Medical Policies Online - Policy #: 05.00.09d

Medical Policy Bulletin

Title:

Bone Growth Stimulators

Policy #:

05.00.09d

The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. 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.

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 Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.

Intent

The intent of this policy is to communicate the medical necessity criteria for bone growth stimulators.

For information on policies related to this topic, refer to the Cross References Table in this policy.

Description:

Normal bone healing consists of several stages, including callous formation and calcification with revascularization of the fracture site, that lead to rigid bone development. However, in a small percentage of fractures, healing is impaired or does not progress at a normal rate, which may cause the fracture to be at risk for nonunion. 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).

Most, if not all, nonunion fractures require�some type of intervention to heal. In some cases, a bone growth stimulator (osteogenesis stimulator) may be used to encourage or reactivate the healing process. These devices provide stimulation through electrodes placed either at or around the fracture site. Studies support the theory that these electrodes produce electromagnetic fields that trigger a small electrical current similar to the signals that the body naturally produces to initiate bone healing.

There are electrical, electromagnetic, and ultrasonic methods of stimulation used to aid bone healing. These methods can be applied through invasive and noninvasive measures. Invasive bone growth stimulators involve the surgical implantation of a current generator in an intramuscular or subcutaneous space. The generator is connected to an electrode that is implanted within the bone fragments that need to be fused. The implanted device typically remains functional for six to nine months after implantation. Although the generator is surgically removed when the course of treatment is complete, the electrode may or may not be removed.

Noninvasive bone growth stimulators consist of an external power supply and externally applied coils or a transducer that generates a weak electrical current through the site where bone growth is desired. Noninvasive devices use pulsed electromagnetic fields (PEMFs), capacitive coupling, or combined magnetic fields technology to generate the current. Noninvasive ultrasonic bone growth stimulators accelerate fracture healing by emitting low-intensity, pulsed ultrasound signals on the skin surface over the fracture site. Ultrasonic bone growth stimulators are typically used in conjunction with cast immobilization.

Electrical bone growth stimulators are used for nonunion fracture(s) of long bone, which is defined
by the Centers for Medicare & Medicaid Services (CMS) to include the following: the clavicle, humerus, radius, ulna, metacarpal, femur, tibia, fibula, malleolus, and metatarsal. However, the safety and effectiveness of electrical bone growth stimulators in individuals under 17 years of age has not been established. In addition, insufficient scientific evidence exists to demonstrate the effectiveness of electrical bone growth stimulators in fresh and delayed union fractures. Fresh fractures are those that are less than seven days from the initial fracture. Delayed union fractures are those that are three months or less from the initial fracture, in which healing has not advanced at the average rate for the location and type of fracture.

The Sonic Accelerated Fracture Healing System (SAFHS�) is a low-intensity ultrasonic bone growth stimulator that received approval from the US Food and Drug Administration (FDA) in October 1994, for the treatment of fresh, closed, posteriorly displaced distal radius fractures (Colles fractures) and fresh closed or Grade I open tibial diaphysis fractures when used as an adjunct to closed reduction and cast immobilization. A Grade I open tibial diaphysis fracture is associated with skin breakage or opening of 1 cm or less. In clinical trials, the use of SAFHS� in fresh fractures of the tibial diaphysis and distal radius demonstrated significantly faster healing times than fractures that were not treated with the device. Fractures of the tibial diaphysis and distal radius are typically associated with a high risk for nonunion.

In 2000, the FDA expanded its approval of low-intensity ultrasonic bone growth stimulators (eg, SAFHS�, Exogen 2000�) to include the treatment of established nonunion fractures, excluding the skull and vertebrae.The safety and effectiveness of low-intensity ultrasonic bone growth stimulators have not been established in individuals under 17 years of age or in individuals with nonunion fractures of the skull and vertebrae. The study of SAFHS� use in nonunion fractures, conducted as part of the FDA premarket approval (PMA) process only included individuals between 17 and 86 years of age; therefore, the effect of SAFHS� in individuals under 17 years of age is unknown. In addition, there is insufficient scientific evidence to demonstrate the effectiveness of low-intensity ultrasonic bone growth stimulators in fresh fractures at sites other than the tibial diaphysis and distal radius, in fresh fractures with intramedullary pinning, or in delayed union fractures.

Policy

MEDICALLY NECESSARY

Electrical bone growth stimulators (noninvasive/invasive) are considered medically necessary and, therefore, covered for individuals 17 years of age or older when one of the following conditions are present:

A fracture secondary to congenital pseudarthrosis (755.8)
A nonunion fracture (733.82) of a long bone (eg, clavicle, humerus, radius, ulna, metacarpal, femur, tibia, fibula, malleolus, 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) prior to starting treatment with the bone growth stimulator.
A failed fusion of a joint other than in the spine (V45.4), when a minimum of nine months has elapsed since the last surgery

Electrical bone growth stimulators (noninvasive/invasive) are considered medically necessary and, therefore, covered following spinal surgery (V45.4) when one of the following criteria is 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 (eg, L3-L5, L4-S1)
Revisional spinal fusion surgery due to a previously failed spinal fusion at the same level

Low-intensity ultrasonic bone growth stimulators (noninvasive) are considered medically necessary and, therefore, covered for the following types of fractures, provided that no exclusion criteria exist (as listed in the Policy section entitled "Exclusion Criteria for Low-Intensity Ultrasonic Bone Growth Stimulators"

Fresh (less than seven days from the initial fracture), closed or Grade l open tibial diaphysis fracture (823.20, 823.30), when used as an adjunct to closed reduction and cast immobilization
Fresh, closed fracture of the distal radius (Colles fracture [813.41, 813.42]), when used as an adjunct to closed reduction and cast immobilization
Nonunion fractures (733.82) of the 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
- 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) prior to starting treatment with the bone growth stimulator.

EXCLUSION CRITERIA FOR LOW-INTENSITY ULTRASONIC BONE GROWTH STIMULATORS

If any of the following exclusion criteria exist, low-intensity ultrasonic bone growth stimulators will be considered experimental/investigational and, therefore, not covered because the safety and/or efficacy of this service for these conditions cannot be established by a review of the available published literature:

For a fracture of the skull or vertebrae
For a fracture that is tumor-related
For concurrent use with another noninvasive osteogenic stimulator
For individuals under 17 years of age
For a fresh fracture, other than one of the tibial diaphysis or distal radius
For a delayed union fracture (a recent fracture [three months or less from the initial fracture], where healing has not advanced at the average rate for the location and type of fracture)

EXPERIMENTAL/INVESTIGATIONAL

The use of electrical bone growth stimulators and low-intensity ultrasonic bone growth stimulators for any condition that does not meet the medical necessity criteria listed above is considered experimental/investigational and, therefore, not covered because the safety and/or efficacy of these devices for those purposes cannot be established by a review of the available published literature. Examples of other uses include, but are not limited to: individuals under 17 years of age, fresh fractures (except for fractures of the tibial diaphysis or distal radius treated with a low-intensity ultrasonic stimulator), and delayed union fractures.

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 reflect the medical necessity of the care and services provided. These medical records may include, but are not limited to: records from the health care professional's office, hospital, nursing home, home health agencies, therapies, and test reports.

An order for each item billed must be signed and dated by the health care professional who is treating the member and kept on file by the supplier. Medical record documentation must include a shipment confirmation or member's receipt of supplies and equipment. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, bone growth stimulators are covered as durable medical equipment (DME) under the medical benefits of most of the Company products when the medical necessity criteria listed in the policy are met. Individual benefits must be verified.

Services that are experimental/investigational are benefit contract exclusions for all products of the Company.

MEDICARE

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

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The FDA has approved several types of bone growth stimulators under the 510(k) process.

References

Agency for Healthcare Research and Quality. Technology Assessment. The role of bone growth stimulating devices and orthobiologics in healing nonunion fractures. [Centers for Medicare & Medicaid Services (CMS) Web site]. 09/21/05. Available at: https://www.cms.hhs.gov/coverage/download/id30M.pdf. Accessed March 23, 2009.

Ahl T, Andersson G, Herberts P, Kalen R. Electrical treatment of non-united fractures. Acta Orthop Scand. 1984;55(6):585-588.

Akai M, Kawashima N, Kimura T, Hayashi K. Electrical stimulation as an adjunct to spinal fusion: a meta-analysis of controlled clinical trials. Bioelectromagnetics. 2002;23(7):496-504.

Centers for Medicare & Medicaid Services (CMS). Decision memo for ultrasound stimulation for nonunion fracture healing (CAG-00022R). [CMS Web site]. 04/27/05. Available at: http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=135. Accessed March 23, 2009.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). 150.2: Osteogenic stimulators. [CMS Web site]. 08/27/05. Available at: http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=150.2&ncd_version=2&basket=ncd%3a150%2e2%3a2%3aosteogenic+stimulators. Accessed March 23, 2009.

Connolly JF. Electrical treatment of nonunions. Its use and abuse in 100 consecutive fractures. Orthop Clin North Am. 1984;15(1):89-106.

de Haas WG, Beaupre A, Cameron H, English E. The Canadian experience with pulsed magnetic fields in the treatment of ununited tibial fractures. Clin Orthop Relat Res. 1986;208:55-58.

DePuy. SpinaLogic� Bone Growth Stimulator. [DePuy Web site]. 04/22/09. Available at:http://www.depuyspine.com/products/other/spinalogic.asp. Accessed April 27, 2009.

Foley KT, Mroz TE, Arnold PM, et al. Randomized, prospective, and controlled clinical trial of pulsed electromagnetic field stimulation for cervical fusion. Spine J. 2008;8(3):436-442.

Hayes, Inc. Custom Brief Technology Assessment. Electrical bone growth stimulation, invasive. February 2004. Available at: http://www.hayesinc.com/ [via subscription only]. Accessed March 23, 2009.

Hodges SD, Eck JC, Humphreys SC. Use of electrical bone stimulation in spinal fusion. J Am Acad Orthop Surg. 2003;11(2):81-88.

Lau JT, Stamatis ED, Myerson MS, Schon LC. Implantable direct-current bone stimulators in high-risk and revision foot and ankle surgery: a retrospective analysis with outcome assessment. Am J Orthop. 2007;36(7):354-357.

National Heritage Insurance Co (NHIC). Local Coverage Determination (LCD). L11501: Osteogenesis stimulators. [NHIC Web site]. 01/01/07. Available at:
http://www.medicarenhic.com/dme/medical_review/mr_lcds/mr_lcd_current/L11501_2007-01-01_PA_2007-01.pdf. Accessed March 31, 2009.

Orthofix. Biologics and bone growth stimulation. [Orthofix Web site]. Available at: http://www.orthofix.com/categories/recon_biobonestim.asp?cid=7. Accessed March 23, 2009.

Petrisor B, Lau JT. Electrical bone stimulation: an overview and its use in high risk and Charcot foot and ankle reconstructions. Foot Ankle Clin. 2005;10(4):609-620.

Reznick DK, Choudhri TF, Dailey AT, et al. Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 17: bone growth stimulators and lumbar fusion. J Neurosurg Spine. 2005;2(6):737-740.

Saxena A, DiDomenico LA, Widtfeldt A, Adams T, Kim W. Implantable electrical bone stimulation for arthrodeses of the foot and ankle in high-risk patients: a multicenter study. J Foot Ankle Surg. 2005;44(6):450-454.

Sharrard WJ, Sutcliffe ML, Robson MJ, Maceachern AG. The treatment of fibrous non-union of fractures by pulsing electromagnetic stimulation. J Bone Joint Surg Br. 1982;64(2):189-193.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Cervical-Stim� Model 505L Cervical Fusion System - P030034. [FDA Web site]. Original: 12/23/04. (Revised: 01/21/05). Available at:
http://www.fda.gov/cdrh/pdf3/p030034.html. Accessed March 23, 2009.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. PMA Final Decisions Rendered for March 1997. Sonic Accelerated Fracture Healing System - P900009/S003. [FDA Web site]. 03/27/09. Available at: http://www.fda.gov/cdrh/pmamar97.html. Accessed March 23, 2009.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. PMA Final Decisions Rendered for June 1998. Orthologic™ 1000 and CC Bone Growth Stimulator - P910066/S008. [FDA Web site]. 06/12/98. Available at: http://www.fda.gov/cdrh/pma/pmajun98.html. Accessed March 23, 2009.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. SpinalPak Bone Growth Stimulator - P850022/S009. [FDA Web site]. Original: 09/24/99. (Revised: 03/08/2000). Available at: http://www.fda.gov/cdrh/pdf/p850022s009.html. Accessed March 23, 2009.

Coding Table

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.

Code System	Code Number(s) and Narrative(s)
CPT	20974; 20975; 20979
ICD Procedure	N/A
ICD Diagnosis	733.82: Nonunion of fracture 755.8: Other specified congenital anomalies of unspecified limb 813.41: Closed Colles' fracture 813.42: Other closed fractures of distal end of radius (alone) 823.20: Closed fracture of shaft of tibia 823.30: Open fracture of shaft of tibia V45.4: Arthrodesis status
HCPCS Level II	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

Revenue Codes	N/A

Cross References

Cross Reference Policies

00.01.25n:

PPO Network Rules for Provision of Specialty Services for Durable Medical Equipment and Laboratory, Radiology, and Physical Medicine and Rehabilitative Services

05.00.21i:Durable Medical Equipment (DME)

05.00.44f:Repair and Replacement of Durable Medical Equipment (DME)

Version Effective Date: 03/22/2007