Michael Barbella, Managing Editor01.02.23
Pennsylvania-headquartered BioTelemetry Inc. and its subsidiary CardioNet LLC are paying a hefty price for their alleged involvement in a billing scam.
The firms are paying $44.87 million to resolve charges they violated the U.S. False Claims Act by submitting claims to Medicare, TRICARE, the U.S. 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 unqualified technicians.
“Federal healthcare 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 U.S. Justice Department’s Civil Division. “This settlement reminds all providers they must observe those standards and reflects the department’s commitment to pursue knowing violations of federal healthcare program requirements.”
The U.S. government claims CardioNet improperly billed Medicare and other federal healthcare 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 prohibiting payment for services conducted outside the United States. Specifically, in 2013, CardioNet contracted with an India-based company to provide diagnostic and analysis services of heart monitoring data, according to the Justice Department. Although BioTelemetry set up a workflow designed to route electrocardiogram data—including information relating to cardiac events (ECG data) for federal healthcare beneficiaries—to a domestic independent diagnostic testing facility for review and analysis, BioTelemetry (with senior management's blessing) diverted certain federal beneficiaries’ ECG data to India when the domestic workflow became backlogged, federal prosecutors charged. BioTelemetry also allegedly sent ECG data for other federal beneficiaries directly to India for review. In 2014, more than 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 perused by India technicians. In 2015, those numbers allegedly rose to more than 47% and 88%, respectively. BioTelemetry began implementing technological controls in late 2015 to prevent personnel in India from accessing the domestic workflow, but those controls were insufficient, and India technicians allegedly continued to review and analyze some ECG data for federal healthcare program beneficiaries thereafter.
“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. Attorney Jacqueline C. Romero for the Eastern District of Pennsylvania. “This office will continue to pursue cases where providers have failed to honor these rules, which were established to provide quality care to elderly citizens and military veterans, among others.”
The U.S. government further alleges that most 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 from 2013 to 2018, fewer than 3% were certified by Cardiovascular Credentialing International (CCI), the only recognized credentialing body for such cardiovascular technicians, according to the Justice Department complaint.
“Providers participating in federal healthcare programs are obligated to obey the laws meant to protect the integrity of those programs and the quality of care furnished to patients,” said Special Agent in Charge Maureen R. Dixon of the Department of Health and Human Services. “With our law enforcement partners, our agency is extremely committed to investigating providers alleged of defying these requirements.”
In connection with the settlement, BioTelemetry Inc. entered into a five-year Corporate Integrity Agreement (CIA) with the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) that requires, among other things, the implementation of a risk assessment and internal review process designed 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 billed to Medicare.
The civil settlement includes the resolution of claims brought under the qui tam or whistleblower provisions of the False Claims Act by Christopher Strasinski and Philip Leone, both former CardioNet employees. The qui tam case is captioned U.S. ex rel. Doe v. BioTelemetry Inc., et al. The whistleblowers will receive approximately $8.3 million as part of the case’s resolution,.
The resolution obtained in this matter was the result of a coordinated effort between the Justice Department’s Civil Division, Commercial Litigation Branch, Fraud Section, and the United States Attorney’s Office for the Eastern District of Pennsylvania. Assistance was provided by HHS-OIG, the Department of Defense’s Defense Criminal Investigative Service, the Department of Veterans Affairs Office of Inspector General and the Office of Personnel Management’s Office of Inspector General.
The investigation and resolution of this matter illustrates the government’s emphasis on combating healthcare fraud. One of the most powerful tools in this effort is the False Claims Act.
Attorneys Amy Kossak and Jessica Sievert of the Civil Division and Assistant U.S. Attorneys Eric Gill and Erin Lindgren for the Eastern District of Pennsylvania prosecuted the case.
The firms are paying $44.87 million to resolve charges they violated the U.S. False Claims Act by submitting claims to Medicare, TRICARE, the U.S. 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 unqualified technicians.
“Federal healthcare 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 U.S. Justice Department’s Civil Division. “This settlement reminds all providers they must observe those standards and reflects the department’s commitment to pursue knowing violations of federal healthcare program requirements.”
The U.S. government claims CardioNet improperly billed Medicare and other federal healthcare 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 prohibiting payment for services conducted outside the United States. Specifically, in 2013, CardioNet contracted with an India-based company to provide diagnostic and analysis services of heart monitoring data, according to the Justice Department. Although BioTelemetry set up a workflow designed to route electrocardiogram data—including information relating to cardiac events (ECG data) for federal healthcare beneficiaries—to a domestic independent diagnostic testing facility for review and analysis, BioTelemetry (with senior management's blessing) diverted certain federal beneficiaries’ ECG data to India when the domestic workflow became backlogged, federal prosecutors charged. BioTelemetry also allegedly sent ECG data for other federal beneficiaries directly to India for review. In 2014, more than 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 perused by India technicians. In 2015, those numbers allegedly rose to more than 47% and 88%, respectively. BioTelemetry began implementing technological controls in late 2015 to prevent personnel in India from accessing the domestic workflow, but those controls were insufficient, and India technicians allegedly continued to review and analyze some ECG data for federal healthcare program beneficiaries thereafter.
“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. Attorney Jacqueline C. Romero for the Eastern District of Pennsylvania. “This office will continue to pursue cases where providers have failed to honor these rules, which were established to provide quality care to elderly citizens and military veterans, among others.”
The U.S. government further alleges that most 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 from 2013 to 2018, fewer than 3% were certified by Cardiovascular Credentialing International (CCI), the only recognized credentialing body for such cardiovascular technicians, according to the Justice Department complaint.
“Providers participating in federal healthcare programs are obligated to obey the laws meant to protect the integrity of those programs and the quality of care furnished to patients,” said Special Agent in Charge Maureen R. Dixon of the Department of Health and Human Services. “With our law enforcement partners, our agency is extremely committed to investigating providers alleged of defying these requirements.”
In connection with the settlement, BioTelemetry Inc. entered into a five-year Corporate Integrity Agreement (CIA) with the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) that requires, among other things, the implementation of a risk assessment and internal review process designed 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 billed to Medicare.
The civil settlement includes the resolution of claims brought under the qui tam or whistleblower provisions of the False Claims Act by Christopher Strasinski and Philip Leone, both former CardioNet employees. The qui tam case is captioned U.S. ex rel. Doe v. BioTelemetry Inc., et al. The whistleblowers will receive approximately $8.3 million as part of the case’s resolution,.
The resolution obtained in this matter was the result of a coordinated effort between the Justice Department’s Civil Division, Commercial Litigation Branch, Fraud Section, and the United States Attorney’s Office for the Eastern District of Pennsylvania. Assistance was provided by HHS-OIG, the Department of Defense’s Defense Criminal Investigative Service, the Department of Veterans Affairs Office of Inspector General and the Office of Personnel Management’s Office of Inspector General.
The investigation and resolution of this matter illustrates the government’s emphasis on combating healthcare fraud. One of the most powerful tools in this effort is the False Claims Act.
Attorneys Amy Kossak and Jessica Sievert of the Civil Division and Assistant U.S. Attorneys Eric Gill and Erin Lindgren for the Eastern District of Pennsylvania prosecuted the case.
