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Medical Necessity Guidelines Recombinant Human Bone Morphogenic Protein for Bone Fusion ( rhBMP) Document ID#: Subject: Effective Date: 2143483 Recombinant Human Bone Morphogenetic Protein September 12, 2012

Clinical Documentation and Prior Authorization Required Not Covered

Type of Review - Case Management Type of Review ­ Precertification Department Administrative Process (Internal Use Only)

RN

Please Note: While you may not be the provider responsible for obtaining prior authorization, as a condition of payment you will need to make sure that prior authorization has been obtained.

Overview

Patients with degenerative disc disease of the lumbar or cervical spine can be treated with a surgical procedure, referred to as spinal fusion or arthrodesis. Bone grafts are commonly used in this procedure to promote fusion of adjacent vertebrae. Bone grafts can be harvested from the patient (autograft), obtained from bone banks (cadaver allograft), or composed of synthetic material. The standard type of graft for spinal fusion is autogenous iliac crest bone graft (AICBG). Autografts have osteoconductive, as well as osteoinductive, properties. The disadvantages of autografts include pain at the graft site, potential injury to local nerves or vessels, postoperative infection or hematoma, and gait disturbances. Allografts also have both osteoconductive and osteoinductive properties. Allografts give less consistent clinical results than autografts, and there is an increased risk of disease transmission and immunogenic response. When allografts are intensively processed to decrease these risks, the osteoinductive potential is lessened and mechanical strength is reduced. Synthetic bone grafts have an osteoconductive role only. Bone morphogenetic protein, or BMP, was discovered in 1965. Since that time, several BMPs have been identified and some are being manufactured using recombinant deoxyribonucleic acid (DNA) technology. They play an important osteoinductive role in bone and cartilage formation, fracture healing, and repairing other musculoskeletal tissues. BMP overcomes the previously mentioned disadvantages of both autografts and bone allografts (Hayes, 2006).

Coverage Guidelines

Tufts Health Plan may authorize the coverage of the Recombinant human bone morphogenetic (rhBMP2) protein when: · Used in combination with a collagen sponge and fusion cage for anterior, single-level spinal fusion surgery in skeletally mature patients with degenerative disc disease at one level from L2S1. · Prior authorization for the spinal procedure must be obtained separately. Please see the Medical Necessity Guideline for Spinal Procedures: Certain Elective.

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Limitations

Tufts Health Plan will not authorize coverage for any of the following because the indications are not considered to be medically necessary at this time: · · · · · · · Use of rhBMP-2 in nonanterior approaches to lumbar fusion or in anterior approaches to lumbar fusion when combined with a carrier other than collagen or with a fusion device other than cage. Use of rhBMP-2 in cervical fusion. Use of rhBMP-2 for the treatment of open tibial fractures. Use of rhBMP-2 for the treatment of closed tibial fractures. Use of rhBMP-2 for the treatment of delayed union or nonunion tibial fractures as part of a planned, staged reconstruction. Use of rhBMP-7 in any application. Use of BMP for the treatment of avascular necrosis (AVN) of the hip.

Codes

The following CPT/HCPCS code requires prior authorization: Code 20930 Description Allograft, morselized, or placement of osteopromotive material, for spine surgery only (List separately in addition to code for primary procedure)

References

1. Burkus JK, Gornet MF, Dickman CA, Zdeblick TA. Anterior lumbar interbody fusion using rhBMP- with tapered interbody cages. J Spinal Disord Tech. 2002;15(5):337-349. 2. Burkus JK, Heim SE, Gornet MF, Zdeblick TA. Is INFUSE Bone Graft superior to autograft bone? An integrated analysis of clinical trials using the LT-Cage Lumbar Tapered Fusion device. J Spinal Disord Tech. 2003;16(2):113-122. 3. Burkus JK, Sandhu HS, Gornet MF, Longley MC. Use of rhBMP-2 in combination with structural cortical allografts: clinical and radiographic outcomes in anterior lumbar spinal surgery. J Bone JointSurg Am. 2005;87(6):1205-1212. 4. Hayes, Inc. Recombinant human bone morphogenetic protein for use in spinal fusion. Medical Technology Directory. September 6, 2006. 5. Hayes, Inc. Recombinant human bone morphogenetic protein for use in spinal fusion. Medical Technology Directory. Update Search. July 3, 2008. 6. Hayes, Inc. Recombinant human bone morphogenetic protein for use in tibia repair. Medical Technology Directory. September 6, 2006 7. Hayes, Inc. Recombinant human bone morphogenetic protein for use in tibia repair. Medical Technology Directory. Update Search. September 17, 2008. 8. Hayes, Inc. Bone morphogenic protein for treatment of avascular necrosis of the hip. Hayes Search & Summary. December 28, 2006.

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Approval History

Reviewed by the Medical Affairs Medical Policy Committee on June 1, 2009 for a November 1, 2009 effective date. · April 2011: Reviewed at MSPAC. No changes. · July 2011: Reviewed by Medical Affairs, Medical Policy. No changes. · January 18, 2012: Reviewed by Integrated Medical Policy, new 2012 CPT code added, effective date is April 1, 2012. · September 12, 2012: Reviewed by Integrated Medical Policy Advisory Committee (IMPAC), and renewed without changes.

Background, Product and Disclaimer Information

Medical Necessity Guidelines are developed to determine coverage for Tufts Health Plan benefits, and are published to provide a better understanding of the basis upon which coverage decisions are made. Tufts Health Plan makes coverage decisions using these guidelines, along with the Member's benefit document, and in coordination with the Member's physician(s) on a case-by-case basis considering the individual Member's health care needs. Medical Necessity Guidelines are developed for selected therapeutic or diagnostic services found to be safe, but proven effective in a limited, defined population of patients or clinical circumstances. They include concise clinical coverage criteria based on current literature review, consultation with practicing physicians in the Tufts Health Plan service area who are medical experts in the particular field, FDA and other government agency policies, and standards adopted by national accreditation organizations. Tufts Health Plan revises and updates Medical Necessity Guidelines annually, or more frequently if new evidence becomes available that suggests needed revisions. Medical Necessity Guidelines apply to all fully insured Tufts Health Plan products unless otherwise noted in this guideline or the Member's benefit document. This guideline does not apply to Tufts Health Plan Medicare Preferred or to certain delegated service arrangements. For self-insured plans, coverage may vary depending on the terms of the benefit document. If a discrepancy exists between a Medical Necessity Guideline and a self-insured Member's benefit document, the provisions of the benefit document will govern. Applicable state or federal mandates will take precedence. Providers in the New SM Hampshire service area are subject to Cigna's provider agreements with respect to CareLink members. Treating providers are solely responsible for the medical advice and treatment of Members. The use of this guideline is not a guarantee of payment or a final prediction of how specific claim(s) will be adjudicated. Claims payment is subject to eligibility and benefits on the date of service, coordination of benefits, referral/authorization, utilization management guidelines when applicable, and adherence to plan policies, plan procedures, and claims editing logic.

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