This document addresses the use of low-intensity pulsed ultrasound devices as a non-invasive treatment to promote healing of some fresh fractures and to accelerate healing for nonunion of other fracture sites.

Note: Please refer to the following document for additional information related to devices used to stimulate bone growth:

• CG-DME-40 Noninvasive Electrical Bone Growth Stimulation of the Appendicular Skeleton

Clinical Indications

Medically Necessary:

1. Fresh Fractures
   Non-invasive, low-intensity pulsed ultrasound treatment is considered medically necessary for the treatment of fresh fractures when any of the following are present:
   1. Closed radial fractures, posteriorly displaced (Colles' fracture); or
   2. Tibial diaphyseal fractures that are either:
      1. Closed; or
      2. Grade I open; or
   3. Closed fracture sites at high risk for nonunion due to:
      1. Location; and
      2. Poor vascular supply, for example:
         1. Fractures of the carpal navicular bone (scaphoid fracture); or
         2. 5^th metatarsal bone fractures (Jones fracture); or
      3. Fractures associated with:
         1. Extensive soft tissue; or
         2. Vascular damage; or
   4.  Closed fractures at high risk for nonunion due to a comorbidity which makes healing likely to be compromised including any of the following:
      1. Diabetes; or
      2. Renal disease; or
      3. Other metabolic diseases; or
      4. History of tobacco use; or
      5. History of alcoholism; or
      6. Nutritional deficiency; or
      7. Obese individuals with:
         1. Body Mass Index (BMI) greater than 30; or
         2. When greater than 50% over ideal body weight (IBW);* or
      8. Severe anemia; or
      9. Steroid therapy.
2. Fracture Nonunions
   Non-invasive, low-intensity pulsed ultrasound treatment is considered medically necessary when all of the following criteria are met
   1. Treatment for fracture nonunion of any bone of the appendicular skeleton ; and
   2. At least 45 days have passed since either of the following:
      1. The date of fracture; or
      2. The date of appropriate fracture care; and
   3. No progressive signs of healing have occurred on imaging studies (for example, bony bridging and callus formation); and
   4. Fracture gap is less than 1 centimeter.

Not Medically Necessary:

Non-invasive, low-intensity pulsed ultrasound treatment is considered not medically necessary when the above criteria are not met including, but not limited to, treatment of any of the following:

1. As an adjunct to bunionectomy procedures at:
   1. The time of surgery; or
   2. Immediately after surgery;** or
2. As an adjunct to distraction osteogenesis procedures for any indication, such as:
   1. Limb lengthening; or
   2. Nonunion corrective surgery; or
   3. Repair of tibial defects at either:
      1. The time of; or
      2. Immediately after surgery;** or
3. Axial skeleton fractures including:
   1. Skull; and
   2. Vertebrae; or
4. Congenital pseudoarthrosis; or
5. Delayed fracture unions; or
6. Fresh open fractures that either:
   1. Require surgical intervention;*** or
   2. Are too unstable for closed reduction/casting when either:
      1. Grade II; or
      2. Grade III open fractures; or
7. Patellar tendinopathy; or
8. Pathological fractures due to:
   1. Bone pathology; or
   2. Tumor/malignancy; or
9. Stress fractures.

Notes:
*See Definitions section for calculation of ideal body weights (IBW).
**When surgical procedures result in nonunion the medically necessary criteria above may apply such as after:

1. Bunionectomy; or
2. Distraction osteogenesis.

***Fractures that are nonunion following surgical treatment should be considered for ultrasound bone growth stimulation applying the criteria under Fracture Nonunions in this document.