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Compliance Programs

Background

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 guidance

  • 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 Compliance Program

  • 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 requirements.

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:

  1. 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.

  2. 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 Director, etc.

  3. Allocate sufficient resources and authority to individual(s) overseeing the program to reasonably assure compliance with standards, policies and procedures.

  4. Exercise due diligence to ensure individual(s) overseeing the program do not have the propensity to engage in illegal behavior.

  5. Act to effectively communicate the program standards, policies and procedures to staff, contractors and volunteers.

  6. Take reasonable steps to achieve compliance with the program’s standards, policies and procedures.

  7. 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.

  8. 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:

  1. Conduct annual and mandatory program training as explained in 42 CFR 483.95(f).

  2. 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.

  3. Designate a compliance liaison at each of the organization’s centers.
Disclaimers

The Compliance Manual and 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 requirements.

AHCA resources are not intended as legal advice and should not be used as or relied upon as legal advice. It is for general informational purposes only and should not substitute for legal advice. Always seek knowledgeable counsel for advice that is tailored to the actual facts and circumstances and takes into account all relevant law and regulation.

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