New Measure Recommended for Endorsement by PQA
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1 New Measure Recommended for Endorsement by PQA Measure: Statin Use in Persons with Diabetes Description: The percentage of patients ages years who were dispensed a medication for diabetes that receive a statin medication. Key Points: The measure is based on the 2013 American College of Cardiology/American Heart Association (ACC/AHA) Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular (ASCV) Risk in Adults. 1 The ACC/AHA Guideline identifies four statin benefit groups where ASCV disease risk reduction outweighs the risk of adverse events. One of these groups includes individuals aged years old with diabetes (type 1 or 2). The ACC/AHA guidelines recommend moderate- to high-intensity statin therapy for primary prevention for persons aged years with diabetes (class I recommendation). The American Diabetes Association s Standards of Medical Care in Diabetes 2014 are similar to the ACC/AHA Guideline, but are not exactly the same. 2 The ADA states that statin therapy is indicated for diabetic patients with overt cardiovascular disease and without cardiovascular disease if they are over 40 years of age and have one or more other risk factors for CVD. Risk factors are listed as family history of cardiovascular disease (CVD), hypertension, smoking, dyslipidemia or albuminuria. Subsequent testing of the guidelines in patients undergoing angiography for a variety of reasons determined that the new AHA/ACC guidelines are more likely to assign patients with heavy plaque to receive statins and less likely to assign patients with no plaque to statins. 3 Testing of the PQA measure was completed by two organizations, each using large databases. One organization used 2012 data and provided measure results for Commercial, Medicare and Medicaid populations. The second organization used 2013 data and provided measure results for a Medicare population only. The average measure rates from testing, using data prior to the release of the new guidelines, were: 1
2 o Medicare population 1: 73%, standard deviation of 8.75% o Medicare population 2: 75% o Commercial population years: 62% o Medicaid population years: 61% o Medicaid population years: 69% Testing of this measure informed the denominator criteria to best identify a population with diabetes using medications as proxy for diagnosis. When using the criteria of 2 fills of a hypoglycemic agent, the great majority (84% - 96%, depending on the line of business [i.e., Commercial vs. Medicare vs. Medicaid]) of the denominator population also had at least one diabetes diagnosis listed in the same calendar year. Medical data was used in the testing to determine whether or not patients with select conditions (i.e., polycystic ovarian syndrome, gestational diabetes or diabetes secondary to another condition) should be excluded from the measure denominator. However, testing results showed that removing patients with the previously stated conditions from the denominator did not significantly change the overall rates across any population. As with other medication measures, there will be a small number of patients for whom the target medication is contraindicated (i.e., statin medications, for this measure). In a population-based measure, it is expected that the small percentage of patients with contraindications will be similar across plans when stratified by product line (i.e., Medicare, Medicaid, Commercial). The measure goal is not expected to reach 100%. Other measure developers are revising cardiovascular measures to align with the ACC/AHA Guidelines. This measure was harmonized with a preliminary draft measure for the Physician Quality Reporting System. Based on scientific evidence and PQA testing results, the Quality Metrics Expert Panel (QMEP) considered the measure to be feasible, important, scientifically valid, and useful for quality improvement. The PQA Staff and QMEP recommend this measure for endorsement by the PQA membership. References: 1. Stone NJ, Robinson J, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PWF ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;00: Accessed 2/3/ full.pdf 2
3 2. National Diabetes Education Initiative ADA Guidelines Summary Recommendations. Accessed 10/20/14 at %20org%20summary%20recommendations%20ADA%202014%20guidelines %20FINAL.pdf 3. Johnson K, Dowe DA Accuracy of statin assignment using the 2013 AHA/ACC cholesterol guideline versus the 2001 NCEP ATP III guideline JACC 2014; 64:
4 Measure Specification: Statin Use in Persons with Diabetes Description The percentage of patients ages years who were dispensed a medication for diabetes that receive a statin medication. Definitions Hypoglycemic Medications See Table A Statin Medications See Table B Rationale The American College of Cardiology/American Heart Association (ACC/AHA) guidelines recommend moderate- to high-intensity statin therapy for primary prevention for persons aged years with diabetes (class I recommendation). Guideline: 2013 ACC/AHA Guideline on Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults: a Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines 1 Prescription claims data are used as a proxy for diabetes diagnosis in this measure as well as other PQA and HEDIS measures. Medical data used in testing confirmed that the denominator criteria of two prescription claims for a hypoglycemic agent identified a population where a great majority had a diagnosis of diabetes during the measurement year. These criteria also included very few persons with select conditions (i.e., polycystic ovarian syndrome, gestational diabetes or diabetes secondary to another condition) that were considered for exclusion from the measure. Eligible Population Ages Continuous Enrollment...using enrollment data Proxy for enrollment when using pharmacy- only data 41 years 75 years as of the last day of the measurement year. Subjects should be continuously enrolled during the measurement period. To determine continuous enrollment for a Medicaid beneficiary for whom enrollment is verified monthly, the member may not have more than a 1-month gap in coverage (i.e., a member whose coverage lapses for 2 months [60 consecutive days] is not considered continuously enrolled). Two or more prescriptions for any medication, with 150 days between the first fill and the last fill, over a 12-month period. Measurement Period The measurement period is generally a calendar year and extends through the last day of the enrollment period or until death or disenrollment. 4
5 Benefit Pharmacy. Event/diagnosis Patients who were dispensed two or more prescription fills for a hypoglycemic agent (see Table A: Oral Hypoglycemic, Insulin, and Incretin Mimetics) during the measurement year. Stratification of Target Population Commercial, Medicaid, Medicare (report each product line separately). Administrative Specification Denominator Numerator Data Source The eligible population. The number of patients in the denominator who received a prescription fill for a statin or statin combination during the measurement year. (Refer to Table B: Statin Medications) Prescription claims data Exclusion Patients in Hospice (Medicare Part D) Table A: Oral Hypoglycemic, Insulin, Incretin Mimetics Biguanides and Biguanide Combination Products metformin pioglitazone & metformin rosiglitazone & metformin repaglinide & metformin sitagliptin & metformin IR & SR saxagliptin & metformin SR linagliptin & metformin glyburide & metformin glipizide & metformin alogliptin & metformin acetohexamide chlorpropamide glipizide & metformin Sulfonylureas and Sulfonylurea Combination Products glimepiride glipizide glyburide & metformin glyburide rosiglitazone & glimepiride pioglitazone & glimepiride tolazamide tolbutamide Meglitinides and Meglitinide Combination Products nateglinide repaglinide repaglinide & metformin acarbose pioglitazone pioglitazone & glimepiride Alpha- Glucosidase Inhibitors miglitol Thiazolidinediones and Thiazolidinedione Combination Products pioglitazone & metformin rosiglitazone rosiglitazone & glimepiride rosiglitazone & metformin alogliptin & pioglitazone Incretin Mimetic Agents exenatide liraglutide albiglutide Amylin Analogs pramlintide 5
6 sitagliptin linagliptin alogliptin DPP-IV Inhibitors and DPP-IV Inhibitor Combination Products saxagliptin alogliptin & metformin alogliptin & pioglitazone linagliptin & metformin sitagliptin & metformin IR & SR saxagliptin & metformin SR sitagliptin & simvastatin insulin aspart insulin aspart Protamine & Aspart insulin detemir insulin glargine insulin glulisine canagliflozin dapagliflozin Insulins insulin isophane & regular human insulin insulin isophane (human N) insulin lispro insulin lispro Protamine & Insulin lispro insulin regular (human R) Sodium glucose co-transporter2 (SGLT2) Inhibitors insulin zinc Note: The active ingredients are limited to oral and injectable formulations only (Includes all dosage forms. Excludes nutritional supplement/dietary management combination products). Table B: Statin Medications lovastatin rosuvastatin niacin & lovastatin atorvastatin & amlodipine Statin Medications fluvastatin pravastatin atorvastatin pitavastatin Statin Combination Products niacin & simvastatin sitagliptin & simvastatin ezetimibe & simvastatin ezetimibe & atorvastatin simvastatin aspirin-pravastatin Note: The active ingredients are limited to oral formulations only. References: 1. Stone NJ, Robinson J, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PWF ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;00: Accessed 2/3/ a.full.pdf 6
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