New Compliance and Ethics Program Requirements for Nursing Facilities

April 1, 2021
April 1, 2021

In the November 2017 issue of Compliance Today, the monthly magazine of the Health Care Compliance Association (HCCA), Gina M. Riddell, MPA-CHA, CHC, writes that nursing facility providers are “required to design and implement a compliance and ethics program... effective as of November 28, 2016, but with a three-part implementation process that spans a three year period.” Without such a program in place, nursing facilities will eventually face penalties; Riddell shares that “although nursing facilities [were] required to be in compliance by November 28, 2017, this regulation will not be enforced until November 28, 2019.”

The statute governing this rule, 42 CFR 483.85, “now formally requires nursing facilities to develop, implement, and maintain programs that consist of eight elements (for organizations with less than five facilities) and eleven elements (for organizations with five or more facilities). These elements are:

  1. Written Compliance and Ethics Standards. Riddell shares that this set of standards will set a “baseline for measurement” and behavior and “reduce the prospect of regulatory guidelines and increase the quality of care.” Importantly, they will “also create a reporting system for suspected violations, as well as an alternate system to report violations anonymously.”
  2. Assigned Oversight. Riddle states that “high-level personnel must be assigned to oversee compliance” and that “the idea is that compliance should be enforced from the top, rather than delegated to lower levels of management.”
  3. Allocation of Resources and Authority. The focus here is on allocating “sufficient resources and authority” to ensure “that those responsible can do their jobs effectively.”
  4. Due Care in Delegation of Authority. Compliance authority should only be given to someone whose trustworthiness and impartiality is unquestioned.
  5. Communication of Standards. This element requires that “policies, procedures, and standards must be shared” and suggests that “mandatory training or orientation programs are a must.”
  6. Reasonable Steps to Achieve Compliance. To put the plan into action, organizations need to establish “audits and monitoring systems to root out violations… [and] follow through on reporting.”
  7. Enforcement of Policies. Consistent enforcement is vital, to demonstrate that “everyone in the organization is subject to the same disciplinary measures.” Riddell makes it clear that the goal is to communicate that “compliance is the job of every member of the organization.”
  8. Response to Violation. Riddell offers that organizations need to follow their policies and procedures after detecting a violation, and “take reasonable steps to prevent further violations.”

Riddell also outlines the three additional elements, as mentioned earlier, that are required for organizations that have five or more facilities. These additional elements are:

  1. Mandatory Annual Training. While annual training is a best practice regardless of organization size, it is only mandatory for organizations with five or more facilities. Riddle shares that when you “reinforce the written standards with consistent annual training… there is then very little excuse for compliance failures.”
  2. Designated Compliance Officer. Larger organizations “require a designated compliance officer whose primary responsibility it is to oversee the compliance and ethics program.” Riddell offers that “the reasoning is that the compliance officer must maintain a level of independence, free from interference from those whose job it is to protect the organization itself.”
  3. Designated Compliance Liaison at Each Center. There must be a person on-site to “assist with oversight of the facility and report to the compliance officer.”

Since we have passed the deadline of November 28, 2017, programs that meet these requirements must now be in place. In conclusion, Riddell recommends that “nursing facility organizations not only develop, implement, and revise a compliance and ethics program internally, but seek outside legal review and analysis to confirm compliance with federal requirements.”

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All quotes are taken from:

Riddell, Gina M., “Compliance Programs for Nursing Facility Providers,” Compliance Today, November 2017, (pp. 52-4).