Medicare TAVR Coverage: Will CMS Expand Access for Millions of Seniors?

Medicare is expected to announce a coverage decision by June 15 regarding transcatheter aortic valve replacement (TAVR). This decision could end 14 years of restrictive “Coverage with Evidence Development” (CED) requirements that have limited access for millions of seniors to this less-invasive heart procedure.

TAVR allows interventional cardiologists to replace a failing heart valve via a catheter, avoiding the need for open-heart surgery. According to the provided data, the procedure allows for quicker recovery and reduces first-year health care costs for taxpayers and Medicare by approximately $10,000 per patient.

Why is the TAVR coverage decision significant?

For 14 years, the Centers for Medicare & Medicaid Services (CMS) has restricted TAVR access using CED policies. Under these rules, Medicare denies coverage for FDA-approved treatments unless beneficiaries participate in limited clinical trials or studies.

These policies impose strict rules on which hospitals and doctors can participate. This has constrained care for millions of beneficiaries annually, as CMS has applied similar CED policies to over 30 treatments for conditions like sickle cell disease and certain cancers.

Did You Know? An estimated 2.5 million people over the age of 75 suffer from aortic stenosis, a common heart valve disease that can be fatal within five weeks once symptoms appear if left untreated.

How did professional societies influence TAVR access?

Health policy experts contend that the Society for Thoracic Surgeons (STS) and the American College of Cardiology (ACC) played an outsized role in shaping TAVR coverage. Joe Grogan, a Nonresident Senior Scholar at the USC Schaeffer Institute, notes that TAVR represented an “existential threat” to thoracic surgeons who previously dominated the open-heart surgery business.

In 2012, these societies advocated for burdensome requirements. These include mandatory separate face-to-face appointments with both a surgeon and cardiologist and a rule that surgeons must be paid to be present during the procedure, even if an interventional cardiologist performs it.

Additionally, hospitals must enroll in the STS-ACC TVT clinical study registry. This involves a $25,000 setup fee and $10,500 annual fee per facility, totaling roughly $9 million in annual fees across 860 qualified sites.

Expert Insight: Samantha Carter suggests that the TAVR case highlights a systemic tension between the desire for rigorous clinical data and the necessity of equitable patient access. When professional societies influence coverage mandates, the resulting financial barriers can inadvertently prioritize data collection over the immediate health needs of vulnerable populations.

What are the financial and human costs of these restrictions?

The financial burden of registry fees often prevents smaller community and rural hospitals from offering TAVR. Consequently, patients in rural areas are underrepresented and often cannot access the procedure near their homes.

Alliance for Aging Research Urges Patients to Contact CMS as It Reconsiders TAVR Coverage

Delayed treatment carries severe risks. Research from the USC Schaeffer Center indicates that patients treated more than 90 days after diagnosis face a 50% higher risk of death over three years and nearly $37,000 in additional health care costs.

Even at qualified TAVR hospitals, the CED requirements add an average of 59 days to the timeline between a patient’s diagnosis and their treatment.

What may happen next for Medicare beneficiaries?

CMS may decide to eliminate the CED requirements, which would align TAVR coverage with that of open-heart surgery. A poll of 1,000 U.S. adults by the Alliance for Aging Research found that 77% agree Medicare should cover TAVR the same way it covers open-heart surgery.

Kelly Cleary, Partner at Akin, suggests that continuing the CED may be difficult to justify legally. She argues that after 14 years, more than 25 clinical trials, and over 1 million patients in the registry, there is sufficient evidence that TAVR is reasonable and necessary.

If CMS maintains the CED, the STS and ACC may continue to receive registry fees, while patients may continue to face delays. However, a shift toward broader access could potentially reduce taxpayer costs and improve survival rates for rural seniors.

Frequently Asked Questions

What is TAVR and why is it preferred?

Transcatheter aortic valve replacement (TAVR) is a less-invasive procedure to replace a heart valve. It is preferred because it avoids open-heart surgery, allows for quicker recovery, and reduces first-year costs by about $10,000 per patient.

What is “Coverage with Evidence Development” (CED)?

CED is a policy used by CMS to deny coverage for newer, FDA-approved treatments unless the patient participates in limited clinical trials or studies. It also places strict rules on qualifying doctors and hospitals.

How does the CED policy affect rural patients?

Because the policy requires hospitals to pay significant registry fees—$25,000 for setup and $10,500 annually—smaller rural hospitals often cannot afford to participate, limiting patient access to the procedure in those areas.

Do you believe clinical data requirements should ever outweigh immediate patient access to FDA-approved treatments?