CCDM Medical Coding 5 — Questions and Answers
Question 1: In ICD-10-CM, an 'excludes1' note means:
- The excluded code can never be reported with the code in question (Correct answer)
- The excluded code may be reported together when both conditions are present
- The condition is included in the code and should not be separately coded
- The code is restricted to inpatient use only
Correct answer: The excluded code can never be reported with the code in question
An 'Excludes1' note means the conditions cannot occur together, so both codes should never be reported simultaneously.
Question 2: When a clinical data manager reviews coded adverse event data before database lock, the primary goal of the coding review is to ensure:
- All verbatim terms are accurately mapped to the appropriate MedDRA terms and no coding errors exist (Correct answer)
- The number of adverse events matches the sponsor's safety expectations
- All events are coded to the same SOC for simplicity
- Coding is completed as quickly as possible to meet lock timelines
Correct answer: All verbatim terms are accurately mapped to the appropriate MedDRA terms and no coding errors exist
The coding review ensures accuracy and completeness of verbatim-to-MedDRA mappings to support reliable safety analysis before database lock.
Question 3: A patient's death during a clinical trial is coded as an adverse event. Under MedDRA, 'Death' at the PT level falls under which SOC?
- General disorders and administration site conditions (Correct answer)
- Injury, poisoning and procedural complications
- Neoplasms benign, malignant and unspecified
- Surgical and medical procedures
Correct answer: General disorders and administration site conditions
The MedDRA PT 'Death' is classified under the SOC 'General disorders and administration site conditions.'
Question 4: Which of the following best describes 'upcoding' in the context of medical billing compliance?
- Assigning a higher-level code than the documentation supports to increase reimbursement (Correct answer)
- Updating codes to a newer ICD version
- Coding a condition that is not documented
- Using combination codes instead of multiple individual codes
Correct answer: Assigning a higher-level code than the documentation supports to increase reimbursement
Upcoding is a fraudulent practice of assigning codes representing more complex or expensive services than those actually documented or performed.
Question 5: In the context of WHO-DD coding, what is the ATC (Anatomical Therapeutic Chemical) classification used for?
- Classifying drugs by the organ system they act on and their therapeutic and chemical properties (Correct answer)
- Assigning unique identifiers to drug manufacturers
- Coding adverse drug reactions in MedDRA
- Labeling investigational products in clinical trial protocols
Correct answer: Classifying drugs by the organ system they act on and their therapeutic and chemical properties
The ATC system classifies drugs according to the organ or system they act on and their pharmacological, therapeutic, and chemical properties.
Question 6: During a coding audit for a Phase III trial, it is discovered that 'headache' was coded to 'Migraine' (a more specific PT) without clinical documentation supporting migraine. This is an example of:
- Over-coding or assumption coding, which violates coding accuracy standards (Correct answer)
- Appropriate specificity coding
- A MedDRA hierarchy error
- An acceptable verbatim-to-LLT mapping
Correct answer: Over-coding or assumption coding, which violates coding accuracy standards
Assigning a more specific code than the source documentation supports (assumption coding) is a coding accuracy violation that can skew safety data.
Question 7: Which regulatory guidance document provides recommendations for standardized coding of adverse events in clinical trial safety reporting?
- ICH E2B(R3) (Correct answer)
- ICH E6(R2)
- 21 CFR Part 11
- ICH E8
Correct answer: ICH E2B(R3)
ICH E2B(R3) provides the international standard for electronic transmission of individual case safety reports (ICSRs), including structured adverse event coding.
CCDM Medical Coding 5
In ICD-10-CM, an 'excludes1' note means: