Developed for the May 2010 COF Conference in San Diego, CA Track 4: Expanding Access to Preventive Care and Quality Health Wed May 26 1615-1645
Evaluation of the Medicare Lifestyle Modification Program Demonstration and the Medicare Cardiac Rehabilitation Benefit Armen H. Thoumaian, Ph. D., LCSW CAPT U.S. Public Health Service Office of Research, Development & Information Centers for Medicare & Medicaid Services 1
2 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 3
Medicare Cardiovascular Lifestyle Modification Program Demonstration “Requested” by President Clinton May 1999 Implemented October 1, 1999 Mandated by Congress January 2001 (PL 106-554 Consolidated Appropriations Act of 2001) 4
Lifestyle modification programs may be useful as secondary prevention to: u Reduce risk factors and thereby…... u Lower ER visits, hospitalizations, and surgical procedures…... u Leading to better health and lower health care costs. 5
Lifestyle Modification Cardiovascular lifestyle modification programs typically include: è smoking cessation, è low fat vegetarian diet, è aerobic physical exercise, and è stress management techniques è group support 6
Medicare Lifestyle Modification Program - Model Selection l Multi-Site Lifestyle Model l 12 Month Treatment Program l Scientific Support for Outcomes l Administration & Congressional Mandate 7
Medicare Lifestyle Modification Program - Evaluation l RFP for Independent Evaluation Awarded to Brandeis University l Matched Paired Design (maximum of 3600 controls) l Quality of Care / Outcomes / Satisfaction / Savings / Feasibility 8
Medicare Lifestyle Modification Program - Policy 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. 9
Medicare Lifestyle Modification Program - Initial Program Model l Dean Ornish Program Sites l $5,760 for 12 months l $1,440 fee to patient (or waived by site) l Allowed to enroll up to 1800 patients l Potential for 30 or more sites 10
Medicare Lifestyle Modification Program - 2 nd Program Model l Cardiac Wellness Program Sites l $3,860 for 12 months l $960 fee to patient (or waived by site) l Allowed to enroll up to 1800 patients l Potential for 12 or more sites 11
Medicare Payment l Dean Ornish Program Sites l Negotiated Fee $5,650 l $4,520 (80%) paid by Medicare for 12 Months l $1,130 (20%) fee to patient (or waived by site) l Cardiac Wellness Program Sites l Negotiated Fee $4,800 l $3,840 (80%) paid by Medicare for 12 months l $960 fee to patient (or waived by site) l Programs allowed to enroll 1800 each. 12
è Comparison of two national, multi-site program models: Ornish program & Benson program. è 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. è Up to 1800 patients may enroll in each program. è Negotiated package price (Ornish-$5650) (M/BMI- $4800). è 12 month treatment program with 12 month follow-up. 13 Demonstration Design :
Program Participants : 14 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
Beneficiary Enrollment Eligibility Criteria : Medicare Part B and Acute myocardial infarction and/or, Stable Angina pectoris and/or, CABG or PTCA in past 12 months. 16
Medicare Lifestyle Modification Program – Initiate New Payment System 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. 17
Medicare Lifestyle Modification Program - Quality Monitoring l Review & Confirm Clinical Eligibility l Monitor Quality of Care l Monitor Outcomes l Investigate Adverse Events l Perform Regular Site Inspections 18 Delmarva Foundation for Medical Care, Inc. (the Maryland Medicare QIO)
Medicare Lifestyle Modification Program - Evaluation 19 Brandeis University l Matched Paired Design l Assess Physical and Psychological Outcomes Patient Satisfaction Savings to Medicare
Program Participants : (376 of 589 completed 1 year programs) 20 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)
21 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) 0.2NS-2.2**-1.8** Total Cholesterol (mg/dl) -8.4NS-13.0***-12.0*** HDL (mg/dl) 1.5NS6.6***5.6*** LDL (mg/dl) -8.1NS-7.7***-7.7*** Triglycerides (mg/dl) -9.2NS-12.6**-11.9*** Cardiac Functional Capacity (METs) 0.9*1.6***1.4*** Overall All Participants OrnishMBMI
22 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-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. 24
Comparison of Program Costs to Medicare versus Provider 1-Year Program18 Weeks OrnishM/BMI Traditional ProgramProgram Card. Rehab. Average Medicare Costs$4,520 $3,840$683 Average Provider Costs$9,895$4,458$1,828 25
Average Medicare payments by program and year* YearNon-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. 26
Summary Remarks About Findings 1.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 Cardiac Rehabilitation Benefit 28
29 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.
30 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)
31 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
32 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
33 Utilization of Cardiac Rehabilitation in the Medicare Population
34 Odds of Cardiac Rehab Utilization by Socio- Economic Status of Residence Those in low income zip codes 19% less likely than those in high income zip codes.
35 CR use by distance to nearest CR facility Those living furthest away were 79% less likely to use Cardiac Rehabilitation.
37 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.
38 Impact of Cardiac Rehabilitation on Survival
39 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?
40 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).
41 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).
45 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.
47 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.
48 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 cardiac rehabilitation can improve patient survival and reduce health care costs.
Final 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=desce nding&itemID=CMS1192588&intNumPerPage=10 49 Evaluation of the Medicare Lifestyle Modification Program Demonstration and the Medicare Cardiac Rehabilitation Benefit