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Congestive Heart Failure (CHF)
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Overview
Most congestive heart failure (CHF) disease management and drug-disease interaction antiarrhythmic measures
address the recommended management of systolic heart dysfunction (depressed left ventricular ejection fraction
generally less than 40%) as opposed to diastolic heart dysfunction; other measures can be applied to the entire CHF
population. Patients with predominant systolic heart dysfunction have a different natural history and require
different treatment strategies than patients with predominant diastolic dysfunction. Systolic and diastolic heart
failure cannot be distinguished based on most heart failure diagnosis codes. New ICD-9 codes published in 2003 are
specific for diastolic heart failure and can identify this population if used appropriately. Patients are excluded from
selected measures, when appropriate, if there is a code for diastolic heart failure within the last 12 months of the
report period.
Disease Management
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Patient(s) currently taking an ACE-inhibitor or acceptable alternative.
ACE-inhibitors are recommended for all patients with significant left ventricular systolic dysfunction
with or without symptoms unless contraindicated or not tolerated (1). This is a Class I*
recommendation from the American College of Cardiology (ACC) and American Heart Association
(AHA) 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the
Adult (1). Results of the Studies of Left Ventricular Dysfunction (SOLVD) prevention trials showed
that ACE-inhibitors significantly reduced the incidence of heart failure, rate of hospitalization, and
mortality in patients with systolic dysfunction (2,3). Results in similar trials have been consistent
across a broad range of patients (age, sex, etiology, and New York Heart Association class). Patients
with lower ejection fractions appear to have the greatest benefit (4-6). Clinicians are encouraged to
use doses that have been shown to reduce the risk of cardiovascular events in clinical trials (1).
ACE-inhibitors may be contraindicated or not tolerated by some patients (1,7). ACE-inhibitors
should not be prescribed to patients who have experienced life-threatening adverse reactions
(angioedema or anuric renal failure) during previous exposure to the drug. ACE-inhibitors are
contraindicated during pregnancy and should be prescribed with caution in patients with very low
systemic blood pressures (systolic blood pressures less than 80mm Hg), markedly elevated serum
creatinine levels (creatinine greater than 3 mg/dL), bilateral renal artery stenosis, or elevated levels of
serum potassium (greater than 5.5 mmol/L) (7). Given the limitations of claims data, it is not
possible to reliably identify contraindications or previous adverse events. In some of these situations,
an acceptable alternative (angiotensin II receptor antagonist or combination hydralazine plus oral or
transdermal nitrates) can be used instead of an ACE-inhibitor (1). These are Class IIa* and Class
IIb* recommendations from the ACC/AHA 2005 Guideline Update for the Diagnosis and
Management of Chronic Heart Failure in the Adult (1). In addition, the African-American Heart
Failure Trial demonstrated that the addition of isosorbide dinitrate plus hydralazine as a fixed-dose
combination with standard heart failure therapy is efficacious and increases survival in black patients
(8).
Patients are excluded from this measure if there is a code for diastolic heart failure within the last 12
months of the report period.
*The ACC/AHA guideline recommendation format for classifying indications and summarizing both
the evidence and expert opinions is as follows (1):
Class I: Conditions for which there is evidence for and/or general agreement that the procedure or
treatment is useful and effective.
Class II: Conditions for which there is conflicting evidence and/or divergence of opinion about the
usefulness/efficacy of a procedure or treatment.
Class IIa: The weight of evidence or opinion is in favor of the procedure or treatment.
Class IIb: Usefulness/efficacy is less well established by evidence or opinion.
Class III: Conditions for which there is evidence and/or general agreement that the procedure or
treatment is not useful/effective and in some cases may be harmful.
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8.
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Jessup M, Abraham WT, Casey DE Feldman AM Francis, GS, Ganiats TG Konstam MA
Mancini DM Rahko PS Silver MA Stevenson LW Yancy CW wrting on behalf of the 2005
Guideline Update for the Diagnosis and Management of Chronic Heart Faiure in the Adult
Writing Committee. 2009 Focused update: ACCF/AHA guidelines for the diagnosis and
management of heart failure in adults: a report of the American College of Cardiology
Foundation/American Heart Association Task Forceon Practice Guidelines. Circulation.
2009;119:1977 – 2016.
The SOLVD Investigators. Effect of enalapril on survival in patients with reduced left
ventricular ejection fractions and congestive heart failure. N Engl J Med 1991;325:293-302.
The SOLVD Investigators. Effect of enalapril on mortality and the development of heart
failure in asymptomatic patients with reduced left ventricular ejection fractions. N Engl J Med
1992;327:685-91.
The CONSENSUS Trial Study Group. Effects of enalapril on mortality in severe congestive
heart failure: results of the Cooperative North Scandinavian Enalapril Survival Study
(CONSENSUS). N Engl J Med 1987;316:1429-35.
Garg R, Usuf S. Overview of randomized trials of Angiotensin-Converting Enzyme Inhibitors
on mortality and morbidity in patients with heart failure. Clinical Trials Branch, National
Heart, Lung, and Blood Institute, Bethesda, MD. JAMA 1995;273(18): 1450-1456.
Cohn JN. The management of chronic heart failure. N Engl J Med 1996;335(7);490-498.
ACC/AHA Guidelines for the evaluation and management of chronic heart failure in the adult.
J Am Coll Cardiol 2001;38:2101-13.
Taylor AL, Ziesche S, Yancy C, Carson P, D'Agostino R Jr, Ferdinand K, Taylor M, Adams K,
Sabolinski M, Worcel M, Cohn JN; African-American Heart Failure Trial Investigators.
Combination of isosorbide dinitrate and hydralazine in blacks with heart failure. N Engl J
Med 2004(20);351:2049-57.
Patient(s) currently taking a beta-blocker.
Beta-blockers are recommended for patients with stable heart failure due to left ventricular
dysfunction unless contraindicated or not tolerated (1). This is a Class I* recommendation from the
ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in
the Adult (1). Like ACE-inhibitors, beta-blockers can reduce the risk of death and the combined risk
of death or hospitalization (1-6).
Beta-blockers may be contraindicated or not tolerated by some patients (1). Patients should not take a
beta-blocker if they have symptomatic bradycardia or advanced heart block (unless treated with a
pacemaker). Beta-blockers may be contraindicated for some patients with reactive airway disease
(1). Given the limitations of claims data, it is not possible to reliably identify contraindications or
previous adverse events.
Patients are excluded from this measure if there is a code for diastolic heart failure within the last 12
months of the report period.
1.
2.
Jessup M, Abraham WT, Casey DE Feldman AM Francis, GS, Ganiats TG Konstam MA
Mancini DM Rahko PS Silver MA Stevenson LW Yancy CW wrting on behalf of the 2005
Guideline Update for the Diagnosis and Management of Chronic Heart Faiure in the Adult
Writing Committee. 2009 Focused update: ACCF/AHA guidelines for the diagnosis and
management of heart failure in adults: a report of the American College of Cardiology
Foundation/American Heart Association Task Forceon Practice Guidelines. Circulation.
2009;119:1977 – 2016.
Packer M, Bristow MR, Cohn JN, et al. The effect of carvedilol on morbidity and mortality in
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6.
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patients with chronic heart failure. U.S. Carvedilol Heart Failure Study Group. N Engl J Med
1996;334:1349-55.
The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet
1999;353:9-13.
Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised
Intervention Trial in Congestive Heart Failure (MERIT-HF). Lancet 1999;353:2001-7.
Packer M, Coats AJ, Fowler MB, et al. Effect of carvedilol on survival in severe chronic heart
failure. N Engl J Med 2001;344:1651-8.
Randomised, placebo-controlled trial of carvedilol in patients with congestive heart failure
due to ischaemic heart disease. Australia/New Zealand Heart Failure Research Collaborative
Group. Lancet 1997;349:375-80.
Patient(s) currently taking a beta-blocker specifically recommended for CHF
management.
Beta-blockers are recommended for patients with stable heart failure due to left ventricular
dysfunction unless contraindicated or not tolerated (1). This is a Class I* recommendation from the
ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in
the Adult (1). Beta-blockers that have been proven in clinical trials to reduce mortality are
specifically recommended. These beta-blockers include bisoprolol, carvedilol, and sustained release
metoprolol succinate (1-5). Based on this recommendation from the ACC/AHA 2005 Guideline
Update for the Diagnosis and Management of Chronic Heart Failure in the Adult and the consensus
opinion of experts, an individual was defined as adherent to this measure if they received any of the
following medications during the last 120 days of the report period through 90 days after the end of
the report period: bisoprolol, carvedilol, sustained release metoprolol succinate, or metoprolol
tartrate.
Beta-blockers may be contraindicated or not tolerated by some patients (1). Patients should not take a
beta-blocker if they have symptomatic bradycardia or advanced heart block (unless treated with a
pacemaker). Beta-blockers may be contraindicated for some patients with reactive airway disease
(1). Given the limitations of claims data, it is not possible to reliably identify contraindications or
previous adverse events.
Patients are excluded from this measure if there is a code for diastolic heart failure within the last 12
months of the report period.
1.
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3.
4.
5.
R-1
9000019
Jessup M, Abraham WT, Casey DE Feldman AM Francis, GS, Ganiats TG Konstam MA
Mancini DM Rahko PS Silver MA Stevenson LW Yancy CW wrting on behalf of the 2005
Guideline Update for the Diagnosis and Management of Chronic Heart Faiure in the Adult
Writing Committee. 2009 Focused update: ACCF/AHA guidelines for the diagnosis and
management of heart failure in adults: a report of the American College of Cardiology
Foundation/American Heart Association Task Forceon Practice Guidelines. Circulation.
2009;119:1977 – 2016.
The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet
1999;353:9-13.
Hjalmarson A, Goldstein S, Fagerberg B, et al. for the MERIT-HF Study Group. Effects of
controlled-release metoprolol on total mortality, hospitalizations, and well-being in patients
with heart failure: the Metoprolol CR/XL Randomized Intervention Trial in congestive heart
failure (MERIT-HF). JAMA 2000;283;1295-1302.
Dargie HJ. Effect of carvedilol on outcome after myocardial infarction in patients with leftventricular dysfunction: the CAPRICORN randomised trial. Lancet 2001;357:1385-1390.
Cleland JG, Pennell DJ, Ray SG, et al. Myocardial viability as a determinant of the ejection
fraction response to carvedilol in patients with heart failure (CHRISTMAS trial): randomised
controlled trial. Lancet 2003;362:14-21.
Patient(s) with CHF and atrial fibrillation currently taking warfarin or oral thrombin
inhibitors.
Warfarin therapy is recommended for patients with heart failure that have paroxysmal or persistent
atrial fibrillation (1). This is a Class I* recommendation from the ACC/AHA 2005 Guideline Update
for the Diagnosis and Management of Chronic Heart Failure in the Adult (1).
The selection of an antithrombotic agent must be based on assessment of the absolute risk of stroke
from AF and the risk of bleeding as a complication of antithrombotic therapy (2). The list of
contraindications includes diseases, identifiable through claims data, which would identify persons at
increased risk of a bleeding complication or impaired cognitive function (i.e., dementia); these
individuals may not be candidates for warfarin therapy. In addition, warfarin is contraindicated in
pregnant women (3). Published lists of contraindications for warfarin along with the consensus
opinion of experts were the primary source of our recommended list of contraindications for warfarin
use (4). Given the limitation of claims data, it is otherwise difficult to identify patients who may have
an increased risk of bleeding as a complication of warfarin therapy.
A new oral direct thrombin inhibitor, dabigatran, has recently been FDA approved for use in
nonvalvular atrial fibrillation. Advantages of this medication class include oral dosing, lack of
required laboratory monitoring or dose adjustment unless creatinine clearance is < 30. Disadvantages
include higher cost, twice daily dosing and lack of reversibility. Use of this medication was reviewed
by the EBM expert consultant panel with recommendation for inclusion of dabigatran as an
alternative to warfarin in patients with congestive heart failure and atrial fibrillation (5).
1.
Jessup M, Abraham WT, Casey DE Feldman AM Francis, GS, Ganiats TG Konstam MA
Mancini DM Rahko PS Silver MA Stevenson LW Yancy CW wrting on behalf of the 2005
Guideline Update for the Diagnosis and Management of Chronic Heart Faiure in the Adult
Writing Committee. 2009 Focused update: ACCF/AHA guidelines for the diagnosis and
management of heart failure in adults: a report of the American College of Cardiology
Foundation/American Heart Association Task Forceon Practice Guidelines. Circulation.
2009;119:1977 – 2016.
2. Fuster V, Rydén LE, Asinger RW, Cannom DS, Crijns HJ, Frye RL, Halperin JL, Kay GN,
Klein WW, Lévy S, McNamara RL, Prystowsky EN, Wann LS, Wyse DG. ACC/AHA/ESC
guidelines for the management of patients with atrial fibrillation: a report of the American
College of Cardiology/American Heart Association Task Force on Practice Guidelines and the
European Society of Cardiology Committee for Practice Guidelines and Policy Conferences
(Committee to Develop Guidelines for the Management of Patients With Atrial Fibrillation). J
Am Coll Cardiol 2001;38:1266i-lxx.
3. Warfarin sodium. Drug Facts and Comparisons. eFacts [online]. 2008. Available from
Wolters Kluwer Health, Inc. Accessed January 24, 2011.
4. Institute for Clinical Systems Improvement (ICSI). Health Care Guideline: Antithrombotic
Therapy Supplement (April 2010). Accessed January 24, 2010. URL: http://www.icsi.org
5. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA,
Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis B,S Darius H,
Diener HC, Joyner CD, Wallentin L, RE-LY Steering Committee and Investigators. Davigatran
versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361(12):1139-51.
Medication Adherence (Minimum compliance 80%)
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Patient(s) compliant with prescribed ACE-inhibitor-containing medication.
Patient(s) compliant with prescribed Angiotensin II Receptor Antagonist-containing
medication.
Patient(s) compliant with prescribed Hydralazine-containing medication.
Patient(s) compliant with prescribed Nitrate.
Patient(s) compliant with prescribed beta-blocker-containing medication.
Patient(s) compliant with prescribed selective aldosterone receptor antagonist.
Patient(s) compliant with prescribed digoxin.
Adherence to a prescribed medication regimen is essential for treatment success. Although no clear
threshold of sub-optimal medication adherence is defined for most medications, many studies use a
threshold of 80 percent and higher to define adherence (1-4). Approximately 75 percent of all
claims-based analysis of individuals with chronic diseases uses an 80 percent or higher threshold (4).
In addition, studies have demonstrated improved outcomes (e.g., decreased hospital rates) when
using a threshold of 80 percent and higher to define adherence (1-3).
Given this information, we use an 80 percent or higher threshold to define medication adherence.
This 80 percent threshold is used for all medications, except antiretroviral medications (see
HIV/AIDS condition) that use a threshold of 85 percent.
Different approaches have been used to measure adherence (1, 4-5). Although adherence cannot be
measured directly from claims information, it can be measured indirectly by evaluating prescription
filling patterns and computing a possession ratio (PR). Possession ratio is defined as the ratio of
days supplied to days elapsed. Days supplied is computed by summing the days supplied field for a
series of prescriptions, excluding the days supplied from the last prescription in the series (the last
prescription is used only to establish the end date). Days elapsed is computed by subtracting the
earliest fill date from the latest fill date and then subtracting any overlapping days of confinement.
The PR assumes that the patient is, on average, refilling prescriptions at or close to the time that the
previous prescription is exhausted. PR uses prescriptions filled during the last 180 days of the
reporting period through 90 days after the end of the reporting period (provided claims incurred after
the reporting period are included in the input data set). A minimum of two prescriptions is required
to compute PR. The following figure illustrates how PR is computed.
1.
2.
3.
4.
5.
Ho PM, Bryson CL, Rumsfeld JS. Medication Adherence: its importance in cardiovascular
outcomes. Circulation 2009;119(23):3028-35.
Sokol MC, McGuigan KA, Verbrugge RR, Epstein RS. Impact of medication adherence on
hospitalization risk and healthcare cost. Med Care 2005 Jun;43(6):521-30.
Roebuck MC, Liberman JN, Gemmill-Toyama M, Brennan TA. Medication adherence leads
to lower health care use and costs despite increased drug spending. Health Aff (Millwood)
2011 Jan;30(1):91-9.
Andrade SE, Kahler KH, Frech F, Chan KA. Methods for evaluation of medication adherence
and persistence using automated databases. Pharmacoepidemiol Drug Saf 2006
Aug;15(8):565-74.
Yeaw J, Benner JS, Walt JG, Sian S, Smith DB. Comparing adherence and persistence across
6 chronic medication classes. J Manag Care Pharm 2009 Nov-Dec;15(9):728-40.
Patient Safety
S-M
9000008
Patient(s) taking ACE-inhibitor, angiotensin II receptor blocker, selective
aldosterone receptor antagonist, or digoxin that had serum potassium test in last 12
reported months.
Serum potassium should be monitored routinely in patients with heart failure (1). This is of
particular importance for patients taking ACE-inhibitors, angiotensin II receptor antagonists, or
selective aldosterone receptor antagonists since these medications can cause hyperkalemia (1,2).
In addition, patients taking digoxin should have their serum potassium assessed periodically; the
frequency of assessment will depend on the clinical setting (3). The consensus opinion of
experts was the primary source of our recommendation for an annual serum potassium at
minimum for patients taking ACE-inhibitors, angiotensin II receptor antagonists, selective
aldosterone receptor antagonists, or digoxin since the frequency of assessment is dependent on the
clinical status of the patient and is not clearly defined in the literature.
1.
2.
3.
S-M
9000009
Jessup M, Abraham WT, Casey DE Feldman AM Francis, GS, Ganiats TG Konstam MA
Mancini DM Rahko PS Silver MA Stevenson LW Yancy CW wrting on behalf of the 2005
Guideline Update for the Diagnosis and Management of Chronic Heart Faiure in the Adult
Writing Committee. 2009 Focused update: ACCF/AHA guidelines for the diagnosis and
management of heart failure in adults: a report of the American College of Cardiology
Foundation/American Heart Association Task Forceon Practice Guidelines. Circulation.
2009;119:1977 – 2016.
Institute for Clinical Systems Improvement (ICSI). Health Care Guideline: Heart Failure in
Adults (Released January 2010). Accessed January 24, 2010. URL: http://www.icsi.org
Digoxin. Drug Facts and Comparisons. eFacts [online]. 2010. Available from Wolters
Kluwer Health, Inc. Accessed Jan 24, 2011.
Patient(s) taking ACE-inhibitor, angiotensin II receptor blocker, selective
aldosterone receptor antagonist, or digoxin that had serum creatinine test in last 12
reported months.
Renal function should be monitored routinely in patients with heart failure (1). This is of
particular importance for patients taking ACE-inhibitors, angiotensin II receptor antagonists, or
selective aldosterone receptor antagonists since these medications can adversely affect renal
function (1,2). In addition, patients taking digoxin should have their renal function assessed
periodically; the frequency of assessments will depend on the clinical setting (3). The consensus
opinion of experts was the primary source of our recommendation for an annual creatinine at
minimum for patients taking ACE-inhibitors, angiotensin II receptor antagonists, selective
aldosterone receptor antagonists, or digoxin since the frequency of assessment is dependent on the
clinical status of the patient and is not clearly defined in the literature.
1.
2.
3.
S-DI
9000014
Jessup M, Abraham WT, Casey DE Feldman AM Francis, GS, Ganiats TG Konstam MA
Mancini DM Rahko PS Silver MA Stevenson LW Yancy CW wrting on behalf of the 2005
Guideline Update for the Diagnosis and Management of Chronic Heart Faiure in the Adult
Writing Committee. 2009 Focused update: ACCF/AHA guidelines for the diagnosis and
management of heart failure in adults: a report of the American College of Cardiology
Foundation/American Heart Association Task Forceon Practice Guidelines. Circulation.
2009;119:1977 – 2016.
Institute for Clinical Systems Improvement (ICSI). Health Care Guideline: Heart Failure in
Adults (Released January 2010). Accessed January 24, 2010. URL: http://www.icsi.org
Digoxin. Drug Facts and Comparisons. eFacts [online]. 2010. Available from Wolters
Kluwer Health, Inc. Accessed Jan 24, 2011.
Patient(s) taking contraindicated Class I antiarrhythmic medication (excludes
patients with diastolic heart failure).
Class I antiarrhythmic agents can exert important cardiodepressant and proarrhythmia effects. The
use of these agents is contraindicated based on the clinical evidence (1). Class I antiarrhythmics
include the following medications: Disopyramide, Procainamide, Quinidine, Lidocaine,
Tocainide, Mexiletine, Encainide, Flecainide, Moricizine, and Propafenone. This is a Class I*
recommendation from the ACC/AHA Guidelines for the Evaluation and Management of Chronic
Heart Failure in the Adult (1).
Patients are excluded from this rule if there is a code for diastolic heart failure within the last 12
months of the report period.
1.
Jessup M, Abraham WT, Casey DE Feldman AM Francis, GS, Ganiats TG Konstam MA
Mancini DM Rahko PS Silver MA Stevenson LW Yancy CW wrting on behalf of the 2005
Guideline Update for the Diagnosis and Management of Chronic Heart Faiure in the Adult
Writing Committee. 2009 Focused update: ACCF/AHA guidelines for the diagnosis and
management of heart failure in adults: a report of the American College of Cardiology
Foundation/American Heart Association Task Forceon Practice Guidelines. Circulation.
2009;119:1977 – 2016.
Care Pattern
CP-I
9000016
Patient(s) that had an annual physician visit.
Initial and ongoing assessment of a patient’s ability to perform routine and desired activities of
daily living is recommended for patients with CHF; this should include assessment of fluid status
(1). The consensus opinion of experts was the primary source of our recommendation for an
annual provider visit at minimum since the frequency of assessment is dependent on the clinical
status of the patient and is not clearly defined in the literature.
1.
CP-I
9000017
Jessup M, Abraham WT, Casey DE Feldman AM Francis, GS, Ganiats TG Konstam MA
Mancini DM Rahko PS Silver MA Stevenson LW Yancy CW wrting on behalf of the 2005
Guideline Update for the Diagnosis and Management of Chronic Heart Faiure in the
Adult Writing Committee. 2009 Focused update: ACCF/AHA guidelines for the diagnosis
and management of heart failure in adults: a report of the American College of
Cardiology Foundation/American Heart Association Task Forceon Practice Guidelines.
Circulation. 2009;119:1977 – 2016.
Patient(s) with indications that had cardiology consultation in last 24 reported
months.
Primary care physicians with knowledge and experience in heart failure should be able to care
for most patients with uncomplicated disease. By contrast, patients who remain symptomatic
despite basic medical therapy may benefit from care directed by a consulting physician with
special expertise and training in the care of patients with heart failure (1,2). Based on this
recommendation, this measure was developed using the EBM Connect consultant panel process.
This measure identifies cardiology consultation within 24 months for patients with two or more
CHF hospitalizations or emergency room visits in the past year. Given the limitation of claims
data, it is otherwise difficult to identify patients that would benefit from specialty consultation.
1.
2.
Jessup M, Abraham WT, Casey DE Feldman AM Francis, GS, Ganiats TG Konstam MA
Mancini DM Rahko PS Silver MA Stevenson LW Yancy CW wrting on behalf of the 2005
Guideline Update for the Diagnosis and Management of Chronic Heart Faiure in the
Adult Writing Committee. 2009 Focused update: ACCF/AHA guidelines for the diagnosis
and management of heart failure in adults: a report of the American College of
Cardiology Foundation/American Heart Association Task Forceon Practice Guidelines.
Circulation. 2009;119:1977 – 2016.
Institute for Clinical Systems Improvement (ICSI). Health Care Guideline: Heart Failure
in Adults (Updated January 2010) 24, 2011. URL: http://www.icsi.org