As the effects of reform continue to implement changes to our nation’s health care structure, providers find themselves forced to act quickly amidst the resultant chaos. Nowhere is the confusion more apparent than when it comes to issues of compliance. Contact Craig Garner for more information (craig (at) craiggarner (dot) com) or visit http://craiggarner.com/compliance/.

1. Sample Hospital
Compliance Program
2012
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2. Table of Contents -- Compliance Program
Introduction Excluded Individuals
Basic Elements and Purpose Self Disclosure
Compliance Officer/Committee Signage Requirements
Code of Conduct HITECH Security Breaches
Compliance Policies/Procedures California Privacy Laws
Training and Education Financial Alerts
Compliance Hotline Tracing an Excluded Individual
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3. Table of Contents -- Compliance Program Resources
Media Relations CMS’ Approach
Fair Market Value Determinations Other Compliance Plans
Audits and Monitoring Independent Review Officer
Record Retention Clinical Research Compliance
RACs, MACs, MICs and ZPICs Overpayments
Quality of Care for an ACO Statutory Background
OIG 2012 Work Plan Additional Resources
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4. Introduction
Return to Table of Contents
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5. Hospital Compliance Program
Your Hospital (“Hospital”) is committed to effective internal controls that promote
adherence to applicable state and federal laws.
By doing so, Hospital:
• Demonstrates its commitment to honest and responsible corporate
conduct.
• Increases the likelihood of preventing, identifying, and correcting
unlawful and unethical behavior at an early stage.
• Encourages employees to report potential problems to allow for
appropriate internal inquiry and corrective action.
• Minimizes any financial loss to government and taxpayers through early
detection and reporting, as well as any corresponding financial loss to
Hospital.
[Statutory Authority: OIG Guidance, 70 Fed. Reg. 4858, 4859 (Jan. 31, 2005)]
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6. Hospital’s Compliance Program, Continued
• Hospital has adopted a proactive, comprehensive compliance program.
Hospital is mindful, however, that a compliance program may never
completely insulate a hospital from mistakes and potential liability.
• In the event of an overpayment, or even an allegation under the federal
False Claims Act (or a related state claim), Hospital recognizes the
importance of an existing, meaningful compliance program.
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7. Hospital’s Compliance Program, Continued
With the goal to exercise due diligence while promoting an organizational culture
that encourages ethical conduct and a commitment to compliance with the law,
Hospital adheres to the following seven essential elements in its compliance
program:
(1) Establish standards and procedures to prevent and detect violations of law
(2) Provide appropriate oversight and promote responsibility at all levels
(3) Exhibit due diligence in hiring and assigning personnel to positions with
substantial authority
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8. Hospital’s Compliance Program, Continued
(4) Communicate compliance standards and procedures to all employees, and
provide training to employees at all levels
(5) Establish procedures for monitoring and auditing, including periodic
evaluation of program effectiveness as well as non-retaliatory internal guidance
and reporting systems
(6) Employ consistent disciplinary mechanisms to promote and enforce
compliance and ethical conduct
(7) Investigate and remediate upon detecting a violation
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9. Reportable Events
Identified compliance issues that remain uncorrected may result in serious
sanctions against any hospital, including exclusion from federal health care
programs.
Hospital has established its Compliance Program so it can be followed.
In the event Hospital discovers a serious issue of non-compliance, immediate
steps will always taken to address the concern, applying a root cause analysis of
the problem.
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10. Reportable Events, Continued
Steps may include, but are not limited to, immediate referral to civil and/or
criminal law enforcement agencies, a plan of correction, a report to the OIG,
and if applicable the return of any overpayments.
The Affordable Care Act requires that “[a]n overpayment must be reported and
returned” within “60 days after the date on which the overpayment was
identified,” or “the date any corresponding cost report is due,” whichever is
later. [Statutory authority 42 U.S.C. § 1320a-7k].
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11. Hospital’s Compliance Organizational Chart
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12. Hospital’s Compliance Organizational Chart
HOSPITAL COMPLIANCE COMMITTEE
Compliance Officer,
_________, M.D./R.N.
C.E.O.
General Counsel
Privacy
CFO CIO CNO
Officer
ER Risk
HR QI
Dir. Mng't
Others as Appropriate Outside Counsel
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13. Basic Elements and Purpose
Return to Table of Contents
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14. Basic Elements of Hospital’s Compliance Program
• Compliance Plan Overview
• Compliance Officer
• Compliance Committee
• Compliance Policies and Procedures
• Confidential Disclosure Program
• Restriction of Employment for Ineligible or Excluded Persons
• Reporting of Overpayments and Other Reportable Events
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15. Basic Purposes of Hospital’s Compliance Program
• Promote Standards and Procedures
• Ensure Proper Oversight
• Educate and Train
• Report as Appropriate
• Enforce Compliance and Disclose/Discipline as Appropriate
• Monitor and Audit
• Investigate and Correct
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16. The Employee’s Role in a Compliance Program
Knowledge of the this Compliance Program is an important factor in
evaluating the performance of all Hospital employees. Hospital is committed
to periodically training employees regarding its Compliance Program,
including specifically Hospital managers and supervisors involved in any
medical claims processes. To further this goal, Hospital will:
• Discuss, as applicable, the compliance policies and legal requirements
described in this Compliance Program with all supervised personnel.
• Inform all supervised personnel that strict compliance with this
Compliance Program is a condition of continued employment.
• Inform all supervised personnel that disciplinary action will be taken,
including possible termination of employment or contractor status, for
violation of this Compliance Program.
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17. Managers and Supervisors
• Managers and supervisors will be subject to discipline for failure to adequately
instruct their subordinates on matters covered by the Compliance Program.
• Managers and supervisors will also be subject to discipline for failing to detect
violations of the Compliance Program where reasonable diligence on the part
of the manager or supervisor would have led to the discovery of a problem or
violation and thus would have provided Hospital with the opportunity to take
corrective action.
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18. Direct Reporting Obligations
An individual has “direct reporting obligations” if the individual
has express authority to communicate personally to the
governing authority “promptly on any matter involving criminal
conduct or potential criminal conduct” and “no less than annually
on the implementation and effectiveness of the compliance and
ethics program.”
[Statutory authority: 75 Fed. Reg. 27388 (May 14, 2010)]
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19. Financial Alerts
Return to Table of Contents
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20. Alerts Dashboard
Sample
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21. Charge Description Master
Sample
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22. Quality Measures
Sample
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23. Tracing an Excluded Individual
Return to Table of Contents
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24. Tracing a Hospital’s Employees
Sample
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25. Tracing a Hospital’s Employees, Continued
Sample
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26. END OF GENERAL
COMPLIANCE PROGRAM
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27. Hospital
Compliance Program Resources
2012
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28. Self Disclosure
Return to Table of Contents
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29. Criminal Offense for Non-Disclosure
Misprision (18 U.S.C. § 4) is a criminal charge against individuals “having
knowledge . . . of a felony” and conceals the felony or “does not as soon as
possible make known the same.” Individuals convicted of misprision “shall
be fined . . . imprisoned . . . or both.” The mere failure to report a known
violation is insufficient to justify a conviction for misprision. Instead, the
crime requires “active concealment.”
Medicare Fraud Statute (42 U.S.C. § 1320a-7b(a)(3): A person or entity
commits a felony where “having knowledge of the occurrence of any event
affecting his initial or continued right to any such benefit or payment, or
the initial or continued right to any such benefit or payment of any other
individual in whose behalf he has applied for or is receiving such benefit
or payment,” the person (or entity) conceals or “fail[s] to disclose” the
information with an “intent fraudulently to secure” excessive or
unauthorized payment.
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30. Other Offenses for Non-Disclosure
False Statements Relating to Health Care Matters (18 U.S.C. § 1035) and False
Statements as to Matters under Federal Jurisdiction (18 U.S.C. § 1001) make it a
crime to knowingly and willfully falsify, conceal or cover up, by any trick, device
or scheme, any material fact in a health care matter.
The Fraud Enforcement and Recovery Act (FERA, 31 U.S.C. § 3729(a)(1)(6))
makes it illegal to “knowingly conceal . . . or knowingly and improperly avoid . . .
or cause . . . an obligation to pay or transmit money or property to the
Government. This is also known as the “reverse false claim” action.
Under the Affordable Care Act, hospitals must disclose and repay overpayments
within 60 days of discovery or the overpayment may become an obligation
pursuant to the False Claims Act. [See Feb. 2012 proposed rules providing
clarification.]
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31. Exclusion for Non-Disclosure
Individuals who know, or should have known, of an overpayment and do
not report and return the overpayment are subject to exclusion. The same
is true for entities.
See Exclusion Section for additional information.
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32. OIG Self Disclosure
Hospitals who wish to voluntarily disclose self-discovered evidence of
potential fraud to the OIG may do so under the Provider Self-Disclosure
Protocol (SDP) (63 Fed. Reg. 58,399).
By self-disclosing, hospitals have the opportunity to avoid the costs and
disruptions associated with a Government-directed investigation and civil
or administrative litigation.
However, under the United States Sentencing Guidelines, a company
cannot receive any reduction in a sentence for an effective compliance
program if high-level personnel within the company “participated in,
condoned, or were willfully ignorant” of the criminal offense committed by
the organization.
See OIG’s March 24, 2009 Open Letter to Health Care Providers.
See self-disclosed settlements with the OIG.
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33. Medicare Self-Referral Disclosure Protocol
The Medicare voluntary self-referral disclosure protocol (“SRDP”) sets
forth a process to enable providers of services and suppliers to self-
disclose actual or potential violations of the physician self-referral statute.
The Stark laws prohibit:
(1) a physician from making referrals for certain designated health
services (“DHS”) payable by Medicare to an “entity” with which he or she
(or an immediate family member) has a direct or indirect financial
relationship (an ownership/investment interest or a compensation
arrangement), unless an exception applies; and
(2) the entity from presenting or causing a claim to be presented to
Medicare (or billing another individual, entity, or third party payor) for
those referred services.
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34. Self-Referral Disclosure Protocol, Continued
The SRDP requires health care providers or suppliers to submit all
information necessary for CMS to analyze the actual or potential violation
of the Affordable Care Act. In return, CMS can reduce the amount due and
owing for violations.
The SRDP is intended to facilitate the resolution of only matters that, in
the disclosing party's reasonable assessment, are actual or potential
violations of the physician self-referral law.
Section 6409 of the Affordable Care Act (42 U.S.C. § 1395nn)
Self-Referral Disclosure Protocol Settlements
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35. OIG 2012 Work Plan
Return to Table of Contents
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36. OIG 2012 Work Plan
The OIG Work Plan summarizes OIG’s most significant findings,
recommendations, investigative outcomes, and outreach activities in 6-month
increments. The 2012 Work Plan for Hospitals includes:
• Hospital Reporting for Adverse Events
• Reliability of Hospital-Reported Quality Measure Data
• Hospital Admissions With Conditions Coded Present on Admission
• Accuracy of Present on Admission Indicators Submitted on Medicare Claims
• Hospital Inpatient Outlier Payments
• Hospital Claims With High or Excessive Payments
• Hospital Same-Day Readmissions
• Acute-Care Hospital Inpatient Transfers to Inpatient Hospice Care
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37. Statutory Background
Return to Table of Contents
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38. Office of Inspector General (OIG)
The Office of Inspector General (OIG) was established within the U.S.
Department of Health and Human Services (HHS):
• To identify and eliminate fraud, waste, and abuse in HHS programs.
• To promote efficiency and economy in HHS operations.
The OIG carries out this mission through a nationwide program of audits,
inspections, and investigations.
In addition, the OIG has the authority:
• To exclude from participation in Medicare, Medicaid and other Federal
health care programs individuals and entities who have engaged in fraud
or abuse.
• To impose civil money penalties (CMPs) for certain misconduct related to
Federal health care programs.
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39. OIG Statutory Background
• In 1977, Congress first mandated the exclusion of physicians and other
practitioners convicted of program-related crimes from participation in
Medicare and Medicaid (Public Law 95-142).
• In 1981, Congress passed the Civil Monetary Penalties Law (CMPL),
authorizing HHS and the OIG to impose CMPs, assessments and program
exclusions against individuals and entities who submit false, fraudulent or
otherwise improper claims for Medicare or Medicaid payment. “Improper
claims” include claims submitted by an excluded individual or entity for
items or services furnished during a period of program exclusion.
• In 1987, Congress passed the Medicare and Medicaid Patient and
Program Protection Act to enhance the OIG’s ability to protect the
Medicare and Medicaid programs and their beneficiaries.
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40. OIG Statutory Background, Continued
• The Health Insurance Portability and Accountability Act (HIPAA) of 1996
[Public Law 104-191] authorized the OIG to provide guidance to the
health care industry in an attempt to prevent fraud and abuse, and to
promote high levels of ethical and lawful conduct.
• The Balanced Budget Act (BBA) of 1997 expanded the OIG's sanction
authorities.
• These statutes extended the application and scope of the current CMP and
exclusion authorities beyond programs funded by HHS to all “Federal
health care programs.”
• BBA also authorized a new CMP authority to be imposed against health
care providers or entities that employ or enter into contracts with excluded
individuals for the provision of services or items to Federal program
beneficiaries.
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41. Contact us for more information
Craig B. Garner
1299 Ocean Avenue, Suite 400
Santa Monica, CA 90401
T. (310) 458-1560
E. craig@craiggarner.com
W. www.craiggarner.com
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