Compliance Developments

In a two-page memorandum, the US Department of Justice (DOJ) announced a broad policy statement prohibiting the use of agency guidance documents as the basis for proving legal violations in civil enforcement actions, including actions brought under the False Claims Act (FCA). The extent to which these policy changes ultimately create relief for health care

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

Each year, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) issues a Work Plan that summarizes new and ongoing OIG reviews and areas of focused attention for the coming year and beyond. The current Fiscal Year (FY) 2016 Work Plan was issued in November 2015 and supplemented by a Mid-Year Update in April 2016. OIG considers work planning a “dynamic process” with adjustments made throughout the year to meet priorities and in response to new issues as necessary. Accordingly, the Work Plan provides health care providers and related entities with a “roadmap” of issues that are currently being addressed or will be addressed in the coming year by OIG. As we look towards OIG’s issuance of the FY 2017 Work Plan in a few months, we are revisiting OIG’s FY 2016 plans, projections, results and mid-year updates that reflect the trajectory of ongoing and future examinations and enforcement priorities.
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“You get no bonus points for having a compliance program.”

– HHS Inspector General Daniel R. Levinson, remarks at the Health Care Compliance Association’s Annual Compliance Institute, April 18, 2016

This statement sums up Mr. Levinson’s announcement of the updated guidance explaining the criteria the Office of Inspector General (OIG) uses for exercising its permissive

On April 18, 2016, Inspector General Daniel R. Levinson announced the publication of updated guidance on how the Office of Inspector General (OIG) makes decisions about using its permissive exclusion authority and requiring integrity obligations when presented with a False Claims Act (FCA) settlement. This document is noteworthy not only to defendants in FCA cases but also to the health care industry in evaluating their compliance program activities.
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The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) annual release of a new Work Plan both summarizes the results achieved last year and highlights new areas for examination in the next. This year’s Work Plan reported rising audit results but declining investigative results, in contrast to previous years.

In examining the new topics added to the Work Plan, two themes emerge. First, many of the new payment audits reflect OIG’s use of data mining to identify providers or suppliers who could potentially be considered “outliers” from the average use of a particular code or procedure. Data mining will also play a significant role in connection with the second theme—a notable increase in OIG’s review of significant, and some controversial, policy issues concerning changes in the country’s health care delivery system, operation of HHS programs and the effectiveness of HHS agency oversight of those changes and programs.
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Several new, highly publicized fraud enforcement initiatives of the U.S. Department of Justice are likely to impact the roles of the general counsel and chief compliance officer. In most organizations, there are elements of overlap in how these officers relate to the compliance program structure and the conduct of internal investigations. In the context of

Health care leaders should closely note the new guidelines on corporate conduct released on September 9, 2015 by the Department of Justice (DOJ) (Memorandum from Sally Quillian Yates, Deputy Attorney General, U.S. Department of Justice, September 9, 2015, Individual Accountability for Corporate Wrongdoing (Guidelines), available at www.justice.gov/dag/file/769036/download). These Guidelines reflect a substantially increased focus