A medical device distributor, Azon Medical, LLC, has agreed to pay $1,019,307.86 to resolve liability under the False Claims Act for allegedly causing improper billing of “P-Stim” devices, in this case branded as “AnSiStim.” From approximately September 1, 2016, through October 26, 2016, Azon marketed and sold AnSiStim devices as reimbursable by Medicare under a code used for implantable neurostimulator devices, which are surgically implanted into the central nervous system or targeted peripheral nerves through procedures that are typically performed by a surgeon in an operating room. Azon’s customers applied AnSiStim devices using only an adhesive and a limited amount of needles, without any surgery or anesthesia, and without the assistance of a surgeon or an operating room.
AnSiStim is an electro-acupuncture device that, pursuant to manufacturer’s instructions, is affixed behind a patient’s ear using an adhesive. Needles are inserted into the patient’s ear and affixed using another adhesive. Once activated, the AnSiStim device then provides intermittent stimulation by electrical pulses. It is a single-use, battery-powered device designed to be worn for several days until its battery runs out, at which time the device is thrown away. Medicare does not reimburse for acupuncture or acupuncture devices like AnSiStim or other brand names of this device, including Stivax, NeuroStim, E-Pulse, and NSS-2 Bridge.
