1. Defining An Effectiveness Standard
Debbie Troklus
Lori S. Richardson Pelliccioni
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2. LSRPelliccioni (copyright 2000)
There Is No Question...
Health Care Compliance
Is Here To Stay!
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3. LSRPelliccioni (copyright 2000)
The Only Question Is...
What Form Will It Take?
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4. Current Health Care Environment
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5. The Current Health Care Compliance Environment
Approximately 80% of all health care providers have some form of a compliance program in place
No 2 compliance programs are alike
There is no “in-practice standard” for what a compliance program should entail
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6. Reasons for implementing health care compliance programs:
Fear of investigation or prosecution
Mitigate risk of qui tam actions
Mitigate risks of shareholder type lawsuits
Business reasons - potential for significant financial liability
Reputation in the community
“Do the right thing”
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7. Goal for corporate compliance programs
to “[cause] organizations to exercise due diligence in seeking to prevent
detect criminal conduct by its employees and other agents.” (56 Fed. Reg )
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8. Goal for corporate compliance programs (cont.)
“Due diligence” definition:
An organization has exercized “due diligence if it has has instituted a corporate compliance program that, at a minimum, includes the following seven (7) components:
compliance standards and procedures
oversight responsibilities
delegation of authority
training and education
monitoring and auditing
enforcement and discipline
response and prevention.
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9. LSRPelliccioni (copyright 2000)
Industry Response
Flurry of compliance program development and implementation:
Goal: to MITIGATE intent and corporate integrity agreement provisions
Cost: SIGNIFICANT
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10. TODAY’S Compliance Programs
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11. Compliance Program Model - TODAY
7 Elements:
 compliance standards and procedures
 oversight responsibilities
 delegation of authority
 training and education
 monitoring and auditing
 enforcement and discipline
 response and prevention
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12. Basis for TODAY’s Compliance Model
Federal Sentencing Guidelines
U.S.Department of Health and Human Services’ Model Compliance Programs
Experience and Opinion
Anecdotal Evidence
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13. Issues re: TODAY’s Compliance Programs
Ambiguity re: defining the 7 elements
No measurements to assess performance on the 7 elements
No standard against which to measure performance
Prosecution continues/increases despite compliance programs
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14. The Government “Raises the Bar”
Lewis Morris, the United States Department of Health and Human Services’ Assistant Inspector General for Legal Affairs
opined that protecting the integrity of federally funded health care programs in the next century would require a “joint government-industry effort”
defined “joint government-industry effort” as requiring health care organizations to implement “effective” compliance programs in their practices in order to self-police against health care fraud.
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15. The Government “Raises the Bar” (cont.)
June Gibbs Brown, the United States Department of Health and Human Services’ Inspector General stated:
“The existence of an effective compliance plan provides evidence that any mistakes were inadvertent, and this evidence would be considered in determining whether a medical practice or health care entity has made reasonable efforts to avoid and detect misbehavior”
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16. Issues re: Effectiveness
No evidence regarding what works and what does not work
No empirical studies
No “controlled trials”
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17. Issues re: Effectiveness (cont.)
General Accounting Office’s report “Early Evidence of Compliance Program Effectiveness is Inconclusive” (April 1999):
Purpose of the study was to determine the extent to which effectiveness can be measured and " how effective these programs are",
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18. Issues re: Effectiveness (cont.)
Conclusion: no satisfactory conclusions could be reached
“The principal measure of a compliance program's effectiveness is its ability to prevent improper Medicare payments. However, it is difficult to measure effectiveness in this way because of the lack of comprehensive baseline data and the existence of many other factors that could affect measurement results… However, [the preliminary evidence gathered in the study] does not demonstrate that compliance programs have reduced improper Medicare payments.” 14
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19. Health Care Compliance TOMORROW
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20. Compliance Program Model - TOMORROW
 Compliance standards and
procedures
 Oversight responsibilities
 Delegation of authority
 Training and Education
 Monitoring and Auditing
 Enforcement and Discipline
 Response and Prevention
Effectiveness
Definitions
Measurements
Definitions
Measurements
Industry Standard
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21. What Is “Effectiveness” ?
Federal Sentencing Guidelines & June Gibbs Brown:
prevent and detect criminal conduct
prevent and detect violations of Medicare laws and regulations
increasing employee awareness
creating a centralized source for distributing information on compliance
developing procedures that allow prompt, thorough investigation of misconduct
developing methodology that encourages employees to report problems
identifying and preventing criminal and unethical conduct
concretely demonstrating to employees and the community strong commitment to honest and responsible conduct
improving the quality of patient care
mitigating against wrongful intent
mitigating penalties and reducing requirements contained in a Corporate Integrity Agreement
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22. Compliance Literature
18,381 articles :
2,693 - Dow Jones Interactive
1,699 - Lexis/Nexis
13,989 - Current Contents Catalog
Search terms: compliance program(s), corporate compliance, compliance effectiveness, corporate integrity agreement(s), and Federal Sentencing Guidelines
Articles addressed compliance programs and compliance effectiveness in health care, environmental, banking, defense and insurance industries
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23. Compliance Literature (cont.)
Substantive Breakdown:
Compliance Elements - ~ 65%
STANDARD OF CONDUCT
OVERSIGHT RESPONSIBILITY
EDUCATION & TRAINING
LINES OF OMMUNICATION
AUDIT & MONITORING
ENFORCEMENT & DISCIPLINE
RESPONSE & PREVENTION
Effectiveness - ~ 25%
Other - ~ 10%
COMPLIANT BEHAVIOR, STATISTICS & SURVEYS, PROGRAM DEVELOPMENT, ETHICS, FEDERAL SENTENCING GUIDELINES
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24. The Compliance Effectiveness Project
Empirically-based research study
In collaboration with Faculty from UCLA School of Public Health, Department of Health Services
Funded by PricewaterhouseCoopers, LLP
Expected to be completed July/August 2000
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25. Forms of TOMORROW’s Compliance Programs
Objective Standard Based on Empirical Evidence
Regulatory Ethics Program
Proactive
Process Oriented
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26. LSRPelliccioni (copyright 2000)
Conclusion
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27. Conclusion - Yesterday’s
The Government Will Go Away When
It is Convinced That The Industry Is
Successfully Policing Itself!
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28. LSRPelliccioni (copyright 2000)
Conclusion - TODAY
The Health Care Industry Must Take
It Upon Itself To Develop a Compliance
Program Standard That The Government
Accepts and Affirmatively Adopts!
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