Transcript Roadmap for an Effective Compliance and Ethics Program

Recipe for a Healthy Compliance Diet
Health Law/Labor & Employment
Law Institute
August 23, 2012
John H. Fisher, II, JD, CHC
Pictures from the National
Archives
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Attributes of a Healthy Diet
Healthy/Nutritious
Appropriate Portions
Delicious
Sustainable
Organic
Consistent
Exercise
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Consequences of Unhealthy Diet
Bad Health
Increased Risk Factors
More Illness
Trips to the Doctor
Eventually Catches Up
Serious Illness
Morbidity
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What?
Guilty of a kickback without specific intent?
Individual criminal/exclusion liability based on position?
Suspension of payment on “any credible allegation of
fraud?”
False Claims Act applied to health care?
FCA penalties applied to overpayments you should have
known about but didn’t
Use of data mining and extrapolation back for 10 years?
What is going on here?
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CMS Statement – 60 Day Rule
We believe defining ‘‘identification’’ in this way
gives providers and suppliers an incentive to
exercise reasonable diligence to determine whether
an overpayment exists. Without such a definition,
some providers and suppliers might avoid
performing activities to determine whether an
overpayment exists, such as self-audits, compliance
checks, and other additional research.
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What is a Compliance Program?
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Prevention, detection, collaboration, and
enforcement
System of policies and procedures
Systems to detect compliance problems
Proactive risk identification
Knitted into the fabric of the organization
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commitment to an ethical way of conducting business
system for doing the right thing
Not a guarantee of perfect compliance
Builds upon itself
If you take your compliance plan off
of the shelf and the dust triggers your
allergies, you might just have a
compliance problem.
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Federal Sentencing Guidelines
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Aggravating factors
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Upper-level employee
Repeat offense
Hindrance during
investigation
Awareness and tolerance of
the violation was pervasive.
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Mitigating factors
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Effective compliance
program
Self-reported violation
promptly
Cooperated in investigation
Accepted responsibility
Importance To Regulators
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Health Care Fraud is a very high priority to regulators
Return on Investment Mentality
OIG Annual Work Plan – source of modification and
focus for compliance plan
Trend Toward Holding Individuals Responsible
Suspension of Payment – Reasonable Allegation of
Fraud
60 Day Repayment - Knowledge
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“Legal” Motivators
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False Claims Act Liability
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3X plus up to $11,000 per claim
60 day return of overpayments
Failure = False Claim
Whistleblowers
Park Doctrine
Caremark Decision
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CMS Statement – 60 Day Rule
We believe defining ‘‘identification’’ in this way
gives providers and suppliers an incentive to
exercise reasonable diligence to determine whether
an overpayment exists. Without such a definition,
some providers and suppliers might avoid
performing activities to determine whether an
overpayment exists, such as self-audits, compliance
checks, and other additional research.
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Top Ten Reasons To Create a Compliance Program
10. Compliance Programs Are Cost
Effective
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Top Ten Reasons To Create a Compliance Program
9. Risk Prevention
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Top Ten Reasons To Create a Compliance Program
8. Identification of Under-billing
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Top Ten Reasons To Create a Compliance Program
7. Enhancement of Quality of Care
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Top Ten Reasons To Create a Compliance Program
6. Communicate Commitment to
Compliance
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Top Ten Reasons To Create a Compliance Program
5. Avoid Government Imposed CIA
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Top Ten Reasons To Create a Compliance Program
4. Reduce threat of whistleblower lawsuits
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Top Ten Reasons To Create a Compliance Program
3. Avoid Astronomical Fines & Penalties
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Top Ten Reasons To Create a Compliance Program
2. Protect individuals from liability
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# 1 Reason – Compliance Programs are Mandatory
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PPACA Made Compliance Programs Mandatory
Nursing Facilities Beginning March 2013
Condition of Participation
Certify Effective Compliance Program
CMS to Issue Regulations
Will providers get the message?
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New York experience
60 Day Knowledge Requirement
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Overpayment Becomes a False Claim
60 Days After Knowledge
“Reckless Disregard”
If No Compliance Program and Program Would Have
Identified The Problem?
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Is this a reckless disregard?
We will see a case like this
ZPIC Practices
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Like a scene from an old gangster movie
Regulatory Agencies
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“No Compliance officer can master all applicable
rules, regulations, codes”
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“All providers will eventually be called upon
to defend the effectiveness of their
compliance program.”
Effective Compliance Programs
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Can you convince a third party?
Comprehensive (Scaled)
Up to date – Laws change rapidly
Integrate OIG Compliance Guidance
Continued “living and breathing” process
Provide for continuous process of feedback and
integration
Effectiveness Cycle
Program
External
Review
Corrections
Outcome
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Measuring Effectiveness
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Process Review
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All seven 8 elements included in the program
Structure in place
Compliance officer, qualified, no conflicts etc.
Compliance work plan
Compliance budgeting process
Compliance topics on department/organization agendas
Employees being trained
Risks being identified
Hotline in place
Reports being addressed
Board engagement
Measuring Effectiveness
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Outcomes Review
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Indications that the process is working
New risk areas identified
Comparing issues year to year
Tracking corrective actions
Reviewing concurrent audits
Educational session pre-and post-tests
Tracking “bill denials”
Organizational survey results
Audit results
Effectiveness Self Assessments
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Time limitations
Resource limitations
“We have good people”
It couldn’t happen here
Fox guarding the hen-house
It is legal’s job
Auditor independence
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External Program Review
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Independence
Detailed Due Diligence Process
Management/Director Interviews
Gap Analysis
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Beware of creating a roadmap
What is reasonable for the size and nature of the
organization
Due Diligence Checklist
DOCUMENT
STANDARDS & OVERSIGHT
Code of Conduct
EXISTS
YES
COPIED
YES
NO
Compliance Budgeting Process/Line Items
YES
Compliance Committee Structure
YES
Compliance Officer Appointment
YES
Compliance Officer Job Description
YES
Compliance Plan Document
YES
Compliance Reporting Structure
YES
Education of Board on Compliance Duties
YES
Historic Compliance Reports to Board/Compliance Committee
YES
Initial Baseline Audits
YES
Process for Communicating Code of Conduct
YES
Records Relating to the Development of a Compliance Program
YES
Risk-Scoring Process
YES
Statements from Administration re: Compliance
YES
YES
NO
YES
NO
NO
YES
NO
YES
NO
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YES
NO
YES
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YES
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YES
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YES
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YES
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YES
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YES
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YES
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YES
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YES
INDEXED
NO
YES
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YES
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YES
NO
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HOTLINE/COMPLIANT PROCESS
Alternative Communication of Hotline (i.e., newsletters, etc.)
YES
YES
NO
Call Logging Process & Forms
YES
YES
NO
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YES
NO
NO
YES
NO
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Effectiveness Checklist
YES
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WRITTEN POLICIES & PROCEDURES
CODE OF CONDUCT/ETHICS – embodies compliance expectations
1.1 Are compliance expectations included in a written code of conduct or
code of ethics?
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Code approved by governing board?
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Code created under auspices of person designated by the
board?
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Clear & non-technical to be understood by all?
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Details fundamental principles, values, and framework for
action
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Articulates compliance commitment
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Brief, easily readable, and broadly applicable
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Identifies expectations and mechanisms for employees and
managers to report in response to violations
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Identifies consequences of failures
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Includes compliance goals and performance expectations for
managers
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Does code include these major topics?
Billing/Claim Filing
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Payments
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Quality of Care
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Governance
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Mandatory Reporting
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Credentialing
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EVIDENCE OF
COMPLIANCE
DISCUSSION
Written Effectiveness Report
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Define Scope
Identify Weaknesses
Suggest Enhancements
Attorney/Client Privilege Issues
Be Careful of the “Roadmap”
Suggesting Everything Is Easy
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7 Key Elements – Process Assessment Focus
1. Policies & procedures
2. Oversight & leadership
3. Education & training
4. Auditing & monitoring
5. Reporting & investigating
6. Enforcement & discipline
7. Response & prevention
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8th - Risk Assessment
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Federal Sentencing Guidelines
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The organization shall…[a]ssess the risk that criminal conduct will
occur
Identifying Risk
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Proactive not Reactive
Compliance Cycle
Interviews and Questionnaires
Declined Reimbursement
External Sources
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OIG Work Plans
Fraud Alerts
Compliance Guidance
Advisory Opinions
Etc.
Ranking and Prioritizing
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Risk Scoring
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Likelihood vs. Consequences
Clearly Illegal Activities
Prioritize Risk Areas
Place In Yearly Compliance Work Plan
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Review or Audit
Compliance Timeline
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Based On Prioritized Risk
Schedule Out Activities
Estimate Costs – Budget
Impossible To Do Everything
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Be Prepared To Show Risk Area Is On Your Schedule
Need To Show Process Not That Every Problem Discovered
Budgeting
Separate Compliance Budget
Costs Can Be Ascertained Through a Process
Savings Are Less Tangible
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Budgeting Process
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Scope and Goals of Plan
Known Risk Areas
Risk Scoring and Prioritization
Annual Compliance Plan
Who should be included in the Compliance
Program?
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Board of Directors
Oversight Committee
Executive Team
Compliance Officer
Managers & Supervisors
Physicians
Staff
Board of Directors
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Critical to the Program success due to their
involvement
Duty to oversee compliance
Understand the Program background and
approval of program
Periodic updates
Education
Tone from the top should not be ZZZZZzzzzz
Compliance Oversight Committee
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Leverage existing talent
Integrates various perspectives:
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Operations, finance, audit, HR, utilization review,
social work, medicine, coding and legal
Employees and managers of key operating units
Compliance Oversight Committee
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Set goal and objectives
Assist in implementation & operation of the
compliance program
Advise the Compliance Officer
Review reports & recommendations from the
Compliance Officer
Annual review & evaluation of the program
Meets monthly or quarterly
Compliance Officer
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Reports directly to the Board of Directors
Authority to make decisions
Communicator
Operational responsibility
- Management of daily compliance operations
- Implementation of each compliance element
Dual Role Compliance Officers
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Should not be or report through legal or CFO
OIG Position
Corporate Integrity Agreements
Medicare Advantage Regulations
Tenet Health Care
Ethical Obligations
Is The Program Effective?
“Apparently, neither Tenet nor its General
Counsel saw any conflict in his wearing two hats
as Tenet’s General Counsel and Chief
Compliance Officer…’
“It doesn’t take a pig farmer from Iowa to smell
the stench of conflict from that arrangement.”
Senator Grassley – July 2004
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Managers & Supervisors
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Leverage Enterprise-Wide Talents
Written Statement
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Goals & objectives for individuals and work units
Periodic performance reviews
System of rewards & recognition of contribution
Corrective action or discipline policies & procedures
Physicians/Staff
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Understand compliance as a necessity
Building trust to facilitate change
Buy-in is the key to succeed
Keep Commitment
Communicate both good & bad news
Allow frustrations to ventilate
Policies & Procedures
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Guidelines for employees to follow
Decision-making structure and guidance
Weave standards into everyday practice
Elevate principles into business relationships
Confirmation of institutional commitment to
compliance
Policies & Procedures
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Plain language to foster clear understanding
Multi-lingual
Consistency with other policies and procedures
Confirmation of Employee understanding
Documented education and training
Employee attestations
Education & Training
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A general session for all employees- to heighten
awareness among all employees, 1 to 3 hours annually,
along with code of conduct and attestation (web based)
Second session covering more specific information for
appropriate personnel
Written annual education plan
Important to be communicated from the top
Internal vs. External
Mandatory vs. Voluntary
Education assessment
Auditing & Monitoring
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On-site visits (Compliance SWAT teams)
Interviews and Questionnaires
Reviews of Medical and Financial records
Reviews of policies and procedures
Trend analysis
Including Compliance language in job
description
Posing compliance-related questions in exit
interviews
Reporting System
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Create an Open Door On Compliance Issues
Assurance Against Retaliation
Confidentiality to the Extent Possible
Hotline
Other Methods
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Drop Box
Difficulty In Small Organization
Compliance Handling
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Prompt and Consistent
Assess Seriousness
Document – Complaint Log
Investigate
Follow-up to Resolution
Time limited
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60 Days
Elder Justice (4 hours)
Response and Prevention
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Meet with In-house or outside counsel
Develop appropriate plan of action
Internal investigation (attorney-client privilege)
Team to meet before and after investigation
Final report within 60 days but within 30 days
to avoid stricter fines
Voluntary disclosure
Enforcement and Discipline
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Fair, equitable, and consistent.
Written policy describing discipline
Progressive discipline
Documentation
An outline of disciplinary procedures
The parties responsible for appropriate action
Discipline must be fair and consistent
Discipline
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For Compliance Breaches
Failure to Report Known Compliance Breaches
For Violation of Anti-Retaliation Policies
Unexpected Visits
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Procedure In Place
Who Is In Charge?
Who Should Be Called?
Employee Responsibility Spelled Out
Obstacles to an Effective Compliance Program
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We have good, honest people
Don’t have time for compliance
Commitment and buy-in
Lack of funding
Too many roles for the compliance officer
Interpreting laws and regulations
Lack of education and training
Resistance to change
Fear of retaliation/retribution
No internal enforcement
Living, Breathing Process
A compliance program is never finished; it
should always be a work in progress.
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©2012 Ruder Ware, L.L.S.C. Accurate reproduction with
acknowledgment granted. All rights reserved.
This document provides information of a general nature
regarding legislative or other legal developments. None of
the information contained herein is intended as legal advice
or opinion relative to specific matters, facts, situations, or
issues, and additional facts and information or future
developments may affect the subjects addressed.
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John H. Fisher, II, JD, CHC
Health Care Counsel
Ruder Ware
Wausau and Eau Claire, Wisconsin
[email protected]
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