Clinical UM Guideline


Subject:   Iontophoresis for Medical Indications
Guideline #:   CG-MED-28Current Effective Date:   04/21/2010
Status:   ReviewedLast Review Date:   02/25/2010

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 Procedure 
99.27Iontophoresis
  
ICD-9 Diagnosis 
 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 such as nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids for musculoskeletal inflammatory disorders and verapamil for the treatment of Peyronie's disease. Overall, the results published in the peer-reviewed medical literature are from small, randomized, placebo-controlled trials and non-randomized, retrospective studies. These results, reported as treatment outcome measurements, do not support the iontophoretic application of NSAIDs or corticosteroids for the treatment of carpal tunnel syndrome (Amirjani, 2009), epicondylitis (Nirschl, 2003), intractable central pain (Vranken, 2005), tendonitis (Leduc, 2003; Neeter, 2003),  plantar fasciitis (Allison, 2006), or verapamil for the treatment of Peyronie's disease (Bennett, 2007; Greenfield, 2007).

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, 2008).

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. 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.
  3. 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.
  4. Bennett NE, Guhring P, Mulhall JP. Intralesional verapamil prevents the progression of Peyronie's disease. Urology. 2007; 69(6):1181-1184.
  5. 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.
  6. 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.
  7. 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.
  8. Niedfeldt M, Rutherford D, Young C. Treatment of plantar fasciitis. Am Fam Physician. 2001; 63(3):467-474.
  9. 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.
  10. 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.
  11. 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 device. Product Code: EGJ. Available at: http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm. Accessed on December 14, 2009.
Index

Iontophoresis

History

Status

Date

Action

Reviewed02/25/2010Medical Policy & Technology Assessment Committee (MPTAC) 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