DOJ said that, in 2014, over 29% of ECG data reviewed for MCT tests and 78% of data reviewed for event monitoring for Medicare patients went under review by India-based technicians. The numbers rose to over 47% and 88%, respectively, in 2015, DOJ alleges. BioTelemetry implanted technological controls in late 2015 to prevent personnel in India from accessing the domestic workflow, DOJ said. But, the controls proved insufficient and reviews continued in India, the government alleged.

Further allegations against BioTelemetry and CardioNet

The government also alleged that most offshore technicians reviewing ECG data did not posses basic qualifications to do so. It said more than 450 India-based technicians reviewed Medicare patients’ ECG data in question between 2013 and 2018. DOJ alleges that fewer than 3% held certification by Cardiovascular Credentialing International (CCI), the only recognized credentialing body for such cardiovascular technicians.

In connection with the settlement, BioTelemetry entered into a five-year corporate integrity agreement with the U.S. It requires the implementation of a risk assessment and internal review process for identifying and addressing compliance risks. This also requires an annual independent review to assess the medical necessity and appropriateness of claims billed to Medicare.

The settlement includes the resolution claims brought under the qui tam (whistleblower) provisions of the False Claims Act. Former CardioNet employees Christopher Strasinski and Philip Leone brought forth the claims. They receive approximately $8.3 million from the settlement.

“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. 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.”