Cape Cod Hospital (CCH), which is based in Hyannis, Massachusetts, has 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 while 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 who suffered 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 personnel independently examine patients to determine if the patients were suitable for a TAVR procedure; document the rationale for the clinical personnel’s clinical judgment; and provide that rationale to the medical team that performed any TAVR procedure. The settlement resolves allegations that, between 2015 and 2022, CCH knowingly submitted claims to Medicare for TAVR procedures where physicians failed to document and share their clinical judgment with the medical team or where an insufficient number of physicians evaluated whether a patient was suitable for a TAVR procedure.

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

As part of the settlement, CCH received cooperation credit under DOJ guidelines that take into account disclosure, cooperation, and remediation in False Claims Act cases. CCH’s cooperative actions included voluntary document productions, identifying relevant medical records, admissions of noncompliance, and implementing remedial measures.

A copy of the settlement agreement is available here.