Establishing and Implementing an Effective Nursing Facility Compliance and Ethics Program

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1 Establishing and Implementing an Effective Nursing Facility Compliance and Ethics Program June 20, 2013 Presented by Brian R. Purtell Dewitt Ross & Stevens S.C. Wisconsin Health Care Association/ Wisconsin Center for Assisted Living

2 Objectives Review ACA requirements for nursing facility compliance programs. Discuss what the ACA requirements mean for nursing facilities in 2013 and beyond. Present a framework for establishing a compliance and ethics program that ensures your facility is meeting compliance program expectations. 2

3 Objectives Session I: What and Why Session II: How and Next steps 3

4 Compliance Program Elements # Element Description 1 Compliance Officer and Oversight A compliance officer, with the support of high-level officials within the organization and a compliance committee, oversees the compliance program. The compliance officer should have direct access to leadership of the organization and posses the authority and independence to raise compliance concerns 2 Written Policies, Procedures, and Standards of Conduct Written standards (Code of Conduct, policies and procedures) help to standardize processes and create accountability for ensuring that processes are followed and standards are maintained. 3 Training and Education All individuals in an organization should be trained regarding compliance expectations and preventing fraud, waste, and abuse. Training encourages compliance at all levels of the organization. 4

5 Compliance Program Elements (continued) # Element Description 4 Effective Lines of Communication A culture of non-retaliation/non-discrimination in which compliance concerns can be raised without fear of retribution promotes compliant behaviors. Compliance officers should maintain high visibility within the organization and serve as a resource for employees and others. 5 Well-publicized Disciplinary Standards Noncompliant behaviors should be subject to disciplinary action. Issues of noncompliance should be escalated through the organization s disciplinary process in the same way as issues of substandard job performance and quality of care concerns. 5

6 Compliance Program Elements (continued) # Element Description 6 Monitoring and Auditing Proactively monitoring and internally auditing business processes for compliance with regulatory standards identifies issues of noncompliance that can be proactively corrected before the concerns are identified by regulatory agencies or law enforcement. 7 Prompt Response to Detected Compliance Concerns Promptly investigating all reports of noncompliance mitigates risk. All substantiated instances of noncompliance should be corrected using a corrective action plan. Corrective actions taken should be monitored. 6

7 Initial Steps Upon understanding of elements of compliance plan, identify elements (in whole or part) that satisfy elements. Designate Compliance Officer who will lead in development. Board/Ownership commitment, allocation of resources Formation of compliance committee 7

8 Initial Steps: Compliance Committee Compliance Committee Responsibilities QAA/HSR Committee Responsibilities and Activities 8

9 Initial Steps: Committee Review Upon formation, committee should review current element in place (in whole or in part). Identify gaps in elements Prioritize gaps to be filled Develop action plan to fill gaps Develop Code of Conduct Train and publicize 9

10 Code of Conduct Nursing Home Compliance Program Guidance Code of Conduct A nursing facility's compliance program begins with a written Code of Conduct. This Code should be brief and easily readable. It should cover general principles about compliance. Function of Code The written Code of Conduct should function as an institution's "constitution" regarding compliance issues. As such, it should formalize essential beliefs, acting as a "one-stop shop" to confirm a nursing home's goals and intentions in this vital area of regulation. Whenever there is doubt about whether a specific action is acceptable, employees and others should be able to refer to the Code of Conduct to obtain a quick answer. 10

11 Code of Conduct Specific Expectations The Code of Conduct should articulate specific expectations of all employees, physicians, suppliers, agents, and contractors of the nursing home. Like a mission statement, the Code should make explicit the goal of nursing home management to comply with all federal, state, and local legal requirements regarding fraud and abuse. Summarize Legal Principles The Code of Conduct should summarize basic legal principles regarding compliance. It should make these summaries in "nonlegalese" to the greatest extent possible, using ordinary easilyunderstood language to discuss these important topics. 11

12 Code of Conduct Distribution The Code of Conduct should be distributed widely. All workers associated with the nursing home should receive the Code in a manner that they can comprehend. That might mean writing the Code at an appropriate reading level for all staff. It also might mean translating the Code into other languages. All new employees should certify in writing that they have read and understood the Code. All employees should have the opportunity to ask questions and receive answers about provisions that they do not understand. Updates The Code of Conduct should be reviewed on a regular basis at least annually, but more often if need arises to verify that the specific language continues to express the institution's dedication to compliance principles. 12

13 Initial Steps: Basic Training As Compliance program is being developed, consider training on Code of Conduct upon development. Code and General Expectations Reminder of current reporting procedures (what, who, when) Process for bringing forward all other compliance concerns No retaliation 13

14 1. Compliance Standards and Procedures Facility must establish compliance standards and procedures to be followed by its employees and other agents that are reasonably capable of reducing compliance violations. (Cross Reference to Compliance Element #2 ) Interpretation - Policies and procedures should: (1) address federal and state requirements, as well as ethical business conduct resident safety and rights; (2) clearly and concisely describe expectations; and (3) be widely distributed. Action Steps: Develop or review your Code of Conduct. Review your P&Ps in addition to specific policies regarding operational expectations, be sure you have polices that address the elements of an effective compliance program. Make sure employees and vendors know how to access P&Ps 14

15 2. Compliance Oversight Specific individuals within high-level personnel of the organization must have been assigned overall responsibility to oversee compliance with such standards and procedures and have sufficient resources and authority to assure such compliance. (Cross Reference to Compliance Element #1) Interpretation Compliance is the responsibility of everyone in the facility. However, the person who is designated with compliance oversight must have a high degree of authority and independence in order to effectively carry out compliance program activities. Action Steps: Appoint one specific person to have compliance oversight responsibilities. Ensure the individual is given appropriate resources to design and implement the compliance and ethics program. Consider giving the person to have a networking/training budget. Consider establishing a compliance committee. Provide mechanisms for the person to provide compliance reports to the CEO and Board of Directors (or other appropriate decision-makers). 15

16 3. Delegation Due Diligence Use due care not to delegate substantial discretionary authority to individuals whom the organization knew or should have known through the exercise of due diligence, had a propensity to engage in criminal, civil, and administrative violations. (Cross Reference to Compliance Element #6 and #7) Interpretation This requirement is intended to prevent fraud, waste, and abuse, as well as to protect residents. Action Steps: Review screening process to assure compliant with requirements (as minimum) WI CBC LEIE for employees and vendors Required and advised review Develop monitoring plans that will detect, identify, and prevent compliance violations: See handbook provisions and training on reporting internally. 16

17 4. Training and Education The organization must have taken steps to communicate effectively its standards and procedures to all employees and other agents, such as by requiring participation in training programs or by disseminating publications that explain in a practical manner what is required. (Cross Reference to Compliance Element #3 and #4) Interpretation Effective training will communicate expectations to staff and other agents regarding compliance and fraud, waste and abuse. All individuals at all levels of the organization must be trained regarding compliance expectations (initial and ongoing training). Action Steps: Review or develop training materials (training methods may vary, i.e., staff meetings, online trainings, one-on-one trainings for high risk job functions). Ensure that training is tailored to meet the needs of the audience. Initial and ongoing training for all staff should cover compliance and fraud waste and abuse issues; job-specific training may be required for high-risk areas (e.g., MDS coordinators). Implement and document training as soon as possible. 17

18 5. Non-retaliation and Effective Lines of Communication The organization must take reasonable steps to achieve compliance with its standards, such as by utilizing monitoring and auditing systems reasonably designed to detect criminal, civil and administrative violations by its employees and other agents and by having in place and publicizing a reporting system that allows violations to be reported without fear of retribution. (Cross Reference to Compliance Element #4 and #6) Interpretation Anyone must be able to report a compliance concern without fear of retaliation. On-going monitoring and auditing of operational activities should identify compliance risks and allow the organization the opportunity to correct deficiencies. Action Steps: Ensure the facility has a well-publicized non-retaliation policy. Ensure that reporting mechanisms exist, including an anonymous option (e.g., hotline). Review high-risk areas and business practices to prioritize monitoring and auditing activities. Develop monitoring and auditing work plans. Document results of monitoring and auditing, distribute results to leadership and implement corrective action plans when necessary. 18

19 6. Well-publicized Disciplinary The compliance standards must have been consistently enforced through appropriate disciplinary mechanisms, including, as appropriate, discipline of individuals responsible for the failure to detect an offense. (Cross Reference to Compliance Element #5) Interpretation Disciplinary policies should apply fairly and consistently to individuals who engage in compliance violations, as well as individuals who knowingly fail to report compliance violations. Compliance is the responsibility of all employees and agents. Action Steps: Ensure human resource policies/handbooks include compliance violations in the list of actions/offenses subject to discipline. Incorporate training to managers on all forms of retaliation/retribution, i.e. not just firing Ensure compliance reporting policies state that failure to report a compliance violation is subject to discipline (applicable to employees, contractors, vendors and volunteers). Consider including compliance and reporting obligations language in vendor contracts. 19

20 7. Prompt Response to Compliance Concerns After an offense has been detected, the organization must have taken all reasonable steps to respond appropriately to the offense and to prevent further similar offenses, including any necessary modification to its program to prevent and detect criminal, civil, and administrative violations. (Cross Reference to Compliance Element #7) Interpretation Compliance reports must be promptly investigated. If the investigation determines that a compliance violation has occurred, corrective action must be taken to mitigate the violation and prevent future violations. Action Steps: Ensure that compliance violation policies give authority for compliance staff to investigate freely and implement corrective action. Consider adding language to vendor contracts that requires the vendor to mitigate and prevent compliance violations. Identify legal counsel who can immediately assist the facility with an investigation, if needed. 20

21 8. Review and Update Program Activities The organization must periodically undertake reassessment of its compliance program to identify changes necessary to reflect changes within the organization and its facilities. (Cross Reference to Compliance Element #1 and #6) Interpretation Compliance programs are constantly evolving. Changes in business practices, processes, new regulations, and new risks all play a role in the ongoing review of effective compliance activities. Networking with other facilities may help the facility identify ways to improve compliance programs. Action Steps: Develop a risk assessment/internal audit tool for assessing your program. Encourage management and staff participation in the assessment/review process. Promptly prioritize and implement identified opportunities for improvement. 21

22 Remember Effective programs are integrated into operations not a set of policies that sit on a shelf! Effective programs are not a burden they are an efficient system for monitoring business practices. Resources invested in creating an effective program will protect the residents, resources and reputation of the facility. 22

23 Resources DHHS OIG Compliance Program Guidance for Nursing Facilities (Federal Register, Vol. 65, No. 52, pp ) (2000), available at: DHHS OIG Supplemental Compliance Program Guidance for Nursing Facilities (Federal Register, Vol. 73, No. 190, pp.56832) (2008), available at: 23

24 Resources (continued) DHHS OIG Compliance 101: DHHS OIG Provider Compliance Training Materials: Provider Compliance Training Videos and Webcasts (short effective videos to use during training sessions): 24

25 Resources (continued) DHHS OIG Work Plan: American Health Care Association How to Design and Implement a Corporate Compliance Program: /default.aspx 25