Biotech companies reach $44M settlement over faulty testing

Dec. 20 (UPI) — A Pennsylvania-based biotech company and its subsidiary agreed on Tuesday to settle a lawsuit alleging they improperly billed Medicare and other federal health care programs for certain cardiac monitoring services.

The deal will see BioTelemetry and its subsidiary CardioNet collectively pay $44,875,000 to resolve allegations that they violated the False Claims Act, the Justice Department said in a statement.

The two companies stand accused of knowingly submitting claims to Medicare, TRICARE, the Veterans Health Administration, and the Federal Employee Health Benefits Program for faulty heart monitoring tests.

In some cases, the tests were performed outside the United States, and in many cases by technicians who were not qualified to perform the tests.

The mobile cardiovascular telemetry tests that were provided overseas, violated federal law prohibiting payment for services outside the United States.

Authorities accused BioTelemetry of diverting certain federal beneficiaries’ ECG Data to India when the domestic workflow became backlogged.

The Justice Department alleged the company’s senior management was aware of the system, which saw it contract a diagnostic firm in India for the diagnostic and analysis services.

Data from that testing was meant to go to an independent diagnostic testing facility for review and analysis, however in some cases that did not happen.

U.S. officials believe the majority of offshore technicians tasked with reviewing ECG Data for federal healthcare program beneficiaries did not have the basic qualifications to perform the tests in question.

Over 29% of the ECG Data reviewed in connection with MCT tests in 2014,, and over 78% of the ECG Data reviewed in connection with event monitoring tests, for Medicare patients was allegedly reviewed by technicians located in India.

“Federal health care beneficiaries deserve care, including remote cardiac monitoring, that complies with federal law and is provided by qualified clinical personnel,” Deputy Assistant Attorney General Brian Boynton said in a statement.

“Providers must act within clear federal healthcare program boundaries to ensure that appropriate care is given to the beneficiaries of those programs,” U.S. Attorney for the Eastern District of Pennsylvania Jacqueline Romero said in a statement.

A pair of former BioTelemetry employees who acted as whistleblowers were collectively awarded $8.3 million from the settlement.

BioTelemetry also entered a five-year Corporate Integrity Agreement with the U.S. Department of Health and Human Services Office of Inspector General that requires, implementation of a risk assessment and internal review process.

Read More