CurrentBlue Cross Blue Shield - MassachusettsPolicy 097

Recombinant human bone morphogenetic protein (rhBMP) use

Defines medical necessity and investigational indications for use of recombinant human bone morphogenetic proteins (eg, rhBMP-2 Infuse, rhBMP-7 OP-1) in musculoskeletal procedures for Blue Cross Blue Shield Massachusetts members.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyRecombinant human bone morphogenetic protein (rhBMP) use

Policy CodePolicy 097

Change TypeNo material change (annual review)

Effective DateN/A

Next Review DateN/A

Key ActionUse Authorization Manager to submit initial authorization requests and include the surgeon's and facility's NPI/provider IDs.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2rhBMP products studied

20930Example CPT code

Prior auth requiredPrecert required (inpatient)

FDA 2008Safety notification

Auth removed 4/2024Admin change

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Coverage Criteria

inv-01: Medically necessary indications

Covered when ALL of the following are met

Medically Necessary Indications for rhBMP-2

Instrumented posterolateral intertransverse spinal fusion procedures when the use of autograft is not feasible.
Anterior lumbar interbody fusion procedures when the use of autograft is not feasible.
Treatment of acute, open fracture of the tibial shaft when the use of autograft is not feasible.

inv-02: Investigational indications

Investigational Indications: Use of recombinant human bone morphogenetic protein (rhBMP), including rhBMP-2, is considered INVESTIGATIONAL for all other indications, including but not limited to spinal fusion when the use of autograft is feasible and craniomaxillofacial surgery.

Evidence is insufficient to determine improvement in net health outcome for these other indications.

inv-03: Evidence-based coverage considerations

Summary statements about evidence and policy status in this excerpt:

Evidence summary - spinal fusion and tibial shaft fractures: RCTs, systematic reviews, and meta-analyses demonstrate that rhBMP-2 promotes bone fusion and can improve outcomes for patients undergoing anterior or posterolateral lumbar spinal fusion and for acute open tibial shaft fractures when autograft is not feasible; overall adverse event rates are low but safety concerns (including possible increased adverse events) have been raised.

Supports selective medical necessity when autograft is not feasible.

Evidence summary - other procedures: For other surgical procedures (eg, oral and maxillofacial, hip arthroplasty, distraction osteogenesis), evidence is limited and indicates rhBMP may be less effective than bone graft in some settings though associated with fewer adverse events; evidence is insufficient for tibial shaft fracture nonunion and other indications to conclude a net health benefit.

These limitations justify investigational status for indications beyond those specified as medically necessary.

Policy status and administrative notes: Policy statements were last reviewed and updated without changing coverage conclusions (annual reviews); prior authorization requirements were removed effective 4/1/2024 and the policy language in 4/2023 clarified that rhBMP-2 is investigational for other indications.

Use of rhBMP products in the cervical spine is not approved by the FDA and has been associated with life‑threatening complications. The FDA issued a public health notification in 2008 describing reports of severe soft‑tissue swelling in the neck and throat after cervical spine use of rhBMP products that resulted in airway compression and/or neurologic compromise, with symptoms including difficulty swallowing, breathing, or speaking.

The available evidence does not permit conclusions about the effect of rhBMP for tibial shaft fracture nonunion; in other words, evidence is insufficient to determine that rhBMP improves net health outcome for tibial shaft fracture nonunion.

When iliac crest autograft is feasible, use of rhBMP for spinal fusion is considered investigational. The policy specifies that rhBMP‑2 (Infuse) may be considered medically necessary only when autograft is not feasible; if autograft (eg, iliac crest bone graft) is feasible, rhBMP use is not covered.

Policy language was revised effective 4/2023 to state that recombinant human bone morphogenetic protein‑2 is considered investigational for all other indications (previously described as not medically necessary), including but not limited to spinal fusion when autograft is feasible and craniomaxillofacial surgery.

Coding and Product References

CPT Codes (informational list)CPT

20930

Allograft, morselized, or placement of osteopromotive material, for surgery only (Report_in addition to the_primary_spinal fusion procedure)

Coding updates referencedmixed

ICD-10 procedure and diagnosis codes (unspecified)

Document notes coding section updated with ICD-10 procedure and diagnosis codes effective 10/2015, but exact codes not included in this excerpt.

Referenced FDA-approved productsHCPCS

INFUSE (device/product)

FDA-approved INFUSE product references added; specific HCPCS/CPT not listed in this excerpt.

Provider Actions and Authorization

Prior Authorization

Prior Authorization Required for Inpatient Services

Precertification/preauthorization is required when the procedure described in this policy is performed inpatient. Providers must submit initial authorization requests using Authorization Manager (available 24/7) — it is the quickest way to review authorization requirements, request authorizations, submit clinical documentation, check existing case status, and view/print decisions.

Enter the appropriate surgeon's NPI or provider ID as the servicing provider (not the billing group).
Enter the facility's NPI or provider ID for where services are being performed.

Note

Prior Authorization Status and History

Prior authorization requirements were removed effective 4/1/2024. Earlier versions of this policy included prior authorization language and references to prior authorization processes; verify current requirements for outpatient services with Authorization Manager or payer guidance.

Background

Bone morphogenetic proteins (BMPs) are members of the transforming growth factor family that act as growth factors to stimulate bone formation. Recombinant human BMPs (rhBMPs) are delivered with carriers (for example, absorbable collagen sponge or putty formulations) to a graft site to promote osteogenesis; carrier and delivery systems influence clinical application and risks such as ectopic bone formation, seroma, and potential neurologic compression with cervical use.

Definitions

rhBMP — definition

TermrhBMP (recombinant human bone morphogenetic protein)

DefinitionA recombinant protein delivered with a carrier to a graft site to stimulate osteogenesis (bone formation).

DeliveryDelivered as part of a surgical procedure using various carrier and delivery systems that maintain local concentration and provide temporary scaffolding for bone growth.

Clinical roleInvestigated as an alternative or adjunct to autograft for spinal fusion, fracture nonunions, and craniofacial reconstruction.

OP-1 Putty (rhBMP-7) — definition

ProductOP-1 Putty (rhBMP-7)

Revision History

2025-06annual_reviewLatest

Annual policy review: summary and references updated; policy statements unchanged.

2024-06annual_review

Annual policy review: references updated; policy statements unchanged.

2024-04-01policy_revision