Developed for the May 2010 COF Conference in

San Diego, CA

Track 4: Expanding Access to Preventive Care and Quality

HealthWed May 26 1615-1645

Evaluation of the Medicare Lifestyle Modification Program Demonstration and the Medicare Cardiac Rehabilitation Benefit

Armen H. Thoumaian, Ph. D., LCSWArmen H. Thoumaian, Ph. D., LCSWCAPT U.S. Public Health Service

Office of Research, Development & Information

Centers for Medicare & Medicaid Services1

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Coronary Heart Disease Statistics• Cardiovascular disease is the leading cause of death in both

developed and developing countries worldwide, with coronary heart disease (CHD) the major subcategory.

• In 2003, over 860,000 people in the U.S. had an acute myocardial infarction (AMI), and 480,000 people died of CHD.*

• Aged Americans (those aged 65+) account for more than 55 percent of AMIs and 86 percent of CHD deaths.**

* Thom T et al. Circulation 2006;113:85-151**Arias E et al. National Vital Statistics Reports. National Center for Health

Statistics, CDC. 1999;52(3).

Coronary artery disease is still the leading cause of death among Americans over the age of 65.

• 5 million elderly have coronary artery disease

• 400,000 die each year

• 1.2 million have heart attacks

• 300,000 have invasive cardiac procedures

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Medicare Medicare Cardiovascular Cardiovascular Lifestyle Modification Program Lifestyle Modification Program DemonstrationDemonstration

““Requested” by President Clinton May 1999Requested” by President Clinton May 1999

Implemented October 1, 1999Implemented October 1, 1999

Mandated by Congress January 2001Mandated by Congress January 2001

(PL 106-554 Consolidated Appropriations Act of 2001)(PL 106-554 Consolidated Appropriations Act of 2001)

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Lifestyle modification programs may be useful as secondary prevention to:

Reduce risk factors and thereby…...

Lower ER visits, hospitalizations, and surgical procedures…...

Leading to better health and lower health care costs.

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Lifestyle Modification

Cardiovascular lifestyle modification programs typically include:

smoking cessation, low fat vegetarian diet, aerobic physical exercise, and stress management techniques group support

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Medicare Lifestyle Modification Medicare Lifestyle Modification Program - Program - Model SelectionModel Selection

Multi-Site Lifestyle Model

12 Month Treatment Program

Scientific Support for Outcomes

Administration & Congressional Mandate

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Medicare Lifestyle Modification Medicare Lifestyle Modification Program - Program - EvaluationEvaluation

RFP for Independent Evaluation Awarded to Brandeis University

Matched Paired Design (maximum of 3600 controls)

Quality of Care / Outcomes / Satisfaction / Savings / Feasibility

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Medicare Lifestyle Modification Medicare Lifestyle Modification Program - Program - Policy ImplicationsPolicy Implications

Payment for lifestyle modification for cardiovascular disease prevention….

Utilizing alternative medicine programs….

Is a departure from traditional Medicare to explore alternative medicine and disease prevention for possible future coverage decisions.

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Medicare Lifestyle Modification Medicare Lifestyle Modification Program - Program - Initial Program ModelInitial Program Model

Dean Ornish Program Sites

$5,760 for 12 months

$1,440 fee to patient (or waived by site)

Allowed to enroll up to 1800 patients

Potential for 30 or more sites

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Medicare Lifestyle Modification Medicare Lifestyle Modification Program - Program - 22ndnd Program Model Program Model

Cardiac Wellness Program Sites

$3,860 for 12 months

$960 fee to patient (or waived by site)

Allowed to enroll up to 1800 patients

Potential for 12 or more sites

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Medicare PaymentMedicare Payment Dean Ornish Program Sites

Negotiated Fee $5,650 $4,520 (80%) paid by Medicare for 12 Months $1,130 (20%) fee to patient (or waived by site)

Cardiac Wellness Program Sites Negotiated Fee $4,800 $3,840 (80%) paid by Medicare for 12 months $960 fee to patient (or waived by site)

Programs allowed to enroll 1800 each.

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Comparison of two national, multi-site program models: Ornish program & Benson program.

Began with 33 sites (O-24) (B-9), but open to “any” medical facility, at “anytime,” throughout U.S., if licensed to provide either lifestyle program.

Up to 1800 patients may enroll in each program.

Negotiated package price (Ornish-$5650) (M/BMI-$4800).

12 month treatment program with 12 month follow-up. 13

Demonstration Design :

Program Participants :Program Participants :

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The Doctor Dean Ornish Program for the Reversal of Heart Disease®

Dean Ornish, M.D.

Preventive Medicine Research Institute

Sausalito, California

The Cardiac Wellness Program

Herbert Benson, M.D.

Benson-Henry Mind/Body Medical Institute

Boston, Massachusetts

Demonstration Time Line:

Initiated……………May 1999

Implemented………October 1, 1999

Enrollment ended....February 28, 2006

Payment ended……February 28, 2007

Evaluation ended…June 2008

Published…………..June 2009 15

Beneficiary Enrollment Eligibility Beneficiary Enrollment Eligibility Criteria :Criteria :

Medicare Part B and

Acute myocardial infarction and/or,

Stable Angina pectoris and/or,

CABG or PTCA in past 12 months.

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Medicare Lifestyle Modification Medicare Lifestyle Modification Program Program –– Initiate New Payment Initiate New Payment SystemSystem

Confirm Part B Eligibility

Confirm Clinical Eligibility

Confirm Enrollment

Provide Electronic Payment to Sites

Payment Schedule: Quarterly at 35%, 15%, 15%, and 35% of total.

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Medicare Lifestyle Modification Medicare Lifestyle Modification Program - Program - Quality MonitoringQuality Monitoring

Review & Confirm Clinical Eligibility

Monitor Quality of Care

Monitor Outcomes

Investigate Adverse Events

Perform Regular Site Inspections 18

Delmarva Foundation for Medical Care, Inc. (the Maryland Medicare QIO)

Medicare Lifestyle Modification Medicare Lifestyle Modification Program - Program - EvaluationEvaluation

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Brandeis University

Matched Paired Design

Assess • Physical and Psychological Outcomes• Patient Satisfaction• Savings to Medicare

Program Participants :Program Participants :(376 of 589 completed 1 year programs)(376 of 589 completed 1 year programs)

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The Doctor Dean Ornish Program for the Reversal of Heart Disease®

Enrollment period: 7 years, 5 months.

24 sites began demo, 12 remained to the end.

Total Enrolled: 147 (90 completed 1 year)

The Cardiac Wellness Program

Enrollment period: 5 years, 6 months.

9 sites began demo, 5 remained to the end.

Total Enrolled: 442 (286 completed 1 year)

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Mean Changes from Baseline Values in Cardiac Risk Factors,at 24 Months, by Program

Note: Negative numbers are beneficial for all risk factors except for HDL and cardiac functional capacity. Statistical significance: * p<0.05, ** p<0.01, *** p<0.001

change

sig. change

sig. change

sig.

Body weight (lbs) -9.3 *** -7.3 *** -7.7 ***BMI (kg/m2) -1.6 *** -1.2 *** -1.3 ***SBP (mm Hg) -4.6 * -8.3 *** -7.6 ***DBP (mmHg) 0.2 NS -2.2 ** -1.8 **Total Cholesterol (mg/dl) -8.4 NS -13.0 *** -12.0 ***HDL (mg/dl) 1.5 NS 6.6 *** 5.6 ***LDL (mg/dl) -8.1 NS -7.7 *** -7.7 ***Triglycerides (mg/dl) -9.2 NS -12.6 ** -11.9 ***Cardiac Functional Capacity (METs) 0.9 * 1.6 *** 1.4 ***

Overall

All Participants

Ornish MBMI

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Mortality compared to CR and non-CR Controls

Ornish Program

M/BMI Program

M/BMI program significantly lower mortality throughout study.

Rehospitalization 3 year follow-upRehospitalization 3 year follow-up

The Doctor Dean Ornish Program for the Reversal of Heart Disease®

No difference compared to CR or non-CR controls.

The Cardiac Wellness Program

Significantly lower rates compared to matched CR and non-CR controls.

Proportion with no cardiovascular hospitalization after enrollment over time compared to CR and No-CR matched controls.

Ornish Program: No difference.

M/BMI Program: stayed out of hospital significantly longer.

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Comparison of Program Costs to Medicare versus Provider

1-Year Program 18 WeeksOrnish M/BMI Traditional Program Program Card.

Rehab.

Average MedicareCosts $4,520 $3,840 $683

Average ProviderCosts $9,895 $4,458 $1,828

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Average Medicare payments by program and year* Year Non-CR Controls CR Controls M/BMI

A. M/BMI Comparison Pre-enrollment (NS) $21,559 $23,930 $22,368 Year 1 (NS) $8,933 $8,519 $9,471 Year 2 (NS) $7,534 $8,709 $7,639 Year 3* $8,521 $9,013 $5,683

B. Ornish Comparison Pre-enrollment (NS) $13,329 $14,303 $15,137 Year 1 (NS) $6,062 $7,499 $9,634 Year 2 (NS) $7,784 $7,922 $4,475 Year 3 (NS) $6,900 $6,396 $6,499

*p<0.05; NS denotes p>0.05. 26

Summary Remarks About Findings1. Enrollment was difficult: After 7 years, only 589 patients

enrolled in the 1-year programs with 213 dropping out.

2. Half of the hospitals across the nation were financially unable to continue either program (12 Ornish and 4 M/BMI closed).

3. Intensive lifestyle modification costs roughly 4-times more than cardiac rehabilitation.

4. With few exceptions, 18 week traditional cardiac rehabilitation achieved comparable outcomes.

5. For the cost of one patient in intensive lifestyle modification, Medicare could provide cardiac rehabilitation for four. 27

Evaluation of the Medicare Evaluation of the Medicare Cardiac Rehabilitation Cardiac Rehabilitation Benefit Benefit

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Background: Cardiac Rehabilitation

• Meta-analyses of randomized trials of cardiac rehabilitation (CR) have found that CR reduces all-cause mortality by 15% to 28%.

• Although Medicare has covered cardiac rehabilitation since the 1980s for beneficiaries with stable angina, heart attack, or bypass surgery, there have been no published outcome cost-effectiveness studies of this treatment benefit.

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Study Objectives

• Measure national use of Cardiac Rehabilitation.• Identify major predictors of use.• Evaluate Cardiac Rehab impact on survival. • In:

– Medicare beneficiaries– Aged 65 and older– Hospitalization in 1997 for acute myocardial infarction

(MI) or coronary artery bypass graft surgery (CABG)• based on principal discharge diagnosis code for AMI (410.xx) or a procedure code for

CABG (36.1x)

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Strengths and limitations

• Strength– Very extensive data base of 601,099 aged Medicare

beneficiaries with outcomes and costs for 5 years

• Limitations– No data from medical records on severity– No data from patients on risk factors or adherence

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Type of hospitalization

• Cardiac Rehabilitation was used in:

18.7% of “definite” candidates (i.e., hospitalized for MI or CABG)

13.9% of patients hospitalized for AMI

31% of those who underwent CABG surgery

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Utilization of Cardiac Rehabilitation in the Medicare Population

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Odds of Cardiac Rehab Utilization by Socio-Economic Status of Residence

0.81

0.87

0.91

0.95

1.00

0.80

0.85

0.90

0.95

1.00

1 2 3 4 5SES of neighborhood, quintile (5 = highest)

Uti

lizat

ion

(O

dd

s R

atio

)

Those in low income zip codes 19% less likely than those in high income zip codes.

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CR use by distance to nearest CR facility1.00

0.93

0.78

0.58

0.29

0.0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0

0 5 10 15 20 25 30 35

Distance to nearest CR (miles)

Rel

ativ

e u

se o

f C

R (

od

ds

rati

o)

Those living furthest away were 79% less likely to use Cardiac Rehabilitation.

37Standardized Rates of CR usage by State 36

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CR sessions among CR users

• Overall: Average of 24.4 sessions (SD 12.0)

• On average, younger Medicare beneficiaries who were white males tended to participate in a higher number of sessions.

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Impact of Cardiac Rehabilitation on Survival

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Survival Question

• Identified 601,099 Medicare beneficiaries with a hospitalization with any coronary related principal diagnosis in 1997

• Among them 73,049 (12.2%) used Cardiac Rehabilitation.

Question:

• Did CR users survive longer than non-users?

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Crude and Adjusted Cumulative Mortality Rates for Cardiac Rehabilitation Use and Nonuse in the Entire Study Cohort of Medicare Beneficiaries (N = 601,099)

All curves begin 1 month after discharge. Observed and adjusted differences in cumulative mortality rates between cardiac rehabilitation (CR) users and nonusers at each time point shown were significant (p 0.0001). Adjusted cumulative mortality rates for CR use from instrumental variables were lower at each time point than rates from single probit (p 0.001 for 12 months, p 0.01 for 24 and 48 months, and p 0.05 for 36 and 60 months). Adjusted differences in annual mortality rates between CR use and non-CR use from instrumental variables were 6.0% in year 1, 2.4% in year 2, 2.9% in year 3, 1.5% in year 4, and 1.5% in year 5 (all at p 0.001).

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Estimates of Cumulative Mortality Rates for Propensity-Based Matched Groups of Cardiac Rehabilitation Usage

All curves begin 1 month after discharge. Differences in cumulative mortality rates between cardiac rehabilitation (CR) users and nonusers at each time point shown were significant (p 0.0001). Differences in cumulative mortality rates between low- and high-CR users were all significant (p 0.001). Differences in annual mortality rates between CR users and nonusers were 3.1% in year 1, 2.0% in year 2, 1.8% in year 3, 1.5% in year 4, and 1.6% in year 5 (all at p 0.001). Differences in annual mortality rates between high- and low-CR users were 1.4% in year 1, 0.7% in year 2, 0.8% in year 3, 0.5% in year 4, and 0.3% in year 5 (all significant at p 0.011).

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Death by propensity score and CR use

Figure 9. Five-year probability of death by use of CR and by quintile of propensity scores

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

35.0%

40.0%

Quintile 1(least likelyto use CR)

Quintile 2 Quintile 3 Quintile 4 Quintile 5(most likelyto use CR)

Quintile of propensity scores

Pro

bab

ilit

y o

f d

eath

Non_CR users CR users

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Cost-effectiveness of Cardiac Rehabilitation

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Total Medicare costs per year alive

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Results: Cost estimation

• Payment per beneficiary year of CR-users and matched controls proved virtually identical.

• However, lifetime payment per beneficiary of CR-users proved greater because they lived longer.

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Study Implications

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Study Findings• Cardiac Rehabilitation is markedly underutilized.

• Utilization associated with whites, males, younger, higher income/education, shorter distance to CR facility, and having

had a CABG.

• Use varies by region, with highest rates in North Central states indicating practice pattern differences.

• CR is associated with longer survival in a wide spectrum of patients.

• Case Study Finding: Cardiac Rehabilitation usage inhibited by attitudes of medical professionals, organizational obstacles, and profit making factors in addition to patient resistance.

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Major Policy Implications• Cardiac Rehabilitation is highly cost-effective.

• Cardiac Rehabilitation is underutilized nation-wide with utilization averaging 12 to 18% of all eligible Medicare patients.

• Those that could gain the greatest benefit are the least likely to use it (i.e., older, female, non-white, lower income, non-CABG admission, distance away).

Finding ways to increasing enrollment and use of cardiacrehabilitation can improve patient survival and reduce health carecosts.

Final Evaluation Report Available at CMS WebsiteFinal Evaluation Report Available at CMS Website

http://www.cms.gov/DemoProjectsEvalRpts/And click on “Medicare Demonstrations” and search.

Or the direct link:

http://www.cms.hhs.gov/DemoProjectsEvalRpts/MD/itemdetail.asp?filterType=none&filterByDID=99&sortByDID=3&sortOrder=descending&itemID=CMS1192588&intNumPerPage=10

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Evaluation of the Medicare Lifestyle Modification Program Demonstration and the Medicare Cardiac Rehabilitation Benefit