2021 MIPS Measure #438: Statin Therapy for the Prevention and Treatment of Cardiovascular Disease

Measure Description

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:

• Adults aged ≥ 21 years who were previously diagnosed with or currently have an active diagnosisof clinical atherosclerotic cardiovascular disease (ASCVD); OR
• Adults aged ≥ 21 years who have ever had a fasting or direct low-density lipoprotein cholesterol (LDL-C) level ≥ 190 mg/dL or were previously diagnosed with or currently have an active diagnosis of familial or pure hypercholesterolemia; OR
• Adults aged 40-75 years with a diagnosis of diabetes with a fasting or direct LDL-C level of 70-189 mg/dL

Instructions

This measure is to be submitted once per performance period for patients seen during the performance period. This measure may be submitted by Merit-based Incentive Payment System (MIPS) eligible clinicians who provide the services in the measure-specific denominator coding.

NOTE: Patient encounters for this measure conducted via telehealth (e.g., encounters coded with GQ, GT, 95, or POS 02 modifiers) are allowable.

Measure Submission Type:

Measure data may be submitted by individual MIPS eligible clinicians, groups, or third-party intermediaries. The listed denominator criteria are used to identify the intended patient population. The numerator options included in this specification are used to submit the quality actions as allowed by the measure. The quality-data codes listed do not need to be submitted by MIPS eligible clinicians, groups, or third-party intermediaries that utilize this modality for submissions; however, these codes may be submitted for those third-party intermediaries that utilize Medicare Part B claims data. For more information regarding Application Programming Interface (API), please refer to the Quality Payment Program (QPP) website.

THERE ARE THREE SUBMISSION CRITERIA FOR THIS MEASURE**:

1) Patients aged ≥ 21 years at the beginning of the measurement period with clinical ASCVDdiagnosis

OR

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

OR

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

**All patients who meet one or more of the following criteria indicated above would be considered at high risk for cardiovascular events under the ACC/AHA guidelines. When submitting this measure, determine if the patient meets denominator eligibility in order of each risk category. There is only one performance rate calculated for this measure.

Denominator (Submission Criteria 1)

Patients aged ≥ 21 years at the beginning of the measurement period with clinical ASCVD diagnosis

Definitions:

Clinical Atherosclerotic Cardiovascular Disease (ASCVD) includes –

• Acute Coronary Syndromes
• History of Myocardial Infarction
• Stable or Unstable Angina
• Coronary or other Arterial Revascularization
• Stroke or Transient Ischemic Attack (TIA)
• Peripheral Arterial Disease of Atherosclerotic Origin

Lipoprotein Density Cholesterol (LDL-C) result – A fasting or direct LDL-C laboratory test performed and test result documented in the medical record.

DENOMINATOR NOTE: *Signifies that this CPT Category I code is a non-covered service under the Medicare Part B Physician Fee Schedule (PFS). These non-covered services should be counted in the denominator population for MIPS CQMs.

Denominator Exclusions should be active at any time during the measurement period.

DENOMINATOR CRITERIA: (Eligible Cases):

Patients aged ≥ 21 years at the beginning of the measurement period

AND

Patient encounter during the performance period (CPT or HCPCS): 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99241*, 99242*, 99243*, 99244*, 99245*, 99385*, 99386*, 99387*, 99395*, 99396*, 99397*, 99401*, 99402*, 99403*, 99404*, 99429*, G0438, G0439

AND

Previously diagnosed or have an active diagnosis of Clinical ASCVD: G9662

AND NOT

DENOMINATOR EXCLUSIONS:

Patients who have a diagnosis of pregnancy: G9778

OR

Patients who are breastfeeding: G9779

OR

Patients who have a diagnosis of rhabdomyolysis: G9780

Numerator (Submission Criteria 1)

Patients who are actively using or who receive an order (prescription) for statin therapy at any point during the measurement period

Definitions:

Statin therapy – Administration of one or more of a group of medications that are used to lower plasma lipoprotein levels in the treatment of hyperlipoproteinemia.

Table 1 - Statin Medication Therapy List (NOTE: List does NOT include dosage):

Denominator Exceptions

Active Liver or Hepatic Disease or Insufficiency – The following ICD-10-CM codes are included in the Denominator Exception (G9781) to define liver disease: B15.0, B15.9, B16.0, B16.1, B16.2, B16.9, B17.0, B17.10, B17.11, B17.2, B17.8, B17.9, B18.0, B18.1, B18.2, B18.8, B18.9, B19.0, B19.10, B19.11, B19.20, B19.21, B19.9, K70.0, K70.10, K70.11, K70.2, K70.30, K70.31, K70.40, K70.41, K70.9, K71.0, K71.10, K71.11, K71.2, K71.3, K71.4, K71.50, K71.51, K71.6, K71.7, K71.8, K71.9, K72.00, K72.01, K72.10, K72.11, K72.90, K72.91, K73.0, K73.1, K73.2, K73.8, K73.9, K74.00, K74.01, K74.02, K74.1, K74.2, K74.3, K74.4, K74.5, K74.60, K74.69, K75.4, O98.411, O98.412, O98.413, O98.419

End Stage Renal Disease – The following ICD-10-CM code is included in the Denominator Exception (G9781) to define end stage renal disease: N18.6

Some patients may not be appropriate to prescribe or use statin therapy (see exceptions and exclusions for the complete list).

"Statin intolerance is the inability to tolerate a dose of statin required to reduce a person's CV risk sufficiently from their baseline risk and could result from different statin related side effects including: muscle symptoms, headache, sleep disorders, dyspepsia, nausea, rash, alopecia, erectile dysfunction, gynecomastia, and/or arthritis" (Banach et al., 2015, p. 2).

Patients that experience symptoms such as these may prefer not to take or continue statin therapy and therefore may be exempt from the denominator.

NUMERATOR NOTE: In order to meet the measure, current statin therapy use must be documented in the patient’s current medication list or ordered during the measurement 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.

Intensity of statin therapy in primary and secondary prevention:
The expert panel of the 2013 ACC/AHA Guidelines (Stone et al., 2014) 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.

Numerator Options:

Performance Met: Patients who are currently statin therapy users or received an order (prescription) for statin therapy (G9664)

OR

Denominator Exception: Documentation of medical reason(s) for not currently being a statin therapy user or receive an order (prescription) for statin therapy (e.g., patient with adverse effect, allergy or intolerance to statin medication therapy, patients who are receiving palliative or hospice care, patients with active liver disease or hepatic disease or insufficiency, and patients with end stage renal disease (ESRD) (G9781)

OR

Performance Not Met: Patients who are not currently statin therapy users or did not receive an order (prescription) for statin therapy (G9665)

Denominator (Submission Criteria 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

Definition:

Lipoprotein Density Cholesterol (LDL-C) result – A fasting or direct LDL-C laboratory test performed and test result documented in the medical record.

DENOMINATOR NOTE: *Signifies that this CPT Category I code is a non-covered service under the Medicare Part B Physician Fee Schedule (PFS). These non-covered services should be counted in the denominator population for MIPS CQMs.

Denominator Exclusions should be active at any time during the measurement period

DENOMINATOR CRITERIA: (Eligible Cases):

Patient aged ≥ 21 years at the beginning of the measurement period

AND

Patient encounter during the performance period (CPT): 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99241*, 99242*, 99243*, 99244*, 99245*, 99385*, 99386*, 99387*, 99395*, 99396*, 99397*, 99401*, 99402*, 99403*, 99404*, 99429*, G0438, G0439

AND

Any fasting or direct LDL-C laboratory test result ≥ 190 mg/dL: G9663

OR

History of or active diagnosis of familial or pure hypercholesterolemia: G9782

AND NOT

DENOMINATOR EXCLUSIONS:

Patients who have a diagnosis of pregnancy: G9778

OR

Patients who are breastfeeding: G9779

OR

Patients who have a diagnosis of rhabdomyolysis: G9780

Numerator (Submission Criteria 2)

Patients who are actively using or who receive an order (prescription) for statin therapy at any point during the measurement period

Definitions:

Statin therapy – Administration of one or more of a group of medications that are used to lower plasma lipoprotein levels in the treatment of hyperlipoproteinemia.

Table 1 - Statin Medication Therapy List (NOTE: List does NOT include dosage):

Denominator Exceptions

Active Liver or Hepatic Disease or Insufficiency – The following ICD-10-CM codes are included in the Denominator Exception (G9781) to define liver disease: B15.0, B15.9, B16.0, B16.1, B16.2, B16.9, B17.0, B17.10, B17.11, B17.2, B17.8, B17.9, B18.0, B18.1, B18.2, B18.8, B18.9, B19.0, B19.10, B19.11, B19.20, B19.21, B19.9, K70.0, K70.10, K70.11, K70.2, K70.30, K70.31, K70.40, K70.41, K70.9, K71.0, K71.10, K71.11, K71.2, K71.3, K71.4, K71.50, K71.51, K71.6, K71.7, K71.8, K71.9, K72.00, K72.01, K72.10, K72.11, K72.90, K72.91, K73.0, K73.1, K73.2, K73.8, K73.9, K74.00, K74.01, K74.02, K74.1, K74.2, K74.3, K74.4, K74.5, K74.60, K74.69, K75.4, O98.411, O98.412, O98.413, O98.419

End Stage Renal Disease – The following ICD-10-CM code is included in the Denominator Exception (G9781) to define end stage renal disease: N18.6

Some patients may not be appropriate to prescribe or use statin therapy (see exceptions and exclusions for a complete list).

"Statin intolerance is the inability to tolerate a dose of statin required to reduce a person's CV risk sufficiently from their baseline risk and could result from different statin related side effects including: muscle symptoms, headache, sleep disorders, dyspepsia, nausea, rash, alopecia, erectile dysfunction, gynecomastia, and/or arthritis" (Banach et al., 2015).
Patients that experience symptoms such as these may prefer not to take or continue statin therapy and therefore may be exempt from the denominator.

NUMERATOR NOTE: In order to meet the measure, current statin therapy use must be documented in the patient’s current medication list or ordered during the measurement 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.

Intensity of statin therapy in primary and secondary prevention:
The expert panel of the 2013 ACC/AHA Guidelines (Stone et al., 2014) 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.

Denominator Exceptions should be active during the measurement period

Numerator Options:

Performance Met: Patients who are currently statin therapy users or received an order (prescription) for statin therapy (G9664)

OR

Denominator Exception: Documentation of medical reason(s) for not currently being a statin therapy user or receive an order (prescription) for statin therapy (e.g., patient with adverse effect, allergy or intolerance to statin medication therapy, patients who are receiving palliative or hospice care, patients with active liver disease or hepatic disease or insufficiency, and patients with end stage renal disease (ESRD) (G9781)

OR

Performance Not Met: Patients who are not currently statin therapy users or did not receive an order (prescription) for statin therapy (G9665)

Denominator (Submission Criteria 3)

Patients aged 40 to 75 years at the beginning of the measurement period with Type 1 or Type 2 diabetes and with a 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

Definition:

Lipoprotein Density Cholesterol (LDL-C) result - A fasting or direct LDL-C laboratory test performed and test result documented in the medical record.

DENOMINATOR NOTE: *Signifies that this CPT Category I code is a non-covered service under the Medicare Part B Physician Fee Schedule (PFS). These non-covered services should be counted in the denominator population for MIPS CQMs.

Denominator Exclusions should be active at any time during the measurement period.

DENOMINATOR CRITERIA: (Eligible Cases):

Patients aged 40 through 75 years at the beginning of the measurement period

AND

Type 1 or Type 2 diabetes diagnosis (ICD-10-CM): E10.10, E10.11, E10.21, E10.22, E10.29, E10.311, E10.319, E10.3211, E10.3212, E10.3213, E10.3219, E10.3291, E10.3292, E10.3293, E10.3299, E10.3311, E10.3312, E10.3313, E10.3319, E10.3391, E10.3392, E10.3393, E10.3399, E10.3411, E10.3412, E10.3413, E10.3419, E10.3491, E10.3492, E10.3493, E10.3499, E10.3511, E10.3512, E10.3513, E10.3519, E10.3521, E10.3522, E10.3523, E10.3529, E10.3531, E10.3532, E10.3533, E10.3539, E10.3541, E10.3542, E10.3543, E10.3549, E10.3551, E10.3552, E10.3553, E10.3559, E10.3591, E10.3592, E10.3593, E10.3599, E10.36, E10.37X1, E10.37X2, E10.37X3, E10.37X9, E10.39, E10.40, E10.41, E10.42, E10.43, E10.44, E10.49, E10.51, E10.52, E10.59, E10.610, E10.618, E10.620, E10.621, E10.622, E10.628, E10.630, E10.638, E10.641, E10.649, E10.65, E10.69, E10.8, E10.9, E11.00, E11.01,E11.10, E11.11, E11.21, E11.22, E11.29, E11.311, E11.319, E11.3211, E11.3212, E11.3213, E11.3219, E11.3291, E11.3292, E11.3293, E11.3299, E11.3311, E11.3312, E11.3313, E11.3319, E11.3391, E11.3392, E11.3393, E11.3399, E11.3411, E11.3412, E11.3413, E11.3419, E11.3491, E11.3492, E11.3493, E11.3499, E11.3511, E11.3512, E11.3513, E11.3519, E11.3521, E11.3522, E11.3523, E11.3529, E11.3531, E11.3532, E11.3533, E11.3539, E11.3541, E11.3542, E11.3543, E11.3549, E11.3551, E11.3552, E11.3553, E11.3559, E11.3591, E11.3592, E11.3593, E11.3599, E11.36, E11.37X2, E11.37X3, E11.37X9, E11.39, E11.40, E11.41, E11.42, E11.43, E11.44, E11.49, E11.51, E11.52, E11.59, E11.610, E11.618, E11.620, E11.621, E11.622, E11.628, E11.630, E11.638, E11.641, E11.649, E11.65, E11.69, E11.8, E11.9, E13.00, E13.01, E13.10, E13.11, E13.21, E13.22, E13.29, E13.311, E13.319, E13.3211, E13.3212, E13.3213, E13.3219, E13.3291, E13.3292, E13.3293, E13.3299, E13.3311, E13.3312, E13.3313, E13.3319, E13.3391, E13.3392, E13.3393, E13.3399, E13.3411, E13.3412, E13.3413, E13.3419, E13.3491, E13.3492, E13.3493, E13.3499, E13.3511, E13.3512, E13.3513, E13.3519, E13.3521, E13.3522, E13.3523, E13.3529, E13.3531, E13.3532, E13.3533, E13.3539, E13.3541, E13.3542, E13.3543, E13.3549, E13.3551, E13.3552, E13.3553, E13.3559, E13.3591, E13.3592, E13.3593, E13.3599, E13.36, E13.37X1, E13.37X2, E13.37X3, E13.37X9, E13.39, E13.40, E13.41, E13.42, E13.43, E13.44, E13.49, E13.51, E13.52, E13.59, E13.610, E13.618, E13.620, E13.621, E13.622, E13.628, E13.630, E13.638, E13.641, E13.649, E13.65, E13.69, E13.8, E13.9, O24.011, O24.012, O24.013, O24.019, O24.02, O24.03, O24.111, O24.112, O24.113, O24.119, O24.12, O24.13, O24.311, O24.312, O24.313, O24.319, O24.32, O24.33, O24.811, O24.812, O24.813, O24.819, O24.82, O24.83

AND

Patient encounter during the performance period (CPT):, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99241*, 99242*, 99243*, 99244*, 99245*, 99385*, 99386*, 99387*, 99395*, 99396*, 99397*, 99401*, 99402*, 99403*, 99404*, 99429*, G0438, G0439

AND

Patient’s highest fasting or direct LDL-C laboratory test result in the measurement period or two years prior to the beginning of the measurement period is 70 –189 mg/dL: G9666

AND NOT

DENOMINATOR EXCLUSIONS:

Patients who have a diagnosis of pregnancy: G9778

OR

Patients who are breastfeeding: G9779

OR

Patients who have a diagnosis of rhabdomyolysis: G9780

Numerator (Submission Criteria 3)

Patients who are actively using or who receive an order (prescription) for statin therapy at any point during the measurement period

Definitions:

Statin therapy - Administration of one or more of a group of medications that are used to lower plasma lipoprotein levels in the treatment of hyperlipoproteinemia.

Table 1 - Statin Medication Therapy List (NOTE: List does NOT include dosage):

Denominator Exceptions

Active Liver or Hepatic Disease or Insufficiency – The following ICD-10-CM codes are included in the Denominator Exception (G9781) to define liver disease: B15.0, B15.9, B16.0, B16.1, B16.2, B16.9, B17.0, B17.10, B17.11, B17.2, B17.8, B17.9,B18.0, B18.1, B18.2, B18.8, B18.9, B19.0, B19.10, B19.11, B19.20, B19.21, B19.9, K70.0, K70.10, K70.11, K70.2, K70.30, K70.31, K70.40, K70.41, K70.9, K71.0, K71.10, K71.11, K71.2, K71.3, K71.4, K71.50, K71.51, K71.6, K71.7, K71.8, K71.9, K72.00, K72.01, K72.10, K72.11, K72.90, K72.91, K73.0, K73.1, K73.2, K73.8, K73.9, K74.00, K74.01, K74.02, K74.1, K74.2, K74.3, K74.4, K74.5, K74.60, K74.69, K75.4, O98.411, O98.412, O98.413, O98.419

End Stage Renal Disease – The following ICD-10-CM code is included in the Denominator Exception (G9781) to define end stage renal disease: N18.6

Some patients may not be appropriate to prescribe or use statin therapy (see exceptions and exclusions for the complete list).

"Statin intolerance is the inability to tolerate a dose of statin required to reduce a person's CV risk sufficiently from their baseline risk and could result from different statin related side effects including: muscle symptoms, headache, sleep disorders, dyspepsia, nausea, rash, alopecia, erectile dysfunction, gynecomastia, and/or arthritis" (Banach et al., 2015, p. 2).

Patients that experience symptoms such as these may prefer not to take or continue statin therapy and therefore may be exempt from the denominator.

NUMERATOR NOTE: In order to meet the measure, current statin therapy use must be documented in the patient’s current medication list or ordered during the measurement 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.

Intensity of statin therapy in primary and secondary prevention:
The expert panel of the 2013 ACC/AHA Guidelines (Stone et al., 2014) 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.

Denominator Exceptions should be active during the measurement period.

Numerator Options:

Performance Met: Patients who are currently statin therapy users or received an order (prescription) for statin therapy (G9664)

OR

Denominator Exception: Documentation of medical reason(s) for not currently being a statin therapy user or receive an order (prescription) for statin therapy (e.g., patient with adverse effect, allergy or intolerance to statin medication therapy, patients who are receiving palliative or hospice care, patients with active liver disease or hepatic disease or insufficiency, patients with end stage renal disease (ESRD) (G9781)

OR

Denominator Exception: Documentation of patients with diabetes who have a most recent fasting or direct LDL- C laboratory testresult < 70 mg/dL and are not taking statin therapy (G9783)

OR

Performance Not Met: Patients who are not currently statin therapy users or did not receive an order (prescription) for statin therapy (G9665)

Rationale

“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” (Benjamin et al., 2018).

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 (Benjamin et al., 2018). 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 (Ference, 2015).

In 2013, guidelines on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults were published (see Stone et al., 2014). 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 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 Atherosclerotic Cardiovascular Disease (ASCVD) in adult men and women (21 years of age or older). 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, or with diabetes and LDL-C 70-189 mg/dL) (Stone et al., 2014).

One study that surveyed U.S. cardiology, primary care, and endocrinology practices found that 1 in 4 guidelineeligible 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 (Navar et al., 2017). The Statin Safety Expert Panel that participated in an NLA Statin Safety Task Force meeting in October 2013 reaffirms the general safety of statin therapy. However, 1 in 10 people who try taking a statin will report some kind of intolerance, most commonly muscle aches. Other known low risk circumstances of statin intolerance include side effects such as myopathy, cognitive dysfunction, increased hepatic transaminase levels, and new onset diabetes. Statin intolerance usually does not involve substantial risk for mortality or permanent disability (Guyton et al., 2014). Ultimately, 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 (Jacobson, 2014).

Clinical Recommendation Statements

This electronic clinical quality measure is intended to align with the 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol (Stone et al., 2014), 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 Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults—Statin Treatment:

Secondary Prevention:

1. High-intensity statin therapy should be initiated or continued as first-line therapy in women and men < 75 years of age who have clinical ASCVD, unless contraindicated. (Level of Evidence A), (Stone et al., 2014)
2. In individuals with clinical ASCVD in whom high-intensity statin therapy would otherwise be used, when highintensity statin therapy is contraindicated or when characteristics predisposing to statin-associated adverse effects are present, moderate-intensity statin should be used as the second option if tolerated. (Level of Evidence A), (Stone et al., 2014)

Primary Prevention in Individuals ≥ 21 Years of Age With LDL-C ≥ 190 mg/dL:

• Adults ≥ 21 years of age with primary LDL–C ≥ 190 mg/dL should be treated with statin therapy (10-year ASCVD risk estimation is not required). (Level of Evidence B), (Stone et al., 2014)

Primary Prevention in Individuals With Diabetes and LDL-C 70-189 mg/dL:

• Moderate-intensity statin therapy should be initiated or continued for adults 40-75 years of age with diabetes. (Level of Evidence A), (Stone et al., 2014)