Coding Rules Current as at 18-Oct-2016 08: 31

Published 15 June 2015,
for implementation 01 July 2015.

Ref No: Q2926 | Published On: 15-Jun-2015 | Status: Current

SUBJECT: Classifying a procedure under investigation in a randomised and placebo-controlled clinical trial

Q:

Is it necessary to assign a procedure code or a Z code to identify patients who are undergoing treatment as part of a clinical trial that is both randomised and placebo-controlled? For example, a patient with acute myocardial infarction who is participating in a placebo-controlled clinical trial (AMICI: Allogeneic Mesenchymal Precursor Cell Infusion in Myocardial Infarction), where the patient may receive either an infusion of stem cells or a placebo directly into a diseased coronary artery following angioplasty.

A:

A placebo-controlled clinical trial is a method of study in which both investigators and participants are blinded as to who received an intervention or a placebo.

Do not assign a code for a procedure that is part of a clinical trial that is placebo-controlled as:

1. 
   the purpose and methodology for collecting data for clinical trials are different to data collected for the Admitted Patient Care National Minimum Data Set (APC NMDS)
   

1. 
   information related to clinical trials are gathered and managed through clinical trial data collection systems
   
2. 
   clinical trials are usually reimbursable through separate grants
   
3. 
   there is no uniform policy or practice across hospitals and jurisdictions that requires clinical trial related activity to be recorded in clinical records.
   

Do not assign Z00.6 Examination for normal comparison and control in clinical research programme to flag patients undergoing treatment as part of a clinical trial. Codes in category Z00 are intended to classify individuals undergoing examination for specific purposes without complaint or reported diagnosis. Codes from this category should not be assigned when there is a documented definitive diagnosis as the indication for treatment.

See also Coding Rules: Same-day chemotherapy for neoplasm; participant in clinical drug trial.

Improvement to ACS 0026 Admission for clinical trial or therapeutic drug monitoring will be considered for a future edition.