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Clinical Research and Clinical Trial Professional and Technical Fee Billing: Difference between revisions
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Clinical Research and Clinical Trial Professional and Technical Fee Billing (view source)
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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 | [[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]] | ||
<br /><br /> | <br /><br /> | ||
Policy No.: '''8008'''<br /> | Policy No.: '''8008'''<br /> | ||
Effective Date: '''DRAFT'''<br /> | Effective Date: '''DRAFT'''<br /> | ||
Revised Date: ''' | Revised Date: '''12/06/17'''<br /> | ||
Reviewed Date: | Reviewed Date: <br /> | ||
<br /> | <br /> | ||
<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 | *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/ | *[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:// | *[https://www.unmc.edu/academicaffairs/_documents/compliance/ABNRequirementsFlowchart.pdf Advanced Beneficiary Notice Requirements Flowchart] | ||
*Nebraska Medicine [https:// | *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:// | *Nebraska Medicine [https://www.unmc.edu/academicaffairs/_documents/compliance/NE_Medicine_MI15_AdvancedBeneficiaryNoticeABN.pdf Advanced Beneficiary Notice (ABN)]Policy (MI15) | ||
*Nebraska Medicine [https:// | *Nebraska Medicine [https://www.unmc.edu/academicaffairs/_documents/compliance/NE_Medicine_MI19_ResearchBillingProcess.pdf Research Billing Process] Policy (MI19) | ||
*Nebraska Medicine [https:// | *Nebraska Medicine [https://www.unmc.edu/academicaffairs/_documents/compliance/NE_Medicine_MI29_InvestigationalDevices.pdf Investigational Devices] Policy (MI29) | ||
*Nebraska Medicine [https:// | *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 | ||