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

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Policy No.: '''8008'''<br />
Policy No.: '''8008'''<br />
Effective Date: '''DRAFT'''<br />
Effective Date: '''DRAFT'''<br />
Revised Date: '''12/06/17'''<br />
Revised Date: '''12/15/17'''<br />
Reviewed Date: <br />  
Reviewed Date: <br />  
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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 grant, 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 maintain patient satisfaction and comply with federal laws, regulations and policies.  
*This policy applies to all clinical trials that include medical, professional and technical fees conducted at the University of Nebraska Medical Center, 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 trials that include medical, professional and technical fees conducted at the University of Nebraska Medical Center, 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.