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The Opioid Crisis: An Emerging False Claims Act Risk Trend

The government’s focus on the US opioid crisis has been consistently expanding over the past year beyond manufacturers to reach prescribers and health care providers who submit claims to federal health care programs for opioid prescriptions. These efforts increasingly include investigations under the False Claims Act and administrative actions, in addition to the more traditional criminal approach to these issues.

With the Trump administration’s public health emergency orders, it is expected for the government’s enforcement activities, including those instigated by relators and their counsel, to grow in this area.

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New Board Compliance Guidance Prompts General Counsel Focus

Health care general counsel should review and brief their internal clients on the new Practical Guidance for Health Care Governing Boards on Compliance Oversight (Guidance), released on April 20, 2015.  A joint effort by the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS), the Association of Healthcare Internal Auditors, the American Health Lawyers Association (AHLA) and the Health Care Compliance Association, the Guidance is a useful and timely resource for both the general counsel and the board.

While the Guidance does not break new ground, it updates and condenses prior publications, addressing such important compliance program considerations as:

(1) The definition of the interrelationship between, and the roles of, the organization’s audit, compliance and legal functions;

(2) Mechanisms for effective and appropriate reporting of compliance issues within an organization;

(3) Methods for identifying regulatory risks; and

(4) Means of encouraging accountability for achievement of compliance goals and objectives throughout the organization.

For a detailed analysis of the Guidance, please read “New Board Compliance Guidance Prompts General Counsel Focus.”

By McDermott’s Health Regulatory Compliance Developments Team: Michael Peregrine, Bernadette Broccolo, Joshua T. Buchman, Tony Maida, Kelsey Leingang and Laura McLane




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