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Compliance 101

Debbie Troklus, CHC, University of

Louisville, School of Medicine

and Greg Warner, Mayo

Clinic

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Why Compliance Programs Are Essential

Communicate Organization’s CommitmentRaise AwarenessMitigating FactorAvoid CIAReduce Threat of Qui-Tams

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Compliance ProgramsHow Comprehensive Should They Be?Medicare Billing ComplianceEmployment/Labor LawEMTALASafetyHIPAAResearchOther Federal &/or State Laws

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How to Prevent Qui Tam Suits

Create an atmosphere that encourages compliance

Set up a hotline

Listen to employees

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A Compliance Program Provides:

EducationPreventionEarly DetectionCollaborationEnforcement

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What Is a Compliance Program?

Recommended by the GovernmentEthical and proper way to do businessCommitmentEncourage problems to be reportedA process with constant monitoring

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Who Needs a Compliance Program?Physician PracticesHospitalsLaboratoriesTeaching InstitutionsDME DistributorsHome Health Agencies/ HospicesOthers

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Organizational Steps to an Organizational Steps to an Effective Compliance ProgramEffective Compliance Program

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Gain Support / Commitment

BoardManagementProvidersStaff

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Financial Support

Development/Start-upEducational MaterialsStaffingOngoing Operations

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Develop Code of Conduct

Organizations ethical attitudeAddress weak areasLetter of endorsementChain of command

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Identify Staffing Needs

Appoint compliance officerDevelop job descriptions for staff

Supply vs. demandOversight CommitteeCounsel

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Conduct Internal Assessment

What is an assessment?Employee interviewsIdentify risk areas

– What is currently occurring?– Who is responsible?– What is the information flow?– What are areas for concern?

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Develop Mission and Goals

AchievableMeasurableCommunicate

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PDCA

PlanDo

CheckAct

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Continuous Improvement

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Case Study (30 min)

You are a new Compliance Officer and charged with implementing a compliance program over the next year. Develop a timeline for implementation along with an organizational chart.(“Regional Health System” 450 bed teaching hospital, two physician practices located within a 50 mile radius and one nursing home two blocks from the hospital)

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Seven Essential Elements of a Compliance PlanStandards and ProceduresOversightEducation and TrainingMonitoring and AuditingReportingEnforcement and DisciplineResponse and Prevention

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Standards and Procedures

Code of ConductKeep It SimpleOutline specific legal dutyAttestation

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Oversight

Compliance OfficerOversight CommitteeOther CommitteesBoard

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Education and Training

Communication ProcessInternal Vs. ExternalMandatory Vs. VoluntaryWeb Based TrainingSanctions

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Monitoring and Auditing

Program EffectivenessInternal “Audits”Compliance “Reviews”Outline Audit ProceduresStaff Training

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Reporting and Investigation

HotlinePolicies and Procedures

No Retribution for Reporting– Privacy and confidentiality

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Enforcement and Discipline

Sanctions for non-compliant behaviorConsistencyStand firmOIG sanctions reviews

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Response and Prevention

Internal InvestigationIs it really a problem?How serious is it?Are their enough facts to investigate?

Contact CounselInterviewCreate Policy

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Government Released Programswww.dhhs.gov/oig

Laboratory Hospital Home Health DMEHospice Nursing FacilitiesMedicare + ChoicePhysician OfficesThird Party Billing

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Health Care Fraud Efforts Continue

Enforcement environment --heightened scrutiny

Enforcement activity – Recoveries

Enforcement weapons

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Compliance Program Elements Where is your program?Federal Sentencing Guidelines l991

CEO and Board Oversight– Frequency of Reporting– Governance structure

Ownership-senior level down– Are sufficient resources allocated?– Are the compliance elements

integrated into performance? – How are compliance issues

reported and handled?Compliance Officer

– Is your CO still the “right fit”?– Personal & Professional Risk

OversightResponsibilities

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Compliance Program Elements(cont)

Discretionary authority delegated appropriately

Background checks

Due CareResponsibilities

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Additional “Due Care” Information

Identifying Arrangements with Sanctioned Providers

– Healthcare Integrity and Protection Data Bank

– OIG’s Cumulative Sanction List

– The GSA’s Department List

– Licensing and Certification Bodies at the State Level

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Compliance Program Elements (cont)

Are risk areas identified and policies developed?

Policy and procedure verification.

Policies “reduce” the prospect of criminal conduct?

Continuous evaluation.

ComplianceStandards andProcedures

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Compliance Program Elements(cont)

Commitment still present?Training geared to increasing

compliance knowledge of employees?

Training for high risk areas all covered?

Training incorporated into day to day business aspects?

Proof and documentation

EmployeeTraining

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Compliance Program Elements(cont)

Have you got an auditing plan?

Audit methodology, what type of audits are being done?

Has your program gone beyond the “process” audits?

Proactive vs. reactive audits

Monitoring andAuditing

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Compliance Program Elements(cont)

Audit strategy – protection of

workpapers and findings.

Results Reporting

Corrective Action and

verification.

Monitoring andAuditing

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Compliance Program Elements(cont)

Appropriate and consistent disciplinary mechanisms in place

Tracking system developed for disciplinary actions

Enforcement andDiscipline

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Compliance Program Elements(cont)

Appropriate and

consistent Reponses

Awareness of roles and

responsibilities

Disciplinary measures

Response andPrevention

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Summary

HCCA’s Annual Survey Summary Results

Benchmarking

Effectiveness Evaluations