A Medical Device Daily

Medegen (Ontario, California), a company involved in infusion therapy medical products, said it has won a legal victory in the Court of Appeals for the Federal Circuit in Washington.

The appellate court's decision reverses a judgment issued by a district court judge in the Central District of California of patent non-infringement entered in favor of ICU Medical (San Clemente, California).

Medegen argued successfully that the lower court's decision inappropriately narrowed the definition of key terms of one of its patents (U.S. patent No. 5,730,418). This patent covers a number of Medegen's novel inventions in needleless connectors, including the use of positive displacement technology, which reduces the occurrence of common vascular access device-related complications.

The case is now returned to the lower court, with the appellate court having interpreted key claim language as Medegen had requested.

"Medegen's intellectual property is valuable, and we feel strongly about protecting our innovations," said President Jeffrey Goble "We are encouraged by the successful outcome of our appeal."

In other legalities: After voluntarily disclosing that it received improper Medicare and Medicaid payments, Condell Health Network (Chicago), parent company of 283-bed Condell Medical Center (Libertyville, Illinois), has agreed without litigation to pay the U.S. and the state of Illinois $36 million as a result of filing false claims for reimbursement, said Patrick Fitzgerald, U.S. Attorney for the Northern District of Illinois.

Condell, the largest healthcare provider in Lake County, Illinois, made the voluntary disclosure earlier this year while in the process of being acquired by Advocate Health Care (Oak Brook, Illinois).

The settlement involves three aspects of the relationship between Condell and its physicians from 2002 through 2007: leases of medical office space at rates below fair market value; improper loans to physicians; and hospital reimbursement to doctors who performed patient services without required written agreements.

By voluntarily disclosing these improper practices, Condell avoided a government lawsuit under the federal False Claims Act and were able to negotiate a settlement at a discount. The settlement agreement calls for Condell to pay the U.S. $33.12 million to resolve claims relating to Medicare patients and $2.88 million to the state of Illinois

to settle claims relating to Medicaid patients. The False Claims Act provides that parties who voluntarily disclose possible violations are liable for double damages, instead of triple damages, and civil penalties between $5,500 and $11,000 for each violation.

As part of the $36 million settlement, Condell does not admit liability and said it agreed to the settlement to avoid the delay, uncertainty and expense of protracted litigation.

According to the settlement agreement, Condell leased space in medical office buildings it owned to physicians in violation of federal laws and regulations governing Medicare and Medicaid reimbursement because either the rental rates were below fair market value or Condell abated or deferred collection of rental payments.

Condell also gave loans to physicians and improperly allowed them to "work off" the debts at hourly rates that were greater than fair market value, as well as with activities that did not benefit the community.

The medical center extended loans to doctors without assessing whether there was a particular community need for such arrangements or physicians, provided loans to doctors already in the hospital's service area, gave loans that benefited individual doctors or physician groups rather than the community, and entered into multiple loan agreements with the same physician or medical group.

Condell also paid its physician recruiters incentive bonuses and its financial support agreements prohibited doctors from obtaining admitting privileges at any other hospital, the settlement agreement states.

In addition, the settlement covers Medicare and Medicaid reimbursements that Condell paid to doctors for performing services at the hospital without required written agreements.

The U.S. was represented by Assistant U.S. Attorney Linda Wawzenski, deputy chief of the U.S. Attorney's Office Civil Division.