LCD L34976: Percutaneous Vertebral Augmentation (PVA) for Vertebral Compression Fracture (VCF)

Compliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits.

History/Background and/or General Information

Percutaneous Vertebroplasty

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).

Covered Indications

Percutaneous vertebroplasty and percutaneous vertebral augmentation (PVA or Kyphoplasty) procedures will be considered medically reasonable and necessary for the following indications:

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

• Both PVP and PVA will be considered reasonable and necessary when ALL of the following criteria are met:

• Acute ( 18,28,42 osteoporotic VCF (T1– L5), based on symptom onset, and documented by advanced imaging demonstrating bone marrow edema on MRI or bone-scan/SPECT/CT uptake 1-3,8,26,43 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)

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.

Limitations

• Exclusion criteria 2,5,8-10,28,31

• Absolute contraindication

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

• Osteomyelitis, discitis or active systemic infection

• Pregnancy

• Active surgical site infection

• 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

Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.

Percutaneous Vertebroplasty (PVP) offers many benefits in the treatment of osteoporotic and malignant compression fractures. The aim of treating these fractures is to restore mobility, reduce pain and minimize the incidence of new fractures. 1,3,4 However, the benefits of PVP do not come without risk of complications as documented in the literature. Due to the risk of complications, guidelines have been established by several specialty panels. These specialty panel guidelines include relative and absolute contraindications to surgical management of compression fractures. 2,8,9,31 Additionally, the 2017 Cardiovascular and Interventional Radiologic Society of Europe (CIRSE) guideline 2 indicates complication rates for osteoporotic PVP is between 2.2 – 3.9% and at 2 suggest complications can be minimized by not injecting cement in its liquid phase, limiting the number of treated levels to not more than five, correct positioning of the needle tip, and taking extra precaution when treating highly vascular lesions.

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. Vertebral compression fractures (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). 8 Medicare claims data shows an 85% 10 year mortality following a VCF diagnosis. 10 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 non-surgical management (NSM) (anti-osteoporosis therapy, analgesics, limited activity/bed rest, back brace, physical therapy) to PVA, PVP and Percutaneous kyphoplasty (PKP). A PVP involves the percutaneous injection of bone cement under image guidance into the VCF. A PKP adds balloon tamponade within the fractured vertebral body to create a low pressure cavity prior to cement injection. Both treatments aim to immobilize the fracture, reduce pain, and improve alignment.