Thank you for submitting this inquiry. QI #438/CMS 347 (Statin Therapy for the Prevention and Treatment of Cardiovascular Disease) is informed by the 2018 ACC/AHA/Multisociety Guideline on the Management of Blood Cholesterol. The most recent (2018) guidelines recommend the following for issues specific to women of childbearing age: Women of childbearing age who are treated with statin therapy and are sexually active should be counseled to use a reliable form of contraception Women of childbearing age with hypercholesterolemia who plan to become pregnant should stop the statin 1 to 2 months before pregnancy is attempted, or if they become pregnant while on a statin, should have the statin stopped as soon as the pregnancy is discovered To address risks of statins for very specific populations (such as women of childbearing age not on contraceptives), the measure specifications for the 2022 performance period, which was released on the Electronic Clinical Quality Improvement (eCQI) Resource Center on May 6, includes the following language from the 2018 guidelines: "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." Therefore, the 2022 performance period measure specifications will provide guidance emphasizing that a clinician-patient risk discussion is an important step in considering statin therapy for any patient, including women of reproductive age that are not on contraceptives. Finally, our measure development team will bring your question of whether women of childbearing age who are not on birth control should be included in the measure to our next meeting with clinical experts for the next measure update cycle.

For Statin Therapy for the Prevention and Treatment of Cardiovascular Disease what is the clinical reasoning for including female patients who are not on birth control? Currently patients who are pregnant are excluded, but my understanding is that Statin therapy is contraindicated during pregnancy as it causes birth defects, so women who are not on reliable contraception should not be on a statin due to the risk.