Local Coverage Determination (LCD)

Percutaneous Vertebral Augmentation (PVA) for Osteoporotic Vertebral Compression Fracture (VCF)

L33569

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LCD Information

Document Information

LCD ID
L33569
LCD Title
Percutaneous Vertebral Augmentation (PVA) for Osteoporotic Vertebral Compression Fracture (VCF)
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL33569
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 12/01/2020
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
10/15/2020
Notice Period End Date
11/30/2020
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CMS Transmittal No. 423, Publication 100-04, Medicare Claims Processing Manual, Change Request #3632, January 6, 2005. Update of the Hospital Outpatient Prospective Payment, includes Kyphoplasty.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Provisions in this LCD and related coding article only address Vertebral Augmentation for Osteoporotic Vertebral Compression Fracture (VCF). Coverage will remain available for medically necessary procedures for other conditions not included in this LCD.

PVA (percutaneous vertebroplasty (PVP) or kyphoplasty (PKP)) is covered in patients with BOTH the following:

  1. Inclusion criteria (ALL are required):
    1. Acute (< 6 weeks) or subacute (6-12 weeks) osteoporotic VCF (T1 – L5), based on symptom onset, and documented by advanced imaging (bone marrow edema on MRI or bone-scan/SPECT/CT uptake) (1-3,10,25,27)
    2. Symptomatic (ONE):
      1. Hospitalized with severe pain (Numeric Rating Scale (NRS) or Visual Analog Scale (VAS) pain score ≥ 8) (4-7)
      2. Non-hospitalized with moderate to severe pain (NRS or VAS ≥5) despite optimal non-surgical management (NSM) (10) (ONE):
        1. Worsening pain
        2. Stable to improved pain (but NRS or VAS still ≥5) (with ≥ 2 of the following):
          1. Progression of vertebral body height loss
          2. > 25% vertebral body height reduction
          3. Kyphotic deformity
          4. Severe impact of VCF on daily functioning (Roland Morris Disability Questionnaire (RDQ) >17
    3. Continuum of care (10) (Both) 
      1. All patients presenting with VCF should be referred for evaluation of BMD and osteoporosis education for subsequent treatment as indicated.
      2. All patients with VCF should be instructed to take part in an osteoporosis prevention/treatment program.
  2. Exclusion criteria (2,5,8-10) (Can have NONE of the following):  

    1. Absolute contraindication
      1. Current back pain is not primarily due to the identified acute or subacute VCF(s).
      2. Osteomyelitis, discitis, active systemic or surgical site infection
      3. Pregnancy
    2. Relative contraindication
      1. Greater than three vertebral fractures per procedure
      2. Allergy to bone cement or opacification agents
      3. Uncorrected coagulopathy
      4. Spinal instability
      5. Myelopathy from the fracture
      6. Neurologic deficit
      7. Neural impingement
      8. Fracture retropulsion/canal compromise

 

Summary of Evidence

Osteoporosis (and low bone mass) affects 50 percent of people over 50 years of age, or over 50 million people in the United States. Its primary impact, fractures (also called fragility or low-trauma fractures), occurs secondary to normal activity (e.g., bending, coughing, lifting, fall from a standing height), and eventually occurs in 50% of women and 20% of men. VCFs constitute one-quarter of osteoporotic fractures (6), often at the midthoracic (T7-T8) and thoracolumbar junction (T12-L1). They may cause significant acute and chronic pain, leading to complications of impaired mobility comparable to a hip fracture (pneumonia, loss of bone and muscle mass, incidental falls, deep venous thrombosis, depression, and isolation) (10). Medicare claims data shows an 85% 10 year mortality following a VCF diagnosis (11). Under-diagnosis and under-treatment may exacerbate morbidity and mortality (10).

Treatment options for symptomatic osteoporotic VCF range from NSM (anti-osteoporosis therapy, analgesics, limited activity/bed rest, back brace, physical therapy) to PVA (PVP and PKP). PVP involves the percutaneous injection of bone cement under image guidance into the VCF. PKP adds balloon tamponade within the fractured vertebral body to create a low pressure cavity prior to cement injection. Both treatments aimed to immobilize the fracture, reduce pain, and improve alignment.

Successful small European series introduced PVP into the United States in 1993; by 2007 encouraging preliminary observational data led to medical society endorsement and clinical acceptance in painful osteoporotic VCFs refractory to medical management. Subsequent early open-label randomized controlled trials (RCTs), including the Vertebroplasty for Painful Chronic Osteoporotic Vertebral Fractures (VERTOS) trial (21), the Fracture Reduction Evaluation (FREE) trial (22, 23), VERTOS II (14), and others, found a benefit of vertebral augmentation over non-surgical management.

VERTOS II was a multicenter RCT that compared PVP and NSM of acute (< 6 weeks) osteoporotic VCF in patients with moderate to severe pain (VAS ≥ 5) (14). Among 202 patients, the primary endpoint of pain relief at one month and one year was greater after PVP (-5.2/-5.7) than after NSM (-2.7/-3.7) (p < 0.001). Secondary outcomes, including RDQ and Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO), were similarly improved. The main limitation in the VERTOS II trial was the lack of blinding. Subsequent analysis of the medical cohort showed that 60% achieved sufficient (VAS ≤ 3) pain relief, most within 3 months (15). The authors acknowledged that despite the VERTOS II results, “clinicians still do not know how to best treat their patients,” but conclude that, pending further RCTs, PVP may be justified in patients with insufficient pain relief after 3 months of conservative treatment (15).

The lack of blinding made the early open-label RCTs, vulnerable to placebo effect. However, in 2009, two high profile, methodologically controversial (e.g., non-rigorous patient selection) double-blinded, RCTs found no benefit of PVP over a “sham” procedure (pedicle periosteal bupivacaine injection) (12,13). Ever since, there has been a lack of consensus on the appropriate management of osteoporotic VCF, particularly the role of PVA (6,10). Medicare claims data shows that among over 2 million VCF patients, PVA was performed in 20% in 2005, peaked at 24% in 2007-2008, and declined to 14% in 2014, a 42% decrease (11). Lower PVA utilization was associated with a 4% increase in propensity-adjusted mortality risk (p < 0.001). A secondary analysis gave a number needed to treat (NNT) at one year to save a life of 22.8 and 14.8 for vertebroplasty and kyphoplasty, respectively (26). Both studies noted the potential for selection bias despite propensity scoring. Subsequent major RCTs, described below, have attempted to address the perceived shortcomings of these two negative studies (primarily more stringent selection criteria and choice of control).

The Vertebroplasty for Acute Painful Osteoporotic Fractures (VAPOUR) double-blinded RCT was designed to compare acute fracture (< 6 weeks) PVP with a sham procedure (subcutaneous, not periosteal, infiltration) for patients with severe pain (NRS ≥ 7) (5). Among 120 randomized patients, the primary endpoint (NRS score < 4 by 14 days) was achieved in 44% and 21% of PVP and sham patients, respectively (p = 0.011), and durable to 6 months. Mean height loss at 6 months was 36% greater in the control group (63% vs. 27%). Hospital inpatients constituted 57% of study patients; among this group, median length of stay was reduced by 5.5 days in the PVP group. In addition to a focus on the acute, severely painful VCF, this study also concentrated on delivering greater cement volumes than prior studies. The authors conclude that PVP is superior to true placebo control of severe pain in VCFs of less than 6 weeks.

VERTOS IV used the same inclusion criteria as VERTOS II, but was a double-blinded comparison of PVP with a sham procedure (pedicle periosteal infiltration) (7). Among the 180 randomized patients, although the reduction in VAS score was clinically (> 1.5 points) and statistically significant up to 12 months in both groups (5.00 at 12 months in the PVP group vs. 4.75 in the sham group), reductions in VAS scores did not differ between groups (p = 0.48). The authors conclude, “the results suggest that periosteal infiltration alone in the early phase provides enough pain relief with no need for additional cementation.” They recommend the “pragmatic approach” of first use of “periosteal infiltration during natural healing” and “cementation only in a selected subgroup of patients with insufficient pain relief after this early phase.” They also highlight a subgroup that may warrant earlier PVP per the VAPOUR trial (hospital inpatients with more comorbidity and severe pain).

The 2018 multicenter, prospective, uncontrolled, EVOLVE study of 354 Medicare-age patients with acute or subacute (≤ 4 mo.) painful (NRS ≥ 7) VCF (all but 8 osteoporotic), found statistical improvement in NRS, Oswestry Disability Index (ODI), Short Form-36 Questionnaire Physical Component Summary (SF-36v2 PCS), and EuroQol-5-Domain (EQ-SD) out to 12 months (24). The authors conclude that “kyphoplasty is a safe, effective, and durable procedure for treating patients with painful VCF due to osteoporosis.”

Analysis of Evidence (Rationale for Determination)

Whether or when to use PVA for osteoporotic VCF has been very controversial since publication of the two negative 2009 RCTs. At the time, some national organizations withdrew (Australia Medical Services Advisory Committee) (6) or severely curbed (American Academy of Orthopaedic Surgeons) (16) endorsement. Others continued recommending PVA in select patients. The National Institute for Health and Care Excellence (NICE) recommends PVA in patients “who have severe ongoing pain after a recent, unhealed vertebral fracture despite optimal pain management and in whom the pain has been confirmed to be at the level of the fracture by physical examination and imaging” (4). In a 2014 consensus statement, the Society of Interventional Radiology (SIR), American Association of Neurological Surgeons (AANS), Congress of Neurological Surgeons (CNS), American College of Radiology (ACR), American Society of Neuroradiology (ASNR), American Society of Spin Radiology (ASSR), Canadian Interventional Radiology Association (CIRA), and the Society of NeuroInterventional Surgery (SNIS) considered PVA a proven medically appropriate therapy for treatment of painful VCFs refractory to brief (24 hrs.) nonoperative medical therapy (1). The 2017 Cardiovascular and Interventional Radiologic Society of Europe (CIRSE) guideline notes that while the evidence for PVP has been conflicting, based on recent data “it seems clear that PVP offers significant pain reduction in patients with acute VCFs after short (<3 wks.) failed medical therapy (2).

A 2018 Cochrane review of 21 trials of PVA for osteoporotic VCF “does not support a role for vertebroplasty for treating acute or subacute osteoporotic vertebral fractures in routine practice (17),” though its methodology has been criticized (25). A 2019 systematic review and meta-analysis by the American Society for Bone and Mineral Research (ASBMR) Task Force concluded: “Vertebroplasty does not work to relieve pain from the fracture, and kyphoplasty should generally only be done in the context of a placebo-controlled clinical trial” (20). Based on the uncertainty of benefit, citing both the recent Cochrane analysis and the VERTOS IV results, UpToDate recommends reserving PVA “for patients with incapacitating pain from acute and subacute VCFs who are unable to taper parenteral opioids or transition to oral opioids within seven days of admission or have intolerable side effects from opioid therapy” (8).

The benefit of PVA is supported by the significantly higher 5-year mortality risk for VCF in Medicare patients after a decline in utilization (11). In a recent systematic review of evidence-based guidelines for the management of osteoporotic VCF, three of four guidelines recommended PVA (19). In 2018, a multispecialty expert panel (orthopedic and neurosurgeons, interventional [neuro] radiologists and pain specialists), endorsed vertebral augmentation for select patients, in a clinical care pathway (developed using the RAND/UCLA Appropriateness Method), based on seven variables (pain duration and evolution, acute fracture by advanced imaging, kyphotic deformity, degree and progression of vertebral height loss, and impact on daily functioning) (10). Whether subgroups of patients might benefit more from vertebroplasty or kyphoplasty, requires further study (6). A review of the 14 published RCTs that examined the role of VA in osteoporotic VCF concluded: “While the RCT data are conflicting, there are patients with acute fractures causing significant pain and disability who can derive benefit with respect to improvement in pain outcomes, reduction in narcotic usage and reduced length of hospital stay” (27). In a meta-analysis of 16 studies with mortality as an outcome, eight reported mortality benefit in VA, seven reported no benefit, and one reported mixed results (28). The analysis found that VA provided a 22% mortality benefit over NSM at 10 years. However, the authors note the potential for “a strong selection bias in the selection of healthier patients for VA that was not captured by the analysis.” They conclude that VA “remains a controversial treatment” and “should be offered in carefully selected patients.”

In summary, the premise of weight-bearing fracture immobilization, to limit pain and deformity, has prima facie validity on first principles. Superimposed is the recent trend toward immediate, focused, surgical immobilization, and away from prolonged, general immobilization (e.g., casting, bracing, bedrest) and prolonged systemic pain management (e.g., opioid analgesics), particularly in the elderly. The preponderance of evidence (studies, national and society guidelines, systematic reviews, multispecialty panel clinical care pathway, and Medicare claims data) favors consideration of early PVA in select patients (moderate to severe and disabling pain due to acute osteoporotic VCF confirmed by physical examination and advanced imaging findings). However, in addition to timely fracture treatment, also warranted is increased emphasis on ensuring the continuum of care, and preventing medical undertreatment of the overarching systemic disease, of which VCF is a symptom (29).

General Information

Associated Information
N/A
Sources of Information
N/A
Bibliography
  1. Barr JD, Jensen ME, Hirsch JA, et al. Position statement on percutaneous vertebral augmentation: a consensus statement developed by the Society of Interventional Radiology (SIR), American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS), American College of Radiology (ACR), American Society of Neuroradiology (ASNR), American Society of Spine Radiology (ASSR), Canadian Interventional Radiology Association (CIRA), and the Society of NeuroInterventional Surgery (SNIS). J Vasc Interv Radiol. 2014;25(2):171-181.
  2. Tsoumakidou G, Too CW, Koch G, et al. CIRSE Guidelines on Percutaneous Vertebral Augmentation. Cardiovasc Intervent Radiol. 2017;40(3):331-342.
  3. McConnell CT, Jr., Wippold FJ, 2nd, Ray CE, Jr., et al. ACR appropriateness criteria management of vertebral compression fractures. J Am Coll Radiol. 2014;11(8):757-763.
  4. NICE 2013 Vertebral Augmentation Guidelines. https://www.nice.org.uk/guidance/ta279/resources/percutaneous- vertebroplasty-and-percutaneous-balloon-kyphoplasty- for- treating-osteoporotic-vertebral-compression-fractures-pdf-82600620856261.
  5. Clark W, Bird P, Gonski P, et al. Safety and efficacy of vertebroplasty for acute painful osteoporotic fractures (VAPOUR): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet. 2016;388(10052):1408-1416.
  6. Chandra RV, Maingard J, Asadi H, et al. Vertebroplasty and Kyphoplasty for Osteoporotic Vertebral Fractures: What Are the Latest Data? AJNR Am J Neuroradiol. 2018;39(5):798-806.
  7. Firanescu CE, de Vries J, Lodder P, et al. Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV): randomised sham controlled clinical trial. BMJ. 2018;361:k1551.
  8. UpToDate- Osteoporotic thoracolumbar vertebral compression fractures: Clinical manifestations and treatment. 2018; https://www.uptodate.com/contents/osteoporotic-thoracolumbar-vertebral-compression-fractures-clinical-manifestations-and-treatment?   search=vertebroplasty&source=search_result&selectedTitle=1~19&usage _type=default&display_rank=1%23H17476846#H1565673.
  9. Chandra RV, Meyers PM, Hirsch JA, et al. Vertebral augmentation: report of the Standards and Guidelines Committee of the Society of NeuroInterventional Surgery. J Neurointerv Surg. 2014;6(1):7-15.
  10. Hirsch JA, Beall DP, Chambers MR, et al. Management of vertebral fragility fractures: A clinical care pathway developed by a multispecialty panel using the RAND/UCLA Appropriateness Method. Spine J. 2018.
  11. Ong KL, Beall DP, Frohbergh M, Lau E, Hirsch JA. Were VCF patients at higher risk of mortality following the 2009 publication of the vertebroplasty "sham" trials? Osteoporos Int. 2018;29(2):375-383.
  12. Buchbinder R, Osborne RH, Ebeling PR, et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. 2009;361(6):557-568.
  13. Kallmes DF, Comstock BA, Heagerty PJ, et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med. 2009;361(6):569-579.
  14. Klazen CA, Lohle PN, de Vries J, et al. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet. 2010;376(9746):1085-1092.
  15. Venmans A, Klazen CA, Lohle PN, Mali WP, van Rooij WJ. Natural history of pain in patients with conservatively treated osteoporotic vertebral compression fractures: results from VERTOS II. AJNR Am J Neuroradiol. 2012;33(3):519-521.
  16. McGuire R. AAOS Clinical Practice Guideline: the Treatment of Symptomatic Osteoporotic Spinal Compression Fractures. J Am Acad Orthop Surg. 2011;19(3):183-184.
  17. Buchbinder R, Johnston RV, Rischin KJ, et al. Percutaneous vertebroplasty for osteoporotic vertebral compression fracture. Cochrane Database Syst Rev. 2018;4:CD006349.
  18. Anselmetti GC, Bernard J, Blattert T, et al. Criteria for the appropriate treatment of osteoporotic vertebral compression fractures. Pain Physician. 2013;16(5):E519-530.
  19. Parreira PCS, Maher CG, Megale RZ, March L, Ferreira ML. An overview of clinical guidelines for the management of vertebral compression fracture: a systematic review. Spine J. 2017;17(12):1932-1938.
  20. Ebeling PR, Akesson K, Bauer DC, et al. The Efficacy and Safety of Vertebral Augmentation: A Second ASBMR Task Force Report. J Bone Miner Res. 2019;34(1):3-21.
  21. Voormolen MH, Mali WP, Lohle PN, et al. Percutaneous vertebroplasty compared with optimal pain medication treatment: short-term clinical outcome of patients with subacute or chronic painful osteoporotic vertebral compression fractures. The VERTOS study. AJNR Am J Neuroradiol. 2007;28(3):555-560.
  22. 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. 2009;373(9668):1016-1024.
  23. Boonen S, Van Meirhaeghe J, Bastian L, et al. Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2-year results from a randomized trial. J Bone Miner Res. 2011;26(7):1627-1637.
  24. Beall DP, Chambers MR, Thomas S, et al. Prospective and Multicenter Evaluation of Outcomes for Quality of Life and Activities of Daily Living for Balloon Kyphoplasty in the Treatment of Vertebral Compression Fractures: The EVOLVE Trial. Neurosurgery.  2018.
  25. Clark W, Bird P, Diamond T, Gonski P, Gebski V. Cochrane vertebroplasty review misrepresented evidence for vertebroplasty with early intervention in severely affected patients. BMJ Evid Based Med. 2019.
  26. Hirsch JA, Chandra RV, Carter NS, Beall D, Frohbergh M, Ong K. Number Needed to Treat with Vertebral Augmentation to Save a Life. AJNR Am J Neuroradiol. 2019
  27. De Leacy R, Chandra RV, Barr JD, et al. The evidentiary basis of vertebral augmentation: a 2019 update. J Neurointerv Surg. 2020
  28. Hinde K, Maingard J, Hirsch JA, Phan K, Asadi H, Chandra RV. Mortality Outcomes of Vertebral Augmentation (Vertebroplasty and/or Balloon Kyphoplasty) for Osteoporotic Vertebral Compression Fractures: A Systematic Review and Meta-Analysis. 2020:191294.
  29. Conley RB, Adib G, Adler RA, et al. Secondary Fracture Prevention: Consensus Clinical Recommendations from a Multistakeholder Coalition. J Bone Miner Res. 2020;35(1):36-52.

Revision History Information

Revision History DateRevision History NumberRevision History ExplanationReasons for Change
12/01/2020 R9

The LCD and Billing and Coding Article were returned for comment from June 4 - July 18, 2020. Changes were made to Inclusion and Exclusion criteria in the Indications section, and Sources were added to the Bibliography.

  • Provider Education/Guidance
12/01/2019 R8

This clarification has been added to the Indications section of the LCD:

Provisions in this LCD and related coding article only address Vertebral Augmentation for Osteoporotic Vertebral Compression Fracture (VCF). Coverage will remain available for medically necessary procedures for other conditions not included in this LCD.

  • Provider Education/Guidance
12/01/2019 R7

The LCD has been revised to address Percutaneous Vertebral Augmentation (PVA) only for Osteoporotic Vertebral Compression Fracture (VCF). Specific inclusion and exclusion criteria have been added to Indications and Limitation of Coverage.

Consistent with Change Request 10901, all coding information, National coverage provisions, and Associated Information (Documentation Requirements, Utilization Guidelines) have been removed from the LCD and placed in the related Billing and coding Article, A56178

  • Provider Education/Guidance
  • Creation of Uniform LCDs With Other MAC Jurisdiction
10/01/2015 R6 The note for Group 2 covered ICD-10 codes has been revised to remove the reference to “pathologic fracture of vertebrae” from the coding requirement.

ICD -10 codes M85.88 and M85.89 have been added to Group 3 diagnoses, and “osteopenic” has been added to Indications where osteoporotic compression fracture was listed.

Some explanatory provisions have been moved from Indications and Limitations to the Abstract section of the LCD. The assistant at surgery designation information has been removed.
  • Provider Education/Guidance
  • Request for Coverage by a Practitioner (Part B)
10/01/2015 R5 Effective for dates of service on or after 10/01/2015, ICD-10 code groups were revised to remove the dual diagnosis requirement for ICD-10 codes that include the fracture and underlying condition required to support medical necessity. Published 11/12/2015.
  • Provider Education/Guidance
  • Request for Coverage by a Practitioner (Part B)
10/01/2015 R4 08/20/2015 - For the following Revenue Codes the description changed:
0321 descriptor was changed
  • Provider Education/Guidance
10/01/2015 R3 ICD-10 codes were revised to add M48.51XD, M48.51XG, M48.51XS, M48.52XD, M48.52XG, M48.52XS, M48.53XD, M48.53XG, M48.53XS, M48.54XD, M48.54XG, M48.54XS, M48.55XD, M48.55XG, M48.55XS,
M48.56XD, M48.56XG, M48.56XS, M48.57XD, M48.57XG, M48.57XS, M48.58XD, M48.58XG, M48.58XS, M80.08XD, M80.08XG, M80.08XK, M80.08XP, M80.08XS, M80.88XD, M80.88XG, M80.88XK, M80.88XP, M80.88XS, M84.58XD, M84.58XG, M84.58XK, M84.58XP, M84.58XS, M84.68XD, M84.68XG, M84.68XK, M84.68XP and M84.68XS to Group 1 covered codes.
  • Provider Education/Guidance
10/01/2015 R2 ICD-10 codes D49.2, M81.0, M81.8, M87.00, M87.30, M87.80, M87.9, M89.9, M90.50, and M94.9 were removed from Group 2 covered ICD-10 codes. ICD-10 codes M87.08, M87.38, and M87.88 were added to Group 2 covered ICD-10 codes.
  • Provider Education/Guidance
10/01/2015 R1 LCD updated to include HCPCS changes effective 01/01/2015.
  • Other

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Keywords

  • Compression fracture
  • Vertebral fracture
  • Fracture spine

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