Tag:

compliance program

Google Becomes the First to Agree to Compliance Monitoring by the DOJ

In an action to keep company executives in check, the Justice Department (DOJ), created a policy where executives and compliance chiefs sign and personally attest to the effectiveness of their compliance programs. The individuals would therefore be held personally liable for their roles in the company’s wrongdoing. The DOJ and Google had a pending dispute, which was due to Google’s non-compliance with assisting authorities in an investigation. The DOJ and Google reached an agreement, with a stipulation attached, resolving the dispute over Google’s loss of data responsive to a 2016 search warrant. In the stipulation, Google has said that it has spent over 90 million dollars on additional systems and resources to improve its compliance programs, including an agreement to allow an Independent Compliance Professional to serve as a third party to monitor that Google is fulfilling its compliance legal obligations. This policy, as already seen in the settlement with Google, is forcing compliance to become a top-tier concern for big companies or face serious consequences.

Averting Disaster: Building Regulations in the Wake of Hurricane Irma

After Hurricane Irma’s dissipation on September 15, 2017, the residents of Florida can now begin to assess the damage caused by the strongest hurricane making landfall since Katrina in 2005. According to early estimates, Irma has caused over 62 billion dollars in damage. However, amongst the destruction there is a silver lining; the damage caused was significantly limited by building regulations that went into effect in 2002. Homes and buildings that would have otherwise been destroyed by Hurricane Irma were able to survive, and suffered only minor damage.

Doing the Right Thing: Labor Force Compliance

Corporate compliance professionals will often define compliance as “doing the right thing.” Indeed, both compliance professionals and scholars agree that ethics are an important aspect of effective compliance programs. This is particularly true when it comes to compliance with forced labor regulations. Using forced labor can be appealing to companies seeking to reduce their operating costs and increase profits. However, in the face of a toxic business culture that values maximizing profits, compliance professionals must convince their colleagues that forced labor is not worth the savings in operating costs.

Theranos: New Compliance Program Hopes to Save the Company

Gilbert Carrillo Executive Editor Loyola University Chicago School of Law, JD 2017 Edmund Tyrrell Associate Editor Loyola University Chicago School of Law, JD 2018   Theranos, the American health-tech and medical-lab-services company, recently hired two executives to oversee regulatory compliance standards. The executives were hired following Theranos receiving multiple sanctions from U.S. regulators about the …
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A New Role for Compliance Programs in HHS-OIG Resolutions of Non-compliant Conduct

Ryan Meade Editor-in-Chief Director of Regulatory Compliance Studies at Loyola University Chicago School of Law   A recent commentary from the U.S. Department of Health & Human Services’ Office of Inspector General (HHS-OIG) indicates it will not consider the existence of an effective compliance program as a positive factor in resolving civil non-compliance but it …
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The Need for a Modified Upjohn: Internal Investigations and When to Warn

Compliance programs rely heavily on internal investigations. Yet unlike their counterparts in the in-house counsel’s office, compliance professionals rarely give notice when they are conducting such investigations. Whether compliance professionals have duty to notify individual directors, officers and employees of an internal investigation remains unclear. This lack of clarity leads to confusion with employees and officers regarding the limits of confidentiality, and the compliance officer’s duty of loyalty. A robust ethics and compliance program should therefore take a proactive stance and integrate Upjohn warnings—a standard of corporate counsel, but modified to fit the compliance function—into the internal investigation process.

CMS Modernizing the Physician Self-Referral and Anti-Kickback Regulations

On October 9, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to modernize and clarify the regulations that interpret the Medicare physician self-referral law (often called the “Stark Law”), which has not been significantly updated since it was enacted in 1989. As CMS tries to reconstruct the healthcare field, it is imperative for compliance programs to prepare for the changes in regulations to come. The following discussion provides a brief overview of the proposed changes but is not an exhaustive list of all rulemakings related to the physician self-referral law.

CMS Issues New Rule to Tighten Provider Enrollment

On September 5, 2019, the Centers for Medicare and Medicaid Services (“CMS”) released its final rule with comments on Program Integrity Enhancements to the Provider Enrollment Process (“ The Program Integrity Enhancements”).  The final rule gives CMS the power to revoke Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) enrollments of providers or suppliers who have an “affiliation” with previously sanctioned entities, even if those providers and suppliers aren’t directly violating any existing rules themselves. CMS says that this new authority will help to “stop fraud before it happens.”

CMS Launched Pilot Project to Offer Individual Market Wellness Programs

Workplace wellness programs — efforts to get workers to lose weight, eat better, stress less and sleep more — are an $8 billion industry in the U.S. Recently, Centers for Medicare and Medicaid Services (CMS) launched a pilot project for states to implement health-contingent wellness programs in the individual market. The project is part of a mandate under the Affordable Care Act that added a provision to the Public Health Service Act calling for health-contingent wellness programs to be tested in the individual market through a pilot project operated by HHS, the Department of Labor and the Treasury Department.

Privacy Lessons Learned from Litigation: The unfair and deceptive practices lawsuit against Zoom

Yet another privacy and data security-related lawsuit has been filed against Zoom Video Communications, Inc. (“Zoom Inc.”). Zoom Inc. has been the subject of several complaints related to its video-conferencing service since its meteoric and spectacular rise in popularity due to the Coronavirus pandemic and related quarantine measures beginning in March 2020. In this particular case, there are compliance lessons to be learned from the unfair and deceptive practices claims alleged against Zoom Inc. in the plaintiff’s D.C. Superior Court filing.