Program Efectiveness: A Resource Guide

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Measuring ComplianceProgram Effectiveness:A Resource GuideISSUE DATE: MARCH 27, 2017HCCA-OIG Compliance Effectiveness RoundtableRoundtable Meeting: January 17, 2017 Washington, DC

Measuring Compliance Program Effectiveness – A Resource GuideHCCA‐OIG Compliance Effectiveness RoundtableRoundtable Meeting: January 17, 2017Washington DCIntroductionOn January 17, 2017, a group of compliance professionals and staff from the Department of Health and Human Services, Office of InspectorGeneral (OIG) met to discuss ways to measure the effectiveness of compliance programs. The intent of this exercise was to provide a largenumber of ideas for measuring the various elements of a compliance program. Measuring compliance program effectiveness is recommendedby several authorities, including the United States Sentencing Commission (see, Chapter 8 of the United States Sentencing Guidelines). This listwill provide measurement options to a wide range of organizations with diverse size, operational complexity, industry sectors, resources, andcompliance programs.During the meeting on January 17, the participants broke into 4 groups of 10 attendees to discuss 2 elements of a compliance program at a time.During four sessions, every participant had a chance to suggest ideas about “what to measure” and “how to measure” with respect to all sevenelements of a compliance program. We used the following categories, from the Health Care Compliance Association’s CHC Candidate Handbook:Detailed Content Outline, as a guide to ensure that all elements of a compliance program were covered:Compliance Program Elements:1.2.3.4.5.6.7.Standards, Policies, and ProceduresCompliance Program AdministrationScreening and Evaluation of Employees, Physicians, Vendors and other AgentsCommunication, Education, and Training on Compliance IssuesMonitoring, Auditing, and Internal Reporting SystemsDiscipline for Non‐ComplianceInvestigations and Remedial MeasuresWe have listed below many individual compliance program metrics. The purpose of this list is to give health care organizations as many ideas aspossible, be broad enough to help any type of organization, and let the organization choose which ones best suit its needs. This is not a“checklist” to be applied wholesale to assess a compliance program. An organization may choose to use only a small number of these in anygiven year. Using them all or even a large number of these is impractical and not recommended. The utility of any suggested measure listed in1

this report will be dependent on the organization’s individual needs. Some of these suggestions might be used frequently and others onlyoccasionally. The frequency of use of any measurement should be based on the organization’s risk areas, size, resources, industry segment, etc.Each organization’s compliance program and effectiveness measurement process will be different. Some may not apply to the organization’senvironment at all and may not be used.Any attempt to use this as a standard or a certification is discouraged by those who worked on this project; one size truly does not fit all.Element 1: Standards, Policies, and ProceduresA. Conduct periodic reviews of policies, procedures, and controls.B. Consult with legal resources.C. Verify that appropriate coding policies and procedures exist.D. Verify that appropriate overpayment policies and procedures exist.E. Integrate mission, vision, values, and ethical principles with code of conductF. Maintain compliance plan and program.G. Assure that a nonretribution/nonretaliation policy exists.H. Maintain policies and procedures for internal and external compliance audits.I. Verify maintenance of a record retention policy.J. Maintain a code of conduct.K. Verify maintenance of:1. A conflict of interest policy2. Appropriate confidentiality policies3. Appropriate privacy policies4. Policies and procedures to address regulatory requirements (e.g., the Emergency Medical Treatment and Labor Act (EMTALA), Clinical LaboratoryImprovement Amendments (CLIA), Anti‐Kickback, research, labor laws, Stark law).L. Verify appropriate policies on interactions with other healthcare industry stakeholders (e.g., hospitals/physicians, pharma/device representatives, vendors).M. Assure policies and procedures address the compliance role in quality of care issues.N. Verify maintenance of a policy on gifts and gratuities.O. Verify maintenance of standards of accountability (e.g., incentives, sanctions, disciplinary policies) for employees at all levels.P. Maintain a Compliance Department operations manual.Q. Verify maintenance of policies on waivers of co‐payments and deductibles.R. Assure governance policies related to compliance are appropriately maintained.Source: CHC Candidate Handbook: Detailed Content Outline2

Element 1: Standards, Policies, and ProceduresWhat to MeasureHow to MeasureAccess:Accessibility 1.2Actual AccessAudit how many actual "hits" on policies and procedures1.3Accessible language for code, standards and policiesFlesch Kincaid measuring standard – no more than 10th grade reading level1.1 1.4Review link to employee accessible website/intranet that includes the Code of ConductSurvey ‐ Can you readily access or reference policies and procedures? (Yes/No/Don't know)Survey ‐ How and where do employees actually access policies and procedures?Test key word search (searchable)Audit and interview staff to show policiesSurvey employees to determine the extent to which the code of conduct and othercompliance communications are available to employeesReview to ensure the standards, policies, and awareness material is updated and distributedwithin organization’s guidelinesCompliance program awareness and communication 1.5Impaired or disabled accessibilityReview accessibility options. Look at methods and speak to individuals.1.6Policy communicationCommunication strategy of policies1.7Availability of policy contentConduct surveys and Policy Coordinator designatedOwnership and accountability of policiesAudit process of how policies get enforced by chain of command when compliance is not the finalapprover. Is management taking responsibility for implementing and following policies?Routine policies and proceduresConfirm that listed owner of each policy and procedure is the actual owner.3

Review/Approval Process:1.11Annual review and Board approval of CompliancePlanAudit: Review of Board minutes1.12Compliance documentation operations manualCompliance or other oversight committee to review annually to ensure it is up to date.1.13Maintenance of policiesCheck last review or revisionNumber of policies reviewed and is the review timelyProcess review/audit. Use checklist to ensure all basic policy elements are in place, updatedconsistently and reviewed/approved by appropriate parties.Policy approvalsChecklist audit. Create list of policies, review committee and board minutes to ensure allapprovals have been obtained.1.16Policy review processAudit process by which policies and procedures are prepared, approved, disseminated, etc.1.17Process for ensuring full organizational participationin policy and procedure developmentReview documentation/minutes to verify input considered and solicited for policy and proceduredevelopment and review1.18Process for review and approvingCheck for written process1.141.15Quality:1.19Are policies (and procedures) as good as industrypractice1.20Integrity of Process for developing and implementingAudit policy and procedure on policy and procedurespolicies and procedures1.211.221.23Peer reviewsLanguage and reading level of policiesAre policies written in plain language, appropriate grade reading level and written in applicablelanguages for organization? Policy review, Word grade level review and interviews of staff tomake sure they understand.Language translationAudit or process review. Are policies and the code of conduct translated into appropriatelanguages for organization?UsefulnessSURVEY ‐ Do department policies and procedures assist you in doing your job effectively?(Yes/No/Don't know)4

1.24Need for policies that don’t existInterview staff to determine if they need the certain policies to strengthen internal controls.1.25Policies and proceduresRequest review from external expertsAssessment:1.26Assessment of all company policiesCheck list of policies; which are compliance and which are business1.27Essential compliance policies and procedures existCan staff actually articulate policies and procedures; test staff1.28Existence of procedure to support policyAudit for procedure to support policyFundamental policies and procedures in placeHave focus groups of work units/departments to determine whether they understand the policiesand procedures necessary to do their jobs.Identifiability 1.31List of policies are applicable to employeesSupervisors to assess direct staff1.32Are those affected by policy given the opportunity toFocus groups and interviews of those affected by policy.weigh in on policy when developed?1.33List of required policiesCreate checklist to make sure minimum policies are in place and then audit against the list.1.34Effectiveness of policiesEffectiveness of policies based on the submission hotline callsPolicies and procedures that have been identified aspart of corrective actionProcess review. Conduct annual meeting with compliance and legal to look at databases andcontrol and prioritize review to ensure implementation and ongoing compliance with policies andprocedures.1.36Policies for high risk and operational areasAudit1.37Policies, standards and procedures are based onassessed risksRisk assessment, policy exists for each risk identified in the risk assessment (coverage of a specificrisk topic)1.38Policy inventory to ensure no overlap andcontradiction of policiesCreate inventory and analyze inventory. Analyze and review past efforts. Look at variousdepartments that might have overlapping policies.Policy review following investigation/issueTop policies implicated in an investigation are reviewed to determine if policy ambiguous,complex, fails to adequately safeguard issues. Validate through audit.1.291.301.351.39Index of policies available and currentNumbered policies, not just titles5

1.40Routine policies and procedures are addressed andfilter down.Review department and committee agendas to ensure policies are addressedCode of Conduct:1.411.421.431.44Code of ConductAudit: Review dates, board approvals, distribution processes, attestations, survey employees forunderstanding, conduct focus groups.Compliance program awareness and communicationSurvey employees to determine the extent to which they know the content of the Standards ofConduct (SOC) and how to access it.Integrate mission, vision, values, and ethicalprinciples with code of conductCompare code with mission and vision statements to see if it includes elements/statements. Checkto see if code is accessible to employeesMaintenance of code of conductIs code written, posted for employees, documented frequency of reviews, and survey/testemployees on ability to locate itDistributionDocumentation of Code of Conduct distribution tracking and results over past two years for allemployees, employed physicians, allied health professionals, independent (contracted) physicians,volunteers and vendors/contractor/consultants in the organizationOrientationAudit to ensure all employees receive orientation to the SOC and compliance policies within 30days of hire.Staff understanding of code of conduct and policiesand procedures 1.451.461.47Review test scores after training.Conduct interviews.Updates:1.481.491.50Compliance program communication of rule changesReview periodically and at rule changes – Audit to ensure there is adequate communication toemployees, including changes in policy/procedure.New and updated policy distribution and educationof appropriate staffProcess review ‐ Does organization have formal process to make workforce aware of new policiesor changes in policies?Practices implemented after new policyAudit practices and review committee minutes and other documentation to determine how newpolicies are implemented.Understanding:1.51Understanding of Policies/Procedures Conduct surveys and/or focus groups on specific policies6

1.521.531.541.55Audit adherence to policy/procedureOrientationEnsure employees are provided instruction by knowledgeable personnel for questions/clarityPolicies reflect practiceUse policies as audit tool and then interview, observe and conduct document review to ensurepolicies are being followed.Questions asked by employeesSystem in place to track employee questions and concerns to ensure consistent guidance. Trackdepartments where questions come from to deploy additional education where necessary.Understandable to board and c‐suiteTest board and c‐suite on location and understandingUnderstandable to employees 1.56Reading comprehension testSituational testsTest of locationCompliance Plan:1.571.58Maintain compliance plan and programReview written plan or written schedule of compliance activitiesMaintain compliance department operations manual Audit existence of written manual, handbook, or reference guideTest whether the manual is current Audit procedure for obtaining confidentiality statements from employeesAudit employee files for signed confidentiality statements from employeesConfidentiality Statements:1.59Verify maintenance of appropriate confidentialitypoliciesEnforcement:1.60Compliance with policiesConduct interviews, observation.1.61Policy violationsAudit policy and procedures to make sure practice consistent with policy.1.62Adherence to policies and procedures for casesinvolving patient harm and reporting to regulatoryagencyReview policies and procedures and cases involving patient harm and validate proper reporting toregulatory agency7

Element 2: Compliance Program AdministrationA. Maintain a compliance budget (e.g., contribute to planning, preparing, and monitoring financial resources).B. Report compliance program activity to the governance board/committee.C. Coordinate operational aspects of a compliance program with the oversight committee.D. Collaborate with others to institute best compliance program.E. Coordinate organizational efforts to maintain a compliance program.F. Define scope of compliance program consistent with current industry standards.G. Assure that the compliance oversight committee’s goals and functions are outlined.H. Evaluate the effectiveness of the compliance program on a periodic basis.I. Maintain knowledge of current regulatory changes and interpretation of laws.J. Assure the credibility and integrity of the compliance program.K. Recognize the need for outside expertise.L. Oversee a compliance education program.M. Verify the organization has defined the authority of the compliance officer at a high level.N. Verify the governing board understands its responsibility as it relates to the compliance program and culture.O. Assure that the role of counsel in the compliance process has been defined.P. Define the responsibilities, purpose, and function for all compliance staff.Q. Assure staffing for the compliance program.R. Verify compliance risk assessments are conducted periodically.S. Participate in the development of internal controls and systems to mitigate risk.T. Incorporate relevant aspects of regulatory agencies’ focus into compliance operations.U. Oversee integration of the compliance program into operations.V. Develop an annual compliance work plan.W. Demonstrate independence and objectivity in all aspects of compliance program.X. Maintain an independent reporting structure to the governing body (e.g., Board, Physician Practice Executive Committee).Source: CHC Candidate Handbook: Detailed Content Outline8

Element 2: Compliance Program AdministrationWhat to MeasureHow to MeasureBoard of Directors: 2.1Active Board of Directors 2.22.3Board understanding and oversight of theirresponsibilities Review of training and responsibilities as reflected in meeting minutes and other documents(training materials, newsletters, etc.). Do minutes reflect board’s understanding?Review/audit board education – how often is it conducted? Conduct interviews to assessboard understanding.Appropriate escalation to oversight body Review minutes/checklist in compliance officer files Review compliance program resources (budget, staff).Review documentation to ensure staff, board and management are actively involved in theprogram.Conduct interviews of board, management and staff.2.4Commitment from top 2.5Review minutes of meetings where Compliance Officer reports in‐person to the Audit andCompliance Committee of the Board of Directors on a quarterly basisConduct inventory of reports given to board and applicable committees.Process for escalation and accountabilityProcess review (document review, interviews, etc.). Is there timely reporting and resolution ofmatters?Compliance Budget:2.6Appropriate oversight of budgetReview charter of governing body (Board) to verify it includes approval of compliance budget2.7Budget is based on an assessment of risk andprogram improvement/effectivenessIs the Board’s approval of the budget based on identified risks and effectivenessevaluation/program improvement?2.8Sufficient compliance program resources (budget,staffing)Review budget and staffing to ensure significant risks are managed appropriatelyCompliance Committees:9

2.9Active involvement of compliance committeemembersTrack percentage of attendance of each compliance committee member over the last year2.10Assure that the compliance oversight committeegoals and functions are outlinedReview charter of committeeCommittee structureReview documentation of structure of committees as well as charters. Ensure no conflictingcharters.2.12Compliance committee composition and attendanceReview charter and minutes to assure attendance.2.13Cascade administration of compliance programthroughout the organizationDifferent operational areas give some certification/disclosure to the compliance office2.14Composition of Compliance CommitteeReview organizational chart to validate correct compositionEffectiveness of compliance committee meetingsKeep executive report card by member qualitative/quantitative with indicators of contribution ontopicsEngagementIn the last two years, have the compliance committee meetings been held in accordance with thecharter?Engagement of Directors/ManagersReview committee structure to evaluate how directors/managers are participating in ComplianceOperational Committee(s) meeting includes agenda, minutes, attendance and reports fromsubcommitteesExecutive Leadership engaged in ComplianceProgramReview frequency of meetings, membership, attendance, agenda and minutes over the past yearof the Compliance Executive Committee to include all members of the Senior Executive teamreceiving information directly from the Compliance Leadership accountabilityAudit documentation and conduct interviews. Some examples might include: Employee education completion rates Demonstration of promotion of compliance (e.g., town hall meeting presentations,newsletters, etc.) Completion of audit or review action items within established time frameManagement accountability for complianceProcess and document review and interviews. Is there a mapping of operational or management responsible for championing compliance?10

Is there a mapping of management responsible for key areas of compliance to ensureaccountability?Does top management support the compliance team? Certification (CHC, CHPC, CHRC)Annual evaluation, coaching, corrective action, professional developmentCompliance Officer:2.21Competency2.22Is the compliance officer a key stakeholder in thestrategic initiatives of the organization Review participation of compliance officer in strategic planning process and due diligenceprocesses.2.2

A Resource Guide . ISSUE DATE: MARCH 27, 2017 . . On January 17, 2017, a group of compliance professionals and stafffrom the Department of Health and Human Services, Office of Inspector General (OIG) met to discuss ways to measure the effectiveness of complianceprograms. . Audit existence of writtenmanual, handbook, or reference guide

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