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

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 == Definitions ==
 ===Clinical Research===
-A funded or unfunded project that involves human subjects, where additional laboratory, radiology, or other services are provided and billed, whether alongside regular clinical care or not. This term, clinical research, includes all clinical trials, but the term clinical trial will be identified separately to clarify where special requirements may be in required for them.  (See [https://www.nichd.nih.gov/health/clinical-research NIH Clinical Research])
+“Clinical research aims to advance medical knowledge by studying people, either through direct interaction or through the collection and analysis of blood, tissues, or other samples.” (See [https://www.nichd.nih.gov/health/clinical-research NIH Clinical Research])
 ===Clinical Trial===
-A federally or other sponsored research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
+A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. Sources of funding could be federal, commercial, or other.
-==Qualified Clinical Trials==
+==Qualified Clinical Trials or Research==
-Only qualified clinical trials or clinical research are eligible for reimbursement for routine costs under Medicare. In order to be a qualified trial, three mandatory criteria must be met as well as have other desirable characteristics per the [https://www.unmc.edu/academicaffairs/_documents/compliance/MedicareQualifyingClinicalTrialsFlowsheet1.pdf Medicare Qualifying Clinical Trials Flowchart].
+Only qualified clinical trials or clinical research are eligible for reimbursement for routine costs under Medicare. In order to be a qualified trial, three mandatory criteria must be met as well as have other desirable characteristics per [https://www.unmc.edu/academicaffairs/_documents/compliance/MedicareQualifyingClinicalTrialsFlowsheet1.pdf Medicare Qualifying Clinical Trials Flowchart].
 ===Three mandatory criteria===
 *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);