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

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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]] | [[Internal Audit]] | [[Credit Hour Definition]]
[[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]]
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Policy No.: '''8008'''<br />
Policy No.: '''8008'''<br />
Effective Date: '''DRAFT'''<br />
Effective Date: '''DRAFT'''<br />
Revised Date: '''08/22/17'''<br />
Revised Date: '''12/06/17'''<br />
Reviewed Date: '''08/18/17'''<br />  
Reviewed Date: <br />  
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<big>'''Clinical Trial Professional and Technical Fee Billing Policy</big>'''
<big>'''Clinical Trial Professional and Technical Fee Billing Policy</big>'''
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== 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 grant, 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 [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.
== Definitions ==
== Definitions ==
===Qualified Clinical Trials===
===Qualified Clinical Trials===
Only qualified clinical trials are eligible for reimbursement for routine costs under Medicare. In order to be a qualified trial, the trial must meet three mandatory criteria and have other desirable characteristics [https://www.unmc.edu/academicaffairs/_documents/compliance/MedicareQualifyingClinicalTrialsFlowsheet1.pdf Medicare Qualifying Clinical Trials Flowchart].  
Only qualified clinical trials are eligible for reimbursement for routine costs under Medicare. In order to be a qualified trial, the trial must meet three mandatory criteria and have other desirable characteristics (see [https://www.unmc.edu/academicaffairs/_documents/compliance/MedicareQualifyingClinicalTrialsFlowsheet1.pdf Medicare Qualifying Clinical Trials Flowchart]).  
====Three mandatory criteria====         
====Three mandatory criteria====         
*Trial evaluates an item or service that falls within a Medicare benefit category (e.g. physicians' service, durable medical equipment, diagnostic test) that is not statutorily excluded from coverage (e.g. cosmetic surgery, hearing aids);
*Trial evaluates an item or service that falls within a Medicare benefit category (e.g. physicians' service, durable medical equipment, diagnostic test) that is not statutorily excluded from coverage (e.g. cosmetic surgery, hearing aids);
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*Items and services provided solely to determine trial eligibility.
*Items and services provided solely to determine trial eligibility.
==Additional Information==
==Additional Information==
*Contact the [mailto:llarson@unmc.edu Director of Clinical Research Operations] or 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/ClinicalTrialProfessionalandTechnicalFeeBillingProcedures.pdf Clinical Trial Professional and Technical Fee Billing Procedures]  
*[https://www.unmc.edu/academicaffairs/_documents/compliance/ClinicalTrialProfessionalandTechnicalFeeBillingProcedures.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]  
 
*Nebraska Medicine [https://secure.compliance360.com/Common/ViewUploadedFile.aspx?PD=PbRt%2bA78MS43j%2bgRKypwmoK9mTBSgSYjiITUtlkdJweW78KTfJAbiVmQGxD0TD%2ffbeiz8FDLCSWkeE%2fsYKVJFIhAUxeq98Xnp%2bnAIlgwmZoHmQZrN79tB6Qj0Jrs%2fiI2HKfoMGmtvHEmfnr3DsPwcwWcTFzyvGpl2jCfUuLMJjm08ZTqhTB89x73qklfUNwq3Ffp0zExgf8Lqka2vCsryrCXjfnRkH4ZLDTEkWkGm9A%3d One Chart Training Classes] Policy (IM10)
*[https://www.unmc.edu/academicaffairs/_documents/compliance/ABNRequirementsFlowchart.pdf Advanced Beneficiary Notice Requirements Flowchart]
*Nebraska Medicine [https://secure.compliance360.com/Common/ViewUploadedFile.aspx?PD=PbRt%2bA78MS4JgjkHyfyOQSZGTUnUfsgmrHFZlIrIPCjzI5ox77H2joeV0Kdj6TqXjg4y6gHb7o15sKS2bifH1QBNvW7sH4mkfwXofVpTWsbbBeZYtvI76B%2fAi35wRDJzTB1xrOzXBxVipPqrm9v6qAKwdgDrsxJrC%2bWKiDkB7TFSBDZL5ZEDzfzU3KYK328HNDx0Mw%2bcHG%2fhGCCGlUG3J4yfJCggcd6kUOigNamkT4ozTo1Kpvrbxg%3d%3d One Chart Research Documentation] Policy (IM41)
*Nebraska Medicine [https://www.unmc.edu/academicaffairs/_documents/compliance/NE_Medicine_IM10_OneChartTraining.pdf One Chart Training Classes] Policy (IM10)
*Nebraska Medicine [https://www.unmc.edu/academicaffairs/_documents/compliance/NE_Medicine_IM41_OneChartResearchDocumentation.pdf One Chart Research Documentation] Policy (IM41)
*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 [https://secure.compliance360.com/Common/ViewUploadedFile.aspx?PD=PbRt%2bA78MS69iTZU2hz55im4W5mC5bKCe26Ln%2bxJFafKC%2fSuzsuML9qNIdaHKum6%2bxWB6ijx0s8OFhvrnUXYzo0Y6G7o88yMcXcStGGjc22hur7jxn%2fszUJWMV4otcVaeNYVKpHIraaxue7ooyN5Qtqnv%2foYtfl9glfzhy%2fhMpJ%2bIViz9Us%2boIrqYZJs4j%2bfUWJsXD6QK8a0%2fqdko78S0E40aVgAJ1hQKnR6GBT4gHE%3d Advanced Beneficiary Notice (ABN)]Policy (MI15)
*Nebraska Medicine [https://www.unmc.edu/academicaffairs/_documents/compliance/NE_Medicine_MI15_AdvancedBeneficiaryNoticeABN.pdf Advanced Beneficiary Notice (ABN)]Policy (MI15)
*Nebraska Medicine [https://secure.compliance360.com/Common/ViewUploadedFile.aspx?PD=PbRt%2bA78MS4JgjkHyfyOQWF2GGAFuWhO3ZA0IDJYUVLcJqUaNWoauX0E2pQ9Vjg3b%2fNmqi5xTmsVLW5gp7cQV3pf8fwDTZlwuaIzDMYsDo4ZzmF9yphQS3wTTcmxqdk1dM9oCRFar0QzY9MqqnySNHsu8qEMWwbqgEFH3g84aE%2fBQRvPw7x7u6eJnx0HWBk5LDLP8yhyKF8V4VhGJMiBSRXVyfrK%2bNtxX%2b5MhsBCU08%3d Research Billing Process] Policy (MI19)
*Nebraska Medicine [https://www.unmc.edu/academicaffairs/_documents/compliance/NE_Medicine_MI19_ResearchBillingProcess.pdf Research Billing Process] Policy (MI19)
*Nebraska Medicine [https://secure.compliance360.com/Common/ViewUploadedFile.aspx?PD=PbRt%2bA78MS6AZSA%2fUYJlSrdfQ09VA71YXqvv5eRl7k%2bIrMGVtDqx%2f3hz0zLbih0vjgM4Hmo3l6yMA3qCDzOM5q9PJ7JIIu%2bD3pcYtIvVIDxbRHHiur8ygC%2fIFat8TfDyjIRibUGTFWv3MaLrEdF1m6qmHjRxNzq0ijMSVNzRpDDLTIfqoBkvw1%2b7pFtORBFKaPLdd3rElYilHm5hFuUl0adpXh1Z5NaHq%2f6NIfFdVpc%3d Investigational Devices] Policy (MI29)
*Nebraska Medicine [https://www.unmc.edu/academicaffairs/_documents/compliance/NE_Medicine_MI29_InvestigationalDevices.pdf Investigational Devices] Policy (MI29)
*Nebraska Medicine [https://secure.compliance360.com/Common/ViewUploadedFile.aspx?PD=PbRt%2bA78MS6AZSA%2fUYJlSsJ7DkaQhgDynu9LjfEwnFuY17jj8ncCgSACMevjKfgiF8DPXYb8NA56R6RUuIAZUZm42JufmYp93ZmRmhD1rickrWYi%2b08T6uvhl0952ex7aDDjXuXS07uBvoGJx2qv6ZlIu%2fMGPcsk0z7dsW8Sn7J%2bGqTkpeNpVZRaMjrt09GVQko7ZpIR%2b%2fZHpBw9FGdJx%2fI1AEsrqs%2fpT3yDzyhcyPk%3d Admission/Registration to Nebraska Medicine] Policy (RI06)
*Nebraska Medicine [https://www.unmc.edu/academicaffairs/_documents/compliance/NE_Medicine_RI06_AdmissionRegistrationtoNebraskaMedicine.pdf Admission/Registration to Nebraska Medicine] Policy (RI06)
*Nebraska Medicine [https://www.unmc.edu/academicaffairs/_documents/compliance/Clinical_Trial_Insurance_Predetermination_Request_Form.pdf Clinical Trial Insurance Predetermination Request] Form
*Nebraska Medicine [https://www.unmc.edu/academicaffairs/_documents/compliance/Clinical_Trial_Insurance_Predetermination_Request_Form.pdf Clinical Trial Insurance Predetermination Request] Form
*Nebraska Medicine [https://www.unmc.edu/academicaffairs/_documents/compliance/NE_Medicine_SOP_201.2_Insurance-Predetermination-signed.pdf SOP 201.2 Insurance Predetermination] Form
*Nebraska Medicine [https://www.unmc.edu/academicaffairs/_documents/compliance/NE_Medicine_SOP_201.2_Insurance-Predetermination-signed.pdf SOP 201.2 Insurance Predetermination] Form