Compliance Developments

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. Continue Reading OIG Work Plan: A Roadmap to Identify Health Care Compliance Risk

“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 exclusion authority under Section 1128(b)(7) of the Social Security Act. Starting from the premise that everyone in health care has a compliance program, and if you do not you pose a higher risk, is an evolution from OIG’s original guidance published in 1997 that reflects the evolution of the health care industry. In 1997, OIG was attempting to encourage wide adoption of compliance programs. It used this guidance to advance that objective by giving a certain amount of credit to defendants settling False Claims Act (FCA) cases who had implemented a compliance program that followed the seven elements of the U.S. Sentencing Guidelines.

Almost 20 years later, OIG has largely achieved its original goal—virtually every health care provider and supplier has adopted some form of compliance program that, among other things, contains the seven elements and addresses federal health care program compliance. Now OIG is completing its pivot to its next goal that began with the 2008 Open Letter and 2013 updated Self-Disclosure Protocol—moving from encouraging the creation of compliance programs to operating effective compliance programs. Continue reading.

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. Continue Reading OIG Issues New Exclusion and CIA Guidance

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. Continue Reading OIG’s 2016 Work Plan: Mixed Results for 2015 and New Data Mining and Policy Efforts in 2016

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 these new initiatives, however, absolute clarity on executive-level leadership is necessary in order to ensure an effective and coordinated organizational response. The governing board, with its obligations for legal compliance oversight, will in most instances conclude that the general counsel is best qualified to lead that response.

Read the full article in Corporate Counsel.

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 These Guidelines reflect a substantially increased focus on individual accountability for corporate wrongdoing, both civil and criminal, and on the importance of corporate cooperation in the context of governmental investigations. It is not a “rifle shot” enforcement initiative focused solely on Wall Street or the broader financial sector. Rather, it is intended to apply across industry sectors (including, health care) (See (note reference to health care). The Guidelines can reasonably be expected to impact an organization’s approach to legal compliance, internal investigations, D&O insurance and indemnification protection, and interaction with management on matters of regulatory concern. They should, therefore, be taken seriously by senior leadership of health care companies.

Read the full article from AHLA Weekly.

Fighting corporate fraud and other misconduct is a top priority of the Department of Justice. Our nation’s economy depends on effective enforcement of the civil and criminal laws that protect our financial system and, by extension, all our citizens. These are principles that the Department lives and breathes- as evidenced by the many attorneys, agents, and support staff who have worked tirelessly on corporate investigations, particularly in the aftermath of the financial crisis.

Read the memo from the US Department of Justice Office of the Deputy Attorney General.