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 performance period:

• Adults aged ≥ 21 years who were previously diagnosed with or currently have an active diagnosis of 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**:

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

OR

• 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

• 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.

Denominator

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

–OR–

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):
Patients 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

–OR–

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, E10.321, E10.3211, E10.3212, E10.3213, E10.3219, E10.329, E10.3291, E10.3292, E10.3293, E10.3299, E10.331, E10.3311, E10.3312, E10.3313, E10.3319, E10.339, E10.3391, E10.3392, E10.3393, E10.3399, E10.341, E10.3411, E10.3412, E10.3413, E10.3419, E10.349, E10.3491, E10.3492, E10.3493, E10.3499 E10.351, 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, E10.359, 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, E11.321, E11.3211, E11.3212, E11.3213, E11.3219, E11.329, E11.3291, E11.3292, E11.3293, E11.3299, E11.331, E11.3311, E11.3312, E11.3313, E11.3319, E11.339, E11.3391, E11.3392, E11.3393, E11.3399, E11.341, E11.3411, E11.3412, E11.3413, E11.3419, E11.349, E11.3491, E11.3492, E11.3493, E11.3499, E11.351, 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, E11.359, 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, E13.321, E13.3211, E13.3212, E13.3213, E13.3219, E13.329, E13.3291, E13.3292, E13.3293, E13.3299, E13.331, E13.3311, E13.3312, E13.3313, E13.3319, E13.339, E13.3391, E13.3392, E13.3393, E13.3399, E13.341, E13.3411, E13.3412, E13.3413, E13.3419, E13.349, E13.3491, E13.3492, E13.3493, E13.3499, E13.351, 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, E13.359, 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

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

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. Statin Medication Therapy List (NOTE: List does NOT include dosage) is included in the clinical recommendations.

Denominator Exceptions

Active Liver or Hepatic Disease or Insufficiency – The following 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, 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)

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)

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, and 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 test result < 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)

“