On January 6, 2022, OIG issued a final rule (Final Rule) that will update the process and procedures that govern advisory opinions in early 2022. The Final Rule will be effective 30 days after its publication in the Federal Register (which is pending).

Historically, OIG has taken the position that it will not issue an advisory opinion when a similar or identical action or question is under investigation, or is the subject of a proceeding involving HHS, DOJ, or another governmental agency. This restriction was put in place to prevent OIG’s review from interfering with the investigatory or prosecutorial authority of other governmental agencies.

The Final Rule removes this restriction and expands OIG’s authority to review this type of conduct. OIG has determined that removing this restriction would allow it more flexibility in considering and issuing opinions while increasing transparency. The Final Rule mentions that the previous restriction prevented industry stakeholders from understanding how their conduct would be evaluated specifically under federal fraud and abuse authorities as other governmental agencies were not reviewing their conduct under this standard.

OIG also indicated that: (a) the existence of an active government investigation or other proceeding with respect to certain conduct could indicate that the conduct runs afoul of the federal anti-kickback statute or OIG’s administrative enforcement authorities and therefore subject to sanctions; and (b) conduct that is similar or identical to conduct that is otherwise under the review of the federal government may call for enforcement actions or sanctions.
The OIG’s Final Rule can be found here.

The Policy Statement can be found here.