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

* The three mandatory criteria are:

# 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:

# 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 />