483.85 Conditions of Participation: Compliance and Ethics

For over 20 years, the Office of Inspector General has recommended voluntary compliance programming by implementing the eight elements of an effective program. These include having a compliance officer and a compliance committee, written policies and procedures, effective training, effective communication, auditing and monitoring, a well-publicized disciplinary policy, ensuring a prompt response to suspected offenses and performing risk assessments.
In July 2022, CMS released revisions to Appendix PP of the State Operations Manual (provides guidance to the surveyors regarding the Conditions of Participation and what to survey) for Compliance and Ethics Programming for Medicare and Medicaid certified facilities. These revisions effective Oct 24, 2022, are the first ever guidance for how surveyors should review your compliance and ethics programs, and your ability to meet the Conditions of Participations new requirement 483.85.
The new compliance survey item requires:
1.       All Employees should be aware of your compliance program and how to report any suspected violation.
2.       All employees should know the name of your Compliance Officer or your Compliance Liaisons.
3.       All organizations require a well-documented routine auditing program that can be shown to the surveyors. The documentation should demonstrate that audits detect wrongdoing and that you are action planning to mitigate them. In addition, the surveyors want to ensure that the compliance department is communicating and working with the QAPI process and committee.
4.       All operating organizations with more than five facilities must have annual compliance training for their employees.
5.       All organizations should employ a compliance officer who has sufficient time and resources to fulfill the responsibilities with discretionary authority to implement the program.
6.       All organizations post a notice of Employee Rights to file a complaint with a State Agency which must be the same size as all other employee signage.
The surveyors can interview team members and ask if they are confident that they may report compliance matters without fear of retaliation.
In addition, CMS has eight requirements for the Compliance and Ethics program, which is similar to the OIG, they include:
1.       Written policies and procedures (i.e., reporting, contacts, disciplinary standards)
2.       Designation of a high-level individual to oversee the program
3.       Sufficient resources and authority
4.       Care with delegating discretionary authority
5.       Effective communication
6.       Monitoring and auditing (systems, processes, data integrity)
7.       Consistent enforcement
8.       Response and remediation
For providers with five or more facilities, they must also designate a compliance officer or compliance liaison as well as have annual compliance training for all staff.
Are you ready for the compliance survey?
1.       Do you have an updated P&P Manual that contains policies to reduce compliance violations and prevent civil, criminal, and administrative violations? Have they been recently reviewed? Do you update as necessary?
2.       Do you have a risk management program, and auditing and monitoring?
3.       Has all staff completed a new hire and annual compliance training?
4.       Did you communicate your disciplinary policies to all team members? Can you prove it in a training checklist?
5.       Do you have a system for anonymous reporting for suspected violations? Do you have a hotline/ Do you track hotline calls?
6.       Can you demonstrate that you took reasonable steps in response to a suspected violation? Do you have a written report? Dashboard?
7.       If a staff member is interviewed by a surveyor, can you ensure that they know about your compliance program? Who the compliance officer or liaison is? How to report a suspected violation? That they can say that they can report without fear of retaliation?
The surveyors began surveying this item Oct 2022, so to avoid F tag 895, review your compliance program elements to ensure your program will not be deemed non-compliant. Feel free to reach out to the Enhance Compliance team with any questions or concerns at 732-740-1166 or lblaire@enhancetherapies.com.