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Justice Department Files Lawsuit Alleging Fresenius Charged for Unneeded Access Procedures

Healio

July 14, 2022

U.S. Department of Justice filed a civil complaint in federal court against Fresenius Vascular Care Inc. alleging that the company billed Medicare and other health plans for more than 1,000 unnecessary procedures in their access centers.

“…For the [Fresenius Vascular Access Centers (FVACs)] located in New York from about January 1, 2012, through June 30, 2018, at least 1,288 out of a total of 2,303 angioplasty procedures among 60 patients (55.92%) were medically unnecessary,” the 54-page, five-count complaint alleges.

The U.S. Attorney for the Eastern District of New York and the U.S. Department of Health and Human Services, Office of Inspector General’s Office of Investigations, which filed the complaint, alleges that Fresenius Vascular Care, a subsidiary of Fresenius Medical Care North America, performed and billed for procedures such as fistulograms and angioplasties to Medicare, Medicaid, Federal Health Benefits Program and TRICARE despite internal documents and a Fresenius-led study showing completing the procedures had little clinical benefit.

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Whistleblower suit

The government filed its complaint after two nephrologists filed a whistleblower lawsuit against Fresenius Vascular Care alleging that the company was billing for unnecessary procedures.

“In their complaint, the whistleblowers allege that the defendants have engaged in a fraudulent scheme to receive government payments for unnecessary surgical procedures and testing,” Cohen Milstein Sellers & Toll PLLC, a law firm representing John Pepe, MD, and Richard Sherman, MD, said in a press release. “The complaint alleges that for many years, once a nephrologist has initially referred a patient with evidence of a clinically significant stenosis to a [Fresenius Vascular Care] facility, and the patient’s vascular access has been treated there, [Fresenius Vascular Care] then continues scheduling periodic follow-up visits every 2 to 4 months indefinitely. … These procedures are performed without evidence of problems in administering dialysis and without a referral by the patient’s nephrologist. Thus, the defendants have no reasonable basis for performing these medically unnecessary procedures and they are not reimbursable by the government health care programs. Nevertheless, defendants have submitted, or caused to be submitted, these fraudulent claims for payment and the government has, in good faith, paid them.”

Read Justice Department Files Lawsuit Alleging Fresenius Charged for Unneeded Access Procedures.