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As transcatheter aortic valve replacement (TAVR) marked the 20th anniversary this year of the , it also reached its 10th anniversary of coverage by CMS.

But despite the randomized trials proving utility in individuals at prohibitive, high, intermediate, and now low surgical risk, the technology remains under the of National Coverage Determinations with Data Collection as a Condition of Coverage (CED).

As the dominant payer for TAVR, still requires operators and facilities to participate in a prospective, national, audited registry -- the Transcatheter Valve Therapy (TVT) registry, created through a collaboration between the Society of Thoracic Surgeons (STS) and the American College of Cardiology.

"By law, at some point in time, when there's been enough evidence generated, then coverage with evidence development needs to sunset," noted Michael Mack, MD, of the Baylor Scott & White Health System in Plano, Texas, and past president of the STS.

CMS guidance states only that evidence produced through the CED registry after approval "will lead to revisions to Medicare coverage policies." CED decisions have no specific or transparent timeline for coverage reconsideration by CMS, noted a recent by Emily Zeitler, MD, MHS, of Dartmouth Hitchcock Medical Center in Lebanon, New Hampshire, and colleagues. Case in point: of the 27 CED decisions issued by CMS since the category was created in 2006, four have had retired data collection requirements after anywhere from 4 to 12 years.

"It seems as though we have enough evidence now, I would argue," said Manesh Patel, MD, of Duke University in Durham, North Carolina, and chair of the American Heart Association Diagnostic and Interventional Cath Committee.

The review tended to agree with Patel, saying that TAVR has all the characteristics of "those that have had data collection requirements retired, but CED requirements remain in place."

And that comes at a price for the healthcare system, which bears the administrative load of collecting and reporting all the data. Enrollment alone for the TVT registry ran $25,000 in 2019, atop the staff hours and other tangible costs.

"Sites view this as a significant burden," Mack noted, pointing to discussion at a Transcatheter Cardiovascular Therapeutics meeting this fall.

In fact, a of the program found that 30% of the 27 CED determinations from 2005 to 2022 were in the cardiovascular space.

"A lot of facilities and physicians would like the choice, not the mandate," said Patel. "You're asking sites to collect data and to input data, and nobody's really saying, 'OK, we're gonna give you extra money to do this.'"

Why Keep CED for TAVR?

Center stage in the argument for keeping the CED requirement is the value of evidence generated by the TVT registry.

"It's amazing database in terms of long-term follow-up with quality of life data, which is so incredibly important in this population," said Suzanne Arnold, MD, MHA, of the University of Missouri-Kansas City, who has done research with the TVT registry. That it includes quality of life via the Kansas City Cardiomyopathy Questionnaire and 1-year follow-up "was incredibly important ... Is there any other procedure that requires that? I don't think so."

And "as long as it is required, I think we're gaining incredible information about safety and outcomes," agreed B. Hadley Wilson, MD, of Sanger Heart & Vascular Institute in Charlotte, North Carolina, and president-elect of the American College of Cardiology. "I actually think there is good support for that to continue as it is."

Arnold told 麻豆传媒 that while "a lot of the key questions have been answered from a reimbursement perspective, in that TAVR does improve quality of life and does improve mortality, I think that that there are still questions in terms of the lowest-risk patients, the patients who are relatively asymptomatic; what is the role of TAVR in those patients? And so, perhaps there are some some questions that you could say CMS is still interested in."

Mack agreed: "I think the position here has been that there is a constant need for new evidence being generated by newer generation devices, expansion to smaller centers, valve-in-valve applications, function in minority populations, that there still is sufficiently valuable evidence being generated, that CED should continue. I have not heard from any quarters, anybody calling for CED to end."

What Might Change Mean?

Even though the coverage decision and evidence generated have been good for the field, "there will be some point where the therapy is mature enough to where that's not going to be required," Patel acknowledged.

And that's a likelihood the registry organizers have anticipated.

"One of the working principles of the TVT registry has always been CED will sunset at some point," Mack said. The question the leadership has pondered, he said, is "How do we create the value proposition that sites still feel that this is a value to them, and they will continue to participate and put cases in it?"

Historically, registry inclusion has dropped off after Medicare stops requiring it.

For example, one of the first devices that fell under CED was implantable cardioverter-defibrillator (ICD) implantation for primary prevention of sudden cardiac death.

In that case, Zeitler's review noted, "data collection for this registry was never systematically incorporated into clinical workflow. As such, substantial burden was shouldered by participating groups."

When that CED ended after more than 12 years, participation in the "just plummeted because sites didn't see the value of continued participation," Mack said. "That lesson has kind of been learned."

On the other hand, there are examples like percutaneous coronary intervention where there is good participation in registries even after the CED ended, Patel noted. "So whether or not that mandate is needed, I think one of the things the professional and the field should continue to do is to embrace the fact that we watch our quality by participating in these."

Other Ways Forward

One route to provide continued value in registry participation -- not only for physicians but also hospitals and health systems -- would be to make it part of certification for accreditation as centers of excellence or a quality grade for other voluntary programs, Wilson agreed.

Already, "a huge boost to the registry has been U.S. News & World Report rankings," Mack said. "You get extra credit if you publicly report your TVT registry outcomes. Hospitals are crawling all over each other to rise up the rankings, and nobody wants to lose that."

And ways to simplify the reporting process are being pursued, Mack noted. Some 50% of the data might be able to be auto-populated from the electronic medical record, and it might be possible to have a vendor follow up with patients so sites don't have to do it directly, he added.

Another possibility might be to have a network with a limited number of sites that could be incentivized to serve as the post-market surveillance "sentinels" in lieu of all sites across the country doing so, he suggested.

And then there's the potential of a path like that for ventricular support devices. When it came time to sunset the CED for that after 10 years, Mack noted, CMS worked with the Joint Commission so one of its requirements for -- which is a requirement for Medicare reimbursement -- is participation in a national registry. "So it was a way to kind of end-run the CED sun-setting," he said.

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