Compliance 202. HCCA Compliance Institute 2005

Transcription

1 HCCA Compliance Institute 2005 Compliance 202 Al Josephs Hillcrest Health Systems Sheryl Vacca Deloitte & Touche, LLP Steve Morreale Compliance & Risk Dynamics

2 Recent Enforcement Activities & Trends OIG Guidances, ie: supplemental hospital, pharma Revised Federal Sentencing Guidelines Sarbanes Quality Standards SEC NIH State Laws, ie: CA-SB1765, etc.

3 State AG s Charged with protecting the public interest, attorney s general are initiating increasingly aggressive demands for public accountability from private not-forprofit (501(c)(3)) institutions

4 Attorney General Legal Basis Authority to investigate charitable organizations Private inurement Charitable Trusts IRS tax issues

5 Recent Compliance Guidance Over the past couple years, Federal Agencies have issued three important documents relating to the structure and operation of Compliance Programs: The OIG Draft Supplemental Compliance Guidance for Hospitals Corporate Compliance: A Resource for Health Care Boards of Directors, published by OIG and AHLA Recent revisions to the Federal Sentencing Guidelines

6 Relationship between Compliance and Senior Management OIG Hospital Compliance Guidance: Compliance Officer should be member of Senior Management and supported by Compliance Committee Allowing Compliance to be subordinate to Senior Management may compromise the independence and objectivity Although Compliance should be independent, a multidisciplinary team approach is needed

7 OIG Compliance Guidance (cont) Compliance Officer s Duties may include: Developing and implementing policies Overseeing and monitoring program implementation Coordinating internal audits Investigating reports of noncompliance Serving as a resource on substantive issues Reporting directly to the board and senior management on compliance matters

8 OIG Compliance Guidance (cont) Key responsibility: investigation and coordination of organization s response to compliance failures

9 US Sentencing Guidelines Revision of Guidelines started about the time that the Enron scandal broke Sentencing Guidelines development influenced by desire to make corporate boards more responsible for the compliance function The influence of the Sarbanes-Oxley debate is evident

10 Sentencing Guidelines Guidelines are used in determining the appropriate sentence for a corporate defendant Are also viewed as important guidance concerning the essential elements of an effective compliance program Play an important role in the development of best practices

11 Sentencing Guidelines Place responsibility on Boards and Executives for oversight and management of Compliance Program High-level personnel who have substantial control over the organization must be responsible and accountable for the program Need not handle day to day operations

12 Sentencing Guidelines Specific individuals within the organization shall be delegated operational responsibility for the program and these individuals shall report to high level personnel and to the board on the effectiveness of the program

13 Sentencing Guidelines High level personnel shall be knowledgeable about the content and operation of the program and must ensure that the organization s program is effective Bottom line: someone at the top must own responsibility for the compliance function

14 Sentencing Guidelines Compliance personnel shall be given adequate resources, appropriate authority and direct access to board

15 OIG Corporate Integrity Agreements In a CIA: Compliance Officer (CO) must be a member of Senior Management CO reports to board at least quarterly CO has access to the board at any time CO not subordinate to General Counsel or to the Chief Financial Officer

16 Sarbanes-Oxley Compared SOX requires a public company to have an audit committee that oversees its financial reporting and financial auditing functions Committee of the board of directors Independent of management Must be able to engage counsel and advisers Must be funded to the extent the audit committee determines is appropriate

17 Sarbanes-Oxley Compared CEO and CFO are responsible for establishing, maintaining, and regularly evaluating internal controls for financial reporting and public disclosure purposes must certify this in SEC reports CEO and CFO must disclose any deficiencies in controls and any fraud to the audit committee and the outside auditor

18 Industry Standard What do we know? HCCA 6 th Annual Survey (2004) Compliance Officers: 75% report to CEO, President and/or the Board 65% had a stand alone department 2.9 FTE s are dedicated to compliance within the organization Positions include compliance auditors, coders, legal, trainers 3-5 additional employees indirectly report to compliance

19 Industry Standard 91% of Programs have compliance committees Responsibilities include planning, disposition of investigations, disposition of audits, reporting to the governing board, self disclosures, enforcement authority 81% of Compliance Officer s chair the org. compliance committee Committee is made up of CFO/Finance, Administration, Billing, HR, CO, Legal, Operations, CEO, Physician Leader Less frequently includes HIM, RM, clinical department head, Nursing, Audit, IS, QA, Lab, Board Member, other, Physicians 95% give a compliance report to the Board Quarterly (50%) Less Frequently (50%)

20 Industry Standard (cont) HCCA survey (cont) Biggest Issues CO is focusing on: 1) Auditing and Monitoring 2) Education and Training 3) Keeping up with government releases 4) Documentation Biggest issues facing Compliance Programs today: 1) Assessing compliance program effectiveness 2) Documenting the compliance program value 3) Information/Communication

21 What about You? How does the relationship of your Compliance Officer to Senior Management compare with these standards member of Senior Management? Meets with senior management periodically? Reports to CEO Has access to Board? Other?

22 Organizational Chart Medical Staff Vice President Medical Affairs. Board of Trustees President/CEO. Medical Network Auxiliary Compliance, Privacy & Internal Audit Facilities Planning Information Technology Risk Management Vice President/CFO Vice President Vice President Vice President Nursing

23 What about your organization? How does your CO s duties compare to the standards and industry practice?

24 Relationship between the Board and the Compliance Officer Compliance Guidance, Sentencing Guidelines, Corporate Compliance Resource and Sarbanes Oxley all emphasize the governing body s responsibility to exercise oversight of the compliance program

25 OIG-AHLA Corporate Compliance Resource Directors have a duty to exercise reasonable diligence in overseeing the compliance function Board should know structure of program and who are the key employees responsible for its implementation and operation Board should receive regular reports

26 COMMUNICATING OMPLIANCE TO THE BOARD OF DIRECTORS

27 Duty of Care Concept Duty of care involves determining whether the directors acted In good faith With the level of care that an ordinarily prudent person would in like circumstances In a manner that they reasonably believe is in the best interest of the corporation Source: HHS OIG/AHLA

28 Board Obligations to Duty of Care Decision-making function Applying duty of care principles to a specific decision or board action Oversight function Applying duty of care principles with respect to the general activity in overseeing the day-to-day business activities of the corporation Source: HHS OIG/AHLA

29 Evolution of Corporate Governance Focus Risk Management Continuing technical education Management Oversight & Corporate Compliance New regulatory requirements Internal Controls Governance Health Check Governance framework for financial reporting Transparency Board Roles & Responsibilities Board Effectiveness Top priorities for Governance include: Corporate governance heath check to assess audit committee and board effectiveness Financial reporting governance framework Board effectiveness Continuing technical education Ethics services New regulatory requirements - interna control

30 Key Questions Boards Should be Asking How is the board structured to oversee compliance issues? How is the compliance program organized and who are the key employees responsible for its implementation and operation? How does the compliance reporting system work? How frequently does the Board receive reports about compliance issues? Source: HHS OIG/AHLA

31 EMERGING FOCUS AREAS

32 Emerging Focus Areas Hospital billing and collection practices Discounting charges OIG guidance Applicable laws Proposed amendments to OIG rule on exclusion for excessive charges

33 Emerging Focus Areas Pharmaceutical companies Targeted risk areas Best price Discounts to private entities without equalizing rebates to Medicaid Average wholesale price (AWP) Purposeful manipulation of AWP Active marketing of the spread Physicians pocket the difference between the acquisition price (heavily discounted by the drug company) and the government reimbursement amount Consulting and advisory payments Payments to physicians for time spent listening to sales pitches for pharmaceutical products

34 Emerging Focus Areas Pharmaceutical companies Targeted risk areas Product conversion or switching arrangements Financial incentives offered by pharmacy benefit managers to switch brands of prescribed drugs Pending whistle-blower actions against Merck/Medco Physician billing for drug samples TAP Pharmaceuticals (Lupron probe) AstraZeneca Pharmaceuticals

35 INTERNAL INVESTIGATIONS

36 Internal Investigations An inevitable consequence of an effective compliance program is the identification of practices that warrant an internal investigation, and when appropriate, disclosure to the government. HHS Office of Inspector General

37 Common Practical Challenges Risk of creating report cards without A s and B s Bad Paper Internal and external resources document things in an unfortunate manner Privilege Issues Established too late Could be waived, voluntarily or involuntarily Stakeholder Exclusion Independence and fairness of investigation

38 Internal Investigations Identifying regulatory exposure OIG compliance program guidance, special fraud alerts, advisory opinions, work plan & semi-annual report Special fraud alerts, bulletins & other guidance CMS advisory opinions & program guidance Law enforcement initiatives & FCA settlements

39 Internal Investigations Triggers Becoming aware of a problem Reports/Allegations by Employees Medical staff & other professionals Third parties (i.e., billing consultants, vendors, etc.) Beneficiaries Internal hotline calls Department referrals Noted errors, noncompliant activity, etc.

40 Internal Investigations Triggers Becoming aware of a problem Monitoring of new physicians Unexplained increase in reimbursement Substantial caseload jump for a specific service Charge master reviews and updates Spot audits (prospective reviews) Statistical audits (retrospective reviews) Legal audits

41 Internal Investigations Triggers Becoming aware of a problem Discovery of faulty billing advice Inquiries by third party payors Increase in denied claims Government investigation Whistle-blower actions Statistics

42 Internal Investigations Prioritizing multiple compliance issues Could the issue have a significant impact on the business bottom line? Does the issue present credible evidence of ongoing misconduct that may violate the law & should be reported immediately? Has the organization established (and followed) its own standards for the amount of time allotted to address incoming compliance concerns?

43 Internal Investigations Prioritizing multiple compliance issues Does a CIA require focus on certain items? Does the problem pertain to a discontinued practice? Can certain billing software be used to perform a preliminary review? Can the suspect billing practice be suspended or ceased until a review can be completed?

44 Internal Investigations Factual due diligence Organizational structure Current & prior years Identify duties & reporting functions Assess functional responsibilities of department(s) involved, ie: in suspect billing pattern(s) or practice(s)

45 Internal Investigations Factual due diligence Claims process analysis Review process through which claims are developed Include methodology through which information from various departments is assimilated What controls exist relating to the suspect claims?

46 Internal Investigations Factual due diligence Interviews Useful in determining historical causes of suspect billing pattern(s) or practice(s) Identify & prioritize individuals & groups to be interviewed Include physicians, senior executives, etc.

47 Internal Investigations Systems review Purpose = identify any problems or weaknesses Process = walk through of the systems(s) & process(es) that generated the sampling unit in error Goal = identify at what point the error that resulted in the overpayment occurred & determine why

48 Internal Investigations Audits & billing samples Although many monitoring techniques are available, one effective tool to promote and ensure compliance is the performance of... compliance audits by internal or external auditors who have experience on federal and state health care statutes, regulations and federal health care programs. HHS Office of Inspector General

49 Internal Investigations

50 Internal Investigations Staffing issues Who will make up the investigative team? Internal staff w/ authoritative knowledge Outside consultants Accounting firms Law firms

51 Internal Investigations Staffing issues How involved should internal staff be? Avoid having the person who is responsible for the area being reviewed involved in the investigation Remove employees under investigation from their current work activity until the investigation is concluded

52 Internal Investigations Staffing issues What type of experts may be necessary? Nature of the problem Suspected extent of the noncompliant activity Potential for criminal, civil or administrative liability

53 Internal Investigations Team management & accountability Who will direct the efforts of the investigative team? Who will the team report to? How far should the team go in developing its analysis of the facts & the resulting conclusion(s)? Should the investigative team include conclusions of law in its analysis?

54 HEN TO INVOLVE LEGAL COUNSEL

55 When to Involve Legal Counsel Privileges What is a privilege? Rule of evidence baring communications from admission in legal proceeding Examples: marital communications privilege, patient-physician privilege & psychotherapistpatient privilege Corporate clients No 5 th Amendment rights against selfincrimination for corporations makes attorneyclient privilege especially important

56 When to Involve Legal Counsel Privileges (cont.) Policy Encourage full and frank communication between an attorney and his or her client This communication is generally more important than the need for evidence in litigation Whose privilege is it? The client holds the privilege (not the attorney) The corporate client (and not its employees or agents) holds the privilege

57 When to Involve Legal Counsel Practical considerations How to decide whether to bring an internal investigation under privilege Ordinary-course auditing and monitoring vs. privileged audits and investigations Risk analysis Varies by organization, risk area and potential exposure to organization

58 When to Involve Legal Counsel Practical considerations (cont.) Timing is everything Get attorney involved with investigation early Attorney can assist client in evaluating risk of conducting investigation outside of privilege Attorney should render advice after non-lawyer advisor delivers work product

59 When to Involve Legal Counsel Practical considerations (cont.) Attorney should control & personally supervise investigation Attorney should retain and personally supervise consultants & non-attorneys Just copying attorney on correspondence probably doesn t do it NOTE: Communications with non-privileged persons (i) are not protected by privilege and (ii) may destroy otherwise privileged conversations

60 DISCLOSURE TO OUTSIDE ENTITIES

61 Disclosure to Outside Entities Has a violation of law occurred? Material violation Substantial overpayment Improper payment Violation of statute, regulation or agency directive Provision of items or services of a substandard quality

62 Disclosure to Outside Entities Has a violation of law occurred? Overpayments [G]enerally result when payment is made by Medicare for non-covered items or services, when payment is made that exceeds the amount allowed by Medicare or when payment is made for items or services that should have been paid by another insurer (Medicare secondary payor obligation). Centers for Medicare & Medicaid Services

63 Disclosure to Outside Entities Has a violation of law occurred? Patterns of incorrect billing Origins of the practice Overall impact on the organization Billing errors There may be instances where there is no monetary loss at all, but corrective action and reporting are still necessary to protect the integrity of the applicable program and its beneficiaries. General HHS Office of Inspector

64 Disclosure to Outside Entities Has a violation of law occurred? Improper billing done intentionally or with reckless disregard Whether or not the individual(s) who caused the errors benefited personally Improper billing by certain individuals may require scrutiny of their entire employment history, an analysis of their effect on other employees, and a review of the directions they may have received from superiors. HHS Office of Inspector General

65 Disclosure to Outside Entities Obligation to disclose Knowledge of events & intent = crucial factors 42 U.S.C. 1320a-7b(a)(3) No obligation to admit to receiving an overpayment &/or submitting an improper charge

66 Disclosure to Outside Entities How far back should you go? The OIG suggests Using reasonable and calculated benchmarks to assist in determining the parameters of an internal investigation Taking a reasonable approach that can be justified under the circumstances Expanding the inquiry if the initial review suggests existence of a broader problem

67 Disclosure to Outside Entities How far back should you go? (cont.) General time period for reopening of Medicare claims is 4 years FCA statute of limitations 6 years after date of violation 3 years after date when material facts are known or should have been known by the government, but in no event more than 10 years after the date on which the violation occurred Fact specific stopping points Change in computer systems Change in personnel

68 Disclosure to Outside Entities Potential risks & benefits Favorable treatment Less rigorous CIA Resolve exclusion remedy Minimize potential disruption Minimize excessive damages Preclude whistle-blower action by requesting Contractor or OIG to investigate disclosed facts Other considerations

69 Disclosure to Outside Entities Where to report? To Program Contractors Matters exclusively involving overpayments or errors that do not suggest a violation of law has occurred Issue = Contractor demands for OIG-style disclosure for routine billing errors To the OIG If in the provider s reasonable assessment the matter(s) is potentially violative of federal, civil or criminal laws

70 Disclosure to Outside Entities Where to report? (cont.) To the DOJ - Main Justice v. USAO - Civil v. Criminal Divisions - Local politics USAO priorities

71 Disclosure to Outside Entities Reporting Timing issues The OIG on prompt reporting Demonstrates the entity s good faith and willingness to work with governmental authorities to correct and remedy the problem Will be considered a mitigating factor in determining administrative sanctions

72 Disclosure to Outside Entities Reporting Timing issues Disclosure within 60 days after Determining credible evidence of a violation Identifying an overpayment Disclosure within 30 days of The time the violation was initially detected May limit risk to double damages under the FCA

73 Disclosure to Outside Entities Reporting Timing issues Immediate disclosure Clear violations of criminal law Significant adverse effect on quality of care Evidence of systemic failure to comply

74 CASE STUDIES

75 Case Studies How far back do you go to self report? Routine audit discovers that a hospital coder, who is a long-term employee, has been inaccurately coding procedures

76 Case Studies How and to whom should this be reported? A physician s ownership in a clinical laboratory is identified during a routine screening after several years of referrals and billing

77 Case Studies Can you safely employ excluded individuals? A hospital wants to find a way to accommodate a senior employee whose exclusion status is discovered during a routine cost report audit by the FI

78 Focus on Regulatory Risks and Controls Sarbanes Calls for evaluation of internal controls COSO Standards Compliance with laws and regulations Federal Sentencing Guidelines Calls for evaluation of internal controls HHS Office of Inspector General Regulatory-specific standards Employee Training Compliance Audits

79 Key Questions Boards Should Ask What are the goals of the compliance program? Does the compliance program address the significant risks that may apply to the organization? How were those risks determined and how are new compliance risks identified and incorporated into the program? How has management determined the adequacy of the resources dedicated to implementing and sustaining the compliance program? Source: HHS OIG/AHLA

80 Board Communication Present annual work plan in support of organizations Business Plan Report on Education Activities Monthly Directors meeting Newsletter Medical Staff Newsletter Mandatory annual training for all employees Remedial Education Design systems for operational oversight Example: Policies and procedures Identify required system-wide policies and procedures (all aspects of operations) Develop standard format and numbering system

81 Board Communication Present annual auditing and monitoring work plans GROUP PROJECT: Identify different ways to maximize board education/commitment/involvement when presenting the auditing and monitoring work plan

82 Monitoring Plan Monitoring never ends each review leads to the next, and the monitoring plan and unplanned issues drive additional monitoring activities. It is a continuous process Finalize Report & Corrective Action Plan Define Review Scope & Assumptions Finalize Report & Corrective Action Plan Develop Review Criteria Define Review Scope & Assumptions Develop Review Criteria Finalize Report & Corrective Action Plan Define Review Scope & Assumptions Obtain Management Response Obtain Management Response Define Review Sample Document Observations & Findings Define Review Sample Develop Review Criteria Document Observations & Findings Conduct Review Document Observations & Findings Test Interrelator Reliability Conduct Review Conduct Review Test Interrelator Reliability Define Review Sample

83 Board Communication Potential risk are evaluated and reported for each of the following: OIG Annual Work Plan Audit Reports, that are applicable to operations, that appear on the OIG website Internal investigations, as identified External surveys, as they occur Follow-up of implementation of consultations recommendations Significant events, including Hotline reports Employee questions

84 Effectiveness what to look for?

85 CMS Project for Effectiveness of Hospital Compliance Programs Announced May 2004 Six N.E. states, D.C., DE, MD, NJ, NY, PA, VA, WV Focus on acute-care hospitals and academic medical centers with a minimum of 100 beds for 18 months Inpatient at least 30% of revenue Medicare at least 25% of revenue participants Evaluate effectiveness of voluntary compliance programs Identify best practices and how to apply them Look at developing incentives to encourage providers with an effective compliance program Expedited appeals Enhanced claims data Better interaction with contractors, more interaction with CMS

86 CMS Pilot Project (cont.) 2 site visits CMS will develop list of indicators to come up with a quantifiable measure of the provider s effectiveness Outcome measures based on, e.g., Medicare claims rejection, overall error rates Educational incentive through enhanced claims data in report-card format

87 Analyzing Effectiveness Internally Organization Culture Governance and Senior Management Commitment Structure and Processes Internal Controls Assessment and Enhancement Auditing and Monitoring

88 Organizational Culture Values and rewards: Compliance Prevention Detection Resolution Code of Ethics/Conduct Core Values Compliance as part of annual performance review

89 Governance and Senior Management Emphasized by OIG Supplemental Compliance Guidance for Hospitals Board Educational Resource How Measured? Formal commitment to compliance Active involvement Allocation of resources Empowerment of compliance professionals

90 Governance and Senior Management Documented Effectiveness Demonstrate and document efforts to get it right the first time through Evaluation of new business ventures for potential risk Proper delegation of authority and accountability Timely response to newly developed rules and regulations Systematic testing of internal control systems tested

91 Senior Management Responsibilities Documentation? Create an environment (culture) which Encourages open discussion of errors and concerns raised by associates Allows for prompt reporting of compliance concerns Designs systems and processes that Ensure compliance Contain adequate controls (compliance, quality, and safety) Are supported by detailed policies and procedures

92 Governance Compliance Committee Documented? Committee s Compliance Functions (as defined by Board Policy) Ensure that appropriate policies and procedures are in place to preserve and safeguard the organizations assets Ensure proper ethical and legal standards are present and maintained in meeting all applicable laws, rules and regulations Monitor compliance with applicable laws, rules and regulations

93 Annual Compliance Audit Plan First Question: Do you have one? Addresses billing systems, claims accuracy Identifies causes of non-compliance Qualified auditors Unannounced audits

94 Audit Emphasis: Specific Risk Areas OIG Workplan OIG Semiannual Report Relevant Compliance Guidance LMRPs Program requirements Specific risk areas for provider s industry segment

95 Responses to Potential Non-Compliance Document responses to issues Investigate as appropriate Internal and external resources as warranted Corrective action plans developed and enacted Refund of all identified overpayments

96 Enforcement of Disciplinary Standards Standards well-publicized Consistently enforced Exclusion lists checked Emphasis on non-retaliation

97 Where do we go from here?

98 Effectiveness Reviewed Annually Assess compliance with 7 elements Billing and coding error rates Refunds Internal or external audit results Employee awareness of compliance program Hotline calls and other referrals Number of investigations and outcomes Responses to issues Consistent enforcement and discipline

99 QUESTIONS?

100 Contact Information Al Josephs Hillcrest Health System 3000 Herring Avenue Waco, TX Office# Fax# Sheryl Vacca Deloitte & Touche LLP 695 Town Center Drive, Suite 1200 Costa Mesa, CA Office# Fax# Stephen A. Morreale, D.P.A., CHC Compliance & Risk Dynamics P.O. Box 72 Southborough, MA Office#

101 Appendix Questions to Ask in Assessing the Seven Elements of an Effective Compliance Program

102 Elements of an effective compliance plan Establishment of compliance standards and procedures Appointment of a compliance officer or committee Exercise of due care in the delegation of discretionary authority Employee education and compliance training On-going monitoring and reporting systems Consistent and continuous enforcement of compliance standards Response to offenses; prevention of reoccurrences

103 Assessing the Seven Elements 1. Designation of Compliance Officer and Compliance Committee Key questions : Is there a compliance officer who is well-qualified, a member of senior management, and who is supported by a Compliance Committee? Is there a clear mission statement? Are there sufficient resources available? Is there an appropriate relationship between the compliance officer and general counsel?

104 Assessing the Seven Elements 1. Designation of Compliance Officer and Compliance Committee Key questions : Is there an active compliance committee? Is the committee comprised of trained representatives of each relevant functional department, and members of senior management? Are ad hoc groups or task forces utilized?

105 Assessing the Seven Elements Key questions: cont d Does the compliance officer have access to: Governing body? Senior management? Legal counsel? Does the compliance officer have good internal working relationships? Does the compliance officer make regular report to the governing body?

106 Assessing the Seven Elements 2. Development of Compliance Policies and Procedures, Including Standards of Conduct Key questions : Have standards of conduct been distributed to: Governing body? All officers? All managers? Employees? Contractors? Medical Staff?

107 Assessing the Seven Elements Key questions cont d: Are policies and procedures: Clearly written? Relevant to day-to-day responsibilities? Readily available to those who need them? Re-evaluated on a regular basis? Is compliance with policies and procedures monitored?

108 Assessing the Seven Elements Key questions cont d: Does the hospital have risk assessment tools that evaluate: Federal health care program requirements? OIG CPGs? Work plans? Special Advisory Bulletins? Special Fraud Alerts?

109 Assessing the Seven Elements 3. Developing Open Lines of Communication Key questions: Has the hospital fostered an organizational culture that: Encourages open communication? Prevents retaliation? Hotline: Has one been established? Is it publicized? Are calls logged and tracked for trends? Do callers receive feedback?

110 Assessing the Seven Elements Key questions cont d: Are all potential fraud and abuse issues investigated? Are results of internal investigations routinely reported to governing body? Is the governing body actively engaged in pursing appropriate remedies to institutional or recurring problems? How are Compliance program activities communicate within the organization? How frequently?

111 Assessing the Seven Elements 4. Appropriate Training and Education Key questions : Does the hospital have qualified trainers? Do the trainers: Conduct annual compliance training? Including general and specific training? Is training evaluated for effectiveness? Has hospital Kept current on changes in Federal health care program requirements? Adapted training and education accordingly?

112 Assessing the Seven Elements Key questions cont d: Is education and training curriculum developed considering the following: Results of audits and investigations? Results of previous training and education activities? Hotline reports received? OIG/CMS communications? Has hospital evaluated effectiveness of training and education utilizing appropriate methods?

113 Assessing the Seven Elements Key questions cont d: Has the governing body been provided with appropriate training? Are training and education activities well documented? Are there attendance requirements?

114 Assessing the Seven Elements Key questions cont d : Has hospital evaluated error rates based on annual audit results? Is there an ongoing effort to uncover hidden weaknesses and deficiencies? Do audits include a review of clinical documentation?

115 Assessing the Seven Elements 5. Internal Monitoring and Auditing Key questions : Is an annual audit plan developed? Does the audit plan include: Assessment of billing systems? Claims accuracy? Root cause analysis of errors? Is audit staff qualified and appropriately certified? Are resources available for unscheduled reviews as requested by the compliance officer?

116 Assessing the Seven Elements 6. Response to Detected Deficiencies Key questions : Does the hospital have in place a process for promptly responding to detected deficiencies? Are all deficiencies thoroughly and promptly investigated? Are corrective action plans developed? Is corrective action taken verified after implementation? When identified, are overpayments promptly re-paid and disclosed appropriately?

117 Assessing the Seven Elements 7. Enforcement of Disciplinary Standards Key questions : Are disciplinary standards well publicized? Are disciplinary standards consistently enforced and documented? Are employees, contractors and medical staff checked routinely against government sanction list?

118 Assessing the Seven Elements In Sum, while no single factor is conclusive of an effective compliance program, the preceding seven areas form a useful starting point for developing and maintaining an effective compliance program.