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

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[[Human Resources]] | [[Safety/Security]] | [[Research Compliance]] | '''[[Compliance]]''' | [[Privacy/Information Security]] | [[Business Operations]] | [[Intellectual Property]]
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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]]<br />
<br />
Policy No.: '''8008'''<br />
Effective Date: ''' 08/23/18'''<br />
Revised Date: <br />
Reviewed Date: '''07/21/23'''<br />
<br />
<big>'''Clinical Research and Clinical Trial Professional and Technical Fee Billing Policy</big>'''
<br /><br />
<br /><br />
[[Compliance Program]] | [[Compliance Hotline]] | [[Investigations by Third Parties]] | [[Research Integrity]] | [[Copyright]] | [[Export Control]] | [[Code of Conduct]] | [[Use of Human Anatomical Material]] | [[Clinical Trial Fee Billing Procedures]] | [[Contracts Policy]] | [[Conflicts of Interest]]
<br /><br />
POLICY NO: '''8008'''<br />
EFFECTIVE DATE: '''DRAFT'''<br />
REVISED DATE:<br />
REVIEWED DATE: '''03/28/08'''<br />
<br /><br />
<big>Clinical Trial Professional and Technical Fee Billing Policy</big>
<br /><br />
See also [http://www.unmc.edu/media/compliance/clinical_trial_professional_and_technical_fee_billing_procedures.doc Clinical Trial Professional and Technical Fee Billing Procedures] / [http://webmedia.unmc.edu/policy/8008_1MedicareQualiflyingFlowchart.doc Medicare Qualifying Clinical Trials Flowchart] / [http://webmedia.unmc.edu/policy/8008_2AdvancedBeneficiaryFlowchart.doc Advance Beneficiary Notice Requirements Flowchart] / [http://webmedia.unmc.edu/policy/8008_3InvestigationalDevices.doc Investigational Devices] / [http://webmedia.unmc.edu/policy/8008_4Pre-StudyEval.doc Clinical Device Trial Pre-Study Evaluation]
== 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.
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 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.


To define procedures for identifying patients who are research subjects and  to accurately charge medical procedure costs to the grant, to the third party payer, or to the 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 Attachments 3&4 for specific medical device trial procedures and tools).   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 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]
*Nebraska Medicine [https://now.nebraskamed.com/policies-and-procedures-manual/ One Chart Tips and Tricks Sheet] - Looking Up Grant Charges on Statements


'''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 (see [http://webmedia.unmc.edu/policy/8008_1MedicareQualiflyingFlowchart.doc Medicare Qualifying Clinical Trials Flowchart] ).
This page maintained by [mailto:mhurlocker@unmc.edu mh].
   
       
# The ''three mandatory criteria'' are:<br \>         
## 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.<br />           
# The ''other desirable characteristics'' are:<br \>           
## Trial is sponsored by: NIH, CDC, AHRQ, CMS, DOD, or VA (called a "deemed" trial); or
## Trial is conducted under an investigational new drug application (IND) reviewed by the FDA; or
## Drug trials exempt from having an IND number under 21 CFR 312.2(b)(1) are automatically qualified until qualifying criteria are developed and the certification process is in place.<br />
<br />
           
'''Routine Costs''':  routine costs of a clinical trial include all items and services that otherwise would be generally available to Medicare beneficiaries regardless of whether they are assigned to the experimental or control arm of a clinical trial.  (Medicare National Coverage Decision Program Memorandum Transmittal AB-01-103, dated July 27, 2001).  Examples of items and services that are specifically included as routine costs are:   
       
* 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 non-covered chemotherapeutic agent).
* The clinically appropriate monitoring of the effects of the item or service, or the prevention 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. <br />
<br />
       
'''Research Costs''':  Patient care costs associated with the research trial.  Examples of items and services that are specifically included as research costs are:
       
* The investigational item or service, itself.
* 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.<br />
<br />
       
'''Plan Codes''': Identify how research is funded.  There are three research-related plan codes:<br />
<br />
{| class="wikitable"
|-
! Code !! Short Title !! Long Title !! Description
|-
| 617 || GNTINTRSF || grantinternalresearchfund || Funded by Internal Research Funds
|-
| 1018 || GNTCMSQUAL || grantCMSqualifying || Qualifying Medicare Trial
|-
| 1019 || GNTCMSNOQUAL || grantCMSnonqualifying || Non-qualifying Medicare Trial
|}
Please forward suggestions, questions or comments on this policy to [mailto:wlawlor@unmc.edu Bill Lawlor] (zip 5080).
 
[http://www.unmc.edu/media/compliance/clinical_trial_professional_and_technical_fee_billing_procedures.doc Clinical Trial Professional and Technical Fee Billing Procedures] / [http://webmedia.unmc.edu/policy/8008_1MedicareQualiflyingFlowchart.doc Medicare Qualifying Clinical Trials Flowchart] / [http://webmedia.unmc.edu/policy/8008_2AdvancedBeneficiaryFlowchart.doc Advance Beneficiary Notice Requirements Flowchart] / [http://webmedia.unmc.edu/policy/8008_3InvestigationalDevices.doc Investigational Devices] / [http://webmedia.unmc.edu/policy/8008_4Pre-StudyEval.doc Clinical Device Trial Pre-Study Evaluation]
 
For additional information, please contact the [mailto:swrobel@unmc.edu Compliance Officer].
 
This page maintained by [mailto:dpanowic@unmc.edu dkp].

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

Human Resources   Safety/Security   Research Compliance   Compliance   Privacy/Information Security   Business Operations   Intellectual Property   Faculty


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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