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Compliance Program: Difference between revisions
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[[Compliance Program]] | [[Compliance Hotline]] | [[Investigations by Third Parties]] | [[Research Integrity]] | [[Copyright]] | [[Export Control]] | [[Code of Conduct]] | [[Use of Human Anatomical Material]] | [[Clinical Trial Fee Billing Procedures]] | [[Contracts | [[Compliance Program]] | [[Compliance Hotline]] | [[Investigations by Third Parties]] | [[Research Integrity]] | [[Copyright]] | [[Export Control]] | [[Code of Conduct]] | [[Use of Human Anatomical Material]] | [[Clinical Trial Fee Billing Procedures]] | [[Contracts]] | [[Conflict of Interest]] | [[Red Flag Identity Theft Prevention Program]] | [[Principles of Financial Stewardship]] | [[Human Tissue Use & Transfer]] | ||
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POLICY NO: '''8000'''<br /> | POLICY NO: '''8000'''<br /> | ||
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REVISED DATE:<br /> | REVISED DATE:<br /> | ||
REVIEWED DATE: '''11/01/06'''<br /> | REVIEWED DATE: '''11/01/06'''<br /> | ||
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<big>'''Compliance Program Policy'''</big> | |||
== Basis for Policy == | == Basis for Policy == | ||
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: | #'''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: | ||
#* analyze laws and regulations applicable to UNMC and coordinate with subject matter experts to ensure compliance with them. | #* analyze laws and regulations applicable to UNMC and coordinate with subject matter experts to ensure compliance with them. | ||
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#* UNMC Physicians | #* UNMC Physicians | ||
#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. | #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. | ||
#'''Compliance Hotline'''. A compliance hotline has been established to provide individuals with an additional communication channel to report compliance concerns. The Compliance Officer shall investigate concerns and take corrective action in response to identified issues. | #'''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]]. | ||
#'''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. | |||
#'''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, | #'''False Claims Act'''. | ||
#'''False Claims Act'''. | #*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. | ||
# | #*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. | ||
# | #*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. | ||
#Compliance areas impacting the UNMC mission include but are not limited to the following: | #Compliance areas impacting the UNMC mission include but are not limited to the following: | ||
#*'''Research Compliance''' | #*'''Research Compliance''' | ||
# | #*#[http://www.unmc.edu/spa/index.cfm?L1_ID=12&CONREF=149 Human Subjects]: Institutional Review Board (IRB) | ||
# | #*#*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. | ||
#:Further information can be obtained through the UNMC IRB website at http://www.unmc.edu/spa/index.cfm?L1_ID=12&CONREF=149. | #:Further information can be obtained through the UNMC IRB website at http://www.unmc.edu/spa/index.cfm?L1_ID=12&CONREF=149. | ||