Sample Hospital Compliance Program
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Sample Hospital Compliance Program

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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 ...

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/.

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Sample Hospital Compliance Program Sample Hospital Compliance Program Presentation Transcript

  • Sample HospitalCompliance Program 2012 1
  • Table of Contents -- Compliance ProgramIntroduction Excluded IndividualsBasic Elements and Purpose Self DisclosureCompliance Officer/Committee Signage RequirementsCode of Conduct HITECH Security BreachesCompliance Policies/Procedures California Privacy LawsTraining and Education Financial AlertsCompliance Hotline Tracing an Excluded Individual 2
  • Table of Contents -- Compliance Program ResourcesMedia Relations CMS’ ApproachFair Market Value Determinations Other Compliance PlansAudits and Monitoring Independent Review OfficerRecord Retention Clinical Research ComplianceRACs, MACs, MICs and ZPICs OverpaymentsQuality of Care for an ACO Statutory BackgroundOIG 2012 Work Plan Additional Resources 3
  • Introduction Return to Table of Contents 4
  • Hospital Compliance ProgramYour Hospital (“Hospital”) is committed to effective internal controls that promoteadherence 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)] 5
  • 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. 6
  • 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 7
  • 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 8
  • Reportable EventsIdentified compliance issues that remain uncorrected may result in serioussanctions against any hospital, including exclusion from federal health careprograms.Hospital has established its Compliance Program so it can be followed.In the event Hospital discovers a serious issue of non-compliance, immediatesteps will always taken to address the concern, applying a root cause analysis ofthe problem. 9
  • Reportable Events, ContinuedSteps may include, but are not limited to, immediate referral to civil and/orcriminal 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 andreturned” within “60 days after the date on which the overpayment wasidentified,”   or “the date any corresponding cost report is due,” whichever islater.  [Statutory authority 42 U.S.C. § 1320a-7k]. 10
  • Hospital’s Compliance Organizational Chart 11
  • 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. Mngt Others as Appropriate Outside Counsel 11
  • Basic Elements and Purpose Return to Table of Contents 12
  • 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 13
  • 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 14
  • The Employee’s Role in a Compliance ProgramKnowledge of the this Compliance Program is an important factor inevaluating the performance of all Hospital employees. Hospital is committedto periodically training employees regarding its Compliance Program,including specifically Hospital managers and supervisors involved in anymedical 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. 15
  • 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. 16
  • 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)] 17
  • Financial Alerts Return to Table of Contents 18
  • Alerts Dashboard Sample 19
  • Charge Description Master Sample 20
  • Quality Measures Sample 21
  • Tracing an Excluded Individual Return to Table of Contents 22
  • Tracing a Hospital’s Employees Sample 23
  • Tracing a Hospital’s Employees, Continued Sample 24
  • END OF GENERALCOMPLIANCE PROGRAM 25
  • HospitalCompliance Program Resources 2012 26
  • Self Disclosure Return to Table of Contents 27
  • Criminal Offense for Non-DisclosureMisprision (18 U.S.C. § 4) is a criminal charge against individuals “havingknowledge . . . of a felony” and conceals the felony or “does not as soon aspossible make known the same.” Individuals convicted of misprision “shallbe fined . . . imprisoned . . . or both.” The mere failure to report a knownviolation is insufficient to justify a conviction for misprision. Instead, thecrime requires “active concealment.”Medicare Fraud Statute (42 U.S.C. § 1320a-7b(a)(3): A person or entitycommits a felony where “having knowledge of the occurrence of any eventaffecting his initial or continued right to any such benefit or payment, orthe initial or continued right to any such benefit or payment of any otherindividual in whose behalf he has applied for or is receiving such benefitor payment,” the person (or entity) conceals or “fail[s] to disclose” theinformation with an “intent fraudulently to secure” excessive orunauthorized payment. 28
  • Other Offenses for Non-DisclosureFalse Statements Relating to Health Care Matters (18 U.S.C. § 1035) and FalseStatements as to Matters under Federal Jurisdiction (18 U.S.C. § 1001) make it acrime to knowingly and willfully falsify, conceal or cover up, by any trick, deviceor 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 theGovernment. This is also known as the “reverse false claim” action.Under the Affordable Care Act, hospitals must disclose and repay overpaymentswithin 60 days of discovery or the overpayment may become an obligationpursuant to the False Claims Act. [See Feb. 2012 proposed rules providingclarification.] 29
  • Exclusion for Non-DisclosureIndividuals who know, or should have known, of an overpayment and donot report and return the overpayment are subject to exclusion. The sameis true for entities.See Exclusion Section for additional information. 30
  • OIG Self DisclosureHospitals who wish to voluntarily disclose self-discovered evidence ofpotential fraud to the OIG may do so under the Provider Self-DisclosureProtocol (SDP) (63 Fed. Reg. 58,399).By self-disclosing, hospitals have the opportunity to avoid the costs anddisruptions associated with a Government-directed investigation and civilor administrative litigation.However, under the United States Sentencing Guidelines, a companycannot receive any reduction in a sentence for an effective complianceprogram if high-level personnel within the company “participated in,condoned, or were willfully ignorant” of the criminal offense committed bythe organization.See OIG’s March 24, 2009 Open Letter to Health Care Providers.See self-disclosed settlements with the OIG. 31
  • Medicare Self-Referral Disclosure ProtocolThe Medicare voluntary self-referral disclosure protocol (“SRDP”) setsforth 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. 32
  • Self-Referral Disclosure Protocol, ContinuedThe SRDP requires health care providers or suppliers to submit allinformation necessary for CMS to analyze the actual or potential violationof the Affordable Care Act. In return, CMS can reduce the amount due andowing for violations.The SRDP is intended to facilitate the resolution of only matters that, inthe disclosing partys reasonable assessment, are actual or potentialviolations of the physician self-referral law.Section 6409 of the Affordable Care Act (42 U.S.C. § 1395nn)Self-Referral Disclosure Protocol Settlements 33
  • OIG 2012 Work Plan Return to Table of Contents 34
  • OIG 2012 Work PlanThe OIG Work Plan summarizes OIG’s most significant findings,recommendations, investigative outcomes, and outreach activities in 6-monthincrements. 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 35
  • Statutory Background Return to Table of Contents 36
  • 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. 37
  • 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. 38
  • 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 OIGs 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. 39
  • 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 40