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Massachusetts Hospital Agrees to Pay $24.3 Million to Resolve Allegations It Didn’t Comply with Medicare Cardiac Procedure Rules | King and Spalding

Cape Cod Hospital (CCH), based in Hyannis, Massachusetts, agreed to pay $24.3 million to resolve allegations that it violated the False Claims Act. CCH allegedly submitted Medicare claims for transcatheter aortic valve replacement (TAVR) procedures knowing that its evaluations of patients for TAVR procedures did not comply with Medicare billing rules.

CCH began offering TAVR procedures in 2015 to patients suffering from aortic stenosis (a heart condition that restricts blood flow from the heart to the body). Medicare rules in effect at the time required hospitals to do at least three things before performing a TAVR procedure: have clinical staff independently examine patients to determine whether they were suitable for a TAVR procedure; document the rationale for the clinical judgment of clinical staff; and provide that justification to the medical team who performed any TAVR procedure. The settlement resolves allegations that, between 2015 and 2022, CCH knowingly submitted claims to Medicare for TAVR procedures in which physicians failed to document or share their clinical judgment with the medical team or in which an insufficient number of physicians They evaluated whether a patient was suitable for TAVR. procedure.

In connection with the agreement, CCH entered into a five-year corporate integrity agreement (CIA) with the OIG. The CIA requires an annual review of CCH’s paid Medicare claims by an Independent Review Organization (IRO).

As part of the settlement, CCH received credit for cooperation under DOJ guidelines that take into account disclosure, cooperation and relief in False Claims Act cases. CCH’s cooperative actions included voluntary production of documents, identification of relevant medical records, admission of noncompliance, and implementation of corrective measures.

A copy of the settlement agreement is available here.