UM, Sinai records subpoenaed

June 23, 1994|By Jonathan Bor | Jonathan Bor,Sun Staff Writer

Federal investigators have subpoenaed records from more than 100 hospitals nationwide -- including two in Baltimore -- in a sweeping probe into the use of medical devices and procedures that lacked federal approval.

The subpoenas, issued last week by the inspector general of the Health and Human Services Department, apparently stem from a belief that Medicaid and Medicare may have been improperly billed for procedures involving medical devices that were still being tested for safety and effectiveness.

Hospitals have been asked to yield records covering a 10-year period ending March 31, 1994, raising the possibility that the government may seek reimbursement of millions of dollars in payments made to the hospitals over the years.

The University of Maryland Medical Center and Sinai Hospital are among the hospitals that have been ordered to turn over extensive lists of procedures done with unapproved devices. The government has requested dates, names of patients, devices, manufacturers and purchase prices, among other information.

In letters to the hospitals, the government listed devices made by 25 manufacturers. The equipment includes heart valves, pacemakers, vascular grafts, lasers and equipment used to diagnose and treat blockages and irregular heartbeats.

"These subpoenas are rather oppressive," said Leonard Homer, a private attorney representing the University of Maryland Medical Center. "They're looking at every device imaginable."

The government wants records of every use of an approved medical device for purposes other than those permitted by the Food and Drug Administration.

Mr. Homer said manuals issued by the Medicare and Medicaid programs specify that medical devices lacking FDA approval are not reasonable and necessary for treatment, but he said there is no similar statement regarding the unauthorized use of an approved device.

Any effort to seek reimbursement of money paid to the hospitals will be complicated by the fact that Medicare and Medicaid pay hospitals for a patient's overall treatment -- not for individual procedures and devices used in the course of treatment, he said.

Many doctors also improvise with devices, using them in ways that were not initially envisioned when the product was designed, tested and approved. For example, he said, the use of balloon catheters -- tubes inserted into the heart to unclog vessels -- has evolved greatly since the devices were approved more than a decade ago.

"Half the balloon angioplasties in the United States are done out of compliance with the [approved] directions because in 14 years technology has progressed," said Mr. Homer. Medicare and Medicaid "have been paying for it for 10 years. Why all of a sudden are they saying we should deny the hospitalization?"

Calls to other hospitals yesterday turned up only two in metropolitan Baltimore -- UM and Sinai -- that received subpoenas. Sinai confirmed that the hospital received a subpoena but declined further comment.

A spokeswoman with the inspector general's office refused to elaborate on the investigation.

Last year, C. R. Bard Inc., a major manufacturer, pleaded guilty to 391 criminal charges stemming from the sale of unapproved heart catheters. The company also admitted that it illegally experimented on people and hid problems from the government.

In a letter to affiliated state organizations, the American Hospital Association said the government may have identified hospitals in the current investigation by examining customer lists obtained in the probe of a "major cardiac medical device manufacturer."

One close observer said the probe began before the Bard settlement and has extended far beyond a single company.

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