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Compliance Program: Difference between revisions
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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]]. | 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]]. | ||
===Code of Conduct=== | ===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. | 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. | ||
===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.<br /> | |||
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.<br /> | |||
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: | |||
*a health care provider bills Medicare for services that were not performed or that were unnecessary; and | |||
*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. <br /> | |||
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 === | ===Compliance Areas === | ||
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: | ||
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The Intellectual Property Office is responsible for ensuring compliance with the Bayh Dole Act (37 CFR 401). The Bayh Dole Act requires organizations receiving federal research funds to report any resulting inventions to the federal funding agencies. At UNMC, all inventions are reported to the IPO which in turn reports all federally funded inventions to the appropriate federal funding agencies. The IPO provides the federal funding agencies with updates as patent protection is sought. Inventions are continually monitored and reported to ensure the government is aware of the progress of each invention. The majority of the reporting to these agencies is done through the [https://s-edison.info.nih.gov/iEdison/ iEdison web site] and allows the University to retain title to materials and products invented with federal funding. The website, established by the NIH and used by almost all agencies involved, captures the necessary information regarding the reporting required to meet federal funding agency/Bayh-Dole Act. A copy of the Bayh-Dole Act and guidance along with iEdisons history is also provided at the iEdison web site. | The Intellectual Property Office is responsible for ensuring compliance with the Bayh Dole Act (37 CFR 401). The Bayh Dole Act requires organizations receiving federal research funds to report any resulting inventions to the federal funding agencies. At UNMC, all inventions are reported to the IPO which in turn reports all federally funded inventions to the appropriate federal funding agencies. The IPO provides the federal funding agencies with updates as patent protection is sought. Inventions are continually monitored and reported to ensure the government is aware of the progress of each invention. The majority of the reporting to these agencies is done through the [https://s-edison.info.nih.gov/iEdison/ iEdison web site] and allows the University to retain title to materials and products invented with federal funding. The website, established by the NIH and used by almost all agencies involved, captures the necessary information regarding the reporting required to meet federal funding agency/Bayh-Dole Act. A copy of the Bayh-Dole Act and guidance along with iEdisons history is also provided at the iEdison web site. | ||
====Copyright==== | ====Copyright==== | ||
Copyright is a form of protection provided by federal law to the author of “original works of authorship” including literary, dramatic, musical, artistic, and certain other intellectual works. Unauthorized reproduction or use of copyrighted works is illegal, and is called copyright infringement. Court decisions over the years have developed a doctrine called “fair use” that permits reproduction of certain works under limited circumstances without the permission of the author. For additional information, see UNMC Policy No. | Copyright is a form of protection provided by federal law to the author of “original works of authorship” including literary, dramatic, musical, artistic, and certain other intellectual works. Unauthorized reproduction or use of copyrighted works is illegal, and is called copyright infringement. Court decisions over the years have developed a doctrine called “fair use” that permits reproduction of certain works under limited circumstances without the permission of the author. For additional information, see UNMC Policy No. 6036, [http://wiki.unmc.edu/Reproducing_Copyrighted_Materials Reproduction of Copyrighted Materials]. | ||
====Export Control==== | ====Export Control==== | ||
Export control regulations prohibit the export of certain materials (including select agents) and information for reasons of national security or protection of trade unless approval is received from the federal government in the form of a license before the export takes place. Two major export control regulations are the Department of Commerce Export Administration regulations (EAR) and the State Department International Traffic in Arms (ITAR) regulations. The term “export” under these regulations includes “deemed exports” that occur when a controlled technology is disclosed to a foreign person in the United States, including university students and employees. For additional information, see UNMC Policy No. 8005, [[Export Control]]. | Export control regulations prohibit the export of certain materials (including select agents) and information for reasons of national security or protection of trade unless approval is received from the federal government in the form of a license before the export takes place. Two major export control regulations are the Department of Commerce Export Administration regulations (EAR) and the State Department International Traffic in Arms (ITAR) regulations. The term “export” under these regulations includes “deemed exports” that occur when a controlled technology is disclosed to a foreign person in the United States, including university students and employees. For additional information, see UNMC Policy No. 8005, [[Export Control]]. | ||
====Environmental and Safety Compliance==== | ====Environmental and Safety Compliance==== | ||
=====Safety===== | =====Safety===== | ||
The Safety Officer is responsible for developing, implementing and directing a comprehensive safety and fire prevention program designed to minimize risk of injury to patients, visitors, staff and students at The Nebraska Medical Center and UNMC.<br /> | |||
The Safety Office maintains a library that includes a complete set of National Fire Protection Association Standards and pamphlets. Material Safety Data Sheets are available electronically via the internet and chemical safety server. <br /> | |||
Organizational Safety Committees – The Nebraska Medical Center and UNMC Safety Committees work to establish and maintain a safe and healthful environment for all employees, students, patients, and visitors. In addition they monitor each organization’s compliance with local, state, and federal requirements.<br /> | |||
For more information on safety, see the Safety website or contact Safety Operations at Extension 9-7315. The UNMC Safety Policy Index can be found at http://wiki.unmc.edu/Safety/Security. | |||
=====Radiation Safety===== | =====Radiation Safety===== | ||
Radiation Safety approves all uses of radioactive material on campus. The Radiation Safety Officer ensures that the State Radioactive Material License is current and that all conditions of the license are met. Radiation Safety routinely performs compliance audits on all authorized users. Radiation Safety manages the personnel radiation monitoring program.<br /> | Radiation Safety approves all uses of radioactive material on campus. The Radiation Safety Officer ensures that the State Radioactive Material License is current and that all conditions of the license are met. Radiation Safety routinely performs compliance audits on all authorized users. Radiation Safety manages the personnel radiation monitoring program.<br /> | ||
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*UNMC Policy No. 2002, [http://wiki.unmc.edu/Shipping_Hazardous_Materials Shipment of Hazardous Materials or Dangerous Goods] | *UNMC Policy No. 2002, [http://wiki.unmc.edu/Shipping_Hazardous_Materials Shipment of Hazardous Materials or Dangerous Goods] | ||
*UNMC Policy No. 2004, [http://wiki.unmc.edu/Bloodborne_Pathogens_Exposure Bloodborne Pathogen Exposure] | *UNMC Policy No. 2004, [http://wiki.unmc.edu/Bloodborne_Pathogens_Exposure Bloodborne Pathogen Exposure] | ||
*UNMC Policy No. 6036, [http://wiki.unmc.edu/Reproducing_Copyrighted_Materials Reproduction of Copyrighted Materials] | |||
*UNMC Policy No. 8001, [[Compliance Hotline]] | *UNMC Policy No. 8001, [[Compliance Hotline]] | ||
*UNMC Policy No. 8005, [[Export Control]] | *UNMC Policy No. 8005, [[Export Control]] | ||