Renal Physicians Association/Physician Consortium for Performance Improvement® Chronic Kidney Disease Physician Performance Measurement Set October 2007 Chronic Kidney Disease Work Group William Haley, MD (Co-Chair; nephrologist) Bonnie McCafferty, MD, MSPH (Co-Chair; occupational medicine; methodologist) Todd Davis, MD (pediatrician) Barbara Fivush, MD (pediatric nephrologist) Richard S. Goldman, MD (nephrologist) John Hartman, MD (nephrologist) Richard Hellman, MD, FACP, FACE (endocrinologist) Edward Jones, MD (nephrologist) Craig B. Langman, MD (pediatric nephrologist) Cathi Martin, RD (registered dietician) Charles McAllister, MD MBA FCAP (nephrologist) Paul Rockswold, MD MPH (family physician) Sam J.W. Romeo, MD, MBA (family physician) Anton C. Schoolwerth, MD FAHA (nephrologist) Lesley Stevens, MD (nephrologist) Joseph Vassalotti, MD (nephrologist) Candace Walworth, MD (nephrologist) Don Wesson, MD (nephrologist) David Witte, MD. PhD, FCAP (pathologist) Jerry Yee, MD (nephrologist) Renal Physicians Association Dale Singer Robert Blaser National Committee for Quality Assurance Phil Renner, MBA Centers for Medicare & Medicaid Services Susan Nedza, MD, MBA, FACEP Desurai Wilson Health Plan Representative (BCBS) Chris Izui The Joint Commission Ann Watts, RN Elvira Ryan, RN American Medical Association Karen S. Kmetik, PhD Erin O. Kaleba, MPH Kendra Hanley, MS, CHE Facilitators Timothy F. Kresowik, MD Rebecca A. Kresowik 1 Physician Performance Measures (Measures) and related data specifications, developed by the Physician Consortium for Performance ImprovementTM (the Consortium), are intended to facilitate quality improvement activities by physicians. 2 These Measures are intended to assist physicians in enhancing quality of care. Measures are designed for use by any physician who manages the care of a patient for a specific condition or for prevention. These performance Measures are not clinical guidelines and do not establish a standard of medical care. The Consortium has not tested its Measures for all potential applications. The Consortium encourages the testing and evaluation of its Measures. Measures are subject to review and may be revised or rescinded at any time by the Consortium. The Measures may not be altered without the prior written approval of the Consortium. Measures developed by the Consortium, while copyrighted, can be reproduced and distributed, without modification, for noncommercial purposes, e.g., use by health care providers in connection with their practices. Commercial use is defined as the sale, license, or distribution of the Measures for commercial gain, or incorporation of the Measures into a product or service that is sold, licensed or distributed for commercial gain. Commercial uses of the Measures require a license agreement between the user and American Medical Association, on behalf of the Consortium. Neither the Consortium nor its members shall be responsible for any use of these Measures. THE MEASURES ARE PROVIDED "AS IS" WITHOUT WARRANTY OF ANY KIND © 2007 American Medical Association. All Rights Reserved Limited proprietary coding is contained in the Measure specifications for convenience. Users of the proprietary code sets should obtain all necessary licenses from the owners of these code sets. The AMA, the Consortium and its members disclaim all liability for use or accuracy of any Current Procedural Terminology (CPT®) or other coding contained in the specifications. THE SPECIFICATIONS ARE PROVIDED “AS IS” WITHOUT WARRANTY OF ANY KIND. Purpose of Measures: These clinical performance measures, developed by the Renal Physicians Association and the Physician Consortium for Performance Improvement® (Consortium), are designed for individual quality improvement. Unless otherwise indicated, the measures are also appropriate for accountability if appropriate methodological, statistical, and implementation rules are achieved. Accountability Measures: Measure #1: Blood Pressure Management Measure #2: ACE Inhibitor (ACE) or Angiotensin Receptor Blocker (ARB) Therapy Measure #3: Laboratory Testing (Calcium, Phosphorus, PTH and Lipid Profile) Measure #4: Plan of Care - Anemia Measure #5: Influenza Immunization Measure #6: Referral for AV Fistula Intended Audience and Patient Population: These measures are designed for use by physicians and for calculating reporting or performance measurement at the individual physician level. When existing hospital-level or plan-level measures are available for the same measurement topics, the Consortium attempts to harmonize the measures to the extent feasible. These measures are designed for nephrologists and other physicians managing the ongoing care of patients aged 18 years and older with advanced chronic kidney disease (CKD) (stage 4 or 5, patients with GFR < 30 ml/min/1.73m², not RRT*) *RRT: renal replacement therapy – dialysis or kidney transplant The Consortium also encourages the use of these measures by non-physician health professionals, where appropriate. Measure Specifications The Consortium seeks to specify measures for implementation using multiple data sources, including paper medical record, administrative (claims) data, and particular emphasis on Electronic Health Record Systems (EHRS). Draft specifications to report on these measures for CKD using administrative (claims) data are included in this document. We have identified codes for these measures, including ICD-9 and CPT (Evaluation & Management Codes, Category I and where Category II codes would apply). Specifications for additional data sources, including EHRS, will be fully developed at a later date. Measure Exclusions: For process measures, the Consortium provides three categories of reasons for which a patient may be excluded from the denominator of an individual measure: Medical reasons Includes: - not indicated (absence of organ/limb, already received/performed, other) - contraindicated (patient allergic history, potential adverse drug interaction, other) Patient reasons Includes: - patient declined - economic, social, or religious reasons - other patient reasons System reasons Includes: - resources to perform the services not available - insurance coverage/payor-related limitations - other reasons attributable to health care delivery system © 2007 American Medical Association. All Rights Reserved. CPT® Copyright 2006 American Medical Association 3 These measure exclusion categories are not available uniformly across all measures; for each measure, there must be a clear rationale to permit an exclusion for a medical, patient, or system reason. The exclusion of a patient may be reported by appending the appropriate modifier to the CPT Category II code designated for the measure: Medical reasons: modifier 1P Patient reasons: modifier 2P System reasons: modifier 3P Although this methodology does not require the external reporting of more detailed exclusion data, the Consortium recommends that physicians document the specific reasons for exclusion in patients’ medical records for purposes of optimal patient management and audit-readiness. The Consortium also advocates the systematic review and analysis of each physician’s exclusions data to identify practice patterns and opportunities for quality improvement. For example, it is possible for implementers to calculate the percentage of patients that physicians have identified as meeting the criteria for exclusion. Please refer to documentation for each individual measure for information on the acceptable exclusion categories and the codes and modifiers to be used for reporting. Measures #1-6 in the CKD measurement set are process measures. For outcome measures, the Consortium specifically identifies all acceptable reasons for which a patient may be excluded from the denominator. Each specified reason is reportable with a CPT Category II code designated for that purpose. There are no outcome measures in the CKD measurement set. The Consortium continues to evaluate and likely will evolve its methodology for handling exclusions as it gains experience in the use of the measures. The Consortium welcomes comments on its exclusions methodology. Data Capture and Measure Calculation The Consortium intends for physicians to collect data on each patient eligible for a measure. Feedback on measures should be available to physicians by patient to facilitate patient management and in aggregate to identify opportunities for improvement across a physician's patient population. Measure calculations will differ depending on whether a rate is being calculated for performance or reporting purposes. The method of calculation for performance follows these steps: first, identify the patients who meet the eligibility criteria for the denominator (PD); second, identify which of those patients meet the numerator criteria (A); and third, for those patients who do not meet the numerator criteria, determine whether an appropriate exclusion applies and subtract those patients from the denominator (C). (see examples below) The methodology also enables implementers to calculate the rates of patient exclusions and to further analyze both low and high rates, as appropriate (see examples below). The method of calculation for reporting differs. One program which currently focuses on reporting rates is the Centers for Medicare and Medicaid Services (CMS) Physician Quality Reporting Initiative (PQRI). Currently, under that program design, there will be a reporting denominator determined solely from claims data (CPT and ICD-9), which in some cases result in a reporting denominator that is much larger than the eligible population for the performance denominator. Additional components of the reporting denominator are explained below. The components that make up the numerator for reporting include all patients from the eligible population for which the physician has reported, including: the number of patients who meet the numerator criteria (A), the number of patients for whom valid exclusions apply (C) and also the number of patients who do not meet the numerator criteria (D). These components, where applicable, are summed together to make up the inclusive reporting numerator. The calculation for reporting will be the reporting numerator divided by the reporting denominator. (see examples below). © 2007 American Medical Association. All Rights Reserved. CPT® Copyright 2006 American Medical Association 4 Examples of calculations for reporting and performance are provided for each measure. Calculation for Performance For performance purposes, this measure is calculated by creating a fraction with the following components: Numerator, Denominator, and Denominator Exclusions. Numerator (A) Includes: Number of patients meeting numerator criteria Performance Denominator (PD) Includes: Number of patients meeting criteria for denominator inclusion Denominator Exclusions (C) Include: Number of patients with valid medical, patient or system exclusions (where applicable; will differ by measure) Performance Calculation A (# of patients meeting numerator criteria) PD (# patients in denominator) – C (# patients with valid denominator exclusions) It is also possible to calculate the percentage of patients excluded overall, or excluded by medical, patient, or system reason where applicable: Overall Exclusion Calculation C (# of patients with any valid exclusion) PD (# patients in denominator) OR Exclusion Calculation by Type C1 (# patients with medical reason) C2 (# patients with patient reason) C3 (# patients with PD (# patients in denominator) PD (# patients in denominator) PD (# patients in denominator) system reason) Calculation for Reporting For reporting purposes, this measure is calculated by creating a fraction with the following components: Reporting Numerator and Reporting Denominator Reporting Numerator includes each of the following components, where applicable. (There may be instances where there are no patients to include in A, C, D, or E). A. Number of patients meeting additional denominator criteria (for measures where true denominator cannot be determined through ICD-9 and CPT Category I coding alone) AND numerator criteria C. Number of patients with valid medical, patient or system exclusions (where applicable; will differ by measure) D. Number of patients not meeting numerator criteria and without a valid exclusion E. All other patients not meeting additional denominator criteria (for measures where true denominator cannot be determined through ICD-9 and CPT Category I coding alone) © 2007 American Medical Association. All Rights Reserved. CPT® Copyright 2006 American Medical Association 5 Reporting Denominator (RD) Includes: RD. Denominator criteria (identifiable through ICD-9 and CPT Category I coding) Reporting Calculation A(# of patients meeting additional denominator criteria AND meeting numerator criteria) + C(# of patients with valid exclusions) + D(# of patients meeting additional denominator criteria NOT meeting numerator criteria) + E(# of patients not meeting additional denominator criteria) RD (# of patients in denominator) © 2007 American Medical Association. All Rights Reserved. CPT® Copyright 2006 American Medical Association 6 Chronic Kidney Disease Measure #1: Blood Pressure Management This measure may be used as an Accountability measure. Clinical Performance Measure Numerator: Patient visits with blood pressure <130/80 mmHg OR ≥130/80 mmHg with a documented plan of care* *A documented plan of care should include one or more of the following: recheck blood pressure at specified future date; initiate or alter pharmacologic therapy; initiate or alter non-pharmacologic therapy; documented review of patient’s home blood pressure log which indicates that patient’s blood pressure is or is not well controlled **If multiple blood pressure measurements are taken at a single visit, use the most recent measurement taken at that visit. Denominator: All visits for patients aged 18 years and older with the diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) Denominator Exclusions: None Measure: Percentage of visits for patients aged 18 years and older with the diagnosis of advanced CKD (stage 4 or 5, not receiving RRT), with a blood pressure <130/80 mmHg OR blood pressure ≥130/80 mmHg with a documented plan of care The following clinical recommendation statements are quoted verbatim from the referenced clinical guidelines and represent the evidence base for the measure: Blood pressure should be measured at each health encounter. (Grade A) (NKF 20041) If a patient has GFR ≤ 30 ml/min/1.73m2, then his/her blood pressure should be checked with every clinic visit. (Grade A) (RPA 20022) If a patient has a GFR ≤30 ml/min/1.73m², and if blood pressure is determined to be elevated (systolic > 130 mmHg OR diastolic >80 mmHg), then s/he should receive intensified antihypertensive therapy (Grade B). (RPA, 20022) Patients with CKD should be considered in the “highest-risk” group for CVD for implementing recommendations for pharmacological therapy, irrespective of cause of CKD (Grade A). (NKF, 20041)Error! Bookmark not defined. Target blood pressure for CVD risk reduction in CKD and diabetic/nondiabetic kidney disease should be <130/80 mmHg (Grade B). (NKF, 20041) Rationale for the measure: Identification of hypertension in patients with CKD is an essential part of management of the disease. Hypertension is common in patients with CKD, and if hypertension is left untreated, it will speed the progression of the disease. Recent research has shown that during office visits, approximately 20% to 30% of CKD patients do not have their blood pressure measured3. Additionally, if the CKD patient is has an anemia/ESA visit, they are even less likely to have their blood pressure measured. In these patients, recent research has shown that 75% do not have their blood pressure measured at an anemia/ESA visit. Patients with CKD should have their blood pressure measured at each office visit so that changes can be identified and treatment initiated as soon as it is necessary. Blood pressure control is important in slowing the progression of chronic kidney disease. By slowing the progression of the disease, quality of life is improved for the patient, and it results in a longer period of time before a patient requires renal replacement therapy. Patients with chronic kidney disease should have a lower target blood pressure (<130/80) than other patients with hypertension. Data elements required for the measure can be captured and the measure is actionable by the physician. © 2007 American Medical Association. All Rights Reserved. CPT® Copyright 2006 American Medical Association 7 Data Capture and Calculations: Calculation for Performance For performance purposes, this measure is calculated by creating a fraction with the following components: Numerator, Denominator. Performance Numerator (A) Includes: Patient visits with blood pressure <130/80 mmHg OR blood pressure ≥130/80 mmHg with a documented plan of care Performance Denominator (PD) Includes: All visits for patients aged 18 years and older with a diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) Performance Calculation A (# of patient visits meeting numerator criteria) PD (# of patient visits in denominator) Components for this measure are defined as: A PD # of patient visits with a blood pressure <130/80 mmHg OR blood pressure ≥130/80 mmHg with a documented plan of care # of patient visits for patients aged 18 years and older with a diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) Calculation for Reporting For reporting purposes, this measure is calculated by creating a fraction with the following components: Reporting Numerator and Reporting Denominator Reporting Numerator includes each of the following instances: A. Patient visits with a blood pressure <130/80 mmHg OR blood pressure ≥130/80 mmHg with a documented plan of care D. Patient visits with blood pressure ≥130/80 mmHg with no documented plan of care OR blood pressure is not measured Reporting Denominator (RD) Includes: Patient visits for patients aged 18 years and older with a diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) Reporting Calculation A(# of patient visits meeting numerator criteria) + D(# of patient visits NOT meeting numerator criteria) RD (# of patient visits in denominator) © 2007 American Medical Association. All Rights Reserved. CPT® Copyright 2006 American Medical Association 8 Components for this measure are defined as: A # of patient visits with a blood pressure <130/80 mmHg OR blood pressure ≥130/80 mmHg with a documented plan of care D # of patient visits blood pressure ≥130/80 mmHg with no documented plan of care OR blood pressure not measured RD # of patient visits for patients aged 18 years and older with a diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) © 2007 American Medical Association. All Rights Reserved. CPT® Copyright 2006 American Medical Association 9 Measure Specifications – Measure #1: Blood Pressure Management Measure specifications for data sources other than administrative claims will be developed at a later date. A. Administrative claims data Administrative claims data collection requires users to identify the eligible population (denominator) and numerator using codes recorded on claims or billing forms (electronic or paper). Users report a rate based on all patients in a given practice for whom data are available and who meet the eligible population/denominator criteria. (Note: The specifications listed below are those needed for performance calculation.) Denominator (Eligible Population): All visits for patients aged 18 years and older with a diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) CPT® E/M Service Code: 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99241, 99242, 99243, 99244, 99245 AND ICD-9 diagnosis codes: 585.4, 585.5 Denominator Exclusion: None Numerator: Patient visits with blood pressure <130/80 mmHg OR ≥130/80 mmHg with a documented plan of care For this measure, the CPT Category II code for blood pressure measurement must be used in addition to the CPT Category II codes for systolic and diastolic blood pressure results. A CPT Category II code for high blood pressure plan of care should be used if a plan of care is documented in the medical chart and blood pressure is ≥130/80 mmHg, If multiple blood pressure measurements are taken at a single visit, use the last measurement taken. Report the CPT Category II code: 2000F – Blood pressure measured Report one CPT Category II codes for systolic blood pressure: 3074F – Most recent systolic blood pressure <130 mmHg 3075F – Most recent systolic blood pressure 130 mmHg to 139 mmHg 3077F – Most recent systolic blood pressure ≥140 mmHg Report one CPT Category II codes for diastolic blood pressure 3078F – Most recent diastolic blood pressure <80 mmHg 3079F – Most recent diastolic blood pressure 80 mmHg to 89 mmHg 3080F – Most recent diastolic blood pressure ≥90 mmHg AND AND AND (if systolic blood pressure is ≥ 130 mmHg or diastolic blood pressure is >80 mmHg) Report CPT Category II code for documented plan of care: 0513F – Elevated blood pressure plan of care documented B. Electronic Health Record System (in development) C. Paper Medical Record (in development) © 2007 American Medical Association. All Rights Reserved. CPT® Copyright 2006 American Medical Association 10 Chronic Kidney Disease Measure #2: ACE Inhibitor (ACE) or Angiotensin Receptor Blocker (ARB) Therapy This measure may be used as an Accountability measure. Clinical Performance Measure Numerator: Patients who were prescribed ACE inhibitor or ARB therapy during the 12 month reporting period Denominator: All patients aged 18 years and older with a diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) and hypertension and proteinuria Denominator Exclusions: Documentation of medical reason(s) for not prescribing ACE inhibitor or ARB therapy Documentation of patient reason(s) for not prescribing ACE inhibitor or ARB therapy Measure: Percentage of patients aged 18 years and older with a diagnosis of advanced CKD (stage 4 or 5, not receiving RRT), and hypertension and proteinuria who were prescribed ACE inhibitor or ARB therapy during the 12 months reporting period The following clinical recommendation statements are quoted verbatim from the referenced clinical guidelines and represent the evidence base for the measure: If a patient has GFR ≤30 ml/min/1.73m² and hypertension, then s/he should receive an ACE inhibitor or an ARB as a first-line agent (Grade C). (RPA 20022) ACE inhibitors and ARBs can be used safely in most patients with CKD. ACE Inhibitors and ARBs should be used at moderate to high doses, as used in clinical trials (Grade A). (NKF 20041) ACE inhibitors and ARBs have not been tested in all types of CKD. Where tested, ACE inhibitors and ARBs have generally similar effects on blood pressure, urine protein excretion, and slowing the progression of kidney disease (Strength of Recommendation: STRONG). (NKF 20041) Rationale for the measure: Evidence has shown that use of ACE inhibitors and ARBs as antihypertensive therapy is effective, and may help slow the progression of CKD. These drugs help control hypertension and decrease proteinuria. However, data shows that only approximately one-third of patients with CKD are treated with an ACE inhibitor or an ARB. 4,5,6 Data elements required for the measure can be captured and the measure is actionable by the physician. Process/goal of care to be improved: Percentage of pts on ACEI or ARB and thereby slowing progression of CKD. Data capture and calculations: Calculation for Performance For performance purposes, this measure is calculated by creating a fraction with the following components: Numerator, Denominator, and Denominator Exclusions. Performance Numerator (A) Includes: Patients who were prescribed ACE inhibitor or ARB therapy during the 12 month reporting period Performance Denominator (PD) Includes: All patients aged 18 years and older AND Diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) and hypertension and proteinuria © 2007 American Medical Association. All Rights Reserved. CPT® Copyright 2006 American Medical Association 11 Performance Denominator Exclusions (C) Include: Documentation of medical reason(s) for not having been prescribed ACE inhibitor or ARB therapy during the 12 month reporting period Documentation of patient reason(s) for not having been prescribed ACE inhibitor or ARB therapy during the 12 month reporting period Performance Calculation A (# of patients meeting measure criteria) PD (# of patients in denominator) – C (# of patients with valid denominator exclusions) Components for this measure are defined as: A # of patients who were prescribed ACE inhibitor or ARB therapy during the 12 month reporting period PD # of patients aged 18 years and older with a diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) and hypertension and proteinuria C # of patients with documented medical reason(s) or documented patient reason(s) for not having been prescribed ACE inhibitor or ARB therapy during the 12 month reporting period Calculation for Reporting For reporting purposes, this measure is calculated by creating a fraction with the following components: Reporting Numerator and Reporting Denominator Reporting Numerator includes each of the following instances: A. Patients who were prescribed ACE inhibitor or ARB therapy during the 12 month reporting period C. Documentation of medical reason(s) for not having been prescribed ACE inhibitor or ARB therapy during the 12 month reporting period or documented patient reason(s) for not having been prescribed ACE inhibitor or ARB therapy during the 12 month reporting period D. Patients who were not prescribed ACE inhibitor or ARB therapy during the 12 month reporting period and there is no documented reason for not doing so Reporting Denominator (RD) Includes: Patients aged 18 years and older AND Diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) and hypertension and proteinuria Reporting Calculation A(# of patients meeting numerator criteria) + C(# of patients with valid exclusions) + D(# of patients NOT meeting numerator criteria) RD (# of patients in denominator) Components for this measure are defined as: A # of patients who were prescribed ACE inhibitor or ARB therapy during the 12 month reporting period C # of patients who were not prescribed ACE inhibitor or ARB therapy during the 12 month reporting period and there is a documented medical reason or a documented patient reason for not doing so D # of patients who were not prescribed ACE inhibitor or ARB therapy during the 12 month reporting period and there is no documented reason for not doing so RD # of patients aged 18 years and older with a diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) and hypertension and proteinuria © 2007 American Medical Association. All Rights Reserved. CPT® Copyright 2006 American Medical Association 12 Measure Specifications – Measure #2: ACE Inhibitor (ACE) or Angiotensin Receptor Blocker (ARB) Therapy Measure specifications for data sources other than administrative claims will be developed at a later date. A. Administrative claims data Administrative claims data collection requires users to identify the eligible population (denominator) and numerator using codes recorded on claims or billing forms (electronic or paper). Users report a rate based on all patients in a given practice for whom data are available and who meet the eligible population/denominator criteria. (Note: The specifications listed below are those needed for performance calculation.) Denominator (Eligible Population): All patients aged 18 years and older with a diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) and hypertension and proteinuria AND CPT® E/M Service Code: 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99241, 99242, 99243, 99244, 99245 ICD-9 diagnosis codes for Chronic Kidney Disease (stage 4 or 5, not receiving RRT): 585.4, 585.5 AND AND ICD-9 diagnosis codes for Hypertension: 401.0, 401.1, 401.9, 402.00, 402.01, 402.10, 402.11, 402.90, 402.91, 403.00, 403.01, 403.10, 403.11, 403.90, 403.91, 404.00, 404.01, 404.02, 404.03, 404.10, 404.11, 404.12, 404.13, 404.90, 404.91, 404.92, 404.93 ICD-9 diagnosis codes for Proteinuria: 791.0 Denominator Exclusion: Documentation of medical reason(s) for not prescribing ACE inhibitor or ARB therapy Append modifier to CPT Category II code: 4009F-1P Documentation of patient reason(s) for not prescribing ACE inhibitor or ARB therapy Append modifier to CPT Category II code: 4009F-2P Numerator: Patients who were prescribed ACE inhibitor or ARB therapy during the 12 month reporting Report the CPT Category II code: 4009F - Angiotensin converting enzyme (ACE) inhibitor or Angiotensin Receptor Blocker (ARB) therapy prescribed B. Electronic Health Record System (in development) C. Paper Medical Record (in development) © 2007 American Medical Association. All Rights Reserved. CPT® Copyright 2006 American Medical Association 13 Chronic Kidney Disease Measure #3: Laboratory Testing (Calcium, Phosphorus, and Intact Parathyroid Hormone (iPTH), and Lipid Profile) To meet this measure, ALL listed laboratory tests must be ordered. This measure may be used as an Accountability measure. Clinical Performance Measure Numerator: Patients who had the following laboratory testing ordered at least once during the 12 month reporting period: serum levels of calcium, phosphorus and intact PTH, and lipid profile Denominator: All patients aged 18 years and older with the diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) Denominator Exclusions: Documentation of medical reason(s) for not ordering serum levels of calcium, phosphorus, intact PTH, and lipid profile measured Documentation of patient reason(s) for not ordering serum levels of calcium, phosphorus, intact PTH, and lipid profile measured Measure: Percentage of patients aged 18 years and older with the diagnosis of advanced CKD (stage 4 or 5, not receiving RRT), who had the following laboratory testing ordered at least once during the 12 month reporting period: serum levels of calcium, phosphorus and intact PTH, and lipid profile The following clinical recommendation statements are quoted verbatim from the referenced clinical guidelines and represent the evidence base for the measure: Serum levels of calcium, phosphorus, and intact plasma parathyroid hormone (PTH) should be measured in all patients with CKD and GFR <60 ml/min/1.73m². (Evidence) (NKF 20037) If a patient has GFR ≤30 ml/min/1.73m², then s/he should have his/her serum calcium and phosphorus measured at least every three months, and iPTH levels measured at least once. (Grade B) (RPA 20022) Patients with CKD should be considered in the “highest-risk” group for CVD for implementing recommendations for pharmacological therapy, irrespective of cause of CKD. (Grade A) (NKF 20041) All adults and adolescents with CKD should be evaluated for dyslipidemias. (Grade B) (NKF 20037) For adults and adolescents with CKD, the assessment of dyslipidemias should include a complete fasting lipid profile with total cholesterol, LDL, HDL, and triglycerides. (Grade B) (NKF 20037) Rationale for the measure: Bone disease is a common complication of chronic kidney disease. Patients with CKD should be monitored for calcium and phosphate imbalances and secondary hyperparathyroidism. Disturbances in mineral and bone metabolism are prevalent in CKD and are an important cause of morbidity, decrease in quality of life, and extraskeletal calcification that has been associated with increased CV mortality (taken verbatim from Definition, evaluation, and classification of renal osteodystrophy: a position statement from the Kidney Disease: Improving Global Outcomes (KDIGO), Moe, et al, Kidney Int, 2006; 69:1945-53). Gaps: USRDS 2006 data show that less than 30% of Medicare (and less than 20% of EGHP) pts receive Ca, Phos, PTH measures within a year. Data elements required for the measure can be captured and the measure is actionable by the physician. Process/goal of care to be improved: identification of abnormalities mineral and bone metabolism that relate to increased morbidity and mortality. © 2007 American Medical Association. All Rights Reserved. CPT® Copyright 2006 American Medical Association 14 Dyslipidemias and/or CVD relate to development and progression of CKD. Likewise, CKD is a risk factor for CVD (10x increased mortality risk ; Go, et al, NEJM 2004) Gaps: USRDS 2006 data show probability of receiving a lipid test within a year in Medicare pts was 0.62 and in EGHP pts was 0.42. Data elements required for the measure can be captured and the measure is actionable by the physician. Process/goal of care to be improved : identification of pts with dyslipidemias not meeting goal and thereby impacting progression of CKD Data capture and calculations: Calculation for Performance For performance purposes, this measure is calculated by creating a fraction with the following components: Numerator, Denominator, and Denominator Exclusions. Performance Numerator (A) Includes: Patients who had the following laboratory testing ordered at least once during the 12 month reporting period: serum levels of calcium, phosphorus and intact PTH, and lipid profile Performance Denominator (PD) Includes: All patients aged 18 years and older AND Diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) Performance Denominator Exclusions (C) Include: Documentation of medical reason(s) for not ordering the following laboratory testing at least once during the 12 month reporting period: serum levels of calcium, phosphorus and intact PTH, and lipid profile Documentation of patient reason(s) for not ordering the following laboratory testing at least once during the 12 month reporting period: serum levels of calcium, phosphorus and intact PTH, and lipid profile Performance Calculation A (# of patients meeting measure criteria) PD (# of patients in denominator) – C (# of patients with valid denominator exclusions) Components for this measure are defined as: A PD C # of patients who had the following laboratory testing ordered at least once during the 12 month reporting period: serum levels of calcium, phosphorus and intact PTH, and lipid profile # of patients aged 18 years and older with a diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) # of patients with documented medical reason(s) or documented patient reason(s) for not having had the following laboratory testing ordered at least once during the 12 month reporting period: serum levels of calcium, phosphorus and intact PTH, and lipid profile Calculation for Reporting For reporting purposes, this measure is calculated by creating a fraction with the following components: Reporting Numerator and Reporting Denominator Reporting Numerator includes each of the following instances: A. Patients who had the following laboratory testing ordered at least once during the 12 month reporting period: serum levels of calcium, phosphorus and intact PTH, and lipid profile © 2007 American Medical Association. All Rights Reserved. CPT® Copyright 2006 American Medical Association 15 C. Documentation of medical reason(s) for not ordering the following laboratory testing at least once during the 12 month reporting period: serum levels of calcium, phosphorus and intact PTH, and lipid profile or documented patient reason(s) for not ordering the following laboratory testing at least once during the 12 month reporting period: serum levels of calcium, phosphorus and intact PTH, and lipid profile D. Patients who have not had the following laboratory testing ordered at least once during the 12 month reporting period: serum levels of calcium, phosphorus and intact PTH, and lipid profile and there is no documented reason for not doing so Reporting Denominator (RD) Includes: Patients aged 18 years and older AND Diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) Reporting Calculation A(# of patients meeting numerator criteria) + C(# of patients with valid exclusions) + D(# of patients NOT meeting numerator criteria) RD (# of patients in denominator) Components for this measure are defined A C D RD # of patients who had the following laboratory testing ordered at least once during the 12 month reporting period: serum levels of calcium, phosphorus and intact PTH, and lipid profile # of patients who have not had the following laboratory testing ordered at least once during the 12 month reporting period: serum levels of calcium, phosphorus and intact PTH, and lipid profile and there is a documented medical reason or a documented patient reason for not doing so # of patients who have not had the following laboratory testing ordered at least once during the 12 month reporting period: serum levels of calcium, phosphorus and intact PTH, and lipid profile and there is no documented reason for not doing so # of patients aged 18 years and older with a diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) © 2007 American Medical Association. All Rights Reserved. CPT® Copyright 2006 American Medical Association 16 Measure Specifications – Measure #3: Laboratory Testing (Calcium, Phosphorus, and Intact Parathyroid Hormone (PTH), and Lipid Profile) Measure specifications for data sources other than administrative claims will be developed at a later date. A. Administrative claims data Administrative claims data collection requires users to identify the eligible population (denominator) and numerator using codes recorded on claims or billing forms (electronic or paper). Users report a rate based on all patients in a given practice for whom data are available and who meet the eligible population/denominator criteria. (Note: The specifications listed below are those needed for performance calculation.) Denominator (Eligible Population): All patients aged 18 years and older with the diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) AND CPT® E/M Service Code: 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99241, 99242, 99243, 99244, 99245 ICD-9 diagnosis codes: 585.4, 585.5 Denominator Exclusion: Documentation of medical reason(s) for not having serum levels of calcium, phosphorus, intact Parathyroid Hormone (iPTH) and lipid profile ordered Append modifier to CPT Category II code: 3278F-1P Documentation of patient reason(s) for not having serum levels of calcium, phosphorus, intact Parathyroid Hormone (iPTH) and lipid profile ordered Append modifier to CPT Category II code: 3278F-2P Numerator: Patients who had the following laboratory testing ordered at least once during the 12 month reporting period: serum levels of calcium, phosphorus and intact PTH, and lipid profile Report the CPT Category II code: 3278F - Serum levels of calcium, phosphorus, intact Parathyroid Hormone (iPTH) and lipid profile ordered B. Electronic Health Record System (in development) C. Paper Medical Record (in development) © 2007 American Medical Association. All Rights Reserved. CPT® Copyright 2006 American Medical Association 17 Chronic Kidney Disease Measure #4: Plan of Care – Elevated Hemoglobin for Patients Receiving Erythropoiesis-Stimulating Agents (ESA) This measure may be used as an Accountability measure. Clinical Performance Measure Numerator: Number of calendar months during which patients’ hemoglobin level is < 13 g/dL OR patients whose hemoglobin level is > 13 g/dL and have a documented plan of care* *A documented plan of care should include reducing the ESA dose and repeating hemoglobin at a specified future date Denominator: Calendar months for all patients aged 18 years and older with the diagnosis of advanced CKD (stage 4 or 5, not receiving RRT), receiving ESA therapy Denominator Exclusion: None Measure: Percentage of calendar months during the 12 months reporting period in which patients aged 18 years and older with the diagnosis of advanced CKD (stage 4 or 5, not receiving RRT), receiving ESA therapy, have a hemoglobin < 13 g/dL OR patients whose hemoglobin is > 13 g/dL have a documented plan of care The following clinical recommendation statements are quoted verbatim from the referenced clinical guidelines and represent the evidence base for the measure: The frequency of HB monitoring in patients treated with ESAs should be at least monthly. (Opinion) (NKF 20068) The HB target is the intended aim of ESA therapy for the individual patient with CKD. In clinical practice, achieved Hb results vary considerably from Hb target. Selection of the Hb target and selection of the Hb level at which ESA therapy is initiated in the individual patient should include consideration of potential benefits (including improvement in the quality of life and avoidance of transfusion) and potential harms (including the risk of life-threatening adverse events). (Clinical Practice Recommendation) (NKF 20079) In dialysis and nondialysis patients with CKD receiving ESA therapy, the selected Hb target should generally be in the range of 11.0 to 12.0 g/dL. (Clinical Practice Recommendation) (NKF 20079) In dialysis and nondialysis patients with CKD receiving ESA therapy, the Hb target should not be greater than 13.0 g/dL. (Clinical Practice Guideline; Moderately Strong Evidence) (NKF, 20079) The initial ESA dose and the ESA dose adjustments should be determined by the patient’s Hb level, the target Hb level, the observed rate of increase in Hb level, and clinical circumstances. (Opinion) (NKF 20068) ESA doses should be decreased, but not necessarily held, when a downward adjustment of Hb level is needed. (Opinion) (NKF 20068) Rationale for the measure: The clinical recommendation regarding Hb levels for CKD patients receiving ESA therapy is that Hb level should generally be in the range of 11.0 to 12.0 g/dL. Additionally, these patients should also have their Hb level checked at least monthly. Given that Hb levels vary for each patient due to numerous factors, it is necessary to monitor Hb level closely in order to make the individualized treatment decisions required in maintaining Hb level in the target range. There is no evidence of benefit from ESA therapy when Hb levels are maintained at greater than 13.0 g/dL. Maintaining Hb at higher levels may result in potential harm to the patient, as well as incur unjustified cost. Evidence linking increased risks for patients with CKD and higher Hb levels were for target Hb levels greater than 13.0g/dL (CHOIR10/CREATE11). The intention of this measure is not to suggest that the goal of ESA treatment is to reach an achieved Hb of 13.0 g/dL. Rather, as a patient safety measures, it is to realize that patients who reach Hb levels higher than 13.0 g/dL are at increased risk for adverse events, and that these elevated Hb levels need to be © 2007 American Medical Association. All Rights Reserved. CPT® Copyright 2006 American Medical Association 18 addressed by adjusting ESA dosage. Data elements required for the measure can be captured and the measure is actionable by the physician. Data capture and calculations: Calculation for Performance For performance purposes, this measure is calculated by creating a fraction with the following components: Numerator, Denominator, and Denominator Exclusions. Performance Numerator (A) Includes: Number of calendar months during which patients’ hemoglobin level is < 13 g/dL OR patients whose hemoglobin level is > 13 g/dL and have a documented plan of care Performance Denominator (PD) Includes: Calendar months for all patients aged 18 years and older AND Diagnosis of advanced CKD (stage 4 or 5, not receiving RRT), on ESA Performance Calculation A (# of calendar months meeting numerator criteria) PD (# of patient calendar months in denominator) Components for this measure are defined as: A PD # of calendar months during which patients’ hemoglobin level is < g/dL 13 OR patients whose hemoglobin level is > 13 g/dL and have a documented plan of care # of patient calendar months for patients aged 18 years and older with a diagnosis of advanced CKD (stage 4 or 5, not receiving RRT), receiving ESA therapy Calculation for Reporting For reporting purposes, this measure is calculated by creating a fraction with the following components: Reporting Numerator and Reporting Denominator Reporting Numerator includes each of the following instances: A. Calendar months during which patients’ hemoglobin level is < 13 g/dL OR patients whose hemoglobin level is > 13 g/dL and have a documented plan of care D. Calendar months during which patients’ hemoglobin level is < 13 g/dL OR patients whose hemoglobin level is > 13 g/dL and do not have a documented plan of care and there is no documented reason for not doing so E. Calendar months for all patients aged 18 years and older with the diagnosis of advanced CKD (stage 4 or 5, not receiving RRT), not receiving ESA therapy Reporting Denominator (RD) Includes: Patients aged 18 years and older AND Diagnosis of advanced CKD (stage 4 or 5, not receiving RRT), receiving ESA therapy © 2007 American Medical Association. All Rights Reserved. CPT® Copyright 2006 American Medical Association 19 Reporting Calculation A(# of patient calendar months meeting additional denominator criteria AND meeting numerator criteria) +D(# of patient calendar months meeting additional denominator criteria NOT meeting numerator criteria) + E(# of patient calendar months not meeting additional denominator criteria) RD (# of patient calendar months in denominator) Components for this measure are defined as: A # of patient calendar months during which a patient receiving ESA therapy has a hemoglobin level is < 13 g/dL OR has a hemoglobin level > 13 g/dL and has a documented plan of care D # of patient calendar months during which patients’ hemoglobin level is > 13 g/dL and do not have a documented plan of care E # of patient calendar months for all patients aged 18 years and older with the diagnosis of advanced CKD (stage 4 or 5, not receiving RRT), not receiving ESA therapy RD # of patient calendar months for patients aged 18 years and older with a diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) © 2007 American Medical Association. All Rights Reserved. CPT® Copyright 2006 American Medical Association 20 Measure Specifications – Measure #4-Plan of Care-Elevated Hemoglobin for Patients Receiving ErythropoiesisStimulating Agents (ESA) Measure specifications for data sources other than administrative claims will be developed at a later date. A. Administrative claims data Administrative claims data collection requires users to identify the eligible population (denominator) and numerator using codes recorded on claims or billing forms (electronic or paper). Users report a rate based on all patients in a given practice for whom data are available and who meet the eligible population/denominator criteria. (Note: The specifications listed below are those needed for performance calculation.) Denominator (Eligible Population CPT® E/M Service Code: 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99241, 99242, 99243, 99244, 99245 AND ICD-9 diagnosis codes: 585.4, 585.5 AND CPT II code to identify patient receiving ESA therapy: 4171F - Patient receiving ErythropoiesisStimulating Agent (ESA) therapy Denominator Exclusion: None Numerator: Number of calendar months during which patients’ hemoglobin level is < 13 OR patients whose hemoglobin level is > 13 and have a documented plan of care Report one of the following CPT Category II code(s): 3281F - Hemoglobin level less than 11 g/dL OR 3280F Hemoglobin level 11 g/dL to 12.9 g/dL OR 3279F - Hemoglobin level greater than or equal to 13 g/dL AND 0514F - Plan of care for elevated hemoglobin level documented for patient receiving Erythropoiesis-Stimulating Agent (ESA) therapy B. Electronic Health Record System (in development) C. Paper Medical Record (in development) © 2007 American Medical Association. All Rights Reserved. CPT® Copyright 2006 American Medical Association 21 Chronic Kidney Disease Measure #5: Influenza Immunization This measure may be used as an Accountability measure. Clinical Performance Measure Numerator: Patients who received the influenza immunization during the flu season (September through February) Denominator: All patients aged 18 years and older with the diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) Denominator Exclusion: Documentation of medical reason(s) for patient not receiving the influenza immunization Documentation of patient reason(s) for patient not receiving the influenza immunization Documentation of system reason(s) for patient not receiving the influenza immunization Measure: Percentage of patients aged 18 years and older with the diagnosis of advanced CKD (stage 4 or 5, not receiving RRT), who received the influenza immunization during the flu season (September through February) The following clinical recommendation statements are quoted verbatim from the referenced clinical guidelines and represent the evidence base for the measure: Vaccination with TIV (trivalent inactivated flu vaccine) is recommended for the following persons who are at increased risk for severe complications from influenza, or at higher risk for influenza-associated clinic, emergency department, or hospital visits: adults and children who have chronic pulmonary (including asthma), cardiovascular (except hypertension), renal, hepatic, hematological, or metabolic disorders (including diabetes mellitus). (CDC 200712) In any given year, the optimal time to vaccinate patients cannot be determined because influenza seasons vary in their timing, and more than one outbreak might occur in a single community in a single year. (CDC 200712) In general, health-care providers should begin offering vaccination soon after vaccine becomes available and if possible, by October. (CDC 200712) Vaccine efforts should continue throughout the season, because the duration of the influenza season varies, and influenza might not occur in certain communities until February or March. The majority of adults have antibody protection against influenza within 2 weeks after vaccination. (CDC 200712) Rationale for the measure: USRDS data shows that Medicare patients with CKD are more likely to receive a flu vaccine versus employer group health plan patients with CKD (0.43 versus 0.08 respectively)6. Additionally, it is estimated that fewer than 20% of all patients in high risk groups receive a flu vaccine each year. Patients with CKD need to be vaccinated yearly in order to decrease morbidity and mortality related to influenza and its complications. Data elements required for the measure can be captured and the measure is actionable by the physician. © 2007 American Medical Association. All Rights Reserved. CPT® Copyright 2006 American Medical Association 22 Data capture and calculations: Calculation for Performance For performance purposes, this measure is calculated by creating a fraction with the following components: Numerator, Denominator, and Denominator Exclusions. Performance Numerator (A) Includes: Patients who received the influenza immunization during the flu season (September through February) Performance Denominator (PD) Includes: All patients aged 18 years and older AND Diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) Performance Denominator Exclusions (C) Include: Documentation of medical reason(s) for not having received the influenza immunization during the 12 month reporting period Documentation of patient reason(s) for not having received the influenza immunization during the 12 month reporting period Documentation of system reason(s) for not having received the influenza immunization during the 12 month reporting period Performance Calculation A (# of patients meeting measure criteria) PD (# of patients in denominator) – C (# of patients with valid denominator exclusions) Components for this measure are defined as: A # of patients who received the influenza immunization during the flu season (September through February) PD # of patients aged 18 years and older with a diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) C # of patients with documented medical reason(s) or documented patient reason(s) or documented system reason(s) for not having received the influenza immunization during the flu season (September through February) Calculation for Reporting For reporting purposes, this measure is calculated by creating a fraction with the following components: Reporting Numerator and Reporting Denominator Reporting Numerator includes each of the following instances: A. Patients who received the influenza immunization during the flu season (September through February) C. Documentation of medical reason(s) for not having received the influenza immunization the flu season (September through February) period or documented patient reason(s) for not having received the influenza immunization during the flu season (September through February) or documented system reason(s) for not having received the influenza immunization during the flu season (September through February) D. Patients who have not received the influenza immunization during the flu season (September through February) and there is no documented reason for not doing so © 2007 American Medical Association. All Rights Reserved. CPT® Copyright 2006 American Medical Association 23 Reporting Denominator (RD) Includes: Patients aged 18 years and older AND Diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) Reporting Calculation A(# of patients meeting numerator criteria) + C(# of patients with valid exclusions) + D(# of patients NOT meeting numerator criteria) RD (# of patients in denominator) Components for this measure are defined as: A # of patients who received the influenza immunization during the flu season (September through February) C # of patients who have not received the influenza immunization during the flu season (September through February) and there is a documented medical reason or a documented patient reason or a documented system reason for not doing so D # of patients who have not received the influenza immunization during the flu season (September through February) and there is no documented reason for not doing so RD # of patients aged 18 years and older with a diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) © 2007 American Medical Association. All Rights Reserved. CPT® Copyright 2006 American Medical Association 24 Measure Specifications – Measure #5-Influenza Immunization Measure specifications for data sources other than administrative claims will be developed at a later date. A. Administrative claims data Administrative claims data collection requires users to identify the eligible population (denominator) and numerator using codes recorded on claims or billing forms (electronic or paper). Users report a rate based on all patients in a given practice for whom data are available and who meet the eligible population/denominator criteria. (Note: The specifications listed below are those needed for performance calculation.) Denominator (Eligible Population): All patients aged 18 years and older with the diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) CPT® E/M Service Code: 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99241, 99242, 99243, 99244, 99245 AND ICD-9 diagnosis codes: 585.4, 585.5 Denominator Exclusion: Documentation of medical reason(s) for patient not receiving the influenza immunization Append modifier to CPT Category II code: 4037F-1P Documentation of patient reason(s) for patient not receiving the influenza immunization Append modifier to CPT Category II code: 4037F-2P Documentation of system reason(s) for patient not receiving the influenza immunization Append modifier to CPT Category II code: 4037F 4037F-3P Numerator: Patients who received the influenza immunization during the flu season (September through February) Report the CPT Category II code: 4037F - Influenza immunization ordered or administered B. Electronic Health Record System (in development) C. Paper Medical Record (in development) © 2007 American Medical Association. All Rights Reserved. CPT® Copyright 2006 American Medical Association 25 Chronic Kidney Disease Measure #6: Referral for AV fistula This measure may be used as an Accountability measure. Clinical Performance Measure Numerator: Patients who were referred for AV fistula at least once during the 12 month reporting period Denominator: All patients aged 18 years and older with the diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) Denominator Exclusion: Documentation of medical reason(s) for not referring for an AV fistula Documentation of patient reason(s) for not referring for an AV fistula Measure: Percentage of patients aged 18 years and older with the diagnosis of advanced CKD (stage 4 or 5, not receiving RRT), who were referred for AV fistula at least once during the 12 month reporting period The following clinical recommendation statements are quoted verbatim from the referenced clinical guidelines and represent the evidence base for the measure: All recommendations listed below are from the NKF (200613) 1.3 Patients should have a functional permanent access at the initiation of dialysis therapy. 1.3.1 A fistula should be placed at least 6 months before the anticipated start of HD treatments. This timing allows for access evaluation and additional time for revision to ensure a working fistula is available at initiation of dialysis therapy. (B) 2.1 The order of preference for placement of fistulae in patients with kidney failure who choose HD as their initial mode of KRT should be (in descending order of preference): 2.1.1 Preferred: Fistulae. (B) o 2.1.1.1 A wrist (radiocephalic) primary fistula. (A) o 2.1.1.2 An elbow (brachiocephalic) primary fistula. (A) o 2.1.1.3 A transposed brachial basilic vein fistula: (B) 2.1.2 Acceptable: AVG of synthetic or biological material, such as: (B) o 2.1.2.1 A forearm loop graft, preferable to a straight configuration. o 2.1.2.2 Upper-arm graft. o 2.1.2.3 Chest wall or “necklace” prosthetic graft or lower-extremity fistula or graft; all upper-arm sites should be exhausted. 2.1.3 Avoid if possible: Long-term catheters. (B) o 2.1.3.1 Short-term catheters should be used for acute dialysis and for a limited duration in hospitalized patients. Noncuffed femoral catheters should be used in bed-bound patients only. (B) o 2.1.3.2 Long-term catheters or dialysis port catheter systems should be used in conjunction with a plan for permanent access. Catheters capable of rapid flow rates are preferred. Catheter choice should be based on local experience, goals for use, and cost. (B) o 2.1.3.3 Long-term catheters should not be placed on the same side as a maturing AV access, if possible. (B) o 2.1.4 Patients should be considered for construction of a primary fistula after failure of every dialysis AV access. (B) 8.1.2 The goals for permanent HD access placement should include: 8.1.2.1 Prevalent functional AVF placement rate of greater than 65% of patients. (B) 8.1.2.2 Cuffed catheter for permanent dialysis access (eg, not as a bridge) in less than 10% of patients. Long-term catheter access is defined as the use of a dialysis catheter for more than 3 months in the absence of a maturing permanent access—graft or fistula. (B) © 2007 American Medical Association. All Rights Reserved. CPT® Copyright 2006 American Medical Association 26 Rationale for the measure: For patients who will require dialysis, an AV fistula is the preferred permanent vascular access. Patients who have an AV fistula as their permanent vascular access for dialysis have fewer complications, such as infection. However USRDS data shows that only 35% of male and 15% of female hemodialysis patients have an AV fistula compared to 50% of male and 60% of female hemodialysis patients that have a long-term catheter as their vascular access6. By improving the rate of which AV fistulas are used, morbidity and mortality due to complications of other types of permanent vascular access will decrease. Data elements required for the measure can be captured and the measure is actionable by the physician. Data capture and calculations: Calculation for Performance For performance purposes, this measure is calculated by creating a fraction with the following components: Numerator, Denominator, and Denominator Exclusions. Performance Numerator (A) Includes: Patients who were referred for AV fistula at least once during the 12 month reporting period Performance Denominator (PD) Includes: All patients aged 18 years and older AND Diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) Performance Denominator Exclusions (C) Include: Documentation of medical reason(s) for not having been referred for AV fistula at least once during the 12 month reporting period Documentation of patient reason(s) for not having been referred for AV fistula at least once during the 12 month reporting period Performance Calculation A (# of patients meeting measure criteria) PD (# of patients in denominator) – C (# of patients with valid denominator exclusions) Components for this measure are defined as: A # of patients who were referred for AV fistula at least once during the 12 month reporting period PD # of patients aged 18 years and older with a diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) C # of patients with documented medical reason(s) or documented patient reason(s) for not having been referred for AV fistula at least once during the 12 month reporting period Calculation for Reporting For reporting purposes, this measure is calculated by creating a fraction with the following components: Reporting Numerator and Reporting Denominator Reporting Numerator includes each of the following instances: A. Patients who were referred for AV fistula/permanent vascular access at least once during the 12 month reporting period C. Documentation of medical reason(s) for not having been referred for AV fistula at least once during the 12 month reporting period or documented patient reason(s) for not having been referred for AV fistula/permanent vascular access at least once during the 12 month reporting period D. Patients who having not been referred for AV fistula at least once during the 12 month reporting period, and there is no documented medical reason or patient reason for doing so © 2007 American Medical Association. All Rights Reserved. 27 CPT® Copyright 2006 American Medical Association Reporting Denominator (RD) Includes: All patients aged 18 years and older AND Diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) Reporting Calculation A(# of patients meeting numerator criteria) + C(# of patients with valid exclusions) + D(# of patients NOT meeting numerator criteria) RD (# of patients in denominator) Components for this measure are defined as: A # of patients who were referred for AV fistula at least once during the 12 month reporting period C D RD # of patients who were not referred for AV fistula at least once during the 12 month reporting period and there is a documented medical reason or a documented patient reason for having not doing so # of patients who were not referred for AV fistula at least once during the 12 month reporting period and there is a documented medical reason or a documented patient reason for having not doing so, and there is no documented medical reason or patient reason for doing so # of patients aged 18 years and older with a diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) © 2007 American Medical Association. All Rights Reserved. CPT® Copyright 2006 American Medical Association 28 Measure Specifications – Measure #6-Referral for AV Fistula Measure specifications for data sources other than administrative claims will be developed at a later date. A. Administrative claims data Administrative claims data collection requires users to identify the eligible population (denominator) and numerator using codes recorded on claims or billing forms (electronic or paper). Users report a rate based on all patients in a given practice for whom data are available and who meet the eligible population/denominator criteria. (Note: The specifications listed below are those needed for performance calculation.) Denominator (Eligible Population): All patients aged 18 years and older with the diagnosis of advanced CKD (stage 4 or 5, not receiving RRT) AND CPT® E/M Service Code: 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99241, 99242, 99243, 99244, 99245 ICD-9 diagnosis codes: 585.4, 585.5 Denominator Exclusion: Documentation of medical reason(s) for not having been referred for AV fistula Append modifier to CPT Category II code: 4051F-1P Documentation of patient reason(s) for not having been referred for AV fistula Append modifier to CPT Category II code: 4051F-2P Numerator: Patients who were referred for AV fistula at least once during the 12 month reporting period Report the CPT Category II code: 4051F - Referred for an arteriovenous (AV) fistula B. Electronic Health Record System (in development) C. Paper Medical Record (in development) © 2007 American Medical Association. All Rights Reserved. CPT® Copyright 2006 American Medical Association 29 Evidence Classification/Rating Schemes NKF K/DOQI Clinical Practice Guidelines on Hypertension and Antihypertensive Agents in Chronic Kidney Disease1 Grades of Recommendation Grade A – It is strongly recommended that clinicians routinely follow the guideline for eligible patients. There is strong evidence that the practice improves health outcomes Grade B - It is recommended that clinicians routinely follow the guideline for eligible patients. There is moderately strong evidence that the practice improves health outcomes. Grade C – It is recommended that clinicians consider following the guideline for eligible patients. This recommendation is based on either weak evidence or on the opinions of the Work Group and reviewers, that the practice might improve health outcomes. RPA Clinical Practice Guideline #3: Appropriate Patient Preparation for Renal Replacement Therapy2 Grades of Recommendation Grade A – The panel strongly recommends that clinicians routinely provide [the service] to eligible patients. (An “A” recommendation indicated good evidence that [the service] improves important health outcomes and that benefits substantially outweigh harms.) Grade B – The panel recommends that clinicians routinely provide [the service] to eligible patients. (A “B” recommendations indicates that at least fair evidence that [the service] improves important health outcomes and concludes that benefits outweigh harms.) Grade C – The panel recommends that clinicians routinely provide [the service] to eligible patients. (A “C” recommendation indicates that there was consensus among the panel to recommend [the service] but that the evidence that [the service] is effective is lacking, of poor quality, or conflicting or the balance of benefits and harms cannot be reliably determined from available evidence.) Grade D – The panel recommends against clinicians routinely providing [the service]. (A “D” recommendation indicates at least fair evidence that [the service] is ineffective or that harms outweigh benefits.) Grade I – The panel concludes that the evidence is insufficient to recommend for or against [the service]. (An “I” recommendation indicates that evidence [the service] is effective is lacking, of poor quality, or conflicting and the balance of benefits and harms cannot be determined, and that the panel lacked a consensus to recommend it.) NKF K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney Disease 7 Strength of Recommendation Evidence – All components of the rational for a guideline are based on published evidence. Opinion – No definite evidence exists, the evidence is inconclusive, or the guideline or steps in its rationale are based on judgment. NKF K/DOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease8 and NKF K/DOQI Clinical Practice Guideline and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease: 2007 Update of Hemoglobin Target9 Strength of Recommendation Strong – It is strongly recommended that clinicians routinely follow the guideline for eligible patients. There is high-quality evidence that the practice results in net medical benefit to the patient. Moderately strong – It is recommended that clinicians routinely follow this guideline for eligible patients. There is at least moderately high-quality evidence that the practice results in net medical benefit to the patient. Clinical Practice Recommendation (CPRs) – Based on consensus of the Work Group that following the recommendations might improve health outcomes. NKF K/DOQI Clinical Practice Guidelines and Clinical Practice Recommendations 2006 Updates: Hemodialysis Adequacy, Peritoneal Dialysis Adequacy, and Vascular Access13 Strength of Recommendation Grade A – It is strongly recommended that clinicians routinely follow the guideline for eligible patients. There is strong evidence that the practice improves health outcomes. Grade B – It is recommended that clinicians routinely follow the guideline for eligible patients. There is moderately strong evidence that the practice improves health outcomes. © 2007 American Medical Association. All Rights Reserved. CPT® Copyright 2006 American Medical Association 30 CPR – It is recommended that clinicians consider the following guideline for eligible patients. This recommendation is based on either weak evidence or on the opinions of the Work Group and reviewers that the practice might improve health outcomes. © 2007 American Medical Association. All Rights Reserved. CPT® Copyright 2006 American Medical Association 31 References National Kidney Foundation. (2004) K/DOQI clincial practice guidelines on hypertension and antihypertensive agents in chronic kidney disease. Am J Kidney Dis. May:43(5 Suppl 1):S1-S290. 2 Renal Physicians Association. (2002). Renal Physicians Association Clinical Practice Guideline #3: Appropriate patient preparation for renal replacement therapy. Rockville, MD. 3 Article in press. Am J Med Qual. 4 Kinchen KS, et al. The timing of specialist evaluation in chronic kidney disease and mortality. Ann Intern Med. 2002;137(6):479-86. 5 McClellan WM, Knight DF, Karp H, Brown WW. Early detection and treatment of renal disease in hospitalized diabetic and hypertensive patients: important differences between practice and published guidelines. Am J Kidney Dis. 1997 Mar;29(3):368-75. 6 United States Renal Data System. ADR 2006. Available at: http://www.usrds.org/adr.htm 7 National Kidney Foundation. (2003). K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Am J Kidney Dis, Oct;42(4 Suppl3):S1-201. 8 National Kidney Foundation. (2006). K/DOQI clinical practice guidelines and clinical practice recommendations for anemia in chronic kidney disease. Am J Kidney Dis. 47(Suppl 3):S1-S146.. 9 National Kidney Foundation. (2007) K/DOQI clinical practice guideline and clinical practice recommendations for anemia in chronic kidney disease: 2007 update of hemoglobin target. Am J Kidney Dis. Sept:50(3):474-530. 10 Singh AK, Szczech L, Tang KL, et al. Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med. 2006;355:2085-98. 11 Drueke TB, Locatelli F, Clyne N, et al. Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Engl J Med. 2006;355:2071-84. 12 Centers for Disease Control and Prevention. Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2007. MMWR. 2007;56(No. RR-6):1-54. 13 National Kidney Foundation. (2006). K/DOQI clinical practice guidelines and clinical practice recommendation updates 2006: hemodialysis adequacy, peritoneal dialysis adequacy, and vascular access. Am J Kidney Dis. 48(Suppl 1):S1-S322. 1 © 2007 American Medical Association. All Rights Reserved. CPT® Copyright 2006 American Medical Association 32