Electrical Bone Growth Stimulators

Both invasive and noninvasive electrical bone growth stimulators have been investigated as an adjunct to spinal fusion surgery, with or without associated instrumentation, to enhance the probability of obtaining a solid spinal fusion. Noninvasive devices have also been investigated to treat a failed fusion.

Electrical and electromagnetic fields can be generated and applied to bones through surgical, noninvasive, and semi-invasive methods.

Invasive Stimulators

Invasive devices require surgical implantation of a current generator in an intramuscular or subcutaneous space, with an accompanying electrode implanted within the fragments of bone graft at the fusion site. The implantable device typically remains functional for six to six 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. Implantable electrodes provide constant stimulation at the nonunion or fracture site but carry increased risks associated with implantable leads.

Noninvasive Stimulators

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 are worn for 24 hours a day until healing occurs, or for up to 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 six to eight hours a day for three to six months. Combined magnetic fields deliver a time-varying magnetic field by superimposing the time-varying field onto an additional static magnetic field. This device involves 30 minutes of treatment daily for 9 months. Patient compliance may be an issue with externally worn devices.

Semi-Invasive Stimulators

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.

Regulatory Status

The following implantable device was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process:

• In 1986, the OsteoStim® (Electro-Biology), which may also be marketed under the trade name SPF (Biomet).

• In 1999, the SpinalPak® bone growth stimulator system (Biolectron, a subsidiary of Electro-Biology), a capacitive coupling system, was approved for use as an adjunct to primary lumbar spinal fusion at 1 or 2 levels.
• In 1979, the EBI Bone Healing System® (Biolectron, a subsidiary of Electro-Biology), a pulsed electromagnetic field system, was approved for nonunions, failed fusions, and congenital pseudoarthroses. The device is secured with a belt around the waist.
• In 1994, the SpinaLogic Bone Growth Stimulator® (Regentek, a division of dj Orthopedics [formerly OrthoLogic]) was approved as a combined magnetic field portable device. This device is secured with a belt around the waist.
• In 1996, the Spinal-Stim Lite® (Orthofix) was approved as a spinal adjunct to the Physio-Stim®. The Spinal-Stim Lite® device was approved to increase the probability of fusion success and as a nonoperative treatment for the salvage of failed spinal fusion, where a minimum of nine months has elapsed since the last surgery.
• In 2004, the Stim® (Orthofix), a pulsed electromagnetic field system, was approved as an adjunct to cervical fusion surgery in patients at high-risk for nonfusion.

FDA product codes: LOE (invasive bone growth stimulator), LOF (noninvasive bone growth stimulator).

Related Policies

• Ultrasound Accelerated Fracture Healing Device (Policy #008 in the Treatment Section)
• Electrical Bone Growth Stimulation of the Appendicular Skeleton (Policy #010 in the Treatment Section)
• Bone Morphogenetic Protein (Policy #056 in the Surgery Seection)
• Lumbar Spinal Fusion (Policy #073 in the Surgery Section)

To access guidelines that apply to members enrolled in plans that HAVE elected the Program, please visit www.evicore.com/HorizonSpineSurgery.

For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)

1. Either invasive (inserted at the time of surgery) or noninvasive (beginning at any time from the time of surgery until up to 6 months after surgery with the exception of this timeline for an urgent/emergent condition for spinal fusion surgery excluding primary or metastatic neoplastic disease) methods of electrical bone growth stimulation is considered medically necessary as an adjunct to a medically necessary spinal fusion surgery (lumbar/lumbosacral, cervical, thoracic) in members at high risk for fusion failure, defined as any one of the following criteria:

· one or more previous failed spinal fusion(s);
· grade 3 or worse spondylolisthesis;
· fusion to be performed at more than 1 level;
· current tobacco use;
· diabetes;
· renal disease;
· other metabolic diseases when bone healing is likely to be compromised
· alcoholism;
· glucocorticoid dependent;
· body mass index (BMI) >30;
· nutritional deficiency/malnutrition;
· osteoporosis defined as T-score of <-2.5 on a recent (within one year) DEXA; or
· severe anemia
· immunocompromised status.

· acute or chronic lumbar spondylolysis (pars interarticularis defect) with or without spondylolisthesis
· failed cervical or lumbar disc arthroplasty
· spinal malignancy
· as nonsurgical treatment of an established pseudarthrosis.

FIDE-SNP:

For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.

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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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Index:
Electrical Stimulation of the Spine as an Adjunct to Spinal Fusion Procedures
Electrical Bone Growth Stimulation of the Spine
Spine, Electrical Bone Growth Stimulation of the
Spinal Fusion, Electrical Bone Growth Stimulation as an Adjunct to
Bone Growth Stimulation of the Spine, Electrical
Stimulation of the Spine, Electrical Bone Growth

References:
1. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Electrical bone growth stimulation as an adjunct to spinal fusion surgery (invasive method). TEC Evaluations. 1992 324-351.

2. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Electrical bone growth stimulation in association with spinal fusion surgery (noninvasive method). TEC Evaluations. 1993:1-12.

3. Kane WJ. Direct current electrical bone growth stimulation for spinal fusion. Spine (Phila Pa 1976). Mar 1988;13(3):363-365. PMID 3291140

4. Mooney V. A randomized double-blind prospective study of the efficacy of pulsed electromagnetic fields for interbody lumbar fusions. Spine (Phila Pa 1976). Jul 1990;15(7):708-712. PMID 2218718

5. Park P, Lau D, Brodt ED, et al. Electrical stimulation to enhance spinal fusion: a systematic review. Evid Based Spine Care J. Oct 2014;5(2):87-94. PMID 25278882

6. Kucharzyk DW. A controlled prospective outcome study of implantable electrical stimulation with spinal instrumentation in a high-risk spinal fusion population. Spine (Phila Pa 1976). Mar 1 1999;24(5):465-468; discussion 469. PMID 10084185

7. Rogozinski A, Rogozinski C. Efficacy of implanted bone growth stimulation in instrumented lumbosacral spinal fusion. Spine (Phila Pa 1976). Nov 1 1996;21(21):2479-2483. PMID 8923635

8. Andersen T, Christensen FB, Egund N, et al. The effect of electrical stimulation on lumbar spinal fusion in older patients: a randomized, controlled, multi-center trial: part 2: fusion rates. Spine (Phila Pa 1976). Oct 1 2009;34(21):2248-2253. PMID 19934803

9. Andersen T, Christensen FB, Ernst C, et al. The effect of electrical stimulation on lumbar spinal fusion in older patients: a randomized, controlled, multi-center trial: part 1: functional outcome. Spine (Phila Pa 1976). Oct 1 2009;34(21):2241-2247. PMID 19934802

10. Andersen T, Christensen FB, Langdahl BL, et al. Fusion mass bone quality after uninstrumented spinal fusion in older patients. Eur Spine J. Dec 2010;19(12):2200-2208. PMID 20429017

11. Goodwin CB, Brighton CT, Guyer RD, et al. A double-blind study of capacitively coupled electrical stimulation as an adjunct to lumbar spinal fusions. Spine (Phila Pa 1976). Jul 1 1999;24(13):1349-1356; discussion 1357. PMID 10404578

12. Linovitz RJ, Pathria M, Bernhardt M, et al. Combined magnetic fields accelerate and increase spine fusion: a double-blind, randomized, placebo controlled study. Spine (Phila Pa 1976). Jul 1 2002;27(13):1383-1389; discussion 1389. PMID 12131732

13. Gaston MS, Simpson AH. Inhibition of fracture healing. J Bone Joint Surg Br. Dec 2007;89(12):1553-1560. PMID 18057352

14. Pountos I, Georgouli T, Blokhuis TJ, et al. Pharmacological agents and impairment of fracture healing: what is the evidence? Injury. Apr 2008;39(4):384-394. PMID 18316083

15. Coric D, Bullard DE, Patel VV, et al. Pulsed electromagnetic field stimulation may improve fusion rates in cervical arthrodesis in high-risk populations. Bone Joint Res. Feb 2018;7(2):124-130. PMID 29437635

16. Foley KT, Mroz TE, Arnold PM, et al. Randomized, prospective, and controlled clinical trial of pulsed electromagnetic field stimulation for cervical fusion. Spine J. May-Jun 2008;8(3):436-442. PMID 17983841

17. U.S. Food and Drug Administration. Summary of Safety and Effectiveness Data: Cervical-Stim Model 505L Cervical Fusion System. 2004; https://www.accessdata.fda.gov/cdrh_docs/pdf3/P030034b.pdf. Accessed January 31, 2020.

18. Mackenzie D, Veninga FD. Reversal of delayed union of anterior cervical fusion treated with pulsed electromagnetic field stimulation: case report. South Med J. May 2004;97(5):519-524. PMID 15180031

19. North American Spine Society (NASS). NASS Coverage Policy Recommendations: Electrical Stimulation for Bone Healing. 2016; https://www.spine.org/PolicyPractice/CoverageRecommendations/AboutCoverageRecommendations.aspx. Accessed January 31, 2020.

20. Kaiser MG, Eck JC, Groff MW, et al. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 17: bone growth stimulators as an adjunct for lumbar fusion. J Neurosurg Spine. Jul 2014;21(1):133-139. PMID 24980594

21. Resnick 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. Jun 2005;2(6):737-740. PMID 16028745

22. Centers for Medicare & Medicaid Services. National Coverage Determination for Osteogenic Stimulators (150.2). 2005; https://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?NCDId=65&ncdver=2&DocID=150.2&ncd_id=150.2&ncd_version=2&basket=ncd%25253A150%25 252E2%25253A2%25253AOsteogenic+Stimulators&bc=gAAAABAAAAAAAA%3d%3d&. Accessed January 31, 2020.

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

20974
20975

E0748
E0749