麻豆传媒

Centers for Medicare and Medicaid Services (CMS) opened up for public comments on transcatheter aortic valve replacement (TAVR) procedural volume requirements for hospitals and heart team members as it revamps the National Coverage Determination (NCD).

The 30-day public comment period opened June 27, ahead of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) panel to convene on July 25.

In particular, panel members will in whether such programs even merit procedural volume requirements anymore.

"The MEDAC will specifically focus on appraisal of the state of evidence for surgical aortic valve replacement (SAVR), TAVR, percutaneous coronary intervention (PCI) and other relevant structural heart disease procedural volume requirements," according to the of the meeting.

Another topic of discussion will be the possibility that hospital volume requirements create unintentional barriers to TAVR for patients from certain geographic locations and socioeconomic backgrounds.

In the , the TAVR volume requirements include:

• 50 total aortic valve replacements (AVRs) in the prior year for a hospital to start a TAVR program
• At least 20 AVRs per year or 40 AVRs every 2 years to maintain an existing program
• 1,000 catheterizations annually to start or maintain a TAVR program
• A cardiovascular surgeon with at least 100 career AVRs, 25 AVRs in 1 year, or 50 AVRs in 2 years to start a program
• To maintain a program, a cardiovascular surgeon and an interventional cardiologist need a combined experience of at least 20 TAVR procedures in the prior year or 40 in the prior 2 years

TAVR centers must also participate in a national prospective registry, according to the current NCD. Another stipulation is that off-label TAVR procedures be performed in clinical studies that meet certain requirements and are approved by CMS.

More and more patients are expected to become candidates for TAVR as it becomes seen as acceptable for younger, lower-risk individuals. For example, Both Sapien 3 and Evolut TAVR valves were approved by the FDA for intermediate-risk patients in 2017.

"As we move forward, our priority will be on assuring that the NCD provides all people with heart valve disease with access to all treatment options, enabling patients to choose the right treatment at the right time. We look forward to continuing to engage with CMS and other stakeholders in the finalization of this important policy, which will define the future of heart valve patients' access to this life-saving care," said a from Edwards Lifesciences, the maker of Sapien valves.

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