Clinical Review Criteria: InFUSE Bone Graft and Bone Graft Substitutes/Adjuncts
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Clinical review criteria governing medical necessity and coverage of InFUSE (rhBMP-2) Bone Graft and listed bone graft substitutes/adjuncts for Kaiser Foundation Health Plan of Washington members and their providers.
INFUSE Bone Graft may be medically necessary for lumbar spinal fusion in skeletally mature persons when implanted via an anterior (ALIF) or lateral approach and when the member meets lumbar fusion medical necessity criteria.
INFUSE Bone Graft may be medically necessary for treatment of acute, open tibial shaft fractures in skeletally mature persons when stabilized with intramedullary nail fixation and applied within 14 days.
Most other uses of INFUSE Bone Graft remain experimental, investigational, or unproven including ankle and cervical fusions.
A non-covered list of specific bone graft substitutes and adjuncts (brand-named products and categories) is included as investigational.
Coverage and Medical Necessity Criteria
Covered: INFUSE for lumbar spinal fusion (Non-Medicare)
INFUSE Bone Graft may be medically necessary when ALL of the following are met for lumbar fusion (Non-Medicare members):
reference to existing lumbar fusion medical necessity policy
coverage limited to these approaches
Covered: INFUSE for acute open tibial shaft fractures (Non-Medicare)
INFUSE Bone Graft may be medically necessary for treatment of acute, open tibial shaft fractures in skeletally mature persons when ALL of the following are met:
requires stabilization prior to INFUSE application
time-limited indication
INFUSE Bone Graft is considered experimental, investigational, or unproven for all other indications not specifically listed as medically necessary in this policy. Examples of such noncovered uses include, but are not limited to, ankle fusions and cervical fusions.
The Kaiser Permanente Medical Technology Assessment Committee (MTAC) reviews and evidence summaries conclude there is insufficient published evidence to determine that INFUSE (rhBMP-2) used with the LT-Cage provides a superior net health outcome compared with standard bone graft for anterior lumbar interbody fusion (ALIF). Multiple MTAC reviews and systematic reviews found little or no clinical advantage in pain or function despite some increased fusion rates in selected analyses, and raised concerns about potential for more serious adverse events. Consequently, prior MTAC determinations have concluded that use of InFUSE Bone Graft/LT-Cage/rhBMP-2 for ALIF does not meet Kaiser Permanente Medical Technology Assessment Criteria.
Billing and Code Status
Provider Requirements and Prior Authorization
Prior Authorization May Be Required
Some CPT/HCPCS codes related to InFUSE and bone graft substitutes may require prior authorization. Verify authorization requirements for the specific code and member plan before scheduling or billing.
Conservative Therapy Required Prior to INFUSE for Lumbar Fusion
For lumbar fusion (INFUSE) in skeletally mature persons, documentation must show adequate trial of conservative, nonoperative therapy prior to use, consistent with FDA guidance and policy criteria. Include dates, modalities, duration, and clinical response to conservative measures.
- Document ≥6 months of nonoperative therapy (e.g., physical therapy, activity modification, medications, injections) unless contraindicated.
- Document failure of conservative measures and medical necessity for fusion per Lumbar Decompression & Fusion Procedures criteria.
Documentation and Plan Verification
Confirm authorization requirements and member benefit details before proceeding. Always check the member's Evidence of Coverage or contact Kaiser Permanente Member Services for benefits and coverage confirmation.
- Verify member-specific Evidence of Coverage.
- Contact Member Services at 1-888-901-4636 (TTY 711) for benefit verification.
Denial Risk for Investigational or Non‑Covered Uses
Certain branded bone graft substitutes, adjuncts, and uses of INFUSE not meeting policy criteria are considered investigational or not medically necessary and may be denied.
- Non‑covered/experimental items may include listed CPT/HCPCS codes and brand‑named products identified in the policy.
- Denials may be issued when documentation does not meet the stated medical necessity criteria (including surgical approach and prior conservative therapy).
Clinical Background
Degenerative disc disease (DDD) can produce axial back pain, radiculopathy, and functional impairment when conservative therapy fails. When instability or persistent symptoms persist despite nonoperative care, surgical options include interbody fusion procedures (for example, anterior lumbar interbody fusion [ALIF], posterior lumbar interbody fusion [PLIF], and transforaminal lumbar interbody fusion [TLIF]) to achieve segmental fusion, restore disc height, and decompress neural elements. INFUSE Bone Graft consists of recombinant human bone morphogenetic protein-2 (rhBMP-2) on an absorbable collagen sponge and is used with a lordotic tapered fusion cage (LT-Cage) to promote bone formation and fusion in the interbody space. The product received FDA approval in 2002 for single-level ALIF (L4–S1) in skeletally mature patients after an adequate trial of nonoperative management (commonly referenced as approximately 6 months of conservative care).
Key Terms and Device Definitions
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