Clinical UM Guideline


Subject:  Iontophoresis for Medical Indications
Guideline #:  CG-MED-28Current Effective Date:  04/15/2014
Status:ReviewedLast Review Date:  02/13/2014

Description

Iontophoresis is a method of transdermal local drug delivery using electrical current. A charged ionic drug is placed on the skin with an electrode of the same charge, allowing direct current to drive the drug into the skin. This document addresses the use of iontophoresis as a technique for drug delivery.

Note: Please see the following document for information regarding the use of iontophoresis for hyperhidrosis:

Clinical Indications

Medically Necessary:

Iontophoresis is considered medically necessary for the administration of local anesthesia prior to a venipuncture or dematologic procedure.

Not Medically Necessary: 

The use of iontophoresis is considered not medically necessary for all other indications including, but not limited to, the administration of nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids as treatment for inflammatory musculoskeletal disorders.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes.    Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

CPT 
97033Application of a modality to one or more areas; iontophoresis, each 15 minutes
  
ICD-9 Diagnosis[For dates of service prior to 10/01/2014]
 All diagnoses
  
ICD-10 Diagnosis[For dates of service on or after 10/01/2014]
 All diagnoses
  
Discussion/General Information

Iontophoresis is a method of transdermal local drug delivery using electrical current. A charged, ionic drug is placed on the skin with an electrode of the same charge, allowing direct current to drive the drug into the skin. Iontophoresis may take advantage of sweat ducts, sebaceous glands, hair follicles, and imperfections in the skin to achieve penetration. Alternatively, electrical potential across the skin could alter its permeability, possibly creating potential-dependent pores in lipid bilayer membranes.

Iontophoresis has been proposed for numerous uses including the delivery of local anesthetic before skin puncture or painful dermal procedures and for local drug delivery for agents including, but not limited to, nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids for musculoskeletal inflammatory disorders, or verapamil for the treatment of Peyronie's disease. Overall, the results published in the peer-reviewed medical literature include small randomized, placebo-controlled or comparative trials and non-randomized retrospective studies. The study results, reported as treatment outcome measurements, do not support the iontophoretic application of NSAIDs, corticosteroids, or other drugs for the treatment of carpal tunnel syndrome (Amirjani, 2009; Bakhtiary, 2013; Gurcay, 2012), chronic foot eczema (Tupker, 2013), epicondylitis (Nirschl, 2003), intractable central pain (Vranken, 2005), migraine headache (Pierce, 2010), onychomycosis (Amichai, 2010), plantar fasciitis (Allison, 2006), tendonitis (Leduc, 2003; Neeter, 2003), trapezial-metacarpal joint arthritis (Jain, 2010), or verapamil (with or without dexamethasone) for the treatment of Peyronie's disease (Bennett, 2007; Greenfield, 2007; Mehrsai, 2013).

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for a number of iontophoresis devices to "introduce ions of soluble salts or other drugs into the body." The FDA prohibits labeling or promoting their use with specific drugs prior to the FDA having approved the drugs for iontophoretic administration (FDA, 2013).

References

Peer Reviewed Publications:

  1. Allison GT, Osborne HR. Treatment of plantar fasciitis by LowDye taping and iontophoresis: short term results of a double blinded, randomized, placebo controlled clinical trial of dexamethasone and acetic acid. Br J Sports Med. 2006; 40:545-549.
  2. Amichai B, Nitzan B, Mosckovitz R, Shemer A. Iontophoretic delivery of terbinafine in onychomycosis: a preliminary study. Br J Dermatol. 2010; 162(1):46-50.
  3. Amirjani N, Ashworth NL, Watt MJ, et al. Corticosteroid iontophoresis to treat carpal tunnel syndrome: a double-blind randomized controlled trial. Muscle Nerve. 2009; 39(5):627-633.
  4. Anderson A, Boeh S, Morris R, et al. Effects of iontophoresis current magnitude and duration on dexamethasone deposition and localized drug retention. Physical Therapy. 2003; 83:161-170.
  5. Bakhtiary AH, Fatemi E, Emami M, Malek M. Phonophoresis of dexamethasone sodium phosphate may manage pain and symptoms of patients with carpal tunnel syndrome. Clin J Pain. 2013; 29(4):348-353.
  6. Bennett NE, Guhring P, Mulhall JP. Intralesional verapamil prevents the progression of Peyronie's disease. Urology. 2007; 69(6):1181-1184.
  7. Greenfield JM, Shah SJ, Levine LA. Verapamil versus saline in electromotive drug administration for Peyronie's disease: a double-blind, placebo controlled trial. J Urol. 2007; 177(3):972-975.
  8. Gurcay E, Unlu E, Gurcay AG, et al. Assessment of phonophoresis and iontophoresis in the treatment of carpal tunnel syndrome: a randomized controlled trial. Rheumatol Int. 2012; 32(3):717-722.
  9. Jain R, Jain E, Dass AG, et al. Evaluation of transdermal steroids for trapeziometacarpal arthritis. J Hand Surg Am. 2010; 35(6):921-927.
  10. Leduc BE, Caya J, Tremblay S, et al. Treatment of calcifying tendonitis of the shoulder by acetic acid iontophoresis: a double-blind randomized controlled trial. Arch Phys Med Rehabil. 2003; 84(10):1523-1527.
  11. Mehrsai AR, Namdari F, Salavati A, et al. Comparison of transdermal electromotive administration of verapamil and dexamethasone versus intra-lesional injection for Peyronie's disease. Andrology. 2013; 1(1):129-132.
  12. Neeter C, ThomeƩ R, Silbernagel KG, et al. Iontophoresis with or without dexamethasone in the treatment of acute Achilles tendon pain. Scand J Med Sci Sports. 2003; 13(6):376-382.
  13. Niedfeldt M, Rutherford D, Young C. Treatment of plantar fasciitis. Am Fam Physician. 2001; 63(3):467-474.
  14. Nirschl RP, Rodin DM, Ochiai DH, Maartmann-Moe C. Iontophoretic administration of dexamethasone sodium phosphate for acute epicondylitis: a randomized, double-blinded, placebo-controlled study. Am J Sports Med. 2003; 31(2):189-195.
  15. Pierce MW. Transdermal delivery of sumatriptan for the treatment of acute migraine. Neurotherapeutics. 2010; 7(2):159-163.
  16. Spierings EL, Brevard JA, Katz NP. Two-minute skin anesthesia through ultrasound pretreatment and iontophoretic delivery of a topical anesthetic: a feasibility study. Pain Med. 2008; 9(1):55-59.
  17. Tupker RA, Coenraads PJ, Zanen P, Schuttelaar ML. Randomized controlled observer-blinded treatment of chronic foot eczema with iontophoresis and bath-PUVA. Acta Derm Venereol. 2013; 93(4):456-460.
  18. Vranken JH, Dijkgraaf MG, Kruis MR, et al. Iontophoretic administration of S(+)-ketamine in patients with intractable central pain: a placebo-controlled trial. Pain. 2005; 118(1-2):224-231.

Government Agency, Medical Society, and Other Authoritative Publications

  1. U.S. Food and Drug Administration (FDA). Devices @ FDA. Iontophoresis. Product Code: EGJ. Available at: http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm. Accessed on December 4, 2013.
History

Status

Date

Action

Reviewed02/13/2014Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Discussion and References sections.
Reviewed02/14/2013MPTAC review. Updated Discussion and References. Removed Index.
Reviewed02/16/2012MPTAC review. Updated References.
Reviewed02/17/2011MPTAC review. Updated Discussion, Coding, and References.
Reviewed02/25/2010MPTAC review. Updated Discussion and References. Removed sections: Place of Service and Discharge Plans.
Reviewed02/26/2009MPTAC review. Updated References.
Reviewed02/21/2008MPTAC review. Updated Discussion and References.
Revised03/08/2007MPTAC review. Clinical Indications revised/clarified.  Discussion, References and Coding updated.
New03/23/2006MPTAC initial document development. 
Pre-Merger Organizations

Last Review Date

Document Number

Title

Anthem, Inc.

 

None 
Anthem Virginia

05/10/2004

Memo 1192Iontophoresis for Medical Indications
WellPoint Health Networks, Inc.

 

None