple myeloma or metastatic malignancies); as a treatment for sacral insufficiency fractures; and as a technique to limit blood loss related to surgery.

Treatment of Vertebral Compression Fracture

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 does not improve with analgesics and may be better addressed through exercise or physical therapy. Improvements in pain and ability to function are the principal outcomes of interest for the treatment of osteoporotic fractures.

Treatment of Sacral Insufficiency Fractures

Similar interventions are used for sacral fractures and include bed rest, bracing, and analgesics. Initial clinical improvements may occur quickly; however, the resolution of all symptoms may not occur for 9 to 12 months.

Vertebral and Sacral Body Metastasis

Metastatic malignant disease of the spine generally involves the vertebrae/sacrum, with pain being the most frequent complaint.

Treatment of Vertebral and Sacral Body Metastasis

While radiotherapy 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 strength in the vertebrae/sacrum, which may necessitate supportive bracing to minimize the risk of vertebral/sacral collapse during healing. Improvements in pain and function are the primary outcomes of interest for treatment of bone malignancy with percutaneous vertebroplasty or sacroplasty.

Surgical Treatment Options

Percutaneous Vertebroplasty and Kyphoplasty

Vertebroplasty is a surgical procedure that involves the injection of synthetic cement (eg, polymethylmethacrylate [PMMA], bis-glycidal dimethacrylate [Cortoss]) into a fractured vertebra. It has been suggested that vertebroplasty may provide an analgesic effect through mechanical stabilization of a fractured or otherwise weakened vertebral body. However, other mechanisms of effect have been postulated, including thermal damage to intraosseous nerve fibers.

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 polymethyl methacrylate. Radiofrequency kyphoplasty (also known as radiofrequency targeted vertebral augmentation) is a modification of balloon kyphoplasty. In this procedure, a small diameter articulating osteotome creates paths across the vertebra. 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.

Percutaneous Sacroplasty

Sacroplasty evolved from the treatment of insufficiency fractures in the thoracic and lumbar vertebrae with vertebroplasty. The procedure, essentially identical to vertebroplasty, entails guided injection of polymethylmethacrylate through a needle inserted into the fracture zone. Although first described in 2000 as a treatment for symptomatic sacral metastatic lesions, it is most often described as a minimally invasive alternative to conservative management for sacral insufficiency fractures.

Mechanical Vertebral Augmentation

Kiva is a mechanical vertebral augmentation technique that uses an implant for structural support of the vertebral body to provide a reservoir for bone cement. The Kiva vertebral compression fractures 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 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, made from PEEK-OPTIMA™, a biocompatible polymer, is deployed over the coil. The coil is then retracted, and polymethyl methacrylate is injected through the lumen of the implant. The polymethyl methacrylate cement flows through small slots in the center of the implant, which fixes the implant to the vertebral body and contains the polymethyl methacrylate in a cylindrical column. The proposed advantage of the Kiva system is a reduction in cement leakage.

SpineJack is a mechanical vertebral augmentation technique that utilizes bipedicular 4.2 mm to 5.0 mm self-expanding jacks to restore vertebral height. Placement of the titanium devices are verified in anteroposterior and lateral view prior to expansion. Once the devices are expanded, a proprietary bone cement is injected. The proposed benefit is greater control over expansion and greater restoration of vertebral height compared to balloon kyphoplasty. The procedure requires good bone quality.

Pain and function are subjective outcomes and, thus, may be susceptible to placebo effects. Furthermore, the natural history of pain and disability associated with these conditions may vary. Therefore, controlled comparison studies would be valuable to demonstrate the clinical effectiveness of vertebroplasty and sacroplasty over any associated nonspecific or placebo effects and to demonstrate the effect of treatment compared with alternatives such as continued medical management.

In all clinical situations, adverse events related to complications from vertebroplasty, kyphoplasty, sacroplasty, and mechanical vertebral augmentation are the primary harms to be considered. Principal safety concerns relate to the incidence and consequences of leakage of the injected polymethyl methacrylate or another injectate.

Vertebroplasty is a surgical procedure and, as such, is not subject to U.S. Food and Drug Administration (FDA) approval.

Polymethylmethacrylate 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 device requiring premarketing applications. Several orthopedic companies have received approval of their bone cement products since 1976. In 1999, polymethylmethacrylate 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 polymethylmethacrylate in vertebroplasty represented an off-label use of an FDA-regulated product before 2005. In 2005, polymethylmethacrylate bone cements such as Spine-Fix® Biomimetic Bone Cement and Osteopal® V were cleared for marketing by the FDA through the 510(k) process for the fixation of pathologic fractures of the vertebral body using vertebroplasty procedures.

The use of polymethylmethacrylate in sacroplasty is an off-label use of an FDA-regulated product (bone cements such as Spine-Fix® Biomimetic Bone Cement [Teknimed] and Osteopal® V [Heraeus]) because the 510(k) approval was for the fixation of pathologic fractures of the vertebral body using vertebroplasty procedures. Sacroplasty was not included.

In 2009, Cortoss® (Stryker) Bone Augmentation Material was cleared for marketing by the FDA through the 510(k) process. Cortoss® is a nonresorbable synthetic material that is a composite resin-based, bis-glycidal dimethacrylate. The FDA classifies this product as a polymethylmethacrylate bone cement.

In 2010, the Parallax® Contour® Vertebral Augmentation Device (ArthroCare) was cleared for marketing by the FDA through the 510(k) process. There have been several other augmentation and bone expander devices (eg, Balex® Bone Expander System, Arcadia® Ballon Catheter, Kyphon Element® Inflatable Bone Tamp) that were also cleared for marketing by the FDA through the 510(k) process. These devices create a void in cancellous bone that can then be filled with bone cement.

Kyphoplasty is a surgical procedure and, as such, is not subject to regulation by the U.S. Food and Drug Administration (FDA). Polymethyl methacrylate bone cement was available as a drug product before enactment of the FDA's device regulation and was at first considered what the FDA termed a "transitional device." It was transitioned to a class III device 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 the 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, KYPHON™ VuE™ Bone Cement, Osteopal® V (Heraeus), and VertehighFix (Xelite Biomed) have received 510(k) marketing clearance for the fixation of pathologic fractures of the vertebral body using vertebroplasty or kyphoplasty procedures.

Balloon kyphoplasty requires the use of an inflatable bone tamp. In July 1998, one such tamp, the KyphX® inflatable bone tamp (Medtronic), was cleared for marketing by the FDA through the 510(k) process. Additional devices for balloon kyphoplasty are listed in the table below.

There are several mechanical vertebral augmentation devices that have received marketing clearance by the FDA through the 510(k) process; these are listed in the table below.

StabiliT® Vertebral Augmentation System (Merit Medical) for radiofrequency vertebral augmentation was cleared for marketing in 2009.

FDA product code: NDN.

Kyphoplasty and Mechanical Vertebral Augmentation Devices Cleared by the U.S. Food and Drug Administration

POLICY

Percutaneous vertebroplasty 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 vertebroplasty may be considered medically necessary for the treatment of symptomatic osteoporotic vertebral fractures that are less than 6 weeks in duration that have led to hospitalization or persist at a level that prevents ambulation.

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

Percutaneous sacroplasty is considered investigational for all indications, including use in sacral insufficiency fractures due to osteoporosis and sacral lesions due to multiple myeloma or metastatic malignancies.

Balloon kyphoplasty may be considered medically necessary for the treatment of symptomatic thoracolumbar osteoporotic vertebral compression fractures that have failed to respond to conservative treatment (eg, analgesics, physical therapy, rest) for at least 6 weeks.

Mechanical vertebral augmentation with an FDA-cleared device may be considered medically necessary for the treatment of symptomatic thoracolumbar osteoporotic vertebral compression fractures that have failed to respond to conservative treatment (eg, analgesics, physical therapy, rest) for at least 6 weeks.

Balloon 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.

Mechanical vertebral augmentation with an FDA-cleared device 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.

Balloon kyphoplasty or mechanical vertebral augmentation with an FDA-cleared device is considered investigational for all other indications, including use in acute vertebral fractures due to osteoporosis or trauma.

Radiofrequency kyphoplasty is considered investigational.

Mechanical vertebral augmentation using any other device is considered investigational.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

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 Mental Health Disorders, 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 medical necessity, “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 HISTORY

2/2000: 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 vertebroplasty 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 vertebroplasty changed from investigational for all indication 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 22520, 22521, 22522, 72291, 72292 moved to covered. HCPCS S2360 and S2361 moved to covered. ICD-9 procedure code 81.65 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 statement revised to add use in acute vertebral fractures due to osteoporosis or trauma is considered investigational. Code reference section updated. Description revised for CPT codes 72291 and 72292.

08/03/2011: Added "Sacroplasty" to the policy title. Policy description updated to add information regarding sacroplasty and sacral fractures. Added the following policy statement: Percutaneous sacroplasty is considered investigational for all indications, including use in sacral insufficiency fractures due to osteoporosis and spinal lesions due to metastatic malignancies or multiple myeloma. Added CPT codes 0200T and 0201T to the Non-Covered Codes table. Deleted outdated references from the Sources section.

04/26/2012: Policy reviewed; no changes.

08/07/2013: Policy reviewed; no changes.

07/11/2014: Policy reviewed; no changes.

12/31/2014: Added the following new 2015 CPT codes to the Code Reference section: 22510, 22511, and 22512. Revised the description of the following CPT codes: 0200T and 0201T. Effective 01/01/2015.

08/26/2015: Code Reference section updated for ICD-10.

12/31/2015: Policy guidelines updated to add medically necessary and investigative definitions. Code Reference section updated to removed deleted CPT codes 22520, 22521, 22522, 72291, and 72292.

03/03/2016: Policy description updated regarding devices. Policy statements unchanged. Sources section updated to remove reference.

05/31/2016: Policy number A.6.01.25 added.

07/10/2017: Policy description updated regarding percutaneous sacroplasty. Added policy statement that percutaneous vertebroplasty may be considered medically necessary for the treatment of symptomatic osteoporotic vertebral fractures that are less than 6 weeks in duration that have led to hospitalization or persist at a level that prevents ambulation.

05/02/2018: Policy description updated regarding vertebroplasty. Policy statements unchanged. Removed deleted HCPCS codes S2360 and S2361.

05/08/2019: Policy reviewed; no changes.

05/18/2020: Policy description updated regarding vertebral compression fracture and sacral insufficiency fractures. Policy statements unchanged.

06/14/2021: Policy reviewed. Investigational statement regarding percutaneous sacroplasty edited for clarity to change "spinal" to "sacral." Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

05/25/2022: Policy description updated regarding devices. Policy statements unchanged.

05/08/2023: Policy reviewed; no changes.

08/01/2024: Policy updated to merge this policy with the Percutaneous Balloon Kyphoplasty, Radiofrequency Kyphoplasty, and Mechanical Vertebral Augmentation medical policy. Policy title changed from "Percutaneous Vertebroplasty and Sacroplasty" to "Minimally Invasive Approaches to Vertebral Fractures and Osteolytic Lesions of the Spine." Policy statements unchanged. Code Reference section updated to add ICD-10 procedure code 0QU14JZ. The following CPT, ICD-10 procedure, and ICD-10 diagnosis codes were removed from the Percutaneous Balloon Kyphoplasty, Radiofrequency Kyphoplasty, and Mechanical Vertebral Augmentation medical policy and added to this policy: 22513, 22514, 22515, 0PS33ZZ, 0PS43ZZ, 0QS03ZZ, 0QS13ZZ, 0QSS3ZZ, 0QU13JZ, 0QUS3JZ, M48.50XA – M48.58XS, M84.48XA – M84.48XS, and M84.68XA – M84.68XS.

10/01/2024: Code Reference section updated to add new ICD-10 diagnosis code C81.7A.

05/07/2025: Policy description updated regarding balloon kyphoplasty, radiofrequency kyphoplasty, and products. Policy statements unchanged.

SOURCE(S)

Blue Cross & Blue Shield Association policy # 6.01.25

CODE REFERENCE

This 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.

Covered Codes

Investigational Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.