Bone Growth Stimulation (Osteogenic) Form

Medical Policy
Policy Number: MP-0181 Effective Date: 6/2/2015 Revised: 07/12/2023 Document Page Length: 4 Subject: Bone Growth Stimulation (Osteogenic) Applies To: Commercial and IFP NOTE: Medicare will use NCD Osteogenic Stimulators (150.2) AND CGS DME MAC Local Coverage Determination for Osteogenesis Stimulators (L33796) Medical Policy Statement: Bone Growth (Osteogenic) Stimulation may be considered medically necessary as defined by this policy.
Definitions:
Electrical Osteogenesis Stimulator: A device that provides electrical stimulation to augment bone repair.
Osteogenic: Bone ossification, or osteogenesis, is the process of bone formation. Clinical Criteria: (Indications/Limitations) I. A non-spinal electrical stimulator is considered medically necessary ONLY for the following indications: A. Nonunion of a long bone (clavicle, humerus, radius, ulna, femur, tibia, fibula, metacarpal, metatarsal) fracture defined as radiographic evidence that fracture healing has ceased for 3 or more months;

1. Non-union of long bone fracture must be documented by a minimum of 2 sets of radiographs obtained prior to starting treatment with the osteogenesis stimulator, separated by at least 90 days, each including multiple views of the fracture site, and with a written interpretation by a physician stating that there has been no clinically significant evidence of fracture healing. B. Failed fusion of a joint other than in the spine where a minimum of 9 months has elapsed since the last surgery; OR C. Congenital pseudoarthrosis

   II. A spinal electrical stimulator is considered medically necessary for the following indications: A. Failed spinal fusion where a minimum of 9 months has elapsed since the last surgery; OR B. Following a multilevel spinal fusion (involves 3 or more vertebrae) surgery; OR C. Following spinal fusion surgery where there is a history of a previously failed spinal fusion at the same site III. Ultrasonic Bone Growth (Osteogenic) Stimulation is considered medically necessary according to the criteria (A OR B) below. A. Acute fracture or osteotomy, and need for adjunctive treatment, as indicated by ALL of the following:

2. Acute fracture or osteotomy, as indicated by 1 or more of the following: a. Closed distal radius (Colles) fracture of wrist b. Fifth metatarsal (Jones) fracture c. Radial shortening osteotomy d. Radius fracture treated with plaster immobilization e. Scaphoid fracture f. Tibial osteotomy for distraction osteogenesis g. Tibial shaft fracture, either closed or grade I open, treated with plaster immobilization h. Ulnar shortening osteotomy
3. Fracture reduced and immobilized
4. Potential for impaired fracture healing due to clinical risk factors or fracture location (eg, complex fracture, significant comorbidities, smoking, corticosteroid use)
5. No infection at fracture site
6. No malignancy at fracture site
7. Member is skeletally mature as evidenced by fusion of epiphyseal plates

8. Delayed or nonunion fracture or osteotomy healing, as indicated by ALL of the following: a. Fracture is of a long-bone or tibial osteotomy and is not of the vertebrae or skull
   b. Fracture reduced and immobilized c. At least 3 months or more from date of injury or osteotomy d. Less than 6 months since most recent operation

   e. Bone loss 15 mm or less f. No clinical or radiographic signs of progress toward healing for 3 or more months as documented by at least 2 sets of radiograph images performed at least 90 days apart confirming that clinically significant healing has not occurred g. No malignancy at fracture site h. The member is skeletally mature as evidenced by fusion of epiphyseal plates Limitations: I. Other applications of low-intensity ultrasound treatment will be denied as not medically necessary and are considered experimental or investigational