The Guidance language states: The exclusion for patients who are clinical trial participants is limited to patients participating in a clinical trial for the same conditions as covered by the measure.
The Denominator Exclusions language states: Patients enrolled in clinical trials.
Therefore the exclusion would cover any patient in any clinical trial, not just those participating in a clinical trial for the same condition covered by the measure. This ambiguity also exists in the logic statements:
OR:
AND NOT: "Occurrence A of Patient Characteristic Clinical Trial Participant: Clinical Trial Participant" ends before start of "Occurrence A of Encounter, Performed: Encounter Inpatient"
AND: "Occurrence A of Patient Characteristic Clinical Trial Participant: Clinical Trial Participant" starts before or during "Occurrence A of Encounter, Performed: Encounter Inpatient"
The current logic therefore will exclude more patients than likely intended. We therefore either suggest that the Denominator language be updated to reflect the intent expressed in the Guidance, or otherwise be synchronized, e.g., clarify that any patient in any clinical trial is excluded from all CQM denominators (not just this one), or that the measure be withdrawn as the definition does not properly reflect the intent of the measure.