As part of the Requirements
of Participation (RoP) published October 2016, nursing centers must
have a Compliance and Ethics Program that meets certain requirements. Starting
November 28, 2019, CMS and state survey agencies will be authorized to issue
survey deficiencies under federal Ftag F895 to facilities that do not have an
effective Compliance Program.
CMS has not yet issued guidance about how F895 will be
interpreted, but AHCA encourages nursing centers to review the requirements at 42
CFR § 483.85 and begin making changes to comply.
AHCA Provider Member Resources
- AHCA Member Toolkit (2018) – for nursing centers to develop and/or revise their Compliance Program
to meet the requirements effective November 2019. Provides an overview of the
components of a Compliance and Ethics program mandated by the RoPs.
- OIG Compliance Guidance for Nursing Facilities (2000) – OIG’s initial voluntary compliance
- OIG Supplemental Guidance for Nursing
Facilities (2008) – OIG’s
supplemental voluntary guidance documents for nursing centers to understand
what federal auditors and surveyors are looking for to demonstrate an effective
- Designing and Implementing a Corporate Compliance
Manual (2013) – provides in depth background on
creating a Compliance Program including checklists and sample language. Note:
This Manual is based on the OIG’s guidance from 2000 and 2008 (linked above)
and was developed prior to the issuance of the RoPs in 2016. The Compliance and
Ethics requirements in the RoPs were informed by the earlier OIG guidance;
however, nursing centers should adapt as needed to ensure compliance with
current federal and state requirements.
- Sample Policies and Procedures for Risk Management (2013)
- Note: The Sample Policies and Procedures were
developed prior to the final Requirements of Participation. Nursing centers
should adapt as needed to ensure compliance with current federal and state
Summary of the
Compliance and Ethics Program Requirements
Nursing centers should consult 42 CFR § 483.85
to review the full requirements. CMS describes minimum requirements for a
Compliance Program, briefly summarized as:
- Establish written standards, policies and
procedures likely to be effective to reduce the prospect of criminal, civil and
administrative violations and promote quality of care.
- Assign high level individual(s) to oversee the
program standards, policies and procedures. These high level individual(s) may
include, for example, the Chief Executive Officer, Board Member, Division
- Allocate 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
- 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 procedures.
- 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 the program.
Organizations with five or more nursing centers must
implement three 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 or chief operating officer.
- Designate a compliance liaison at each of the