According to a recent DOJ Press Release, Cape Cod Hospital (CCH) has reached a $24.3 million False Claims Act settlement. The settlement relates to the submission of improper claims to Medicare for transcatheter aortic valve replacement (TAVR) procedures.
Cape Cod Hospital Did Not Follow CMS Requirements for TAVR Procedures
According to the government, in 2015, CCH began performing TAVR procedures to treat patients with aortic stenosis. Aortic stenosis is a severe condition that narrows the heart valve, restricting blood flow. TAVR is a minimally invasive procedure that replaces the damaged valve with an artificial one.
Medicare covers TAVR as an alternative to open-heart surgery under certain conditions. To qualify, the following criteria must be met:
- The patient has severe aortic valve stenosis;
- The replacement valve and system are approved by the FDA;
- The patient is under the care of a heart team before and after surgery;
- The heart team and hospital meet certain criteria;
- The heart team and hospital participate in a national registry that tracks the outcome of TAVR patients;
- The procedure is furnished with a complete aortic valve and implantation system that has received FDA premarket approval (PMA);
- Two cardiac surgeons certify that the patient isn’t a candidate for open-heart repair; and,
- A cardiothoracic surgeon and an interventional cardiologist are in the operating room during the procedure.
However, from November 1, 2015, to December 31, 2022, CCH allegedly submitted numerous claims to Medicare for TAVR procedures that did not meet these requirements. In some cases, the evaluations were conducted by an insufficient number of physicians. In others, the physicians failed to document and share their clinical assessments properly.
Medicare permitted coverage for this newly developed cardiac procedure only under certain conditions to ensure patient safety. Cape Cod Hospital ignored those rules and received millions of dollars from Medicare to which it was not entitled. This conduct persisted for years despite internal warnings. This investigation and settlement ensures that patient safety is prioritized over a hospital’s bottom line.
-Remarks by Acting U.S. Attorney Joshua S. Levy for the District of Massachusetts.
Cape Cod’s Misconduct Revealed by a Whistleblower
CCH’s misconduct was initially brought to light by a former physician at CCH under the qui tam provision of the False Claims Act. The qui tam provisions allow private individuals to file actions on behalf of the United States and share in any financial recovery. In this case, the whistleblower will receive approximately $4.36 million.
Cape Cod Hospital Settlement Includes a Corporate Integrity Agreement
As part of the settlement, CCH signed a five-year corporate integrity agreement with the Department of Health and Human Services, Office of Inspector General (HHS-OIG). The agreement includes an annual review of the hospital’s Medicare claims by an Independent Review Organization to ensure compliance with Medicare rules.
CCH received some leniency in the settlement due to its proactive measures. Specifically, CCH voluntarily disclosed the non-compliance issues, cooperated with the investigation, and took steps to remedy the situation. These actions included producing relevant materials, identifying pertinent medical records, acknowledging its failure to meet Medicare requirements, and implementing corrective measures.
We Help Whistleblowers Expose Fraud
The Whistleblower Law Collaborative LLC, based in Boston, devotes its practice entirely to representing clients nationwide in bringing actions under the federal and state False Claims Acts and other whistleblower programs. Among the firm’s many successes is the government’s $217 million settlement with WellCare Health for upcoding in the Medicare Part C program, among other allegations. If you are aware of healthcare fraud, we urge you to contact us for a free, confidential, consultation.
