Medical Policies - Radiology


Percutaneous Balloon Kyphoplasty, Radiofrequency Kyphoplasty, and Mechanical Vertebral Augmentation

Number:RAD601.041

Effective Date:06-01-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Percutaneous balloon kyphoplasty and mechanical vertebral augmentation with Kiva® may be considered medically necessary for:

The treatment of symptomatic osteoporotic vertebral compression fractures that have failed to respond to conservative treatment (e.g., analgesics, physical therapy, rest) for at least 6 weeks.

The treatment of severe pain due to osteolytic lesions of the spine related to multiple myeloma or metastatic malignancies.

Percutaneous balloon kyphoplasty and mechanical vertebral augmentation with Kiva® is considered experimental, investigational and/or unproven for all other indications, including use in acute vertebral fractures due to osteoporosis or trauma.

Percutaneous radiofrequency kyphoplasty or percutaneous mechanical vertebral augmentation using any other device, including but not limited to vertebral body stenting is considered experimental, investigational and/or unproven.

Description:

Percutaneous balloon kyphoplasty, radiofrequency 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 options to provide mechanical support and symptomatic relief in patients with osteoporotic vertebral compression fracture or in those with osteolytic lesions of the spine (i.e., multiple myeloma, metastatic malignancies).

Background

Osteoporotic Vertebral Compression Fracture

Osteoporotic compression fractures are common. It is estimated that up to 50% of women and 25% of men will have a vertebral fracture at some point in their lives. However, only about one-third of vertebral fractures reach clinical diagnosis, and most symptomatic fractures will heal within a few weeks or 1 month. A minority of patients will exhibit chronic pain following osteoporotic compression fracture that presents challenges for medical management. Chronic symptoms do not tend to respond to the management strategies for acute pain such as 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 is not improved with analgesics and may be better addressed through exercise.

Osteolytic Vertebral Body Fractures

Vertebral body fractures can also be pathologic, due to osteolytic lesions, most commonly from metastatic tumors. Metastatic malignant disease involving the spine generally involves the vertebral bodies, with pain being the most frequent complaint. While 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 vertebral body strength, which may necessitate supportive bracing to minimize the risk of vertebral body collapse during healing.

Treatment

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 (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.

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 to provide a reservoir for bone cement. The Kiva VCF (vertebral compression fracture) 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.

Another variant of kyphoplasty is vertebral body stenting, which uses 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. (1)

Regulatory Status

Kyphoplasty is a surgical procedure and, as such, is not subject to regulation by the United States (U.S.) Food and Drug Administration (FDA). Balloon kyphoplasty requires the use of an inflatable bone tamp. In July 1998, one such tamp, the KyphX® inflatable bone tamp, was cleared for marketing by FDA through the 510(k) process. Other devices with FDA 510(k) marketing clearance include the AVAmax® Vertebral Balloon system (CareFusion), NeuroTherm Parallax® Balloon Inflatable Bone Tamp (NeuroTherm), Stryker iVAS® Balloon catheter, and Synthes Synflate™ Vertebral Balloon System (Synthes). StabiliT® Vertebral Augmentation System (DFINE) for radiofrequency vertebral augmentation was cleared for marketing in 2009. FDA product code NDN.

To date, vertebral body stenting (VBS™; Synthes, Switzerland) is only available in Europe. (2)

In 2014, the Kiva® VCF Treatment System (Benvenue Medical) was cleared for marketing by the FDA through the 510(k) process. FDA product code NDN.

PMMA bone cement was available as a drug product before enactment of the FDA’s device regulation and was at first considered what 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, and Osteopal® V have received 510(k) marketing clearance for the fixation of pathologic fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. FDA product code: NDN.

Rationale:

This medical policy was created in March 2002 and has been updated regularly with searches of the MEDLINE database. The most recent literature update was performed through January 2018.

This medical policy is based on a 2000 Blue Cross Blue Shield Association (BCBSA) Technology Evaluation Center (TEC) Assessment, updated in 2004, 2005, 2008, 2009, and 2010. (3-8)

Assessment of efficacy for therapeutic intervention involves a determination of whether the intervention improves health outcomes. The optimal study design for this purpose is a randomized controlled trial (RCT) that includes clinically relevant measures of health outcomes. Intermediate outcome measures, also known as surrogate outcome measures, may also be adequate if there is an established link between the intermediate outcome and true health outcomes. Nonrandomized comparative studies and uncontrolled studies can sometimes provide useful information on health outcomes, but are prone to biases such as noncomparability of treatment groups, placebo effect, and variable natural history of the condition.

For treatment of osteoporosis and malignancy with percutaneous kyphoplasty, the primary beneficial outcomes of interest are relief of pain and improvement in ability to function. Kyphoplasty may also restore lost vertebral body height and reduce kyphotic deformity. Potential health outcomes related to kyphotic deformity include pulmonary or gastrointestinal compression and associated symptoms, and vertebral compression fractures (VCFs) may be associated with lower health-related quality of life.

The natural history of pain and disability associated with these conditions vary. In addition, pain and functional ability are subjective outcomes, susceptible to placebo effects. Nonspecific or placebo effects can be quite large for an invasive procedure such as kyphoplasty for which there is no blinding. (9, 10) The placebo effect may be on the order of 6 to 7 mm on a 100-mm scale, for invasive procedures, (9-11) and even larger effects (10%) have been observed in the sham-controlled vertebroplasty trials. (13, 14) Therefore, sham-controlled comparison studies are important to demonstrate the clinical effectiveness of kyphoplasty over and above any associated nonspecific or placebo effects.

Adverse effects related to kyphoplasty are the primary harms to be considered. Principal safety concerns relate to the incidence and consequences of leakage of the injected polymethylmethacrylate (PMMA).

Osteoporotic Vertebral Compression Fractures

The evidence on the treatment of VCFs includes 2 multicenter RCTs that compared kyphoplasty with conservative care, a comparative analysis of mortality risk from the Medicare dataset, a meta-analysis of trials that compared kyphoplasty with vertebroplasty, and 2 RCTs that compared mechanical vertebral augmentation with balloon kyphoplasty.

Balloon Kyphoplasty Versus Conservative Care

In 2009, Wardlaw et al. reported on the FREE trial, a nonblinded industry-sponsored, multisite RCT in which 300 adults with 1 to 3 painful osteoporotic VCFs of less than 3 months in duration were assigned to kyphoplasty or conservative care. (15) Twenty-four-month results were reported by Boonen et al. (2011) and by Van Meirhaeghe et al. (2013). (16, 17) Scores for the primary outcome, 1-month change in 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) score, were significantly higher for those in the kyphoplasty group. The difference between groups was 5.2 points (95% confidence interval, 2.9 to 7.4 points; p<0.001). Kyphoplasty was associated with greater improvements in SF-36 PCS scores at 6-month follow-up (3.39 points), but not at 12- or 24-month follow-ups. Greater improvement in back pain was observed over 24 months for kyphoplasty (-1.49 points) and remained statistically significant at 24 months. Participants in the kyphoplasty group also reported greater improvements in quality of life and Roland-Morris Disability Questionnaire (RMDQ) scores at short-term follow-up. At 12 months, fewer kyphoplasty patients (26.4% vs 42.1%) had received physical therapy or walking aids, back braces, wheelchairs, miscellaneous aids, or other therapy. Fewer kyphoplasty patients used opioid medications through 6 months (29.8% vs 42.9%) and fewer pain medications through 12 months (51.7% vs. 68.3%). Other differences between groups were no longer apparent at 12 months, possibly due to natural healing of fractures.

Berenson et al. reported on the results of an international multicenter RCT in 2011. (18) They enrolled 134 patients with cancer who were at least 21 years of age. Participants had at least 1 and not more than 3 painful VCFs. The primary outcome was change in functional status from baseline at 1 month as measured by the RMDQ. Treatment allocation was not blinded, and the primary outcome at 1 month was analyzed using all participants with data both at baseline and at 1 month. Participants needed to have a pain score of at least 4 on a 0-to-10 scale. Crossover to the balloon kyphoplasty arm was allowed after 1 month. Reviewers reported scores for the kyphoplasty and nonsurgical groups of 17.6 and 18.2 at baseline, respectively, and 9.10 and 18.0 at 1-month follow-ups (between-group difference in scores, p<0.001).

In 2011, Edidin et al. reported on mortality risk in Medicare patients who had VCFs and had been treated with vertebroplasty, kyphoplasty, or nonoperatively. (19) This study was industry-funded. Using the U.S. Medicare dataset, the authors identified 858,978 patients who had VCFs between 2005 and 2008. The data set included 119,253 kyphoplasty patients and 63,693 vertebroplasty patients. Survival was calculated from the index diagnosis date until death or the end of follow-up (up to 4 years). Cox regression analysis was used to evaluate the joint effect of multiple covariates, which included sex, age, race/ethnicity, patient health status, type of diagnosed fracture, site of service, physician specialty, socioeconomic status, year of diagnosis, and census region. After adjusting for covariates, patients in the surgical cohorts (vertebroplasty or kyphoplasty) had a higher adjusted survival rate (60.8%) than patients in the nonsurgical cohort (50.0%) and were 37% less likely to die. The adjusted survival rates for vertebroplasty or kyphoplasty were 57.3% and 62.8%, respectively, a 23% lower relative risk for kyphoplasty. As noted by the authors, a causal relation could not be determined from this study.

Balloon Kyphoplasty Versus Vertebroplasty

In 2015, Chang et al. reported on a meta-analysis of prospective studies that compared vertebroplasty with kyphoplasty. (20) Included were 6 RCTs and 14 prospective comparative studies (total N=1429 patients). Outcomes were compared for the short (≤1 week after surgery) and long (>6 months) terms. The time to perform vertebroplasty was significantly shorter than kyphoplasty. There was no significant difference between groups in visual analog scale (VAS) pain scores or Oswestry Disability Index (ODI) scores at either short- or long-term follow-up. There was no significant difference between treatments in adjacent-level fractures. Cobb angle at long-term follow-up was improved in the kyphoplasty group compared with vertebroplasty. Kyphoplasty had a significantly lower number of procedures with cement extravasion, although the percentage of cases with cement leakage is high for both procedures. For example, a 2014 RCT by Dohm et al. (KAVIAR study) reported overall cement extravasion in 157 (73.4%) of 214 levels treated with kyphoplasty compared with 164 (81.6%) of 201 levels treated with vertebroplasty (p=0.047). (21) Intravascular cement extravasion occurred in 59 (27.6%) of 214 levels treated with kyphoplasty compared with 76 (37.8%) of 201 levels treated with vertebroplasty. The clinical significance of a 10% difference in cement extravasion is uncertain; the occurrences of device-related cement embolism were similar, with 1 (0.5%) case in each group. Kyphosis correction was better in the kyphoplasty group by 1.42° (p=0.036). Pain and function improvements were similar for both procedures.

Mechanical Vertebral Augmentation With Kiva versus Balloon Kyphoplasty

Vertebral augmentation with the Kiva VCF System was compared with balloon kyphoplasty in a 2015 pivotal noninferiority RCT. (22) This industry-sponsored, multicenter open-label (KAST) trial was conducted in 300 patients with 1 or 2 osteoporotic VCFs. Included were patients with VAS scores for back pain of at least 70 mm (/100 mm) after 2 to 6 weeks of conservative care or VAS scores of at least 50 mm after 6 weeks of conservative care, and ODI scores of at least 30%. The primary composite end point at 12 months was a reduction in fracture pain by at least 15 mm on the VAS, maintenance or improvement in function on the ODI, and absence of device-related serious adverse events. The primary end point was met by 94.5% of patients treated with Kiva and 97.6% of patients treated with kyphoplasty (Bayesian posterior probability of 99.92% for noninferiority, using as-treated analysis). In the 285 treated patients, Kiva resulted in a mean improvement of 70.8 points in VAS scores, compared with a 71.8-point improvement for kyphoplasty. There was a 38.1-point improvement in ODI score for the Kiva group compared with a 42.2-point improvement for the kyphoplasty group. There were no device-related serious adverse events. The total volume of cement was 50% less with Kiva and there was less cement extravasion (16.9%) compared with kyphoplasty (25.8%).

In 2013, Korovessis et al. reported on a randomized trial comparing mechanical vertebral augmentation with the Kiva device with balloon kyphoplasty in 180 patients with osteoporotic VCFs. (23) The groups showed similar improvements in VAS scores for back pain, SF-36 scores, and ODI scores. For example, there was a more than 5.5-point improvement in VAS scores in 54% of patients in the Kiva group and in 43% of patients in the balloon kyphoplasty group. Radiologic measures of vertebral height were similar in both groups. Kiva reduced the Gardner kyphotic angle, while residual kyphosis of more than 5° was more frequently observed in the balloon kyphoplasty group. Patients and outcome assessors were reported to be unaware of group assignments, although it is not clear if the Kiva device was visible on radiographs. Cement leakage into the canal only occurred in 2 patients treated with balloon kyphoplasty, necessitating decompression, compared with none following the Kiva procedure.

Section Summary: Osteoporotic Vertebral Compression Fractures

Two moderately sized unblinded RCTs have reported short-term benefits of kyphoplasty for pain and other outcomes in patients with painful osteoporotic fractures compared with conservative care. Other RCTs, summarized in a meta-analysis, found similar outcomes for kyphoplasty and vertebroplasty.

For mechanical vertebral augmentation with Kiva, evidence to date includes a large industry-sponsored, multicenter investigational device exemption trial and a large independent randomized trial. These randomized comparative trials showed outcomes similar to kyphoplasty.

Vertebral Body Stenting Versus Balloon Kyphoplasty

An RCT by Werner et al. performed independent of industry support, found no advantage of vertebral body stenting (VBS) over balloon kyphoplasty. (24) Sixty-five patients were included who had 1 or more fresh osteoporotic VCFs and marked pain. A total of 100 VCFs were randomized to either VBS or balloon kyphoplasty. There was no significant difference between the procedures in radiation time, or in the mean reduction of kyphosis (4.7º after VBS, 4.5 º after kyphoplasty). There was also no significant difference between the 2 intervention arms in cement leakage (20% balloon kyphoplasty and 30% VBS). Intraoperative pressure was higher and material-related complications were greater (9 of the 50 levels, including failure of the cannulas, incomplete or no opening of the stent, and balloon rupture) in the VBS group compared with 1 of the 50 vertebral levels (balloon rupture) in the kyphoplasty group.

Section Summary: Vertebral Body Stenting Versus Balloon Kyphoplasty

Currently, vertebral body stenting (VBS™; Synthes, Switzerland) is only available in Europe. (2) Early evidence suggests that vertebral body stenting may have worse outcomes compared with balloon kyphoplasty therefore, it is considered experimental, investigational, and/or unproven

Osteolytic Vertebral Compression Fractures

In 2016, Health Quality Ontario produced a technology assessment on vertebral augmentation for cancer related VCFs. (25) The assessment identified 33 reports with 1690 patients who were treated with kyphoplasty for spinal metastatic cancers, multiple myeloma, or hemangiomas. For cancer-related VCFs there were 5 case series (110 patients) on multiple myeloma and 6 reports (2 RCTs, 4 case series; 308 patients) on mixed cancers with spinal metastases. Vertebral augmentation resulted in reductions in pain intensity scores, opioid or other analgesic use, and disability scores. One RCT (N=129) compared kyphoplasty with nonsurgical management for cancer-related VCFs, reporting that pain scores, pain related disability, and health-related quality of life were significantly improved in the kyphoplasty group than in the usual care group. The second RCT compared the Kiva device with kyphoplasty in 47 patients with cancer-related compression fractures, finding no significant differences between groups for improvements in VAS pain and ODI scores.

Radiofrequency Kyphoplasty Versus Balloon Kyphoplasty

In 2016, Petersen et al. reported on an RCT with 80 patients that compared radiofrequency kyphoplasty (RFK) with balloon kyphoplasty. (26) Patients had been admitted to the hospital for severe back pain and met criteria for surgery after failed conservative treatment. All had osteoporotic compression fractures. Prior to treatment, VAS pain scores on movement were similar in both groups (8.4 in the balloon kyphoplasty group vs 8.0 in the RFK group). Postoperatively, VAS scores improved by 4.6 after balloon kyphoplasty and 4.4 after RFK (p=NS). Pain at 12 months also did not differ significantly between both groups, with 58% of patients in the balloon kyphoplasty group and 66% of patients in the RFK group reporting no to mild pain on movement (p=NS). There was a trend for greater restoration of the kyphosis angle.

Adverse Events

Yi et al. (2014) assessed the occurrence of new VCFs after treatment with cement augmenting procedures (vertebroplasty or kyphoplasty) vs conservative treatment in an RCT with 290 patients (363 affected vertebrae). (27) Surgically treated patients were discharged the next day. Patients treated conservatively (pain medication, bedrest, a body brace, physical therapy) had a mean length of stay of 13.7 days. Return to usual activity occurred at 1 week for 87.6% of surgically treated patients and at 2 months for 59.2% of conservatively treated patients. All patients were evaluated with radiographs and magnetic resonance imaging at 6 months and then at yearly intervals until the last follow-up session. At a mean follow-up of 49.4 months (range, 36-80 months), 10.7% of patients had experienced 42 new symptomatic VCFs. There was no significant difference in the incidence of new vertebral fractures between the operative (n=18; 9 adjacent, 9 nonadjacent) and conservative (n=24; 5 adjacent, 16 nonadjacent, 3 same level) groups, but the mean time to a new fracture was significantly shorter in the surgical group (9.7 months) compared with the nonoperative group (22.4 months).

Section Summary: Radiofrequency Kyphoplasty Versus Balloon Kyphoplasty

For RFK, a randomized comparative trial with 80 patients was identified that showed similar results compared with balloon kyphoplasty. Corroboration of these results in a larger number of patients is needed to determine with greater certainty whether RFK has outcomes similar to balloon kyphoplasty. The major limitation of all these RCTs was the lack of a sham procedure. Due to the possible sham effect observed in the recent trials of vertebroplasty, the validity of results from non-sham-controlled trials is questionable. Therefore, it is not possible to conclude that these improvements are a true treatment effect. Cement leakage, although slightly reduced in kyphoplasty relative to vertebroplasty, remains a concern.

Summary Of Evidence

For individuals who have osteoporotic vertebral compression fractures who receive balloon kyphoplasty, or mechanical vertebral augmentation (Kiva), the evidence includes randomized controlled trials (RCTs) and meta-analyses of RCTs. Relevant outcomes include symptoms, functional outcomes, quality of life, hospitalizations, and treatment-related morbidity. Two 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. Two randomized trials that compared mechanical vertebral augmentation (Kiva) with kyphoplasty have reported similar outcomes for both procedures. A major limitation of all these RCTs is the lack of a sham procedure. Due to the possible sham effect observed in the recent trials of vertebroplasty, the validity of the results from non-sham-controlled trials is unclear. Therefore, whether these improvements represent a true treatment effect is uncertain. The evidence is insufficient to determine the effects of the technology on health outcomes.

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. One RCT has 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. However, because the results of the comparative studies of vertebroplasty have suggested possible placebo or natural history effects, the evidence these studies provide is insufficient to warrant conclusions about the effect of kyphoplasty on health outcomes. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have osteoporotic or osteolytic vertebral compression fractures who receive radiofrequency kyphoplasty, the evidence includes an 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. Corroboration of these results in a larger number of patients is needed to determine with greater certainty whether radiofrequency kyphoplasty has outcomes similar to balloon kyphoplasty. The evidence is insufficient to determine the effects of the technology on health outcomes.

After consideration of the available evidence, it was concluded that, although the scientific evidence does not permit conclusions about the impact on health outcomes and that comparative studies with long-term outcomes are lacking, numerous case series, including large prospective reports, have consistently shown that vertebroplasty and percutaneous balloon kyphoplasty may alleviate pain and improve function in patients with osteoporotic vertebral fractures who have failed to respond to conservative treatment (at least 6 weeks) with analgesics, physical therapy, and rest. More recent randomized trials, which have compared percutaneous balloon kyphoplasty with medical management, have also reported benefit. Given the absence of alternative treatment options and the morbidity associated with extended bedrest, percutaneous balloon kyphoplasty and mechanical vertebral augmentation may be considered reasonable treatment options in patients with vertebral fractures who fail to improve after 6 weeks of conservative therapy and, therefore, may be considered medically necessary both for this patient population and populations with severe pain due to osteolytic lesions of the spine related to multiple myeloma or metastatic malignancies.

Practice Guidelines And Position Statements

American College of Radiology, et al.

The American College of Radiology (ACR) and 7 other surgical and radiologic specialty associations published a joint position statement on percutaneous vertebral augmentation in 2014. (28) 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.

Society of Interventional Radiology

In a 2014 quality improvement guideline on percutaneous vertebroplasty from the Society of Interventional Radiology (SIR), vertebral augmentation was recommended for compression fractures refractory to medical therapy. (29) Failure of medical therapy includes the following situations:

1. Patients who are “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. Patients 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. Patients with “a weakened or fractured vertebral body, and 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 2010, the American Academy of Orthopaedic Surgeons (AAOS) approved clinical guidelines on the treatment of osteoporotic spinal compression fractures, which had a weak recommendation for offering kyphoplasty to patients who “present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms and who are neurologically intact.” (30) The Academy indicated that future evidence could overturn existing evidence and that the quality of the current literature is poor. These recommendations were based on literature reviewed through September 2009.

National Institute for Health and Care Excellence

The National Institute for Health and Care Excellence (NICE) issued a 2013 guidance that recommended percutaneous vertebroplasty and percutaneous balloon kyphoplasty as treatment 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 through physical exam and imaging at the level of the fracture. (31) This guidance did not address balloon kyphoplasty with stenting, because the manufacturer of the stenting system (Synthes) stated there is limited evidence for vertebral body stenting given that the system had only recently become available.

In 2008, the Institute issued guidance on the diagnosis and management of adults with metastatic spinal cord compression. It was last reviewed in 2008, and placed on the static list (no major ongoing studies identified, with the next review in 5 years). (32) The guidance stated that vertebroplasty or kyphoplasty should be considered for patients who have vertebral metastases, and no evidence of spinal cord compression or spinal instability, if they have mechanical pain resistant to conventional pain management and vertebral body collapse. Surgery should only be performed when all appropriate specialists, agree. Despite a relatively small sample base, the Institute concluded the evidence suggests, in a select subset of patients, that early surgery may be more effective at maintaining mobility than radiotherapy.

Ongoing And Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 1.

Table 1. Summary of Key Trials

NCT No.

Trial Name

Planned Enrollment

Completion Date

Ongoing

NCT02461810a

A Prospective, Multicenter, Randomized, Comparative Clinical Study to Compare the Safety and Effectiveness of Two Vertebral Compression Fracture (VCF) Reduction Techniques: the SpineJack® and the KyphX Xpander® Inflatable Bone Tamp

152

Mar 2018

NCT: national clinical trial.

a Denotes industry-sponsored or cosponsored trial.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

22513, 22514, 22515

HCPCS Codes

None

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. DynaMed Plus [Internet]. Ipswich (MA): EBSCO Information Services. 1995 - Record No. 114371, Thoracolumbar vertebral compression fracture. Sep 16, 2016. Available at <http://www.dynamed.com> Accessed January 5, 2018.

2. Spinasanta S. Current and Prospective Management of Vertebral Compression Fractures and Osseous Spinal Metastases: Meeting Highlight from NASS 2014. SpineUniverse Feb 23, 2017. Available at < https://www.spineuniverse.com> Accessed January 9, 2018.

3. Percutaneous Vertebroplasty. Chicago, Illinois: Blue Cross Blue Shield Association – Technology Evaluation Center Specialty Report (2000); Volume 15:Tab 21.

4. Percutaneous kyphoplasty for vertebral fractures caused by osteoporosis and malignancy. Chicago, Illinois: Blue Cross Blue Shield Association – Technology Evaluation Center Specialty Report (2004); Volume 19:Tab 12.

5. Percutaneous kyphoplasty for vertebral fractures caused by osteoporosis or malignancy. Chicago, Illinois: Blue Cross Blue Shield Association – Technology Evaluation Center Specialty Report (2005); Volume 20:Tab 7.

6. Percutaneous kyphoplasty for vertebral fractures caused by osteoporosis or malignancy. Chicago, Illinois: Blue Cross Blue Shield Association – Technology Evaluation Center Specialty Report (2008); Volume 23:Tab 5.

7. Percutaneous vertebroplasty or kyphoplasty for vertebral fractures caused by osteoporosis. Chicago, Illinois: Blue Cross Blue Shield Association – Technology Evaluation Center (2009); Volume 24:Tab 7.

8. Percutaneous vertebroplasty or kyphoplasty for vertebral fractures caused by osteoporosis. Chicago, Illinois: Blue Cross Blue Shield Association – Technology Evaluation Center (2010); Volume 25:Tab 9.

9. Jarvik JG, Deyo RA. Cementing the evidence: time for a randomized trial of vertebroplasty. AJNR Am J Neuroradiol. Sep 2000; 21(8):1373-1374. PMID 11003266

10. Moerman DE, Jonas WB. Deconstructing the placebo effect and finding the meaning response. Ann Intern Med. Mar 19 2002; 136(6):471-476. PMID 11900500

11. 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. PMID 11372012

12. 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. PMID 12406519

13. 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. PMID 19657121

14. 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. PMID 19657122

15. 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. PMID 19246088

16. 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. PMID 21337428

17. 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. PMID 23446769

18. 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, randomized controlled trial. Lancet Oncol. Mar 2011; 12(3):225-235. PMID 21333599

19. 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. PMID 21308780

20. Chang X, Lv YF, Chen B, et al. Vertebroplasty versus kyphoplasty in osteoporotic vertebral compression fracture: a meta-analysis of prospective comparative studies. Int Orthop. Mar 2015; 39(3):491-500. PMID 25260399

21. Dohm M, Black CM, Dacre A, et al. A randomized trial comparing balloon kyphoplasty and vertebroplasty for vertebral compression fractures due to osteoporosis. AJNR Am J Neuroradiol. Dec 2014; 35(12):2227-2236. PMID 25300981

22. 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. PMID 25822543

23. Korovessis P, Vardakastanis K, Repantis T, et al. Balloon kyphoplasty versus KIVA Vertebral augmentationcomparison of 2 techniques for osteoporotic vertebral body fractures: a prospective randomized study. Spine (Phila Pa 1976). Feb 15, 2013; 38(4):292-299. PMID 23407406

24. Werner CM, Osterhoff G, Schlickeiser J, et al. Vertebral body stenting versus kyphoplasty for the treatment of osteoporotic vertebral compression fractures: a randomized trial. J Bone Joint Surg Am. Apr 3, 2013; 95(7):577- 584. PMID 23553291

25. Health Quality Ontario. 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. PMID 27298655

26. 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. PMID 26482590

27. 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. PMID 24287674

28. 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. PMID 24325929

29. Baerlocher MO, Saad WE, Dariushnia S, et al. Quality improvement guidelines for percutaneous vertebroplasty. J Vasc Interv Radiol. Feb 2014; 25(2):165-170. PMID 24238815

30. American Academy of Orthopaedic Surgeons (AAOS). Clinical practice guideline, Treatment of osteoporotic spinal compression fractures. 2010. Available at <http://www.aaos.org> Accessed January 8, 2018.

31. National Institute for Health and Care Excellence (NICE). Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for treating osteoporotic vertebral compression fractures [TA279]. 2013; Available at <https://www.nice.org.uk> Accessed January 8, 2018.

32. National Institute for Health and Care Excellence (NICE). Metastatic spinal cord compression in adults: risk assessment, diagnosis and management [CG75]. 2008. Available at <https://www.nice.org.uk> Accessed January 8, 2018.

33. Percutaneous kyphoplasty. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (August 2017) Medicine 6.01.38

Policy History:

Date Reason
6/1/2018 Document updated with literature review. The following changes were made to Coverage. 1) added “compression” to state “The treatment of symptomatic osteoporotic vertebral compression fractures that have failed to respond to conservative treatment (e.g., analgesics, physical therapy, rest) for at least 6 weeks” 2) Editorial change” for immediate” changed to “including” in the experimental, investigational and/or unproven coverage statement. 3) Added “Radiofrequency” and maintained language “including but not limited to vertebral body stenting” to the experimental, investigational and/or unproven coverage statement for devices. Title changed from Percutaneous Balloon Kyphoplasty and Mechanical Vertebral Augmentation.
12/1/2016 Reviewed. No changes.
2/1/2016 Document updated with literature review. 1) mechanical vertebral augmentation with Kiva was changed to medically necessary for a) the treatment of symptomatic osteoporotic vertebral fractures that have failed to respond to conservative treatment (e.g., analgesics, physical therapy, rest) for at least 6 weeks; and b) for the treatment of severe pain due to osteolytic lesions of the spine related to multiple myeloma or metastatic malignancies. 2) Percutaneous balloon kyphoplasty and mechanical vertebral augmentation with Kiva® is considered experimental, investigational, and/or unproven for immediate use in acute vertebral fractures due to osteoporosis or trauma. 3)Percutaneous balloon kyphoplasty and mechanical vertebral augmentation with Kiva® is considered experimental, investigational, and/or unproven for all other indications.4) Percutaneous mechanical vertebral augmentation using any other device, including but not limited to vertebral body stenting, is considered experimental, investigational, and/or unproven.
2/15/2015 Document updated with literature review. The following was added to Coverage: Percutaneous mechanical vertebral augmentation using any other device, including but not limited to Kiva® and vertebral body stenting, is considered experimental, investigational and/or unproven. In addition, “Percutaneous Vertebroplasty and Sacroplasty” were removed from this policy and are now on Medical Policy RAD601.056 Percutaneous Vertebroplasty and Sacroplasty. The title of this document changed from “Percutaneous Vertebroplasty, Percutaneous Kyphoplasty, and Percutaneous Sacroplasty.”
9/15/2012 Document updated with literature review. Title changed to include “Percutaneous Sacroplasty”. The following change was made to coverage: Percutaneous sacroplasty is considered experimental, investigational and unproven for all indications, including use in sacral insufficiency fractures due to osteoporosis and spinal lesions due to metastatic malignancies or multiple myeloma.
9/1/2010 Document updated with literature review. Title changed from “Percutaneous Polymethylmethacrylate Vertebroplasty, Percutaneous Kyphoplasty”. The following changes were made 1) Percutaneous Polymethylmethacrylate Vertebroplasty (PPV) or Percutaneous Kyphoplasty (PK) may be considered medically necessary for the treatment of symptomatic osteoporotic vertebral fractures that have failed to respond to conservative treatment, or for the treatment of severe pain due to osteolytic lesions of the spine related to multiple myeloma or metastatic malignancies. 2) PPV and PK are considered experimental, investigational and unproven for all other indications. 3). Sacroplasty is considered experimental, investigational and unproven for all indications.
2/15/2008 Revised/Updated Entire Document
1/1/2007 Codes Revised/Added Deleted
2/1/2006 Revised/Updated Entire Document
1/1/2006 Codes Revised/Added/Deleted
3/30/2004 Revised/Updated Entire Document
3/1/2002 New Medical Document

Archived Document(s):

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