Hospital Pays $24.39M To Settle FCA Case Over TAVR Procedures

Cape Cod Hospital in Hyannis, Massachusetts, has agreed to pay $24.39 million to settle false claims allegations over claims for transcatheter aortic valve replacement (TAVR) procedures that didn’t comply with Medicare’s national coverage determination (NCD), the U.S. Attorney’s Office for the District of Massachusetts said May 16.[1] Although the hospital had refunded overpayments for four noncompliant procedures, there were hundreds more, according to the settlement.[2]

In resolving the allegations, the hospital got cooperation credit because it “voluntarily produced materials, identified the relevant medical records, admitted that it failed to adhere to the applicable Medicare requirements and implemented appropriate remedial measures,” the U.S. attorney’s office said. As part of the settlement, the hospital entered into a five-year corporate integrity agreement with the HHS Office of Inspector General.

The case was set in motion by a whistleblower, Richard B. Zelman, M.D., an interventional cardiologist who was employed by Cape Cod Hospital. The U.S. Department of Justice (DOJ) intervened in the complaint “in part for the purpose of settlement.”

According to the settlement, Cape Cod Hospital accepted responsibility for certain facts. In 2015, the hospital started offering TAVR procedures to treat aortic stenosis, which is the narrowing of the aortic valve and subsequent restriction of blood flow from the heart to the rest of the body. TAVR involves replacing the patient’s damaged valve with an artificial one.

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