Labs
NCCN Guidelines
Procedures
Scans
Drugs
100

Hematology is requested in the protocol to be performed. This is the lab that will be associated.

What is a CBC?

100

These are the guidelines to assess when looking for recommendations for Colorectal Patients.

What are the Colon and Rectal Guidelines?

100

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?

100
An ECHO is included in the protocol. This is the other item that can be performed in place of the ECHO.

What is MUGA?

100

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?

200

These are common side effects that support billing a CBC.

What is Anemia, Neutropenia, Leukopenia, and/or Thrombocytopenia?

200

These are the guidelines to assess when a patient can enroll with GI cancers.

What are the Gastric, GEJ, and Esophageal Cancer Guidelines?
200

True or False:

Physical Exams include 1 set of vital signs.

True. 

Additional vital signs should be added as another line.

200

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?

200
The combination drug is being provided by the Sponsor. This is the designation in the CA.

What is S-P?

300

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)?

300

This is the NCCN Imaging Compendium.

What is the imaging AUC?

300

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. 

300

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.

300

True or False:

IV Drugs require 3 lines in the CA.

True. 

The drug itself, The administration, and the pharmacy dispending.

400

This is the side effect to support billing PT/INR.

What are signs of over-anticoagulation (signs/symptoms of thrombosis or hemorrhage)?

400

The sections in the NCCN guidelines you should look for when determining coverage for Follow-Up Visits.

What is surveillance?

400

This is the side effects to support billing a single ECG.

What are heart rhythm changes?

400

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.

400

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. 

500

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

500
These are the guidelines for Immunotherapy Drugs (like Pembrolizumab).

What are the guidelines called, Management of Immunotherapy-Related Toxicities?

500

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.

500

True or False:

Scans can be billed based on side effects.

False. No side effects will support this. Recommendations required.

500

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?

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