View source for Clinical Research and Clinical Trial Professional and Technical Fee Billing

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Policy No.: '''8008'''<br />
Effective Date: ''' 08/23/18'''<br />
Revised Date: '''07/09/24'''<br />
Reviewed Date: '''07/09/24'''<br /> 
<br />
<big>'''Clinical Research and Clinical Trial Professional and Technical Fee Billing Policy</big>'''
<br /><br />
== 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 [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==
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.
==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==
*Contact the [Mailto:sarah.glodencarlson@unmc.edu Chief Compliance Officer]]
*Nebraska Medicine Policy MI19, [https://now.nebraskamed.com/policies-and-procedures-manual/ Research Billing Process policy]
*Nebraska Medicine IM41, [https://now.nebraskamed.com/policies-and-procedures-manual/ One Chart Research Documentation]
*[https://nebraskamed.service-now.com/esc?id=kb_article&table=kb_knowledge&sysparm_article=KB0012293 IT Service Now- One Chart Tip Sheets, Looking Up Grant Charges on Statement (Send a Detail Bill)] 

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