Limitations on the use of the False Claims Act to enforce quality of care standards.

The False Claims Act (FCA) is established as the federal government's prosecutorial weapon of choice in combating fraud and abuse in healthcare today. The FCA's substantial penalties present potential defendants with daunting risks should they elect to put the government's case to the test at trial. The government and relators have sought to extend the contours of the FCA's coverage beyond actions involving "factually false" claims to pursue cases involving alleged violations of other laws that give rise to "legally false" claims. This article considers the viability of the legal bases upon which the FCA may be used in this regard, with specific attention to the appropriateness of implied and express false certification liability theories to punish violations of the Medicare Conditions of Participation. It is the thesis of this article that on both sound legal and policy grounds, the FCA is not an appropriate tool for punishing the failure to provide quality care, unless the quality of care provided is so substandard as to result in a factually false claim (e.g., the services billed were not actually rendered).

The hospital board at risk and the need to restructure the relationship with the medical staff: bylaws, peer review and related solutions.

This article argues that the current structure of the hospital governing board and medical staff relationship does not support and promote quality and patient-centered care. The fundamental flaw in the current structure is the interdependent, yet independent and discordant relationships between hospital governing boards and medical staffs. These relationships are described as cultures and fit into three types of "silos": organizational (the "structural silo"); professional (the "professional silo", including the "culture of blame"); and the fragmented quality information silo (the "informational silo"). While case law, statutory requirements and regulatory expectations clearly state that governing boards are ultimately responsible for quality of patient care, governing boards delegate these functions to medical staff without having sufficient information to measure and monitor quality. As a result, problems manifest because of these failures of oversight and compliance. Dramatic lapses in quality occur due to overuse, underuse, and misuse of healthcare services. Furthermore, the challenges and opportunities from improved quality and patient safety, as a strategic business driver, cannot be seized until the underlying structural flaws are understood and addressed. This article proposes that solutions become apparent when the various health care constituencies are educated about these cultural impacts and when multidisciplinary bodies, with board leadership and direct authority, integrate and consider quality information.