Federal Probers Target Unapproved Medical Devices : Health care: Hospitals are subpoenaed in an investigation of possible fraud in use of equipment not sanctioned by the FDA.

Federal investigators have issued subpoenas to more than 100 hospitals as part of a nationwide probe into possible Medicare and Medicaid fraud involving the use of unapproved medical devices.

Hospital officials and health care lawyers said Monday that the inspector general of the Department of Health and Human Services has issued the subpoenas to hospitals and some medical equipment manufacturers during the last several weeks. The probe is another sign of the Clinton Administration’s aggressive prosecution of health care fraud as part of its efforts to curtail the growth of medical expenditures, hospital officials and lawyers said.

“By the scope, breadth and number of subpoenas people got, the federal government is continuing to focus on health care in a very big way,” said Paul DeMuro, a San Francisco lawyer. “They are looking for big-sum recoveries.”

In this case, the government is seeking information about a broad array of medical devices used in surgical procedures, many of which involve cardiac catheters and other equipment used in heart surgery, hospital officials and lawyers said. Investigators are examining whether medical devices not approved for marketing by the Food and Drug Administration were used in surgical procedures, or whether FDA-approved devices were used for unauthorized procedures, they said.

The government has not charged any hospital or medical device company with any wrongdoing in the investigation. But if evidence of illegal activities is uncovered, it could mean that hospitals and physicians billed the government for procedures using medical devices that were never proven to be safe or effective.

John Steiner, associate general counsel for the American Hospital Assn., said the subpoenas were sent to as many as 130 hospitals and seek information covering a 10-year period. “We take anything like this very seriously,” he said. “The inspector general in the last year or two has settled some very major cases.”

Last year, C.R. Bard Inc., a large manufacturer of medical devices, pleaded guilty to criminal charges related to the illegal sale of heart catheters that had not received FDA approval. The company admitted selling the devices without federal approval and illegal testing of the equipment on people.

The subpoenas, a copy of which was obtained by The Times, seek the names of “any and all persons employed as the director of the cardiac catheter laboratory, supervisor of the electrophysiology department, the cardiac nursing supervisor (or) the operating room nurse.” It also seeks the names of patients, the company that made the device and the physician involved in the procedure.

The subpoenas seeks information for the period from April 5, 1984, to March 31, 1994.

The subpoenas also show that the government is probing the “submission of false or improper claims to, and their payment by, the Medicare and Medicaid programs.”

Medicare, the federal insurance program for elderly and disabled people, and Medicaid, which covers the poor, typically do not provide reimbursement for the use of medical devices that have not been federally approved. If a hospital submitted a claim to the federal government for a surgical procedure that involved an unapproved medical device, that would be an illegal claim.

A spokeswoman for Inspector General June Gibbs Brown declined to comment.

Hospital industry officials said it appears that virtually every U.S. hospital that handles a large volume of cardiac procedures was asked to supply information to federal investigators. Among the California institutions that received subpoenas were UCLA and UC San Diego medical centers, said Mike Alva, a University of California spokesman. Cedars-Sinai Medical Center in Los Angeles also received requests for information.

“We’ve received the subpoena and we will respond appropriately to it,” said Ronald Wise, a spokesman for Cedars-Sinai.

In addition to possible fraudulent billing, lawyers said the federal government is seeking evidence on whether illegal payments were made to hospitals that used certain cardiac devices. The subpoenas ask for information on “all payments, gifts, stock and stock options, discounts or reduction in price, services or any other remuneration received from the manufacturers of the devices.”

The lawyers said hospitals and device manufacturers are attempting to clarify the scope of the information requested by the government. They also say the government’s July 1 deadline to provide the information is unrealistic.