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1 Northwestern University Feinberg School of Medicine Northwestern Memorial Hospital DISCLOSURES Consultant/speaker/honoraria: none Editorial Boards: American Heart Journal, American Journal of Cardiology (associate editor); Circulation; Circulation-Heart Failure; JACC- Associate Editor, HF, (2014) Guideline writing committees: Chair, ACC/AHA, chronic HF; member, hypertrophic cardiomyopathy, atrial fibrillation; former member, ACC/AHA Guideline Taskforce; chair, methodology subcommittee Federal appointments: FDA: Chair, Cardiovascular Device Panel; ad hoc consultant; NIH former CICS study section; Advisory Committee to the Director; AHRQ- adhoc study section chair; NHLBI- consultant; PCORI- methodology committee member Volunteer Appointments: American Heart Association- President, American Heart Association, 2009-2010; American College of Cardiology, Founder- CREDO American College of Cardiology Oregon Chapter Symposium American College of Cardiology Oregon Chapter Symposium “How to Prevent Heart Failure Readmission” “How to Prevent Heart Failure Readmission” Clyde W. Yancy, MD, MSc, FACC, FAHA, MACP Magerstadt Professor of Medicine Professor of Medical Social Sciences Chief of Cardiology Northwestern University, Feinberg School of Medicine & Associate Medical Director Bluhm Cardiovascular Institute Chicago, IL [email protected]

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Page 1: Yancy - Oregon ACC Symposium - Heart Failure, Healthcare ... · PDF fileafter ~ 1,500,000 heart failure hospitalizations from >4,000US hospitals, 2004–2006. Ross J S et al. Circ

1

Northwestern University

Feinberg School of

Medicine

Northwestern Memorial Hospital

DISCLOSURES

• Consultant/speaker/honoraria: none

• Editorial Boards: American Heart Journal, American Journal of Cardiology (associate editor); Circulation; Circulation-Heart Failure; JACC- Associate Editor, HF, (2014)

• Guideline writing committees: Chair, ACC/AHA, chronic HF; member, hypertrophic cardiomyopathy, atrial fibrillation; former member, ACC/AHA Guideline Taskforce; chair, methodology subcommittee

• Federal appointments: FDA: Chair, Cardiovascular Device Panel; ad hoc consultant; NIH former CICS study section; Advisory Committee to the Director; AHRQ- adhoc study section chair; NHLBI- consultant; PCORI- methodology committee member

• Volunteer Appointments: American Heart Association-President, American Heart Association, 2009-2010; American College of Cardiology, Founder- CREDO

American College of Cardiology

Oregon Chapter Symposium

American College of Cardiology

Oregon Chapter Symposium

“How to Prevent Heart Failure

Readmission”

“How to Prevent Heart Failure

Readmission”

Clyde W. Yancy, MD, MSc, FACC, FAHA, MACP

Magerstadt Professor of Medicine

Professor of Medical Social Sciences

Chief of Cardiology

Northwestern University, Feinberg School of Medicine

&

Associate Medical Director

Bluhm Cardiovascular Institute

Chicago, IL

[email protected]

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Let’s start with heart failure…

Stages, Phenotypes and Treatment of HF

Survival (years)

Ammar et al. Circulation 2007; 115:1563

Prevalence and prognostic significance of HF Stages

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Stages, Phenotypes and Treatment of HF

Pharmacologic Treatment for Stage C HFrEF

Results: Mortality Reduction Based on Number of Guideline-Recommended Therapies at Baseline

24 Month Mortality

Adjusted Odds Ratios (95% CI Displayed)Number of Therapies(vs 0 or 1 therapy)

2 therapies

3 therapies

4 therapies

5, 6, or 7 therapies

Odds Ratio(95% confidence interval)

0.63 (0.47-0.85)(p=0.0026)

0.38 (0.29-0.51)(p<0.0001)

0.30 (0.23-0.41)(p<0.0001)

0.31 (0.23-0.42)(p<0.0001)

0 0.5 1 1.5 2

Fonarow GC, … Yancy, C. J Am Heart Assoc 2012;1:16-26.Fonarow GC… Yancy CW. J Am Heart Assoc 2012;1:16-26.

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GAME-CHANGER?

Simplified schematic of the renin–angiotensin–aldosterone system.

von Lueder T G et al. Circ Heart Fail. 2013;6:594-605

Copyright © American Heart Association, Inc. All rights reserved.

Simplified schematic of the natriuretic peptide system (NPS).

von Lueder T G et al. Circ Heart Fail. 2013;6:594-605

Copyright © American Heart Association, Inc. All rights reserved.

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Cardiac antiremodeling effects of angiotensin receptor neprilysin inhibitors (ARNi) in vitro and in vivo.

von Lueder T G et al. Circ Heart Fail. 2013;6:594-605

Copyright © American Heart Association, Inc. All rights reserved.

PARADIGM - HF

PARADIGM HF

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Stages, Phenotypes and Treatment of HF

TOPCAT - Results

• 3,445 patients were randomized, 1,722 to spironolactone and to 1,723 to placebo.

• Baseline characteristics were similar between the two arms.

• The baseline EF was 56%

• 52% were female

• 2/3 of the patients had New York Heart Association (NYHA) class II symptoms.

• Hypertension was present in 92% of patients. Coronary artery disease was noted in 59% and atrial fibrillation in 35%.

• Baseline K was 4.3 mEq/L.

The primary endpoint of CV death, chronic HF (CHF) hospitalization, or resuscitated cardiac arrest over 6 years was similar between the spironolactone and placebo arms (18.6% vs. 20.4%, hazard ratio = 0.89, 95% confidence interval 0.77-1.04, p = 0.14).

• Individual components including CV mortality (9.3% vs. 10.2%. p = 0.35) and aborted cardiac arrest (3 vs. 5 events, p = 0.48) were similar between the two arms.

• CHF hospitalizations were lower (12.0% vs. 14.2%, p = 0.042); all-hospitalizations were similar (p = 0.25).

• Hyperkalemia (18.7% vs. 9.1%, p < 0.001) and renal failure, defined as doubling of creatinine >2 upper limit of normal were both significantly higher in the spironolactone arm.

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Kaplan–Meier Plot of Time to the First Confirmed Primary-Outcome Event.

Pitt B et al. N Engl J Med 2014;370:1383-1392

Kaplan–Meier Plots of Two Components of the Primary Outcome.

Pitt B et al. N Engl J Med 2014;370:1383-

1392

TOPCAT – Adjusted results

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Treatment of HFpEFRecommendations COR LOE

Systolic and diastolic blood pressure should be controlled

according to published clinical practice guidelines I B

Diuretics should be used for relief of symptoms due to

volume overloadI C

Coronary revascularization for patients with CAD in

whom angina or demonstrable myocardial ischemia is

present despite GDMT

IIaC

Management of AF according to published clinical

practice guidelines for HFpEF to improve symptomatic

HF

IIa C

Use of beta-blocking agents, ACE inhibitors, and ARBs

for hypertension in HFpEF IIa C

ARBs might be considered to decrease hospitalizations in

HFpEFIIb B

Nutritional supplementation is not recommended in

HFpEF

III: No

BenefitC

Now, health care reform…

The premise: what we spend on

health care--

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National Health Expenditures per Capita,

1960-2010

Notes: According to CMS, population is the U.S. Bureau of the Census resident-based population, less armed forces overseas and population of

outlying areas, plus the net undercount.

Source: Centers for Medicare and Medicaid Services, Office of the Actuary, National Health Statistics Group, at

http://www.cms.hhs.gov/NationalHealthExpendData/ (see Historical; NHE summary including share of GDP, CY 1960-2010; file nhegdp10.zip).

5.2% 7.2% 9.2% 12.5% 13.8% 14.5% 15.4% 15.9% 16.0% 16.1% 16.2% 16.4% 16.8% 17.9% 17.9%

NHE as a Share of GDP

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The U.S. as an outlier…

Bending the Curve 2

9Spending Growth Continues Downward Trajectory

Percent Increase in National

Health Care Spending

2003-2011

Source: Centers for Medicare and Medicaid, “National Health Expenditure Accounts”, 2013, available at: www.cms.gov/Research-Statistics-Data-and-Sy stems/Statistics-Trends-and Reports/NationalHealthExpendData/Downloads/tables.pdf; Department of Health and Human Services, “Growth in Medicare Spending Per Benef iciary Continues to Hit Historic Lows”, January, 2013, available at: http://aspe.hhs.gov/health/reports/2013/medicarespendinggrowth/longdesc.shtml; Marketing and Planning Leadership Council interviews and analysis.

Medicare Spending Growth

per Beneficiary

2010-2012

Tensions remain: Physicians

determine ~ 60% of all health care

costs; what do physicians think?

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Date of download: 7/25/2013Copyright © 2012 American Medical

Association. All rights reserved.

From: Views of US Physicians About Controlling Health Care Costs

JAMA. 2013;310(4):380-388. doi:10.1001/jama.2013.8278

What about hospital costs and

executive compensation?

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JAMA, Internal Medicine, 2014

Date of download: 1/20/2014Copyright © 2014 American Medical

Association. All rights reserved.

From: Compensation of Chief Executive Officers at Nonprofit US Hospitals

JAMA Intern Med. 2014;174(1):61-67. doi:10.1001/jamainternmed.2013.11537

Distribution of Chief Executive Officer PayHistogram of chief executive officer pay at US nonprofit hospitals in calendar year 2009.

Figure Legend:

Expanding Coverage3

6Will Coverage Expansion Offset Decline in Per Capita Utilization?

Source: CBO, “Letter to the Honorable John Boehner Providing an Estimate for H.R.6079, The Repeal of Obamacare Act,” July 24, 2012, av ailable at: www.cbo.gov; CBO, “Effects of the Affordable Care Act on Health Insurance Coverage—February 2013 Baseline,” February 5, 2013, available at: www.cbo.gov; Health Care Advisory Board interviews and analysis.

1) Disproportionate Share Hospital.2) Non-elderly population.

Projected Coverage Expansion

Net Reduction in Uninsured Individuals22013-2023

ACA Hospital Payment Cuts

1

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Coverage options

• Employer based coverage

• Medicare

• Medicaid (CHIPs)

• Insurance

� Private (personal) Insurance

� Marketplace/Exchange

AFFORDABLE CARE ACT

Health Insurance Marketplace

38

AFFORDABLE CARE ACT

Health Insurance Marketplace

Those remaining uninsured

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Proposed Medicaid Disproportionate Share Hospital (DSH) Allotments for Fiscal Year 2014 and Reductions

for States with Baseline DSH Allotments Greater Than $200 Million.

Neuhausen K et al. N Engl J Med 2013. DOI: 10.1056/NEJMp1310572

Every state has Medicaid but the definitions of poverty vary; in Mississippi: < $3,000/year.

Consumer (financial) Accountability = Transparency4

1HDHP1 Enrollees Have Greater Motivation to Price Shop

Source: KFF, “2012 Employer Health Benefits Survey,” available at: www.kff.org; New Choice Health, “N ew Choice Health Medical Cost Comparison,” available at: www.newchoicehealth.com; Healthcare Blue Book, “Healthcare Pricing,” available at: www.healthcarebluebook.com; Kliff S, “How much does an MRI cost? In D.C., anywhere from $400 to $1,861,” Washington Post, March 13, 2013, av ailable at: www.washingtonpost.com; Health Care Advisory Board interviews and analysis.

1) High-deductible health plan.2) $2,086; based on KFF report of average HDHP deductible.3) $733; based on KFF report of average PPO deductible.

Consumers Paying More Out-of-Pocket

Fall within HDHP deductible2

$730

$900

$1,269

$2,183

$411

• Price-sensitive shoppers will be acutely aware of price variation

• MRI prices range from $400 to $2,183

MRI Price Variation Across

Washington, DC

Fall within PPO

deductible3

What About Readmissions for HF?-

HRRP

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The natural history of HF s/p HF

hospitalization

Jong P et al. Arch Intern Med. 2002;162:1689

0

25

50

75

100

Hospital Readmissions

0

25

50

75

100

Mortality

Median hospital LOS: 6 days

Annual mortality rate

NYHA class III HF: 12% [COPERNICUS

DATA]

NYHA class II HF: 7% [SCD-HeFT DATA]

20%

50%

30days

6months

12%

50%

30days

12months

33%

5years

Date of download:

3/10/2013

Copyright © The American College of Cardiology.

All rights reserved.

From: National Trends in Heart Failure Hospital Stay Rates, 2001 to 2009

J Am Coll Cardiol. 2013;61(10):1078-1088. doi:10.1016/j.jacc.2012.11.057

Heart Failure Hospital Stay Rate by Age Category/100,000 Persons

Heart failure hospital stay rate/100,000 over time from 2001 to 2009, stratified by age categories.

Figure Legend:

Date of download:

3/10/2013

Copyright © The American College of Cardiology.

All rights reserved.

From: National Trends in Heart Failure Hospital Stay Rates, 2001 to 2009

J Am Coll Cardiol. 2013;61(10):1078-1088. doi:10.1016/j.jacc.2012.11.057

In-Hospital Survival for Heart Failure Hospital Stay, by Hospital Day

Proportion of hospitalized heart failure patients who remain alive by hospital day, stratified by time periods 2001 to 2003, 2004 to 2006, and 2007

to 2009.

Figure Legend:

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Frequency distribution of rehospitalizations for fee-for-service Medicare beneficiaries discharged after ~ 1,500,000 heart failure hospitalizations from >4,000US hospitals, 2004–2006.

Ross J S et al. Circ Heart Fail 2010;3:97-103

Copyright © American Heart A ssociation

Medicare Provisions in PPACA

Readmissions

Hospitals will have

1. Readmission rates

made publically

available

2. Hospitals with high

risk adjusted

readmissions with

no steps to reduce

readmission will be

required to report on

process.

• Source: US House of Representatives, “Amendment in the Nature of a Substitute to H.R. 4872, as Reported,” March 18, 2010; US Senate, The Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act,” December 24, 2009; Health Care Advisory Board interviews and analysis.

Age, years over 65

Male

Cardiovascular

History of Percutaneous Transluminal Coronary Angioplasty (ICD9

V45.82)

History of Coronary Artery Bypass Graft Surgery (ICD9 V45.81)

History of heart failure (HCC 80)

History of Myocardial Infarction (HCC 81)

Unstable angina (HCC 82)

Chronic atherosclerosis (HCC 83-84)

Cardiopulmonary-respiratory failure and shock (HCC 79)

Valvular heart disease (HCC 86)

Comorbidity

Hypertension (HCC 89-91)

Stroke (HCC 95-96)

Renal failure (HCC 131)

Chronic Obstructive Pulmonary Disease (HCC 108)

Pneumonia (HCC 111-113)

Diabetes (HCC 15-20, 120)

Protein-calorie malnutrition (HCC 21)

Dementia (HCC 49-50)

Hemiplegia, paraplegia, paralysis, functional disability (HCC 100-

102, 68-69, 177-178)

Peripheral vascular disease (HCC 104-105)

Metastatic cancer (HCC 7-8)

Trauma in last year (HCC 154-156, 158-162)

Major psychiatric disorders (HCC 54-56)

Chronic liver disease (HCC 25-27)

Not Adjusted for in the Model

Systolic blood pressure on admissionHeart rate on admission

Respiratory rate on admissionBody mass indexBUN on admission

Creatinine on admissionSodium on admissionHemoglobin on admissionBrain natriuretic peptide on admission

Left ventricular ejection fractionLeft ventricular end diastolic diameterFunctional status (New York Heart Association Class)

Socio-economic statusMechanical ventilation (initial)Inotropic agent treatment

Krumholz HM, et al. Circulation 2006;113:1693-1701.

30-Day Mortality Risk Adjustment in HF: Hierarchical Regression Model for HF Based on Administrative Claims Data

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Medicare Assessment and

Penalty- 2014• Hospitals’ Heart Failure 30 day readmission

benchmark data are measured from July 1, 2003-June 30, 2011

• In 2013, up to a 1% penalty on all DRGs was withheld from those hospitals with 30 day excessive readmissions

• In 2014, up to a 2% penalty is allowed

• By 2015 up to a 3% penalty on all DRGs can be withheld those hospitals with 30 day excessive readmissions

The imperfectness of the HRRP

• Unexplained excess mortality may be an off-target association

• Safety net and teaching hospitals are disproportionately impacted by penalties

• Readmissions are front-loaded in the 30 day window; a 30 day period is not physiological

• Fewer than half of the causes for readmission are related to the primary illness

• Patient population matters: CMS, Frailty, Race, Poverty; Physicians and hospitals may not

Comparison of Risk-Adjusted Hospital Readmission Rates and Mortality Rates 30 Days after an Index

Admission for Heart Failure.

Gorodeski EZ et al. N Engl J Med 2010;363:297-298.

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Date of download: 2/11/2013Copyright © 2012 American Medical

Association. All rights reserved.

From: Characteristics of Hospitals Receiving Penalties Under the Hospital Readmissions Reduction Program

JAMA. 2013;309(4):342-343. doi:10.1001/jama.2012.94856

Date of download: 2/11/2013Copyright © 2012 American Medical

Association. All rights reserved.

From: Diagnoses and Timing of 30-Day Readmissions After Hospitalization for Heart Failure, Acute Myocardial

Infarction, or Pneumonia

JAMA. 2013;309(4):355-363. doi:10.1001/jama.2012.216476

The denominators used to calculate the percentage of 30-day readmissions on each day after hospitalization were 329 308 30-day readmissions following heart failure hospitalization, 108 992 30-day readmissions following acute myocardial infarction hospitalization, and 214 239 30-day readmissions following pneumonia hospitalization.

Figure Legend:

Date of download: 2/11/2013Copyright © 2012 American Medical

Association. All rights reserved.

From: Diagnoses and Timing of 30-Day Readmissions After Hospitalization for Heart Failure, Acute Myocardial

Infarction, or Pneumonia

JAMA. 2013;309(4):355-363. doi:10.1001/jama.2012.216476

The denominators used to calculate the percentage of 30-day readmissions due to common readmission diagnoses during each cumulative period after hospitalization for heart failure were 44 257 readmissions for days 0 through 3, 104 362 for days 0 through 7, 201 005 for days 0 through 15, and 329 308 for days 0 through 30. Analogously, following acute myocardial infarction hospitalization, the denominators used were 20 801 readmissions for days 0 through 3, 43 687 for days 0 through 7, 73 641 for days 0 through 15, and 108 992 for days 0 through 30. Following pneumonia hospitalization, the denominators used were 32 829 readmissions for days 0 through 3, 71 995 for days 0 through 7, 134 033 for days 0 through 15, and 214 239 for days 0 through 30.

Figure Legend:

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Unadjusted 30-day all-cause and HF-related readmission

rates and 95% CI by payer.

Allen L A et al. Circ Heart Fail 2012;5:672-679

Copyright © American Heart A ssociation

N.B., very low

rate of HF

related

readmissions

Frailty• Distinct biological syndrome

• Characterized by profound weight loss, sarcopenia, physical exhaustion, weakness, decline in walking speed and reduced functional capacity; “Fried” or “Lach’s” criteria

• Prevalence: 3% @ 65-70; 23% @ >90

• Attributable to inflammation and associated with elevated C-reactive protein, factor VIII and reduced vit D

Murad K, Kitzman, D. Heart Failure Reviews. 31 May 2011

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Frailty and multiple co-morbidities in the elderly patient with

heart failure: implications for management

Khalil Murad1, 2 and Dalane W. Kitzman3

Update on HRRP – FY ‘14

Proportion of Hospitals Facing No Readmissions Penalty (Panel A) and Median Amount of Penalty (Panel B),

According to the Proportion of Hospital's Patients Who Receive Supplemental Security Income.

Joynt KE, Jha AK. N Engl J Med 2013. DOI:

10.1056/NEJMp1300122

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Physician Volume, Specialty, and Outcomes of Care for Patients With Heart Failure Clinical Perspective

by Karen E. Joynt, E. John Orav, and Ashish K. Jha

Circ Heart FailVolume 6(5):890-897September 17, 2013

Copyright © American Heart Association, Inc. All rights reserved.

A, Relationship between physician volume and 30-day risk-adjusted mortality, stratified by hospital volume: adjusted for patient characteristics, physician specialty, and hospital

characteristics including teaching status, hospital size, urban vs rural location, region of the country, and ownership (public, private nonprofit, private profit).

Joynt K et al. Circ Heart Fail 2013;6:890-897

Copyright © American Heart Association, Inc. All rights reserved.

Update on the HRRP- FY ‘14

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Hospital Discharge

Recommendation or Indication COR LOE

Performance improvement systems in the hospital and early postdischarge outpatient setting

to identify HF for GDMTI B

Before hospital discharge, at the first postdischarge visit, and in subsequent follow-up visits,

the following should be addressed:

a) initiation of GDMT if not done or contraindicated;

b) causes of HF, barriers to care, and limitations in support;

c) assessment of volume status and blood pressure with adjustment of HF therapy;

d) optimization of chronic oral HF therapy;

e) renal function and electrolytes;

f) management of comorbid conditions;

g) HF education, self-care, emergency plans, and adherence; and

h) palliative or hospice care.

I B

Multidisciplinary HF disease-management programs for patients at high risk for hospital

readmission are recommended I B

A follow-up visit within 7 to 14 days and/or a telephone follow-up within 3 days of hospital

discharge is reasonableIIa B

Use of clinical risk-prediction tools and/or biomarkers to identify higher-risk patients is

reasonableIIa B

Healthcare Reform; A grand idea,

an imperfect plan, a failed

hypothesis?

Hmm…

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6

7Multiple Pay-for-Performance Initiatives Underway

Source: Centers for Medicare and Medicaid Services, “CMS Hospital Inpatient Quality Reporting Program Hospital-Acquired Condition Measures,” March 21, 2011; Health Care Advisory Board interviews and analysis.

1) Includes eight possible conditions. Penalties involve reduced Medicare inpatient payments by 1% starting in FY 2015 to bottom 25% of all hospitals, relative to national average.

2) Example based on Pleasantville Hospital model of 16,000 annual discharges: 25th percentile: 0 events, 50th percentile: 0.442*16=7 events,75th percentile: 1.627*16=26 events, 95th percentile: 5.202*16=82 events.

Initiative Description

Readmissions

Penalties

• FY 2013 readmissions penalty

based upon readmissions performance between July 1, 2008

and June 30, 2011

• Penalties start at 1% of Medicare

inpatient revenue, rising to 3% by FY 2015

Value-Based

Purchasing Program

(VBP)

• Performance assessed on 20

quality, satisfaction metrics• Payment withhold commences

at 1% in FY 2013, rises to 2%

by FY 2017

Inclusion of Medicare Spending per

Beneficiary metric in FY 2015

• All part A and B payments included during episode of care

• Includes transfers, readmits,

additional admits

Pay-for-Performance Payment Changes

• Distribution of HAC events

per 1,000 discharges in hospitals1

Based on 16,000 annua l

discharges, occurrence of 26+

HACs results in bottom

quartile performance,

Medicare payment penalty2

• Hospital Acquired Conditions (HAC) in FY2015

Fostering Payment Innovation

From 30,000 Feet: ACA as a Grand Experiment

6

8Affordable Care Act Sets in Motion Decade of Change

Source: Centers for Medicare and Medicaid Services; Health Care Adv isory Board interviews and analysis.

1) Value-Based Purchasing.2) Accountable Care Organization.

• Medicaid CapitationPilot Operation

2010

• Shared Savings Program

• (Early Adopters)

• Hospital VBP1

(Phase 1: Quality)• Hospital VBP

(Phase 2: Efficiency)

• Readmission Penalties for Poor Performers

• Pediatric ACO2 (Shared Savings) Pilot

• Shared Savings Program

• (Competitive Pressure Expansion)

• Integrated Care Demonstration (Medicaid Episodic Bundling)

• National Episodic Bundling Pilot

• Payment Adjustments for Hospital Acquired Conditions

• Officially

Announced

2011 2012 2013 2014 2015 2016 2017 2018 2019 2020

The critical question--

• Will health care reform measures taken to reduce health care costs – HRRP, VBP, ACO, Bundled Payments --preserve quality, improve quality or hamper quality?

Reduce Costs Improve Quality

HRRP yes no

VBP yes ?

ACO ? ?

Hospital acquired conditions

yes ?

Bundled Payments

? ?

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Conclusions

• Health care costs may be declining, i.e., the rate of growth in health care spending is slowing

• Improved access to care may not be fully realized

• The economics of US health care remain complex and convoluted

• We should subject major components of health care reform – HRRP, VBP, HAC, ACO and Bundled Payments- to the scrutiny used for new drugs and devices. “first do no harm…”

• The Affordable Care Act is an imperfect law. At what point do we challenge its imperfection?