This artifact provides statin therapy recommendations for primary and secondary prevention of CVD for patients considered to be at high risk of cardiovascular events
Artifact Creation and Usage
This artifact was developed by MITRE software engineers and clinical informaticists, in collaboration with clinical subject matter experts from the eCQM developer (Quality Insights of Pennsylvania) and the Cholesterol Management Work Group.
Additional information about MITRE's health expertise is available here.
If you would like further information, would like to give us feedback, or have any questions about this artifact, please contact us at ClinicalDecisionSupport@ahrq.hhs.gov.
|This CDS logic is expressed using Clinical Quality Language (CQL) and the FHIR Draft Standard for Trial Use 2 (DSTU2) data model. All value sets referenced in the logic are published on the Value Set Authority Center (VSAC). Additional details about these resources can be accessed via the following URLs:
FHIR DSTU2: https://www.hl7.org/fhir/DSTU2/index.html
Structured code that is interpretable by a computer (includes data elements, value sets, logic)
CDS logic evaluates a patient's presence in one of 3 high risk groups for ASCVD and provides statin therapy recommendations if exclusions do not apply. eCQM specifications (which align with the 2013 ACC/AHA guidelines) specify the high risk groups as:
- Individuals ≥ 21 years with clinical ASCVD
- Individuals ≥ 21 years with primary elevations of LDL-c level ≥190 mg/dL or familial or pure hypercholesterolemia without clinical ASCVD
- Individuals 40 to 75 years of age with diabetes and LDL–C level of 70 to 189 mg/dL without clinical ASCVD or familial or pure hypercholesterolemia
Individuals >= 21 years old
This artifact is intended to be used by providers in the context of outpatient encounters
The quality measure from which this artifact is derived looks for patients who are taking statins or have been ordered statins, irrespective of intensity, despite 2013 ACC/AHA guideline recommendations which list specific statin intensities for each risk group (based of the average expected LDL-c response to specific statin and dose). While recognizing that statin intensity is an important component of cholesterol management, the measure developer considered assessment of appropriate intensity and dosage as adding too much complexity to the measure (given unique circumstances for each individual patient). The CQL logic is structured to enable implementers to replace recommendation messages with more specific statin intensity notifications, if desired. At present, the recommendation messages align with eCQM specifications (i.e., to consider initiation of a low, moderate or high intensity statin).
This artifact does not consider all statin therapy benefit groups, such as individuals with certain levels of estimated 10 year ASCVD risk.
Note: This artifact is derived from CMS 347v3, which was derived from the 2013 ACC/AHA Management of Blood Cholesterol guideline. The ACC/AHA released new guidelines for the Management of Blood Cholesterol on 2018. Please be aware that this CDS logic may no longer align with the most recent evidence-based guidance. The 2018 guidelines can be accessed here.
Additional information and resources: CDS Connect artifacts are not “standalone” and are not intended to be completely plug-and-play (i.e., healthcare systems will need to integrate each artifact with components of their health information technology [IT] system for the artifact to work). CQL Services, an open source publicly-available tool that facilitates integration of CQL code with a health IT system, can be used by organizations that build out a coded expression of this artifact for pilot implementation in their healthcare organization. CQL Services is available here: https://github.com/AHRQ-CDS/AHRQ-CDS-Connect-CQL-SERVICES. Implementers should conduct extensive testing, including clinical testing in real-life workflows, of all artifacts. It is expected that artifacts will be customized and adapted to local clinical and IT environments.
This artifact was derived from CMS 347v3: Statin Therapy for the Prevention and Treatment of Cardiovascular Disease
Centers for Medicare and Medicaid Services. eCQI Resource Center. CMS 347v3: Statin Therapy for the Prevention and Treatment of Cardiovascular Disease (available here).
2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults (available here).
All patients who meet one or more of the following criteria (considered at "high risk" for cardiovascular events, under ACC/AHA guidelines):
1) Patients aged >= 21 years at the beginning of the measurement period with clinical ASCVD diagnosis
2) Patients aged >= 21 years at the beginning of the measurement period who have ever had a fasting or direct laboratory result of LDL-C >=190 mg/dL or were previously diagnosed with or currently have an active diagnosis of familial or pure hypercholesterolemia
3) Patients aged 40 to 75 years at the beginning of the measurement period with type 1 or type 2
diabetes and with an LDL-C result of 70-189 mg/dL recorded as the highest fasting or direct laboratory test result in the measurement year or during the two years prior to the beginning of the measurement period
Patients who have a diagnosis of pregnancy
Patients who are breastfeeding
Patients who have a diagnosis of rhabdomyolysis
Patients with adverse effect, allergy, or intolerance to statin medication
Patients who are receiving palliative care or hospice care
Patients with active liver disease or hepatic disease or insufficiency
Patients with end-stage renal disease (ESRD)
Patients with diabetes who have the most recent fasting or direct LDL-C laboratory test result < 70 mg/dL and are not taking statin therapy
Patients who are actively using or who receive an order (prescription) for statin therapy at any point during the measurement period
Although the eCQM specifications were derived from ACC/AHA Graded recommendations, the eCQM specifications themselves, do not have a designated 'Strength of Recommendation'. A Technical Expert Panel advising on measure development provided recommendation, which represents a minimum performance requirement for statin prescription and does not take into account statin therapy intensity. See cautions.
Decision notes are outlined in the attached Implementation Guide
|Trigger Type||Named event|
|Trigger Event||Provider opens an outpatient encounter|
|Patient is >= 21 years AND one of the following:|
|History of ASCVD|
|LDL-C >=190 mg/dL at any point in time (fasting or direct LDL-C test)|
|OR Familial Hypercholesterolemia|
|AND NOT ASCVD|
|Patient is >=40 and <=75 years|
|AND Diabetes (Type 1 or 2)|
|AND highest LDL-C < 190 mg/dL within the past 3 years (fasting or direct LDL-C test)
AND MOST RECENT LDL-C >=70 mg/dL
|AND NOT LDL-C <190 mg/dL at any point in time (fasting or direct LDL-C test)|
|AND NOT ASCVD OR Familial Hypercholesterolemia|
|Pregnancy OR Pregnancy Observation within the past 42 weeks|
|OR Breastfeeding OR Breastfeeding Observation within the past year|
|OR Adverse effect, allergy, or intolerance to statin medications|
|OR Hepatitis A OR Hepatitis B|
|OR Cirrhosis OR elevated ALT > 150 (> 3 x's normal limit)|
|OR Receiving palliative or hospice care|
|OR Already receiving a statin medication (Medication Active or Medication Order during the past year)|
|Intervention||DISPLAY notification to provider:
• Population 1: "Consider a statin for this patient. Criterion: >=21 years old with ASCVD. Note: Benefit is not clearly demonstrated for patients over 75 years old. Exclusions may apply."
• Population 2: “Consider a statin for this patient. Criterion: >=21 years old with at least one LDL-C >=190 mg/dL in past 3 years, or active diagnosis of familial hypercholesterolemia. Note: Evaluate comorbidities, safety considerations, and priorities of care before considering a statin for patients over > 75 years old. Exclusions may apply.”
• Population 3: “Consider a statin for this patient. Criterion: 40-75 years old with diabetes and LDL-C 70-189 mg/dL measured in the past three years. Exclusions may apply. ”
2) Error Message When Missing Data Prevents CDS From Being Processed
• Missing LDL: "Guidelines for recommending statins cannot be processed because the patient has had no LDL-C result in the past three years. Consider obtaining an LDL-C test."
• Missing age: "Inadequate data to assess recommendations for statins, because patient age is missing"
DISPLAY link to eCQM specifications: https://ecqi.healthit.gov/ecqm/measures/cms347v1
DISPLAY link to statin shared decision making tool (e.g. Mayo Clinic Shared Decision Making National Resource Center Statin/Aspirin Choice Decision Aid)
|Action||REQUEST medication order for indicated statin intensity|
|Action||DOCUMENT any new medication (i.e. statin) on the active medication list|
|Action||DOCUMENT provider response if a reason for not prescribing a statin is provided (e.g., incorrect conditions captured, patient already on statin, patient has undocumented resistance, patient declines)|
|Action||DOCUMENT diagnosis consistent with artifact exclusions|
|Action||DOCUMENT therapy consistent with artifact exclusions|
|Action||DOCUMENT allergy/intolerance/sensitivity consistent with artifact exclusions|
This artifact has not been tested in a clinical setting.