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Policy No.: '''8000'''<br />
 
Policy No.: '''8000'''<br />
 
Effective Date: '''11/01/06'''<br />
 
Effective Date: '''11/01/06'''<br />
Revised Date:<br />
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Revised Date: '''01/02/14'''<br />
Reviewed Date: '''11/01/06'''<br />  
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Reviewed Date: '''01/02/14'''<br />  
 
<br />
 
<br />
 
<big>'''Compliance Program Policy'''</big>
 
<big>'''Compliance Program Policy'''</big>
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The University of Nebraska Medical Center (UNMC) shall comply with all applicable federal, state and local laws and regulations and University of Nebraska and UNMC Policies and Procedures.
 
The University of Nebraska Medical Center (UNMC) shall comply with all applicable federal, state and local laws and regulations and University of Nebraska and UNMC Policies and Procedures.
 
== Compliance Program Structure ==
 
== Compliance Program Structure ==
#'''Compliance Officer'''. The Compliance Officer is responsible for overseeing the development of and coordinating the implementation of policies, procedures and practices necessary to effect compliance with federal, state, and local laws and regulations. The compliance officer shall report to the Vice Chancellor for Academic Affairs, but has the authority to communicate directly with the Chancellor or Vice Chancellors for Business and Finance and Research on compliance matters. The Compliance Officer shall:
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===Compliance Officer===
#* analyze laws and regulations applicable to UNMC and coordinate with subject matter experts to ensure compliance with them.
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The Compliance Officer is responsible for overseeing the development of and coordinating the implementation of policies, procedures and practices necessary to effect compliance with federal, state, and local laws and regulations. The compliance officer shall report to the Vice Chancellor for Academic Affairs, but has the authority to communicate directly with the Chancellor or Vice Chancellors for Business and Finance and Research on compliance matters. The Compliance Officer shall:
#* monitor day-to-day compliance activities.
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* analyze laws and regulations applicable to UNMC and coordinate with subject matter experts to ensure compliance with them.
#* establish compliance audits of risk areas and develop corrective action plans in response to identified deficiencies.
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* monitor day-to-day compliance activities.
#* oversee visits by regulatory agencies and responses to inquiries and investigations.
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* establish compliance audits of risk areas and develop corrective action plans in response to identified deficiencies.
#* make periodic reports regarding compliance matters directly to the UNMC Chancellor’s Council.
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* oversee visits by regulatory agencies and responses to inquiries and investigations.
#* coordinate with the Associate General Counsel for Health Care on legal issues.
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* make periodic reports regarding compliance matters directly to the UNMC Chancellor’s Council.
#* respond to compliance hotline calls.
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* coordinate with the Associate General Counsel for Health Care on legal issues.
#* chair the compliance committee.
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* respond to compliance hotline calls.
#'''Compliance Committee'''. The Compliance committee shall support the Compliance Officer in meeting his/her responsibilities.  The committee shall analyze UNMC’s risk areas and oversee the monitoring of internal audits and external investigations.  The Compliance Committee shall be composed of representatives from the following departments:
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* chair the compliance committee.
#* Associate General Counsel for Health Care
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===Compliance Committee===
#* College of Dentistry
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The Compliance committee shall support the Compliance Officer in meeting his/her responsibilities.  The committee shall analyze UNMC’s risk areas and oversee the monitoring of internal audits and external investigations.  The Compliance Committee shall be composed of representatives from the following departments:
#* College of Medicine
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* Associate General Counsel for Health Care
#* College of Nursing
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* College of Dentistry
#* College of Pharmacy
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* College of Medicine
#* Comparative Medicine
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* College of Nursing
#* Compliance
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* College of Pharmacy
#* Eppley Institute
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* College of Public Health
#* Facilities Management
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* Comparative Medicine/Institutional Animal Care and Use Committee (IACUC)
#* Financial Compliance
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* Compliance
#* Human Resources
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* Eppley Institute
#* Information Technology Services
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* Facilities Management
#* Institutional Animal Care and Use Committee (IACUC)
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* Financial Compliance
#* Institutional Review Board (IRB)
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* Human Resources
#* Intellectual Property
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* Information Technology Services
#* Munroe-Meyer Institute
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* Institutional Review Board (IRB)
#* Sponsored Programs Accounting
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* Intellectual Property
#* Sponsored Programs Administration
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* Munroe-Meyer Institute
#* The Nebraska Medical Center
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* Sponsored Programs Accounting
#* UNMC Physicians  
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* Sponsored Programs Administration
#Compliance Committee representatives shall assist the Compliance Office with communicating compliance policies and procedures and other information within their respective units. The Compliance Committee shall meet no less than quarterly. The Compliance Office shall complete meeting minutes and maintain them on file for no less than seven years. The meeting minutes shall be confidential.  Meeting minutes shall be distributed to committee members, vice chancellors, college deans and executive directors to inform UNMC leadership about compliance activities.
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* The Nebraska Medical Center
#'''Compliance Hotline'''. A compliance hotline has been established to provide individuals with an additional communication channel to report compliance concerns. The [http://mailto:swrobel@unmc.edu Compliance Officer] shall investigate concerns and take corrective action in response to identified issues. For additional information, see UNMC Policy No. 8001, [[Compliance Hotline | Compliance Hotline]].
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* UNMC Physicians  
#'''Code of Conduct'''. The UNMC Code of Conduct applies to all UNMC faculty, staff, and students, and guides them in carrying out daily activities within appropriate ethical and legal standards. UNMC Policy No. 8006, [[Code of Conduct]] codifies UNMC’s commitment to full compliance with all federal, state, and local regulatory requirements and mandates that the UNMC Community abide by the Code.
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===Compliance Committee Representatives ===
#'''False Claims Act'''.
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Compliance Committee representatives shall assist the Compliance Office with communicating compliance policies and procedures and other information within their respective units. The Compliance Committee shall meet no less than quarterly. The Compliance Office shall complete meeting minutes and maintain them on file for no less than seven years. The meeting minutes shall be confidential.  Meeting minutes shall be distributed to committee members, vice chancellors, college deans and executive directors to inform UNMC leadership about compliance activities.
#*The False Claims Act is a federal law that provides that whoever knowingly submits to the federal government a false claim for payment, or creates a false record in support of a claim for payment, or knowingly retains the proceeds of a false claim for payment submitted to the government shall be liable for a civil penalty in the amount of $5,500 to $11,000 per claim, and three times the actual damages sustained by the government.
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====Compliance Hotline====
#*The Federal False Claims Act contains qui tam, or whistleblower provisions that allow citizens with evidence of fraud against government contracts and programs to sue, on behalf of the government, in order to recover the funds. In compensation for the risk and effort of filing a qui tam case, the citizen whistleblower or “relator” may be awarded a portion of the funds recovered, typically between 15 and 25 percent.
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A compliance hotline has been established to provide individuals with an additional communication channel to report compliance concerns. The [http://mailto:swrobel@unmc.edu Compliance Officer] shall investigate concerns and take corrective action in response to identified issues. For additional information, see UNMC Policy No. 8001, [[Compliance Hotline | Compliance Hotline]].
#*While the False Claims Act covers fraud involving any federally funded contract or program, in the health care area it has been applied to the Medicare and Medicaid programs, and also to federal research grants. Examples of health care-related False Claims Act violations are: 1) a health care provider bills Medicare for services that were not performed or that were unnecessary; and 2) a federal grant recipient charges the Government for costs not related to the grant.
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===Code of Conduct===
#*In addition to the Federal False Claims Act, Nebraska has a False Medicaid Claims Act (Neb. Rev. Statute 68-1073) that provides that any person who presents a false Medicaid claim is subject to civil penalties of not more than ten thousand dollars and damages in the amount of three times the amount of the false claim submitted to the state. The Nebraska False Medicaid Claims Act does not contain qui tam relator provisions.  
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The UNMC Code of Conduct applies to all UNMC faculty, staff, and students, and guides them in carrying out daily activities within appropriate ethical and legal standards. UNMC Policy No. 8006, [[Code of Conduct]] codifies UNMC’s commitment to full compliance with all federal, state, and local regulatory requirements and mandates that the UNMC Community abide by the Code.
#*Any individual who suspects that potential False Claims Act violations may have occurred at UNMC should contact the Compliance Officer or contact the compliance hotline at 1-866-568-5430. See UNMC Policy No. 8001, Compliance Hotline. Individuals are encouraged to report concerns. Retribution against individuals raising concerns is prohibited.
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===False Claims Act===
#Compliance areas impacting the UNMC mission include but are not limited to the following:
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*The False Claims Act is a federal law that provides that whoever knowingly submits to the federal government a false claim for payment, or creates a false record in support of a claim for payment, or knowingly retains the proceeds of a false claim for payment submitted to the government shall be liable for a civil penalty in the amount of $5,500 to $11,000 per claim, and three times the actual damages sustained by the government.
#*'''Research Compliance'''
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*The Federal False Claims Act contains qui tam, or whistleblower provisions that allow citizens with evidence of fraud against government contracts and programs to sue, on behalf of the government, in order to recover the funds. In compensation for the risk and effort of filing a qui tam case, the citizen whistleblower or “relator” may be awarded a portion of the funds recovered, typically between 15 and 25 percent.
#**[http://www.unmc.edu/spa/index.cfm?L1_ID=12&CONREF=149 Human Subjects]: Institutional Review Board (IRB)
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*While the False Claims Act covers fraud involving any federally funded contract or program, in the health care area it has been applied to the Medicare and Medicaid programs, and also to federal research grants. Examples of health care-related False Claims Act violations are: 1) a health care provider bills Medicare for services that were not performed or that were unnecessary; and 2) a federal grant recipient charges the Government for costs not related to the grant.
 +
*In addition to the Federal False Claims Act, Nebraska has a False Medicaid Claims Act (Neb. Rev. Statute 68-1073) that provides that any person who presents a false Medicaid claim is subject to civil penalties of not more than ten thousand dollars and damages in the amount of three times the amount of the false claim submitted to the state. The Nebraska False Medicaid Claims Act does not contain qui tam relator provisions.  
 +
*Any individual who suspects that potential False Claims Act violations may have occurred at UNMC should contact the Compliance Officer or contact the compliance hotline at 1-866-568-5430. See UNMC Policy No. 8001, Compliance Hotline. Individuals are encouraged to report concerns. Retribution against individuals raising concerns is prohibited.
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===Compliance Areas ===
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Compliance areas impacting the UNMC mission include but are not limited to the following:
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====Research Compliance====
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=====Institutional Review Board (IRB)[http://www.unmc.edu/spa/index.cfm?L1_ID=12&CONREF=149 Human Subjects]  
 
#***The UNMC IRB shall review and approve all human subject research conducted by the faculty, students, staff, or other representatives of the University of Nebraska Medical Center and The Nebraska Medical Center, when the research is part of their institutional responsibilities. In addition, the UNMC IRB shall review and approve all human subject research conducted by anyone on the premises of UNMC and the Nebraska Medical Center, including its community based clinics.
 
#***The UNMC IRB shall review and approve all human subject research conducted by the faculty, students, staff, or other representatives of the University of Nebraska Medical Center and The Nebraska Medical Center, when the research is part of their institutional responsibilities. In addition, the UNMC IRB shall review and approve all human subject research conducted by anyone on the premises of UNMC and the Nebraska Medical Center, including its community based clinics.
 
#***The UNMC IRB, which is administratively housed within the Office of Regulatory Affairs (ORA), exercises its authority in compliance with DHHS regulations at 45 CFR 46, and FDA regulations at 21 CFR 50 and 56.  This authority includes review and approval of exempt research under 45 CFR 46.101 (b); research which qualifies for expedited review under 45 CFR 46.110 and 21 CFR 56.110; and research which requires review by the full IRB.
 
#***The UNMC IRB, which is administratively housed within the Office of Regulatory Affairs (ORA), exercises its authority in compliance with DHHS regulations at 45 CFR 46, and FDA regulations at 21 CFR 50 and 56.  This authority includes review and approval of exempt research under 45 CFR 46.101 (b); research which qualifies for expedited review under 45 CFR 46.110 and 21 CFR 56.110; and research which requires review by the full IRB.

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