Speaker 1: Welcome, today we will discuss the new Compliance and Ethics Program Guidance for the requirements in 483.85. Specifically, we will review the requirements of new FTAG F895 for the Compliance and Ethics Program. We will also review the intent of these requirements, pertinent definitions, requirements that apply to all facilities, as well as additional requirements that apply to operating organizations with five or more facilities, investigative procedures for surveyors, and training requirements. The intent of the new Compliance and Ethics Program requirements at F895 is to ensure the facility has an effective system to deter any criminal, civil, and administrative violations which ultimately promotes the quality of care for nursing home residents. On March 16, 2000, the Department of Health and Human Services Office of the Inspector General, also known as OIG, released Compliance Program Guidance for nursing home facilities to promote a higher level of ethical and lawful conduct throughout the entire healthcare industry. The OIG previously issued guidance for other segments of the healthcare industry based on the belief that a healthcare provider can use internal controls to more efficiently monitor adherence to applicable statutes, regulations, and program requirements. This guidance also provided the basis for the Patient Protection and Affordable Care Act, which amended a section of the Social Security requiring Medicare-skilled nursing facilities and Medicaid nursing facilities to have a Compliance and Ethics Program. The OIG guidance recommended seven elements which should be included in an effective, comprehensive Compliance and Ethics Program. 1. Implementing written policies, procedures, and standards of conduct. 2. Designation of a Compliance Officer and Compliance Committee. 3. Conducting effective training and education. 4. Developing effective lines of communication. 5. Enforcing standards through well-publicized disciplinary guidelines. 6. Conducting internal monitoring and auditing. 7. Responding promptly to detected violations and corrective action. There are a number of common risk areas which are mostly associated with the delivery of health care to nursing facility residents. Some of them include sufficient staffing, comprehensive care plans, medication management, infection prevention, appropriate use of psychotropic medications, and resident abuse, neglect, and safety. Additional risk areas include resident rights, fraud prevention, billing and cost reporting, employee screening, resident assessment accuracy, creation and retention of records, falsification and modification of documentation, conflicts of interest, kickbacks, inducements, and self-referrals. In the requirements, there are two specific regulatory definitions we want to highlight. The first is high-level personnel, which is the person or people who have substantial control over the organization or who has a substantial role in making policies in the operating organization. The second definition clarifies that an operating organization is one or more individuals or entity that operates a facility. The operating organization of each facility must have a compliance and ethics program that has been reasonably designed, implemented, maintained, and enforced so that it is likely to be effective in preventing and detecting criminal, civil, and administrative violations under the Social Security Act and in promoting quality of care. It is important for the facility to consider their facility assessment developed according to 483.70E in identifying risk areas, developing and maintaining their compliance and ethics program, and determining resources needed for the program. Next, we will discuss the required components. The operating organization must have written standards, policies, and procedures for its compliance and ethics program, which include, at a minimum, designation of an appropriate compliance and ethics program contact to whom an individual can report suspected violations, an alternate method of reporting suspected violations anonymously without fear of retribution, and disciplinary standards that describe the consequences for committing violations for the entire staff. The operating organization must assign specific individuals within the high-level personnel of the organization with the overall responsibility of overseeing adherence to the compliance and ethics program standards, policies, and procedures. High-level personnel means individuals who have substantial control over the operating organization or who have a substantial role in the making of policy within the operating organization. The individuals considered high-level personnel will differ according to each operating organization structure. Some examples include a director, executive officers, including the chief executive officer, members of the board of directors, an individual in charge of a major business or functional unit of the operating organization, or an individual with a substantial ownership interest in the operating organization. The program must also include provisions ensuring that specific individuals designated with oversight responsibility have sufficient resources and authority to assure compliance with program standards, policies, and procedures. The resources devoted should include both human and financial resources. Individuals must exercise the care that a reasonable person would use under the same circumstances when delegating substantial discretionary authority to individuals to ensure that the delegation is not made to an individual who the operating organization knew or should have known through the exercise of due diligence had engaged in or had the predisposition to engage in unethical acts or potential criminal, civil, and or administrative violations of the act. The facility is also required to effectively communicate to the entire staff the standards, policies, and procedures of the Compliance and Ethics Program. These include mandatory participation and training, orientation programs, and or dissemination of information that explains what is required under the program in a practical manner. Under 483.85c6, the facility must take reasonable steps to achieve compliance with the program standards, policies, and procedures. These steps include utilizing monitoring and auditing systems to detect criminal, civil, and administrative violations under the Social Security Act by any of the facility staff, publicizing a reporting system whereby any of the organization's entire staff could report violations anonymously within the operating organization without fear of retaliation, and having a process for ensuring the integrity of any reported data. The Compliance and Ethics Program must establish appropriate disciplinary mechanisms and effectively communicate those mechanisms so that the operating organization's entire staff is clearly aware of the consequences of program violations. The operating organization is required to consistently enforce its standards, policies, and procedures through appropriate disciplinary mechanisms, which may include discipline of individuals who fail to detect and report a violation to the appropriate party identified in the organization's Compliance and Ethics Program. After an operating organization detects a violation, it must ensure that all reasonable steps identified in its program are taken to respond appropriately to the violation and to prevent further similar violations. This includes any necessary modification to the organization's program. The program should clearly identify the reasonable steps to take when a violation is detected. Such steps may include a corrective action plan, the return of overpayments, a report to the government and or a referral to criminal and or civil law enforcement authorities. The steps will differ depending upon the size of the operating organization, the position of the individual reporting the violation, and the type of violation. For example, an operating organization's program may state that a staff member should immediately notify their immediate supervisor when he or she detects the violation. However, if it is the immediate supervisor or the operating organization's management whom the staff believes is committing the violation, the staff member should have an alternate process to report the violation, such as an executive officer of the organization, the office of the state long-term care ombudsman, or other appropriate agency or law enforcement authority. Facilities should integrate the information and data from their Compliance and Ethics programs into their Quality Assurance and Performance Improvement, also known as QAPI, program. The QAPI committee should work with the compliance officer to determine if there are trends or patterns of systemic problems. The operating organization for each facility must review its compliance and ethics annually. Additionally, as an operating organization becomes aware of changes in laws or requirements, it should modify its program to ensure it is current with requirements. The operating organization's performance in prior years should also be used to improve its program. As an operating organization revises its program, it should ensure that those changes are communicated to its entire staff. There are additional requirements for operating organizations with five or more facilities. These organizations must have a more formal Compliance and Ethics program that includes written policies which define the standards and procedures the employees must follow, and they must develop a Compliance and Ethics program that is appropriate for the complexity of their organization and the facilities they operate. Additionally, operating organizations with five or more facilities must have a mandatory annual training program. The annual training should be delivered in a practical manner based on its resources. The complexity of the operating organization and its facilities in accordance with Compliance and Ethics training requirements found at F946. Operating organizations with five or more facilities must designate a Compliance Officer for whom the Compliance and Ethics program is a major responsibility. The operating organization should ensure that the assigned Compliance Officer has sufficient time and other resources to fulfill all of his or her responsibilities under the operating organization's Compliance and Ethics program. The Compliance Officer should be able to communicate with the governing body without being subject to any coercion or intimidation. This ensures that the Compliance Officer is not unduly influenced by the other managers or executive officers, such as the General Counsel, Chief Financial Officer, or Chief Operating Officer. Additionally, the designated Compliance Liaison must be located at each of the operating organization's facilities. The minimum, the facility-based liaison should be responsible for assisting the Compliance Officer with his or her duties under the operating organization's program at their individual facilities. When investigating concerns related to a criminal, civil, or administrative violation in the facility, surveyors should review the facility's written standards, policies, and procedures for the Compliance and Ethics program and interview high-level personnel who are designated to oversee the program and staff. The guidance contains probes in F-895 to consider during investigation and when making compliance determination. Some of the probes include, does the operating organization have written standards, policies, and procedures for the Compliance and Ethics program that are reasonably capable of reducing the possibility of criminal, civil, and administrative violations under the Act? Interview high-level personnel designated to oversee the organization's Compliance and Ethics program about their involvement in the program to determine how the facility uses monitoring and auditing systems to detect criminal, civil, and administrative violations by staff, and if they are aware of the potential violation under investigation, and what was their response. Ask staff if they are aware of the facility's Compliance and Ethics program. There is a method for staff to anonymously report suspected violations. They are confident in reporting compliance matters without fear of retaliation. If the operating organization has five or more facilities, have a compliance officer and a facility-based compliance liaison been designated? As part of this training, we want to emphasize that surveyors should always investigate the appropriate quality of care requirements when a determination is made related to the facility's failure to meet the requirements of F-895. In regards to concerns that are related to the facility's systems of care and management practices, written policies and procedures for feedback, data collection systems, monitoring, analyzing and acting on available data, surveyors should also consider the requirements in F-867, Quality Assurance and Performance Improvement. We want to remind you about the Compliance and Ethics training requirements in F-946. Please review the CMS training presentation and Appendix PP of the SOM for additional information on the training requirements. If you have questions about the Compliance and Ethics program requirements at F-895, please send them to the D&H triage mailbox at dnh-triageteam at cms.hhs.gov. Thank you for your continued efforts towards our shared goal in providing quality care to America's nursing home residents.