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 Research and 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]] | [[Disclosing Foreign Support and International Activities]] | [[Health Care Vendor Interactions]] | [[Credit Hour Definition]] | [[Whistleblower]]<br />
[[Compliance Program]] | [[Compliance Hotline]] | [[Investigations by Third Parties]] | [[Research Integrity]] | [[Export Control]] | [[Code of Conduct]] | [[Use of Human Anatomical Material]] | [[Clinical Research and 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]] | [[Disclosing Foreign Support and International Activities]] | [[Health Care Vendor Interactions]] | [[Credit Hour Definition]] | [[Whistleblower]] | [[Electronic Digital Signatures and Records]]<br />
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<br />
Policy No.: '''8008'''<br />
Policy No.: '''8008'''<br />
Effective Date: ''' 08/23/18'''<br />
Effective Date: ''' 08/23/18'''<br />
Revised Date: <br />
Revised Date: <br />
Reviewed Date: '''08/12/20'''<br />  
Reviewed Date: '''07/21/23'''<br />  
<br />
<br />
<big>'''Clinical Research and Clinical Trial Professional and Technical Fee Billing Policy</big>'''
<big>'''Clinical Research and Clinical Trial Professional and Technical Fee Billing Policy</big>'''
<br /><br />
<br /><br />
== 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 billing charges for clinical research that are accurate, timely and in accordance with Medicare NCD guidelines (National Coverage Determination) 310.1 and institutional 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 research payer, to a third party payer, or to a patient, as appropriate, to comply with federal laws, regulations and policies and maintain patient satisfaction.  
*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).  
To define process for identifying research-related charges for accurately billing to research payers, third-party payers, and/or patient while complying with federal laws, regulations and institutional policies and maintain patient satisfaction.
*This policy does not apply to dental clinical trials.
 
* 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.
* This policy does not apply to dental clinical trials.
 
== Definitions ==
== Definitions ==
===Clinical Research===
===Clinical Research===
“Clinical research aims to advance medical knowledge by studying people, either through direct interaction or through the collection and analysis of blood, tissues, or other samples.” (See [https://www.nichd.nih.gov/health/clinical-research NIH Clinical Research])
Clinical research aims to advance medical knowledge by studying people, either through direct interaction or through the collection and analysis of blood, tissues, or other samples.  
===Clinical Trial===
===Clinical Trial===
A 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. Sources of funding could be federal, commercial, or other.
A 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. Sources of funding could be federal, commercial, or other.  
==Qualified Clinical Trials or Research==
==Qualified Clinical Trials or Research==
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 [https://www.unmc.edu/academicaffairs/_documents/compliance/MedicareQualifyingClinicalTrialsFlowsheet1.pdf Medicare Qualifying Clinical Trials Flowchart].
Qualified clinical trials or research are eligible for reimbursement for routine costs under Medicare NCD 310.1 (also called the Clinical Trial Policy). Per NCD 310.1, to be deemed a qualified trial a study must meet three mandatory criteria and include seven desirable characteristics. A study can be considered automatically a qualified trial based on criteria from the Agency for Healthcare Research and Quality (AHRQ) in consultation with other agencies represented on a multiagency panel. For trials that are automatically deemed qualifying, the principal investigator does not need to certify that they meet the criteria but must enroll them in the Clinical Trials Registry (also known as ClinicalTrials.gov) for administrative purposes. Refer to [https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=1&ncdver=2&DocID=310.1&show=ncd&t=2010422105232&bc=gAAAAAgAAAAA& Medicare NCD (310.1), Clinical Trial Policy], for more information.
===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 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
*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===
*The principal purpose of the trial is to test whether the intervention potentially improves the participants’ health outcomes;
*The trial is well-supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use;
*The trial does not unjustly duplicate existing studies;
*The trial design is appropriate to answer the research question being asked in the trial;
*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;
*All aspects of the trial are conducted according to the appropriate standards of scientific integrity.  
==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. <br />
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 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
*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. <br />
Routine costs of clinical trials include all items and services provided in the experimental or control arm that are otherwise generally available to Medicare beneficiaries absent a clinical trial. Refer to [https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=1&ncdver=2&DocID=310.1&show=ncd&t=2010422105232&bc=gAAAAAgAAAAA& Medicare NCD (310.1), Clinical Trial Policy], for more information.
 
Routine costs in clinical trials include:
*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);
*The clinically appropriate monitoring of the effects of the item or service, or the prevention of complications; and
*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 that are solely performed for research are typically paid by the research grant or contract. These costs are not billable to Medicare and/or a third party payer.<br />
Patient care costs arising from services performed solely for research purposes are charged to the study. Research-only items and services are not billable to patients or third parties.  
 
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;
*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);
*Items and services customarily provided by the research sponsors free of charge for any enrollee in the trial;
*Items and services provided solely to determine trial eligibility.
==Additional Information==
==Additional Information==
*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/wiki/Clinical_Trial_Professional_and_Technical_Fee_Billing_Procedures.pdf Clinical Trial Professional and Technical Fee Billing Procedures]
*Nebraska Medicine Policy MI19, [https://now.nebraskamed.com/policies-and-procedures-manual/ Research Billing Process policy]
*[https://www.unmc.edu/academicaffairs/_documents/compliance/MedicareQualifyingClinicalTrialsFlowsheet1.pdf Medicare Qualifying Clinical Trials Flowchart]
*Nebraska Medicine IM41, [https://now.nebraskamed.com/policies-and-procedures-manual/ One Chart Research Documentation]
*[https://www.unmc.edu/academicaffairs/_documents/compliance/ABNRequirementsFlowchart.pdf Advanced Beneficiary Notice Requirements Flowchart]  
*Nebraska Medicine [https://now.nebraskamed.com/policies-and-procedures-manual/ One Chart Tips and Tricks Sheet] - Looking Up Grant Charges on Statements
*Nebraska Medicine Policy IM10, [https://www.unmc.edu/academicaffairs/_documents/compliance/NE_Medicine_IM10_OneChartTraining.pdf One Chart Training Classes]  
*Nebraska Medicine IM41, [https://www.unmc.edu/academicaffairs/_documents/compliance/NE_Medicine_IM41_OneChartResearchDocumentation.pdf One Chart Research Documentation]  
*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 Policy MI15, [https://www.unmc.edu/academicaffairs/_documents/compliance/NE_Medicine_MI15_AdvancedBeneficiaryNoticeABN.pdf Advanced Beneficiary Notice (ABN)]
*Nebraska Medicine Policy MI19, [https://www.unmc.edu/academicaffairs/_documents/compliance/NE_Medicine_MI19_ResearchBillingProcess.pdf Research Billing Process]
*Nebraska Medicine Policy MI29, [https://www.unmc.edu/academicaffairs/_documents/compliance/NE_Medicine_MI29_InvestigationalDevices.pdf Investigational Devices]
*Nebraska Medicine Policy RI06, [https://www.unmc.edu/academicaffairs/_documents/compliance/NE_Medicine_RI06_AdmissionRegistrationtoNebraskaMedicine.pdf Admission/Registration to Nebraska Medicine]
*[https://www.unmc.edu/academicaffairs/_documents/compliance/NE_Medicine_FNC-201_Financial_Clinical_Trial_Insurance_Preauthorization_Insured_and_NonInsured.pdf Nebraska Medicine Policy FNC-201, Financial Clinical Trial Insurance Preauthorization Insured and Noninsured] (unmc.edu)
*[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/ACCESS-REGSP-110.pdf Nebraska Medicine ACCESS-REGSP-110]
* [https://grants.nih.gov/policy/clinical-trials/definition.htm National Institutes of Health]


This page maintained by [mailto:dpanowic@unmc.edu dkp].
This page maintained by [mailto:mhurlocker@unmc.edu mh].

Latest revision as of 13:54, September 13, 2023

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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 Research and 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 | Disclosing Foreign Support and International Activities | Health Care Vendor Interactions | Credit Hour Definition | Whistleblower | Electronic Digital Signatures and Records

Policy No.: 8008
Effective Date: 08/23/18
Revised Date:
Reviewed Date: 07/21/23

Clinical Research and Clinical Trial Professional and Technical Fee Billing Policy

Policy

University of Nebraska Medical Center is committed to billing charges for clinical research that are accurate, timely and in accordance with Medicare NCD guidelines (National Coverage Determination) 310.1 and institutional policies.

Basis for Policy

To define process for identifying research-related charges for accurately billing to research payers, third-party payers, and/or patient while complying with federal laws, regulations and institutional policies and maintain patient satisfaction.

  • 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.
  • This policy does not apply to dental clinical trials.

Definitions

Clinical Research

Clinical research aims to advance medical knowledge by studying people, either through direct interaction or through the collection and analysis of blood, tissues, or other samples.

Clinical Trial

A 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. Sources of funding could be federal, commercial, or other.

Qualified Clinical Trials or Research

Qualified clinical trials or research are eligible for reimbursement for routine costs under Medicare NCD 310.1 (also called the Clinical Trial Policy). Per NCD 310.1, to be deemed a qualified trial a study must meet three mandatory criteria and include seven desirable characteristics. A study can be considered automatically a qualified trial based on criteria from the Agency for Healthcare Research and Quality (AHRQ) in consultation with other agencies represented on a multiagency panel. For trials that are automatically deemed qualifying, the principal investigator does not need to certify that they meet the criteria but must enroll them in the Clinical Trials Registry (also known as ClinicalTrials.gov) for administrative purposes. Refer to Medicare NCD (310.1), Clinical Trial Policy, for more information.

Routine Costs

Routine costs of clinical trials include all items and services provided in the experimental or control arm that are otherwise generally available to Medicare beneficiaries absent a clinical trial. Refer to Medicare NCD (310.1), Clinical Trial Policy, for more information.

Research Costs

Patient care costs arising from services performed solely for research purposes are charged to the study. Research-only items and services are not billable to patients or third parties.

Additional Information

This page maintained by mh.

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