Hematology is requested in the protocol to be performed. This is the lab that will be associated.
What is a CBC?
These are the guidelines to assess when looking for recommendations for Colorectal Patients.
What are the Colon and Rectal Guidelines?
These are the human side effects listed in the ICF:
Nausea and heart rhythm changes
These are the two procedures that can be billed via this support.
What is a physical exam and single ECG?
What is MUGA?
Pembrolizumab is FDA approved for the patient population in the protocol. We would find that information on this site (not the guidelines).
What is Dailymed?
These are common side effects that support billing a CBC.
What is Anemia, Neutropenia, Leukopenia, and/or Thrombocytopenia?
These are the guidelines to assess when a patient can enroll with GI cancers.
True or False:
Physical Exams include 1 set of vital signs.
True.
Additional vital signs should be added as another line.
The patient population includes any solid tumor type of cancer. These are the imaging locations that should be included.
What are Brain/Chest/Neck/Abdomen/Pelvis/Whole Body for CT/MRI/Bone Scan/PET/CT scans?
What is S-P?
These are common side effects to support billing a CMP.
What are changes in: liver enzymes (ALT/AST), blood glucose, electrolytes (low potassium/sodium), and/or kidney function (elevated BUN and creatinine)?
This is the NCCN Imaging Compendium.
What is the imaging AUC?
There are side effects listed for heart rhythm, however, an ECG is only listed at screening and not afterward. This would be the designation.
What is Research? This is due to the lack of assessment during treatment to assess any changes in heart rhythm.
True or False:
A CT of the Neck is recommended for the patient population. An MRI of the neck would be billable to the patient instead.
True.
One or the other would be billable to the patient.
True or False:
IV Drugs require 3 lines in the CA.
True.
The drug itself, The administration, and the pharmacy dispending.
This is the side effect to support billing PT/INR.
What are signs of over-anticoagulation (signs/symptoms of thrombosis or hemorrhage)?
The sections in the NCCN guidelines you should look for when determining coverage for Follow-Up Visits.
What is surveillance?
This is the side effects to support billing a single ECG.
What are heart rhythm changes?
Sponsor budget states "Scans to be performed every 6 weeks throughout treatment". However, there are no recommendations for scans in the guidelines for more frequently than every 8 weeks. This is the designation during treatment.
*See Notes.
SOC at every other visit.
The ICF states that this study drug has animal testing results stating that we have several severe side effects. What would be the billable items based on these side effects?
Trick question. None, due to no human side effects.
True or False:
CMP includes: Albumin (82040) Total Bilirubin (82247) Calcium (82310) Carbon Dioxide (bicarbonate) (82374) Chloride (82435) Creatinine (82565) Glucose (82947) Phosphatase, alkaline (84075) Potassium (84132), Phosphorus (84100), Protein, total (84155) Sodium (84295) Transferase, alanine amino (ALT) (SGPT) (84460) Transferase, aspartate amino (AST) (SGOT) (84450) Urea Nitrogen (BUN) (84520)
False - It does not include Phosphorus
What are the guidelines called, Management of Immunotherapy-Related Toxicities?
True or False:
There are known heart rhythm changes due to the study drug. Therefore, a triplicate ECG is billable.
False, triplicate ECGs are never billable.
True or False:
Scans can be billed based on side effects.
False. No side effects will support this. Recommendations required.
Diphenhydramine is required as a premedication. According to the protocol, it can be administered via IV infusion or orally. These are the lines that are required in the CA for this drug to be included.
What is the Drug itself (PO line and IV line), an IV administration line, and pharmacy dispensing for either administration route?