Practice Trends                                                                                                                     RHEUMATOLOGY NEWS •  March 2005
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                    Medicare May Cover Diet, Lifestyle Programs
                             BY JOYCE FRIEDEN                       coronary artery disease and compared             of the effect we’re observing is simply re-     the Ornish program for heart disease pre-
                           Associate Editor, Practice Trends        them with 139 controls. Although no pa-          gression to the mean?” he asked.                vention in 2002. 
                                                                    tients in the intervention group had had a         Dr. Ornish admitted that there was              More than 400 patients, average age 56,
                    BALTIMORE — There might not have                recent cardiac event, 55% had had a prior        some regression but added, “there is a di-      have participated, with a 90% completion
                    been thunderous applause at last month’s        myocardial infarction, compared with 28%         rect correlation between degree of ad-          rate, Mr. Lambert said. “They collective-
                    meeting of the Medicare Coverage Advi-          of controls.                                     herence and outcomes at 1 year.”                ly reduced their risk of a cardiac event by
                    sory Committee, but the quiet approval             The researchers found that after 3 years,       Adherence was a concern for several           50% as measured by the ATP Framingham
                    was quite enough for Dean Ornish, M.D.          77% of intervention patients who met in-         panel members who wondered whether              risk tool, and lowered their LDL by 21%.” 
                       The committee, which advises Medicare        surance company criteria to undergo by-          patients could really keep up with strict         He noted that the average cost of the be-
                    on coverage issues, voted to recommend          pass or angioplasty were able to avoid it,       regimens such as Dr. Ornish’s.                  havioral management program was $5,700,
                    that Medicare cover the use of physician-       saving Mutual of Omaha $30,000 per pa-             But Dr. Ornish said he was merely ask-        compared with the average cost of heart
                    supervised intensive diet and lifestyle         tient, Dr. Ornish reported.                      ing for these types of programs to be treat-    surgery, which ranges from $57,000 to
                    change programs for preventing and re-             He admitted that his program requires a       ed the same way as other interventions.         $67,000. “By avoiding one procedure, it pays
                    versing heart disease—programs such as          lot of commit-                                                                                   for 10 members to complete the program.”
                    the one developed by Dr. Ornish.                ment. For the                                                                                      The committee also heard from Alex
                       “I’m pleased by the opportunity to have      first few months,                                                                                Clark, Ph.D., of the University of Alber-
                    all the evidence considered,” he said after     participants at-                                                                                 ta’s Centre for Health Evidence in Ed-
                    the panel approved the recommendation,          tend two 4-hour                                                                                  monton. The Centers for Medicare and
                    adding that he hoped that the evidence          sessions, each                                                                                   Medicaid Services contracted with Dr.
                    was compelling enough for Medicare to           consisting of ex-                                                                                Clark’s center to review outcomes studies
                    make this type of lifestyle intervention a      ercise, medita-                                                                                  for patients with symptomatic coronary
                    part of its benefits package.                   tion or other                                                                                    artery disease undergoing one of three
                       Medicare is not obligated to accept the      stress reduction,                                                                                types of therapy: cardiac rehabilitation
                    recommendation of its advisory commit-          a support group                                                                                  (group education and counseling only),
                    tee.                                            meeting, and a                                                                                   comprehensive cardiac rehabilitation
                       Dr. Ornish, president of the Preventive      lunch/lecture.                                                                                   (such as Dr. Ornish’s program, which in-
                    Medicine Research Institute, Sausalito,         Later, they de-                                                                                  cludes exercise in addition to group edu-
                    Calif., outlined his program, which con-        crease to once-                                                                                  cation and counseling), and individual
                    sists of putting patients on a very low-fat     weekly sessions,                                                                               EEcounseling. All studies had to have out-
                    diet (about 10% fat), getting them on a         but continue for                                                                               E. Lcomes for at least 50 patients to be in-
                    moderate exercise program, teaching             9 months.                                                                                        cluded in the review. 
                    them stress management techniques such             In a payment                                                                                IVIANThe reviewers found that all three types
                                                                                                                                                                   V
                    as stretching and meditation, and enrolling     demonstration        Many insurers pay for statins even though patients go off the               of programs had some long-term benefits,
                    them in support groups.                         project for drugs after a few months, Dr. Dean Ornish noted at the meeting.                      including reductions in mortality and hos-
                       In a 1-year study of 28 patients who         Medicare, Dr.                                                                                    pitalization, and improved quality of life,
                    took part in the program and 20 controls,       Ornish found that patients’ body weight            “We will pay for bypass surgery and an-       Dr. Clark said. “The foundation for change
                    he found that the average percentage di-        decreased both at 12 weeks and at 1 year.        gioplasty, but diet and lifestyle interven-     is happening at 12 months.”
                    ameter stenosis regressed from 40% to              He noted that the primary determinant         tions, Medicare generally doesn’t pay for         Information on program costs was
                    37.8% in the experimental group, com-           of how much patients improved on the             it,” he said, adding that many insurers pay     sketchier, he noted. Only 6 out of 41 stud-
                    pared with an average progression from          program was adherence. “The more peo-            for cholesterol-lowering statin drugs even      ies mentioned costs, and three of those
                    42.7% to 46.1% in the control group.            ple changed, the better they got,” he said.      though studies have shown that patients         “reported or implied” cost savings without
                       In addition, there was a 91% reduction          Advisory committee members ex-                go off the drugs after a few months be-         giving any relevant data. Most of the stud-
                    in angina in the intervention group, com-       pressed several concerns about Dr. Or-           cause they don’t like the side effects.         ies were heavy on male participants, with
                    pared with a 165% increase in the control       nish’s results.                                    Also testifying were spokesmen from           seven studies having no women at all.
                    group.                                             Clifford Goodman, Ph.D., a senior sci-        two Blue Cross Blue Shield plans—Moun-            In the end, panel members generally
                       Dr. Ornish also investigated whether         entist with the Lewin Group, a Falls             tain State in West Virginia and Highmark        agreed that the Ornish program and sim-
                    other providers could be trained to im-         Church, Va., consulting firm, noted that         in Pennsylvania—that pay patients to en-        ilar interventions improved patients’ long-
                    plement his program, so he set up demon-        some of the improvements in the patient          roll in the Ornish program. Both said           term survival rates and quality of life, but
                    stration projects in other sites with more      groups started to reverse slightly after a       their plans were happy with the clinical        they were less certain that other providers
                    than 2,000 patients.                            year, and speculated that many patients          outcomes and the cost savings.                  would be able to successfully implement
                       In the first project, funded by Mutual of    may be self-selecting for the program at a         David Lambert, vice president of health       the program and that it could be easily
                    Omaha, the researchers studied 194 pa-          time when their weight and other negative        services for Mountain State Blue Cross          translated to Medicare patients, many of
                    tients with angiographically documented         indicators are at their peak. “How much          Blue Shield, said his plan began covering       whom have multiple chronic illnesses. ■
                    Benefit of Heart Failure Disease Management Scrutinized
                                      BY BRUCE JANCIN                               savings. According to our study, those promises may be           recommendations was left to the physician’s discretion.
                                            Denver Bureau                           empty,” said Dr. Galbreath, vice chairman for clinical pro-        Patients randomized to disease management survived
                                                                                    grams in the department of medicine at the University            an average of 76 days longer than controls over the course
                    NEW ORLEANS — Participation in a disease man-                   of Texas, San Antonio.                                           of 18 months of follow-up. However, their performance
                    agement program for heart failure resulted in a moder-             Prior studies which concluded that disease management         on a standard 6-minute walking test wasn’t significantly
                    ate survival benefit but no objective improvement in func-      programs are both clinically effective and cost-effective were   better than that of controls, and neither was their mean
                    tional capacity, no reduction in health care utilization, and   small, nonrandomized, and/or based upon relatively ho-           left ventricular ejection fraction. The disease management
                    no cost savings in the largest and most rigorous study to       mogeneous HMO populations.                                       program did not reduce hospitalizations, office or ER vis-
                    date of any disease management program.                            Recognition of these deficiencies provided the impetus        its, procedures, or medications.
                       The lack of demonstrable cost savings is a key finding.      for the South Texas Congestive Heart Failure Disease Man-          Subgroup analysis suggested the survival benefit was
                    Disease management is a trendy public policy issue now,         agement Project, in which 1,069 patients with systolic or        greatest in patients with New York Heart Association class
                    with Medicare and many state Medicaid programs ac-              diastolic heart failure were randomized 2:1 to a disease man-    III and IV systolic heart failure. But even in these patients
                    tively pushing disease management programs for de-              agement program or usual care and followed for 18 months,        with more severe heart failure, disease management did
                    pression, diabetes, and other chronic diseases as a means       she explained.                                                   not result in economic savings.
                    of saving money, Autumn Dawn Galbreath, M.D., ob-                  Subjects in the disease management group were assigned          “If you factor in the cost of having to pay for the dis-
                    served at the annual scientific sessions of the American        a nurse case manager who provided in-depth patient edu-          ease management services, disease management actual-
                    Heart Association.                                              cation and recommended medication changes in accord              ly costs money over and above the cost of traditional
                       “There’s a great deal of money being spent on disease        with national heart failure guidelines to the patient’s pri-     care,” Dr. Galbreath said. The investigators plan to ana-
                    management at this time in anticipation of promised cost        mary care physician, although whether or not to follow the       lyze the data further to obtain cost-benefit ratios.       ■