Thank you for your question. Clinical trials are still modeled in the VTE and STK measures, however, it is no longer a stand alone data element. Clinical trial is included in the Medical Reason value set (OID: 2.16.840.1.113883.3.117.1.7.1.473). This change was made in order to make the clinical trial contextual to the intervention. Here is an example, in STK-3, where it is modeled as a denominator exception: • OR: Union of:             ◦ "Medication, Discharge not done: Medical Reason" for "Anticoagulant ingredient specific" This exception uses the Medical Reason value set, and inside of this value set there is a clinical trial code: 428024001 Clinical trial participant (person)    The PC eCQMs never had a clinical trial data element.   For EP measures CMS 140 and 141, the clinical trial does need to be specific to breast cancer (CMS 140) and colon cancer (CMS 141) respectively.

Our organization will be reporting on selected eMeasures (measures in VTE, STK, ED and PC). Currently for chart-abstracted measures, patients in a clinical trial respective to VTE, STK or PC, for example, would be excluded if they are enrolled in a clinical trial respective to the measure that is being abstracted. Based on the latest value sets (Dec v 1.7), it states the data element "Clinical Trial Participant" is only applicable for CMS140v4 (NQF 0387) and CMS141v5 (NQF 0385) which are related to Breast Cancer and Colon Cancer Measures respectively. Since our hospitals are not choosing either of these measures, do we still need to map Clinical Trials for eCQM purposes? How about patients on a research study, research protocols? Are they considered the same and does the research study or protocol have to be measure-specific? Does the "Clinical Trial" data element not apply to any other measures or does it apply for all measures? Thank you