Bone Growth Stimulators

Revised: April 15, 2021

· Overview

· Eligible Providers

· Eligible Members

· Covered Services

· Noncovered Services

· Authorization

· Billing

Overview

Bone growth (osteogenesis) stimulators are used to stimulate bone growth and assist in healing fractures when healing has stalled. Bone growth stimulators are considered Class III medical devices by the Food and Drug Administration (FDA) 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 to assist members for whom MHCP is not the primary payer.

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

Eligible Members

Bone growth stimulators are covered for eligible MHCP members 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 addition 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 addition 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

Noncovered 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 members 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 non-healing spinal fusions, at least two x-rays over the course of three months are required. For non-healing fractures, at least two 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.

FDA-approved Devices (not an exhaustive list)

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-user device	· Nonunion of vertebrae or flat bones · Width of the nonunion is greater than half the width of the bone · Members with synovial pseudarthrosis · Members who are not skeletally mature Members with pacemakers, unless documentation from the cardiologist establishes that use of the bone growth stimulator is safe and appropriate · Members whose electrical impedance of the tissue between the electrodes will not allow the device to operate within the prescribed 5 to 10 milliamperes range · Members with nonunion secondary to, or in conjunction with, a pathological condition · Members 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 · Members with synovial pseudarthrosis · Members with demand pacemakers or implantable defibrillators, unless documentation from the cardiologist establishes that use of the bone growth stimulator is safe and appropriate · Members who are pregnant · Members 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 · Members with synovial pseudarthrosis · Members who have demand-type pacemakers, unless documentation from the cardiologist establishes that use of the bone growth stimulator is safe and appropriate · Members who have external or internal fixation devices that are constructed from magnetic materials · Members who are not skeletally mature · Members who are pregnant or nursing · Members with nonunion secondary to, or in conjunction with, a pathological condition · Members with mental or physical conditions which preclude patient compliance with the physician and device instructions · Members 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 half the width of the bone · Members who have synovial pseudarthrosis · Members who are not skeletally mature · Members who have a demand type pacemaker when the bone growth stimulator will be placed in close proximity to the pacemaker. If a member has a pacemaker, documentation from a cardiologist is required.
E0748	ActaStim-S Manufacturer: Theragen	· Adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels Note: FDA approved as a single-user device	· None on FDA approval. Please take warnings and precautions on product label into consideration.
E0748	Spinal-Stim Manufacturer: Orthofix	· Adjunct to spinal fusion · Salvage of failed spinal fusion Note: FDA approved as a single-user device	· Members who have an implanted cardiac pacemakers · Members who are pregnant or nursing · Members who are not skeletally mature · Members with mental or physical conditions which preclude compliance with physician and device instructions · Members 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	· Members who have cardiac pacemakers or cardioverters, unless documentation from the cardiologist establishes that use of the bone growth stimulator is safe and appropriate · Members who are pregnant or intending to become pregnant · Members 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	· Members with demand-type pacemakers or implantable cardiovertor defibrillators · Members who are pregnant · Members who are not skeletally mature · Members with osseous or ligamentous spinal trauma, spondylitis, Paget’s disease, severe osteoporosis, metastatic cancer, renal disease, or uncontrolled diabetes mellitus · Members with mental or physical conditions which preclude patient compliance with the physician and device instructions · Members 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 · Members who are not skeletally mature · Members who are pregnant or nursing · Members 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 · Members with thrombophlebitis, vascular insufficiency, abnormal skin sensitivity, sensory paralysis, alcoholism or nutritional deficiency · Members receiving steroid, anti-coagulant, prescription non-steroidal anti-inflammatory, calcium channel blocker or diphosphonate therapy

Billing

· Use MN–ITS 837P Professional or X12 Batch

· Refer to the provider basics Billing Policy Overview webpage for more information.