Romero for the Eastern District of Pennsylvania. “Providers must act within clear federal healthcare program boundaries to ensure that appropriate care is given to the beneficiaries of those programs,” said U.S. Boynton, head of the Justice Department’s Civil Division. “Today’s settlement reminds all providers that they must observe those standards and reflects the department’s commitment to pursue knowing violations of federal health care program requirements.” “Federal health care beneficiaries deserve care, including remote cardiac monitoring, that complies with federal law and is provided by qualified clinical personnel,” said Principal Deputy Assistant Attorney General Brian M.
Although BioTelemetry began implementing technological controls in late 2015 to prevent personnel in India from accessing the domestic workflow, those controls were insufficient, and technicians in India allegedly continued to review and analyze some ECG Data for federal healthcare program beneficiaries thereafter. In 2015, those numbers allegedly rose to over 47% and over 88%, respectively. In 2014, over 29% of the ECG Data reviewed in connection with MCT tests, and over 78% of the ECG Data reviewed in connection with event monitoring tests, for Medicare patients were allegedly reviewed by technicians located in India. BioTelemetry also allegedly sent ECG data for other federal beneficiaries directly to India for review. Although BioTelemetry set up a workflow that was designed to route electrocardiogram data, including data relating to cardiac events (ECG Data) for federal healthcare beneficiaries, to a domestic independent diagnostic testing facility for review and analysis, the government alleged that BioTelemetry - with the knowledge of then senior management - diverted certain federal beneficiaries’ ECG Data to India when the domestic workflow became backlogged. More specifically, the government alleged that, in 2013, CardioNet contracted with a company located in India for the provision of diagnostic and analysis services of heart monitoring data. The United States alleged that CardioNet improperly billed Medicare and other federal health care programs for certain cardiac monitoring services - including Holter, event monitoring, and mobile cardiovascular telemetry (MCT) tests - that were performed overseas in violation of federal law that prohibits payment for services furnished outside the United States. and its subsidiary CardioNet LLC, both headquartered in Pennsylvania (collectively “BioTelemetry”), have agreed to pay $44,875,000 to resolve allegations that they violated the False Claims Act by knowingly submitting claims to Medicare, TRICARE, the Veterans Health Administration, and the Federal Employee Health Benefits Program for heart monitoring tests that were performed, in part, outside the United States, and in many cases by technicians who were not qualified to perform such tests.
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