On November 6, the Department of Health and Human Services
Office of Inspector General (OIG) released a “General Compliance Program Guidance”
(GCPG). This GCPG draws from numerous existing sources of OIG
guidance and reiterates key OIG positions found in the 2003
Compliance Program Guidance for Pharmaceutical Manufacturers, the
original four 1998 Compliance Program Guidelines
(CPGs),1 various special fraud alerts, and
other guidance documents. The publication follows OIG’s April
2023 announcement for plans to improve and update
compliance program guidance more generally.2 As
with other OIG guidance documents, while the recommendations in the
GCPG are a valuable source of insight into the agency’s current
enforcement approach, they are not legally binding on the various
industries within the scope of OIG’s jurisdiction. Much of the
content is not new, but there are a few areas worth noting for
legal and compliance professionals in the health care and life
sciences industries. We have outlined these below. Otherwise,
OIG’s guidance continues to parallel — and emphasize the
importance of — the seven elements of an effective compliance
program,3 as outlined in the Federal…
