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Fine for outsourcing cardiac tests to India

WorldFine for outsourcing cardiac tests to India

‘Most offshore technicians tasked with reviewing ECG data did not have basic qualifications to perform tests in question’.

New Delhi: Two United States-based companies that manufacture medical devices, including heart monitoring equipment, will pay $44.8 million to resolve allegations that they outsourced the reading and analysis of the results of their tests to non-qualified India-based technicians.
The said companies—BioTelemetry, Inc and its subsidiary CardioNet, LLC, both headquartered in Pennsylvania—were acquired by business conglomerate Philips in December 2020 for $2.8 billion. At that time, they were monitoring 1 million cardiac patients remotely and its equipment, including wearable heart monitors, AI-based data analytics and services, are used and prescribed by physicians across the world, including in India.
As per the order of the Department of Justice (DoJ), US government, that was released in December last year, the two companies also improperly billed multiple US government agencies, including those which provide healthcare to veterans for certain cardiac monitoring services, including Holter, event monitoring, and Mobile Cardiovascular Telemetry (MCT) tests.
As per the DoJ, “In 2013, CardioNet contracted with a company located in India for the provision of diagnostic and analysis services of heart monitoring data. Although BioTelemetry set up a workflow that was designed to route electrocardiogram data, including data relating to cardiac events to a domestic independent diagnostic testing facility for review and analysis, BioTelemetry—with the knowledge of then senior management—diverted certain federal beneficiaries’ ECG Data to India when the domestic workflow became backlogged. BioTelemetry also allegedly sent ECG data for other federal payer patients directly to India for review. 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. In 2015, those numbers allegedly rose to over 47% and over 88%, respectively.”
As per DoJ, “Most of the offshore technicians tasked with reviewing ECG data for federal healthcare program beneficiaries did not have the basic qualifications to perform the tests in question. Of the more than 450 India-based technicians who reviewed Medicare patients’ ECG data in connection with MCT services that CardioNet billed to Medicare during the 2013 to 2018 period, the government alleged that fewer than 3% were certified by Cardiovascular Credentialing International (CCI), the only recognized credentialing body for such cardiovascular technicians.”
The said matter was brought into the knowledge of government agencies by whistleblowers who were awarded approximately $8.3 million by the DoJ. The Sunday Guardian’s email to Philips seeking details of reports of how many Indian patients were a part of this fiasco did not elicit any response till the time the story went to press.

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