It's a quintessential government outcome. A program intended to increase access to promising medical innovations is actually preventing Medicare beneficiaries from receiving FDA-approved treatments. Medicare’s “coverage with evidence development” (CED) was never authorized by Congress. Instead, the Centers for Medicare & Medicaid Services created the program in 2005 by leveraging its authority to determine which medical technologies patients can access.
This is a tragedy playing out for people with Alzheimer’s disease. In a landmark decision, FDA just approved a new blood test that will make it much easier to diagnose the condition. But unless CED is removed, people with an Alzheimer’s diagnosis will be discouraged and even prevented from benefiting from medicines that can slow the disease and help them live longer with more independence. This regulatory overreach needs to be reversed.
CED’s original purpose was to help patients access new medical devices that were demonstrating promising potential. But its scope has expanded over time and now applies to medicines that the FDA has already approved as safe and efficacious, making it a duplicative safety and efficacy burden.
According to the Partnership to Fight Chronic Disease, following CMS’ designation that a medicine must be subjected to the CED process, it can take up to two years to fulfill the regulatory requirements and enroll the first patient in the trial. This process can include up to 30 additional requirements that must be fulfilled, including selecting a study governance, seeking CMS approval, and establishing an institutional review board. Throughout this two-year period, no Medicare patients can access the medicines, which the FDA has already approved as safe and efficacious.
A study conducted by Cencora surveyed healthcare providers’ experience with the program, and the results were not flattering: “…the CED restriction overcomplicated the process and led to additional steps on top of an already burdensome insurance process that included additional paperwork and time spent away from direct patient care. Many said they lack the resources needed to manage the additional burden of this process. Healthcare providers also thought the CED restrictions would prolong the time it took for patients to get treatment and would restrict patient access.”
These concerns are well founded. By definition of the trial format, medicines subject to CED are not widely available. They can only be dispensed to beneficiaries in the approved health facilities participating in the CED study. These approved settings tend to be in urban settings that impose even greater access restrictions for patients living in rural areas, low-income communities, and communities of color.
In a survey conducted for a CED established for a heart valve treatment – transcatheter aortic value replacement, TAVR – 36% of rural adults aged 65 and older found “it difficult to access large city hospitals. These individuals reported that appointment availability, insurance coverage, distance of travel, wait times, and cost of travel are the top barriers to accessing large city hospitals for treatment.” The same survey also showed that most patients served by the CED hospitals (78%) were from “higher income zip codes”.
Similar barriers now exist for Alzheimer’s drugs despite the large burden and progressive nature of the disease. An estimated 6 million Americans are living with Alzheimer’s, which imposes $360 billion in annual care costs. And according to Us Against Alzheimer’s, “African Americans are twice as likely as non-Hispanic whites to develop Alzheimer’s disease and Latinos are 1.5 times as likely.”
New FDA approved medicines exist that can help slow the progression of the disease, but only if the disease is caught early. Despite these realities, CMS took the unprecedented step of covering FDA-approved Alzheimer’s therapies only under CED with additional clinical study. In 2023, under public pressure the agency changed policy to remove the clinical trial requirement. But instead of allowing full coverage, it only reimburses physicians for patients enrolled in a registry.
Top neurologists at leading academic medical centers argued that this administrative burden carried unnecessary costs that would effectively discourage physicians and qualified patients from utilizing new therapies. Infusion centers, which often administer treatment in suburban and rural areas, similarly argued that the registry created problems that undermined support for patients seeking treatment.
In the Cencora study cited above, 74% of dementia specialists were aware of CMS’ CED for amyloid PET scans, an important tool for diagnosing Alzheimer’s disease and administering FDA-approved therapies—but only 12% participated. In another study, Spherix Global Insights surveyed 75 neurologists in October 2023 and found that it took more than 45 minutes to complete the CMS registry and other related requirements. This is a problem for rural patients with Alzheimer’s disease, who are more likely to be diagnosed and treated exclusively by a primary care physician with limited time and staff resources. The survey also found that two of every five patients deemed eligible for treatment were not prescribed therapy because they could not obtain Medicare or other insurance approvals.
As many as 3,000 people transition from mild to moderate Alzheimer’s every day, which means the opportunity for these medicines to help these people has been severely diminished due to these unnecessary regulatory delays. CED’s original intention to expand patients’ access to promising medical technologies made sense. In practice, the program creates unnecessary administrative burdens that impede patients from accessing innovative medicines. The lost access imposes irreversible and unnecessary harm on patients and makes a mockery of the oath to first do no harm.
