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  1. eCQM Issue Tracker
  2. CQM-4954

Remove pregnancy denominator exclusion per FDA direction

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Details

    • EP/EC eCQMs
    • Status: Open
    • Moderate
    • Resolution: Unresolved
    • None

    Description

      Brief Description of Measure:
      CMS347: 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 measurement period:
      *All patients who were previously diagnosed with or currently have an active diagnosis of clinical atherosclerotic cardiovascular disease (ASCVD), including an ASCVD procedure; OR
      *Patients aged >= 20 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 40-75 years with a diagnosis of diabetes

      Description of Issue:
      ‚ÄčIn July 2021, the FDA directed pregnancy be removed as a contraindication in prescribing information of the entire class of statins. The FDA expects removing the contraindication will enable health care professionals and patients to make individual decisions about benefit and risk, especially for those at very high risk of heart attack or stroke.

      Please refer to https://www.fda.gov/safety/medical-product-safety-information/statins-drug-safety-communication-fda-requests-removal-strongest-warning-against-using-cholesterol.

      The measure steward and expert work group recommends the measure align with the FDA direction, and proposes to remove the prengnacy denominator exclusion for all three Populations. This may result in an increase in the denominator eligible counts.

      Proposed Solution:
      Current Denominator Exclusions Language:
      Patients who have a diagnosis of pregnancy at any time during the measurement period
      Patients who are breastfeeding at any time during the measurement period
      Patients who have a diagnosis of rhabdomyolysis at any time during the measurement period

      Proposed Denominator Exclusions Language:
      Patients who are breastfeeding at any time during the measurement period
      Patients who have a diagnosis of rhabdomyolysis at any time during the measurement period

      Current Logic:
      Denominator Exclusions
      exists ( ( ["Diagnosis": "Pregnancy or Other Related Diagnoses"]
      union ["Diagnosis": "Breastfeeding"]
      union ["Diagnosis": "Rhabdomyolysis"] ) ExclusionDiagnosis
      where ExclusionDiagnosis.prevalencePeriod overlaps "Measurement Period"

      Proposed Logic:
      Denominator Exclusions
      exists ( ( ["Diagnosis": "Breastfeeding"]
      union ["Diagnosis": "Rhabdomyolysis"] ) ExclusionDiagnosis
      where ExclusionDiagnosis.prevalencePeriod overlaps "Measurement Period"

      Rationale for Change:
      Removing the pregnancy exclusion follows FDA guidelines and the steward and expert work group recommendations.

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            khancock Mathematica EC eCQM Team
            khancock Mathematica EC eCQM Team
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            Dates

              Created:
              Updated: