Percutaneous Balloon Kyphoplasty and Mechanical Vertebral Augmentation

Medical Policy Percutaneous Balloon Kyphoplasty and Mechanical Vertebral Augmentation

Table of Contents  Policy: Commercial  Coding Information  Information Pertaining to All Policies  Policy: Medicare  Description  References  Authorization Information  Policy History  Endnotes

Policy Number: 485 BCBSA Reference Number: 6.01.38

Related Policies  Percutaneous Vertebroplasty and Sacroplasty, #484

Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity Percutaneous balloon kyphoplasty may be MEDICALLY NECESSARY for the treatment of:  Symptomatic osteoporotic vertebral fractures that have failed to respond to conservative treatment (e.g., analgesics, physical therapy, and rest) for at least 6 weeks  Severe pain due to osteolytic lesions of the spine related to multiple myeloma or metastatic malignancies.

Percutaneous balloon kyphoplasty is INVESTIGATIONAL for all other indications, including use in acute vertebral fractures due to osteoporosis or trauma.

Percutaneous mechanical vertebral augmentation using any other device, including but not limited to Kiva and vertebral body stenting, is INVESTIGATIONAL.

Medicare HMO BlueSM and Medicare PPO BlueSM Members Indications: Radiographic studies to identify the fracture, estimate the duration of the fracture, define the fracture anatomy, and assess for posterior vertebral body wall deficiency should be part of preoperative planning for vertebroplasty or vertebral augmentation surgery. Lateral radiographs are essential for planning the trajectory of any percutaneous procedure. MRI and bone scan have proven to be useful in determining the acuity of a vertebral compression fracture.

A pathologic fracture is defined as "one due to weakening of the bone structure by pathologic processes, such as neoplasia, osteomalacia, osteomyelitis, and other disease." They are also called "secondary fractures and spontaneous fractures" (Dorland's Illustrated Medical Dictionary 2000; 29th edition). Vertebral compression fractures due to osteoporosis are considered pathologic fractures. A "recent"

1 compression fracture is defined as one which demonstrates uptake on a bone scan or exhibits increased intensity on fluid-sensitive MRI sequences.

The principal indications for percutaneous vertebroplasty include:  An osteoporotic compression fracture of the lumbar or thoracic vertebrae with persistent debilitating pain that has not responded to accepted standard medical treatment generally within six (6) weeks to three months;  Osteolytic metastasis with severe back pain related to a destruction of the vertebral body;  Multiple myeloma with severe back pain related to a destruction of the vertebral body;  Painful and/or aggressive vertebral hemangiomas (or eosinophilic granulomas of the spine);  Painful vertebral fracture associated with osteonecrosis (Kummell Disease); and  Reinforcement, or stabilization, of vertebral body prior to surgery.  The principal indications for percutaneous vertebral augmentation include:  A "recent" osteoporotic compression fracture of the lumbar or thoracic vertebrae with persistent debilitating pain that has not responded to accepted standard medical treatment; and/or  Osteolytic vertebral collapse secondary to multiple myeloma or osteolytic metastatic disease causing persisting or progressive pain.

Limitations: Neither percutaneous vertebroplasty, nor percutaneous vertebral augmentation, are to be considered prophylactic procedures for osteoporosis of the spine. Neither percutaneous vertebroplasty, nor percutaneous vertebral augmentation should 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.

The decision for treatment should be multidisciplinary and consider such factors as the extent of disease, the underlying etiology, the spinal level involved, the severity of the pain, the nature of any neurologic dysfunction, the outcome of any previous non-invasive treatment attempts, and the general state of the patient’s health.

Absolute contraindications to both percutaneous vertebroplasty and vertebral augmentation procedures include:  Any existing uncorrected coagulopathy or anticoagulation therapy;  A known allergy to any materials used in the procedure such as the contrast media or bone cement;  Ongoing local or systemic infection;  Retropulsed bone fragments resulting in spinal canal compromise and myopathy; and  Spinal canal compromise secondary to tumor resulting in myelopathy.

Relative contraindications to percutaneous vertebroplasty include:  Significant vertebral collapse (i.e., vertebra reduced to less than one-third [l/3] of its original height);  Neurologic symptoms related to the compression of the vertebrae;  Radiculopathy in excess of vertebral pain caused by a compressive syndrome unrelated to vertebral collapse;  Asymptomatic retropulsion of a fracture fragment causing significant spinal canal compromise;  Asymptomatic tumor extension into the epidural space; and/or  Extensive vertebral destruction (extreme caution must be used in these patients during cement injection to prevent new or further neurologic compression that might result from leakage of the acrylic polymer into the epidural space).

Relative contraindications to percutaneous vertebral augmentation include:  Painful benign neoplasms;  Fractures caused by high-velocity injury; or  Other causes of disabling back pain not due to acute fracture.

2 Local Coverage Determination (LCD): Vertebroplasty and Vertebral Augmentation (Percutaneous) (L26439) http://cms.gov/medicare-coverage-database/details/lcd- details.aspx?LCDId=26439&ContrId=292&ver=58&ContrVer=1&Date=&DocID=L26439&SearchType=Ad vanced&bc=KAAAAAgAIAAAAA%3d%3d&

Prior Authorization Information Pre-service approval is required for all inpatient services for all products. See below for situations where prior authorization may be required or may not be required for outpatient services. Yes indicates that prior authorization is required. No indicates that prior authorization is not required. Outpatient Commercial Managed Care (HMO and POS) Yes Commercial PPO and Indemnity Yes Medicare HMO BlueSM Yes Medicare PPO BlueSM Yes

CPT Codes / HCPCS Codes / ICD-9 Codes The following codes are included below for informational purposes. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member. A draft of future ICD-10 Coding related to this document, as it might look today, is included below for your reference Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

CPT Codes CPT codes: Code Description 22523 Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device, one vertebral body, unilateral or bilateral cannulation (e.g., kyphoplasty); thoracic 22524 Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device, one vertebral body, unilateral or bilateral cannulation (e.g., kyphoplasty); lumbar 22525 Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device, one vertebral body, unilateral or bilateral cannulation (e.g., kyphoplasty); each additional thoracic or lumbar vertebral body (list separately in addition to code for primary procedure) 72291 Radiological supervision and interpretation, percutaneous vertebroplasty or vertebral augmentation including cavity creation, per vertebral body; under fluoroscopic guidance 72292 Radiological supervision and interpretation, percutaneous vertebroplasty or vertebral augmentation including cavity creation, per vertebral body; under CT guidance

ICD-9 Diagnosis Codes ICD-9-CM diagnosis codes: Code Description 170.2 Malignant neoplasm of vertebral column, excluding sacrum and coccyx 198.5 Secondary malignant neoplasm of bone and bone marrow 203.00 Multiple myeloma, without mention of having achieved remission 203.01 Multiple myeloma, in remission

3 203.02 Multiple myeloma, in relapse 338.3 Neoplasm related pain (acute) (chronic) 733.13 Pathologic fracture of vertebrae

ICD-9 Procedure Codes ICD-9-CM procedure codes: Code Description 81.66 Percutaneous vertebral augmentation

ICD-10 Diagnosis Codes ICD-10-CM Diagnosis codes: Code Description C41.2 Malignant neoplasm of vertebral column C79.51 Secondary malignant neoplasm of bone C79.52 Secondary malignant neoplasm of bone marrow C90.00 Multiple myeloma not having achieved remission C90.01 Multiple myeloma in remission C90.02 Multiple myeloma in relapse G89.3 Neoplasm related pain (acute) (chronic) Collapsed vertebra, not elsewhere classified, site unspecified, initial encounter for M48.50xA fracture Collapsed vertebra, not elsewhere classified, site unspecified, subsequent encounter M48.50xD for fracture with routine healing Collapsed vertebra, not elsewhere classified, site unspecified, subsequent encounter M48.50xG for fracture with delayed healing M48.50xS Collapsed vertebra, not elsewhere classified, site unspecified, sequela of fracture Collapsed vertebra, not elsewhere classified, occipito-atlanto-axial region, initial M48.51xA encounter for fracture Collapsed vertebra, not elsewhere classified, occipito-atlanto-axial region, subsequent M48.51xD encounter for fracture with routine healing Collapsed vertebra, not elsewhere classified, occipito-atlanto-axial region, subsequent M48.51xG encounter for fracture with delayed healing Collapsed vertebra, not elsewhere classified, occipito-atlanto-axial region, sequela of M48.51xS fracture Collapsed vertebra, not elsewhere classified, cervical region, initial encounter for M48.52xA fracture Collapsed vertebra, not elsewhere classified, cervical region, subsequent encounter for M48.52xD fracture with routine healing Collapsed vertebra, not elsewhere classified, cervical region, subsequent encounter for M48.52xG fracture with delayed healing M48.52xS Collapsed vertebra, not elsewhere classified, cervical region, sequela of fracture Collapsed vertebra, not elsewhere classified, cervicothoracic region, initial encounter M48.53xA for fracture Collapsed vertebra, not elsewhere classified, cervicothoracic region, subsequent M48.53xD encounter for fracture with routine healing Collapsed vertebra, not elsewhere classified, cervicothoracic region, subsequent M48.53xG encounter for fracture with delayed healing M48.53xS Collapsed vertebra, not elsewhere classified, cervicothoracic region, sequela of fracture Collapsed vertebra, not elsewhere classified, thoracic region, initial encounter for M48.54xA fracture M48.54xD Collapsed vertebra, not elsewhere classified, thoracic region, subsequent encounter for

4 fracture with routine healing Collapsed vertebra, not elsewhere classified, thoracic region, subsequent encounter for M48.54xG fracture with delayed healing M48.54xS Collapsed vertebra, not elsewhere classified, thoracic region, sequela of fracture Collapsed vertebra, not elsewhere classified, thoracolumbar region, initial encounter for M48.55xA fracture Collapsed vertebra, not elsewhere classified, thoracolumbar region, subsequent M48.55xD encounter for fracture with routine healing Collapsed vertebra, not elsewhere classified, thoracolumbar region, subsequent M48.55xG encounter for fracture with delayed healing M48.55xS Collapsed vertebra, not elsewhere classified, thoracolumbar region, sequela of fracture Collapsed vertebra, not elsewhere classified, lumbar region, initial encounter for M48.56xA fracture Collapsed vertebra, not elsewhere classified, lumbar region, subsequent encounter for M48.56xD fracture with routine healing Collapsed vertebra, not elsewhere classified, lumbar region, subsequent encounter for M48.56xG fracture with delayed healing M48.56xS Collapsed vertebra, not elsewhere classified, lumbar region, sequela of fracture Collapsed vertebra, not elsewhere classified, lumbosacral region, initial encounter for M48.57xA fracture Collapsed vertebra, not elsewhere classified, lumbosacral region, subsequent M48.57xD encounter for fracture with routine healing Collapsed vertebra, not elsewhere classified, lumbosacral region, subsequent M48.57xG encounter for fracture with delayed healing M48.57xS Collapsed vertebra, not elsewhere classified, lumbosacral region, sequela of fracture Collapsed vertebra, not elsewhere classified, sacral and sacrococcygeal region, initial M48.58xA encounter for fracture Collapsed vertebra, not elsewhere classified, sacral and sacrococcygeal region, M48.58xD subsequent encounter for fracture with routine healing Collapsed vertebra, not elsewhere classified, sacral and sacrococcygeal region, M48.58xG subsequent encounter for fracture with delayed healing Collapsed vertebra, not elsewhere classified, sacral and sacrococcygeal region, M48.58xS sequela of fracture Age-related osteoporosis with current pathological fracture, vertebra(e), initial M80.08xA encounter for fracture Age-related osteoporosis with current pathological fracture, vertebra(e), subsequent M80.08xD encounter for fracture with routine healing Age-related osteoporosis with current pathological fracture, vertebra(e), subsequent M80.08xG encounter for fracture with delayed healing Age-related osteoporosis with current pathological fracture, vertebra(e), subsequent M80.08xK encounter for fracture with nonunion Age-related osteoporosis with current pathological fracture, vertebra(e), subsequent M80.08xP encounter for fracture with malunion M80.08xS Age-related osteoporosis with current pathological fracture, vertebra(e), sequela Other osteoporosis with current pathological fracture, vertebra(e), initial encounter for M80.88xA fracture Other osteoporosis with current pathological fracture, vertebra(e), subsequent M80.88xD encounter for fracture with routine healing Other osteoporosis with current pathological fracture, vertebra(e), subsequent M80.88xG encounter for fracture with delayed healing Other osteoporosis with current pathological fracture, vertebra(e), subsequent M80.88xK encounter for fracture with nonunion Other osteoporosis with current pathological fracture, vertebra(e), subsequent M80.88xP encounter for fracture with malunion

5 M80.88xS Other osteoporosis with current pathological fracture, vertebra(e), sequela M84.48xA Pathological fracture, other site, initial encounter for fracture M84.48xD Pathological fracture, other site, subsequent encounter for fracture with routine healing M84.48xG Pathological fracture, other site, subsequent encounter for fracture with delayed healing M84.48xK Pathological fracture, other site, subsequent encounter for fracture with nonunion M84.48xP Pathological fracture, other site, subsequent encounter for fracture with malunion M84.48xS Pathological fracture, other site, sequela Pathological fracture in neoplastic disease, other specified site, initial encounter for M84.58xA fracture Pathological fracture in neoplastic disease, other specified site, subsequent encounter M84.58xD for fracture with routine healing Pathological fracture in neoplastic disease, other specified site, subsequent encounter M84.58xG for fracture with delayed healing Pathological fracture in neoplastic disease, other specified site, subsequent encounter M84.58xK for fracture with nonunion Pathological fracture in neoplastic disease, other specified site, subsequent encounter M84.58xP for fracture with malunion M84.58xS Pathological fracture in neoplastic disease, other specified site, sequela M84.68xA Pathological fracture in other disease, other site, initial encounter for fracture Pathological fracture in other disease, other site, subsequent encounter for fracture with M84.68xD routine healing Pathological fracture in other disease, other site, subsequent encounter for fracture with M84.68xG delayed healing Pathological fracture in other disease, other site, subsequent encounter for fracture with M84.68xK nonunion Pathological fracture in other disease, other site, subsequent encounter for fracture with M84.68xP malunion M84.68xS Pathological fracture in other disease, other site, sequela

ICD-10 Procedure Codes ICD-10-PCS procedure codes: Code Description 0PU33JZ Supplement Cervical Vertebra with Synthetic Substitute, Percutaneous Approach Supplement Cervical Vertebra with Synthetic Substitute, Percutaneous Endoscopic 0PU34JZ Approach 0PU43JZ Supplement Thoracic Vertebra with Synthetic Substitute, Percutaneous Approach Supplement Thoracic Vertebra with Synthetic Substitute, Percutaneous Endoscopic 0PU44JZ Approach 0QU03JZ Supplement Lumbar Vertebra with Synthetic Substitute, Percutaneous Approach Supplement Lumbar Vertebra with Synthetic Substitute, Percutaneous Endoscopic 0QU04JZ Approach 0QU13JZ Supplement Sacrum with Synthetic Substitute, Percutaneous Approach

Description Percutaneous balloon kyphoplasty and mechanical vertebral augmentation with Kiva® are interventional techniques involving the fluoroscopically guided injection of polymethylmethacrylate (PMMA) into a cavity created in the vertebral body with a balloon or mechanical device. These techniques have been investigated as an option to provide mechanical support and symptomatic relief in patients with osteoporotic vertebral compression fracture, or in those with osteolytic lesions of the spine, ie, multiple myeloma or metastatic malignancies.

6 Balloon kyphoplasty is a variant of vertebroplasty and uses a specialized bone tamp with an inflatable balloon to expand a collapsed vertebral body as close as possible to its natural height before injection of the PMMA. Radiofrequency kyphoplasty is a modification of balloon kyphoplasty. In this procedure, an ultra-high viscosity cement is injected into the fractured vertebral body, and radiofrequency is used to achieve the desired consistency of the cement. The ultra-high viscosity cement is designed to restore height and alignment to the fractured vertebra, along with stabilizing the fracture.

It has been proposed that kyphoplasty may provide an analgesic effect through mechanical stabilization of a fractured or otherwise weakened vertebral body. However, other possible mechanisms of effect have been postulated, one of which is thermal damage to intraosseous nerve fibers given that PMMA undergoes a heat-releasing (exothermic) reaction during its hardening process.

Kiva® is another mechanical vertebral augmentation technique that uses an implant for structural support of the vertebral body and to provide a reservoir for bone cement. The Kiva® VCF system consists of a flexible polymer implant which is filled with bone cement. The implant is made from PEEK-OPTIMA®, a biocompatible polymer, and is inserted into the vertebral body over a removable spiral shaped guide wire. The implant can be customized by changing the number of loops of the coil, with a maximum height of 12 mm. PMMA is injected through the lumen of the implant, which fixes the implant to the vertebral body and contains the PMMA in a cylindrical column. The proposed advantage of the Kiva system is a reduction in cement leakage.

Another variant of kyphoplasty is vertebral body stenting, which utilizes an expandable scaffold instead of a balloon to restore vertebral height. The proposed advantages of vertebral body stenting are to reduce the risk of cement leakage by formation of a cavity for cement application and to prevent the loss of correction that is seen following removal of the balloon used for balloon kyphoplasty.

Summary After consideration of the available evidence and uniform clinical input, it was concluded that although the scientific evidence does not permit conclusions about the impact on health outcomes and that comparativestudies with long-term outcomes are lacking; numerous case series, including large prospectivereports,consistently showedthat vertebroplasty or kyphoplasty may alleviate painand improve functionin patients with vertebral fractures who fail to respond to conservative treatment (at least 6 weeks) with analgesics, physical therapy, and rest. More recent randomized trials that compare kyphoplasty with medical management have also reported benefit, so have not changed these conclusions. Given the absence of alternative treatment options and the morbidity associated with extended bedrest,kyphoplastymay be considered a reasonable treatment option in patients with vertebral fractures who failto improve after 6 weeks of conservative therapy and therefore may be considered medically necessary both for this patient population, as well as for patients who have severe pain due to osteolytic lesions of the spine related to multiple myeloma or metastatic malignancies.

There is insufficient evidence to permit conclusions on the use of kyphoplasty for an acute (<6 weeks) vertebral fracture. The scientific evidence does not permit conclusions about the impact on net health outcome; sham-controlled comparativestudies are needed. There are no additional data to alter these conclusions.

There is a single published randomized trial on mechanical vertebral augmentation using the Kiva VCF System. Results from the pivotal FDA-regulated investigational device exemption trial have been reported as an abstract from a scientific meeting. In both trials, the Kiva system is compared with kyphoplasty. It is considered investigational pending publication and review of the IDE trial. Early evidence suggests that vertebral body stenting may have worse outcomes compared with balloon kyphoplasty and is considered investigational.

7 Policy History Date Action 9/2014 BCBSA National medical policy review. New investigational indications described. Effective 9/1/2014. 6/2014 Updated Coding section with ICD10 procedure and diagnosis codes, effective 10/2015. 2/2014 Local Coverage Determination (LCD) for Percutaneous Vertebroplasty/Percutaneous Augmentation (L11417) retired and replaced by LCD L26439 Vertebroplasty and Vertebral Augmentation (Percutaneous). Effective October 25, 2013. 10/2013 BCBSA National medical policy review. New investigational indications described. Effective 10/1/2013. 11/2011- Medical policy ICD 10 remediation: Formatting, editing and coding updates. 4/2012 No changes to policy statements. 1/2012 Reviewed - Medical Policy Group - Neurology and Neurosurgery. No changes to policy statements. 12/2011 BCBSA National medical policy review. Changes to policy statements. 1/2011 Reviewed - Medical Policy Group - Neurology and Neurosurgery. No changes to policy statements. 7/2010 Reviewed - Medical Policy Group - Orthopedics, Rehabilitation Medicine and Rheumatology. No changes to policy statements. 6/2010 BCBSA National medical policy review. Changes to policy statements. 1/2010 Reviewed - Medical Policy Group - Neurology and Neurosurgery. No changes to policy statements. 7/2009 Reviewed - Medical Policy Group - Orthopedics, Rehabilitation Medicine and Rheumatology. No changes to policy statements. 6/2009 New policy, effective 6/1/2009, describing covered and non-covered indications. 11/2008 BCBSA National medical policy review. No changes to policy statements. 7/2008 Reviewed - Medical Policy Group - Orthopedics, Rehabilitation Medicine and Rheumatology. No changes to policy statements. 1/2008 Reviewed - Medical Policy Group - Neurology and Neurosurgery. No changes to policy statements. 1/2007 Reviewed - Medical Policy Group - Neurology and Neurosurgery. No changes to policy statements.

Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

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