By Miles Indest, J.D./M.B.A candidate at Tulane University: Law Clerk, The Health Law Firm

On April 20, 2016, the U.S. Department of Health and Human Services Office of Inspector General (OIG) released updated non-binding criteria that disclosed when a company or individual can be barred from participating in Medicare, Medicaid, and other federal health care programs.

The OIG has permissive authority to exclude a person or company from participation in federal health care programs for engaging in certain prohibited conduct, such as false claims or kickbacks. The OIG has consistently asserted that there is a presumption in favor of exclusion. The new guidance updates the OIG’s position by stating that its presumption in favor of exclusion is rebuttable in certain situations. Importantly, the OIG guidance outlines those situations and the risk factors that trigger an exercise of its permissive authority.

Four Factors May Affect OIG’s Decision to Exclude an Individual or Entity.

In its release, the OIG outlined four non-binding factors that signal a compliance risk and can affect its decision to pursue an exclusion: (1) the nature and circumstances of the prohibited conduct; (2) the conduct during the Government’s investigation; (3) any significant ameliorative efforts; and (4) the history of compliance.

First, the OIG will evaluate the nature and circumstances of the bad actor’s conduct. For instance, conduct that causes physical, mental, or financial harm to others increases compliance risk, thereby increasing the likelihood that the OIG will pursue an exclusion. Similar to the Department of Justice’s heightened focus on individual accountability, the OIG stressed that it will scrutinize an individual’s role in planning or leading unlawful conduct, which increases compliance risk.

Second, the OIG will assess the bad actor’s conduct during the Government’s investigation. If that person obstructed or impeded the investigation of the unlawful conduct, then the OIG will be more likely to pursue an exclusion. Notably, the OIG stated that a prompt response to a subpoena is “expected” and will not favorably affect the risk assessment.

Third, the OIG will weigh the bad actor’s ameliorative or remedial steps taken after the prohibited conduct occurred. For example, an entity that takes disciplinary action against individuals responsible or the conduct will lower its compliance risk. Similarly, individuals that receive new training or retain a mentor to improve their health care practice will face a lower risk of exclusion.

Finally, the OIG will focus on the bad actor’s history of compliance with the OIG. Importantly, the existence of a compliance program will not affect the risk assessment— likely another “expected” requirement of health care organizations. In contrast, the absence of a compliance program will increase compliance risk and the likelihood that the OIG will pursue an exclusion.

The OIG update ultimately reflects the government’s increased expectations of compliance programs and heightened scrutiny of individual wrongdoing. As federal agencies continue to prioritize the prosecution of fraud and abuse, health care organizations and practitioners would be wise to proactively address these concerns internally.

Contact Health Law Attorneys Experienced in Defending Against Action to Exclude an Individual or Business from the Medicare Program and Assisting in Reinstatement Applications.

The attorneys of The Health Law Firm have experience in dealing with the Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS), and defending against action to exclude an individual or business entity from the Medicare Program, in administrative hearings on this type of action, in submitting applications requesting reinstatement to the Medicare Program after exclusion, and removal from the List of Excluded Individuals and Entities (LEIE).

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at

About the Author: Miles Indest, J.D./M.B.A. candidate, will graduate in May 2016 from Tulane University Law School and the Freeman School of Business. He has served three years as a member of Tulane Law Review, and currently serves as the Writing Skills Chair of Tulane Moot Court.


“Criteria for Implementing Section 1128(b)(7) Exclusion Authority.” U.S. Department of Health and Human Services Office of Inspector General. (2016). Web.

Dani Kass. “HHS Watchdog Lays Out New Grounds For Exclusion List.” Law360. (2016). Web.

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