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Policy No.: '''8008'''<br /> | Policy No.: '''8008'''<br /> | ||
Effective Date: '''DRAFT'''<br /> | Effective Date: '''DRAFT'''<br /> | ||
Revised Date: '''12/ | Revised Date: '''12/15/17'''<br /> | ||
Reviewed Date: <br /> | Reviewed Date: <br /> | ||
<br /> | <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 | 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. |