True/False
Designations
QCT
100
True or False:
The NCCN guidelines state that a CBC is recommended "as clinically indicated" at workup. This lab is billable at screening.
False, the guidelines do not state the clinical indication required, so all patients cannot be confirmed to have said indication for billing. Therefore, this does not support billing at screening.
100
This is the analysis for Staff Time (PI Time, Study Coordinator, Data Entry, Nurse Time) if the Sponsor does not include on the Sponsor Budget.
What is "This is not a billable item or service"?
100
This is a major point in determining if the trial is qualifying.
*hint: what kind of intent is required?
The trial must have therapeutic intent for the patient population.
200
True or False: The number of tabs/grids in the CA should match the number of grids in the Sponsor Budget.
True.
200
A Direct Bilirubin lab should be performed if "clinically indicated" in the protocol. This would be the designation.
What is SOC?
200
Is safety and tolerability of the study drug support to consider a trial qualifying?
No, typically we are looking for something along the lines of "Overall Response Rate".
300
True or False. A Sponsor only provides a Visit Total only Budget. We assume that the Sponsor is paying for all items.
False, a complete CA is required for all items to determine coverage.
300
These side effects must be present in order to support billing a Urinalysis without an NCCN recommendation.
What are changes in urine; UTI, blood, protein, etc.?
300
True/False: A study does not have an IND. This study is non-qualifying.
False IF the trial meets the requirements below. True if the trial does not meet the requirements.
400
True or False: The following items are always SOC:
ECOG, Observation Time, and Questionnaires
False, these are time and effort items only.
400
*See Notes is listed on a CT of the Chest in the cell. This is due to the designation being ___/___.
What is SOC/R-Inv?
400
This is the section of the protocol where you would find whether or not the trial has therapeutic intent.
What is the Objectives and Endpoints section of the protocol?
500
True or False: Sponsors can choose to pay for items that have been denied by Medicare.
False, this is due to the Secondary Payor rules.
500
What is the S-P Designation meaning?
What is Sponsor Provided?
500
The study is non-qualifying. What does that mean for our CA?
Patients cannot be billed for items as the trial is not qualifying, therefore, the Sponsor must pay for all items included in the budget.