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Clinical Research and Clinical Trial Professional and Technical Fee Billing: Difference between revisions
Clinical Research and Clinical Trial Professional and Technical Fee Billing (view source)
Revision as of 09:27, August 2, 2012
, August 2, 2012→Definitions
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## 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 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 | ## 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 /> | ## 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 \> | # The ''other desirable characteristics'' are:<br \> | ||
## Trial is sponsored by: NIH, CDC, AHRQ, CMS, DOD, or VA (called a "deemed" trial); or | ## Trial is sponsored by: NIH, CDC, AHRQ, CMS, DOD, or VA (called a "deemed" trial); or | ||