life style modification

7/28/2019 Life Style Modification

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Benefits and Costs of Intensive Lifestyle ModificationPrograms for Symptomatic Coronary Disease inMedicare BeneficiariesWu Zeng, MD, MS, PhD, William B. Stason, MD, MSci, Stephen Fournier, PhD, Moaven Razavi, PhD, Grant Ritter,PhD, Gail K. Strickler, PhD, Sarita M. Bhalotra, MD, PhD, Donald S. Shepard, PhD

Am Heart J. 2013;165(5):785-792.

Abstract and IntroductionAbstract

Background This study reports outcomes of a Medicare-sponsored demonstration of two intensive lifestylemodification programs (LMPs) in patients with symptomatic coronary heart disease: the Cardiac WellnessProgram of the Benson-Henry Mind Body Institute (MBMI) and the Dr Dean Ornish Program for ReversingHeart Disease (Ornish).

Methods This multisite demonstration, conducted between 2000 and 2008, enrolled Medicare beneficiarieswho had had an acute myocardial infarction or a cardiac procedure within the preceding 12 months or had

stable angina pectoris. Health and economic outcomes are compared with matched controls who had receivedeither traditional or no cardiac rehabilitation following similar cardiac events. Each program included a 1-yearactive intervention of exercise, diet, small-group support, and stress reduction. Medicare claims were used toexamine 3-year outcomes. The analysis includes 461 elderly, fee-for-service, Medicare participants and 1,795controls.

Results Cardiac and non-cardiac hospitalization rates were lower in participants than controls in each programand were statistically significant in MBMI (P< .01). Program costs of $3,801 and $4,441 per participant for theMBMI and Ornish Programs, respectively, were offset by reduced health care costs yielding non-significantthree-year net savings per participant of about $3,500 in MBMI and $1,000 in Ornish. A trend towards lowermortality compared with controls was observed in MBMI participants (P= .07).

Conclusions Intensive, year-long LMPs reduced hospitalization rates and suggest reduced Medicare costs inelderly beneficiaries with symptomatic coronary heart disease.

Introduction

Cardiovascular diseases, including high blood pressure, stroke, and coronary heart disease (CHD), imposelarge health and economic burdens in the United States and worldwide through acute illness, disability, lostproductivity, and premature death. In the United States in 2008, CHD was responsible for about one in fivedeaths, 1.2 million new or recurrent heart attacks, and $156 billion in direct and indirect costs. Most CHDdeaths (82%) were in individuals aged 65 or older.[1,2] Although major advances have been made in thetreatment of CHD, the success of efforts to reduce risk by changing individual behavioral risk factors has beenmixed. For example, smoking rates have decreased in adults, while other risk factors for CHD, such asdiabetes and obesity, have increased.

Medicare has covered cardiac rehabilitation (CR) programs for patients who have had acute myocardialinfarctions (AMIs) or have undergone coronary artery bypass graft surgery (CABG) since 1982.[3] Coverage wasextended to include percutaneous coronary interventions (PCIs) and heart or heart-lung transplants in 2006. [3]

In 1997 however, only 18.7% of eligible Medicare beneficiaries actually received CR following their cardiacevents.[4]

Cardiac rehabilitation has been shown to reduce mortality in individual randomized controlled trials and inmeta-analyses, though most trials were based on care delivered in the 1980s or 1990s and enrolled middle-aged white men with moderately severe CHD.[59] More recent studies have largely, though not universally,reinforced these findings. A study of Medicare beneficiaries who received CR following cardiac procedures in1997, which used propensity-score matching and instrumental variables to control for confounding, verifiedmortality benefits.[10] Similarly, a study in a national five percent sample of Medicare beneficiaries who receivedCR between 2000 and 2005 identified a strong dose-response relationship between the number of CR
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sessions and the reduced risk of death or MI after four years of follow-up.[11] An observational study in patientswho received PCIs between 1994 and 2008 in Olmsted County, Minnesota found significant relationshipsbetween participation in CR and lower all-cause mortality, but no effects on rates of subsequent AMIs or theneed for cardiac revascularization.[12] Contrary to these positive results, a multicenter randomized controlled trialperformed in the United Kingdom between 1997 and 2000 found that "comprehensive" CR following AMI hadno important effects on mortality, morbidity, or cardiac risk factors. [13]

The Lifestyle Modification Program Demonstration (LMPD) was begun by the Centers for Medicare & MedicaidServices (CMS) in 1999 to examine the effectiveness of intensive and prolonged lifestyle modificationprograms. Participants were Medicare beneficiaries with symptomatic CHD who enrolled in one of 2 multisitelifestyle modification programs (LMPs): the Dr. Dean Ornish Program for Reversing Heart Disease (Ornish) orthe Cardiac Wellness Program of the Benson-Henry Mind Body Medical Institute (MBMI). The demonstrationprotocol included a one-year active program and an additional year of active follow-up for all participants.[14]

This report describes the impacts of these two programs on mortality, recurrence of cardiovascular events, andhealth care costs in a matched-pair design study that compares participants in each program with up to fourmatched controls, two of whom had received traditional CR following the qualifying cardiac event and two ofwhom had not.

MethodsDemonstration Design

Medicare's demonstration was designed to test the premise that aggressive cardiac risk factor reduction mayslow, stop or even reverse the progression of CHD, improve health outcomes, and be a cost-effective or cost-saving use of Medicare funds. The participating lifestyle modification programs had multiple, geographicallydispersed, clinical sites that were serving non-institutionalized individuals with CHD. Both fee-for-service andmanaged care Medicare beneficiaries were eligible to participate if they met clinical criteria and lived within aone hour drive of the clinical site. The demonstration included a one-year active treatment program withmonitored exercise, nutrition counseling, stress management, and group support beginning with an intensivethree-month period followed by nine months of less frequent sessions and more emphasis on homemaintenance of healthy behaviors. Participants were contacted over the second year, but program visits wereno longer funded under the demonstration. Adherence to protocols was closely monitored by the DelmarvaFoundation for Medical Care, Inc. a CMS contracted Quality Improvement Organization headquartered inEaston, MD.

The two programs had many similarities, but also important differences. Ornish advocated a vegetarian dietlimited to 10% of calories from fat and used yoga, stretching, and relaxation techniques to reduce stress. MBMIrecommended the American Heart Association's diet that includes 30% of calories from fat and placedparticular emphasis on training and practice in the relaxation response, mindfulness, cognitive-behavioral skills,and positive psychology and spiritual connectedness in small group settings to elicit social support. Ornish wasmore intensive than MBMI in terms of both the duration and frequency of sessions. Both programs includedmonitored exercise and group support. summarizes the programs' key components.

Table I. Components of the lifestyle modification programs

Component Ornish MBMI

Diet and nutritioncounseling

Vegetarian diet with 10% caloriesfrom fat

Individualized diets aimed at weight control andreducing cardiac risk factors. Target - AHA dietwith 30% calories from fat.

Aerobic exerciseCondition-appropriate, monitoredexercise at least 3 hours per week

Same

Stressmanagement

Daily practice in stretching, relaxation,imagery, and meditation

Training and practice in the relaxation responseand cognitive behavioral skills

Small groupsupport

Yes Yes

Program sessionsmonths 13

4-hour group sessions:3 in week 1; 2in weeks 211, and 3 in week 12

One 3-hour session per week


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Program sessionsmonths 412

12 or 24 weekly 2-hour sessions or 40weekly 4-hour sessions depending onmedical risk

3-hour sessions twice a month

Notation: AHA denotes American Heart Association.

Participant Enrollment and Personal Characteristics

Ornish included twelve participating clinical sites, and MBMI included five sites. A total of 580 participantsentered the demonstration between June 1, 2000 and February 28, 2006, including 440 from MBMI sites and140 from Ornish sites. Of these, 79% were enrolled in fee-for-service Medicare and 21% in health maintenanceorganizations. All participants had at least one qualifying cardiac event, including acute myocardial infarction(AMI), cardiac artery bypass surgery (CABG), or percutaneous coronary intervention (PCI) (angioplasty with orwithout stent placement) during the 12 months preceding enrollment, or had stable angina pectoris. Negotiatedmaximum allowed charges per participant for the full program were $5,650 for Ornish and $4,800 for MBMI.Medicare paid 80% of these amounts. Payments by Medicare were linked to continued active participationduring each 3-month period. This report, which depends on Medicare claims data, includes only the 461 fee-for-service beneficiaries (324 in MBMI and 137 beneficiaries in Ornish).

Matched Controls

Four matched controls were sought for each participant from Medicare claims data, 2 of whom had received

traditional CR within 12 months following their cardiac events (CR controls) and 2 of whom had not (non-CRcontrols). Matching was based on the type of cardiac event, the time between the event and enrollment into thedemonstration, age, gender, location of residence, and diagnostic cost group (DxCG) risk scores. The DxCGscore is a continuous case-mix adjustment score based on the patient's inpatient diagnoses, includingcomorbidities over the past year. The DxCG score is used by CMS for risk adjustment in Medicare+Choiceplans. In addition, controls had to live within a 25-mile radius of the program site attended by the participant if itwas in an urban area or within 50 miles if it was in a rural areahence, controlling for geographic location.Controls, like participants, had to have been enrolled in fee-for-service Medicare Parts A and B during the yearpreceding the demonstration and the following three years. Matching was exact on gender and qualifyingevent, within a decade on age, and to the nearest month for the time lag between the onset of the qualifyingevent and enrollment into the LMPD or CR program. To find the closest matches for each participant, we useda combined indicator of DxCG scores and age, where a difference of one year of age was weighted equivalentto a difference of 0.1 point in DxCG score (ie, a 10% change in risk). This weighting was chosen toapproximate the increase in risk of hospitalization[15] and death[16] per year of increasing age in the elderly. The

pool for matching was much larger for non-CR controls than CR controls. Each participant was matched to twoCR and two non-CR controls in 421 cases (91%).

Data Sources

Primary data sources were Medicare's National Claims History files, standard analytic files, and Medicaremaster enrollment files for years 1998 to 2008. Medicare's master enrollment database included information ondate of birth, sex, date of death (where applicable), residence zip code, Medicare eligibility over time, andgroup health plan membership. CMS's payment file for the LMPD was used to sum quarterly payments to sitesfor each LMPD participant.

Outcome Measures

Outcome measures were (1) mortality rates during the three post-enrollment years; (2) total hospitalizations; (3)hospitalizations with a cardiac-related principal discharge diagnosis; and (4) Medicare-paid costs of care.

Survival data were unavailable in Medicare files for 22 beneficiaries (12 MBMI participants, 1 Ornishparticipant, and 9 controls). In our analysis, we made the conservative assumption that participants without vitalinformation had died and that their deaths were equally distributed among the three years of follow-up. Controlswithout vital information were assumed to be alive at end of the follow-up. For hospitalizations, we assumedthat patients who had more than one claim for inpatient services within a 24-hour period had been transferredfrom another hospital and classified them as having had a single hospitalization. Reported costs are amountspaid by Medicare for medical services from 1 year prior to enrollment (or the pseudo-enrollment date forcontrols) and up to 3 years following enrollment or until death. For LMPD participants, total costs includepayments made by CMS to the demonstration sites where lifestyle modification services were performed.Because of limitations in retrieving data from the CMS Data Extraction System, data for skilled nursing facilities


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and home health agencies were available only through 2004 and durable medical equipment expenditureswere imputed. Thereafter, costs were estimated using regression models based on the costs of inpatient,outpatient, and physician visits during each year.

Data Analysis

Mortality rates and total and cardiac hospitalizations were first examined descriptively. Then, multipleregressions using hierarchical linear models were used to determine the effects of the MBMI and Ornishprograms on hospitalizations, controlling for historical hospitalizations, type of qualifying event, gender, and ageat the time of enrollment. Since most lifestyle participants had 2 CR and two non-CR controls, models wereused to address the clustering of these five observations. The effects of lifestyle programs on the numbers andtypes of hospitalizations were calculated from descriptive results and through coefficients to compareparticipants with their respective CR and non-CR controls. Results are presented as average annualdifferences. The differences derived from regression models were tested by linearly combining the associatedcoefficients from the model. 2 tests were used to examine differences in hospitalization rates and mortalityrates among groups. Costs were compared between participants and CR and non-CR control groups adjustingfor key independent variables. These were (1) medical costs in the year before enrollment; (2) the participant'streatment group; (3) type of qualifying cardiac event; and (4) the participant's gender and age. Interactionsamong variables were also included. Cost results are presented as average annual differences between eachlifestyle program and its respective controls.

Funding Sources

Financial support for our evaluation of the LMPD came from the Centers for Medicare & Medicaid Servicesunder contracts 500-95-0060 to Brandeis University and 500-02-0012 to the Delmarva Foundation for MedicalCare and from grant 7R01 DP000339-03 from the Centers for Disease Control to the Benson-Henry Mind BodyProgram at the Massachusetts General Hospital to support data analysis.

ResultsBaseline Characteristics

Of the 580 Medicare beneficiaries who participated in the demonstration, 461 (79%) were enrolled in fee-for-service Medicare and are the focus of this report. Sociodemographic and clinical characteristics of fee-for-service participants are summarized in . Their mean age was 72 years, two thirds were men, more than 90%were white, 60% had received at least some college education, and 38% had completed a college degree ormore.

Table II. Characteristics of fee-for-service participants in the lifestyle modification programs and their

controls

Characteristic

MBMI Ornish

Non-CRcontrols (N =

626)

CRcontrols(N =

627)

MBMI(N =324)

PNon-CR

controls(N =272)

CRcontrols(N =

270)

Ornish(N =137)

P

Age (mean SD)

72.6 5.5 72.7 6.172.2 5.2

.38 71.8 5.2 72.4 5.6 71.3 5.3 .11

Gender (%male)

65.0% 65.4% 64.8% .98 65.8% 65.6% 65.7% 1.00

Race/ethnicityWhite 89.4% 93.4% 94.2% .02 97.3% 97.0% 98.3% .75

Non-white 10.6% 6.6% 5.8% 2.7% 3.0% 1.7%

Qualifying event

AMI 14.5% 14.4% 14.2% 1.00 19.1% 18.9% 19.0% 1.00

AP 17.7% 16.8% 17.6% 25.7% 25.6% 26.3%

CABG 31.6% 32.7% 32.7% 18.4% 18.5% 18.2%


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PCI 36.1% 36.2% 35.5% 36.8% 37.0% 36.5%

Note: Missing observations are not included in statistical comparisons of participants in the Benson-Henry MindBody Institute (MBMI) or Ornish participants.

AP, Angina pectoris.

More than one-third of participants (35.8%) had received percutaneous coronary interventions (PCIs); 28.4%had undergone CABG; 15.6% had had an AMI with no subsequent surgical procedure; and 20.2% had stableangina pectoris. Baseline cardiovascular disease diagnoses differed between participants in the two programs.Ornish included larger proportions of participants with stable angina pectoris (26.3% vs. 17.6%) and AMIs(19.0% vs. 14.2%), while MBMI included more who had received CABG surgery as their qualifying event(32.7% vs. 18.2%). Over 91% of participants were matched with two CR and two non-CR controls, and theremainder were matched with at least one of each. At baseline, 87% of participants were receiving anantilipemic agent and nearly 80% were receiving a beta-blocker.

Hospitalizations

Hospitalization rates are summarized in . The high rates of cardiac-related hospitalizations during the yearbefore the demonstration reflect the study's eligibility and matching criteria. During the active intervention andfollow-up years, total, cardiac, and non-cardiac hospitalizations were lower in MBMI participants than theircontrols for each comparison (P< .001). Ornish showed a similar pattern with significantly lower hospitalization

rates for non-cardiac diagnoses (P= .002) and all causes (P= .02), and a non-significant reduction inhospitalizations for cardiac diagnoses (P= .21). The difference-in-difference analysis showed that participantsin MBMI had 46% fewer total and 50% fewer cardiac hospitalizations than controls, while correspondingreductions in Ornish participants were 30% and 15%.

Table III. Annual cardiac and non-cardiac hospitalization rates per person in lifestyle program participants

and controls

Year

MBMI Ornish

Non-CRcontrol

CRcontrol

MBMIF

valueNon-CRcontrol

CRcontrol

OrnishF

value

Total hospitalizations

Year 0 0.97 1.03 0.87 3.19* 0.96 0.84 0.72 2.36

Average(years 13)

0.46 0.46 0.25 17.58 0.42 0.40 0.29 4.05*

Cardiac-related hospitalizations

Year 0 0.79 0.85 0.72 4.38* 0.66 0.73 0.58 1.74

Average(years 13)

0.20 0.19 0.10 11.83 0.16 0.19 0.15 1.57

Non-cardiac-related hospitalizations

Year 0 0.18 0.18 0.16 0.27 0.30 0.11 0.13 6.68

Average(years 13)

0.27 0.27 0.15 9.49 0.26 0.21 0.14 6.21

CR denotes cardiac rehabilitation.

*P< .05.

P< .01.

P< .001.


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Multiple regression analyses showed similar patterns (). Compared with controls, MBMI participants hadsignificantly fewer total, cardiac, and non-cardiac hospitalizations than controls. Findings in Ornish participantswere similar in direction but less significant statistically due, in part, to smaller sample sizes. Overall, annualabsolute reductions in hospitalizations per participant compared with CR and non-CR controls, respectively,were 0.19 and 0.20 for MBMI and 0.10 and 0.11 for Ornish.

Table IV. Effects of lifestyle modification programs on hospitalization rates per person adjusted for

differences in patient characteristics

Lifestyle programcompared with controls

Total hospitalizationsper year

Cardiac-relatedhospitalizations per year

Non cardiac-relatedhospitalizations per year

MBMI program

Non-CR control 0.20 0.09 0.11

CR control 0.19 0.08 0.11

Ornish program

Non-CR control 0.11 0.01 0.10

CR control 0.10* 0.04 0.07

CR denotes cardiac rehabilitation.

*P< .05.

P< .01.

P< .001.

Medicare Costs

Mean Medicare payments per person-year, excluding the costs of the lifestyle modification programs, weresimilar in participants and controls for each program during the year before enrollment, indicating that matchingwas successful with respect to prior care received (Figure 1). Participants in MBMI had higher average baselinecosts than Ornish participants (t= 3.28, P< .001) due, principally, to the higher proportion who had receivedCABG surgery as their qualifying cardiac event. Mean annual Medicare costs during the program year were

lower in participants than controls for each program. Unadjusted cost reductions were $2,849 (P< .05) and$3,290 (P< .001) in matched CR and non-CR controls, respectively, for MBMI and $2,332 (P= .19) and $869(P= .25) in Ornish. Corresponding mean cost reductions during the two follow-up years after the interventionyear were $5,076 and $3,600 for MBMI and $2,789 and $3,818 for Ornish.


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Figure 1.

Medicare cost per participant per year of MBMI and Ornish participants and their controls.

Mean program costs were $3,801 for MBMI and $4,441 for Ornish program participants and exceededMedicare cost savings in Year 1. Net savings were achieved by both programs; however, over 3 years offollow-up, with cumulative savings of $4,122 and $3,087 compared with CR and non-CR controls, respectively,in MBMI participants and $551 and $245 in Ornish participants. Cost savings in Ornish were not statisticallysignificant, however, because of high variations in costs.

Multiple regression analyses of subsequent Medicare costs, controlling for Medicare costs in the year prior toparticipation in the lifestyle program, found significant positive relations with prior year medical care costs inboth programs, patient age in MBMI, and a diagnosis of angina in Ornish. Lower subsequent costs occurred inpatients receiving CABG in MBMI. Controlling for patient-level variables, lifestyle program participants hadlower costs compared with non-CR controls, but not CR controls, in both programs. This finding wasstatistically significant only for MBMI, however. Three-year cumulative, regression-adjusted, net savings were$3,509 compared with CR controls and $3,562 compared with non-CR controls for MBMI and $1,047 and$1,025, respectively, for Ornish. Three-year savings for each program are statistically significant (P< .001 forMBMI and P< .05 for Ornish).

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Mortality rate trends were lower in MBMI program participants than each control group at the end the activeintervention year and after each year of follow-up, even using the conservative assumption that persons withmissing vital status data were dead. After year 1, the mortality rate was 1.5% in MBMI program participantscompared with 2.5% and 4.2%, respectively, in CR and non-CR controls; after year 3, comparable figures were6.2% in MBMI participants, 10.5% in CR controls, and 11.0% in non-CR controls. These mortality differencesfor MBMI reached borderline significance (P= .08) (Figure 2). In Ornish, mortality trends were in favorabledirections but not statistically significant. Residual case-mix differences between participants and controls may

contribute to these mortality results.

Figure 2.

Mortality in lifestyle modification program participants and controls. Note: MBMI is on left, Ornish on right. Vitalstatus data were missing for 12 MBMI participants, one Ornish participant, and 9 controls. Conservatively,participants with missing vital status were assumed to be dead, and controls were assumed to be alive.

Discussion

Our study examined the clinical and economic benefits of two intensive, year-long, lifestyle modificationprograms in elderly Medicare beneficiaries who had had a cardiac event (AMI, CABG, or PCI) within the

preceding 12 months or stable angina pectoris with documented myocardial ischemia. We assessed 3-yearhospitalization rates, Medicare costs, and mortality. Comparisons are between MBMI and Ornish participantsand matched controls who received either Medicare-supported CR or no CR. Both programs emphasizedmonitored physical exercise and nutritional counseling. Major differences from traditional CR programs werethe greater intensity and longer durations of active interventions and emphases on the importance of stressreduction and small group support.

Major findings were reductions in cardiac and non-cardiac hospitalizations, modest net savings in Medicarecosts for participants compared with matched controls in each program, and trends toward lower mortality ratesin MBMI participants. These findings are present after adjusting for risk factor differences between participants


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and controls using the data available in Medicare claims records. Incomplete matching cannot be fullyexcluded, however, because of the limitations of Medicare claims data in assessing the severity of cardiacdisease and the possible exclusion of high-risk patients by the demonstration's eligibility criteria, anddifferences in motivation and adherence to medical regimens.

Benefits of the lifestyle modification programs are supported by the favorable changes in cardiac risk factorsand cardiac function that were achieved. [17] Systolic blood pressure, total serum cholesterol, and cardiac

functional capacity all improved during the intense period of the intervention, and improvements weremaintained or improved further at 12 and 24 months in participants with active follow-up.

Reductions in hospitalizations may reflect risk factor reductions, increased exercise, and the emphasis placedon stress reduction and small group support. Stress, depression, and lack of social support have beenassociated with higher risks of complications from CHD in several studies. [1822] MBMI emphasized practice ofthe relaxation response during formal sessions plus daily practice at home, while Ornish included regular yogaand stress reduction sessions while encouraging practice at home. Small group support and spiritualconnectedness were important objectives of both programs. Participation in these lifestyle programs wasassociated with statistically significant net savings in Medicare costs over the three-year period of the study ofabout $3,500 and $1,000 per participant for MBMI and Ornish, respectively.

The study's findings are consistent with meta-analyses of randomized controlled trials that have demonstratedlower mortality and better functional outcomes in CR participants than non-CR controls.[5,6,812,23] Mortality trends

shown in Figure 2 favor CR recipients over non-CR controls, even though 3-year follow-up results are notstatistically significant. Important differences from previous studies are that this Medicare demonstration waslimited to elderly Medicare beneficiaries (mean 72 years), included a larger proportion of women (35 percent),and represented advancements in cardiac care provided in recent years (20022008). Most trials reported inmeta-analyses focus on care delivered before 2000 that included younger men and few women and wereconducted before recent improvements in cardiac procedures and reductions in risks due to the widespreaduse of medications such as statins and -blockers.

The limitations of the study need to be acknowledged. First, matching of lifestyle program participants tocontrols was based on factors available in Medicare claims data including age, gender, race, cardiacprocedures and diagnosis, and the presence of comorbidities. We used the DxCG score, a well-standardizedand widely used approach by Medicare to adjust costs of care for the presence and severity of clinicalconditions. This approach does not fully adjust for the severity of underlying cardiac or comorbid diseases,cardiac risk factors, or the intensity of concurrent medical therapy. Nevertheless, the large pool of non-CRcontrols for selection to match LMPD participants allowed for close matching on characteristics in claims data.However, supplemental data for a subset of participants and controls suggested that participants were morehighly educated than controls, with 38% having graduated from college compared with 32% of controls with CRand 22% of those with no CR. [24] However, there is no unanimous agreement that higher education contributesto positive behavior changes for better survival among patients with cardiovascular diseases.[25]

Second, Medicare's eligibility criteria for the demonstration excluded high-risk individuals who had involvementof the left main coronary artery, severe congestive heart failure, or impaired cognitive function. It is unlikely,however, that the matched controls included significant proportions of such cases.

Third, the statistical power of the analysis was limited by the relatively small size of the study population (324fee-for-service beneficiaries in MBMI and 137 in Ornish). Data from participants who were enrolled in healthmaintenance organizations could not be included because Medicare claims data were not available for them.

The policy implications of our findings emphasize the high priority that needs to be given to innovative

approaches to improving health outcomes while controlling or reducing health care costs. Intensive lifestylemodification programs such as MBMI and Ornish fall into this category. The Medicare Improvements forPatients and Providers Act of 2008[26] extended coverage under Medicare Part B beginning on January 1, 2010to include intensive cardiac rehabilitation and provide reimbursement for substantially more hours thanstandard comprehensive rehabilitation. Our study's findings support the benefits of extending enhancedinsurance coverage to additional qualified programs that can be shown to reduce hospitalization rates, reducecosts, and, possibly, reduce mortality.

References


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1. Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke statistics2011 update: a reportfrom the American Heart Association. Circulation 2011;123(4):e18e209.

2. Rosamond W, Flegal K, Furie K, et al. Heart disease and stroke statistics2008 update: a report fromthe American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation2008;117(4):e25e146.

3. Centers for Medicare and Medicaid Services. Medicare national coverage determinations manual.www.cms.gov/manuals/downloads/ncd103c1_Part1.pdf, 2010 Accessed: 22 Aug 2011.

4. Suaya JA, Shepard DS, Normand SL, et al. Use of cardiac rehabilitation by Medicare beneficiariesafter myocardial infarction or coronary bypass surgery. Circulation 2007;116(15):165362.

5. Clark AM, Hartling L, Vandermeer B, et al. Meta-analysis: secondary prevention programs for patientswith coronary artery disease. Ann Intern Med 2005;143(9):65972.

6. Jolliffe JA, Rees K, Taylor RS, et al. Exercise-based rehabilitation for coronary heart disease.Cochrane Database Syst Rev 2001;1:CD001800.

7. O'Connor GT, Buring JE, Yusuf S, et al. An overview of randomized trials of rehabilitation with exerciseafter myocardial infarction. Circulation 1989;80(2):23444.

8. Oldridge NB, Guyatt GH, Fischer ME, et al. Cardiac rehabilitation after myocardial infarction.Combined experience of randomized clinical trials. JAMA 1988;260(7):94550.

9. Taylor RS, Brown A, Ebrahim S, et al. Exercise-based rehabilitation for patients with coronary heartdisease: systematic review and metaanalysis of randomized controlled trials. Am J Med2004;116(10):68292.

10. Suaya JA, Stason WB, Ades PA, et al. Cardiac rehabilitation and survival in older coronary patients. JAm Coll Cardiol 2009;54(1):2533.

11. Hammill BG, Curtis LH, Schulman KA, et al. Relationship between cardiac rehabilitation and long-termrisks of death and myocardial infarction among elderly Medicare beneficiaries. Circulation2010;121:6370.

12. Goel K, Lennon RJ, Tilbury RT, et al. Impact of cardiac rehabilitation on mortality and cardiovascular

events after percutaneous coronary intervention in the community. Circulation 2011;123:234452.

13. West RR, Jones DA, Henderson AH. Rehabilitation after myocardial infarction trial (RAMIT): multi-centre randomized controlled trial of comprehensive cardiac rehabilitation in patients following acutemyocardial infarction. Heart 2011, http://dx.doi.org/10.1136/heartjrl-2011300302.

14. Shepard DS. Lifestyle Modification to Control Heart Disease: Evidence and Policy. Sudbury, MA:Jones & Bartlett; 2010.

15. Healthcare Cost and Utilization Project (HCUP), Agency for Healthcare Research and Quality (US).HCUP Facts and Figures: Statistics on Hospital-based Care in the United States, 2007.http://www.ncbi.nlm.nih.gov/books/NBK53003, 2009 Accessed: 8 June 2012.

16. US Centers for Disease Control, National Center for Health Statistics. Worktable 23R. Death Rates by10-Year Age Groups. http://www.cdc.gov/nchs/data/dvs/MortFinal2007_Worktable23r.pdf, 2007

Accessed: 8 June 2012.

17. Shepard DS, Stason WB, Strickler G, et al. Evaluation of the Medicare Lifestyle Modification ProgramDemonstration. Centers for Medicare and Medicaid Services.http://people.brandeis.edu/~shepard/LMPD_FER.zip, 2009 Accessed: 6 Jan 2013.

18. Hearn MD, Murray DM, Luepker RV. Hostility, coronary heart disease, and total mortality: a 33-yearfollow-up study of university students. J Behav Med 1989;12(2):10521.


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19. Hemingway H, Marmot M. Evidence based cardiology: psychosocial factors in the aetiology andprognosis of coronary heart disease. Systematic review of prospective cohort studies. BMJ1999;318(7196):14607.

20. Jin H, Folsom D, Sasaki A, et al. Increased Framingham 10-year risk of coronary heart disease inmiddle-aged and older patients with psychotic symptoms. Schizophr Res 2011;125(23):2959.

21. Kubzansky LD, Park N, Peterson C, et al. Healthy psychological functioning and incident coronaryheart disease: the importance of self-regulation. Arch Gen Psychiatry 2011;68(4):4008.

22. Stansfeld SA, Fuhrer R, Shipley MJ, et al. Psychological distress as a risk factor for coronary heartdisease in the Whitehall II Study. Int J Epidemiol 2002;31(1):24855.

23. Lavie CJ, Milani RV. Cardiac rehabilitation and exercise training in secondary coronary heart diseaseprevention. Prog Cardiovasc Dis 2011;53(6):397403.

24. Shepard DS, Stason WB, Strickler G, et al. Evaluation of Lifestyle Modification and CardiacRehabilitation in Medicare Beneficiaries Centers for Medicare and Medicaid Services.http://www.cms.gov/Medicare/Demonstration-Projects/DemoProjectsEvalRpts/downloads/LMPD_Summary_of_Findings.pdf, 2009 Accessed: 6 Jan2013.

25. Chan R, Gordon N, Chong A, et al. Influence of socioeconomic status on lifestyle behaviormodifications among survivors of acute myocardial infarction. Am J Cardiol 2008;102(12):15838.

26. Government Printing Office. Public Law No. 110275;74. Reg. 61,738,520,62,004. 2008.

Acknowledgements

The authors thank Clare L. Hurley for assistance in preparing this manuscript. The principal fundingorganization (CMS) implemented the demonstration and approved the design of its evaluation by BrandeisUniversity. Data collection and adherence to lifestyle modification protocols were monitored by the DelmarvaFoundation for Medical Care, Inc. a CMS-contracted Quality Improvement Organization in Easton, MD. We areparticularly grateful to Roxanne Rodgers, PMP, RN and William J. Oetgen, MD, MBA for ensuring the highquality of collected data. The findings and conclusions of the paper are those of the authors alone.

Am Heart J. 2013;165(5):785-792. 2013 Mosby, Inc.

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