This Medical Policy is provided for informational purposes only.

If Members have any questions about the medical necessity of a service or procedure, they should discuss the question with their Network Provider or call a member of our Customer Service Team.

MEDICAL POLICY USE DISCLAIMER

  1. Medical Policy is used by Blue Cross & Blue Shield of Mississippi, A Mutual Insurance Company ("BCBSMS") as one set of guidelines (among other sets of guidelines) to assist BCBSMS in making benefit coverage decisions. BCBSMS utilizes Medical Policy adopted by our Medical Policy Advisory Committee ("MPAC") which is supported by the Blue Cross and Blue Shield Association Medical Policy, research and development. Medical Policies are the property of BCBSMS and any use of Medical Policy not agreed to by BCBSMS is strictly prohibited. The use of Medical Policy for purposes related to the health care of a BCBSMS plan member is permitted and is not a violation of the proprietary rights of BCBSMS.
  2. These Medical Policies are based on scientifically meritorious evidence provided through research for a particular medical technology. Medical Policy is also based on data from peer-reviewed scientific literature, from criteria developed by specialty societies and from guidelines adopted by other health care organizations.
  3. These Medical Policies apply to members/subscribers who have health insurance through BCBSMS. This Medical Policy also applies to Members of a self-insured group health plan for which Blue Cross & Blue Shield of Mississippi provides claims administration and persons covered by a Medicare Supplement policy offered by BCBSMS. This Medical Policy does not apply to any other individuals. Medical Policies may differ for Federal employees covered under the Federal Employees Health Benefits Plan.
  4. In the event of any conflict between this Medical Policy and any benefit plan, Summary Plan Description or other coverage document, the benefit plan, Summary Plan Description or other coverage document will govern.
  5. Medical technology is rapidly changing and these Medical Policies are subject to change without notice. Also, please be aware that as a result of ongoing changes being made to Medical Policy, BCBSMS cannot and does not guarantee that these Medical Policies are current.

BCBSMS Medical Policies are Subject to the Following Restrictions


This Medical Policy is provided for informational purposes only.

If Members have any questions about the medical necessity of a service or procedure, they should discuss the question with their Network Provider or call a member of our Customer Service Team.

MEDICAL POLICY USE DISCLAIMER

  1. Medical Policy is used by Blue Cross & Blue Shield of Mississippi, A Mutual Insurance Company ("BCBSMS") as one set of guidelines (among other sets of guidelines) to assist BCBSMS in making benefit coverage decisions. BCBSMS utilizes Medical Policy adopted by our Medical Policy Advisory Committee ("MPAC") which is supported by the Blue Cross and Blue Shield Association Medical Policy, research and development. Medical Policies are the property of BCBSMS and any use of Medical Policy not agreed to by BCBSMS is strictly prohibited. The use of Medical Policy for purposes related to the health care of a BCBSMS plan member is permitted and is not a violation of the proprietary rights of BCBSMS.
  2. These Medical Policies are based on scientifically meritorious evidence provided through research for a particular medical technology. Medical Policy is also based on data from peer-reviewed scientific literature, from criteria developed by specialty societies and from guidelines adopted by other health care organizations.
  3. These Medical Policies apply to members/subscribers who have health insurance through BCBSMS. This Medical Policy also applies to persons covered by the Mississippi Children's Health Insurance Program, Members of a self-insured group health plan for which Blue Cross & Blue Shield of Mississippi provides claims administration and persons covered by a Medicare Supplement policy offered by BCBSMS. This Medical Policy does not apply to any other individuals. Medical Policies may differ for Federal employees covered under the Federal Employees Health Benefits Plan.
  4. In the event of any conflict between this Medical Policy and any benefit plan, Summary Plan Description or other coverage document, the benefit plan, Summary Plan Description or other coverage document will govern.
  5. Medical technology is rapidly changing and these Medical Policies are subject to change without notice. Also, please be aware that as a result of ongoing changes being made to Medical Policy, BCBSMS cannot and does not guarantee that these Medical Policies are current.

BCBSMS Medical Policies are Subject to the Following Restrictions


This Medical Policy is provided for informational purposes only.

If Members have any questions about the medical necessity of a service or procedure, they should discuss the question with their Network Provider or call a member of our Customer Service Team.

MEDICAL POLICY USE DISCLAIMER

  1. Medical Policy is used by Blue Cross & Blue Shield of Mississippi, A Mutual Insurance Company ("BCBSMS") as one set of guidelines (among other sets of guidelines) to assist BCBSMS in making benefit coverage decisions. BCBSMS utilizes Medical Policy adopted by our Medical Policy Advisory Committee ("MPAC") which is supported by the Blue Cross and Blue Shield Association Medical Policy, research and development. Medical Policies are the property of BCBSMS and any use of Medical Policy not agreed to by BCBSMS is strictly prohibited. The use of Medical Policy for purposes related to the health care of a BCBSMS plan member is permitted and is not a violation of the proprietary rights of BCBSMS.
  2. These Medical Policies are based on scientifically meritorious evidence provided through research for a particular medical technology. Medical Policy is also based on data from peer-reviewed scientific literature, from criteria developed by specialty societies and from guidelines adopted by other health care organizations.
  3. These Medical Policies apply to members/subscribers who have health insurance through BCBSMS. This Medical Policy also applies to persons covered by the Mississippi Children's Health Insurance Program, Members of a self-insured group health plan for which Blue Cross & Blue Shield of Mississippi provides claims administration and persons covered by a Medicare Supplement policy offered by BCBSMS. This Medical Policy does not apply to any other individuals. Medical Policies may differ for Federal employees covered under the Federal Employees Health Benefits Plan.
  4. In the event of any conflict between this Medical Policy and any benefit plan, Summary Plan Description or other coverage document, the benefit plan, Summary Plan Description or other coverage document will govern.
  5. Medical technology is rapidly changing and these Medical Policies are subject to change without notice. Also, please be aware that as a result of ongoing changes being made to Medical Policy, BCBSMS cannot and does not guarantee that these Medical Policies are current.

BCBSMS Medical Policies are Subject to the Following Restrictions

Medical Policy Search
Printer Friendly Version Electrical Stimulation of the Spine as an Adjunct to Spinal Fusion Procedures

Electrical Stimulation of the Spine as an Adjunct to Spinal Fusion Procedures

 

DESCRIPTION

Both invasive and noninvasive electrical bone growth stimulators are used as an adjunct to spinal fusion surgery, with or without associated instrumentation, to enhance the chances of obtaining a solid spinal fusion. Noninvasive devices may also be used to treat a failed fusion. Invasive devices use direct current; these devices require surgical implantation of a current generator in an intramuscular or subcutaneous space, while an electrode is implanted within the fragments of bone graft at the fusion site. The implantable device typically remains functional for 6 to 9 months after implantation, and, although the current generator is removed in a second surgical procedure when stimulation is completed, the electrode may or may not be removed. Semi-invasive (semi-implantable) stimulators use percutaneous electrodes and an external power supply, obviating the need for a surgical procedure to remove the generator when treatment is finished.

Noninvasive electrical bone growth stimulators generate a weak electrical current within the target site using either pulsed electromagnetic fields, capacitive coupling, or combined magnetic fields. In capacitive coupling, small skin pads/electrodes are placed on either side of the fusion site and worn for 24 hours per day until healing occurs or up to nine (9) months. In contrast, pulsed electromagnetic fields are delivered via treatment coils that are placed into a back brace or directly onto the skin and are worn for 6–8 hours per day for 3 to 6 months. Combined magnetic fields deliver a time-varying magnetic field by superimposing the time-varying magnetic field onto an additional static magnetic field. This device involves a 30-minute treatment per day for nine (9) months. Patient compliance may be an issue with externally worn devices.

The OsteoStim® from Electro-Biology, Inc., an implantable device, received U.S. Food and Drug Administration (FDA) premarket approval (PMA) in 1984. The SpinalPak® bone growth stimulator system, a capacitive coupling system, received PMA in 1999 for use as an adjunct to primary lumbar spinal fusion at one or two levels. Pulsed electromagnetic field systems with FDA PMA include the EBI Bone Healing System® from Electrobiology, Inc., which was first approved in 1979 and indicated for nonunions, failed fusions, and congenital pseudarthroses; and the Cervical-Stim® from Orthofix, which was approved in 2004 as an adjunct to cervical fusion surgery in patients at high risk for non-fusion.

No semi-invasive electrical bone growth stimulator devices were identified with FDA approval or clearance.

Note: Noninvasive electrical bone growth stimulation of the appendicular skeleton is addressed in the Noninvasive Electrical Bone Growth Stimulation of the Appendicular Skeleton policy.

Note: Ultrasound devices for bone growth stimulation is addressed in the Ultrasound Accelerated Fracture Healing Device policy.

 

POLICY

Either invasive or noninvasive methods of electrical bone growth stimulation may be considered medically necessary as an adjunct to lumbar spinal fusion surgery in patients at high risk for fusion failure, defined as any one of the following criteria:
  • One or more previous failed spinal fusion(s);
  • Grade III or worse spondylolisthesis;
  • Fusion to be performed at more than one level;
  • Current tobacco use;
  • Diabetes;
  • Renal disease;
  • Alcoholism
  • Steroid use

Noninvasive electrical bone stimulation may be considered medically necessary as a treatment of patients with failed lumbar spinal fusion. Failed spinal fusion is defined as a spinal fusion that has not healed at a minimum of six (6) months after the original surgery, as evidenced by serial x-rays over a course of three (3) months.

Semi-invasive electrical stimulation is considered investigational as an adjunct to lumbar fusion surgery and for failed lumbar fusion. 

Invasive, semi-invasive, and noninvasive electrical stimulation are considered investigational as an adjunct to cervical fusion surgery and for failed cervical spine fusion.

 

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

 

POLICY GUIDELINES

Noninvasive and Invasive Electrical Bone Growth Stimulators are covered as part of the Durable Medical Equipment (DME) benefit, and are subject to any applicable DME co-insurance maximums.

Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

 

POLICY HISTORY

6/6/2007: Policy added. The "Fracture Healing Devices: Electrical Bone Growth Stimulation & Ultrasound-Accelerated Healing" policy has been replaced with the "Electrical Stimulation of the Spine as an Adjunct to Spinal Fusion Procedures" policy

7/19/2007: Policy reviewed and approved by Medical Policy Advisory Committee (MPAC)

8/18/2008: Policy reviewed, no changes

04/26/2010: Policy description updated regarding FDA-approval status of devices. Policy statement updated to add "lumbar" to the statements. Steroid use added as a high-risk condition for non-fusion. New policy statements added that semi-invasive stimulators are investigational for lumbar spine fusion and that electrical bone-growth stimulators are investigational for use in cervical spine fusion.  Added FEP verbiage added to the Policy Exceptions section.  Added CPT code 20974.

04/18/2011: Policy reviewed; no changes.

01/17/2012: Policy reviewed. "Current smoking habit" changed to "Current tobacco use" in the policy statement.

12/13/2012: Policy reviewed; no changes.

 

SOURCE(S)

Blue Cross Blue Shield Association Policy # 7.01.85

 

CODE REFERENCE

This is not intended to be a comprehensive list of codes. Some covered procedure codes have multiple descriptions.

The code(s) listed below are ONLY covered if the procedure is performed according to the "Policy" section of this document.

Covered Codes

Code Number

Description

CPT-4

20974  Electrical stimulation to aid bone healing; noninvasive (nonoperative) (Added 04-26-2010) 

20975

Electrical stimulation to aid bone healing; invasive (operative)

ICD-9 Procedure

78.90, 78.91, 78.92, 78.93, 78.94, 78.95, 78.96, 78.97, 78.98, 78.99

Insertion of bone stimulator

83.92

Insertion or replacement of skeletal muscle stimulator

ICD-9 Diagnosis

738.4

Acquired spondylolisthesis

756.12

Anomalies of the spine (spondylolisthesis)

V45.4

Arthrodesis status

HCPCS

E0748

Osteogenesis stimulator, electrical, noninvasive, spinal applications

E0749

Osteogenesis stimulator, electrical, surgically implanted

 

 

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