By: Christopher A. Parrella, Esq., CPC, CHC, CPCOc
Parrella Health Law, Boston, Ma.
A Health Law Defense and Compliance Firm

Cape Cod Hospital in Hyannis, Massachusetts, has agreed to a $24.3 million settlement to resolve allegations that it submitted false claims to Medicare for transcatheter aortic valve replacement (TAVR) procedures. This settlement addresses claims that the hospital did not comply with specific Medicare rules for evaluating patient suitability for TAVR procedures. Background on the Case
In 2015, Cape Cod Hospital began offering TAVR procedures, a treatment for aortic stenosis that involves replacing a damaged heart valve with an artificial one. Medicare’s rules required hospitals to have specific clinical personnel independently examine prospective patients, document their rationale, and share it with the medical team performing the procedure. However, from November 1, 2015, through December 31, 2022, Cape Cod Hospital allegedly failed to comply with these requirements, resulting in hundreds of improper claims to Medicare.

Violations and Settlement
The hospital’s non-compliance included instances where not enough physicians examined a patient’s suitability for TAVR, or where the physicians failed to document and share their clinical judgment appropriately. The settlement resolves these allegations, ensuring that patient safety is prioritized over financial gains.

Government’s Response
Principal Deputy Assistant Attorney General Brian M. Boynton emphasized the importance of compliance with Medicare rules. Acting U.S. Attorney Joshua S. Levy for the District of Massachusetts highlighted that Cape Cod Hospital’s disregard for these rules led to improper Medicare payments, and the settlement underscores the importance of adhering to patient safety standards.

Corporate Integrity Agreement
As part of 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). This agreement includes an annual review of the hospital’s paid Medicare claims by an Independent Review Organization, ensuring ongoing compliance and integrity.

Whistleblower Involvement
The claims were brought to light by Dr. Richard Zelman, a former physician at Cape Cod Hospital, under the qui tam provisions of the False Claims Act. As a result of the settlement, Dr. Zelman will receive approximately $4.36 million for his role in the case.

Conclusion
This settlement is a result of coordinated efforts between the Justice Department’s Civil Division, the U.S. Attorney’s Office for the District of Massachusetts, HHS-OIG, and the FBI. It highlights the importance of compliance with Medicare regulations and the significant consequences of failing to meet these standards.

If you have any questions or need assistance with False Claims Act issues or compliance with the issues which led to this Qui Tam settlement, please contact Parrella Health Law at 857.328.0382 or email me directly at cparrella@parrellahealthlaw.com. We’re here to help you navigate these complex legal and compliance issues and ensure your compliance with applicable healthcare rules and regulations.

Christopher Parrella, ESQ, CPC, CHC, CPCO, is the founding partner of Parrella Health Law in Boston, Mass. The firm focuses exclusively on healthcare defense and compliance matters. Chris also travels the country on behalf of a wide range of healthcare organizations, lecturing on a variety of health care enforcement and compliance topics. Chris is one of a handful of health care attorney’s that are also Certified Professional Coders (CPC) and is a member of the AAPC’s National Legal Advisory Board and Ethics Committee.  He is also a Certified Professional Compliance Officer (CPCO) and Certified in Health Care Compliance (CHC.)