Unnecessary Replacements Of Batteries In Implanted Heart Rhythm Devices: On September 14, 2022, the United States Attorney for the Eastern District of New York announced that a settlement was reached to resolve allegations that a former physician at New York-Presbyterian/Queens performed services that were not medically necessary and then billed federal health care programs for those services. The services involved the replacement of implantable cardioverter defibrillator (ICD) pulse generator batteries.
A physician who was formerly affiliated with New York-Presbyterian/Queens repeatedly replaced ICD batteries earlier than was necessary — he repeatedly replaced ICD batteries before they reached the elective replacement interval (ERI). Because the batteries were functioning normally, the physician therefore subjected his patients to unneeded and risky surgical procedures. New York-Presbyterian/Queens then submitted claims for payments to federal health care programs for these procedures.
As a result of an internal investigation, New York-Presbyterian/Queens learned of the physician’s conduct. It voluntarily self-disclosed that conduct to the United States Department of Health and Human Services, Office of Inspector General. The settlement, which requires New York-Presbyterian/Queens to pay $2,588,882.50 to the United States, resolves claims that the conduct violated the federal False Claims Act.
What Is An Implantable Cardioverter Defibrillator (ICD)?
An ICD is akin to a pacemaker. It is placed under a patient’s skin and is designed to ensure that the patient’s heart beats on a regular rhythm. ICDs run on batteries. Like all batteries, ICD batteries will eventually fail, which could lead to disastrous consequences, even death. But replacing an ICD battery involves a surgical procedure, which carries risk. Physicians closely monitor the functioning of ICD batteries so that they replace the batteries when they are nearing the end of their lives, but no earlier. That way, physicians can balance the risks associated with a failing ICD battery against the risk of the procedure needed to replace that battery. Put in more technical terms, the standard of care is to replace an ICD battery only when it reaches what is called the elective replacement interval (ERI) as determined by device interrogation conducted by specially equipped computerized monitors.
Breon Peace, United States Attorney for the Eastern District of New York, stated in announcing the settlement: “This more than $2.5 million settlement rectifies that New York-Presbyterian/Queens was paid by the federal government for unnecessary procedures. This Office is committed to combatting fraud and abuse of our federal health care programs, especially when such conduct potentially puts patients at risk.”
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