Please refer to CMS website for the most current applicable National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/CMS Online Manual System/Transmittals.

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

Page: 2 of 11

ID Number

Medicare Administrative Contractors (MACs)

Applicable States/Territories

• LCD LCA Percutaneous Vertebral Augmentation (PVA) for Vertebral Compression Fracture (VCF) 138213 ~ A57630 J5, J8 - Wisconsin Physicians Service Insurance Corporation IA, KS, MO, NE IN. MI
• LCD Percutaneous Vertebral Augmentation (PVA) for L33569 J6, JK - National Government Services, Inc. (Part A/B MAC) J15 - CGS Administrators, LLC (Part A/B MAC) IL, MN, WI
• LCA Osteoporotic Vertebral Compression Fracture (VCF) Percutaneous Vertebral Augmentation (PVA) for Vertebral Compression Fracture | (VCF) L38201 A57282 KY, OH
• LCD LCA Percutaneous Vertebral Augmentation (PVA) for Osteoporotic Vertebral Compression Fracture (VCF) L34228 A56572 JH, JL - Noridian Healthcare Solutions, LLC CA, HI, NV, American Samoa, Guam, Northern Mariana Islands
• LCD LCA Percutaneous Vertebral Augmentation (PVA) for Osteoporotic Vertebral Compression Fracture (VCF) L34106 A56573 JF Noridian Healthcare Solutions, LLC AK, AZ, ID, MT, ND, OR, SD, UT, WA, WY
• LCD LCA Percutaneous Vertebral Augmentation (PVA) for Vertebral Compression Fracture | (VCF) L35130 A57752 JH, JL - Novitas Solutions, Inc. (Part A/B MAC) AR, CO, NM, OK, TX, LA, MS DE, DC, MD, NJ, PA
• LCD LCA Percutaneous Vertebral Augmentation (PVA) for Vertebral Compression Fracture | (VCF) L38737 A58275 Robert J, JM - Palmetto GBA (Part A/B MAC) AL, GA, TN NC, SC, VA, WV
• LCD LCA Percutaneous Vertebral Augmentation (PVA) for Vertebral Compression Fracture | (VCF) L34976 A57872 JN - First Coast Service Options, Inc. (Part A/B MAC) FL PR, US VI uo

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.

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.

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.

Coverage Determination

Humana follows the CMS requirement that only allows coverage and payment for services that are reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare.

In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the following criteria:

Please refer to the above CMS guidance for percutaneous vertebroplasty/kyphoplasty for osteoporotic vertebral compression fractures.

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

Page: 4 of 11

Percutaneous vertebroplasty or kyphoplasty (balloon-assisted vertebroplasty) in the cervical, lumbar or thoracic regions of the spine will be considered medically reasonable and necessary when the following requirements are met:

• 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) or hemangioma which correlates to the individual’s signs and symptoms; AND
• In the absence of an osteoporotic vertebral compression fracture;
• 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
  • Steroid-induced fracture

The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy.

Coverage Limitations

US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage

Sacroplasty for any indication including, but not limited to, osteoporotic sacral insufficiency fractures will not be considered medically reasonable and necessary. A review of the current medical literature shows that the evidence is insufficient to determine that this service is standard medical treatment.

There remains an absence of randomized, blinded clinical studies examining benefit and long-term clinical outcomes establishing the value of this service in clinical management.

Summary of Evidence

Sacroplasty Hayes evaluated percutaneous sacroplasty for the treatment of sacral insufficiency fractures and reported there is a small, very-low-quality body of evidence that does not allow for conclusions to be drawn.30

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

Page: 5 of 11

UpToDate reported that invasive treatments for insufficiency fractures of the pelvis such as sacroplasty have not been well studied.46