Is an ultrasonic bone growth stimulator (E0760) medically necessary for a 59-year-old female with left leg and ankle pain?

Ultrasonic Bone Growth Stimulator is NOT Medically Necessary for This Patient

The request for an ultrasonic bone growth stimulator (E0760) should be denied for this patient, as she does not meet any of the established clinical criteria for its use, and current high-quality evidence strongly recommends against LIPUS for bone healing regardless of fracture status. 1

Primary Rationale for Denial

No Documented Fracture Present

• The most recent radiographs from 10/1/25 show "no obvious fracture, abnormality or malalignment" - this is the fundamental disqualifying factor 2
• The diagnosis code S82.892A (other fracture of left lower leg, initial encounter for closed fracture) is not supported by any radiographic evidence 2
• The clinical presentation describes soft tissue injury ("other injury of muscle and tendon to lower left leg") with medial tibial tenderness, not a fracture requiring bone healing stimulation 2

Failure to Meet MCG Criteria

The patient fails to meet ALL of the required MCG criteria for ultrasonic bone growth stimulator use 2:

• No delayed union or nonunion present - radiographs are normal, with no evidence of deficient or scarce callus formation 2
• No fracture gap documented - the 10mm or less requirement cannot be assessed when no fracture exists 2
• No fracture reduction or immobilization documented - only an ankle brace was provided for soft tissue support, not fracture stabilization 2
• No surgical intervention - the less than 6 months post-operation criterion is not applicable 2
• No long-bone fracture or tibial osteotomy documented - this is a critical requirement that is completely absent 2

Evidence-Based Recommendation Against LIPUS

Strong Guideline Recommendations

The British Medical Journal (2017) provides a strong recommendation AGAINST the use of LIPUS for bone healing based on moderate to high certainty evidence 1:

• LIPUS demonstrates little to no impact on time to return to work, time to full weight bearing, pain reduction, or radiographic healing across various fracture types 1
• The BMJ panel unanimously agreed that "all or nearly all informed patients would elect not to apply LIPUS" 1
• Further research is unlikely to alter this evidence 1

Cost and Resource Considerations

• LIPUS devices cost between $1,300-$5,000 and do not represent an efficient use of health resources given their lack of demonstrated benefit 1, 2
• Healthcare organizations may reasonably choose to stop reimbursements based on best current evidence 1

Patient Burden Without Benefit

• LIPUS requires 15-20 minutes daily use for 14-140 days, is cumbersome to travel with, and patient compliance is limited 1
• The device provides no clinical benefit to justify this burden 1

Appropriate Management for This Patient

Current Standard of Care is Adequate

• The patient received appropriate treatment with an ankle brace for soft tissue injury and support - this addresses the actual pathology (muscle/tendon injury) 2
• Conservative management with protected weight-bearing, ice, and activity modification is the evidence-based approach for soft tissue injuries without fracture 2

If Fracture Were Present (Hypothetically)

Even if a fracture were documented, LIPUS would still not be indicated because 1, 2:

• The BMJ strongly recommends against LIPUS for ALL fracture types, including fresh fractures
• The TRUST trial (2016) found no benefit of LIPUS in 501 adults with tibial fractures compared to sham device
• Mechanical stabilization and standard fracture care remain the cornerstone of treatment

Common Pitfalls to Avoid

• Do not approve bone stimulators based solely on diagnosis codes - radiographic confirmation of fracture with evidence of delayed/nonunion is mandatory 2
• Do not confuse soft tissue injury with fracture - tenderness over bone does not equal fracture; imaging confirmation is required 2
• Do not assume bone stimulators are harmless adjuncts - they represent significant cost without demonstrated benefit and may give false reassurance while delaying appropriate care 1

Clinical Bottom Line

This patient has a soft tissue injury (muscle/tendon) without radiographic evidence of fracture. She is receiving appropriate conservative management with bracing. The ultrasonic bone growth stimulator is not indicated for soft tissue injuries, and even if a fracture were present, current high-quality guidelines strongly recommend against LIPUS use due to lack of efficacy on patient-important outcomes. 1, 2