- The Washington Times - Saturday, January 18, 2003

BALTIMORE (AP) Johns Hopkins Hospital improperly charged Medicare millions of dollars for procedures involving experimental cardiac devices, the U.S. Department of Justice said.

Between 1986 and 1995, Johns Hopkins submitted "false and fraudulent patient claims and hospital cost reports" to Medicare for procedures that had yet to be approved as safe and effective for general medical use by the Food and Drug Administration (FDA), according to a lawsuit filed by the Justice Department this week.

The procedures involved cardiac defibrillators, pacemakers and angioplasty devices, the suit says. A similar lawsuit also was filed against Methodist Hospitals of Memphis.

"The hospitals are using these devices lawfully," said Justice Department spokesman Charles Miller, "but Medicare does not allow experimental devices to be billed."

A former medical-device salesman, Kevin Cosens, originally sued the hospitals under the False Claims Act, which allows private citizens to sue on the federal government's behalf and share in any proceeds.

A Johns Hopkins spokesman said the hospital acted properly.

"The patients received the best available care, and the billing to the government was appropriate," Hopkins spokesman Gary Stephenson said in a statement.

Ray Shepard, an attorney representing Hopkins, said the government's claims stem from a 1986 Medicare instruction that said the program wouldn't cover devices not approved by the FDA.

He said the policy was issued without proper notice to providers and beneficiaries and was rescinded in 1995.

"This double standard would have treated Medicare patients differently," Mr. Shepard said.

"The rest of the population could receive these devices and in most cases have their insurance pay for them, but the policy would have denied Medicare patients state-of-the-art technology."

Federal prosecutors previously have reached settlements with 31 hospitals in related lawsuits for a total of about $42 million, the Justice Department said.

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