How CED Limits Access to Treatments for Conditions Like Severe Aortic Stenosis

Under CED policies, Medicare denies coverage for newer, FDA-approved treatments except when beneficiaries participate in limited clinical trials or other studies. Medicare also places strict rules on which doctors and hospitals qualify to participate in the CED studies, which further constrain access.

Since 2005, when Medicare created CED, more than 30 treatments and tests for certain cancers, hearing loss, early Alzheimer’s and heart valve disease, among other conditions, have been limited by CED policies. Such CED policies often lag behind current clinical guidelines from professional medical societies, interfere with doctor’s recommendations and override patient preferences.

For example, an estimated 2.5 million people over the age of 75 have aortic stenosis, one of the most common types of heart valve disease. Left untreated, it can progress rapidly and unpredictably to severe AS. It is estimated that 1 in 10 patients experiencing severe AS symptoms may die within five weeks.

There are two main treatment options for severe AS, and both focus on replacing the damaged valve. The first is open-heart surgery, which involves cutting through the breastbone to directly access the heart. The second is transcatheter aortic valve replacement, a minimally invasive procedure that uses a catheter inserted into a patient’s artery to guide and replace the heart valve using advanced imaging techniques.

When the FDA first approved TAVR in 2011, it was an important advancement for older adults with severe, symptomatic aortic stenosis who needed their valves replaced but were too ill or frail to withstand open-chest surgery.

By 2017, TAVR became the clinical standard of care for most patients with symptomatic, severe AS, supported by robust randomized trial data and reflected in professional society guidelines soon thereafter.

Despite this clear professional society consensus nearly 10 years ago, Medicare coverage for TAVR has remained subject to CED since 2012.

New Hope for Aortic Stenosis Patients

After significant pressure from the patient advocacy community, there is some good news: Medicare is finally reconsidering whether to continue CED for TAVR, with an expected decision this June.

Continued innovation since the TAVR CED started in 2012 is forcing the debate. Research in the October 2024 New England Journal of Medicine study found that treating severe AS patients with TAVR prior to experiencing any symptoms lowered risk of death, stroke or unplanned hospitalization for cardiovascular outcomes compared with those who had routine clinical surveillance (also known as “watchful waiting”).

The FDA approved TAVR to treat asymptomatic AS in May 2025, and patients have been facing inconsistent Medicare coverage as they wait for the program to make its decision.

According to Karissa Charles, executive director of Heart Valve Voice-US, Medicare beneficiaries are done waiting for fair access to TAVR: “You’d think that the hardest part of giving our valued older generation more time would be developing science, not accessing it. It's time for Medicare to look at this policy and ensure that it no longer acts as a barrier to healthy aging."

This incongruence is starkly reflected in patient access. In 2019, the CED registry reported that only 72,991 patients received TAVR. That may sound like a high level of access, but a 2017 article in the American Heart Association Journal, Circulation: Cardiovascular Quality and Outcomes, found that only 31% of U.S. patients potentially eligible for TAVR had been treated with the procedure.

Not surprisingly, TAVR access issues hit patients who live in underserved communities the hardest. Research on TAVR access inequalities from February 2026 found that areas with lower-than-expected TAVR utilization due to CED coverage restrictions are not just experiencing access gaps, but also significantly higher rates of death.

“The current TAVR CED requirements prevent equal access to a preferred, less invasive treatment option — including shorter hospital stays and recovery times, better quality of life measures, and lower incidence of some major complications across all surgical risk levels,” said Dr. Aaron Horne, co-chair of the Structural Heart Disease Task Force Program for the Association of Black Cardiologists. “After 14 years of CED, Medicare needs to make this right for all eligible patients.”

Heart Valve Voice-US and ABC are two organizations of dozens representing patients, health professionals and family caregivers that have called for an end to Medicare CED policies more broadly over many years. During the first Trump administration, then-Health and Human Services General Counsel Robert Charrow issued an Advisory Opinion that labeled Medicare’s basis for claiming legal authority for imposing CED “fundamentally inconsistent” with regulatory definitions, and he stated that such limits were “unlawful.”

“Medicare is a payer; it is not the FDA or anyone’s family doctor,” said Celina Gorre, CEO of WomenHeart. “The use of CED for TAVR and other treatments is arbitrarily restrictive for Medicare beneficiaries and has had a negative influence on private insurance utilization management practices. If Medicare doesn’t end CED, Congress should step in.”