The decision for treatment should take into consideration the local and
general extent of the disease, the spinal level involved the severity of pain
experienced by the patient as well as his or her neurologic condition,
previous treatments and their outcomes, the general state of health, and life
expectancy.

Percutaneous Vertebroplasty or Vertebral Augmentation including cavity
creation is not to be considered a prophylactic procedure for osteoporosis of
the spine. It also should not be used for chronic back pain of long-standing
duration, even if associated with old compression fractures, unless pain is
localized to a specific chronic fracture and medical therapy has failed.

**Percutaneous vertebroplasty (PVP)** is a therapeutic, interventional
neurosurgical and radiological procedure that consists of the percutaneous
injection of a biomaterial, methyl methacrylate, into a lesion of a thoracic
or lumbar vertebral body. The procedure is utilized for pain relief and bone
strengthening of weakened vertebral bodies. The procedure is performed under
fluoroscopic guidance, although some prefer the use of computed tomography
(CT) with fluoroscopy for needle positioning and injection assessment. An
intraosseous venogram is sometimes performed before cement injection to
determine whether the needle is positioned within a direct venous anastomosis
to the central or epidural veins, to minimize extravasation into venous
structures. Conscious sedation with additional local anesthesia (1% lidocaine)
is generally utilized; however, patients who experience difficulties with
ventilation or are unable to tolerate prone position during the procedure may
require general anesthesia or deep sedation with airway and ventilation
support. The methyl methacrylate is injected into the vertebral body until
resistance is met or until cement reaches the posterior wall.

**Percutaneous Vertebral Augmentation** Percutaneous vertebral augmentation
(PVA) is a minimally invasive procedure for the treatment of compression
fractures of the vertebral body. The procedure includes the creation of a
cavity, which results in fracture reduction along with an attempt to restore
vertebral body height and alignment. Using imaging guidance x-rays, incisions
are made and a probe is placed into the vertebral space in the location of the
fracture. The collapsed vertebral body is drilled and a device, which
displaces, removes, or compacts the compressed area of the vertebrae, is used
to create a cavity prior to injection of the bone filler
(polymethylmethacrylate) (PMMA).

**Osteoporotic Conditions**  
Painful, debilitating, osteoporotic vertebral collapse/compression fractures,
that have not responded to non-surgical management (e.g. narcotic and/or non-
narcotic medication, physical therapy modalities) with or without methods of
immobility (e.g. bed rest, bracing).

Both PVP and PVA will be considered reasonable and necessary for osteoporotic
conditions when **ALL** of the following criteria are met:

  * Acute (< 6 weeks) or subacute (6-12 weeks) osteoporotic VCF (T1 - L5) based on symptom onset, and documented by recent (within 30 days) advanced imaging (bone marrow edema on MRI or bone-scan/SPECT/CT uptake)1-3, 10,25,27 **  and**
  * The beneficiary is symptomatic and is hospitalized with severe pain (Numeric Rating Scale [NRS] or visual Analog Scale [VAS] pain score  8)4-7  **or** is non-hospitalized with moderate to severe pain (NRS or VAS  5) despite optimal non-surgical management (NSM)8 with one of the following:

  *     * Worsening pain or
    * Stable to improved pain (but NRS or VAS  5) **when 2 or more of the following are present:**
      * Progression of vertebral body height loss
      * >25% vertebral body height reduction
      * Kyphotic deformity
      * Severe impact of VCF on daily functioning (Roland Morris Disability Questionnaire (RDQ) > 17)
      * Steroid-induced fractures
      * Reinforcement or stabilization of vertebral body prior to surgery
  * **Continuum of Care**  
All patients presenting with vertebral compression fractures (VCF) should be
referred for evaluation of bone mineral density and osteoporosis education for
subsequent treatment as indicated and instructed to take part in an
osteoporosis prevention/treatment program.8

**Malignant Vertebral Fractures**  
Osteolytic vertebral metastasis or myeloma with severe back pain related to a
destruction of the vertebral body, not involving the major part of the
cortical bone.

  1. Painful osteolytic metastasis
  2. Multiple myeloma with painful vertebral body involvement

**Traumatic Compression Fractures**  
Trauma, even minor falls, can produce a spine fracture. Many of these injuries
will never require surgery, but major fractures can result in serious long-
term problems unless treated promptly and properly. These severe injuries
frequently result in spinal instability, with a high risk of spinal cord
injury and pain, which can produce a spine fracture. WPS is reinstating
coverage of PVA as reasonable and necessary for the following traumatic
conditions.

  1. Stable and/or unstable burst fractures
  2. Wedge compression fractures
  3. Fracture-dislocations that occur following auto accidents or falls from height

**Limitations**  
Exclusion criteria for any patient considered for percutaneous vertebroplasty
or vertebral augmentation2,5,8-10:

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

**Osteoporotic Compression Fractures**  
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.8 Vertebral augmentation
provides a significant mortality benefit over nonsurgical management with a
low number needed to treat (NNT).43

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,11 the Fracture Reduction
Evaluation (FREE) trial,12,13 VERTOS II14 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 1 month and 1 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, 2 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).16,17 Ever since, there has been a lack of consensus on the
appropriate management of osteoporotic VCF, particularly the role of PVA.6,8
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.10 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 2 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.18 The authors conclude that
"kyphoplasty is a safe, effective, and durable procedure for treating patients
with painful VCF due to osteoporosis."

Hirsch, et al,43 is a claims-based analysis of national registries and
insurance datasets that indicates a significant mortality benefit for patients
with vertebral compression fractures who receive vertebral augmentation. Both
vertebroplasty and kyphoplasty modalities conferred a prominent mortality
benefit over nonsurgical management in the analysis of the US Medicare
registry, with a low number needed to treat. The calculations based on this
data base resulted in a low number needed to treat to save 1 life at 1 year
and at 5 years. This analysis of >2,000,000 patients with vertebral
compression fracture (VCF) revealed that only 15 patients need to be treated
to save 1 life at 1 year. This large dataset analysis suggests that vertebral
augmentation provides a significant mortality benefit over nonsurgical
management with a low number needed to treat (NNT).

**Malignant Compression Fractures**  
Rastogi, et al,19 is a peer reviewed article outlining the use of vertebral
augmentation for compression fractures caused by malignant disease.
Vertebroplasty or kyphoplasty is used as the principal palliative treatment
for painful compression fractures caused by malignant disease. Vertebral
augmentation provides rapid onset of pain relief and significant improvement
in function, quality of life, and vertebral stability.

Mansoorinasab, et al,20 is a peer reviewed article updating new methods to
determine the influence and the long-term consequences of percutaneous
vertebroplasty (PVP) in the treatment of painful vertebral fractures (VFs) in
metastatic patients of multifarious cancer of various sites on the spine. In
patients with vertebral metastasis, PVP is considered a successful method for
providing fast pain control, preventing most spinal cord compression, and
vertebral collapse. The results of the peer review state that PVP is safe,
feasible, reliable, effective, and useful procedure, a minimally invasive
treatment, and a significant tool for reduction of pain.

Health Quality Ontario performed a systematic literature search for studies on
vertebral augmentation of cancer-related vertebral compression fractures.21
The objective was to evaluate the effectiveness and safety of percutaneous
image-guided vertebroplasty and kyphoplasty for palliation of cancer-related
vertebral compression fractures. The data was compiled into categories of pain
intensity, analgesic use, pain-related disability and physical performance,
and health-related quality of life and patient satisfaction. In all of the
clinical studies researched, patients that had either vertebroplasty or
kyphoplasty, had high pain intensity levels (Visual Analogue Scale [VAS] 
7.0) pre-procedure which were reduced post-procedurally to mild to low pain
intensity levels (VAS < 4.0). Patients that were in the vertebroplasty group,
reported change in analgesics, either discontinuation or a dose reduction.
Patients from the kyphoplasty group infrequently reported analgesic use after
the procedure. Both groups of patients showed improvement with pain-related
disability and physical performance. The number of patients that required
orthopedic braces or wheelchairs was significantly reduced after the
procedures, as well as the number of patients that were bedridden or immobile.
The health-related quality of life for both groups of patients was improved
and remained improved at 1-year follow up. Both vertebroplasty and kyphoplasty
rapidly reduced pain intensity levels in cancer patients with spinal fractures
that were refractory to conservative care, usually bed rest and opioids. Both
of these procedures were associated with a low-risk safety profile.

Kircelli, et al,22 is a 12 month retrospective clinical study of 72 patients
(mean age of 78.938.77 years) with malignant vertebral compression fractures
who underwent balloon kyphoplasty to investigate clinical results. Vertebral
compression fractures due to bone metastases have limited treatment options
which include bone-strengthening with cement and supportive care. Patients
with metastatic vertebral compression fractures have reported reduced pain and
improved functionability and quality of life post percutaneous kyphoplasty. In
this study, the mean follow-up period was 18.913.71 months and mean bone
mineral density (BMD) values were 3.190.46. The kyphosis angle (KA),
vertebral height ratio (VHR), visual analog scale (VAS), and Oswerty
disability Index (ODI) were compared pre and post balloon kyphoplasty. The KA
decreased from 13.456.73 to 8.551.55, the VHR increased from 55.7512.82% to
74.2710.54, the VAS decreased from 8.110.83 to 2.551.16, and the ODI
decreased from 65.517.32 to 25.184.37 at the 12th postoperative month,
respectively (p<0.001). Post-procedural pain decreased significantly with a
mean cement volume of 4.61.3ml. The authors conclude that percutaneous
kyphoplasty is an effective method for reducing pain and disability in
patients with vertebral compression fractures due to metastases thereby
improving patient quality of life. Kyriakou, et al,23 is a review statement
from the International Myeloma Working Group (IMWG) on the use of cement
augmentation with percutaneous vertebroplasty and percutaneous kyphoplasty for
the treatment of vertebral compression fractures in multiple myeloma (MM). A
majority of MM patients develop spinal osteolysis, which can result in painful
vertebral compression fractures impacting quality of life and overall well-
being. Pain associated with vertebral compression fractures can be disabling
causing progressive deformities and resulting in significant chronic pain.
Treatment of malignant vertebral compression fractures with balloon
kyphoplasty (BKP) and percutaneous vertebroplasty (PV) is directed towards
rapid pain reduction, keeping the patient ambulatory with a normal level of
function in a relatively short period of time. The IMWG concludes the use of
cement augmentation is an effective way to stabilize the spinal column and
indicates balloon kyphoplasty (BKP) and percutaneous vertebroplasty (PV)
allows the majority of patients the ability to return to a near normal level
of function in a relatively short period of time by significantly reducing
back pain and decreasing the use of pain relief. Further, the consensus
statement from the IMWG states "multiple myeloma patients with significant
pain at a fracture site should be offered a balloon kyphoplasty or
percutaneous vertebroplasty procedure and the procedure should be performed
within 4-8 weeks unless there are medical contraindications".

**Multi-Jurisdictional Contractor Advisory Committee (CAC) Meeting**  
After review of highly graded evidence-based literature from the years 2004
-2018, the opinions amongst the CAC Advisory Committee (CAC) members and the
Subject Matter Experts (SME) varied on many of the proposed questions
regarding the strength of evidence for the treatment of osteoporotic vertebral
compression fractures with vertebroplasty and kyphoplasty. Multiple pieces of
literature were discussed to determine if osteoporotic vertebral compression
fractures receiving intervention treatment during the acute or subacute
timeframes were supported. Also discussed were if current literature and
quality of evidence addressed an acute, subacute or chronic fracture time
frame, and if highly graded evidence existed for supporting conservative, non-
interventional treatment. Topics within the discussion reviewed strength of
evidence regarding pain relief, overall opioid usage, quality of life,
mobility as well as mortality risk. CAC members and SMEs discussed the need
for further research trials to strengthen existing data as others felt the
benefits of these procedures have been proven in evidence-based literature
from trials that have already been performed.

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)24 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".28

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, 3 of 4 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 7 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".45 In a meta-analysis of 16 studies with
mortality as an outcome, 8 reported mortality benefit in VA, 7 reported no
benefit, and 1 reported mixed results.46 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 under treatment of the
overarching systemic disease, of which VCF is a symptom.47

**Malignant Compression Fractures**  
Percutaneous vertebroplasty (PV) and balloon kyphoplasty (BKP) procedures have
played a major role in the effective treatment of painful malignant
compression fractures refractory to conservative care. Vertebroplasty
procedures have been shown to provide rapid pain control and improved overall
quality of life. After careful review of the literature, vertebral
augmentation for malignant compression fractures is a reasonable and necessary
procedure providing rapid pain control with a decrease in the need for
analgesics, improvement in pain related disability and physical performance,
and improved vertebral stability. The literature reviewed supports the
clinical utility, the clinical validity and is relevant to the Medicare
population. Therefore, coverage of PV and BKP will be added for the treatment
of painful malignant compression fractures refractory to conservative care.

**Traumatic Compression Fractures**  
WPS received multiple comments primarily concerning the denial of claims when
PVA is performed for conditions related to trauma and malignancy. Our data
supported the findings stated by the commenters. Since WPS had previously
covered PVA for these conditions, we are reinstating coverage in this revision
of the LCD.