The U.S. Justice Department is investigating the medical necessity of angiograms performed at a DaVita HealthCare Partners subsidiary, the company disclosed Wednesday in a filing with the Securities and Exchange Commission.
The False Claims Act investigation centers on the medical necessity of the procedures performed at two Florida centers that are part of RMS Lifeline, a DaVita subsidiary that provides vascular access management services for dialysis patients, according to the filing. The Justice Department has asked for medical records for 10 patients, among other documents, from January of 2008 through the present.
Denver-based DaVita said in a statement Wednesday that it “will work diligently to resolve this matter.”
“Over the past several years, we have enhanced our compliance programs companywide, dedicating additional resources and personnel to our compliance practices,” DaVita said in the statement.
During dialysis, it's important that blood flow freely through the veins. When flow is compromised, sometimes an angiogram, a minimally invasive medical imaging test, is done to detect what is causing the narrowing of the vein. The hope is to prevent blood clots and improve the long-term function of the fistula or graft used to access the vein. However, studies show inconclusive results on whether this actually improves care.
The clinical safety and effectiveness of this procedure for all regions of the body has not been proven, and Medicare provides coverage on a limited basis, according to a CMS National Coverage Determination.
Earlier this year, DaVita Kidney Care, a division of DaVita Healthcare Partners, settled with whistle-blowers for $450 million in a different False Claims Act case. That case centered on allegations that the company's dialysis clinics billed Medicare and Medicaid for full vials of drugs but only used part of the vials.
In that case, DaVita Chief Legal Officer Kim Rivera said in a statement earlier this year: "Although we believe strongly in the merits of our case, we decided it was in our stakeholders' best interests to resolve it. The potential mandatory penalties for being found in the wrong in even a small percentage of instances were simply too large."
