Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Osteogenic Stimulators (i.e., Electrical Bone Growth Stimulation and Low-Intensity Ultrasound Accelerated Fracture Healing System)
Policy #:MA05.018a

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

ELECTRICAL BONE GROWTH STIMULATORS

MEDICALLY NECESSARY
Non-Spinal (E0747, E0749)

Electrical bone growth stimulators (noninvasive/invasive) are considered medically necessary and, therefore, covered when any of the following criteria are met:
    • For noninvasive/invasive: A nonunion fracture of a long bone (i.e., clavicle, humerus, radius, ulna, metacarpal, femur, tibia, fibula, metatarsal)
      • Nonunion fracture is defined as the point at which healing has stopped and further healing has ceased for three or more months (as evidenced by serial radiographic documentation, including a minimum of two sets of radiographs, each including multiple views of the fracture site, separated by a minimum of 90 days) prior to starting treatment with the bone growth stimulator
    • For noninvasive: A fracture secondary to congenital pseudarthrosis
    • For noninvasive: A failed surgical fusion of a joint other than in the spine when a minimum of nine months have elapsed since the last surgery

Spinal (E0748, E0749)

Electrical bone growth stimulators (noninvasive/invasive) are considered medically necessary and, therefore, covered following spinal surgery when any of the following criteria are met:
    • A failed spinal fusion when the most recent surgery was performed a minimum of nine months after the previous surgery
    • A multilevel spinal fusion surgery involving three or more vertebrae (e.g., L3-L5)
    • Following a spinal fusion surgery, with a history of a previously failed spinal fusion at the same site

NOT MEDICALLY NECESSARY
All other uses for electrical bone growth stimulators are considered not medically necessary and, therefore, not covered.

EXPERIMENTAL/INVESTIGATIONAL
Semi-invasive electrical bone growth stimulators are not approved by the US Food and Drug Administration (FDA) and are considered experimental/investigational and, therefore, not covered.

LOW-INTENSITY ULTRASOUND ACCELERATED FRACTURE HEALING SYSTEM (E0760)

MEDICALLY NECESSARY
A low-intensity ultrasound accelerated fracture healing system (noninvasive) is considered medically necessary and, therefore, covered when all of the following criteria are met:
    • Nonunion bone fracture (e.g., clavicle, scapula, humerus, radius, ulna, carpal, metacarpal, phalanges [fingers or toes], femur, patella, tibia, fibula, malleolus, talus, calcaneus, cuboid, navicular, cuneiform, tarsal, metatarsal, rib(s), sternum, and pelvis), prior to any surgical intervention
      • Nonunion fracture is defined as the point at which healing has stopped and further healing has ceased for three or more months (as evidenced by serial radiographic documentation, including a minimum of two sets of radiographs, each including multiple views of the fracture site, separated by a minimum of 90 days) prior to starting treatment with the bone growth stimulator.
    • The fracture is not of the skull or vertebrae
    • The fracture is not tumor related

NOT MEDICALLY NECESSARY
A low-intensity ultrasound accelerated fracture healing system (noninvasive) is considered not medically necessary and, therefore, not covered, for all other indications, including, but not limited to the following:
    • Concurrent use with another noninvasive osteogenic stimulator
    • Treatment of fresh fractures
    • Treatment of delayed union fractures

Supplies

Ultrasound conductive coupling gel is billed using code A4559.

FACE-TO-FACE REQUIREMENTS

As a condition for payment, a professional provider must have a face-to-face examination with the individual for whom the item is ordered that meets all of the following requirements:
    • The treating professional provider must have an in-person examination with the individual within the six (6) months prior to the date of the written order prior to delivery.
    • This examination must document that the individual was evaluated and/or treated for a condition that supports the need for the item(s) of DME ordered.
A new face-to-face examination is required each time a new prescription for one of the specified items is ordered. A new prescription is required:
    • For all claims for purchases or initial rentals
    • When there is a change in the prescription for the accessory, supply, drug, etc.
    • If periodic prescription renewal required per medical policy
    • When an item is replaced
    • When there is a change in the supplier
    • When required by state law

In this policy the specified items are:

Code
NARRATIVE
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

REQUIRED DOCUMENTATION
The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include but are not limited to: records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports. This policy is consistent with Medicare's documentation requirements, including the following required documentation:

PRESCRIPTION (ORDER) REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective order at the time of an audit or after an audit for submission as an original order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY
Medical record documentation must include a contemporaneously prepared delivery confirmation or member’s receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the DME supplier/provider. All documentation is to prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES
The durable medical equipment (DME) supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately seven days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual’s medical record. Delivery of the supplies should not be done earlier than approximately five days before the individual would exhaust their on-hand supply.
Documentation of a face to face encounter, between the treating professional provider and the individual meeting the above requirements, including an assessment of the individual’s clinical condition supporting the need for the prescribed DME item(s) must be provided to and kept on file by the DME supplier.

If required documentation is not available on file to support a claim at the time of an audit or record request, the durable medical equipment (DME) supplier may be required to reimburse the Company for overpayments.
Policy Guidelines

This policy is consistent with Medicare’s coverage determination. The Company’s payment methodology may differ from Medicare.

Subject to the terms and conditions of the applicable Evidence of Coverage, electrical bone growth stimulators (noninvasive/invasive) and/or a low-intensity ultrasound accelerated fracture healing system are covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

However, services that are identified in this policy as not medically necessary are not eligible for coverage or reimbursement by the Company.

Description

ELECTRICAL OSTEOGENIC STIMULATORS

Electrical stimulation to augment bone repair can be attained either invasively or non-invasively. Invasive devices provide electrical stimulation directly at the fracture site either through percutaneously placed cathodes or by implantation of a coiled cathode wire into the fracture site. The power pack for the latter device is implanted into soft tissue near the fracture site and subcutaneously connected to the cathode, creating a self-contained system with no external components. The power supply for the former device is externally placed and the leads connected to the inserted cathodes. With the non-invasive device, opposing pads, wired to an external power supply, are placed over the cast. An electromagnetic field is created between the pads at the fracture site.

ULTRASONIC OSTEOGENIC STIMULATORS

An ultrasonic osteogenic stimulator is a noninvasive device that emits low intensity, pulsed ultrasound. The device is applied to the surface of the skin at the fracture site and ultrasound waves are emitted via a conductive coupling gel to stimulate fracture healing. The ultrasonic osteogenic stimulators are not be used concurrently with other non-invasive osteogenic devices.
References

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). 150.2 Osteogenic Stimulators. [CMS Web site]. Effective 4/27/2015. Available at:
http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=65&ncdver=2&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=Pennsylvania&KeyWord=osteogenic&KeyWordLookUp=Title&KeyWordSearchType=And&list_type=ncd&bc=gAAAABAAAAAA&. Accessed April 6, 2017.

Noridian. Local Coverage Determination (LCD). L33796 Osteogenesis stimulators. [Noridian Web site]. 10/01/2015. Available at: https://med.noridianmedicare.com/documents/6547796/6558289/Osteogenesis+Stimulators.pdf/da14c326-0bef-4f5d-8d0e-9fc27ec3efe1. Accessed April 6, 2017.

Noridian. Local Coverage Article. Effective 10/01/2015. (A52513). Available at:
https://med.noridianmedicare.com/documents/6547796/6558289/Osteogenesis+Stimulators.pdf/da14c326-0bef-4f5d-8d0e-9fc27ec3efe1. Accessed April 6, 2017.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

MEDICALLY NECESSARY

THE FOLLOWING CODE IS USED TO REPRESENT NONINVASIVE ELECTRICAL STIMULATION

20974

THE FOLLOWING CODE IS USED TO REPRESENT INVASIVE ELECTRICAL STIMULATION

20975

THE FOLLOWING CODE IS USED TO REPRESENT NONINVASIVE ULTRASOUND STIMULATION

20979


EXPERIMENTAL/INVESTIGATIONAL

THE FOLLOWING CODE IS USED TO REPRESENT SEMI-INVASIVE ELECTRICAL BONE GROWTH STIMULATION

20999


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

N/A


HCPCS Level II Code Number(s)



MEDICALLY NECESSARY

THE FOLLOWING CODE IS USED TO REPRESENT A NONINVASIVE ELECTRICAL STIMULATOR FOR NON-SPINAL APPLICATIONS:
E0747 Osteogenesis stimulator, electrical, noninvasive, other than spinal applications

THE FOLLOWING CODE IS USED TO REPRESENT A NONINVASIVE ELECTRICAL STIMULATOR FOR SPINAL APPLICATIONS:
E0748 Osteogenesis stimulator, electrical, noninvasive, spinal applications

THE FOLLOWING CODE IS USED TO REPRESENT AN INVASIVE ELECTRICAL STIMULATOR:
E0749 Osteogenesis stimulator, electrical, surgically implanted

THE FOLLOWING CODE IS USED TO REPRESENT A NONINVASIVE ULTRASOUND STIMULATOR:
E0760 Osteogenesis stimulator, low intensity ultrasound, noninvasive

SUPPLIES

A4559 Coupling gel or paste, for use with ultrasound device, per oz

EXPERIMENTAL/INVESTIGATIONAL

THE FOLLOWING CODE IS USED TO REPRESENT A SEMI-INVASIVE ELECTRICAL BONE GROWTH STIMULATOR:
E1399 Durable medical equipment, miscellaneous



Revenue Code Number(s)

N/A


Misc Code

Modifiers:

EY - No physician or other health care provider order for this item or sevice
KF - FDA Class III Device


Coding and Billing Requirements






Policy History

MA05.018a
10/10/2018The policy has been reviewed and reissued to communicate the Company’s continuing position on Osteogenic Stimulators (i.e., Electrical Bone Growth Stimulation and Low-Intensity Ultrasound Accelerated Fracture Healing System).
05/10/2017The policy has been reviewed and reissued to communicate the Company’s continuing position on Osteogenic Stimulators (i.e., Electrical Bone Growth Stimulation and Low-Intensity Ultrasound Accelerated Fracture Healing System).
12/21/2016The policy has been reviewed and reissued to communicate the Company’s continuing position on osteogenic stimulators.
11/06/2015This version of the policy will become effective 11/06/2015.

The following policy statements for low-intensity accelerated fractures healing system (E0760) have been revised:
  • The medically necessary and not medically necessary statements were revised.

Existing durable medical equipment documentation requirements, in accordance with Medicare, are now included with examples.

MA05.018
01/01/2015This is a new policy.




Version Effective Date: 11/06/2015
Version Issued Date: 11/06/2015
Version Reissued Date: 10/10/2018