Medical technology company BioTelemetry and its heart rate monitoring subsidiary CardioNet agreed to pay more than $44.8 million to settle allegations they violated U.S. federal health laws by improperly billing Medicare and other federal programs for heart monitoring and cardiac test analyses performed by a company in India.
Federal law requires services for patients of federal health programs, like Medicare, be provided within the United States to be reimbursed.
The trouble began for BioTelemetry in 2013, when it contracted with a group in India to conduct Holter-associated monitoring and interpret the results. The Holter heart monitor is designed to detect faulty and dangerous heart rhythms related to heart attacks and poor heart function.
BioTelemetry knew it would be a violation of federal law for patients of federal health programs to be billed for being monitored in India, so it created an alternative workflow for that data to be handled by technicians in the United States, the Department of Justice (DOJ) alleged in a press release Tuesday.
When domestic technicians faced backlogs, some data of patients was diverted to India for analysis with the full knowledge of senior BioTelemetry management, the DOJ alleged. At other times, even when there were no backlogs, data of patients was sent directly to India, the DOJ said.
BioTelemetry took steps in 2015 to stop personnel in India from accessing the U.S. tests but “those controls were insufficient,” the DOJ said.
About 97 percent of the technicians in India were not qualified to conduct the cardiac tests, the DOJ said.
CardioNet received millions in payments from false claims for heart tests and monitoring it had submitted to Medicare and other federal health programs from January 2013 through June 2022, the DOJ said.
BioTelemetry agreed to a five-year corporate integrity agreement (CIA) with the Department of Health and Human Services as part of its settlement, filed in U.S. District Court for the Eastern District of Pennsylvania.
Within 90 days, BioTelemetry must appoint a compliance officer who will report directly to the head of business for the company and shall not be acting in any capacity as legal counsel, according to the CIA. The compliance officer will report directly to the board as needed.
The compliance officer will develop and implement policies, procedures, and practices “designed to ensure compliance with the requirements set forth in this CIA and with Federal healthcare program requirements,” the agreement said.
Within 90 days, the company must also create a compliance committee chaired by the compliance officer and including all senior managers necessary to meet the CIA’s requirements. The committee will be responsible for training and reviewing the compliance program annually, among other tasks.
The company must create a risk assessment and internal review process aimed at identifying and addressing compliance risks. BioTelemetry must hire an outside organization to annually “assess the medical necessity and appropriateness of claims billed to Medicare,” the DOJ said.
Of the $44.8 million BioTelemetry and CardioNet must pay, $22.4 million is restitution.
The allegations against CardioNet were originally raised in a qui tam whistleblower case brought by two former employees, Christopher Strasinski and Philip Leone, in April 2018. The two will receive a total of approximately $8.3 million from the federal portion of the recovery, the DOJ said.
“Federal healthcare beneficiaries deserve care, including remote cardiac monitoring, that complies with federal law and is provided by qualified clinical personnel,” said Brian Boynton, deputy assistant attorney general and head of the DOJ’s Civil Division, in the agency’s release. “Today’s settlement reminds all providers that they must observe those standards and reflects the department’s commitment to pursue knowing violations of federal healthcare program requirements.”
Philips, which acquired BioTelemetry in 2021, did not respond to a request for comment.