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

Jurisdiction: J5 MAC Part B. States: Iowa, Kansas, Missouri, Nebraska. Type: Active LCD

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, and 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 ( 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. Painful osteolytic metastasis 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. Stable and/or unstable burst fractures Wedge compression fractures Fracture-dislocations that occur following auto accidents or falls from height Limitations Exclusion criteria for any patient considered for percutaneous vertebroplasty or vertebral augmentation 2,5,8-10 : Absolute contraindication Current back pain is not primarily due to the identified acute VCF(s). Osteomyelitis, discitis, or active systemic infection Relative contraindication Greater than 3 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