Justice Department files lawsuit alleging Fresenius charged for unneeded access procedures
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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.
“Behind the veneer of concern about quality outcomes, [Fresenius Vascular Care (FVC)] was focused on increasing volume or ‘growth’ in both patients and procedures,” the complaint said. “FVAC and FVC regional directors communicated monthly about targets for volumes of procedures performed.” The company’s 66 interventional centers, located in 25 states, competed against each other to claim the highest number of access procedures, the complaint said.
Medicare fraud
“The conduct alleged in this case is egregious, as Fresenius not only defrauded federal [health care] programs but also subjected particularly vulnerable people to medically unnecessary procedures,” Breon Peace, the U.S. Attorney who filed the complaint, said in the press release. “This Office will hold medical providers accountable for practices that needlessly expose patients to harm for financial gain at taxpayer expense.”
The U.S. Attorney is seeking damages and penalties under the False Claims Act, according to the press release.
In a statement, Brad Puffer, spokesperson for Fresenius Medical Care North America, told Healio, “Our network of vascular centers is leading efforts to reduce total healthcare costs and improve patient outcomes by expanding access to innovative and less-invasive procedures. Our policies are intended to result in a high standard of care and compliance with government regulations. We dispute the allegations contained in both the relators’ complaint and the U.S. government’s complaint and intend to vigorously defend the litigation,” Puffer said.
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.”
“Dialysis patients are highly vulnerable and must trust their doctors to look out for their best interests. We believe that Fresenius has acted for financial gain at the expense of the patient and the U.S. taxpayer,” Pepe said in the release.
References:
Federal government joins whistleblower lawsuit filed by two physicians against national dialysis company. Available at: https://www.cohenmilstein.com/update/federal-government-joins-whistleblower-lawsuit-filed-two-physicians-against-nationwide-0. Published July 13, 2022. Accessed July 14, 2022.
United States files claims alleging Fresenius Vascular Care, Inc. defrauded Medicare and other healthcare programs by billing for unnecessary procedures performed on dialysis patients. Available at: www.justice.gov/usao-edny/pr/united-states-files-claims-alleging-fresenius-vascular-care-inc-defrauded-medicare-and Published July 13, 2022. Accessed July 14, 2022.
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