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

Reviewed Date: '''11/29/16'''<br />  

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.   

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 1 & 2 for specific medical device trial procedures and tools).  

*This policy does not apply to dental 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).'''

The three mandatory criteria are:         

:*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

*Participants must be individuals with diagnosed disease rather than healthy volunteers, except for trials involving diagnostic intervention that require proper control groups.

*The trial is in compliance with Federal regulations relating to the protection of human Subjects;

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.

*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 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.   

*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

*[ Clinical Trial Professional and Technical Fee Billing Procedures]  

*[ Medicare Qualifying Clinical Trials Flowchart]

*[ Advance Beneficiary Notice Requirements Flowchart]

*[ Clinical Device Trial Pre-Study Evaluation]