Subject:
Low Intensity Pulsed Ultrasound Fracture Healing Device
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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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.
| Populations | Interventions | Comparators | Outcomes |
| Individuals:With fresh fractures (surgically managed or nonsurgically managed) | Interventions of interest are:Low-intensity pulsed ultrasound as an adjunct to routine care | Comparators of interest are:Routine care without low-intensity pulsed ultrasound | Relevant outcomes include:SymptomsMorbid eventsFunctional outcomesQuality of life |
| Individuals:With fracture nonunion or delayed union fractures | Interventions of interest are:Low-intensity pulsed ultrasound as an adjunct to routine care including surgery, if appropriate | Comparators of interest are:Routine care including surgery, if appropriate, without low-intensity pulsed ultrasound | Relevant outcomes include:SymptomsMorbid eventsFunctional outcomesQuality of life |
| Individuals:With stress fractures, osteotomy sites, or distraction osteogenesis | Interventions of interest are:Low-intensity pulsed ultrasound as an adjunct to routine care | Comparators of interest are:Routine care without low-intensity pulsed ultrasound | Relevant outcomes include:SymptomsMorbid eventsFunctional outcomesQuality of life |
BACKGROUND
Bone Fractures
An estimated 7.9 million fractures occur annually in the United States. 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.1, 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).1,
Fracture Nonunion
There is no standard definition of a fracture nonunion.2, The Food and Drug Administration 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 three to six 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 threeand nine 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 (LIPUS) has been proposed to accelerate healing of fractures. LIPUS 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 LIPUS may stimulate the production or the activities of the following compounds that contribute to the bone healing process: cyclooxygenase-2, collagenase, integrin proteins, calcium, chondroblasts, mesenchymal cells, fibroblasts, and osteoblasts.
LIPUS treatment is self-administered, once daily for 20 minutes, until the fracture has healed, usually for 5 months.
Regulatory Status
In 1994, the Sonic Accelerated Fracture Healing System (SAFHS®; renamed Exogen 2000® and since 2006, Exogen 4000+; Bioventus) was approved by the U.S. Food and Drug Administration through the premarket approval process for treatment of fresh, closed, posteriorly displaced distal radius (Colles) fractures and fresh, closed, or grade I open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopedically managed by closed reduction and cast immobilization. In February 2000, the labeled indication was expanded to include the treatment of established nonunions, excluding skull and vertebra. Food and Drug Administration product code: LPQ.
Related Policies
- Electrical Bone Growth Stimulation of the Appendicular Skeleton (Policy #010 in the Treatment Section)
- Bone Morphogenetic Protein (Policy #056 in the Surgery Section)
- Electrical Stimulation of the Spine as an Adjunct to Spinal Fusion Procedures (Policy #154 in the Treatment Section)
Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
1. Low-intensity ultrasound treatment is considered medically necessary when used as an adjunct to conventional management (ie, closed reduction and cast immobilization) for the treatment of fresh, closed fractures in skeletally mature individuals. Candidates for ultrasound treatment are those at high risk for delayed fracture healing or nonunion. These risk factors may include either locations of fractures or patient comorbidities and include the following.
Patient comorbidities:
- Diabetes
- Steroid therapy
- Osteoporosis
- History of alcoholism
- History of smoking
Fracture locations:
- Jones fracture
- Fracture of navicular bone in the wrist (also called the scaphoid)
- Fracture of metatarsal
- Fractures associated with extensive soft tissue or vascular damage
2. Low-intensity ultrasound treatment is considered medically necessary as a treatment of delayed union of bones, including delayed union of previously surgically treated fractures, and excluding the skull and vertebra. (See the Policy Guidelines section for definition of delayed union.)
3. Low-intensity ultrasound treatment is considered medically necessary as a treatment of fracture nonunions of bones, including nonunion of previously surgically treated fractures, and excluding the skull and vertebra. (See the Policy Guidelines section for definition of nonunion.)
4. Other applications of low-intensity ultrasound treatment are investigational, including, but not limited to, treatment of congenital pseudarthroses, open fractures, fresh surgically treated closed fractures, stress fractures, and arthrodesis or failed arthrodesis.
Medicare Coverage:
Coverage and eligibility for Medicare Advantage Products differs from the Horizon BCBSNJ Medical Policy.
Noridian Healthcare Services, LLC, the Local DME Medicare Carrier for jurisdiction JA, has determined that an ultrasonic osteogenesis stimulator (E0760) is covered when LCD L33796 criteria is met. Ultrasonic osteogenic stimulators may not be used concurrently with other non-invasive osteogenic devices.
Ultrasonic osteogenic stimulators for fresh fractures and delayed unions is non-covered.
For additional information and eligibility, refer to Local Coverage Determination (LCD): Osteogenesis Stimulators (L33796) and Local Coverage Article: Osteogenesis Stimulators - Policy Article (A52513. Available to be accessed at Noridian Healthcare Services, LLC, (DME MAC), Local Coverage Determinations (LCDs) search page: https://www.cms.gov/medicare-coverage-database/indexes/lcd-list.aspx?Cntrctr=389&ContrVer=1&CntrctrSelected=389*1&s=38&DocType=1&bc=AAgAAAAAAAAA&#aFinal.
National Coverage Determination (NCD) for Osteogenic Stimulators (150.2). Available to be accessed at CMS National Coverage Determinations (NCDs) Alphabetical Index search page: https://www.cms.gov/medicare-coverage-database/indexes/ncd-alphabetical-index.aspx.
Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.
FIDE SNP:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.
Policy Guidelines: (Information to guide medical necessity determination based on the criteria contained within the policy statements above.)
Fresh (Acute) Fracture
There is no standard definition for a “fresh” fracture. A fracture is most commonly defined as fresh for 7 days after the fracture occurs (Heckman et al, 1994; Kristiansen et al, 1997; Emami et al, 1999), but there is definitional variability. For example, 1 study defined fresh as less than 5 days after fracture (eg, Lubbert et al, 2008), while another defined fresh as up to 10 days postfracture (Mayr et al. [Does low intensity, pulsed ultrasound speed healing of scaphoid fractures?] [German]. Handchir Mikrochir Plast Chir. Mar 2000;32(2):115-122). Most fresh closed fractures heal without complications using of standard fracture care (ie, closed reduction and cast immobilization).
Nonunion
There is no consensus on the definition of nonunions. One definition is a failure of progression of fracture healing for at least 3 consecutive months (and at least 6 months postfracture) accompanied by clinical symptoms of delayed/nonunion (pain, difficulty weight bearing; Buza & Einhorn, 2016).
The definition of nonunion used in U.S. Food and Drug Administration labeling suggests that nonunion is considered established when the fracture site shows no visibly progressive signs of healing, without providing guidance on the timeframe of observation. The following patient selection criteria are consistent with those proposed for electrical stimulation as a treatment of nonunions (see 'Electrical Bone Growth Stimulation of the Appendicular Skeleton' - Policy #010 in the Treatment Section):
· At least 3 months have passed since the date of the fracture, and
· serial radiographs have confirmed that no progressive signs of healing have occurred, and
· the fracture gap is 1 cm or less, and
· the patient can be adequately immobilized and, based on age, is likely to comply with nonweight bearing.
Delayed Union
Delayed union is defined as a decelerating healing process as determined by serial radiographs, together with a lack of clinical and radiologic evidence of union, bony continuity, or bone reaction at the fracture site for no less than 3 months from the index injury or the most recent intervention.
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Low Intensity Pulsed Ultrasound Fracture Healing Device
Ultrasound Accelerated Fracture Healing Device
Ultrasonic Bone Growth Stimulation
Bone Growth Stimulation, Ultrasonic
Fracture Healing Device, Ultrasound Accelerated
Sonic Accelerated Fracture Healing System (Exogen, Inc.)
Stimulation, Ultrasonic Bone Growth
References:
1. Buza JA, 3rd, Einhorn T. Bone healing in 2016. Clin Cases Miner Bone Metab. May-Aug 2016;13(2):101-105. PMID 27920804
2. 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 1 2012;94(15):e1091-1096. PMID 22854998
3. 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
4. Seger EW, Jauregui JJ, Horton SA, et al. Low-intensity pulsed ultrasound for nonoperative treatment of scaphoid nonunions: a meta-analysis. Hand (N Y). Apr 01 2017:1558944717702470. PMID 28391752
5. 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
6. 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
7. Griffin XL, Parsons N, Costa ML, et al. Ultrasound and shockwave therapy for acute fractures in adults. Cochrane Database Syst Rev. Jun 23 2014;6(6):CD008579. PMID 24956457
8. 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
9. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Ultrasound accelerated fracture healing. TEC Assessments 1995;Volume 10:Tab 14.
10. 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- 420. PMID 15748694
11. 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):1014-1021. PMID 18757179
12. Strauss E, Ryaby JP, McCabe J. Treatment of Jones' fractures of the foot with adjunctive use of low-pulsed ultrasound stimulation [abstract]. J Orthop Trauma. 1999;13(4):310. PMID
13. 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
14. Busse JW, Bhandari M, Einhorn TA, et al. Trial to re-evaluate ultrasound in the treatment of tibial fractures (TRUST): a multicenter randomized pilot study. Trials. Jun 04 2014;15:206. PMID 24898987
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, Petren-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):252-257. PMID 10342350
17. 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):1444-1452. PMID 18656872
18. 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
19. Ricardo M. The effect of ultrasound on the healing of muscle-pediculated bone graft in scaphoid non-union. Int Orthop. Apr 2006;30(2):123-127. PMID 16474939
20. Nolte, PP, Anderson, RR, Strauss, EE, Wang, ZZ, Hu, LL, Xu, ZZ, Steen, RR. Heal rate of metatarsal fractures: A propensity-matching study of patients treated with low-intensity pulsed ultrasound (LIPUS) vs. surgical and other treatments. Injury, 2016 Nov 5;47(11). PMID 27641221
21. Rue JP, Armstrong DW, 3rd, Frassica FJ, et al. The effect of pulsed ultrasound in the treatment of tibial stress fractures. Orthopedics. Nov 2004;27(11):1192-1195. PMID 15566133
22. 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
23. 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):1376-1380. PMID 22071933
24. Salem KH, Schmelz A. Low-intensity pulsed ultrasound shortens the treatment time in tibial distraction osteogenesis. Int Orthop. Jul 2014;38(7):1477-1482. PMID 24390009
25. 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):121-124. PMID 15685456
26. 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-A(11):2399-2405. PMID 15523009
27. Lou S, Lv H, Li Z, Tang P, Wang Y. Effect of low-intensity pulsed ultrasound on distraction osteogenesis: a systematic review and meta-analysis of randomized controlled trials. J Ortho Surg and Research 2018; 13(1)205. PMID 30119631
28. MAGIC: Making GRADE the Irrestible Choice. n.d.; www.magicproject.org. Accessed February 1, 2018.
29. Poolman RW, Agoritsas T, Siemieniuk RA, et al. Low intensity pulsed ultrasound (LIPUS) for bone healing: a clinical practice guideline. BMJ. Feb 21 2017;356:j576. PMID 28228381
30. 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 February 27, 2019.
31. 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 February 27, 2019.
32. 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 February 27, 2019.
33. 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; https://www.nice.org.uk/guidance/mtg12. Accessed February 1, 2018.
34. American Academy of Orthopaedic Surgeons. The treatment of distal radius fractures. 2009; http://www.aaos.org/research/guidelines/drfguideline.pdf. Accessed February 27, 2019.
35. 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 February 27, 2019.
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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