A detailed summary of investigations into DaVita

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A detailed summary of investigations into DaVita
By The Denver Post
POSTED: 05/08/2011 01:00:00 AM MDT

DaVita's practices have attracted the attention of federal investigators, who are probing the company for things ranging from whether it overused an anemia drug to its financial relationships with doctors.

DaVita officials defend the company's practices and say patient care always has been paramount. They stressed that they have never settled a federal claim.

"Investigations, subpoenas and audits are common in health care and alone are not markers of wrongdoing," said William Myers, vice president of corporate communications for DaVita.

Indeed, a federal judge ordered Fresenius Medical Care North America — a competing dialysis provider — and two of its subsidiaries to pay the federal government $19.4 million in March 2009 for fraudulent Medicare bills for home-dialysis care. Prosecutors are seeking to have that judgment increased to $104 million. In 2004, Gambro Healthcare, which DaVita bought in 2005, paid $350 million in fines and penalties to settle health care fraud allegations.

DaVita officials say they are prepared to vigorously contest all allegations.

The summary below lists the status of investigations into DaVita and ongoing litigation:

Investigation: U.S. attorney's office in St. Louis, covering activities from 1996 to the present.

Allegations: DaVita overused anemia drug Epogen and then billed the government for it. DaVita entered into improper relationships with pharmaceutical companies and physicians.

Response: The company has said in corporate filings that it believes the relationships it has with doctors are legal but that it "could suffer severe consequences" if the federal government found those relationships violated anti-kickback laws. Company officials in interviews have said Epogen dosing in clinics is at levels considered medically necessary.

Status: Open.

Investigation: In 2010, in corporate filings, DaVita said the Dallas office of the Inspector General of the U.S. Department of Human Services was conducting an investigation.

Allegations: Subpoenas have been issued into DaVita's "financial relationships with physicians and joint ventures." A subpoena also was issued to Pinnacle Group, a consultant partner of DaVita. Records show that investigation relates to "false or otherwise improper claims" by DaVita.

Response: DaVita, in corporate filings, has said it has done the best it can to structure its relationships with its partners so they do not run afoul of federal anti-kickback statutes. The company maintains those relationships are legal. DaVita said its billing has been for medically necessary treatment.

Status: Open.

Lawsuit: In 2009, DaVita and federal prosecutors filed court documents in Atlanta revealing the federal government was investigating the company in connection with a whistle-blower lawsuit there.

Allegations: The company submitted fraudulent Medicare claims for dialysis drugs.

Response: Company officials said they will respond if they are served with the suit. In interviews, they have denied submitting fraudulent Medicare claims and have maintained that dosing has been to medically necessary levels.

Status: The federal government has filed court documents declining to intervene in the case. The whistle- blower lawsuit filed by Alon Vanier, a medical director for DaVita dialysis clinics, and Daniel Barbir, a former DaVita clinic director, remains active.

Lawsuit: A whistle-blower lawsuit filed by Ivey Woodard, who worked as an accounts manager for Amgen, the drug manufacturer of Epogen.

Allegation: Collusion by DaVita and Amgen, the drug company that is the sole provider of Epogen, to drive up profits through false claims submitted to Medicare. Woodard claims Amgen trained Da Vita staff in "how to manipulate the system" to maximize Epogen use. The allegations include letting Amgen review patient charts to find reasons to push more of the drug.

Response: DaVita said many of the claims were vague and should be dismissed, with no specific details about the alleged training or chart reviews, or Amgen influencing DaVita's protocols.

Allegation: DaVita made a practice of capturing free "overfill" in Epogen packages, then billing Medicare for amounts of the drug despite not paying for it.

Response: DaVita's court filings say government regulators were aware of companies using overfill and "condoned billing" for it.

Status: The federal government has not filed papers stating whether it will intervene in the case. The whistle-blower lawsuit remains active.

Investigation: Probing Da Vita laboratory in Florida.

Allegation: Improper Medicare billing.

Response: DaVita maintains it did nothing wrong.

Result: Administrative law judges ruled in favor of Da Vita. The company recouped $95 million in Medicare reimbursements that had been withheld.

Compiled by The Denver Post



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