Misc.
This Medicare policy outlines the requirements for qualifying clinical trials.
What is NCD 310.1?
These sections of the NCCN Guidelines are usually most useful when assessing standard follow-up monitoring.
What are Surveillance sections?
These side effects commonly support billing a CMP.
What are abnormalities/changes in liver enzymes, kidney function, electrolytes, or glucose?
True or False: Every clinical trial without an IND is automatically non-qualifying.
What is False?
A protocol requires magnesium testing every cycle, but NCCN only recommends routine CMP monitoring. There are no known human side effects of the study drug.
What is the designation for magnesium?
Research.
A study drug is associated with thrombocytopenia and neutropenia.
What lab would be reasonable and necessary to monitor those side effects?
CBC
A study is determined to be non-qualifying. The sponsor budget does not mention ECGs.
Who pays for the ECGs?
The Sponsor. Patients cannot be billed in a non-qualifying trial.
You are unable to find imaging recommendations in disease-specific NCCN Guidelines.
What additional NCCN resource should be reviewed for recommendations?
NCCN Imaging Appropriate Use Criteria (AUC).
Human side effects include heart palpitations and QT prolongation.
What procedure may be supported?
ECG
True or False: Imaging can be designated SOC solely because the sponsor requires it.
False
This guideline should be reviewed whenever an immune checkpoint inhibitor is part of the treatment regimen.
What is Management of Immunotherapy-Related Toxicities?
Animal studies show significant kidney toxicity, but no human toxicity data are available.
Can CMP monitoring be billed based solely on the animal data?
No, only human side effects.
True or False.
Triplicate ECGs can be billed in place of single ECGs.
False - Triplicate ECGs are NEVER billable. ALWAYS research.
A drug is not FDA approved for the study indication but is recommended by NCCN.
Is the drug potentially billable?
Yes, because it may be medically accepted with support in the NCCN.
The protocol requires urinalysis every cycle. No guideline recommendation exists, but the ICF reports recurrent hematuria and proteinuria.
What designation the urinalysis have?
SOC - as long as it's human side effects.