Medicare may revise its 14‑year Coverage With Evidence Development (CED) rules for TAVR by June 15. Critics argue CED’s registry mandates, dual specialist visits, surgeon‑in‑room payments, and hospital volume thresholds add cost, delay care (about 59 days on average), and limit access—especially in rural areas. Registry evidence and dozens of trials now suggest initial volume‑based rationales are outdated, and public polling shows strong support for expanding Medicare coverage for TAVR.
Why Medicare’s 14-Year TAVR Rules Matter — And Why They May Change by June 15
For 14 years, patient access to TAVR has been restricted for Medicare beneficiaries under a Coverage with Evidence Development requirement by CMS. This could change by June 15.shefkate - stock.adobe.com
By June 15, Medicare is expected to announce whether it will revise long-standing Coverage With Evidence Development (CED) rules that limit beneficiary access to transcatheter aortic valve replacement (TAVR), a less-invasive alternative to open‑heart valve surgery. Advocates say the change could improve access for millions of older Americans, speed treatment, and reduce first‑year Medicare spending by about $10,000 per patient.
How Medicare’s CED Policy Has Restricted Access
Since 2012, CMS has required that most Medicare beneficiaries receiving TAVR enroll in narrowly defined studies or registries and meet a set of programmatic requirements. These include mandatory enrollment in the STS‑ACC TVT registry, separate in‑person consultations with both a surgeon and a cardiologist, surgeon presence payments during the procedure, and minimum hospital procedural volumes. Together, these rules raise costs for hospitals, create administrative burdens, and can delay care.
Who Sets The Rules—and Why It Matters
Professional societies—the Society for Thoracic Surgeons (STS) and the American College of Cardiology (ACC)—helped design the specific CED conditions for TAVR and jointly govern the TVT registry. Critics and health policy experts argue that the societies' influence reflects not only clinical judgment but also professional and financial interests as practice patterns shifted from surgery to catheter-based care.
“The response by the thoracic surgery and cardiology specialty societies to these shifting tides has been to join forces on Medicare coverage determinations for new technologies like TAVR,” says Joe Grogan, Nonresident Senior Scholar at the USC Schaeffer Institute.
Costs, Fees, and Transparency Concerns
The TVT registry charges roughly $25,000 for a hospital to set up and about $10,500 per year to participate. With approximately 860 qualifying sites, those facility fees amount to roughly $9 million annually—before counting revenue from device makers and researchers who pay for data access. Smaller community and rural hospitals often cannot absorb these costs, limiting local access to TAVR.
Although CMS relies on registry data when shaping coverage policy, the agency does not have direct access to the raw TVT data and has limited enforcement power to ensure CED research questions are answered and results are publicly reported. The most recent aggregate registry report was published six years ago and covers data only through 2019, raising transparency concerns about how evidence informs policy.
Evidence Versus Ongoing Restrictions
TAVR has an extensive evidence base: more than 25 clinical trials, registry data covering over 1 million patients, and thousands of published articles. Analyses of TVT data show outcomes have improved across all center sizes and that initial procedural‑volume justifications for limiting which hospitals could offer TAVR are no longer strongly supported by the evidence.
Human Costs: Delays and Unequal Access
The administrative and financial burdens of CED affect patients, especially those in rural or low‑resource areas. USC Schaeffer Center research finds rural patients are underrepresented at TAVR centers. Delays matter: patients treated more than 90 days after diagnosis face about a 50% higher risk of death over three years and incur roughly $37,000 in additional health‑care costs compared with patients treated promptly. On average, CED requirements add about 59 days to the time between diagnosis and treatment.
Public Reaction and Policy Questions
Public polling by the Alliance for Aging Research found that 77% of respondents favor Medicare covering TAVR the same way it covers open‑heart surgery, and 67% said they would be more likely to support a candidate who broadens Medicare access to TAVR.
“Can CMS plausibly say that after 14 years of evidence development there is still insufficient evidence that TAVR is reasonable and necessary for Medicare coverage purposes?” asks Kelly Cleary, former CMS chief legal officer. She and others argue that continued restrictions are increasingly difficult to justify legally and ethically when waits force patients to delay an FDA‑approved treatment their clinicians recommend.
What’s Next
The upcoming Medicare decision will test whether long‑running CED requirements should remain in place for a widely adopted and well‑studied therapy. If CMS removes or relaxes those conditions, it could broaden access, reduce delays, and ease financial and operational burdens on hospitals—particularly smaller and rural programs. The final decision will shape how Medicare balances continued evidence collection with timely access to proven therapies.
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