Medical Policy Updates

Table Of Contents

Notification of Policy Revisions Effective May 13, 2014 (Posted March 11, 2014)

Medical Policy Revision
Bone Morphogenetic Protein "Notification" Specialty Matched Consultant Advisory Panel review 2/2014. Medical Director review 2/2014. Policy statement revised as follows: "BCBSNC will provide coverage for FDA-approved Bone Morphogenetic Proteins when it is determined to be medically necessary because the medical criteria and guidelines show below are met. BCBSNC will not provide coverage for non FDA-approved BMPs or for non-FDA-approved indications ("off label" use) of BMP's because they are considered investigational. BCBSNC does not cover investigational services." "When Covered" section revised as follows: "Use of recombinant human bone morphogenetic protein-2 (rhBMP-2, InFUSE) may be considered medically necessary in skeletally mature patients undergoing interbody spinal fusion when: the fusion is single-level, the approach is anterior, the fusion involves vertebral bodies L4 - S1, with or without spondylolisthesis of no more than grade 1 (25% displacement), and use of autograft is unfeasible. Use of recombinant human bone morphogenetic protein-2 (rhBMP-2, InFUSE) may be considered medically necessary in skeletally mature patients for the treatment of acute, open fracture of the tibial shaft, when use of autograft is unfeasible. Use of recombinant human bone morphogenetic protein-7 (rhBMP-7, OP-1) may be considered medically necessary in skeletally mature patients: For revision (i.e., repeat procedure after prior failure) posterolateral intertransverse lumbar spinal fusion, when use of autograft is unfeasible. For recalcitrant long-bone nonunions where use of autograft is unfeasible and alternative conservative treatments have failed." "When not Covered" section revised to delete "not medically necessary" and replace with "investigational" as follows: "Bone morphogenetic protein (rhBMP-2 or rhBMP-7) is considered investigational for all other indications, including but not limited to spinal fusion or treatment of acute, open fracture of the tibial shaft when use of autograft is feasible, or when used for non-FDA-approved indications (i.e., "off label"). Use of InFUSE for posterior (PLIF), posterolateral (TLIF) or lateral (XLIF) approaches to spinal fusion is not FDA-approved and is considered investigational. Use of InFUSE for multilevel (more than single level) fusion is not FDA-approved and is considered investigational. Use of OP-1 for interbody fusion is not FDA-approved and is considered investigational." Policy Guidelines updated. References updated. Policy noticed on 3/11/14 for effective date 5/13/14.