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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, may require different dosages of rhBMP along with different carriers and delivery systems. For example, BMP with pedicle and screw devices are commonly used for instrumented intertransverse fusion, while BMP with interbody cages are used for interbody spinal fusion. In addition, interbody fusion of the lumbar spine can be approached from an anterior, lateral, or posterior direction. Surgical procedures may include decompression of the spinal canal and insertion of pedicle screws and rods to increase stability of the spine.

• Anterior lumbar interbody fusion (ALIF) provides direct visualization of the disc space through a peritoneal or retroperitoneal approach.
• Extreme lateral interbody fusion (XLIF) and direct lateral interbody fusion (DLIF) use a lateral (retroperitoneal) approach through the psoas.
• An axial approach to lumbar interbody fusion (AxiaLIF) is performed perpendicular to the long axis of the spine with access through the sacrum.
• Posterior lumbar interbody fusion (PLIF) is performed through either a traditional open procedure with a long midline incision and wide muscle retraction with laminotomy, or with a minimally invasive approach using bilateral paramedian incisions.
• Transforaminal interbody fusion (TLIF) provides posterior access to the spine with a unilateral approach to the disc space (facetectomy) through the intervetebral foramen. In minimally invasive TLIF, a single incision about 2-3 cm in length is made approximately 3 cm lateral to the midline and a tubular retractor is docked on the facet joint complex to provide a working channel for facetectomy with partial laminectomy.

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 BMP 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).

• OP-1 consists of rh-BMP-7 and bovine collagen, which is reconstituted with saline to form a paste. The addition of carboxymethylcellulose forms a putty.
• The InFUSE™ system consists of rh-BMP-2 on an absorbable collagen sponge carrier.

The labeled indications for these devices are summarized below.

1. InFUSE™ Bone Graft in conjunction with 1of 2 interbody fusion devices, i.e., either the LT-CAGE™ Lumbar Tapered Fusion Device of the Inter Fix RP Threaded Fusion device has received FDA approval through the PMA (premarket approval) process:

The device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at 1 level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, function deficit, and/or neurological deficit and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level or retrolistheses. The InFUSE™ Bone Graft/LT-CAGE™ devices are to be implanted via an anterior open or a laparoscopic approach. The InFUSE™ Bone Graft/INTER FIX™ Threaded Fusion Device; and InFUSE™ Bone Graft/INTER FIX™ RP Threaded Fusion Device are to be implanted via an anterior open approach only. Patients receiving the InFUSE™ Bone Graft/Interbody Fusion Device should have had at least 6 months of nonoperative treatment prior to treatment with the InFUSE™ Bone Graft/Interbody Fusion Device. (Note: A collagen sponge consists of the carrier, while the interbody fusion device is a delivery system.)

• For the treatment of acute, open fractures of the tibial shaft
• For sinus augmentations, and for localized aveolar ridge augmentations for defects associated with extraction sockets.

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:

• “OP-1 Implant is indicated for use as an alternative to autograft in recalcitrant long bone nonunions where use of autograft is unfeasible and alternative treatments have failed.”
• “OP-1 Putty is indicated for use as 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. Examples of compromising factors include osteoporosis, smoking and diabetes.”

Stryker® recently 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.

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.

• 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*
• 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
• For the treatment of acute, open fracture of the tibial shaft**

Use of recombinant human bone morphogenetic protein-7 (rhBMP-7, OP-1) may be considered medically necessary for the following indications:

• As an alternative to autograft in compromised patients (e.g., osteoporosis, tobacco use, or diabetes) requiring non-instrumented revision posterolateral intertransverse lumbar spinal fusion, for whom autologous bone and bone marrow harvest are not feasible or are not expected to promote fusion***
• As an alternative to autograft in recalcitrant long bone nonunions where use of autograft is unfeasible and alternative conservative treatments have failed***

Bone morphogenetic protein (rhBMP-2 or rhBMP-7) is considered investigational for all other indications, including but not limited to:

• Cervical spinal fusion
• Posterior or transforaminal lumbar interbody spinal fusion
• As initial treatment or revision of non-instrumented posterolateral intertransverse spinal fusion that does not meet the criteria listed above
• As an alternative or adjunct to bone grafting in other locations, including craniomaxillofacial** surgeries

*FDA approved for one level
**FDA-approved indication
***FDA approved under a Humanitarian Device Exemption (HDE) 

Other indications for Electrical Stimulation of the Spine as an adjunct to Spinal Fusion are discussed in a separate policy. 

• one or more previous failed spinal fusion(s);
• grade III or worse spondylolisthesis;
• fusion to be performed at more than one level;
• current tobacco use;
• diabetes;
• renal disease;
• alcoholism;
• steroid use

Because of the differing benefits and risks of iliac crest bone graft harvest and bone morphogenetic protein, patients should make an informed choice between the procedures.

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.

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.

http://www.fda.gov/cdrh/ode/H010002sum.html 

Blue Cross Blue Shield Association policy # 7.01.100

Hayes Medical Technology Directory

The code(s) listed below are ONLY covered if the procedure is performed according to the "Policy" section of this document. 

Covered Codes

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