Fresenius Medical CareFederal attorneys accused Fresenius Medical Care’s vascular care unit of performing unnecessary procedures on dialysis patients and billing the federal government.

U.S. Attorney for the Eastern District of New York Breon Peace made the allegations yesterday against Fresenius Vascular Care — doing business as Azura Vascular Care — as part of a whistleblower suit filed by two doctors in 2014.

Bad Homburg, Germany-based parent company Fresenius Medical Care said it disputes the allegations and intends to mount a vigorous defense.

“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,” the company said in a statement sent to Medical Design & Outsourcing. “Our policies are intended to result in a high standard of care and compliance with government regulations.”

Prosecutors said Azura Vascular Care clinics in New York falsified patient records and routinely performed procedures on end-stage renal disease (ESRD) patients without sufficient clinical indication, including fistulagrams and angioplasties, from around January 2012 through June 2018.

During that time, Azura Vascular Care owned or operated nine outpatient vascular access center facilities in Brooklyn, Queens, Staten Island, Long, Island, Manhattan, the Bronx, and Westchester.

At least 1,288 out of a total 2,303 angioplasty procedures performed on 60 patients were medically unnecessary, the government said in its complaint, noting that these figures “do not represent the entirety of the false claims at issue in this action but are based on a statistically valid random sample review of medical files drawn from larger universe.”

Fresenius billed Medicare, Medicaid, TRICARE, and the Federal Employees Health Benefits Program FEHBP for the procedures, which prosecutors say did not meet Medicare’s “reasonable and necessary” requirement.

The civil complaint said the Fresenius division knew it was subjecting patients to unjustified interventions that were uncomfortable, time-consuming and dangerous, with risks including over-sedation, infection, ruptured blood vessels, internal or external bleeding, and stenoses that could require more invasive procedures, “thereby setting the stage for cyclical dependency on interventions.”

“Defendant nonetheless took advantage of patients to promote its own financial gain,” government attorneys said in the complaint. “This conduct came at a cost to patients.”

Fresenius should have known, the government said, because FMC’s Clinical Research Division published a study in 2011 that found “elective” or “preventative” angioplasties could actually restrict vascular access rather than help. Fresenius Chief Medical Officer Frank Maddux was one of the authors of that study, though he is not identified by name in the lawsuit.

Despite that study, Fresenius pushed for preemptive interventions in marketing materials distributed to clinics to increase revenue and set goals and quotas with bonuses for procedure volumes, government attorneys said.

“The conduct alleged in this case is egregious, as Fresenius not only defrauded federal healthcare programs but also subjected particularly vulnerable people to medically unnecessary procedures,” Peace said in a news release. “This office will hold medical providers accountable for practices that needlessly expose patients to harm for financial gain at taxpayer expense.”

The DOJ is seeking per-violation penalties ranging from $11,000 to $25,076, plus damages worth three times the amount of fraudulent payments.

The government’s complaint can be downloaded as a PDF here.