Spinalogic Insurance Criteria

Criteria

Single Level Fusion with Risk Factors

Obesity
Diabetes
Current Tobacco Use
Osteoporosis
Grade II Spondylolisthesis
Bone Depleting Medications

Multi-Level Fusion*

Revision of Previous Failed Fusion*

Non-Operative Salvage of Pseudoarthrosis

9 months after previous surgery*

Order Processing Requirements

(Guidelines may vary by insurance)

Valid Prescription
Insurance Info
Op Report*
Patient Demo Sheet
Supporting documents for medical necessity

*Requirements/criteria per Medicare

Ryaby, J.T., et al., The Role of Insulin-like Growth Factor in Magnetic Field Regulation of Bone Formation, Bioelectrochemistry and Bioenergetics, 35: 87-91, 1994
Fitzsimmons RJ, Ryaby JT, Magee FP, Baylink DJ. IGF-II receptor number is increased in TE-85 osteosarcoma cells by combined magnetic fields. J Bone Miner Res. 1995 May;10(5):812-9.
Charles Sfeir, DDS, PhD, Lawrence Ho, Bruce A. Doll, DDS, PhD, Kodi Azari, MD, and Jeffrey O. Hollinger, DDS, PhD. Fractrue Repair. Bone Regeneration and Repair, Biology and Clinical Applications. 2005, XII, 398p
Raiszadeh, Ramin, et al. "Effectiveness of combined magnetic field bone growth stimulation on lumbar spinal fusion outcomes: a single center retrospective analysis comparing combined magnetic field to no-stimulation." International Journal of Research in Orthopaedics 6.3 (2020): 1. A retrospective study that utilized radiographic fusion criteria, included data from 4 surgeons, consisted of a heterogenous patient population and had minimum 6 months follow up.
Wu N, Lee YC, Segina D, Murray H, Wilcox T, Boulanger L. The economic impact of US patients With fracture non-union, Orthopedic Research and Reviews, 2013; 5:21–33
[PMA 910066] Phillips, Mark, et al. "The Use of Combined Magnetic Field Treatment for Fracture Nonunion: A Prospective Observational Study." Journal of Long-Term Effects of Medical Implants 26.3 (2016).
NASS coverage reccomendations: https://www.spine.org/coverage
Linovitz, Raymond J., et al. "Combined magnetic fields accelerate and increase spine fusion: a double-blind, randomized, placebo controlled study." Spine 27.13 (2002): 1383-1388.
Mcleod, Kenneth J., and C. T. Rubin. "The effect of low-frequency electrical fields on osteogenesis." J Bone Joint Surg Am 74.6 (1992): 920-9.
[P910066 / S005] Phillips, Mark, et al. "Use of Combined Magnetic Field Treatment for Fracture Nonunion." Journal of Long-Term Effects of Medical Implants 26.3 (2016).
Joel Russell, Sheila Sprague, Sam Harper, Michelle Green & Mohit Bhandari (2021) An early cost analysis of magnetic bone growth stimulation in England, Expert Review of Pharmacoeconomics & Outcomes Research, DOI: 10.1080/14737167.2021.1920402
Fitzsimmons RJ, Ryaby JT, Magee FP, Baylink DJ. Combined magnetic fields increased net calcium flux in bone cells. Calcified Tissue International. 1994;55(5):376-380. doi:10.1007/bf00299318
Aleem IS, Aleem I, Evaniew N, et al. Efficacy of electrical stimulators for Bone Healing: A meta-analysis of randomized sham-controlled trials. Scientific Reports. 2016;6(1). doi:10.1038/srep31724
Patient IFU Fracture
Cottrill E, Pennington Z, Ahmed AK, et al. The effect of electrical stimulation therapies on Spinal Fusion: A cross-disciplinary systematic review and meta-analysis of the preclinical and Clinical Data. Journal of Neurosurgery: Spine. 2019;32(1):106-126. doi:10.3171/2019.5.spine19465
Rami E, Rae S, John A. Increased spinal lumbar fusion with combined magnetic field (CMF) bone growth stimulation. Journal of Orthopedic Surgery and Techniques. 2020;3(1). doi:10.36959/453/526
Stippick TW, Sheller MR. Combined magnetic fields provide robust coverage for interbody and posterolateral lumbar spinal fusion sites. Medical & Biological Engineering & Computing. 2015;54(1):113-122. doi:10.1007/s11517-015-1319-2
Patient IFU Spine
Baumhauer Phillips M, Baumhauer J, Sprague S, Zoltan J. Use of Combined Magnetic Field Treatment for Fracture Nonunion. J Long Term Eff Med Implants. 2016;26(3):277-284. doi: 10.1615/JLongTermEffMedImplants.2016016818. PMID: 28134611.
Enovis™ CMF PMA: P910066/S005, May 1997
“Tough/Difficult fracture” defined per the following: Success rates obtained on fractures greater than 9 months post-injury; Mean time since initial injury = 29.3 months; Mean number of prior surgeries = 2.5.
Elsabeh R, Stegall R, Abrahams J (2020) Increased Spinal Lumbar Fusion with Combined Magnetic Field (CMF) Bone Growth Stimulation. J Orthop Surg Tech 3(1):84-91.
PMA P210016 1/17/2025
Heckman JD, Ryaby JP, McCabe J, Frey J, Kilcoyne RF. Acceleration of tibial fracture-healing by non-invasive, low-intensity pulsed ultrasound. J Bone Joint Surg Am. 1994;76(1):26-34. doi:10.2106/00004623-199401000-00004
Kristiansen TK, Ryaby JP, McCabe J, Frey JJ, Roe LR. Accelerated healing of distal radial fractures with the use of specific, low-intensity ultrasound. A multicenter, prospective, randomized, double-blind, placebo-controlled study. J Bone Joint Surg Am. 1997;79(7):961-73. doi:10.2106/00004623-199707000-00002
Nolte PA, van der Krans A, Patka P, Janssen IM, Ryaby JP, Albers GH. Low-intensity pulsed ultrasound in the treatment of nonunions. J Trauma. 2001;51(4):693-703. doi:10.1097/00005373-200110000-00012
OL1000 PMA 910066
https://www.spine.org/coverage
The only technology approved and with clinical evidence at 30 minutes per day.
Goodwin CB, Brighton CT, Guyer RD, Johnson JR, Light KI, Yuan HA. A double-blind study of capacitively coupled electrical stimulation as an adjunct to lumbar spinal fusions. Spine. 1999;24(13):1349-1356.
PMA P850007/S6. February 1990 and Jenis, Louis G., et al. "Prospective comparison of the effect of direct current electrical stimulation and pulsed electromagnetic fields on instrumented posterolateral lumbar arthrodesis." Clinical Spine Surgery 13.4 (2000): 290-296.
Cook SD, Ryaby JP, McCabe J, Frey JJ, Heckman JD, Kristiansen TK. Acceleration of tibia and distal radius fracture healing in patients who smoke. Clin Orthop Relat Res. 1997;(337):198-207. doi:10.1097/00003086-199704000-00022 (need to get paper to determine if these were within 0-7 days)
Zura R, Mehta S, Della Rocca GJ, Jones J, Steen RG. A cohort study of 4,190 patients treated with low-intensity pulsed ultrasound (LIPUS): findings in the elderly versus all patients. BMC Musculoskelet Disord. 2015;16:45. (Fresh and Intermediate <90 days is fresh, 0-90 days)
Nolte P, Anderson R, Strauss E, et al. Heal rate of metatarsal fractures: a propensity matching study of patients treated with low-intensity pulsed ultrasound (LIPUS) vs. surgical and other treatments. Injury. 2016;47(11):2584-90. doi:10.1016/j.injury.2016.09.023
Gebauer D, Mayr E, Orthner E, Ryaby JP. Low-intensity pulsed ultrasound: effects on nonunions. Ultrasound Med Biol. 2005;31(10):1391-402. doi:10.1016/j.ultrasmedbio.2005.06.002
Lerner A, Stein H, Soudry M. Compound high-energy limb fractures with delayed union: our experience with adjuvant ultrasound stimulation (exogen). Ultrasonics. 2004;42(1-9):915-7. doi:10.1016/j.ultras.2003.11.014
Schofer MD, Block JE, Aigner J, Schmelz A. Improved healing response in delayed unions of the tibia with low-intensity pulsed ultrasound: results of a randomized sham-controlled trial. BMC Musculoskelet Disord. 2010;11:229. doi:10.1186/1471-2474-11-229

*This patient’s statement relates an account of their response to treatment. This account is genuine, typical and documented. However, this response does not provide any indication, guide, warranty or guarantee as to the response other people may have to the treatment. The response other individuals have to the treatment could be different. Responses to the treatment can and do vary. Not every response is the same.

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