1. CAMSS 41 st Annual Education Forum Indian Wells, California Compliance in Healthcare: A Potpourri of Issues that Impact Credentialing Presented by Lowell Brown, Arent Fox LLP Vicki L. Searcy, CPMSM, Morrissey Consulting Services May 16, 2012

2. CAMMS: Compliance in Healthcare2 Objectives At the end of this session participants will be able to:  Understand the interrelated nature of issues that frequently arise in peer review and compliance investigations and the related legal implications  Understand new affirmative obligation to report and return overpayments and its impact on peer review and compliance efforts  Begin developing practical strategies for maintaining effective peer review processes while ensuring robust compliance efforts and minimizing the risk of False Claims Act liability

3. CAMMS: Compliance in Healthcare3 Overview 1.Why This Matters, or, What Can Go Wrong  United Memorial Hospital  Tenet Healthcare: the Redding case  More recent cases 2.Three Different Worlds that Increasingly Intersect and Overlap:  Peer Review  Compliance  False Claims Act

4. CAMMS: Compliance in Healthcare4... Overview 3.Emerging issues  New affirmative reporting obligations  Coordinating investigations  Preserving confidentiality  Governance  Medi-Cal and Medicare opt-out  Criminal background checks  Americans with Disabilities Act (ADA)  Contracting vs. Credentialing 4.Practical Approaches

5. CAMMS: Compliance in Healthcare5 1. Why This Matters, or, What Can Go Wrong

6. CAMMS: Compliance in Healthcare6 Spectacular (and tragic) Failures of Peer Review and Compliance

7. CAMMS: Compliance in Healthcare7 …Spectacular (and tragic) Failures of Peer Review and Compliance United Memorial Hospital  Physician allowed to grant his own privileges  Repeated complaints about care and volume with no action (complaining individuals labeled as uncooperative, replaceable)  Board told they lacked power to initiate review of physician quality  MEC finally did a review, intentionally selecting a reviewer who would not antagonize the physician

8. CAMMS: Compliance in Healthcare8 …Spectacular (and tragic) Failures of Peer Review and Compliance …United Memorial Hospital…  Review was unable to conclude if procedures were medically necessary because of inadequate documents. Physician told to improve his documentation  Impact:  Multiple patient deaths  Adverse publicity  Federal and state criminal investigations, prosecution and convictions  Civil and administrative liability for hospital and physicians  Copy of Plea Agreement attached

9. CAMMS: Compliance in Healthcare9 …Spectacular Failures (cont.) Tenet Healthcare – Redding Memorial  10 years of complaints regarding volume and medical necessity with little action  4 CMS, Licensing and Joint Commission surveys – all noting peer review problems (including condition legal deficiency)  FBI Raid  Impact  Hundreds of unnecessary procedures performed  Divestiture of hospital  $54 Million FCA settlement from Tenet and hospital  $32.5 Million from physicians  $395 Million to settle medical malpractice lawsuits

10. CAMMS: Compliance in Healthcare10 …Spectacular Failures (cont.) More Recently:  Peninsula Regional Medical Center agrees to pay $1.8 Million to resolve allegations that it failed to prevent medically unnecessary cardiac stent procedures. August 2011  St. Joseph Medical Center in Maryland to pay $22 Million to resolve False Claims and Anti-Kickback Act Allegations (medically unnecessary stents performed). November 2010

11. CAMMS: Compliance in Healthcare11 …The Consequences: Quality of Care CIA’s Training  Medical staff peer review procedures  Medical staff credentialing and privileging  Quality assessment and performance improvement activities Peer Review Consultant:  Assess and evaluate the peer review, credentialing, privileging, medical staff training, and discipline practices  Strengths and weaknesses in peer review  Conclusions and recommendations shall be provided to OIG Engage Independent Review Organization

12. CAMMS: Compliance in Healthcare12 …The Consequences: Quality of Care CIA’s Physician Executive  Responsible for oversight of medical staff quality, including performance improvement, quality assessment, patient safety, utilization review, medical staff peer review, medical staff credentialing and privileging, medical staff training, medical staff discipline  Physician executive shall be a member of senior management of the hospital  Physician executive shall make periodic (at least quarterly) reports regarding quality of care directly to the Board of Directors  Minimum – 1.0 FTE Policies  Medical staff credentialing and privileging procedures including collecting, verifying, and assessing current licensure, education, relevant training, experience, ability and competence  Monitoring practitioners with current privileges  Review by Physician Executive and Medical Staff Executive Committee  Reporting to the Governing Board credentialing and privileging activities

13. CAMMS: Compliance in Healthcare13 2. Three Different Worlds that Intersect and Overlap …and can collide.

14. CAMMS: Compliance in Healthcare14 Different Worlds: The Peer Review Perspective Goal: Root out error, correct, but maintain confidentiality; confidentially encourages vigorous effort Overlay is standard of care, not regulatory (Actual vigor and efficacy variable and questionable) Cultural resistance to openness Delicacy of efforts to improve; Physicians usually not hospital employees No real hotlines; fear of retaliation often exists Mostly disincentives for reporting (liability, chilling of peer review)

15. CAMMS: Compliance in Healthcare15 Different Worlds: The Compliance Perspective Goal: Root out error, correct (potentially including repayment and disclosure), evaluate vulnerability of future failure, monitor corrective action Regulatory overlay: “Follow the law” Enforcement pressure:  Encourages vigorous effort  Actual vigor and efficacy growing as a result  Obligations and/or incentives (e.g., more lenient treatment) for reporting Cultural change constantly favors openness  Provider organization (e.g., hospital) usually controls employees  Hotlines

16. CAMMS: Compliance in Healthcare16 Different Worlds: The FCA Risk Management Perspective Goal: Ensure that when peer review or compliance investigations identify potential overpayments;  any actual overpayments identified are reported/returned within 60 days of identification; and  any determinations that issues identified did not result in overpayments are well- documented. Overlay is judicial review: How would a judge or jury view the facts?

17. CAMMS: Compliance in Healthcare17 Can these worlds exist separately? Peer review problems become compliance nightmares:  Sluggish peer review  Disruptive practitioners  Dysfunctional board-medical staff relationship Compliance problems become peer review nightmares:  Physician hearing rights  Transparency  Reporting obligations/Disclosure Decisions about how to address problems identified in both investigations can now trigger False Claims Act liability

18. CAMMS: Compliance in Healthcare18 3. Emerging Issues

19. CAMMS: Compliance in Healthcare19 Emerging Issues: New Affirmative Reporting Obligations ACA imposes new legal obligation to report and return overpayments (effective 1/1/2011): (d) REPORTING AND RETURNING OF OVERPAYMENTS – (1) IN GENERAL – if a person has received an overpayment, the person shall – (A) report and return the overpayment to the Secretary, the State, an intermediary, a carrier, or a contractor, as appropriate, at the correct address; and (B) notify the Secretary, State, intermediary, carrier, or contractor to whom the overpayment was returned in writing of the reason for the overpayment

20. CAMMS: Compliance in Healthcare20 Emerging Issues: New Affirmative Reporting Obligations Any overpayment retained by a person after the deadline for reporting and returning the overpayment under paragraph (2) is an obligation (as defined in the False Claims Act) False Claims Act (as amended in 2009) imposes liability for a person who “knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay or transmit money or property to the Government” “knowingly” includes reckless disregard, deliberate ignorance

21. CAMMS: Compliance in Healthcare21 Emerging Issues: Coordinating Investigations How can you conduct a peer review investigation without compromising the organization’s ability also to conduct a compliance investigation? How can you conduct a compliance investigation without compromising the medical staff from conducting an effective peer review? How can you ensure that peer review and compliance investigations do not heighten the risk of FCA liability tied to failure to report and return overpayments?

22. CAMMS: Compliance in Healthcare22 Emerging Issues: Coordinating Investigations Avoiding compromise....  Peer review and compliance actions proceed on a separate track  Does the compliance officer know what is going on?  Does the medical staff know what is going on?  Confidentiality concerns: The leaky medical staff

23. CAMMS: Compliance in Healthcare23 Emerging Issues: Coordinating Investigations Reporting obligations: do they jeopardize compliance disclosures?  Physician hearing rights  Outside investigations triggered  State Medical boards  Joint Commission  CMS

24. CAMMS: Compliance in Healthcare24 Emerging Issues: Preserving Confidentiality Discovery protections:  Can you preserve discovery protections while allowing disclosure of sensitive but important information to your own compliance officials?  Can you preserve discovery protections while relying on documentation of peer review decision-making to defend a FCA case alleging failure to report overpayments? Is it necessary to step outside the immunities available in order to conduct compliance investigations and disclosures? Are there alternatives?

25. CAMMS: Compliance in Healthcare25 Emerging Issues: Governance Are there reasonable ways to meet this need while still allowing the necessary flow of information within the provider organization?  The medical staff members of the Board: Conflicting duties?  Who controls confidential peer review information?  What about Corporate Integrity Agreements?

26. CAMMS: Compliance in Healthcare26 How Does the Government See This?

27. CAMMS: Compliance in Healthcare27 Emerging Issues: Governance Government perspective  “Corporate Responsibility and Health Care Quality: A Resource for Health Care Boards of Directors” released on June 27, 2007:  “The oversight of quality is a core fiduciary duty of members of the governing Boards of health care organizations.”

28. CAMMS: Compliance in Healthcare28 Emerging Issues: Governance Government perspective  Boards are also responsible under state law for exercising due care in their oversight of medical staff credentialing, privileging, and peer review. The ultimate responsibility lies with the governing body. Elam v. College Park Hospital, 132 Cal. App. 3d 332; 183 Cal. Reptr. 156 (1982).

29. CAMMS: Compliance in Healthcare29 Evaluating Peer Review Effectiveness Government perspective...  “Do the organization’s competency assessment and training, credentialing, and peer review processes adequately recognize the necessary focus on clinical quality and patient safety issues?” Who is responsible for evaluating effectiveness of peer review?  Medical Staff  Compliance  External entities?  Governance Oversight Management and oversight of corrective actions

30. CAMMS: Compliance in Healthcare30 Medicare and Medi-Cal Opt Out Who is checking the opt-out web site? What is the communication pathway? What is your organization’s policy related to granting privileges to practitioners who are excluded from Medicare and Medi-Cal? By government action By their own decision What about private contracts with patients?

31. CAMMS: Compliance in Healthcare31 Criminal Background Checks Most organizations are now conducting background checks as part of the credentialing process at least at the time of initial privileging The issues are:  The scope of the background check  The timing of the background check (is it done before a contract is offered or as part of the credentialing process?)  Determining how to react to uncovered information

32. CAMMS: Compliance in Healthcare32 ADA Today Impact of increased number of contracted physicians Can health-related questions still be asked as part of the credentialing process (i.e., “can you safely and competently exercise granted clinical privileges?”) How should health questions be dealt with as part of the contracting process?

33. CAMMS: Compliance in Healthcare33 Contracting vs. Credentialing In light of increased numbers of practitioners who are being recruited, organizations are evaluating the “onboarding” process to determine how to make the process more efficient and timely.

34. CAMMS: Compliance in Healthcare34 Contracting vs. Credentialing, cont. Onboarding may involve all or many of the following: Recruitment Contracting HR Faculty appointment Joining the PHO Credentialing/Privileging Enrollment

35. CAMMS: Compliance in Healthcare35 Contracting vs. Credentialing, cont In onboarding, organizations try to sequence activities in the most appropriate order in order to avoid duplication of effort (on the part of the physician AND the organization) Eliminate duplicate submissions of applications Determine best time to obtain background check, references, etc.

36. CAMMS: Compliance in Healthcare36 Contracting vs. Credentialing, cont Goal of effective onboarding is not to offer a contract to a practitioner who will be unable to be credentialed and/or granted clinical privileges

37. CAMMS: Compliance in Healthcare37 4. Practical Approaches

38. CAMMS: Compliance in Healthcare38 Practical Approaches A medical staff quality-compliance checklist Board, medical staff, and compliance programs must be functional  Dispute-resolution processes  Involve medical staff leadership in compliance planning (seek buy-in) and emerging compliance issues:  NCDs, LCDs  Clinical Documentation Programs  Privacy  OIG Work Plan, Risk Assessments, investigations

39. CAMMS: Compliance in Healthcare39 Practical Approaches Compliance function must communicate with peer review function  Administrative level  Board level – a must Standardize documentation of decision-making process with respect to overpayment determinations Coordinate investigations through general counsel

40. CAMMS: Compliance in Healthcare40 Questions and Discussions