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Clinical Research and Clinical Trial Professional and Technical Fee Billing: Difference between revisions
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Clinical Research and Clinical Trial Professional and Technical Fee Billing (view source)
Revision as of 08:23, August 2, 2012
, August 2, 2012→Definitions
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# The ''three mandatory criteria'' are: | # The ''three mandatory criteria'' are: | ||
<br \><br \> | |||
## 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: | ||
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## 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 | ||
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| 1019 || GNTCMSNOQUAL || grantCMSnonqualifying || Non-qualifying Medicare Trial | | 1019 || GNTCMSNOQUAL || grantCMSnonqualifying || Non-qualifying Medicare Trial | ||
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Please forward suggestions, questions or comments on this policy to Bill Lawlor (zip 5080). | Please forward suggestions, questions or comments on this policy to [mailto:wlawlor@unmc.edu Bill Lawlor] (zip 5080). | ||
[http://www.unmc.edu/media/compliance/clinical_trial_professional_and_technical_fee_billing_procedures.doc Clinical Trial Professional and Technical Fee Billing Procedures] / [http://webmedia.unmc.edu/policy/8008_1MedicareQualiflyingFlowchart.doc Medicare Qualifying Clinical Trials Flowchart] / [http://webmedia.unmc.edu/policy/8008_2AdvancedBeneficiaryFlowchart.doc Advance Beneficiary Notice Requirements Flowchart] / [http://webmedia.unmc.edu/policy/8008_3InvestigationalDevices.doc Investigational Devices] / [http://webmedia.unmc.edu/policy/8008_4Pre-StudyEval.doc Clinical Device Trial Pre-Study Evaluation] | [http://www.unmc.edu/media/compliance/clinical_trial_professional_and_technical_fee_billing_procedures.doc Clinical Trial Professional and Technical Fee Billing Procedures] / [http://webmedia.unmc.edu/policy/8008_1MedicareQualiflyingFlowchart.doc Medicare Qualifying Clinical Trials Flowchart] / [http://webmedia.unmc.edu/policy/8008_2AdvancedBeneficiaryFlowchart.doc Advance Beneficiary Notice Requirements Flowchart] / [http://webmedia.unmc.edu/policy/8008_3InvestigationalDevices.doc Investigational Devices] / [http://webmedia.unmc.edu/policy/8008_4Pre-StudyEval.doc Clinical Device Trial Pre-Study Evaluation] | ||