Latest Review Date: April 2024

Category: Surgery                                                                 

POLICY:

Use of recombinant human bone morphogenetic protein-2 (rhBMP-2, InFUSE) may be considered medically necessary in skeletally mature individuals:

• For anterior lumbar interbody fusion procedures when use of autograft is not feasible; or
• For instrumented posterolateral intertransverse spinal fusion procedures when use of autograft is not feasible*; or
• For the treatment of acute, open fracture of the tibial shaft, when use of autograft is not feasible

Use of bone morphogenetic protein (rhBMP-2) is considered investigational for all other indications, including but not limited to spinal fusion and craniomaxillofacial surgery when use of autograft is feasible.

*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 ICBGH than available (e.g., for multi-level fusion).

DESCRIPTION OF PROCEDURE OR SERVICE:

Two recombinant human bone morphogenetic proteins (rhBMPs) have been extensively studied: recombinant human bone morphogenetic protein-2 (rhBMP-2), applied with an absorbable collagen sponge (Infuse™), and recombinant human bone morphogenetic protein-7 (rhBMP-7), applied in putty (OP-1®; not currently available in the U.S.). These protein 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 Protein and Carrier and Delivery Systems

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 recombinant human bone morphogenetic proteins (rhBMPs) are delivered to the bone grafting site as part of a surgical procedure; a variety of carrier and delivery systems has been investigated. Carrier systems, which are absorbed over time, maintain the concentration of the rhBMP 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 provide mechanical support.

Applications

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; ALIF), lateral (XLIF), 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 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 noninstrumented posterolateral intertransverse fusion (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.

KEY POINTS:

This policy has been updated regularly with searches of the PubMed database. The most recent literature update was performed through February 24, 2023.

Summary of Evidence

For individuals who are undergoing anterior or posterolateral lumbar spinal fusion and in whom autograft is not feasible who receive recombinant human bone morphogenetic proteins (rhBMP), the evidence includes randomized controlled trials (RCTs), systematic reviews, and meta-analyses. Relevant outcomes are symptoms, morbid events, functional outcomes, and treatment-related morbidity. In 2013, 2 systematic reviews of recombinant human bone morphogenetic proteins (rhBMP-2) trials using manufacturer-provided individual patient data were published. Overall, these reviews found little to no benefit of rhBMP-2 over iliac crest bone graft for all patients undergoing spinal fusion, with an uncertain risk of harm. The small benefits reported do not support the widespread use of rhBMP-2 as an alternative to iliac crest autograft. However, the studies do establish that rhBMP-2 has efficacy in promoting bone fusion and will improve outcomes for patients for whom use of iliac crest bone graft is not feasible. The overall adverse event rate was low, though concerns remain about increased adverse event rates with rhBMP-2, including cancer. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who are undergoing surgery for acute tibial shaft fracture and in whom autograft is not feasible who receive rhBMP, the evidence includes RCTs and systematic reviews of the RCTs. Relevant outcomes are symptoms, morbid events, functional outcomes, and treatment-related morbidity. Two systematic reviews have concluded that rhBMP can reduce reoperation rates compared with soft-tissue management with or without intramedullary nailing. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals undergoing other surgical procedures (e.g., oral and maxillofacial, hip arthroplasty, distraction osteogenesis) who receive rhBMP, the evidence includes a health technology assessment, systematic review, clinical trials, and small case series. Relevant outcomes are symptoms, morbid events, functional outcomes, and treatment-related morbidity. The evidence generally shows that rhBMP may not be as effective as a bone graft approach in craniomaxillofacial surgery; however, its use is associated with fewer adverse events. The evidence does not permit conclusions about the effect of rhBMP for tibial shaft fracture nonunion. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American Association of Neurological Surgeons et al

Guidelines on lumbar spinal fusion from the American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons were updated in 2014. AANS/CNS gave a Grade B recommendation (multiple level II studies) for the use of rhBMP-2 as a substitute for autologous iliac crest bone for anterior lumbar interbody fusion and single-level posterolateral instrumented fusion. Grade C recommendations were made for rhBMP-2 as an option for PLIF and TLIF, posterolateral fusion in patients older than 60 years, and as a graft extender for either instrumented or noninstrumented posterolateral fusions. AANS/CNS also gave a Grade C recommendation (based on multiple level IV and V studies) that the use of rhBMP-2 as a graft option has been associated with a unique constellation of complications of which the surgeon should be aware when considering the use of this graft extender/substitute.

North American Spine Society

In 2014, the North American Spine Society (NASS) issued coverage policy recommendations outlining the clinical indications for the adjunct use of rhBMP-2 in spinal fusion surgeries based on the strength of the available evidence (level I to level IV). NASS recommends adjunct use of rhBMP-2 in spinal fusion surgeries for the following clinical scenarios and qualifying criteria, as appropriate:

1. "Stand-Alone Anterior Lumbar Interbody Fusion (ALIF): in all patient groups except males with a strong reproductive priority"
2. "Posterolateral Lumbar Fusion: in all patients at high risk for nonunion with autogenous bone graft or in those with inadequate or poor quality autogenous bone available"
3. "Posterior Lumbar Interbody Fusion (PLIF and TLIF) in patients at high risk for nonunion with autogenous bone graft or in those with inadequate or poor quality autogenous bone available"
4. "Posterior Cervical or Thoracic Fusions"
   1. "in pediatric patients at very high risk for fusion failure (eg, neuromuscular scoliosis, occipitocervical pathology)"
   2. "in adult patients at high risk for nonunion, for example, revision surgery"
5. "Anterior Cervical Fusion: in patients at high risk for nonunion, for example, revision surgery"

The NASS emphasizes that rhBMP-2 is not indicated in the following scenarios:

1. "Routine anterior and posterior cervical fusion procedures"    
2. "Single level posterior/posterolateral fusions in healthy adults"
3. "Routine pediatric spine fusion procedures (eg, adolescent idiopathic scoliosis)"

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Bone morphogenetic protein, BMP, InFUSE®, OP-1, bone morphogenetic protein-2, rhBMP-2, bone morphogenetic protein-7, rhBMP-7, InFUSE™ Bone Graft/LT-CAGE™, InFUSE™ Bone Graft/INTER FIX™ Threaded Fusion Device, OP-1 Implant, OP-1 Putty, osteobiologics, BMP-7, BMP, Recombinant human bone morphogenetic protein

APPROVED BY GOVERNING BODIES:

The INFUSE® Bone Graft product (Medtronic) consists of rhBMP-2 on an absorbable collagen sponge carrier; it is used in conjunction with several carrier and delivery systems. The INFUSE® line of products has been approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process (PMA) (see summary of key approvals in Table 1).

In 2008, FDA issued a public health notification on life-threatening complications associated with rhBMP in cervical spine fusion, based on reports of complications with use of rhBMP in cervical spine fusion.1 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 described 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 FDA for AMPLIFY™. The AMPLIFY™ rhBMP-2 Matrix uses a higher dose of rhBMP (2.0 mg/mL) with a compression-resistant carrier.

OP-1® Putty (Stryker Biotech), which consists of rhBMP-7 and bovine collagen and carboxymethylcellulose, forms a paste or putty when reconstituted with saline. OP-1® Putty was initially approved by FDA through the humanitarian device exemption process (H020008) for 2 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 Biotech sought FDA permission to expand the use of OP-1® Putty to include uninstrumented posterolateral lumbar spinal fusion for the treatment of lumbar spondylolisthesis. In 2009, FDA Advisory Committee voted against the expanded approval. Olympus Biotech (a subsidiary of Olympus Corp.) acquired OP-1® assets in 2010. In 2014, Olympus closed Olympus Biotech operations in the United States and discontinued domestic sales of Olympus Biotech products. The rhBMP-7 product is no longer marketed in the United States.

Table 1. rhBMP Products and Associated Carrier and Delivery Systems Approved by FDA

Systems	Manufacturer	Approved	PMA No.
INFUSE® Bone Graft Alternative to autogenous bone graft for sinus augmentations For localized alveolar ridge augmentations in extraction socket defects	Medtronic	03/07	P050053
INFUSE® Bone Graft Expanded indication for spinal fusion procedures in skeletally mature patients with degenerative disc disease at 1 level from L4 to S1 Expanded indication for acute, open tibial shaft fractures stabilized with nail fixation		10/09	P050053/S012
INFUSE™ Bone Graft/LT-CAGE™ Lumbar Tapered Fusion Device Indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease at 1 level from L4 to S1 Up to grade 1 spondylolisthesis at involved level Implantation via anterior open or anterior laparoscopic approach	Medtronic Sofamor Danek USAa	07/02	P000058
INFUSE™ Bone Graft/LT-CAGE™ Lumbar Tapered Fusion Device Extension of device use from L2 to S1 May be used with retrolisthesis		07/04	P000058/S002
INFUSE™ Bone Graft/LT-CAGE™ Lumbar Tapered Fusion Device Indicated for acute, open tibial shaft fractures stabilized with nail fixation Alternative to autogenous bone graft for sinus augmentations For localized alveolar ridge augmentations in extraction socket defects		10/09	P000058/S033
INFUSE™ Bone Graft/Medtronic Interbody Fusion Device (Marketing name change) Expanded indication for 2 additional interbody fusion devices Perimeter Interbody Fusion Device implanted via retroperitoneal ALIF L2 to S1 or OLIF L5 to S1 Clydesdale Spinal System implanted via OLIF at single level from L2-S5		12/15	P000058/S059
INFUSE™ Bone Graft/Medtronic Interbody Fusion Device Expanded indication for 2 additional interbody fusion devices: Divergence-L Anterior/Oblique Lumbar Fusion System Pivox™ Oblique Lateral Spinal System		09/17	P000058/S065

ALIF: anterior lumbar interbody fusion; FDA: Food and Drug Administration; OLI: oblique lateral interbody fusion; rhBMP: recombinant human bone morphogenetic protein; S: supplement.

a Medtronic is the manufacturer for all of the INFUSE bone graft and carrier systems.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP: Special benefit consideration may apply. Refer to member’s benefit plan.

CURRENT CODING:

There is not CPT or HCPCS code for bone morphogenic protein.  In 2011, CPT code 20930 was revised to include BMP-type materials used in spine surgery. 

CPT Code:

20930

Allograft, morselized, or placement of osteopromotive material, for spine surgery only (List separately in addition to code for primary procedure)

REFERENCES:

1. Cannada LK, Tornetta P, Obremskey WT et al. A Randomized Controlled Trial Comparing rhBMP-2/Absorbable Collagen Sponge Versus Autograft for the Treatment of Tibia Fractures With Critical Size Defects. J Orthop Trauma. Aug 2019;33(8): 384-391.
2. Carragee EJ, Chu G, Rohatgi R et al. Cancer risk after use of recombinant bone morphogenetic protein-2 for spinal arthrodesis. J Bone Joint Surg Am Sep 04 2013; 95(17):1537-1545.
3. Carragee EJ, Hurwitz EL, Weiner BK. A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lessons learned. Spine J Jun 2011; 11(6):471-491.
4. Cooper GS, Kou TD. Risk of cancer after lumbar fusion surgery with recombinant human bone morphogenic protein-2 (rh-BMP-2). Spine. Oct 1 2013;38(21): 1862-8.
5. Cooper GS, Kou TD. Risk of Cancer Following Lumbar Fusion Surgery With Recombinant Human Bone Morphogenic Protein-2 (rhBMP-2): An Analysis Using a Commercially Insured Patient Population. Int J Spine Surg. Apr 2018; 12(2): 260-268.
6. 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.
7. Dettori JR, Chapman JR, DeVine JG et al. Longer follow-up continues to reveal no increased risk of cancer with the use of recombinant human bone morphogenetic protein in spine fusion. Spine J. Oct 2019;19(10): 1640-1647.
8. Einhorn TA. Clinical applications of recombinant human BMPs: early experience and future development. J Bone Joint Surg Am. 2003; 85-A Suppl 3: 82-8.
9. Feng JT, Yang XG, Wang F et al. Efficacy and safety of bone substitutes in lumbar spinal fusion: a systematic review and network metaanalysis of randomized controlled trials. Eur Spine J. Jun 2020; 29(6): 1261-1276.
10. 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.
11. Garrison KR, Shemilt I, Donell S et al. Bone morphogenetic protein (BMP) for fracture healing in adults. Cochrane Database Syst Rev. Jun 16 2010(6): CD006950.
12. Govender S, Csimma C, Genant HK, et al. Recombinant human bone morphogenetic protein-2 for treatment of open tibial fractures: a prospective, controlled, randomized study of four hundred and fifty patients. J Bone Joint Surg Am. Dec 2002; 84(12): 2123-34.
13. Howard JM, Glassman SD, Carreon LY. Posterior iliac crest pain after posterolateral fusion with or without iliac crest graft harvest. Spine J June 2011; 11(6):534-537.
14. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
15. 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. Jul 2014; 21(1): 106-132.
16. Khan TR, Pearce KR, McAnany SJ, et al. Comparison of transforaminal lumbar interbody fusion outcomes in patients receiving rhBMP-2 versus autograft. Spine J. Mar 2018; 18(3):439-446.
17. Liu S, Wang Y, Liang Z et al. Comparative Clinical Effectiveness and Safety of Bone Morphogenetic Protein Versus Autologous Iliac Crest Bone Graft in Lumbar Fusion: a meta-analysis and systematic review. Spine. (Phila Pa 1976). Jun 15 2020; 45(12): E729-E741.
18. Lyon T, Scheele W, Bhandari M, et al. Efficacy and safety of recombinant human bone morphogenetic protein-2/calcium phosphate matrix for closed tibial diaphyseal fracture: a double-blind, randomized, controlled phase-II/III trial. J Bone Joint Surg Am. Dec 4 2013; 95(23):2088-2096.
19. Mariscal G, Nunez JH, Barrios C et al. A meta-analysis of bone morphogenetic protein-2 versus iliac crest bone graft for the posterolateral fusion of the lumbar spine. J. Bone Miner. Metab. Jan 2020;38(1): 54-62.
20. North American Spine Society (NASS). NASS Coverage Policy Recommendations: Recombinant Human Bone Morphogenetic Protein (rhBMP-2). 2014. www.spine.org/Product-Details?productid=%7B9567DDCC-4EC7-E411-9CA5-005056AF031E%7D.
21. Ramly EP, Alfonso AR, Kantar RS et al. Safety and Efficacy of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2) in Craniofacial Surgery. Plast Reconstr Surg Glob Open. Aug 2019;7(8): e2347.
22. Ratko TA, Belinson SE, Samson D, et al. Bone Morphogenetic Protein: The State of the Evidence of On-Label and Off-Label Use. Rockville (MD): Agency for Healthcare Research and Quality (US); August 6, 2010.
23. Schultz DG, Center for Devices and Radiological Health, Food and Drug Administration (FDA). FDA Public Health Notification: Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion [letter]. 2008 July 1; www.tccortho.com/pdf/FDAPublic%20Health%20Note.pdf
24. 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. 
25. U.S. Food and Drug Administration (FDA). Summary of Safety and Effectiveness: InFUSE Bone Graft/LT-Cage Lumbar Tapered Fusion Device [P000058]. 2002; www.accessdata.fda.gov/cdrh_docs/pdf/P000058b.pdf.
26. U.S. Food and Drug Administration. Infuse Bone Graft. Summary of safety and effectiveness data. March 2007. www.accessdata.fda.gov/cdrh_docs/pdf5/P050053B.pdf.
27. United States Senate Finance Committee. Staff report on Medtronic’s influence on INFUSE clinical studies. Int J Occup Environ Health. 2013; 19(2):67-76.
28. Valentin-Opran A, Wozney J, Csimma C, et al. Clinical evaluation of recombinant human bone morphogenetic protein-2. Clin Orthop Relat Res. Feb 2002; (395): 110-20.
29. Wu Z, Zhou B, Chen L, et al. Bone morphogenetic protein-2 against iliac crest bone graft for the posterolateral fusion of the lumbar spine: A meta-analysis. Int J Clin Pract. Apr 2021; 75(4): e13911. 
30. Zadegan SA, Abedi A, Jazayeri SB, et al. Bone morphogenetic proteins in anterior cervical fusion: a systematic review and meta-analysis. World Neurosurg. Aug 2017; 104:752-787.

POLICY HISTORY:

Medical Policy Group, July 2004 (2)

Medical Policy Administration Committee, August 2004

Available for comment August 11-September 24, 2004

Medical Policy Group, July 2006 (1)

Medical Policy Group, July 2008 (1)

Medical Policy Panel, June 2009

Medical Policy Group, June 2009 (2)

Medical Policy Administration Committee, July 2009

Available for comment July 2-August 15, 2009

Medical Policy Group, August 2010 (2)

Medical Policy Administration Committee, September 2010

Available for comment September 4-October 18, 2010

Medical Policy Group, October 2010

Medical Policy Panel, November 2012

Medical Policy Group, January 2013 (2): Policy statement excluding coverage for cervical fusion added.  Key Points, Approved by Governing Bodies, References updated to reflect changes.  Information regarding high-risk patients for fusion added to Key Points

Medical Policy Administration Committee, February 2013

Available for comment February 21 through April 7, 2013

Medical Policy Panel, September 2013

Medical Policy Group, September 2013 (2): Policy statement changed to coverage when harvesting of iliac crest bone graft bone is unfeasible.  Description, Key Points, References updated to support policy changes.  CPT code added.  ICD-10-PC code added. Deleted coverage statements prior to 2009

Medical Policy Group, October 2013 (2): Removed ICD-9 Procedure codes; no change to policy statement.

Medical Policy Administration Committee, October 2013

Available for comment October 16 through November 30, 2013

Medical Policy Panel, November 2013

Medical Policy Group, November 2013 (2): Policy updated with literature review through October 2013. Added coverage for treatment of tibial shaft with BMP-2 (when autograft is unfeasible). Returned to use of FDA language regarding treatment of noninstrumented revision posterolateral intertransverse lumbar spinal fusion with BMP-7 where use of autograft is unfeasible.  Additional instructions added to Coding section.  Key Points and References updated to support policy changes. 

Medical Policy Administration Committee, December 2013

Available for comment December 17, 2013 through January 30, 2014

Medical Policy Panel, November 2014

Medical Policy Group (4): Added to Policy that OP-1 is no longer sold in United States. Update to Description, Key Points, and References. Added Appendix section.

Medical Policy Panel, April 2016

Medical Policy Group, April 2016 (7): Note added to Policy Statement that rhBMP-7, OP-1 no longer being marketed in the US as of 2014; Description,  Key Points, Approved by Governing Bodies, and References.

Medical Policy Panel, October 2017

Medical Policy Group, October 2017 (7): 2017 Updates to Key Points, Approved by Governing Bodies and References. Updated policy statement- rhBMP-7, OP-1 removed from policy statement due to rhBMP-7, OP-1 no longer being marketed in the US as of 2014. Craniomaxillofacial surgery added to “included, but not limited…” to statement as not meeting medical criteria for coverage.

Medical Policy Panel, April 2018

Medical Policy Group, May 2018 (7): Updates to Key Points and References. No change in Policy Statement.

Medical Policy Panel, April 2019

Medical Policy Group, April 2019 (7): Updates to Key Points and References. No change in Policy Statement.

Medical Policy Panel, April 2020

Medical Policy Group, April 2020 (7): Updates to Key Points and References. No change in Policy Statement.

Medical Policy Panel, April 2021

Medical Policy Group, April 2021 (7): Updates to Description, Key Points, and References. No change to Policy Statement.

Medical Policy Panel, April 2022

Medical Policy Group, April 2022 (7): Updates to Key Points and References. No change to Policy Statement.

Medical Policy Panel, April 2023

Medical Policy Group, April 2023 (7): Updates to Key Points, Benefit Application and References. Replaced the word “patients” with the word “individuals” and “not medically necessary” statement replaced with “Investigational” in Policy Statement. No change to policy intent.

Medical Policy Panel, April 2024

Medical Policy Group, April 2024 (7): Updates to Key Points and References. Removed contraindication information and statement, “As of 2014, rhBMP-7 is no longer marketed in the United States,” from Policy Statement. No change in policy intent.

 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

 

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.

Appendix

Procedures used for lumbar interbody fusion differ primarily in the direction of approach to the spine, i.e., from the front (anterior), from the back (posterior or transforaminal) or from the side (lateral). An alternative approach to interbody fusion is arthrodesis of the transverse processes alone (posterolateral), which does not fuse the adjoining vertebral bodies. Circumferential fusion fuses both the adjacent vertebral bodies and the transverse processes, typically using both an anterior and posterior approach to the spine.

Open and Minimally Invasive Approaches to Lumbar Interbody Fusion

Procedures	Access	Approach	Visualization
Anterior (ALIF)	Open, MI, or laparoscopic	Transperitoneal or retroperitoneal	Direct, endoscopic or laparoscopic with fluoroscopic guidance Direct, endoscopic or microscopic, with fluoroscopic guidance
Posterior (PLIF)	Open or MI	Incision centered over spine with laminectomy/laminotomy and retraction of nerve	Direct, endoscopic or microscopic, with fluoroscopic guidance
Transforaminal (TLIF)	Open or MI	Offset from spine, through the intervertebral foramen via unilateral facetectomy	Direct, endoscopic or microscopic, with fluoroscopic guidance
Lateral Extreme lateral (XLIF) Direct Lateral (DLIV)	MI	Retroperitoneal through transpsoas	Direct, with neurologic monitoring and fluoroscopic guidance

LIF: lumbar interbody fusion; MI: minimally invasive

Anterior Lumbar Interbody Fusion

Anterior access provides direct visualization of the disc space, potentially allowing a more complete discectomy and better fusion than lateral or posterior approaches. An anterior approach avoids trauma to the paraspinal musculature, epidural scarring, traction on nerve roots, and dural tears. However, the retraction of the great vessels, peritoneal contents, and superior hypogastric sympathetic plexus with a peritoneal or retroperitoneal approach place these structures at risk of iatrogenic injury. Access to the posterior space for the treatment of nerve compression is also limited. Laparoscopic anterior lumbar interbody fusion has also been investigated.

Posterior Lumbar Interbody Fusion

Posterior lumbar interbody fusion (PLIF) can be performed through either a traditional open procedure with a midline incision or with a minimally invasive approach using bilateral paramedian incisions. In the open procedure, the midline muscle attachments are divided along the central incision to facilitate wide muscle retraction and laminectomy. In minimally invasive PLIF, tubular retractors may be used to open smaller central bilateral working channels to access the pedicles and foramen. Minimally invasive PLIF typically involves partial laminotomies and facetectomies. The decompression allows treatment of spinal canal pathology (e.g., spinal stenosis, lateral recess and foraminal stenosis, synovial cysts, hypertrophic ligamentum flavum), as well as stabilization of the spine through interbody fusion.

Transforaminal Lumbar Interbody Fusion

Transforaminal lumbar interbody fusion (TLIF) is differentiated from the more traditional bilateral PLIF by a unilateral approach to the disc space through the intervertebral foramen. In minimally invasive TLIF, a single incision about 2 to 3 cm in length is made approximately 3 cm lateral to the midline. A tubular retractor is docked on the facet joint complex and a facetectomy with partial laminectomy is performed. Less dural retraction is needed with access through the foramen via unilateral facetectomy, and contralateral scar formation is eliminated. TLIF provides access to the posterior elements along with the intervertebral disc space.

Lateral Interbody Fusion

Lateral interbody fusion (e.g., extreme lateral interbody fusion or direct lateral interbody fusion) uses specialized retractors in a minimally invasive, lateral approach to the anterior spine through the psoas. In comparison with ALIF, the lateral approach does not risk injury to the peritoneum or great vessels. However, exposure to the spine may be more limited, and dissection of the psoas major places the nerves of the lumbar plexus at risk. Electromyographic monitoring and dissection predominantly within the anterior psoas major may be utilized to reduce the risk of nerve root injury. These various factors decrease the ability to perform a complete discectomy and address pathology of the posterior elements.

Circumferential Fusion

Circumferential fusion is 360° fusion that joins vertebrae by their entire bodies and transverse processes, typically through an anterior and posterior approach.

Posterolateral Fusion

Posterolateral fusion is a procedure where the transverse processes of the involved segments are decorticated and covered with a mixture of bone autograft or allograft.