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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 09:26, August 2, 2012
, August 2, 2012→Definitions
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# The ''three mandatory criteria'' are: | # The ''three mandatory criteria'' are:<br \> | ||
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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 | ||
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# The ''other desirable characteristics'' are: | # 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 | ||
## Trial is conducted under an investigational new drug application (IND) reviewed by the FDA; or | ## Trial is conducted under an investigational new drug application (IND) reviewed by the FDA; or | ||