BlueCross and BlueShield of Montana Medical Policy/Codes
Percutaneous Vertebroplasty and Sacroplasty
Chapter: Surgery: Procedures
Current Effective Date: May 03, 2012
Original Effective Date: June 25, 2002
Publish Date: May 03, 2012
Revised Dates: March 1, 2005, July 21, 2005, August 1, 2006, June 9, 2009, March 26, 2012
Description

Percutaneous Vertebroplasty

Percutaneous vertebroplasty (PVP) is an interventional radiology technique involving the fluoroscopically guided injection of polymethylmethacrylate (PMMA) through a needle inserted into a weakened vertebral body. The technique has been investigated as an option to provide mechanical support and symptomatic relief in patients with osteoporotic vertebral compression fracture or in those with osteolytic lesions of the spine, i.e., multiple myeloma or metastatic malignancies. Percutaneous vertebroplasty has also been investigated as an adjunct to surgery for aggressive vertebral body hemangiomas, as a technique to limit blood loss related to surgery. The technique has been used in all levels of the vertebrae, i.e., cervical, thoracic, and lumbar.

It has been proposed that PVP 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, including thermal damage to intraosseous nerve fibers, since PMMA undergoes a heat-releasing (exothermic) reaction during its hardening process.

Vertebroplasty is a surgical procedure and, as such, is not subject to U.S. Food and Drug Administration (FDA) approval. PMMA bone cement was available as a drug product prior to enactment of the FDA’s device regulation and was at first considered what the FDA terms a “transitional device.” It was transitioned to a class III device requiring premarketing applications. Several orthopedic companies have received approval of their bone cement products since 1976. In October 1999, PMMA was reclassified from class III to class II, which requires future 510(k) submissions to meet “special controls” instead of “general controls” to assure safety and effectiveness. The FDA issued a guidance document on July 17, 2002 (last accessed September 2002, available online at: http://www.fda.gov/cdrh/ode/guidance/668.pdf.), that outlines the types of special controls required and describes the recommended labeling information.

Thus, use of PMMA in vertebroplasty represented an off-label use of an FDA-regulated product prior to 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 pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures.

The FDA also issued a “Public Health Web Notification: Complications related to the use of bone cement in vertebroplasty and kyphoplasty procedures,” which is available online at: www.fda.gov/cdrh/safety/bonecement.html. This notification is intended to inform the public about reports on safety and to encourage hospitals and other user facilities to report adverse events related to bone cement malfunctions, either directly to manufacturers or to MedWatch, the FDA’s voluntary reporting program.

Percutaneous Sacroplasty

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 2001 as a treatment for symptomatic sacral metastatic lesions, (1,2) it is most often described as a minimally invasive procedure employed as an alternative to conservative management (3-5) for sacral insufficiency fractures (SIFs). SIFs are the consequence of excessive stress on weakened bone and are often the cause of low back pain among the elderly. Osteoporosis is the most common risk factor for SIF.

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 and Osteopal® V) as the 510(k) marketing clearance was for the fixation of pathologic fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Sacroplasty was not included.

Osteoporotic Vertebral Compression Fracture

Osteoporotic compression fractures are a common problem, and it is estimated that up to one half of women and approximately one quarter of men will have a vertebral fracture at some point in their lives. However, only about one third of vertebral fractures actually reach clinical diagnosis, and most symptomatic fractures will heal within a few weeks or 1 month. However, a minority of patients will exhibit chronic pain following osteoporotic compression fracture that presents challenges for medical management. Chronic symptoms do not tend to respond to the management strategies for acute pain such as bed rest, immobilization/bracing device, and analgesic medication, sometimes including narcotic analgesics. The source of chronic pain after vertebral compression fracture may not be from the vertebra itself but may be predominantly related to strain on muscles and ligaments secondary to kyphosis. This type of pain frequently is not improved with analgesics and may be better addressed through exercise.

Sacral Insufficiency Fractures

Spontaneous fracture of the sacrum in patients with osteoporosis was described by Lourie in 1982 and presents as lower back and buttock pain with or without referred pain in the legs. (6,7) Although common, SIFs can escape detection due to low provider suspicion and poor sensitivity on plain radiographs, slowing the application of appropriate intervention. Similar interventions are used for sacral and vertebral fractures including bed rest, bracing and analgesics. Initial clinical improvements may occur quickly; however, the resolution of all symptoms may not occur for 9 to 12 months. (6,8)

Vertebral/Sacral Body Metastasis

Metastatic malignant disease involving the spine generally involves the vertebrae/sacrum, with pain being the most frequent complaint. While radiation and chemotherapy are frequently effective in reducing tumor burden and associated symptoms, pain relief may be delayed days to weeks, depending on tumor response. Further, these approaches rely on bone remodeling to regain strength in the vertebrae/sacrum, which may necessitate supportive bracing to minimize the risk of vertebral/sacral collapse during healing.

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 radiation therapy to surgical approaches using anterior spinal surgery for resection and decompression. There is the potential for large blood loss during surgical resection, and vascular embolization techniques have been used as adjuncts to treatment to reduce blood loss. Percutaneous vertebroplasty has been proposed as a way to treat and stabilize some hemangioma to limit the extent of surgical resection and as an adjunct to reduce associated blood loss from the surgery.

Policy

Prior authorization is recommended. Call Blue Cross and Blue Shield of Montana (BCBSMT) customer service at 1-800-447-7828 or fax your request to the Medical Review Department at 406-441-4624. A retrospective review will be performed if services are not prior authorized.

Medically Necessary

Percutaneous vertebroplasty may be considered medically necessary for the treatment of symptomatic osteoporotic vertebral fractures that have failed to respond to conservative treatment (e.g., analgesics, physical therapy and rest) for at least 6 weeks.

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

Investigational 

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

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

Federal Mandate

Federal mandate prohibits denial of any drug, device, or biological product fully approved by the FDA as investigational for the Federal Employee Program (FEP). In these instances coverage of these FDA-approved technologies are reviewed on the basis of medical necessity alone. Call the BCBSMT FEP Customer Service Department at 1-800-634-3569 for benefit information.

Policy Guidelines

In 2001, the following CPT codes were introduced to specifically describe percutaneous vertebroplasty of thoracic or lumbar vertebrae:

  • 22520 - 22521
  • 22522
  • 72291 - 72292

Prior to 2001, the following nonspecific CPT codes may have been used to describe individual components of the procedure:

  • 22851
  • 36680
  • 36005:
  • 75872:
  • 76003

There are CPT category III codes for sacroplasty:

  • 0200T
  • 0201T

Rationale

This policy was originally based on a 2000 TEC Assessment (9) and updated with TEC Assessments in 2004,2005, 2008, 2009, and 2010. (10-14) Originally, the available data were observational. Evidence from observational studies were generally consistent in showing significant decreases in pain from an initial preoperative level of 8 to 9 on a visual analog scale (VAS, or similar score proportionate to the highest possible score) to 2 to 4, typically within 1 day of receiving the procedure. Such pain relief appears to be lasting in the limited studies that reported long-term outcomes. In terms of adverse outcomes, leakage of the cement outside of the vertebral body is a common occurrence, occurring in between 19% and 72% in 8 studies that reported its occurrence. The largest of the case series reported results from a prospectively collected database with 552 patients from a large academic department. (15) The database consisted of baseline and postoperative measures, with follow-up by telephone at 1 week and 1, 6, 12, and 24 months (89%, 84%, 75%, 67%, and 62% patients at follow-up, respectively). The average age of the patients was 74 years (range: 28-96 years). Eighty-four percent of the procedures were performed for compression fractures related to osteoporosis, with an average duration of symptoms before treatment of 3.6 months. New compression fractures were observed following 23% (156) of the procedures; of these, 106 (68%) underwent an additional vertebroplasty procedure. Vertebroplasty was reported to decrease pain levels at rest and during activity by 50% or more (VAS of 4.5 to 1.7, and 8.4 to 3.6, respectively) beginning 2 hours after surgery; 87% of patients reported a decrease in pain. The Roland-Morris disability score improved from 18.4 at baseline to 10.8 at 1-week follow-up and remained near this level throughout follow-up. Medication use was reported to decrease in more than 66% of patients. Beginning in 2007, data from randomized clinical trials (RCTs) began appearing in the literature. This policy is now focused on RCT data.

Outcomes of Treatment

For treatment of osteoporosis and malignancy with percutaneous vertebroplasty (PVP) or sacroplasty, the primary beneficial outcomes of interest are relief of pain and improvement in ability to function. Ex vivo cadaver studies reporting bone strength as a surrogate outcome measure have been reported but are not included in this evaluation of health outcomes. In treatment of aggressive hemangioma, the primary benefits of PVP include relief of pain and reduction of blood loss associated with surgical treatment.

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

In all clinical situations, adverse effects related to complications from PVP and sacroplasty are the primary harms to be considered. Principal safety concerns relate to the incidence and consequences of leakage of the injected PMMA.

The VERTOS 1 study was a small randomized clinical trial of 34 patients. (16) Patients had been refractory to medical management for at least 6 weeks and no longer than 6 months. The authors noted that many patients had been referred for vertebroplasty following failed conservative treatment and did not want to be randomized to the optimized medication control group or chose to crossover to vertebroplasty after only 2 weeks of conservative treatment. Thus, the follow-up in the study was very short. Vertebroplasty was found to decrease analgesic use (1.9 to 1.2 vs. 1.7 to 2.6 in the optimized medication group) and resulted in a 19% improvement in the Roland-Morris Disability Questionnaire (RMDQ) (vs. -2% in controls) 2 weeks following the procedure. Excluding 2 patients (11%) who had adjacent vertebral compression fractures by the 2-week follow-up, mean VAS scores for pain decreased from 7.1 to 4.4 (vs. 7.6 to 6.4 for controls). Patients who crossed over from conservative management to vertebroplasty had improvements after the procedure.

In 2009, two randomized trials compared vertebroplasty to a sham procedure (that included local anesthetic) that mimicked the vertebroplasty procedure up to the point of cement injection. (17,18) Buchbinder and colleagues reported results of a four-center, randomized, double-blind, sham-controlled trial in which 78 participants with 1 or 2 painful osteoporotic vertebral fractures of duration less than 1 year were assigned to undergo vertebroplasty or sham procedure (i.e., injection of local anesthetic into the facet capsule and/or periosteum). (17) Ninety-one percent of participants completed 6-month follow-up. This study was designed to determine short-term efficacy and safety of vertebroplasty for alleviating pain and improving physical functioning in persons with painful osteoporotic vertebral fractures. The participants, investigators (other than the radiologists performing the procedure), and outcome assessors were blind to the treatment assignment.

Recruitment took place within the practices of both general practitioners and specialists from hospital inpatient and emergency departments. In general, participants were required to have back pain of no more than 12 months and the presence of at least 1 but no more than 2 recent vertebral fractures. Participants were evaluated at baseline, then with a mailed questionnaire at 1 week and 1, 3, and 6 months after the procedure. The primary outcome was overall pain (over the course of the previous week) measured on a 0 to 10 VAS, with 1.5 representing the minimal clinically important difference. A sample size of 24 per group was calculated to provide 80% power with 2-sided α 0.05 to show a 2.5-point post-procedure difference assuming a 3-point standard deviation (SD). All analyses were performed according to intention-to-treat principles. Results are presented as difference from baseline. For the primary outcome of overall pain, the authors report no significant difference in VAS pain score at 3 months.

The major methodologic strength of the trial was employing a sham procedure to control for nonspecific (placebo) effects, which has been reported to be quite large for invasive procedures, on the order of 6 to 7 mm on a 100-mm scale. (19-22) However, the sham used in the trial is not without controversy, as it might be considered an active control—the effect of injecting local anesthetic in the facet capsule and/or periosteum is unknown. Without a clear understanding of the short- and long-term effects of the injection on pain, questions will remain. With reductions in pain and improvements in quality of life observed in both groups, the authors concluded vertebroplasty provided no benefit.

There was considerable variability in pain scores, which may in part be due to a lack of minimum pain score at entry. The primary outcome measure was the mean difference in VAS from baseline. For some continuous outcomes, pain being one, there is a magnitude of improvement that is clinically meaningful on an individual level; someone achieving that minimal change can be considered a responder. Under these circumstances, a fundamental limitation of continuous effect measures is failing to identify the proportion of patients experiencing a meaningful clinical response. (23) Since a clinically meaningful important improvement has been established, the proportion of patients responding is the most informative outcome. (24) Moreover, when considered in this manner, response or meaningful improvement (2.5 on the VAS) in overall pain at 1, 3, and 6 months was more frequent with vertebroplasty—respective relative risks (RRs) of 1.2 (95% confidence interval [CI]: 0.7 to 2.0), 1.5 (95% CI: 0.9 to 2.6), and 1.3 (95% CI: 0.8 to 2.1). However, detecting an increase in response from 40% (sham) to 60% with 80% power would have required a sample exceeding 200 participants. Also, at entry, many participants had experienced pain longer than 3 months; (25) suggesting that the VAS may not be as responsive as other measures for these patients. (25) This adds to the uncertainty as to whether a mean change in VAS will capture clinically meaningful improvement.

Kallmes et al. also conducted a multicenter, randomized, double-blind, sham-controlled trial in which 131 participants with 1 to 3 painful osteoporotic vertebral fractures of duration less than 1 year were assigned to undergo vertebroplasty or sham procedure (injection of local anesthetic into the facet capsule and/or periosteum). (18) Ninety-seven percent completed a 1-month follow-up, and 95% completed 3 months. Participants were enrolled from five centers each in the U.S. and the U.K., and one in Australia. Sites were selected based on experience performing vertebroplasty for osteoporotic fractures. The trial was designed to determine the efficacy of vertebroplasty patients with painful osteoporotic compression fractures, as compared to a simulated procedure. Both participants and outcome assessors were blinded to the treatment assignment. Participants had back pain for no more than 12 months and had a current pain rating of at least 3 on VAS at baseline. Participants were evaluated at baseline, then again at various time points to 1-year post-procedure. The primary outcomes were scores on the RMDQ and average back pain intensity during the preceding 24 hours at 1 month. A reduction of 30% on the RMDQ and VAS pain was considered a clinically meaningful difference. (26)

The study initially had 80% power to detect differences in both primary and secondary outcomes with 250 patients, with a 2-sided alpha of 0.05 on the basis of a 2.5-unit advantage for vertebroplasty over placebo on the RMDQ and 1.0 point difference on VAS. After recruitment difficulty and interim analysis on first 90 participants, target sample size was decreased to 130 participants with 80% power for primary aims maintained. All primary analyses were performed according to intention-to-treat principles and results presented as mean score for the RMDQ and pain intensity.

Like the Buchbinder et al. trial, (17) this trial employed an elaborate sham procedure (injection of local anesthetic). For the primary endpoints at 1 month, there were no significant between group differences. There was a trend toward a higher clinically meaningful improvement in pain at 1 month (30% reduction from baseline) in the vertebroplasty group (64% vs. 48%, respectively; p=0.06). At 3 months, 43% from the control group vs. 12% in the vertebroplasty group crossed over (p<0.001). The crossovers did not affect study outcomes, as they occurred after the primary outcome assessment. However, significantly more participants in the control group chose to cross over than in the vertebroplasty group.

As in the Buchbinder et al. trial, Kallmes et al. employed the same sham procedure, which is both a major strength and a potential threat to the validity of their conclusions due to the unknown effect of the sham on short- and long-term self-reported pain. Response or a clinically meaningful improvement was also not the primary outcome. With the decrease in sample size due to recruitment issues, the study was left underpowered for its secondary aims. This leaves uncertainty around the interpretation of lack of statistical significance of the difference in proportions of patients responding to treatment with a clinically meaningful improvement in pain.

The 2 randomized, sham-controlled trials concluded that vertebroplasty showed no benefit above sham for painful osteoporotic fractures. However some uncertainty remains around the interpretation of their conclusions. Both trials were underpowered to observe and compare the proportion of participants experiencing a clinically meaningful difference in pain, which is the most informative outcome measure. Furthermore, the responder outcome measures in both trials showed differences in the clinically meaningful difference in pain albeit not statistically significant.

Due to questions in methodology, including but not limited to the choice of sham procedure, the potential effect of the sham procedure on outcomes and the appropriateness of chosen outcome measures to detect clinically meaningful differences in pain, uncertainty remains regarding potential efficacy of vertebroplasty based on these studies. The 2009 TEC Assessment concluded that the scientific evidence did not permit conclusions concerning the effects of vertebroplasty on net health outcome for osteoporotic vertebral fractures. (12)

Following the 2009 TEC Assessment, two randomized trials were published. Rousing et al. (27) reported on a nonblinded randomized trial in which participants were randomized to either vertebroplasty or conservative management. These participants had no conservative therapy prior to enrolling in the trial. The study enrolled 40 participants with acute fractures and 10 with subacute (2–8 weeks). While immediate pain relief was observed in the vertebroplasty group, reductions in pain from baseline to 3-month follow-up were similar in the two groups. The authors concluded that conservative management should be used in the acute phase. The primary limitations of this study include its small size and incomplete pain assessment at the baseline visit.

Klazen et al. (28) conducted an open-label prospective randomized trial, of 202 patients, at 6 hospitals in the Netherlands and Belgium. Participants with at least one painful osteoporotic vertebral fracture of duration of 6 weeks or less were assigned to undergo vertebroplasty or conservative management (i.e., bed rest, analgesia, and cast and physical support). Ninety-three participants received vertebroplasty while 95 received conservative management; 81% of participants completed 1-year follow-up. The trial was designed to assess the efficacy of vertebroplasty compared to conservative management for the treatment of osteoporotic vertebral compression fractures. There was no blinding of participants, investigators, or outcome assessors to treatment assignment, due to the lack of a sham procedure.

Participants were recruited after referral from their primary care provider for spine radiography because of back pain. In general, participants were required to be at least 50 years of age or older, have compression fracture with height loss of the vertebral body of at least 15% on x-ray of the spine, the level of fracture was Th5 or lower back with pain of a duration of 6 weeks or less with a severity of at least 5 on the VAS. Participants were clinically evaluated at baseline, 1 day, 1 week, 1 month, 3 months, 6 months and 12 months after treatment. Primary outcome was pain relief at 1 month and 12 months measured on a 10-point VAS scale. A sample size of 100 per group was calculated to provide 80% power with an alpha of 0.05 to show a 25% difference in pain relief. All analyses were performed according to intention-to-treat principles. Clinically significant pain relief was defined as 30% change on the VAS (0-10 scale).

One hundred and one participants were enrolled into the treatment group and 101 into the control arm; 81% completed 12 months’ follow-up. Except for the primary outcome, difference in mean pain score from baseline, at 3 months, and 12 months, vertebroplasty resulted in greater pain relief than did medical management at 1 month and 1 year; there were significant between group differences at 1 month (2.6; 1.74 to 3.37, p<0.0001) and at 1 year (2.0; 1.13 to 2.80, p<0.0001). Survival analysis showed significant pain relief was quicker (29.7 vs. 115.6 days) and was achieved in more patients after vertebroplasty than after conservative management. There was cement leakage in 72% of patients after vertebroplasty with all patients remaining asymptomatic, and at a mean of 11.4 months’ follow-up, there was no significant difference in number of new fractures between groups, with 18 new fractures in 15 patients who had vertebroplasty compared to 30 new fractures in 21 participants undergoing medical management.

A methodologic strength of this study is the study’s focus on acute fracture, a subset of those with osteoporotic vertebral compression fractures, while other studies (Buchbinder et al. 2009 [17]; Kallmes et al. 2009 [18]) enrolled participants with pain out to 1 year. The inclusion of both chronic and acute fractures may mask the efficacy of the procedure in one subset. Klazen and colleagues also provided an a priori definition of clinically significant change in pain as one that registered a 30% difference on the 10-point VAS. (28) These data were incorporated as events in a survival analysis as part of the analysis of the primary outcome.

Although not randomized, there was one other comparative study specifically aimed at patients with acute fracture. Diamond et al. enrolled 79 consecutive patients with acute vertebral fractures. (29) All patients were offered vertebroplasty, and those who declined followed as a comparison group. The two groups had balanced baseline characteristics. At 24 hours, the group undergoing vertebroplasty (n=55) had much improved pain compared to the control group (n=24). However, at 6 weeks and between 6 and 12 months, there were no differences between groups in pain scores. The control group had an identical mean pain score to the vertebroplasty group at the end of follow-up. Similar findings were shown for the Barthel index of physical functioning. At long-term follow-up, there was still slightly higher functioning in the group undergoing vertebroplasty but no difference in the percent improvement from baseline between groups. The authors interpreted these findings as demonstrating that vertebroplasty produced faster resolution of symptoms than conservative management, as was shown in the Klazen trial.

Percutaneous Sacroplasty

Sacroplasty is an evolving technique with numerous methods (short axis, long axis, balloon-assisted short axis, and iliosacral screws). No randomized trials of sacroplasty have been reported. Published evidence is mostly from case reports (30-34) and small case series (all but one enrolling fewer than 13 patients). (35-44) No consensus for best practices has been published. The largest experience is a prospective observational cohort study of 52 consecutive patients undergoing sacroplasty for sacral insufficiency fractures using the short axis technique. (45) Patients had a mean age of 75.9 years and a mean duration of symptoms of 34.5 days (range: 4-89 days) and mean VAS score of 8.1 at baseline. Improvement on the VAS scale was measured at 30 minutes and 2, 4, 12, 24, and 52 weeks postprocedure. At each interval, statistically significant improvement over baseline was observed and maintained through 52 weeks. Additional literature reports are mostly consistent reporting immediate improvement following the procedure. Due to the small size of the evidence base, harms associated with sacroplasty have not been adequately studied. There are complications of cement leakage with sacroplasty that are not observed with vertebroplasty. Leakage of PMMA into the presacral space, spinal canal, sacral foramen, or sacroiliac joint may result in pelvic injection of PMMA, sacral nerve root or sacral spinal canal compromise, or sacroiliac joint dysfunction. (46) Performing sacroplasty on Zone 1 fractures only can minimize these risks. (47)

Physician Specialty Society and Academic Medical Center Input

In response to requests, input was received from 5 physician specialty societies and 2 academic medical centers while this policy was under review in 2008. Unsolicited input was received from a sixth physician specialty society. While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted. All reviewers disagreed with the proposed policy and provided references in support of the use of vertebroplasty.

Summary

In 2008 after consideration of the uniform clinical input, it was concluded that although the scientific evidence does not permit conclusions about the impact on health outcomes and although comparative studies with long-term outcomes were lacking, numerous case series, including large prospective reports, consistently show that vertebroplasty 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). Given the absence of alternative treatment options and the morbidity associated with extended bed rest, vertebroplasty may be considered a reasonable treatment option in patients with vertebral fractures who fail to improve after 6 weeks of conservative therapy. There are no additional data that would alter this conclusion.

After reviewing the literature, there is insufficient evidence to permit conclusions on the use of vertebroplasty for an acute fracture. The Klazen et al. trial (28) is a well-done study, whose results should be replicated and verified.

Sacroplasty is under development. Varying techniques, patient indications, and small numbers of treated patients leaves uncertainty regarding the impact of sacroplasty on health outcomes and does not permit conclusion on its use for sacral insufficiency fractures or other indication.

Practice Guidelines and Position Statements

In 2010, the American Academy of Orthopaedic Surgeons (AAOS) Board of Directors approved a new clinical practice guideline on the treatment of osteoporotic spinal compression fractures, which is available online at: http://www.aaos.org/Research/guidelines/SCFguideline.asp. The Board approved a strong recommendation against the use of vertebroplasty for patients who “present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms and who are neurologically “intact.” In coming out with a strong recommendation, the committee expressed their confidence that future evidence is unlikely to overturn the existing evidence. As a note, these recommendations were based on a literature review through September 2009; therefore, the Klazen et al. trial was not included in the systematic review.

The updated 2009 TEC Assessment showed that data provide consistent, although not statistically significant, improvements in clinically meaningful differences in pain with vertebroplasty. With limited power for these outcomes, and the consistent but uncontrolled evidence from nonrandomized comparative studies and case series, there is uncertainty regarding potential efficacy of vertebroplasty based on these studies. The 2009 TEC Assessment concluded that the evidence for vertebroplasty did not meet TEC criteria because the scientific evidence did not permit conclusions concerning the effects of vertebroplasty on net health outcome for osteoporotic vertebral fractures. (12)

The United Kingdom’s National Institute for Health and Clinical Excellence (NICE) concluded in 2003 and 2006 that the current evidence on the safety and efficacy of balloon vertebroplasty for vertebral compression fractures appears 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, and also for people with symptomatic vertebral hemangioma and painful vertebral body tumors (metastases or myeloma), provided that normal arrangements are in place for consent, audit, and clinical governance. (48,49) The guidance recommends that the procedure be limited to patients whose pain is refractory to more conservative treatment.

A 2007 joint position from the American Society of Interventional and Therapeutic Neuroradiology, Society of Interventional Radiology, American Association of Neurological Surgeons/Congress of Neurological Surgeons, and American Society of Spine Radiology (“the Societies”) states that, “percutaneous vertebral augmentation with vertebroplasty and kyphoplasty is a safe, efficacious, and durable procedure in appropriate patients with symptomatic osteoporotic and neoplastic fractures when performed in a manner in accordance with published standards. These procedures are offered only when traditional medical therapy has not provided pain relief or pain is substantially altering the patient’s lifestyle.” (50)

Guidelines from the American College of Radiology (ACR, 2006) consider percutaneous vertebroplasty appropriate for painful osteoporotic or neoplastic vertebral compression fracture(s) refractory to medical therapy. (51) It is noted that when fewer than 95% of percutaneous vertebroplasty in an institution are performed for the above indication, it should prompt a review of practices related to selection of patients for this procedure. The guidelines also list absolute contraindications of asymptomatic vertebral body compression fractures, including patient improving on medical therapy; nonfractured vertebral levels; prophylaxis in osteoporotic patients (unless being performed as part of a research protocol); osteomyelitis of the target vertebra; myelopathy originating at the fracture level; uncorrectable coagulopathy; allergy to bone cement or opacification agent. Relative contraindications are listed as radiculopathy in excess of local vertebral pain, caused by a compressive syndrome unrelated to vertebral collapse (occasionally preoperative percutaneous vertebroplasty can be performed before a spinal decompressive procedure); asymptomatic retropulsion of a fracture fragment causing significant spinal canal compromise; asymptomatic tumor extension into the epidural space; ongoing systemic infection.

Indications and contraindications similar to those provided by the ACR were described by the Society of Interventional Radiology (SIR) in 2003. (52)

Rationale for Benefit Administration

This medical policy was developed through consideration of peer reviewed medical literature, FDA approval status, accepted standards of medical practice in Montana, Technology Evaluation Center evaluations, and the concept of medical necessity. BCBSMT reserves the right to make exceptions to policy that benefit the member when advances in technology or new medical information become available.

The purpose of medical policy is to guide coverage decisions and is not intended to influence treatment decisions. Providers are expected to make treatment decisions based on their medical judgment. Blue Cross and Blue Shield of Montana recognizes the rapidly changing nature of technological development and welcomes provider feedback on all medical policies.

When using this policy to determine whether a service, supply or device will be covered please note that member contract language will take precedence over medical policy when there is a conflict.

ICD-9 Codes
170.2, 198.5, 203.00-203.01, 228.09, 238.6, 733.1, 81.65 
ICD-10 Codes
C41.2, C79.51 – C75.52, C90.00 – C90.02, D18.09, D47.Z9, M48.50- – M48.58, M80.08, M84.48, M84.58, M84.68, 0PU33JZ, 0PU34JZ, 0PU43JZ, 0PU44JZ, 0QU03JZ, 0QU04JZ, 0QU13JZ, 0QU14JZ 
Procedural Codes: 22520, 22521, 22522, 72291, 72292, 0200T, 0201T, S2360, S2361
References
  1. Dehdashti AR, Martin JB, Jean B et al. PMMA cementoplasty in symptomatic metastatic lesions of the S1 vertebral body. Cardiovasc Intervent Radiol 2000; 23(3):235-7.
  2. Marcy PY, Palussiere J, Descamps B et al. Percutaneous cementoplasty for pelvic bone metastasis. Support Care Cancer 2000; 8(6):500-3.
  3. 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.
  4. 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):2502-6.
  5. Newhouse KE, el-Khoury GY, Buckwalter JA. Occult sacral fractures in osteopenic patients. J Bone Joint Surg Am 1992; 74(10):1472-7.
  6. Gotis-Graham I, McGuigan L, Diamond T et al. Sacral insufficiency fractures in the elderly. J Bone Joint Surg Br 1994; 76(6):882-6.
  7. Lourie H. Spontaneous osteoporotic fracture of the sacrum. An unrecognized syndrome of the elderly. JAMA 1982; 248(6):715-7.
  8. 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.
  9. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Percutaneous Vertebroplasty. TEC Assessments 2000; Volume 15, Tab 21.
  10. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Percutaneous Vertebroplasty for Vertebral Fractures Caused by Osteoporosis, Malignancy, or Hemangioma. TEC Assessments 2004; Volume 19, Tab 13.
  11. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Percutaneous Vertebroplasty for Vertebral Fractures Caused by Osteoporosis or Malignancy. TEC Assessments 2005; Volume 20, Tab 6.
  12. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Percutaneous Vertebroplasty or Kyphoplasty for Vertebral Fractures Caused by Osteoporosis. TEC Assessments 2009; Volume 24, Tab 7.
  13. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Percutaneous Vertebroplasty or Kyphoplasty for Vertebral Fractures Caused by Osteoporosis or Malignancy. TEC Assessments 2008; Volune 23; Tab 5.
  14. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). TEC Assessments 2010; Volume 25, Tab TBA.
  15. Layton KF, Thielen KR, Koch CA et al. Vertebroplasty, first 1000 levels of a single center: evaluation of the outcomes and complications. AJNR Am J Neuroradiol 2007; 28(4):683-9.
  16. Voormolen MH, Mali WP, Lohle PN et al. Percutaneous vertebroplasty compared with optimal pain medication treatment: short-term clinical outcome of patients with subacute or chronic painful osteoporotic vertebral compression fractures. The VERTOS study. AJNR Am J Neuroradiol 2007; 28(3):555-60.
  17. Buchbinder R, Osborne RH, Ebeling PR et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med 2009; 361(6):557-68.
  18. Kallmes DF, Comstock BA, Heagerty PJ et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med 2009; 361(6):569-79.
  19. Hrobjartsson A, Gotzsche PC. Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment. N Engl J Med 2001; 344(21):1594-602.
  20. Jarvik JG, Deyo RA. Cementing the evidence: time for a randomized trial of vertebroplasty. AJNR Am J Neuroradiol 2000; 21(8):1373-4.
  21. Moerman DE, Jonas WB. Deconstructing the placebo effect and finding the meaning response. Ann Intern Med 2002; 136(6):471-6.
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  23. Senn S. Statistical Issues in Drug Development. NY: Wiley and Sons; 2007.
  24. Masala S, Massari F, Assako OP et al. Is 3T-MR spectroscopy a predictable selection tool in prophylactic vertebroplasty? Cardiovasc Intervent Radiol 2010; 33(6):1243-52.
  25. Grotle M, Brox JI, Vollestad NK. Concurrent comparison of responsiveness in pain and functional status measurements used for patients with low back pain. Spine (Phila Pa 1976) 2004; 29(21):E492-501.
  26. 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 (Phila Pa 1976) 2008; 33(1):90-4.
  27. Rousing R, Andersen MO, Jespersen SM et al. Percutaneous vertebroplasty compared to conservative treatment in patients with painful acute or subacute osteoporotic vertebral fractures: three-months follow-up in a clinical randomized study. Spine (Phila Pa 1976) 2009; 34(13):1349-54.
  28. 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):1085-92.
  29. Diamond TH, Bryant C, Browne L et al. Clinical outcomes after acute osteoporotic vertebral fractures: a 2-year non-randomised trial comparing percutaneous vertebroplasty with conservative therapy. Med J Aust 2006; 184(3):113-7.
  30. Garant M. Sacroplasty: a new treatment for sacral insufficiency fracture. J Vasc Interv Radiol 2002; 13(12):1265-7.
  31. Layton KF, Thielen KR, Wald JT. Percutaneous sacroplasty using CT fluoroscopy. AJNR Am J Neuroradiol 2006; 27(2):356-8.
  32. Sciubba DM, Wolinsky JP, Than KD et al. CT fluoroscopically guided percutaneous placement of transiliosacral rod for sacral insufficiency fracture: case report and technique. AJNR Am J Neuroradiol 2007; 28(8):1451-4.
  33. Smith DK, Dix JE. Percutaneous sacroplasty: long-axis injection technique. AJR Am J Roentgenol 2006; 186(5):1252-5.
  34. Tjardes T, Paffrath T, Baethis H et al. Computer assisted percutaneous placement of augmented iliosacral screws: a reasonable alternative to sacroplasty. Spine (Phila Pa 1976) 2008; 33(13):1497-500.
  35. Binaghi S, Guntern D, Schnyder P et al. A new, easy, fast, and safe method for CT-guided sacroplasty. Eur Radiol 2006; 16(12):2875-8.
  36. Brook AL, Mirsky DM, Bello JA. Computerized tomography guided sacroplasty: a practical treatment for sacral insufficiency fracture: case report. Spine (Phila Pa 1976) 2005; 30(15):E450-4.
  37. Butler CL, Given CA, 2nd, Michel SJ et al. Percutaneous sacroplasty for the treatment of sacral insufficiency fractures. AJR Am J Roentgenol 2005; 184(6):1956-9.
  38. Deen HG, Nottmeier EW. Balloon kyphoplasty for treatment of sacral insufficiency fractures. Report of three cases. Neurosurg Focus 2005; 18(3):e7.
  39. Gjertsen O, Schellhorn T, Nakstad PH. Fluoroscopy-guided sacroplasty: special focus on preoperative planning from three-dimensional computed tomography. Acta Radiol 2008; 49(9):1042-8.
  40. Heron J, Connell DA, James SL. CT-guided sacroplasty for the treatment of sacral insufficiency fractures. Clin Radiol 2007; 62(11):1094-100; discussion 101-3.
  41. Pommersheim W, Huang-Hellinger F, Baker M et al. Sacroplasty: a treatment for sacral insufficiency fractures. AJNR Am J Neuroradiol 2003; 24(5):1003-7.
  42. Strub WM, Hoffmann M, Ernst RJ et al. Sacroplasty by CT and fluoroscopic guidance: is the procedure right for your patient? AJNR Am J Neuroradiol 2007; 28(1):38-41.
  43. Whitlow CT, Mussat-Whitlow BJ, Mattern CW et al. Sacroplasty versus vertebroplasty: comparable clinical outcomes for the treatment of fracture-related pain. AJNR Am J Neuroradiol 2007; 28(7):1266-70.
  44. Kamel EM, Binaghi S, Guntern D et al. Outcome of long-axis percutaneous sacroplasty for the treatment of sacral insufficiency fractures. Eur Radiol 2009 [Epub ahead of print].
  45. Frey ME, Depalma MJ, Cifu DX et al. Percutaneous sacroplasty for osteoporotic sacral insufficiency fractures: a prospective, multicenter, observational pilot study. Spine J 2008; 8(2):367-73.
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  48. Furstenberg CH, Grieser T, Wiedenhofer B et al. The role of kyphoplasty in the management of osteogenesis imperfecta: risk or benefit? Eur Spine J 2010; 19 Suppl 2:S144-8.
  49. Ma R, Chow R, Shen FH. Kummell's disease: delayed post-traumatic osteonecrosis of the vertebral body. Eur Spine J 2010; 19(7):1065-70.
  50. Jensen ME, McGraw JK, Cardella JF et al. Position statement on percutaneous vertebral augmentation: a consensus statement developed by the American Society of Interventional and Therapeutic Neuroradiology, Society of Interventional Radiology, American Association of Neurological Surgeons/Congress of Neurological Surgeons, and American Society of Spine Radiology. J Vasc Interv Radiol 2007; 18(3):325-30.
  51. Sonmez E, Yilmaz C, Caner H. Development of lumbar disc herniation following percutaneous vertebroplasty. Spine (Phila Pa 1976) 2010; 35(3):E93-5.
  52. McGraw JK, Cardella J, Barr JD et al. Society of Interventional Radiology quality improvement guidelines for percutaneous vertebroplasty. J Vasc Interv Radiol 2003; 14(9 Pt 2):S311-5.
History
July 2005  Code update to add S2362, S2363 
March 2012  Policy Vertebroplasty and Kyphoplasty divided into each their own policy. Medically Necessary statement policy guidelines, rationale, and references updated; No coding changes
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Percutaneous Vertebroplasty and Sacroplasty