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

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== Policy ==  
== Policy ==  
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 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 (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 [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 [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);
*Trial has therapeutic intent.  
*Trial has therapeutic intent.  
:*To have therapeutic intent, the trial must, to some extent, assess the effect of the intervention on the patient outcome. The trial must not be designed to exclusively test for toxicity or disease pathophysiology; and
:*To have therapeutic intent, the trial must, to some extent, assess the effect of the intervention on the patient outcome. The trial must not be designed to exclusively test for toxicity or disease pathophysiology; and
*Participants must be individuals with diagnosed disease rather than healthy volunteers, except for trials involving diagnostic intervention that require proper control groups.<br />
*Participants must be individuals with diagnosed disease rather than healthy volunteers, except for trials involving diagnostic intervention that require proper control groups.
 
====Seven desirable characteristics====
====Seven desirable characteristics====
*The principal purpose of the trial is to test whether the intervention potentially improves the participants’ health outcomes;
*The principal purpose of the trial is to test whether the intervention potentially improves the participants’ health outcomes;
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*The trial is sponsored by a credible organization or individual capable of executing the proposed trial successfully;
*The trial is sponsored by a credible organization or individual capable of executing the proposed trial successfully;
*The trial is in compliance with federal regulations relating to the protection of human subjects;
*The trial is in compliance with federal regulations relating to the protection of human subjects;
*All aspects of the trial are conducted according to the appropriate standards of scientific integrity.
*All aspects of the trial are conducted according to the appropriate standards of scientific integrity.  
===Deeming Criteria===
===Deeming Criteria===
Some clinical trials are automatically qualified to receive Medicare coverage of their routine costs because they have been deemed by the Agency for Healthcare Research and Quality (AHRQ), in consultation with other agencies represented on the multiagency panel to be highly likely to have the above-listed seven desirable characteristics of clinical trials. The principal investigators of these automatically qualified trials do not need to certify that the trials meet the qualifying criteria, but must enroll the trials in the Medicare clinical trials registry (ClinicalTrials.gov) for administrative purposes.
Some clinical trials are automatically qualified to receive Medicare coverage of their routine costs because they have been deemed by the Agency for Healthcare Research and Quality (AHRQ), in consultation with other agencies represented on the multiagency panel to be highly likely to have the above-listed seven desirable characteristics of clinical trials. The principal investigators of these automatically qualified trials do not need to certify that the trials meet the qualifying criteria, but must enroll the trials in the Medicare clinical trials registry [ClinicalTrials.gov ClinicalTrials.gov] for administrative purposes. <br />


Effective September 19, 2000, clinical trials that are deemed to be automatically qualified are:
Effective September 19, 2000, clinical trials that are deemed to be automatically qualified are:  
*Trials funded by: NIH, CDC, AHRQ, CMS, DOD, or VA
*Trials funded by: NIH, CDC, AHRQ, CMS, DOD, or VA;
*Trials supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, CMS, DOD, and VA;  
*Trials supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, CMS, DOD, and VA;  
*Trials conducted under an investigational new drug application (IND) reviewed by the FDA; or
*Trials conducted under an investigational new drug application (IND) reviewed by the FDA; or
*Drug Trials that are exempt from having an IND number under 21 CFR 312.2(b)(1) will be deemed automatically qualified until qualifying criteria are developed and the certification process is in place. At that time, the principal investigators of these trials must certify that the trials meet the qualifying criteria in order to maintain Medicare coverage of routine costs. This certification process will only affect the future status of the trial and will not be used to retroactively change the earlier deemed status.
*Drug Trials that are exempt from having an IND number under 21 CFR 312.2(b)(1) will be deemed automatically qualified until qualifying criteria are developed and the certification process is in place. At that time, the principal investigators of these trials must certify that the trials meet the qualifying criteria in order to maintain Medicare coverage of routine costs. This certification process will only affect the future status of the trial and will not be used to retroactively change the earlier deemed status.
===Routine Costs===
===Routine Costs===
Routine costs of a clinical trial include all items and services that otherwise would be generally available to Medicare beneficiaries (i.e., there exists a benefit category, it is not statutorily excluded, and there is not a national non-coverage decision) that are provided in either the experimental or control arm of a clinical trial.  
Routine costs of a clinical trial include all items and services that otherwise would be generally available to Medicare beneficiaries (i.e., there exists a benefit category, it is not statutorily excluded, and there is not a national non-coverage decision) that are provided in either the experimental or control arm of a clinical trial. <br />


Routine costs in clinical trials include:
Routine costs in clinical trials include:  
*Items or services typically provided absent a clinical trial (i.e. conventional care);
*Items or services typically provided absent a clinical trial (i.e. conventional care);
*Items or services required solely for the provision of the investigational item or service (e.g. administration of a covered chemotherapeutic agent);
*Items or services required solely for the provision of the investigational item or service (e.g. administration of a covered chemotherapeutic agent);
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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.  
Patient care costs associated with the research trial. <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:  
*The investigational item or service, itself unless otherwise covered outside of the clinical trial.
*The investigational item or service, itself unless otherwise covered outside of the clinical trial.
*Items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient (e.g. monthly computed tomography scans for a condition usually requiring only a single scan); and
*Items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient (e.g. monthly computed tomography scans for a condition usually requiring only a single scan); and
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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/ClinicalTrialProfessionalandTechnicalFeeBillingProcedures.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 [https://secure.compliance360.com/Common/ViewUploadedFile.aspx?PD=PbRt%2bA78MS43j%2bgRKypwmoK9mTBSgSYjiITUtlkdJweW78KTfJAbiVmQGxD0TD%2ffbeiz8FDLCSWkeE%2fsYKVJFIhAUxeq98Xnp%2bnAIlgwmZoHmQZrN79tB6Qj0Jrs%2fiI2HKfoMGmtvHEmfnr3DsPwcwWcTFzyvGpl2jCfUuLMJjm08ZTqhTB89x73qklfUNwq3Ffp0zExgf8Lqka2vCsryrCXjfnRkH4ZLDTEkWkGm9A%3d One Chart Training Classes] Policy (IM10)
*Nebraska Medicine [F9iTLHQ5j32zKaueRrAxCiCH1yUT45MeJ%2fV%2bJDAV%2frX%2bwPONyIzwudP2%2fOW1bCqZNFugEix701tr%2fUMjUqR9pcaFY7M1JiTEgWd025E%3d 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://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://secure.compliance360.com/Common/ViewUploadedFile.aspx?PD=PbRt%2bA78MS4JgjkHyfyOQWF2GGAFuWhO3ZA0IDJYUVLcJqUaNWoauX0E2pQ9Vjg3b%2fNmqi5xTmsVLW5gp7cQV3pf8fwDTZlwuaIzDMYsDo4ZzmF9yphQS3wTTcmxqdk1dM9oCRFar0QzY9MqqnySNHsu8qEMWwbqgEFH3g84aE%2fBQRvPw7x7u6eJnx0HWBk5LDLP8yhyKF8V4VhGJMiBSRXVyfrK%2bNtxX%2b5MhsBCU08%3d 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://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/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/ACCESS-REGSP-110.pdf ACCESS-REGSP-110]


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