The evidentiary bar for Medicare reimbursement of new interventions, including imaging technologies, has risen over the past decade, making coverage more restrictive, according to an article published in this month’s Health Affairs.
The authors, including James. D. Chambers, PhD, MPharm, MSc, with Tufts Medical Center in Boston, examined which big-ticket medical services and procedures were paid for by Medicare after noting that recent trends have suggested coverage for new medical interventions is difficult to come by.
“In this article we address the question of whether obtaining coverage for new medical interventions is becoming harder,” the authors wrote. “We focus on Medicare, the largest public health insurance program in the United States, whose coverage policies are thought to influence those of private payers.”
The researchers studied CMS coverage data from 1999 through 2012 and developed data sets to investigate whether CMS’s coverage of interventions has become more restrictive.
“We selected characteristics that CMS considers in its decision making (clinical trials and reviews of the clinical evidence base) and other characteristics that contribute to decision making (input from the public and from professional societies and clinical guidelines), as presented in decision memos for national coverage determinations,” Chambers and colleagues wrote.
The data set contained 213 decisions culled from the 13-year study period. Of these, there were 126 positive decisions, 74 noncoverage decisions and 13 coverage with evidence development policies.
“Compared with medical interventions evaluated during the first quartile, the coverage odds for interventions evaluated during the most recent quartile was approximately twenty times less likely to be positive,” the authors found.
The findings, Chambers et al concluded, were that the evidentiary bar for medical intervention coverage had risen. Medicare coverage had grown more restrictive over the study period.
They offered several reasons for Medicare coverage being more difficult to achieve. They include:
- A quest for efficiency;
- Increasing restrictiveness; and
- Coverage with evidence development.
“CMS faces the challenging task of striking an appropriate balance among affected parties: patients, industry, and taxpayers,” Chambers and colleagues wrote. "The goal should be to set evidence requirements to meet the 'reasonable and necessary' criterion and improve patient outcomes, but also to ensure that requirements are not so burdensome as to discourage future innovation.”
The authors cautioned that improving healthcare and patient outcomes depends on new, innovative medical interventions, and that by making it more difficult to gain coverage, manufacturers might be less willing to risk the cost of developing and testing new treatments that could impact the industry.