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DESCRIPTIONTwo recombinant human bone morphogenetic proteins (rhBMPs) have been extensively studied: rhBMP-2, applied with an absorbable collagen sponge (Infuse) and rhBMP-7, applied in putty (OP-1). These products have been investigated as alternatives 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 (BMPs) are members of the transforming growth factors family. At present, some 20 BMPs have been identified, all with varying degrees of tissue-stimulating properties. The RhBMPs 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 rhBMP 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 spine stabilization and are differentiated from instrumented or non-instrumented PLF, which involves the transverse processes. 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 present, two rhBMPs 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) was approved by FDA through the premarket approval process:
2. OP-1 (Stryker Biotech, Hopkinton, MA) was approved by FDA through the Humanitarian Device Exemption (HDE) process for two indications. 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 the expanded approval. Olympus Biotech (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. rhBMP-7 is no longer marketed in the United States.
Both OP-1 and Infuse® Bone Graft/LT-CAGE Lumbar Tapered Fusion device are contraindicated in patients who are pregnant, may be allergic to any materials contained in the devices, have an infection near the area of the surgical incision, 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 on life-threatening complications associated with recombinant human bone morphogenetic protein in cervical spine fusion, based on reports of complications with the use of rhBMP in cervical spine fusion. Complications were associated with swelling of neck and throat tissue, which resulted in compression of the airway and/or neurologic 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 efficacy of rhBMP in the cervical spine have not been demonstrated. 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 uses a higher dose of rhBMP (2.0 mg/mL) with a compression-resistant carrier.
POLICYUse of recombinant human bone morphogenetic protein-2 (rhBMP-2, Infuse®) may be considered medically necessary in skeletally mature patients for the following indications:
Bone morphogenetic protein (rhBMP-2) 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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Use 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).
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
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.
08/28/2015: Code Reference section updated for ICD-10. Removed ICD-9 procedure codes 79.00 – 79.99, 81.00 – 81.08, 81.30 – 81.39 and ICD-9 diagnosis codes 722.52, 733.82, 823.30, and 823.32 from the Code Reference section.
05/31/2016: Policy number added. Policy Guidelines updated to add medically necessary and investigative definitions.
07/21/2016: Policy description updated regarding devices. Removed rhBMP-7 from policy statements.
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.