Affordable Care Act (ACA), §6102, nursing facility (NF)
providers are required to design and implement a compliance and
ethics program (e.g., a written and operational program specifying an
organization’s policies, procedures and actions to help prevent
and detect violations of federal and state laws and regulations
including detecting and preventing any allegations of fraud and abuse),
by March 23, 2013.
On October 4, 2016, CMS finalized a compliance and ethics program as part of the
Requirements of Participation regulations (42 C.F.R. § 483.85), and will begin enforcement November 28, 2019. At that time, nursing
centers must have a Compliance and Ethics Program that meet the
standards outlined in the rule. Creating
an effective program requires advanced planning to have in place the
appropriate staff, training, and policies and procedures. AHCA members
this toolkit to review a summary of the requirements with helpful, practical tips for implementation.
the CMS regulation, 42 CFR 483.85, NFs must develop,
implement and maintain a compliance and ethics program that has the following 8
- Establish written
standards, policies and procedures “likely to be effective” to reduce the
prospect of criminal, civil and administrative violations and promote quality
- Assign “high
level” individual[s] (e.g., Chief
Executive Officer (CEO), Board Member, Division Director, etc.) to oversee the
program standards, policies and procedures.
sufficient resources and authority to individual(s) overseeing the program to
“reasonably assure compliance” with standards, policies and procedures.
- Exercise “due
diligence” to ensure individual(s) overseeing the program do not have the
“propensity” to engage in illegal behavior.
- Act to
“effectively” communicate the program standards, policies and procedures to
staff, contractors and volunteers.
- Take “reasonable
steps” to achieve compliance with the program’s standards, policies and
- Apply consistent
enforcement of the program standards, policies and procedures through
appropriate disciplinary mechanisms including as appropriate, discipline for
individual(s) failure to detect and report a violation to the program contact.
- Ensure all
“reasonable steps” are taken to “respond appropriately” to a violation and to
“prevent further similar violations” including any necessary modification to
Organizations with 5+ NFs must
implement 3 additional requirements:
- Conduct annual
and mandatory program training as explained in 42 CFR 483.95(f).
- Designate a
compliance officer whose “major responsibility” is to oversee the program, and
who reports to the “governing body.” Note: The compliance officer cannot
be “subordinate to the general counsel, chief financial officer [CFO] or chief
operating officer [COO].”
- Designate a
compliance liaison at each of the organization’s centers.
a more detailed explanation of these elements, see AHCA’s Action Brief. For additional background information, see HHS, Office of Inspector General
(OIG) Compliance Guidance for
NFs (released in 2000) and OIG’s Supplemental
Compliance Program Guidance for NFs (released in 2008).