497 Form

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Medical Policy Ultrasound Accelerated Fracture Healing Device Table of Contents
• Policy: Commercial • Description
• References • Policy: Medicare • Policy History
• Coding Information • Authorization Information • Information Pertaining to All Policies

Policy Number: 497 BCBSA Reference Number: 1.01.05 (For Plan internal use only) Related Policies
• Bone Morphogenetic Protein, #097 • Electrical Bone Growth Stimulation of the Appendicular Skeleton, #499 • Electrical Stimulation of the Spine as an Adjunct to Spinal Fusion Procedures, #498 Policy
Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity

Low-intensity pulsed ultrasound is considered INVESTIGATIONAL as a treatment of fresh fractures (surgically managed or non-surgically managed).

Low-intensity pulsed ultrasound is considered INVESTIGATIONAL as a treatment of fracture nonunion and delayed union fractures.

Low-intensity pulsed ultrasound is considered INVESTIGATIONAL as a treatment of stress fractures, osteotomy, and distraction osteogenesis.

Prior Authorization Information
Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

Outpatient Commercial Managed Care (HMO and POS) This is not a covered service. Commercial PPO and Indemnity This is not a covered service. CPT Codes / HCPCS Codes / ICD Codes

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Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

The following codes are included below for informational purposes only; this is not an all-inclusive list.

The following CPT and HCPCS codes are considered investigational for Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity:

CPT Codes CPT codes: Code Description 20979 Low intensity ultrasound stimulation to aid bone healing, noninvasive (nonoperative) HCPCS Codes HCPCS codes: Code Description E0760 Osteogenesis stimulator, low-intensity ultrasound, non-invasive

Description Bone Fractures An estimated 178 million new fractures were reported worldwide in 2019.1, Most bone fractures heal spontaneously over several months following standard fracture care (closed reduction if necessary, followed by immobilization with casting or splinting). However, approximately 5% to 10% of all fractures have delayed healing, resulting in continued morbidity and increased utilization of health care services.2, Factors contributing to a nonunion include which bone is fractured, fracture site, the degree of bone loss, time since injury, the extent of soft tissue injury, and patient factors (eg, smoking, diabetes, systemic disease).2

Fracture Nonunion There is no standard definition of a fracture nonunion.3, The U.S. Food and Drug Administration (FDA) has defined nonunion as when "a minimum of 9 months has elapsed since injury, and the fracture site shows no visibly progressive signs of healing for a minimum of 3 months." Other definitions cite 3 to 6 months of time from the original injury, or simply when serial radiographs fail to show any further healing. These definitions do not reflect the underlying conditions in fractures that affect healing, such as the degree of soft tissue damage, alignment of the bone fragments, vascularity, and quality of the underlying bone stock.

Delayed Union Delayed union is generally considered a failure to heal between 3 and 9 months post-fracture, after which the fracture site would be considered a nonunion. The delayed union may also be defined as a decelerating bone healing process, as identified in serial radiographs. (In contrast, nonunion serial radiographs show no evidence of healing.) It is important to include both radiographic and clinical criteria to determine fracture healing status. Clinical criteria include the lack of ability to bear weight, fracture pain, and tenderness on palpation.

Treatment Low-intensity pulsed ultrasound has been proposed to accelerate healing of fractures. Low-intensity pulsed ultrasound is believed to alter the molecular and cellular mechanisms involved in each stage of the healing process (inflammation, soft callus formation, hard callus formation, and bone remodeling). The mechanism of action at the cellular level is not precisely known, but it is theorized that low-intensity pulsed ultrasound may stimulate the production or the activities of the following compounds that

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contribute to the bone healing process: cyclooxygenase-2, collagenase, integrin proteins, calcium, chondroblasts, mesenchymal cells, fibroblasts, and osteoblasts.

Low-intensity pulsed ultrasound treatment is self-administered, once daily for 20 minutes, until the fracture has healed.

Summary Description Low-intensity pulsed ultrasound (LIPUS) has been investigated as a technique to accelerate healing of fresh fractures, surgically treated closed fractures, delayed unions, nonunions, stress fractures, osteotomy sites, and distraction osteogenesis. LIPUS is administered using a transducer applied to the skin surface overlying the fracture site.

Summary of Evidence For individuals who have fresh fractures (surgically or nonsurgically managed) who receive low-intensity pulsed ultrasound (LIPUS) as an adjunct to routine care, the evidence includes randomized controlled trials (RCTs) and several meta-analyses. Relevant outcomes are symptoms, morbid events, functional outcomes, and quality of life. The evidence base has evolved with the publication of a large RCT and meta- analysis significantly shifting the weight of the evidence. Conclusions based on several earlier and small RCTs, rated at high-risk of bias, showed a potential benefit; however, the large RCT published in 2016, rated at low-risk of bias, showed no benefit. A 2017 meta-analysis including only trials with low-risk of bias found no difference in days to full weight-bearing, pain reduction, or days to radiographic healing. Similarly, the overall results of the meta-analysis found no significant difference in return to work, subsequent operations, or adverse events. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have fracture nonunion or delayed union fracture who receive LIPUS as an adjunct to routine care including surgery, if appropriate, the evidence includes systematic reviews, RCTs, and uncontrolled studies. Relevant outcomes are symptoms, morbid events, functional outcomes, and quality of life. There are 2 meta-analyses (2017) without controlled comparative results. A third meta-analysis, which included all types of fractures, identified 3 RCTs of patients with nonunion; however, all 3 trials were considered at high-risk of bias (one published as a thesis). One meta-analysis specific to individuals with instrumented, infection, or fragility-related non-union found few RCTs and results were largely based on case series. A Canadian multicenter, prospective, double-blinded RCT (SNAPU) trial evaluated whether active LIPUS accelerates the time to union following surgery for scaphoid nonunion, involving 142 subjects (69 in the active LIPUS group and 73 in the sham group). The study found no significant differences in the time to union (p =.854) or any secondary outcomes, except for wrist flexion at baseline (p =.008) and final follow-up (p =.043). Subgroup analyses based on device compliance showed no differences in union rates or time to union between compliance subgroups. Of the earlier 2 RCTs, one did not include functional outcomes; the second trial had a small sample size and did not describe the randomization procedure. The observational study reported similar healing rates with LIPUS and surgery, although the retrospective nature of the study limits meaningful interpretation of these results. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have stress fractures, osteotomy sites, or distraction osteogenesis who receive LIPUS as an adjunct to routine care, the evidence includes only lower quality studies consisting of small RCTs, retrospective comparative observational studies, and one meta-analysis for distraction osteogenesis. Relevant outcomes are symptoms, morbid events, functional outcomes, and quality of life. Results do not generally include functional outcomes and results across various outcomes, primarily time to radiographic healing, are inconsistent. The meta-analysis of 3 trials using LIPUS ultrasound for distraction osteogenesis reported no statistically significant differences in physiological or functional outcomes. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Policy History

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Date Action 6/2025 Policy updated with literature review through January 30, 2025; references added. Policy statements unchanged. 5/2024 Annual policy review. References updated. Policy statements unchanged. 5/2023 Annual policy review. Description, summary and references updated. Policy statements unchanged. 5/2022 Annual policy review. Description, summary and references updated. Not medically necessary policy statements updated to investigational for policy standardization purposes. Policy intent unchanged.
4/2021 Annual policy review. References updated. Policy statements unchanged. 1/2021 Medicare information removed. See MP #132 Medicare Advantage Management for local coverage determination and national coverage determination reference.
5/2020 Annual policy review. Description, summary and references updated. Policy statements unchanged. 4/2019 Annual policy review. Description, summary and references updated. Policy statements unchanged. 4/2018 Annual policy review. Summary clarified. 2/2018 Annual policy review. The following indications were changed from medically necessary to not medically necessary: fresh fractures (surgically and nonsurgically managed) and nonunion/delayed union fractures. Clarified coding information. Effective 2/1/2018. 10/2016 Annual policy review. New references added. 10/2016 Coding information clarified. 3/2015 Annual policy review. New references added.
7/2014 Updated Coding section with ICD10 procedure and diagnosis codes. Effective 10/2015. 6/2014 Annual policy review. New investigational indications described; medically necessary indications clarified. Effective 6/1/2014. 4/2013 Annual policy review. New investigational indications described. Effective 4/1/2013. 2/2013 Ultrasound Accelerated Fracture Healing Device transferred to medical policy #497. 11/2011- 4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates. No changes to policy statements.

Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

References

1. Wu AM, Bisignano C, James SL, et al. Global, regional, and national burden of bone fractures in 204 countries and territories, 1990-2019: a systematic analysis from the Global Burden of Disease Study
2. Lancet Healthy Longev. Sep 2021; 2(9): e580-e592. PMID 34723233
3. Buza JA, Einhorn T. Bone healing in 2016. Clin Cases Miner Bone Metab. 2016; 13(2): 101-105. PMID 27920804
4. Bhandari M, Fong K, Sprague S, et al. Variability in the definition and perceived causes of delayed unions and nonunions: a cross-sectional, multinational survey of orthopaedic surgeons. J Bone Joint Surg Am. Aug 01 2012; 94(15): e1091-6. PMID 22854998
5. Schandelmaier S, Kaushal A, Lytvyn L, et al. Low intensity pulsed ultrasound for bone healing: systematic review of randomized controlled trials. BMJ. Feb 22 2017; 356: j656. PMID 28348110
6. Seger EW, Jauregui JJ, Horton SA, et al. Low-Intensity Pulsed Ultrasound for Nonoperative Treatment of Scaphoid Nonunions: A Meta-Analysis. Hand (N Y). May 2018; 13(3): 275-280. PMID 28391752
7. Lou S, Lv H, Li Z, et al. The effects of low-intensity pulsed ultrasound on fresh fracture: A meta-analysis. Medicine (Baltimore). Sep 2017; 96(39): e8181. PMID 28953676

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7. Leighton R, Watson JT, Giannoudis P, et al. Healing of fracture nonunions treated with low-intensity pulsed ultrasound (LIPUS): A systematic review and meta-analysis. Injury. Jul 2017; 48(7): 1339-1347. PMID 28532896
8. Leighton R, Phillips M, Bhandari M, et al. Low intensity pulsed ultrasound (LIPUS) use for the management of instrumented, infected, and fragility non-unions: a systematic review and meta-analysis of healing proportions. BMC Musculoskelet Disord. Jun 11 2021; 22(1): 532. PMID 34116673
9. Searle HK, Lewis SR, Coyle C, et al. Ultrasound and shockwave therapy for acute fractures in adults. Cochrane Database Syst Rev. Mar 03 2023; 3(3): CD008579. PMID 36866917
10. Busse JW, Kaur J, Mollon B, et al. Low intensity pulsed ultrasonography for fractures: systematic review of randomised controlled trials. BMJ. Feb 27 2009; 338: b351. PMID 19251751
11. Schortinghuis J, Bronckers AL, Stegenga B, et al. Ultrasound to stimulate early bone formation in a distraction gap: a double blind randomised clinical pilot trial in the edentulous mandible. Arch Oral Biol. Apr 2005; 50(4): 411-20. PMID 15748694
12. Schortinghuis J, Bronckers AL, Gravendeel J, et al. The effect of ultrasound on osteogenesis in the vertically distracted edentulous mandible: a double-blind trial. Int J Oral Maxillofac Surg. Nov 2008; 37(11): 1014-21. PMID 18757179
13. Strauss E, Ryaby JP, McCabe J. Treatment of Jones' fractures of the foot with adjunctive use of low- pulsed ultrasound stimulation. J Orthop Trauma. 1999;13(4):310. https://journals.lww.com/jorthotrauma/Citation/1999/05000/Treatment_of_Jones__fractures_of_the_fo ot_with.76.aspx. Accessed January 23, 2024.
14. Busse JW, Bhandari M, Einhorn TA, et al. Re-evaluation of low intensity pulsed ultrasound in treatment of tibial fractures (TRUST): randomized clinical trial. BMJ. Oct 25 2016; 355: i5351. PMID 27797787
15. Tarride JE, Hopkins RB, Blackhouse G, et al. Low-intensity pulsed ultrasound for treatment of tibial fractures: an economic evaluation of the TRUST study. Bone Joint J. Nov 2017; 99-B(11): 1526-1532. PMID 29092994
16. Emami A, Petrén-Mallmin M, Larsson S. No effect of low-intensity ultrasound on healing time of intramedullary fixed tibial fractures. J Orthop Trauma. May 1999; 13(4): 252-7. PMID 10342350
17. Gopalan A, Panneerselvam E, Doss GT, et al. Evaluation of Efficacy of Low Intensity Pulsed Ultrasound in Facilitating Mandibular Fracture Healing-A Blinded Randomized Controlled Clinical Trial. J Oral Maxillofac Surg. Jun 2020; 78(6): 997.e1-997.e7. PMID 32145206
18. Lubbert PH, van der Rijt RH, Hoorntje LE, et al. Low-intensity pulsed ultrasound (LIPUS) in fresh clavicle fractures: a multi-centre double blind randomised controlled trial. Injury. Dec 2008; 39(12): 1444-52. PMID 18656872
19. White NJ, Patterson ED, Dhaliwal GS, et al. Low-Intensity Pulsed Ultrasound Versus Sham in the Treatment of Operatively Managed Scaphoid Nonunions: The SNAPU Randomized Controlled Trial. J Bone Joint Surg Am. Sep 04 2024; 106(17): 1573-1582. PMID 38950101
20. Schofer MD, Block JE, Aigner J, et al. Improved healing response in delayed unions of the tibia with low-intensity pulsed ultrasound: results of a randomized sham-controlled trial. BMC Musculoskelet Disord. Oct 08 2010; 11: 229. PMID 20932272
21. Ricardo M. The effect of ultrasound on the healing of muscle-pediculated bone graft in scaphoid non- union. Int Orthop. Apr 2006; 30(2): 123-7. PMID 16474939
22. Nolte P, Anderson R, Strauss E, et al. Heal rate of metatarsal fractures: A propensity-matching study of patients treated with low-intensity pulsed ultrasound (LIPUS) vs. surgical and other treatments. Injury. Nov 2016; 47(11): 2584-2590. PMID 27641221
23. Rue JP, Armstrong DW, Frassica FJ, et al. The effect of pulsed ultrasound in the treatment of tibial stress fractures. Orthopedics. Nov 2004; 27(11): 1192-5. PMID 15566133
24. Urita A, Iwasaki N, Kondo M, et al. Effect of low-intensity pulsed ultrasound on bone healing at osteotomy sites after forearm bone shortening. J Hand Surg Am. Mar 2013; 38(3): 498-503. PMID 23375786
25. Goshima K, Sawaguchi T, Horii T, et al. Low-intensity pulsed ultrasound does not promote bone healing and functional recovery after open wedge high tibial osteotomy. Bone Jt Open. Nov 2022; 3(11): 885-
26. PMID 36373863
27. Dudda M, Hauser J, Muhr G, et al. Low-intensity pulsed ultrasound as a useful adjuvant during distraction osteogenesis: a prospective, randomized controlled trial. J Trauma. Nov 2011; 71(5): 1376-
28. PMID 22071933

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27. Salem KH, Schmelz A. Low-intensity pulsed ultrasound shortens the treatment time in tibial distraction osteogenesis. Int Orthop. Jul 2014; 38(7): 1477-82. PMID 24390009
28. El-Mowafi H, Mohsen M. The effect of low-intensity pulsed ultrasound on callus maturation in tibial distraction osteogenesis. Int Orthop. Apr 2005; 29(2): 121-4. PMID 15685456
29. Tsumaki N, Kakiuchi M, Sasaki J, et al. Low-intensity pulsed ultrasound accelerates maturation of callus in patients treated with opening-wedge high tibial osteotomy by hemicallotasis. J Bone Joint Surg Am. Nov 2004; 86(11): 2399-405. PMID 15523009
30. Lou S, Lv H, Li Z, et al. Effect of low-intensity pulsed ultrasound on distraction osteogenesis: a systematic review and meta-analysis of randomized controlled trials. J Orthop Surg Res. Aug 17 2018; 13(1): 205. PMID 30119631
31. Song MH, Kim TJ, Kang SH, et al. Low-intensity pulsed ultrasound enhances callus consolidation in distraction osteogenesis of the tibia by the technique of lengthening over the nail procedure. BMC Musculoskelet Disord. Mar 14 2019; 20(1): 108. PMID 30871538
32. National Institute for Health and Care Excellence (NICE). EXOGEN ultrasound bone healing system for long bone fractures with non-union or delayed healing [MTG12]. 2013 (Updated 2019); https://www.nice.org.uk/guidance/mtg12. Accessed January 20, 2024.
33. National Institute for Health and Care Excellence (NICE). Low-intensity pulsed ultrasound to promote healing of fresh fractures at low risk of non-healing [IPG621]. 2018; https://www.nice.org.uk/guidance/ipg621. Accessed January 23, 2024.
34. National Institute for Health and Care Excellence (NICE). Low-intensity pulsed ultrasound to promote healing of fresh fractures at high risk of non-healing [IPG622]. 2018; https://www.nice.org.uk/guidance/ipg622. Accessed January 22, 2024.
35. National Institute for Health and Care Excellence (NICE). Low-intensity pulsed ultrasound to promote healing of delayed-union and non-union fractures [IPG623]. 2018; https://www.nice.org.uk/guidance/ipg623. Accessed January 21, 2024.
36. American Academy of Orthopaedic Surgeons. Management of distal radius fractures. 2021; https://www.aaos.org/quality/quality-programs/upper-extremity-programs/distal-radius-fractures/. Accessed January 23, 2024.
37. American Academy of Orthopaedic Surgeons. Management of hip fractures in older adults. 2021; https://www.aaos.org/quality/quality-programs/lower-extremity-programs/hip-fractures-in-the-elderly/. Accessed January 22, 2024.
38. Wright M, Della Rocca GJ. American Academy of Orthopaedic Surgeons Clinical Practice Guideline Summary on the Treatment of Clavicle Fractures. J Am Acad Orthop Surg. Sep 15 2023; 31(18): 977-
39. PMID 37432981
40. Centers for Medicare & Medicaid Services. National Coverage Decision for Osteogenic Stimulators (150.2). 2005; https://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?NCDId=65&ncdver=2&DocID=150.2&bc=gAAAABAAAAAA&. Accessed January 23, 2024.