The Office of Inspector General (OIG) of the Department of Health and Human Services identifies the underlying purpose of its exclusion authority as to protect federal health care programs and their beneficiaries from "untrustworthy health care providers, i.e., individuals and entities who pose a risk to program beneficiaries or the integrity of these programs." The OIG now has published a new proposed rule that would greatly expand the bases upon which it could affirmatively exclude an individual or entity from participation in federal health care programs.
Reed Smith has prepared a Client Alert that provides an overview of the Proposed Rule, including: proposed revisions to definitions; new grounds for exclusion; clarifications to existing regulations to add mitigating and aggravating factors; early reinstatement procedures; and proposed procedural changes in the OIG's exclusion authorities.… Continue Reading
On December 13, 2010, the United States District Court for the District of Columbia affirmed the decision of Kathleen Sebelius, Secretary of the Department of Health and Human Services (the "Secretary") excluding three former pharmaceutical executives for twelve years from participation in Medicare, Medicaid, and all other federal health care programs. The exclusion - the latest weapon in governmental assaults on pharmaceutical company wrongdoing - was imposed by the Office of Inspector General of the Department of Health and Human Services ("OIG"). The executives, who included the company's former general counsel, were excluded notwithstanding the fact that they asserted no knowledge of the misbranding conduct for which their former employer, Purdue Frederick Company ("Purdue"), previously settled with the government.
The decision illustrates the government's enhanced focus on individual liability and punishment in the context of fraud and abuse by health care entities, and it represents a significant development in enforcement activity in this area.… Continue Reading
On October 20, 2010, the Office of Inspector General (OIG) of the Department of Health and Human Services issued significant new guidance for implementing its permissive exclusion authority under section 1128(b)(15) of the Social Security Act. Section 1128(b)(15) specifically authorizes the OIG to exclude an owner, officer or managing employee of a sanctioned entity, i.e., health care provider, supplier, or manufacturer, from participation in federal health care programs. The OIG's new guidance sets out non-binding factors that the OIG intends to consider in deciding whether to impose exclusion on owners, officers and managing employees.… Continue Reading