On May 9, 2014, the Office of Inspector General (OIG) of the Department of Human Services (HHS) published a proposed rule that would significantly expand the exclusion regulations applicable to persons or entities that receive, directly or indirectly, funds from federal health care programs. The Affordable Care Act (ACA) expanded the OIG’s authority for exclusion and authorized the use of testimonial subpoenas in investigations of exclusion cases. In this proposed rule, the OIG incorporates these statutory changes, revises the definitions applicable to exclusions, proposes early reinstatement procedures, and offers a number of proposed policy changes as to when and how exclusions may take place. Comments on the proposed rule are due July 8, 2014. 

Separately, on May 12, the OIG published a proposed rule that would implement the ACA’s expanded civil monetary penalty (CMP) authorities, including penalties for: failure to grant OIG timely access to records; ordering or prescribing while excluded; making false statements, omissions, or misrepresentations in an enrollment application; failure to report and return an overpayment; and making or using a false record or statement that is material to a false or fraudulent claim. The proposed rule addresses when and how these CMPs are applied, the methodology for calculating the penalties, and the liability guidelines under other OIG authorities. Comments will be accepted until July 11, 2014. Reed Smith is preparing Client Alerts regarding both rules, which will be available shortly.