Latest Review Date: April 2024

Category: Radiology/Surgical                                                

 

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 six (6) weeks.

Percutaneous vertebroplasty may be considered medically necessary for the treatment of severe pain due to osteolytic lesionsof the spine related to multiple myeloma or metastatic malignancies.

Percutaneous vertebroplasty may be considered medically necessary for the treatment of vertebral hemangiomas with severe pain or nerve compression.

Percutaneous vertebroplasty is considered investigational for all other indications.

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

Mechanical vertebral augmentation or percutaneous balloon kyphoplasty with an FDA-cleared device* may be considered medically necessary for the treatment of the following conditions:

• Symptomatic osteoporotic vertebral fractures that have failed to respond to conservative treatment (e.g., analgesics, physical therapy, and rest) for at least six (6) weeks.
• Severe pain due to osteolytic lesions of the spine related to multiple myeloma or metastatic malignancies.
• Vertebral hemangiomas with severe pain or nerve compression.

 

Mechanical vertebral augmentation or percutaneous balloon kyphoplasty with an FDA-cleared device* for any other indication not listed above do not meet medical criteria for coverage and is considered investigational.

Percutaneous radiofrequency kyphoplasty does not meet medical criteria for coverage and is considered investigational.

Vertebral body stenting does not meet medical criteria for coverage and is considered investigational.

* See Approved by Governing Bodies for list of FDA-cleared devices for kyphoplasty and vertebral augmentation.

DESCRIPTION OF PROCEDURE OR SERVICE:

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 (e.g., multiple myeloma, metastatic malignancies); as a treatment for sacral insufficiency fractures; and as a technique to limit blood loss related to surgery.

Treatment of Vertebral Compression Fractures

Chronic symptoms do not tend to respond to the management strategies for acute pain such as bedrest, 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. Improvements in pain and ability to function are the principal outcomes of interest for treatment of osteoporotic fractures.

Treatment of Sacral Insufficiency Fractures

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

Vertebral/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 (e.g., 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 polymethylmethacrylate (PMMA). 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

Percutaneous 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).

Mechanical Vertebral Augmentation

Kiva is another mechanical vertebral augmentation technique that uses an implant for structural support of the vertebral body 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.

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 AP 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.

Vertebral Hemangiomas

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 radiotherapy 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 vertebroplasty has been proposed 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.

Another variant of kyphoplasty is vertebral body stenting, which utilizes an expandable scaffold instead of a balloon to restore vertebral height. The proposed advantages of vertebral body stenting are to reduce the risk of cement leakage by formation of a cavity for cement application and to prevent the loss of correction that is seen following removal of the balloon used for balloon kyphoplasty.

KEY POINTS:

The most recent literature update for this policy was performed through February 16, 2024.

Summary of Evidence

For individuals who have symptomatic osteoporotic vertebral fractures of between 6 weeks and 1 year old who receive vertebroplasty, the evidence includes 2 randomized sham-controlled trials, nonblinded randomized controlled trials (RCTs) comparing vertebroplasty with conservative management, and systematic reviews of these RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, hospitalizations, medication use, and treatment-related morbidity. Despite the completion of numerous RCTs, including 2 with sham controls, the efficacy of vertebroplasty for painful osteoporotic compression fractures remains uncertain. Two meta-analysis studies which included the 2 sham-controlled trials have demonstrated mixed results. The 2 studies had methodologic issues, including the choice of sham procedure and the potential effect of the sham procedure having a therapeutic effect by reducing pain. Questions have also been raised about the low percentage of patients screened who participated in the trial, the volume of polymethylmethacrylate injected, and the inclusion of patients with chronic pain. One network meta-analysis found that relative to conservative treatment, vertebroplasty provided short-term and long-term improvements to pain relief and disability scores. Overall, conclusions about the effect of vertebroplasty remain unclear. However, clinical input in 2008 provided uniform support for the use of vertebroplasty in painful osteoporotic fractures. After consideration of the available evidence and input, the consistent results of numerous case series, including large prospective reports, were sufficient to determine that vertebroplasty was a reasonable treatment option in patients with vertebral fractures who have failed to respond to conservative treatment (at least 6 weeks with analgesics, physical therapy, and rest). It is also clinically reasonable to consider the evidence supporting the clinical benefit of vertebroplasty in osteoporotic vertebral fracture to support its use in osteolytic lesions of the spine (e.g., multiple myeloma, metastatic malignancies).

For individuals with symptomatic osteoporotic vertebral fractures less than 6 weeks old who receive vertebroplasty, the evidence includes a randomized sham-controlled trial and other nonblinded RCTs comparing vertebroplasty with conservative management. Relevant outcomes are symptoms, functional outcomes, quality of life, hospitalizations, medication use, and treatment-related morbidity. For acute fractures, conservative therapy consisting of rest, analgesics, and physical therapy is an option, and symptoms will resolve in a large percentage of patients with conservative treatment only. However, a sham-controlled randomized trial in patients who had severe pain of less than 6 weeks in duration found a significant benefit of vertebroplasty for the treatment of osteoporotic vertebral fracture at the thoracolumbar junction. Other RCTs without sham controls have reported that vertebroplasty is associated with significant improvements in pain and reductions in the duration of bedrest. Given the high morbidity associated with extended bedrest in older adults, this procedure is considered to have a significant health benefit. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals with sacral insufficiency fractures who receive sacroplasty, the evidence includes 3 prospective cohort studies, several retrospective reviews, and a case series. Relevant outcomes are symptoms, functional outcomes, quality of life, hospitalizations, medication use, and treatment-related morbidity. No RCTs have been reported. The prospective cohort studies and retrospective series with 243 patients have reported rapid and sustained decreases in pain following percutaneous sacroplasty. Additional literature has mostly reported immediate improvements following the procedure. However, due to the small size of the evidence base, the harms associated with sacroplasty have not been adequately studied. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have osteoporotic vertebral compression fractures who receive balloon kyphoplasty, or mechanical vertebral augmentation (Kiva), the evidence includes an AHRQ comparative effectiveness review, randomized controlled trials (RCTs) and meta-analyses of RCTs. Relevant outcomes include symptoms, functional outcomes, quality of life, hospitalizations, and treatment-related morbidity. The Agency for Healthcare Research and Quality (AHRQ) review concluded that vertebroplasty was probably more effective at reducing pain and improving function in patients >65 years of age, but benefits were small. Kyphopasty was found to be probably more effective than usual care for pain and function in older patients with vertebral compression fracture at up to 1 month and may be more effective at >1 month to ≥1 year but has not been compared against sham therapy. A meta-analysis and moderately sized unblinded RCTs have compared kyphoplasty with conservative care and found short-term benefits in pain and other outcomes. Other RCTs, summarized in a meta-analysis, have reported similar outcomes for kyphoplasty and vertebroplasty. Three randomized trials that compared mechanical vertebral augmentation (Kiva or SpineJack) with kyphoplasty have reported similar outcomes for both procedures.

For individuals who have osteolytic vertebral compression fractures who receive balloon kyphoplasty or mechanical vertebral augmentation (Kiva), the evidence includes RCTs, case series, and a systematic review of these studies. Relevant outcomes include symptoms, functional outcomes, quality of life, hospitalizations, and treatment-related morbidity. Two RCTs have compared balloon kyphoplasty with conservative management and another has compared Kiva with balloon kyphoplasty. Results of these trials, along with case series, would suggest a reduction in pain, disability, and analgesic use in patients with cancer-related compression fractures.

After consideration of the available evidence and uniform clinical input, it was concluded that kyphoplasty may alleviate pain and improve function in patients with vertebral fractures who fail to respond to conservative treatment (at least 6 weeks) with analgesics, physical therapy, and rest. More recent randomized trials that compare kyphoplasty with medical management have also reported benefit. Given the absence of alternative treatment options and the morbidity associated with extended bed rest, kyphoplasty may be considered a reasonable treatment option in patients with vertebral fractures who fail to improve after 6 weeks of conservative therapy and for patients who have severe pain due to osteolytic lesions of the spine related to multiple myeloma or metastatic malignancies.

For individuals who have osteoporotic or osteolytic vertebral compression fractures who receive radiofrequency kyphoplasty, the evidence includes a systematic review and RCT. Relevant outcomes include symptoms, functional outcomes, quality of life, hospitalizations, and treatment-related morbidity. The only RCT (n=80) identified showed similar results between radiofrequency kyphoplasty and balloon kyphoplasty. The systematic review suggested that radiofrequency kyphoplasty is superior to balloon kyphoplasty in pain relief, but the review itself was limited by the inclusion of a small number of studies as well as possible bias. Corroboration of these results in a larger number of patients would be needed to determine with greater certainty whether radiofrequency kyphoplasty provides outcomes similar to balloon kyphoplasty. The evidence is insufficient to determine the effects of the technology on health outcomes.

Early evidence suggests that vertebral body stenting may have worse outcomes compared with balloon kyphoplasty and is considered investigational.

Practice Guidelines and Position Statements

American College of Radiology

The American College of Radiology and 7 other surgical and radiologic specialty associations published a joint position statement on percutaneous vertebral augmentation in 2014.  This document stated that percutaneous vertebral augmentation, using vertebroplasty or kyphoplasty and performed in a manner consistent with public standards, is a safe, efficacious, and durable procedure in appropriate patients with symptomatic osteoporotic and neoplastic fractures. The statement also indicated that these procedures be offered only when nonoperative medical therapy has not provided adequate pain relief, or pain is significantly altering the patient's quality of life.

A joint practice parameter for the performance of vertebral augmentation was updated in 2017.

In 2022, the American College of Radiology (ACR) revised its Appropriateness Criteria for the use of percutaneous vertebral augmentation in the management of vertebral compression fractures. The table below shows the appropriateness categories for each variant.

ACR Appropriateness Criteria for the use of Percutaneous Vertebral Augmentation for the Management of Vertebral Compression Fractures

Variants	Appropriateness Category
"Asymptomatic, osteoporotic VCF. Initial treatment"	Usually Not Appropriate
"Symptomatic osteoporotic VCF with bone marrow edema or intravertebral cleft. Initial treatment"	Usually Appropriate
"New symptomatic VCF. History of prior vertebroplasty or surgery. Initial treatment."	Usually Appropriate
"Benign VCF with worsening pain, deformity, or pulmonary dysfunction. Initial treatment"	Usually Appropriate
"Pathological VCF with ongoing or increasing mechanical pain. Initial treatment"	Usually Appropriate

CT: computed tomography; MRI: magnetic resonance imaging; ACR: American College of Radiology.

In 2014, the ACR and 7 other medical specialty associations, including the Society for Radiology, updated a 2012 joint position statement on percutaneous vertebral augmentation. The statement indicated that percutaneous vertebral augmentation with the use of vertebroplasty or kyphoplasty is a safe, efficacious, and durable procedure in appropriate patients with symptomatic osteoporotic and neoplastic fractures, when performed in accordance with public standards. The document also stated that these procedures are offered only when nonoperative medical therapy has not provided adequate pain relief, or pain is significantly altering patients’ quality of life.

Society for Interventional Radiology

In a 2014 quality improvement guideline for percutaneous vertebroplasty from the Society of Interventional Radiology, failure of medical therapy was defined as follows:

1. A patient rendered nonambulatory as a result of pain from a weakened or fractured vertebral body, pain persisting at a level that prevents ambulation despite 24 hours of analgesic therapy;
2. A patient with sufficient pain from a weakened or fractured vertebral body that physical therapy is intolerable, pain persisting at that level despite 24 hours of analgesic therapy; or
3. Any patient with a weakened or fractured vertebral body, unacceptable side effects such as excessive sedation, confusion, or constipation as a result of the analgesic therapy necessary to reduce pain to a tolerable level.

American Academy of Orthopaedic Surgeons

In 2011, the American Academy of Orthopaedic Surgeons (AAOS) published practice guidelines on the treatment of osteoporotic spinal compression fractures. The AAOS approved "a Strong recommendation against the use of vertebroplasty for patients who present with an acute osteoporotic spinal compression fracture and are neurologically intact."

National Institute for Health and Care Excellence

The U.K.’s National Institute for Health and Care Excellence (NICE) concluded in its 2003 guidance on percutaneous vertebroplasty that the current evidence on the safety and efficacy of vertebroplasty for vertebral compression fractures appeared “adequate to support the use of this procedure” to “provide pain relief for people with severe painful osteoporosis with loss of height and/or compression fractures of the vertebral body….”The guidance also recommended that the procedure be limited to patients whose pain is refractory to more conservative treatment. A 2013 NICE guidance, which was reaffirmed in 2016, indicated that percutaneous vertebroplasty and percutaneous balloon kyphoplasty “are recommended as options for treating osteoporotic vertebral compression fractures” in persons having “severe, ongoing pain after a recent, unhealed vertebral fracture despite optimal pain management” and whose “pain has been confirmed o be at the level of the fracture by physical examination and imaging.”

In 2008, NICE issued guidance on the diagnosis and management of adults with metastatic spinal cord compression. This guidance indicated that vertebroplasty or kyphoplasty should be considered for “patients who have vertebral metastases and no evidence of MSCC [metastatic spinal cord compression] or spinal instability if they have: mechanical pain resistant to conventional pain management, or vertebral body collapse.”

American Society of Pain and Neuroscience

In 2021, the American Society of Pain and Neuroscience (ASPN) published practice guidelines for the interventional management of cancer-associated pain. The guideline included a best practice statement that stated "vertebral augmentation should be strongly considered for patients with symptomatic vertebral compression fractures from spinal metastases (evidence level 1-A)." However, ASPN noted that there is little data to suggest the superiority of either vertebroplasty or kyphoplasty when treating malignant vertebral compression fractures.

U.S Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Percutaneous kyphoplasty, polymethylmethacrylate, PMMA, vertebral fracture, vertebral compression fracture, skyphoplasty, SKy bone expander, mechanical vertebral augmentation, Kiva®, VCF Treatment System, KyphX , StabiliT®, AVAmax®, Vertebral Balloon system, NeuroTherm Parallax®   Balloon Inflatable Bone Tamp (NeuroTherm), Stryker iVAS®, Balloon catheter, Synthes Synflate™ Vertebral Balloon System (Synthes), radiofrequency kyphoplasty, vertebral body stenting, SpineJack, SpineKure, Kyphon HV-R Bone cement, Modified Winch Kyphoplasty, 13G InterV Kyphoplasty, 11G InterV Kyphoplasty, Mini-Flex, Micro, Medinaut, Osteopal Plus, AVAflex Vertebral Balloon System, Osseoflex SB, Guardian-SG Inflatable Bone Expander, ZVplasty, Joline, TRACKER, TRACKER Plus, KYPHONTM VuETM, Renova

APPROVED BY GOVERNING BODIES:

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

Polymethylmethacrylate (PMMA) bone cement was available as a drug product before enactment of FDA’s device regulation and was at first considered what 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 vertebroplasty represented an off-label use of an FDA-regulated product before 2005. In 2005, PMMA bone cements such as Spine-Fix® Biomimetic Bone Cement and Osteopal® V were issued 510(k) marketing clearance for the fixation of pathologic fractures of the vertebral body using vertebroplasty procedures.

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

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

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

Kyphoplasty is a surgical procedure and, as such, is not subject to regulation by the U.S. Food and Drug Administration (FDA). 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 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, KYPHONTM VuETM Bone Cement, and Osteopal® V (Heraeus) 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. There are several mechanical vertebral augmentation devices that have received marketing clearance by the FDA through the510(k) process. StabiliT®   Vertebral Augmentation System (Merit Medical) for radiofrequency vertebral augmentation was cleared for marketing in 2009. FDA product code NDN.

The table below lists examples of FDA-cleared devices for kyphoplasty and vertebral augmentation.

 

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

Device	Manufacturer	Date Cleared	510(k) No.	Indication
BALLOOON KYPHOPLASTY
TRACKER Plus Kyphoplasty System	GS Medical Co., Ltd	10/28/2021	K211797	Reduction of fractures and/or creation of a void
Joline Kyphoplasty System Allevo	Joline GmbH & Co.	5/27/2020	K192449	To repair vertebral compression fractures
TRACKER Kyphoplasty System	GS Medical Co., Ltd	12/4/2019	K192335	Reduction of fractures or creation of a void
Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)	Stryker Corporation	12/21/2018	K181752	To repair vertebral compression fractures
SpineKure Kyphoplasty System	Hanchang Co. Ltd.	5/29/2018	K172871	To repair vertebral compression fractures
Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters	G-21 s.r.l.	8/23/2017	K172214	To repair vertebral compression fractures
13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)	Pan Medical Ltd.	11/1/2016	K162453	To repair vertebral compression fractures
MEDINAUT Kyphoplasty System	Imedicom Co. Ltd.	7/29/2016	K153296	To repair vertebral
AVAflex Vertebral Balloon System	Carefusion	11/24/2015	K151125	To repair vertebral compression fractures
Osseoflex SB Straight Balloon 10g/4ml Osseoflex SB Straight Balloon 10g/2ml	Osseon LLC	4/9/2015	K150607	To repair vertebral compression fractures
InterV Kyphoplasty Catheter (Balloon Length: 1015 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10 15 and 20mm)	Pan Medical Ltd.	3/6/2015	K150322	To repair vertebral compression fractures
GUARDIAN-SG Inflatable Bone Expander System	BM Korea Co. Ltd.	1/16/2015	K143006	To repair vertebral compression fractures
ZVPLASTY	Zavation LLC	9/12/2014	K141419	To repair vertebral compression fractures
MECHANICAL VERTEBRAL AUGMENTATION
SpineJack Expansion Kit	Vexim SA	8/30/2018	K181262	To repair vertebral compression fractures
KIVA VCF TREATMENT SYSTEM	Benvenue Medical Inc.	8/14/2014	K141141	To repair vertebral compression fractures
V-Strut Vertebral Implant	Hyprevention SAS	3/5/2020	K191709	Treatment of vertebral fractures in the thoracic and lumbar spine

 

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.   

CURRENT CODING: 

CPT Codes:

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
0201T	; two or more needles includes imaging guidance and bone biopsy, when performed
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 cervicothoracic 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)
64999	Unlisted procedure, nervous system

PREVIOUS CODING: 

CPT Codes:

01936

Anesthesia for percutaneous image guided procedures on the spine and spinal cord; therapeutic (Deleted 12/31/21)

REFERENCES:

1. ACR–ASNR–ASSR–SIR–SNIS Practice guideline for the performance of vertebral augmentation 2012. www.acr.org/~/media/ACR/Documents/PGTS/guidelines/Vertebral_Augmentation.pdf.
2. Alsoof D, Anderson G, McDonald CL, et al. Diagnosis and Management of Vertebral Compression Fracture. Am J Med. Jul 2022;135(7): 815-821.
3. Aman MM, Mahmoud A, Deer T, et al. The American Society of Pain and Neuroscience (ASPN) Best Practices and Guidelines for the Interventional Management of Cancer-Associated Pain. J Pain Res. 2021; 14: 2139-2164.
4. American College of Radiology. Management of vertebral compression fractures. https://acsearch.acr.org/docs/70545/Narrative/. Published 2022.
5. Aretxabala I, Fraiz E, Perez-Ruiz F et al. Sacral insufficiency fractures. High association with pubic rami fractures. Clin Rheumatol 2000; 19(5):399-401.
6. Bae H, Hatten HP, Jr., Linovitz R, et al. A prospective randomized FDA-IDE trial comparing Cortoss with PMMA for vertebroplasty: a comparative effectiveness research study with 24-month follow-up. Spine (Phila Pa 1976). Apr 01 2012;37(7):544-550.
7. Baerlocher MO, Saad WE, Dariushnia S et al. Quality improvement guidelines for percutaneous vertebroplasty. J Vasc Interv Radiol. Feb 2014; 25(2):165-170.
8. Baerlocher MO, Saad WE, Dariushnia S, et al. Quality improvement guidelines for percutaneous vertebroplasty. J Vasc Interv Radiol. Feb 2014; 25(2):165-170.
9. 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.
10. Beall DP, Shonnard NH, Shonnard MC, et al. An Interim Analysis of the First 102 Patients Treated in the Prospective VertebralAugmentation Sacroplasty Fracture Registry. J Vasc Interv Radiol. Sep 2023; 34(9): 1477-1484.
11. Berenson J, Pflugmacher R, Jarzem P, et al. Balloon kyphoplasty versus non-surgical fracture management for treatment of painful vertebral body compression fractures in patients with cancer: a multicentre, randomised controlled trial. Lancet Oncol. Mar 2011; 12(3):225-235.
12. Boonen S, Van Meirhaeghe J, Bastian L, et al. Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2-year results from a randomized trial. J Bone Miner Res. Jul 2011; 26(7):1627-1637.
13. Buchbinder R, Johnston RV, Rischin KJ, et al. Percutaneous vertebroplasty for osteoporotic vertebral compression fracture. Cochrane Database Syst Rev. Apr 04 2018; 4: CD006349.
14. Buchbinder R, Osborne RH, Ebeling PR et al.  A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures.  N Engl J Med. Aug 6 2009;361(6):557-568.
15. Buchbinder R, Osborne RH, Ebeling PR, et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. Aug 6 2009; 361(6):557-568.
16. Chang M, Zhang C, Shi J, et al. Comparison Between 7 Osteoporotic Vertebral Compression Fractures Treatments: Systematic Review and Network Meta-analysis. World Neurosurg. Jan 2021; 145: 462-470.e1.
17. Chen D, An ZQ, Song S, et al. Percutaneous vertebroplasty compared with conservative treatment in patients with chronic painful osteoporotic spinal fractures. J Clin Neurosci. Mar 2014;21(3):473-477.
18. Chou R, Fu R, Dana T, et al. Interventional treatments for acute and chronic pain: systematic review [Internet]. AHRQ Comparative Effectiveness Reviews. Rockville (MD): Agency for Healthcare Research and Quality; 2021 Sep. Report No.: 21-EHC030.
19. Clark W, Bird P, Gonski P, et al. Safety and efficacy of vertebroplasty for acute painful osteoporotic fractures (VAPOUR): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet. Oct 01 2016; 388(10052): 1408-1416.
20. Comstock BA, Sitlani CM, Jarvik JG et al. Investigational vertebroplasty safety and efficacy trial (INVEST): patient-reported outcomes through 1 year. Radiology. Oct 2013; 269(1):224-231.
21. Dehdashti AR, Martin JB, Jean B, et al. PMMA cementoplasty in symptomatic metastatic lesions of the S1 vertebral body. Cardiovasc Intervent Radiol. May-Jun 2000;23:235-237.
22. Denis F, Davis S, Comfort T. Sacral fractures: an important problem. Retrospective analysis of 236 cases. Clin Orthop Relat Res. Feb 1988;227:67-81.
23. Dougherty RW, McDonald JS, Cho YW et al. Percutaneous sacroplasty using CT guidance for pain palliation in sacral insufficiency fractures. J Neurointerv Surg. Jan 2014; 6(1):57-60.
24. Edidin AA, Ong KL, Lau E, et al. Morbidity and mortality after vertebral fractures: comparison of vertebral augmentation and nonoperative management in the Medicare population. Spine (Phila Pa 1976). Aug 01 2015;40(15):1228-1241.
25. Edidin AA, Ong KL, Lau E, et al. Mortality risk for operated and nonoperated vertebral fracture patients in the medicare population. J Bone Miner Res. Jul 2011;26(7):1617-1626.
26. Edidin AA, Ong KL, Lau E, et al. Mortality risk for operated and nonoperated vertebral fracture patients in the Medicare population. J Bone Miner Res. Jul 2011;26(7):1617-1626.
27. Farrokhi MR, Alibai E, Maghami Z. Randomized controlled trial of percutaneous vertebroplasty versus optimal medical management for the relief of pain and disability in acute osteoporotic vertebral compression fractures. J Neurosurg Spine. May 2011; 14(5):561-569.
28. Feng L, Shen JM, Feng C, et al. Comparison of radiofrequency kyphoplasty (RFK) and balloon kyphoplasty (BKP) in the treatment of vertebral compression fracturs: A meta-analysis. Medicine (Baltimore). Jun 2017; 96(25):e7150.
29. Firanescu CE, de Vries J, Lodder P, et al. Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV): randomised sham controlled clinical trial. BMJ. 2018 May 9;361:k1551.
30. Frey ME, Depalma MJ, Cifu DX, et al. Percutaneous sacroplasty for osteoporotic sacral insufficiency fractures: a prospective, multicenter, observational pilot study. Spine J. Mar-Apr 2008; 8(2): 367-73.
31. Frey ME, Warner C, Thomas SM, et al. Sacroplasty: a ten-year analysis of prospective patients treated with percutaneous sacroplasty: literature review and technical considerations. Pain Physician. Nov 2017;20(7):E1063-E1072.
32. Gotis-Graham I, McGuigan L, Diamond T, et al. Sacral insufficiency fractures in the elderly. J Bone Joint Surg Br. Nov 1994;76(6):882-886.
33. Halvachizadeh S, Stalder AL, Bellut D, et al. Systematic Review and Meta-Analysis of 3 Treatment Arms for Vertebral Compression Fractures: A Comparison of Improvement in Pain, Adjacent-Level Fractures, and Quality of Life Between Vertebroplasty, Kyphoplasty, and Nonoperative Management. JBJS Rev. Oct 25 2021; 9(10).
34. Hinde K, Maingard J, Hirsch JA, et al. Mortality Outcomes of Vertebral Augmentation (Vertebroplasty and/or Balloon Kyphoplasty) for Osteoporotic Vertebral Compression Fractures: A Systematic Review and Meta-Analysis. Radiology. Apr 2020; 295(1): 96-103.
35. Hinde K, Maingard J, Hirsch JA, et al. Mortality Outcomes of Vertebral Augmentation (Vertebroplasty and/or Balloon Kyphoplasty) for Osteoporotic Vertebral Compression Fractures: A Systematic Review and Meta-Analysis. Radiology. Apr 2020; 295(1): 96-103.
36. Hrobjartsson A, Gotzsche PC. Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment. N Engl J Med. May 24 2001; 344(21):1594-1602.
37. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
38. Jarvik JG, Deyo RA. Cementing the evidence: time for a randomized trial of vertebroplasty. AJNR Am J Neuroradiol. Sep 2000; 21(8):1373-1374.
39. Kallmes DF, Comstock BA, Heagerty PJ et al.  A randomized trial of vertebroplasty of osteoporotic spinal fractures.  N Engl J Med. Aug 6 2009; 361(6):569-579.
40. Kallmes DF, Comstock BA, Heagerty PJ, et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med. Aug 6 2009; 361(6):569-579.
41. Katz J, Melzack R. Measurement of pain. Surg Clin North Am. 1999 Apr;79(2):231-252. 
42. Klazen CA, Lohle PN, de Vries J et al. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet 2010; 376(9746):1085-1092.
43. Korovessis P, Vardakastanis K, Repantis T et al. Balloon Kyphoplasty Versus KIVA Vertebral Augmentation-Comparison of 2 Techniques for Osteoporotic Vertebral Body Fractures: A Prospective Randomized Study. Spine (Phila Pa 1976). Feb 15 2013; 38(4):292-299.
44. Korovessis P, Vardakastanis K, Vitsas V, et al. Is Kiva implant advantageous to balloon kyphoplasty in treating osteolytic metastasis to the spine? Comparison of 2 percutaneous minimal invasive spine techniques: a prospective randomized controlled short-term study. Spine (Phila Pa 1976). Feb 15 2014; 39(4): E231-9. 
45. Kortman K, Ortiz O, Miller T et al. Multicenter study to assess the efficacy and safety of sacroplasty in patients with osteoporotic sacral insufficiency fractures or pathologic sacral lesions. J Neurointerv Surg. Sep 2013; 5(5):461-466.
46. Kroon F, Staples M, Ebeling PR, et al. Two-year results of a randomized placebo-controlled trial of vertebroplasty for acute osteoporotic vertebral fractures. J Bone Miner Res. Jun 2014;29(6):1346-1355.
47. Leali PT, Solla F, Maestretti G, et al. Safety and efficacy of vertebroplasty in the treatment of osteoporotic vertebral compression fractures: a prospective multicenter international randomized controlled study. Clin Cases Miner Bone Metab. Sep-Dec 2016;13(3):234-236.
48. Leroux JL, Denat B, Thomas E et al. Sacral insufficiency fractures presenting as acute low-back pain. Biomechanical aspects. Spine (Phila Pa 1976) 1993; 18(16):2502-2506.
49. Lin J, Lachmann E, Nagler W. Sacral insufficiency fractures: a report of two cases and a review of the literature. J Womens Health Gend Based Med 2001; 10(7):699-705.
50. Lin JH, Chien LN, Tsai WL, et al. Early vertebroplasty associated with a lower risk of mortality and respiratory failure in aged patients with painful vertebral compression fractures: a population-based cohort study in Taiwan. Spine J. Sep 2017;17(9):1310-1318.
51. Liu Y, Liu J, Suvithayasiri S, et al. Comparative Efficacy of Surgical Interventions for Osteoporotic Vertebral Compression Fractures: ASystematic Review and Network Meta-analysis. Neurospine. Dec 2023; 20(4): 1142-1158.
52. Lourie H. Spontaneous osteoporotic fracture of the sacrum: an unrecognized syndrome of the elderly. JAMA 1982;248(6):715-717.
53. Marcy PY, Palussiere J, Descamps B, et al. Percutaneous cementoplasty for pelvic bone metastasis. Support Care Cancer 2000;8(6):500-503.
54. Mattie R, Brar N, Tram JT, et al. Vertebral Augmentation of Cancer-Related Spinal Compression Fractures: A Systematic Review and Meta-Analysis. Spine (Phila Pa 1976). Dec 15 2021; 46(24): 1729-1737. 
55. McGuire R. AAOS Clinical Practice Guideline: the Treatment of Symptomatic Osteoporotic Spinal Compression Fractures. J Am Acad Orthop Surg. Mar 2011; 19(3): 183-4.
56. Moerman DE, Jonas WB. Deconstructing the placebo effect and finding the meaning response. Ann Intern Med. Mar 19 2002; 136(6):471-476.
57. National Institute for Health and Care Excellence (NICE). IPG 12: Percutaneous vertebroplasty. 2003. https://publications.nice.org.uk/percutaneous-vertebroplasty-ipg12.
58. National Institute for Health and Care Excellence (NICE). Metastatic spinal cord compression in adults: risk assessment, diagnosis and management [CG75]. 2014; https://www.nice.org.uk/guidance/cg75/chapter/1-Guidance.
59. National Institute for Health and Care Excellence (NICE). Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for treating osteoporotic vertebral compression fractures [TA279]. 2013; https://www.nice.org.uk/guidance/ta279.
60. National Institute for Health and Clinical Excellence (NICE). CG 75 Metastatic spinal cord compression, diagnosis and management of adults 2008. https://publications.nice.org.uk/metastatic-spinal-cord-compression-cg75.
61. National Institute for Health and Clinical Excellence (NICE). TA 279 Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for treating osteoporotic vertebral compression fractures. 2013. https://publications.nice.org.uk/percutaneous-vertebroplasty-and-percutaneous-balloon-kyphoplasty-for-treating-osteoporotic-vertebral-ta279.
62. Newhouse KE, el-Khoury GY, Buckwalter JA. Occult sacral fractures in osteopenic patients. J Bone Joint Surg Am. Dec 1992; 74(10):1472-1477.
63. Noriega D, Marcia S, Theumann N et al. A prospective, international, randomized, noninferiority study comparing an implantable titanium vertebral augmentation device versus balloon kyphoplasty in the reduction of vertebral compression fractures (SAKOS study). Spine J. 2019 Nov;19(11).
64. Ong KL, Beall DP, Frohbergh M et al. Were VCF patients at higher risk of mortality following the 2009 publication of the vertebroplasty "sham" trials?. Osteoporos Int. 2018 Feb;29(2).
65. Ostelo RW, Deyo RA, Stratford P et al.  Interpreting change scores for pain and functional status in low back pain:  towards international consensus regarding minimal important change.  Spine. Jan 1 2008;33(1):90-94.
66. Petersen A, Hartwig E, Koch EM, et al. Clinical comparison of postoperative results of balloon kyphoplasty (BKP) versus radiofrequency-targeted vertebral augmentation (RF-TVA): a prospective clinical study. Eur J Orthop Surg Traumatol. Jan 2016; 26(1):67-75.
67. Pron G, Holubowich C, Kaulback K. Vertebral Augmentation Involving Vertebroplasty or Kyphoplasty for Cancer-Related Vertebral Compression Fractures: A Systematic Review. Ont Health Technol Assess Ser. 2016; 16(11): 1-202. 
68. Sarigul B, Ogrenci A, Yilmaz M, et al. Sacral insufficiency fracture: a single-center experience of 185 patients with a minimum 5-yearfollow-up. Eur Spine J. Nov 13 2023.
69. Shah, LM, Jennings JW, Kirsch CFE et al. ACR appropriateness Criteria management of vertebral compression fractures. J Am Coll Radiol. 2018 Nov; 15(11S).
70. Staples MP, Kallmes DF, Comstock BA et al. Effectiveness of vertebroplasty using individual patient data from two randomised placebo controlled trials: meta-analysis. BMJ 2011; 343:d3952.
71. Stratford PW, Binkley J, Solomon P, et al. Defining the minimum level of detectable change for the Roland-Morris questionnaire. Phys Ther. Apr 1996; 76(4): 359-65; discussion 366-8.
72. Sun HB, Jing XS, Tang H, et al. Clinical and radiological subsequent fractures after vertebral augmentation for treating osteoporotic vertebral compression fractures: a meta-analysis. Eur Spine J. Oct 2020; 29(10): 2576-2590.
73. Tutton SM, Pflugmacher R, Davidian M, et al. KAST Study: The Kiva System as a vertebral augmentation treatment-a safety and effectiveness trial: a randomized, noninferiority trial comparing the Kiva System with balloon kyphoplasty in treatment of osteoporotic vertebral compression fractures. Spine (Phila Pa 1976). Jun 15 2015; 40(12):865-875.
74. Van Meirhaeghe J, Bastian L, Boonen S, et al. A randomized trial of balloon kyphoplasty and nonsurgical management for treating acute vertebral compression fractures: vertebral body kyphosis correction and surgical parameters. Spine (Phila Pa 1976). May 20 2013; 38(12):971-983.
75. Vase L, Riley JL, 3rd, Price DD. A comparison of placebo effects in clinical analgesic trials versus studies of placebo analgesia. Pain. Oct 2002; 99(3):443-452.
76. Wardlaw D, Cummings SR, Van Meirhaeghe J, et al. Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet. Mar 21 2009; 373(9668):1016-1024.
77. Xie L, Zhao ZG, Zhang SJ, et al. Percutaneous vertebroplasty versus conservative treatment for osteoporotic vertebral compression fractures: An updated meta-analysis of prospective randomized controlled trials. Int J Surg. Nov 2017;47:25-32.
78. Yang EZ, Xu JG, Huang GZ, et al. Percutaneous Vertebroplasty versus conservative treatment in aged patients with acute osteoporotic vertebral compression fractures: a prospective randomized controlled clinical study. Spine (Phila Pa 1976). Apr 2016;41(8):653-660.
79. Yi X, Lu H, Tian F et al. Recompression in new levels after percutaneous vertebroplasty and kyphoplasty compared with conservative treatment. Arch Orthop Trauma Surg. Jan 2014; 134(1):21- 30.
80. Yi X, Lu H, Tian F, et al. Recompression in new levels after percutaneous vertebroplasty and kyphoplasty compared with conservative treatment. Arch Orthop Trauma Surg. Jan 2014; 134(1):21-30.
81. Zaman FM, Frey M, Slipman CW. Sacral stress fractures. Curr Sports Med Rep. Feb 2006; 5(1):37-43.
82. Zhang L, Zhai P. A Comparison of Percutaneous Vertebroplasty Versus Conservative Treatment in Terms of Treatment Effect for Osteoporotic Vertebral Compression Fractures: A Meta-Analysis. Surg Innov. Feb 2020; 27(1): 19-25.
83. Zhao S, Xu CY, Zhu AR, et al. Comparison of the efficacy and safety of 3 treatments for patients with osteoportoic vertebral compression fractures: A network meta-analysis. Medicine (Baltimore). Jun 2017; 96(26):e7328.

POLICY HISTORY:

Medical Policy Group, November 1999

Medical Review Committee, January 2000

TEC Review, April 2000

Medical Policy Group, January 2001

Medical Review Committee, March 2001

TEC Review, May 2001

Medical Policy Group, February 2002 (2)

Medical Review Committee, March 2002

Available for Comment April 15-May 29, 2002

Medical Policy Group, June 2003 (2)

Medical Review Committee, June 2003

Medical Review Committee, July 2003

Medical Policy Administration Committee, July 2003

Available for comment July 28-September 10, 2003

Medical Policy Group, August 2003 (2)

Medical Review Committee, September 2003

Medical Policy Administration Committee, October 2003

Available for comment October 7-November 20, 2003

Medical Policy Group, October 2005 (2)

Medical Policy Administration Committee, November 2005

Available for comment November 30, 2005-January 13, 2006

Medical Policy Group, July 2006 (1)

Medical Policy Administration Committee, July 2006

Available for comment July 18-August 31, 2006

Medical Policy Group, January 2007 (2)

Medical Policy Group, June 2007 (2)

Medical Policy Group, July 2007 (2)

Medical Policy Administration Committee, July 2007

Available for comments July 16-September 3, 2007

Medical Policy Group, March 2008 (2)

Medical Policy Administration Committee, April 2008

Available for comment April 4-May 18, 2008

Medical Policy Group, May 2008 (2)

Medical Policy Administration Committee, June 2008

Available for comment June 11-July 26, 2008

Medical Policy Group, June 2009 (2)

Medical Policy Administration Committee, July 2009

Available for comment July 1-August 14, 2009

Medical Policy Panel, February 2010

Medical Policy Group, March 2010 (2)

Medical Policy Administration Committee, April 2010

Available for comment April 12-May 26, 2010

Medical Policy Panel, February 2011

Medical Policy Group, June 2011 (2): Key Points and Reference Updated

Medical Policy Group, December 2011 (3): Updated verbiage on CPT 22520 & 22521 for 2012 code update.

Medical Policy Panel, April 2013

Medical Policy Group, August 2013 (2): Title change to include Mechanical Vertebral Augmentation.   Policy statement added that all other percutaneous mechanical vertebral augmentation devices, including but not limited to Kiva are investigational.   Description, Key Points, Approved by Governing Bodies, Key Words, and Reference updated to support new policy statement and literature search.  

Medical Policy Administration Committee, September 2013

Available for comment September 19 through November 2, 2013

Medical Policy Group, March 2014 (2): Corrected policy statement with addition of coverage for vertebral hemangiomas with severe pain or nerve compression.

Medical Policy Group, March 2014 (5): Added ICD-9 and ICD-10-CM diagnosis under Coding; no change to policy statement.

Medical Policy Panel, July 2014

Medical Policy Group, July 2014 (3):  2014 Updates to Key Points, Governing Bodies & References; no change in policy statements; removed policy statements for 2010 & prior years

Medical Policy Group, November 2014 (3): 2015 Annual Coding update; added CPT codes 22510-22515 and moved previous codes 22520-22525 and 72291-72292; changed verbiage on 0200T & 0201T by adding ‘includes imaging guidance and bone biopsy, when performed.

Medical Policy Panel, April 2015

Medical Policy Group, May 2015 (2): 2015 Updates to Description, Key Points, Current Coding, and References; no change to policy statement. 

Medical Policy Group, November 2015:  2016 Annual Coding Update; Moved HCPCS codes S2360 and S2361 from current coding to previous coding.

Medical Policy Panel, November 2016

Medical Policy Group, November 2016 (7): 2016 Updates to Key Points, Coding- Removed previous codes deleted in 2006 and ICD-9 and ICD-10-CM diagnosis under Coding Section. No change to policy statement.

Medical Policy Panel, April 2018

Medical Policy Group, April 2018 (7): 2018 Updates to Title, Description, Key Points, Key Words, Approved by Governing Bodies and References; removed all aspects of kyphoplasty and mechanical augmentation, now in separate policy, #648. Policy Statement clarified- removed “including use in acute vertebral fractures due to osteoporosis or trauma”. No change in intent.

Medical Policy Panel, April 2019

Medical Policy Group, May 2019 (7): Updates to Key Points and References. No change in Policy Statement.

Medical Policy Panel, April 2020

Medical Policy Group, May 2020 (7): Updates to Key Points and References. No change in Policy Statement.

Medical Policy Panel, April 2021

Medical Policy Group, June 2021 (7): Updates to Key Points and References. Investigational policy statement edited for clarity. No change in intent of policy.

Medical Policy Group, December 2021 (7): 2022 Annual Coding Update. Moved CPT 01936 from Current coding section.  Created Previous Coding section to include code 01936.

Medical Policy Panel, April 2022

Medical Policy Group, May 2022 (7): Updates to Key Points, Approved by Governing Bodies and References. Added Keywords: “Balex Bone Expander System, Arcadia Balloon Catheter, Kyphon Element Inflatable Bone Tamp.” No change in Policy Statement.

Medical Policy Panel, April 2023

Medical Policy Group, May 2023(7): Updates to Key Points, Benefit Application, and References. No change in Policy Statement.

Medical Policy Panel, April 2024

Medical Policy Group, April 2024 (7): Merged MP#648 Percutaneous Balloon Kyphoplasty, Radiofrequency Kyphoplasty and Mechanical Vertebral Augmentation into this policy. Updates to Title, Description, Key Points and References. Added Key Words: “Renova.” No change to Policy Statements. Available for comment May 1, 2024 through June 15, 2024.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1.   The technology must have final approval from the appropriate government regulatory bodies;
2.  The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3.  The technology must improve the net health outcome;
4.  The technology must be as beneficial as any established alternatives;
5.  The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1.  In accordance with generally accepted standards of medical practice; and
2.  Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3.  Not primarily for the convenience of the patient, physician or other health care provider; and
4.  Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.