Brief Description of Measure:
CMS347: Statin Therapy for the Prevention and Treatment of Cardiovascular Disease:
 Percentage of the following patients - all considered at high risk of cardiovascular events - who were prescribed or were on statin therapy during the measurement period:
*All patients who were previously diagnosed with or currently have an active diagnosis of clinical atherosclerotic cardiovascular disease (ASCVD), including an ASCVD procedure; OR
*Patients aged >= 20 years who have ever had a low-density lipoprotein cholesterol (LDL-C) level >= 190 mg/dL or were previously diagnosed with or currently have an active diagnosis of familial hypercholesterolemia; OR
*Patients aged 40-75 years with a diagnosis of diabetes

Description of Issue:
​​To align with the with 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease, the measure developer is exploring adding a 10-year ASCVD risk assessment tool to the measure (CMS347 Statin Therapy for the Prevention and Treatment of Cardiovascular Disease) as 4th Population criterion, at the direction of the measure steward and expert work group.
We are looking for both clinical and technical input. Below are a couple of questions we are seeking input on.
CLINICAL/WORKFLOW QUESTIONS
1. Will adding a 4th population increase the complexity of the measure?
2. How would a 4th population impact the performance of the measure?
 
TECHNICAL QUESTIONS
1. For capturing the 10-year ASCVD risk assessment score what is your recommendation on capturing the risk score?
    a.) If the clinician is using a risk assessment tool that is integrated into the EHR?  Or 
    b.) If the clinician is using a risk assessment tool that is outside the EHR?
2. In our proposed CQL logic, for the definition: Ten Year CVD Risk is High do you recommend that we use either Intervention, Performed or Assessemnt, Performed or both when capturing if the risk scores are high or >=20%?

Proposed Solution:
​The measure developer proposes adding a 4th Population:
 
PROPOSED HEADER LANGUAGE CHANGES
ADD THE FOLLOWING STATEMENT TO THE DESCRIPTION:
Patients aged 40 to 75 years with LDL-C >= 70 <190 mg/dL and without a diagnosis of diabetes mellitus who have a 10-year cardiovascular disease  (CVD) risk assessment with a high or >= 20% result.
 
ADD THE FOLLOWING STATEMENT TO RATE AGGREGATION:
Population 4: Patients aged 40 to 75 years at the beginning of the measurement period with LDL-C >= 70 <190 mg/dL and without a diagnosis of diabetes mellitus who have a 10-year CVD risk assessment with a high or >= 20% result during the measurement period.
 
REVISE THE EXISTING CONTENT IN RATE AGGREGATION TO:
For the purposes of this measure, a single performance rate can be calculated as follows:
 
Performance Rate = (Numerator 1 + Numerator 2 + Numerator 3 + Numerator 4)/ [(Denominator 1 - Denominator Exclusions 1 - Denominator Exceptions 1) + (Denominator 2 - Denominator Exclusions 2 - Denominator Exceptions 2) + (Denominator 3 - Denominator Exclusions 3 - Denominator Exceptions 3) + (Denominator 4 - Denominator Exclusions 4 - Denominator Exceptions 4)]
 
ADD THE FOLLOWING GUIDANCE:
Initial Population 4:
Patients aged 40 to 75 years at the beginning of the measurement period with LDL-C >= 70 <190 mg/dL and without a diagnosis of diabetes mellitus who have a 10-year CVD risk assessment with a high or >= 20% result during the measurement period.
 
If YES, meets Initial Population 4 risk category
-If NO, patient does NOT meet Initial Population criteria and is NOT eligible for measure inclusion
 
Clinicians are required to use a 10-year Pooled Cohort Equations (PCE) risk assessment tool.  The only validated 10-year PCE tool available today is the ASCVD Risk Estimator Plus.
 
ADD THE FOLLOWING TO THE INITIAL POPULATION STATEMENT:
Patients aged 40 to 75 years at the beginning of the measurement period with LDL-C >= 70 <190 mg/dl and without a diagnosis of diabetes mellitus who have a 10-year ASCVD risk assessment with a high or >= 20% result during the measurement period.
 
Denominator Exception, Denominator Exclusion and Numerator are the same as the other 3 populations.   
PROPOSED CQL FOR POPULATION CRITERIA 4:
Initial Population
  "Patients Age 40 to 75 Years and LDL Greater than or Equal to 70 but less than 190 and have a 10 Year CVD Risk of High without ASCVD and High LDL and Diabetes"
 and exists "Qualifying Encounter during Measurement Period"
 
Patients Age 40 to 75 Years and LDL Greater than or Equal to 70 but less than 190 and have a 10 Year CVD Risk of High without ASCVD and High LDL and Diabetes
 ( AgeInYearsAt(date from start of "Measurement Period")>= 40
     and AgeInYearsAt(date from start of "Measurement Period")<= 75 )
   and exists ( "Most Recent LDL Result Greater Than or Equal To 70 and Less Than 190" )
   and "Ten Year CVD Risk is High"
   and not ( exists "ASCVD Diagnosis Overlaps the Measurement Period or ASCVD Procedure Starts before the end of the Measurement Period"
       or exists "Hypercholesterolemia Diagnosis"
       or exists "LDL Result Greater Than or Equal To 190"
       or "Has Diabetes Diagnosis"
 
Most Recent LDL Result Greater Than or Equal To 70 and Less Than 190 [DC1] 

{ Last(["Laboratory Test, Performed": "LDL Cholesterol"] LDL70ToLessThan190     where(LDL70ToLessThan190.result >= 70 'mg/dL'          and LDL70ToLessThan190.result < 190 'mg/dL')        and Global."NormalizeInterval"(LDL70ToLessThan190.relevantDatetime, LDL70ToLessThan190.relevantPeriod)starts before       end of "Measurement Period"      sort by start of Global."NormalizeInterval"(relevantDatetime, relevantPeriod) )}

 
Ten Year CVD Risk is High  
 ( ( exists ["Intervention, Performed": "Assessment for risk of cardiovascular disease (procedure)"] AtRiskCVD
       where AtRiskCVD.result as Quantity >= 20 '%'
         and Global."NormalizeInterval" ( AtRiskCVD.relevantDatetime, AtRiskCVD.relevantPeriod ) during "Measurement Period" )
     or exists ( ["Intervention, Performed": "Assessment for risk of cardiovascular disease (procedure)"] CVDRisk
         where CVDRisk.result = "High (qualifier value)"
           and Global."NormalizeInterval" ( CVDRisk.relevantDatetime, CVDRisk.relevantPeriod ) during "Measurement Period" )
     or ( exists ["Assessment, Performed": "Cardiovascular disease 10Y risk [Likelihood] ACC-AHA Pooled Cohort by Goff 2013"] CVDRiskQN
         where CVDRiskQN.result as Quantity >= 20 '%'
           and Global."NormalizeInterval" ( CVDRiskQN.relevantDatetime, CVDRiskQN.relevantPeriod ) during "Measurement Period")
     or exists ( ["Assessment, Performed": "Cardiovascular disease 10Y risk [Likelihood] ACC-AHA Pooled Cohort by Goff 2013"] CVDRiskORD
         where CVDRiskORD.result = "High (qualifier value)"
          and Global."NormalizeInterval" ( CVDRiskORD.relevantDatetime, CVDRiskORD.relevantPeriod ) during "Measurement Period"  ))
 
PROPOSED CODING
"Assessment for risk of cardiovascular disease (procedure)" ("SNOMEDCT Code (441829007)")
"Cardiovascular disease 10Y risk [Likelihood] ACC-AHA Pooled Cohort by Goff 2013" ("LOINC Code (79423-0)")
 
Please note that the LOINC is a placeholder and will not be used in production.  The measure developer has submitted a new LOINC code for future use to indicate the Cardiovascular Disease 10Y risk. 
 
The measure steward and expert work group also agreed that that clinicians should use the Pooled Cohort Equations (PCE) risk assessment tools. The only validated PCE tool available today is the ASCVD Risk Estimator Plus. This is recommended in 2009 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease and used in Million Hearts. 

Rationale for Change:
This change aligns with the with 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease by adding a 10-year ASCVD risk assessment tool to the measure.