Cadaveric or Demineralized Allograft
Spinal bone grafting with a cadaveric allograft or demineralized bone allograft is medically necessary for spinal fusions.
Spinal fusion using a cadaveric allograft or demineralized bone allograft.
rhBMP-2 (INFUSE™) for Qualifying Lumbar Spinal Fusion
Spinal bone grafting with recombinant human bone morphogenetic protein 2 (rhBMP-2, INFUSE™) is medically necessary when ALL of the following criteria are met.
ALL of the following
ONE of the following procedures
Anterior Lumbar Interbody Fusion (ALIF) or Oblique Lumbar Interbody Fusion (OLIF) for single-level degenerative disc disease from the second lumbar vertebra (L2) through the first sacral vertebra (S1), causing discogenic back pain, in conjunction with an FDA-approved interbody fusion device.
FDA-approved INFUSE devices include: INFUSE™ Bone Graft/Medtronic Interbody Fusion Device; Divergence-L Anterior/Oblique Lumbar Fusion System; Pivox™ Oblique Lateral Spinal System; Perimeter Interbody Fusion Device implanted via retroperitoneal ALIF from L2 to S1 or OLIF from L5 to S1; Clydesdale Spinal System implanted via OLIF at a single level from L2 to S5; INFUSE™ Bone Graft/LT-CAGE™ Lumbar Tapered Fusion Device; INFUSE™ Bone Graft/Inter Fix™ Threaded Fusion Device; and INFUSE™ Bone Graft/Inter Fix™ RP Threaded Fusion Device.
Transforaminal Lumbar Interbody Fusion (TLIF) at one or two levels from L2 through S1, using either a PEEK (polyetheretherketone) or titanium interbody cage.
The member does not have greater than grade I spondylolisthesis (25% displacement) at the involved level.
The member is not known or suspected to have malignancy and is not known or suspected to have an active infection at the operative site.
The member is 18 years old or older.>= 18 years
Other or Off-Label rhBMP-2 Use
rhBMP-2 (INFUSE™) is considered experimental and investigational for all other spinal bone grafting indications or approaches, or when used for non-FDA-approved indications (off-label).
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Experimental, Investigational, or Unproven Bone Graft Substitutes
The following bone graft substitutes for enhancement of bone healing are considered experimental, investigational, or unproven. This list is not all-inclusive.
INFUSE/MASTERGRAFT Posterolateral Revision Device.
Human amniotic membrane bone graft substitute.
Cell-based substitutes other than bone marrow aspirate for enhancing bone healing.
Human growth factor substitutes, such as fibroblast growth factor or insulin-like growth factor, for enhancing bone healing.
rhBMP-2 (INFUSE™) uses outside the specifically listed ALIF, OLIF, or TLIF indications are considered experimental, investigational, or unproven, including use for non-FDA-approved indications (off-label).
Bone graft substitutes used only as stand-alone stabilization devices for fusion are considered experimental, investigational, or unproven. This includes allograft bone graft substitutes used only as stand-alone stabilization devices for fusion.
Interlaminar stabilization devices, including Coflex, Dynesys, LimiFlex, Zimmer DTO, BioFlex, CD Horizon Agile, DSS, Dynabolt, Graf ligamentoplasty/Graf artificial ligament, Isobar, NFix, Satellite, Stabilimax NZ, and Zodiak DynaMo, are considered experimental and investigational. Interspinous process spacers, including the Superion Interspinous Spacer, are also considered experimental and investigational due to low-quality evidence.
HCPCS L8699 (prosthetic implant, not otherwise specified) is not covered when used for any bone graft substitute.