LSHC Horizons Brochure 2024 - Flipbook - Page 94
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | United States
94
OIG’s General Compliance Program Guidance
In November 2023, the U.S. Department of
Health & Human Services Office of Inspector
General (OIG) released its first ever General
Compliance Program Guidance (GCPG). The
GCPG is a high-level amalgamation of OIG’s
existing guidance and applies to all individuals
and entities involved in the U.S. health
care sector.
While much of the information contained in the
GCPG is not new, there are a few key highlights.
• The GCPG provides prescriptive guidance
on compliance program resources and
common functions and activities, such as
policies and procedures, training, annual risk
assessments, and the use of data analytics.
One particularly noteworthy statement in
the GCPG is that OIG recommends including
quality and patient safety considerations
within the compliance function.
• In another noteworthy statement, the GCPG
speaks directly to OIG’s concerns “about the
impact of ownership incentives (e.g., return
on investment) on the delivery of high quality,
efficient health care” and clearly states that
private equity firms and other investors
are responsible for understanding the laws
applicable to the health care industry and
the role of an effective compliance program,
particularly for those investors “that provide
management services or a significant amount
of operational oversight for and control in a
health care entity”.
Eliza L. Andonova
Partner
Washington, D.C.
• The GCPC includes specific recommendations
for the role of the Compliance Officer, the
corporate Compliance Committee, and the
Board. It reemphasizes the OIG’s emphasis
on “tone at the top” and the need for wellinformed, active oversight for an effective
compliance program.
• The GCPG encourages both “sticks”
and “carrots” to encourage compliance.
The “sticks” include well-documented
disciplinary protocols and requiring
compliance program participation (e.g.,
training, absence of discipline) in annual
performance evaluations. The “carrots”
align with the Department of Justice’s
(DOJ’s) 2023 Pilot Program Regarding
Compensation Incentives and Clawbacks by
encouraging the integration of compensation
with compliance.
OIG acknowledges that compliance programs
are not one-size-fits-all, and advises on
adjustments that may be needed for larger
or smaller corporations, as well as the
U.S. subsidiaries of large international
organizations. In addition to reviewing their
compliance program against the GCPG,
companies operating on the U.S. should be on
the lookout for forthcoming industry-sectorspecific compliance guidance from OIG.
Ronald L. Wisor, Jr.
Partner
Washington, D.C.
Laura Hunter
Senior Associate
Washington, D.C.