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, possible 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 procedure, 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.
A number of iontophoresis devices have received 510(k) marketing clearance from the Food and Drug Administration (FDA) 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 specifically approved the drugs for iontophoretic administration. Two iontophoretic transdermal devices are being developed for patient-activated delivery of fentanyl for post-operative pain. The IONSYS™ fentanyl iontophoretic transdermal system is manufactured by ALZA and marketed by Ortho-McNeil. Transdermal iontophoretic fentanyl (IONSYS) received FDA approval in May 2006. Janssen-Cilag EMEA is also investigating a patient-controlled fentanyl iontophoretic transdermal delivery system in Europe. These patch systems are intended for 24-hour use in hospitals, and allow patients to control the number of doses of fentanyl (40 mcg delivered over 10 minutes), with a maximum delivery of 6 doses per hour.
Iontophoresis – CPT 97033
Ionotophoresis, Current Procedural Terminology ? (CPT) 97033, is listed in the Local Medical Review Policy (LMRP) as a non-covered service because there is no evidence from published, controlled clinical studies demonstrating the efficacy of this as a physical medicine modality. And as a result, this service will be denied as not medically necessary. The provider should be aware that billing iontophoresis will result in a medical review denial of no medical necessity with provider liability.