Data reviewed by the Centers for Medicaid and Medicare Services to inform Medicare coverage decisions reflect significantly different populations from the Medicare population, a recent analysis has shown.
The Medicare Evidence Development and Coverage Advisory Committee (MedCAC) reviews the literature described in a technology assessment and votes on the evidence to determine the health benefit of the procedure or device, wrote Sanket S. Dhruva and Dr. Rita F. Redberg, both of the University of California, San Francisco, which, along with the Robert Wood Johnson Foundation, provided support for the study. Dr. Redberg is a member of MedCAC, but had no financial conflicts of interest.
To examine whether the data used by MedCAC was generalizable to the Medicare population, Mr. Dhruva and Dr. Redberg looked at all six MedCAC decisions involving a cardiovascular product or service and analyzed the sample size, demographics, inclusion criteria, study location, and outcome stratification of the relevant technology assessments. The data included 141 peer-reviewed reports and 40,009 patients (Arch. Intern. Med. 2008;168:136-40).
Participants in the technology assessments had a mean age of 61 versus a mean age of 72 for Medicare beneficiaries. Several trials excluded older patients, but “the mean age in studies with explicit age exclusions (59.0 years) and those without such exclusions (61 years) did not differ,” the authors wrote. Also, overall, 75.4% were men, versus 44% of Medicare beneficiaries.
Clinical trial location also differed. Of 135 studies that reported location, 37% took place at least partly in the United States. However, most (51%) were done in Europe, 9% in Asia, and 7% in other locations. Overall, 40% of the technology assessment study participants were U.S. residents, compared with 100% of the Medicare population.
In addition, many of the trials excluded patients with renal insufficiency, arrhythmias, and diabetes.
The study concluded that the data used by MedCAC “are derived from populations that differ significantly from the Medicare beneficiary population in terms of age, sex, country of residence, and comorbid conditions.” Trial patients are “younger, healthier, male, non-U.S. populations,” with a “persistent underrepresentation of women and elderly” in clinical trials in general, the authors noted.
The authors suggested all future studies include demographic data, as “the accuracy and risk-benefit profiles of many diagnostic tests and therapies differ substantially by age and often by sex.” They also suggested the CMS require data on women and the elderly, or for the CMS to issue coverage decisions dependent on the addition of subgroup data within a specified period of time.
The population from which MedCAC draws its data differs from the Medicare population in age, sex, and health. DR. REDBERG