Physician Sentenced in Device Adulteration Scheme

Sarasota, FL (WorkersCompensation.com) – Earlier this year, a North Carolina provider was indicted for reusing single use medical devices in sinus surgeries. Ear, Nose, and Throat specialist Anita Louise Jackson, MD of Lumberton, North Carolina had re-sterilized balloon devices that had come into contact with bodily fluids and used them in over 1,200 sinus surgeries.

Earlier this week, in a similar case the Department Of Justice announced that Internist Donald Woo Lee of Temecula, California was sentenced to 93 months in prison for re-packaging single-use catheters for re-use on patients, healthcare fraud, and false declarations in a bankruptcy proceeding.

Lee operated a private practice that he opened in 1994. One of the services that he offered was treatment for varicose veins. The minimally invasive treatment consisted of using a single-use percutaneous catheter, guided by ultrasound, into the vein. In some cases, an infusion was delivered through the catheter. In both cases, the goal was to close veins where reflux had occurred resulting in a healthier diversion of blood flow.

In order to cover these services, federal payers required documentation of non-invasive conservative treatment for at least 6 to 8 weeks prior to the vein ablation procedures. Examples of conservative treatment included use of compression stockings, rest, and elevation of the legs.

According to the indictment, Lee convinced patients that they needed vein ablation procedures when in some cases the patients didn’t even have varicose veins, and no symptoms. Additionally, the procedures were performed without the required course of conservative care.

Along with performing the medically unnecessary procedures, Lee up-coded his claims to 37241 for venous embolization which has a higher reimbursement, instead of using the appropriate codes 37799 or 36299. From 2014 to 2015, Lee billed approximately $14,699,359 in charges to Medicare, of which $12,448,300 were for vein ablation procedures, resulting in a $4.5 million reimbursement.

According to the FDA, a medical device is considered adulterated if “it includes any filthy, putrid, or decomposed substance, or if it is prepared, packed, or held under unsanitary conditions.”

Lee used a ClariVein OC Device in his vein ablation procedures. Per the manufacturer’s website, the ClariVein is a single use catheter. Reuse or reprocessing, or re-sterilization can compromise the device’s structure, lead to device failure, and result in injury or death. Re-sterilization of the device can lead to infection or cross-infection.

According to the indictment, starting around 2016 Lee re-packaged the ClariVein catheter devices in blue peel packs after use in his surgeries.

Lee was convicted in 2019 after a 5 day trial in which the jury found him guilty of seven counts of healthcare fraud, one count medical device adulteration. In March 2020, Lee pleaded guilty to one count of false declarations in a bankruptcy proceeding. In addition to his 93-month sentence, he was also sentenced to three years supervised release, and required to pay $4.5 million in restitution to Medicare.

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