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Bone Growth Stimulators

Revised: 04-08-2014


  • • Overview
  • • Eligible Providers
  • • Eligible Recipients
  • • Covered Services
  • • Non-Covered Services
  • • Authorization
  • • Billing
  • Overview

    Bone growth (osteogenesis) stimulators are used to stimulate bone growth and healing of fractures when healing has stalled.Bone growth stimulators are considered Class III medical devices by the Food and Drug Administration, and should only be used in a way that is consistent with the FDA approved package insert.

    Eligible Providers

    The following providers may provide bone growth stimulators:

  • • Medical suppliers
  • • Hospitals
  • • Indian Health Services
  • • Federally Qualified Health Center
  • • Rural Health Clinic

  • TPL and Medicare

    Providers must meet any provider criteria, including accreditation, for third party insurance or for Medicare in order to assist recipients for whom MHCP is not the primary payer.

    MHCP quantity limits and thresholds apply to all recipients unless only Medicare co-insurance or deductible is requested.

    Eligible Recipients

    Bone growth stimulators are covered for eligible MHCP recipients who meet medical necessity criteria.

    Covered Services

    Codes:
    E0747: osteogenesis stimulator, electrical, noninvasive, other than spinal application
    E0748: osteogenesis stimulator, electrical, noninvasive, spinal applications
    E0749: osteogenesis stimulator, electrical, surgically implanted
    E0760: osteogenesis stimulator, low intensity ultrasound

    Nonspinal, noninvasive electrical bone growth stimulators (E0747) are covered for treatment of fracture nonunion:

  • • At least 3 months have elapsed since the date of fracture
  • • The fracture gap is less than one-half the bone diameter or less than one centimeter
  • • Patient can be adequately immobilized
  • • Patient is compliant with medical treatment including orders to be non-weight bearing
  • • Patient is capable of using the bone growth stimulator or has a caregiver capable of using it
  • • The device is requested for an FDA approved indication
  • • None of the conditions listed as contraindications for the requested device are present

  • Noninvasive electrical bone growth stimulators (E0747) are covered for congenital pseudoarthroses in the appendicular skeleton (only if the specific device requested is FDA approved for this indication):

  • • Patient can be adequately immobilized
  • • Patient is compliant with medical treatment including orders to be non-weight bearing
  • • Patient is capable of using the bone growth stimulator or has a caregiver capable of using it
  • • None of the conditions listed as contraindications for the requested device are present

  • Noninvasive electrical spinal bone growth stimulators (E0748) for treatment of failed spinal fusion:

  • • Spinal fusion has not healed 9 months after the original surgery
  • • Patient is compliant with medical treatment, including any appropriate restrictions on mobility
  • • Patient is capable of using the bone growth stimulator or has a caregiver capable of using it
  • • The device is requested for an FDA approved indication
  • • None of the conditions listed as contraindications for the requested device are present

  • Noninvasive (E0748) or invasive (E0749) electrical spinal bone growth stimulators as an adjunct to spinal fusion surgery for patients at high risk of fusion failure:

  • • One or more previous failed spinal fusions
  • • Grade III or worse spondylolisthesis
  • • Multi-level fusion
  • • Current smoker
  • • Diabetes
  • • Renal disease
  • • Alcoholism
  • • Patient is compliant with medical treatment, including any appropriate restrictions on mobility
  • • Patient is capable of using the bone growth stimulator or has a caregiver capable of using it
  • • The device is requested for an FDA approved indication
  • • None of the conditions listed as contraindications for the requested device are present

  • Low-intensity ultrasound bone growth stimulators (E0760) are covered for treatment of fracture nonunion:

  • • At least 3 months have elapsed since the date of fracture
  • • The fracture gap is one centimeter or less
  • • Patient can be adequately immobilized
  • • Patient is compliant with medical treatment including orders to be non-weight bearing
  • • Patient is capable of using the bone growth stimulator or has a caregiver capable of using it
  • • The device is requested for an FDA approved indication
  • • None of the conditions listed as contraindications for the requested device are present

  • Low-intensity ultrasound bone growth stimulators (E0760) are covered as an adjunct to conventional treatment of fresh, closed fractures for patients at high risk of nonunion:

  • • Patient has one or more of the listed risk factors
  • • Fracture associated with extensive soft tissue or vascular damage
  • • Diabetes
  • • Recent steroid therapy
  • • Osteoporosis
  • • Current smoker
  • • Patient can be adequately immobilized
  • • Patient is skeletally mature
  • • Patient is compliant with medical treatment including orders to be non-weight bearing
  • • Patient is capable of using the bone growth stimulator or has a caregiver capable of using it
  • • The device is requested for an FDA approved indication
  • • None of the conditions listed as contraindications for the requested device are present
  • Non-Covered Services

  • • Noninvasive or invasive electrical bone growth stimulators are considered investigative for treatment of a fresh fracture
  • • Noninvasive or invasive electrical bone growth stimulators and low-intensity ultrasound bone growth stimulators are considered investigative for treatment of delayed (as opposed to stalled) union fracture
  • • Invasive bone growth stimulators are considered investigative for any indication other than as an adjunct to spinal fusion
  • • Low-intensity ultrasound bone growth stimulators for treatment of congenital pseudoarthroses are not FDA approved and are considered investigative
  • • Low-intensity ultrasound bone growth stimulators are considered investigative for treatment of open fractures
  • • Low-intensity ultrasound bone growth stimulators are not considered an appropriate and effective use of limited programs funds and are not the least costly, medically appropriate treatment for patients with fresh fractures who do not have the risk factors specified above
  • • Bone growth stimulators are not covered for recipients who have any contraindication listed in the device’s package insert.
  • • Bone growth stimulators are not covered for any indication for which the specific stimulator has not been approved by the Food and Drug Administration.
  • Authorization

    Authorization is always required. Submit authorization requests and documentation to the authorization medical review agent.

    Authorization for noninvasive bone growth stimulators will be approved up to 3 months rental at a time unless the device is approved by the FDA only as a single user product. Devices approved by the FDA as single user products will be approved as purchases. If authorization for a rental unit is requested beyond the approved 3 months, new x-rays or radiology reports must be submitted.

    All authorization requests for treatment of nonunion must include serial x-rays which demonstrate that no progressive signs of healing have occurred. For nonhealing spinal fusions, at least 2 x-rays over the course of three months are required. For nonhealing fractures, at least 2 x-rays 30 days or more apart are required.

    All authorization requests must document that the device is requested for an FDA approved indication, that coverage criteria listed above are met, and that no contraindications are present.

    HCPCS code

    Device Name and manufacturer

    MHCP covered / FDA approved indications

    MHCP non-covered indications / Contraindications

    E0747

    OrthoPak 2

    Manufacturer: EBI Medical, Inc

  • • Established nonunion acquired secondary to trauma

  • * note: FDA approved as a single userdevice

  • • Nonunion of vertebrae or flat bones
  • • Width of the nonunion is greater than ½ the width of the bone
  • • Recipients with synovial pseudarthrosis
  • • Recipients who are not skeletally mature (usually not under age 18)
  • • Recipients with pacemakers, unless documentation from the cardiologist establishes that use of the bone growth stimulator is safe and appropriate
  • • Recipients whose electrical impedance of the tissue between the electrodes will not allow the device to operate within the prescribed 5 to 10 milliamperes range
  • • Recipients with nonunion secondary to, or in conjunction with, a pathological condition
  • • Recipients who are pregnant or nursing
  • E0747

    EBI Bone Healing System Model 2001

    Manufacturer: EBI Medical, Inc

  • • Fracture nonunion
  • • Failed fusion
  • • Congenital pseudarthrosis

  • * Note: FDA approved as a single user device

  • • Fractures of the spine or skull
  • • Fracture gaps of more than 1 cm
  • • Recipients with synovial pseudarthrosis
  • • Recipients with demand pacemakers or implantable defibrillators, unless documentation from the cardiologist establishes that use of the bone growth stimulator is safe and appropriate
  • • Recipients who are pregnant
  • • Recipients with fixation devices made from magnetic materials
  • E0747

    OL1000

    Manufacturer:
    dj Orthopedics, LLC

  • • Established nonunion acquired secondary to trauma

  • * Note: FDA approved as a single user device

  • • Nonunion of vertebrae or flat bones
  • • Recipients with synovial pseudarthrosis
  • • Recipients who have demand-type pacemakers, unless documentation from the cardiologist establishes that use of the bone growth stimulator is safe and appropriate
  • • Recipients who have external or internal fixation devices that are constructed from magnetic materials
  • • Recipients who are not skeletally mature (usually not under age 18)
  • • Recipients who are pregnant or nursing
  • • Recipients with nonunion secondary to, or in conjunction with, a pathological condition
  • • Recipients with mental or physical conditions which preclude patient compliance with the physician and device instructions
  • • Recipients with conditions of atrophy
  • E0747

    Physio-Stim

    Manufacturer: Orthofix

  • • Established nonunion acquired secondary to trauma

  • * note: FDA approved as a single user device

  • • Nonunion of vertebrae or flat bones
  • • Nonunion secondary to, or in connection with, a pathological condition
  • • Width of the nonunion gap is more than ½ the width of the bone
  • • Recipients who have synovial pseudarthrosis
  • • Recipients who are not skeletally mature (usually not under age 18)
  • • Recipients who have a demand type pacemaker when the bone growth stimulator will be placed in close proximity to the pacemaker. If a recipient has a pacemaker, documentation from a cardiologist is required.
  • E0748

    Spinal-Stim

    Manufacturer: Orthofix

  • • Adjunct to spinal fusion
  • • Salvage of failed spinal fusion

  • * note: FDA approved as a single user device

  • • Recipients who have an implanted cardiac pacemakers
  • • Recipients who are pregnant or nursing
  • • Recipients who are not skeletally mature (usually not under age 18)
  • • Recipients with mental or physical conditions which preclude compliance with physician and device instructions
  • • Recipients with osseous or ligamentous spinal trauma, Paget’s disease, moderate to severe osteoporosis, metastatic cancer, renal disease or uncontrolled diabetes mellitus
  • E0748

    SpinalPak II

    Manufacturer: EBI Medical, Inc

  • • Adjunct to primary spinal fusion for one or two levels

  • * note: FDA approved as a single user device

  • • Recipients who have cardiac pacemakers or cardioverters, unless documentation from the cardiologist establishes that use of the bone growth stimulator is safe and appropriate
  • • Recipients who are pregnant or intending to become pregnant
  • • Recipients with spondylitis, infection, Paget’s disease, osteoporosis, cancer, renal disease, diabetes mellitus or trauma of the lumbar spine
  • E0748

    SpinaLogic

    Manufacturer:
    dj Orthopedics, LLC

  • • Adjunct to primary lumbar spinal fusion surgery for one or two levels

  • * Note: FDA approved as a single user device

  • • Recipients with demand-type pacemakers or implantable cardiovertor defibrillators
  • • Recipients who are pregnant
  • • Recipients who are not skeletally mature (usually not under age 18)
  • • Recipients with osseous or ligamentous spinal trauma, spondylitis, Paget’s disease, severe osteoporosis, metastatic cancer, renal disease, or uncontrolled diabetes mellitus
  • • Recipients with mental or physical conditions which preclude patient compliance with the physician and device instructions
  • • Recipients who are unable to abstain from smoking during treatment periods
  • E0760

    Exogen 4000+

    Manufacturer: Smith & Nephew

  • • Established nonunions excluding skull and vertebra
  • • Fresh, closed, posteriorly displaced distal radius fractures
  • • Fresh, closed tibial diaphysis fractures

  • * note: FDA approved as a single user device

  • • Nonunion fracture of skull or vertebra
  • • Fresh fractures other than the distal radius or tibial diaphysis
  • • Fresh fractures with post-reduction displacement of more than 50%
  • • Fresh fractures due to bone pathology or malignancy
  • • Recipients who are not skeletally mature (usually not under age 18)
  • • Recipients who are pregnant or nursing
  • • Recipients who have active, implantable devices such as cardiac pacemakers, unless documentation from the cardiologist establishes that use of the bone growth stimulator is safe and appropriate
  • • Recipients with thrombophlebitis, vascular insufficiency, abnormal skin sensitivity, sensory paralysis, alcoholism and/or nutritional deficiency
  • • Recipients receiving steroid, anti-coagulant, prescription non-steroidal anti-inflammatory, calcium channel blocker and/or diphosphonate therapy

  • Billing

  • • Use MN−ITS 837P Professional. Refer to the MN-ITS User guide for DME/Med Supply/Prosthetics/Orthotics for billing instructions.
  • • The HCPCS code and modifiers must match the authorization.
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