UnitedHealthcare Spinal Fusion Coverage Update

Coverage Criteria for Spinal Fusion and Bone Healing Enhancement Products

Covered / Medically Necessary Criteria

Covered when ALL of the following are met for specific products:

Demineralized Bone Matrix and allograft/autograft: Demineralized Bone Matrix (DBM) without products listed as unproven; autografts (including bone marrow aspirate used for bone grafting); and allograft-based products not listed as unproven are covered when used to enhance spinal fusion.

Anterior/oblique interbody approach: The approach is anterior or oblique and used in conjunction with an FDA‑approved interbody fusion device.

InFUSE lumbar spine (rhBMP-2) specific criteria: InFUSE (rhBMP-2) for lumbar spine is covered only when ALL of the following are met: patient is skeletally mature (≥18 years of age or radiographic evidence of epiphyseal closure) with degenerative disc disease; fusion is single‑level; fusion involves vertebral bodies L2–S1; and any spondylolisthesis at the involved level is no greater than grade 1 (≤25% displacement).

InFUSE/MASTERGRAFT posterolateral revision device criteria: The InFUSE/MASTERGRAFT Posterolateral Revision Device System (or InFUSE BMP used with MASTERGRAFT) is covered when used according to FDA indications and ALL of the following are met: presence of symptomatic posterolateral lumbar pseudoarthrosis; implantation via a posterolateral approach; patient is skeletally mature (older than 21 years or radiographic evidence of epiphyseal closure); and autologous bone and/or bone marrow harvest is not feasible or is not expected to promote fusion.

Unproven / Not Medically Necessary

Not medically necessary or unproven for enhancement of spinal fusion:

Unproven allograft-based and other products: Human amniotic tissue materials (including amniotic fluid stem cell substitutes) are considered unproven and not medically necessary.

Unproven rhBMP-2/MASTERGRAFT uses: Recombinant human bone morphogenetic protein-2 (rhBMP-2/InFUSE) and InFUSE/MASTERGRAFT Posterolateral Revision Device when used for indications other than those specified as covered above are considered unproven and not medically necessary.

Combination with bone marrow aspirate: Use of products listed above (including rhBMP-2/InFUSE) in combination with other grafts, including bone marrow aspirate, for indications not specified as covered is considered unproven and not medically necessary.

Expandable interbody fusion systems are considered unproven and not medically necessary.

Evidence-based coverage considerations

Coverage considerations based on available evidence and regulatory guidance

rhBMP-2 lumbar fusion evidence: Randomized trials and comparative reviews report earlier and higher fusion rates with rhBMP-2 versus iliac crest bone graft in lumbar fusion, but improvements in pain, disability, or quality of life are not consistently demonstrated; short‑term safety appears reasonable while long‑term serious risks (including a low potential cancer risk) remain incompletely characterized.

rhBMP-2 off-label safety concerns: Use of rhBMP-2 in cervical spine and other off‑label spinal applications has been associated with increased adverse events (eg, ectopic bone formation, osteoclast‑mediated resorption) and has prompted FDA safety notifications; off‑label use requires strong justification and documentation.

Ceramic and synthetic substitutes: Ceramic-based bone substitutes are osteoconductive and can achieve comparable fusion in some contexts, but the body of evidence is heterogeneous and superiority to autograft is not established; consider use with adjunctive biologics and document radiographic fusion timing and patient‑reported outcomes when used.

Guideline-based option statements

Guideline-based recommendations (AANS/Kaiser et al., 2014) summarized as options:

DBM and calcium-based extenders: DBM may be used as a bone extender for 1‑ and 2‑level instrumented posterolateral fusions. b‑TCP mixed with local autograft can be considered a substitute for autologous iliac crest bone for single‑level instrumented posterolateral fusion. HA may be used as a graft extender when mixed with autologous iliac crest bone or with local autograft/BMA for instrumented posterolateral fusion.

rhBMP-2 option with caution: rhBMP-2 is described as an option in several interbody and posterolateral contexts per guideline statements, but is associated with unique complications and insufficient evidence for some standalone or supplemental uses; clinical judgment and documentation of risks/benefits are advised.

Use in older patients and extenders: A 15% HA/85% b‑TCP matrix supplemented as a substitute for autologous iliac crest bone is an option in single‑level posterolateral instrumented fusions; extenders may be considered as alternatives to AICB in patients older than 60 years.

Interbody Fusion

Use of specific bone graft substitutes in interbody fusion procedures is described as optional or insufficiently evidenced in certain scenarios.

Interbody fusion options and limits: rhBMP-2 as a substitute for autologous iliac crest bone is an option for ALIF with threaded interbody cages and can be considered as a bone extender in TLIF with a structural interbody graft; rhBMP-2 as a substitute for AICB in single‑level PLIF is an option though heterotopic bone formation has been observed. There is insufficient evidence to recommend rhBMP-2 as a supplement for standalone ALIF using femoral allograft or when used with a resorbable spacer in TLIF.

Posterolateral Fusion

Policy provides options for use of 15% HA/85% b-TCP matrix, extenders, and notes evidence gaps in specific populations.

Posterolateral fusion options and evidence gaps: A 15% hydroxyapatite/85% beta‑tricalcium phosphate matrix supplemented as a substitute for autologous iliac crest bone is an option in single‑level instrumented posterolateral fusions; use as an extender with AICB or local bone is an option for instrumented or noninstrumented posterolateral fusions; extenders as alternatives to AICB may be considered for single‑level instrumented posterolateral fusions in patients older than 60 years. There is insufficient evidence to recommend rhBMP‑2/local bone as a substitute for AICB in revision posterolateral fusions or rhBMP‑2 calcium‑based extenders for single‑level posterolateral fusions in smokers.

NASS-based Indications

NASS evidence-based coverage recommendations identify indications for structural allograft, DBM, and rhBMP-2 in specific spinal fusion scenarios.

Structural allograft indications: Structural cortical or corticocancellous allograft (fresh‑frozen or freeze‑dried), with or without autograft, is indicated for anterior cervical spinal reconstruction in clinical scenarios including uninstrumented single level, instrumented single‑ or multilevel, and one or more level cervical corpectomy.

DBM indications: DBM (nonstructural allograft) may be indicated for anterior cervical reconstruction and fusion for cervical radiculopathy and/or myelopathy in multiple scenarios and for posterior instrumented fusion when combined with autograft; there is no significant evidence to support DBM as a stand‑alone product in non‑instrumented posterior fusion or anterior fusion at this time.

rhBMP-2 recommended uses and restrictions: NASS states rhBMP-2 may be considered as an adjunct to fusion in patients at high risk for nonunion (eg, certain posterolateral lumbar fusions, stand‑alone ALIF except males with strong reproductive priority, PLIF/TLIF in high‑risk patients, very high‑risk pediatric patients, posterior cervical/thoracic fusions, and anterior cervical fusion in high‑risk adults). NASS also states rhBMP‑2 should not be used for single‑level posterior/posterolateral fusions in healthy adults, routine anterior and posterior cervical fusion procedures, or routine pediatric spine fusion procedures.

The policy lists several products as unproven and not medically necessary for enhancement of spinal fusion, including human amniotic tissue materials (including amniotic fluid stem cell substitutes), certain uses of rhBMP-2 / InFUSE or InFUSE/MASTERGRAFT outside specified indications, expandable interbody fusion systems, and bioactive glass when used alone or in combination with other grafts such as bone marrow aspirate. These products are identified as lacking sufficient evidence of efficacy or safety to support routine coverage for spinal fusion enhancement.

Use of rhBMP-2 (InFUSE) for indications outside the FDA‑approved single‑level ALIF with specified cage constructs is considered off‑label and requires strong justification and supporting documentation. The policy cites safety concerns and prior FDA notifications related to cervical and other off‑label uses, and notes that adverse events and dosing issues have been reported in the literature; authorization for off‑label spinal fusion uses should include evidence addressing these safety and efficacy uncertainties.

Bioactive glass products are synthetic silica‑based materials claimed to promote rapid bone bonding, but the policy states there is insufficient high‑quality evidence to conclude their efficacy and safety compared with iliac crest bone graft or other established materials. In the absence of randomized controlled trials demonstrating clinical benefit, bioactive glass remains investigational for spinal fusion.

The policy specifies that rhBMP-2 should not be used for routine single‑level posterior or posterolateral fusions in healthy adults, for routine anterior or posterior cervical fusion procedures, or for routine pediatric spine fusion. This aligns with society guidance and prior safety reviews that document increased adverse events with rhBMP‑2 in some off‑label spine applications.

Human amniotic tissue derivatives and certain synthetic substitutes have only limited clinical evidence in orthopedic and lumbar fusion applications; the policy states that long‑term safety and efficacy have not been established. Consequently, these products are categorized as unproven and not medically necessary for enhancement of spinal fusion until higher‑quality data are available.

For revision anterior cervical discectomy and fusion (ACDF), the policy notes there is insufficient evidence to support routine use of various osteobiologics and that comparative outcome data for revision ACDF are lacking. Use of these products in revision ACDF should be justified by high‑quality evidence because current literature is sparse and does not demonstrate improved health outcomes.

Expandable interbody fusion systems are considered unproven in this policy because the available studies are retrospective or limited in size and design; the policy emphasizes the lack of prospective randomized controlled trials with larger sample sizes and long‑term follow‑up needed to establish clinical efficacy.

The policy indicates there is insufficient evidence to support use of rhBMP‑2 as a supplement for standalone ALIF when used with certain femoral allografts or with resorbable spacers in TLIF procedures. While rhBMP‑2 has option status in some interbody contexts, these specific supplemental or standalone applications lack high‑quality data to recommend routine use.

Procedure and Product Coding

Referenced Procedure CodesCPT

0814T	Percutaneous injection of calcium-based biodegradable osteoconductive material, proximal femur; including imaging guidance, unilateral.
20930	Allograft, (description listed in policy as to be used in addition to code for primary procedure).
20931	Allograft; structural, for spine surgery only (List separately in addition to code for primary procedure).
20939	Bone marrow aspiration for bone grafting, spine surgery only, through separate skin or fascial incision (List separately in addition to code for primary procedure).
22899	Unlisted procedure, spine

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization and Plan Verification

Prior authorization is recommended for off‑label use of recombinant human bone morphogenetic protein‑2 (rhBMP‑2) (e.g., indications other than the FDA‑approved single‑level ALIF) and for the use of biologic grafts and substitutes in specified fusion procedures when plan coverage is not explicit. Providers should obtain prior authorization or verify plan‑specific requirements before proceeding.

Prior authorization recommended for off‑label rhBMP‑2 use — justify clinical indication, levels treated, and dosing in the request.
Prior authorization recommended for biologics and substitutes — include rationale when using DBM, b‑TCP, HA, ceramic products, or other allograft/biologic options in lieu of autograft.
Verify prior authorization with plan — benefit coverage is governed by federal, state, or contractual plan terms; check for Pennsylvania‑specific requirements.

Note

State‑Specific Coverage Criteria

State‑specific criteria apply. This policy is specific to Pennsylvania; requests that do not meet Pennsylvania criteria will be evaluated on a case‑by‑case basis and may be denied. Always reference applicable state regulations and the PARP when submitting authorization requests.

Background

Autologous iliac crest bone graft (AICB) has historically been the standard for spinal fusion because it provides osteoconductive, osteoinductive, and osteogenic properties. The policy acknowledges AICB’s role as the reference standard while also noting donor site morbidity that has driven development of alternative biologics and synthetic substitutes.

Definitions and Product Descriptions

inv-34: Allograft — Definition and policy context

DefinitionTransplant of tissue from one individual to another of the same species with a different genotype.

Common usesStructural or nonstructural grafts in spinal fusion when autograft is unavailable or undesirable.

Product considerationsStructural allograft may be fresh-frozen or freeze-dried and used with or without autograft depending on procedure and indication.

Policy contextListed as a proven/medically necessary product when not specifically identified as unproven in policy guidance.

inv-35: Autograft — Definition and policy context

DefinitionTissue transplanted from one part of the body to another in the same individual.

Policy Revision History

2024-11-01RevisionLatest

Supporting Information: Clinical Evidence and References sections updated; previous policy version CSOOIPAR archived.

OpenPayer

Spinal Fusion and Bone Healing Enhancement Products (for Pennsylvania Only)