Sometimes a well-intended policy has unintended consequences. Such is the case with a Medicare approach known as “Coverage with Evidence Development.”
The Centers for Medicare and Medicaid Services applies the designation to a handful of medical devices, medications and procedures. Under the Coverage with Evidence Development program, patients can access those treatments only if they join a patient registry or participate in a clinical trial. Facilities, meanwhile, can offer the treatments only if they pass clinical trial requirements.
The agency hoped the program would promote patient access while allowing CMS to collect further data. In reality, however, Coverage with Evidence Development and registry requirements create new barriers for patients and health care providers alike.
Barriers and Paperwork, but Few Results
A total of 27 treatments and services have been designated for Coverage with Evidence Development, meaning clinicians face complicated start-up tasks before they can offer a treatment. Clinicians must engage a research sponsor to collect clinical trial data, enduring institutional review, and creating complex reporting and governance protocols.
The administrative and financial barriers are often impossible for small practices or lower-resourced providers to navigate, making marginalized patients even less likely to get cutting-edge care. And communities of color, including Black Americans, may be less likely to participate in clinical trials.
Restrictions related to Alzheimer’s have drawn particular scrutiny. For instance, in 2023, the FDA approved a drug, lecanemab, to treat Alzheimer’s disease. In trial, the drug was observed to slow the rate of cognitive decline by 27%. Under Medicare, however, patients and providers must participate in a Coverage with Evidence Development registry to access the treatment.
The added requirement is particularly problematic for patients and their caregivers, for whom the burden of disease already makes daily life difficult. Meanwhile, another recently approved Alzheimer’s medication is subject to a clinical trials requirement due to Coverage with Evidence Development.
Registries “Compromise Treatment,” One Physician Says
Even patients who eventually get to try a treatment covered through Coverage with Evidence Development, treatment may suffer from the lengthy process, physicians say.
“The biggest problem with a registry is the ability to access timely care,” says Darlene Dunay, DO, a primary care physician in Pennsylvania. “By the time a patient has enrolled in a registry, the disease has often progressed from mild to moderate and is out of the range of treatability.”
“Registries compromise treatment,” she summarizes.
Revisiting Coverage with Evidence Development
Last year, the Centers for Medicare and Medicaid Services issued a new proposal, and began collecting comments.
Ten years have elapsed since the last guidance. In that time, substantial shortcomings with the program have been uncovered, including uncompleted studies, limited access to data and a lack of independent evaluation. Only four products have graduated from Coverage with Evidence Development to full coverage, despite in some cases years of data collection. For the rest, the required registries or clinical trials remain a barrier to access for patients and researchers alike.
Coverage with Evidence Development was implemented to make novel treatments available to patients while still collecting data on efficacy. Today, however, it’s clear the policy severely limits timely access for patients who need treatment.
