Mist Therapy System Determined to be Investigational by Palmetto

The MIST Therapy System, CPT Code 97610, consists of an equipment component (an ultrasonic generator and transducer) and a disposable component (sterile applicator). The sterile disposable applicator is attached to the generator’s transducer and has been designed to accept a pre-packaged sterile bottle of saline. Generally, treatment consists of three sessions per week, during which time the nurse or therapist holds the device near the wound while ultrasonic energy generated by the device atomizes the saline and delivers a continuous mist to the treatment site. The disposable applicator contains an on/off valve that controls the flow of sterile saline to the ultrasound transducer surface. This device is designed to deliver low levels of ultrasound energy to the wound bed by means of the generated mist without direct contact of the device with the wound, thereby avoiding possible contamination.

At the present time, the published evidence is insufficient to demonstrate the safety and efficacy of low-frequency ultrasound therapy for wound care management, as compared to conventional treatment options.

Palmetto GBA A/B MAC considers the use of low-frequency, non-contact, non-thermal, ultrasound therapy to be investigational and will be denied as investigational.