2026 MIPS Measure #438: Statin Therapy for the Prevention and Treatment of Cardiovascular Disease

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.

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, POS 02, POS 10) are allowable.

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 (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 (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 (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 1: (Eligible Cases):
All patients, regardless of age

AND

Patient encounter during the performance period (CPT or HCPCS): 98000, 98001, 98002, 98003, 98004, 98005, 98006, 98007, 98008, 98009, 98010, 98011, 98012, 98013, 98014, 98015, 98016, 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

Denominator Criteria 2: (Eligible Cases):
Patient aged 20 to 75 years at the beginning of the performance period

AND

Patient encounter during the measurement period (CPT): 98000, 98001, 98002, 98003, 98004, 98005, 98006, 98007, 98008, 98009, 98010, 98011, 98012, 98013, 98014, 98015, 98016, 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

Denominator Criteria 3: (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.A0, E10.A1, E10.A2, 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, E11.37X1, 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): 98000, 98001, 98002, 98003, 98004, 98005, 98006, 98007, 98008, 98009, 98010, 98011, 98012, 98013, 98014, 98015, 98016, 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

Denominator Criteria 4: (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): 98000, 98001, 98002, 98003, 98004, 98005, 98006, 98007, 98008, 98009, 98010, 98011, 98012, 98013, 98014, 98015, 98016, 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

STATIN THERAPY MEASURE – SUBMISSION CRITERIA 1 – SUMMARY:

SUBMISSION CRITERIA 1:
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 medications used to lower plasma lipoprotein levels in the treatment of hyperlipoproteinemia.

TABLE 1 – STATIN MEDICATION THERAPY LIST (NOTE: List does NOT include dosage):

Generic Name / Brand or Trade Name / Medication Type:
- Atorvastatin (Lipitor) – Statin
- Fluvastatin (Lescol XL or Lescol) – Statin
- Lovastatin / Mevinolin (Mevacor or Altoprev) – Statin
- Pitavastatin (Livalo or Zypitamag or Nikita) – Statin
- Pravastatin Sodium (Pravachol) – Statin
- Rosuvastatin Calcium (Crestor) – Statin
- Simvastatin (Zocor) – Statin
- Amlodipine Besylate/Atorvastatin (Caduet) – Fixed Dose Combination
- Ezetimibe/Simvastatin (Vytorin) – Fixed Dose Combination
- Ezetimibe/Rosuvastatin (Roszet) – Fixed Dose Combination

DENOMINATOR EXCEPTIONS (G9781) – Documented medical reason(s) for not using statin therapy:

1. Active Liver or Hepatic Disease or Insufficiency:
ICD-10-CM: 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

2. End Stage Renal Disease (ESRD):
ICD-10-CM: N18.6

3. Statin-Associated Muscle Symptoms (SAMS) – including myalgias, myositis, myopathy, or statin-associated autoimmune myopathy:
ICD-10-CM: G72.0, G72.9, M60.9, M79.10

4. Other medical reasons (e.g., allergy to statin medication therapy, palliative care, hospice care) – use G9781

NUMERATOR REPORTING CODES:

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

Denominator Exception:
- G9781 – Documentation of medical reason(s) for not currently being a statin therapy user or receiving an order (prescription) for statin therapy

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

NUMERATOR NOTE:
- Current statin therapy use must be documented in patient's current medication list OR ordered during performance period
- ONLY statin therapy meets numerator criteria (NOT other cholesterol-lowering medications)
- Prescription/order does NOT need to be linked to an encounter or visit – may be called to pharmacy
- Statin medication "samples" can be documented as "current statin therapy" if documented in medication list
- Patients who meet denominator criteria but are not prescribed or using statin therapy = Performance Not Met
- Adherence to statin therapy is NOT calculated in this measure

INTENSITY OF STATIN THERAPY:
- 2018 ACC/AHA/MS Guidelines define intensity based on expected LDL-C response
- This measure assesses prescription of ANY statin therapy, irrespective of intensity
- Assessment of appropriate intensity and dosage is NOT included in this measure

DENOMINATOR EXCEPTIONS MUST BE ACTIVE DURING THE PERFORMANCE PERIOD.

KEY TAKEAWAYS:
1. Measure assesses ANY statin therapy use or order during performance period
2. Statin list includes 7 single-agent statins + 3 fixed-dose combinations
3. Denominator exceptions: Liver disease, ESRD, SAMS, allergy, palliative/hospice
4. Use G9664 for Performance Met, G9781 for Exception, G9665 for Performance Not Met
5. ONLY statins qualify – NOT other lipid-lowering agents
6. Samples count if documented in medication list
7. Intensity of therapy is NOT assessed in this measure

STATIN THERAPY MEASURE – SUMMARY:

SUBMISSION CRITERIA 2:
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 medications used to lower plasma lipoprotein levels in the treatment of hyperlipoproteinemia.

TABLE 1 – STATIN MEDICATION THERAPY LIST (NOTE: List does NOT include dosage):

Generic Name / Brand or Trade Name / Medication Type:
- Atorvastatin (Lipitor) – Statin
- Fluvastatin (Lescol XL or Lescol) – Statin
- Lovastatin / Mevinolin (Mevacor or Altoprev) – Statin
- Pitavastatin (Livalo or Zypitamag or Nikita) – Statin
- Pravastatin Sodium (Pravachol) – Statin
- Rosuvastatin Calcium (Crestor) – Statin
- Simvastatin (Zocor) – Statin
- Amlodipine Besylate/Atorvastatin (Caduet) – Fixed Dose Combination
- Ezetimibe/Simvastatin (Vytorin) – Fixed Dose Combination
- Ezetimibe/Rosuvastatin (Roszet) – Fixed Dose Combination

DENOMINATOR EXCEPTIONS (G9781) – Documented medical reason(s) for not using statin therapy:

1. Active Liver or Hepatic Disease or Insufficiency:
ICD-10-CM: 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

2. End Stage Renal Disease (ESRD):
ICD-10-CM: N18.6

3. Statin-Associated Muscle Symptoms (SAMS) – including myalgias, myositis, myopathy, or statin-associated autoimmune myopathy:
ICD-10-CM: G72.0, G72.9, M60.9, M79.10

4. Other medical reasons (e.g., allergy to statin medication therapy, palliative care, hospice care) – use G9781

NUMERATOR REPORTING CODES:

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

Denominator Exception:
- G9781 – Documentation of medical reason(s) for not currently being a statin therapy user or receiving an order (prescription) for statin therapy

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

NUMERATOR NOTE:
- Current statin therapy use must be documented in patient's current medication list OR ordered during performance period
- ONLY statin therapy meets numerator criteria (NOT other cholesterol-lowering medications)
- Prescription/order does NOT need to be linked to an encounter or visit – may be called to pharmacy
- Statin medication "samples" can be documented as "current statin therapy" if documented in medication list
- Patients who meet denominator criteria but are not prescribed or using statin therapy = Performance Not Met
- Adherence to statin therapy is NOT calculated in this measure

INTENSITY OF STATIN THERAPY:
- 2018 ACC/AHA/MS Guidelines define intensity based on expected LDL-C response
- This measure assesses prescription of ANY statin therapy, irrespective of intensity
- Assessment of appropriate intensity and dosage is NOT included in this measure

DENOMINATOR EXCEPTIONS MUST BE ACTIVE DURING THE PERFORMANCE PERIOD.

KEY TAKEAWAYS:
1. Measure assesses ANY statin therapy use or order during performance period
2. Statin list includes 7 single-agent statins + 3 fixed-dose combinations
3. Denominator exceptions: Liver disease, ESRD, SAMS, allergy, palliative/hospice
4. Use G9664 for Performance Met, G9781 for Exception, G9665 for Performance Not Met
5. ONLY statins qualify – NOT other lipid-lowering agents
6. Samples count if documented in medication list
7. Intensity of therapy is NOT assessed in this measure

STATIN THERAPY MEASURE – SUBMISSION CRITERIA 3 – SUMMARY:

SUBMISSION CRITERIA 3:
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 medications used to lower plasma lipoprotein levels in the treatment of hyperlipoproteinemia.

TABLE 1 – STATIN MEDICATION THERAPY LIST (NOTE: List does NOT include dosage):

Generic Name / Brand or Trade Name / Medication Type:
- Atorvastatin (Lipitor) – Statin
- Fluvastatin (Lescol XL or Lescol) – Statin
- Lovastatin / Mevinolin (Mevacor or Altoprev) – Statin
- Pitavastatin (Livalo or Zypitamag or Nikita) – Statin
- Pravastatin Sodium (Pravachol) – Statin
- Rosuvastatin Calcium (Crestor) – Statin
- Simvastatin (Zocor) – Statin
- Amlodipine Besylate/Atorvastatin (Caduet) – Fixed Dose Combination
- Ezetimibe/Simvastatin (Vytorin) – Fixed Dose Combination
- Ezetimibe/Rosuvastatin (Roszet) – Fixed Dose Combination

DENOMINATOR EXCEPTIONS (G9781) – Documented medical reason(s) for not using statin therapy:

1. Active Liver or Hepatic Disease or Insufficiency:
ICD-10-CM: 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

2. End Stage Renal Disease (ESRD):
ICD-10-CM: N18.6

3. Statin-Associated Muscle Symptoms (SAMS) – including myalgias, myositis, myopathy, or statin-associated autoimmune myopathy:
ICD-10-CM: G72.0, G72.9, M60.9, M79.10

4. Other medical reasons (e.g., allergy to statin medication therapy, palliative care, hospice care) – use G9781

NUMERATOR REPORTING CODES:

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

Denominator Exception:
- G9781 – Documentation of medical reason(s) for not currently being a statin therapy user or receiving an order (prescription) for statin therapy

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

NUMERATOR NOTE:
- Current statin therapy use must be documented in patient's current medication list OR ordered during performance period
- ONLY statin therapy meets numerator criteria (NOT other cholesterol-lowering medications)
- Prescription/order does NOT need to be linked to an encounter or visit – may be called to pharmacy
- Statin medication "samples" can be documented as "current statin therapy" if documented in medication list
- Patients who meet denominator criteria but are not prescribed or using statin therapy = Performance Not Met
- Adherence to statin therapy is NOT calculated in this measure

INTENSITY OF STATIN THERAPY:
- 2018 ACC/AHA/MS Guidelines define intensity based on expected LDL-C response
- This measure assesses prescription of ANY statin therapy, irrespective of intensity
- Assessment of appropriate intensity and dosage is NOT included in this measure

DENOMINATOR EXCEPTIONS MUST BE ACTIVE DURING THE PERFORMANCE PERIOD.

KEY TAKEAWAYS:
1. Measure assesses ANY statin therapy use or order during performance period
2. Statin list includes 7 single-agent statins + 3 fixed-dose combinations
3. Denominator exceptions: Liver disease, ESRD, SAMS, allergy, palliative/hospice
4. Use G9664 for Performance Met, G9781 for Exception, G9665 for Performance Not Met
5. ONLY statins qualify – NOT other lipid-lowering agents
6. Samples count if documented in medication list
7. Intensity of therapy is NOT assessed in this measure
8. Submission Criteria 3 is clinically identical to Criteria 1 and 2 – difference may be in denominator population or measure application

STATIN THERAPY MEASURE – SUBMISSION CRITERIA 4 – SUMMARY:

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 medications used to lower plasma lipoprotein levels in the treatment of hyperlipoproteinemia.

TABLE 1 – STATIN MEDICATION THERAPY LIST (NOTE: List does NOT include dosage):

Generic Name / Brand or Trade Name / Medication Type:
- Atorvastatin (Lipitor) – Statin
- Fluvastatin (Lescol XL or Lescol) – Statin
- Lovastatin / Mevinolin (Mevacor or Altoprev) – Statin
- Pitavastatin (Livalo or Zypitamag or Nikita) – Statin
- Pravastatin Sodium (Pravachol) – Statin
- Rosuvastatin Calcium (Crestor) – Statin
- Simvastatin (Zocor) – Statin
- Amlodipine Besylate/Atorvastatin (Caduet) – Fixed Dose Combination
- Ezetimibe/Simvastatin (Vytorin) – Fixed Dose Combination
- Ezetimibe/Rosuvastatin (Roszet) – Fixed Dose Combination

DENOMINATOR EXCEPTIONS (G9781) – Documented medical reason(s) for not using statin therapy:

1. Active Liver or Hepatic Disease or Insufficiency:
ICD-10-CM: 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

2. End Stage Renal Disease (ESRD):
ICD-10-CM: N18.6

3. Statin-Associated Muscle Symptoms (SAMS) – including myalgias, myositis, myopathy, or statin-associated autoimmune myopathy:
ICD-10-CM: G72.0, G72.9, M60.9, M79.10

4. Other medical reasons (e.g., allergy to statin medication therapy, palliative care, hospice care) – use G9781

NUMERATOR REPORTING CODES:

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

Denominator Exception:
- G9781 – Documentation of medical reason(s) for not currently being a statin therapy user or receiving an order (prescription) for statin therapy

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

NUMERATOR NOTE:
- Current statin therapy use must be documented in patient's current medication list OR ordered during performance period
- ONLY statin therapy meets numerator criteria (NOT other cholesterol-lowering medications)
- Prescription/order does NOT need to be linked to an encounter or visit – may be called to pharmacy
- Statin medication "samples" can be documented as "current statin therapy" if documented in medication list
- Patients who meet denominator criteria but are not prescribed or using statin therapy = Performance Not Met
- Adherence to statin therapy is NOT calculated in this measure

INTENSITY OF STATIN THERAPY:
- 2018 ACC/AHA/MS Guidelines define intensity based on expected LDL-C response
- This measure assesses prescription of ANY statin therapy, irrespective of intensity
- Assessment of appropriate intensity and dosage is NOT included in this measure

DENOMINATOR EXCEPTIONS MUST BE ACTIVE DURING THE PERFORMANCE PERIOD.

KEY TAKEAWAYS:
1. Measure assesses ANY statin therapy use or order during performance period
2. Statin list includes 7 single-agent statins + 3 fixed-dose combinations
3. Denominator exceptions: Liver disease, ESRD, SAMS, allergy, palliative/hospice
4. Use G9664 for Performance Met, G9781 for Exception, G9665 for Performance Not Met
5. ONLY statins qualify – NOT other lipid-lowering agents
6. Samples count if documented in medication list
7. Intensity of therapy is NOT assessed in this measure
8. Submission Criteria 4 is clinically identical to Criteria 1, 2, and 3 – difference may be in denominator population or measure application

STATIN THERAPY MEASURE – NUMERATOR OPTIONS FOR ALL 4 SUBMISSION CRITERIA:

SUBMISSION CRITERIA 1 – NUMERATOR OPTIONS:
- Performance Met: G9664 – Patients who are currently statin therapy users OR received an order (prescription) for statin therapy
- Denominator Exception: G9781 – Documentation of medical reason(s) for not currently being a statin therapy user or receiving an order (prescription) for statin therapy
- Performance Not Met: G9665 – Patients who are not currently statin therapy users OR did not receive an order (prescription) for statin therapy

SUBMISSION CRITERIA 2 – NUMERATOR OPTIONS:
- Performance Met: G9664 – Patients who are currently statin therapy users OR received an order (prescription) for statin therapy
- Denominator Exception: G9781 – Documentation of medical reason(s) for not currently being a statin therapy user or receiving an order (prescription) for statin therapy
- Performance Not Met: G9665 – Patients who are not currently statin therapy users OR did not receive an order (prescription) for statin therapy

SUBMISSION CRITERIA 3 – NUMERATOR OPTIONS:
- Performance Met: G9664 – Patients who are currently statin therapy users OR received an order (prescription) for statin therapy
- Denominator Exception: G9781 – Documentation of medical reason(s) for not currently being a statin therapy user or receiving an order (prescription) for statin therapy
- Performance Not Met: G9665 – Patients who are not currently statin therapy users OR did not receive an order (prescription) for statin therapy

SUBMISSION CRITERIA 4 – NUMERATOR OPTIONS:
- Performance Met: G9664 – Patients who are currently statin therapy users OR received an order (prescription) for statin therapy
- Denominator Exception: G9781 – Documentation of medical reason(s) for not currently being a statin therapy user or receiving an order (prescription) for statin therapy
- Performance Not Met: G9665 – Patients who are not currently statin therapy users OR did not receive an order (prescription) for statin therapy

SUMMARY – ALL 4 CRITERIA USE THE SAME 3 CODES:
- G9664 = Performance Met
- G9781 = Denominator Exception
- G9665 = Performance Not Met

NOTE: The difference between Criteria 1, 2, 3, and 4 lies in the DENOMINATOR POPULATION (e.g., different age groups, risk categories, or prevention types), NOT in the numerator options or reporting codes.

“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'