by John R. Fischer
, Senior Reporter | December 23, 2022
BioTelemetry, a Philips company and the owner of the one of the largest remote cardiac monitoring service networks in the world, will pay approximately $45 million to settle False Claims allegations relating to its CardioNet subsidiary and the outsourcing of heart monitoring services for U.S. patients.
Former employees say that from 2013 to 2022, CardioNet defrauded U.S. taxpayers by outsourcing remote heart monitoring services to technicians in India, despite being required by federal law to perform them in the U.S. It then improperly billed Medicare and other federal programs.
Senior management for the Malverne, Pennsylvania-based BioTelemetry was aware of the issue and also outsourced electrocardiogram (ECG) data for certain federal beneficiaries when facing a backlog in its domestic workflow, according to the settlement. It also allegedly sent ECG data for other federal beneficiaries directly to India for review.
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Of the more than 450 technicians, fewer than 3% were certified by Cardiovascular Credentialing International (CCI), the only recognized credentialing body for such cardiovascular technicians, said the U.S. government in the suit.
BioTelemetry was acquired
in 2021 by Philips, which was informed about the ongoing Civil Investigative Demand issue by the Department of Justice in 2018, and the underlying whistleblower lawsuit at the time of the acquisition.
"Philips has agreed to the settlement agreement to resolve this legacy complaint...Cardionet and BioTelemetry deny the allegations, and the settlement agreement does not represent an admission of liability," Steve Klink, head of Philips global press office and industry relations, told HCB News.
The whistleblower lawsuit was filed in 2018 by Ross Feller Casey LLP, of Philadelphia. The federal government investigated the claims for more than four years before joining the case, accusing BioTelemetry of violating the False Claims Act, under which citizens can report cases of fraud against federal programs or funds in exchange for a portion of the settlement.
In 2014, the Indian technicians reviewed over 29% of the ECG data from mobile cardiac telemetry tests and over 78% from event monitoring tests administered to Medicare patients, according to the lawsuit. Those numbers rose to over 47% and over 88%, respectively, in 2015.
BioTelemetry implemented technological controls in late 2015 to stop the technicians from accessing the data, but those controls were insufficient and the foreign workers were still able to review and analyze some ECG information belonging to federal healthcare program beneficiaries.
The whistleblowers in this case will split $8.3 million.
As part of its settlement, BioTelemetry has agreed to a a five-year Corporate Integrity Agreement (CIA) with the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG), which requires it to implement a risk assessment and internal review process to identify and address evolving compliance risks.
The CIA also requires an independent review organization to annually assess the medical necessity and appropriateness of claims that it bills to Medicare.