Intensive Cardiac Rehabilitation (ICR) Program - Benson-Henry Institute Cardiac Wellness Program

The Centers for Medicare & Medicaid Services (CMS) has determined that the evidence is sufficient to expand the intensive cardiac rehabilitation (ICR) benefit to include the Benson-Henry Institute Cardiac Wellness Program, which meets the ICR program requirements set forth by Congress in §1861(eee)(4)(A) of the Social Security Act and in our regulations at 42 C.F.R. §410.49(c).

TO:		Administrative File: CAG-00434N   
   
FROM:	Tamara Syrek Jensen, JD   
		Acting Director/Deputy Director   
		Coverage and Analysis Group   
		   
		Lori Ashby   
		Acting Director   
		Division of Medical and Surgical Services   
		   
		Joseph Chin, MD, MS   
		Lead Medical Officer   
		   
		Michelle Issa, MBA   
		Lead Analyst	   
		   
SUBJECT:	Decision Memorandum for Coverage of Intensive Cardiac Rehabilitation Program - Benson-Henry Institute Cardiac Wellness Program.  	   
   
DATE:		May 6, 2014

I. Decision

The Centers for Medicare & Medicaid Services (CMS) has determined that the evidence is sufficient to expand the intensive cardiac rehabilitation (ICR) benefit to include the Benson-Henry Institute Cardiac Wellness Program, which meets the ICR program requirements set forth by Congress in §1861(eee)(4)(A) of the Social Security Act and in our regulations at 42 C.F.R. §410.49(c).

II. Background

The following acronyms are used throughout this document. For the readers convenience they are listed here in alphabetical order.

AHA - American Heart Association
BMI - body mass index
BP - blood pressure
CMS - Centers for Medicare & Medicaid Services
CAD - coronary artery disease
CR - cardiac rehabilitation
CHL - cholesterol
DBP - diastolic blood pressure
DM - diabetes medications
ICR - intensive cardiac rehabilitation
LDL - low density lipoprotein
LMPD - Medicare Lifestyle Modification Program Demonstration
MBMI - Cardiac Wellness Program of the Benson-Henry Mind Body Medical Institute
MET - metabolic equivalents of task
NCA - national coverage analysis
NCD - national coverage determination
PTCA - percutaneous transluminal coronary angioplasty
RCT - randomized controlled trial
SBP - systolic blood pressure
SH - systolic hypertension
TG - triglycerides

Cardiac rehabilitation (CR) was developed in the 1950s from the concept of early mobilization after acute myocardial infarction. (Pashkow, 1993) The standard of care prior to the widespread adoption of CR was bed-rest and inactivity after acute myocardial infarction. (Forman, et al., 2000) In the 1970s, cardiac rehabilitation developed into highly structured, physician supervised, electrocardiographically-monitored exercise programs. However, the programs consisted almost solely of exercise alone. (Ades, 2000) Foreman (2000) stated that "over subsequent years, CR broadened beyond exercise into a composite of cardiac risk modification. Lipid, blood pressure and stress reductions, smoking cessation, diet change, and weight loss were coupled to goals of exercise training."

ICR incorporates the main interventions in CR while increasing the frequency and number of specific interventions to improve cardiovascular outcomes. The fundamental concepts of the Benson-Henry Institute Cardiac Wellness Program were developed by Herbert Benson, MD, over 40 years ago. Benson stated that "in the middle 1960s, when I noticed that people's blood pressures were higher during visits to my office than at other times and wondered whether stress wasn't causing that rise. Stress wasn't on the radar then, so I began investigating a connection between stress and hypertension." (http://www.ideafit.com/fitness-library/mind-body-medicine-balanced-approach)

The Cardiac Wellness Program is a multicomponent intervention program that includes supervised exercise, behavioral interventions and counseling and is designed to reduce cardiovascular risk and improve health outcomes. It was also one of two programs selected for the Medicare Lifestyle Modification Program Demonstration. Medicare currently covers two ICR programs: Dr. Ornish's Program for Reversing Heart Disease (CAG-00419N), the other program in Medicare Lifestyle Modification Program Demonstration, and the Pritikin Program (CAG-00418N).

III. History of Medicare Coverage

Sections 1861(s)(2)(DD) and 1861(eee)(4)(A-C) of the Social Security Act (the Act) provide for coverage of items and services furnished under a ICR program under part B. As required by §1861(eee)(4)(A), an ICR program must show, in peer-reviewed published research, that it accomplished one or more of the following:

(1) positively affected the progression of coronary heart disease;
(2) reduced the need for coronary bypass surgery; or
(3) reduced the need for percutaneous coronary interventions.

It must also demonstrate through peer-reviewed published research that it accomplished a statistically significant reduction in five or more of the following measures for patients from their levels before cardiac rehabilitation services to after cardiac rehabilitation services:

(1) low density lipoprotein;
(2) triglycerides;
(3) body mass index;
(4) systolic blood pressure;
(5) diastolic blood pressure; and
(6) the need for cholesterol, blood pressure, and diabetes medications.

As required by §1861(eee)(4)(B) of the Act, to be eligible for an intensive cardiac rehabilitation program, an individual must have:

(1) had an acute myocardial infarction within the preceding 12 months;
(2) had coronary bypass surgery;
(3) stable angina pectoris;
(4) had heart valve repair or replacement;
(5) had percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting; or
(6) had a heart or heart-lung transplant.

Individual ICR programs must be approved through the national coverage determination (NCD) process to ensure that they demonstrate these accomplishments (42 CFR §410.49(c)(3)). Using this process, CMS added coverage for Dr. Ornish's Program for Reversing Heart Disease and the Pritikin Program in 2010. CMS initiated this national coverage analysis (NCA) after receiving a formal request from Gregory Fricchione, MD, Herbert Benson, MD, and Aggie Casey, RN, MS, for a national coverage determination (NCD) to provide coverage for the Benson-Henry Institute Cardiac Wellness Program.

IV. Benefit category

Medicare is a defined benefit program. An item or service must fall within a benefit category as a prerequisite to Medicare coverage [§1812 (Scope of Part A); §1832 (Scope of Part B); §1861(s) (Definition of Medical and Other Health Services)]. An item or service must meet one of the statutorily defined benefit categories in the Social Security Act and not otherwise be excluded.

As noted above, Congress specifically authorized coverage of certain items and services furnished by a qualified ICR program under Part B of the Medicare program (Sections1861(s)(2)(DD) and 1861(eee)(4) of the Act.

V. Timeline of Recent Activities

V. FDA

The Benson-Henry Institute Cardiac Wellness Program is not subject to FDA oversight.

VI. General Methodological Principles

When making national coverage determinations concerning ICR programs, CMS evaluates peer-reviewed published research to determine whether or not the ICR program meets the criteria required in §1861(eee) of the Act.

Public comments sometimes cite the published clinical evidence and give CMS useful information. Public comments that give information on unpublished evidence such as the results of individual practitioners or patients are less rigorous and therefore less useful for making a coverage determination. Public comments that contain personal health information (PHI) will be redacted and the PHI will not be made available to the public. CMS uses the initial public comments to inform its proposed decision. CMS responds in detail to the public comments on a proposed decision when issuing the final decision memorandum.

VII. Evidence

A. Introduction

In this coverage analysis, we considered peer-reviewed evidence specifically on the Benson-Henry Institute Cardiac Wellness Program to assess whether the program meets the statutorily defined requirements to be included as an intensive cardiac rehabilitation program under the Medicare program as listed in §1861(eee).

B. Literature Search

CMS searched PubMed from 2000 (when CR interventions broadened and formalized into multicomponent intervention programs) to December 2013 using key words Benson-Henry, cardiac wellness, cardiac rehabilitation and exercise. We initially focused our search on randomized controlled trials (RCTs) and large prospective observational studies that evaluated adults ≥ 65 years but expanded the search to include all studies and all populations. Abstracts without a complete publication were excluded. In addition to our search, the requestors submitted several published articles which were reviewed and included as appropriate.

C. Discussion of Evidence Reviewed

For this analysis, we focused on the following question:

Does the Benson-Henry Institute Cardiac Wellness Program meet the requirements set forth in §1861(eee)(4) of the Act for an ICR program:

(1) positively affected the progression of coronary heart disease;
(2) reduced the need for coronary bypass surgery; or
(3) reduced the need for percutaneous coronary interventions?

Also, as required by §1861(eee)(4)(A)(ii) of the Act, an ICR program must demonstrate through peer-reviewed published research that it accomplished a statistically significant reduction in five or more of the following measures for patients from their levels before cardiac rehabilitation services to after cardiac rehabilitation services:

(1) low density lipoprotein;
(2) triglycerides;
(3) body mass index;
(4) systolic blood pressure;
(5) diastolic blood pressure; and
(6) the need for cholesterol, blood pressure, and diabetes medications.

1. External technology assessment

None were found.

2. Internal technology assessment

Casey A, Chang BH, Huddleston J, Virani N, Benson H, Dusek JA. A model for integrating a mind/body approach to cardiac rehabilitation: outcomes and correlators. J Cardiopulm Rehabil Prev. 2009 Jul-Aug;29(4):230-8; quiz 239-40. doi: 10.1097/HCR.0b013e3181a33352.

Casey and colleagues reported the results of a case series study to evaluate CR in patients with coronary artery disease. From 1997 to 2005, 637 patients with coronary artery disease were enrolled and completed a 13-week CR program that incorporated components of the Cardiac Wellness Program at one center. Measurements were performed at baseline and at the end of the program. All patients had coronary artery disease. Other inclusion and exclusion criteria were not specified. The programs consisted of 13 weekly three hour sessions that included supervised exercise, relaxation techniques, stress management and behavioral interventions. "The Mediterranean diet, 50% to 55% carbohydrates, with an emphasis on fruits, vegetables, and whole grains; 20% to 30% fat, with emphasis on monounsaturated and polyunsaturated fats; and 15% to 20% protein, was recommended to patients." Aerobic exercises included walking, swimming and biking.

Mean age of participants was 63 years (range 27-92 years). Men comprised 72% of the study population. Ninety percent were white. The authors reported significant improvements in "outcomes (blood pressure, lipids, weight, exercise conditioning, frequency of symptoms of chest pain and shortness of breath) and psychological outcomes (general severity index, depression, anxiety, and hostility) (P <.0001)." They concluded that "our data demonstrate the success and effectiveness of a mind/body CR program in reducing medical and psychological risks in men and women with CAD."

Dusek JA, Hibberd PL, Buczynski B, Chang BH, Dusek KC, Johnston JM, Wohlhueter AL, Benson H, Zusman RM. Stress management versus lifestyle modification on systolic hypertension and medication elimination: a randomized trial. J Altern Complement Med. 2008 Mar;14(2):129-38. doi: 10.1089/acm.2007.0623.

Dusek and colleagues reported the results of a randomized controlled trial of stress management compared to lifestyle modification in reducing systolic blood pressure (SBP) in older adults with isolated systolic hypertension (SH). A total of 122 patients were randomly assigned to either stress management, specifically relaxation response (RR) training (n = 61) or lifestyle modification (n = 61). Inclusion criteria were age of 55 years or older, systolic blood pressure 140-159 mm Hg, diastolic blood pressure less than 90 mm Hg, and at least two antihypertensive medications. Patients were "ineligible if the dose of any antihypertensive medication had been changed within the 4 weeks prior to screening; if they had a major medical illness in the previous 6 months (heart, kidney or liver disease, stroke, cancer, endocrinopathy, or psychiatric illness); if they had an abnormal laboratory test; if they currently smoked; or if they previously practiced any mind/body techniques." Primary outcome was change in systolic blood pressure at eight weeks. Stress management intervention consisted of weekly relaxation response training instruction, guided relaxation elicitation and health education. Lifestyle modification consisted of weekly written and verbal information on stress reduction and cardiac risk factor modification.

Mean age of participants was 67 years (range not reported). Men comprised 55% of the study population. Eighty seven percent were white. The authors reported: "After controlling for differences in characteristics at the start of medication elimination, patients in the relaxation response group were more likely to successfully eliminate an antihypertensive medication (odds ratio 4.3, 95% confidence interval 1.2-15.9, p = 0.03). Although both groups had similar reductions in SBP, significantly more participants in the relaxation response group eliminated an antihypertensive medication while maintaining adequate blood pressure control." They concluded that "8 weeks of RR training and lifestyle modification reduced SBP by ~9 mm Hg in elderly patients with SH, but patients receiving RR training were more likely to eliminate at least one antihypertensive medication."

Shepard DS, Stason WB, Strickler GK, Lee AJ, Bhalotra SM, Ritter, GA, Suaya JA, Gurewich D, Fournier S, Zeng W, Razavi SM, Hurley CL. Executive Summary: Evaluation of Lifestyle Modification and Cardiac Rehabilitation in Medicare Beneficiaries. Schneider Institutes for Health Policy, Heller School, MS 035, Brandeis University, Waltham, MA 02454-9110 April 30, 2009. Available at: http://www.cms.gov/Medicare/Demonstration-Projects/DemoProjectsEvalRpts/Medicare-Demonstrations-Items/CMS1192588.html

Stason WB, Shepard DS, Fournier S, Ritter G, Strickler GK, Bhalotra SM, Suaya JA. Effects of the Medicare Lifestyle Modification Program Demonstration on Cardiac Risk and Quality of Life. Appendix A.3 of the Evaluation of Lifestyle Modification and Cardiac Rehabilitation in Medicare Beneficiaries. Schneider Institutes for Health Policy Heller School, MS 035, Brandeis University Waltham, MA 02454-9110 USA. April 15, 2009.

Shepard and colleagues reported the results of the Medicare Lifestyle Modification Program Demonstration (LMPD), a CMS funded project designed to test the effectiveness of providing payment for cardiovascular lifestyle modification program services to Medicare beneficiaries age 65 or older with moderate to severe coronary artery disease. Beneficiaries who had stable angina with substantial coronary artery disease, who had a myocardial infarction or who had cardiac revascularization (bypass or percutaneous) within the previous 12 months were eligible. Main outcomes were change in cardiac risk factors, psychological health (Symptom Checklist-90™) and cardiac function (metabolic equivalents of task (METs); one MET is the oxygen consumption at rest). Two programs were studied: the Ornish program and the Benson Cardiac Wellness Program (later to be renamed Benson-Henry). "Each lifestyle program consisted of a one-year treatment program that included supervised exercise, nutrition counseling, stress management, and group support beginning with a three month period of intensive supervised interventions followed by nine months of less frequent sessions with a greater emphasis on home maintenance of healthy behaviors." Participants in the Benson program received one three hour session per week for 13 weeks, with emphasis "on adhering to the American Heart Association diet (about 30% of calories from fat), group support and behavior change, and one-on-one health contracting and assessment sessions," followed by twice month sessions for a total of one year. "The evaluation of the demonstration used a matched-paired control group design to compare outcomes and Medicare costs in demonstration participants with controls who did not receive the lifestyle modification program but were matched on clinical and sociodemographic characteristics using administrative data. The evaluation used three types of data: (1) before and after clinical and cardiac risk factor measurements obtained for participants during the demonstration; (2) self-reported health-related behaviors of participants and matched controls obtained by mailed and telephone surveys; and (3) Medicare claims data to obtain data on subsequent clinical events and Medicare costs for both participants and matched controls."

Enrollment in the LMPD began in October 1999 and ended in February 2006. At nine sites in the U.S., 442 beneficiaries were enrolled into the Benson program. Of these, 284 completed the one year program. Mean age of participants in the Benson program was 72 years. Men comprised 65% of the study population. Eighty five percent were white. The authors found significant improvements over baseline in body weight, body mass index, systolic blood pressure, diastolic blood pressure, total cholesterol, high density lipoprotein, low density lipoprotein and triglycerides at three months, 12 months and 24 months for participants in the Benson program. Cardiac function and psychological health also significantly improved at three and 12 months for both and at 24 months for cardiac function. "Cox regression models of mortality showed that after controlling for gender, qualifying event, and age at enrollment, the M/BMI program reduced the death hazard among the participants compared to the non-CR control group." Stason and colleagues reported that "[a]ll-cause deaths occurred in 5 participants (3.5%) in the Ornish program and 3 participants (0.7%) in the M/BMI program (p = 0.026)."

Zeng W, Stason WB, Fournier S, Razavi M, Ritter G, Strickler GK, Bhalotra SM, Shepard DS. Benefits and costs of intensive lifestyle modification programs for symptomatic coronary disease in Medicare beneficiaries. Am Heart J. 2013 May;165(5):785-92. doi: 10.1016/j.ahj.2013.01.018. Epub 2013 Mar 1.

Zeng and colleagues published the results of the Medicare Lifestyle Modification Program Demonstration (LMPD), as previously described by Shepard and colleagues in their 2009 report to CMS, with additional evaluation of hospitalizations and mortality at three years. This analysis included 461 participants and 1795 matched controls using Medicare claims data from 1998 to 2008. "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-CR controls)." Outcomes 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." Multivariate regression was used for the analysis.

Of the 324 participants in the Benson-Henry Mind Body Medical Institute (MBMI) program analysis, mean age was 72 years (range not reported). Men comprised 65%. Ninety four percent were white. The authors found that "[d]uring the active intervention and follow-up years, total, cardiac, and non-cardiac hospitalizations were lower in MBMI participants than their controls for each comparison (P<.001)." They further reported: "After year 1, the mortality rate was 1.5% in MBMI program participants compared with 2.5% and 4.2%, respectively, in CR and non-CR controls; after year 3, comparable figures were 6.2% in MBMI participants, 10.5% in CR controls, and 11.0% in non-CR controls. These mortality differences for MBMI reached borderline significance (P = .08)." "Program costs of $3,801 and $4,441 per participant for the MBMI and Ornish Programs, respectively, were offset by reduced health care costs yielding non-significant three-year net savings per participant of about $3,500 in MBMI and $1,000 in Ornish."

3. Professional Society

No professional society statements were found on this program.

4. Medicare Evidence Development & Coverage Advisory Committee (MEDCAC)

The MEDCAC was not convened for this review.

5. Evidence-based guidelines

None were found.

6. Consensus statement

None were found.

7. Public Comments

Initial 30-day comment period – (09/03/2013-10/03/2013)

During the initial 30-day comment period, CMS received one public comment. The commenter opposed coverage for this program. The comment may be accessed on the CMS website at View Public Comments: http://www.cms.gov/medicare-coverage-database/details/nca-view-public-comments.aspx?NCAId=271

Final 30-day comment period – (02/27/2014-03/29/2013)

Public Comments on the Proposed Decision Memorandum

CMS received 11 comments on the proposed decision. There were five comments from academic institutions, two from health management and health research consultants, and four from individuals who did not identify an associated organization. These same commenters did not support the proposed decision to cover the Benson-Henry Institute Cardiac Wellness Program.

Comment:
Several commenters asserted that the intent of the statutory ICR benefit in MIPPA 2008, Section 144(a), was to establish a separate benefit for programs that "reverse the progression of coronary heart disease."

Response:
As an administrative agency, CMS is bound by the language that is enacted by Congress and that is signed by the President. We have summarized the statute in this decision memorandum (pages 2-3), as well as in our proposed decision memorandum, and when we established rules for intensive cardiac rehabilitation programs. See 42 C.F.R. § 410.49. Contrary to the commenters' suggestion, the statute does not expressly require that an ICR program must demonstrate that the program has "reversed the progression of coronary artery disease." The statute provides three alternative tests that can be used in approving an ICR program under part B. CMS has applied the same statutory and regulatory standards to all ICR programs that have sought approval through the NCD process.

Comment:
Commenters claimed that the Benson-Henry program did not meet the requirement "that it accomplished one or more of the following for its patients: (1) positively affected the progression of coronary heart disease; (2) reduced the need for coronary bypass surgery; and (3) reduced the need for percutaneous coronary interventions."

Response:
We disagree with this comment. We find that the Benson Henry program meets the first criterion - positively affected the progression of coronary heart disease - as shown in a peer-reviewed publication (Zeng, 2013). The statute requires only that an ICR program meet one or more of the three requirements. An ICR program is not required to meet all three standards.

As outlined in the analysis, in the article by Zeng and colleagues, the authors stated that "[c]ardiac and non-cardiac hospitalization rates were lower in participants than controls in each program [Cardiac Wellness Program of the Benson-Henry Mind Body Institute (MBMI) and the Dr. Dean Ornish Program for Reversing Heart Disease®] and were statistically significant in MBMI (P < .01)." Hospitalization rate (which includes hospital readmissions) has long been recognized and accepted as an important health outcome for individuals with cardiovascular disease including coronary heart disease. Reducing hospitalization readmission is also an important focus for the Medicare program. In addition, coronary heart disease may cause or progress to other cardiac and non-cardiac conditions, the total cardiac hospitalization rate is an important outcome. For example, coronary heart disease is one of the leading causes of chronic heart failure which in turn is one of the leading discharge diagnoses in the Medicare population. The rate of total hospitalizations (cardiac and non-cardiac) is a meaningful outcome since it may provide a better indication of overall health status than disease specific hospitalizations where the magnitude of net benefit may be offset by an increase in other hospitalizations. This is similar to the reasoning for selecting all-cause mortality as a primary outcome rather than disease specific mortality. With these considerations, we have concluded that the reduction in hospitalization rates (cardiac and non-cardiac) directly indicated that the Benson-Henry program positively affected the progression of coronary heart disease.

Comment:
Commenters noted that the statistical significance level of 0.05 was not met for the demonstrated mortality benefit.

Response:
We agree that statistical significance is commonly set at a p-value (probability of observing a study outcome as extreme or more extreme than the one observed) of 0.05, with results that have a level less than or equal to 0.05 considered statistically significant. While a detailed discussion of statistical significance is beyond the scope of this response, it is related to power calculations and study sample size. For example, in some studies with a large sample size, the results may be statistically significant while having a small incremental benefit on health outcomes. In other studies with a small sample size, results may not be statistically significant but the magnitude of the observed benefit may be large. This does not necessarily mean the observed benefit is not a true effect but that it was not demonstrated significantly in the study. The significance level influences the interpretation of certainty of net benefit so a follow up study would be helpful to confirm the initial results.

We believe the mortality finding in the Benson-Henry study is consistent with the second scenario noted above. It is also consistent with other large trials such as the HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training; (O'Connor, 2011)) which showed that "[a]fter adjustment for highly prognostic predictors of the primary end point, exercise training was associated with modest significant reductions for both all-cause mortality or hospitalization and cardiovascular mortality or heart failure hospitalization."

We noted that the mortality benefit reported by Zeng and colleagues was supportive and approached significance. We encourage additional study of the Benson-Henry program's effect on mortality to confirm or refute the impressive initial trend observed (seen in figure below).

Figure 2, Page 790. Zeng W, Stason WB, Fournier S, Razavi M, Ritter G, Strickler GK, Bhalotra SM, Shepard DS. Benefits and costs of intensive lifestyle modification programs for symptomatic coronary disease in Medicare beneficiaries. Am Heart J. 2013 May;165(5):785-92. PMID: 23622916.

Comment:
Commenters noted that the Benson-Henry program should be covered as traditional CR and not ICR.

Response:
We disagree with this comment. CR and ICR are statutorily defined benefits. The requirements for ICR programs are specific. Based on the evidence in peer reviewed publications, we have concluded that the Benson-Henry program met the requirements to be included as an approved Medicare ICR program.

VIII. CMS Analysis

This NCD is a scope of benefit determination and is made by the Secretary with respect to whether or not a particular ICR program meets the coverage requirements under title XVIII of the Social Security Act. §1861(eee)(4)(A).

The criteria and approval of intensive cardiac rehabilitation programs are defined by statute (Sections1861(s)(2)(DD) and 1861(eee)(4)(A-C) of the Social Security Act). To be approved as an ICR program, it must demonstrate through peer-reviewed, published research that it has accomplished one or more of the following for its patients:

(1) positively affected the progression of coronary heart disease;
(2) reduced the need for coronary bypass surgery; or,
(3) reduced the need for percutaneous coronary interventions.

An ICR program must also demonstrate through peer-reviewed, published research that it accomplished a statistically significant reduction in five or more of the following measures for patients from their levels before CR services to after CR services:

(1) low density lipoprotein;
(2) triglycerides;
(3) body mass index;
(4) systolic blood pressure;
(5) diastolic blood pressure; and
(6) the need for cholesterol, blood pressure, and diabetes medications.

Question: Does the Benson-Henry Institute Cardiac Wellness Program meet the requirements set forth in §1861(eee)(4)(A) of the Act to be added as an ICR program?

Progression of coronary heart disease, reduction in the need for coronary bypass surgery, or reduction in the need for percutaneous coronary interventions.

Two reports (Zeng, 2013; Shepard/Stason, 2009) provided evidence on the progression of coronary heart disease. In an analysis of the Medicare Lifestyle Modification Program Demonstration, Zeng reported in a peer-reviewed publication that the mortality rate of participants in the Benson-Henry Institute Cardiac Wellness Program was lower at one year and three years compared to rigorously matched controls. Since coronary heart disease remains the leading cause of death for the Medicare population, reductions in all-cause mortality and cardiovascular mortality are extremely important health outcomes. With specific interventions that targeted cardiac risk factors, a reduction in the progression of coronary heart disease to cardiovascular endpoints is likely the main contributor to the reduction in overall mortality. Zeng further noted that "[c]ardiac and non-cardiac hospitalization rates were lower in participants than controls in each program and were statistically significant in MBMI (P<.01)." While specific hospital diagnoses were not reported, the need for coronary artery bypass surgery may have been reduced as well, and a specific presentation of bypass hospitalizations would be informative. In a report submitted directly to CMS, Shepard noted that "Cox regression models of mortality showed that after controlling for gender, qualifying event, and age at enrollment, the MBMI program reduced the death hazard among the participants compared to the non-CR control group." While not fully published in a peer-reviewed journal, the report by Shepard is important supportive evidence since it was exclusively focused on the Medicare population.

Statistically significant reduction in 5 or more of the following measures: (1) low density lipoprotein (LDL); (2) triglycerides (TG); (3) body mass index (BMI); (4) systolic blood pressure (SBP); (5) diastolic blood pressure (DBP); and (6) the need for cholesterol (CHL), blood pressure (BP), and diabetes medications (DM).

Two reports (Casey, 2009; Dusek, 2008) that were published in peer-reviewed journals provided evidence on statistically significant reductions in cardiac risk factors (five or more of the above measures). One additional report (Shepard, 2009) provided supportive evidence. These are summarized in the table below:

Based upon evidence published in the peer-reviewed medical literature, the Benson-Henry Institute Cardiac Wellness Program meets the requirements set forth in MIPPA 2008 for an ICR program. Including this program as a covered ICR program will increase access to ICR services for Medicare beneficiaries.

Disparities

Participants in the reviewed studies and reports on the Benson-Henry Institute Cardiac Wellness Program were predominately white (87% - 94%). CMS encourages representative participation in all ICR programs and recommends that ICR programs actively recruit minority beneficiaries.

Summary

The CMS found evidence in recent peer-reviewed medical literature that supported a lower mortality rate of participants in the Benson-Henry Institute Cardiac Wellness Program. Coronary heart disease remains the leading cause of death for Medicare beneficiaries, and reductions in all-cause mortality and cardiovascular mortality are very important health outcomes. Interventions that target cardiac risk factors and leads to a reduction in the progression of coronary heart disease to cardiovascular endpoints will likely lead to the reduction in overall mortality of Medicare beneficiaries. We believe the available evidence is sufficient to support expanding the ICR benefit to include the Benson-Henry Institute Cardiac Wellness Program.

IX. Conclusion

The CMS has determined that the evidence reviewed is satisfactory to conclude that expanding the ICR benefit to include the Benson-Henry Institute Cardiac Wellness Program, meets the ICR program requirements as set forth by Congress in §1861(eee)(4)(A) of the Social Security Act and in our regulations at 42 C.F.R. §410.49(c).

20.31 - Intensive Cardiac Rehabilitation (ICR) Programs

Casey A, Chang BH, Huddleston J, Virani N, Benson H, Dusek JA. A model for integrating a mind/body approach to cardiac rehabilitation: outcomes and correlators. J Cardiopulm Rehabil Prev. 2009 Jul-Aug;29(4):230-8. PMID: 19451830.

Dusek JA, Hibberd PL, Buczynski B, Chang BH, Dusek KC, Johnston JM, Wohlhueter AL, Benson H, Zusman RM. Stress management versus lifestyle modification on systolic hypertension and medication elimination: a randomized trial. J Altern Complement Med. 2008 Mar;14(2):129-38. PMID: 18315510.

O'Connor CM, Whellan DJ, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE, Kitzman DW, Blumenthal JA, Rendall DS, Miller NH, Fleg JL, Schulman KA, McKelvie RS, Zannad F, Piña IL; HF-ACTION Investigators. Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA. 2009 Apr 8;301(14):1439-50. doi: 10.1001/jama.2009.454.

Shepard DS, Stason WB, Strickler GK, Lee AJ, Bhalotra SM, Ritter, GA, Suaya JA, Gurewich D, Fournier S, Zeng W, Razavi SM, Hurley CL. Executive Summary: Evaluation of Lifestyle Modification and Cardiac Rehabilitation in Medicare Beneficiaries. Schneider Institutes for Health Policy, Heller School, MS 035, Brandeis University, Waltham, MA 02454-9110. April 30, 2009. Available at: http://www.cms.gov/Medicare/Demonstration-Projects/DemoProjectsEvalRpts/Medicare-Demonstrations-Items/CMS1192588.html

Stason WB, Shepard DS, Fournier S, Ritter G, Strickler GK, Bhalotra SM, Suaya JA. Effects of the Medicare Lifestyle Modification Program Demonstration on Cardiac Risk and Quality of Life. Appendix A.3 of the Evaluation of Lifestyle Modification and Cardiac Rehabilitation in Medicare Beneficiaries. Schneider Institutes for Health Policy Heller School, MS 035, Brandeis University Waltham, MA 02454-9110 USA. April 15, 2009. Available at: http://www.cms.gov/Medicare/Demonstration-Projects/DemoProjectsEvalRpts/Medicare-Demonstrations-Items/CMS1192588.html

Zeng W, Stason WB, Fournier S, Razavi M, Ritter G, Strickler GK, Bhalotra SM, Shepard DS. Benefits and costs of intensive lifestyle modification programs for symptomatic coronary disease in Medicare beneficiaries. Am Heart J. 2013 May;165(5):785-92. PMID: 23622916.