Performance Measure Review Screening, Monitoring, and ...

Performance Measure Review

Screening, Monitoring, and Management of Chronic Kidney Disease: Review of the Performance Measures by the Performance Measurement Committee of the American College of Physicians Writing Committee Amir Qaseem, MD, Robert Centor, MD and Andrew Dunn, MD

ACP Performance Measurement Committee Members* David W. Baker, MD, MPH (Chair); Robert M. Centor, MD; J. Thomas Cross, MD, MPH; Andrew Dunn, MD; Mary Ann Forciea, MD; Sandra Adamson Fryhofer, MD; Robert A. Gluckman, MD; Robert H. Hopkins, MD; Eve Kerr, MD; Kesavan Kutty, MD; Ana Maria López, MD, MPH; Catherine MacLean, MD, PhD; Nasseer A. Masoodi, MD; Stephen D. Persell, MD, MPH; and Terrence Shaneyfelt, MD

Corresponding author: A. Qaseem 190 N. Independence Mall West Philadelphia, PA 19106 Email [email protected]

* Individuals who served on the Performance Measurement Committee from initiation of the project until its approval

Introduction Approximately 11.1% of adults (22.4 million people) in the United States have stage 1-3 chronic kidney disease (CKD) and data suggest that the prevalence is increasing (1). Stage 1-3 CKD, characterized by reduced glomerular filtration rate (GFR) and albuminuria, is associated with adverse health outcomes and the management of stage 1-3 CKD often focuses on treating associated conditions and complications accompanying CKD including hypertension, cardiovascular disease, and diabetes. The American College of Physicians (ACP) published a clinical practice guideline on the screening, monitoring, and treatment of stage 1-3 CKD (2) based on an evidence report sponsored by the Agency for Healthcare Research and Quality (AHRQ) (3). The goal of the guideline is to present the available evidence on the screening, monitoring, and treatment of stage 1-3 CKD. In order to encourage alignment between clinical guidelines and performance measures, the ACP Performance Measurement Committee (PMC) reviewed performance measures related to stage 1-3 CKD based on the evidence presented in the ACP guideline to assess whether the measures are evidence-based, methodologically sound, and clinically meaningful.

Methods The PMC performed a search to identify relevant performance measures from the National Quality Forum (NQF), the American Medical Association-Physician Consortium for Performance Improvement (AMAPCPI), and National Quality Measure Clearinghouse (NQMC) websites. The inclusion criteria included performance measures developed in the United States that are endorsed by the NQF or currently used in the Centers for Medicare and Medicaid Services (CMS) Physician Quality Reporting System (PQRS) or currently used in the CMS Electronic Record Incentive program. The PMC identified and reviewed six measures on stage 1-3 CKD.

Conclusion

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Recommendation ACP does not support NQF 0621: “Non-Diabetic Nephropathy - Use of ACE Inhibitor or ARB Therapy.” Rationale While the clinical reasoning underlying the measure is sound, it does not reflect the most recent Kidney Disease | Improving Global Outcomes (KDIGO) guidelines on the management of CKD (4). Cut-points in the denominator and exclusion criteria should be updated to align with current recommended practice standards. Specifically, KDIGO recommends an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) for diabetic CKD patients with albumin excretion of 30-300 mg/24 hours, and for patients with albumin excretion greater than 300 mg/24 hours, regardless of diabetes 2 status. The division of stage 3 CKD into stages 3a (GFR 45-59 ml/min/1.73 m ) and 3b (GFR 30-44 2 ml/min/1.73 m ) should also be noted explicitly in the exclusion criteria along with guidance as to whether both patient populations should be excluded.

Measure Specifications NQF 0621: Non-Diabetic Nephropathy - Use of ACE Inhibitor or ARB Therapy Status: Measure Steward: Description:

NQF Endorsed Oct 05, 2012 ActiveHealth Management

Clinical Topic: Numerator Statement: Denominator Statement: Exclusions:

CKD, Renal Patients with a current fill for an ACE inhibitor or ARB

The percentage of patients aged 18 years and older with proteinuria who are taking an ACE inhibitor or ARB

All patients aged 18 years and older with a urine protein >= 200 mg/g Specific exclusions: Patients with contraindication to an ACE inhibitor or ARB, including pregnancy, prior angioedema, hypotension, hyperkalemia, rising creatinine, chronic kidney disease stage 3-5 (without dialysis), aortic stenosis, hypertrophic cardiomyopathy, multiple myeloma with treatment, diabetes diagnosis, renal transplant, immunosuppressive therapy General exclusions: • Evidence of metastatic disease or active treatment of malignancy (chemotherapy or radiation therapy) in the last 6 months; • Patients who have been in a skilled nursing facility in the last 3 months

Risk Adjustment: Type of Measure: Level of Analysis: Care Setting: Data Source:

NA Process National Other Other

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Recommendation ACP does not support NQF 1668: “Laboratory Testing (Lipid Profile).” Rationale The ACP guideline (2) states that there is inconclusive evidence for periodic monitoring (i.e. lipid profile) in patients diagnosed with stage 1-3 CKD.

Measure Specifications NQF 1668: Laboratory Testing (Lipid Profile) Title:

Laboratory Testing (Lipid Profile)

Status: Measure Steward: Description:

Endorsed Jul 10, 2012 (2013 PQRS Measure #121) AMA-PCPI

Clinical Topic: Numerator Statement: Denominator Statement:

CKD, Renal Patients who had a fasting lipid profile performed at least once within a 12-month period

Percentage of patients aged 18 years and older with a diagnosis of CKD (stage 3, 4 or 5, not receiving Renal Replacement Therapy (RRT)) who had a fasting lipid profile performed at least once within a 12-month period

All patients aged 18 years and older with a diagnosis of CKD (stage 3, 4 or 5, not receiving RRT) Definition: RRT - For the purposes of this measure, RRT includes hemodialysis, peritoneal dialysis, and kidney transplantation

Exclusions:

Risk Adjustment: Type of Measure: Level of Analysis: Care Setting: Data Source:

Documentation of patient reason(s) for not performing a fasting lipid profile (eg, patient declined, other patient reasons) NA Process Group/Practice, Individual, Team Clinician Office/Clinic, Dialysis Facility, Home Health, Laboratory, Nursing Home/Skilled Nursing Facility, Other Administrative claims, Electronic Clinical Data, Electronic Health Record, Laboratory, Registry

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Recommendation ACP does not support PQRS 122: “Adult Kidney Disease: Blood Pressure Management.”

Rationale The ACP guideline (2) states that there is no difference in outcomes between strict blood pressure control and standard blood pressure control (128-133 mmHg vs. 134-141 mmHg systolic, and 75-81 mmHg vs. 81-87 mmHg diastolic). This measure lost NQF endorsement due to a lack of evidence. In addition, the currently endorsed measure (NQF 0018) specifies the percentage of patients 18–85 years of age who had a diagnosis of hypertension and whose blood pressure was adequately controlled (= 130/80 mmHg with plan of care (component 2)  % of patient visits meeting blood pressure < 130/80 mmHg AND patient visits meeting blood pressure >= 130/80 mmHg with plan of care (total measure score)

Denominator Statement:

All patient visits for those patients aged 18 years and older with a diagnosis of CKD (stage 3, 4 or 5, not receiving RRT) and proteinuria

Definitions: Proteinuria: 1) >300mg of albumin in the urine per 24 hours OR 2) albumin to creatinine ratio (ACR) >300 mcg/mg creatinine OR 3) Protein to creatinine ratio > 0.3 mg/mg creatinine. RRT - For the purposes of this measure, RRT includes hemodialysis, Performance Measure Review www.acponline.org/clinical_information/performance_measurement ©2014 American College of Physicians www.acponline.org. All rights reserved. Page 5 of 12

peritoneal dialysis, and kidney transplantation Exclusions: Risk Adjustment: Type of Measure: Level of Analysis: Care Setting: Data Source:

None NA Process/Outcomes Individual practitioner Ambulatory Care Electronic Health Record (EHR) data, Prospective Claims-Based Reporting

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Recommendation ACP does not support measure NQF 1666: “Adult Kidney Disease: Patients on Erythropoiesis-Stimulating Agent (ESA) – Hemoglobin Level > 12 g/dL.” Rationale According to the ACP guideline (6), there is no benefit for higher compared to lower (ranging from 9 to 11.3 g/dL) hemoglobin targets in patients with comorbid CKD and heart disease, and aggressive ESA use to normalize hemoglobin was associated with increased the risk of venous thromboembolic events and suggested increased mortality rates (6-9). The KDOQI Guideline on CKD patients with anemia (5) recommends target hemoglobin levels in the range of 11.0 to 12.0g/dL in patients receiving ESA therapy. Measure Specifications NQF 1666: Adult Kidney Disease: Patients on Erythropoiesis-Stimulating Agent (ESA) – Hemoglobin Level > 12.0 g/dL Title:

Patients on Erythropoiesis-Stimulating Agent (ESA)--Hemoglobin Level > 12.0 g/dL

Status: Measure Steward: Description:

Clinical Topic: Numerator Statement:

Denominator Statement:

NQF Endorsed: Jul 10, 2012 (2013 PQRS #123) American Medical Association - Physician Consortium for Performance Improvement (AMA-PCPI) Percentage of calendar months within a 12-month period during which a Hemoglobin is measured for patients aged 18 years and older with a diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) or ESRD (who are on hemodialysis or peritoneal dialysis) who are also receiving ESA therapy and have a Hemoglobin Level > 12.0 g/dL CKD, ESRD, Renal Calendar months during which patients have a Hemoglobin level > 12.0 g/dL* *The hemoglobin values used for this measure should be the most recent (last) hemoglobin value recorded for each calendar month All calendar months during which a Hemoglobin level is measured for patients aged 18 years and older with a diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) or ESRD (who are on hemodialysis or peritoneal dialysis ) who are also receiving ESA therapy Definitions: RRT - For the purposes of this measure, RRT includes hemodialysis, peritoneal dialysis, and kidney transplantation

Exclusions: Risk Adjustment: Type of Measure: Level of Analysis: Care Setting:

Data Source:

None NA Outcome Group/Practice, Individual, Team Clinician Office/Clinic, Dialysis Facility, Home Health, Nursing Home/Skilled Nursing Facility, Other Administrative claims, Electronic Clinical Data, Electronic Health Record, Registry

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Recommendation ACP does not support NQF 0062: “Diabetes: Urine Protein Screening.” Rationale The ACP guideline (2) states that there is inconclusive evidence to support microalbumiuria testing in asymptomatic adults with risk factors (e.g. diabetic patients). There are known risk factors for CKD such as diabetes, hypertension, and cardiovascular disease. ACP found that the current evidence is insufficient to evaluate the benefits and harms of screening for CKD in asymptomatic adults with risk factors for CKD. Also, ACP recommends against routinely testing for proteinuria in adults with or without diabetes who are currently taking an ACE inhibitor or an ARB (Grade: weak recommendation, low-quality evidence). These patients are already receiving the appropriate treatment. There is insufficient evidence that monitoring proteinuria levels in patients taking ACE inhibitors or ARBs is beneficial or that reduced proteinuria levels are a valid surrogate marker of improved outcomes in patients with CKD. Measure Specifications NQF 0062: Diabetes: Urine Protein Screening (PQRS #119) Title:

Diabetes: Urine Protein Screening

Status: Measure Steward: Description:

Jan 03, 2012 National Committee for Quality Assurance

Clinical Topic: Numerator Statement: Denominator Statement:

Diabetes, Endocrine A nephropathy screening test or evidence of nephropathy

Exclusions:

Risk Adjustment: Type of Measure: Level of Analysis: Care Setting: Data Source:

Percentage of adult diabetes patients aged 18-75 years with at least one test for microalbumin during the measurement year or who had evidence of medical attention for existing nephropathy (diagnosis of nephropathy or documentation of microalbuminuria or albuminuria)

Patients 18-75 years of age as of December 31 of the measurement year who had a diagnosis of diabetes (type 1 or type 2). Exclude patients with a diagnosis of polycystic ovaries on the problem list who did not have a diagnosis of diabetes on the problem list during the measurement year or year prior to the measurement year. Exclude patients with a diagnosis of gestational diabetes or steroid-induced diabetes on the problem list who did not have a diagnosis of diabetes on the problem list during the measurement year or year prior to the measurement year. No Process Group/Practice, Individual, Integrated Delivery System, National, Regional, State Clinician Office/Clinic Administrative claims

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Recommendation ACP does not support NQF 0604: “Adult(s) with Diabetes Mellitus that had a Serum Creatinine in Last 12 Reported Months.” Rationale While this may be a common clinical practice, the ACP guideline (2) states that there is inconclusive evidence to support serum creatinine testing in asymptomatic adults with risk factors (i.e. diabetic patients). In addition, there is insufficient evidence to support the timing of a serum creatinine assessment (i.e. annual assessment). Measure Specifications NQF 0604: Adult(s) with Diabetes Mellitus that had a Serum Creatinine in Last 12 Reported Months Title:

Adult(s) with Diabetes Mellitus that had a Serum Creatinine in Last 12 Reported Months

Status: Measure Steward: Description:

Oct 05, 2012 Ingenix

Clinical Topic: Numerator Statement:

Diabetes, Endocrine Was there a test for serum creatinine (code set PR0081, LC0033) or an ACE/ARB therapeutic monitoring test (code set PR0272) during the following time period: 12 months report period through 90 days after the end of the report period? Time Window: 12 months prior to the end of the report period through 90 days after the end of the report period

Denominator Statement:

This measure identifies adults with diabetes mellitus that had a serum creatinine test in last 12 reported months.

For condition confirmation, the following criteria must be met: 1. All males or females 18-75 years of age at the end of the report period 2. Patient must have been continuously enrolled: Medical benefits throughout the 12 months prior to the end of the report period AND Pharmacy benefit plan for 6 months prior to the end of the report period Note: The standard enrollment break logic allows unlimited breaks of no more than 45 days and no breaks greater than 45 days. 3. Either one of the following criteria (A or B): A. The patient is listed on the Disease Registry Input File for this condition, if a Disease Registry Input File is available. OR B. During the 24 months prior to the end of the report period, did the patient meet any of the following criteria: Patient has 2 or more outpatient or nonacute inpatient encounters (HEDIS) (code set PR0199, RV0199, PR0195, RV0195), where the diagnosis is Diabetes (HEDIS) (code set DX0227) OR Patient has 1 or more acute inpatient or emergency department encounters (HEDIS) (code set PR0330, RV0330, PR0194, RV0194), where the diagnosis is Diabetes (HEDIS) (code set DX0227) OR Patient has 1 or more prescriptions for Insulin or Oral Hypoglycemics/Antihyperglycemics (HEDIS) (code set RX0221) Time Window: 24 months prior to the end of the report period

Exclusions:

During the 12 months prior to the end of the report period, did the patient have 1 or more of the following services or events, where the diagnosis was Polycystic Ovaries (code set DX0312), Gestational Diabetes (DX0313), or Steroid-induced Diabetes (DX0314): - Professional Encounter Code Set (code set PR0107, RV0107)

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- Professional Supervision (code set PR0108) - Facility Event – Confinement/Admission - Facility Event – Emergency Room - Facility Event – Outpatient Surgery Risk Adjustment: Type of Measure: Level of Analysis: Care Setting: Data Source:

No Process Community, County or City, Facility, Group/Practice, Health Plan, Individual, Integrated Delivery System, National, Regional, State, Team Ambulatory Surgery Center, Clinician Office/Clinic, Inpatient Rehabilitation Facility, Nursing Home/Skilled Nursing Facility, Outpatient Rehabilitation, Urgent Care Administrative claims, Laboratory

Gaps in Performance Measurement — Opportunities to Promote High-Value Care The PMC recommends development of a performance measure addressing the overuse of ESA in patients with CKD. The rationale for this is that the harms outweigh the benefits for treating patients with mild to moderate anemia using ESAs (6). The potential harms associated with ESA therapy include increased risks of thromboembolic events and stroke.

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REFERENCES

1.

Levey AS, de Jong PE, Coresh J, El Nahas M, Astor BC, Matsushita K, et al. The definition, classification, and prognosis of chronic kidney disease: a KDIGO Controversies Conference report. Kidney Int. 2010;80(1):17-28.

2.

Qaseem A, Hopkins RH, Sweet DE, Starkey M, Shekelle P. Screening, Monitoring, and Treatment of Stage 1-3 Chronic Kidney Disease: A Clinical Practice Guideline from the Clinical Guidelines Committee of the American College of Physicians. Under review.

3.

Fink HA, Ishani A, Taylor BC, Greer NL, MacDonald, R, Rossini D, et al. Chronic Kidney Disease Stages 1–3: Screening, Monitoring,and Treatment. Comparative Effectiveness Review No. 37. (Prepared by the Minnesota Evidence-based Practice Center under Contract No. HHSA 2902007-10064-I.) AHRQ Publication No. 11(12)-EHC075-EF. Rockville, MD: Agency for Healthcare Research and Quality. January 2012. www.effectivehealthcare.ahrq.gov/reports/final.cfm.

4.

KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int Suppl 2013 Jan;3(1):1-136.

5.

KDOQI Clinical Practice Guideline and Clinical Practice Recommendations for anemia in chronic kidney disease: 2007 update of hemoglobin target. Am J Kidney Dis. 2007 Sep;50(3):471-530.

6.

Qaseem A, Humphrey L, Fitterman N, Starkey M, Shekelle P. Treatment for Anemia in Patients with Heart Disease: A Clinical Practice Guideline from the Clinical Guidelines Committee of the American College of Physicians. Under review.

7.

Szczech LA, Barnhart HX, Sapp S, Felker GM, Hernandez A, Reddan D, et al. A secondary analysis of the CHOIR trial shows that comorbid conditions differentially affect outcomes during anemia treatment. Kidney International. 2010;77(3):239-46.

8.

Pfeffer MA, Burdmann EA, Chen C-Y, Cooper ME, de Zeeuw D, Eckardt K-U, et al. Baseline characteristics in the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT). American Journal of Kidney Diseases. 2009;54(1):59-69.

9.

Besarab A, Goodkin DA, Nissenson AR, Normal Hematocrit Cardiac Trial A. The normal hematocrit study--follow-up. New England Journal of Medicine. 2008;358(4):433-4.

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Financial Statement: Financial support for the Performance Measurement Committee comes exclusively from the ACP operating budget.

Conflicts of Interest: Any financial and nonfinancial conflicts of interest of the group members were declared, discussed, and resolved. A record of conflicts of interest is kept for each PMC meeting and conference call and can be viewed at: http://www.acponline.org/running_practice/performance_measurement/pmc/conflicts_pmc.htm rd

APPROVED BY THE ACP BOARD OF REGENTS ON: November 23 , 2013

Members of the PMC: Individuals who served on the Performance Measurement Committee from initiation of the project until its approval: David W. Baker, MD, MPH Robert M. Centor, MD J. Thomas Cross, Jr., MD, MPH Andrew Dunn, MD Mary Ann Forciea, MD Sandra Adamson Fryhofer, MD Robert A. Gluckman, MD Robert H. Hopkins, MD Kesavan Kutty, MD Eve Askanas Kerr, MD, MPH Ana María López, MD, MPH Catherine MacLean, MD, PhD Nasseer A. Masoodi, MD Stephen D. Persell, MD, MPH Terrence Shaneyfelt, MD, MPH

Requests and inquiries: Amir Qaseem, MD, PhD, MHA, FACP, American College of Physicians, 190. N Independence Mall West, Philadelphia, PA 19106: email, [email protected]

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