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n r r 8 < = l f U D $ ) + + + + + + $ j O O 4 d d ) ) `! ! d z 0 ! H ! ! T O O ! r { : ROUTINE COSTS UNDER A MEDICARE QUALIFYING CLINICAL TRIAL
(NOT APPLICABLE TO DEVICE TRIALS)
To determine whether a clinical trial item or services is considered a routine cost that can be billed to Medicare, complete the following questionnaire. THIS IS ONLY A TOOL TO ASSIST YOU IN YOUR DETERMINATION. YOU SHOULD CONFIRM THIS WITH THE MEDICAL PROVIDER WHO MAY BE BILLING SUBJECTS (if allowable).
Question #1 Yes No Notes1. Is item or service generally available to Medicare beneficiaries (and the item or service is not otherwise excluded under Medicare)?
FORMCHECKBOX FORMCHECKBOX
If YES, move to the next question, if NO, the item is not covered under Medicare.
Question #2
Is the item or service characterized as one of the following: Yes No If yes, specify/notes1. Is the investigational item or service provided or paid for by the research sponsor? FORMCHECKBOX FORMCHECKBOX 2. Is the item or service used solely to satisfy data collection and analysis needs and not used in direct clinical management of the patient (e.g., monthly CT scans for a condition requiring only one CT scan?
FORMCHECKBOX FORMCHECKBOX 3. Is the item or service customarily provided by research sponsors free of charge for any study subject in the trial?
FORMCHECKBOX FORMCHECKBOX 4. Is the item or service provided solely to determine trial eligibility? FORMCHECKBOX FORMCHECKBOX
If you answered NO to all of the above statements in Question #2, continue to Question #3. If you answered YES to any of the above statements, the item or service is not covered as routine cost under Medicare and should not be billed to Medicare.
Question #3
Is the item or service contained within one of the following categories: Yes No If yes, specify/notes1. Item or service is typically provided absent a clinical trial (e.g., conventional/routine care)?
FORMCHECKBOX FORMCHECKBOX 2. Item or service required solely for the provision of investigational item or service (e.g., administration of a non-covered chemotherapeutic agent)?
FORMCHECKBOX FORMCHECKBOX 3. Item or service required for the clinically appropriate monitoring of the effects of the investigational item or service or the prevention of complications from item or service?
FORMCHECKBOX FORMCHECKBOX 4. Item or service is medically necessary for reasonable and necessary care arising from the provision of an investigation item or service in particular, for the diagnosis or treatment of complications?
FORMCHECKBOX FORMCHECKBOX
If you answered YES to any of the above in #3, service or item qualifies for coverage as routine cost under Medicare. If you answered NO to all the above in #3, the item or service is not covered as routine cost under Medicare and should not be billed to Medicare.
This is only a tool to assist you with your determination of the billing of routine.
BE SURE TO CONFIRM THIS INFORMATION WITH THE MEDICAL PROVIDER WHO WILL BE HANDLING ANY BILLING OF SUBJECTS.
The University of Tennessee
Office of Research Administration
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