Humana Percutaneous Vertebroplasty, Kyphoplasty, Sacroplasty Form

Description

Percutaneous vertebroplasty is a procedure that involves injection of acrylic bone cement (usually a polymethylmethacrylate [PMMA]) into an osteoporotic vertebral body compression fracture or osteolytic lesion of the spine with the goal of relieving pain, improving mobility and preventing further collapse of the bone. The procedure is performed under fluoroscopic guidance with local anesthesia and moderate sedation.

An alternative to traditional bone cement is Cortoss Bone Augmentation Material. Cortoss is an injectable, nonresorbable synthetic material that functions as a strengthening agent for injection into vertebral bodies with compression fractures.

Page: 1 of 13

Percutaneous Vertebroplasty, Kyphoplasty (Balloon-Assisted Vertebroplasty), Sacroplasty

Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 12/14/2023

Policy Number: HUM-0367-021 Page: 2 of 13

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Kyphoplasty (also known as balloon-assisted vertebroplasty) is a modification of the vertebroplasty procedure that involves the use of an inflatable balloon to reduce the fracture prior to the injection of the bone cement. Examples of devices used in kyphoplasty include, but may not be limited to, the AVAflex Vertebral Balloon System, iVAS Balloon System (including the iVAS Elite System), Kyphon Balloon System, Kyphon Express II Inflatable Bone Tamp, Kyphon XPander II IBT and MEDINAUT-X Inflatable Bone Expander System.

The Kiva VCF Treatment System is an implantable device which may be used with either the vertebroplasty or kyphoplasty procedure for reduction and treatment of spinal fractures. PMMA bone cement is used to fill the implant once it is placed. The SpineJack device is similar to the Kiva VCF system and has been developed as an additional alternative to the inflatable balloon used in kyphoplasty. SpineJack is an expandable titanium implant designed to restore the height of the vertebral body in osteoporotic vertebral fracture. After implantation, PMMA is injected into the vertebral body to provide additional stabilization.

VCFix was recently granted a breakthrough device designation from the US Food & Drug Administration (FDA) as a proposed treatment for vertebral compression fractures. It utilizes a 3D-printed structure which purportedly stimulates bone ingrowth and provides stability of loads in the spine. For information regarding the use of 3D-printed implants, please refer to Code Compendium (Miscellaneous) Medical Coverage Policy.

Sacroplasty is a variation of vertebroplasty that has been proposed for the treatment of sacral insufficiency fractures. Under fluoroscopic guidance, PMMA is injected into the sacrum at the fracture site, in an attempt to stabilize the fracture. (Refer to Coverage Limitations section)

Coverage Determination

Humana members may be eligible under the Plan for percutaneous vertebroplasty or kyphoplasty (balloon-assisted vertebroplasty) in the cervical, lumbar or thoracic regions of the spine when the following criteria are met:

• Absence of contraindications (absolute and relative); AND

Page: 3 of 13

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Imaging studies (x-ray, computed tomography [CT] scan or magnetic resonance imaging [MRI]) eliminates other origins for the pain (eg, herniated intervertebral disc) and confirms the presence of a vertebral compression fracture (VCF) which correlates to the individual’s signs and symptoms; AND any of the following indications:
• Painful and/or aggressive hemangioma; OR
• Painful multiple myeloma involving the vertebral body; OR
• Painful osteolytic vertebral body metastatic disease; OR
• Severe pain and functional debilitation related to activities of daily living (ADLs) due to chronic VCF that requires hospitalization for pain control and treatment (conservative medical management is not considered appropriate for such individuals); OR
• Steroid-induced fracture; OR
• Painful debilitating osteoporotic VCF and ALL of the following:
  • Documentation of lack of response to conservative treatment (a 4 week period of immobilization); AND
  • Greater than one-third of the original vertebral height remains for the affected vertebra; AND
  • Requested procedure is performed within 4 months of pain onset

Coverage Limitations

Humana members may NOT be eligible under the Plan for percutaneous vertebroplasty or kyphoplasty (balloon-assisted vertebroplasty) for any indications other than those listed above including, but may not be limited to, reinforcement or stabilization of the vertebral body prior to spinal surgery or in conjunction with a spinal fusion. These are considered experimental/investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for percutaneous vertebroplasty or kyphoplasty (balloon-assisted vertebroplasty) in the presence of any of the following absolute contraindications:Active osteomyelitis of the target vertebra; OR Allergy to bone cement or contrast media; OR Asymptomatic vertebral compression fractures; OR Infection along the intended trajectory of access; OR Septicemia/sepsis; OR Uncorrectable coagulopathy

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for percutaneous vertebroplasty or kyphoplasty (balloon-assisted vertebroplasty) in the presence of any of the following relative contraindications:

• Epidural tumor extension with encroachment on the spinal canal; OR
• Individual is improving on medical treatment; OR
• Myelopathy or cauda equina syndrome originating at the fracture level; OR
• Ongoing systemic infection; OR
• Prophylactic treatment for osteoporosis to prevent future fractures; OR
• Radiculopathy caused by a compression syndrome unrelated to vertebral collapse/fracture; OR

Page: 4 of 13

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Page: 5 of 13

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Retropulsion of a fracture fragment causing spinal/neurological compromise (motor and/or neurosensory loss, including symptoms of cauda equina syndrome or myelopathy)

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for sacroplasty for any indication including, but may not be limited to, osteoporotic sacral insufficiency fractures. This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Background

Additional information about multiple myeloma or osteolytic lesions of the spine (bone metastasis) may be found from the following websites:

• American Cancer Society
• National Library of Medicine

Medical Alternatives

Alternatives to percutaneous vertebroplasty or kyphoplasty include, but may not be limited to, the following:

• Physical therapy (please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy)

Alternatives to sacroplasty include, but may not be limited to, the following:

• Activity modification
• Bracing (please refer to Orthotics Medical Coverage Policy)
• Physical therapy (please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy)

Percutaneous Vertebroplasty, Kyphoplasty (Balloon-Assisted Vertebroplasty), Sacroplasty Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 12/14/2023 Policy Number: HUM-0367-021 Page: 6 of 13

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Prescription drug therapy

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.