CMS Agrees to Cover TAVR for FDA-Approved Use

The Centers for Medicare and Medicaid Services (CMS) has formally decided to cover transcatheter aortic valve replacement (TAVR). Specific details that were released online May 1, 2012, largely echo the agency’s proposal from February 2012, with a few notable exceptions.

In a press release issued jointly with the Society of Thoracic Surgeons, American College of Cardiology (ACC) president William A. Zoghbi, MD, of The Methodist Hospital (Houston, TX), said the organization “commends CMS on its decision and its comprehensive approach to the introduction of TAVR. This means that this transformative technology will be available to Medicare patients who do not have other options for treating severe, debilitating aortic stenosis.”

The decision by CMS balances patient access to TAVR with measures that ensure the procedure is carried out by qualified operators and hospitals, Dr. Zoghbi said, adding, “The ACC hopes this [national coverage determination] proves to be a successful model for providing rapid access to promising new technologies for Medicare beneficiaries while focusing on patient safety, quality care and outcome.”

Only 6 months ago, the US Food and Drug Administration (FDA) approved the Sapien device (Edwards Lifesciences, Irvine, CA) for use in patients with severe symptomatic aortic stenosis who are not surgical candidates.

Decision Emphasizes Cooperation, Experience

CMS stipulates in the recent decision that “TAVR is covered for the treatment of symptomatic aortic valve stenosis when furnished according to an FDA approved indication,” and when certain conditions are met. Importantly, stenosis is no longer qualified with the word “severe.”

The 5 conditions for coverage are:

• TAVR should be performed using a complete valve and implantation system that has received premarket approval for its indication
• TAVR should take place in a facility using a ‘heart team’ approach with adequate experience in both interventional and surgical procedures, varying according to whether the center has previously participated in a premarket approval clinical trial. (Updates include more emphasis on the specialists who should comprise the team; interdisciplinary collaboration, hospital infrastructure including on-site surgical back-up a range of noninvasive imaging technologies, and intensive care facilities with experience in managing patients who have undergone open-heart valve procedures; and hospital volume of diagnostic catheterization and PCI)
• Two cardiac surgeons should evaluate the patient’s suitability for open surgery. (The current document specifies that the exam should take place “face-to-face” and that the clinicians document their rationale for the ‘heart team’)
• Procedure should be carried out by physicians who have specific qualifications and experience levels, which differ for surgeons and interventionalists. (The coverage decision now requires each interventionalist to  have a lifetime experience of 100 structural heart disease procedures or annual volume of 30 left-sided structural procedures, with 60% being balloon aortic valvuloplasty and not including ASD or PFO closure)
• Patient and treating physician team should be enrolled in a prospective, audited national registry. (Follow-up is now only mandated for at least 1 year, whereas the proposal had suggested at least 5 years)

In addition, “TAVR is covered for uses that are not expressly listed as an FDA-approved indication when performed within a clinical study” that fulfills certain requirements, the CMS document notes.

Much hinges on the phrase “FDA-approved indication,” as the agency’s Circulatory System Devices Panel will be meeting on June 13, 2012. The panel plans to discuss a premarket approval application for the Edwards Sapien device “in patients with symptomatic severe aortic stenosis who have high operative risk,” according to an FDA notice.

More information about the CMS proposal, subsequent decision, and public comment period can be found online.

 

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Source:
Centers for Medicare and Medicaid Services. Decision memo for Transcatheter Aortic Valve Replacement (TAVR). http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=257&ver=4&NcaName=Transcatheter+Aortic+Valve+Replacement+%28TAVR%29&bc=ACAAAAAAIAAA& 2. Published on May 1, 2012. Accessed on May 4, 2012.

 

Related Stories:

• CMS Publishes Proposed TAVR Coverage Conditions
• Expert Consensus Document on TAVR Provides ‘Roadmap’ for Clinicians
• FDA Approves Sapien Transcatheter Valve for Inoperable Aortic Stenosis

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