2024 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 performance period:

• All patients who were previously diagnosed with or currently have a diagnosis of clinical atherosclerotic cardiovascular disease (ASCVD), including an ASCVD procedure; OR
• Patients aged 20 to 75 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 to 75 years with a diagnosis of diabetes; OR
• Patients aged 40 to 75 with a 10-year ASCVD risk score of ≥ 20 percent.

Instructions

This measure is to be submitted once per performance period for all 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 (including but not limited to encounters coded with GQ, GT, 95, POS 02, POS 10) 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 FOUR 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)/Multisociety (MS) guidelines.

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.

Denominator (Submission Criteria 1)

All patients who were previously diagnosed with or currently have a diagnosis of clinical ASCVD, including an ASCVD procedure

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

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 Criteria: (Eligible Cases):

All patients, regardless of age

AND

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

AND

Previously diagnosed or have a diagnosis of clinical ASCVD, including ASCVD procedure: G9662

AND NOT

DENOMINATOR EXCLUSIONS:

Patients who are breastfeeding at any time during the performance period: G9779

OR

Patients who have a diagnosis of rhabdomyolysis at any time during the performance period: G9780

Numerator (Submission Criteria 1)

Patients who are actively using or who receive an order (prescription) for statin therapy at any time during the performance 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

Statin-Associated Muscle Symptoms (SAMS) – The 2018 ACC/AHA/MS Guideline (Grundy et al., 2019) includes the following SAMS: myalgias, myositis, myopathy, or statin-associated autoimmune myopathy. Patients who experience significant or repeated statin-associated muscle symptoms may prefer not to take or continue statin therapy and therefore may be removed from the denominator. The following ICD-10-CM codes are included in the Denominator Exception (G9781) to define SAMS: G72.0, G72.9, M60.9, M79.10.

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 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.

Denominator Exceptions should be active during the performance period

References

Grundy, S. M., Stone, N. J., Bailey, A. L., Beam, C., Birtcher, K. K., Blumenthal, R. S., Braun, L. T., …Yeboah, J. (2019) 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol. Journal of the American College of Cardiology, 73 (24), e286-e343. doi.10.1016/j.jacc.2018.11.003

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 receiving an order (prescription) for statin therapy (e.g., patients with statin-associated muscle symptoms or an allergy 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], or other medical reasons) (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 20 to 75 years at the beginning of the performance period who have ever had a laboratory result of LDLC ≥ 190 mg/dL or were previously diagnosed with or currently have an active diagnosis of familial hypercholesterolemia

Definition:

Lipoprotein Density Cholesterol (LDL-C) result – A fasting or non-fasting LDL-C laboratory test performed and direct or calculated test result documented in the medical record. When both direct and calculated test results are available on the same day, the direct LDL-C test result should be used.

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 Criteria (Eligible Cases):

Patient aged 20 to 75 years at the beginning of the performance period

AND

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

AND

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

AND

Any LDL-C laboratory result ≥ 190 mg/dL: G9663

OR

History of or active diagnosis of familial hypercholesterolemia: G9782

AND NOT

DENOMINATOR EXCLUSIONS:

Patients who are breastfeeding at any time during the performance period: G9779

OR

Patients who have a diagnosis of rhabdomyolysis at any time during the performance period: G9780

Numerator (Submission Criteria 2)

Patients who are actively using or who receive an order (prescription) for statin therapy at any time during the performance 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

Statin-Associated Muscle Symptoms (SAMS) – The 2018 ACC/AHA/MS Guideline (Grundy et al., 2019) includes the following SAMS: myalgias, myositis, myopathy, or statin-associated autoimmune myopathy. Patients who experience significant or repeated statin-associated muscle symptoms may prefer not to take or continue statin therapy and therefore may be removed from the denominator. The following ICD-10-CM codes are included in the Denominator Exception (G9781) to define SAMS: G72.0, G72.9, M60.9, M79.10.

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 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.

Denominator Exceptions should be active during the performance period.

References

1. Grundy, S. M., Stone, N. J., Bailey, A. L., Beam, C., Birtcher, K. K., Blumenthal, R. S., Braun, L. T., …Yeboah, J. (2019) 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol. Journal of the American College of Cardiology, 73 (24), e286-e343. doi.10.1016/j.jacc.2018.11.003

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 receiving an order (prescription) for statin therapy (e.g., patients with statin-associated muscle symptoms or an allergy 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], or other medical reasons) (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 performance period with Type 1 or Type 2 diabetes.

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 Criteria (Eligible Cases):

Patients aged 40 to 75 years at the beginning of the performance 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, 99242*, 99243*, 99244*, 99245*, 99385*, 99386*, 99387*, 99395*, 99396*, 99397*, 99401*, 99402*, 99403*, 99404*, 99429*, G0438, G0439

AND NOT

DENOMINATOR EXCLUSIONS:

Patients who are breastfeeding at any time during the performance period: G9779

OR

Patients who have a diagnosis of rhabdomyolysis at any time during the performance period: G9780

Numerator (Submission Criteria 3)

Patients who are actively using or who receive an order (prescription) for statin therapy at any time during the performance 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

Statin-Associated Muscle Symptoms (SAMS) – The 2018 ACC/AHA/MS Guideline (Grundy et al., 2019) includes the following SAMS: myalgias, myositis, myopathy, or statin-associated autoimmune myopathy. Patients who experience significant or repeated statin-associated muscle symptoms may prefer not to take or continue statin therapy and therefore may be removed from the denominator. The following ICD-10-CM codes are included in the Denominator Exception (G9781) to define SAMS: G72.0, G72.9, M60.9, M79.10.

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 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.

Denominator Exceptions should be active during the performance period.

References

1. Grundy, S. M., Stone, N. J., Bailey, A. L., Beam, C., Birtcher, K. K., Blumenthal, R. S., Braun, L. T., …Yeboah, J. (2019) 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol. Journal of the American College of Cardiology, 73 (24), e286-e343. doi.10.1016/j.jacc.2018.11.003

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 receiving an order (prescription) for statin therapy (e.g., patients with statin-associated muscle symptoms or an allergy 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] or other medical reasons) (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 4)

Patients aged 40 to 75 years at the beginning of the performance period with a 10-year ASCVD risk score of ≥ 20 percent during the performance period

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. The 10-year ASCVD risk score is calculated using the Pooled Cohort Equations: 1) the 2013 ACC/AHA ASCVD Risk Estimator OR 2) the ACC Risk Estimator Plus. If your EHR does not have either of these risk calculators, we recommend that you use the on-line versions. The 10- year ASCVD risk assessment must be performed during the performance period.

Denominator Criteria (Eligible Cases):

Patients aged 40 to 75 years at the beginning of the performance period

AND

Calculated 10-year ASCVD risk score of ≥ 20 percent during the performance period: M1364

AND

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

AND NOT

DENOMINATOR EXCLUSIONS:

Patients who are breastfeeding at any time during the performance period: G9779

OR

Patients who have a diagnosis of rhabdomyolysis at any time during the performance period: G9780

Numerator (Submission Criteria 4)

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

Definition:

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

Statin-Associated Muscle Symptoms (SAMS) – The 2018 ACC/AHA/MS Guideline (Grundy et al., 2019) includes the following SAMS: myalgias, myositis, myopathy, or statin-associated autoimmune myopathy. Patients who experience significant or repeated statin-associated muscle symptoms may prefer not to take or continue statin therapy and therefore may be removed from the denominator. The following ICD-10-CM codes are included in the Denominator Exception (G9781) to define SAMS: G72.0, G72.9, M60.9, M79.10.

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 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.

Denominator Exceptions should be active during the performance period.

References

1. Grundy, S. M., Stone, N. J., Bailey, A. L., Beam, C., Birtcher, K. K., Blumenthal, R. S., Braun, L. T., …Yeboah, J. (2019) 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol. Journal of the American College of Cardiology, 73 (24), e286-e343. doi.10.1016/j.jacc.2018.11.003

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 receiving an order (prescription) for statin therapy (e.g., patients with statin-associated muscle symptoms or an allergy 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] or other medical reasons) (G9781)

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” [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% 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 followup 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].

References

1. Benjamin, E.J., Virani, S.S., Callaway, C.W., Chamberlain, A.M., Chang, A.R., Cheng, S., ...Munter, P. (2018). Heart disease and stroke statistics—2018 update: A report from the American Heart Association. Circulation, 137(12), e67-e492. doi.10.1161/CIR.00000000000005582.

2. Ference, B.A. (2015, March 10). Statins and the risk of developing new-onset Type 2 diabetes: Expert analysis. Retrieved from https://www.acc.org/latest-in-cardiology/articles/2015/03/10/08/10/statins-and-therisk-of-developing-new-onset-type-2-diabetes

3. Grundy, S. M., Stone, N. J., Bailey, A. L., Beam, C., Birtcher, K. K., Blumenthal, R. S., Braun, L. T., …Yeboah, J. (2019). 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol. Journal of the American College of Cardiology, 73 (24), e286-e343. doi.10.1016/j.jacc.2018.11.003

4. Navar, M., Wang, T. Y., Li, S.,Robinson, J. G., Goldberg, A. C., Virani, S., …Peterson, E. D. (2017). Lipid management in contemporary community practice: Results from the Provider Assessment of Lipid Management (PALM) Registry. American Heart Journal, 193, 84-92. doi.10.1016/j.ahj.2017.08.005

5. Nanna, M. G., Navar, A. M., Wang, Y. T., Li, S., Virani, S. S., Li, Z., … Peterson, E. D. (2019a). PracticeLevel Variation in Statin use and Low-Density Lipoprotein Cholesterol Control in the United States: Results from the Patient and Provider Assessment of Lipid Management (PALM) Registry. American Heart Journal, 214, 113–124. doi:10.1016/j.ahj.2019.05.009'

6. Gu, A., Kamat, S., Argulian, E. (2018). Trends and disparities in statin use and low-density lipoprotein cholesterol levels among US patients with diabetes, 1999–2014. Diabetes Research and Clinical Practice, 139, 1-10. doi:10.1016/j.diabres.2018.02.019

7. Zhang, H., Plutzky, J., Shubina, M., & Turchin, A. (2016). Drivers of the Sex Disparity in Statin Therapy in Patients with Coronary Artery Disease: A Cohort Study. PloS one, 11(5), e0155228. doi:10.1371/journal.pone.0155228

8. Nanna, M. G., Wang, T. Y., Xiang, Q., Goldberg, A. C., Robinson, J. G., Roger, V. L., … Navar, A. M. (2019). Sex Differences in the use of Statins in Community Practice. Circulation. Cardiovascular Quality & Outcomes, 12(8), e005562. doi:10.1161/CIRCOUTCOMES.118.005562

9. 'Puri, R., Nissen, S. E., Shao, M., Ballantyne, C. M., Barter, P. J., Chapman, M. J., … Nicholls, S. J. (2014). Sex-related differences of coronary atherosclerosis regression following maximally intensive statin therapy: insights from SATURN. JACC. Cardiovascular imaging, 7(10), 1013–1022. doi:10.1016/j.jcmg.2014.04.019

10. Jacobson, T. A. (2014). Executive summary: NLA Task Force on Statin Safety—2014 update. Journal of Clinical Lipidology, 8(3 Suppl.), S1-S4. doi:10.1016/jacl.2014.03.002'

Clinical Recommendation Statements

This clinical quality measure is intended to align with the 2018 ACC/AHA/MS Guideline on the Management of Blood Cholesterol [1], 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:

1. 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% or greater reduction in LDL-C levels (Class I Recommendation), [1].
2. 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% to 49% reduction in LDL-C levels (Class I Recommendation), [1].
3. In patients older than 75 years of age with clinical ASCVD, it is reasonable to initiate moderate- or highintensity 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), [1].

Primary Prevention:

1. 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), [1].
2. 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), [1].
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), [1]. 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% to less than 10% has at least a small net benefit, [2].

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), [1].

References

1. Grundy, S. M., Stone, N. J., Bailey, A. L., Beam, C., Birtcher, K. K., Blumenthal, R. S., Braun, L. T., …Yeboah, J. (2019) 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol. Journal of the American College of Cardiology, 73 (24), e286-e343. doi.10.1016/j.jacc.2018.11.003

2. USPSTF (2022). Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: US Preventive Services Task Force Recommendation Statement. Journal of the American Medical Association, 328 (8), 746-753. doi:10.1001/jama.2022.13044