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Proposed LCD Percutaneous Vertebral Augmentation (PVA) for Osteoporotic Vertebral Compression Fracture (VCF) (DL33569)


Contractor Information

Contractor Name Contract Type Contract Number Jurisdiction State(s)
National Government Services, Inc. MAC - Part A 06101 - MAC A J - 06 Illinois
National Government Services, Inc. MAC - Part B 06102 - MAC B J - 06 Illinois
 
National Government Services, Inc. MAC - Part A 06201 - MAC A J - 06 Minnesota
 
National Government Services, Inc. MAC - Part B 06202 - MAC B J - 06 Minnesota
 
National Government Services, Inc. MAC - Part A 06301 - MAC A J - 06 Wisconsin
 
National Government Services, Inc. MAC - Part B 06302 - MAC B J - 06 Wisconsin
 
National Government Services, Inc. A and B and HHH MAC 13101 - MAC A J - K Connecticut
 
National Government Services, Inc. A and B and HHH MAC 13102 - MAC B J - K Connecticut
 
National Government Services, Inc. A and B and HHH MAC 13201 - MAC A J - K New York - Entire State
 
National Government Services, Inc. A and B and HHH MAC 13202 - MAC B J - K New York - Downstate
 
National Government Services, Inc. A and B and HHH MAC 13282 - MAC B J - K New York - Upstate
National Government Services, Inc. A and B and HHH MAC 13292 - MAC B J - K New York - Queens
National Government Services, Inc. A and B and HHH MAC 14111 - MAC A J - K Maine
National Government Services, Inc. A and B and HHH MAC 14112 - MAC B J - K Maine
National Government Services, Inc. A and B and HHH MAC 14211 - MAC A J - K Massachusetts
National Government Services, Inc. A and B and HHH MAC 14212 - MAC B J - K Massachusetts
 
National Government Services, Inc. A and B and HHH MAC 14311 - MAC A J - K New Hampshire
 
National Government Services, Inc. A and B and HHH MAC 14312 - MAC B J - K New Hampshire
 
National Government Services, Inc. A and B and HHH MAC 14411 - MAC A J - K Rhode Island
 
National Government Services, Inc. A and B and HHH MAC 14412 - MAC B J - K Rhode Island
 
National Government Services, Inc. A and B and HHH MAC 14511 - MAC A J - K Vermont
 
National Government Services, Inc. A and B and HHH MAC 14512 - MAC B J - K Vermont

LCD Information

Document Information

Source LCD ID

L33569

Proposed LCD ID

DL33569

Original ICD-9 LCD ID

L26439

Proposed LCD Title

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

AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2018 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

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CMS National Coverage Policy

Language quoted from Centers for Medicare and Medicaid Services (CMS), National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the Local Coverage Determination (LCD) Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:

Title XVIII of the Social Security Act (SSA):

Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

CMS Publications:

CMS Publication 100-04; Medicare Claims Processing Manual, Chapter 13:

    80 Supervision and Interpretation (S & I) Codes and Interventional Radiology

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

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) osteoporotic VCF (T5 – L5) by recent (within 30 days) advanced imaging (bone marrow edema on MRI or bone-scan/SPECT/CT uptake) (1-3,10,25)
    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. Multidisciplinary team consensus (referring physician (e.g., rheumatologist, endocrinologist), treating physician (i.e., performing the PVA), radiologist, neurologist) (2)
  2. Exclusion criteria (2,5,8-10) (Can have NONE of the following):  

    1. Other cause of back pain
    2. Osteomyelitis, discitis or active systemic infection
    3. Neurological complications
    4. Significant spinal stenosis or compressive myelopathy resulting from retropulsion of fractured fragment.
    5. Unstable spinal fracture
    6. Severe uncorrectable coagulopathy
    7. Allergy to bone cement or opacification agents
    8. Fracture of the posterior column
    9. Greater than three vertebral fractures
    10. Pregnancy

*at least an acute component (e.g., acute on chronic)

**consider including pedicle periosteal infiltration (7)

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 a 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). 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).

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).


Proposed Process Information

Changes Fields Changes
N/A
Coverage Indications Limitations and/or Medical Necessity
Sources of Information and Basis for Decision
ICD-10 Codes that Support Medical Necessity

Associated Information

Documentation Requirements:

The patient's medical record must contain documentation that fully supports the medical necessity for services included within this LCD. (See "Indications and Limitations of Coverage.") This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.

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.

Open Meetings

Meeting Date Meeting State(s) Meeting Information
06/27/2019 Connecticut
Illinois
Maine
Massachusetts
Minnesota
New Hampshire
New York - Downstate
New York - Entire State
New York - Queens
New York - Upstate
Rhode Island
Vermont
Wisconsin
Illinois State Medical Society
20 N. Michigan Avenue Suite
700 Michigan Room
Chicago, IL. 60602

12:00-1:30 p.m. CT

Contractor Advisory Committee (CAC) Meetings

Meeting Date Meeting State(s) Meeting Information
03/20/2019 Connecticut
Illinois
Maine
Massachusetts
Minnesota
New Hampshire
New York - Downstate
New York - Entire State
New York - Queens
New York - Upstate
Rhode Island
Vermont
Wisconsin
Telephonic

MAC Meeting Information URL(s)

N/A

Proposed LCD Posting Date

06/06/2019

Comment Period Start Date

06/06/2019

Comment Period End Date

07/20/2019

Released to Final LCD Date

Please Note: This is not the LCD Effective Date.

N/A

Reason for Proposed LCD

    • Creation of Uniform LCDs With Other MAC Jurisdiction
    • Provider Education/Guidance

Proposed Contact

Virginia Muir
LCD Comments
P.O. Box 7108
Indianapolis, IN 46207-7108
PartBLCDComments@anthem.com


Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

N/A

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the policy, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

Refer to Coding Article A56178

N/A

CPT/HCPCS Codes

Group 1 Paragraph:
Refer to Coding Article A56178

Group 1 Codes:

Code Description
XX000 Not Applicable

ICD-10 Codes that Support Medical Necessity

Group 1 Paragraph:
Refer to Coding Article A56178

Group 1 Codes:

ICD-10 Code Description
XX000 Not Applicable

ICD-10 Codes that DO NOT Support Medical Necessity

N/A

Additional ICD-10 Information

N/A


Associated Documents

Attachments

N/A

Related Local Coverage Documents

Article(s)
A56178 - Billing and Coding: Percutaneous Vertebral Augmentation (PVA) for Osteoporotic Vertebral Compression Fracture (VCF)

Related National Coverage Documents

N/A


Keywords

N/A

Proposed LCD for Percutaneous Vertebral Augmentation (PVA) for Osteoporotic Vertebral Compression Fracture (VCF) (DL33569)
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