Indian-origin Dr Sanjeev Kumar, a gynecologic oncologist of Memphis in Tennessee, has been found guilty of 18 counts of adulteration of medical devices, sixteen counts of misbranding medical devices, and six counts of health care fraud. According to court documents, Dr Kumar submitted and caused his employees to submit fraudulent claims to Medicare and Medicaid for hysteroscopy with biopsy procedures that were not medically necessary and conducted with adulterated devices — from 2019 to 2024. Dr Kumar’s defense, however, contended that it’s untrue that Dr Kumar did not disinfect those devices; they said the government did not like his process for disinfecting though it was recommended by the CDC.
Single-use hysteroscope used again and again
Between 2019 and 2024, Dr Kumar and his team performed over 15,000 hysteroscopies with biopsy in 5,559 Medicare and Medicaid patients. The hysteroscopy with biopsy is an in-office procedure where a hysteroscope is inserted into the vagina, pushed through the cervix, and into the uterus. A grasper or pipelle is then inserted through the hysteroscope to take a sample of the endometrial lining of the uterus. The procedure is used to diagnose endometrial cancer. Dr Kumar purchased less than 200 new single-use hysteroscopes, and 3 of the 6 single-use graspers of a certain type he purchased in 2019 were still in use in the office in April 2024.Dr Kumar billed more than $41 million for the hysteroscopy with biopsy procedures between September 2019 and April 2024. He netted more than $4.8 million for this procedure from Medicare and Medicaid alone, the court documents said. “The single-use devices were to be used once and then discarded. To correctly disinfect the devices cleared for reprocessing, Kumar had to strictly follow manufacturer instructions. Kumar routinely failed to subject the reusable devices to vital reprocessing steps between patient use, thereby, endangering patient safety. The single-use devices, even if they had been correctly reprocessed, had to be labeled as such, and Kumar did not label them,” the DOJ said. After being found guilty, Dr Sanjeev Kumar said his fight is far from over but he respects the process. “I served every patient like a family member, never turned anybody away. As far as science is concerned, we are confident that we are on the right side of the scientific facts,” he said.
