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DESCRIPTIONTwo recombinant human bone morphogenetic proteins (rhBMPs) are now commercially available, rh-BMP-2, applied with an absorbable collagen sponge (InFUSE®, Medtronic, Memphis, TN) and rh-BMP-7, applied in putty (OP-1®). These products have been investigated as an alternative to bone autografting in a variety of clinical situations, including spinal fusions, internal fixation of fractures, treatment of bone defects, and reconstruction of maxillofacial conditions.
Bone morphogenetic proteins (BMP) are members of the family of transforming growth factors. At present, some 20 different BMPs have been identified, all with varying degrees of tissue stimulating properties. Rh-BMPs are delivered to the bone grafting site as part of a surgical procedure; a variety of carrier and delivery systems have been investigated. Carrier systems, which are absorbed over time, function to maintain the concentration of the rh-BMP at the treatment site, provide temporary scaffolding for osteogenesis, and prevent extraneous bone formation. Carrier systems have included inorganic material, synthetic polymer, natural polymers, and bone allograft. The rh-BMP and carrier may be inserted via a delivery system, which may also function to provide mechanical support.
The carrier and delivery system are important variables in the clinical use of rhBMPs, and different clinical applications, such as long bone non-union, or interbody or intertransverse fusion, have been evaluated with different carriers and delivery systems. For example, rhBMP putty with pedicle and screw devices are used for instrumented intertransverse fusion (posterolateral fusion [PLF]), while rhBMP in a collagen sponge with bone dowels or interbody cages are used for interbody spinal fusion. In addition, interbody fusion of the lumbar spine can be approached from an anterior (anterior lumbar interbody fusion), lateral, or posterior direction (posterior lumbar interbody fusion [PLIF] or transforaminal lumbar interbody fusion [TLIF]). Surgical procedures may include decompression of the spinal canal and insertion of pedicle screws and rods to increase stability of the spine.
Posterior approaches (PLIF and TLIF) allow decompression (via laminotomies and facetectomies) for treatment of spinal canal pathology (e.g., spinal stenosis, lateral recess and foraminal stenosis, synovial cysts, hypertrophic ligamentum flavum) along with stabilization of the spine and are differentiated from instrumented or non-instrumented posterolateral intertransverse fusion, which involves the transverse processes alone. Due to the proximity of these procedures to the spinal canal, risks associated with ectopic bone formation are increased (e.g., radiculopathies). Increased risk of bone resorption around rhBMP grafts, heterotopic bone formation, epidural cyst formation, and seromas has also been postulated.
At the present time, two rh-BMPs and associated carrier/delivery systems have received approval from the U.S. Food and Drug Administration (FDA).
The labeled indications for these devices are summarized below.
1. InFUSE™ Bone Graft in conjunction with 1 of 2 interbody fusion devices, i.e., either the LT-CAGE Lumbar Tapered Fusion Device or the Inter Fix RP Threaded Fusion device has received FDA approval through the PMA (premarket approval) process:
2. OP-1 (Stryker Biotech) has received two FDA approvals through the Humanitarian Device Exemption (HDE) process. HDE is available to devices intended for fewer than 4,000 patients per year; as part of this process, the manufacturer is not required to demonstrate unequivocal benefit, but only “probable” benefit. OP-1 received the following labeled indications:
Stryker Biotech sought FDA permission to expand use of OP-1 Putty to include use in uninstrumented posterolateral lumbar spinal fusion for the treatment of lumbar spondylolithesis. In March 2009, an FDA advisory committee voted 6-1 against recommending the expanded approval. Olympus Biotech Corp., a subsidiary of Olympus Corp., acquired OP-1 assets in 2010. In 2014, Olympus Corp. closed Olympus Biotech operations in the United States and discontinued sales of the Olympus Biotech products in this country.
Both OP-1 and InFUSE Bone Graft/LT-CAGE Lumbar Tapered Fusion device are contraindicated in patients who are pregnant, who may be allergic to any of the materials contained in the devices, who have an infection near the area of the surgical incision, who have had a tumor removed from the area of the implantation site or currently have a tumor in that area, or who are skeletally immature.
In July 2008, the FDA issued a public health notification regarding life-threatening complications associated with recombinant human bone morphogenetic protein in cervical spine fusion. The FDA has received reports of complications with the use of rhBMP in cervical spine fusion. These complications were associated with swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Some reports describe difficulty swallowing, breathing or speaking. Severe dysphagia following cervical spine fusion using rhBMP products has also been reported in the literature. As stated in the public health notification, the safety and effectiveness of rhBMP in the cervical spine have not been demonstrated, and these products are not approved by FDA for this use.
In 2011, Medtronic received a “nonapprovable letter” from the FDA for AMPLIFY. The AMPLIFY rhBMP-2 Matrix utilizes a higher dose of rhBMP (2.0 mg/mL) with a compression-resistant carrier and is being evaluated for posterolateral fusion of single-level lumbar (L2–S1) degenerative disc disease.
POLICYUse of recombinant human bone morphogenetic protein-2 (rhBMP-2, InFUSE) may be considered medically necessary in skeletally mature patients for the following indications:
Use of recombinant human bone morphogenetic protein-7 (rhBMP-7, OP-1) may be considered medically necessary in skeletally mature patients for the following indications:
Bone morphogenetic protein (rhBMP-2 or rhBMP-7) is considered not medically necessary for all other indications, including but not limited to spinal fusion when use of autograft is feasible.
Other indications for Electrical Stimulation of the Spine as an adjunct to Spinal Fusion are discussed in a separate policy.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESUse of iliac crest bone graft (ICBG) may be considered unfeasible due to situations that may include, but are not limited to, prior harvesting of ICBG or need for a greater quantity of ICBG than available (eg, for multilevel fusion).
There is not a consensus for the definition of nonunions. One proposed definition is failure of progression of fracture healing for at least 3 consecutive months (and at least 6 months following the fracture) accompanied by clinical symptoms of delayed/nonunion (pain, difficulty weight bearing).
The following patient selection criteria are described in the Ultrasound Accelerated Fracture Healing Device and Electrical Bone Growth Stimulation of the Appendicular Skeleton medical policies in the treatment of nonunions:
A recalcitrant nonunion would thus be considered to be a nonunion with a larger fracture gap (eg, greater than 1 cm) or a nonunion that has persisted for a longer duration of time with no response to conservative treatment (eg, 3 months of ultrasound or electrical stimulation).
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY7/2003: Approved by Medical Policy Advisory Committee (MPAC)
9/2/2003: Code Reference section completed
9/24/2004: Code Reference section updated, ICD-9 procedure code 84.52 added
7/21/2005: Reviewed by MPAC, change from investigational to be consistent with BCBSA policy # 7.01.100, BMP is medically necessary as an alternative to autograft in recalcitrant long bone nonunions where use of autograft is unfeasible and alternative treatments have failed. (i.e., labeled indication of OP-1), in conjunction with an LT-cage lumbar tapered fusion for spinal fusion procedures in skeletally mature patients with degenerative disc disease at 1 level from L4-S1. (i.e., labeled indication for InFUSE), AND for the treatment of acute, open fracture of the tibial shaft (i.e., labeled indication for InFUSE), BMP is considered investigational for other indications, including but not limited to: an alternative to autograft in compromised patients requiring revision posterolateral (intertransverse) lumbar spinal fusion, for whom autologous bone and bone marrow harvest are not feasible or are not expected to promote fusion. (i.e., a labeled indication of OP-1), treatment of multiple levels of spinal fusion, or spinal fusion in the thoracic or cervical vertebrae, as an alternative or adjunct to bone grafting in other locations, including craniomaxillofacial surgeries, title "Bone Morphogenetic Protein (BMP-7) for Repair of Recalcitrant Long Bone Non-Union Fractures" renamed "Bone Morphogenetic Protein," Sources updated, this change is effective October 1, 2005
10/7/2005: Code Reference section updated. A statement was added under CPT-4 indicating that the insertion of bone morphogenetic proteins should not be reported separately. Diagnosis codes 733.11, 733.12, 733.14, 733.15, & 733.16 deleted; codes 722.52, 733.82, 823.30, and 823.32 added.
8/28/2006: Policy reviewed, "Policy section" rewritten for clarity
1/14/2008: Policy reviewed, no changes
8/07/2009: Policy Description Section updated to add an FDA labeled indication for the InFUSE™ system, as well as contraindications and FDA information for both the InFUSE™ system and the OP-1 implant. Policy Statement Section revised to add rhBMP-2 and rhBMP-7 medically necessary criteria, investigational criteria, as well as FDA approved indications. Policy Guidelines Section updated to add investigative language, Covered Codes Table revised to add coding guidelines and ICD-9 Procedure codes 79.00-79.99, 81.00-81.08, 81.30-81.39.
09/09/2010: Policy description updated regarding devices and approaches. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section.
02/24/2012: Clarified that cervical spinal fusion and posterior or transforaminal lumbar interbody spinal fusion are investigational indications. Added high risk for fusion failure to the Policy Guidelines.
03/13/2013: Policy reviewed; no changes.
01/22/2014: Policy description updated. The medically necessary policy statement was updated as follows: "For anterior spinal interbody fusion procedures, in conjunction with an FDA-approved interbody fusion device, at one or more levels in skeletally mature patients with degenerative disc disease from L2-S1. Patients should have failed at least 6 months of conservative treatment" was changed to "For anterior lumbar interbody fusion procedures when use of autograft is unfeasible." The statement "For instrumented posterolateral intertransverse spinal fusion procedures, in conjunction with an FDA-approved device, at one or more levels in skeletally mature patients with degenerative disc disease from L2-S1. Patients should have failed at least 6 months of conservative treatment" was changed to "For instrumented posterolateral intertransverse spinal fusion procedures when use of autograft is unfeasible." The investigational policy statement was revised to state that bone morphogenetic protein (rhBMP-2 or rhBMP-7) is considered not medically necessary for all other indications, including but not limited to spinal fusion when use of autograft is feasible. Policy guidelines updated regarding patient selection criteria. Deleted outdated references from the Sources section.
04/07/2014: Policy statement on the use of recombinant human bone morphogenetic protein-7 revised to add "in skeletally mature patients" to the medically necessary statement. Deleted "As an alternative to autograft in" and replaced with "For" in the second indication of the human bone morphogenetic protein-7 criteria.
12/22/2014: Policy reviewed; description updated regarding devices. Added the following statement to the policy section: OP-1 is no longer sold in the United States.
SOURCE(S)Blue Cross Blue Shield Association policy # 7.01.100
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.