Compliance

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The United States District Court for the Eastern District of Michigan recently dismissed a False Claims Act (“FCA”) lawsuit brought against the City of Detroit.  The core issue in United States ex rel. Lynn v. City of Detroit revolved around Detroit’s annual certifications and assurances to comply with federal laws and regulations as a condition…

In a pivotal ruling that may reshape the landscape of False Claims Act (“FCA”) litigation, the United States Court of Appeals for the Second Circuit adopted a nuanced interpretation of “willfulness” under the federal Anti-Kickback Statute (“AKS”).Continue Reading Significant Implications for FCA Defendants: Second Circuit Clarifies “Willfulness” in McKesson Decision

The Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) published the General Compliance Program Guidance (GCPG) on November 6, 2023. The GCPG provides updated descriptions of the seven elements of an effective compliance program that health care entities have long relied upon. The new guidance also includes…

The role of a health care entity’s governing board in the implementation and oversight of a compliance program is not always clear. Although board members are not often directly involved in care delivery, the Department of Health and Human Services’ Office of the Inspector General (OIG) views the governing board as integral to setting the tone for an organization’s compliance and oversight culture. To help the organizational leadership of health care entities understand how to oversee these compliance functions, the OIG, in collaboration with the Association of Healthcare Internal Auditors (AHIA), the American Health Lawyers Association (AHLA), and the Health Care Compliance Association (HCCA), has now published “Practical Guidance for Health Care Governing Boards on Compliance Oversight” (the “Guidance”).

The Guidance was developed through a landmark collaboration between government and private organizations representing key professionals in the health care compliance and integrity industry. First, the Guidance provides helpful distinctions between five essential functions that a robust compliance program should incorporate.

  • Compliance: to promote the “prevention, detection, and resolution” of identified issues that present risk under applicable laws, regulations, policies, or business standards.
  • Legal: to provide advice to the organization to address legal risks and help determine appropriate responses to potential and actual violations.
  • Internal Audit: to objectively assess “risk and internal control systems” (often data-based) used to evaluate the organization’s vulnerabilities and facilitate easy detection of compliance issues.
  • Human Resources: to manage “the recruiting, screening, and hiring of employees” who ultimately would have compliance-related responsibilities.
  • Quality Improvement: to review the clinical processes of the organization in view of patient needs, safety, and efficiency.

Then, the remainder of the 19-page Guidance includes references to other OIG publications, regulatory commentary, and external resources on board governance, compliance responsibilities, and fiduciary obligations. The overall substance of the Guidance provides educational information on the role of health care governing boards in compliance oversight, including the following takeaways:Continue Reading OIG Teams Up With Private Sector to Provide Guidance to Health Care Governing Boards