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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-20000-32

Original Effective Date: 01/01/06

Reviewed: 05/26/16

Revised: 06/15/16

Subject: Bone Morphogenetic Protein (BMP)

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Update  
           

DESCRIPTION:

Bone morphogenetic proteins (BMPs) 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. The 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 nonunion, 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]; see Appendix). 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, TLIF) allow decompression (via laminotomies and facetectomies) for treatment of spinal canal pathology (eg, spinal stenosis, lateral recess and foraminal stenosis, synovial cysts, hypertrophic ligamentum flavum) along with stabilization of the spine and are differentiated from instrumented or noninstrumented 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 (eg, radiculopathies). Increased risk of bone resorption around rhBMP grafts, heterotopic bone formation, epidural cyst formation, and seromas has also been postulated.

Regulatory Status

At the present time, two rh-BMPs and associated carrier/delivery systems have received approval from the U.S. Food and Drug Administration (FDA):

  1. OP-1 (rhBMP-7) received FDA approval through the Humanitarian Device Exemption (HDE) process. 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-like substance. As of 2014, OP-1 (rhBMP-7) is no longer sold in the United States.
  2. The InFUSE™ system consists of rh-BMP-2 on an absorbable collagen sponge carrier. 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. The labeled indications for these devices are summarized below.

The InFUSE™ Bone Graft/LT-Cage Lumbar Tapered Fusion device is contraindicated in patients who are pregnant, who may be allergic to any of the materials contained in the device, 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.

POSITION STATEMENT:

Use of recombinant human bone morphogenetic protein-2 (rhBMP-2, InFUSE™) meets the definition of medical necessity in skeletally mature individuals for the following indications:

*NOTE: Use of iliac crest bone graft (ICBG) may be considered not feasible due to situations that may include, but are not limited to, prior harvesting of ICBG, or a need for a greater quantity of ICBG than is available (eg, for multilevel fusion).

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

BILLING/CODING INFORMATION:

There is no specific CPT or HCPCS code for bone morphogenetic protein. In 2011, CPT code 20930 was revised to include BMP-type materials used in spine surgery.

LOINC Codes:

The following information may be required documentation to support medical necessity: Physician history and physical, initial assessment, procedure note, visit note.

Documentation Table

LOINC Codes

LOINC
Time Frame
Modifier Code

LOINC Time Frame Modifier Codes Narrative

Physician history and physical

28626-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Physician Initial Assessment

18736-9

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Physician procedure note

11505-5

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Attending physician visit note

18733-6

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline reviewed date.

DEFINITIONS:

Autograft: a tissue (or an organ) transferred by grafting into a new position in the body of the same individual.

Discogenic: having to do with vertebral disc.

Intertransverse: see “posterolateral”.

Intramedullary: associated with the medullary cavity of a long bone, usually the femur or tibia.

Morphogenetic (morphogenesis): the ability of a molecule or group of molecules to assume a certain shape; differentiation of cells and tissues in the early embryo that establishes the form and structure of the various organs and parts of the body.

Nonunion fractures: fracture site that shows no visibly progressive signs of healing after 3 months or more, as confirmed by serial radiographs (i.e., bone healing has ceased).

Posterolateral: behind and to one side of, specifically to the outer side.

Recalcitrant: resistant; stubborn.

Retrolisthesis: Prolapsed intervertebral disc; a condition in which, due to a tear in the outer fibrous ring, the central part of the intervertebral disc is protruding into the spinal canal; most commonly occurring in the lowermost part of the spine, especially between the fourth and fifth vertebral bodies and between the fifth vertebral body and the sacrum; the protrusion usually occurs to one side of the spinal canal, at the point where a nerve root leaves the canal.

RELATED GUIDELINES:

None applicable.

OTHER:

Other index terms for bone morphogenetic protein:

Note: The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Bone morphogenetic protein
Bone morphogenic protein
InFUSE™ Bone Graft – INTER FIX or LT-Cage Lumbar Tapered Fusion Device
InFUSE™ Bone Graft/Interbody Fusion Device
OP-1 Implant or Putty
rh-BMP-2
rh-BMP-7

REFERENCES:

  1. Agency for Healthcare Research and Quality (AHRQ). Technology Assessment, Bone Morphogenetic Protein: The State of the Evidence of On-Label and Off-Label Use (08/06/10).
  2. American Academy of Orthopaedic Surgeons. Bone Grafts in Spine Surgery, (07/10)
  3. American Academy of Orthopaedic Surgeons. Nonunions, (06/10).
  4. American Academy of Orthopaedic Surgeons. Spinal Fusion, (updated 07/01; accessed 08/09/06).
  5. American Association of Neurological Surgeons/Congress of Neurological Surgeons. “Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 16: bone graft extenders and substitutes”. National Guideline Clearinghouse completed by ECRI 01/08/07; verified 01/29/07.
  6. Baskin DS, Ryan P, Sonntag V, Westmark R, Widmayer MA. “A prospective, randomized, controlled cervical fusion study using recombinant human bone morphogenetic protein-2 with the CORNERSTONE-SR allograft ring and the ATLANTIS anterior cervical plate.” Spine. 2003 Jun 15; 28(12): 1219-25; discussion 1225.
  7. Blue Cross Blue Shield Association Medical Policy 7.01.100 Bone Morphogenetic Protein, (April 2016).
  8. Boden SD, Kang J, Sandhu H, Heller JG. “Use of recombinant human bone morphogenetic protein-2 to achieve posterolateral lumbar spine fusion in humans: a prospective, randomized clinical pilot trial: 2002 Volvo Award in clinical studies.” Spine. 2002 Dec 1; 27(23): 2662-73.
  9. Brown JV, et al. Systematic review and meta-analysis of the safety and efficacy of recombinant human bone morphogenetic protein-2 (rhBMP-2) for spinal fusion. Report to the YODA Project. (2013).
  10. Burkus JK, Dorchak JD, Sanders DL. “Radiographic assessment of interbody fusion using recombinant human bone morphogenetic protein type 2.” Spine. 2003 Feb 15; 28(4): 372-7.
  11. Burkus JK, Gornet MF, Dickman CA, Zdeblick TA. “Anterior lumbar interbody fusion using rhBMP-2 with tapered interbody cages.” J Spinal Disord Tech. 2002 Oct; 15(5): 337-49.
  12. 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 Joint Surg Am. 2005 Jun; 87(6): 1205-12.
  13. Burkus JK, Sandhu HS, Gornet MF. Influence of rhBMP-2 on the healing patterns associated with allograft Interbody constructs in comparison with autograft. Spine. 2006 Apr 1; 31(7): 775-81.
  14. Burkus JK, Transfeldt EE, Kitchel SH, Watkins RG, Balderston RA. “Clinical and radiographic outcomes of anterior lumbar interbody fusion using recombinant human bone morphogenetic protein-2.” Spine. 2002 Nov 1; 27(21): 2396-408.
  15. Dahabreh Z, Calori GM, Kanakaris NK, Nikolaou VS, Giannoudis PV. A cost analysis of treatment of tibial fracture nonunion by bone grafting or bone morphogenetic protein-7. Int Orthop. 2009 Oct;33(5):1407-14. Epub 2008 Dec 4.
  16. Dai J, Li L, Jiang C, et al. Bone Morphogenetic Protein for the Healing of Tibial Fracture: A Meta-Analysis of Randomized Controlled Trials. PLoS One. 2015;10(10):e0141670.
  17. ECRI Health Technology Assessment. Interbody cage with bone morphogenetic protein for degenerative disc disease. (December 2003).
  18. ECRI Target Report #849Osteogenic protein-1 (OP-1) for spinal fusion. (07/04).
  19. ECRI Windows on Medical Technology. (2004, December). Interbody cage with bone morphogenetic protein (InFUSE/LT-CAGE) for degenerative disc disease (12.04).
  20. ECRI Windows on Medical Technology. Recombinant human osteogenic protein-1 (rhOP-1) for healing nonunion fractures of the tibia. (01/05).
  21. Fiorellini JP, Howell TH, Cochran D, Malmquist J, Lilly LC, Spagnoli D, Toljanic J, Jones A, Nevins M. “Randomized study evaluating recombinant human bone morphogenetic protein-2 for extraction socket augmentation.” J Periodontol. 2005 Apr; 76(4): 605-13.
  22. Friedlaender GE. “Osteogenic protein-1 in treatment of tibial nonunions: current status.” Surg Technol Int. 2004; 13: 249-52.
  23. Fu R, Selph S, McDonagh M, et al. Effectiveness and harms of recombinant human bone morphogenetic protein-2 in spine fusion: a systematic review and meta-analysis. Ann Intern Med. Jun 18 2013;158(12):890-902.
  24. Garrison K, Shemilt I, Donell S, Ryder J, Mugford M, Harvey I, Song F. Bone morphogenetic protein (BMP) for fracture healing in adults. (Protocol) Cochrane Database of Systematic Reviews 2008, Issue 1. Art. No.: CD006950. DOI: 10.1002/14651858.CD006950.
  25. Haid RW Jr, Branch CL Jr, Alexander JT, Burkus JK. “Posterior lumbar interbody fusion using recombinant human bone morphogenetic protein type 2 with cylindrical interbody cages.” Spine J. 2004 Sep-Oct; 4(5): 527-38; discussion 538-9.
  26. Hayes Medical Technology Directory; “Recombinant Human Bone Morphogenetic Protein for Use In Bone Repair” (03/06/04).
  27. Hoffmann MF, Jones CB, Sietsema DL. Recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) in posterolateral lumbar spine fusion: complications in the elderly. J Orthop Surg Res. 2013 Jan 14;8:1.
  28. Hunter DJ, Pike MC, Jonas BL, Kissin E, Krop J, McAlindon T. Phase 1 safety and tolerability study of BMP-7 in symptomatic knee osteoarthritis. BMC Musculoskelet Disord. 2010 Oct 10;11:232.
  29. Johnsson R, Stromqvist B, Aspenberg P. “Randomized radiostereometric study comparing osteogenic protein-1 (BMP-7) and autograft bone in human noninstrumented posterolateral lumbar fusion: 2002 Volvo Award in clinical studies.” Spine. 2002 Dec 1; 27(23): 2654-61.
  30. Jones AL, Bucholz RW, Bosse MJ, Mirza SK, Lyon TR, Webb LX, Pollak AN, Golden JD, Valentin-Opran A; BMP-2 Evaluation in Surgery for Tibial Trauma-Allgraft (BESTT-ALL) Study Group. Recombinant human BMP-2 and allograft compared with autogenous bone graft for reconstruction of diaphyseal tibial fractures with cortical defects. A randomized, controlled trial. J Bone Joint Surg Am. 2006 Jul; 88(7): 1431-41.
  31. Kaiser MG, Groff MW, Watters WC, 3rd, et al. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 16: bone graft extenders and substitutes as an adjunct for lumbar fusion. J Neurosurg Spine. 2014; 21(1):106-32.
  32. Kanayama M, Hashimoto T, Shigenobu K, Yamane S, Bauer TW, Togawa D. A prospective randomized study of posterolateral lumbar fusion using osteogenic protein-1 (OP-1) versus local autograft with ceramic bone substitute: emphasis of surgical exploration and histologic assessment. Spine. 2006 May 1; 31(10): 1067-74.
  33. Katayama Y, Matsuyama Y, Yoshihara H, Sakai Y, Nakamura H, Imagama S, Ito Z, Wakao N, Kamiya M, Yukawa Y, Kanemura T, Sato K, Iwata H, Ishiguro N. Clinical and radiographic outcomes of posterolateral lumbar spine fusion in humans using recombinant human bone morphogenetic protein-2: an average five-year follow-up study. Int Orthop. 2009 Aug;33(4):1061-7. Epub 2008 Jun 26.
  34. Luhmann SJ, Bridwell KH, Cheng I, Imamura T, Lenke LG, Schootman M. Use of bone morphogenetic protein-2 for adult spinal deformity. Spine. 2005 Sep 1; 30(17 Suppl): S110-7.
  35. Simmonds MC, Brown JV, Heirs MK, et al. Safety and effectiveness of recombinant human bone morphogenetic protein-2 for spinal fusion: a meta-analysis of individual-participant data. Ann Intern Med. Jun 18 2013;158(12):877-889.
  36. Skovrlj B, Marquez-Lara A, Guzman JZ, Qureshi SA. A review of the current published spinal literature regarding bone morphogenetic protein-2: an insight into potential bias. Curr Rev Musculoskelet Med. 2014 Sep;7(3):182-8.
  37. Swiontkowski MF, Aro HT, Donell S, Esterhai JL, Goulet J, Jones A, Kregor PJ, Nordsletten L, Paiement G, Patel A. Recombinant human bone morphogenetic protein-2 in open tibial fractures. A subgroup analysis of data combined from two prospective randomized studies.J Bone Joint Surg Am. 2006 Jun;88(6):1258-65.
  38. U.S. Food and Drug Administration Summary of Safety and Effectiveness. InFUSE Bone Graft/LT Cage Lumbar Tapered Fusion Device, (accessed 10/27/05).
  39. U.S. Food and Drug Administration Summary of Safety and Probable Benefit. OP-1 Putty, (accessed 10/27/05).
  40. U.S. Food and Drug Administration Summary of Safety and Probable. OP-1 Implant Benefit, (accessed 10/27/05).
  41. U.S. Food and Drug Administration; indications for INTER FIX Threaded Fusion Device, (accessed 10/27/05).
  42. U.S. Food and Drug Administration. FDA Public Health Notification: Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion. 2008. Accessed at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062000.htm.
  43. Vaccaro AR, Anderson DG, Patel T, Fischgrund J, Truumees E, Herkowitz HN, Phillips F, Hilibrand A, Albert TJ, Wetzel T, McCulloch JA. Comparison of OP-1 Putty (rhBMP-7) to iliac crest autograft for posterolateral lumbar arthrodesis: a minimum 2-year follow-up pilot study. Spine. 2005 Dec 15; 30(24): 2709-16.
  44. Vaccaro AR, Patel T, Fischgrund J, Anderson DG, Truumees E, Herkowitz HN, Phillips F, Hilibrand A, Albert TJ, Wetzel T, McCulloch JA. A pilot study evaluating the safety and efficacy of OP-1 Putty (rhBMP-7) as a replacement for iliac crest autograft in posterolateral lumbar arthrodesis for degenerative spondylolisthesis. Spine. 2004 Sep 1; 29(17): 1885-92.
  45. Villavicencio AT, Burneikiene S, Nelson EL, Bulsara KR, Favors M, Thramann J. Safety of transforaminal lumbar interbody fusion and intervertebral recombinant human bone morphogenetic protein-2. J Neurosurg Spine. 2005 Dec; 3(6): 436-43.
  46. Woo EJ. Adverse events after recombinant human BMP2 in nonspinal orthopaedic procedures. Clin Orthop Relat Res. 2013 May;471(5):1707-11.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 05/26/16.

GUIDELINE UPDATE INFORMATION:

01/01/06

New Medical Coverage Guideline.

09/15/06

Scheduled review; expand coverage statement to include multiple level spinal fusions; remove non-coverage statement regarding multiple level spinal fusion procedures.

09/15/07

Scheduled review; typographical corrections were made; reformatted guideline; updated references.

07/15/08

Scheduled review; no change in position statement; references updated; guideline is moved to “no longer scheduled for routine review” status.

11/15/10

Reviewed and revised to clarify Position Statements; formatting changes; references updated.

09/15/11

Revision; formatting changes.

04/15/12

Scheduled review; Position Statement revised; references updated; formatting changes.

05/11/14

Revision: Program Exceptions section updated.

10/15/14

Revision: Billing and Coding Information section.

06/15/16

Scheuled review. Revised description section, Position Statement, and Billing/Coding Information section. Updated references. Reformatted guideline.

Date Printed: December 16, 2017: 09:21 PM