Bone Growth Stimulators Form

Page 1 of 4

Bone Growth Stimulators Medical Policy

Service: Bone Growth Stimulators

PUM 250-0016-1812

Medical Policy Committee Approval 02/28/2024 Effective Date 03/01/2024 Prior Authorization Needed Yes

Description:

Bone growth stimulators (also called osteogenic stimulators) apply electrical or ultrasonic current to bone fractures or joint fusions to promote healing. Ultrasonic stimulation is applied externally, while electrical stimulation can be applied either from the outside of the body (noninvasive) or from the inside of the body (invasive).

Definitions: For the purposes of this medical policy, the following are defined:

• Acute or Fresh Fracture: Fracture occurred less than 14 days ago

• Delayed Union: No progressive signs of healing (callus, periosteal reaction, or less distinct fracture line) radiographically for at least 3 months

Indications of Coverage:

A. Invasive or non-invasive electrical bone growth stimulator is considered medically necessary as an adjunct to lumbar spinal fusion when at least one of the following risk factors is present:

1. History of previous failed fusion

2. Grade II or greater spondylolisthesis

3. Multilevel fusion (fusion at more than one level)

4. The individual has a co-morbid condition that may impact bone healing (e.g., obesity, current smoking, diabetes, osteoporosis, renal disease, steroid use, alcoholism)

   B. Invasive or Non-invasive electrical bone growth stimulator is considered medically necessary for the treatment of non-pathological fracture nonunion of long bones* of the appendicular skeleton or failed joint fusion secondary to failed joint arthrodesis when all of the following are met:

5. Fracture gap of less than one centimeter

Page 2 of 4

2. Fracture of long bone or arthrodesis of joint occurred at least 3 months ago.

3. There is no indication of malignancy in the area.

4. Limited progress toward healing demonstrated on radiographs or MR/CT with EITHER of the following:

   a) no surgical fixation but serial imaging obtained at least 3 months apart

   documents deficient or scarce callus; OR

   b) surgical fixation but imaging at least 3 months postoperatively

   demonstrates deficient or scarce callus.

5. The fracture is adequately immobilized and stable with no evidence of hardware loosening or failure (if present).

   • Long Bones: Clavicle, femur, tibia, fibula, humerus, radius, ulna, metacarpals and metatarsals of the hands and feet, and phalanges of the fingers and toes.

   C. Non-invasive electrical bone growth stimulator is considered medically necessary for treatment of congenital pseudoarthroses in the appendicular skeleton.

   D. External Ultrasonic bone growth stimulator (also called low intensity pulsed ultrasound bone growth stimulator) is considered medically necessary when all of the following are met:

6. The stimulator is being used due to delayed healing of tibial osteotomy, delayed union of reduced and immobilized long bone* fracture or failed joint arthrodesis.

7. Limited progress toward healing demonstrated on serial radiographs or MR/CT obtained at least 3 months apart, with deficient or scarce callus.

8. If surgery had been performed, the most recent surgical procedure for the condition was within the last 6 months.

9. The individual is skeletally mature.

10. No indication of malignancy in the area

11. Fracture gap of less than one centimeter

    E. When D. 4, 5, and 6 are met, but the diagnosis is either acute/subacute fracture of either the scaphoid (navicular) bone of the wrist, or the 5th metatarsal of the foot.

    • Long Bones: Clavicle, femur, tibia, fibula, humerus, radius, ulna, metacarpals and metatarsals of the hands and feet, and phalanges of the fingers and toes

Page 3 of 4

Limitations of Coverage:

A. Review contract and endorsements for exclusions and prior authorization or benefit requirements.

B. If used for a condition/diagnosis other than is listed in the Indications of Coverage, it will be denied as experimental, investigational, and unproven to affect health outcomes.

C. If used for a condition/diagnosis that is listed in the Indications of Coverage; but the criteria are not met, it will be denied as not medically necessary.

D. Semi-invasive bone growth stimulators will be denied as experimental, investigational, and unproven to affect health outcomes.

E. The use of invasive or non-invasive electrical bone growth stimulator or ultrasonic bone growth stimulator will be denied as experimental, investigational, and unproven to affect health outcomes when used to treat or in the presence of any of the following:

1. Acute or fresh fracture (except for acute fractures of the scaphoid of the wrist or of the 5th metatarsal) (See Indications of Coverage E. above).

2. Stress or insufficiency fracture

3. Pathological fracture or underlying bony malignancy.

4. Cervical spinal surgery

5. Spondylolysis, or pars interarticulares fractures

6. Vertebral compression fracture or odontoid fractures

7. Avascular necrosis or treatment of bone infarcts

8. Synovial pseudoarthrosis

9. Fracture gap of greater than one centimeter

10. Less than 3 months since fracture or most recent operative treatment (except for scaphoid [wrist] fracture).

11. Sesamoid fracture

12. Acute osteotomy

13. For treatment of an acute joint fusion/arthrodesis, other than lumbar spinal fusion.

Page 4 of 4

14. For treatment of the calvarium or treatment of the tarsal bones, except in cases of arthrodesis nonunion.

    Documentation Required:

    • Office notes (must include documentation of original injury, related surgical history, other applicable treatments, and current status) • Xray/imaging reports

    Disclaimer: This policy is for informational purposes only and does not constitute medical advice, plan authorization, an explanation of benefits, or a guarantee of payment. Benefit plans vary in coverage and some plans may or may not provide coverage for all services listed in this policy. Coverage decisions are subject to all terms and conditions of the applicable benefit plan, including specific exclusions and limitations, and to applicable state and federal law. Some benefit plans administered by the organization may not utilize Medical Affairs medical policy in all their coverage determinations. Contact customer services as listed on the member card for specific plan, benefit, and network status information.

    Medical policies are based on constantly changing medical science and are reviewed annually and subject to change. The organization uses tools developed by third parties, such as the evidence-based clinical guidelines developed by MCG to assist in administering health benefits. This medical policy and MCG guidelines are intended to be used in conjunction with the independent professional medical judgment of a qualified health care provider. To obtain additional information about MCG, email medical.policies@wpsic.com.

    Medical Policy Review History:

    Implemented 10/01/19, 06/01/20, 06/01/21, 06/01/22, 03/01/23, 03/01/24 Medical Policy Committee Approval 06/21/19, 01/31/20, 01/28/21, 01/27/22, 02/23/23, 02/28/24 Reviewed

    01/31/20, 01/28/21, 02/23/23, 02/28/24 Developed 06/21/19

    Approved by the Medical Director