1. www.ober.com Mandatory Compliance Plans: Are You Ready? 2011 Medical Practice Strategies Conference Montgomery County Medical Society Bill Mathias Ober | Kaler 410-347-7667 wtmathias@ober.com Kristin Carter Ober | Kaler 410-347-7309 kccarter@ober.com

2. www.ober.com 2 Agenda Government Enforcement Environment Why Develop a Compliance Plan? Elements of an Effective Compliance Plan Risk Areas for Physician Practices New Compliance Obligations

3. www.ober.com 3 Medicare and Medicaid Regulations Remain Incredibly Complex

4. www.ober.com 4 “There can be no doubt but that the statutes and provisions in question, involving the financing of Medicare and Medicaid, are among the most completely impenetrable texts within human experience. Indeed, one approaches them at the level of specificity herein demanded with dread, for not only are they dense reading of the most tortuous kind, but Congress also revisits the area frequently, generously cutting and pruning in the process and making any solid grasp of matters addressed merely a passing phase.” — Chief Judge Ervin United States Court of Appeals for the fourth Circuit in Rehabilitation Association of Virginia v. Kozlowski, 42 F. 3d 1444, 1450 (4 th Circuit 1994)

5. www.ober.com 5 Fighting Fraud is a Good Investment Government continues to view Fraud, Waste, and Abuse as a significant source of revenue The return-on-investment (ROI) for Health Care Fraud and Abuse Control (HCFAC) program –Since 1997, $4.9 returned for every $1.0 expended. –3-year average (2008-2010), $6.8 returned for every $1.0 expended

6. www.ober.com 6 Have You Seen the OIG’s Website Lately?

7. www.ober.com 7 Aggressive Enforcement From new joint DOJ/OIG website www.stopmedicarefraud.gov www.stopmedicarefraud.gov –“A joint effort by HHS and the Department of Justice recovered a record $4 billion from fraudsters in FY2010.”

8. www.ober.com 8 Why Develop a Compliance Plan? Federal Sentencing Guidelines –Must be an effective program to prevent and detect violations of the law. OIG Compliance Guidance –Individual and Small Group Physician Practices, 65 Fed. Reg. 59,434 (Oct. 5, 2000)

9. www.ober.com 9 Health Care Reform –Compliance plans to become mandatory as a condition of participation in Medicare and Medicaid –... but only after CMS promulgates implementing regulations to establish the core elements for mandatory compliance programs Why Develop a Compliance Plan?

10. www.ober.com 10 Need a Plan??

11. www.ober.com 11 Elements of an Effective Compliance Plan Compliance Standards and Procedures Monitoring and Auditing Enforcement and Discipline Response and Prevention Education and Training Oversight Responsibilities Open Lines of Communication

12. www.ober.com 12 Elements of an Effective Compliance Plan Compliance Standards and Procedures

13. www.ober.com 13 Compliance Standards and Procedures Establish compliance standards and procedures that are reasonably capable of reducing the prospect of erroneous claims and fraudulent activity, while identifying any aberrant billing practices. Effective compliance standards will identify the organization’s risk areas and establish internal controls to contain those risks.

14. www.ober.com 14 Elements of an Effective Compliance Plan Compliance Standards and Procedures Oversight Responsibilities

15. www.ober.com 15 Oversight Responsibilities The organization must designate one or more high-level individuals to oversee compliance activities. Responsibilities may include oversight of all compliance activities or be limited to implementation of specific compliance functions. The organization must use due care not to put individuals who have demonstrated a propensity for violating the law into positions of substantial discretionary authority.

16. www.ober.com 16 Elements of an Effective Compliance Plan Compliance Standards and Procedures Education and Training Oversight Responsibilities

17. www.ober.com 17 Education and Training The organization must communicate its standards and procedures to all employees, professional staff, and physicians in a meaningful and effective manner by implementing an effective training program that explains the requirements of the compliance program and applicable laws. Compliance training may involve in-person training sessions, newsletters, other written materials, and/or bulletin boards.

18. www.ober.com 18 Elements of an Effective Compliance Plan Compliance Standards and Procedures Monitoring and Auditing Education and Training Oversight Responsibilities

19. www.ober.com 19 Monitoring and Auditing The organization must evaluate the effectiveness of its compliance program on an ongoing basis by monitoring compliance with its standards and procedures and by reviewing its standards and procedures to ensure they are current and complete. A review of pending claims not yet submitted can establish a benchmark that will be used in ongoing reviews to chart the success of the organization’s compliance efforts. (Counsel often recommend this be conducted under attorney-client privilege).

20. www.ober.com 20 Elements of an Effective Compliance Plan Compliance Standards and Procedures Monitoring and Auditing Education and Training Oversight Responsibilities Open Lines of Communication

21. www.ober.com 21 Open Lines of Communication The organization must put in place an accessible system for reporting inappropriate activities and for communicating compliance questions and concerns. Standards and procedures must emphasize that failure to report erroneous or fraudulent conduct is a violation of the compliance program. Standards and procedures also must stress that no retaliation may be taken against individuals who in good faith report what reasonably appears to be misconduct or a violation of the compliance program.

22. www.ober.com 22 Elements of an Effective Compliance Plan Compliance Standards and Procedures Monitoring and Auditing Enforcement and Discipline Education and Training Oversight Responsibilities Open Lines of Communication

23. www.ober.com 23 Enforcement and Discipline The organization must enforce its compliance standards through consistent and appropriate disciplinary action. Disciplinary procedures should include, as appropriate, discipline of individuals who should have detected an offense but failed to do so.

24. www.ober.com 24 Elements of an Effective Compliance Plan Compliance Standards and Procedures Monitoring and Auditing Enforcement and Discipline Response and Prevention Education and Training Oversight Responsibilities Open Lines of Communication

25. www.ober.com 25 Response and Prevention If an compliance violation is detected, the organization should take all reasonable steps to respond appropriately to the violation –Take corrective action to rectify any harm resulting from the current offense –Prevent similar offenses from occurring in the future.

26. www.ober.com 26 “Health Care in the New Millennium”

27. www.ober.com 27 Risk Areas for Physician Practices OIG Compliance Guidance for Physicians –Accurate Coding & Billing Billing for non-covered services, unbundling, failure to properly use coding modifiers, upcoding –Reasonable & Necessary Services Medical record & orders should support appropriateness of service –Physician Documentation –Improper Inducements, Kickback and Self-Referrals Financial arrangements with referrals sources, joint ventures, leases, gifts/gratuities

28. www.ober.com 28 Risk Areas for Physician Practices OIG Work Plan FY 2012 –Compliance with Medicare Assignment Rules –Physician-Owned Distributorships –“Incident-To” Services –Evaluation & Management Service Coding

29. www.ober.com 29 New Compliance Obligations Did You Know??

30. www.ober.com 30 60-Day Repayment Requirement §6402 of PPACA requires reporting and repayment of overpayments within 60 days of identification (or due date of next cost report, if applicable) –Applies to Medicare and other federal health care programs –What’s “identification”? Failure to repay within 60-days may be a false claim

31. www.ober.com 31 Regulatory guidance will be forthcoming... (or so we’ve heard) Absent guidance, providers must struggle to come up with practical approaches to complying with the 60-day requirement 60-Day Repayment Requirement

32. www.ober.com 32 Monthly Exclusion Checking What is exclusion checking? Growing number of State Medicaid Programs are requiring monthly screening of current employees and contractors. State Medicaid Director Letter instructed states to “require providers to search the HHS-OIG website monthly to capture exclusions and reinstatements that have occurred since the last search.” HHS-OIG CIAs still only require annual screening

33. www.ober.com 33 Need to have a policy –Before hiring and at least annually Need to check the websites –http://exclusions.oig.hhs.gov/search.htmlhttp://exclusions.oig.hhs.gov/search.html –http://epls.arnet.govhttp://epls.arnet.gov Check everyone, including physicians Monthly Exclusion Checking

34. www.ober.com 34 Conclusion – What’s Next? Increasingly aggressive federal/state enforcement –Alphabet soup of government contractors looking for fraud, waste and abuse Whistleblowers driving government priorities Increasing importance of comprehensive and aggressive compliance efforts

35. www.ober.com 35 “Be careful out there”

36. www.ober.com Questions? Bill Mathias Ober | Kaler 410-347-7667 wtmathias@ober.com Kristin Carter Ober | Kaler 410-347-7309 kccarter@ober.com