(3) Hired and compensated physicians as medical directors for their dialysis clinics based on the number and volume of anticipated patient referrals to Gambro clinics.
Gambro also violated the Anti-Kickback Act, the DOJ said, by entering into joint venture relationships with physician partners and contractual dealings "premised upon the number and volume of anticipated patient referrals."
"Kickbacks of this type are prohibited," according to the DOJ, "to ensure that health care providers do not make treatment decisions based upon improper financial considerations rather than the necessity, reasonableness, quality and effectiveness of services."
As part of the overall scheme, Gambro Supply was set up as a medical equipment company, to inflate billings in a way that would allow the company to earn nearly $500 more per patient each month. The company billed for the rate charged at clinics rather than the lower rate it should have billed for home dialysis.
In addition, Gambro Supply, then known as REN Supply Corp, intentionally left a line blank on Medicare application forms in 1993 and 1996 to conceal its connection to the parent company, which made it possible to collect the extra $500 per person.
According to court records, in St Louis, Gambro Supply pled guilty to one felony count of execution of a health care fraud scheme, paid a $25 million fine and was permanently barred from the Medicare program.
This was the second time in four years that Gambro paid large fines for ripping off government programs. In 2000, the company and two subsidiaries, Dialysis Holdings Laboratory services and Gambro Healthcare Laboratory Services, paid over $53 million to settle charges of health car fraud similar to the allegations in the later investigation.
The $53 million settlement resolved charges that the firms submitted false claims to Medicare, Medicaid and Tricare, the Defense Department's health care program, for laboratory services provided to End Stage Renal Disease patients, according to the US Department of Justice.
In a move that seems kind of silly in hindsight, as part of the 2000 settlement, Gambro entered into a 5-year integrity agreement with the Department of Health and Human Services' Office of Inspector General. Under the agreement, reportedly designed to promote compliance with federal program requirements, Gambro agreed to provide compliance training to employees, undergo annual independent audits and submit annual reports to the Office of Inspector General.
"The corporate integrity agreement provides important safeguards to prevent misconduct and requires ongoing monitoring of the companies to help ensure compliance with federal health care program requirements," Inspector General June Gibbs Brown said at the time.
In light of the recent $300 million plus 2004 settlement, its probably safe to assume that signing the "integrity agreement" was a meaningless gesture on the part of Gambro.
However, for whatever its worth, if anything, Gambro was required to sign another "integrity agreement" as part of the December 2004 settlement.
The charges above beg the questions of how many patients received unnecessary testing, medications and equipment, and how many patients went without services that were billed for? Also, how much out-of-pocket money did patients lose in co-payments as a result of bogus billings for services not rendered or for services rendered needlessly?
Gambro also has a long history of causing death and injury by producing faulty products. On June 19, 1998, the New York Times National News Brief reported that four "hemodialysis patients died and at least 40 others required hospitalization because of defective tubing that damaged their red blood cells."
Gambro issued a nationwide recall of the products. A company press release at the time said the "blood tubing sets may be associated with incidents of hemolysis that have been reported in Nebraska, New Jersey, Alabama, Massachusetts, and Maryland within the past three (3) weeks."
Hemolysis is the medical term for the destruction of the red blood cells, according to the company.
Gambro also violated the Anti-Kickback Act, the DOJ said, by entering into joint venture relationships with physician partners and contractual dealings "premised upon the number and volume of anticipated patient referrals."
"Kickbacks of this type are prohibited," according to the DOJ, "to ensure that health care providers do not make treatment decisions based upon improper financial considerations rather than the necessity, reasonableness, quality and effectiveness of services."
As part of the overall scheme, Gambro Supply was set up as a medical equipment company, to inflate billings in a way that would allow the company to earn nearly $500 more per patient each month. The company billed for the rate charged at clinics rather than the lower rate it should have billed for home dialysis.
According to court records, in St Louis, Gambro Supply pled guilty to one felony count of execution of a health care fraud scheme, paid a $25 million fine and was permanently barred from the Medicare program.
This was the second time in four years that Gambro paid large fines for ripping off government programs. In 2000, the company and two subsidiaries, Dialysis Holdings Laboratory services and Gambro Healthcare Laboratory Services, paid over $53 million to settle charges of health car fraud similar to the allegations in the later investigation.
The $53 million settlement resolved charges that the firms submitted false claims to Medicare, Medicaid and Tricare, the Defense Department's health care program, for laboratory services provided to End Stage Renal Disease patients, according to the US Department of Justice.
In a move that seems kind of silly in hindsight, as part of the 2000 settlement, Gambro entered into a 5-year integrity agreement with the Department of Health and Human Services' Office of Inspector General. Under the agreement, reportedly designed to promote compliance with federal program requirements, Gambro agreed to provide compliance training to employees, undergo annual independent audits and submit annual reports to the Office of Inspector General.
"The corporate integrity agreement provides important safeguards to prevent misconduct and requires ongoing monitoring of the companies to help ensure compliance with federal health care program requirements," Inspector General June Gibbs Brown said at the time.
In light of the recent $300 million plus 2004 settlement, its probably safe to assume that signing the "integrity agreement" was a meaningless gesture on the part of Gambro.
However, for whatever its worth, if anything, Gambro was required to sign another "integrity agreement" as part of the December 2004 settlement.
The charges above beg the questions of how many patients received unnecessary testing, medications and equipment, and how many patients went without services that were billed for? Also, how much out-of-pocket money did patients lose in co-payments as a result of bogus billings for services not rendered or for services rendered needlessly?
Gambro also has a long history of causing death and injury by producing faulty products. On June 19, 1998, the New York Times National News Brief reported that four "hemodialysis patients died and at least 40 others required hospitalization because of defective tubing that damaged their red blood cells."
Gambro issued a nationwide recall of the products. A company press release at the time said the "blood tubing sets may be associated with incidents of hemolysis that have been reported in Nebraska, New Jersey, Alabama, Massachusetts, and Maryland within the past three (3) weeks."
Hemolysis is the medical term for the destruction of the red blood cells, according to the company.
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