1. LeadingAge Is Your Compliance Program Working? How to Implement an Effective Compliance Program and Ensure its Continued Success November 4, 2015 Dennis P. Kennedy Carrie S. Gilbert Dressman Benzinger LaVelle psc dkennedy@dbllaw.com cgilbert@dbllaw.com 859-341-1881

2. Why compliance programs? “On or after the date that is 36 months after the date of enactment of this section, a facility shall, with respect to the entity that operates the facility...have in operation a compliance and ethics program that is effective in preventing and detecting criminal, civil, and administrative violations under this Act and in promoting quality of care consistent with regulations.” – Sec. 6102 of PPACA

3. Why compliance programs?  Protect patients/residents  Protect organization  Protect employees  Minimize issues  Streamline response  Save costs

4. I.Compliance Enforcement Authorities II.Compliance Update III.Components of Effective Compliance Program

5. I.Compliance Enforcement Authorities II.Compliance Update III.Components of Effective Compliance Program

6. Compliance Enforcement Authorities 1.U.S. Office of the Inspector General 2.Center for Medicare & Medicaid Services 3.Department of Justice 4.State Department of Medicaid Services 5.State Office of the Inspector General

7. Office of the Inspector General  Fraud and Abuse  Civil Monetary Penalties  Provider Exclusions  Medicare Fraud Strike Force  Medicaid Fraud Control Units  Joint efforts with DOJ

8. Health and Human Serviecs/Centers for Medicare & Medicaid Services  Medicaid & Medicare enrollment & integrity  HIPAA  Self-referral disclosure protocol

9. Department of Justice  False Claims Act  Health Care Fraud and Abuse Control Program  Health Care Fraud Prevention & Enforcement Action Team (HEAT)  Criminal penalties  Monetary penalties

10. State Department of Medicaid Services  Medicaid program integrity  Fraud and abuse laws – mirror federal laws  Provider exclusions  Often work with State OIG offices

11. State Office of Inspector General  Licensure  Fraud & Abuse  Long-term care Surveys

12. Cooperation with Regulators  Cooperate with federal, state, and local regulatory and law enforcement agencies  Provide honest & complete answers  Request for interview  Develop policies for appropriately responding to requests or correspondence and cooperating if regulators on-site  All employees know how to respond?  Know when to involve legal counsel

13. I.Compliance Enforcement Authorities II.Compliance Update III.Components of Effective Compliance Program

14. 2015 Work Plan – LTC  January 2015  Outlines OIG’s current focus areas and primary objectives of each project  Provider insight into OIG process and what issues OIG will be looking for

15. 2015 Work Plan – LTC  Changes to Part A billing practices – therapy  Monitor Part B billing  Conduct a series of studies  Monitor to ensure no excessive services are provided  Review unintended consequences of national background check program  Examine preventable admissions to hospital from nursing facility

16. 2015 Work Plan – LTC  Monitoring of length of stay in hospice in assisting living facilities  Review appropriate use of hospice general inpatient care  Monitor home health agency billing  Home health agency employment of individuals with criminal convictions

17. Compendium of Unimplemented Recommendations  March 2015  Identifies top 25 unimplemented recommendations that would most positively impact cost savings and/or quality  CMS does not necessarily agree with or implement the recommendations

18. 2015 Compendium  Ensure face-to-face encounter for home health services  CMS has agreed to implement plan for oversight  Skilled nursing facility billing for therapy  CMS agreed to implement  1 st phase complete – identify potential alternative payments methods  2 nd phase in progress – examining extent to which billing affect Medicare

19. I.Compliance Enforcement Authorities II.Compliance Update III.Components of Effective Compliance Program

20. Components of an Effective Compliance Program 1.Written policies, procedures and standards of conduct; 2.Oversight by high level personnel; 3.Periodic and timely education of employees and governance;

21. Components of an Effective Compliance Program 4.Developing effective lines of communication; 5.Enforcing standards through well-publicized guidelines and corrective action; 6. A system of monitoring and auditing;

22. Components of an Effective Compliance Program 7.Prompt inquiry, response, and appropriate follow- up; 8.Association with Trustworthy Individuals/Entities;

23. Components of an Effective Compliance Program 1.Written Policies/Code of Conduct 2.Oversight 3.Training and Education 4.Communication 5.Enforcement 6.Monitoring & Auditing 7.Response 8.Trustworthy Individuals

24. A Code of Conduct  What to include in a Code of Conduct:  Principles – entity’s guiding polices  Standards – guidance to employees to comply  Areas to address  Regulatory Compliance  Ethical Conduct  Quality of Care  Confidentiality  Conflicts of Interest  Protection of Assets

25. Regulatory Compliance  Fraud & Abuse  Tax and antitrust  Copyright  Environmental  Labor & employment

26. Ethical Conduct  Honest communication  Accurate and complete documentation  Misappropriation of property  Reporting concerns

27. Quality of Care  Patient environment  Patient rights  Customer service  Staff competency

28. Confidentiality  Patient information – HIPAA compliance program  Proprietary information  Personnel actions/decisions

29. Conflicts of Interest  Outside financial interests  Services for competitors  Participation on boards  Gifts and gratuities

30. Protection of Assets  Internal control  Financial reporting  Personal use of assets

31. Components of an Effective Compliance Program 1.Code of Conduct 2.Oversight 3.Training and Education 4.Communication 5.Enforcement 6.Monitoring & Auditing 7.Response 8.Trustworthy Individuals

32. Oversight by high-level personnel  Compliance Officer  Responsible for implementation, effectiveness and continued success of compliance program  Responsible for fielding and responding to all concerns  All employees have direct access

33. Components of an Effective Compliance Program 1.Code of Conduct 2.Oversight 3.Training & Education 4.Communication 5.Enforcement 6.Monitoring & Auditing 7.Response 8.Trustworthy Individuals

34. Training & Education  Educate all employees  New hires  Periodically re-train  Do employees know what to do in certain situations?  Do employees know to whom they can report concerns?

35. Components of an Effective Compliance Program 1.Code of Conduct 2.Oversight 3.Training and Education 4.Communication 5.Enforcement 6.Monitoring & Auditing 7.Response 8.Trustworthy Individuals

36. Effective Lines of Communication  Mechanism for reporting compliance concerns in good faith  Reporting process  Hotline  Drop box  Affirmative duty?  Prohibition against retaliation  Reporting to Board

37. Reporting Process  No retaliation  Direct access to Compliance Officer  Ability to report anonymously  Culture of compliance  False Claims Act  Patient/resident system for reporting

38. Components of an Effective Compliance Program 1.Code of Conduct 2.Oversight 3.Training and Education 4.Communication 5.Enforcement 6.Monitoring & Auditing 7.Response 8.Trustworthy Individuals

39. Enforcement  If processes are not in compliance with Code of Conduct or compliance program, then implement corrective action  System of disciplinary measures for employees, vendors, or contracts who violate compliance program or Code of Conduct

40. Components of an Effective Compliance Program 1.Code of Conduct 2.Oversight 3.Training and Education 4.Communication 5.Enforcement 6.Monitoring and Auditing 7.Response 8.Trustworthy Individuals

41. Monitoring, Auditing, and Reporting  Areas to audit  quality of care;  patients’ rights;  billing and cost reporting;  employee screening; and  kickbacks, inducements, and self-referrals.

42. Monitoring, Auditing, and Reporting  Audit processes  on-site visits;  interviews with personnel involved in management, operations, billing, sales, marketing, referrals, and other related activities;  review contracts with and compliance plans of vendors and contractors;  review of materials and documentation used by facility; or  billing and coding analysis and audits.

43. Periodic Risk Assessment  Assess effectiveness of compliance program  Assess risks  Assign levels for prioritization  Assess facility/organizational changes

44. Components of an Effective Compliance Program 1.Code of Conduct 2.Oversight 3.Training and Education 4.Communication 5.Enforcement 6.Monitoring and Auditing 7.Response 8.Trustworthy Individuals

45. Prompt inquiry, response, and appropriate follow-up  Clear and efficient processes for responding to issues and concerns  Clear and efficient processes for responding to inquiries or visits from regulators

46. Components of an Effective Compliance Program 1.Code of Conduct 2.Oversight 3.Training and Education 4.Communication 5.Enforcement 6.Monitoring and Auditing 7.Response 8.Trustworthy Individuals

47. Association with Trustworthy Individuals  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.  Background checks  Verification against exclusionary databases

48. Questions?

49. Thank you Dennis Kennedy Carrie S. Gilbert Dressman Benzinger LaVelle psc dkennedy@dbllaw.com cgilbert@dbllaw.com 859-341-1881