mp-331
print Print Back Back

Ultrasound Accelerated Fracture Healing Device

Policy Number: MP-331

Latest Review Date: March 2022

Category:  DME                                                                    

POLICY:

Fresh Fracture

Low-intensity ultrasound treatment (E0760) may be considered medically necessary when used as an adjunct to conventional management (i.e., 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 nonunions. These risk factors may include either locations of fractures or patient morbidities and include any one of the following:

  • Patient Comorbidities
    • Diabetes
    • Steroid therapy
    • Osteoporosis
    • Alcoholism history
    • Smoking
    • Obesity greater than 50% over ideal weight
    • Severe anemia
    • End Stage Renal disease
  • Fracture locations:
    • Radial fractures that are closed & posteriorly displaced (Colles fx)
    • Tibial diaphysis fractures that are closed or grade I open (wound <1cm with minimal soft tissue injury, wound bed is clean and bone injury is simple with minimal comminution)
    • Jones Fracture, 5th metatarsal
    • Navicular (scaphoid) fracture
    • Fractures associated with extensive soft tissue or vascular damage
    • Metatarsal fracture

Delayed Union

Low intensity ultrasound treatment (E0760) may be considered medically necessary as a treatment of delayed union of bones, including nonunion of previously surgically-treated fractures, and excluding the skull and vertebra, when the following criteria are met:

  • A decelerating healing process is documented by a lack of clinical and radiologic (serial x-rays) evidence of union, bony continuity or bone reaction at the fracture site for no less than 16 weeks from the index injury or the most recent intervention.

Non-Union

Low-intensity ultrasound treatment (E0760) may be considered medically necessary as a treatment of fracture non-unions of bones, including nonunion of previously surgically-treated fractures, and excluding the skull and vertebra, when all of the following criteria are met:

  • The treatment is for nonunion of bones other than the skull or vertebrae (e.g., radius, ulna, humerus, clavicle, tibia, femur, fibula, carpal, metacarpal, tarsal and metatarsal).
  • The nonunion is not related to, or due to, a malignancy.
  • It is ≥ 90 days from the date of initial treatment of the fracture.
  • The fracture nonunion is documented by at least 2 sets of appropriate imaging studies, multiple views, separated by a minimum of 90 days confirming that clinically significant healing has not occurred, with written interpretation by a physician stating such.
  • A fracture gap of ≤1 cm.
  • The patient can be adequately immobilized and is of an age where he/she is likely to comply with non-weight bearing (if fracture is of a weight-bearing bone).

Low-intensity ultrasound treatment (E0760) is considered investigational when utilized for other applications including but not limited to:

  • Congenital pseudarthrosis
  • Fractures that are Open Grade II or III
  • Fresh surgically-treated closed fractures (with or without internal fixation)
  • Fractures too unstable for closed reduction/casting
  • Fractures involving immature skeletal system
  • Pathological fractures due to bone pathology or malignancy
  • Treatment of Charcot foot disorder
  • Avascular necrosis of the femoral head
  • Fractures, failed fusions, or nonunions of the axial skeleton (skull and vertebrae)
  • Chronic epicondylitis
  • Prosthesis loosening following hip arthroplasty
  • Stress fractures

DESCRIPTION OF PROCEDURE OR SERVICE:

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.

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, but there is definitional variability. For example, one study defined fresh as less than 5 days after fracture, while another defined fresh as up to 10 days post-fracture. Most fresh closed fractures heal without complications using of standard fracture care (i.e., closed reduction and cast immobilization).

Nonunion

There is no consensus on the definition of nonunion. One definition is a failure of progression of fracture healing for at least 3 consecutive months(and at least 6 months post-fracture) accompanied by clinical symptoms of delayed/nonunion (pain, difficulty weight-bearing.

The definition of nonunion used in U.S. Food and Drug Administration (FDA) 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 :

  • 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 non-weight 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.

KEY POINTS:

The most recent literature update was performed through February 3, 2022.

Summary of Evidence

For individuals who have fresh fractures (surgically or nonsurgically managed) who receive LIPUS as an adjunct to routine care, the evidence includes RCTs and several meta-analyses. The relevant outcomes are symptoms, morbid events, functional outcomes, and QOL. The evidence base has recently 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 of LIPUS; 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.

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 only lower quality studies consisting of a small systematic review in scaphoid nonunions, a meta-analysis of nonunion in various locations, two low-quality RCTs, and one observational comparative study. The relevant outcomes are symptoms, morbid events, functional outcomes, and QOL. Of the two RCTs, one did not include functional outcomes. The second RCT had a small sample size and did not describe the randomization procedure. The observational study reported similar healing rates with LIPUS and surgery, though the retrospective nature of the study, limits meaningful interpretation of these results. Additionally, the evidence base on the use of LIPUS in the management of fresh fractures has evolved as described above, and there is no demonstrated physiologic mechanism suggesting differential results of LIPUS in fracture nonunion or delayed union.

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 and one meta-analysis for distraction osteogenesis. The relevant outcomes are symptoms, morbid events, functional outcomes, and QOL. Results do not generally include functional outcomes and results across various outcomes, primarily time to radiographic healing, are inconsistent. The meta-analysis of three trials using LIPUS for distraction osteogenesis reported no statistically significant differences in physiological or functional outcomes. Additionally, the evidence base on the use of LIPUS in the management of fresh fractures has evolved as described above and there is no demonstrated physiologic mechanism suggesting differential results of LIPUS in stress fractures, osteotomy sites, or distraction osteogenesis. The evidence is insufficient to determine the technology results in an improvement in net health outcomes.

Practice Guidelines and Position Statements

National Institute for Health and Clinical Excellence

In 2013, the National Institute for Health and Care Excellence (NICE) published guidance on Exogen for the treatment of long-bone fractures with nonunion and delayed fracture healing.

The NICE concluded that use of the Exogen bone healing system to treat long-bone fractures with nonunion is supported by "clinical evidence" and "cost savings … through avoiding surgery." For long-bone fractures with delayed healing, defined as no radiologic evidence of healing after 3 months, there was "some radiologic evidence of improved healing." However, due to "substantial uncertainties about the rate at which bone healing progresses without adjunctive treatment between 3 and 9 months after fracture" and need for surgery, "cost consequences" were uncertain. In 2019, the Exogen guidance was updated with a review of studies published after June 2012. The review decision stated, "Overall the additional clinical evidence identified since the guidance was published in 2013 supports the current recommendations." The reviewers did not consider the Schandelmaier et al (2017) systematic review because it pooled fresh fractures and distraction osteogenesis alongside non-unions.

​​​​​In 2018, NICE published guidance on the use of low-intensity pulsed ultrasound in 3 clinical circumstances, The guidance made the following conclusions:

  • To promote healing of fresh fractures at low-risk of non-healing: "Current evidence does not show efficacy. Therefore, this procedure should not be used for this indication."
  • To promote healing of fresh fractures at high-risk of non-healing: "Current evidence on efficacy is very limited in quantity and quality.Therefore, this procedure should only be used in the context of research."
  • To promote healing of delayed and nonunion fractures: "Current evidence on efficacy is inadequate in quality. Therefore, this procedure should only be used with special arrangements for clinical governances, consent and audit or research."

American Academy of Orthopaedic Surgeons

In 2020, the American Academy of Orthopaedic Surgeons published updated guidelines on the treatment of distal radius fractures. Although the Academy issued a limited recommendation for the use of low-intensity pulsed ultrasound for adjuvant treatment of distal radius fractures in its prior 2009 guidelines, low-intensity pulsed ultrasound was not mentioned in the updated guidelines.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Fracture, nonunion, delayed union, bone growth stimulator, ultrasound accelerated fracture healing device, low intensity ultrasound stimulator, osteogenesis stimulator, percutaneous, pseudarthrosis, pseudoarthrosis, Exogen 2000™, Exogen 3000, SAFHS® Model 2A, SAFHS® Model 2000, Exogen 4000, AccelStim, Orthofix

APPROVED BY GOVERNING BODIES:

In 1994, the Sonic Accelerated Fracture Healing System (SAFHS®; later renamed Exogen 2000® and since 2006, Exogen 4000+; Bioventus) was approved by the FDA 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.

In May 2022, the AccelStim (Orthofix Medical) received FDA pre-market approval for the AccelStim bone healing therapy class III device. The AccelStim system is a nonsurgical treatment designed to be worn for 20 minutes per day to repair fresh bone breaks and fractures that have not healed on their own. The AccelStim device is lightweight, adjustable and portable. According to the release, it includes a rechargeable battery that allows freedom of movement during treatment. Treatment length may vary and is determined by the prescribing physician on an individual basis according to the fracture healing process.

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.  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING: 

CPT Codes:

20979

Low intensity ultrasound stimulation to aid bone healing, non-invasive (nonoperative)

 

HCPCS:

E0760

Osteogenesis stimulator, low intensity ultrasound; non-invasive

 

REFERENCES:

  1. 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 2012; 94(15):e1091-6.
  2. Biglari B, Yildirim TM, Swing T, Bruckner T, Danner W, Moghaddam A. Failed treatment of long bone non-unions with low intensity pulsed ultrasound. Arch Orthop Trauma Surg. Aug 2016; 136(8):1121-1134.
  3. 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.
  4. 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. 2014; 15:206.
  5. Buza JA, 3rd, Einhorn T. Bone healing in 2016. Clin Cases Miner Bone Metab. May-Aug 2016;13(2):101-105.
  6. Dijkman BG, Busse JW, Walter SD et al. The impact of clinical data on the evaluation of tibial fracture healing. Trials 2011; 12:237.
  7. 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 2011; 71(5):1376-80.
  8. Gopalan A, Panneerselvam E, Doss GT, et al. Evaluation of Efficacy of Low Intensity Pulsed Ultrasound in Facilitating Mandibular FractureHealing-A Blinded Randomized Controlled Clinical Trial. J Oral Maxillofac Surg. Jun 2020; 78(6): 997.e1-997.e7.
  9. Griffin XL, Parsons N, Costa ML, et al. Ultrasound and shockwave therapy for acute fractures in adults. Cochrane Database Syst Rev. 2014; 6:CD008579.
  10. Griffin XL, Smith N, Parsons N et al. Ultrasound and shockwave therapy for acute fractures in adults. Cochrane Database Syst Rev 2012; 2:CD008579.
  11. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  12. 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.
  13. Lou S, Lv H, Li Z, et al. Effect of low-intensity pulsed ultrasound on distraction osteogenesis: a systematic review and meta-analysis ofrandomized controlled trials. J Orthop Surg Res. Aug 17 2018; 13(1): 205.
  14. 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.
  15. MAGIC: Making GRADE the Irrestible Choice. n.d.; www.magicproject.org. Accessed February 1, 2018.
  16. 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.
  17. 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.
  18. 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.
  19. National Institute for Health and Care Excellence. Low-intensity pulsed ultrasound to promote fracture healing. IPG 374. 2010; https://www.nice.org.uk/guidance/ipg374/chapter/1-Guidance.
  20. National Institute for Health and Care Excellence. NICE medical technology guidance 12: EXOGEN ultrasound bone healing system for long bone fractures with non-union or delayed healing. 2013. Available online at: www.nice.org.uk/nicemedia/live/14018/62289/62289.pdf.
  21. 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.
  22. 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.
  23. Rutten S, Klein-Nulend J, Guit GL, et al. Low-intensity pulsed ultrasound stimulation of delayed unions of the osteotomized fibula: a prospective randomized double-blind trial. Low-intensity pulsed ultrasound treatment in delayed bone healing [thesis]. Amsterdam, the Netherlands: Vrije Universiteit Amsterdam; 2012.
  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.
  25. 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.
  26. 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 2010; 11:229.
  27. 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.
  28. Song MH, Kim TJ, Kang SH, et al. Low-intensity pulsed ultrasound enhances callus consolidation in distraction osteogenesis of the tibia by thetechnique of lengthening over the nail procedure. BMC Musculoskelet Disord. Mar 14 2019; 20(1): 108.
  29. 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.
  30. 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 2013; 38(3):498-503.
  31. Watanabe, YY, Arai, YY, Takenaka, NN, Kobayashi, MM, Matsushita, TT. Three key factors affecting treatment results of low-intensity pulsed ultrasound for delayed unions and nonunions: instability, gap size, and atrophic nonunion.. J Orthop Sci, 2013 Jun 19;18(5).
  32. Zura R, Della Rocca GJ, Mehta S, et al. Treatment of chronic (>1 year) fracture nonunion: heal rate in a cohort of 767 patients treated with low-intensity pulsed ultrasound (LIPUS). Injury. Oct 2015; 46(10):2036-2041.
  33. Zura R, Mehta S, Della Rocca GJ, et al. A cohort study of 4,190 patients treated with low-intensity pulsed ultrasound (LIPUS): findings in the elderly versus all patients. BMC Musculoskelet Disord. 2015; 16:45.

POLICY HISTORY:

Medical Policy Group, October 2008 (4)

Medical Policy Administration Committee, November 2008

Available for comment November 20, 2008-January 5, 2009

Medical Policy Group, February 2009 (4)

Medical Policy Administration Committee, March 2009

Available for comment February 27-April 13, 2009

Medical Policy Group, October 2009 (1)

Medical Policy Administration Committee, October 2009

Available for comment October 20-December 3, 2009

Medical Policy Group, November 2009 (1)

Medical Policy Administration Committee, December 2009

Available for comment December 4, 2009-January 19, 2010

Medical Policy Group, February 2010 (1)

Medical Policy Administration Committee, April 2010

Available for comment April 7-May 21, 2010

Medical Policy Group, February 2010; Regular update (1)

Medical Policy Group, November 2011 (1): Electrical bone stimulator portion removed and put into separate policy #082; Update to Description, Policy, Key Points, and References with criteria for coverage for delayed union

Medical Policy Administration Committee, January 2012

Available for comment January 11 – February 27, 2012

Medical Policy Panel, December 2012

Medical Policy Group, March 2013 (1): Update to policy statement with clarifications, no change to coverage criteria; update to Key Points and References, also.

Medical Policy Panel, January 2014

Medical Policy Group, January 2014 (1): Update to Policy, Key Points and References related to clarification of coverage concerning surgically-treated fractures, fresh versus nonunion; policy statements prior to March 2010 removed

Medical Policy Administration Committee, February 2014

Available for comment February 15 through March 31, 2014

Medical Policy Panel, February 2015

Medical Policy Group, (6): 2015 Update to Key Points and References; no change to policy statement.

Medical Policy Panel, August 2016

Medical Policy Group, August 2016, (6): Updates to Description, Key Points, Summary and References. No change to policy statement.

Medical Policy Panel, March 2017

Medical Policy Group, March 2017 (6): Updates to Key points, Key Words, Governing Bodies, Practice guidelines and References; removed previous policy statement from 2013.

Medical Policy Panel, July 2017

Medical Policy Group, August 2017 (6): Updates to Description, Key Points, and References. No change to policy statement.

Medical Policy Panel March 2018

Medical Policy Group, April 2018 (6): Updates to Key Points, Practice Guidelines and References.  

Medical Policy Panel, March 2019

Medical Policy Group, April 2019 (6): Updates to Description, Key Points, Practice Guidelines and References. Title changed to “Ultrasound Accelerated Fracture Healing Device”. No change to policy statement.

Medical Policy Panel, March 2020

Medical Policy Group, March  2020 (6): Updates to Key Points, Practice Guidelines and Position Statements, Approved by Governing Bodies, and References. No change in Policy Statement.

Medical Policy Panel, March 2021

Medical Policy Group, March 2021 (6): Updates to Key Points and References. Policy statement updated to remove "medically necessary", no change to policy intent.

Medical Policy Panel, March 2022

Medical Policy Group, March 2022 (6): Updates to Description, Key Points, Practice Guidelines and References.

Medical Policy Group, May 2022 (6): Updates to Key Words and Practice Guidelines.

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.