Coverage Policy Manual - Arkansas Blue Cross and Blue Shield

Coverage Policy Manual
Policy #:	2005031
Category:	Surgery
Initiated:	November 2005
Last Review:	May 2023

Sacroplasty

Description:

Sacral insufficiency fractures are the consequence of stress on weakened bone and often cause low back pain in the elderly population (Gotis-Graham, 1994). Osteoporosis is the most common risk factor for sacral insufficiency fractures. Lourie described spontaneous fracture of the sacrum in patients with osteoporosis as presenting as lower back and buttock pain with or without referred pain in the legs (Lourie, 1982). Although common, sacral insufficiency fractures can escape detection due to low provider suspicion and poor sensitivity on plain radiographs, slowing the application of appropriate intervention. The purpose of sacroplasty is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as conservative management, in patients with sacral insufficiency fractures.

Sacroplasty evolved from the treatment of insufficiency fractures in the thoracic and lumbar vertebrae with vertebroplasty. The procedure, essentially identical to vertebroplasty, entails guided injection of polymethylmethacrylate through a needle inserted into the fracture zone. Although first described in 2000 as a treatment for symptomatic sacral metastatic lesions, it is most often described as a minimally invasive alternative to conservative management for sacral insufficiency fractures (Dehdashti, 2000; Marcy, 2000; Aretxabala, 2000; Leroux, 1993; Newhouse, 1992).

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

Coding

There are CPT category III codes for sacroplasty:

0200T: Percutaneous sacral augmentation (sacroplasty), unilateral injection(s), including the use of a balloon or mechanical device, when used, 1 or more needles

0201T: Percutaneous sacral augmentation (sacroplasty), bilateral injections, including the use of a balloon or mechanical device, when used, 2 or more needles

Policy/
Coverage:

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Sacroplasty does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.

For members with contracts without primary coverage criteria, sacroplasty is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Rationale:

There is no review of sacroplasty by any outside technology assessment groups. There are no position papers by national medical societies. There are several articles describing case reports of 1-3 patients.

Zelle and others described a large case series. “During a 6-year period, 177 patients with a displaced sacral fracture were treated at our level-one trauma centre. At the initial presentation, 13 patients demonstrated a neurological deficit as a result of their sacral fracture. Six patients underwent surgical decompression, and seven patients were managed without surgical decompression. All patients were re-assessed at an average follow-up of 27.1 (range 12-84) months using the modified SOFCOT Index and the SF-36. Patients undergoing surgical decompression had a significantly better neurological improvement as measured by the modified SOFCOT Index (p=0.014). Moreover, patients undergoing surgical decompression had a significantly better physical function than the patients that were managed without surgical decompression, as measured by the SF-36 (p=0.044). We therefore believe that patients undergoing surgical decompression achieve better neurological improvement and better functional results.”

2009 Update

Pubmed search for literature through May 2009 was performed. There continues to be sparse literature, one retrospective study of 33 patients (Whitlow, 2007), or articles addressing the technique of the procedure (Heron, 2007, Jayaraman, 2009; Betts. 2009). Frey and colleagues (2008) reported a prospective observational cohort of 52 patients who experienced significant pain relief 30 minutes post procedure with a continued decrease in the VAS score to 52 weeks. Even with this reported significant improvement the authors stated more rigorous trials are warranted to provide definitive evidence of the safety and efficacy of sacroplasty for sacral insufficiency fractures.

2010 Update

A PubMed search through 8/31/10 was performed. No reports of randomized controlled trials were identified.

In a 2009 review of the literature Bayley and colleagues identified 7 case series, 5 technical reports and 3 case reports with a combined total of 108 patients. Since that report several case reports/small case series have been published. Lyders et al. (2010) report increasing use of sacroplasty though there is still a lack of validating controlled studies and unique technical considerations including difficulty in the detection of sacral insufficiency fractures the lack of resistance during cement extrusion that necessitates very close fluoroscopic monitoring.

Currently there is no new medical literature to support a revision of the noncoverage statements in this policy.

2012 Update

A literature search was conducted using the MEDLINE database through July 2012. There was no new information identified that would prompt a change in the coverage statement. Sacroplasty is still 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 indications.

2013 Update

A literature search was conducted through April 2013. There was no new literature identified that would prompt a change in the coverage statement. Two retrospective reports assessing the use of percutaneous sacroplasty were identified (Kortman, 2012; Dougherty, 2013).

The largest series is a retrospective multicenter analysis of 204 patients with painful sacral insufficiency fractures and 39 patients with symptomatic sacral lesions treated with either the short-axis or long-axis technique (Kortman, 2012). One hundred and sixty-nine patients had bilateral sacral insufficiency fractures and 65 patients had additional fractures of the axial skeleton. VAS improved from 9.2 before treatment to 1.9 after treatment in patients with sacral insufficiency fractures, and from 9.0 to 2.6 in patients with sacral lesions. There was one case of radicular pain due to extravasation of cement requiring surgical decompression.

Another series was a retrospective review of 57 patients treated with sacroplasty under computed tomography (CT) guidance for sacral insufficiency fractures (Dougherty, 2013). The short- or long-axis approach was dictated by the length and type of the fracture and patient anatomy. Follow-up data at 2.5 weeks was available for 45 patients (79%), and the outcome measures were inconsistent. For example, activity pain scores were collected from 13 patients, and rest pain scores were collected from 29 patients. Of the 45 patients with outcome data, 37 (82%) were reported to have experienced either a numerical or descriptive decrease from initial pain of at least 30%.

In 2012, a joint practice guideline on the performance of vertebral augmentation was published by the American College of Radiology (ACR), the American Society of Neuroradiology (ASN), the American Society of Spine Radiology (ASSR), the Society of Interventional Radiology (SIR), and the Society of Neurointerventional Surgery (SNIS). (37) This guideline addresses vertebral augmentation in general and refers to all percutaneous techniques used to achieve internal vertebral body stabilization, including vertebroplasty, balloon kyphoplasty, radiofrequency ablation and coblation, mechanical void creation, and injection of bone graft material or bone substitutes. The ACR, ASN, ASSR, SIR, and SNIS consider vertebral augmentation to be an established and safe procedure and provide guidelines for appropriate patient selection, qualifications and responsibilities of personnel, specifications of the procedure, equipment quality control, and quality improvement and documentation.

2014 Update

A search of the MEDLINE database conducted through April 2014 did not reveal any new clinical trials assessing the use of sacroplasty. The policy statement is unchanged.

2015 Update

A literature search conducted through April 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.

Chen and colleagues reported a nonblinded RCT of vertebroplasty compared with conservative management (Chen, 2014).The study included 89 patients with chronic compression fractures confirmed by MRI and persistent severe pain for 3 months or longer. Evaluation was performed at 1 week and at 1, 3, 6, and 12 months. Over the course of the year, pain scores decreased from 6.5 to 2.5 in the vertebroplasty group and from 6.4 to 4.1 in the control group (p < 0.001). Complete pain relief was reported by 84.8% of patients in the vertebroplasty group compared with 34.9% of controls. The final ODI score was 15.0 in the vertebroplasty group and 32.1 in the conservative management group (p < 0.001), and the final Roland Morris Disability Score was 8.1 for vertebroplasty and 10.7 for controls (p < 0.001).

2016 Update

A literature search conducted using the MEDLINE database through April 2016 did not reveal any new information that would prompt a change in the coverage statement.

2017 Update

A literature search conducted through April 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.

No RCTs on percutaneous sacroplasty for sacral insufficiency have been reported. The available evidence includes one prospective cohort study with 52 patients and a retrospective series with 243 patients. These studies reported rapid and sustained decreases in pain following percutaneous sacroplasty. Additional literature reports are mostly consistent in reporting immediate improvement following the procedure. Due to the small size of the evidence base, harms associated with sacroplasty have not been adequately studied. The small numbers of treated patients leave uncertainty regarding the impact of sacroplasty on health outcomes.

2018 Update

Annual policy review completed with a literature search using the MEDLINE database through May 2018. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.

PERCUTANEOUS VERTEBROPLASTY FOR VERTEBRAL COMPRESSION FRACTURES OF BETWEEN 6 WEEKS AND 1 YEAR OLD

Xie et al, in a meta-analysis of RCTs, evaluated efficacy and safety in percutaneous vertebroplasty and conservative treatment for patients with osteoporotic vertebral compression fractures (Xie, 2017). Thirteen studies were selected (total N=1231 patients; 623 to vertebroplasty, 608 to conservative treatment); among them were the two sham-controlled trials described below. Outcomes included pain relief (from 1 week to 6 months), quality of life assessments, and the rate of adjacent-level vertebral fracture. Vertebroplasty was superior for pain relief at 1 week (mean difference [MD], 1.36; 95% CI, 0.55 to 2.17) and 1 month (MD=1.56; 95% CI, 0.43 to 2.70); it was inferior to conservative treatment for pain relief at 6 months (MD = -1.59; 95% CI, -2.9 to -0.27; p<0.05). Vertebroplasty showed improvement over conservative treatment for quality of life, as measured using the Quality of Life Questionnaire of the European Foundation for Osteoporosis (MD = -5.03; 95% CI, 7.94 to -2.12). No statistically significant differences were found between treatments for the rate of adjacent-level vertebral fractures (relative risk: 0.59; 95% CI, 0.43 to 0.81). Limitations included the inclusion of several studies with inadequate blinding and heterogenous reporting of patient characteristics outcomes.

Vertebroplasty vs Medical Management Without Sham Controls

Lin et al reported on mortality risk in elderly patients (>70 years old) who had vertebral compression fractures and were treated with early vertebroplasty (within 3 months) or conservative therapy (Lin, 2017). The data set consisted of 10,785 Taiwanese patients who were selected through the National Health Insurance Research Database, of whom 1773 patients received vertebroplasty, and 5324 did not; a minority of these patients had osteoarthritis. Using conditional Cox proportional hazard modeling to determine the risk of death and respiratory-related issues, the authors found that a “significant difference in survival curves of mortality and respiratory failure” existed between both groups of patients (p<0.05). The incidence of death at 1 year in the vertebroplasty group was 0.46 per 100 person-months (95% CI, 0.38 to 0.56). The incidence of death at 1 year in the nonvertebroplasty group was 0.63 per 100 person-months (95% CI, 0.57 to 0.70). With regard to respiratory failure, hazard ratio between groups was 1.46 (95% CI, 1.04 to 2.05; p=0.028). Limitations of this study included the broad selection of the population, which was not restricted only to patients with osteoporotic lesions. Also, authors were limited by the database, which did not report on pain or functional outcomes.

PERCUTANEOUS SACROPLASTY

Frey et al reported on patients treated with percutaneous sacroplasty, particularly the long-term efficacy of sacroplasty vs nonsurgical management (Frey, 2017). This prospective, observational cohort study spanned ten years and comprised 240 patients with sacral insufficiency fractures. Thirty-four patients were treated with nonsurgical methods, and 210 patients were treated with sacroplasty. Pain, as measured by VAS, was recorded before treatment and at several follow-ups. Mean pretreatment VAS for the sacroplasty group was 8.29; for the nonsurgical treatment group, it was 7.47. Both forms of treatment resulted in significant VAS improvement from pretreatment to the 2-year follow-up (p<0.001). However, the sacroplasty treatment group experienced significant VAS score improvement consistently at many of the follow-up points (pretreatment to post [p<0.001]; posttreatment through 2 weeks [p>0.001]; 12 weeks through 24 weeks [p=0.014]; 24 weeks through 1 year [p=0.002]). Meanwhile, the group with nonsurgical treatment only experienced one significant pain improvement score—at the 2-week follow-up posttreatment (p=0.002). One major limitation of this study was that the nonsurgical treatment group was not followed up with at the 10-year mark whereas the sacroplasty group did receive follow-up.

2019 Update

Annual policy review completed with a literature search using the MEDLINE database through April 2019. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.

Frey et al reported on patients treated with percutaneous sacroplasty, particularly the long-term efficacy of sacroplasty vs nonsurgical management (Frey, 2017). This prospective, observational cohort study spanned ten years and comprised 240 patients with sacral insufficiency fractures. Thirty-four patients were treated with nonsurgical methods, and 210 patients were treated with sacroplasty. Pain, as measured by VAS, was recorded before treatment and at several follow-ups. Mean pretreatment VAS for the sacroplasty group was 8.29; for the nonsurgical treatment group, it was 7.47. Both forms of treatment resulted in significant VAS improvement from pretreatment to the 2-year follow-up (p<0.001). However, the sacroplasty treatment group experienced significant VAS score improvement consistently at many of the follow-up points (pretreatment to post [p<0.001]; posttreatment through 2 weeks [p>0.001]; 12 weeks through 24 weeks [p=0.014]; 24 weeks through 1 year [p=0.002]). Meanwhile, the group with nonsurgical treatment only experienced one significant pain improvement score-at the 2-week follow-up posttreatment (p=0.002). One major limitation of this study was that the nonsurgical treatment group was not followed up with at the 10-year mark whereas the sacroplasty group did receive follow-up.

2020 Update

A literature search was conducted through April 2020. There was no new information identified that would prompt a change in the coverage statement.

2021 Update

Annual policy review completed with a literature search using the MEDLINE database through April 2021. No new literature was identified that would prompt a change in the coverage statement.

2022 Update

Annual policy review completed with a literature search using the MEDLINE database through April 2022. No new literature was identified that would prompt a change in the coverage statement.

2023 Update

Annual policy review completed with a literature search using the MEDLINE database through April 2023. No new literature was identified that would prompt a change in the coverage statement.

CPT/HCPCS:

References:

ACR–ASNR–ASSR–SIR–SNIS Practice guideline for the performance of vertebral augmentation 2012. Available online at: http://www.acr.org/~/media/ACR/Documents/PGTS/guidelines/Vertebral_Augmentation.pdf. Last accessed April, 2013.

Angtuaco EE, St. Amour TE, Nokes SR.(2005) Sacroplasty. J Arkansas Med Soc 2005; 102:162-3.

Aretxabala I, Fraiz E, Perez-Ruiz F, et al.(2000) Sacral insufficiency fractures. High association with pubic rami fractures. . Clin Rheumatol. 2000; 19(5): 399-401. PMID 11055834

Bayley E, Srinivas S, Boszczyk BM.(2009) Clinical outcomes of sacroplasty in sacral insufficiency fractures: a review of the literature. Eur Spine J, 2009; 18(9):1266-71.

Betts A.(2009) Vertebroplasty of the first sacral vertebra. Pain Physician, 2009; 12(3):651-7.

Blake P, Connors AM.(2004) Sacral insufficiency fracture. Br J Radiol 2004; 77:891-6.

Butler CL, Given CA, et al.(2005) Percutaneous sacroplasty for the treatment of sacral insufficiency fractures. Am J Roentgenol 2005; 184:156-9.

Chen D, An ZQ, Song S, et al.(2014) Percutaneous vertebroplasty compared with conservative treatment in patients with chronic painful osteoporotic spinal fractures. J Clin Neurosci. Mar 2014;21(3):473-477. PMID 24315046

Dehdashti AR, Martin JB, Jean B, et al.(2000) PMMA cementoplasty in symptomatic metastatic lesions of the S1 vertebral body. Cardiovasc Intervent Radiol. May-Jun 2000; 23(3): 235-7. PMID 10821903

Dougherty RW, McDonald JS, Cho YW et al.(2013) Percutaneous sacroplasty using CT guidance for pain palliation in sacral insufficiency fractures. J Neurointerv Surg 2013.

Frey ME, Depalma MJ, et al.(2008) Percutaneous vertebroplasty for osteoporotic sacral insufficiency fractures: a prospectiive, multicenter, observational pilot study. Spine J, 2008; 8(2):367-73.

Frey ME, Warner C, Thomas SM, et al(2017) Sacroplasty: a ten-year analysis of prospective patients treated with percutaneous sacroplasty: literature review and technical considerations. Pain Physician. Nov 2017;20(7):E1063-E1072. PMID 29149151

Frey ME, Warner C, Thomas SM, et al.(2017) Sacroplasty: a ten-year analysis of prospective patients treated with percutaneous sacroplasty: literature review and technical considerations. Pain Physician. Nov 2017;20(7):E1063-E1072. PMID 29149151

Garant M.(2002) Sacroplasty: a new treatment for sacral insufficiency fracture. J Vasc Interv Radiol 2002; 13: 1265-67.

Georgy BA.(2007) Interventional techniques in managing persistent pain after vertebral augmentation procedures: a retrospective evaluation. Pain Physician, 2007; 10(5):673-6.

Gotis-Graham I, McGuigan L, Diamond T, et al.(1994) Sacral insufficiency fractures in the elderly. J Bone Joint Surg Br. Nov 1994; 76(6): 882-6. PMID 7983111

Heron J, Connell DA, James SL.(2007) CT-guided sacroplasty for the treatment of sacral insufficiency fractures. Clin Radiol, 2007; 62(11):1094-1103.

Hoshino Y, Doita M, et al.(2004) Unstable pelvic insufficiency fracture in a patient with rheumatoid arthritis. Rheumatol Int 2004; 24:46-9.

Jayaraman MV, Chang H, Ahn SH.(2009) An easily identifiable anatomic landmark for fluoroscopically guided sacroplasty: anatomic description and validation with treatment in 13 patients. AJNR Am J Neuroradiol, 2009; 30(5):1070-3.

Kortman K, Ortiz O, Miller T et al.(2012) Multicenter study to assess the efficacy and safety of sacroplasty in patients with osteoporotic sacral insufficiency fractures or pathologic sacral lesions. J Neurointerv Surg 2012.

Leroux JL, Denat B, Thomas E, et al.(1993) Sacral insufficiency fractures presenting as acute low-back pain. Biomechanical aspects. Spine (Phila Pa 1976). Dec 1993; 18(16): 2502-6. PMID 8303454

Lin JH, Chien LN, Tsai WL, et al.(2017) Early vertebroplasty associated with a lower risk of mortality and respiratory failure in aged patients with painful vertebral compression fractures: a population-based cohort study in Taiwan. Spine J. Sep 2017;17(9):1310-1318. PMID 28483705

Lin JH, Chien LN, Tsai WL, et al.(2017) Early vertebroplasty associated with a lower risk of mortality and respiratory failure in aged patients with painful vertebral compression fractures: a population-based cohort study in Taiwan. Spine J. Sep 2017;17(9):1310-1318. PMID 28483705

Lin JT, Lane JM.(2003) Sacral stress fractures. J Women Health (Larchmt) 2003; 12:879-88.

Lourie H.(1982) Spontaneous osteoporotic fracture of the sacrum. An unrecognized syndrome of the elderly. JAMA. Aug 13 1982; 248(6): 715-7. PMID 7097924

Lyders EM, Whitlow CT, et al.(2010) Imaging and treatment of sacral insufficiency fractures. AJNR Am J Neuroradiol, 2010; 31(2):201-10.

Marcy PY, Palussiere J, Descamps B, et al.(2000) Percutaneous cementoplasty for pelvic bone metastasis. Support Care Cancer. Nov 2000; 8(6): 500-3. PMID 11094996

Newhouse KE, el-Khoury GY, Buckwalter JA.(1992) Occult sacral fractures in osteopenic patients. J Bone Joint Surg Am. Dec 1992; 74(10): 1472-7. PMID 1364816

Pommersheim W, Juang-Hellinger F, et al.(2003) Sacroplasty: a treatment for sacral insufficiency fractures. Am J NeuroRad 2003; 24:1003-7.

Richards AM, Mears SC, et al.(2009) Biomechanical analysis of sacroplasty: does volume or location of cement matter? AJNR Am J Neuroradiol, 2009; 30(2):315-7.

Slipman CW, Gilchrist RV, et al.(2003) Sacral stress fracture in a female field hockey player. Am J Phys Med Rehab 2003; 82:893-6.

Tailander J, Langue F, et al.(2003) Mortality and functional outcomes of pelvic insufficiency fractures in older patients. Joint Bone Spine 2003; 70:287-9.

Vaccaro AR, Kim DH, et al.(2004) Diagnosis and management of sacral spine fractures. Inst Course Lect 2004; 53:375-85.

Whitlow CT, Mussat-Whitlow, BJ, et al.(2007) Sacroplasty versus vertebroplasty: comparable clinical outcomes for the treatment of fracture-related pain. AJNR Am J Neuroradiol, 2007; 28(7):1266-70.

Xie L, Zhao ZG, Zhang SJ, et al.(2017) Percutaneous vertebroplasty versus conservative treatment for osteoporotic vertebral compression fractures: An updated meta-analysis of prospective randomized controlled trials. Int J Surg. Nov 2017;47:25-32. PMID 28939236

Xie L, Zhao ZG, Zhang SJ, et al.(2017) Percutaneous vertebroplasty versus conservative treatment for osteoporotic vertebral compression fractures: An updated meta-analysis of prospective randomized controlled trials. Int J Surg. Nov 2017;47:25-32. PMID 28939236

Zelle BA, Gruen GS, et al.(2004) Sacral fractures with neurological injury: is early decompression beneficial. Int Orthop 2004; 28:244-51.

Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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