CurrentAmbetter NevadaPolicy CP.MP.194

Clinical Policy: Osteogenic Stimulation

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Medical necessity criteria and coding guidance for noninvasive and invasive electrical osteogenic stimulators and low-intensity pulsed ultrasound (LIPUS) to enhance bone healing for members of Ambetter Nevada (Centene-affiliated health plans).

Policy Summary

PayerAmbetter Nevada

PolicyClinical Policy: Osteogenic Stimulation

Policy CodePolicy CP.MP.194

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and document imaging, timing, fracture gap, infection status, stabilization, and risk factors to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

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CurrentAmbetter NevadaPolicy CP.MP.194

Clinical Policy: Osteogenic Stimulation

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Policy Summary

PayerAmbetter Nevada

PolicyClinical Policy: Osteogenic Stimulation

Policy CodePolicy CP.MP.194

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and document imaging, timing, fracture gap, infection status, stabilization, and risk factors to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Coverage Criteria for Osteogenic Stimulation

Noninvasive electrical osteogenesis stimulators — Covered when ANY of the following apply

Covered when ANY of the following apply

Noninvasive electrical: nonunion of long bone fracture

The bone is not infected.
The two portions of the bone involved in the nonunion are separated by less than 1 cm.
The bone is stable at both ends by means of appropriate fracture care/immobilization.
Serial imaging has confirmed that fracture healing has ceased for three or more months prior to starting treatment. Serial imaging must include a minimum of two sets of images, each including multiple views of the fracture site, separated by a minimum of 90 days.

Noninvasive electrical: failed fusion (non-spine): Failed fusion of a joint other than the spine when a minimum of 6 months has elapsed since the last surgery.6 months since last surgery

I.B

Noninvasive electrical: congenital pseudoarthrosis: Congenital pseudoarthrosis.

I.C

Noninvasive electrical: adjunct to spinal fusion: As an adjunct to spinal fusion surgery for patients at high risk of pseudoarthrosis due to previously failed fusion surgery or for those undergoing a multilevel spinal fusion (involving three or more vertebrae).multilevel = >=3 vertebrae

I.D

Noninvasive electrical: risk factors for delayed/non-union: Risk of delayed or non-union of fractures due to conditions including but not limited to alcoholism, chemotherapy, diabetes, obesity, osteoporosis, renal disease, tobacco or steroid use.

I.E

Invasive electrical osteogenesis stimulators — Covered when ANY of the following apply

Covered when ANY of the following apply

Invasive electrical: nonunion of long bone fracture

The bone is not infected.
The two portions of the bone involved in the nonunion are separated by less than 1 cm.
The bone is stable at both ends by means of appropriate fracture care/immobilization.
Serial imaging has confirmed that fracture healing has ceased for three or more months prior to starting treatment with the invasive stimulator. Serial imaging must include a minimum of two sets of images, each including multiple views of the fracture site, separated by a minimum of 90 days.

Invasive electrical: failed spinal fusion: Failed spinal fusion when a minimum of 9 months has elapsed since the last surgery and/or as an adjunct to spinal fusion surgery for patients at high risk of pseudoarthrosis.

Ultrasonic (LIPUS) osteogenesis stimulators — Covered when ANY of the following apply

Covered when ANY of the following apply

LIPUS: adjunct for selected fresh closed fractures: Used as an adjunct to conventional management (e.g., closed reduction and cast immobilization) for treatment of fresh, closed fractures when there is high risk for delayed fracture healing or nonunion and at least one listed risk factor exists. Indications include but are not limited to: fractures associated with extensive soft tissue or vascular damage; fresh (seven days or less in duration), closed or grade I open, short oblique or short spiral tibial diaphyseal fractures treated with closed reduction and cast immobilization in skeletally mature patients; fresh, closed distal radius (Colles') fractures treated with closed reduction and cast immobilization in skeletally mature patients; fresh Jones fracture (5th metatarsal); fresh scaphoid fractures.fresh <=7 days for certain tibial fractures

III.A

LIPUS: nonunion (non-skull/vertebrae): Nonunion of bones other than the skull or vertebrae in skeletally mature patients, excluding malignancy-related nonunions, when documented by at least two imaging sets obtained prior to treatment separated by a minimum of 90 days and when the fracture gap is less than 1 cm.2 imaging sets >=90 days apart; gap <1 cm

III.B

It is the policy of health plans affiliated with Centene Corporation that osteogenic devices are not medically necessary for nonunion fractures of the skull, vertebrae, or fractures that are related to malignancy (tumor-related).

Coverage of devices and procedures described in this clinical policy is subject to all terms, conditions, exclusions and limitations of the member’s coverage documents (for example, evidence of coverage, certificate of coverage, policy or contract). This clinical policy is a guide to medical necessity and does not guarantee payment; benefit determinations and administration of coverage follow the member’s plan documents and applicable state and federal requirements.

Ultrasonic (LIPUS) osteogenesis stimulators are considered not medically necessary when used in combination with other noninvasive osteogenic stimulators and for specific indications including: avascular necrosis of the femoral head; stress fractures; fractures with a gap > 1 cm; fresh fractures in locations other than distal radius, tibial diaphysis, scaphoid or Jones 5th metatarsal; fresh tibial diaphyseal or tibial and fibular fractures treated with closed reduction and intramedullary nailing without risk factors for poor healing; preoperative use prior to surgical intervention or fixation; and tibial stress fractures.

This clinical policy is intended as a guide to medical necessity and does not itself establish entitlement to payment. Providers must follow applicable coverage documents and Health Plan administrative policies when submitting claims; the policy does not replace professional judgment and the Health Plan makes final coverage determinations based on the member’s benefit terms and other available clinical information.

Coding and Imaging Requirements

Referenced CPT CodesCPT

20974	Electrical stimulation to aid bone healing; noninvasive (nonoperative).
20975	Electrical stimulation to aid bone healing; invasive (operative).
20979	Low intensity ultrasound stimulation to aid bone healing, noninvasive (nonoperative).

Referenced HCPCS CodesHCPCS

A4559	Coupling gel or paste, for use with ultrasound device, per oz.
E0747	Osteogenesis stimulator; electrical, noninvasive, other than spinal applications.
E0748	Osteogenesis stimulator; electrical, noninvasive, spinal applications.
E0749	Osteogenesis stimulator; electrical, surgically implanted.
E0760	Osteogenesis stimulator, low intensity ultrasound, noninvasive

No explicit codes in this document segmentmixed

No codes listed

inv-11: Imaging separation interval — Two sets of imaging separated by a minimum of 90 days

RequirementSerial imaging must include a minimum of two sets of images, each with multiple views, separated by a minimum of 90 days.

Use caseRequired to document cessation of fracture healing for nonunion criteria prior to starting electrical or ultrasonic stimulators.

DocumentationImaging must show fracture gap (<1 cm) and absence of infection when applicable.

inv-12: Maximum fracture gap for nonunion candidacy — < 1 cm

Maximum gapThe two portions of the bone involved in the nonunion must be separated by less than one centimeter (<1 cm).

Applies to

Provider Actions, Prior Authorization & Documentation

Prior Authorization

Prior authorization required for referenced CPT/HCPCS codes

Prior authorization is expected for osteogenic stimulation procedures and devices billed with the referenced CPT and HCPCS codes; providers should document that medical necessity criteria are met including imaging, timing since fracture or surgery, fracture gap (<1 cm), infection status, stability/immobilization, and relevant risk factors.

Referenced codes include CPT 20974, 20975, 20979 and HCPCS A4559, E0747, E0748, E0749, E0760.
Document serial imaging (minimum two sets, multiple views, separated by >=90 days) when applicable.
Document elapsed time thresholds (e.g., >=90 days since fracture or surgical treatment for noninvasive electrical nonunion; >=9 months for failed spinal fusion with invasive electrical stimulators).

Prior Authorization

Check plan-level prior authorization and benefit rules

Prior authorization requirements and determinations of medical necessity must follow the Health Plan's administrative procedures and the member's coverage terms; check plan-level rules as authorization may be required or denied if not consistent with those documents.

Background and Rationale

Fracture healing is a complex biological process influenced by factors such as blood supply, adequacy of immobilization, the size of the fracture gap, infection, bone or soft-tissue loss, nutrition, osteoporosis, and metabolic dysfunction. Standard management emphasizes stabilization (cast, internal or external fixation) and may include bone grafting or adjunctive methods to induce osteogenesis. Electrical stimulation and low-intensity pulsed ultrasound (LIPUS) are adjunctive therapies used to promote bone healing in selected cases of nonunion, failed fusion, or high-risk fresh fractures; diagnosis of nonunion is based on clinical findings (motion, pain, tenderness) and imaging, and treatment decisions require documentation of fracture stability, absence of infection, and imaging that demonstrates lack of healing.

Definitions

inv-26: Noninvasive electrical osteogenic stimulator

DefinitionExternally applied systems delivering electrical current to the fracture site via capacitive coupling (CC), pulsed electromagnetic field (PEMF), or combined electromagnetic field technology (CEMF) through treatment coils placed around the fracture.

IndicationsUsed for nonunion of long bone fractures, failed non-spine fusions, congenital pseudoarthrosis, adjunct to spinal fusion in high-risk patients, and risk of delayed/nonunion due to specific conditions.

Timing/requirementsNonunion indication requires >=90 days elapsed since fracture or surgical treatment and serial imaging documenting cessation of healing (minimum two sets >=90 days apart).

inv-27: Invasive (implantable) electrical osteogenic stimulator

DefinitionDevices delivering direct current to the fracture or fusion site via implanted electrodes or percutaneously placed cathodes/coiled cathode wires (implantable/invasive electrical stimulators).

Policy Summary

PayerAmbetter Nevada

PolicyClinical Policy: Osteogenic Stimulation

Policy CodePolicy CP.MP.194

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and document imaging, timing, fracture gap, infection status, stabilization, and risk factors to support medical necessity.

SourceLink

On This Page

Invasive electrical: multilevel spinal fusion: Following a multilevel spinal fusion (involving three or more vertebrae).multilevel = >=3 vertebrae

II.C

Invasive electrical: history of previously failed fusion at same site: Following spinal fusion surgery where there is a history of a previously failed spinal fusion at the same site.

II.D

Invasive electrical: risk factors for delayed/non-union: Risk of delayed or non-union of fractures due to conditions including but not limited to alcoholism, chemotherapy, diabetes, obesity, osteoporosis, renal disease, tobacco or steroid use.

II.E

LIPUS: risk factors: Risk of delayed or nonunion of any fresh, closed fractures due to conditions including but not limited to alcoholism, chemotherapy, diabetes, obesity, osteoporosis, renal disease, tobacco or steroid use.

III.C

inv-13: Time since fracture or surgical treatment for noninvasive electrical nonunion — >= 90 days

Minimum elapsed time>= 90 days since date of fracture or date of surgical treatment of the fracture before initiating noninvasive electrical stimulation for nonunion.

ContextPart of noninvasive electrical stimulator nonunion criteria requiring imaging and stability parameters.

DocumentationProviders must document elapsed time since fracture/surgery in authorization and clinical records.

inv-14: Time since last surgery for failed spinal fusion (invasive electrical) — >= 9 months

Minimum elapsed time>= 9 months since the last surgery for failed spinal fusion prior to invasive (implantable) electrical osteogenic stimulator use.

Alternate useAlso may be used as an adjunct to spinal fusion surgery for patients at high risk of pseudoarthrosis.

ScopeSpecific to invasive/implantable electrical stimulators addressing failed spinal fusion.

inv-15: Time since last surgery for failed joint fusion (non-spine, noninvasive) — >= 6 months

Minimum elapsed time>= 6 months since the last surgery for failed joint fusion (non-spine) before noninvasive electrical stimulation is considered medically necessary.

Applies toFailed fusion of a joint other than the spine.

DocumentationProviders should document date of last surgery and clinical indication for stimulator use.

inv-16:

Policy scopeCoverage decisions are subject to the terms, conditions, exclusions and limitations of the member's coverage documents and applicable Health Plan administrative policies.

Guidance natureThis clinical policy is a guide to medical necessity and does not guarantee payment or constitute a contract.

Provider responsibilityProviders are expected to exercise professional medical judgment and follow plan procedures when submitting claims and authorizations.

Follow the Health Plan's prior authorization process and any plan-specific administrative policies.
Verify member benefits and coverage documents (e.g., EOB, certificate of coverage) before submission.

Step Therapy

Document conservative management and LIPUS daily use

When prescribing LIPUS, document prior conservative management and that the device is being used as an adjunct to stabilization or as secondary therapy for nonunions; note that LIPUS is typically prescribed for at‑home use 20 minutes once daily until healing.

For fresh, closed fractures eligible for LIPUS, document risk factors for delayed healing and timing (some tibial indications require ≤7 days from fracture).
For nonunions, document two imaging sets ≥90 days apart and fracture gap <1 cm where required.

Note

No action specified

No additional provider-action content provided in the source for this block.

Documentation Required

Obtain and submit required serial imaging and clinical documentation

Provide serial imaging that documents cessation of fracture healing: obtain a minimum of two sets of images, each with multiple views of the fracture site, separated by at least 90 days; also document fracture gap (<1 cm), absence of infection, and elapsed time since fracture or surgery per device-specific criteria.

Minimum two imaging sets, multiple views, separated by ≥90 days for nonunion criteria.
Document fracture gap measurement (<1 cm) and that bone is not infected.
Document stability/immobilization and the required elapsed time (e.g., ≥90 days for noninvasive electrical nonunion; ≥9 months for invasive electrical failed spinal fusion).

Documentation Required

Follow coverage documents and administrative claims policies

When submitting claims, follow applicable coverage documents and Health Plan administrative policies; this clinical policy is a guide to medical necessity and does not guarantee payment—claims inconsistent with coverage terms may be denied.

Reference the most current coding guidance and include required documentation to support medical necessity.
This policy does not constitute a contract or guarantee of payment.

Denial Risk

Denial risk: ultrasound and other device exclusions

Ultrasonic (LIPUS) devices and other osteogenic stimulators may be denied as not medically necessary for numerous indications including use with other noninvasive osteogenic stimulators; avascular necrosis of the femoral head; stress fractures; fractures with gap >1 cm; fresh fractures outside specified locations (distal radius, tibial diaphysis, scaphoid, Jones 5th metatarsal); preoperative use prior to surgical fixation; tibial stress fractures; and nonunion fractures of the skull, vertebrae, or tumor-related fractures.

Do not bill LIPUS for combined use with other noninvasive osteogenic stimulators.
Do not bill LIPUS for excluded fracture locations or when fracture gap >1 cm.
Verify non-malignant indication and that fracture is not skull or vertebra before submission.

Denial Risk

Verify member benefits and plan-level limitations

Coverage is subject to the terms, conditions, exclusions and limitations of the member's coverage documents and applicable plan-level administrative policies; verify member benefits prior to ordering or billing osteogenic stimulation services.

Claims may be denied if services are inconsistent with the member's evidence of coverage or plan exclusions.
Confirm plan-specific requirements, prior authorizations, and any state or federal mandates that supersede this policy.

IndicationsCovered for nonunion of long bone fractures with imaging and stability criteria, failed spinal fusion after >=9 months, multilevel spinal fusion, and prior failed fusion at the same site.

inv-28: Low-intensity pulsed ultrasound (LIPUS)

DefinitionA noninvasive device emitting low-intensity pulsed ultrasound applied over the skin with conductive coupling gel; typical home use is 20 minutes once daily until healing occurs.

IndicationsAdjunct to conventional management for selected fresh, closed fractures at high risk for delayed healing and as secondary therapy for nonunions (non-skull/vertebrae) when imaging and gap criteria are met.

LimitationsNot medically necessary when used with other noninvasive osteogenic stimulators, for fractures with gap >1 cm, avascular necrosis of femoral head, stress fractures, or certain fresh fracture locations.

inv-29: LIPUS — Low-Intensity Pulsed Ultrasound (LIPUS)

AcronymLow-Intensity Pulsed Ultrasound (LIPUS).

Typical regimenPrescribed for at-home daily use, 20 minutes once daily, until healing occurs (patient-applied device).

Clinical rolesUsed as adjunct for selected fresh closed fractures and as secondary therapy for nonunions after other therapies; requires documented imaging and gap <1 cm for nonunion use.

inv-30: Electrical/EMF stimulation — Electromagnetic field/electrical stimulation for bone healing

DefinitionElectromagnetic field/electrical stimulation modalities (PEMF, CC, CEMF) that deliver electrical current or fields to promote bone healing either noninvasively via external coils or invasively via implanted electrodes.

Evidence summaryAvailable evidence supports PEMF/CEMF benefits for long bone nonunions and as adjuncts for spinal fusion, though effectiveness varies by device, location, and study methodology.

Coding/authorizationPrior authorization is expected for procedures/devices using referenced CPT/HCPCS codes; documentation should show imaging, timing, gap size, infection status, immobilization, and risk factors.