National Medical Policy

Transcription

1 National Medical Policy Subject: Policy Number: Kyphoplasty NMP62 Effective Date*: October 2003 Updated: August 2015 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate Medicaid Manuals for coverage guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link National Coverage Determination (NCD) National Coverage Manual Citation X Local Coverage Determination (LCD)* Vertebroplasty (Percutaneous) and Vertebral Augmentation including cavity creation; Percutaneous Vertebral Augmentation: Article (Local)* Other None Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) Kyphoplasty Aug 15 1

2 If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Current Policy Statement Health Net, Inc. considers percutaneous kyphoplasty medically necessary after failure of standard medical therapy when imaging studies (e.g., X-ray, MRI, CT scan, fluoroscopy, bone scan) indicate a non-healing osteoporotic or pathologic fracture in patients when any of the following is met: 1. Osteoporotic vertebral collapse with persistent debilitating pain for 2 weeks which has not responded to accepted standard medical therapy, such as, but not limited to, initial immobilization with bed rest, narcotic or non-narcotic analgesics, bracing, strengthening exercises to correct postural deformity and increase muscle tone, salmon calcitonin, bisphosphonates and calcium supplementation; or 2. Osteolytic vertebral metastasis or myeloma with severe back pain related to destruction of the vertebral body not involving the major part of the cortical bone, when chemotherapy and radiation therapy have failed to relieve symptoms; or 3. Vertebral hemangiomas with severe pain or nerve compression and/or aggressive radiological signs, and radiation therapy has failed to relieve symptoms; or 4. Painful vertebral eosinophilic granuloma with spinal instability; or 5. Traumatic or steroid-induced vertebral fracture with persistent debilitating pain, which has not responded to standard medical therapy; or 6. Osteoporotic vertebral collapse requiring hospitalization due to incapacitating pain. Note: The pain should be reproducible with manual palpation over the posterior aspect of the compressed vertebrae. Other causes of pain, such as herniated intervertebral disc, should have been ruled out by computed tomography (CT) or magnetic resonance imaging (MRI). The affected vertebra should not have been extensively destroyed and is at least one third of its original height. Kyphoplasty should not be performed on a prophylactic basis, either for osteoporosis of the spine or chronic back pain, even if associated with old, healed compression fracture(s). Contraindications Uncorrected coagulation disorder exists Underlying infection (osteomyelitis of the involved vertebra) Very severe cardiopulmonary disease Extensive vertebral destruction (such as vertebra reduced to less than onehalf its original height) Neurological symptoms related to spinal compression Kyphoplasty Aug 15 2

3 Lack of neurosurgical backup for emergency decompression in the event a neurological deficit develops during the injection of polymethylmethacrylate (PMMA) Percutaneous vertebroplasty or kyphoplasty of more than 2 vertebral levels at one time Health Net, Inc. does not consider kyphoplasty medically necessary for treatment of any of the following: 1. Asymptomatic fractures 2. Fractures healing by conservative means 3. Kyphosis without fracture 4. Prevention of fractures due to documented osteoporosis or prior fractures 5. Treatment of secondary complications of kyphosis, such as reduced pulmonary function or gastrointestinal (GI) complications Definitions AANS American Association of Neurological Surgeons VCF Vertebral compression fracture PMMA Polymethylmethacrylate VAS Visual analog scale PVP Percutaneous vertebroplasty PKP Percutaneous kyphoplasty SF-36 Short Form 36 Health Survey PH Posterior vertebral body height AH Anterior vertebral body height BK Balloon Kyphoplasty BMD Bone mineral density Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures will be replaced by ICD-10 code sets. Health Net National Medical Policies will now include the preliminary ICD-10 codes in preparation for this transition. Please note that these may not be the final versions of the codes and that will not be accepted for billing or payment purposes until the October 1, 2015 implementation date. ICD-9 Codes Malignant neoplasm of vertebral column, excluding sacrum and coccyx Secondary malignant neoplasm of bone and bone marrow Multiple myeloma Kyphoplasty Aug 15 3

4 Neoplasm of uncertain behavior of plasma cells Fracture of vertebral column without mention of spinal cord injury, dorsal [thoracic], closed Fracture of vertebral column without mention of spinal cord injury, lumbar, closed Pathological fracture of vertebrae Osteoporosis, unspecified Idiopathic osteoporosis Disuse osteoporosis Other ICD-10 Codes C41.2 Malignant neoplasm of vertebral column C79.51 Secondary malignant neoplasm of bone C79.52 Secondary malignant neoplasm of bone marrow C90.00-C90.02 D47.Z9 Multiple myeloma Other specified neoplasms of uncertain behavior of lymphoid, hematopoietic and related tissue M48.54 Collapsed vertebra, not elsewhere classified, thoracic region M48.55 Collapsed vertebra, not elsewhere classified, thoracolumbar region M48.56 Collapsed vertebra, not elsewhere classified, lumbar region M80.08 Age-related osteoporosis with current pathological fracture, vertebra (e) M81.0-M81.8 S S S S Osteoporosis without current pathological fracture Fracture of thoracic vertebra Fracture of lumbar vertebra CPT Codes Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device, one vertebral body, unilateral or bilateral cannulation (eg, kyphoplasty); thoracic (code deleted 12/14) lumbar (code deleted 12/14) each additional thoracic or lumbar vertebral body (code deleted 12/14) Unlisted procedure, spine Unlisted diagnostic radiographic procedure 2015 CPT Codes Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (e.g. kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; thoracic Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (e.g. kyphoplasty), 1 vertebral body, Kyphoplasty Aug 15 4

5 unilateral or bilateral cannulation, inclusive of all imaging guidance; lumbar each additional thoracic or lumbar vertebral body HCPCS Codes N/A Scientific Rationale Update August 2015 Guidelines from the American Academy of Orthopaedic Surgeons (AAOS), The Treatment of Symptomatic Osteoporotic Spinal Compression Fractures, (Sept 2010) state, Kyphoplasty is an option for patients who present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms and who are neurologically intact. Wang et al (2015) assessed the safety and efficacy of percutaneous balloon kyphoplasty (PKP) compared to percutaneous vertebroplasty (PVP) in the treatment of single level osteoporotic vertebral compression fractures (OVCF). Studies with the following criteria were included: patients with VCFs due to osteoporosis; PKP comparing PVP; study design, RCT or prospective or retrospective comparative studies. Furthermore, the studies which reported at least one of the following outcomes: subjective pain perception, quality of life evaluation, incidence of new adjacent vertebral fracture, bone cement leakage, and post-operative kyphotic angle. Articles were excluded in our meta-analysis if they had a neoplastic etiology (i.e., metastasis or myeloma), infection, neural compression, traumatic fracture, neurological deficit, spinal stenosis, severe degenerative diseases of the spine, previous surgery at the involved vertebral body, and PKP or PVP with other invasive or semi-invasive intervention treatment. Eight studies, encompassing 845 patients, met the inclusion criteria. Overall, the results indicated that there were significant differences between the 2 groups in the short-term visual analog scale (VAS) scores, the long-term Oswestry Disability Index (ODI), short- and long-term kyphosis angle, the kyphosis angle improvement, the injected cement, and the cement leakage rates. However, there were no significant differences in the long-term VAS scores, the short-term ODI scores, the short- and long-term SF-36 scores, or the adjacentlevel fracture rates. The authors concluded PKP and PVP are both safe and effective surgical procedures in treating OVCF. PKP has a similar long-term pain relief, function outcome (short-term ODI scores, short-and long-term SF-36 scores), and new adjacent VCFs in comparison to PVP. PKP is superior to PVP for the injected cement volume, the short-term pain relief, the improvement of short- and long-term kyphotic angle, and lower cement leakage rate. However, PKP has a longer operation time and higher material cost than PVP. To confirm this evaluation, a large multicenter randomized controlled trial (RCT) should be conducted. Zhang et al (2015) investigated the complications and preventive measures of bone cement in PVP for the treatment of osteoporotic vertebral compression fractures. A retrospective analysis of 134 cases of osteoporotic vertebral compression fracture patients treated with PVP, which involved 182 vertebral fractures, was performed. The bone cement-related complications, the reasons causing these complications, and the preventive measures were investigated. Successful operation was performed in all patients. Operative bone cement toxic reaction occurred in 1 patient. Different degrees of leakage of bone cement were found in 21 patients with 25 fractures and 1 case needed operation treatment. During the long term follow-up, bone necrosis absorption and cement drifted away which needed operation treatment Kyphoplasty Aug 15 5

6 was found in 1 patient with vertebral fracture. Thirteen adjacent vertebral fractures were found in 11 patients and 10 patients underwent operation treatment again. The authors concluded with careful surgery, complications associated with bone cement could be greatly reduced. Huang et al (2015) sought to identify the characteristics and risk factors of the refractures after PKP and PVP in a retrospective analysis of 148 patients who had undergone PKP or PVP between March 2006 and October In the study, 29 patients with 42 refractured vertebra and 119 patients without refracture were included. All the patients were observed for a time of (34.4±26.8) months. Clinical, imaging and procedure related factors (gender, age, height, weight, body mass index, the level of the injured vertebra, the time interval between the procedure and the refracture, the level of the refractured vertebra, the bone cement volume injected, performed PKP or PVP performed unilateral or bilateral, the percentage of anterior vertebral height restoration, the correction of the Cobb angle, cement diffusion, bone mineral density, presence or absence of diabetes mellitus, history of fractures of the whole body, anti-osteoporosis treatment, cement leakage) for each group were analyzed by Cox proportional hazards regression analysis. Of all the patients,16 (55.17%, 16/29) had refractures in the adjacent vertebra, and 13 (44.83%, 13/29) had refractures in the nonadjacent vertebra. Refractures within 3 months accounted for 31.03% (9/29) of all the refractures, and within 1 year accounted for 55.17% (16/29). Both older age (P=0.027, HR=1.051, 95% CI= ) and a history of fractures of the whole body (P=0.012, HR=0.386, 95% CI= ) were statistically significant as the independent risk factors for predicting refractures. Others were not associated with refractures (P>0.05). The authors concluded older age and a history of fractures of the whole body are the independent risk factors of the refractures after PKP and PVP. The mechanism of the refractures after PKP and PVP is mainly the natural development of osteoporosis. Wang et al (2015) assessed the safety and efficacy of high-viscosity cement vertebroplasty (HVCV) compared with balloon kyphoplasty (BKP) in a prospective cohort study. One hundred seven patients suffering from painful OVCFs were randomly assigned into HVCV or BKP groups. Visual Analog Scale (VAS), Oswestry Disability Index (ODI), cement leakage, and vertebral height restoration were evaluated. All occurring complications and injected cement volumes were recorded. The follow-up time was one year. VAS and ODI scores improved in both groups, and did not differ significantly between the 2 groups. More cement was used in the BKP group than in HVCV group (4.22 vs ml, P < ). The incidence of cement leakage in the HVCV group was lower than that of the BKP group (13.24% vs 30.56%, P < 0.05). No symptomatic cement leakages occurred in the HVCV group. In the BKP group, one patient experienced discogenic back pain related to a disc leak, and another patient had asymptomatic cement emboli in the lung related to venous leakage. The mean compression rate before the procedure was 29.98% in the HVCV group and 28.67% in the BKP group (P = 0.94). The vertebral height was improved significantly and maintained at one-year follow-up in both groups. BKP was more effective in vertebral height restoration than HVCV (44.87% vs %, P < ). There was one case of a new adjacent vertebral fracture in the HVCV group (2%), and 4 cases of new nonadjacent vertebral fractures in the BKP group (7.84%) (P = 0.18). The author concluded HVCV and BKP are safe and effective in improving quality of life and relieving pain. HVCV has a lower cement leakage rate, whereas BKP is more effective in vertebral height restoration. Subsequent fractures are not different between the 2 groups. Kyphoplasty Aug 15 6

7 Markmiller (2015) evaluated the benefits of minimally invasive BKP in patients with cancer and painful pathologic vertebral lesions. In this longitudinal, prospective, consecutive study, patients received BKP at one or more vertebral levels. The BKP procedure was guided by computed tomographic fluoroscopy. Orthopaedic bone tamps were inflated to create a cavity and the fracture was stabilized using viscous polymethylmethacrylate bone cement. After the procedure, early mobilization was encouraged. Overall, 115 patients (52.2 % with vertebral fractures) received BKP. The majority (82.6 %) of patients received BKP as a stand-alone procedure. BKP treatment provided significant (P < ) improvements in Visual Analogue Scale (VAS)-pain (median change: -4), Oswestry Disability Index (ODI; mean change: ), and Karnofsky Performance Status (KPS; median change: 15) scores at 6 and 12 months. In total, 23 % of patients achieved increased vertebral height (7.4 % mean improvement in angle index). The presence of height restoration and the number of levels treated did not affect VAS or ODI scores; improvements in KPS scores were numerically higher in patients who received BKP plus additional surgery (15-20) compared with stand-alone BKP (10-15). Mean hospital times were 7.2 ± 6.5 days. The majority (97.4 %) of patients showed no complications related to the procedure; three patients (2.6 %) had a temporary radiculopathy. Incidences of cement leakage were observed in 40 patients (34.8 %). The authors concluded minimally invasive BKP provided excellent long-term palliation of pain and improved mobility in patients with cancer and painful osteolytic spinal lesions or vertebral fractures. Song et al (2015) sought to perform an updated systematic review and metaanalysis of the studies with more rigorous inclusion criteria on the effects of vertebral augmentation techniques and conservative treatment for OVCF on the incidence of secondary vertebral fractures. A total of 13 articles were included. The pooled results from included studies showed no statistically significant differences in the incidence of secondary vertebral fractures between patients treated with vertebral augmentation techniques and conservative treatment. Subgroup analysis comparing different study designs, durations of symptoms, follow-up times, races of patients, and techniques were conducted, and no significant differences in the incidence of secondary fractures were identified (P>0.05). No obvious publication bias was detected by either Begg's test (P=0.360>0.05) or Egger's test (P=0.373>0.05). The reviewers concluded despite current thinking in the field that vertebral augmentation procedures may increase the incidence of secondary fractures, we found no differences in the incidence of secondary fractures between vertebral augmentation techniques and conservative treatment for patients with OVCFs. Scientific Rationale Update August 2014 Yu et al (2014) evaluated the effectiveness and safety of balloon kyphoplasty (BK) in the treatment of symptomatic vertebral compression fractures (VCFs). Between July 2011 and June 2012, one hundred and eighty-seven patients with two hundred and fifty-one vertebras received balloon kyphoplasty in a single center. There were sixtyfive male and one hundred and twenty-two female patients with an average age of 74.5 (range, 61 to 95 years). The pain symptoms and quality of life, were measured before operation and at one day, three months, six months and one year following kyphoplasty. Radiographic data including restoration of kyphotic angle, anterior vertebral height, and any leakage of cement were defined. The mean visual analog pain scale decreased from a preoperative value of 7.7 to 2.2 at one day (p <.05) following operation and the Oswestry Disability Index improved from 56.8 to 18.3 (p <.05). The kyphotic angle improved from a mean of 14.4 before surgery to 6.7 at one day after surgery (p <.05). The mean anterior vertebral height increased Kyphoplasty Aug 15 7

8 significantly from 52% before surgery to 74.5% at one day after surgery (p <.05) and 70.2% at one year follow-up. Minor cement extravasations were observed in twenty-nine out of two hundred and fifty-one procedures, including six leakage via basivertebral vein, three leakage via segmental vein and twenty leakage through a cortical defect. None of the leakages were associated with any clinical consequences. Investigators concluded balloon kyphoplasty not only rapidly reduced pain and disability but also restored sagittal alignment in our patients at one-year follow-up. The treatment of osteoporotic vertebral compression fractures with balloon kyphoplasty is a safe, effective, and minimally invasive procedure that provides satisfactory clinical results. Xiao et al (2014) compared complications of percutaneous vertebroplasty (PVP) and BK for the treatment of osteoporotic vertebral compression fractures (OVCFs). Online databases were searched for studies comparing complications of PVP and BKP for OVCFs, the randomized controlled trials, clinical controlled trials and cohort studies that provided related data were identified. Demographic characteristics and complications related to procedures were extracted and analysed from all of the included studies. Nineteen studies encompassing 1,787 patients in total, of whom 887 received PVP and 900 received BK, met the inclusion criteria. For subsequent fractures, our meta-analysis detected no significant difference between the two procedures, both for adjacent fractures (p = 0.29) and non-adjacent fractures (p = 0.37). For cement extravasations, there was no significant difference between the two interventions if considering disc spaces extravasations only (p = 0.24), while considering total extravasations and paravertebral extravasations, the cement leakage rate in the PVP group was significantly higher than the BK group (total: p < 0.01; paravertebral: p < 0.01). Reviewers concluded the two procedures suffer from equal risk of subsequent spinal fractures; PVP has a significant higher cement leakage rate compared to BK, mainly caused by a higher paravertebral leakage, patients with extremely poor pulmonary function or unstable haemodynamic are better candidates for BK. Li et al (2014) retrospectively compared kyphoplasty (KP) and vertebroplasty (VP) in pain improvement, cement leakage incidence, and the cost of treatment of malignant VCF. The authors performed a retrospective study of clinical data for 80 patients with multiple spinal metastases, treated with KP in 42 cases and VP in 38. Visual analog scale (VAS) scores were collected pre-operatively, post-operatively, at 1 month, 6 months, and 1 year after treatment. Cement leakage was identified using fluoroscopy and CT scan. Total cost per patient was also collected. There was a significant difference between the pre- and post-operative VAS scores (7.4 ± 2.0 to 3.8 ± 1.6, P < in the KP group; 6.7 ± 2.4 to 3.7 ± 1.4, P < in the VP group), and was maintained at 1-year follow-up (3.2 ± 1.4 in the KP group, 3.1 ± 1.3 in the VP group). However, the difference in VAS score between these two groups was insignificant at baseline and every follow-up assessment post-operatively (P > 0.05). The incidence of cement leakage in the KP group was lower than that of the VP group (16.9% (14/83) vs 30.3% (23/76), P < 0.05). However, none of the patients developed any symptoms. The length of postoperative hospital stay in the VP group was shorter than that of the KP group ((2.4 ± 1.3) vs (5.3 ± 1.9) days, P < 0.05). Total hospital cost in the KP group was much higher than that of the VP group (RMB Yuan ± vs RMB Yuan ± 1 341, P < 0.01). The authors concluded VP and KP are both effective in providing pain relief for patients with cancer-related VCF. KP provides no greater degree of pain improvement. KP is associated with a lower rate of cement leakage compared with VP Kyphoplasty Aug 15 8

9 Hübschle et al (2013) analyzed reports on the 1 year results of patients after BK treatment in a prospective multicenter observational case series and included data on 625 cases with 819 treated vertebrae documented from March 2005 to May Outcome measures included surgeon-administered outcome instruments were primary intervention form for BK and the follow-up form; patient self-reported measures were EuroQol-5D questionnaire, North American Spine Society outcome instrument /Core Outcome Measures Index (including visual analog scale), and a comorbidity questionnaire. Outcome measures were back pain, medication, quality of life (QoL), cement extrusions, and new fractures within the first postoperative year. Data were recorded preoperatively and at 3 to 6-month and 1-year follow-ups. Wilcoxon signed-rank test was used for comparison of pre- with postoperative measurements. Multivariate logistic regression was used to identify factors with a significant influence on the outcome. Seventy percent of patients were women with mean age of 71 years (range, years); mean age of men was 65 years (range, years). Significant and clinically relevant reduction of back pain, improvement of QoL, and reduction of pain killer consumption was seen within the first postoperative year. Preoperative back pain decreased from 69.3 to 29.0 at 3 to 6- month and remained unchanged at 1-year follow-ups. Consequently, QoL improved from 0.23 to 0.71 and 0.75 at the same follow-up intervals. The overall vertebrabased cement extrusion rates with and without extrusions into intervertebral discs were 22.1% and 15.3%, respectively. Symptomatic cement extrusions with radiculopathy were five (0.8%). A new vertebral fracture within a year from the BK surgery was observed in 18.4% of the patients. The authors concluded the results of the largest observational study for BK so far are consistent with published randomized trials and systematic reviews. In this routine health care setting, BK is safe and effective in reducing pain, improving QoL, and lowering painkiller consumption and has an acceptable rate of cement extrusions. Postoperative outcome results show clear and significant clinical improvement at early follow-up that remain stable during the first postoperative year. Jseph et al (2013) reported that despite controversial outcomes of recent published trials, percutaneous cement augmentation remains widely used in managing painful vertebral compression fractures. We prospectively assessed patients with such fractures using an eleven-point visual analogue scale for pain and the Qualeffo 41 questionnaire for quality of life. Consecutive patients undergoing percutaneous cement augmentation for painful vertebral compression fractures were recruited. Patients were assessed pre-procedure by completing a visual analogue scale for pain, on a scale of 0 to 10. A Qualeffo 41 questionnaire was also completed. Patients were followed up at 1 week and 3 months. Fifty six patients were prospectively recruited (111 vertebroplasty and 5 kyphoplasty). Visual analogue scores dropped from 6.4 ± 2.3 pre-procedure to 4.0 ± 2.7 at 1 week (p < ) and 4.3 ± 2.7 (p < ) at 3 months. Three subgroups were identified; osteoporotic patients (n = 28), a second non-osteoporotic group (n = 20) who had acute fracture following fall and a third group with compression fractures secondary to metastatic disease (n = 8). At 3-month follow-up, patients with osteoporotic fractures had reduction in pain score from 6.3 ± 2.1 to 4.8 ± 2.7 (p = 0.02). Patients who had traumatic fractures experienced more significant pain relief, 6.4 ± 2.6 to 3.8 ± 2.7 (p = ) but patients with malignant fracture had most benefit, 6.0 ± 3.0 to 1.8 ± 0.8 (p = 0.01). Total Qualeffo scores improved from 63 ± 15 to 49 ± 22 (p < ). Within the domains of the Qualeffo questionnaire, most improvement was seen in pain and physical function. Median in-patient stay post procedure was one day. The authors concluded percutaneous cement augmentation is safe and efficacious in the management of painful VCF related to osteoporosis, trauma and cancer, achieving Kyphoplasty Aug 15 9

10 rapid and significant pain reduction and improvement in physical function as measured with a visual analogue scale and the Qualeffo 41 questionnaire. Spross et al (2014) reported the SWISSspine registry (SSR) was launched in 2005 to assess the safety and effectiveness of balloon kyphoplasty (BK). In the meantime, repeated reports on high rates of adjacent vertebral fractures (ASF) after BK of vertebral insufficiency fractures were published. The causes for ASF and their risk factors are still under debate. The current study was to report the incidence and potential risk factors of ASF within the SSR dataset. The SSR data points are collected perioperatively and during follow-ups, with surgeon- and patient-based information. All patients documented with a monosegmental osteoporotic vertebral insufficiency fracture between March 2005 and May 2012 were included in the study. The incidence of ASF, significant associations with co-variates (patient age, gender, fracture location, cement volume, preoperative segmental kyphosis, extent of kyphosis correction, and individual co-morbidities) and influence on quality of life (EQ-5D) and back pain (VAS) were analyzed. A total of 375 patients with a mean follow-up of 3.6 months was included. ASF were found in 9.9 % (n = 37) and occurred on average 2.8 months postoperatively. Preoperative segmental kyphosis >30 (p = 0.026), and rheumatoid arthritis (p = 0.038) and cardiovascular disease (p = 0.047) were significantly associated with ASF. Furthermore, patients with ASF had significantly higher back pain at the final follow-up (p = 0.001). No further significant associations between the studied co-variates and ASF were seen in the adjusted analysis. The authors concluded the findings suggest that patients with a preoperative segmental kyphosis >30 or patients with co-morbidities like rheumatoid arthritis and a cardiovascular disease are at high risk of ASF within 6 months after the index surgery. In case of an ASF event, back pain levels are significantly increased. Scientific Rationale Update August 2013 Van Meirhaeghe et al (2013) compared the efficacy and safety of balloon kyphoplasty (BK) to non-surgical management (NSM) over 24 months in patients with painful vertebral compression fractures (VCF) in a multicenter randomized controlled trial. Adults with 1-3 VCF were randomized within 3 months of pain to undergo bilateral BK (n = 149) or NSM (n = 151). Surgical parameters, subjective quality of life (QOL) assessments and objective functional (timed up and go [TUG]) and radiographic assessments were collected. Compared with NSM, the BK group had greater improvements in SF-36 physical component summary (PCS) scores at one month (5.4 points, 95%CI, ; p<0.0001) and when averaged across the 24-months (overall treatment effect 2.7 points, 95% CI, ; p<0.0001). The kyphoplasty group also had greater functionality by assessing TUG (overall treatment effect -2.5 seconds, 95% CI, -0.8 to -4.2; p = ). At 24 months, the change in index fracture kyphotic angulation was statistically significantly improved in the kyphoplasty group (average 3.1 of correction for kyphoplasty compared to 0.8 in the control, p = 0.003). Number of baseline prevalent fractures (p = 0.003) and treatment assignment (p = 0.004) are the most predictive variables for PCS improvement; however in BKP patients there may also be a link with kyphotic angulation. In BK, the highest quart for kyphotic angulation correction had higher PCS improvement (13.4 points) compared to the quart having lowest correction of angulation (7.40 points, p = for difference). The most common adverse events (AEs) temporally related to surgery (i.e., within 30-days) were back pain (20 BK, 11 NSM) new VCF (11 BK, 7 NSM), nausea/vomiting (12 BK, 4 NSM) and urinary tract infection (10 BK, 3 NSM). Several other AEs were possibly related to patient positioning in the operating room. Investigators concluded that compared with NSM, Kyphoplasty Aug 15 10

11 BK improves patient QOL and pain averaged over 24-months and results in better improvement of index vertebral body kyphotic angulation. Peri-operative complications may be reduced with more care in patient positioning. Korovessis et al (2013) compared the efficacy in sagittal vertebral height and wedge deformity restoration, polymethylmethacrylate cement leakage safety, and functional outcome of balloon kyphoplasty (BK) versus KIVA (a novel vertebral augmentation technique) implant for the augmentation of fresh osteoporotic vertebral body fractures in a prospective, parallel-group, controlled comparative randomized study. KIVA is a novel percutaneous uniportal vertebral augmentation device that is designed to restore the vertebral body and reduce polymethylmethacrylate leakage. From a total 190 patients with osteoporotic fractures who were initially enrolled in this prospective randomized study, 10 patients were excluded (5 met exclusion criteria, 5 with evidence of metastasis). This study examined 82 patients (69 ± 11 yr) with 133 fractures who received KIVA and 86 patients (72 ± 9 yr) with 122 fractures that were reinforced with BK. Anterior (anterior vertebral body height ratio [AVBHr]), midline (midline vertebral body height ratio [MVBHr]), and posterior (posterior vertebral body height ratio [PVBHr]) vertebral body height ratio and Gardner segmental vertebral wedge deformity were measured preoperatively to postoperatively. New fractures were recorded at the final observation. The baseline anthropometric and roentgenographic parameters did not differ between the 2 groups. Any cement leakage was examined on plain roentgenograms and computed tomographic scan. All patients were followed for an average of 14 months (range, mo) postoperatively. At the final observation, both KIVA and BK restored significantly AVBHr, PVBHr, and MVBHr. However, only KIVA device reduced significantly the Gardner angle (P = 0.002). Residual kyphosis of more than 5 was measured significantly more (P < 0.001) in the BK than in KIVA spines. KIVA showed significantly lower (0.03%, χ2, P 0.05) leakage) (paravertebral, intradiscal) rate per vertebra than BK (0.098%) in which because of intracanal leakage 2 patients developed acute paraplegia and were reoperated in emergency. New fracture rate was similar in both groups. Back pain scores (visual analogue scale), 36-Item Short Form Health Survey (Physical Function and Mental Health domains), and Oswestry Disability Index scores improved significantly in the patients of both groups. Investigators concluded both KIVA and BK restored in short-term similarly vertebral body height, but only KIVA restored vertebral body wedge deformity. KIVA was followed by significantly lower and harmless always extracanal leakage rate than BK. Longer observation is needed to show whether these radiological changes have any functional impact. Scientific Rationale Update December 2010 In March 2007, an American Association of Neurological Surgeons (AANS) press release identified the indications for patients to undergo kyphoplasty and vertebroplasty procedure, including the following criteria: Osteoporotic vertebral compression fracture (VCFs) in any area of the spine that have been present for more than two weeks, causing moderate to severe pain, and unresponsive to conservative therapy Painful metastases and multiple myelomas Painful vertebral hemangiomas (benign, malformed vascular tumors composed of newly formed blood vessels) Vertebral osteonecrosis (a condition resulting from poor blood supply to an area of bone, which causes bone death) Kyphoplasty Aug 15 11

12 Reinforcement of a pathologically weak vertebral body before a surgical stabilization procedure Patients with any of the following criteria should not undergo these procedures: A VCF that is completely healed or is responding effectively to conservative therapy A VCF that has been present for more than one year Greater than 80 to 90 percent collapse of the vertebral body Spinal curvature such as scoliosis or kyphosis that is due to causes other than osteoporosis Spinal stenosis or herniated discs with nerve or spinal cord compression and loss of neurological function not associated with a VCF Untreated coagulopathy (a disease or condition affecting the blood's ability to coagulate) Osteomyelitis (an inflammation of the bone and bone marrow, usually caused by bacterial infection) Discitis (nonbacterial inflammation of an intervertebral disc or disc space) Significant compromise of the spinal canal caused by impeding bone fragment or tumor A position statement for the performance of percutaneous vertebroplasty and kyphoplasty has been developed by a collaborative panel of 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. This position statement supports the use of percutaneous vertebroplasty and kyphoplasty and suggests these procedures are medically appropriate for the treatment of painful VCFs refractory to medical therapy when performed for the medical indications outlined in the published standards. A 2009 California Technology Assessment Forum (CTAF) on Balloon Kyphoplasty as a Treatment for Vertebral Compression Fractures concluded that balloon kyphoplasty with PMMA meets CTAF criteria 1-5 for safety, effectiveness and improvement in health outcomes for the treatment of recent (<3 month old) osteoporotic vertebral compression fractures confirmed by MRI. The CTAF noted further, balloon kyphoplasty does not meet CTAF criteria 3-5 for safety, effectiveness and improvement in health outcomes for the treatment of chronic (>3 month old) osteoporotic, traumatic, or pathologic vertebral compression fractures. Liu et al (2010) investigated the radiological and clinical outcomes of vertebroplasty and kyphoplasty in one hundred cases of VCF at the thoraco-lumbar junction. Individuals were randomly assigned into two groups: vertebroplasty or kyphoplasty (50 cases each.) Polymethylmethacrylate (PMMA) was used as the bone filler. Pain before and after treatment was assessed with visual analog scale (VAS) scores and vertebral body height and kyphotic wedge angle were measured from reconstructed computed tomography images. More PMMA was used in the kyphoplasty group than in the vertebroplasty group (5.56 +/ vs / ml, p < 0.001). Vertebral body height and kyphotic wedge angle of the T-L spine were also improved (p < 0.001). VAS pain scores did not differ significantly between the treatment groups. The duration of follow-up was 6 months. Two patients in the kyphoplasty group had an adjacent segment fracture. The investigators concluded in terms of clinical outcome there was little difference between the treatment groups. Kyphoplasty Aug 15 12

13 Yan et al (2010) also compared the therapeutic effect of percutaneous vertebroplasty (PVP) and percutaneous kyphoplasty (PKP) in the treatment of VCFs. A total of 244 patients with VCFs were treated by PVP or PKP and 192 had follow-up for at least 1 year. Clinical outcomes were determined by pain VAS and Short Form 36 Health Survey (SF-36). Preoperative and postoperative radiographic assessment included measurement of posterior and anterior vertebral body height (AH and PH), as well as the kyphotic angle by the Cobb method. A total of 192 cases had follow-up for at least 1 year and 52 cases lost. The average amount of PMMA cement introduced per vertebra was 3.4 ± 1.5 ml in PVP and 4.5 ± 0.8 ml in PKP (P < 0.05). All patients subjectively reported immediate relief of their typical fracture pain, and the mean VAS decreased significantly from presurgery to postsurgery during the 1-year of follow-up. The role physical, body pain and general health dimensionality values of SF-36 in PKP were higher than PVP (P < 0.05). The improvement on AH was ± 5.68% in PVP and ± 9.87% in PKP (P < 0.01); on PH was 2.25 ± 1.36% in PVP and 7.57 ± 2.49% in PKP (P < 0.01). The average improvement in the kyphotic angle after the procedure was 5.21 ± 2.33 in PVP and ± 5.18 in PKP (P < 0.01). The investigators concluded PVP and PKP have the ability of reducing pain in osteoporotic VCF patients. The correction of kyphotic deformity and restoration of the anterior vertebral body heights associated with osteoporotic VCFs was better in PKP. Movrin et al (2010) evaluated the adjacent level fracture risk after balloon kyphoplasty (BK) as compared with PVP and the possible dominant risk factor associated with new compression fractures. 73 consecutive patients with painful VCF s were enrolled in a prospective nonrandomized study. BK was performed in 46 patients (51 vertebral bodies) and VP in 27 patients (32 vertebral bodies). The first patient's visit was before the operative procedure, when clinical and radiographical examinations were done. The follow-up visits, considered in the analysis, were on the first day and after 1 year, postoperatively. In 1 year, 3 out of 46 patients (6.5%) treated with BK, and 2 out of 27 patients (7.4%) treated with VP sustained adjacent level fracture. More patients with a bone mineral density (BMD) higher or equal to 3.0 experienced a new fracture than those with a BMD less than 3.0.and the risk for adjacent level fractures decreased significantly when the postoperative kyphotic angle was less than 9 degrees compared with that of higher or equal to 9 degrees. The investigator concluded results indicate that BK and VP are methods with a low risk of adjacent level fractures. The most important factors for new VCFs after a percutaneous augmentation procedure are the degree of osteoporosis and altered biomechanics in the treated area of the spine due to resistant kyphosis. These results suggest that the adjacent vertebrae would fracture eventually, even without the procedure. BK and VP offer a comparable rate of pain relief. Kasperk et al (2010) pain, mobility and fracture incidence 3 years after kyphoplasty in 40 patients with painful osteoporotic vertebral fractures; 20 patients who were selected for kyphoplasty but chose not to undergo the procedure served as controls. All patients received pharmacologic antiosteoporosis treatment, pain medication, and physiotherapy. Pain (visual analog scale of 0-100), mobility (European Vertebral Osteoporosis Study questionnaire score of 0-100), and incident vertebral fractures were assessed at baseline, postprocedurally, and after 12 and 36 months. Pain score improved after kyphoplasty from 73.8 to 55.9 (immediately after kyphoplasty), 55.6 (12 months), and 54.0 (36 months). Pain score in the control group changed from 66.4 to 65.7 at 12 months and 64.0 at 36 months. The pain score of the kyphoplasty group was significantly improved versus controls after 36 months. Mobility score improved after kyphoplasty from 43.8 to 54.2 (immediately after Kyphoplasty Aug 15 13

14 kyphoplasty), 54.5 (12 months), and 54.8 (36 months;) and remained increased compared with controls (39.8 immediately after kyphoplasty, 44.3 at 12 months, and 43.6 at 36 months). The incidence of new vertebral fractures after kyphoplasty was significantly reduced versus controls after 3 years. The investigator concluded kyphoplasty reduces pain and improves mobility as long as 3 years after the procedure. The long-term risk of new vertebral fractures after kyphoplasty of chronically painful vertebral fractures is reduced versus controls. Röllinghoff et al (2009) performed a prospective study of 90 patients with fresh osteoporotic vertebral fractures who had been treated with vertebroplasty or kyphoplasty. Clinical analysis included Oswestry score and VAS index; the vertebral body height restoration (mean vertebral body height, kyphosis angle, anterior/posterior edge) was evaluated radiologically; furthermore, all occurring complications were recorded. The follow-up time was 1 year, 80 patients could be examined at follow-up; 8 patients had died of a tumor disease, lost to follow-up were 2.2%. Both procedures succeeded in significantly (p<0.001) increasing quality of life (Oswestry score) and reducing pain (VAS). Following vertebroplasty there were two cases of cement leakage into the spinal canal with consecutive paraparesis which disappeared completely after the cement had been surgically removed. Altogether, 11 adjacent level fractures were observed, 4 in the vertebroplasty and 7 in the kyphoplasty group. The investigator concluded were no differences between the groups with regard to quality of life and pain improvement, but the rate of serious complications was higher after vertebroplasty. Mean vertebral body height restoration at 1 year follow-up was significantly higher in the kyphoplasty group, however, future long-term studies will determine whether or not restoration of vertebral body height has an effect on the clinical result. Scientific Rationale Update November 2006 Vertebral compression fracture (VCF) is a common and debilitating problem that occurs in patients with osteoporosis and osteolytic tumors. Standard conservative management with bed rest, pain control, bracing, and strength training is often ineffective, and major reconstructive surgery is poorly tolerated by this frail patient population. The limitations of conventional treatments stimulated the development of minimally invasive, percutaneous vertebral augmentation techniques, including vertebroplasty and kyphoplasty, which have become established as safe and effective treatments for VCF. Kyphoplasty, a minimally invasive technique, has been developed to provide immediate pain relief, biomechanical stabilization, prevention of fracture progression, vertebral height restoration, and prevention or reversal of kyphosis to patients with osteoporotic vertebral compression fractures (VCF). Garfin et al (2006) conducted a prospective, multicenter interventional treatment study of balloon kyphoplasty to evaluate the safety and effectiveness of balloon kyphoplasty to treat symptomatic vertebral body compression fractures (VCFs) in a total of 155 elderly patients. Patients reported severe back pain (15/20 on visual analog scale) interfering with daily activities 90% of days per month before kyphoplasty. Physical functioning and quality of life were also markedly impaired. Statistically significant (P < 0.001) improvements occurred in all pain, functional, and mental health outcomes at the first follow-up after treatment and were maintained for 24 months. The authors concluded that elderly patients with symptomatic VCFs had rapid, significant, and sustained improvements in back pain, back function, and quality of life following balloon kyphoplasty. Kyphoplasty Aug 15 14

15 Hulme et al (2006) performed a systematic literature review to evaluate the safety and efficacy of kyphoplasty using the data presented in published clinical studies, with respect to patient pain relief, restoration of mobility and vertebral body height, complication rate, and incidence of new adjacent vertebral fractures. They state that current reviews provide an overview of the procedures but are not comprehensive and tend to rely heavily on personal experience. This article aimed to compile all available data and evaluate the clinical outcome of kyphoplasty. The methodological quality of included studies was evaluated, and data were collected targeting specific standard measurements. Where possible, a quantitative aggregation of the data was performed. They found that 92% of subjects had some pain relief with kyphoplasty. Vertebral height restoration was possible using kyphoplasty (average 6.6 degrees). Cement leaks occurred in only 9% of treated vertebrae for kyphoplasty. New fractures of adjacent vertebrae occurred at rates that are higher than the general osteoporotic population but approximately equivalent to the general osteoporotic population that had a previous vertebral fracture. It was their opinion that the problem with stating definitely that kyphoplasty is a safe and effective procedure is the lack of comparative, blinded, randomized clinical trials. They suggested that standardized evaluative methods should be adopted. Bouza et al (2006) evaluated the efficacy and safety of balloon kyphoplasty (BK) in the management of vertebral compression fractures (VCFs) based on a systematic review of the literature and meta-analysis of clinical studies assessing the efficacy and safety of BK in the treatment of VCFs. A total of 26 studies met the inclusion criteria. Although studies displayed considerable methodological limitations, the results of the clinical series indicate significant improvements in pain intensity, vertebral height, sagittal alignment, functional capacity, and quality of life. Compared with conventional medical management, BK afforded significant improvement in pain intensity and mobility. Likewise, a significant reduction was observed in vertebral collapse, kyphotic deformity, the development of new vertebral fractures, and hospital stay. Compared with vertebroplasty, the technique reduced the loss of height and the degree of kyphotic deformity, and afforded a significantly lower leakage rate. Regarding adverse effects, leakage affected 7% of all levels treated, while complications were recorded in 2% of the patients, and new vertebral fractures in 16%. The available evidence suggests that BK can be effective and safe in application to VCFs. However, existing studies contain substantial methodological limitations and relatively short follow-up periods. They conclude that better clinical research is required to determine the capacity of BK to avoid the functional and physiological sequelae of VCFs and to define the true role of the technique among the existing therapeutic options. Bohndorf et al (2006) state that, although kyphoplasty has become well established as an effective technique to treat painful vertebral body fractures, some questions remain unanswered and are the subject of controversial debate; for example, the results of several biomechanical studies are in part contradictory. Clinical data on subsequent fractures are also still inadequate, although the majority of studies show no elevated rate of subsequent fractures following treatment with cementoplasty, generally polymethylmethacrylate (PMMA), in comparison to the natural course in patients with osteoporotic fractures. Kyphoplasty has the advantage of being able to restore the vertebral body height or reduce the kyphosis angle without leading to different clinical outcomes in comparison to vertebroplasty. Biomechanical considerations on whether restoration of the vertebral body's normal shape could reduce the rate of subsequent fractures still need scientific substantiation. In their clinic, they feel that kyphoplasty seems to be indicated when the height of the Kyphoplasty Aug 15 15

16 anterior portion of the vertebral body is reduced by one-third compared to the norm or a kyphosis angle of more than degrees is present. The goals of therapy are restoring the shape and reducing the kyphosis angle. This can only succeed, however, in fractures that are not older than 3 weeks. In all other cases vertebroplasty is performed. Shedid et al (2006), however, asserted that early diagnosis and treatment of compression fractures with kyphoplasty allow restoration of normal anatomy as much as possible. Vertebral augmentations by kyphoplasty are efficacious treatments for osteoporotic compression fractures. Kyphoplasty minimizes the risk for cement leakage by compacting the cancellous bone to the periphery, sealing off the fracture clefts, and creating a cavity into which cement is poured. This technique may prevent propagation of further fractures by reducing the collapsed vertebral bodies toward its native height, normalizing the sagittal spinal alignment and the force transmission along the spine. Ledlie et al (2006) reported on a retrospective single-center consecutive case series of 117 patients (151 fractures) with two-year follow-up to examine kyphoplasty patients for long-lasting clinical and radiological outcomes, including effects on vertebral body shape. Pain scores, patient ability to ambulate independently and without difficulty, and need for prescription pain medications improved significantly after kyphoplasty and remained unchanged or improved at 2 years. Vertebral heights significantly increased at all postoperative intervals, with > or = 10% height increases in 84% of fractures. Asymptomatic cement extravasation occurred in 11.3% of fractures, and during the follow-up period additional fractures occurred in previously untreated levels at a rate of 4.5% per year. There were no kyphoplastyrelated complications. The researchers came to the conclusion that kyphoplasty markedly improves clinical outcome and results in significant vertebral height restoration and normalization of morphologic shape indices that remain stable for at least two years following treatment. At present, there are no scientific evidence-based data on the long-term efficacy of kyphoplasty as presented in randomized controlled trials (RCT). Nevertheless, the vast majority of nonrandomized, prospective and retrospective short-term observational and case-control studies comparing kyphoplasty to conservative management consistently show that patients receiving kyphoplasty have greater improvements in pain relief and functional status compared to patients on conservative treatment. A small number of studies have been recently published reporting continuation of symptom relief in the long term (up to 2 years). Scientific Rationale Update September 2005 During the last 15 years, percutaneous kyphoplasty has gained an increasing popularity in the treatment of osteoporotic fractures of the spine. The exponential increase in the use of kyphoplasty has up to now not been supported by scientific, evidence-based data. There exist no prospective randomized controlled trials that support the efficacy of the treatment, not even adequate controlled studies. Instead, one has to rely on prospective and retrospective uncontrolled short-term observational studies and case-control studies. These studies consistently indicate that the short-term results after this procedure in the treatment of osteoporotic vertebral fractures are favorable, regarding both pain relief and functional status. However, if a kyphoplasty produces a better outcome than conservative treatment, and if the long-term results are as favorable as the short-term results in the treatment of osteoporotic vertebral fractures, is currently unknown. Additional trials Kyphoplasty Aug 15 16

17 are required to establish conclusively the effectiveness of kyphoplasty as compared with conservative medical therapy and vertebroplasty. Long-term outcomes, including the fate of the injected material and the effect on adjacent vertebrae, have yet to be determined. This lack of objective data allows market forces and opinions to have a large influence on utilization and patient referral. Scientific Rationale Update April 2005 Kyphoplasty is a minimally invasive surgical technique for treating fractures of the spine that occur due to osteoporosis, usually in postmenopausal women. Generally, osteoporotic fractures of the spine result in a collapsing of the front portion of the vertebrae causing it to compact into a wedge shape, thus causing pain, a loss of height and a hunched-over appearance (called "dowager's hump" or "widow's hump".) Kyphoplasty uses a two-step process of inserting of a special balloon device into the compacted vertebrae to attempt to restore the vertebrae to a more normal shape. subsequently, a cement-like material (polymethylmethacrylate) is injected into the space created by the balloon to retain the correction. By restoring the vertebrae to a more normal state, alignment of the spine may be improved. Although complications of this procedure are relatively uncommon, they can be potentially very serious. The most commonly reported complication was cement leakage. In the largest published series the reported complication rate was 1.2%. This included one patient With epidural hematoma, one patient with partial paralysis, one patient with transient fever and hypoxia, and one patient with anterior cord syndrome. So far only reports on single cases or short-term results from case series exist regarding the success of this technique. As kyphoplasty is a new therapy, long-term results are not known, nor are the effects of the therapy on the surrounding vertebrae. As reported in the Spine journal on October 22, 2004, the rate of vertebral fractures after kyphoplasty is higher than would be expected if the index fractures had gone untreated. The increased fracture risk seems to be limited to a 2- month period following the procedure. Although the reason for this association is unclear, it may be because cement augmentation at one vertebral level places further stress on adjacent levels. It has not yet been verified which patients benefit in which way from this intervention and which risks and long-term effects have to be taken into consideration. Kyphoplasty is typically compared to vertebroplasty. No comparative evidence for balloon kyphoplasty versus medical therapy is currently available in the published medical literature, and makes it difficult to determine the placebo effect of this procedure. In general the studies are small and of low methodological quality. Many papers did not specifically describe the inclusion and exclusion criteria used to select study participants. In a number of papers the denominator used to report outcome measures was unclear. While papers reported on patients with both osteoporotic and multiple myeloma vertebral compression fractures, the majority of evidence published is in respect to patients with osteoporotic bone disease. Mean duration of symptoms also varied among the study populations. This may be an important factor, as individuals with early fractures may benefit more from balloon kyphoplasty. The majority of the studies had short-term follow-up. Only one study reported on outcomes at one year and this was in a subset of patients. It is difficult to gauge the experience of the surgeons undertaking balloon kyphoplasty, and the possible learning curve associated with this procedure. Most authors described their Kyphoplasty Aug 15 17

18 papers as phase I studies or reporting on their initial experience or preliminary results. There is a currently a randomized controlled trial underway comparing balloon kyphoplasty with medical treatment. Based on this analysis, our position on our commercial members remains unchanged. Scientific Rationale - Initial Percutaneous kyphoplasty is a variant of vertebroplasty, which involves the introduction of an inflatable balloon through an 11-gauge needle to re-expand a collapsed vertebral body back to its natural height before injection of polymethylmethacrylate using low pressure under fluoroscopy. Proponents state that this procedure has the potential advantages over vertebroplasty in that it uses low rather than high-pressure injections and it restores the height of the collapsed vertebral body, thus reducing deformity of the spine. It is usually performed on both sides of the vertebral body through each pedicle. While the kyphoplasty procedure is usually well-tolerated, serious neurological complications have been reported. The most common adverse event is nerve root pain usually caused when polymethylmethacrylate cement leaks into the intravertebral foramen. Also, when used in the treatment of osteoporotic vertebral compression fractures, the question of whether the procedure is followed by an increased risk of osteoporotic fractures in adjacent vertebrae remains unanswered. Review History October 16, 2003 March 2004 January 2005 April 2005 September, 2005 November 2006 March 2007 December 2010 September 2011 August 2012 August 2013 August 2014 August 2015 Medical Advisory Council initial Approval Revised New 2005 codes added Update Medicare-specific criteria added Update Policy unchanged Revised - procedure medically appropriate in commercial members when patient meets criteria Coding Updates Update no revision Update. Added Revised Medicare Table with link to LCD. No Revisions. Update. No revisions. Update no revisions. Code updates. Update no revisions Update no revisions. Code Updates This policy is based on the following evidence-based guidelines: 1. National Institute for Clinical Excellence (NICE). Balloon kyphoplasty. Understanding NICE guidance information for people considering the procedure, and for the public. November DVO-Guideline: Osteoporosis in Postmenopausal Women The Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) Percutaneous Kyphoplasty for Vertebral Fractures Caused by Osteoporosis and Malignancy. Volume 19, No. 12. December National Osteoporosis Foundation. Health professional's guide to rehabilitation of the patient with osteoporosis. Washington (DC): National Osteoporosis Foundation; Kyphoplasty Aug 15 18

19 5. American Medical Directors Association (AMDA). Osteoporosis. Columbia (MD) North American Spine Society. Percutaneous Vertebral Augmentation Arthritis Foundation. Bulletin on the Rheumatic Diseases. Clinical Efficacy of Vertebroplasty and Kyphoplasty. 8. Hayes Medical Technology Directory. Percutaneous Kyphoplasty. Feb Updated April 23, Update April Update March Jensen ME, Mcgraw JK, Cardella JF, Hirsch JA. 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 Jul;20(7 Suppl):S Available at: California Technology Assessment Forum. Balloon Kyphoplasty as a Treatment for Vertebral Compression Fractures. June 17, Available at: BlueCross BlueShield Association (BCBSA), Technology Evaluation Center (TEC). Percutaneous vertebroplasty or kyphoplasty for vertebral fractures caused by osteoporosis. TEC Assessment Program. Assessment Program. Volume 25, No. 9, June National Institute for Health and Clinical Excellence (NICE). Vertebral fractures vertebroplasty and kyphoplasty: final protocol. Updated February 28, London, UK: National Institute for Clinical Excellence; NICE Technology Appraisal Guideline No National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). NIH Osteoporosis and Related Bone Diseases National Resource Center. Osteoporosis Available at: American Academy of Orthopaedic Surgeons. The Treatment of Symptomatic Osteoporotic Spinal Compression Fractures. Sept Available at: References - Update August Bozkurt M, Kahilogullari G, Ozdemir M, et al. Comparative analysis of vertebroplasty and kyphoplasty for osteoporotic vertebral compression fractures. Asian Spine J Feb;8(1): Chen AT, Cohen DB, Skolasky RL. Impact of nonoperative treatment, vertebroplasty, and kyphoplasty on survival and morbidity after vertebral compression fracture in the medicare population. J Bone Joint Surg Am Oct 2;95(19): Civelek E, Cansever T, Yilmaz C, et al. The retrospective analysis of the effect of balloon kyphoplasty to the adjacent-segment fracture in 171 patients. J Spinal Disord Tech Apr;27(2): Druschel C, Schaser KD, Rohlmann A, et al. Prospective quantitative assessment of spinal range of motion before and after minimally invasive surgical treatment of vertebral body fractures. Arch Orthop Trauma Surg Jun Fang XT, Yu F, Fu SL, et al. Clinical outcomes of percutaneous kyphoplasty under local anesthesia for osteoporotic vertebral compression fractures. Zhonghua Yi Xue Za Zhi Sep 3;93(33): Kyphoplasty Aug 15 19

20 6. Hübschle L, Borgström F, Olafsson G, et al. Real-life results of balloon kyphoplasty for vertebral compression fractures from the SWISSspine registry. Spine J Dec Huang Z, Wan S, Ning L, Han S. Is Unilateral Kyphoplasty as Effective and Safe as Bilateral Kyphoplasties for Osteoporotic Vertebral Compression Fractures? A Meta-analysis. Clin Orthop Relat Res Jun Joseph RN, Swift AJ, Maliakal PJ. Single centre prospective study of the efficacy of percutaneous cement augmentation in the treatment of vertebral compression fractures. Br J Neurosurg Aug;27(4): Li Z, Ni C, Chen L, et al. Kyphoplasty versus vertebroplasty for the treatment of malignant vertebral compression fractures caused by metastases: a retrospective study. Chin Med J (Engl). 2014;127(8): Lin J, Zhang L, Yang HL. Unilateral versus bilateral balloon kyphoplasty for osteoporotic vertebral compression fractures. Pain Physician Sep- Oct;16(5): Maestretti G, Sutter P, Monnard E, et al. A prospective study of percutaneous balloon kyphoplasty with calcium phosphate cement in traumatic vertebral fractures: 10-year results. Eur Spine J Jun;23(6): Papanastassiou ID, Eleraky M, Murtagh R, et al. Comparison of Unilateral versus Bilateral Kyphoplasty in Multiple Myeloma Patients and the Importance of Preoperative Planning. Asian Spine J Jun;8(3): Spross C, Aghayev E, Kocher R, et al. Incidence and risk factors for early adjacent vertebral fractures after balloon kyphoplasty for osteoporotic fractures: analysis of the SWISSspine registry. Eur Spine J Jun;23(6): Stevenson M, Gomersall T, Lloyd Jones M, et al. Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for the treatment of osteoporotic vertebral fractures: a systematic review and cost-effectiveness analysis. Health Technol Assess Mar;18(17): Tomé-Bermejo F, Piñera AR, Duran-Álvarez C, et al. Identification of Risk Factors for the Occurrence of Cement Leakage During Percutaneous Vertebroplasty for Painful Osteoporotic or Malignant Vertebral Fracture. Spine (Phila Pa 1976) Feb Yu CW, Hsieh MK, Chen LH, et al. Percutaneous balloon kyphoplasty for the treatment of vertebral compression fractures. BMC Surg Jan 14;14: Xiao H, Yang J, Feng X, et al. Comparing complications of vertebroplasty and kyphoplasty for treating osteoporotic vertebral compression fractures: a metaanalysis of the randomized and non-randomized controlled studies. Eur J Orthop Surg Traumatol Jul 3. References Update August Anderson PA, Froyshteter AB, Tontz WL Jr. Meta-analysis of vertebral augmentation compared with conservative treatment for osteoporotic spinal fractures. J Bone Miner Res Feb;28(2): Asenjo JF, Rossel F. Vertebroplasty and kyphoplasty: new evidence adds heat to the debate. Curr Opin Anaesthesiol Oct;25(5): Bornemann R, Koch EM, Wollny M, Pflugmacher R. Treatment options for vertebral fractures an overview of different philosophies and techniques for vertebral augmentation. Eur J Orthop Surg Traumatol Jun Bornemann R, Otten LA, Koch EM, et al. Kiva VCF Treatment System - clinical study on the efficacy and patient safety of a new system for augmentation of vertebral compression fractures. Z Orthop Unfall Dec;150(6): Chitale A, Prasad S. An evidence-based analysis of vertebroplasty and kyphoplasty. J Neurosurg Sci Jun;57(2): Kyphoplasty Aug 15 20

21 6. Erdem E, Akdol S, Amole A, et al. Radiofrequency-targeted vertebral augmentation for the treatment of vertebral compression fractures as a result of multiple myeloma. Spine (Phila Pa 1976) Jul 1;38(15): Kolb JP, Kueny RA, Püschel K, et al. Does the cement stiffness affect fatigue fracture strength of vertebrae after cement augmentation in osteoporotic patients? Eur Spine J Jul;22(7): Korovessis P, Vardakastanis K, Repantis T, Vitsas V. Balloon kyphoplasty versus KIVA vertebral augmentation--comparison of 2 techniques for osteoporotic vertebral body fractures: a prospective randomized study. Spine (Phila Pa 1976) Feb 15;38(4): Panagiotis K, Konstantinos V, Thomas R, Vasilios V. Balloon Kyphoplasty versus KIVA vertebral Augmentation. Comparison of two Techniques for Osteoporotic Vertebral Body Fractures: A Prospective Randomized Study. Spine (Phila Pa 1976) Jul Saget M, Teyssédou S, Prébet R, et al. Acrylic Kyphoplasty in Recent Nonosteoporotic Fractures of the Thoracolumbar Junction. A Prospective Clinical and 3D radiologic Study of 54 Patients. J Spinal Disord Tech May Spiegl UJ, Hauck S, Merkel P, et al. Long-term results of kyphoplasty with additive dorsal instrumentation of incomplete burst fractures of the thoracolumbar spine in the elderly. Orthop Unfall Dec;150(6): Thaler M, Lechner R, Nogler M, et al. Surgical procedure and initial radiographic results of a new augmentation technique for vertebral compression fractures. Eur Spine J Jul;22(7): Van Meirhaeghe J, Bastian L, Boonen S, et al. A Randomized Trial of Balloon Kyphoplasty and Non-Surgical Management for Treating Acute Vertebral Compression Fractures: Vertebral Body Kyphosis Correction and Surgical Parameters. Spine (Phila Pa 1976) Mar Zou J, Mei X, Zhu X, et al. The long-term incidence of subsequent vertebral body fracture after vertebral augmentation therapy: a systemic review and meta-analysis. Pain Physician Jul-Aug;15(4):E References Update August American College of Radiology (ACR). ACR ASNR ASSR SIR SNIS Practice Guideline for the Performance of Vertebral Augmentation. Revised Bornemann R, Hanna M, Kabir K, et al. Continuing conservative care versus crossover to radiofrequency kyphoplasty: a comparative effectiveness study on the treatment of vertebral body fractures. Eur Spine J Epub ahead of print. January 11, Available at: 3. Grafe IA, Da Fonseca K, Hillmeier J, et al. Reduction of pain and fracture incidence after kyphoplasty: 1-year outcomes of a prospective controlled trial of patients with primary osteoporosis. Osteoporos Int. 16(12): References Update September 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): Rousing R, Lauritsen J, Thomsen K, et al. Percutaneous vertebroplasty as a treatment for osteoporotic vertebral fractures, a Health Technology Assessment. Copenhagen, Denmark: National Board of Health, Danish Centre for Health Technology Assessment; 2010;10(1). 3. Sheon RP, Rosen HN. Clinical manifestations and treatment of osteoporotic thoracolumbar vertebral compression fractures. UpToDate. May 4, Kyphoplasty Aug 15 21

22 References Update December Bouza C, López-Cuadrado T, Cediel P, et al. Balloon kyphoplasty in malignant spinal fractures: a systematic review and meta-analysis. BMC Palliat Care Sep 9;8: Chen L, Yang HL, Tang TS. Unilateral versus bilateral balloon kyphoplasty in the treatment of multi-vertebral osteoporotic compression fractures. Zhonghua Wai Ke Za Zhi Nov;47(21): Dong Y, Wang DY. Treatment of osteoporotic vertebral compression fractures by balloon kyphoplasty. Zhongguo Gu Shang Jun;23(6): Felder-Puig R, Piso B, Guba B, Gartlehner G. Kyphoplasty and vertebroplasty for the management of osteoporotic vertebral compression fractures: a systematic review. Orthopade Jul;38(7): Gan M, Yang H, Zhou F, et al. Kyphoplasty for the treatment of painful osteoporotic thoracolumbar burst fractures. Orthopedics Feb;33(2): Huber FX, McArthur N, Tanner M, et al. Kyphoplasty for patients with multiple myeloma is a safe surgical procedure: results from a large patient cohort. Clin Lymphoma Myeloma Oct;9(5): Jha RM, Yoo AJ, Hirsch AE, et al. Predictors of successful palliation of compression fractures with vertebral augmentation: single-center experience of 525 cases. J Vasc Interv Radiol Jun;20(6): Kasperk C, Grafe IA, Schmitt S, et al. Three-year outcomes after kyphoplasty in patients with osteoporosis with painful vertebral fractures. J Vasc Interv Radiol May;21(5): Kumar K, Nguyen R, Bishop S. A comparative analysis of the results of vertebroplasty and kyphoplasty in osteoporotic vertebral compression fractures. Neurosurgery Sep;67(3 Suppl Operative): Liu JT, Liao WJ, Tan WC, et al. Balloon kyphoplasty versus vertebroplasty for treatment of osteoporotic vertebral compression fracture: a prospective, comparative, and randomized clinical study. Osteoporos Int Feb;21(2): Lovi A, Teli M, Ortolina A, et al. Vertebroplasty and kyphoplasty: complementary techniques for the treatment of painful osteoporotic vertebral compression fractures. A prospective non-randomised study on 154 patients. Eur Spine J Jun;18 Suppl 1: McArthur N, Kasperk C, Baier M, et al kyphoplasties over 7 years: indications, techniques, and intraoperative complications. Orthopedics Feb;32(2): McGirt MJ, Parker SL, Wolinsky JP, et al. Vertebroplasty and kyphoplasty for the treatment of vertebral compression fractures: an evidenced-based review of the literature. Spine J Jun;9(6): Movrin I, Vengust R, Komadina R. Adjacent vertebral fractures after percutaneous vertebral augmentation of osteoporotic vertebral compression fracture: a comparison of balloon kyphoplasty and vertebroplasty. Arch Orthop Trauma Surg Sep;130(9): Röllinghoff M, Siewe J, Zarghooni K, et al. Effectiveness, security and height restoration on fresh compression fractures--a comparative prospective study of vertebroplasty and kyphoplasty. Minim Invasive Neurosurg Oct;52(5-6): Sandri A, Carbognin G, Regis D, et al. Combined radiofrequency and kyphoplasty in painful osteolytic metastases to vertebral bodies. Radiol Med Mar;115(2): Kyphoplasty Aug 15 22

23 17. Santiago FR, Abela AP, Alvarez LG, et al. Pain and functional outcome after vertebroplasty and kyphoplasty. A comparative study. Eur J Radiol Aug;75(2):e Schofer MD, Efe T, Timmesfeld N, et al. Comparison of kyphoplasty and vertebroplasty in the treatment of fresh vertebral compression fractures. Arch Orthop Trauma Surg Oct;129(10): Vcelák J, Tóth L, Slégl M, et al. Vertebroplasty and kyphoplasty--treatment of osteoporotic vertebral fractures. Acta Chir Orthop Traumatol Cech Feb;76(1): 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;373(9668): Yan D, Duan L, Li J, S, et al. Comparative study of percutaneous vertebroplasty and kyphoplasty in the treatment of osteoporotic vertebral compression fractures. Arch Orthop Trauma Surg Sep Yang T, Liu S, Lv X, Wu X. Balloon kyphoplasty for acute osteoporotic compression fractures. Interv Neuroradiol Mar;16(1): Zhao YL, Yang HL, Konrad J, et al. Kyphoplasty does not maintain all restored height postoperatively: a prospective, comparative study. Orthopedics Aug 11;33(8). References Update - November Shindle MK, Gardner MJ, Koob J, Bukata S, et al. Vertebral height restoration in osteoporotic compression fractures: kyphoplasty balloon tamp is superior to postural correction alone. Osteoporos Int Sep Deen HG. Current status of percutaneous vertebral augmentation techniques for vertebral compression fractures. Neurol Neurochir Pol July- August;40(4): Garfin SR, Buckley RA, Ledlie J. Balloon Kyphoplasty Outcomes Group. Balloon kyphoplasty for symptomatic vertebral body compression fractures results in rapid, significant, and sustained improvements in back pain, function, and quality of life for elderly patients. Spine Sep 1;31(19): Babb A, Carlson WO. Vertebral compression fractures: treatment and evaluation. S D Med Aug;59(8):343-5, Hulme PA, Krebs J, Ferguson SJ, Berlemann U. Vertebroplasty and kyphoplasty: a systematic review of 69 clinical studies. Spine Aug 1;31(17): Bohndorf K, Fessl R. Vertebroplasty and kyphoplasty in patients with osteoporotic fractures: secured knowledge and open questions. Radiologe Aug 2; 7. Burton AW, Mendel E. Vertebroplasty and kyphoplasty. Pain Physician Jul;6(3): Shedid D, Togawa D, Lieberman IH. Kyphoplasty: vertebral augmentation for compression fractures. Clin Geriatr Med Aug;22(3): Yeh HS, Berenson JR. Myeloma bone disease and treatment options. Eur J Cancer Jul;42(11): Epub 2006 Jun Pflugmacher R, Kandziora F, Schroeder RJ, et al. Percutaneous balloon kyphoplasty in the treatment of pathological vertebral body fracture and deformity in multiple myeloma: a one-year follow-up. Acta Radiol May;47(4): Watts NB. Osteoporotic vertebral fractures. Neurosurg Focus Apr 15;10(4):E12. Kyphoplasty Aug 15 23

24 12. Machinis TG, Fountas KN, Feltes CH, et al. Pain outcome and vertebral body height restoration in patients undergoing kyphoplasty. South Med J May;99(5): Noez S, Collignon L, Bex V, Sacre F, Crielaard JM. Kyphoplasty for the treatment of painful vertebral hemangioma. Rev Med Liege Feb;61(2): Hee HT. Percutaneous vertebroplasty: current concepts and local experience. Neurol India Dec;53(4): Bouza C, Lopez T, Magro A, Navalpotro L, Amate JM. Efficacy and safety of balloon kyphoplasty in the treatment of vertebral compression fractures: a systematic review. Eur Spine J Jul;15(7): Ledlie JT, Renfro MB. Kyphoplasty treatment of vertebral fractures: 2-year outcomes show sustained benefits. Spine Jan 1;31(1): Karlsson MK, Hasserius R, Gerdhem P, et al. Vertebroplasty and kyphoplasty: New treatment strategies for fractures in the osteoporotic spine. Acta Orthop Oct;76(5): Neviaser A, Toro-Arbelaez JB, Lane JM. Is kyphoplasty the standard of care for compression fractures in the spine, especially in the elderly? Am J Orthop Sep;34(9): Hacein-Bey L, Baisden JL, Lemke DM, Wong SJ, Ulmer JL, Cusick JF. Treating osteoporotic and neoplastic vertebral compression fractures with vertebroplasty and kyphoplasty. J Palliat Med Oct;8(5): References Update September Grafe IA, Da Fonseca K, Hillmeier J, et al. Reduction of pain and fracture incidence after kyphoplasty: 1-year outcomes of a prospective controlled trial of patients with primary osteoporosis. Osteoporos Int Aug 3; [Epub ahead of print] 2. Dixon RG, Mathis JM. Vertebroplasty and kyphoplasty: rapid pain relief for vertebral compression fractures. Curr Osteoporos Rep Dec;2(4): Lemke DM. Vertebroplasty and kyphoplasty for treatment of painful osteoporotic compression fractures. J Am Acad Nurse Pract Jul;17(7): No authors listed. Complications after vertebroplasty and kyphoplasty--cement emboli recognized on typical radiographic images. Rofo Jul;177(7):934. German. 5. Togawa D, Schlenk R, Lieberman IH. Cement emboli in vertebroplasty and kyphoplasty. AJR Am J Roentgenol Jul;185(1):277; author reply Boszczyk BM, Bierschneider M, Hauck S, et al. Transcostovertebral kyphoplasty of the mid and high thoracic spine. Eur Spine J Jun 21; [Epub ahead of print] 7. Karlsson MK, Hasserius R, Gerdhem P, et al. Treatment of osteoporotic vertebral compression. Explosive interest for vertebroplasty and kyphoplasty. Lakartidningen May 23-29;102(21):1644-6, Heaney RP. Advances in Therapy for Osteoporosis. Clin Med Res Apr;1(2): Grohs JG, Matzner M, Trieb K, Krepler P. Minimal invasive stabilization of osteoporotic vertebral fractures: a prospective nonrandomized comparison of vertebroplasty and balloon kyphoplasty. J Spinal Disord Tech Jun;18(3): Majd ME, Farley S, Holt RT. Preliminary outcomes and efficacy of the first 360 consecutive kyphoplasties for the treatment of painful osteoporotic vertebral compression fractures. Spine J May-Jun;5(3): Wong W, Mathis JM. Vertebroplasty and kyphoplasty: techniques for avoiding complications and pitfalls. Neurosurg Focus Mar 15;18(3):e Spivak JM, Johnson MG. Percutaneous treatment of vertebral body pathology. Kyphoplasty Aug 15 24

25 J Am Acad Orthop Surg Jan-Feb;13(1): Ohlin A, Johnell O. Vertebroplasty and kyphoplasty in the fractured osteoporotic spine. Clin Calcium Jan;14(1):65-9. References Update April Suresh SP, Whitehouse RW. Vertebroplasty and kyphoplasty. J Br Menopause Soc Mar;11(1): Feltes C, Fountas KN, Machinis T, et al. Immediate and early postoperative pain relief after kyphoplasty without significant restoration of vertebral body height in acute osteoporotic vertebral fractures. Neurosurg Focus Mar 15;18(3):e5. 3. Burton AW, Rhines LD, Mendel E. Vertebroplasty and kyphoplasty: a comprehensive review. Neurosurg Focus Mar 15;18(3):e1. 4. Kasperk C, Hillmeier J, Noldge G, et al. Treatment of painful vertebral fractures by kyphoplasty in patients with primary osteoporosis: a prospective nonrandomized controlled study. J Bone Miner Res Apr;20(4): Epub 2004 Dec Masala S, Lunardi P, Fiori R, et al. Vertebroplasty and kyphoplasty in the treatment of malignant vertebral fractures. J Chemother Nov;16 Suppl 5: No authors listed. Percutaneous kyphoplasty for vertebral fractures caused by osteoporosis and malignancy. Technol Eval Cent Asses Program Exec Summ Dec;19(12): Rodriguez JE, Rodriguez LE. Kyphoplasty for the management of osteoporotic and malignant fractures of the spine. Bol Asoc Med P R Jan-Feb;96(1): Fribourg D, Tang C, Sra P, Delamarter R, Bae H. Incidence of subsequent vertebral fracture after kyphoplasty. Spine Oct 15;29(20):2270-6; discussion Harrop JS, Prpa B, Reinhardt MK, Lieberman I. Primary and secondary osteoporosis' incidence of subsequent vertebral compression fractures after kyphoplasty. Spine Oct 1;29(19): Lin JT, Lane JM. Osteoporosis: a review. Clin Orthop Relat Res Aug;(425): Crandall D, Slaughter D, Hankins PJ, Moore C, Jerman J. Acute versus chronic vertebral compression fractures treated with kyphoplasty: early results. Spine J Jul-Aug;4(4): Rhyne A 3rd, Banit D, Laxer E, Odum S, Nussman D. Kyphoplasty: report of eighty-two thoracolumbar osteoporotic vertebral fractures. J Orthop Trauma May-Jun;18(5): Heini PF, Orler R. Kyphoplasty for treatment of osteoporotic vertebral fractures. Eur Spine J May;13(3): Epub 2004 Feb 25. References - Initial 1. Weill A, Chiras J, Simon JM et al. Spinal metastases: Indications for and results of percutaneous injection of acrylic surgical cement. Radiology 1996;1999: Cyteval C, Sarrabere MP, Roux JO et al. Acute osteoporotic vertebral collapse: Open study on percutaneous injection of acrylic surgical cement in 20 patients. AJR 1999;173: Lieberman IH, Dudeney S, Reinhardt K. Initial outcome and efficacy of "kyphoplasty" in the treatment of painful osteoporotic vertebral compression fractures. Spine 2001;26: Kyphoplasty Aug 15 25

26 4. Garfin SR, Yuan HA, Reiley MA. Kyphoplasty and vertebroplasty for the treatment of painful osteoporotic compression fractures. Spine 2001;26: Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member s benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. In some states, prior notice or website posting is required before an amendment is deemed effective. No Medical Advice. The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. No Authorization or Guarantee of Coverage. The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Member s Contract Controls Coverage Determinations. Statutory Notice to Members: The materials provided to you are guidelines used by this plan to authorize, modify, or deny care for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member s contract shall govern. The Policies do not replace or amend the Member s contract. Policy Limitation: Legal and Regulatory Mandates and Requirements Kyphoplasty Aug 15 26

27 The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Reconstructive Surgery CA Health and Safety Code requires health care service plans to cover reconstructive surgery. Reconstructive surgery means surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function or (2) To create a normal appearance, to the extent possible. Reconstructive surgery does not mean cosmetic surgery," which is surgery performed to alter or reshape normal structures of the body in order to improve appearance. Requests for reconstructive surgery may be denied, if the proposed procedure offers only a minimal improvement in the appearance of the enrollee, in accordance with the standard of care as practiced by physicians specializing in reconstructive surgery. Reconstructive Surgery after Mastectomy California Health and Safety Code requires treatment for breast cancer to cover prosthetic devices or reconstructive surgery to restore and achieve symmetry for the patient incident to a mastectomy. Coverage for prosthetic devices and reconstructive surgery shall be subject to the co-payment, or deductible and coinsurance conditions, that are applicable to the mastectomy and all other terms and conditions applicable to other benefits. "Mastectomy" means the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician and surgeon. Policy Limitations: Medicare and Medicaid Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid members shall not be construed to apply to any other Health Net plans and members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation. Kyphoplasty Aug 15 27