CurrentHealth NetPolicy CP.MP.194

Osteogenic Stimulation

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Medical necessity criteria and coding guidance for invasive and noninvasive electrical bone growth stimulators and low-intensity pulsed ultrasound (LIPUS) to enhance fracture healing and spinal fusion; applies to Health Net / Centene-affiliated health plans and providers requesting coverage.

Policy Summary

PayerHealth Net

PolicyOsteogenic Stimulation

Policy CodePolicy CP.MP.194

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain and document prior authorization and serial imaging (minimum two sets separated by ≥90 days) showing cessation of healing before initiating therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

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CurrentHealth NetPolicy CP.MP.194

Osteogenic Stimulation

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Policy Summary

PayerHealth Net

PolicyOsteogenic Stimulation

Policy CodePolicy CP.MP.194

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain and document prior authorization and serial imaging (minimum two sets separated by ≥90 days) showing cessation of healing before initiating therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3modality categories

90imaging separation (days)

1 cmmax fracture gap

6 mofailed fusion (non-spine) wait

9 mofailed spinal fusion wait

~13bibliography

Medically Necessary and Not Medically Necessary Criteria

inv-01: Noninvasive electrical stimulators - medically necessary

Covered when ANY of the following are met:

ANY of the following

I.A Nonunion of long bone fracture
- The bone is not infected
- The two portions of the bone involved in the non-union are separated by less than 1 cm
- The bone is stable at both ends by means of appropriate fracture care and 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, each including multiple views, separated by a minimum of 90 days
I.B Failed joint fusion (non-spine): Failed fusion of a joint other than the spine with a minimum of six months elapsed since the last surgery
I.C Congenital pseudoarthrosis: Congenital pseudoarthrosis
I.D Adjunct to spinal fusion for high risk or multilevel fusion: Used as an adjunct to spinal fusion 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)
I.E Risk of delayed/nonunion: 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

inv-02: Invasive electrical stimulators - medically necessary

Covered when ANY of the following are met:

ANY of the following

II.A Nonunion of long bone fracture: Nonunion of long bone and all of the following: the bone is not infected; the two portions of the bone involved in the non-union are separated by less than 1 cm; the bone is stable at both ends by means of appropriate fracture care and 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, each including multiple views, separated by a minimum of 90 days
II.B Failed spinal fusion: Failed spinal fusion in which a minimum of nine months has elapsed since the last surgery and/or use as an adjunct to spinal fusion surgery for patients at high risk of pseudoarthrosis
II.C Following multilevel spinal fusion: Following a multilevel spinal fusion (involving three or more vertebrae)

inv-03: Ultrasonic (LIPUS) stimulators - medically necessary

Covered when ANY of the following are met:

ANY of the following

III.A Adjunct for fresh closed fractures at high risk
- Risk factors include: fracture 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 fractures of the scaphoid
III.B Nonunion (non skull/vertebrae): Nonunion of bones other than the skull or vertebrae in skeletally mature patients, excluding malignancy-related, when documented by a minimum of two sets of imaging obtained prior to starting treatment separated by a minimum of 90 days, and the two portions of the bone involved in the non-union are separated by less than 1 cm
III.C Risk of delayed/nonunion due to comorbidities:

Ultrasonic (LIPUS) osteogenesis stimulators are not medically necessary for certain indications. Specifically, ultrasonic stimulators used in combination with other noninvasive osteogenic stimulators are excluded. Ultrasonic stimulation is also not medically necessary for avascular necrosis of the femoral head, stress fractures, fractures in which the gap exceeds 1 cm, fresh fractures in locations outside the distal radius, tibial diaphysis, scaphoid, or 5th metatarsal (Jones fracture), fresh tibial diaphyseal or tibial and fibular fractures treated with closed reduction and intramedullary nailing when no risk factors for poor healing exist, preoperative use for fractures that require surgical intervention or internal/external fixation, and tibial stress fractures. In addition, osteogenic devices are not medically necessary for nonunion fractures of the skull, vertebrae, or those that are tumor-related.

Coverage for osteogenic stimulators is subject to the terms, conditions, exclusions and limitations of the member's benefit documents and applicable Health Plan administrative policies. For Medicaid members, state Medicaid coverage provisions take precedence when they conflict with this clinical policy. Providers should consult the member's coverage documents and relevant state Medicaid manuals when determining benefit applicability.

Osteogenic devices, including ultrasonic stimulators, are considered not medically necessary for nonunion fractures of the skull or vertebrae and for fractures that are tumor-related. Ultrasonic devices are likewise not indicated for several specified fracture types and uses (see exclusions), including fractures with gap > 1 cm, preoperative use when surgical fixation is required, and certain tibial fractures treated with intramedullary nailing in the absence of risk factors for delayed healing.

Relevant CPT/HCPCS Codes and Numeric Criteria

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 CPT Codes (duplicate) - see HCPCS for device specificsCPT

No codes listed

Referenced HCPCS/National 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.

inv-09: Maximum fracture gap for nonunion treatment

Maximum fracture gapLess than 1 cm

ContextApplies to nonunion criteria for noninvasive and invasive devices and to LIPUS nonunion criteria (excluding skull/vertebrae and malignancy-related)

Documentation requirementGap must be documented on imaging obtained prior to starting stimulation treatment

inv-10: Minimum separation between imaging sets to demonstrate cessation of healing

Minimum separation between imaging sets>= 90 days

Imaging sets requiredMinimum of two sets, each with multiple views of the fracture site

Prior Authorization, Documentation, and Operational Notes for Providers

Prior Authorization

Prior Authorization Required

Prior authorization is required and will be guided by medical necessity determinations in this clinical policy. Providers must obtain PA for devices and services when plan coverage decisions are required prior to delivery. Coverage is determined consistent with the medical necessity criteria in this policy and any applicable Health Plan administrative requirements.

PA required where plan decisions are needed; refer to medical necessity criteria in policy

Documentation Required

Required Imaging and Clinical Documentation

Serial imaging and clinical documentation are required to support diagnoses of delayed union or nonunion. For nonunion, include a minimum of two sets of images (each with multiple views of the fracture site) separated by at least 90 days demonstrating cessation of healing, documentation of fracture age, evidence of stability and lack of infection, and any prior surgical or non-surgical treatments.

Key Terms and Device Definitions

inv-20: Noninvasive electrical osteogenic stimulator

DefinitionNoninvasive electrical osteogenic stimulator: device delivering electrical current to the fracture site externally via capacitive coupling (CC), pulsed electromagnetic field (PEMF), or combined electromagnetic field technology (CEMF) through treatment coils placed around the fracture.

ModalitiesCapacitive coupling (CC), Pulsed electromagnetic field (PEMF), Combined electromagnetic field technology (CEMF)

Delivery methodsExternal treatment coils with an external power supply; categorized as noninvasive (also contrasted with invasive/semiinvasive implantable devices)

inv-10: Ultrasonic (LIPUS) osteogenic stimulator

DefinitionUltrasonic (LIPUS) osteogenic stimulator: a noninvasive device that emits low-intensity pulsed ultrasound applied to the skin at the fracture site using conductive coupling gel to stimulate fracture healing.

Clinical Background and Evidence Context

Fracture healing can be impaired by multiple factors. Contributing conditions include insufficient blood supply, infection, inadequate immobilization at the fracture site, excessive separation between fracture ends, bone/tissue loss, poor nutrition, osteoporosis, and other metabolic dysfunctions. Standard management emphasizes stabilization (casting or internal/external fixation) and, when indicated, bone grafting; electrical or low-intensity pulsed ultrasound (LIPUS) therapies are adjunctive measures intended to promote osteogenesis in cases of delayed union or nonunion.

Document History and References

This clinical policy includes bibliographic references supporting the discussion of electrical stimulation and LIPUS in fracture healing. Representative citations include a 2018 review of electrical stimulation and bone healing, Cochrane and other systematic reviews of electromagnetic and ultrasound modalities, and recent articles examining LIPUS in specific fracture types. (See reference list for approximately 13 citations.)

This clinical policy is intended as a guide to medical necessity and does not constitute a contract or guarantee of payment. Coverage determinations and benefit administration remain subject to all terms, conditions, exclusions, and limitations of the applicable coverage documents, as well as state and federal requirements. For Medicare members, applicable NCDs, LCDs, and Medicare Coverage Articles should be reviewed. This document is the property of the Health Plan and is protected by Centene Corporation copyright; unauthorized copying or distribution is prohibited.

Policy Summary

PayerHealth Net

PolicyOsteogenic Stimulation

Policy CodePolicy CP.MP.194

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain and document prior authorization and serial imaging (minimum two sets separated by ≥90 days) showing cessation of healing before initiating therapy.

SourceLink

On This Page

II.D Following spinal fusion with prior 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.E Risk of delayed/nonunion: 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

Risk of delayed or non-union of any fresh, closed fractures due to conditions including but not limited to alcoholism, chemotherapy, diabetes, obesity, osteoporosis, renal disease, tobacco or steroid use

PurposeTo document cessation of healing for three or more months prior to initiating stimulatory treatment

Minimum two sets of imaging separated by >= 90 days

Document fracture age, stability, and absence of infection

Record prior treatments and surgery dates

Note

Therapy Sequencing and Home Use

Low-intensity pulsed ultrasound (LIPUS) is typically prescribed for at‑home use — generally 20 minutes once daily — as an adjunct to appropriate fracture stabilization. Providers should consider sequencing of therapies (stabilization, internal/external fixation, casting) and use osteogenic stimulators only as adjuncts when indicated by the policy (e.g., nonunion, high-risk fresh fractures).

LIPUS home regimen: ~20 minutes once daily until healing
Use LIPUS as adjunct to stabilization (cast, fixation) and per indications in policy
Consider sequencing: stabilization and/or surgical management prior to adjunctive stimulation

Denial Risk

Denial for Excluded Indications

Devices or indications explicitly listed as not medically necessary or excluded in this policy should be denied. Examples include osteogenic devices for nonunion of the skull or vertebrae, tumor‑related nonunions, and ultrasonic stimulation for excluded fresh fracture locations and other listed contraindicated uses.

Deny for indications listed as not medically necessary in policy (see exclusions)
Document rationale for denial in the medical record and PA system

Note

Coverage Decisions and Administrative Limits

Coverage decisions and administration of benefits are subject to the member’s applicable coverage documents, contractual terms, exclusions and limitations, and to state and federal requirements. This clinical policy is a guide to medical necessity and does not guarantee payment. The Health Plan may change or withdraw the policy and will follow legal/regulatory requirements for provider notification.

Coverage subject to evidence of coverage, certificate of coverage, policy or contract terms
Policy is a guide to medical necessity and not a guarantee of payment

Note

Provider Responsibility

Providers are expected to exercise professional medical judgment when applying this policy. The clinical policy is not intended to dictate individual patient care; clinicians remain responsible for diagnosis and treatment decisions and should supply complete clinical documentation to support medical necessity determinations.

Provider responsibility to use professional judgment and document clinical rationale
Supply complete records to support any PA or claims review

Prescribed for at-home use about 20 minutes once daily until healing occurs; used adjunctively with fracture stabilization or as secondary therapy for nonunions.

Mechanism summaryTransmits high-frequency acoustic pressure waves producing micromechanical stresses and biochemical cellular changes that promote bone formation.

inv-22: Multilevel spinal fusion

DefinitionMultilevel spinal fusion: spinal fusion involving three or more vertebrae (policy-defined).

Policy roleUsed as a criterion for adjunctive osteogenic stimulation in both noninvasive and invasive device coverage when patients undergo multilevel fusion.

Reference noteDefinition was added/clarified in policy revisions and applied to criteria I.D. and II.C.

inv-23: Low-Intensity Pulsed Ultrasound (LIPUS)

DefinitionLow-Intensity Pulsed Ultrasound (LIPUS): a noninvasive ultrasound modality that delivers low-intensity, pulsed acoustic waves to stimulate and potentially accelerate bone healing.

MechanismDelivers micromechanical stresses and strain leading to biochemical cellular changes that promote bone formation and accelerate fracture healing.

Usage and evidenceUsed adjunctively with stabilization or as secondary therapy for nonunions; recent reviews and case series are cited (e.g., Palanisamy et al. 2022; Murakami et al. 2021; Bawale et al. 2021).

inv-24: Electrical stimulation

DefinitionElectrical stimulation: use of electrical or electromagnetic fields to promote bone-cell response and fracture healing, delivered invasively (implanted electrodes) or noninvasively (external coils delivering CC, PEMF, or CEMF).

Modalities and deliveryInvasive/semiinvasive devices deliver direct current via implanted electrodes; noninvasive systems use external coils and waveforms (PEMF, CEMF, CC).

Evidence baseReviews and summaries of technology and clinical applications are cited (e.g., Khalifeh et al. 2018; deVet et al. 2021) describing variable effectiveness and mechanisms.