Section 1128 of the Social Security Act (42 U.S.C. 1320a–7) (available here) established mandatory and permissive authority for exclusion of health care providers from federal health care programs based on provider conduct.  In April 2016, the Office of Inspector General of the Department of Health and Human Services (“OIG”) issued an updated list of non-binding criteria for evaluation of provider exclusion under the permissive exclusion authority (the “Exclusion Guidance”).   The new Exclusion Guidance is available here.  The Exclusion Guidance (i) establishes a presumption of exclusion for any provider who defrauds a federal health care program, (ii) contemplates that the presumption may be rebutted, and (iii) sets forth a list of criteria to be used by the OIG in making a determination whether to seek exclusion.

In applying the Exclusion Guidance, the OIG assesses whether the entity presents a future risk to a federal health care program  One of the considerations is an evaluation of the provider’s history of compliance.  Lack of a preexisting compliance plan that incorporating the U.S. Sentencing Commission Guidelines Manual’s seven elements of an effective compliance program (available here)  indicates that a provider presents a higher risk to the federal health care program supporting exclusion.  On the other hand, if the provider has a history of “significant self-disclosures made appropriately and in good faith,” the provider presents a lower risk.  The fact that the provider has a preexisting compliance plan alone (in the absence of a history of self-disclosures) does not impact the risk assessment.

Health care providers are subject to a broad range of laws and regulations requiring the development of internal policies and plans to ensure training, ongoing compliance and appropriate response to suspected violations. Parker Poe’s attorneys understand the complex requirements of these laws and regulations and work closely with our health care clients to conduct a risk assessment to identify the appropriate scope of compliance plans, to design and implement those plans, to design training for staff, and to develop procedures to monitor for compliance. When suspected violations of the compliance plan are identified, we work with clients to appropriately investigate and address any non-compliant activity.