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Policy No.: '''8008'''<br /> | Policy No.: '''8008'''<br /> | ||
Effective Date: ''' | Effective Date: ''' 08/24/18'''<br /> | ||
Revised Date: | Revised Date: <br /> | ||
Reviewed Date: | Reviewed Date: <br /> | ||
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<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 | 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. |