Statin Therapy for the Prevention and Treatment of Cardiovascular Disease

Measure Specification

“Cardiovascular disease (CVD) is the leading cause of death in the United States, causing approximately 1 of every 3 deaths in the United States in 2015. In 2015, stroke caused approximately 1 of every 19 deaths in the United States and the estimated annual costs for CVD and stroke were $329.7 billion, including $199.2 billion in direct costs (hospital services, physicians and other professionals, prescribed medications, home health care, and other medical durables) and $130.

5 billion in indirect costs from lost future productivity (cardiovascular and stroke premature deaths). CVD costs more than any other diagnostic group” [1]. Data collected between 2011 and 2014 indicate that more than 94.6 million U.S. adults, 20 years or older had total cholesterol levels equal to 200 mg/dL or more, while almost 28.5 million had levels 240 mg/dL or more [1].

Elevated blood cholesterol is a major risk factor for CVD and statin therapy has been associated with a reduced risk of CVD. Numerous randomized trials have demonstrated that treatment with a statin reduces LDL-C and reduces the risk of major cardiovascular events by approximately 20 percent [2]. In 2018, updated guidelines on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults were published [3].

This guideline was published by an Expert Panel, which synthesized evidence from randomized controlled trials to identify people most likely to benefit from cholesterol- lowering therapy. The ACC/AHA/MS Guideline recommendations are intended to provide a strong evidence-based foundation for the treatment of blood cholesterol for the primary and secondary prevention and treatment of ASCVD in patients of all ages.

The document concludes the addition of statin therapy reduces the risk of ASCVD among high-risk individuals, defined as follows: individuals with clinical ASCVD, with LDL-C ≥ 190 mg/dL, with diabetes, or individuals with ≥ 20 percent risk of ASCVD as determined via use of an ASCVD risk estimator derived from the Pooled Cohort Equations [3]. One study surveying U.

S. cardiology, primary care, and endocrinology practices found that 1 in 4 guideline-eligible patients were not on a statin and less than half were on the recommended statin intensity. Untreated and undertreated patients had significantly higher LDL-C levels than those receiving guideline-directed statin treatment [4]. In a follow-up study authored by Nanna et al.

, the same clinics were divided into tertiles based on the percentage of patients with guideline-recommended statin use. The researchers found that patients in the high-tertile clinics were more likely to achieve target LDL-C levels than patients at the low- or mid-tertile clinics, and this held true when patients were stratified by primary and secondary prevention [5].

Research also indicates that certain populations are far less likely to receive guideline-recommended statin therapy than others. A retrospective study of the National Health and Nutrition Examination Survey found that Black and Hispanic race or ethnicity, low income, lack of health insurance coverage, poor health care access, young age, and female gender are predictors of lower statin utilization [6].

In particular, there is extensive evidence that women are far less likely than men to be prescribed guideline- recommended statin therapy [7, 8], despite research showing that female patients with cardiovascular disease derive the same or greater benefit from statin therapy as male patients with cardiovascular disease [9]. The Statin Safety Expert Panel that participated in a National Lipid Association (NLA) Statin Safety Task Force meeting in October 2013 reaffirms the general safety of statin therapy.

The panel members concluded that for most patients requiring statin therapy, the potential benefits of statin therapy outweigh the potential risks. In general terms, the benefits of statins to prevent non-fatal myocardial infarction, revascularization, stroke, and CVD mortality, far outweighs any potential harm related to the drug [10].

This clinical quality measure is intended to align with the 2018 ACC/AHA/MS Guideline on the Management of Blood Cholesterol [3], which indicates the use of statins as the first line of cholesterol-lowering medication therapy to lower the risk of ASCVD among at-risk populations. Recommendations for Management of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults—Statin Treatment: Secondary Prevention: In patients who are 75 years of age or younger with clinical ASCVD, high-intensity statin therapy should be initiated or continued with the aim of achieving a 50 percent or greater reduction in LDL-C levels (Class I Recommendation), [3].

In patients with clinical ASCVD in whom high-intensity statin therapy is contraindicated or who experience statin-associated side effects, moderate-intensity statin therapy should be initiated or continued with the aim of achieving a 30 percent to 49 percent reduction in LDL-C levels (Class I Recommendation), [3]. In patients older than 75 years of age with clinical ASCVD, it is reasonable to initiate moderate- or high-intensity statin therapy after evaluation of the potential for ASCVD risk reduction, adverse effects, and drug–drug interactions, as well as patient frailty and patient preferences (Class IIa Recommendation), [3].

Primary Prevention: In patients 20 to 75 years of age with an LDL-C level of 190 mg/dL or higher (>= 4.9 mmol/L), maximally tolerated statin therapy is recommended (Class I Recommendation), [3]. In adults 40 to 75 years of age with diabetes mellitus, regardless of estimated 10-year ASCVD risk, moderate-intensity statin therapy is indicated (Class I Recommendation), [3].

To facilitate decisions about preventive interventions, it is recommended to screen for traditional ASCVD risk factors and apply the race- and sex-specific Pooled Cohort Equations (PCE) to estimate 10-year ASCVD risk for asymptomatic adults 40 to 75 years of age. The higher the estimated risk, the more likely the patients is to benefit from statin treatment (Class I Recommendation).

[3]. The US Preventive Services Task Force (USPSTF) concludes with moderate certainty that statin use for the prevention of CVD events and all-cause mortality in adults aged 40 to 75 years with no history of CVD and who have 1 or more of these CVD risk factors and an estimated 10-year CVD event risk of 7.5 percent to less than 10 percent has at least a small net benefit, [11].

Statin Safety and Statin-Associated Side Effects: A clinician–patient risk discussion is recommended before initiation of statin therapy to review net clinical benefit, weighing the potential for ASCVD risk reduction against the potential for statin-associated side effects, statin–drug interactions, and safety, while emphasizing that side effects can be addressed successfully (Class I Recommendation), [11].

This measure contains four strata defined by four submission criteria. This measure produces a single performance rate. There are 4 Submission Criteria for this measure: 1) All patients who were previously diagnosed with or currently have a diagnosis of clinical ASCVD, including an ASCVD procedure OR 2) Patients aged 20 to 75 years at the beginning of the performance period who have ever had a laboratory result of LDL-C ≥ 190 mg/dL or were previously diagnosed with or currently have an active diagnosis of familial hypercholesterolemia OR 3) Patients aged 40 to 75 years at the beginning of the performance period with Type 1 or Type 2 diabetes OR 4) Patients aged 40 to 75 years at the beginning of the performance period with a 10-year ASCVD risk score of ≥ 20 percent All patients who meet one or more of the following criteria indicated above would be considered at high risk for cardiovascular events under the American College of Cardiology (ACC)/American Heart Association (AHA)/Multi-society (MS) guidelines.

The measure will be calculated with 1 performance rate: Percentage of patients at high risk of cardiovascular events who are actively using or receive an order (prescription) for statin therapy at any time during the performance period. For the purposes of MIPS implementation, this patient-process measure is submitted a minimum of once per patient for the performance period.

The most advantageous quality data code will be used if the measure is submitted more than once. There is only one performance rate calculated for this measure. Patients can only be counted once and cannot be in more than one submission criteria. When submitting this measure, determine if the patient meets denominator eligibility in order of each risk category defined in the denominator submission criteria.

For example, first evaluate if the patient meets denominator Submission Criteria 1. If no, then evaluate if the patient meets denominator Submission Criteria 2. If yes, then the patient will be in Submission Criteria 2 and is not eligible for denominator Submission Criteria 3 and 4. In order to meet the measure, current statin therapy use must be documented in the patient’s current medication list or ordered during the performance period.

Only statin therapy meets the measure Numerator criteria (NOT other cholesterol lowering medications). Prescription or order does NOT need to be linked to an encounter or visit; it may be called to the pharmacy. Statin medication “samples” provided to patients can be documented as “current statin therapy” if documented in the medication list in health/medical record.

Patients who meet the denominator criteria for inclusion but are not prescribed or using statin therapy will NOT meet performance for this measure. Adherence to statin therapy is not calculated in this measure. It may not be appropriate to prescribe statin therapy for some patients (see exceptions and exclusions for the complete list). Intensity of statin therapy in primary and secondary prevention: The expert panel of the 2018 ACC/AHA/MS Guidelines [1] defines recommended intensity of statin therapy on the basis of the average expected LDL-C response to specific statin and dose.

Although intensity of statin therapy is important in managing cholesterol, this measure assesses prescription of ANY statin therapy, irrespective of intensity. Assessment of appropriate intensity and dosage documentation added too much complexity to allow inclusion of statin therapy intensity in the measure at this time.