LCD L33569: Percutaneous Vertebral Augmentation (PVA) for Osteoporotic Vertebral Compression Fracture (VCF)

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 percutaneous kyphoplasty (PKP)) is covered in patients who qualify based on the following criteria :

• Inclusion criteria (ALL are required) :

• Acute ( 1-3,10,25,27

• Symptomatic ( ONE ):

• Hospitalized with severe pain (Numeric Rating Scale (NRS) or Visual Analog Scale (VAS) pain score ≥ 8) 4-7

• Non-hospitalized with moderate to severe pain (NRS or VAS ≥5) despite optimal non-surgical management (NSM) (10) ( ONE ):

• Worsening pain

• Stable to improved pain (but NRS or VAS still ≥5) (with ≥ 2 of the following):

• 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

• Continuum of care 10 (Both)

• All patients presenting with VCF should be referred for evaluation of BMD and osteoporosis education for subsequent treatment as indicated.

• All patients with VCF should be instructed to take part in an osteoporosis prevention/treatment program.

Exclusion criteria 2,5,8-10:

• Absolute contraindication:

• Current back pain is not primarily due to the identified acute or subacute VCF(s).

• Osteomyelitis, discitis, active systemic or surgical site infection

• Pregnancy

• 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

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 ( 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 The Vertebroplasty for Acute Painful Osteoporotic Fractures (VAPOUR) double-blinded RCT was designed to compare acute fracture ( 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).