Now that the November 2019 deadline for long-term care facilities to implement a compliance and ethics program has passed, organizations are expected to have a fully functioning program in operation that serves to detect criminal, civil and administrative violations and mitigate risk, as well as promote quality care. There are steps every long-term care organization should take to ensure your compliance and ethics program is effective in meeting regulatory guidelines. According to the LTC Final Rule (42 CFR § 483.85), organizations must structure the program around the following:
- Define the compliance team
- Develop a program that follows best practice
- Audit the program to identify potential gaps
Due to industry wide backlash, CMS made updates to the final rule that removes previous requirements for organizations of five or more facilities to have a designated compliance officer, facility compliance liaisons, and mandatory annual training. In addition, they reduced the program review from annually to periodically. Even though there were modifications to the final rule, this does not negate the necessity of having a compliance and ethics program. A fully implemented compliance and ethics program is still required by CMS.
Currently, there is no guidance for surveyors on how the compliance and ethics program will be reviewed during an inspection. Even without this guidance, there are still steps that can be taken to ensure a compliance and ethics program is effective in meeting regulatory guidelines. First, let’s consider the source of this regulation. There’s no question § 483.85 is modeled after the Office of Inspector General’s (OIG) seven components of compliance. Following OIG’s seven components of compliance can guide a long-term care organization in creating an effective compliance program that meets the new regulations for compliance. Let’s breakdown the OIG’s seven elements of compliance as they relate to these regulations.
- Standards, Policies and Procedures – The OIG requires a written code of conduct and policies outlining the governance of compliance. It also includes ethical standards with proper billing practice, reporting compliance violations, quality of care and professional relationships. This OIG element meets § 483.85(c)(1) of the regulation.
- Compliance Program Administration – In this OIG component, the structure and function of the compliance program is outlined. Processes to include are a work plan, risk assessment and monitoring of compliance complaints or hotline calls. The functions and authority of the compliance committee should be outlined in a compliance charter. The job description of the compliance officer would need to reflect this position’s authority and reporting structure. Using the annual facility assessment in long-term care should identify the authority and utilization of sufficient resources for a compliance program. This component of OIG’s compliance program meets both § 483.85(c)(2) and § 483.85(c)(3) of the regulation.
- Screening and Evaluation of Employees, Physicians, Vendors and other Agents – OIG’s intent off this component is the development of an ethical process of both hiring and contracting stakeholders with a criminal-free background and are active, licensed providers without governmental sanctions. This OIG component meets § 483.85(c)(4) of the regulation.
- Communication, Education and Training on Compliance – The OIG expects a solid training program of compliance be communicated to all stakeholders. Training covers subjects like code of conduct, ethical standards, reporting violations without retaliation, gift polices, and compliance plans found during a risk assessment. Compliance related training should also be identified in the annual facility assessment. This OIG component meets § 483.85(c)(5) of the regulation.
- Monitoring, Auditing, and Internal Reporting Systems – Regular monitoring of staff practice should be performed as identified in the annual workplan. Monitoring includes billing practice, overpayment rates, unethical relationship practice and falsification of records. Auditing of compliance should be routinely completed and reported directly to the board or ownership by the compliance officer. Also, a structure for communicating violations and an escalation plan if the violation is severe should be in place. This OIG component meets § 483.85(c)(6) of the regulation.
- Discipline for Non-Compliance – Outlined in this OIG component is the disciplinary response to a stakeholders’ practice of non-compliance. The level of discipline should match the level of non-compliance confirmed, which may include reporting to a governing agency. All stake holders are subject to this process, not just employees. This OIG component meets § 483.85(c)(7) of the regulation.
- Investigations and Remedial Measures – In this OIG component, a response plan is outlined for findings of non-compliance. Actions to include in the investigation would include a determination as to whether an issue is isolated or wide spread throughout the organization. Actionable responses should be included to report to the effected agency and make changes warranted to prevent further occurrence. This OIG component meets §483.85(c)(8) of the regulation.
As you can see, the adoption of OIG’s seven components of compliance can guide a long-term care community to creating an effective compliance program that meets the new regulations for compliance. What is outlined in these seven components is a highlight of what these standards are, how they meet the regulation and how you can leverage them as you start to build out a robust compliance and ethics program.
Read more on OIG’s compliance program guidance for long-term care facilities.
Learn more about McBee’s solutions for long-term care facilities.