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Policy No.: 8008
Effective Date: DRAFT
Revised Date:
Reviewed Date: 03/28/08

Clinical Trial Professional and Technical Fee Billing Policy

See also Clinical Trial Professional and Technical Fee Billing Procedures / Medicare Qualifying Clinical Trials Flowchart / Advance Beneficiary Notice Requirements Flowchart / Investigational Devices / Clinical Device Trial Pre-Study Evaluation

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.

Basis for Policy

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.

Definitions

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 Medicare Qualifying Clinical Trials Flowchart ).

1. The three mandatory criteria are:
   
   1. 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);
   2. 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
   3. Participants must be individuals with diagnosed disease rather than healthy volunteers, except for trials involving diagnostic intervention that require proper control groups.
      
2. The other desirable characteristics are:
   
   1. Trial is sponsored by: NIH, CDC, AHRQ, CMS, DOD, or VA (called a "deemed" trial); or
   2. Trial is conducted under an investigational new drug application (IND) reviewed by the FDA; or
   3. 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.
      

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.
  

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.
  

Plan Codes: Identify how research is funded. There are three research-related plan codes:

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 Bill Lawlor (zip 5080).

Clinical Trial Professional and Technical Fee Billing Procedures / Medicare Qualifying Clinical Trials Flowchart / Advance Beneficiary Notice Requirements Flowchart / Investigational Devices / Clinical Device Trial Pre-Study Evaluation

Additional Information

Contact the Compliance Officer.

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