the 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. CMS, however, did not finalize a compliance and ethics program
regulation until October 4, 2016, and it will not enforce that requirement
until November 28, 2019. Although, CMS has not yet begun enforcement, AHCA
recommends that NF providers (if they haven’t already) begin the process of
designing and implementing an effective compliance and ethics program moving
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).