Clinical Research and Clinical Trial Professional and Technical Fee Billing: Difference between revisions

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<td style="border-bottom:2px solid #A3B1BF" width="3">&#160;</td>
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<td style="padding:0.5em; background-color:#e5e5e5; font-size:90%; line-height:0.95em; border:1px solid #A3B1BF; border-bottom:solid 2px #A3B1BF" width="20">[[Intellectual Property]]</td>
<td style="border-bottom:2px solid #A3B1BF" width="3">&#160;</td>
<td style="padding:0.5em; background-color:#e5e5e5; font-size:90%; line-height:0.95em; border:1px solid #A3B1BF; border-bottom:solid 2px #A3B1BF" width="20">[[Faculty]]</td>
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[[Compliance Program]] | [[Compliance Hotline]] | [[Investigations by Third Parties]] | [[Research Integrity]] | [[Export Control]] | [[Code of Conduct]] | [[Use of Human Anatomical Material]] | [[Clinical Trial Professional and Technical Fee Billing]] | [[Contracts]] | [[Conflict of Interest]] | [[Red Flag Identity Theft Prevention Program]] | [[Principles of Financial Stewardship]] | [[Human Tissue Use and Transfer]] | [[International Research Policy]] | [[Health Care Vendor Interactions]] | [[Credit Hour Definition]] | [[Whistleblower]]
[[Compliance Program]] | [[Compliance Hotline]] | [[Investigations by Third Parties]] | [[Research Integrity]] | [[Export Control]] | [[Code of Conduct]] | [[Use of Human Anatomical Material]] | [[Clinical Research and Clinical Trial Professional and Technical Fee Billing]] | [[Contracts]] | [[Conflict of Interest]] | [[Red Flag Identity Theft Prevention Program]] | [[Principles of Financial Stewardship]] | [[Human Tissue Use and Transfer]] | [[Disclosing Foreign Support and International Activities]] | [[Health Care Vendor Interactions]] | [[Credit Hour Definition]] | [[Whistleblower]]<br />
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Policy No.: '''8008'''<br />
Policy No.: '''8008'''<br />
Effective Date: ''' DRAFT'''<br />
Effective Date: ''' 08/23/18'''<br />
Revised Date: '''07/30/18'''<br />
Revised Date: <br />
Reviewed Date: '''07/30/18''' <br />  
Reviewed Date: '''07/29/21'''<br />  
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<br />
<big>'''Clinical Research and Clinical Trial Professional and Technical Fee Billing Policy</big>'''
<big>'''Clinical Research and Clinical Trial Professional and Technical Fee Billing Policy</big>'''
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University of Nebraska Medical Center is committed to submitting charges for clinical research that are in full compliance with applicable federal laws, regulations and policies.   
University of Nebraska Medical Center is committed to submitting charges for clinical research that are in full compliance with applicable federal laws, regulations and policies.   
== Basis for Policy ==
== Basis for Policy ==
To define procedures for identifying patients who are research subjects and to accurately charge medical procedure costs to a research payer, to a third party payer, or to a patient, as appropriate to maintain patient satisfaction and comply with federal laws, regulations and policies.  
To define procedures for identifying patients who are research subjects and to accurately charge medical procedure costs to a research payer, to a third party payer, or to a patient, as appropriate, to comply with federal laws, regulations and policies and maintain patient satisfaction.  
*This policy applies to all clinical research and clinical trials that include medical, professional and technical fees conducted at the University of Nebraska Medical Center/Nebraska Medicine, including medical device trials (see [https://www.unmc.edu/academicaffairs/_documents/compliance/MedicareQualifyingClinicalTrialsFlowsheet1.pdf Medicare Qualifying Clinical Trials Flowchart] and [https://www.unmc.edu/academicaffairs/_documents/compliance/ABNRequirementsFlowchart.pdf Advanced Beneficiary Notice Requirements Flowchart] for specific medical device trial procedures and tools).  
*This policy applies to all clinical research and clinical trials that include medical, professional and technical fees conducted at the University of Nebraska Medical Center/Nebraska Medicine, including medical device trials (see [https://www.unmc.edu/academicaffairs/_documents/compliance/MedicareQualifyingClinicalTrialsFlowsheet1.pdf Medicare Qualifying Clinical Trials Flowchart] and [https://www.unmc.edu/academicaffairs/_documents/compliance/ABNRequirementsFlowchart.pdf Advanced Beneficiary Notice Requirements Flowchart] for specific medical device trial procedures and tools).  
*This policy does not apply to dental clinical trials.
*This policy does not apply to dental clinical trials.
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==Additional Information==
==Additional Information==
*Contact the [mailto:sarah.glodencarlson@unmc.edu Chief Compliance Officer]
*Contact the [mailto:sarah.glodencarlson@unmc.edu Chief Compliance Officer]
*[https://www.unmc.edu/academicaffairs/_documents/compliance/ClinicalTrialProfessionalandTechnicalFeeBillingProcedures.pdf Clinical Trial Professional and Technical Fee Billing Procedures]  
*[https://www.unmc.edu/academicaffairs/_documents/compliance/wiki/Clinical_Trial_Professional_and_Technical_Fee_Billing_Procedures.pdf Clinical Trial Professional and Technical Fee Billing Procedures]  
*[https://www.unmc.edu/academicaffairs/_documents/compliance/MedicareQualifyingClinicalTrialsFlowsheet1.pdf Medicare Qualifying Clinical Trials Flowchart]  
*[https://www.unmc.edu/academicaffairs/_documents/compliance/MedicareQualifyingClinicalTrialsFlowsheet1.pdf Medicare Qualifying Clinical Trials Flowchart]  
*[https://www.unmc.edu/academicaffairs/_documents/compliance/ABNRequirementsFlowchart.pdf Advanced Beneficiary Notice Requirements Flowchart]  
*[https://www.unmc.edu/academicaffairs/_documents/compliance/ABNRequirementsFlowchart.pdf Advanced Beneficiary Notice Requirements Flowchart]  
*Nebraska Medicine Policy IM10, [http://now.nebraskamed.com/?utm_source=default&utm_medium=ie&utm_campaign=now One Chart Training Classes]  
*Nebraska Medicine Policy IM10, [https://www.unmc.edu/academicaffairs/_documents/compliance/NE_Medicine_IM10_OneChartTraining.pdf One Chart Training Classes]  
*Nebraska Medicine IM41, [http://now.nebraskamed.com/?utm_source=default&utm_medium=ie&utm_campaign=now One Chart Research Documentation]  
*Nebraska Medicine IM41, [https://www.unmc.edu/academicaffairs/_documents/compliance/NE_Medicine_IM41_OneChartResearchDocumentation.pdf One Chart Research Documentation]  
*Nebraska Medicine [https://www.unmc.edu/academicaffairs/_documents/compliance/NE_Medicine_2015-Tip-Sheet-Looking-Up-Grant-Charges-on-Statements.pdf One Chart Tips and Tricks Sheet] - Looking Up Grant Charges on Statements
*Nebraska Medicine [https://www.unmc.edu/academicaffairs/_documents/compliance/NE_Medicine_2015-Tip-Sheet-Looking-Up-Grant-Charges-on-Statements.pdf One Chart Tips and Tricks Sheet] - Looking Up Grant Charges on Statements
*Nebraska Medicine Policy MI15, [http://now.nebraskamed.com/?utm_source=default&utm_medium=ie&utm_campaign=now) Advanced Beneficiary Notice (ABN)]
*Nebraska Medicine Policy MI15, [https://www.unmc.edu/academicaffairs/_documents/compliance/NE_Medicine_MI15_AdvancedBeneficiaryNoticeABN.pdf Advanced Beneficiary Notice (ABN)]
*Nebraska Medicine Policy MI19, [http://now.nebraskamed.com/?utm_source=default&utm_medium=ie&utm_campaign=now Research Billing Process]  
*Nebraska Medicine Policy MI19, [https://www.unmc.edu/academicaffairs/_documents/compliance/NE_Medicine_MI19_ResearchBillingProcess.pdf Research Billing Process]  
*Nebraska Medicine Policy MI29, [http://now.nebraskamed.com/?utm_source=default&utm_medium=ie&utm_campaign=now Investigational Devices]  
*Nebraska Medicine Policy MI29, [https://www.unmc.edu/academicaffairs/_documents/compliance/NE_Medicine_MI29_InvestigationalDevices.pdf Investigational Devices]  
*Nebraska Medicine Policy RI06, [http://now.nebraskamed.com/?utm_source=default&utm_medium=ie&utm_campaign= Admission/Registration to Nebraska Medicine]
*Nebraska Medicine Policy RI06, [https://www.unmc.edu/academicaffairs/_documents/compliance/NE_Medicine_RI06_AdmissionRegistrationtoNebraskaMedicine.pdf Admission/Registration to Nebraska Medicine]
*[https://www.unmc.edu/academicaffairs/_documents/compliance/NE_Medicine_FNC-201_Financial_Clinical_Trial_Insurance_Preauthorization_Insured_and_NonInsured.pdf Nebraska Medicine Policy FNC-201, Financial Clinical Trial Insurance Preauthorization Insured and Noninsured] (unmc.edu)
*[https://www.unmc.edu/academicaffairs/_documents/compliance/Clinical_Trial_Insurance_Predetermination_Request_Form.pdf Clinical Trial Insurance Predetermination Request] Form
*[https://www.unmc.edu/academicaffairs/_documents/compliance/Clinical_Trial_Insurance_Predetermination_Request_Form.pdf Clinical Trial Insurance Predetermination Request] Form
*Nebraska Medicine [http://now.nebraskamed.com/?utm_source=default&utm_medium=ie&utm_campaign=now Nebraska Medicine SOP 201.2 Insurance Predetermination] Form
*Nebraska Medicine [https://www.unmc.edu/academicaffairs/_documents/compliance/ACCESS-REGSP-110.pdf Nebraska Medicine ACCESS-REGSP-110]
*Nebraska Medicine [http://now.nebraskamed.com/?utm_source=default&utm_medium=ie&utm_campaign=now Nebraska Medicine ACCESS-REGSP-110]
* [https://grants.nih.gov/policy/clinical-trials/definition.htm National Institutes of Health]
* [https://grants.nih.gov/policy/clinical-trials/definition.htm National Institutes of Health]


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