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Clinical Research and Clinical Trial Professional and Technical Fee Billing: Difference between revisions
Clinical Research and Clinical Trial Professional and Technical Fee Billing (view source)
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Policy No.: '''8008'''<br /> | Policy No.: '''8008'''<br /> | ||
Effective Date: '''DRAFT'''<br /> | Effective Date: '''07/20/18 DRAFT'''<br /> | ||
Revised Date: ''' | Revised Date: '''07/20/18'''<br /> | ||
Reviewed Date: <br /> | Reviewed Date: '''07/20/18''' <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 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. | 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 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. | ||
== Definitions == | == Definitions == | ||
===Clinical Research=== | |||
'''A funded or unfunded project that involves human subjects, where additional laboratory, radiology, or other services are provided and billed, whether alongside regular clinical care or not. This term, clinical research, includes all clinical trials, but the term clinical trial will be identified separately to clarify where special requirements may be in required for them.''' | |||
===Clinical Trial=== | |||
A federally or other sponsored research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. | |||
===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, | Only qualified clinical trials or clinical research are eligible for reimbursement for routine costs under Medicare. In order to be a qualified trial, three mandatory criteria must be met as well as have other desirable characteristics per the [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 or services needed for reasonable and necessary care arising from the provision of an investigational item or service – in particular, for the diagnosis or treatment of complications. | *Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service – in particular, for the diagnosis or treatment of complications. | ||
===Research Costs=== | ===Research Costs=== | ||
Patient care costs associated with the research trial. <br /> | Patient care costs that are associated with the research trial or clinical research should be paid by the research grant or contract. These costs are not billable to Medicare and/or a third party payer. <br /> | ||
Examples of items and services that are specifically included as research costs are: | Examples of items and services that are specifically included as research costs are: | ||
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*Contact 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/MedicareQualifyingClinicalTrialsFlowsheet1.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] | |||
*[https://www.unmc.edu/academicaffairs/_documents/compliance/ABNRequirementsFlowchart.pdf Advanced Beneficiary Notice Requirements Flowchart] | *Nebraska Medicine [http://now.nebraskamed.com/?utm_source=default&utm_medium=ie&utm_campaign=now One Chart Training Classes] Policy (IM10) | ||
*Nebraska Medicine [ | *Nebraska Medicine [http://now.nebraskamed.com/?utm_source=default&utm_medium=ie&utm_campaign=nowOne Chart Research Documentation] Policy (IM41) | ||
*Nebraska Medicine [ | |||
*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 [ | *Nebraska Medicine [http://now.nebraskamed.com/?utm_source=default&utm_medium=ie&utm_campaign=now Advanced Beneficiary Notice (ABN)]Policy (MI15) | ||
*Nebraska Medicine [ | *Nebraska Medicine [http://now.nebraskamed.com/?utm_source=default&utm_medium=ie&utm_campaign=now Research Billing Process] Policy (MI19) | ||
*Nebraska Medicine [ | *Nebraska Medicine [http://now.nebraskamed.com/?utm_source=default&utm_medium=ie&utm_campaign=now Investigational Devices] Policy (MI29) | ||
*Nebraska Medicine [ | *Nebraska Medicine [http://now.nebraskamed.com/?utm_source=default&utm_medium=ie&utm_campaign=now Admission/Registration to Nebraska Medicine] Policy (RI06) | ||
*[https://www.unmc.edu/academicaffairs/_documents/compliance/Clinical_Trial_Insurance_Predetermination_Request_Form.pdf Clinical Trial Insurance Predetermination Request] Form | *[https://www.unmc.edu/academicaffairs/_documents/compliance/Clinical_Trial_Insurance_Predetermination_Request_Form.pdf Clinical Trial Insurance Predetermination Request] Form | ||
*Nebraska Medicine [ | *Nebraska Medicine [http://now.nebraskamed.com/?utm_source=default&utm_medium=ie&utm_campaign=now SOP 201.2 Insurance Predetermination] Form | ||
*Nebraska Medicine [ | *Nebraska Medicine [http://now.nebraskamed.com/?utm_source=default&utm_medium=ie&utm_campaign=now ACCESS-REGSP-110] | ||
This page maintained by [mailto:dpanowic@unmc.edu dkp]. | This page maintained by [mailto:dpanowic@unmc.edu dkp]. | ||