Clinical UM Guideline

This document addresses the use of iontophoresis, the passing of an ionized substance through intact skin by the application of a direct electrical current. It has been evaluated as a technique for drug delivery and proposed as a treatment for hyperhidrosis.

Medically Necessary:

Iontophoresis is considered medically necessary for any of the following indications:

1. For the administration of local anesthesia prior to a venipuncture or dermatologic procedure; or
2. In the treatment of primary or secondary hyperhidrosis only for individuals who have tried prescription strength antiperspirants without success and meet any ONE of the following criteria:
   1. Presence of medical complications or skin maceration with secondary infection; or
   2. Significant functional impairment, as documented in the medical record.

Not Medically Necessary:

The use of iontophoresis is considered not medically necessary when the above criteria are not met and for all other indications, including, but not limited to treatment of temporomandibular disorders, and as a technique for drug delivery involving the administration of nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids as treatment for inflammatory musculoskeletal disorders.

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.

When services may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met, for all other indications including for the following diagnosis codes, or for situations designated in the Clinical Indications section as not medically necessary.

Iontophoresis is a method of transdermal local ion delivery using electrical current. A charged ionic substance is placed on the skin with an electrode of the same charge, allowing direct current to drive the substance 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.

Drug Delivery

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, 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), keratoconus (Lombardo, 2017; Lombardo, 2019; Vinciguerra, 2019), migraine headache (Pierce, 2010), onychomycosis (Amichai, 2010), patellar tendinopathy (Rigby, 2015), plantar fasciitis (Allison, 2006), recalcitrant scarring after open trigger finger release (Dardas, 2014), rotator cuff disease (Page, 2016), tendonitis (Leduc, 2003; Neeter, 2003), trapezial-metacarpal joint arthritis (Jain, 2010), or verapamil (with or without dexamethasone or in combination therapy) for the treatment of Peyronie’s disease (Bennett, 2007; Greenfield, 2007; Mehrsai, 2013; Paulis, 2013).

In a Cochrane review, Kroeling and colleagues (2013) evaluated the short-, intermediate- and long-term effects of electrotherapy, including iontophoresis, on pain, function, disability, patient satisfaction, global perceived effect, and quality of life in adults with neck pain with and without radiculopathy or cervicogenic headache. The effects of iontophoresis versus no treatment were evaluated in a single study of very low quality evidence and a high risk of bias. No difference between the groups was reported in cervicogenic headache or neck pain relief after 5 weeks of treatment. When direct current iontophoresis combined with diclofenac gel was compared to interferential current and multimodal treatment (that is, traction, therapeutic exercise, and massage), no difference between the groups was reported in cervicogenic headache or neck pain after 5 weeks of treatment. The authors concluded that for individuals with acute whiplash, iontophoresis was no more effective than no treatment, interferential current, or a combination of traction, exercise and massage for relieving neck pain with headache.

Sayegh and Strauch (2014) performed a meta-analysis of randomized controlled trials (RCTs) comparing any form of nonsurgical treatment, including corticosteroid iontophoresis, with either observation only or placebo at 6 months or greater follow-up for the treatment of lateral epicondylitis. The primary objective was to establish the superiority of nonsurgical treatments over non-treatment in the following outcomes: “(1) better overall improvement, (2) less need for escape interventions, (3) better outcome scores, and (4) improved grip strength at intermediate- to long-term follow-up.” A total of 22 studies with intermediate- to long-term follow-up met the inclusion criteria; however, only 1 small study (n=64) of “good methodologic quality” and short duration (6 months) compared the use of corticosteroid iontophoresis to placebo. Pooled data from all RCTs indicated a lack of intermediate- to long-term clinical benefit after nonsurgical treatment of lateral epicondylitis compared with observation only or placebo, including the use of corticosteroid iontophoresis.

Iontophoresis is considered in accordance with generally accepted standards of medical practice for the administration of local anesthesia prior to a venipuncture or dermatologic procedure. A number of studies have demonstrated that iontophoresis appears to be a safe and effective method of local anesthesia delivery for procedures in children (DeCou, 1999; Zempsky, 2003; Lustig, 2020) and adults (Arvidsson, 1984; Zempsky, 2004). Lidocaine iontophoresis provides effective pain relief for venous catheter placement or venipuncture within 10 to 20 minutes (Squire, 2000; Zempsky, 1998). However, the emergence of liposomal lidocaine as a topical anesthetic that has an onset of action similar to iontophoresis has resulted in less frequent use of iontophoresis in clinical practice.

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, 2023).

Hyperhidrosis

Hyperhidrosis is a relatively uncommon condition of exaggerated perspiration due to excessive secretion of the eccrine sweat glands in amounts greater than required for physiologic needs of thermoregulation and electrolyte alteration (Nawrocki, 2019). Primary hyperhidrosis is idiopathic in nature, typically involving the hands (palmar), feet (plantar) or armpits (axillae). Secondary hyperhidrosis can result from a variety of drugs, such as tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), or underlying disease/conditions, such as febrile disease, diabetes mellitus or menopause. Gustatory hyperhidrosis may be primary or secondary in nature, but is usually considered separately from these two classes of hyperhidrosis. As a primary condition, it is characterized by excessive sweating of the lips, nose, and forehead after eating certain foods. As a secondary condition, this sweating condition is the result of complications from surgery to the parotid gland and subsequent aberrant regenerating parasympathetic fibers.

The consequences of hyperhidrosis are primarily psychosocial in nature. Excessive sweating may be socially embarrassing, may require several changes of clothing a day or result in staining of clothing or shoes. In some situations, hyperhidrosis may interfere with the activities of daily living. For example, palmar hyperhidrosis may interfere with those jobs that require detailed work with the hands.

Treatment of secondary hyperhidrosis naturally focuses on treatment of the underlying cause. A variety of therapies have been investigated for primary hyperhidrosis, including topical therapy with aluminum chloride or tanning agents, iontophoresis, and endoscopic transthoracic sympathectomy.

Iontophoresis for hyperhidrosis involves the introduction of an electrical current through the skin using water as a medium. Iontophoresis is a long-standing method of treatment for palmar or plantar hyperhidrosis with a reported success rate of up to 85% (Levit, 1980; Pariser, 2014). The mechanism of action of iontophoresis is not precisely known but is thought to be related to plugging of the sweat gland pores. The typical device consists of water-filled trays containing electrodes. A special axillary electrode can be used in the treatment of axillary hyperhidrosis, but this treatment is often less effective because of difficulty obtaining uniform contact of the electrode with the axillary skin.  The individual inserts the hands or feet in the tray or positions the electrode in the axilla, and the current is turned on. Individuals are treated for approximately 20 minutes, with treatments every 2 to 5 days for 5 to 10 sessions before an effect is observed. Maintenance therapy may be required every 2 weeks after a normal level of sweating is achieved. Treatment may be uncomfortable and, in some cases, painful. Potential side effects include dry, cracked hands or feet, skin erythema, and transient vesiculation. Nonetheless, treatment of primary or secondary hyperhidrosis with iontophoresis is considered in accordance with generally accepted standards of medical practice only for individuals who have tried prescription strength antiperspirants without success when medical complications or skin maceration with secondary infection is present or when hyperhidrosis results in significant functional impairment.

Several iontophoresis devices have been approved by the FDA. There are some machines that can only be used by physicians in an office setting. Four commercially available machines are intended for home use by individuals with a prescription. These devices are the Drionic^® device (General Medical Co., Los Angeles, CA), the Dermadry^® device (Dermadry Laboratories Inc., Montreal, QC), the Hidrex device (Hidrex USA, Austin, TX), and the Fischer^™ MD-1a Galvanic Unit (R.A. Fischer Co., Northridge, CA.).

Eccrine gland: A gland in the skin that secretes sweat. These glands are located all over the body, and greater concentrations may be found in certain areas of the body such as the armpits, feet, and hands.

Functional impairment: Significant functional impairment may include physical, social, emotional, and psychological impairments or potential impairments.

Hyperhidrosis: Severe and uncontrollable localized sweating of the scalp, torso (truncal), face (facial) hands (palmar), underarms (axillary), or the feet (plantar or pedal).

Iontophoresis: The passing of an ionized substance through intact skin by the application of a direct electrical current.

Primary hyperhidrosis: Hyperhidrosis due to unknown causes.

Secondary hyperhidrosis: Hyperhidrosis that results from an underlying cause; some common causes include prescribed drug side-effects and medical conditions such as anxiety disorders, diabetes mellitus, and menopause.

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. Arvidsson SB, Ekroth RH, Hansby AMC, et al. Painless venipuncture. A clinical trial of iontophoresis of lidocaine for venipuncture in blood donors. Acta Anaesthesiol Scand. 1984; 28:209-210.
6. 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.
7. Bennett NE, Guhring P, Mulhall JP. Intralesional verapamil prevents the progression of Peyronie's disease. Urology. 2007; 69(6):1181-1184.
8. Dardas A, Bae GH, Yule A, et al. Acetic acid iontophoresis for recalcitrant scarring in post-operative hand patients. J Hand Ther. 2014; 27(1):44-48.
9. DeCou JM, Abrams RS, Hammond JH, et al. Iontophoresis: a needle-free, electrical system of local anesthesia delivery for pediatric surgical office procedures. J Pediatr Surg. 1999; 34(6):946-949.
10. 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.
11. 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.
12. Jain R, Jain E, Dass AG, et al. Evaluation of transdermal steroids for trapeziometacarpal arthritis. J Hand Surg Am. 2010; 35(6):921-927.
13. 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.
14. Levit F. Treatment of hyperhidrosis by tap water iontophoresis. Cutis. 1980; 26(2):192-194.
15. Lombardo M, Giannini D, Lombardo G, Serrao S. Randomized controlled trial comparing transepithelial corneal cross-linking using iontophoresis with the Dresden protocol in progressive keratoconus. Ophthalmology. 2017; 124(6):804-812.
16. Lombardo M, Serrao S, Lombardo G, Schiano-Lomoriello D. Two-year outcomes of a randomized controlled trial of transepithelial corneal crosslinking with iontophoresis for keratoconus. J Cataract Refract Surg. 2019; 45(7):992-1000.
17. Lustig LR, Ingram A, Vidrine DM, et al. In-office tympanostomy tube placement in children using iontophoresis and automated tube delivery. Laryngoscope. 2020; 130 Suppl 4(Suppl 4):S1-S9.
18. 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.
19. Nawrocki S, Cha J. The etiology, diagnosis, and management of hyperhidrosis: a comprehensive review: therapeutic options. J Am Acad Dermatol. 2019; 81(3):669-680.
20. Neeter C, Thomeé 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.
21. Niedfeldt M, Rutherford D, Young C. Treatment of plantar fasciitis. Am Fam Physician. 2001; 63(3):467-474.
22. 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.
23. Pariser DM, Ballard A. Iontophoresis for palmar and plantar hyperhidrosis. Dermatol Clin. 2014; 32(4):491-494.
24. Paulis G, Cavallini G, Giorgio GD, et al. Long-term multimodal therapy (verapamil associated with propolis, blueberry, vitamin E and local diclofenac) on patients with Peyronie's disease (chronic inflammation of the tunica albuginea). Results of a controlled study. Inflamm Allergy Drug Targets. 2013; 12(6):403-409.
25. Pierce MW. Transdermal delivery of sumatriptan for the treatment of acute migraine. Neurotherapeutics. 2010; 7(2):159-163.
26. Rigby JH, Mortensen BB, Draper DO. Wireless versus wired iontophoresis for treating patellar tendinopathy: a randomized clinical trial. J Athl Train. 2015; 50(11):1165-1173.
27. Sayegh ET, Strauch RJ. Does nonsurgical treatment improve longitudinal outcomes of lateral epicondylitis over no treatment? A meta-analysis. Clin Orthop Relat Res. 2015; 473(3):1093-1107.
28. 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.
29. Squire SJ, Kirchhoff KT, Hissong K. Comparing two methods of topical anesthesia used before intravenous cannulation in pediatric patients. J Pediatr Health Care. 2000; 14(2):68-72.
30. 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.
31. Vinciguerra P, Rosetta P, Legrottaglie EF, et al. Iontophoresis CXL with and without epithelial debridement versus standard CXL: 2-year clinical results of a prospective clinical study. J Refract Surg. 2019; 35(3):184-190.
32. 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.
33. Yu T, Zhang S, Cao X, et al. Iontophoretic delivery of transdermal patches containing ropivacaine: sustaining the anesthetic effect in children. Acta Biochim Pol. 2019; 66(2):167-172.
34. Zempsky WT, Anand KJ, Sullivan KM, et al. Lidocaine iontophoresis for topical anesthesia before intravenous line placement in children. J Pediatr. 1998; 132(6):1061-1063.
35. Zempsky WT, Parkinson TM. Lidocaine iontophoresis for topical anesthesia before dermatologic procedures in children: a randomized controlled trial. Pediatr Dermatol. 2003; 20(4):364-368.
36. Zempsky WT, Sullivan J, Paulson DM, et al. Evaluation of a low-dose lidocaine iontophoresis system for topical anesthesia in adults and children: a randomized, controlled trial. Clin Ther. 2004; 26(7):1110-1119.                                  

Government Agency, Medical Society, and Other Authoritative Publications

1. Kroeling P, Gross A, Graham N, et al. Electrotherapy for neck pain. Cochrane Database Syst Rev. 2013;(8):CD004251.
2. Page MJ, Green S, Mrocki MA, et al. Electrotherapy modalities for rotator cuff disease. Cochrane Database Syst Rev. 2016;(6):CD012225.
3. U.S. Food and Drug Administration (FDA). CFR – Code of Federal Regulations Title 21. Sec. 890.5525 Iontophoresis device. Current as of June 7, 2023. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=890.5525. Accessed on August 16, 2023.
4. 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 August 16, 2023.

1. American Academy of Dermatology. Hyperhidrosis: Diagnosis and Treatment. Available at: https://www.aad.org/public/diseases/a-z/hyperhidrosis-treatment. Accessed on August 16, 2023.

Dermadry
Drionic
Fischer MD-1a Galvanic Unit
Hidrex
Hyperhidrosis
Iontophoresis

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Federal and State law, as well as contract language including definitions and specific coverage provisions/exclusions, and Medical Policy take precedence over Clinical UM Guidelines and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Clinical UM Guidelines, which address medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Clinical UM Guidelines periodically. Clinical UM guidelines are used when the plan performs utilization review for the subject. Due to variances in utilization patterns, each plan may choose whether or not to adopt a particular Clinical UM Guideline. To determine if review is required for this Clinical UM Guideline, please contact the customer service number on the back of the member's card.