BlueCross BlueShield of Tennessee Medical Policy Manual

Iontophoresis for Medical Indications

DESCRIPTION

Iontophoresis is a method of transdermal local drug delivery using electrical current. A charged, ionic drug is placed on the skin using 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. It has been proposed for numerous uses, including delivering local anesthetic before skin puncture or other painful dermal procedures, local drug delivery for agents such as nonsteroidal anti-inflammatory drugs, or corticosteroids for musculoskeletal inflammatory disorders. In the treatment of musculoskeletal disorders, iontophoresis is often offered in the physical medicine and rehabilitation setting. Iontophoresis has also been investigated for the treatment of hyperhidrosis of the hands and feet.

POLICY

• Iontophoresis as a transdermal drug delivery technique for medical indications is considered investigational.

IMPORTANT REMINDERS

• Any specific products referenced in this policy are just examples and are intended for illustrative purposes 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. These examples are contained in the parenthetical e.g. statement.

• We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION

Scientific evidence in the form of well-designed studies in peer reviewed journals regarding the efficacy of iontophoresis as a drug delivery technique are lacking.

SOURCES

BlueCross BlueShield Association. Medical Policy Reference Manual. (11:2009). Iontophoresis as a technique for drug delivery- Archived (8.03.14). Retrieved November 15, 2011. (17 articles and/or guidelines reviewed)

BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2011). Treatment of hyperhidrosis (8.01.19). Retrieved November 15, 2011 from BlueWeb. (37 articles and/or guidelines reviewed)

BlueCross BlueShield Association. Medical Policy Reference Manual. (7:2011). Temporomandibular joint dysfunction (2.01.21). Retrieved Novemebr 15, 2011 from BlueWeb. (13 articles and/or guidelines reviewed)

Panchal, S., Damaraju, C., Nelson, W., Hewitt, D., & Schein, J. (2007) System related events and analgesic gaps during postoperative pain management with fentayl iontophoretic transdermal system and morphine intravenous patient controlled analgesia. Anesthesia and Analgesia, 105 (5), 1437 – 1441. (Level 2 Evidence - Industry supported)

Tesselaar, E., Henricson, J., Jonsson, S., & Sioberg, F. (2008). A time-response model for analysis of drug transport and blood flow response during iontophoresis of acetylcholine and sodium nitroprusside. Journal of Vascular Research, 46 (4), 270-277. (Level 4 Evidence - Independent study)

U. S. Food and Drug Administration. (2008, June). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K080580. Retrieved February 17, 2009 from http://www.fda.gov/cdrh/pdf8/K080580.pdf.

U. S. Food and Drug Administration. (2006, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K060579. Retrieved February 17, 2009 from http://www.fda.gov/cdrh/pdf6/K060579.pdf.

Viscusi, E. R., Reyolds, L., Tait, S., Melson, T., & Atkinson, L. E. (2006). An iontophoretic fentanyl patient-activated analgesic delivery system for postoperative pain: A double-blind, placebo-controlled trial. Anesthesia and Analgesia, 102 (1), 188-194. (Level 1 Evidence - Industry sponsored)

ORIGINAL EFFECTIVE DATE:  10/1/2000

MOST RECENT REVIEW DATE:  1/12/2012

ID_BA

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

This document has been classified as public information.