Pending Policies - DME
Ultrasound Accelerated Fracture Healing Device
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Low-intensity pulsed ultrasound treatment 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 (<14 days), closed fractures in skeletally mature individuals who are at high risk (see NOTE 1) for delayed fracture healing or nonunion.
NOTE 1: Candidates for ultrasound treatment are those at high risk for delayed fracture healing or nonunion. These high-risk factors may include patient comorbidities AND/OR locations of fractures, such as:
• Patient comorbidities:
2. Steroid therapy,
4. History of alcoholism,
5. History of smoking.
• Fracture locations:
Low-intensity pulsed ultrasound treatment may be considered medically necessary as a treatment of delayed union of bones (see NOTE 2), excluding the skull and vertebra.
NOTE 2: Delayed union is defined as a decelerating healing process as determined by serial x-rays, 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.
Low-intensity pulsed ultrasound treatment may be considered medically necessary as a treatment of fracture nonunion of bones (see NOTE 3), excluding the skull and vertebra.
NOTE 3: A nonunion is normally defined as a fracture that shows no progressive visible signs of healing after 3 months.
Other applications of low-intensity pulsed ultrasound treatment are considered experimental, investigational and/or unproven including, but not limited to, treatment of congenital pseudarthroses, open fractures, fresh surgically treated closed fractures, stress fractures, arthrodesis or failed arthrodesis.
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.
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 (e.g., smoking, diabetes, systemic disease). (1)
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.
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 (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. FDA product code: LPQ.
This medical policy was created in April 1996 and has been updated regularly with searches of the MEDLINE database. The most recent literature update was performed through January 8, 2018.
Medical policies assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function--including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.
To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.
Systematic Reviews with Mixed Populations of Fresh Closed Fractures, Open Fractures, and Surgically Treated Closed Fractures
A 2002 meta-analysis conducted by Busse et al. supported the use of low-intensity pulsed ultrasound (LIPUS) as a technique for fractures treated nonoperatively. (3) This review was updated in 2009 and included RCTs of LIPUS for any type of fracture. (4) Thirteen trials were included; in 5 of them, patients were managed conservatively, and in 8 studies, patients received ultrasound (US) therapy after operative management (distraction osteogenesis in 3 studies, bone graft for nonunion in 1, operative treatment of fresh fractures in 4. US therapy significantly accelerated radiographic healing of fractures in all 3 RCTs of conservatively managed fresh fractures that assessed this outcome.
The trials of operatively managed (open) fresh fractures outcomes were inconsistent; 4 trials provided low-quality evidence for acceleration of healing by US therapy. Pooled results of 2 trials showed a nonsignificant mean reduction in radiographic healing time of 16.6%.
A 2014 update of a Cochrane review on US and shockwave therapy included 12 studies on US; 8 of the studies were RCTs with placebo controls, 2 were RCTs without placebo controls, and 2 were quasirandomized. (5) Selected studies were limited in methodologic quality, with all having some evidence of bias. There was very limited evidence on functional outcomes. Pooling results from 8 studies (446 fractures) showed no significant reduction in time to union of complete fractures. This systematic review included studies of conservatively managed fractures along with surgically treated fractures and stress fractures. Subgroup analysis comparing conservatively and operatively treated fractures raised the possibility that pulsed US may be effective in reducing healing time in conservatively managed fractures, but a test for subgroup differences did not confirm a significant difference between the subgroups. The review concluded that while a potential benefit of US for acute fractures could not be ruled out, the currently available evidence was insufficient to support its routine use.
Fresh Closed Fractures
This policy on fresh fractures is based in part on a 1995 Blue Cross Blue Shield Association (BCBSA) Technology Evaluation Center (TEC) Assessment, which concluded that US fracture healing met the TEC criteria for the indications labeled by the U.S. Food and Drug Administration (FDA): treatment of closed, fresh fractures of the tibial or distal radius (i.e., Colles fractures). (6) Since that TEC Assessment, numerous RCTs and systematic reviews of clinical trials have evaluated the use of US to improve healing in fresh fractures.
In a 1997 multicenter RCT by Kristiansen et al., 60 patients with dorsally angulated fractures of the distal radius treated with manipulation and cast were randomly assigned to 10 weeks of daily treatment with a pulsed US device or an inactive device. (7) All patients started US within 7 days of fracture. Blinded radiographic and clinical examinations showed faster healing in the US group (61 days) than in the control group (98 days; p<0.001). Each radiographic stage of healing also was significantly accelerated in the treatment group.
Heckman et al. (1994) performed a double-blind RCT comparing US treatment (n=33) with a placebo control device (n=34) in closed or grade-I (clean, <1 cm puncture) open fractures of the tibial shaft. (8) Treatment began within 7 days postfracture and consisted of one 20-minute daily session. Time-to-healing was 86 days in the treatment group and 114 days in the control group (p=0.01); time to overall (clinical and radiographic) healing was 96 days in the treatment group compared with 154 days in the control group (p<0.001).
Scaphoid fractures were treated with US in a 2000 study done in Germany. (9) Fifteen patients with fresh scaphoid fractures (≤10 days) were randomly assigned to treatment and 15 to a placebo device. Healing was assessed by computed tomography (CT) scans every 2 weeks. Fractures treated with US healed faster (43.2 days) than with placebo (62 days; p<0.01). Pooled data from these studies demonstrated a mean reduction in radiographic healing time of 36.9% (95% confidence interval [CI], 25.6% to 46.0%).
The benefit of LIPUS may depend on the location and type of bone. Lubbert et al. performed a multicenter double-blind RCT of US treatment of fresh (<5 days) clavicle shaft fractures. (10) Patients were taught to use US devices for 20 minutes daily for 28 days and to record daily their subjective feeling as to whether the fracture healed (the primary outcome measure), pain on visual analog scale (VAS), level of daily activities expressed as hours of activity (work, household work, sport), and analgesic use. A total of 120 patients (61 active, 59 placebo) started treatment. The day that the fracture clinically healed according to patient perception was determined in 92 patients (47 active, 45 placebo); mean duration of time to clinical healing was 26.77 days in the active group versus 27.09 days in the placebo group. Between-group differences in terms of analgesic use and mean VAS were not significant. The time to healing with these fractures is substantially lower than in other studies.
Analysis of an FDA-required postmarketing registry was published by Zura et al. in 2015. (11) This study included 4190 patients, representing 73% of patients in the registry with fresh fractures. The healing rate was 96% for patients who were compliant; 11% of patients were noncompliant or withdrew from the study. Factors found to reduce healing rate were open fracture, current smoking, diabetes, vascular insufficiency, osteoporosis, cancer, rheumatoid arthritis, and prescription nonsteroidal anti-inflammatory drugs. Older age (≥60 years) did not reduce the healing rate.
Section Summary: Fresh Closed Fractures
A 1995 BCBSA TEC Assessment concluded that US fracture healing met BCBSA TEC criteria for the indications labeled by the U.S. Food and Drug Administration (FDA): treatment of fresh closed fractures of the tibia or distal radius (i.e., Colles fractures). (6) Since that TEC Assessment, a number of RCTs and systematic reviews have evaluated LIPUS to improve healing in fresh fractures. A 2009 systematic review found that LIPUS significantly accelerated radiographic healing of fractures in all 3 RCTs of conservatively managed fresh fractures that assessed this outcome. More recently, in a 2014 Cochrane review that included 12 trials but did not distinguish between closed and open fractures; subgroup analysis found that pulsed US may be effective in reducing healing time in conservatively managed fractures. The efficacy of LIPUS to accelerate fracture healing may depend on the location and type of bone along with risk factors for healing.
Open Fractures and Surgically Treated Closed Fractures
For the treatment of open fractures, data are conflicting regarding the efficacy of LIPUS, specifically for patients treated surgically with placement of an intramedullary nail. For example, Emami et al. (1999) conducted a double-blind, sham-controlled trial that randomized 32 patients who had a fresh tibial fracture fixed with an intramedullary rod to additional treatment with an active (n=15) or inactive (n=17) LIPUS device. (12) LIPUS treatment began within 3 days of surgery (1 patient began treatment within 7 days of injury) and was self-administered for 20 minutes a day for 75 days. Radiographs were taken every third week until healing. Results showed that LIPUS did not shorten healing time based on any of the following measures: time to first visible callus (mean, 40 days for LIPUS vs 37 days for sham; p=0.44); time to radiographic healing assessed by radiologist (mean, 155 days [median, 113 days] for LIPUS vs mean, 125 days [median, 112 days] for sham; p=0.76); and time to radiographic healing assessed by orthopedic surgeon (mean, 128 days, for LIPUS vs mean, 114 days for sham; p=0.40).
Leung et al. (2004) randomly assigned 30 complex tibial fractures (in 28 patients) treated with internal or external fixation to receive or not receive additional treatment with LIPUS. (13) US treatment was begun when the patient’s condition had stabilized, and the open wound was covered with simple closure or skin grafts. The duration of tenderness, time to weight bearing, and time to callus formation were significantly less in those in the US group.
In 2011, Dijkman et al. reported a substudy of 51 patients from a larger RCT that enrolled patients with open or closed tibial shaft fractures that were treated surgically with an intramedullary nail. (14) A 2014 publication from Busse et al. reported a sham-controlled pilot of the industry-sponsored TRUST trial to determine feasibility for the larger trial. (15) According According to www.ClinicalTrials.gov (NCT00667849), 501 patients were enrolled, but the trial was “terminated due to futility” at study midpoint. Results posted on the website show no benefit for the primary outcomes measures of 36-Item Short-Form Health Survey Physical Component Summary score or days to radiographically confirmed healing.
Lou et al. (2017) conducted a meta-analysis focusing on fresh fractures. (16) Studies included patients that had been surgically managed and conservatively managed. Time to fracture union was significantly lower in patients receiving LIPUS than inpatients not receiving low-intensity pulsed ultrasound (LIPUS) (standard mean difference, -0.65; 95% CI, -1.13 to -0.17). Subgroup analysis showed that this significant reduction in healing time with LIPUS was seen only among patients conservatively managed, while there was no difference in healing time among patients surgically managed. Reviewers concluded that patients with fresh fractures might benefit from the use of LIPUS but warned that there were methodologic limitations in the trials.
Busse et al. (2016) reported on results from a concealed, blinded, sham-controlled, randomized trial (TRUST) evaluating LIPUS for the treatment of patients who underwent intramedullary nailing for fresh tibial fractures. (17) This is the largest RCT to date, enrolling 501 patients; 250 received a LIPUS device, and 251 received a sham device. Treatment was self-administered for 20 minutes a day until there was radiographic evidence of healing. Coprimary end points were radiographic healing and return to function (as measured by the 36-Item Short-Form Health Survey Physical Component Summary score). Both radiographic and functional assessments had to show a clinically important effect for the results to be considered positive. All patients, clinicians, investigators, data analysts, and the industry sponsor were blinded to allocation until data analysis was complete. Patient compliance was considered moderate, with 73% of patients administering over half of all recommended treatments. There was no difference in time to radiographic healing between the treatment groups (hazard ratio, 1.07; 95% CI, 0.86 to 1.34; p=0.55). Additionally, there was no difference in the 36-Item Short-Form Health Survey Physical Component Summary scores (mean difference, 0.55; 95% CI, -0.75 to 1.84; p=0.41).
Tarride et al. (2017) provided additional analyses using data from the TRUST trial, comparing health care resource use among patients using LIPUS with patients using the sham device. (18) There were no significant differences between groups (11% in patients receiving LIPUS vs 10% in patients receiving sham) in need for secondary procedures (e.g., removal of lock screw, implant exchange or removal. There were also no statistically significant differences in use of physical therapy (44% vs 46%), use of anticoagulants (42% vs 36%), or use of nonsteroidal anti-inflammatory drugs (28% vs 35%) among patients receiving LIPUS compared with patients receiving sham, respectively.
Section Summary: Open Fractures and Surgically Treated Closed Fractures
Findings are not consistent for studies of fresh open fractures. The inconsistent results from randomized trials and the negative findings of the meta-analyses do not support use of LIPUS for treating open fractures. In addition, a large and well-designed sham-controlled trial of LIPUS for surgically treated fresh tibial fractures was terminated due to futility after half of the patients completed the study.
The evidence on nonunion of fractures is based on data presented to the FDA as part of the approval process for the Sonic Accelerated Fracture Healing System (SAFHS®). The following data were reported and are included in the device package insert. (19)
• Data were collected on 74 cases of established nonunion with a mean fracture age of nearly 3 years. The principal outcome measure was the percentage of patients with healed nonunions, as determined clinically and by radiographic analysis. Each case served as its own control, based on the definition of nonunion that suggests that nonunions have a 0% probability of achieving a healed state without an intervention.
• A total of 64 (86%) of 74 cases healed with use of low-intensity US. Time-to-healing was 173 days. The healing rate of scaphoid bones was lower, at 33% (2 of 6 cases), which was partially responsible for a significant difference between the healing rates of long bones (92%) versus other bones (67%).
• Fracture age also affected healing rates, with fractures over 5 years old having a healing rate of 50% compared with a healing rate of 95% in those present for no more than 1 year.
In 2015, Zura et al. analyzed data from a FDA-required postmarketing registry that included 767 patients with chronic fracture nonunion. (20) Patients with chronic (>1 year) nonunion were selected if they had the following information recorded: date of fracture, start of US treatment, end of US treatment, and healed/failed status using both clinical and radiographic outcomes. Patients had undergone an average of 3.1 prior surgical procedures without success. The reported healing rate was compared with the expected healing rate for chronic nonunion, which is negligible without intervention. With an average of 179.5 days of US treatment, the overall healing rate was 86.2%. For patients with a nonunion of at least 5 years in duration (n=98), the healing rate was 82.7%; for patients with a nonunion of greater than 10 years (n=12), the healing rate was 63.2%. Age was the only factor affecting healing rate.
A 2007 study used prospectively defined criteria to analyze all Dutch patients (96 participating clinics) who had been treated with US for established nonunion of the tibia (characterized by a total stop of all fracture repair processes). (21) Included in the analysis were 71 patients at least 3 months from the last surgical intervention who did not show any healing improvements in the 3 months before US treatment (average fracture age, 257 days; range, 180-781 days). All patients completed follow-up (average, 2.7 years) by questionnaire, or by phone, if needed. The overall healing rate was 73%, at an average 184 days to healing (range, 52-739 days). No differences in healing rates for open and closed fractures were observed.
Section Summary: Fracture Nonunion
Due to the low likelihood of healing without intervention, cohort studies demonstrating high rates of healing are considered adequate evidence to demonstrate improved outcomes for this indication. The largest study analyzed data from a registry and focused on patients with chronic nonunion. Many of these patients had failed to heal despite surgical treatment, but had a high rate of healing with US.
Delayed Fracture Union
In 2010, Schofer et al. reported an industry-sponsored, multicenter, randomized, double-blinded, sham-controlled trial of LIPUS in 101 patients with delayed union of the tibia. (22) Delayed union was defined as lack of clinical and radiologic 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. Roughly one-third of patients had an open fracture. Fifty-one patients were randomized to daily treatment with US and 50 were randomized to an inactive sham device (20 minutes daily for 16 weeks). The primary outcome measure was change in bone mineral density (BMD) over the 16 weeks, assessed by CT attenuation coefficients (or Hounsfield units). Gap area at the fracture site was a secondary end point. The primary analysis was intention-to-treat with imputation of missing values. Mean improvement in BMD was 34% (90% CI, 14% to 57%) greater for US-treated subjects than for sham-treated subjects. Analysis of “completers” showed a medium effect size (0.53) of the treatment. A mean reduction in bone gap area (as measured on a log scale) also favored US treatment, with a mean change in log gap area of -0.131 mm2 for active treatment and -0.097 mm2 for sham (effect size, -0.47; 95% CI, -0.91 to -0.03). Untransformed data showed a difference between groups of -0.457 mm2 (90% CI, -0.864 to -0.049), which was statistically significant. The clinical significance of this difference is unclear. There was a trend (p=0.07) for more subjects receiving LIPUS to be judged as healed by participating physicians at the end of the 16-week study period (65% [33/51] of US vs 46% [23/50] of sham).
Section Summary: Delayed Fracture Union
The best evidence for US treatment for delayed fracture union is from a moderately sized (n=101), double-blinded, sham-controlled trial. Analysis of patients who completed the study showed a moderate effect size for increased bone mineral density and a trend for increased rate of clinical healing. While there was not a statistically significant improvement in the rate of healing, improvements in intermediate outcomes and corroborating evidence from trials of patients with similar indications (e.g., fracture nonunion) make it very likely that this treatment is efficacious for delayed union.
Rue et al. (2004) reported on a double-blind RCT that examined the effects of 20 minutes of daily LIPUS on tibial stress fracture healing outcomes such as pain, function, and resumption of professional and personal activities in 26 military recruits. (23) The delay from onset of symptoms to diagnosis was 32 days in the LIPUS group and 28 days in the placebo group. This trial found no significant difference in healing times between LIPUS treatment and sham, with a mean time of return to duty of 56 days for both groups.
Section Summary: Stress Fractures
One small RCT was identified on LIPUS for the treatment of tibial stress fractures. LIPUS did not significantly reduce the healing time for the tibial stress fractures in this double-blind study. Additional study in a larger sample of patients is needed to determine the effect of US treatment on stress fractures with greater certainty.
Urita et al. (2013) published a small (n=27) quasi-randomized study (alternating assignment) of LIPUS after ulnar-shortening osteotomy for ulnar impaction syndrome or radial-shortening osteotomy for Kienböck disease. (24) Patients in the LIPUS group received a daily 20-minute treatment for at least 12 weeks postoperatively. Blinded evaluation of radiographic healing showed that LIPUS reduced the mean time to the cortical union by 27% (57 days vs 76 days) and endosteal union by 18% (121 days vs 148 days) compared with sham treatment. At the time of endosteal healing, the osteotomy plus LIPUS group and the osteotomy-only group had similar results, as measured using the Modified Mayo Wrist Score and no pain at the osteotomy site.
The 2009 systematic review by Busse et al. found 3 trials of distraction osteogenesis that used a variety of surrogate outcome measures with inconsistent results and provided very low-quality evidence of accelerated functional improvement. (4) In 2011, a small (n=36) nonblinded RCT of LIPUS found no significant differences between active and control groups in efficacy measures, although the treatment period (fixator gestation period) was decreased by more than 1 month. (25) A 2014 study randomized 21 patients undergoing callus distraction for posttraumatic tibial defects to LIPUS or no treatment (controls). (26) In this nonblinded study, US shortened healing by 12 d/cm and the total fixator time by 95 days.
Section Summary: Distraction Osteogenesis
The literature on LIPUS for distraction osteogenesis consists of small trials with inconsistent results. Double-blind trials with larger numbers of subjects are needed to evaluate the health benefits of this procedure.
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1.
Table 1. Summary of Key Trials
A Randomized Controlled Trial Comparing Low-Intensity, Pulsed Ultrasound to Placebo in the Treatment of Operatively Managed Scaphoid Non-unions
Observational, Non-Interventional Use of LIPUS to Mitigate Fracture Non-Union in Patients at Risk (BONES)
Trial to Evaluate UltraSound in the Treatment of Tibial Fractures (TRUST)
EXO-SPINE: A Prospective, Multi-center, Double-blind, Randomized, Placebo Controlled Pivotal Study of Ultrasound as Adjunctive Therapy for Increasing Posterolateral Fusion Success Following Single Level Posterior Instrumented Lumbar Surgery
Terminated (interim analysis)
NCT: national clinical trial.
a denotes an industry-sponsored or cosponsored trial.
Summary of Evidence
For individuals who have fresh closed fractures who receive low-intensity pulsed ultrasound (LIPUS), the evidence includes randomized controlled trials (RCTs) and systematic reviews of RCTs. Relevant outcomes are symptoms, morbid events, functional outcomes, and quality of life. This evidence indicates that LIPUS improves clinical and radiographic healing for fresh closed fractures, although the magnitude of benefit may differ depending on the location of the bone and risk factors for healing. The evidence is sufficient to determine qualitatively that the technology results in a meaningful improvement in the net health outcome.
For individuals who have open fractures or surgically treated closed fractures who receive LIPUS, the evidence includes RCTs. Relevant outcomes are symptoms, morbid events, functional outcomes, and quality of life. Results from RCTs of LIPUS for this patient population are mixed, and do not consistently demonstrate improved outcomes. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals who have fracture nonunion who receive LIPUS, the evidence includes prospective case series. Relevant outcomes are symptoms, morbid events, functional outcomes, and quality of life. The case series are considered adequate evidence for nonunions, due to the negligible chance of healing without intervention and the lack of other noninvasive alternatives. The evidence is sufficient to determine qualitatively that the technology results in a meaningful improvement in the net health outcome.
For individuals who have delayed fracture union who receive LIPUS, the evidence includes an RCT. Relevant outcomes are symptoms, morbid events, functional outcomes, and quality of life. Evidence for ultrasound (US) treatment for delayed fracture union (a moderately sized double-blinded sham-controlled trial) showed a moderate effect size for increased bone mineral density and a trend toward increased rate of clinical healing with US treatment. In addition, improvements in intermediate outcomes (e.g., radiographic appearance), combined with the efficacy of US for fresh closed fractures and fracture nonunion, make it very likely that this treatment is also efficacious for delayed union. The evidence is sufficient to determine qualitatively that the technology results in a meaningful improvement in the net health outcome.
For individuals who have tibial stress fractures, osteotomy sites, or distraction osteogenesis who receive LIPUS, the evidence includes small RCTs and nonrandomized comparative trials. Relevant outcomes are symptoms, morbid events, functional outcomes, and quality of life. One small RCT was identified on US for the treatment of tibial stress fractures. LIPUS did not significantly reduce healing time for these fractures in this double-blind study. One small quasi-randomized study was identified on use of US for osteotomy sites. Clinical outcomes appear to have been assessed only at the time of radiographic healing and did not show any differences between groups at that time point. The literature on pulsed US for distraction osteogenesis (small trials) has shown inconsistent results. The evidence is insufficient to determine the effects of the technology on health outcomes.
Practice Guidelines and Position Statements
National Institute for Health and Care Excellence
The National Institute for Health and Care Excellence (NICE) published guidance (2010) on LIPUS to promote fracture healing. (27) NICE concluded that this procedure “can reduce fracture healing” and is particularly beneficial for “delayed healing and fracture non-union.”
NICE published guidance (2013) on Exogen for the treatment of long-bone fractures with nonunion and delayed fracture healing. (28) 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.
American Academy of Orthopaedic Surgeons
The American Academy of Orthopaedic Surgeons (2009) published guidelines on the treatment of distal radius fractures. (29) The Academy issued a limited recommendation for the use of LIPUS for adjuvant treatment of distal radius fractures. While evidence from 1 study demonstrated an increased rate of healing (measured by the absence of pain and radiographic union), the additional cost of LIPUS resulted in a “limited” recommendation.
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14. Dijkman BG, Busse JW, Walter SD, et al. The impact of clinical data on the evaluation of tibial fracture healing. Trials. 2011; 12:237. PMID 22050862
15. 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. PMID 24898987
16. 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
17. 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
18. 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
19. Summary of Safety and Effectiveness Data. Exogen 2000® or Sonic Accelerated Fracture Healing System (SAFHS®) Exogen®, a Smith and Nephew Company, Piscataway, NJ.
20. 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. PMID 26052056
21. Rutten S, Nolte PA, Guit GL, et al. Use of low-intensity pulsed ultrasound for posttraumatic nonunions of the tibia: a review of patients treated in the Netherlands. J Trauma. Apr 2007; 62(4):902-908. PMID 17426546
22. 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. PMID20932272
23. 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
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. 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
26. 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
27. National Institute for Health and Care Excellence (NICE). Low-intensity pulsed ultrasound to promote fracture healing [IPG 374]. 2010. Available at: <http://www.nice.org> (accessed February 1, 2018).
28. 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 at: <http://www.nice.org> (accessed February 1, 2018).
29. American Academy of Orthopaedic Surgeons. The treatment of distal radius fractures. 2009. Available at: <http://www.aaos.org> (accessed February 1, 2018).
30. Ultrasound Accelerated Fracture Healing Device. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (March 2018) Medicine 1.01.05.
|8/15/2018||Document updated with literature review. Coverage unchanged. Added references 1-2, 11, 15-18, 20, 27. Document title changed from: Low Intensity Ultrasound Accelerated Fracture Healing Device.|
|12/1/2017||Reviewed. No changes.|
|11/1/2016||Document updated with literature review. The following criteria: “who are at high risk (see NOTE #1) for delayed fracture healing or nonunion” was added to the following coverage statement: “Low-intensity ultrasound treatment 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 (<14 days) , closed fractures in skeletally mature individuals.” In addition Note #1 was added to the coverage section noting the following: “Candidates for ultrasound treatment are those at high risk for delayed fracture healing or nonunion. These high risk factors may include either patient comorbidities or locations of fractures and include the following: diabetes, steroid therapy, osteoporosis, history of alcoholism, history of smoking, jones fracture, fracture of navicular bone in the wrist (also called the scaphoid), fracture of metatarsal, and factures associated with extensive soft tissue or vascular damage.” The condition of “fresh surgically treated closed fractures” was added to the listing of the experimental, investigational and/or unproven coverage statement.|
|1/1/2015||Reviewed; no changes|
|3/15/2013||Document updated with literature review. The following was added: 1) Low-intensity ultrasound treatment may be considered medically necessary as a treatment of delayed union of bones, excluding the skull and vertebra. NOTE : Delayed union is defined as a decelerating healing process as determined by serial x-rays, 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. 2) Arthrodesis or failed arthrodesis added as examples of experimental, investigational and unproven indications.|
|7/1/2011||Document updated with literature review. No change in coverage. Stress fracture added as example of experimental, investigational and unproven indications. Rationale completely revised. Title changed to Low Intensity Ultrasound Accelerated Fracture Healing Device.|
|4/15/2008||Revised/updated entire document|
|11/1/2000||Revised/updated entire document|
|3/1/2000||Revised/updated entire document|
|4/1/1999||Revised/updated entire document|
|2/1/1997||Revised/updated entire document|
|4/1/1996||New medical document|
|Title:||Effective Date:||End Date:|
|Ultrasound Accelerated Fracture Healing Device||08-15-2018||06-30-2019|
|Low Intensity Ultrasound Accelerated Fracture Healing Device||12-01-2017||08-14-2018|
|Low Intensity Ultrasound Accelerated Fracture Healing Device||11-01-2016||11-30-2017|
|Low Intensity Ultrasound Accelerated Fracture Healing Device||01-01-2015||10-31-2016|
|Low Intensity Ultrasound Accelerated Fracture Healing Device||03-15-2013||12-31-2014|
|Low Intensity Ultrasound Accelerated Fracture Healing Device||07-01-2011||03-14-2013|
|Ultrasound Accelerated Fracture Healing Device||06-01-2009||06-30-2011|
|Ultrasound Accelerated Fracture Healing Device||04-15-2008||05-31-2009|
|Ultrasound Accelerated Fracture Healing Device||11-01-2000||04-14-2008|