Beginning in 2015, Cape Cod Hospital began offering TAVR procedures for patients suffering from aortic stenosis, a serious heart condition that restricts blood flow from the heart to rest of the body. A TAVR procedure involves replacing a patient’s damaged heart valve with an artificial one. Medicare rules at the time required that, prior to performing a TAVR procedure, hospitals engage specified clinical personnel to conduct an independent examination of prospective patients to evaluate their suitability for TAVR, document the rationale for their clinical judgment and make the rationale available to the medical team performing the TAVR procedure.
The settlement resolves allegations that from Nov. 1, 2015, through Dec. 31, 2022, Cape Cod Hospital knowingly submitted hundreds of claims to Medicare for TAVR procedures that did not comply with the applicable Medicare requirements. In some instances, not enough physicians examined a patient’s suitability for the procedure, while in other instances the physicians failed to document and share their clinical judgment with the medical team responsible for the TAVR procedure.
In connection with the settlement, Cape Cod Hospital has entered into a five-year corporate integrity agreement with the Department of Health and Human Services, Office of Inspector General (HHS-OIG), which provides for an annual review of its paid Medicare claims by an Independent Review Organization.
Cape Cod Hospital received credit under the department’s guidelines for taking disclosure, cooperation and remediation into account in False Claims Act cases. Among other actions, Cape Cod Hospital 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 claims resolved by the resolution include claims that were brought under the qui tam or whistleblower provisions of the False Claims Act by Richard Zelman, a physician formerly employed by Cape Cod Hospital. Under the Act, a private party can file an action on behalf of the United States and receive a portion of any recovery. The qui tam case is captioned United States ex rel. Zelman v. Cape Cod Hospital, No. 1:22-cv-11204 (D. Mass.). As part of this resolution, Dr. Zelman will receive approximately $4.36 million.